Examination Guidelines forPatent Applications at IPOS

These Guidelines will be updated at regular intervals to take account of recent developments includingchanges in the law and judicial decisions. They are based on IPOS’ interpretation of the currently
applicable law and practice of patents. These Guidelines should not be used as a set of legal
requirements, and should not be taken as a substitute for any legislation or case law or as a conclusive
view of the law.
It follows that no update can ever claim to be complete. Any feedback from readers drawing attention
to errors as well as suggestions for improvement will be greatly appreciated and this may be sent by email to: operations@iposinternational.com.
These Guidelines refer to the Singapore Patents Act and Rules with effect from 26th May 2022.

REVISION HISTORY
VersionDescription of revisions

Release dateFeb 2014

First version.

14 Feb 2014

Apr 2015

Addition of Chapter 9 relating to Supplementary
Examination.

16 Apr 2015

May 2016

Revision to Chapter 8, Section A in relation to Patentable
Subject Matter.

16 May 2016

Apr 2017

Revisions to Chapters 1-9 to improve clarity.

20 Apr 2017

Expansion of Chapter 8, Sections C, D and E in relation
to Methods of medical treatment, Medical use andMorality respectively.
Addition of Chapter 10 relating to Examination Review.
Revisions to all Chapters to refer to the Patents Act andRules with effect from 14th Feb 2014.
Oct 2017

Revisions to Chapters 3 and 9 in view of legislative
amendments relating to Grace period and to
Supplementary Examination.

30 Oct 2017

Revision to Chapter 8, Section A in relation to Patentable
Subject Matter (Isolated natural materials).
Revision to Chapter 7, Section E in relation to
Allowability of post-grant amendments.

Apr 2019

Revision to Chapter 8, Section A in relation to Patentable
Subject Matter for Artificial intelligence and machinelearning methods.
Revisions to Chapters 2, 3, 5, 8 and 9 to clarify specificareas of guidance, including Grace period, Conciseness ofclaims and Claim relatedness.

26 Apr 2019

Mar 2020

Revisions to Chapters 2, 3, 5, 6, 7 and 8 to clarify specific 26 Mar 2020
areas of guidance.
Main revisions relate to Validity of priority claims,
Examination where there is a lack of unity andUndisclosed disclaimers.

Oct 2021

Revisions to Chapter 3, Section B and Chapter 9, Section
H in relation to Third party observations.

1 Oct 2021

Addition of Chapter 11 relating to Ex-parte Reexamination.
IPOS logo updated and re-released on 1 Nov 2021.
Jun 2022

Addition of Chapter 5, Section M and Chapter 7, Section
B, sub-section iii in view of legislative amendments
relating to Sequence listing and Invitation to amend.

2 Jun 2022

Revisions to Chapters 6 and 10 in view of legislative
amendments relating to Examination where there are 2 ormore inventions and Examination review.
Revisions to Chapters 2 and 8 to clarify specific areas of
guidance.
Oct 2023

Revision to Chapter 7, Section K in relation to
Corrections in view of [2022] SGHC 164.
Revision to Chapter 6, Section I in relation to Double
patenting. Addition of Chapter 8, Section D, sub-section
iv in relation to Antibodies.
Revisions to Chapters 2, 3, 5, 6, 7, 8 and 9 to clarify
specific areas of guidance.
Updated all Chapters to refer to the provision numberingsin the 2020 Revised Edition of the Patents Act.
Revisions made to the previous version (Jun 2022
version) are denoted by vertical bars in the left margin.
Page numbers and paragraph numbers have been updated
accordingly.

11 Oct 2023

TABLE OF CONTENTS
1.

2.

INTRODUCTION .......................................................................................................... 1
A.

Statutory requirements ............................................................................................ 1

B.

Standard of proof .................................................................................................... 2

CONSTRUING THE SPECIFICATION AND CLAIMS .......................................... 5A.

Background ............................................................................................................. 5

B.

Scope of the patented invention .............................................................................. 6

C.

Purposive construction to be used in examination .................................................. 7

D.

The person skilled in the art .................................................................................. 11E.

The common general knowledge .......................................................................... 13

F.

Guide to construction ............................................................................................ 17
Special meanings ......................................................................................... 19ii.

Avoid importing gloss or re-drafting claims ............................................... 21iii.

Independent and dependent claims .............................................................. 22

iv.

Open- and closed-ended terms .................................................................... 25v.

Reference numbers in claims....................................................................... 26

vi.

“Use of … in …” claims.............................................................................. 27

vii.

“Product for …” claims and “Method for …” claims, etc........................... 28

viii. Product-by-process claims........................................................................... 32

3.

ix.

Claims to process using a known apparatus ................................................ 34x.

Alternatives/Markush claims ....................................................................... 35

NOVELTY .................................................................................................................... 36
A.

Statutory requirements .......................................................................................... 36

B.

Raising new prior art ............................................................................................. 38i.

Third party observations .............................................................................. 40

C.

Prior disclosure ..................................................................................................... 43

D.

Enablement............................................................................................................ 46

E.

Publication ............................................................................................................ 47

F.

Implicit disclosure ................................................................................................. 50

G.

“Inherent” disclosure............................................................................................. 51

H.

Errors in citations .................................................................................................. 53

I.

Anticipation by specific disclosure ....................................................................... 55

J.

Anticipation of ranges ........................................................................................... 56

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K.

Anticipation of parametric claims ......................................................................... 58

L.

Anticipation of “for” and “use” claims ................................................................. 59

M.

Prior use ................................................................................................................ 63

N.

Prior art under Section 14(3) ................................................................................. 66

O.

Priority dates ......................................................................................................... 68

P.

Exceptions to novelty: grace period ...................................................................... 77
Learned society ............................................................................................ 84

4.

INVENTIVE STEP ...................................................................................................... 86A.

Statutory requirements .......................................................................................... 86

B.

General principles ................................................................................................. 87C.

Avoiding hindsight: the test for inventive step ..................................................... 91

D.

The “Windsurfing test” ......................................................................................... 92

E.

The modified “Windsurfing test”: the “Pozzoli” approach .................................. 94

F.

The inventive concept ........................................................................................... 95G.

The starting point for the inventive step consideration ......................................... 98

H.

Combining disclosures (“mosaicing”) for inventive step ................................... 101

I.

Is the invention obvious? .................................................................................... 104“Lying in the Road”................................................................................... 107
ii.

Workshop variation ................................................................................... 109

iii.

Commercial success and long-felt want .................................................... 111

iv.

“So obvious” .............................................................................................. 115v.

Technical prejudice.................................................................................... 116

vi.

Overcoming practical difficulties .............................................................. 118

vii.

Advantages of the invention ...................................................................... 119

viii. Selection inventions................................................................................... 120

5.

ix.

Why was it not done before? ..................................................................... 122

x.

Obvious to try ............................................................................................ 123

THE APPLICATION................................................................................................. 125
A.

Statutory requirements ........................................................................................ 125

B.

Number of claims (Rule 19(6)) and numbering of claims (Rule 19(6A)) .......... 126

C.

Invention shall be defined in technical terms (Rule 19(7)) ................................. 128

D.

Claims drafted in two-part form or as a single sentence (Rule 19(8)) ................ 129

E.

Omnibus claims (Rule 19(9)) .............................................................................. 130

F.

Sufficiency of disclosure (Section 25(4) and Section 25(5)(c)) ......................... 131

G.

Deposit of Micro-organisms ............................................................................... 135

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H.

Claims shall define the matter for which protection is sought (Section 25(5)(a))............................................................................................................................. 137

I.

Clarity and conciseness of claims (Section 25(5)(b)) ......................................... 138
Indefinite terms .......................................................................................... 139
ii.

Relative terms ............................................................................................ 140

iii.

“Preferred” and “optional” definitions ...................................................... 141

iv.

Lack of antecedent ..................................................................................... 143v.

Ranges ....................................................................................................... 144

vi.

Compositions with only one ingredient ..................................................... 147

vii.

Multiple alternatives .................................................................................. 148

viii. Inconsistencies between claims and description ....................................... 149

J.

ix.

Conciseness ............................................................................................... 151

x.

Definition by reference to (or use with) another entity ............................. 152

Claims shall be supported by description (Section 25(5)(c)) .............................. 153
Mere coincidence of language is not sufficient ......................................... 155ii.

The technical contribution ......................................................................... 156

iii.

The enablement requirement ..................................................................... 158

iv.

Inconsistencies – essential features ........................................................... 161v.

Claims by result ......................................................................................... 163

vi.

Features defined by function ..................................................................... 165

vii.

Parametric claims ...................................................................................... 166

viii. Reach-through claims ................................................................................ 168
K.

Disclosure of the invention ................................................................................. 170
Enabling disclosure ................................................................................... 170

6.

ii.

The role of the skilled person .................................................................... 172

iii.

Description must be clear .......................................................................... 175

iv.

Reference to prior art ................................................................................. 176v.

Trademarks and industry standards ........................................................... 177

L.

The abstract ......................................................................................................... 178

M.

Sequence listing .................................................................................................. 180

UNITY OF INVENTION .......................................................................................... 182
A.

Statutory requirements ........................................................................................ 182

B.

Approach for determining lack of unity in Singapore ........................................ 184

C.

General principles ............................................................................................... 186

D.

Assessment of unity of invention ........................................................................ 188
i.

Lack of unity a priori ................................................................................ 188

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7.

ii.

Lack of unity a posteriori .......................................................................... 190

iii.

Avoid literal or over-technical approaches ................................................ 193

iv.

Claims that are unduly complex ................................................................ 196

v.

Combinations of claims of different categories or of interrelated products................................................................................................................... 199

vi.

Markush claims ......................................................................................... 202

vii.

Intermediate and final products ................................................................. 206

E.

Biotechnology examples ..................................................................................... 208

F.

ICT examples ...................................................................................................... 210

G.

Search and examination of additional inventions ............................................... 212

H.

Divisional applications (Section 26(11)/Rule 27) ............................................... 216

I.

Double patenting (Rule 46(1)(f)) ........................................................................ 218

AMENDMENTS AND CORRECTIONS ................................................................ 224
A.

Statutory requirements ........................................................................................ 224

B.

General power to amend before grant ................................................................. 226
General process for amendments before grant .......................................... 227
ii.

Amendments made in response to written opinions (Rule 46(3)) ............. 229

iii.

Amendments made in response to an invitation to amend (Rule 46AA) .. 231

C.

Allowability of pre-grant amendments (Section 84(3)) ...................................... 233

D.

General power to amend after grant (Section 38) ............................................... 234
General process for amendments after grant (Rule 52) ............................. 235

E.

Allowability of post-grant amendments (Section 84(4)) .................................... 236

F.

Consideration of PCT amendments in the national phase (Section 86(5)) ......... 241

G.

Allowability of PCT amendments in the national phase..................................... 243

H.

Added matter in divisional applications (Section 84(1)) .................................... 245

I.

Added matter in applications having declared a priority due to later filed
description (Section 84(2)).................................................................................. 246

J.

The test for added subject matter ........................................................................ 247
Basis of the consideration: the application as filed ................................... 249
ii.

Incorporation by reference......................................................................... 250

iii.

Comparing disclosures: clearly and unambiguously disclosed ................. 252

iv.

Express and implicit disclosures................................................................ 254

v.

Matter which extends beyond the original disclosure ............................... 256

vi.

Data submitted after the filing date ........................................................... 257

vii.

Intermediate generalisation........................................................................ 258

viii. Generic disclosure as a basis for amendment to a specific feature ........... 261

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K.

ix.

Addition and deletion of features .............................................................. 262

x.

Ranges ....................................................................................................... 264

xi.

Disclaimers ................................................................................................ 265

Corrections (Section 107) ................................................................................... 270
The “two-step test” .................................................................................... 272
Errors in translations .................................................................................. 278

8.

PATENTABLE SUBJECT MATTER AND INDUSTRIAL APPLICABILITY . 279
A.

Statutory requirements ........................................................................................ 279
Discoveries ................................................................................................ 282

B.

ii.

Scientific theories and mathematical methods .......................................... 285

iii.

Aesthetic creations: literary, dramatic, musical or artistic works.............. 288

iv.

Schemes, rules or methods for performing a mental act, playing a game ordoing business ........................................................................................... 289

v.

Presentation of information ....................................................................... 290

Industrial applicability ........................................................................................ 291
Subject matter contrary to established physical laws ................................ 292

C.

Methods of medical treatment............................................................................. 293
Therapy ...................................................................................................... 295

D.

ii.

Claims to both therapeutic and non-therapeutic methods ......................... 297

iii.

Surgery ...................................................................................................... 299

iv.

Some specific examples of therapeutic/surgical and non-therapeutic/
surgical methods ........................................................................................ 304

v.

Diagnosis ................................................................................................... 315

Medical use ......................................................................................................... 321
First medical use ........................................................................................ 321

E.

ii.

Second medical use ................................................................................... 329

iii.

Devices ...................................................................................................... 355

iv.

Antibodies.................................................................................................. 357

Morality ............................................................................................................... 358
Methods of human cloning, generation of human embryos and human stem
cell lines ..................................................................................................... 361
ii.

Genetically modified organisms ................................................................ 365

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9.

SUPPLEMENTARY EXAMINATION ................................................................... 367
A.

Overview of supplementary examination ........................................................... 367

B.

General process ................................................................................................... 370

C.

Requirements under Section 29(1)(d) ................................................................. 372

D.

i.

Prescribed documents for a corresponding or related Application............ 373

ii.

Prescribed documents for a PCT Application ........................................... 374

iii.

Certified copies .......................................................................................... 375

iv.

Translations ............................................................................................... 376

v.

Prescribed offices ...................................................................................... 377

vi.

Final results ............................................................................................... 378

Corresponding applications................................................................................. 380
Corresponding applications: Divisional applications ................................ 381
ii.

Corresponding applications: PCT national phase applications ................. 382

E.

Related national phase applications .................................................................... 383

F.

Corresponding international applications ........................................................... 384

G.

PCT applications entering the national phase in Singapore ................................ 385

H.

Grounds for examination .................................................................................... 386
Claim relatedness ....................................................................................... 389
ii.

Medical use claims .................................................................................... 394

iii.

Third party observations ............................................................................ 396

I.

Responding to written opinions .......................................................................... 397

J.

Annex .................................................................................................................. 398
i.

Corresponding applications ....................................................................... 398

i(a). Corresponding applications: Divisional applications ................................ 400
i(b). Corresponding applications: PCT national phase applications ................. 406

10.

ii.

Related national phase applications ........................................................... 409

iii.

Corresponding international applications .................................................. 411

iv.

PCT application entering the national phase in Singapore ........................ 414

EXAMINATION REVIEW....................................................................................... 415
A.

Overview of examination review ........................................................................ 415

B.

General process ................................................................................................... 417

C.

Unresolved objections ......................................................................................... 419

D.

Examination review report .................................................................................. 421

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11.

EX PARTE RE-EXAMINATION ............................................................................ 424
A.

General process ................................................................................................... 424

B.

Acceptance of re-examination request ................................................................ 427

C.

Grounds for re-examination ................................................................................ 429
Written opinion and re-examination report ......................................................... 431
Request for interview under Rule 52A(5) ................................................. 434
Conclusion of the re-examination process .......................................................... 435

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1.

INTRODUCTION

A.

Statutory requirements

1.1

Upon receiving a request from the applicant for a search and examination or an
examination under Section 29, Rule 2A(1)1 sets out the matters to be determined by an
Examiner when conducting an examination are, inter alia —(a)whether, taking into consideration all the relevant prior art, if any, that the
Examiner is aware of or that has been discovered in a search —(i)each claim of the invention disclosed in the application satisfies eachcondition or requirement for patentability under section 13;(ii)

the conditions specified in section 25(4) and (5) have been compliedwith;(iii) the application discloses any additional matter referred to in section
84(1) or (2) or any matter referred to in section 84(3);…
(d)

whether there is —(i)any other application for a patent for the same invention, with the samepriority date, filed by the same applicant or his successor in title; and(ii)

any earlier grant of a patent for the same invention, with the samepriority date, to the same applicant or his successor in title.

1.2

The Guidelines aims to provide the Examiner with a better understanding to theapplication of the Patents Act and Rules during the course of their work.

1

In the Patents Act with effect immediately before 14/02/2014, the matters to be determined during an
examination were prescribed in Section 29.

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B.

Standard of proof

1.3

While the Patents Act and Rules set out the requirements for patentability, there is no
legislative standard of proof set out in the Act for applicants to meet these requirements.
In this regard, legal precedent in the UK may provide some guidance for Examiners in
Singapore.

1.4

The standard of proof for patentability in the UK was recently considered by Floyd J in
the UK Patents Court (Blacklight Power Inc v The Comptroller-General of Patents[2008] EWHC 2763 (Pat)). Floyd J reviewed the authorities (Fujitsu’s Application[1996] RPC 511, Macrossan’s Application [2006] EWHC 705 which was heard on
appeal together with Aerotel’s Application [2007] RPC 7). These were cases related topatentable subject matter, but Floyd J considered they were applicable more broadly.
He stated that:“I think that the effect of these authorities is as follows. It is not the law that any
doubt, however small, on an issue of fact would force the Comptroller to allow theapplication to proceed to grant. Rather he should examine the material before him
and attempt to come to a conclusion on the balance of probabilities. If he considers
that there is a substantial doubt about an issue of fact which could lead topatentability at that stage, he should consider whether there is a reasonable
prospect that matters will turn out differently if the matter is fully investigated at atrial. If so he should allow the application to proceed.”

1.5

He went on to detail the approach that an Examiner should take:“The examiner will first raise an objection and put it to the applicant. The applicant
then has an opportunity of persuading the Comptroller that his basis forconsidering that the objection applies is not sound. If the applicant does not
persuade him to withdraw the objection he may refuse the application... But at thatstage he should consider whether, because there is a substantial doubt about anissue of fact, there is a reasonable prospect that matters may turn out differently ata trial, when there will be a full exploration of the matter with the benefit of expert
evidence. If there is such a reasonable prospect he should allow the matter toproceed to grant. It goes without saying that mere optimism and a reasonable

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prospect of matters turning out differently are not the same thing. The reasonable
prospect must be based on credible material before the Office… Moreover thegreater has been the opportunity for the applicant to produce such material at theapplication stage, the smaller scope there is for supposing that giving him thebenefit of the doubt will lead to a different conclusion.”
1.6

Thus Examiners should consider the material before them on the balance of
probabilities. If there is a fact in contention, the Examiner should consider whether there
is a reasonable prospect that the matters may turn out differently at a trial, when there
will be a full exploration of the matter with the benefit of expert evidence. Thus, forexample, there would be little prospect of success that an applicant would be able toproduce evidence that a perpetual motion machine could operate in the real world, andon that basis an objection would be maintained.

1.7

However, questions as to the common general knowledge in a particular area may beless clear cut and a full consideration with the benefit of expert evidence may give areasonable prospect of a different outcome. Indeed in Martek Biosciences Corporationv Cargill International Trading Pte Ltd [2012] SGHC 35, the Court cautioned against a
Tribunal making decisions in the absence of clear evidence on the common generalknowledge:“… the basis upon which the Tribunal arrived at the conclusion that claim 1 lacked
inventive step was an assertion that it would have been obvious to a skilled reader
to combine different features of the various prior art. With respect the Tribunal
erred in doing so. The Tribunal did not possess the expertise to determine for itself,
on the face of the prior art and the Patent, whether the invention would have been
obvious to a skilled reader without any basis in evidence as to what a skilled reader
would have known or understood. The test of whether a claim involves an inventive
step is premised on the viewpoint of the skilled reader.”1.8This of course does not absolve applicants from their onus of providing the Examiner
with compelling submissions, or indeed evidence that addresses an objection. An
objection that is soundly based in the principles of inventive step and where the
Examiner has construed the documents according to the established law is likely to only

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be overcome by evidence from the applicant addressing the objection, rather than by anargument as to the Examiner lacking evidence of the common general knowledge.

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2.

CONSTRUING THE SPECIFICATION AND
CLAIMSA.

Background

2.1

The patent when granted will only confer protection on the invention as defined by theclaims, but the claims are interpreted in light of the description and drawings.
Construction of claims is pivotal to any consideration of infringement and validity andto almost every aspect of examination including novelty, inventive step, searching of
the claim and claim amendments.

2.2

In order to provide certainty for the public and patentees, there should be consistentconstruction of the claims of a patent specification, irrespective of the subject matter athand. In an examination context, this might mean that the Examiner should avoid
construing terms broadly for the purpose of novelty but narrowly for the purpose of
support. In a broader perspective this means that the claims should be interpreted in thesame way for both infringement and validity considerations.

2.3

From a practical point, Examiners may find the following tips helpful when construinga patent document:

2.4

(a)

Read the claims before the description.

(b)Draw the invention from the definition given in the claims.

(c)Consult with other Examiners.

These techniques will particularly help to avoid introducing any “gloss” from thedescription and drawings (that is, reading limitations from the description and drawings
into the claims that are not defined by the language of the claims themselves).

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B.

Scope of the patented invention

2.5

The extent of protection conferred by a patent is set out in Section 113(1) as follows:
For the purposes of this Act, an invention for a patent for which an application has
been made or for which a patent has been granted shall, unless the context
otherwise requires, be taken to be that specified in a claim of the specification of
the application or patent, as the case may be, as interpreted by the description andany drawings contained in that specification, and the extent of the protection
conferred by a patent or application for a patent shall be determined accordingly.

2.6

This provision essentially codifies a “purposive approach” to patent construction as set
out by the House of Lords in Catnic Components Limited v Hill & Smith Limited [1982]
RPC 183, and forbids a purely literal interpretation of the terms used in the claims.

2.7

In Singapore, this provision has been considered by the Court of Appeal in First
Currency Choice Pte Ltd v Main-Line Corporate Holdings Ltd [2008] 1 SLR 335, FE
Global Electronics Pte Ltd v Trek Technology (Singapore) Pte Ltd [2006] 1 SLR 874,
Bean Innovations Ltd v Flexon Ltd [2001] 3 SLR 121 and Genelabs Diagnostics Pte
Ltd v Institut Pasteur & Anor [2001] 1 SLR 121. In each decision, the Courts haveadopted a purposive approach.

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C.

Purposive construction to be used in examination

2.8

A purposive approach should always be adopted during the course of examination.
Claim construction is a matter of law, and construction is not concerned with what thepatentee himself actually meant to say. The patent should be construed in order todetermine what the person skilled in the art would have understood the patentee to meanby using the language of the claims.

2.9

It is a convention in infringement and validity actions neither the patentee nor witnesses
are consulted on that matter (British Celanese v Courtaulds [1935] 52 RPC 171 at 196).
The specification is fixed in time and cannot be subject to the possibility that thepatentee might change their mind about what he meant by the words he used.

2.10This was also noted by the Court of Appeal in First Currency Choice Pte Ltd v MainLine Corporate Holdings Ltd [2008] 1 SLR 335. As set out by the Court of Appeal, thestarting point of construction is what the person skilled in the art would have understood
the patentee to mean by the use of the language of the claims. In this regard the Courtof Appeal cited Lord Hoffmann in Kirin-Amgen v Hoechst Marion Roussel [2005] RPC
9 and further guidance can be taken from this UK decision.

2.11

Construction is therefore objective in as much as it is concerned with what the person
skilled in the art would have understood the patentee to mean by the words he used. The
specification is to be read through the eyes of the person skilled in the art attempting togive it practical meaning (Ratiophram v Alza [2009] EWHC 213). Wherever possible
the specification should be construed so as not to lead to a “foolish” result (EMI v Lissen
56 RPC 23).

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2.12

Generally, a document will destroy the novelty of a claim only if it discloses each andevery feature of the claim. If the claim contains equivalent or additional features, thenthe question normally becomes one of obviousness. However, since a patent
specification should be given a purposive construction rather than a purely literal one,the protection conferred may go beyond the literal wording of the claim. One possible
consequence of purposive construction is that a term may be construed to encompass
variants which the person skilled in the art would have realised to have no material
effect upon the way the invention worked, and excluded those which would have beenthought to have a material effect. As held by Lord Diplock in the Catnic Components
Ltd and another v Hill and Smith Ltd [1982] RPC 183, a claim to a lintel having interalia a support member “extending vertically” was held to have been infringed byotherwise identical lintels in which the support member was 6o or 8o from vertical, since
this produced a negligible reduction in the vertical support provided by the member.
Therefore, depending on the facts of the case, a disclosure comprising only variationsin “unessential” features from the claimed invention may still fall within the scope ofthe claims because the person skilled in the art would have understood the patentee had
intended to claim these variations by using the language in the claim and reading thespecification as a whole.

2.13

Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2005] RPC 9 made it clear that there
is no “doctrine of equivalents” in the UK in the sense that the protection afforded by thepatents cannot extend beyond the claims. The purposive construction approach
therefore combines a fair degree of protection for the patentee with a reasonable degreeof certainty for third parties.

2.14

The purposive construction approach adopted since the Catnic decision was reaffirmedin the case of Improver Corporation v Remington Consumer Products Ltd [1990] FSR
181. The “Improver questions” (subsequently dubbed the “Protocol questions”)
provide a guidance for applying the principle of purposive construction in the context
of equivalents, which can be used when assessing whether or not a variant falls withina claim (Wheatley v Drillsafe Ltd [2001] RPC 7).

2.15

Improver Corporation v Remington Consumer Products Ltd [1990] FSR 181 involved
a consideration of an infringement of claims defining a depilatory (hair removal) device
which comprised a rotating spring. In the opposing device the spring had been replaced

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by a rubber rod that comprised a number of parallel slits. The Court applied thefollowing general questions to the variant:1)

Does the variant have a material effect upon the way the invention works?
If yes, the variant falls outside the claim. If no:2)

Would this fact (i.e., that the variant has no material effect) have been
obvious to the person skilled in the art at the date of publication of the patent?
Or alternatively:
Would this fact solve the problem underlying the invention by means whichhave the same technical effect?
If no, the variant falls outside the claim. If yes:

3)

Would the person skilled in the art nevertheless have understood from thelanguage of the claim that the patentee intended that strict compliance withthe primary meaning was an essential requirement of the invention?
Or alternatively:
Whether it would have been apparent to the person skilled in the art from thewording of the claim that a limitation to exclude the variant could have been
intended by the patentee? If yes, the variant is outside the claim. If no, thenthe variant falls within the scope of the claim.

2.16

The Court determined that the change to a rubber rod had no material effect on the way
the invention worked and it would have been obvious to the person skilled in the art that
this variant would work in the same way. However, the person skilled in the art would
have understood from the patent that the patentee meant to limit the claim to a “helicalspring”. Thus, the variant did not meet the third requirement and was considered as not
infringing the claims.

2.17

However, the Improver/Protocol questions may not be useful in determining the extent
of protection in rapidly-developing, high-technology fields. In these cases, a claim
could, on its proper construction, cover products or processes which involve the use oftechnology unknown at the time the claim was drafted if the person skilled in the art
would have understood the description in a way which was sufficiently general toinclude the new technology.

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2.18

Difficulties in applying the Improver/Protocol questions also occur where there is nocommon understanding of whether a word was being used in a strictly conventional orlooser sense. In Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2005] RPC 9 the Court
cautioned that the Improver questions should only be considered as guidelines for
applying the principle of purposive construction and not as rules for determining thescope of protection – there is only one compulsory question, namely what would aperson skilled in the art have understood the patentee to have used the language of theclaim to mean? In this case there was no suggestion that “an exogenous DNA sequencecoding for erythropoietin” could have some looser meaning to include “an endogenous
DNA sequence coding for erythropoietin”. Rather, the question was whether the person
skilled in the art would have understood the invention as operating at a level ofgenerality which made it irrelevant whether the DNA which coded for erythropoietin
was exogenous or not.

2.19

It should also be noted that in most cases the Improver/Protocol questions are most
relevant in the context of infringement. During examination variants are more likely to
be considered under inventive step.

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D.

The person skilled in the art

2.20

The specification is construed through the eyes of the person skilled in the art and isconsidered as a whole in the light of the surrounding circumstances without reference,as relevant, to an alleged infringement, prior art, documents subsequent to thespecification, etc. (Glaverbel v British Coal [1995] RPC 255). The addressee is taken
to be a person of ordinary skill in the art who possesses the common general knowledge
in the particular art at the earliest validly claimed priority date of the invention.

2.21

In Peng Lian Trading v Contour Optik [2003] 2 SLR 560, the Court referred to theEnglish case of Technograph Printed Circuits Ltd v Mills & Rockley (Electronics) Ltd[1972] RPC 346 which stated that:“… the hypothetical addressee is a skilled technician who is well acquainted withworkshop technique and who has carefully read the relevant literature. He is
supposed to have an unlimited capacity to assimilate the contents of, it may be,scores of specifications but to be incapable of a scintilla of invention.”

2.22

In Institut Pasteur & Anor v Genelabs Diagnostics & Anor [2000] SGHC 53, the Court
referred to various definitions from UK case law:1)

he is not the “mechanician of genius nor… the mechanical idiot”, Van der
Lely NV v Bamfords Ltd [1961] RPC 296;2)

he is “assumed to be of standard competence at his work without being of animaginative or inventive turn of mind”, General Tire & Rubber Co v
Firestone Tyre & Rubber Co Ltd & Ors [1972] RPC 457;

3)

he is “the normally skilled but unimaginative addressee in the art at thepriority date”, Windsurfing International Inc v Tabur Marine (Great Britain)
Ltd [1985] RPC 59;

4)

he is “not the man of inventive imagination who might see straightaway what
was required, but a hypothetical unimaginative technician skilled in theparticular art”.

5)

the person skilled in the art may comprise a team if more than one skill isrequired in the technology where the invention lies.

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2.23

Prakash J in Ng Kok Cheng v Chua Say Tiong [2001] SGHC 143 summed up theessential indicators of a person skilled in the art as a person who:1)

possesses common general knowledge of the subject matter in question;2)

has a practical interest in the subject matter of the patent or is likely to act on
the directions given in it; and3)whilst unimaginative is reasonably intelligent and wishes to make thedirections in the patent work.

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E.

The common general knowledge

2.24

Possession of the common general knowledge in the art is one of the most significant
aspects of the hypothetical person skilled in the art. To a large extent this can be said tobe what characterises the person skilled in the art. In a purposive construction it is thisknowledge that the person skilled in the art uses to construe the specification, and it iswith such a background and context that the person skilled in the art reads the prior art.

2.25

A good description of common general knowledge was given by Laddie J in Bourns Inc
v Raychem Corp [1998] RPC 31:“The common general knowledge is the technical background of the notional[skilled person]… This is not limited to material he has memorised and has at thefront of his mind. It includes all that material in the field he is working in which heknows exists, which he would refer to as a matter of course if he cannot remember
it and which he understands is generally regarded as sufficiently reliable to use asa foundation for further work or to help him understand the pleaded prior art.”

2.26

It is important to distinguish common general knowledge from public knowledge – justbecause something is in the public domain does not make it part of the common generalknowledge. As Laddie J also explained:“This does not mean that everything on the shelf which is capable of being referred
to without difficulty is common general knowledge nor does it mean that every word
in a common text book is either.”

2.27

However, he went on to say that it may be assumed in most cases that standard textbooks
or readily available trade literature may be considered common general knowledge in
the art.

2.28

Sachs LJ (General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd [1972] RPC457) noted that patent documents would not normally be considered common generalknowledge, but if a particular patent is well known or one that skilled persons in aparticular industry would routinely consider, this may not be the case:“The two classes of documents which call for consideration in relation to common

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general knowledge in the instant case were individual patent specifications and‘widely read publications’.
As to the former, it is clear that individual patent specifications and their contents
do not normally form part of the relevant common general knowledge, though there
may be specifications which are so well known amongst those versed in the art thatupon evidence of that state of affairs they form part of such knowledge, and also
there may occasionally be particular industries (such as that of colour
photography) in which the evidence may show that all specifications form part of
the relevant knowledge.”
2.29

In the case of scientific papers, he referred to Luxmoore J in British Acoustic Films[1936] 53 RPC 221:
“In my judgment it is not sufficient to prove common general knowledge that a
particular disclosure is made in an article, or series of articles, in a scientificjournal, no matter how wide the circulation of that journal may be, in the absenceof any evidence that the disclosure is accepted generally by those who are engaged
in the art to which the disclosure relates. A piece of particular knowledge as
disclosed in a scientific paper does not become common general knowledge merely
because it is widely read, and still less because it is widely circulated. Such a pieceof knowledge only becomes general knowledge when it is generally known andaccepted without question by the bulk of those who are engaged in the particular
art; in other words, when it becomes part of their common stock of knowledge
relating to the art.
… It is certainly difficult to appreciate how the use of something which has in fact
never been used in a particular art can ever be held to be common generalknowledge in the art.” [emphasis added]

2.30

The choice of person skilled in the art will depend on the nature of the technology. In
some cases this may mean that the common general knowledge in the field is possessedby relatively few people. For example, in Apimed Medical Honey Ltd v Brightwake Ltd[2011] RPC 16, the invention related to surgical dressings comprising honey and agelling agent. The Court determined that even though there were few people having the

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knowledge of treating wounds with honey, this still formed part of the common generalknowledge in that field.
2.31

However, even if a matter may be well-known to a few, it is not considered part of thecommon general knowledge unless it can be shown to be known to and accepted by thelarge majority of those skilled in the art. In Beloit v Valmet (No.2) [1997] RPC 489
Aldous L J stated that:“It has never been easy to differentiate between common general knowledge andthat which is known by some. It has become particularly difficult with the modern
ability to circulate and retrieve information. Employees of some companies, withthe use of libraries and patent departments, will become aware of information soonafter it is published in a whole variety of documents; whereas others, without such
advantages, may never do so until that information is accepted generally and put
into practice. The notional skilled addressee is the ordinary man who may not havethe advantages that some employees of large companies may have. The information
in a patent specification is addressed to such a man and must contain sufficientdetails for him to understand and apply the invention. It will only lack an inventive
step if it is obvious to such a man.
It follows that providing evidence that a fact is known or even well-known to awitness does not establish that the fact forms part of the common generalknowledge. Neither does it follow that it will form part of the common generalknowledge if it is recorded in a document.”

2.32

In most cases, an assertion that certain information forms part of common generalknowledge should be supported by documentary evidence if it is challenged.
Alternatively, documentary evidence may also be provided in anticipation of such achallenge. As noted above, a description in standard textbooks may provide a strong
indication of being the common general knowledge. It may also be assumed that ascientific paper that is widely cited has entered into the common general knowledge. A
set of industry standards may be considered to be part of the common generalknowledge. It is not expected that the person skilled in the art would know the
information, but rather that he would know where to find the relevant information(Nokia v Ipcom [2010] EWHC 3482). In other cases, an Examiner may assert that a

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document is common general knowledge based on evidence ascertained (for example,
that the document has been published in a widely-read or respected publication, or
where patents would form part of the common stock of knowledge of persons skilled inthat technology). However, evidence to the contrary from the applicant may besufficient to overcome such an assertion.

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F.

Guide to construction

2.33

While the description and claims are to be read together, they serve different functions:the description is intended to convey to the public what the patentee considers is theinvention, and the claims set out the monopoly the patentee has chosen to obtain. These
are not necessarily the same (First Currency v Mainline [2008] 1 SLR 335, citing Laddie
J in Merck & Co. Inc. v Generics (UK) Ltd [2004] RPC 31). To this end, the claims may
be narrower than what is disclosed in the specification, but the claim must never be
broader than what is supported by the specification.

2.34

Each claim should be read giving the words the meaning and scope which they normally
have. However, the everyday meaning of words used in a claim may not be their true
meaning when read in the light either of a definition found elsewhere in the specification
or of technical knowledge possessed by persons skilled in the art (Fabio Perini SPA v
LPC Group plc and others [2010] EWCA Civ 525 and Occlutech GMBH and anr v
AGA Medical Corp. and anr [2010] EWCA Civ 702). Therefore, the claim should also
be read with an attempt to make technical sense of it; such a reading may involve a
departure from the strict, literal meaning of the wording of a claim (see sub-section i ofthis Section on “Special meanings”).

2.35

Prior art references may be useful when construing terms used in a specification. For
example if the specification identifies a particular feature of the prior art as having aproblem that the inventor has overcome, then the terms used in relation to that particularsolution may be construed as excluding the prior art feature. However, even where apurposive approach is taken to construing specifications, if a term in a claim is used ina manner that is inconsistent with the meaning given to it when the specification isconsidered as a whole, then the claim will lack clarity (IGT/Acres Gaming Inc.’sApplication [2008] EWHC 568). In such cases the scope of the claim would be rendered
unclear to the person skilled in the art. As noted in Glaverbel S A v British Coal
Corporation [1995] RPC 255, the claims should be read together with the body of thespecification; but if a claim is expressed in clear language, the monopoly sought cannot
be extended or cut down by reference to the rest of the specification.

2.36

During examination, Examiners should avoid making the claim say something that it
does not say at all, or create ambiguities which do not reasonably exist. Where there is

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a choice between two meanings of a claim, one should, if possible, reject that meaning
which leads to an absurd result in favour of one that works.

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Special meanings
2.37

When interpreting the words in a claim, one should initially assume that the words takethe meanings they would ordinarily have been given by the person skilled in the art at
the time of the invention. If a term is given a special meaning by the author, this needs
to be taken into account (Kirin-Amgen Inc. v Roche Diagnostics GmbH [2002] RPC 1).
A general approach would be to consider:
1)

Does a term in a claim have a plain meaning to the person skilled in the art?

2)

Does the context in which the term is used in the specification change themeaning of the term?

3)
2.38

Does the specification impose a special meaning on the term?

For example, if the claim defines “a crane hook comprising features X, Y and Z”, theplain meaning would impart a particular shape in the form of a hook and certain
limitations on the size of the hook. If the specification provided a special meaning “asused herein the term crane hook is taken to mean a sling hook” then the claim would beinterpreted as being a sling hook and not, for example, a ramshorn hook (a double hookused in cranes for lifting heavy loads). If this special meaning was not given, then theterm would most likely be read as including any type of crane hook, unless, for example,
the person skilled in the art would read the invention as only being a particular type of
crane hook because of the features defined or the context.

2.39

Ideally, if the description provides a special meaning for a particular term, it should beclear from the wording of the claim alone that the term is defined in such a manner.
However, this should only be required where it is considered that a person skilled in theart would need such a definition in the claim. Hence, if the description already clearly
demarcates that a particular term is intended to take on a special meaning, and there is
no ambiguity to the skilled person that the term is used in accordance with said special
meaning throughout the specification, there is no need for the special meaning to be
defined in the claims.

2.40

Where a special meaning is given to a term or phrase by a definition in the description,
the use of a reference, such as the phrase “as hereinbefore defined”, in a claim can
indicate that a particular term is limited to the special meaning. This should not be

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confused with the use of similar phrases in omnibus claims (see Section E in Chapter5), which would not be allowable under Rule 19(9).
2.41

Moreover, it should be clear from the specification that the special meaning given to theterm is the only intended meaning. This will be obvious from phrases such as:“as used herein, the term alkyl means C1 to C5 straight or branched chain alkyl…”.
If the term is defined in a less definite manner then it should not be considered a special
meaning. Some of these non-limiting phrases are:“suitable elastomers include ...”
“the elastomers may be ...”
“The term elastomeric includes but is not limited to ...”

2.42

If a special meaning is indicated in one part of the description but there is departurefrom that meaning in another part, then the special meaning should not be given wheninterpreting the claims.

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ii.

Avoid importing gloss or re-drafting claims

2.43

While the description and claims should be read together also taking into account special
meanings, care should be taken not to import a gloss or rewrite the claims by relying on
the limitations in the description (First Currency v Mainline [2008] 1 SLR 335). This is
not the intention of taking a purposive approach to construction. This was affirmed by
Rubin J in Flexon (Pte) Ltd v Bean Innovations Pte Ltd and another [2000] SGHC 219,
where he cited Lord Russell of Killowen in Electric & Musical Industries, Ltd v Lissen
Ltd [1938] 4 All ER 221 at 227:
“I know of no canon or principle which will justify one in departing from theunambiguous and grammatical meaning of a claim and narrowing or extending its
scope by reading into it words which are not in it, or which will justify one in using
stray phrases in the body of the specification for the purpose of narrowing or
widening the boundaries of the monopoly fixed by the plain words of a claim.”

2.44

For example, if the ordinary meaning of the term “slit” is a long narrow opening, thenit would not be appropriate to read this in a narrower manner based on the embodiments
given in the specification (Fabio Perini SPA v LPC Group plc & others [2010] EWCA
Civ 525). Similarly if the description gives certain preferred ranges or embodiments fora feature in a claim, then these should not be read into the claim (unless they clearly
indicate a special meaning). However, if a term in the claim could only be read to takea particular meaning, then it would be permissible to read the claim more narrowly(Glatt’s Application [1983] RPC 122).

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iii.

Independent and dependent claims

2.45

Claims can either be independent or dependent. Generally an independent claim is one
that does not refer to any other claim. Some independent claims may refer to otherclaims. For example, in chemistry, an independent claim appended on another claim
may be encountered. It stands alone in defining the invention or an aspect of it. An
independent claim is not necessarily the broadest claim in the application, but thebroadest claim in an application is normally an independent claim. This is because there
may be numerous independent claims, each covering a different aspect of the invention.

2.46

A dependent claim can depend upon one or more independent claims or one or more
dependent claims. It should be noted that while some countries will not allow multiple
dependent claims (that is, claims that are dependent on several claims), these areallowed under the Singapore law. Singapore law also allows claims to be dependent on
multiple dependent claims. Examples of multiple dependent claims are:
“The method of claim 1 or 2, further comprising …”“The process of any of claims 1-4 …, comprising …”“The composition according to any one of the preceding claims, wherein …”

2.47

Furthermore, a claim may refer to a later claim or claims rather than a preceding claim
or claims. In most cases this may be due to an error in drafting and the Examiner may,
as a matter of courtesy, bring it to the attention of the applicant. However, unless theerror results in a lack of clarity, no objection is necessary.

2.48

Independent claims should define all of the essential features of an invention. Generally,
the preamble will indicate the subject matter of the claim:“A compound of Formula I …” (the subject is a compound)“A method of preparing article X …” (the subject is a method)“An apparatus comprising …” (the subject is an apparatus)

2.49

Claims which are appended to another claim will generally import all of the features of
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2.50

1.

An apparatus comprising component A and component B.

2.

The apparatus of Claim 1 wherein component B is an in-line filter.

In this case Claim 2 is dependent on Claim 1 and all of the features of Claim 1 areimported into Claim 2. The scope of the claim is then narrowed to the apparatus in which
component B is a particular embodiment.

2.51

In contrast, the following claim, while appended is not truly dependent.
1.

A method of preparing Article X comprising the steps of ...

2.

Article X as defined in Claim 1 having features ...

In this case the preamble of Claim 2 suggests that the claim is directed to the article per
se and not to the process of making the article. This appendence does not import thefeatures of Claim 1 (in this case the steps of the method), and may simply be a shorthandway of defining the article without reiterating matter that has already been defined in
the previous clam (for example in the case of chemicals, it might avoid re-defining large
numbers of substituents). This claim is not dependent despite the fact that it is appended
to Claim 1. Furthermore, this impacts on the scope of the search since a search of Claim
2 would not necessarily be limited to the features defined in Claim 1.
2.52

Other examples of this type are the following:
1.

Process for the preparation of compounds of Formula X wherein R is alkyl,
halo or aryl comprising the steps of …

2.

Compound of Formula X wherein R is halo or aryl.

In this case the inventor has found a new way of preparing compounds of Formula X
and has claimed it for the preparation of compounds of Formula X wherein R is alkyl,
halo or aryl. Claim 2 appears to be directed to a subgroup of compounds of Formula X– presumably the inventor considers these are novel and is seeking to claim thecompound per se. The search in this case would need to cover both the general
preparation, as well as the compounds of Formula X having R as halo and aryl.

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2.53

In the following case:1.

Apparatus comprising component A and component B.

2.

Component B as defined in Claim 1 comprising …

Claim 2 would be interpreted as having a kind of “partial dependency” where the claim
is directed to component B only and would not include component A. A search would
need to cover both the apparatus of claim 1 and the component B of claim 2.
2.54

In some cases, a dependent claim will include embodiments that do not fall within thescope of the claim to which it is appended. This situation can often occur in thechemistry area where a novelty objection results in amendment of the independent claim
to remove some matter, but the dependent claim is not amended accordingly to remove
specific embodiments. In such cases a clarity objection will probably be required.

2.55

A similar situation occurs where a claim that appears to be dependent removes a feature,for example:
1.

A composition comprising A, B and C.

2.

The composition of Claim 1 wherein C is absent.

In this case, Claim 2 is actually broader than Claim 1. However, this may not be
objectionable since it is not mandatory that the broadest claim be the first claim. Indeed
in some cases the broadest claim may be a later claim. The key consideration when
determining whether an objection is required will be whether the person skilled in theart could readily ascertain the scope of the claim. Full support will be a consideration –is component C indicated as being essential to the invention, or merely optional? Are
there inconsistencies between these and other claims that result in a lack of clarity as tothe scope of the claims? In any case, the Examiner will also need to ensure that the
search covers the broadest claim.

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iv.

Open- and closed-ended terms

2.56

The term “consisting of” is generally interpreted to be closed ended – the feature will
be selected only from the listed alternatives. Thus, “a combination consisting ofcomponents A and B” would not include a combination of components A, B and C.

2.57

The term “comprising” is generally interpreted as being open-ended – other alternatives
might be included. For example, “a combination comprising components A and B”
would include a combination of components A, B and C. The terms “contains” and“including” are similarly considered open-ended terms.

2.58

The term “consisting essentially of” is construed to include the specified materials or
steps, as well as other materials or steps that do not materially affect the working of theclaimed invention (T 0759/10, Raision Nutrition Ltd/ Texturizing Compositions for use
in fat blends in food).

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v.

Reference numbers in claims

2.59

Claims may refer to reference signs used in drawings, if a specification contains
drawings. Reference signs do not limit the scope of the claims to the particular drawing,but merely assist the reader to understand the definition (Virgin Atlantic Airways Ltd v
Premium Aircraft Interiors UK Ltd [2010] RPC 8). Unless necessary, the presence ofthe reference signs should not form the basis for an objection.

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vi.

“Use of … in …” claims

2.60“Use of … in …” claims are interpreted as claims to a method, and are not interpreted
as directed to the substance intended for use. This will be particularly pertinent inpharmaceutical applications where claims of the following type will be interpreted as a
non-patentable medical use:
“Use of compound X in the treatment of disease Y.”

2.61“… when used …” claims are interpreted as defining a method. Thus the following
claim is interpreted as a method of using compound X as an initiator:“Compound X when used to initiate polymerisation in a system of …”

2.62

A claim to a product when used in a particular method is interpreted as a claim to amethod per se. A claim to an apparatus or material “when used in” a particular process
is regarded as protecting the use of the apparatus or material in such a process, and its
novelty is therefore destroyed only by a disclosure referring to such use.

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vii.

“Product for …” claims and “Method for …” claims, etc.

2.63

A claim to an apparatus or material for a particular purpose is generally construed as aclaim to any apparatus or material suitable for that purpose (Adhesive Dry Mounting Co
Ltd v Trapp and Co [1910] 27 RPC 341; G.E.C’s Application [1943] RPC 60). Thus
“Product for …”claims are interpreted as requiring the particular apparatus or material
to be suitable for the defined purpose.

2.64

However, the suitability for a particular purpose does not limit the scope of the claim to
the apparatus when used in that way (L’Air Liquide Societe’s Application 49 RPC 428).
Thus, if a prior art document otherwise discloses all of the features of the invention andwould be suitable for that purpose, then it will constitute a novelty-destroying
disclosure. On the other hand, a known product that has the same material orcomposition as defined in the claim, but which is in a form which is clearly unsuitable
for the stated use, would not deprive the claim of novelty. Likewise, an apparatus which
has to undergo physical modification before it can be used for the stated purpose, would
not be suitable for the particular use.

2.65

For example, in the claim “Hook for fishing comprising features X, Y and Z”, any
suitable hook comprising features X, Y and Z that can be used for fishing would
anticipate the claim, regardless of whether the hook was stated to be used in fishing or
not in the prior art. The claim is also not saved by amending the claim to “a fishing hookcomprising features X, Y and Z” as it would essentially mean the same thing. However,the claim would preclude within its scope, a crane hook comprising features X, Y andZ, which would have certain physical limitations (e.g. dimensions and weight) that makeit unsuitable to be used as a fishing hook.

2.66

The meaning of the phrase “adapted to” was considered in FH Brundle v Perry [2014]
EWHC 475. The claims in the patent related to a product with the following features:(i) a bracket for securing a fence panel to a fence post, (ii) the bracket being adapted toembrace a corner of a fence panel, (iii) and comprising a main body having a rectangularcentral portion, (iv) adapted in use to lie along the top of the panel, (v) and twocontiguous triangular portions, (vi) adapted in use to lie one each side of the panel, (vii)with one apex adjacent the post and the other spaced therefrom, (viii) and flange means,

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(ix) adapted in use to lie against and be attached to the post. In construing the terms“adapted to” and “adapted in use to”, Hacon, J. said:“I accept that as a matter of ordinary English usage, ‘adapted’ carries a
connotation of adaption or modification in design to achieve the purpose stated in
the feature. However in my view… these [features] are to be construed such thatthey contain no subjective element. To my mind it is irrelevant where the designer
started and what adaptations were made in the design process. Because thesefeatures must be assessed objectively, it seems to me that ‘adapted to’ and ‘adaptedin use to’ mean the same thing as ‘suitable for’.”However, the judge also cautioned:“I do not say that in the context of other claims it will never be possible to discerna difference between ‘suitable for’ on the one hand and ‘adapted to’ or ‘adaptedin use to’, or ‘constructed to’ for that matter, on the other. But I think in this claim
the first three mean the same thing.”
Therefore, the terms ‘adapted to’, ‘adapted for’, ‘adapted for use’ in a product orapparatus claim may be construed as “suitable for”. Although, as cautioned by Hacon
J., it should be noted that there may be circumstances where the context of thespecification would suggest a different construction should be taken. In T 289/84
WELLCOME/3-Amino-pyrazoline derivatives, the Board of Appeal held that there wasa difference in meaning between a claim to a composition “adapted for” topical use, as
opposed to one “suitable for” such a use. While eye drops and injectable formulations
typically consist of sterile aqueous solutions, an eye-drop formulation was not“adapted” for use as an injectable solution or vice versa – injectable solutions had to beboth sterile and pyrogen-free, whereas eye-drops do not need to be pyrogen-free but
have a very narrow range of acceptable pH. Hence, the construction of “adapted” would
generally depend on the context of the specification. In a similar vein, the term
“specially adapted for” would require a reading of the specification as a whole (see subsection v of Section D in Chapter 6, Example 4). Equivalent terms, such as ‘configuredto’, ‘designed to’ and ‘made to’, should generally be construed in the same way.

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2.67

Another term which may be encountered by Examiners during examination is the term
“constructed to receive”. The meaning of this term was considered by Birss J. in
Schenck Rotec GmbH v Universal Balancing Limited [2012] EWHC 1920, which relates
to a device “constructed to receive” a plurality of balancing weights. Consistent withthe judgment in FH Brundle v Perry [2014] EWHC 475, the judge rejected thesuggestion that the phrase “constructed to receive” referred to the intention of the device
designer (or anyone else), because he found there was nothing in the specification thatwould lead the skilled person to that conclusion. Instead Birss J. found, in thecircumstances, that a skilled person would understand that the device was “constructedin such a way that it is capable of receiving” a plurality of balancing weights. That is,
he found there had to be some physical construction of the device which achieves theclaimed objective, and the device can actually work this way in practice.

2.68

A claim to a substance or composition “for use …” would normally be construed as a
substance or composition “suitable for use …”. However, first medical use claims are
an exception to this rule (see sub-section i of Section D in Chapter 8), and the claim isinterpreted as being specifically limited to the medical purpose. On the other hand, if
the substance or composition has already been known to be useful for a medical purpose,then in order to protect a further new medical use of the substance or composition, asecond medical use format (“Swiss type format”) must be used.

2.69

Similarly, in the data-processing/computer programming field, a claim to a “means for”
performing a certain function is interpreted as a means specific for performing therelevant function, rather than merely suitable for carrying out the function. Accordingly,
a device without the relevant software that enabled the functions is “not suitable for”
the functions in question. A bare computer would not be “suitable for” the activities in
the claims because it simply could not achieve them (Rovi Solutions Corporation &Anor v Virgin Media Ltd & Ors [2014] EWHC 1559).

2.70

A claim merely directed to “Apparatus for carrying out the method of ... according toclaim X”, or some such wording will not normally be clear in scope. The claim should
clearly specify the essential features of the apparatus unless all the integers which would
constitute such apparatus are clearly implicit in the method claimed.

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2.71

The interpretation of a claim directed to a “Method for …” depends on the specificwording of the claim and the specification when read as a whole. Generally, in claims
to a “Method for …” or a “Process for …”, the indication of the intended purpose of themethod or process should be seen as limiting to the extent that the method is suitable
for that purpose (T 0304/08 Method for reducing malodor/ BASF). Consequently, aprior disclosure of the same method suitable for a particular purpose, would anticipate
a claim to a method or process for that purpose, even when the purpose is not indicatedin the prior disclosure.

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viii. Product-by-process claims
2.72

A product-by-process claim is one in which the product is defined in whole or in part interms of the process used to manufacture the product, instead of solely by structure,composition, properties or characteristics (see Section L in Chapter 3 about its novelty
assessment). For all practical purposes, product-by-process claims fall into either the
statutory category of article of manufacture or composition of matter claims.

2.73

A claim to a product obtained by a process:“Product X obtained/prepared by process Y”
is normally construed as a claim to the product per se, irrespective of whether the term
“obtained”, “obtainable”, “directly obtained” or an equivalent wording is used (KirinAmgen Inc v Hoechst Marion Roussel Ltd [2005] RPC affirming EPO law, i.e., Decision
T 150/82 International Flavors and Fragrances Inc. [1984] 7 OJEPO 309). Such aclaim lacks novelty if a prior art product, even if made by an undisclosed process,appears to be the same as, or indistinguishable from, the claimed product. The
patentability of a product defined by a product-by-process claim does not depend on its
method of production. Therefore, a product is not rendered novel merely by the fact that
it is produced by means of a new process.

2.74

However, where a product cannot be satisfactorily characterized with reference to its
structure, composition, properties or other means (such as when the structure orcomposition of a product is unknown), it might be allowable to claim the product using
a product-by-process claim. During examination, such a claim should be construed as aclaim to the product per se that possesses the characteristics derived from the
manufacturing process as stated in the claim. For example, when a claim recites “a twolayer structured panel which is made by welding together an iron sub-panel and a nickel
sub-panel.”, the process of “welding” would be considered by the Examiner in assessing
patentability over the prior art since the process of welding produces physical properties
in the end product which are different from those produced by processes other thanwelding; that is, the product can only be defined by the process step. Novelty of theclaim is not brought into question unless an identical two-layer structural panel madeby means of welding is discovered in the prior art.

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2.75

Where a product that can be accurately described by referring to its structure,composition or means other than its method of preparation or production, but is definedusing a product-by-process claim, the Examiner may raise a clarity objection. If there isanother claim to the identical product in the application, then the product-by-process
claim may also lack conciseness as the two product claims might have an identical scopeof protection. In order to overcome said objections, the applicant should provide
evidence to the contrary.

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ix.

Claims to process using a known apparatus

2.76

A claim to a method of using a known apparatus may be regarded as new if the claimed
method of use is new. In Flour Oxidizing Co Ltd v Carr and Co Ltd [1908] 25 RPC 428,
Parker J stated that “when the question is solely a question of prior publication, it is not,in my opinion, enough to prove that an apparatus described in an earlier specification
could have been used to produce this or that result. It must also be shown that the
specification contains clear and unmistakable directions in order to use it”.

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x.

Alternatives/Markush claims

2.77

In many cases some or all of the features of an invention may be substituted by similaror technically equivalent alternatives, but the properties of the product are still retained.
Such claims are often referred to as Markush claims (named after the applicant on an
early case of this type), and may be based on a relatively small number of alternatives
or in some cases may extend to many millions of possible alternatives.

2.78

Markush claims are often used in chemical cases where different functional groups may
be substituted at various positions and expected to retain the same properties, e.g.
biological activity. In most cases the general formula will contain a consistent coreelement that provides the basic activity while other parts of the molecule may varydepending on the types of substituents the person skilled in the art would consider could
be accommodated in the molecule.

2.79

A simple example of a Markush formula is as follows:
R1 – R2
wherein R1 is phenyl or 1-naphthalene, and R2 is chlorine or bromine.
This claim would include chlorobenzene, bromobenzene, 1-chloronaphthalene and 1bromonaphthalene. For novelty purposes, a disclosure of even just one of thesecompounds in the prior art would render the claim lacking in novelty.

2.80

Markush claims can be difficult to search and often a risk-management approach is
required in order to search the claims efficiently. In some cases the broad nature of theclaims may raise issues of lack of unity, sufficiency and support. However, it should be
noted that the breadth of the claim alone is not objectionable provided theserequirements are satisfied.

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3.

NOVELTY

A.

Statutory requirements

3.1

Section 14(1) provides that:
An invention shall be taken to be new if it does not form part of the state of the art.

3.2

Sections 14(2) and 14(3) set out the state of the art as follows:(2) The state of the art in the case of an invention shall be taken to comprise all
matter (whether a product, a process, information about either, or anything else)
which has at any time before the priority date of that invention been made available
to the public (whether in Singapore or elsewhere) by written or oral description, by
use or in any other way.
(3) The state of the art in the case of an invention to which an application for apatent or a patent relates shall be taken also to comprise matter contained in an
application for another patent which was published on or after the priority date ofthat invention, if the following conditions are satisfied:(a)that matter was contained in the application for that other patent bothas filed and as published; and

(b)
3.3

the priority date of that matter is earlier than that of the invention.

Thus, an invention defined in a claim lacks novelty if the specified combination offeatures has already been disclosed in the prior art. In Trek Technology (Singapore) Pte
Ltd v FE Global Electronics Pte Ltd (No. 2) [2005] 3 SLR 389, Lai Kew Chai J provided
the following guidance in determining novelty:
1)

the issue is determined by asking whether an invention forms part of the stateof the art;2)

the prior art must, in order to invalidate the patent, be such that a person ofordinary skill and knowledge of the subject would at once perceive andunderstand and be able to practically apply the discovery without thenecessity of making further experiments;

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3)

the prior art documents must be construed as at the date of publication and it
is not permissible to perform an ex post facto analysis;

4)each prior art document has to be considered separately and not combined
into a mosaic to arrive at the invention;5)

the person skilled in the art is an unimaginative person of competent but
average technical skill;6)

the prior art document must contain clear directions to do what the patentclaims to have invented.

3.4

The Singapore Courts have followed UK precedent in approaching the determination ofnovelty. The UK approach has recently been summarized in SmithKline Beecham Plc’s(Paroxetine Methanesulfonate) Patent [2006] RPC 10, where the House of Lords held
there were two requirements for anticipation: prior disclosure and enablement. These
are distinct concepts, each of which has to be satisfied and each of which has its own
rules.

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B.

Raising new prior art

3.5

Where the applicant requests an examination or a search and examination of theapplication, Rule 2A(1) requires that the Examiner take into account all the relevant
prior art that has been discovered in a search, or that the Examiner is “aware of”.

3.6

Generally, when a request for an examination relying on a search report is received, theExaminer will conduct the examination based on the search report. The general principle
is the claims to be examined should have been covered by the original search.

3.7

Where a claim relates to an invention in respect of which no search has been completed,
Rule 46(1)(e) provides that an Examiner may decide not to carry out the examination in
respect of that claim and advise the Registrar accordingly. In most cases, this will be
where in the search report has specified that no search has been carried out for aparticular claim for reasons such as a lack of unity.

3.8

If an additional feature is introduced into a claim by amendment there may be instanceswhere the original search may not have covered that embodiment. For example, thesearch may have been limited to particular embodiments but as a result of the cited priorart, the claims have been amended to cover different embodiments that would not havebeen covered by the initial search. However, this should be an unusual circumstance –in most cases the claims will be limited to preferred embodiments provided in thespecification and in other cases these should have been covered by a search of thebroader claim. Additional searching may be performed in such situations, but extensive
searching should be avoided.

3.9

During the course of the examination, the Examiner may raise new prior art that has notbeen identified in the search report or discovered in the search but that the Examiner
has become “aware of”. Thus, for example, if a search report from a foreign familyequivalent identifies highly relevant prior art that impacts on the patentability of thepatent, then the Examiner may raise this new prior art. However, in the case of an
examination based on a foreign search report, extensive additional or original searchingshould be avoided. Moreover, a new document should not be raised if it essentiallyrepeats the matter provided by an existing citation. To raise a new, but equivalent
document would result in additional costs for the applicant.

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3.10

Where new prior art is raised, this should be highlighted in the Examiner’s report, anda copy of the document may be provided (subject to copyright restrictions). The full
bibliographic details and relevant portions of the document must be provided in theopinion.

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i.

Third party observations

3.11

Where an application for a patent has been published and before the establishment of
the search and examination report, or examination report, as the case may be, a third
party may make observations in writing to the Registrar, under Section 32, on thequestion of whether the invention is a patentable invention, stating the reasons for suchobservations. Observations received after the establishment of the examination reportor the search and examination report will be put on record but will not be forwarded to
the Examiner, nor will it be made available on the Patents Open Dossier (POD).
Examiners will consider timely observations submitted by third parties in a request foran examination or a request for a search and examination of the application (forobservations submitted by third parties for an application under supplementary
examination, see sub-section iii of Section H in Chapter 9).

3.12

As third parties do not become a party to any proceedings before the Registrar solely
because of making observations under Section 32, the Examiner will consider theobservations based only on the documentation submitted by the third party. Section
32(1) requires reasons for the observations to be stated, and hence observations madeshould provide clear reasoning based on Singapore patent laws. Where suchobservations rely on supporting documents, such as prior art documents or documents
showing that the priority claims are invalid, it is strongly encouraged that these
supporting documents be submitted together with the observations. If these are notsubmitted, and the Examiner requires them in the course of considering theobservations, the Registrar is empowered by Rule 105 to direct the third party to furnish
such documents, information or evidence. For supporting documents that are provided
in a language other than English, the Registrar may, under Rule 112(6)(a), require an
English translation of the whole or relevant parts of the document to be filed.

3.13

The reasoning provided in the third party observations should include accurate feature
matching to the claims of the application, with references to the cited prior art whereappropriate. While various prior art may be submitted, observations made using themost relevant prior art are likely to better support the third party’s assertions that theclaimed invention under examination is not a patentable invention.

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3.14

Additionally, the reasoning must include information on the date on which the prior art
relied upon was made available to the public, based on factual evidence on such
availability. For example, where the prior art relied upon is an article from a scientificjournal, a copy of its bibliographical information containing an online publication dateshould also be submitted. In the case of pamphlets, brochures and catalogues, thereasoning should provide evidence of the dates such documents were made available tothe public. Assertions of prior use should be accompanied by compelling documentary
evidence demonstrating such use.

3.15

When observations are received by the Registrar before the establishment of theexamination report or the search and examination report, the Registrar will inform theapplicant that third party observations have been received (Rule 45A(1)), and makethem available, subject to certain limitations (e.g. copyright restrictions), on the Patents
Open Dossier (POD). The Registrar will also send a copy of the third party observations
to the Examiner in accordance with Rule 45A(2). The Examiner must consider whether
such observations are relevant to the patentability of any claims that are pending in theapplication (Rule 45A(2)). If new prior art referred to in such observations impacts thepatentability of any pending claims, the Examiner should take into account such newprior art during examination.

3.16

Where a third party observation has been made, the Examiner should include astatement in the written opinion and/or examination report, indicating that the third party
observation has been considered, whether or not the observation is adopted in theestablishment of the written opinion or the examination report. New prior art submitted
in the third party observation and taken into account by the Examiner should beindicated in the written opinion and/or examination report as citations from the third
party observation.

3.17

When an Examiner finds reasons to object to one or more claims in an application basedon a third party observation that has previously not been brought to the attention of theapplicant in a written opinion, the Examiner should generally allow a further written
opinion to provide an opportunity for the applicant to overcome the objection. On theother hand, where the claims are already considered not to be patentable in view of theprior art on hand, and the third party observations merely further support the Examiner’s
conclusions, a negative examination report may be issued in accordance with Rule

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46(8). In such a situation, the Examiner may make use of the third party observations,as needed, for the reasoning in the negative examination report.

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C.

Prior disclosure

3.18

It would be sufficient to prove that a prior art discloses an invention, if the matter relied
upon as prior art discloses subject matter which, if performed, would result in
infringement of the patent (a “reverse infringement” test) as set out by the Court ofAppeal in General Tire & Rubber Company v Firestone Tyre & Rubber Company
Limited [1972] RPC 457 and followed in Muhlbauer AG v Manufacturing Integration
Technology Ltd [2010] SGCA 6:“If the prior inventor’s publication contains a clear description of, or clear
instructions to do or make, something that would infringe the patentee’s claim if
carried out after the grant of the patentee’s patent, the patentee’s claim will havebeen shown to lack the necessary novelty, that is to say, it will have been
anticipated. The prior inventor, however, and the patentee may have approached
the same device from different starting points and may for this reason, or it may befor other reasons, have so described their devices that it cannot be immediately
discerned from a reading of the language which they have respectively used thatthey have discovered in truth the same device; but if carrying out the directions
contained in the prior inventor’s publication will inevitably result in something
being made or done which, if the patentee’s patent were valid, would constitute an
infringement of the patentee’s claim, this circumstance demonstrates that thepatentee’s claim has in fact been anticipated.”

3.19

In Merck & Co Inc v Pharmaforte Singapore Pte Ltd [1999] SGHC 323, the plaintiffs
argued that any prior art that is relied on to destroy novelty must unequivocally point to
the invention and must not merely be a signpost on the path to discovering the invention.
Lai Kew Chai J in delivering the judgment of the High Court agreed that in order for
anticipation to arise, the prior art must disclose to a notional instructed reader essential
integers to the invention as claimed.

3.20

The provision of novelty therefore involves a consideration of whether the prior art
discloses all of the features of the claim in question. In general a prior disclosure will
destroy the novelty of a later claim only if it discloses each and every feature specified
in that claim. If the claim contains technically equivalent or additional features, then an
objection of obviousness would be more appropriate.

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3.21

However, a purposive construction of a claim may indicate that one or more features do
not materially affect the working of the invention – in effect they are non-essential. In
such rare occasions an objection of lack of novelty may be warranted. For example if
the invention consists of a known drug in a package together with instructions for usage,
an objection of lack of novelty based on a document disclosing the known drug in a
package with the same manner of usage may be appropriate, since the feature of thewritten instructions merely makes explicit the presence of instructions describing the
known manner of usage, but does not materially affect the working of the invention –that is, the biological effect of the active ingredient.

3.22

A disclosure which is capable of being carried out in a manner which falls within thescope of the claim, but is also capable of being carried out in a different manner, does
not anticipate - although it may form the basis of an obviousness objection. This wasnoted in General Tire as follows:“If, on the other hand, the prior publication contains a direction which is capableof being carried out in a manner which would infringe the patentee’s claim, butwould be at least as likely to be carried out in a way which would not do so, thepatentee’s claim will not have been anticipated, although it may fail on the groundof obviousness. To anticipate the patentee’s claim the prior publication must
contain clear and unmistakable directions to do what the patentee claims to haveinvented ... A signpost, however clear, upon the road to the patentee’s invention
will not suffice. The prior inventor must be clearly shown to have planted his flagat the precise destination before the patentee”.

3.23

In

discussing

thisjudgmentinSmithKline

Beecham

Plc’s(Paroxetine

Methanesulfonate) Patent [2006] RPC 10, Lord Hoffmann added:“But the infringement must not merely be a possible or even likely consequence ofperforming the invention disclosed by the prior disclosure; it must be necessarily
entailed. If there is more than one possible consequence, one cannot say that
performing the disclosed invention will infringe. The flag has not been planted on
the patented invention, although a person performing the invention disclosed by
the prior art may carry it there by accident or (if he is aware of the patented
invention) by design. Indeed it may be obvious to do so.”

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3.24

Thus, as Lord Hoffmann summarised the disclosure requirement as follows:“Anticipation requires prior disclosure of subject-matter which, when performed,
must necessarily infringe the patented invention.”

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D.

Enablement

3.25

The principle that a citation must provide an enabling disclosure of the invention wasaffirmed by the Singapore Court of Appeal in Merck & Co v Pharmaforte Singapore
Pte Ltd [2000] 2 SLR(R) 708:
“for a prior publication to anticipate the patent it must be established that
following the teachings in the prior publication would inevitably lead to theinvention covered by the patent. The prior disclosure must not only identify the
subject matter of the claim in the later patent, it must do so in a way that enables
the skilled person to make or obtain it, a kind of enabling disclosure.”

3.26

Thus the person skilled in the art must be able to perform the invention (SmithKline
Beecham Plc’s (Paroxetine Methanesulfonate) Patent [2006] RPC 10). In Smithkline
Beecham, the House of Lords held that the test for enablement of a prior disclosure forthe purpose of anticipation is the same as the test of enablement of the patent itself forthe purpose of sufficiency.

3.27

The two requirements of disclosure and enablement should be kept distinct (SmithKline
Beecham). In particular, the role of the person skilled in the art is different.

3.28

In the case of disclosure, the document is read using the common general knowledge,
available at the date of the disclosure, of the person skilled in the art who is trying tounderstand what the author meant by the language they used. Once this is determined,
the person skilled in the art takes no further part in the determination.

3.29

On the other hand, for enablement, the person skilled in the art is assumed to be willingto make trial and error experiments to get it to work, and the question is not what theperson skilled in the art would think the disclosure meant, but rather whether he would
be able to work the disclosed invention.

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E.

Publication

3.30

A disclosure becomes part of the state of the art on the date it first becomes available tothe public. Notably, the Act does not place any requirements on the age of the disclosure,the location of the disclosure, the type of disclosure (paper or electronic), or the
language of publication.

3.31

Communication to a single member of the public without inhibiting fetter is enough toamount to making available to the public (Bristol-Myers Co.’s Application [1969] RPC
146). Similarly, in Monsanto (Brignac’s) Application [1971] RPC 153, the Court heldthat the company had published a document by supplying it to its salesmen without arestriction on disclosure.

3.32

A document is available to the public even if a fee is required to view it. Furthermore,
there is no need to show that the document has actually been read by a member of the
public - a document is regarded as having been published provided it can be inspected
as of right by the public. Guidance in the Singapore context was given by Tay Yong
Kwang J in Insitutut Pasteur v Genelabs Diagnostics Pte Ltd [2000] SGHC 53 at [188]:“The law concerning anticipation is strict to the patentee and to the challenger ofthe patent. A claim is invalid if it covers any item of the prior art which has been
disclosed to anyone (except in confidence), by any means (written or oral or byuse), anywhere in the world, at any time in history (before the priority date). Even
availability to a single member of the public will suffice. Similarly, availability tothe public is satisfied if the document can be found on the shelves of a public
library. It is irrelevant whether anyone knew it was available or had inspected it.
[Vitoria, Encyclopedia of United Kingdom and European Patent Law] Anticipation
can therefore encompass a disclosure which the inventor was totally ignorant of.”

3.33

If a publication date is present upon a document (for example the publication date on apatent or journal article), then this is assumed to be the date of publication. In the eventthat this date is disputed by the applicant then evidence to the contrary will be required.
Internet dates and the like may be problematic but in general, if a date is associated withthe web page it may be considered the actual date of publication. On the other hand, if
the web page itself does not explicitly indicate a publication date, Examiners may utilize

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Internet archiving databases such as the “WayBack Machine” on archive.org to provide
evidence of when the web page was published.
3.34

Disclosures, such as conference proceedings published before the relevant priority date
may be used as a basis for a novelty objection. In the absence of evidence to the contrary,
it may be assumed that the proceedings are an accurate reflection of the content of thelecture or public disclosure.

3.35

Generally, the Act does not require consideration of the actual time that a document was
published when establishing whether or not the document forms part of the state of theart; Section 14 merely specifies that the state of the art constitutes all matter madeavailable to the public before the priority date of the invention. However, in the casewhere a publication date is close to the priority date, the time zone of publication may
be important to interpret the publication date. This is particularly pertinent to internet
disclosures, which are made available to the public simultaneously worldwide at the
point of publication. Hence, because of the difference in time zones, it is conceivablethat a particular internet disclosure may have a different publication date in a different
part of the world. It would therefore be necessary to consider a frame of reference indetermining the publication date of such a disclosure.

3.36

In Unwired Planet v Huawei and Samsung [2015] EWHC 3366 (Pat), it was held thatfor the purposes of Section 2(2) of the UK Patents Act 1977, the equivalent provision
to Section 14(2), the frame of reference should be the time zone of the patent office atwhich the priority document was filed. For example, in relation to a Singapore patentapplication which claims priority to a US patent application filed at the USPTO (GMT-5) on 7 February 2015, an internet disclosure on 7 February 2015 at 9 a.m. Singapore
time (GMT +8) would constitute the state of the art under Section 14(2), since thepublication date of said disclosure would have been 6 February 2015 at GMT -5, which
is before the date on which the priority document was filed.

3.37

The prior art disclosure must be a single document. Lack of novelty cannot be argued
on a mosaic of documents; an obviousness objection may be appropriate in such cases.
However, two separate documents may be read as though they were a single document
if the person skilled in the art would take them to be such a disclosure. This was stated

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by Tay Yong Kwang J in Insitutut Pasteur v Genelabs Diagnostics Pte Ltd [2000]
SGHC 53 at [190]:“Anticipation must be found within the document alleged to have anticipated theinvention. It is not permissible to combine the teachings of two or more documents
except where one of these directs the reader to study the other. One cannot createa ‘mosaic of extracts’ from documents spread over a number of years [Von Heydonv Neustadt, (1880) 50 LJ Ch. 126]. Similarly, ‘it is not open to you to take a packet
of prior documents and by putting a puzzle together produce what you say is adisclosure in the nature of a combination of the various elements which have been
contained in the prior documents. … it is necessary to point to a clear and specificdisclosure of something which is said to be like the patentee’s invention’ [Lowndes’
Patent, (1928) 45 RPC 48].”
3.38

Nevertheless, it should be noted that the mere presence of a cross-reference in a cited
document to a second document is not sufficient indication that the two may be read
together. It should be established that the cross-reference necessitates that part or all of
the disclosure of the second referenced document be considered as part of the disclosureof the cited document. The use of expressions such as “incorporated by reference” whenreferring to the second document in the cited document may suggest such necessity. For
example, a cited document may refer explicitly to a second document as being
incorporated by reference for providing more detailed information on certain features
identified in the cited document. In this case, the teaching of the second referenced
document would be regarded as part of the disclosure of the cited document for the
purposes of enablement, only if the second referenced document was also available tothe public at the publication date of the cited document. This is because, for the purposesof novelty, the cited document must provide a sufficient disclosure at its date of
publication.

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F.

Implicit disclosure

3.39

The prior art is read through the eyes of the person skilled in the art, and as aconsequence the implicit features of a document may also be taken into account for
novelty purposes. Thus, if the person skilled in the art would read a disclosure as
including a particular feature without it being specifically mentioned it would beconsidered an implicit feature of that disclosure.

3.40

The teaching must be such that it would be understood by a person skilled in the art
reading in the light of common general knowledge – available at the date of thedisclosure – special knowledge must not be required in order for the matter to beunderstood (H.Lundbeck A/S v Norpharma SpA [2011] RPC 23). The prior art document
must be construed at the date of the disclosure and not in light of the subsequent patent(SmithKline Beecham Plc’s (Paroxetine Methanesulfonate) Patent [2006] RPC 10).

3.41

For example the disclosure of a control arrangement for the cooling system of aninternal combustion engine might not refer to the presence of a radiator or other heatexchanger in the system, but it is common knowledge that this is necessary. A novelty
objection could therefore be raised even if a citation did not specify this feature. In
contrast, it may be a common practice for the radiator to be mounted in front of theengine, but this is not necessarily always the case. In this situation, a novelty objection
cannot be raised based on a citation that does not specifically disclose this feature. An
objection of obviousness would then be appropriate.

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G.

“Inherent” disclosure

3.42

As noted in General Tire v Firestone, the claimed invention will lack novelty if carryingout the directions contained in a prior publication will inevitably result in something
being made or done that would constitute an infringement of the claims. This isparticularly relevant to claims that define the invention by reference to parameters. Thismay be distinguished from an implicit disclosure – in this case the person skilled in theart would not read the feature as being disclosed by the prior art, but if they were torepeat the teaching of the prior art they would inevitably obtain that result.

3.43

For example a process or a product is anticipated by a disclosure which, when put into
practice, would necessarily fall within the scope of the claim, even if the disclosure does
not disclose these particular parameters. However, it must be noted that a determinationthat a prior art teaching will inevitably result in the claimed invention must be based on
sound reasoning.

3.44

In particular, the operating conditions used in a process will need to be very similar inorder to sustain an argument that a reaction or process will inevitably give the same
product. For example, a claim defines an industrial process for preparing a productcomprising a particular ratio of compounds A and B wherein a particular series of steps
are carried out using specific reaction conditions (temperature, etc.). A prior art citation
discloses a similar process for preparing a mixture of A and B, but does not disclose thespecific ratio of these components claimed in the present application. In this case, it may
be necessary to consider the examples provided in the prior art document in order todetermine whether the conditions are sufficiently similar that it could be concluded thatthe prior art disclosure would inevitably result in the presently claimed ratio.

3.45

Similarly a genetically modified organism characterized by a particular transgene and aparticular characteristic may be novel in view of the same organism with the sametransgene for which there is no discussion of the same characteristic. This will
particularly be the case where there has been an intermediate selection step for the
specific traits.

3.46

However, inevitability does not require 100% certainty on every occasion the prior art
process is carried out. In Kirin-Amgen Inc. v Roche Diagnostics GmbH [2002] RPC 1,

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Neuberger J held that “the law of patents is ultimately concerned with practicality”. He
considered that a prior art experiment which reliably produced a particular result on
more than 99 percent of the occasions on which it is conducted would be regarded as“inevitably” leading to the claimed result.
3.47

In T 303/86 (CPC Int) [1993] EPOR 241 the Technical Board of Appeal of the EPO
considered anticipation arising from two cook-book recipes of a process for making
flavour concentrates from vegetable or animal substances by extraction with fat solvents
under pressure in the presence of water. The claim specified certain parameters for theratio between the vapour pressure of the water in the meat or vegetables and the vapour
pressure of the free water. The Board said:“It is sufficient to destroy the novelty of the claimed process that this process andthe known process are identical with respect to the starting material and reaction
conditions since processes identical in these features must inevitably yield identicalproducts.”
Furthermore, it did not matter that the cook did not realise that he was not only frying achicken, but also making a “flavour concentrate” in the surplus oil. It was enough, as
the Board said, that “some flavour of the fried chicken is extracted into the oil during
the frying process even if this is not the desired result of that process.”

3.48

In Merrell Dow Pharmaceuticals Inc v H N Norton & Co Ltd [1996] RPC 76 theinvention related to an acid metabolite of the known pharmaceutical terfenadine. The
metabolite formed in the liver following administration of terfenadine. The acidmetabolite was held to be anticipated not by prior use (see paragraph 3.77) but because
its formation was the inevitable result of carrying out the directions in the earlier
terfenadine patent. In this regard, Lord Hoffmann held that Section 2(2) – the equivalent
provision to Section 14(2) of the Singapore Patents Act – does not require that the stateof the art include a knowledge of the chemical composition. Rather, it is the invention
which must be new and which must therefore not be part of the state of the art. In thiscase, there was sufficient information disclosed in the prior art to work the invention.

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H.

Errors in citations

3.49

Occasionally, citations will contain errors. The key question in such cases is what the
document would disclose to the person skilled in the art, and not merely what a strictly
literal interpretation of the document would provide.

3.50

For example, a feature of the invention may be disclosed in an abstract but the document
referred to in the abstract shows that the abstract is wrong. In this case the document
referred to would be regarded as providing the definitive description of the matter andthe abstract would not form part of the state of the art (see T 77/87, OJ EPO 1990). The
person skilled in the art would recognize the error and would know how to correct it.
Only the corrected version would therefore be taken into account.

3.51

In Dr Reddy’s Laboratories (UK) Ltd v Eli Lilly and Co Ltd [2008] EWHC 2345 (Pat),
the Court considered a situation where a citation apparently contained an error in achemical formula. The invention related to the compound olanzapine (an unsubstituted
4-methylpiperazinyl-10H-thienobenzodiazepine).

A

table

showedaformulacorresponding to olanzapine, but in which the piperazine ring was piperidine.
Furthermore, the article was entitled “A Free-Wilson Study of 4-piperazinyl-10Hthienobenzo diazepine analogues”. Reddy’s argued that the person skilled in the art
would recognize that the citation contained an error on the basis that:(a)the numbering in the ring was consistent with a piperazine derivative rather
than piperidine;(b)the document title referred to “piperazines” and it was easier to make an error
in a formula rather than a title;(c)

if the bridge carbon was carbon rather than nitrogen then it would be chiralbut this was not indicated in the formula.

3.52

The second and third points were not considered persuasive since the authors may nothave been concerned with stereochemistry and there was no basis for concluding that
one error would be more likely than another. The Court considered that the first point
was the strongest, but accepted submissions that the person skilled in the art would notnecessarily notice this point or indeed consider it important. The Court noted a finding
where the person skilled in the art would, on balance, conclude that citation was

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disclosing piperazines is not the same as a finding where he would conclude that it was
doing so clearly and unambiguously.
3.53

Thus:
(a)

if the person skilled in the art would have recognised that the document
contained an error, and would have known how to correct it, the correctedmaterial forms part of the state of the art;(b)

if the person skilled in the art would have recognised the error, but not known
how to rectify it, neither the error nor the corrected matter form the state of
the art; and(c)if the person skilled in the art would not have recognised the error, but
submissions or evidence from the applicant establishes that there is an error,
then the matters relating to that error are not part of the state of the art.

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I.

Anticipation by specific disclosure

3.54

A claim lacks novelty if there is a prior disclosure of something falling within its scope.
Hence, a claim which defines the invention by reference to alternatives will lack novelty
if one of these alternatives is already known. For example, a disclosure of a copper coilspring will anticipate a later claim to a metal coil spring. In such cases it may be possible
to overcome an objection of lack of novelty by means of a disclaimer.

3.55

In contrast, a generic prior art disclosure will generally not anticipate a subsequent, more
specific claim. Thus a prior art disclosure of a metal coil spring will not anticipate alater claim to a coil spring made of copper.

3.56

Nevertheless, a disclosure of a relatively small number of possible alternatives may betaken to be a disclosure of each and every member of the class. For example, in Norton
Healthcare Ltd v Beecham Group Plc (BL C/62/95) Jacob J held that a disclosure of a
combination of sodium or potassium clavulanate with amoxycillin or ampicillin
trihydrate was a disclosure of each of the four possible combinations.

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J.

Anticipation of ranges

3.57

In considering the novelty of claims which define the invention by parameters within
numerical ranges, the same considerations as indicated in the previous section apply.
Hence, a claimed range will lack novelty if a single example falling within the range, orat its end-points, is already known.

3.58

A claimed invention may also be characterized by the selection of a narrower sub-rangeof numerical values within a broader known range, where said narrower sub-range has
not been explicitly mentioned in the prior art. To establish the novelty of the sub-range,
the selected sub-range should be narrow and sufficiently specific from the known
broader range, illustrated by means of examples. The presence or absence of a particulartechnical effect within the sub-range appears to fall back upon considerations whichshould be taken into account in the assessment of inventive step, and hence, should not
be considered when assessing novelty (T 230/07 Colloidal binder/PAROC and T
1233/05 Refrigerant compositions/INEOS). The meaning of “narrow” and “sufficiently
removed” has to be decided on a case-by-case basis. If it is determined that the subrange is novel, it must also meet the criteria for “selection inventions” set out in subsection viii of Section I in Chapter 4.

3.59

Where the claimed range overlaps with a numerical range disclosed in a prior art
document, the claimed range would clearly lack novelty if there is an explicit mention
in the prior art of a specific example falling in the overlapping range or at its end-points.
In the absence of such a specific example, the question to be asked is whether the priorart, read in light of the common general knowledge, taught the skilled person that heshould operate in the area of the overlapping range. This was the approach adopted in
Element Six Technologies Ltd v IIa Technologies Pte Ltd [2020] SGHC 26 at [234],
after the Court had considered the decision of the UK Court of Appeal in Jushi Group
Co Ltd v OCV Intellectual Capital LLC [2019] RPC 1. The invention in Element Six
Technologies v IIa Technologies involved a method of producing a CVD diamondmaterial that includes producing a synthesis atmosphere containing a range of nitrogen
which overlapped with the prior art process. However, as the most preferred range ofnitrogen in the prior art was not the same as the overlapping range and the amount of
nitrogen stated in the examples in the prior art was completely outside of the

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overlapping range, Thean J determined that this was sufficient to find that the claimed
invention was novel over the prior art.

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K.

Anticipation of parametric claims

3.60

Patent claims generally define the invention in terms of specific features or function.
Specific parameters, such as directly measurable physical properties (e.g. the melting
point of a substance, the flexural strength of a steel, the resistance of an electricalconductor) or mathematical combinations of several variables in the form of formulae,
are generally included to distinguish the invention from the prior art.

3.61

The key consideration for such claims with respect to novelty is whether the claim may
be distinguished from prior art that prima facie possesses all the features of theinvention, but does not specifically disclose the defined parameter; or prior art thatprima facie possesses all the features of the invention but discloses a different
parameter. For example, if the known and the claimed products are identical in all otherrespects (which is to be expected if, for example, the starting products and the
manufacturing processes are identical), then in the first place an objection of lack ofnovelty would be appropriate. The burden of proof that the defined parameter is adistinguishing feature vis-à-vis the prior art is shifted to the applicant. If the applicant
fails to provide convincing evidence proving otherwise, no benefit of doubt can beaccorded (see for example decision T 1764/06). If, on the other hand, the applicant isable to show, e.g. by appropriate comparison tests, that differences do exist with respect
to the defined parameter, it may be further considered whether the application under
examination discloses all the features (e.g. process steps) essential to manufacture theclaimed product having the parameters specified in the claims, or the novelty objection
may otherwise be withdrawn.

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L.

Anticipation of “for” and “use” claims

3.62

A claim for a new method of using a known apparatus may be regarded as novel. Thiswas established by Parker J in Flour Oxidizing Co Ltd v Carr and Co Ltd 25 RPC 428:
“But when the question is solely a question of prior publication, it is not, in myopinion, enough to prove that an apparatus described in an earlier specification
could have been used to produce this or that result. It must also be shown that the
specification contains clear and unmistakable directions so to use it”.
However, the form of claim must be such as to limit the monopoly to the new use.

3.63

A claim to an apparatus for a particular purpose (e.g. for carrying out the process ofanother claim) is normally construed as a claim to an apparatus suitable for that purpose.
That is, the intended use does not restrict the claim to the apparatus when used in thatway (L’Air Liquide Societe’s Application 49 RPC 428). Accordingly any apparatus
which has all of the features specified in the claim and is suitable for that purpose will
anticipate that claim even if it is used for a different purpose. Furthermore, a claim to amaterial or composition for a particular purpose is regarded as a claim to the material
or composition per se (Adhesive Dry Mounting Co Ltd v Trapp and Co 27 RPC 341). A
known product which is per se the same as the material or composition defined in theclaim, but which is in a form which would render it unsuitable for the stated use, would
not deprive the claim of novelty. However, if the known product is in a form in which
it is in fact suitable for the stated use, though it has never been described for that use, itwould deprive the claim of novelty. A claim to, for example, the use of a known
substance as an additive to perform a particular function, is not novel if this function
was inherent (though unrecognised) in the prior art use of that substance. This iscontrary to G 2/88 Friction reducing additive, which determined that with respect to aclaim to the use of a known compound in a composition for a new non-medical purposeof friction reduction reflecting a newly discovered technical effect of said known
compound, the attaining of such technical effect should be considered as a functional
technical feature of the claim. However, the approach in G 2/88 should not be followed,
because such friction reduction would have inherently occurred in its previous use.

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3.64

Note that definitions such as “fish-hook” and “hook for fishing” are essentiallyequivalent. Accordingly a citation disclosing a hook that is suitable for this purpose
would anticipate a claim using either form.

3.65

An exception to this approach is a claim to a known substance or composition for use
in a surgical, therapeutic or diagnostic method. In this case the defined use does place alimitation on the scope of the claim. Thus a claim to “compound X for use in therapy”
would only be anticipated by a disclosure of the use of compound X in therapy and notby the disclosure of compound X in any non-therapeutic use. Anticipation of medical
use claims is further discussed in Section D in Chapter 8.

3.66

In some cases a term in a claim may appear to only require a product to be suitable fora specified use, but is in fact limited to a particular environment or interaction withanother element. For example, a claim to:“An isolating and matching device to enable a heating element of a motor vehicle
electrically heatable window, not designed specifically to be an aerial andessentially aperiodic and non-resonant at RF frequencies, to be used as a receiving
aerial …”
was held to define the matching device in association with the window heating element.
In this case the Court considered that in order to define the invention it was necessary
to take into account the interaction with the heating element in the window since eachwould have different impedance (BSH Industries Ltd’s Patents [1995] RPC 183).

3.67

Furthermore, if the prior art disclosure of the claimed matter is in a form which would
render it entirely unsuitable for the defined use it will not anticipate the claim. Similarly
if the prior art disclosure would require modification in order for it to be suitable for thedefined use, it will not anticipate the claim.

3.68

A claim to a product when used in a particular method is interpreted as a claim to amethod per se. For example, a claim to “compound X when used as a herbicide” is aclaim to a method of using compound X as a herbicide. Similarly, a claim to “the use ofcompound X as a herbicide” is interpreted as a method of using compound X as aherbicide. These claims would be anticipated only by a document disclosing such amethod.

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3.69

The novelty of product-by-process claims was considered in Element Six Technologies
Ltd v IIa Technologies Pte Ltd [2020] SGHC 26. In contemplating the key issue in suchclaims, Thean J referred to para 11.129 of Terrell on the Law of Patents (Colin Birss
gen ed, Sweet & Maxwell, 18th Ed, 2016):“A claim to a product when made by a new process is not enough in itself to makethe product new, for ‘it is still the same product even if made in a different way’.
However this is a rule of the law of novelty, not a rule of mandatory claim
interpretation. Thus the process feature in question has to be ignored for the
purposes of novelty but taken into account for the purposes of infringement andinsufficiency.” [emphasis added]
Thus, the essential issue for novelty is whether the product, when produced by theprocess is itself a new, or unique, product.

3.70

During examination, a product-by-process claim will generally be interpreted as a claim
to the product per se, irrespective of whether the term “obtained”, “obtainable”,“directly obtained” or an equivalent wording is used. For example,
1. A method of preparing Article X comprising the steps of …
2. Article X produced by the method of Claim 1.
Since Claim 1 is a method claim and Claim 2 is a product claim, the process steps ofClaim 1 would not limit product Claim 2. As a result, if the Examiner finds a prior art
which discloses Article X produced by a different process, Claim 2 would still lacknovelty even though Claim 1 might be novel.

3.71

An exception to the interpretation of a product-by-process claim will be where theprocess steps result in the product possessing unique properties. In such instances, theproduct-by-process claim would only be anticipated by a disclosure of a product withthe same unique properties or by a disclosure of a product produced by the same process
as defined in the claim. However, where there are no unique properties, the claim will
be anticipated by any disclosure of the product per se. This should be factored into thesearch strategy for the claim.

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3.72

A claim to a method or process for a particular purpose, depending on the wording of
the claim, should generally be understood in the sense that the method or process has tobe suitable for said purpose, rather than the method limited for said purpose (T 304/08
Method for reducing malodor/BASF). Consequently, a prior disclosure of the same
method or process, comprising the same steps and performed under the same conditions,but without an indication of its intended purpose, would nevertheless anticipate theclaim.

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M. Prior use
3.73

The state of the art as set out by Section 14 includes matter that is made available to the
public through prior use. Notably, the prior use must be in the public domain and does
not include secret use (the rights of secret prior users may be protected under Section
71). The information must have been made available to at least one member of the public
who, in that capacity, was free, in law and equity, to make use of it (PLG Research Ltd
v Ardon International Ltd [1993] FSR 197). However, if the viewer is bound by
confidentiality then it will not be taken to disclose the invention (J Lucas (Batteries) Ltdv Gaedor Ltd [1978] RPC 297).

3.74

In considering prior use, the UK Patents Act 1977 has determined that “it now requires
the prior use, to constitute anticipation, to have made available to the public an enabling
disclosure of the invention” (Quantel Ltd v Spaceward Microsystems Ltd [1990] RPC
83). Similarly in PLG Research v Ardon International Aldous J stated:“Under the 1977 Act, patents may be granted for an invention covering a productthat has been put on the market provided the product does not provide an enabling
disclosure of the invention claimed. In most cases, prior sale of the product will
make available information as to its contents and its method of manufacture, but it
is possible to imagine circumstances where that will not happen. In such cases a
subsequent patent may be obtained and the only safeguard given to the public issection 64 of the Act.”

3.75

The information made available to the public will depend on the nature of the invention
and the manner in which it has been made available. Relevant factors include whether
a member of the public had access to the invention in a manner that would allow themto handle, measure and test or whether they could merely look at it. Depending on thecircumstances a person skilled in the art might be able to determine how an article wasconstructed and operated but in other cases they may not (Lux Traffic Controls Ltd v
Pike Signals Ltd and Faronwise Ltd [1993] RPC 107). In Folding Attic Stairs Ltd v Loft
Stairs Co. Ltd. [2009] FSR 24 the Court determined that viewing of a prototype (in anon-public location) by a small and defined group of visitors without any duty ofconfidentiality was not novelty-destroying since it was highly improbable that thevisitors would or could have ascertained the features of the claimed invention.

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3.76

In contrast, in Milliken Denmark AS v Walk Off Mats Ltd and Anr [1996] FSR 292 theCourt held that the hiring of mats to customers who were free to inspect them amounted
to anticipatory prior use even though the mats relied on perforations not visible to thenaked eye for their function. In this case once an inspection had been carried out,knowledge of the perforations would be sufficient to enable the person skilled in the art
to perform the invention. This would provide an anticipation of the article per se, andfurthermore of the process of preparation if this could be deduced by the person skilledin the art.

3.77

In Merrell Dow Pharmaceuticals Inc v H N Norton & Co Ltd [1996] RPC 76, Lord
Hoffmann held that making matter available to the public requires the communicationof information since an invention is a piece of information. He went on to hold that theuse of a product makes an invention part of the state of the art only so far as that use
makes available the necessary information. Thus, acts which are done without
knowledge of the relevant facts, would not count as anticipations. However, they would
amount to infringement after the grant of the patent. In Merrell Dow the fact thatvolunteers in clinical trials had taken terfenadine and therefore had made the acidmetabolite in their livers, was held not to constitute anticipation by use. In contrast, in
Evans Medical Ltd’s Patent [1998] RPC 517, a prior art vaccine had been madeavailable to the public in such a way that it would have been possible to analyse it todetermine its contents.

3.78

In most cases prior use will be raised by an Examiner in relation to the invention being
displayed at an exhibition or read before a conference. This may be material that comesto light as a result of conference proceedings or internet disclosures (for example
photographs of a show display or newspaper articles). Alternatively there may bematerial filed by third parties. As a consequence, the Examiner is unlikely to be in aposition to test the evidence in relation to prior use, and particularly whether thedisclosure would be enabling to a person skilled in the art. In the case of prior use, theSingapore approach has followed the standard of proof required by the UK Intellectual
Property Office as follows:“In cases of alleged prior use, the required standard of proof is the balance of
probabilities. Within this standard, the Patents County Court in Kavanagh
Balloons Pty Ltd v Cameron Balloons Ltd, [2004] RPC 5 held that a flexible degree

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of probability should be applied to evidence relating to prior use. The cogency ofthe evidence had to match the occasion and be proportionate to the subject matter.
Because of the nature of the monopoly itself and question of public interest, nostricter standard should be applied. It was held that it was not necessary for an
opponent to prove his case ‘up to the hilt’ as had been required by the EPO
Technical Board of Appeal in Sekisui/shrinkable sheet, [1998] OJEPO 161 (T472/92). The hearing officer in Colley’s Application, [1999] RPC 97 also
distinguished from Sekisui by not requiring proof ‘up to the hilt’, but followed thisdecision and Demmeler Maschinenbau GmbH & Co KG (T 908/95) in holding thatmere assertion of prior use was insufficient: place, time and detail were essential.”
3.79

Accordingly the Examiner must weigh up the details provided in a disclosure and theevidence in response. Mere assertions (particularly by third parties) are unlikely to be
sufficient without details and supporting evidence of the nature of the alleged prior use.

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N.

Prior art under Section 14(3)3.80

Section 14(3) also provides for Singapore applications that were not published at thepriority date of the application to be taken into account for the purpose of determining
novelty:
The state of the art in the case of an invention to which an application for a patentor a patent relates shall be taken also to comprise matter contained in an application
for another patent which was published on or after the priority date of thatinvention, if the following conditions are satisfied:(a)that matter was contained in the application for that other patent bothas filed and as published; and

(b)
3.81

the priority date of that matter is earlier than that of the invention.

The usual requirements for anticipation are required: namely the citation must constitutea disclosure of the invention, and must be enabling. Prior art according to Section 14(3)cannot be taken into account for assessing obviousness.

3.82

It is a requirement that the relevant document is an application under the Singapore
Patents Act. This means that if the disclosure is in a PCT application, then thatapplication must have entered the Singapore national phase in order for it to be taken
into account under Section 14(3). Once the prior application has entered the Singapore
national phase, the subsequent fate of the application (whether it has been withdrawn,
lapsed, etc.) is not a relevant consideration and the document remains citable prior art.

3.83

In the event that a PCT application is cited in a search report as a P,X or E category
citation and it has been considered that the said PCT application may be relevant to theopinion for novelty under Section 14(3), the IPOS Patents Open Dossier (POD) website
may be consulted in order to confirm whether the application has entered the national
phase in Singapore. In the event that the period for the citation to enter the national
phase in Singapore has yet to expire (30 months from earliest priority), the Examinershould warn the applicant that it may become relevant under Section 14(3) if it later
enters the national phase in Singapore and reserve further comment.

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3.84

Only matter that was present both in the specification as filed and as published forms
part of the state of the art under Section 14(3).

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O.

Priority dates

3.85

Section 17 of the Act sets out the relevant considerations for priority:(1)

For the purposes of this Act, the priority date of an invention to which an
application for a patent relates and also of any matter (whether or not thesame as the invention) contained in the application is, except as provided by
the provisions of this Act, the date of filing the application.

(2)

Where in or in connection with an application for a patent (referred to in thissection as the application in suit) a declaration is made, whether by theapplicant or any predecessor in title of his, complying with the relevant
requirements of the rules and specifying one or more earlier relevant
applications for the purposes of this section made by the applicant or apredecessor in title of his, and the application in suit has a date of filing,
within the period referred to in subsection (3)(a) or (b), then(a)

if an invention to which the application in suit relates is supported bymatter disclosed in the earlier relevant application or applications, thepriority date of that invention shall, instead of being the date of filingthe application in suit, be the date of filing the relevant application inwhich that matter was disclosed or, if it was disclosed in more than one
relevant application, the earliest of them; and(b)the priority date of any matter contained in the application in suit which
was also disclosed in the earlier relevant application or applications
shall be the date of filing the relevant application in which that matter
was disclosed or, if it was disclosed in more than one relevant
application, the earliest of them.

3.86

Section 17(2) therefore permits the applicant to specify one or more earlier relevant
applications for the purposes of establishing the priority date of the invention to which
an application for a patent relates. Section 17(9) further specifies that a “relevant
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(b)an application in or for a convention country for protection in respect of an
invention or an application which, in accordance with the law of a convention
country or a treaty or international convention to which a convention country
is a party, is equivalent to such an application.

3.87

Hence, Section 17(9) prescribes the kinds of applications that may serve as the basis ofa valid priority claim under Section 17(2). Notably, what constitutes “protection in
respect of an invention” is not specified in the Act; however, it is likely that an
application for a patent (in a convention country) would fall under such a definition andhence be considered a relevant application. In addition, an application for theregistration of a utility model (e.g. German Gebrauchsmuster), for a utility certificate orfor an inventor’s certificate would each appear to be a relevant application so long as
the laws of the respective countries in which they are applied indicate that said
application is for protecting an invention. For example, a US provisional patentapplication would also be considered as a relevant application. However, an application
for a registered design is not a relevant application (Agfa-Gevaert AG’s Application[1982] RPC 441).

3.88

In order for the invention in an application to be accorded its claimed priority date,
Section 17(2) further prescribes that said invention must be supported by matter
disclosed in the earlier relevant application or applications that are the subject of thepriority claim.

3.89

In Element Six Technologies Ltd v IIa Technologies Pte Ltd [2020] SGHC 26, theSingapore High Court has adopted the “structured approach” referred to in Unwired
Planet International Ltd v Huawei Technologies Co Ltd and others [2017] Bus LR 1971
in considering questions of entitlement to priority under Section 17(2). The structured
approach is as follows:a)First, to read and understand, through the eyes of the person skilled in the art,
the disclosure of the priority document as a whole.

b)Second, to determine the subject matter of the relevant claim.

c)

Third, to decide whether, as a matter of substance and not form, the subject
matter of the claim can be derived directly and unambiguously from thedisclosure of the priority document.

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3.90

Thean J went on to summarise two further points of relevance made by the UK Courtof Appeal in Unwired Planet v Huawei:a)

The assessment of priority is not done by asking whether everything whichfalls within the claim is clearly and unambiguously taught by the priority
document. The exercise of determining priority involves asking whether theinvention is directly and unambiguously derivable from the priority
document, not whether every possible embodiment of the invention is so
derivable.

b)

The priority document must be read with the benefit of the common generalknowledge which forms the factual matrix against which the technicaldisclosure is assessed. Consequently, the disclosure may mean something
different to a person skilled in the art who possesses the requisite knowledge
than it does to someone reading the document without that knowledge. Thatobservation is particularly relevant in a case where one is concerned not
merely with what is made explicit by the document, but also with what is
implicit in it, given that both explicit and implicit disclosure may be taken
into account for priority. [emphasis added]

3.91

The disclosure in the earlier application must also enable the skilled person to work theinvention in accordance with the claim in the application in suit (Unilin Beheer BV v
Berry Floor NV [2004] EWCA (Civ) 1021 at [48], which was also referred to in
Unwired Planet v Huawei). Furthermore, it was held in Pharmacia Corp. v Merck &Co. Inc. [2002] RPC 41 that the technical contribution to the art contained in the earlier
application has to justify the claimed monopoly in the application in suit, such that theearlier application must contain sufficient information to constitute an enabling
disclosure across the entire width of the claim in the application in suit.

3.92

Thus, the focus of the enquiry is on whether the earlier application as a whole directly
and unambiguously, taking into account the common general knowledge of the skilled
person, discloses the subject matter of the claim in the application in suit whose priority
is in question. The disclosure may be explicit or implicit, and must enable the skilled
person to work the invention in accordance with the claim in the application in suit.
Depending on the facts of the case, the earlier application need not necessarily describe
every possible embodiment of the invention in order for it to disclose and enable the

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subject matter of the claim. For instance, where the claimed invention relates to aprinciple of general application, it may be sufficient that the earlier application describes
a limited number of individual embodiments of the general application. The number ofand extent to which the individual embodiments need to be disclosed will vary fromcase to case.
3.93

This is consistent with the position of the Enlarged Board of Appeal in G 2/98
Requirement for claiming priority of the “same invention”, in which it was held that
implicit disclosure in the earlier application may be taken into account. Notably, for apriority claim to be valid, the Enlarged Board was of the opinion that the skilled person
must be able to derive the subject matter of the claim of the application in suit “directly
and unambiguously, using common general knowledge, from the previous application
as a whole”. Hence, the subject matter present in a claim in the application in suit mustat least be implicitly disclosed in the earlier application in order for the priority claim to
be valid.

3.94

In T 843/03 Human papillomavirus/THE UNIVERSITY OF ROCHESTER the Board of
Appeal, in applying G 2/98, recognised that priority of a previous application in respectof a claim is to be acknowledged only if the skilled person can derive the subject matterof the claim directly and unambiguously, using common general knowledge, from theprevious application as a whole. Further, the priority document also has to provide an
enabling disclosure (cf. point (3) of the reasons for the decision), because an incomplete
technical disclosure cannot be seen as being “the same” as a complete one for the
purposes of establishing a right of priority for the same invention. The reasons for thedecision also mentions that it has been established in a number of decisions of theBoards of Appeal that sufficient disclosure (for enablement) presupposes that the skilled
person is able to obtain substantially all embodiments falling within the ambit of theclaims and, in order to reach this goal, may not be confronted with undue burden. Thisappears to be consistent with position of the UK Courts in the context of enablement forpriority claims as described in paragraph 3.91 above.

3.95

Since Section 17(2) permits the applicant to specify one or more earlier relevant
applications for the purposes of priority claims, it is therefore possible for the claims in
the application under examination to have different priority dates, depending on thefiling date of each of the earlier relevant applications. The priority date of a feature or

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combination of features, as defined in a particular claim, is the filing date of the earliest
application whose disclosure supports that feature or combination.
3.96

Examiners should exercise caution when dealing with applications claiming priority
from multiple earlier relevant applications with different filing dates. For suchapplications, a prior disclosure occurring after the earliest claimed priority date may still
be relevant for both novelty and inventive step for claims that are accorded a priority
date that is later than the earliest claimed priority date. The aforementioned principle
was illustrated in G 3/93 Priority interval, which provided the following example:−

On 1 January 1990, an applicant files an application P1 containing theelements A + B;−

On 1 February 1990, a document D is published containing the elements A +B;−

On 1 March 1990, the same applicant files an application P2 containing theelements A + B + C;−

On 1 June 1990, the same applicant files a European patent application with
Claim 1 containing the elements A + B, and Claim 2 containing the elements
A + B + C; priority is claimed from P1 and P2;

3.97

The Enlarged Board of Appeal stated that claim 2 in the European patent application
cannot derive priority from application P1, since P1 and claim 2 do not concern thesame invention. Therefore, claim 1 would be accorded the priority date of P1, whereas
claim 2 would only be accorded the priority date of application P2, which is later thanthe publication date of document D. As a consequence, D forms part of the state of theart in respect of claim 2, and is citable against claim 2. Under the same circumstances,
document D would analogously form part of the state of the art in respect of claim 2
should said claim have been filed in a Singapore patent application since the

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combination of A + B + C is only supported by P2, and would hence be accorded thepriority date of P2.
3.98

The Enlarged Board affirmed, in G 1/15, that it may be possible for a single claim tohave multiple priority dates if the claim defines more than one embodiment of theinvention in a manner such that each embodiment can be treated as a distinct part,complete in itself. For example, a claim directed to the elements A OR B may derivepriority from an application P1, disclosing element A, and from an application P2,
disclosing element B for use as an alternative to element A. The claim would hence beentitled to partial priority from the priority date of P1, and partial priority from thepriority date of P2.

3.99

As stated in Section 17(3), for the purposes of a priority claim, the application in suit
may be filed in the period of 12 months immediately following the date of filing of thespecified earlier relevant application or, if there is more than one relevant application,
the earliest of them. Sections 17(4)-(6) indicate certain exceptions in respect of theaforementioned period.

3.100 Section 17(7) further prescribes that:
Where an invention or other matter contained in the application in suit was also
disclosed in 2 earlier relevant applications filed by the same applicant as in the caseof the application in suit or a predecessor in title of his and the second of those
relevant applications was specified in or in connection with the application in suit,
the second of those relevant applications shall, so far as it concerns that invention
or matter, be disregarded unless —(a)

it was filed in or in respect of the same country as the first; and(b)

not later than the date of filing the second, the first (whether or not so
specified) was unconditionally withdrawn, or was abandoned or
refused, without —(i)having been made available to the public whether in Singapore
or elsewhere;(ii)

leaving any right outstanding; and(iii) having served to establish a priority date in relation to anotherapplication, wherever made.

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3.101 Section 17(7) deals with the situation where two (or more) earlier relevant applications
both contain the subject matter of the application in suit. The effect of this subsection isthat, in most circumstances, a valid priority claim may only be made to the first (orearliest) relevant application by the same applicant containing that matter. Notably, a
relevant application in the context of Section 17(7), is the same as that described inparagraphs 3.86 and 3.87 above. However, the subsection also provides an exception tothat position by which the applicant may validly claim priority to a second (orsubsequent) earlier relevant application. This exception only applies when certain
specific conditions have been met.
3.102 In particular, an applicant who files, in the same country, a second application and wants
to use it for priority purposes must therefore ensure that the first application has notbeen published or used to form the basis of a priority claim. He must also ensure that,at the time of filing the second application, the first application has been unconditionallywithdrawn, abandoned or refused “without leaving any rights outstanding”. Suchoutstanding rights may include the right to request for an extension of time limits under
Rule 108. In order for a priority claim to the second application to be valid, the applicant
therefore needs to ensure that any such outstanding rights on the first application have
explicitly been given up before or on the date of filing of the second application.
Withdrawing the first application and filing a second application while meeting these
conditions is often referred to as “regenerating the priority date”.
3.103 If the conditions for regenerating the priority date have not been met, and the applicationin suit is filed too late to use the first application as a basis for claiming priority (Section
17(3)), then the application in suit will not be able to use either the first or the second
application as a basis for claiming priority of the subject matter in question. The effectis that the priority date of that subject matter is the date of filing of the application insuit. If either of the earlier (first or second) applications has been published, then that
disclosure will also form part of the state of the art with respect to the application insuit.
3.104 In summary, for the application in suit to make a valid priority claim to an earlier
relevant application, the following conditions must be satisfied:

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(i)the earlier relevant application that is the subject of the priority claim must
be one of those referred to in paragraphs 3.86 and 3.87 (Sections 17(2) and17(9));(ii)

the earlier relevant application must be filed by the same applicant or apredecessor in title of his (Section 17(2));(iii) the invention to which the application in suit relates must be supported bymatter disclosed in the earlier relevant application (Section 17(2));(iv) the application in suit must be filed in the period of 12 months immediately
following the date of filing of the earlier relevant application (Section 17(3),subject to certain exceptions in Sections 17(4)-(6)); and(v)

the earlier relevant application must have been the first (earliest) application
containing the same subject matter as that in the application in suit (Section
17(7)).

3.105 During the search process, Examiners should identify as far as possible, all relevant
prior art immediately before the date of filing of a patent application, regardless ofwhether there is a priority declaration made in the patent application.
3.106 During the examination process, the Examiner will generally not investigate the validityof the priority claim. However, the Examiner shall do so when: i) there is a potential
prior art that is published on or after the priority date but before the date of filing of theapplication under examination; or ii) there is a prior application that is potentiallyrelevant under Section 14(3) whose priority date is on or after the priority date but before
the date of filing of the application under examination.
3.107 In addition, particular care should also be taken when the Examiner discovers apotentially relevant disclosure that is an application made by the same applicant (or his
predecessor in title) with an earlier priority date or date of filing, and is not the priority
document of the application under examination. In such an instance, the validity of thepriority claim of the application under examination may be called into question under
Sections 17(2) and 17(7) since, prima facie, the priority document is not the earliest
application containing the same subject matter as that in the application under
examination.

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3.108 In Singapore, priority documents are not furnished by the applicants as a matter ofcourse in all cases. They are to be furnished by the applicants when the Examiner
informs the Registrar of the need. However, the Examiner should exhaust all readily
available avenues first, including databases such as Patentscope, the European Patent
Register and USPTO Public PAIR, prior to requesting documents through the Registry.
3.109 Likewise, in the case of non-English priority documents, Rule 9C states that translations
need to be furnished only when required and where the validity of the claim to priority
is relevant to determining whether the invention concerned is patentable.

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P.

Exceptions to novelty: grace period

3.110 Sections 14(4)-(9) provide for certain matter to be disregarded for the purposes ofSection 14 – if the disclosure was made under certain circumstances, and within a 12month “grace period”:(4)

For the purposes of this section, the disclosure of matter constituting an
invention shall be disregarded in the case of a patent or an application for apatent if occurring later than the beginning of the period of 12 months
immediately preceding the date of filing the application for the patent andeither ―(a)the disclosure was due to, or made in consequence of, the matter having
been obtained unlawfully or in breach of confidence by any person —(i)from the inventor or from any other person to whom the matter
was made available in confidence by the inventor or who
obtained it from the inventor because he or the inventor believedthat he was entitled to obtain it; or(ii)

from any other person to whom the matter was made available inconfidence by any person mentioned in sub-paragraph (i) or inthis sub-paragraph or who obtained it from any person somentioned because he or the person from whom he obtained it
believed that he was entitled to obtain it;(b)the disclosure was made in breach of confidence by any person who
obtained the matter in confidence from the inventor or from any otherperson to whom it was made available, or who obtained it, from theinventor;(c)the disclosure was due to, or made in consequence of, the inventor
displaying the invention at an international exhibition;(d)

the disclosure was due to, or made in consequence of, the inventor
describing the invention in a paper read by him or another person withhis consent or on his behalf before any learned society or publishedwith his consent in the transactions of any learned society; or(e)subject to subsections (6) and (7), the disclosure was made to the publicby the inventor, or by a person who obtained the matter directly or

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indirectly from the inventor, in any circumstances not described inparagraphs (a) to (d).
(5)

In subsection (4)(d), learned society includes any club or association
constituted in Singapore or elsewhere whose main object is the promotion of
any branch of learning or science.

(6)

Subsection (4)(e) applies to the disclosure of matter constituting an invention
due to, or in consequence of, the publication by an intellectual property
administrator (being a person who obtained the matter directly or indirectlyfrom the inventor) of an application for an intellectual property right (being
an application containing the matter, but not being the application for a patentmentioned in subsection (4)), or a registration of an intellectual property right
pursuant to such an application, only if —(a)

the application was filed, without the consent of the inventor, by aperson who obtained the matter directly or indirectly from the inventor;or(b)

the publication was erroneous by reason that —(i)the application had been withdrawn, refused or abandoned before
the date of the publication; and(ii)

consequently, the publication was not required under the law(whether of Singapore or elsewhere) or treaty governing theapplication.

(7)

For the purposes of subsection (4)(e), where —(a)the disclosure of matter constituting an invention is due to, or inconsequence of, the publication by an intellectual property
administrator (being a person who obtained the matter directly or
indirectly from the inventor) of an application for an intellectual
property right (being an application containing the matter, but not being
the application for a patent mentioned in subsection (4)), or aregistration of an intellectual property right pursuant to such an
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(b)the publication was erroneous by reason that the publication occurredearlier than provided under the law (whether of Singapore orelsewhere) or treaty governing the application,

the matter is to be treated as disclosed to the public on the date when the
publication should have occurred under that law or treaty.
(8)

If the applicant relies on any circumstances described in any paragraph ofsubsection (4) when —(a)complying with section 29(1)(b) or (c), (3) or (9); or(b)making a request under section 29B(1) for a review of an examination
report issued under section 29(4) or a search and examination reportissued under section 29(5),the applicant must file written evidence complying with the prescribed
requirements in support of the applicant’s reliance on those circumstances.
(9)

In this section, references to the inventor include references to any proprietorof the invention for the time being.

3.111 Section 14(4) provides for circumstances in which disclosures made prior to the filingof a patent application are to be disregarded during the determination of the “state of
the art”. Since Section 14(1) takes reference from Sections 14(2) and 14(3), and Section
15 takes reference from Section 14(2), in respect of the state of the art, any disclosurethat is disregarded under Section 14(4) cannot be used for the assessment of novelty andof inventive step. The criteria for a disclosure to be disregarded under Section 14(4) inrespect of a patent or a patent application are as follows:1)

The disclosure should be of “matter constituting an invention”;

2)

The disclosure must be made within the period of 12 months immediately
before the date of filing the application for the patent; and3)

The disclosure should be due to the circumstances described in Sections
14(4)(a)-(e).

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If the aforementioned criteria 1) to 3) are met, a disclosure of “matter constituting an
invention” which would otherwise qualify as prior art shall be disregarded from the stateof the art.
3.112 Notably, Section 14(4) specifies that the disclosure must be made within the period of
12 months before the date of filing the application. This means the date of filing theapplication in Singapore and not the date of filing the priority document (for example
the basic document in a foreign country). Examiners should not disregard any disclosureof matter constituting an invention where the disclosure occurred before theabovementioned period.
3.113 Section 14(8) specifies that if the applicant intends to rely on any of the circumstances
described in Sections 14(4)(a)-(e) when requesting for an examination report, a searchand examination report, a review of an examination report or a review of a search andexamination report, or when responding to a written opinion issued by an Examiner, theapplicant must file written evidence complying with the prescribed requirements insupport of the reliance on those circumstances. The prescribed requirements are set out
in Rule 8 of the Patents Rules. Rule 8(1)(a) requires that the supporting written evidence
must be by statutory declaration or affidavit, and must enclose all supporting
documents.
3.114 In general, the onus is on the applicant to make out a sufficient prima facie case in thestatutory declaration or affidavit (in which all supporting documents are to be enclosed)that one of the circumstances in Sections 14(4)(a)-(e) is satisfied.
3.115 Sections 14(4)(c) and 14(4)(d) provide for the disregarding of inventor-originateddisclosures made at international exhibitions or before a learned society (see subsection
i of this Section on “Learned society”), while Section 14(4)(e), which allows thedisregarding of public disclosures of matter constituting an invention by the inventor,
or by a person who obtained the matter directly or indirectly from the inventor, provides
for the disregarding of other forms of inventor-originated disclosures that do not fallwithin the circumstances in Sections 14(4)(a) to 14(4)(d). Where Section 14(4)(c) or
14(4)(d) is claimed, the written evidence that is filed by the applicant under Section
14(8) should show that the disclosure was “due to, or made in consequence of, theinventor”, whereas if Section 14(4)(e) is claimed, the supporting written evidence

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should show that the disclosure was made to the public “by the inventor, or by a person
who obtained the matter directly or indirectly from the inventor”.
3.116 Disclosures made by a joint inventor are to be treated as disclosures made by aninventor. In respect of a printed publication, it is apparent that a disclosure is by theinventor (or joint inventors) if said disclosure:a)Names the inventor (or joint inventor(s)) as an author; andb)

Does not name additional persons as authors.

3.117 To explain this point, where the application does not name additional persons as joint
inventors relative to the persons named as authors in the printed publication (e.g. theapplication names as joint inventors A, B, and C, and the printed publication names as
authors A and B), it would be apparent that the disclosure is made by the inventor (orjoint inventor(s)), and the printed publication should be disregarded by the Examiner asprior art during examination if it was published within 12 months immediately before
the date of filing the application. In such a situation, the applicant is not required tosubmit supporting written evidence. If, however, the application names fewer joint
inventors than the printed publication (e.g. the application names as joint inventors A
and B, and the publication names as authors A, B and C), then it would not be readily
apparent from printed publication alone, that the disclosure is by the inventor (or joint
inventor(s)). In such a situation, for the printed publication to be disregarded under
Section 14(4), the applicant would need to submit written evidence enclosing supporting
documents (that makes out a sufficient prima facie case) to demonstrate otherwise(pursuant to Rule 8(1)(a), the applicant must enclose all supporting documents in his
statutory declaration or affidavit). In the absence of evidence of the contrary, an“unequivocal” statement in the statutory declaration that the inventor or joint inventor(or some specific combination of named inventors) invented the subject matter of thedisclosure accompanied by a reasonable explanation of the presence of additional
authors may be acceptable. Supporting documents demonstrating inventorship may be
filed together with the statutory declaration as well.
3.118 In respect of other kinds of disclosures (other than printed publications), the supporting
documents enclosed with the written evidence that is filed by the applicant under
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(a)(If Section 14(4)(c) or 14(4)(d) is claimed) show that the disclosure was “dueto, or made in consequence of, the inventor”; or(b)(If Section 14(4)(e) is claimed) show that the disclosure was made to the
public “by the inventor, or by a person who obtained the matter directly or
indirectly from the inventor”.

3.119 While an intellectual property administrator may be considered a person who obtained
matter constituting an invention “directly or indirectly from the inventor” (because of
Section 14(6)), Section 14(4)(e) does not permit an inventor’s (or joint inventors’) own
applications for intellectual property rights (e.g. patent applications, utility models, etc.)from being disregarded, unless under the very limited circumstances prescribed in
Sections 14(6) and 14(7). These circumstances are likely to be rare, and hence aninventor’s (or joint inventors’) own earlier patent applications would normally form partof the state of the art under Section 14(2) or Section 14(3).
3.120 In accordance with the savings and transitional provisions of the Patents (Amendment)
Act 2017, Sections 14(4)(e), 14(6) and 14(7) only apply to disclosures of matter
constituting an invention, made to the public on or after 30 October 2017 (i.e. the dateof commencement of Sections 14(4)(e), 14(6) and 14(7)). Hence, it should be noted thatthe applicant may rely on Sections 14(4)(e), 14(6) and 14(7) to disregard an inventororiginated disclosure only if said inventor-originated disclosure itself was made to the
public on or after 30 October 2017.
3.121 In any case, any disregarded disclosures, discovered by the Examiner or declared by theinventor/applicant, should still be documented during the course of search or
examination of an application along with appropriate indication of the relevance of said
disclosure to the prosecution of the application. For search reports, a disclosure that is
likely to be disregarded at the examination stage may be indicated as an L-category
citation. For written opinions (or examination reports), an appropriate comment may bemade in Box V in respect of any disregarded disclosures.
3.122 The statutory declaration or affidavit filed for the purposes of Section 14(8) should
contain facts about the contents of the disclosure, the date of the disclosure, and theidentity of the disclosing entity and its link to the inventor. These, and other related
facts, must be laid out to the extent that allows the Examiner to establish that the

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disclosure is: 1) of matter constituting the invention in the application; 2) was madewithin the period of 12 months immediately before the date of filing the application;and 3) satisfies the link to the inventor in the relevant Section 14(4) ground that isclaimed (e.g. if Section 14(4)(e) is claimed, the link to the inventor to be satisfied is “bythe inventor or by a person who obtained the matter directly or indirectly from theinventor”).
3.123 In the case where the applicant claims the international exhibitions ground in Section
14(4)(c), the supporting written evidence must (i) state that the invention to which theapplicant’s application relates was in fact displayed at an international exhibition; (ii)state the opening date of the exhibition and, where the first disclosure of the invention
did not take place on the opening date, the date of the first disclosure; and (iii) enclose
one or more supporting documents identifying the invention that was displayed at theexhibition (Rule 8(1)(b)).
3.124 In the case of erroneous publications by a foreign intellectual property office, thesupporting written evidence must enclose an acknowledgment from the foreign
intellectual property office stating that the publication was erroneous and the reason forthe publication being erroneous, and if Section 14(7)(b) applies, stating the earliest dateon which the publication ought to have been made under the law or treaty governing theerroneously published application (Rule 8(1)(c)).
3.125 For PCT national-phase (SG) entry applications that claim the international exhibitions
ground in Section 14(4)(c), when the applicant files a request for examination with
IPOS, the Examiner will note that a disclosure at an international exhibition was madeat the international phase and this fact is mentioned in the international search report(Rule 33.1 of the PCT Regulations). While the Examiner may be aware of said
disclosure at an international exhibition from the international search report, theapplicant must still file the requisite written evidence under Section 14(8).

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Learned society
3.126 A learned society includes any club or association constituted in Singapore or elsewhere
whose main object is the promotion of any branch of learning or science (Section 14(5)).
This suggests that a “learned society” includes any body of persons seeking to promote
and organize the development of specific subjects, usually by the provision of a forum
for the exchange and discussion of ideas and the dissemination of information, usually
through the publication of its proceedings. However, some caution should be exercisedin how this provision is applied. For example a meeting organized by a government
department, university department or company may in some instances not constitute alearned society. On the other hand a conference organized by the Royal Society ofChemistry or IEEE would generally be considered a learned society.
3.127 In Ralph M. Parsons Co (Beavon’s) Application [1978] FSR 226, it was considered thatlearned societies would disseminate the relevant learning without consideration of
economic gain. Thus, a learned society would normally be a non-commercial body of
persons, and is not typically associated with commercial exploitation. For a publication
to be regarded as a “transaction” of a learned society, it has to be published under the
auspices of and finally be the responsibility of the learned society. Therefore, apublication that occurs via a third party, such as a reporter, who is present at theconference, would not be regarded as a publication by the society.
3.128 In Western Minerals Technology Pty Ltd v Western Mining Corporation Limited [2001]
APO 32, a conference organized by the Camborne School of Mines (CSM) was
considered to be a conference organized by “an institution of higher learning,
conducting teaching and research at the undergraduate and postgraduate level”. CSM
was not regarded as a learned society as there was no evidence that it was “a society
made up of persons seeking to promote and organize the study of specific subjects by
the provision of a forum for discussion and a means of contact for those of a common
interest”. The participants at the conference, which might comprise highly learned
individuals, were not a consideration for the case. The Delegate considered theparticipants to represent an ad hoc group – “a wide range of people, for example fromacademia, research institutes, industry and consultancy” who had responded to “notices
placed in international journals and the like”. The publication of the conference

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proceedings in the journal Minerals Engineering Vol. 4, Nos.7-11, 1991, entitledSpecial Issue Material Engineering ’91 was also clearly not by a learned society, but by
Pergamon Press Plc, a publishing company.

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4.

INVENTIVE STEP

A.

Statutory requirements

4.1

Section 13(1)(b) states that a patentable invention is one that involves an inventive step.

4.2

Section 15 sets out the meaning of an inventive step:
An invention shall be taken to involve an inventive step if it is not obvious to aperson skilled in the art, having regard to any matter which forms part of the stateof the art by virtue only of Section 14(2) and without having regard to Section
14(3).

4.3

Section 14 sets out a definition for the state of the art as follows:(2) The state of the art in the case of an invention shall be taken to comprise all
matter (whether a product, a process, information about either, or anything else)
which has at any time before the priority date of that invention been made available
to the public (whether in Singapore or elsewhere) by written or oral description, by
use or in any other way.
(3) The state of the art in the case of an invention to which an application for apatent or a patent relates shall be taken also to comprise matter contained in an
application for another patent which was published on or after the priority date ofthat invention, if the following conditions are satisfied:(a)That matter was contained in the application for that other patent bothas filed and as published; and(b)Version: Oct 2023

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B.

General principles

4.4

A claim lacks novelty if every element or step is explicitly or inherently disclosed within
the prior art. The condition of inventive step is a separate consideration which
essentially involves a consideration of whether the invention, when compared to thestate of the art at the priority date of the application, would have been obvious to aperson skilled in the art. As a consequence, inventive step may alternatively be referred
to as obviousness.

4.5

Lord Hoffmann gave an overview of inventive step in Biogen Inc v Medeva plc [1997]
RPC 1 (at page 34) as follows:“Whenever anything inventive is done for the first time it is the result of the additionof a new idea to the existing stock of knowledge. Sometimes, it is the idea of using
established techniques to do something which no one had previously thought ofdoing. In that case the inventive idea will be doing the new thing. Sometimes it isfinding a way of doing something which people had wanted to do but could notthink how. The inventive idea would be the way of achieving the goal. In yet othercases, many people may have a general idea of how they might achieve a goal but
not know how to solve a particular problem which stands in their way. If someone
devises a way of solving the problem, his inventive step will be that solution, but
not the goal itself or the general method of achieving it.”

4.6

As noted in Trek Technology (Singapore) Pte Ltd v FE Global Electronics Pte Ltd[2005] 3 SLR(R) 389, the legal test for inventive step in Singapore is as set out inWindsurfing International Inc. v Tabur Marine (Great Britain) Ltd [1985] RPC 59 (seeSection D in this Chapter).

4.7

Objections should be structured to reflect these considerations. However, there is noneed to specifically address each consideration if the particular issue is self-evident fromthe material on file. In First Currency Choice Pte Ltd v Main-Line Corporate Holdings
Ltd and Another Appeal [2007] SGCA 50, the Court considered the rationale
underpinning the requirement of obviousness was as set out by Millett LJ in PLG
Research Ltd v Ardon International Ltd [1995] RPC 287:

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“[T]he public should not be prevented from doing anything which was merely an
obvious extension or workshop variation of what was already known at the priority
date …
… There are many cases in which obviousness has been held not to have been
established, even though the prior art relied upon was very close … Where theprior art yields many possible starting points for further development, it may not
be obvious without hindsight to select a particular one of them for the development
which leads to the invention claimed. If the patentee has come up with a solution
to his problem which is no more than an obvious extension or workshop variation
to some piece of the prior art, he cannot have a monopoly for his solution whether
or not the skilled man would be likely to have known of the prior art in question.
On the other hand, if it is found that, even if he had known of it, the skilled man
would not have regarded it as the obvious starting point for the solution of the
problem with which he was confronted, this will usually demonstrate that his
discovery was not an obvious extension or mere workshop variation of that prior
art.”
4.8

Inventive step is assessed at the priority date of the claim in question. As noted by
Jacob LJ:“… one might assume that when an invention becomes obvious it must remain so
thereafter. But such an assumption would be wrong: obviousness must be
determined as of a particular date. There is at least one other well-known example
showing how an invention which might be held obvious on one date, would not be
so held at a later date. That is where there has been commercial success following
a long-felt want. Time can indeed change one’s perspective. The perspective thecourt must bring to bear is that of the skilled man at the priority date and not any
earlier time.”

4.9

Inventive step is an objective determination. As noted by the Court of Appeal inWindsurfing International Inc. v Tabur Marine (Great Britain) Ltd [1985] RPC 59:“the question of whether the alleged invention was obvious has to be answered
objectively by reference to whether, at the material time (that is, immediately prior

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to the priority date), the allegedly inventive step or concept would have been
obvious to a skilled addressee” and that “what has to be determined is whether
what is now claimed as inventive would have been obvious, not whether it would
have appeared commercially worthwhile to exploit it.”
4.10

The key question is whether the invention would have been obvious to a hypotheticalperson skilled in the art, and not whether it would have been obvious to the inventor ora particular expert in the particular technology. Moreover, the particular circumstancesby which the inventor developed the invention are also not a relevant consideration. For
example, it is not a relevant consideration that the inventor developed an invention in afield which is remote from their own field of expertise (see for example EP Board of
Appeal decision in T36/82). Similarly the fact that a researcher has developed aninvention with no knowledge of particular prior art would not be a relevant
consideration (Allmanna Svenska Elektriska AB v The Burntisland Shipbuilding Co Ltd
69 RPC 63).

4.11

“Inventive step” determination is a wholly objective qualitative test and is not aquantitative test in as much as it does not involve a consideration of whether the patent
discloses something sufficiently inventive to deserve the grant of a monopoly. That is,a small inventive step will suffice for the grant of a patent (Prakash J in Ng Kok Chengv Chua Say Tiong [2001] 3 SLR 487, citing Molnlycke AB v Procter & Gamble Ltd[1994] RPC 49).

4.12

As noted by the Court in FE Global Electronics Pte Ltd v Trek Technology (Singapore)
Pte Ltd [2006] 1 SLR 874, care should be taken in assessing inventiveness, particularly
where the technology appears relatively simple:“… some may view the invention as a simple one but simplicity has never been abar to inventiveness and it has been reiterated often enough that ex post facto
analysis can often be unfair to inventors”

4.13

As stated by Aldous L. J in Beloit Technologies Inc v Valmet Paper Machinery Inc[1997] RPC 489:
“The court must put on ‘the spectacles’ of the notional skilled addressee at thepriority date of the patent and, using such contemporary evidence as there may be,

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make sure that any conclusion reached is not the result of hindsight.”
4.14

In a similar vein, Lawton L. J in Jamesigns (Leeds) Ltd’s Application [1983] RPC 68
noted that:“[H]indsight is not the mother of invention”.

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C.

Avoiding hindsight: the test for inventive step

4.15

A significant issue in examination is the use hindsight or ex post facto analysis. The
Examiner should attempt to place themselves in the shoes of the person skilled in theart faced with the problem. This is difficult in practice since the Examiner approaches
the consideration having both the problem and the solution in hand. Various approaches
have been developed by the Courts to minimise the danger of hindsight in theirconsiderations, and in Singapore the Courts have adopted the so-called “Windsurfing
approach”. Wherever possible the principles of this test should be followed in
examination.

4.16

Nevertheless, as noted Jacob LJ in Angiotech Pharmaceuticals v Conor Medsystems Inc[2007] EWCA Civ 5, the threshold question is a relatively simple one:“… one can over-elaborate a discussion of the concept of ― obviousness so that it
becomes metaphysical or endowed with unwritten and unwarranted doctrines, subdoctrines or even sub-sub-doctrines. … In the end the question is simply ― was
the invention obvious?”

4.17

Similarly, in First Currency Choice Pte Ltd v Main-Line Corporate Holdings Ltd [2008]
1 SLR(R) 335, the Court recognised that it may be appropriate in some cases to apply asimpler approach:“Be that as it may, simplicity is certainly to be appreciated, and, in assessing theobviousness of an alleged invention, it may sometimes suffice in straightforward
cases to refer to the test formulated by Lord Herschell in Vickers, Sons And Co,
Limited v Siddell (1890) 7 RPC 292, where he stated (at 304) that an invention
lacked an inventive step if what was claimed was ‘so obvious that it would at once
occur to anyone acquainted with the subject, and desirous of accomplishing theend’. Quite often, it is difficult, in practice, to break down the Windsurfing test …
into its component parts. Thus, while the Windsurfing test remains a useful guide,
it is no more than that. Above all, it should be borne in mind that the Windsurfing
test is merely a manifestation of judicial inventiveness on how best to pragmaticallyinterpret and elucidate the requirements of s 15 of the Act.”

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D.

The “Windsurfing test”

4.18

The test set out in Windsurfing International Inc. v Tabur Marine (Great Britain) Ltd[1985] RPC 59 has been adopted in a number of Singapore Court decisions, including:
V-Pile Technology (Luxembourg) SA and Others v Peck Brothers Construction Pte Ltd[2000] 3 SLR 358; Merck & Co Inc v Pharmaforte Singapore Pte Ltd [2000] 3 SLR
717; Genelabs Diagnostics & Anor v Institut Pasteur & Anor [2001] 1 SLR 121; Ng
Kok Cheng v Chua Say Tiong [2001] 3 SLR 487; Peng Lian Trading Co v Contour
Optik Inc & Ors [2003] 2 SLR 560; Trek Technology (Singapore) Pte Ltd v FE Global
Electronics Pte Ltd [2005] 3 SLR(R) 389; First Currency Choice Pte Ltd v Main-Line
Corporate Holdings Ltd and Another Appeal [2007] SGCA 50; and Martek Biosciences
Corporation v Cargill International Trading Pte Ltd [2012] SGHC 35.

4.19

The UK Court of Appeal in Windsurfing held that the question of obviousness“has to be answered, not by looking with the benefit of hindsight at what is known
now and what was known at the priority date and asking whether the former flows
naturally and obviously from the latter, but by hypothesizing what would have been
obvious at the priority date to a person skilled in the art to which the patent in suit
relates.”

4.20

In order to reduce the risk of hindsight, the Court formulated a four-step approach toassessing obviousness:
1)

Identify the claimed inventive concept.

2)

Assume the mantle of the normally skilled but unimaginative addressee inthe art at the priority date and to impute to him what was, at that date,common general knowledge of the art in question.

3)

Identify what, if any, differences exist between the matter cited as being“known or used” and the alleged invention.

4)

Decide, without any knowledge of the alleged invention, whether thesedifferences constitute steps which would have been obvious to the person
skilled in the art or whether they require any degree of invention.

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4.21

When using this framework, Examiners should note that the third step refers to mattercited as being “known or used”. This was the language of the previous UK Patents Act.
Examiners should ensure that they have regard to the “state of the art” and use such aterm in the objection.

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E.

The modified “Windsurfing test”: the “Pozzoli” approach

4.22

The “Windsurfing approach” was elaborated upon by Jacob LJ in Pozzoli SPA v BDMOSA [2007] EWCA Civ 588. Singapore Courts have not formally adopted this modified
test, but in any case the differences are essentially in form rather than substance. Jacob
LJ provided the following reasoning:“First one must actually conduct the first two operations in the opposite order –mantle first, then concept. For it is only through the eyes of the skilled man thatone properly understand what such a man would understand the patentee to havemeant and thereby set about identifying the concept.
Next, that first step actually involves two steps, identification of the attributes of
the notional ‘person skilled in the art’ (the statutory term) and second identificationof the common general knowledge (‘cgk’) of such a person.”

4.23

Thus, the modified test can be summarised as follows:1)(a) Identify the notional “person skilled in the art”(b) Identify the relevant common general knowledge of that person;

2)

Identify the inventive concept of the claim in question or if that cannot readily
be done, construe it;

3)

Identify what, if any, differences exist between the matter cited as forming
part of the “state of the art” and the inventive concept of the claim or theclaim as construed;

4)

Viewed without any knowledge of the alleged invention as claimed, do thosedifferences constitute steps which would have been obvious to the person
skilled in the art or do they require any degree of invention?

4.24

While this modified test has not formally been adopted by the Singapore Courts,
Examiners may use the “Pozzoli” approach when formulating an inventive step
objection. Steps (1)(a) and (1)(b) are required in any case when construing a claim, so
in essence the “Pozzoli” approach merely articulates an implicit step in the Windsurfing
test.

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F.

The inventive concept

4.25

The inventive concept is determined by the technical facts of the case in question. In
Generics (UK) Limited v H Lundbeck A/S [2009] UKHL 12, Lord Walker stated that:“‘Inventive concept’ is concerned with the identification of the core (or kernel, or
essence) of the invention—the idea or principle, of more or less general application(see Kirin-Amgen, [2005] RPC 169 paras 112-113) which entitles the inventor’sachievement to be called inventive. The invention’s technical contribution to theart is concerned with the evaluation of its inventive concept—how far forward has
it carried the state of the art? The inventive concept and the technical contribution
may command equal respect but that will not always be the case.”

4.26

Lord Neuberger agreed with Lord Walker stating:“‘Inventive step’ suggests how something has been done, and, in the case of a
product claim at any rate, one is primarily concerned with what has been allegedly
invented, not how it has been done. On the other hand where the claim is for aprocess or (as in Biogen, [1997] RPC 1) includes a process, the issue of how thealleged invention has been achieved seems to be more in point.”

4.27

Jacob J observed in Unilever PLC v Chefaro Proprietaries Ltd [1994] RPC 567 at page580 (cited with favour in ASM Assembly Automation Ltd v Aurigon Technology Pte
Ltd and Others [2009] SGHC 206):“It is the inventive concept of the claim in question which must be considered, notsome generalised concept to be derived from the specification as a whole. Different
claims can, and generally will, have different inventive concepts. The first stage ofidentification of the concept is likely to be a question of construction: what does
the claim mean? It might be thought there is no second stage -- the concept is what
the claim covers and that is that. But that is too wooden and not what courts,
applying Windsurfing stage one, have done. It is too wooden because if one merely
construes the claim one does not distinguish between portions which matter andportions which, although limitations on the ambit of the claim, do not. One is trying
to identify the essence of the claim in this exercise.”

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4.28

Finding the essence of a claim will involve constructing something akin to a précis of
the claim – essentially stripping out unnecessary verbiage from the purposively
construed claim. In Raychem Corp.’s Patents [1998] RPC 31 it was noted that a properly
drafted claim will state the inventive concept concisely. However, where claims areprolix and opaque the Court should break free of the language and concern itself withwhat they really meant. In particular, Laddie J noted:“One of the arguments advanced … was that Raychem’s patents were an exercise
in what has become known amongst patent lawyers as parametritis. This is thepractice of seeking to repatent the prior art by limiting claims by reference to aseries of parameters which were not mentioned in the prior art. Sometimes it
includes reference to parameters measured on test equipment which did not exist
at the time of the prior art. The attraction of this to a patentee is that it may be
impossible to prove now that the prior art inevitably exhibited the parameters andtherefore it is impossible for an opponent to prove anticipation …
There is another practice which can be used to obscure the patentee’s contribution,
if any, to the art. This takes the form of drafting claims in an unnecessarily
complicated way so that they are difficult to work through … Unnecessary
obscurity is not a separate ground for invalidating a claim. Within wide limits apatentee can use what language he likes to define his invention. But the court has
to guard against being impressed by the form and language of the claims rather
than the substance of the patentee’s alleged technical contribution.
In all cases, and no matter what the nature of the attack on validity or arguments
on infringement, the court must have in mind the first of the four steps set out inWindsurfing International Inc. v. Tabur Marine (Great Britain), [1985] RPC 59.
It must identify the inventive concept embodied in the claims. In many cases theclaim will state that concisely. That is what a properly drafted claim should do.
The first step in Windsurfing does not require the court to substitute its own
language for that of the patentee if the latter is clear. But where, as here, the claims
are prolix and opaque it should break free of the language and concern itself withwhat the claims really mean.”

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4.29

Furthermore, while the inventive concept can be broader than the claim (because
immaterial features of the claim may be ignored), it cannot be narrower than the claim.
In Datacard Corp. v Eagle Technologies Ltd [2011] RPC 17, Arnold J held that theinventive concept cannot be defined in terms which apply only to a narrow sub-groupof embodiments with certain technical advantages, and which do not apply to the restof the claim. If the patentee has chosen to claim the invention broadly, the inventive
concept must be of at least equivalent breadth.

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G.

The starting point for the inventive step consideration

4.30

The applicant may set out the starting point for the inventive step consideration, often
by stating the problem to be solved, or by setting out the prior art. However, Examiners
are not bound by such statements by the applicant, and can approach the considerationfrom a different direction. In some cases, the same invention may be arrived at from anattempt to solve different problems, in some cases with a different level of inventive
step.

4.31

Any document from the state of the art as set out in Section 14(2) may be used as thestarting-point for an inventive step objection. The general principle was set out by
Laddie J in Pfizer Ltd’s Patent [2001] FSR 16:“A real worker in the field may never look at a piece of prior art for example hemay never look at the contents of a particular public library or he may be put off
because it is in a language he does not know. But the notional addressee is taken
to have done so. This is a reflection of part of the policy underlying the law ofobviousness. Anything which is obvious over what is available to the public cannot
subsequently be the subject of valid patent protection even if, in practice, few would
have bothered looking through the prior art or would have found the particular
items relied on.”

4.32

As a consequence an inventive step objection will not be overcome by merely arguingthat the person skilled in the art would have been unaware of the document, if that
document has been made public anywhere in the world, in any language, at any time
before the priority date. See also Wake Forest University Health Sciences & Ors v Smith& Nephew Plc & Anor [2009] EWCA Civ 848, where a document that was shown to beavailable in only four libraries in the former Soviet Union was nonetheless available foruse in an inventive step argument.

4.33

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1)

whether the person skilled in the art could reasonably be expected to find the
document when conducting a diligent search for material relevant to the
problem in hand; and2)whether if he had found the document, he would have given it serious
consideration. In some cases the age of the document may be relevant, as
may be whether, if it is one of a large number of relevant documents, there
was any reason why the person skilled in the art should have selected thisparticular document.

4.34

However, any piece of prior art must be viewed through the eyes of the person skilledin the art at the priority date. The prior art may teach towards the invention, but on theother hand, it may cause the person skilled in the art to disregard it. Examiners should
ensure that they take all common general knowledge into consideration, including prior
art that teaches away from the invention. For example, in Actavis v Merck, [2008] RPC
26, the invention involved the treatment of alopecia (baldness). A published document
indicated that a particular drug was useful for the treatment of this ailment. However,
the Court of Appeal found that at the priority date of the application, the common
general knowledge in the field was that this drug was ineffective at any dosage.
Accordingly, claims to the treatment at a particular dosage were found inventive.

4.35

In some cases, there may be a relatively short time lapse between the publication of adocument and the priority date of the application under consideration. However, this is
not a consideration – the question is whether the claimed invention is obvious over theprior art, not whether there would in fact be time to arrive at the invention by the priority
date (Merck Sharp & Dohme Corp v Teva UK Ltd [2011] EWCA Civ 382).

4.36

On the other hand, a document may be relatively old, and submission made along thelines that if it was obvious why wasn’t it done sooner? This argument was addressed by
Laddie J in Brugger and others v Medic-Aid Ltd [1996] RPC 635:
“The fact that a document is old does not, per se, mean that it cannot be a basis
for an obviousness attack. On the contrary, if a development of established andageing art is or would be obvious to the skilled worker employed by a hungry new
employer, it cannot be the subject of valid patent protection even if those who havebeen in the trade for some time, through complacency or for other reasons, have

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not taken that step. Each pleaded piece of prior art must therefore be assessed as
if it was being considered afresh at the priority date. It is not to be excluded fromthis exercise merely because it is old. There is no rule of commerce that every new
product or process must be developed and put on the market or published inliterature as soon as it becomes obvious.
It is only when the answer to the question ‘why was this not developed earlier’ is‘a likely and reasonable explanation is that people looking for a way round an
existing problem did not see this as the answer’ that the age of the prior art shouldplay a part in meeting an obviousness attack. If it is likely that in the real world noone was looking for an answer the fact that none was found says nothing about
whether the answer proposed in the patent under attack was obvious.” [emphasis
added]
4.37

Another area in which old documents are particularly relevant in a consideration of
inventive step is where technological advances make a previously impractical invention
viable. For example, a particular invention may not be commercially viable because thecost of materials render it too expensive. However, the development of new materials
or new processes for the preparation of materials may make such inventionscommercially viable.

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H.

Combining disclosures (“mosaicing”) for inventive step

4.38

While any single disclosure forming the state of the art may be used for a considerationof inventive step, when combining two or more disclosures an assessment of whether
the person skilled in the art would combine such disclosures must first be undertaken.

4.39

In ASM Assembly Automation Ltd v Aurigin Technology Pte Ltd and others [2009]
SGHC 206, Tan J stated that:“one is entitled to make a ‘mosaic’ out of relevant documents if it can be put
together by an unimaginative man with no inventive capability (see Technographv Mills & Rockely, [1972] RPC 346)”

4.40

Tay JC referred to the UK decision in Lowndes Patent [1928] 45 RPC 48:“it is not open to you to take a packet of prior documents and by putting a puzzle
together to produce what you say is a disclosure in the nature of the various
elements which have been contained in the prior documents … it is necessary topoint to a clear and specific disclosure of something which is said to be like thepatentee’s invention.”

4.41

In Martek Biosciences Corporation v Cargill International Trading Pte Ltd [2012]
SGHC 35, Tay J referred to an article by Ng-Loy Wee Loon in Law of Intellectual
Property of Singapore (Sweet & Maxwell Asia, Rev Ed, 2009) at 30.1.50:“… the skilled addressee assesses the obviousness of an invention by reference tothe whole of the state of the art relevant to this invention, whereas he assesses thenovelty of the invention by reference to each individual piece of prior art in thisstate of the art. There is, however, an exception to this scenario: ‘mosaicing’ is not
permitted in the obviousness inquiry if it would not be obvious to the skilledaddressee to ‘mosaic’ the different pieces of prior art.”

4.42

Tay J went on to consider whether it would have been obvious to the person skilled in
the art to mosaic the documents. Notably, this “obvious to combine” does notnecessarily require an express cross reference in the documents in order for an inventive
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statements by Laddie J in Pfizer Ltd’s Patent [2001] FSR 16 may provide usefulguidance:“When any piece of prior art is considered for the purposes of an obviousness
attack, the question asked is ‘what would the skilled addressee think and do on thebasis of the disclosure?’ He will consider the disclosure in the light of the common
general knowledge and it may be that in some cases he will also think it obvious to
supplement the disclosure by consulting other readily accessible publicly available
information. This will be particularly likely where the pleaded prior art encourages
him to do so because it expressly cross-refers to other material. However, I do notthink it is limited to cases where there is an express cross-reference. For example
if a piece of prior art directs the skilled worker to use a member of a class ofingredients for a particular purpose and it would be obvious to him where and how
to find details of members of that class, then he will do so and that act of pulling inother information is itself an obvious consequence of the disclosure in the prior
art.”
4.43

In deciding whether it is obvious to combine the disclosure in two or more documents,
the UK Manual of Patent Practice (April 2009) states that the following considerations
are likely to be relevant:1)

How the nature and the contents of the documents influence whether the
person skilled in the art would combine them. For example where thedisclosed features seem at first sight to have an inherent incompatibility or
where one document has a tendency to lead from the mosaic, this would be apointer towards the combinations being inventive.

2)

Whether the documents came from the same technical field or fromneighbouring or remote technical fields.

3)

The presence of references in one document to another.

4)

The amount of selection required to isolate the separate disclosures from thesurrounding documentary material.

5)

Whether the contents of one document are so well known that the person
skilled in the art would always have them in mind in reading otherdocuments.

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4.44

Notably, Section 14(2) sets out that the state of the art comprises all “matter (whether aproduct, a process, information about either, or anything else)”. Section 15 states thatthe invention will involve an inventive step if it is not obvious having regard to any suchmatter. Thus for example a “mosaic” does not require a combination of separate
documents – in particular, a mosaic of different pieces of information from within asingle document may be appropriate.

4.45

If the invention can be produced by combining the teaching of one document with
common general knowledge, there is a strong presumption that such a combination
would be obvious to the person skilled in the art. In raising such an objection, theExaminer should clearly detail the basis for asserting that certain features are common
general knowledge. This should be based on legal precedent as to what constitutes
common general knowledge, but may also be taken from the application. For example,
if the application refers to prior art as “conventional”, this may be taken to indicate thatthe prior art is common general knowledge (NEC Corporation’s Application BL
O/038/00). An assertion that something is common general knowledge may need to bebacked by documentary evidence (see paragraph 2.32).

4.46

There is no limit to the number of pieces of information that may be combined for an
inventive step objection. However, in general the greater the number of features to be
combined the greater the chance of there being an inventive step. However, if theinvention constitutes no more than a combination of separate entities, each performing
its usual function, then the invention is likely to be a mere collocation.

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I.

Is the invention obvious?

4.47

The last two questions in the “Windsurfing approach” require the Examiner to identify
the differences that exist between the prior art and the invention in question, and thento determine whether those differences constitute steps which would have been obvious
to the person skilled in the art or whether they require any degree of invention.

4.48

Examiners will often have technical skills relevant to the technology or will haveacquired a good working knowledge of the areas in which they examine. As aconsequence they will generally be in a position to decide based on the material before
them, including application and the prior art, whether the invention possesses aninventive step. The Examiner should reassess their position once further submissions
and/or evidence have been provided by the applicant. In most cases, the Examiner will
not be in a position to refute expert evidence from a person working in the particularfield. In such cases the Examiner is unlikely to be able to maintain an objection unlessthey are able to produce documentary evidence to the contrary. However, if the response
from the applicant consists of assertions without any supporting material (such as
documents or experimental results), then the documentary support for a rebuttal will be
relatively low.

4.49

While the Windsurfing test sets a framework by which inventive step is assessed, theultimate question is essentially the same question facing the Examiner at the start – isthe invention obvious? As cautioned by Warren J in Actavis UK Ltd v Novartis AG[2009] EWHC 41:“It is in this context always important, in assessing obviousness, as it is withnovelty, to bear carefully in mind the statutory words. It is easy to find in the cases
words more or less apposite to the facts of the case (e.g., would/could, motive,
expectation of success, workshop variants, whether there is a reason for taking thestep from the prior art) to describe how the court has made its decisions, using
concepts which cannot be of universal application. Time and time again, the Courts
have emphasised that the correct question is that laid down in the statute, namely
whether the invention was obvious to the person skilled in the art: see in particular… Conor (Conor Medsystems Incorporated v Angiotec Pharmaceuticals
Incorporated, [2008] RPC 28). In that case, Lord Hoffmann cited with approval

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the observations of Kitchin J in Generics v Lundbeck [2007] RPC 32 at 72 inconsidering how a number of different factors should be taken into account:‘The question of obviousness must be considered on the facts of each case.
The court must consider the weight to be attached to any particular factor in
the light of all the relevant circumstances. These may include such mattersas the motive to find a solution to the problem the patent addresses, thenumber and extent of the possible avenues of research, the effort involved inpursuing them and the expectation of success.’”
4.50

Various approaches have been used by the Singapore Courts to determine obviousness:“lying in the road” (Peng Lian Trading Co v Contour Optik Inc & Ors [2003] 2
SLR 560, and Merck & Co Inc v Pharmaforte Singapore Pte Ltd [2000] 3 SLR 717)
“workshop variation” (ASM Assembly Automation Ltd v Aurigin Technology
Pte Ltd and others [2009] SGHC 206)
“commercial success” and “long-felt want” (Muhlbauer AG v Manufacturing
Integration Technology Ltd [2009] SGHC 45 and Trek Technology (Singapore)
Pte Ltd v FE Global Electronics Pte Ltd [2005] 3 SLR 389, upheld on appeal in FE
Global Electronics Pte Ltd v Trek Technology (Singapore) Pte Ltd [2006] 1 SLR
876)“so obvious” (First Currency Choice Pte Ltd v Main-Line Corporate Holdings Ltd
and Another Appeal [2007] SGCA 50)“technical prejudice” (Muhlbauer AG v Manufacturing Integration Technology
Ltd [2010] SGCA 6)“overcoming practical difficulties” (V-Pile Technology (Luxembourg) SA andOthers v Peck Brothers Construction Pte Ltd [2000] 3 SLR 358)

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4.51

In addition to these tests, guidance may be taken from some UK case law, andparticularly: “Why was it not done before?”, “Advantages of the invention”, “Obvious
to try”, and “Selection inventions”.

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“Lying in the Road”
4.52

In some cases the solution to a particular problem is one which uses materials that arereadily available on hand and which are prima facie a matter of routine for the person
skilled in the art. Philips (Bosgra’s) Application [1974] RPC 241 at page 251, Whitford
J considered such issues noting that the “road” itself must be one that the research
worker would naturally choose to take:“Nothing … would be more undesirable than that persons should be stopped …
from using materials which it is also established would lie readily to their hand,
and would come to their mind as being likely materials to use. … I think these(emulsifying) agents were obvious in this sense, indeed in the true sense of theword, that they were lying in the road, that they were there for the research worker
to use, and it is quite wrong that he should be stopped from using them.”

4.53

The Court in Peng Lian Trading Co v Contour Optik Inc & Ors [2003] 2 SLR 560 citeda later restatement of this principle:“In this regard, the words of Whitford J in Philips (Bosgra’s) Application, [1974]
RPC 241 at 251 as expressed and approved by Dillon J in Genentech Inc’s Patent,[1989] RPC 147 at 243, are worthy of note:‘[T]o render an invention obvious it was not necessary that the material inquestion should have been the first choice of the notional research worker;
it was enough that the material was ‘lying in the road’ and there for the
research worker to use.’”

4.54

In Merck & Co Inc v Pharmaforte Singapore Pte Ltd [2002] 2 SLR 515 (upheld on
appeal in Merck & Co Inc v Pharmaforte Singapore Pte Ltd [2000] 3 SLR 717), theinvention involved the purification of lovastatin to reduce the presence of a dimeric
impurity. The claims were directed to lovastatin having lesser than 0.2% of dimeric
impurity. Lai J was presented with evidence that processes disclosed in two of thepatentee’s own previous patents could produce the desired impurity level and the Court
held that the claims lacked novelty. The patent was also attacked on the ground that it
was obvious to use techniques such as recrystallization and charcoal treatment in order

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to reduce impurities. The Court cited Genentech Inc’s Patent [1989] RPC 147 withfavour in seeking a ‘spark of imagination’ beyond that which may be attributable to a
man skilled in the art. Moreover, they stated that:“if various techniques and processes were available which the man skilled in theart thought were worth trying out to yield beneficial results, or if the same could
be said to be ‘lying in the road’ for the research worker to use (Genentech at pp242-243), the case for ‘obviousness’ in the inventive idea is that much stronger.
The same could be said of the myriad of processes … which could be applied to thepurification of the Lovastatin compound.”
4.55

Notably, Lai J considered that an argument that the invention had required extensive
research was not relevant in this case:“The plaintiffs gave evidence that much effort had gone into researching processesof purification. The sweat of their labours is hardly relevant to the issue of inventive
step. I am prepared to find that they embarked on a well-charted journey, where
the purification of the compound to levels of 0.2% or less was the obvious next step,
given the processes that were known at the priority date.”

4.56

In general, where a claimed solution:1)

is one of several options that the person skilled in the art would consider insolving either the identified problem or any subsequent practical difficulty;

2)

the options would at once suggest themselves to the person skilled in the art,e.g. the options are part of the common general knowledge, or clearly
indicated in the prior art;3)

there is no practical difficulty in implementing the particular solution
claimed; and4)neither the prior art, nor the common general knowledge, teaches away fromthe particular solution;then an inventive step objection will apply. In this situation, the claimed solution is said
to be ob via (the Latin root of the word obvious), or “lying in the road”.

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ii.

Workshop variation

4.57

If a claim is a “mere workshop improvement” over the prior art, it will lack an inventive
step. This is implicit in the definition of a person skilled in the art as a person who has
the skill to make routine workshop developments but not to exercise inventive ingenuityor think laterally (see Pfizer Ltd’s Patent [2001] FSR 16). However, whether something
constitutes a mere workshop improvement or modification may be difficult todetermine:“Nobody, however, has told me, and I do not suppose that anybody ever will tellme, what is the precise characteristics or quality the presence of which
distinguishes invention from a workshop improvement” (Samuel Parkes & Co Ltdv Cocker Brothers Ltd, [1929] 46 RPC 241).

4.58

Some guidance was given by Laddie J in Hoechst Celanese Corporation v BP
Chemicals Limited [1997] EWHC 370 (Pat) as follows:“… mere workshop modifications, none of which would be expected to produce
significant technical or commercial benefits are still obvious. To adopt an example
sometimes given by Jacob J., if it is known to make a 5 inch plate, it is obvious tomake a 51/4 inch plate. Technicians and businessmen frequently want to maketrivial variations in established or known products. Similarly if the prior art
discloses two wooden parts held together by screws it would be obvious to glue
them, even if so doing would not be expected to advance the industry. The notional
addressee is likely to want to use materials readily at hand to make essentially thesame thing as is disclosed in the prior art. That is sufficient motivation and the useof those materials is, accordingly, obvious.”

4.59

In ASM Assembly Automation Ltd v Aurigin Technology Pte Ltd and others [2009]
SGHC 206, the invention involved an apparatus and method for automatically placing
an array of solder balls onto a substrate. The Court found that the claims were lacking
in novelty, but nevertheless further considered their inventiveness. Notwithstanding thatTan J concluded that the evidence at trial showed that ASM’s patent involved nothing
more than an “aggregation of known features in the art”, the key matter was considered
under the guise of workshop improvement. Tan J referred to Shaw v Burnet & Co [1924]

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41 RPC 432 and Curtis & Son v Heward & Co [1923] 40 RPC 53 as being instructive
as to workshop improvements being insufficient to establish inventiveness.
4.60

Evidence at trial was provided by expert witnesses as to what constituted a workshop
variation in the particular technology, and in particular to the use of a tilting mechanism
to reduce the risk of shearing of the solder balls by the trailing wall of the container.
This type of mechanism was disclosed in two prior art documents. Based on the expert
evidence the Court considered that it would be obvious to use the features disclosed inthese documents to modify the known prior art devices to arrive at the claimed
invention.

4.61

Generally, a workshop improvement will involve trivial modification of an existingproduct which the person skilled in the art would be expected to implement without
practical difficulty and without the expectation of a significant technical or commercial
improvement. Notably, the considerations under “workshop variation” are similar to
those under “lying in the road”, and it may be that objection could be formulated undereither. Evidence from the applicant of a practical difficulty or a surprising advantage
may be sufficient to circumvent such an objection.

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iii.

Commercial success and long-felt want

4.62

Evidence of a long-felt want or that the invention has been commercially successful
may be a relevant consideration for inventive step (see for example Hickman v Andrews[1983] RPC 147 and PLG Research Ltd v Ardon International Ltd [1993] FSR 197).
Most patents are prosecuted early in the development of an invention so commercial
success may be difficult to gauge at first action. However, this may be a relevant
consideration later in the examination process.

4.63

A good statement of the underpinning reasons for taking commercial success into
account when assessing inventive step was given by the court in Dr Reddy’sLaboratories (UK) Ltd v Eli Lilly and Co Ltd [2008] EWHC 2345 (Pat):“Commercial success can be a relevant secondary indicator of non-obviousness.
Like all secondary indications it needs to be kept in its place. Why is it relevant at
all? It is said that, when coupled with a long felt want which skilled researchers
were attempting to meet, it is evidence that the claimed solution cannot have been
obvious. In other words, commercial incentives would have driven those skilledin the art to the claimed solution but for one thing: it was not obvious.” [emphasis
added]

4.64

The UK decision in Schlumberger Holdings Limited v Electromagnetic Geoservices AS[2009] EWHC 58 (Pat) at [77] to [78] provides a good summary as to the approach tobe taken in relation to inventive step, and particularly where commercial success may
be a relevant factor:“The leading authority on the place of this evidence is the decision of the Court ofAppeal in Mölnycke AB v Procter & Gamble Ltd, [1994] RPC 49 … The material
points which emerge from it are:1.

The expert evidence is the primary evidence; the contemporaneousevidence is relevant, and has the merit of being untainted by hindsight,
but secondary. It can be used to test the expert evidence.

2.

There is a danger in getting too caught up in an investigation of what
was and what was not obvious to certain identified (and even more so

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unidentified) individuals, because they may not all have been aware of
the state of the art - the state of the art (within the meaning of thestatute) is the important starting point.
3.

The evidence may invite a degree of inadmissible speculation as to theinventiveness of the persons involved.

4.

Commercial success (if relied on) may be attributable to novelty (wantof obviousness), but there may be other factors operating. Care must
be taken to ensure that is not the case.

5.

The importance and weight of the evidence will vary from case to case.

In addition, where contemporaneous evidence is relied on, and it demonstrates
some sort of commercial success of the idea, one must be live to the distinction
between what was commercially obvious (or not obvious) and what was technicallyobvious (or not obvious). A new approach may find success because it has become
appreciated that it has become commercially worthwhile, rather than its being
appreciated as something new which will assist. If the success is attributable to theformer, then the evidence does not support novelty in patent terms.”
4.65

In FE Global Electronics Pte Ltd v Trek Technology (Singapore) Pte Ltd, [2006] 1 SLR
876, the invention comprised a thumb drive device that could be plugged directly intoa USB. At the time commercially available memory storage devices were usually fitted
within the computer (such as ROM or RAM storage), or surface based storage devices(generally discs). The thumb drive had no moving parts which enabled the memorystorage device to be more compact. The Court found that:“In our view, Trek had an inventive concept for a new type of data storage device
that was quite different from and more convenient to use than conventional data
storage devices. Admittedly, all the elements required for this invention wereavailable to those skilled in the art. Solid-state non-volatile memory was wellknown and USB plugs were standard. Yet before Trek applied for the patent inquestion, no one else thought of combining all the elements together … Having
looked at the device, some may view the invention as a simple one but simplicity
has never been a bar to inventiveness and it has been reiterated often enoughthat ex post facto analysis can often be unfair to inventors …” [emphasis added]

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4.66

Similarly, in the UK case Schlumberger Holdings Ltd v Electromagnetic Geoservies AS[2010] RPC33, the Court of Appeal held that:“The plain fact is that there was no real explanation of why the idea was not taken
up well before the date of the Patent. The simplest explanation – indeed the only
one that fits the known facts – is that the inventors hit upon something which others
had missed.”

4.67

In Mühlbauer AG v Manufacturing Integration Technology Ltd [2009] SGHC 45, Tay
Yong Kwang J noted that when using commercial success as an indicator of inventive
step one should be mindful of other factors that can contribute to commercial success:“Where commercial success of an invention is concerned, this factor alone is notconclusive. A product that sells well is not necessarily novel or one involving an
inventive step. Good advertising, marketing and pricing could also play a part. The
converse is also true. As stated in Main-Line Corporate Holdings Ltd v United
Overseas Bank Ltd, [2007] 1 SLR 1021 at [71]:Something that is new and inventive does not automatically become anovernight success or ― ‘the next big thing’. Even if it is not, like theplaintiff’s Teh Kor Lak said, ― ‘a big deal’, it is nevertheless something new
and inventive which, after the invention is known, others may wish they had
thought of or wonder why they had never thought of it. Some patents achievemuch more commercial success and are more life-changing than (many)others. The fact that the invention has not been widely adopted in the credit
card industry is therefore not an adverse reflection on its inventive quality.”

4.68

Notably the Court cautioned that commercial success may be due to factors other than
the inherent properties of the invention per se. Commercial success therefore needs tobe carefully considered as to whether the success is indeed related to a long-felt needbeing satisfied rather than being the result of clever marketing or the price of the
product.

4.69

Laddie J in Haberman v Jackal [1999] FSR 685, provided a number of relevant
questions that may help in such a consideration:

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1)What was the problem which the patented development addressed?

2)

How long had that problem existed?

3)

How significant was the problem seen to be?

4)

How widely known was the problem and how many were likely to be seeking
a solution?

5)

What prior art would have been likely to be known to all or most of those
who would have been expected to be involved in finding a solution?

6)

What other solutions were put forward in the period leading up to the
publication of the patentee’s development?

7)

To what extent were there factors which would have held back the
exploitation of the solution even if it was technically obvious?

8)

How well had the patentee’s development been received?

9)

To what extent could it be shown that the whole or much of the commercial
success was due to the technical merits of the development?

4.70

In Haberman v Jackal, the invention consisted of a “trainer cup” which had been
modified to make it leak-proof. The design was relatively simple and used readily
available materials. Despite a relatively small advertising budget and poorly developed
aesthetics, the product was well-received in the market. Such commercial success washeld as being indicative that the product satisfied a long-felt want in the market.

4.71

In addition to the Haberman questions, other matters that the UK Courts have taken into
account include:1)

all matter within the scope of the claim must include the features contributing
to the commercial features of the invention (Tetra Molectric Ltd v Japan
Imports Ltd, [1976] RPC 547); and2)whether the absence of a product on the market could be attributed to a preexisting patent – for example an argument based on the commercial successof an isolated enantiomer would fail if the racemic mixture were covered bya patent that would restrict its use by others (Generics (UK) Ltd v H Lundbeck
A/S, [2007] EWHC 1040).

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iv.

“So obvious”

4.72

The Court of Appeal in First Currency Choice Pte Ltd v Main-Line Corporate Holdings
Ltd and Another Appeal [2007] SGCA 50 discussed the use of the Windsurfing test,
noting that critics considered the Courts merely pay lip service to the first three. They
went on to say that:“Be that as it may, simplicity is certainly to be appreciated, and, in assessing theobviousness of an alleged invention, it may sometimes suffice in straightforward
cases to refer to the test formulated by Lord Herschell in Vickers, Sons And Co,
Limited v Siddell, (1890) 7 RPC 292, where he stated (at 304) that an invention
lacked an inventive step if what was claimed was ‘so obvious that it would at once
occur to anyone acquainted with the subject, and desirous of accomplishing theend’. Quite often, it is difficult, in practice, to break down the Windsurfing test([41] above) into its component parts. Thus, while the Windsurfing test remains a
useful guide, it is no more than that.”

4.73

Thus, in some cases it may be appropriate to depart from a strict application of theWindsurfing test. This is most likely to be where obviousness is so self-evident that
there is little benefit in following the structured approach required by Windsurfing.
However, if such an approach is taken care must be taken to avoid hindsight.

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v.

Technical prejudice4.74

The common general knowledge is a key consideration in the assessment of inventive
step. Importantly, the Examiner should consider what the skilled person would consider
doing, but also what the skilled person would be prejudiced against doing. An invention
may be regarded as non-obvious if it goes against the generally accepted views andpractices in the art (see for example, Dyson Appliances Ltd v Hoover Ltd [2001] RPC
26).

4.75

Examples where this may be a determining factor include;1)

if the common general knowledge was such that the skilled person did not
perceive a problem with the prior art.

2)

if certain materials or techniques would be considered by the skilled person
as unsuitable for a particular purpose and the inventor has found that thisprejudice is not well-founded.

3)

If a certain step in a method or component in an apparatus was consideredessential, but the inventor has found that it may be omitted.

4.76

The technical prejudice must be one which is commonly shared in the art: that is, theprejudice must be sufficiently widespread for it to be attributed to the notional person
skilled in the art. Thus if views in the art are divided in relation to a particular point,then it is not a prejudice that may be said to be widely held in the art. For example in
Glaxo Group’s Patent [2004] RPC 43, there was significant dispute in the art in relation
to the use of β2-antagonists in the treatment of asthma. The Court held that as aconsequence of this dispute the technical prejudice could not be considered sufficiently
widespread to be attributed to the skilled person.

4.77

Similarly, a prejudice held in one group may be in conflict with the practices of another.
For example, in Ancare New Zealand Ltd’s Patent [2003] RPC 8 the invention involved
a dual treatment for round worm ad tapeworm. The applicant argued that the invention
lay in using an agent against tapeworm since there was a prevailing scientific prejudiceagainst treating lambs for tapeworm. However, the Court heard that despite thescientific views it was common practice for farmers to treat lambs for tapeworm. The
Court held that the invention was obvious since:

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“the fact that scientific opinion might have thought that something was perfectly
useless did not mean that practising it, or having the idea of making a preparation
to do it, was an inventive step. Otherwise, anyone who adopted an obvious methodfor doing something which was widely practised but which the best

scientificopinion thought was pointless could obtain a patent.”
4.78

Notably the invention must lie in recognising that a prejudice is ill-founded – there will
be no invention in simply accepting the disadvantages that underpin the prejudice. For
example, the prevailing view in the art may be that a ferrous metal should not be used
in a particular reactor because it is susceptible to corrosion under the reaction
conditions. An invention employing such a reactor would not be inventive if it was
simply accepting that it would have a reduced lifespan. Similarly if the prejudice against
a particular material is founded on it being unviable or expensive and a subsequentdevelopment makes the material more readily available or cheaper, then an invention
merely taking advantage of that development would not be inventive. Of course theimproved process of making the material itself may be patentable.

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vi.

Overcoming practical difficulties

4.79

In V-Pile Technology (Luxembourg) SA v Peck Brothers Construction Pte Ltd [2000] 3
SLR 358 followed the decision of the UK Court of Appeal in Gadd and Mason v
Manchester Corporation (1892) 9 RPC 516, in which Rubin J held that a new use of aknown contrivance may be non-obvious if the new use involves practical difficulties
that the inventor has overcome by ingenuity of his own.

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vii.

Advantages of the invention

4.80

Where the invention has no advantages, or is even disadvantageous, it could be argued
that it would not be obvious to the skilled person. Nevertheless, if the invention is one
which a skilled person would consider, then it will lack inventive step (Technical Boardof Appeal of the EPO in Decision T119/82). However, if the invention has an
unexpected advantage, then it may constitute a valid “selection”. Similarly if the skilled
person would expect the invention to be disadvantageous but this is in fact not the case,then it may be non-obvious. “Selection” inventions will be dealt with below.

4.81

If the prior art leads directly to an invention then it is not made inventive by any
additional advantage obtained. In Inventa AG’s Application [1956] RPC 45, a processof spinning nylon which had (before the introduction of nylon) been disclosed forspinning artificial filaments was held to be obvious despite having an additional
advantage. In particular, no further modification of the process was required to secure
this advantage. Similarly, in Union Carbide Corporation (Hostettler’s) Application[1972] RPC 601 at page 609, Whitford J stated that “if in fact the step taken was an
obvious step, it remains an obvious step however astonishing the result of taking it may
be”.

4.82

In general, an otherwise obvious combination is not saved from a finding of obviousness
by some unexpected advantage caused by an unpredictable co-operation between theelements of the combination (see Glaxo Group Ltd’s Patent [2004] RPC 43).

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viii. Selection inventions
4.83

If the invention is one of many possible alternatives, and there is no indication in theprior art that any particular alternative is more advantageous than another then theinvention may be considered non-obvious. This most often arises in chemical
applications, where Markush-style claims can cover a broad range of compounds, but
only specifically disclose a limited range of embodiments. Subsequent applications
which claim a specific subset of the compounds on the basis of an unexpected advantage
may be patentable. Such situations are often referred to as “selections”.

4.84

The law on selection patents was first set out in I G Farbenindustrie AG’s Patent [1930]47 RPC 289.

4.85

However, in Dr Reddy’s Laboratories (UK) Ltd v Eli Lilly & Co Ltd [2010] RPC 9,
Jacob LJ stated that as these rules related to pre-1977 law they could be regarded “aspart of legal history, not as part of the living law”. Instead the criteria set out by the
EPO Board of Appeal decision in T 939/92 AGREVO/Triazoles were followed:(i)

the selection must not be arbitrary but must be justified by a hitherto
unknown technical effect;(ii)

a technical effect which justifies the selection of the claimed group must be
one which can be fairly assumed to be produced by substantially all theselected members;(iii) this technical effect can only be taken into account if it can be accepted ashaving been indicated in the specification as filed.
4.86

Jacob LJ noted that the criteria set out in I G Farbenindustrie AG’s Patent were
formulated under the common law and did not draw a distinction between lack ofnovelty and obviousness. Instead these were dealt with under the general umbrella of“lack of subject-matter”. He stated that the “rules were carried over by the judges into
the newly codified law in 1932 and remained, almost as a special sub-branch ofpatentability, as part of English law until the “new law of patents” (a recital to the
Patents Act 1977) came in.”

4.87

The judge also expressed concern that the final test – that the property be peculiar to theselected group – was not one that could be applied in practice without testing “quite a

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lot” of the prior class. On that basis he considered the approach taken by the EPO in
AGREVO was preferable. If dealing with selections, the AGREVO approach should betaken by Examiners.
4.88

A selection would be regarded as obvious if it has made no real technical advance. This
was noted by Jacob LJ in Dr Reddy’s:“… it regards what can fairly be regarded as a mere arbitrary selection from aclass as obvious. If there is no more than an arbitrary selection then there is simply
no technical contribution provided by the patentee.”

4.89

The “hitherto unknown technical effect” should be clearly indicated. This can be by
explicit statement, or may be implied from tests provided in the application at the timeof filing. Later-filed evidence may be used to provide support for the first two criteria,
but unexpected bonus effects not described in the specification cannot form the basis ofa valid claim to a selection invention (Glaxo Group Ltd’s Patent [2004] RPC 43).

4.90

A “bonus effect” refers to the effects that are observed in an otherwise obvious
invention. Generally, the situation is one where there is a “one-way street” – theinvention is one which would be obvious to the skilled person, and any unexpected
results are merely a bonus effect from following an otherwise obvious pathway.

4.91

If the specification as filed does not state the advantage (or if it cannot be implied fromexperimental data), then it cannot be amended later to include such a statement. In
Richardson-Vicks Inc.’s Patent [1995] RPC 568 at [581], Jacob J stated that whether or
not the advantage was demonstrated “by experiments conducted after the date of thepatent cannot help show obviousness or non-obviousness … and it would be quite
wrong for later-acquired knowledge to be used to justify the amended claim.”

4.92

In this regard the usual considerations for amendments should be made – in particularwould the skilled person learn something about the invention from the amended
specification that they would not have learned from the specification as filed.

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ix.

Why was it not done before?

4.93

A question that could be asked in response to an inventive step objection is “if it was so
obvious why wasn’t it done before?”

4.94

Clearly, this is an ill-founded argument since any invention that had not been done
before (that is, was new) would automatically be held inventive. Nevertheless thereasons as to why the invention has not previously been done are a relevant
consideration.

4.95

In particular, if the inventor has solved a long-recognised problem by means which
others could have used but did not, then there may be an inventive step (Minnesota
Mining and Manufacturing Co v Rennicks (UK) Ltd [1992] RPC 331).

4.96

However:1)

if a long-standing problem has been solved using materials or techniques
which have only recently become available in a conventional manner;2)

if a product has not been made from a particular material or by a particular
process for reason of cost, and the material or process becomes cheaper orthe market value of the product increases; or3)

if a newly-arisen problem is solved by the use of available resources in an
obvious way, then there is no inventive step (unless the inventor has been thefirst to identify the problem);then it is unlikely that the invention will be considered as having an inventive step.

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x.

Obvious to try

4.97

The “obvious to try” test for inventive step, first used in Johns-Manville Corporation’s
Patent [1967] RPC 479, has not been adopted by Singapore Courts in their considerationof inventive step. However, it has been applied under the UK Patents Act 1977 and asa consequence could provide some guidance.

4.98

As recently noted in Kitchin LJ in Novartis AG v Generics (UK) Limited (t/a Mylan)[2012] EWCA Civ 1623:“[I]n deciding whether the invention was obvious to the skilled but unimaginative
addressee at the priority date the court will have regard to all the circumstancesof the case including, where appropriate, whether it was obvious to try a particularroute with a reasonable or fair expectation of success. What is a reasonable or fair
expectation of success will again depend upon all the circumstances and will varyfrom case to case.”

4.99

Notably, the enquiry is one as to whether there is a “reasonable or fair expectation of
success” as opposed to a “hope to succeed” (MedImmune v Novartis [2012] EWCA Civ
1234). Thus simply including something in a research project is unlikely to be enough,but if it is self-evident that what is being tested ought to work then the invention may
be considered obvious (Saint-Gobain PAM SA v Fusion Provida Ltd and Electrosteel
Castings Ltd [2005] EWCA Civ 177). However, in Novartis v Generics, Kitchin LJ
stated:“But I reject the submission that the court can only make a finding of obviousness
where it is manifest that a test ought to work. That would be to impose astraightjacket upon the assessment of obviousness which is not warranted by thestatutory test and would, for example, preclude a finding of obviousness in a casewhere the results of an entirely routine test are unpredictable.”

4.100 Kitchin LJ went on to say that the “correct approach” was that set out in MedImmune v
Novartis:“[O]ne of the matters which it may be appropriate to take into account is whether
it was obvious to try a particular route to an improved product or process. There

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may be no certainty of success but the skilled person might nevertheless assess
the prospects of success as being sufficient to warrant a trial.” [emphasis added]
4.101 If a particular route is an obvious one to take or try, it is not rendered non-obvious
merely because it is one of a number of other obvious routes. As noted by Laddie J in
Brugger and others v Medic-Aid Ltd [1996] RPC 635, there “is no rule of law or logic
which says that only the option which is likely to be tried first or second is to be treatedas obvious for the purposes of patent legislation”. However, this does not mean that theskilled person would pursue every avenue of research relentlessly where there were only
the mildest reasons for doing so.
4.102 In Lilly Icos Ltd v Pfizer Ltd [2002] EWCA Civ 1, a document disclosed the use ofcompounds as vasodilators through inhibition of cGMP PDE. The Court found that thefurther use of this to treat impotence was obvious in view of a second document which
disclosed that compounds that inhibited this enzyme may be useful for treating
impotence. In particular, the Court considered that the claimed invention was little morethan putting into practice something that the prior art suggested and which would havebeen considered by the skilled person as being sound and worth trying.
4.103 In Omnipharm Limited v Merial [2011] EWHC 3393 (Pat), the invention related to a
“spot on” formulation for the treatment of fleas in pets. The closest prior art was a “sprayon” formulation comprising the same active ingredient. Despite the Court consideringthat it would be obvious to try to develop a spot on formulation since they haveadvantages in terms of ease of application, there was no basis on which the skilled
person would predict that a “spot on” formulation would work. That is, the skilled
person would not have had sufficient expectation of success to render the invention
obvious.

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5.

THE APPLICATIONA.

Statutory requirements

5.1

Section 25 lays down what is required of a patent application. Besides formality
requirements for the application, most of which will have been checked during initialprocessing, this section also provides a number of substantive requirements that the
Examiner needs to ensure are complied with.

5.2

Section 25(4) requires that:
The specification of an application shall disclose the invention in a manner which
is clear and complete for the invention to be performed by a person skilled in the
art.

5.3

Section 25(5) states that:
The claim or claims shall —(a)define the matter for which the applicant seeks protection;(b)

be clear and concise;(c)be supported by the description;…

5.4

Rule 19 expands upon these formality and substantive requirements and the following
section of the Guidelines deals with the application of these requirements during
examination.

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B.

Number of claims (Rule 19(6)) and numbering of claims(Rule 19(6A)2)

5.5

Rule 19(6) states that the number of claims shall be reasonable in consideration of thenature of the invention claimed, and Rule 19(6A) specifies that where there are 2 ormore claims, the claims shall be numbered consecutively in Arabic numerals.

5.6

While Rule 19(6) suggests that the number of claims shall be reasonable, there is no
specific limitation in this regard. In practice, consideration of this Rule would be
essentially the same as that required under Section 25(5)(b) (the claim or claims shall…
be clear and concise). An objection under Rule 19(6) that the number of claims isexcessive will be rare, and if there is any doubt in this regard it should be discussed witha Senior Examiner prior to raising the objection.

5.7

Rule 19(6A) also requires that the claims be numbered consecutively in Arabic
numerals. An objection of this nature is likely to be raised where a claim number has
been inadvertently omitted during drafting, thus resulting in a particular claim not being
numbered in the application as filed. This should be indicated in Box VI of the written
opinion as it would be a defect in the form of the application, and the Examiner may
append a suitable label to the unnumbered claim for the purpose of examination.

5.8

In addition, since such omission would also affect the indication of the basis of thewritten opinion in Box I, an appropriate explanatory comment should be made under“4. Additional observations”. Claim numbers should be whole numbers alone and othercombinations (for example, 9a, 9b, 9c, etc., letters or other forms of numbering such as
Roman numerals) should be objected to.

5.9

Notably, Rule 19(6A) states that where there are 2 or more claims they shall benumbered consecutively in Arabic numerals. It follows that a single claim need not benumbered and no objection should be raised in such cases.

2

In the Patents Rules with effect immediately before 14/02/2014, the requirement that the claims be numberedconsecutively was specified in Rule 19(6).

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5.10

It should also be noted that amendments and corrections comprising marked up changes
are generally filed in which claim numbers may be omitted. Such cases may be objected
to in the same manner as prescribed in paragraphs 5.7 and 5.8 above.

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C.

Invention shall be defined in technical terms (Rule 19(7))

5.11Rule 19(7) states that the definition in the claim of the matter for which protection issought shall be in terms of the technical features of the invention which may be
expressed in structural, functional or mathematical terms.

5.12

The fact that the technical features of the invention may be expressed in structural,functional or mathematical terms provides the applicant with a great deal of flexibility
as to how they choose to define their invention. For example, an invention may be
defined in terms of function rather than structure and an objection should not be raised
merely on the form of the claim.

5.13

Rule 19(7) essentially sets out the requirements under Section 25(5)(a) in order for theclaims to define the matter for which the applicant seeks protection. Accordingly, inmost cases an objection will refer to Section 25(5)(a) as the statutory basis for suchobjections. Further details are given below in the discussion of Section 25(5)(a).

5.14

An objection under Rule 19(7)/Section 25(5)(a) may be appropriate to be raised in thecase of applications that prima facie contain patentable subject matter, but where theinvention has been defined in a manner that does not include a technical feature
disclosed in the specification.

5.15

Where the claims comprise definitions of weights and measures, these should be
expressed in terms of the metric system, in accordance with Rule 23(20) and Rule23(21). Rule 23(22) prescribes that temperatures should be expressed in degrees
Celsius. It should be noted the aforementioned rules apply to the rest of the specification
as well.

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D.

Claims drafted in two-part form or as a single sentence (Rule19(8))

5.16

Rule 19(8) does not prescribe a particular single format to be followed by applicants inall cases. Instead claims can follow one of two formats:
1)

A two-part format having the structure of:(a)a first part containing a statement indicating the general class ofinvention followed by a definition of features that appear to be part ofthe prior art;(b)a bridging phrase (“characterised in that”, “characterised by”, “wherein
the improvement comprises” or other words to the same effect); and(c)a second part which is the characterising portion stating the features
which add to the prior art.

2)
5.17

A single statement setting out the features of the invention.

In the two-part format, there is no requirement that all features of the prior art be definedin the first part indicating the general class of invention. The applicant may define only
those features that they consider relevant to the invention, and features that the skilled
person would understand to be implicit in the invention need not be set out in the claims.
For example, a bicycle would be understood to have wheels, a frame and pedals, so aclaim to a bicycle incorporating a new type of handlebar arrangement would not needto set out these features.

5.18

If the search discovers prior art disclosing one or more features of the second part in
combination with the features of the first part, then these features form part of the priorart and should be transferred into the first part. However, there may be alternative ways
for claiming a combination, so the Examiner can take a fairly flexible approach whenconstruing such claims provided the scope of the claim would be clear to the skilled
person.

5.19

A claim having two or more sentences and other claim formality issues should generally
be objected to.

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E.

Omnibus claims (Rule 19(9))

5.20Rule 19(9) requires that the claims shall not rely, in respect of the technical features of
the invention, on references to the description or drawings, unless such a reference isnecessary for the understanding of the claim or enhances the clarity or conciseness ofthe claim.

5.21

Examples of omnibus-type claims that refer broadly to the specification, examples orfigures are:
“An infant formula substantially as hereinbefore described with reference to the
Examples.”5.22

Objection should not be taken where a claim refers to sequence listings, tables of atomic
coordinates and the like, where recitation of these is necessary for sake of clarity andconciseness. Similarly, if a particular feature cannot be defined in any other manner thanby reference to a figure or the like then no objection should be raised. This will include
situations such as the invention including a shape (for example, a curved surface) whichcannot be defined by means of a formula or the like.

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F.

Sufficiency of disclosure (Section 25(4) and Section 25(5)(c))

5.23

Section 25(4) requires that the specification shall disclose the invention in a manner
which is clear and complete for the invention to be performed by a person skilled in theart. Commonly known as the requirement of sufficiency of disclosure or enablement,
Section 25(4) is closely related to Section 25(5)(c), which states that the claim or claims
should be supported by the description.

5.24

Section 80(1)(c) states that a patent may be revoked if the specification of the patentdoes not disclose the invention clearly and completely for it to be performed by a person
skilled in the art. Therefore, non-compliance with Section 25(4) is a ground forrevocation of the patent under Section 80(1)(c), and unlike Section 25(5)(c) which can
only be applied pre-grant, there is a large amount of case law that relates to Section
80(1)(c) that can be applied to the analysis of Section 25(4). Because Section 25(4) and25(5)(c) are closely related, certain aspects of enablement will be considered alongsidesupport in the discussion on the disclosure of the invention below.

5.25

It is not common for an objection to be raised under Section 25(4) pre-grant. The
Examiner should give careful consideration when making a sufficiency of disclosure
objection, and should reserve such objections for those instances where the invention
cannot be readily enabled by narrowing the scope of the monopoly claimed. Usually theinvention will also lack support, and Section 25(5)(c) can also be considered as well(this will become apparent when Section 25(5)(c) is discussed below).

5.26

The determination of whether a disclosure is sufficient is highly sensitive to the natureof the invention (Dien Ghin Electronic (S) Pte Ltd v Khek Tai Ting (trading as Soon
Heng Digitax) [2011] SGHC 36, Kirin-Amgen Inc v Hoechst Marion Roussel [2005]
RPC 9). Thus, the general approach to determine whether a specification complies withthe requirements of Section 25(4) is to identify the invention and what it claimed toenable the skilled person to do, and then ask whether the specification enabled him to
do it.

5.27

The specification must provide sufficient disclosure across the full scope of the claims(Chiron Corp. v Murex Diagnostics Ltd [1996] RPC 535). At least one embodiment of
the invention or at least one method of performing the invention must be described

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according to Rule 19(5)(e). If the claims themselves provide an enabling disclosure andare supported by the description, then this may provide a sufficient disclosure. In manycases a single example or embodiment will suffice, but where the claims cover a broad
field several examples or alternative embodiments or variations extending over the area
to be protected by the claims may be necessary. The disclosure of one method of
preparation of a product may provide sufficient disclosure for a claim to a single
compound (Generics (UK) Limited and others v H Lundbeck A/S [2009] RPC 13).
5.28

However, if the invention is unpredictable in nature then more detail may be required.
For example, where the specification claims a synergistic combination and gives little
or no guidance on, for example, appropriate concentrations or ratios of the compounds
that will provide the synergistic result, it may impose an undue burden on the person
skilled in the art to test all possible combinations to determine those that fall within thescope of the claims.

5.29

Claims using functional definitions or that define the invention in terms of a desired
result are dealt with in the same manner as any other claim. The specification should
provide sufficient information for the skilled person to determine whether or not they
have achieved the defined result without undue experimentation and without exercising
any inventive ingenuity. For example, a specification defining a device in terms of an
improved effect without specifying the degree of improvement and how it could beobtained would be considered insufficient (Birtcher Medical Systems’ Patent BL
O/70/96).

5.30

The specification does not need to disclose all the details required to work the invention
if these would be known or obvious to the skilled person. In Halliburton Energy
Services Inc v Smith International (North Sea) Ltd [2006] RPC 2, Pumfrey J stated thatthe straightforward test for sufficiency is whether the specification required theaddressee to carry out tests or developments that went beyond routine trials. One
approach is to ask whether the skilled person would need to discover something new inorder to work the invention (Edison and Swan Electric Light Co v Holland, 6 RPC 243
at page 282). It follows that the specification must disclose features that are essential tocarry out the invention or provide sufficient detail for the skilled person to work theinvention without needing to undertake further invention to do so. These principles wereaffirmed in Ng Kok Cheng v Chua Say Tiong [2001] SGHC 143.

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5.31

Some examples of such considerations are as follows:
Reference to an “autoclave” in the specification without specifying the material ofwhich it is made could be insufficient if it is necessary for the invention to work that the
autoclave be made of iron rather than the usual enamel type (Badische Anilin and Soda
Fabrik v La Societe etc du Rhone, 15 RPC 359).
In Mayne Pharma v Debiopharm and Sanofi-Synthélabo [2006] EWHC 1123 (Pat), thedescription related to the preparation of a stable form of oxaliplatin which involved theuse of “an effective stabilising amount of a buffering agent selected from oxalic acid oran alkali metal salt thereof”. In this instance, Pumfrey J considered that:“When one is confronted with a claim which requires ‘an effective stabilising
amount’ of a material, it must be possible to design a test which can answer thequestion ‘Have I used such an amount or not?’. There will always be problems on
the edges of claim, but it should in general, be possible to know what the test is. If
one cannot identify the test on the basis of the disclosure, then I think that thedisclosure is insufficient”.
In this case, the answer to the test was that “you don’t have to add any at all”, and as aconsequence the description was found insufficient.

5.32

In Chiron Corporation v Organon Teknika Ltd [1994] FSR 202, claims to a vaccine
were found invalid as it took the applicants several years after the filing of theapplication to develop a vaccine. The description was therefore insufficient as it did notprovide sufficient information for a skilled person to repeat the invention without
invention.

5.33

A specification claiming a surgical suture made of a particular polymer did not disclose
the step of drying the polymer and freeing it from undesired monomer. However, theCourt found the patent to be sufficient as these were steps which “the instructed reader
desirous of achieving success could be expected, if necessary, to take” (American
Cyanamid v Ethicon [1979] RPC 265).

5.34

Errors in the specification will not result in a lack of sufficiency provided they are
obvious errors that the skilled person would have recognised and have known how to

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correct. For example in Ng Kok Cheng v Chua Say Tiong [2001] SGHC 143, the Court
dealt with such an error in the following manner:“It was obviously an error to use the word ‘through’ in the claim in such a waythat it could be argued that ‘through’ applied to both the main body as well as theauxiliary body where the drawings and the prior art, made it quite clear that such
could never have been the intention of the inventor. This error could, however, bereadily corrected by the skilled performer in the art in the process of making theinvention.”

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G.

Deposit of Micro-organisms

5.35

For inventions that require for their performance the use of micro-organisms which is
not available to the public at the date of filing the application, and which cannot be
described in the specification in such a manner as to enable the invention to be
performed by a person skilled in the art, the specification shall, in relation to themicroorganism itself, be treated as disclosing the invention, if one of the conditions set
out in sub-paragraph (2) of the Fourth Schedule to the Patents Rules is satisfied.

5.36

The Patents Act and the Patents Rules does not provide a definition for the term “microorganism”. This term is also not defined in the Budapest Treaty (the Treaty on theInternational Recognition of the Deposit of Micro-organisms for the purposes of patent
procedure done at Budapest in 1977). For the purposes of Section 114 Patents Act, Rule
20 and the Fourth Schedule of the Patents Rules, Examiners should regard biologicalmaterials that have been successfully accepted for deposit with any international
despository authority as defined in the Fourth Schedule of the Patents Rules, as “microorganisms”.

5.37

Section 114 prescribes that the Rules may require that the applicant or patentee (a) totake such steps as may be prescribed for the purposes of making available to the public
samples of the micro-organism; and (b) not to impose or maintain restrictions on theuses to which such samples may be put, except as may be prescribed. A warning is also
provided in Section 114(5) that an application for revocation of the patent under Section
80(1)(c) may be made if any of the requirements pertaining to making samples of microorganisms available in accordance with the Rules ceases to be complied with. Therefore,
the applicant or patentee has to be mindful of the requirements relating to availabilityof the deposited micro-organism during the application of the patent as well as for theduration of the patent, in accordance with Fourth Schedule of the Rules.

5.38

Where a deposit was made, Examiners are to check that the name of the international
depository authority, the date when the culture was deposited and the accession numberof the deposit are provided in the specification of the application.

5.39

When an application claims priority to an earlier application and the invention relies
upon a deposit for sufficiency purposes, the deposit should have been made not later

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than the date of filing of that earlier application (T 0107/09 Bristol-Myers
Squibb/CD40CR receptor and ligands thereof). Otherwise, priority cannot be claimed
for the subject matter where deposit is required in order for the matter to be sufficiently
disclosed.
5.40

In cases where the biological material used in a process is well known and the process
can be adequately described by written description, then as long as the process can be
performed in a repeatable manner, even if the final product is a new biological material,a deposit may not be required as long as the product can be prepared without undue
burden by a skilled person by following the written description.

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H.

Claims shall define the matter for which protection is sought(Section 25(5)(a))

5.41

Section 25(5)(a) requires that the claim or claims shall define the matter for which theapplicant seeks protection. As noted above, Rule 19(7) requires that this is done by using
the technical features of the invention which may be expressed in structural, functionalor mathematical terms.

5.42

The claims should not contain any statements relating, for example, to commercial
advantages or other non-technical matter. However, this should be applied narrowly –for example, a definition of a particular property using a comparison with a commercial
product would generally not constitute a statement of commercial advantage. For
example, a functional definition such as “wherein the antibody binds with pKa greaterthan (known) antibody X” would not be considered a statement of commercial
advantage but rather a reference by which the scope of the claim may be determined.

5.43

However, an objection will arise where the claim does not define any technical featuresand instead uses statements of a non-technical nature such as:“My invention will solve world poverty.”“My invention is worth a million dollars.”
Such claims are most likely to be filed by applicants who are not represented by anattorney.

5.44This consideration is also related to that of inherent patentability since such claims do
not define a technical feature. Where the Examiner considers that the application
discloses patentable subject matter but the claims have simply been poorly drafted (suchas in the examples above) an objection under Section 25(5)(a) will be appropriate.
However, if there is no apparent patentable subject matter in the application then an
objection that said application does not relate to an invention may be more relevant.

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I.

Clarity and conciseness of claims (Section 25(5)(b))

5.45

Section 25(5)(b) requires that the claim or claims shall be clear and concise. The test forclarity is whether the skilled person would have difficulty in understanding the language
used (Strix Ltd v Otter Controls Ltd [1995] RPC 607). The requirement applies to boththe claims as a whole and to individual claims.

5.46

However, no objection should be raised merely on the basis that a clearer definition
could be provided. The key consideration is whether the skilled person together withthe surrounding common general knowledge in the art would be able to understand themeaning of the terms. A degree of imprecision is permissible provided it would be clear
to the skilled person (General Tire v Firestone [1971] RPC 173, upheld on appeal in[1972] RPC 457).

5.47

Claims may be considered to be unclear simply due to its wording, such as by the useof relative terms (wide, thin, thick), or unclear antecedents or dependencies and such
defects can usually be rectified by simple amendments.

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Indefinite terms
5.48

A degree of indefiniteness is permissible in claims. Indeed, a purposive construction
according to the principles discussed in Catnic allows for such imprecision in somecases.

5.49

The appropriateness of imprecise terms such as “substantially”, “about”, “more orless” and “approximately” will depend on the specific circumstances of the case. For
example, the definition of a temperature of “about 50 degrees” may be appropriate sincein practical terms the person skilled in the art would not expect that precise temperatures
could be achieved under standard operating conditions. Where terms such as “about”
are used, the degree of variance from the defined value will depend on what the person
skilled in the particular art would understand it to mean. In the case of a temperature ofabout 50 degrees, this might mean 51 or 52 degrees. However, in a definition of about
20K there may be a more significant variance. Conversely, in a feature defined toseveral decimal points, the degree of variance may be more restricted.

5.50

In some cases the use of indefinite terms is objectionable. For example, a definition ofa radical having “about 6 carbons” in a chemical compound would be unclear since inthe chemical field a more precise definition might be expected. This may be a different
consideration in the area of polymers where a product may comprise a mixture ofpolymers of various lengths.

5.51

In general, an objection should only be raised if the use of an indefinite term introduces
an ambiguity in the scope of the claim (that is, the skilled person would be unable toreasonably determine the scope of the claim), or if the invention is not clearly
distinguished from the prior art with respect to novelty and inventive step (such as where
there is only a relatively small difference between the range defined in a claim and adisclosure in the prior art – usually in combination with a consideration of inventivestep).

5.52

Generalising expressions such as “substantially” may be allowable if it does not render
the scope of the claims indeterminate. If the word “substantially” merely indicates thatthe patentee is not limiting his monopoly to that precisely shown in the drawings anddescription, then the term may be allowable.

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ii.

Relative terms

5.53

A claim should not use a relative term such as “thin”, “wide”, “strong” and the likeunless the term has a well-recognized meaning in the particular art, for example “highfrequency” in relation to an amplifier, and this is the meaning intended.

5.54

If a relative term appears in a claim, the Examiner should consider whether the skilled
person would be able to determine the scope of the claim either by following a standard
disclosed in the description for measuring the degree of that relative term or in view of
the common general knowledge in the art. However, even if a standard (for example an
ISO-type standard) is provided, this may not provide sufficient clarity since different
international standards may exist, or such standards can change over time. However,where there is no basis in the disclosure for a clear definition and the relative term is nolonger the only distinguishing feature, it may be retained in the claim, because deleting
it would generally lead to added matter beyond the content of the application as filed.

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iii.

“Preferred” and “optional” definitions

5.55

The terms “such as”, “for example”, “preferably”, “particularly” or “moreparticularly” generally will not introduce ambiguity into the claims – the scope of theclaim will be set out by the broader definition, with the subsequent narrower terms
merely being preferred embodiments that do not limit the scope of the claim. An
objection (lack of clarity) should only be raised if the scope of the claim is rendered
unclear. For example, if one of the optional features does not fall within the scope ofthe broader definition then an objection should be taken. For example:“wherein the colour is a primary colour, preferably red, orange or yellow, more
preferably pink”
In this case, the optional features introduce a lack of clarity since the claim defines thecolour broadly to be a primary colour but pink (a non-primary colour) is given as an
option (a similar issue would arise if pink was provided as a preferred embodiment in
an appended claim).

5.56

The term “and the like” may cause a lack of clarity in some cases. For example, adefinition such as “domestic pets including cats, dogs and the like” could be interpreted
in different ways. “and the like” could mean including other domestic pets (e.g. birds,
fish, reptiles). However, it could also mean other mammalian domestic pets (e.g. mouse,
hamster, horse). These expressions should be objected to if they cast doubt on the scopeof a claim.

5.57

Terms like “generally”, “typically”, “in some cases” in a claim may be a source of
ambiguity as they define the scope in uncertain terms. If the scope of the claim isrendered unclear to the skilled person by using such terms, then an objection should betaken.

5.58

Terms such as “optionally”, “if desired”, “when required” suggest that thecomponent, part or condition to which they relate is optional, not essential. If the term
relates to a non-essential element, then it is immaterial to the working of invention, andno objection should be taken. However, if the element is deemed essential, an objection

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should be made. This is likely an objection of lack of support instead of lack of clarity– the claim does not include an essential feature.

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iv.

Lack of antecedent

5.59

Lack of antecedent arises where a definition refers to a previously undefined term, forexample:“A device for cracking nuts consisting of a cup shaped base and a striker element,
said lever tripping the hammer at timed intervals.”

5.60

In this claim, there are no proper antecedents for “said lever” and “the hammer”. In
general, an objection for lack of clarity should be taken when the person skilled in theart would be unable to determine the scope of the claim.

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v.

Ranges

5.61

The following defects can arise in the use of ranges in a claim:
1)0% to X% of a constituent

A claim must include all of the essential features of an invention and define an operative
arrangement. A lower limit of 0% means that the ingredient may or may not be present.
Thus, a range comprising 0% should not be permitted if the element is essential to theinvention, or if the claim would encompass an inoperative composition of matter for the
purpose taught.
Further, in the case of a composition, if the claim recites that the composition “consists”
of two ingredients A and B, but ingredient A is defined with a lower limit of 0%, then
only ingredient B is properly defined by the claim, and a lack of clarity may arise. Where
ingredient B is a pure substance (element or compound), the claim would be unclear
since it encompasses a composition “consisting” of a single pure substance (see subsection vi of Section I in this Chapter).
2)
5.62

Components do not add up to 100%

In a composition claim comprising ranges (by weight, by volume, etc...), where the sumof the lower and/or upper bounds of the ranges for the components do not combine toreach 100%, clarity of the claim may be a consideration. For example, a composition
consisting of 20-60% of A and 40-70% of B is unclear because if A is 20% (lower limit)
and B can at most be 70%, it equals 90% which leaves the reader in doubt as to what
the missing 10% consists of. On the other hand, a composition comprising 20-60% of
A and 40-70% of B is clear because if A is at 20% (lower limit) and B is at 70% (upper
limit), which adds up to 90%, the missing 10% can consist of ingredients inherent or ofcommon general knowledge in the field because the composition is defined with theopen ended “comprising”.
3)

5.63

Ranges not specifically disclosed

When an application includes claims containing a specific limitation with respect tooperating conditions, which limitation falls within a broader range disclosed, no

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objection should be made to the narrow claim solely on the grounds that it is not
specifically shown in the description, or that the description does not indicate thesignificance of the disclosed range.
5.64

For example, an application may disclose a process carried out within certain
temperature limits, say between 1000°C and 1500°C. No objection should be made ifsome claims are directed to the process carried out between 1000°C and 1500°C andothers to the process carried out at a temperature falling within a smaller range within
the disclosed range; say between 1200°C and 1300°C. However, should the broader
claims fall in view of prior art, the narrower claims would also fall unless it can beshown that by restricting the process to the narrower range, a new and unobvious result
is obtained, e.g. a selection invention (see sub-section viii of Section I in Chapter 4).

5.65

In Auchincloss and another v Agricultural & Veterinary Supplies Ltd. and Others,[1997] RPC 649, a departure from stated range is not considered to be a variant in theCatnic sense; i.e., the applicant is held to the “literal meaning” of their stated range.
This was in the case of a claim to a biocidal composition comprising a formulation of anumber of ingredients in varying amounts, where each of the ingredients was stated to
be used in amounts within the specified ranges.

5.66

It was further held in Auchincloss that ranges found in patent claims are not to be treatedas descriptive words or phrases, but rather as simply defining the numerical range
encompassed and no further. Accordingly, imprecise terms like “about” and“approximately” generally should be objected to when used with ranges.

5.67

However, Aldous L.J. in Lubrizol Corp. v. Esso Petroleum Co. Ltd [1998] RPC 727 at[748] held that a claim to “at least 1.3 succinic groups” include 1.28 or 1.29 succinic
groups. In other words, the claim was not construed as a claim to at least 1.30 succinic
groups but to 1.3 rounded. Similarly, Pumfrey J in Halliburton Energy Services Inc v
Smith International (North Sea) Ltd, [2006] RPC 2, construed a claim to “between 31%
and 35% of the total axial force” to mean the number is specified to two significant
figures, so including 30.5% to 35.4%, or 30.50% to 35.49%, or 30.500% to 35.499%.

5.68

Therefore, the Examiner has to consider how the skilled person would construe a
claimed range in the case under examination. This was summarized by Mr David Young

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QC (sitting as Deputy judge) in Goldschmidt v EOC Belgium [2000] EWHC Patents
175 at [91] and [92] as follows:“The evidence is that pH is generally measured by a pH meter and in an industrial
plant to one decimal point. The pH values for each of the Examples in the patent
are also recorded to one decimal point. This is to be contrasted with the claimed
pH range of from 5 to 8.
I consider that one skilled in the art when viewing a pH range of 5 to 8 would nothave read such figures as being 5.0 to 8.0 but would have understood them to be
to one significant figure only … It is also consistent with comparative Example A4
having a pH of 8.6. In other words when construed purposively, the lower limit pHof 5 is to avoid corrosion problems caused by a pH of below 4.5 and the upper pH
limit of 8 is to avoid solidification above a pH of 8.5.”
5.69

Consequently, if the Examiner considers the claimed range to be unclear to the skilled
person, a clarity objection should be raised.

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vi.

Compositions with only one ingredient5.70

A claim to a composition “comprising” a single ingredient that characterises thecomposition is unlikely to result in an objection of lack of clarity, but may lack novelty
if the ingredient per se is known. On the other hand, a claim to a composition“consisting” of a single pure substance (element or compound) would be unclear.

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vii.

Multiple alternatives

5.71

The term “and/or” is not always objectionable. The phrase “A and/or B” can mean
three things: A, B or A+B. As long as each of these conditions is acceptable and thescope of the claim remains clear, then the claim is allowable.

5.72

However, if the term appears twice in a claim, such as (A and/or B) and (X and/or Y),
there are 9 different conditions that must be verified, and the task becomes more onerous
and other issues such as clarity, unity and support may arise. Generally, overuse of theterm may call for an objection on the ground that the scope of the claims for which
protection is being sought is unclear. This will depend on the specific circumstances of
the case and the number of potential alternatives defined.

5.73

More substantive clarity issues arise where there are internal inconsistencies between
the claims.

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viii. Inconsistencies between claims and description
5.74

Section 113 prescribes that the extent (scope) of protection conferred is determined inaccordance with the claims of the application, as interpreted by the description and any
drawings contained in the specification.

5.75

Therefore, the description should not contain material that renders the scope of theclaimed invention unclear. Thus, if embodiments are provided that do not fall within
the apparent scope of the invention then it should be made clear that these are intended
for comparative purposes and are not intended to be claimed. Similarly, statements inthe description that purport to extend the scope of the claims (such as “the invention
should be taken to include modifications…”) should be avoided. For example, when aclaim is directed to a compound, then terms such as solvates, metabolites, prodrugs,
derivatives and similar terms which are not claimed and which make the boundary of
the compound claim unclear, should be removed from the description. This is consistent
with the decision in American Home Products vs Novartis Pharmaceuticals [2000]
EWCA Civ 231, where the Court had construed a claim to rapamycin as encompassing
within its scope derivatives of rapamycin in view of a passage in the description. With
respect to compounds and formulae which are not claimed, it should be clear from thedescription that they are not part of the embodiments of the invention. However,removing the unclaimed compounds and formulae from the description may not benecessary if the scope of the compound claim can be clearly determined when it is read
together with the description.

5.76

In cases where, as a result of amendment, there are specifically described embodiments
or statements in the description and drawings which are inconsistent with the claims, aclarity objection to the claims should be raised if such inconsistency would throw doubt
upon the scope of protection sought by the applicant. It is up to the applicant how thisobjection (if raised) is overcome; normally the simplest course will be to delete thesubject matter which is now outside the scope of the claims, but the matter may beretained provided it is made clear in the description that the matter does not constitutean embodiment of the invention. This latter approach may be preferable in a situation
where embodiments falling within the claims are partly described with reference to suchmatter. On the other hand, if the applicant, by way of submissions in response, can show

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persuasively that the scope of the claims would be clear to a person skilled in the art,
then the objection should be withdrawn.

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ix.

Conciseness

5.77

An objection under lack of conciseness may arise where there is undue repetition ofwords or unduly long recitations in a single claim or an undue multiplicity of claims ofa trivial nature to the extent which renders it unduly burdensome to determine the matterfor which protection is sought. The extreme case of unduly repetitious or unduly
multiplied claims would be the net result is to confuse or obscure the matter for which
protection is sought rather than to clarify.

5.78

An objection on the basis of conciseness may also be appropriate in the case where there
is “unnecessary proliferation of independent claims”. However, an overly academic or
rigid approach should not be adopted with respect to the presence of a number of claimsof different wording but apparently of similar effect.

5.79

On the other hand, if claims of the same application are identical in wording or are
identical in scope in the sense that prima facie they cover the same subject matter despite
a slight difference in wording, an objection on the basis of conciseness may beappropriate. However, such an objection can be overcome if the change in the wordingof the claims results even in a small difference in scope between the claims.

5.80

The situation where claims lack conciseness due to identical scope could also arise in
the case of product-by-process claims. Namely, a product-by-process claim may lackconciseness if there is another claim to the identical product in the application, since thetwo product claims might have an identical scope of protection (see subsection viii of
Section F in Chapter 2 on the construction of product-by-process claims). Notably, a
product-by-process claim may also be unclear if it is determined that the product can be
accurately described by referring to its structure, composition or means other than its
method of preparation or production.

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x.

Definition by reference to (or use with) another entity

5.81

A claim to an entity (an apparatus or a product) may seek to define the invention byreference to features comprised in another entity that is not part of the claimed entity
but that is related to it through use. An example of such a claim is “a cylinder head foran engine”, where the former is defined by features of the location where it is connectedin the latter. In assessing the claim for the requirements of clarity, it should beestablished whether the claim is directed to the first entity or to a combination of thefirst and second entities. The wording of the claim must be adapted appropriately toreflect this, otherwise the claim would be objected to for lack of clarity.

5.82

Where a claim is directed to the first entity, wording such as “connectable” (instead of“connected”) should be used to describe its relationship with the second entity. In thiscase, the first entity’s features are considered suitable to be used with the second entity’s
features, and the subject matter of the claim is interpreted as not including the second
entity or its features. On the other hand, where a claim is clearly directed to a
combination of the first and second entities, the features of the second entity are limiting
for the subject matter of the claim. In the example above, wording such as “engine witha cylinder head” or “engine comprising a cylinder head” would be indicative that theclaim is directed to a combination of two entities.

5.83

It may be permissible to define the dimensions and/or shape of a first entity in an
independent claim by reference to the dimensions and/or corresponding shape of asecond entity that is not part of the claimed first product but is related to it through use.
This applies particularly in instances where the size of the second entity is in some way
standardised, such as in the case of a mounting bracket for a vehicle number-plate where
the bracket frame and fixing elements are specified in relation to the outer shape of thenumber-plate.

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J.

Claims shall be supported by description (Section 25(5)(c))

5.84

Section 25(5)(c) states that the claim or claims shall be supported by the description. In
practice, this means that:(a)the scope of the claims should be justified by the disclosure provided by thedescription, drawings and sequence listing, and in particular “should notextend to subject matter which, after reading the description, would still
not be at the disposal of the person skilled in the art” (Generics (UK) Ltd
v Lundbeck A/S [2009] RPC 13 at [36]); and(b)the specification must provide a disclosure that enables the invention to be
performed across the breadth of the claims. (Asahi Kasei Kogyo KK’s
Application [1991] RPC 485).

5.85

Most claims will represent a generalisation of the inventive concept. The extent to whichthat generalisation is supported will vary from case to case. Thus, as stated by Lord
Hoffmann in Biogen Inc v Medeva Plc [1996] UKHL 18:“… if the patentee has hit upon a new product which has a beneficial effect but
cannot demonstrate that there is a common principle by which that effect will beshared by other products of the same class, he will be entitled to a patent for that
product but not for the class, even though some may subsequently turn out to havethe same beneficial effect: see May & Baker Ltd v. Boots Pure Drug Co Ltd (1950)
67 RPC 23, 50. On the other hand, if he has disclosed a beneficial property whichis common to the class, he will be entitled to a patent for all products of that class(assuming them to be new) even though he has not himself made more than one or
two of them.”

5.86

Consistent with this approach, an applicant may claim more broadly than the specificembodiments set out in the description, including obvious variants, technicalequivalents and the like. One way of approaching this is whether the skilled person
would predict that such variants and equivalents would have the same properties as
those specifically described. Notably this may differ between where the invention is ina well-worked art and where the invention is in a new field. In some cases the scope ofterms in a well-worked art may be narrower as there is more certainty as to the types of

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variants that may be substituted for certain features. In a newer field, it may be lesspredictable so more flexibility may be given to the drafting. However, if there isinsufficient enablement across the full scope then an objection of lack of support may
arise.
5.87

Where the invention relates to a “principle of general application” the claims may be incorrespondingly broad terms. The applicant need not show that they have proved its
application in every individual instance. On one hand, if the claims include a number of
discrete methods or products, the applicant must enable the invention to be performedin respect of each of them. On the other hand, inventions consisting of a single
embodiment, such as a single chemical compound, will generally be supported(Generics (UK) v H Lundbeck A/S [2009] RPC 13 at [25]).

5.88

Particular types of claims will often be more likely to involve a consideration of whether
there is sufficient support: broad claims, claims by result, claims in which features aredefined by function and reach through claims. While these are dealt with specifically in
the Guidelines it should be noted that no special rules exist for such claims and theyshould be construed as per any other type of claim.

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Mere coincidence of language is not sufficient
5.89

More than just a mere coincidence of language is needed between the claims anddescription to meet the requirement that the claims are not broader than justified by thedescription and drawings. As noted by Aldous J in Schering Biotech Corp’s Application[1993] RPC 249 at [252]-[253]:“to decide whether the claims are supported by the description, it is necessary toascertain what is the invention which is specified in the claims and then comparethat with the invention which has been described in the specification. Thereafter
the court’s task is to decide whether the invention in the claims is supported by thedescription. I do not believe mere mention in the specification of features appearing
in the claim is not necessarily sufficient support. The word ‘support’ means morethan that and requires the description to be the base which can fairly entitle thepatentee to a monopoly of the width claimed.”

5.90

Where the subject matter is clearly disclosed in a claim but not elsewhere in thespecification it may be permissible to amend the description to incorporate such matter.
The key consideration will then be whether the amendment introduces additional matter.

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ii.

The technical contribution

5.91

In Biogen Inc v Medeva Plc [1996] UKHL 18, Lord Hoffmann noted that it is a longestablished principle of UK patent law that:“… the specification must enable the invention to be performed to the full extent of
the monopoly claimed. If the invention discloses a principle capable of generalapplication, the claims may be in correspondingly general terms. The patentee
need not show that he has proved its application in every individual instance. On
the other hand, if the claims include a number of discrete methods or products, thepatentee must enable the invention to be performed in respect of each of them.”
He further stated that:“the extent of the patent monopoly, as defined by the claims, should correspond to
the technical contribution to the art in order for it to be supported, or justified.”

5.92

One means of identifying the technical contribution to the art is to determine what is
new and non-obvious (Generics (UK) Limited and others v H Lundbeck A/S [2009]
UKHL 12; [2009] RPC 13 at [30]). In this case, Lord Walker noted that the terms“inventive concept” and “technical contribution to the art” are not synonymous. In
particular he noted that in Biogen, Lord Hoffmann used these expressions several times– “inventive concept” in relation to inventive step and “technical contribution in theart”. Lord Walker stated that:“‘Inventive concept’ is concerned with the identification of the core (or kernel, or
essence) of the invention – the idea or principle, of more or less general application(see Kirin-Amgen [2005] RPC 169 paras 112-113) which entitles the inventor’sachievement to be called inventive. The invention’s technical contribution to theart is concerned with the evaluation of its inventive concept – how far forward has
it carried the state of the art? The inventive concept and the technical contribution
may command equal respect but that will not always be the case.”

5.93

In Biogen, Lord Hoffmann considered there is more than one way in which the breadthof the claim could exceed the technical contribution to the art of the invention (atparagraph 71):

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“The patent may claim results which it does not enable, such as making a wideclass of products when it enables only one of those products and discloses noprinciple which would enable others to be made. Or it may claim every way ofachieving a result when it enables only one way and it is possible to envisage otherways of achieving that result which makes no use of the invention.”
5.94

Thus, in general lack of support may be a consideration in the following situations:1)the description does not provide sufficient enablement across the full scopeof the claims. This is likely to be an issue where the claim is so broad as toinclude a number of alternative products and there is no apparent principle ofgeneral application;2)

the claims encompass other matter that is unconnected to the invention. Thiswas expressed in Biogen as:“it is not whether the claimed invention could deliver the goods, butwhether the claims cover other ways in which they might be delivered:ways which owe nothing to the teaching of the patent or any principle
which it disclosed.”3)

the invention is defined in terms of a desired result or known goal, but theinvention lies in the particular means by which that goal has been achieved.

4)

there is a serious inconsistency between the claims and description in as muchas the claims lack an essential feature of the invention.

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iii.

The enablement requirement

5.95

A claim will lack support if the description does not provide an enabling disclosure of
the claimed invention (Asahi Kasei Kogyo KK’s Application [1991] RPC 485) – that is,
it must provide sufficient information that enables the invention to be performed by the
person skilled in the art across the breadth of what is claimed without undue burden ofexperimentation or the need for further invention.

5.96

A feature in the claims will be sufficiently enabled if, prima facie:
The disclosure teaches a principle that the person skilled in the art would need tofollow in order to achieve each and every embodiment falling within a claim; andthe specification discloses at least one application of the principle and provides
sufficient information for the person skilled in the art to perform alternative
applications of the principle in a way that, while not explicitly disclosed, would
nevertheless be obvious to the person skilled in the art (Kirin-Amgen Inc. v Hoechst
Marion Roussel Ltd, [2005] RPC 9 at [112]).

5.97

If the invention relates to a single product per se the disclosure of one method of making
the product provides an enabling disclosure across the full scope of the claim. The
applicant is not required to provide all possible methods of making the product(Generics v Lundbeck [2009] UKHL 12; [2009] RPC 13 at [80]). For example if theinvention relates to a single compound and the specification provides one method of
how it may be prepared, the specification is generally considered to provide sufficient
support for a claim to the compound per se.

5.98

Where the claims relate to a number of discrete processes or products, the consideration
is whether the enablement of one of these provides enablement of the others. Where
there are different embodiments, each must be sufficiently disclosed and enabled.
(Chiron Corp. and Ors v Murex Diagnostics Ltd and Ors [1996] RPC 535 at [612-613]).
For example, the definition of a “connecting means” may be enabled if the skilled
person would reasonably expect the invention to work with any means of connection.
However, it would not be necessary in such a case for the specification to show that a
broad range of other connectors would work. However, a broad claim for apparatus for“influencing” substances by means of high frequency electrical energy may not be

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supported if it includes any kind of influence on any kind of substance (Esau’sApplication 49 RPC 85). In this situation, the disclosure of a single embodiment will
not always satisfy the requirement for an enabling disclosure (see also Biogen v Medeva[1996] UKHL 18 at [22]). Whether the skilled person would be required to undertake
an undue burden of experimentation in order to achieve the invention may also be aconsideration.
5.99

For example, a claimed product comprises two components, each selected from separate
vast lists. To perform the invention, the person skilled in the art is required to select apair of components to achieve particular desirable characteristics in the final product.
In this situation, the specification would lack an enabling disclosure where:1)

the specification contains little or no guidance on how to select a pair ofcomponents which would achieve the desired characteristics in the resulting
product; and/or

2)

the specification provides no information on how the desirable characteristics
could be measured or otherwise determined in a product containing any pairof components.

In such cases, performing the invention over the entire scope of the claims may beconsidered to impose an undue burden on the skilled person. However, by narrowing
the scope of the claims to a specific pair of components, the invention may be performedby the skilled person. Nevertheless, care should be taken to ensure that there is basis in
the specification as filed for this narrower claim to avoid added matter. If there is nobasis for a narrower claim then an objection under Section 25(4) may be more
appropriate.
5.100 The following claim was found to be unsupported in Pottier’s Application [1967] RPC
170:“A process for the treatment of hydrated seedlings which comprises subjecting theseedlings to cold shock at a temperature below 0°C for a period sufficiently longto affect the size of the resulting plant.”

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In this case, the description only showed the treatment of sugar beet seedlings and there
was no basis on which the treatment of sugar beet could be applied to other plants
generally.

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iv.

Inconsistencies – essential features

5.101 A lack of support may arise where there is a serious inconsistency between thedescription and claims. In particular, the claim should include all of the essential
features of the invention in order to be supported. These are the features that have amaterial effect on the way an invention works. A feature may be considered to be
essential if:
1)

it is evident from a reading of the description that a particular featurematerially affects the way an invention works;

2)

the description clearly states that a particular feature is essential;

3)

the description says or implies, e.g. by its object clause in the Summary of
the Invention, that the features are essential to the invention and cannot be
omitted from the claims; and4)when a functional clause (e.g. whereby clause) appears in a claim which
promises a result to be achieved, then an element required to achieve that
result is considered essential.

5.102 Non-essential features are those that have no material effect on the way an invention
works. Generally, if there is no working interrelationship, or potential working
interrelationship, between a given feature and the other features recited in the claims,
then that feature does not usually materially affect the way that the invention works. It
is not necessary to set out in the claims all the non-essential elements that may make a
combination workable. For example, a claim to an article for conditioning fabrics in alaundry dryer and comprising a flexible woven or non-woven sheet having on it areasof fabric conditioning composition was found to lack support as the description
indicated that it was an essential feature of the invention that the material was permeable
to air (Glatt’s Application [1983] RPC 122).
5.103 Similarly, a claim may define a particular method of treating “synthetic resin
mouldings” to obtain changes in physical characteristics. If all of the examples
described related to thermoplastic resins and the method appeared unsuitable forthermosetting resins, then it may be an essential feature of the invention that
thermoplastic resins are used. However, it should be remembered that the applicant does

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not need to exemplify each and every embodiment they claim – in cases such as this it
must be clear that the feature is essential to the invention.

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v.

Claims by result

5.104 Claims by result generally define the invention in terms of a desired outcome orproperty. For example:“Modified protein X having binding activity more than the unmodified protein X.”
5.105 In this case, the inventor may have found a particular way of modifying protein X toproduce greater binding activity, but has attempted to claim all modified forms of theprotein that exhibit this greater binding activity. Depending on the facts of the case, thismay or may not be an allowable type of claim.
5.106 In particular, where a claim defines the invention in terms of desirable results the
specification will need to provide enough instruction for the skilled person to make eachproduct and/or work all the processes that are encompassed by the claim, without undue
burden or the need for further invention. An objection should not be raised merely on
the basis that the claim defines the invention in terms of a desired result. The usual
considerations of whether the specification enables the full scope of the claim andwhether the claims encompass matter that owes nothing to the teaching of the invention
will apply.
5.107 “All means” claims may also be allowable if the invention lies in the identification of
the problem. In David Kahn Inc v Conway Stewart & Co Ltd [1974] RPC at [319]-[320],
it was stated that:“A patentee may rightly claim a monopoly wider in extent that what he had
invented. If he has discovered a general principle or invented a general methodand discloses one way of carrying it out, he may claim all ways of carrying it out,
but he is not entitled to claim a monopoly more extensive than is necessary toprotect what he has himself said is his invention. He cannot claim all solutions to
a problem unless invention lies in identification of the problem.”
5.108 Thus for example, in No-Fume Ltd v Frank Pitchford Co Ltd [1935] 52 RPC 231, an“all means” claim of the following form was considered supported:“An ash tray receptacle which without the use of movable parts, retains the smoke

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arising from objects thrown into it.”In this case, it was determined that the invention could not be adequately characterisedin any other manner. Furthermore the invention could be realised by using dimensions
other than those specifically disclosed in the specification, and the skilled person could
determine these without any inventive ingenuity.
5.109 In contrast, a claim to the use of all vectors producing a certain result may not be
supported if the invention is the use of a particular new insert in a vector to produce apolypeptide having a certain activity (Schering Biotech Corp’s Application [1993] RPC
249).
5.110 Similarly, in N V de Bataafsche Petroleum Maatschappij’s Application [1956] 57 RPC
65, the claim broadly defined that an aqueous dispersion of a bituminous substanceforming part of a mixture which penetrated the soil and coagulated therein was “suitably
stabilized”. The specification provided no instructions as to how this was achieved andas a consequence the claim was found to lack support. In this case, the Court followed
the guidance of Lord Parker in British United Shoe Machinery Co Ltd v Simon Collier
Ltd 26 RPC 21 at [49]-[50]:“The problem was simply how to do automatically what could already be done by
the skill of the workman. On the other hand, the principle which the inventor
applies for the solution of the problem is the capacity of a cam to vary the relative
positions of two parts of a machine while the machine is running. Assuming thisprinciple to be new, it might be possible for the inventor, having shown one methodof applying it to the solution of the problem, to protect himself during the life of his
patent from any other method of applying it for the same purpose, but I do not thinkthat the novelty of the principle applied would enable him to make a valid claim
for all means of solving the problem whether the same or a different principle wereapplied to its solution.”
5.111 Thus, if the problem is known, then the invention cannot lie in identifying the problem.
In such cases the claims will need to be limited to the particular features that the inventor
has found to solve the problem.

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vi.

Features defined by function

5.112 Claims will often define one or more elements of a claim in terms of what it does rather
than what it is. The monopoly includes any elements that will achieve this desired result,e.g. “fastening means”, “braking means”. The following claim was found to acceptablein Lightening Fastener v Colonial Fastener [1934] 51 RPC 349:
“A machine for making fasteners having means for feeding a tape step by step,means for feeding fastener members into position to be compressed on to said tape,and means for compressing the fastener members thereon.”
5.113 Claims may also define a desired result from the combination of one or more features,
often indicated by a “whereby” clause, in which, after the claimed elements are set out,
the result flowing from the use of these elements is defined, for example “... whereby
the fluid passes from the first tank to the second tank.”
5.114 Claims may broadly define features in terms of their function, even where only one
example of the particular feature has been given in the description, provided the skilled
person would appreciate that other means could be used for the same function. However,
if on a reading of the application it appears that the function must be performed in a
specific manner, then the claim may lack support (American Home Products Corp v
Novartis Pharmaceuticals UK Ltd [2001] RPC 8 at [39]-[43]). In this regard, vague
references or general statements in the specification may not be sufficient, particularly
if it is not reasonably clear what the alternatives might be or how they might be used.
5.115 Since functional claims are generally broader than claims reciting structural elements,
the Examiner should be certain that the claims are neither ambiguous nor unduly broad.
The judgment should be made as to the technical contribution made by the invention,
and whether the claim goes beyond that contribution.

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vii.

Parametric claims

5.116 Parametric claims comprise definitions of specific parameters, such as directly
measurable physical properties or mathematical combinations of several variables in theform of formulae. At first instance, the key consideration for such claims is likely to be
novelty (see Section K in Chapter 3).
5.117 With respect to clarity, the consideration for such claims is whether the specified
parameters would introduce ambiguity to the scope of the claims to the extent that no
meaningful comparison with the prior art can be made. If it is considered unclear to theskilled person which products do indeed possess the parameters required and therefore
would fall within the scope of the claims, a lack of clarity objection should be raised.
For example, applications in which non-accessible apparatuses are used for measuring
the specified parameter(s) are prima facie objectionable on grounds of lack of clarity,
as no meaningful comparison with the prior art can be made. Such applications mightalso disguise a lack of novelty. A clarity issue may also arise in the event where thescope of the claimed subject matter might vary when different measurement methods
are used for characterizing the specified parameters. In principle, a clear disclosure in
the specification of the measurement method is necessary for the unambiguous
definition of the parameter, unless a person skilled in the art would know what method
to use (e.g. because there is only one method, or because a particular method iscommonly used) or all known methods would yield the same result. It is generally
considered unnecessary to recite the method of and the means used for thecharacterization of the specified parameters in the claims; however, suchcharacterization methods and means should be clearly determined by the skilled person
when reading the specification as a whole.
5.118 Depending on the facts of the case, parametric claims are in effect claims by result which
may be subject to lack of support/sufficiency objections. The usual considerations arewhether the claims encompass matter that owes nothing to the teachings of the invention
in the specification. If it is considered that the skilled person would be faced with undue
burden to arrive at the full scope of the claim by following the exemplification given in
the specification or procedures common in the art, a lack of support/sufficiency
objection should be raised. Admittedly, there is a delicate balance between theconsiderations for clarity and lack of support/sufficiency, which have to be assessed
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based on the facts of each individual case. Objections should not arise merely on thebasis that parameters not known in the prior art are used in the claims. In the event it isevident from the specification that the skilled person would face no difficulty in carryingout the characterization disclosed and would be able to establish the exact meaning of
the specified parameters (see for example decision T 231/01), use of such parameters
would be allowable.

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viii. Reach-through claims
5.119 Reach-through claims generally occur where an invention relates to an upstream orplatform technology, and the claims are drafted in such a way as to claim future
downstream innovations that make use of that technology. The claims are essentially“reaching” through to claim matter that is not actually disclosed in the specification, but
may be developed using the invention.
5.120 Reach-through claims have most often arisen in the field of biotechnology. A common
situation involved screening techniques and claims of the following type:1.

Purified receptor X having SEQ ID NO 1.

2.

Method of screening for inhibitors of receptor X comprising the following
steps …

3.

Inhibitors identified by the method of Claim 2.

In this case, Claim 3 is a reach-through claim. This covers any inhibitors that are
identified by the screening method, but in most cases the description will enable few, ifany, specific inhibitors. This raises two issues:
1)

if the specification screens libraries of known compounds then the mere
identification of a new property of a known compound will not confer novelty
on that compound. The claim will lack novelty;

2)enablement will only be provided for any specific compounds (or classes ofcompounds) disclosed in the description. It would otherwise be an undue
burden for the skilled person to isolate and characterize all potential
compounds, without any effective pointer to their identity. A claim is
insufficient if the specification merely constitutes an invitation for the skilled
person to perform a research programme (Eli Lilly v Human Genome
Sciences [2012] EWCA Civ 1185).

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5.121 There is no case law from Singapore or Europe that relates specifically to reach throughclaims, however, there is a consensus that such claims are not allowable as their scope
extends beyond what has been disclosed in the description (see, for example, thetrilateral report on reach through claims, https://www.trilateral.net/projects/biotechnolo
gy/B3b.pdf). This practice was also affirmed in the judgment of the US Federal Courtof Appeal case University of Rochester v G.C Searle & Co 358 F.3d 916 (Fed. Cir.
2004).

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K.

Disclosure of the invention
Enabling disclosure

5.122 The claims play an important role since they define the scope of the monopoly conferred
by a patent. However, the grant of an exclusive monopoly to an applicant is in exchange
for a full disclosure of the invention and how it may be worked. The importance of a
sufficient disclosure and the consequences of insufficiency in revocation were discussed
in Ng Kok Cheng v Chua Say Tiong [2001] SGHC 143, where the Court referred to theguidance provided by the UK decision of Biogen Inc. v Medeva plc [1997] RPC 1 at
[47]:
“The requirement of an enabling disclosure in a patent specification is a matter ofsubstance and not form. Its absence should therefore be a ground not only forrefusal of the application but also for revocation of the patent after grant.”
5.123 The statutory requirements of proper disclosure are set out in Sections 25(4) and25(5)(c), which requires that the description of the invention and its operation or use
must be in such complete and clear terms as to enable any person skilled in the art orscience of the invention or in the art closest to it, to make, construct, compound or use
the invention.
5.124 Section 25(4) states that the application “shall disclose the invention in a manner which
is clear and complete for the invention to be performed by a person skilled in the art”.
This requirement was considered in Ng Kok Cheng v Chua Say Tiong [2001] SGHC 143
at [49], where the Court stated that:“There is one small point here which I should dispose of before dealing with thedefendant’s submissions on the merits. This relates to what level of description isrequired under ss 25(4) and 80(1)(c). The wording requires the specification todisclose the invention ‘clearly and completely’ for it to be performed.
The equivalent English wording is ‘clearly and completely enough’. Mr Kang
submitted that the requirement of the UK Act is more lax and that the Singapore
requirement is stricter so that the specification must be clear and complete.

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I do not agree. Although the word ‘enough’ does not appear in the Singapore
provisions, the phrase ‘clear and complete’ is not an unqualified one in either of
those sections. Instead, it is followed by the words ‘for it to be performed by aperson skilled in the art’. This is a clear qualification implying that as long as aperson skilled in the art would find the wording of the specification sufficient toenable him to make the invention, it does not matter that the specification does notstate every single step that has to be followed in order to make the invention. Thus,
the clear meaning of the legislation taken as a whole is that it is sufficient if thespecification is clear enough and complete enough and absolute clarity andcompleteness are not required.”
5.125 Notably, the approach that absolute clarity and completeness are not required has been
followed in First Currency Choice Pte Ltd v Main-Line Corporate Holdings Ltd [2007]
SGCA 50 and Dien Ghin Electronic (S) Pte Ltd v Khek Tai Ting (trading as Soon Heng
Digitax) [2011] SGHC 36.
5.126 The date at which sufficiency has to be judged is the date of filing, not the date of
publication (Biogen Inc. v Medeva plc). It follows that a specification that is insufficientat the time of filing cannot be made sufficient by subsequent developments in the art.

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ii.

The role of the skilled person

5.127 The specification is addressed to a non-inventive person of ordinary skill in the art.
Therefore, objection should not be raised to any terminology that would be clear inmeaning to the skilled person. Moreover, the specification is a technical document thatis intended to instruct a skilled person on how to work the invention, and if thespecification meets that purpose then no objection should be raised on the basis that it
is possible to describe the invention more clearly in a different way (Schwarzkopf andOrs’ Application, 31 RPC 437).
5.128 The skilled person can include a group or team of such persons. The abilities of theskilled person were stated in Valensi and another v British Radio Corporation Ltd,[1973] RPC at page 377:
“We think the effect of these cases as a whole is to show that the hypotheticaladdressee is not a person of exceptional skill and knowledge that his is not to be
expected to exercise any invention or any prolonged research, inquiry or
experiment. He must, however, be prepared to display a reasonable degree of skill
and common knowledge of the art in making trials and to correct obvious errors inthe specification, if a means of correcting them may be found.”5.129 If the skilled person comprises a team then different parts of the specification may be
addressed to the different skilled addressees, who cooperate to work the invention(Osram Lamp Works Ltd v Pope’s Electric Lamp Co Ltd 34 RPC at page 391).
5.130 The description should enable the skilled person wishing to achieve success rather than
failure to work the invention without an undue expenditure of time and effort andwithout undue experimentation (Mayne Pharma v Debiopharm and Sanofi-Synthélabo
[2006] EWHC 1123 (Pat) at [65]). The general principles relating to undue
experimentation were stated by Aldous J in Mentor v Hollister [1993] RPC 7 as follows:“The section requires the skilled man to be able to perform the invention but does
not lay down the limits as to the time and energy that the skilled person must spend
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contemplates that patent specifications need not set out every detail necessary for
performance, but can leave the skilled man to use his skill to perform the invention.
In doing so he must seek success. He should not be required to carry out any
prolonged research, enquiry or experiment. He may need to carry out the ordinary
methods of trial and error, which involve no inventive step and generally arenecessary in applying the particular discovery to produce a practical result. In
each case, it is a question of fact, depending on the nature of the invention, as towhether the steps needed to perform the invention are ordinary steps of trial anderror which a skilled man would realise would be necessary and normal to produce
a practical result.”
5.131 The Court in Institut Pasteur v Genelabs Diagnostics followed these principles indetermining that sufficiency does not require minute, step-by-step directions, and thatthe skilled person does not need to be told information that would be common generalknowledge in the art.
5.132 Insufficiency will not arise merely on the basis that some difficulty is experienced inworking the invention. Generally this will be according to acceptable levels of failurein the particular art. However, if the invention is not repeatable or if success isunpredictable then the specification may be insufficient. Nevertheless, it can be assumed
that the skilled person should be trying to make the invention work (Kirin-Amgen Inc v
Hoechst Marion Roussel [2005] RPC 9). Thus, if the skilled person would quickly
realise that one method would work and another would fail, the specification is notinsufficient because the claim is expressed in terms broad enough to include bothmethods. However, the specification must be sufficient to allow the invention to be
performed without undue burden, having regard to the fact that the specification should
explain to the skilled person how the invention can be performed. The question whether
a burden is undue must be sensitive to the nature of the invention, the abilities of theskilled person and the art in which the invention has been made (Eli Lilly & Co. v Human
Genome Sciences Inc [2008] EWHC 1903 (Pat) [2008] RPC 29).
5.133 The test for enablement of a prior disclosure for the purpose of anticipation is the sameas the test of enablement of the patent itself for the purpose of sufficiency (SmithKline
Beecham Plc’s (Paroxetine Methanesulfonate) Patent, [2006] RPC 10). However, therole of the person skilled in the art is different. In the case of disclosure, the skilled
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person is taken to be trying to understand what the author meant. His common generalknowledge forms the background in construing the disclosure, with the patent being
construed on similar principles. On the other hand, for enablement, the person skilledin the art is assumed to be willing to make trial and error experiments to get it to work,and the question is not what the skilled person would think the disclosure meant, butrather whether the skilled person would be able to work the disclosed invention.

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iii.

Description must be clear

5.134 The description should be drafted in language that would be clear to the person skilledin the art. Unnecessary or irrelevant material should be avoided (Francis’ Application
27 RPC 87). Similarly, discussion of the principles behind the invention and othermaterial such as background calculations are unnecessary unless they are required for a
full understanding of the invention. However, no objection should be taken unless the
additional discussion is unduly extensive.
5.135 As the specification is addressed to a person skilled in the art it is therefore acceptable
for a description to use art-specific technical terms. However, the use of these terms
must be consistent with the recognised meaning – a different meaning should not begiven to a term if it is likely to be unclear to the skilled reader. Nevertheless, thelanguage used in the specification should be readily understandable to the skilled
person. Where the invention is difficult to explain, such as where it is so groundbreaking that standard nomenclature is not yet available, then some allowance may be
given (Natural Colour Kinematograph Co Ltd v Bioschemes Ltd 32 RPC 256 at page269).
5.136 An opening statement or ‘consistory clause’ setting out the nature of the invention isnormally included in the description. The consistory clause may, however, be omitted
if the description indicates explicitly or implicitly and without ambiguity the essential
feature of the invention.
5.137 If it becomes necessary for the applicant to restrict the scope of the main claim in order
to meet an objection of prior publication, any corresponding statement of invention
should be similarly restricted as the applicant can then no longer allege the broadstatement to be the invention. A claim which is wider in scope than the statement of
invention may be open to objection on the grounds that it is not supported by thedescription. An objection based on a lack of support may not be overcome by theaddition of further examples or features to the specification since this is prohibited under
Section 84, however, an objection to the excessive breadth of the claims may beremedied by restricting the scope of the claims.

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iv.

Reference to prior art

5.138 The description may refer to another document to provide additional backgroundmaterial or further information about the invention, often as an “incorporation byreference”. Generally, such references will only be an issue where the information
disclosed in these documents is essential for a clear and complete disclosure of theinvention.
5.139 While prior art may be cited to assist with an understanding of the invention, there is norequirement under the Singapore law that the specification must give details of such
documents. Thus, no objection should be raised that prior art cited in, for example, asearch report has not been included in the specification.
5.140 However, the specification must be sufficient at its date of filing, and any references
given in the description should have been published by the date of filing (Halliburton
Energy Services Inc v Smith International (North Sea) Ltd [2006] RPC 2). If a referenceis unpublished at the time of filing, and the information contained in said reference isnecessary for a person skilled in the art to carry out the invention, then the specification
may be insufficient. Amendment to incorporate such matter is likely to constitute added
matter (see sub-section ii of Section J in Chapter 7).

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v.

Trademarks and industry standards

5.141 Reference to trademarks should be avoided since it is an indication of origin rather thanof composition or content. However, there is likely to be no issue if the properties of afeature are initially described in structural terms and subsequently further characterised
by reference to a material by its trade mark. A trademark should be indicated as being
such in order to recognise the proprietor’s rights.
5.142 If a specification refers to a proprietary article or similar material that prima facie is notknown, then the description should provide sufficient information for the skilled person
to obtain or prepare such. Alternatively, the applicant may provide submissions, and if
necessary evidence, to show that the skilled person would be able to determine themeaning of the reference.
5.143 Nevertheless, trademarks should be avoided in claims as they are indicative of the originof goods and not a definitive characterisation of the product they contain. In particular
the composition of a trademarked product can change over time. The use of a trademark
in a claim should only be permitted where the applicant is able to show that its use isunavoidable and does not introduce ambiguity. Similarly, claims defined by an industry
standard which could change over time should be objected to under clarity.
5.144 However, some judgment may be exercised as to whether an objection is warranted. For
example, if the trademark is used in relation to an optional feature, then objection may
not be necessary. Similarly if the invention is defined in a manner that clearly sets out
the characteristics of a component and an appended claim uses a trademark tocharacterise a preferred embodiment of that component, it could be assumed that theskilled person would be able to determine the scope of the claim.

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L.

The abstract

5.145 Section 25(3) requires that an application for a patent contain an abstract, and Rule 22
prescribes specific requirements pertaining to the abstract. In particular, the Rule statesthat the abstract should, inter alia, contain a concise summary of the disclosure, saidsummary indicating the technical field to which the invention belongs, and be draftedin such a way which allows a clear understanding of the technical problem to which theinvention relates, the gist of the solution of that problem through the invention, and theprincipal use or uses of the invention.
5.146 Rule 22(9) specifies the intended purpose of the abstract, which is to constitute anefficient instrument for the purposes of searching in the particular technical field, inparticular by making it possible to assess whether there is a need to consult the
specification of the application itself. The scope of the abstract, and the words used init, should therefore be selected to ensure that retrieval from electronic databases would
be likely when searching similar applications at a later date.
5.147 In cases where the abstract submitted by the applicant does not fulfil its purpose, theExaminer is empowered by the Registrar, under Section 25(7), to revise the abstract sothat it does. In doing so, he should consider not only the text of the abstract, but also theselection of the figure(s) for publication with it (Rule 22(7)). However, the Examinershould avoid seeking an amendment of the abstract from the applicant, since the abstract
does not form part of the specification under examination (see paragraph 7.74).
5.148 The checklist provided in the “WIPO Codes and Guidelines” (Standard ST.12/A) would
serve as a useful guide for the writer or reviser of an abstract. It indicates that, provided
that the specification contains the information, the abstract should include the following:a)where the invention is an article, its identity, use, construction, organisationand method of manufacture;b)

where the invention is a chemical compound, its identity (structure if
appropriate), method of preparation, properties and uses;c)

where the invention is a mixture, its nature, properties, use, essential
ingredients (identity, function), proportions of ingredients (if significant),
and preparation;

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d)where the invention is a machine, apparatus or system, its nature, use,
construction, organisation and operation;e)where the invention is a process or operation, its nature and characterisingfeatures, material and conditions employed, product (if significant), and thenature of a relationship between the steps, if more than one.

In particular, the content of the abstract should be determined by the new technicaldisclosure of the whole specification rather than by only the inventive concept of theclaims.
5.149 Rule 22(5) specifies that the abstract should be as concise as the disclosure permits andshould normally not contain more than 150 words.

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M. Sequence listing
5.150 As set out in Rule 19A(1), where an application for a patent discloses a sequence, thedescription of the application for the patent must include a sequence listing, presented
as a separate part of the description and in a manner that complies with the practicedirections issued by the Registrar. The relevant practice directions are in PracticeDirection No. 1/2022. The term “sequence listing” should be understood henceforth asreferring to a nucleotide and/or amino acid sequence listing which gives a detailed
disclosure of the nucleotide and/or amino acid sequences and other available
information.
5.151 In cases where a sequence listing is submitted on the date of filing of an application fora patent, the sequence listing may form part of the description (and also for the purposesof search) or may serve as a reference for the purposes of search only. On that note, any
sequence listing not included in the description of an application for a patent on the dateof filing (as defined in Section 2(1)) does not form part of the application for the patent,
as stipulated by Rule 19A(4).
5.152 In cases where an application for a patent discloses a sequence and:a)a sequence listing is not included in the description of the application for thepatent; orb)the sequence listing that is included in the description is not presented in amanner that complies with the practice directions issued by the Registrar,as the case may be, and the Examiner requires a sequence listing for the purposes ofsearch, the Examiner will inform the Registrar of the need. Upon invitation from theRegistrar and within the period specified in the invitation, the applicant is to furnish asequence listing, presented in a manner that complies with the practice directions issued
by the Registrar, in accordance with Rule 19A(2). For instance, such a need may arise
from an application for a patent where the sequences are essential features of theclaimed invention, but said sequences are in a form that is not suited for the purposes ofsearch, such as only being presented in the drawings.

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5.153 Rule 19A(3) further states that, if the applicant does not submit the required sequencelisting within the period specified in the invitation, the Examiner need only search theapplication to the extent that a meaningful search may be carried out, without thesequence listing, or with the sequence listing that is included in the description of theapplication for the patent, but not presented in a manner that complies with the practicedirections issued by the Registrar. This may entail the claimed sequences in theapplication being partially or wholly excluded from the scope of the search. In theextreme case where a search is clearly not possible without the required sequencelisting, a search would not be conducted by the Examiner.
5.154 The applicant may, of his own volition, amend or correct the description of an
application for a patent in relation to a sequence listing (Rule 19A(5)), subject to thecompliance with the requirements as set out in Section 84 (see Section J in Chapter 7)
or Rule 91(2) (see Section K in Chapter 7). With regard to the procedural aspects ofmaking an amendment or correction to a sequence listing of the description of an
application for a patent, the applicant may refer to the IPOS Patents Formalities Manualfor guidance. Of note, the cover letter accompanying a request for amendment or
correction should clearly explain the changes made and indicate the basis for theamendment or correction. In addition, for all statements mentioned in paragraphs
2.2.31-2.2.33 of the IPOS Patents Formalities Manual, the Examiner would generally
assume that the statements submitted by the applicant are true and accurate in theabsence of any clear evidence to the contrary.

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6.

UNITY OF INVENTION

A.

Statutory requirements

6.1

Section 25(5)(d) requires that the claims relate to one invention or group of inventions
which are so linked as to form a single inventive concept.

6.2

Rule 25 further sets out that:1)

where 2 or more inventions are claimed (whether in separate claims or asalternatives within a single claim), such inventions shall be treated as being
so linked as to form a single inventive concept only where there is a technicalrelationship among those inventions involving one or more of the same orcorresponding special technical features.

2)

In this rule, “special technical features” means those technical features which
define a contribution which each of the claimed inventions, considered as awhole, makes over the prior art.

6.3

Whether or not a particular technical feature makes a “contribution” over the prior art,
and therefore constitutes a “special technical feature”, is considered with respect tonovelty and inventive step.

6.4

Unity is a ground for refusal under the Patents Act but is not a ground for revocation,
and as a consequence there is no judicial or hearing guidance from Singapore on thisissue. However, the wording of the Singapore law mirrors the wording of PCT Rules
13.1 and 13.2. Guidance for practice in Singapore is therefore taken from Chapter 10 of
the PCT International Search and Preliminary Examination Guidelines (“The PCT
Guidelines”) (http://www.wipo.int/export/sites/www/pct/en/texts/pdf/ispe.pdf).

6.5

There are several administrative considerations that underpin this requirement: thepresence of multiple inventions in a granted patent make it more onerous for third
parties undertaking searches of the prior art or seeking to determine their freedom tooperate; there are additional costs in search and examination without additional fees tocover the cost; and a patent for several inventions could result in additional complexity

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in the system (for example multiple infringement/revocation actions in relation to thesame patent on different matter and grounds).

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B.

Approach for determining lack of unity in Singapore

6.6

Most cases under examination in Singapore are national phase filings based on PCTapplications. The applicant often requests examination be conducted based on theInternational Search Report. Given that PCT practice in relation to unity will have been
followed, generally the determination provided by the ISA should be directly applicablein Singapore.

6.7

The Singapore Examiner is not bound to follow the ISR, and may disagree with thedetermination made by the International Examiner (that is, if the ISR raises a lack ofunity the Examiner may decide to follow the objection in full, to follow in part or withdifferent reasoning, or to differ). However, the ensuing should be followed:(a)

A lack of unity should only be raised in the clearest cases when it has notbeen raised in the ISR or foreign search.

(b)

Any objection of lack of unity should follow the guidance provided in the
PCT Guidelines and provide sufficient detail for the applicant to fully
understand the basis of the objection.

(c)

Lack of unity is preferably raised a priori (Section C and sub-section i of
Section D in this Chapter).

6.8

The following should be followed when considering a posteriori lack of unity:(a)Lack of unity is not to be raised where the common feature is clearly novel
and inventive.

(b)

Lack of unity a posteriori is most likely to be a consideration where thecommon feature is well known. This is likely to be where the common
feature is disclosed in a manner that suggests it is part of the common
general knowledge of the person skilled in the art.

(c)

Lack of unity may be raised if a feature is not well known, but rather isdisclosed in a document that constitutes public knowledge – such as a single
journal article or patent document. Lack of unity should not be raised wherea document provides only a generic disclosure of the common feature. In
these cases the common feature is not “known” as such.

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(d)Generally, lack of unity should not be raised where the features are obvious
in view of a combination of documents.

6.9

Notably, the PCT Guidelines set out two extremes – situations where the common
feature is well known and unity is clearly lacking, and those where there is a novel andinventive feature in common and unity is clearly evident. Between these, the situationis less clear, and rigid rules cannot be applied. Each case should be considered on its
merits with the benefit of any doubt being given to the applicant.

6.10

Other guidance as to the level of detail required and the manner in which the inventions
are broken down should follow the PCT Guidelines. However, further guidance is givenin the sections that follow.

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C.

General principles

6.11

Lack of unity is determined on the basis of the invention(s) as defined by the claims.
An application may describe a number of different inventions having different
inventive concepts, but an objection of lack of unity will only arise if the different
inventions are claimed. Lack of unity can occur between different claims or within asingle claim where said claim contains distinct embodiments which are not linked by asingle inventive concept. When considering unity, the description and drawings may betaken into account when interpreting the claims to determine the invention.

6.12

Detailed reasons for the objection of lack of unity must be given in the report. Chapter
10 of the PCT Guidelines provides general guidance on how to determine whether there
is a lack of unity. The examples at 10.20-10.59 provide a framework for certain
technology-specific situations.

6.13

Lack of unity will be either “a priori”, that is, before considering the prior art, or may
only become apparent “a posteriori” following a search of the prior art. All objections
must be drafted following these principles.

6.14

The test for unity of invention may start from identifying common or corresponding
technical features in the inventions claimed and determining whether the same orcorresponding “special technical features” are present in all the claimed inventions.

6.15

If there are no common or corresponding technical features, then there is a strong
indication that there is a lack of unity a priori. When there are common or corresponding
technical features, there would be unity if the common or corresponding technicalfeatures are considered to be special technical features; on the other hand, if the common
or corresponding technical features are not considered to be special technical features,
there may be a lack of unity a priori or a posteriori.

6.16

If the common feature is disclosed in a P,X or E-category citation, it cannot be used tosupport an objection of lack of unity. The common feature must be made available tothe public at the priority date of the application in order to support an objection of lackof unity.

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6.17

In general, the initial consideration will be directed to the independent claims only.
However, further consideration of dependent claims which depend on an independentclaim may be necessary if the features defined in said independent claim are found in
the prior art (see sub-section ii of Section D in this Chapter).

6.18

The following are some scenarios to illustrate whether a lack of unity objection shouldbe raised among dependent claims:(a)

In cases where an independent claim merely defines features that are part ofthe common general knowledge, and its respective dependent claims
additionally define separate inventions, an objection of lack of unity may beraised among the dependent claims.

(b)

In cases where an independent claim is novel and inventive, then an objectionof lack of unity should not be raised even when the dependent claims merely
define trivial features that would be part of the common general knowledge.

(c)

In cases where an independent claim lacks novelty and/or inventive step andthe dependent claims are closely interdependent (that is, they merely define
specific embodiments of the invention claimed in the independent claim),
then it may be more appropriate to assess novelty and/or inventive step
instead of raising an objection of lack of unity to the dependent claims.

6.19

It should be noted that this is case dependent and a decision to raise an objection of lackof unity should take into account all circumstances specific to the case in hand (subsection iii of Section D in this Chapter).

6.20

Alternative forms of an invention may be claimed in a single claim (Markush claims are
an example). However, a lack of unity will arise if the alternatives within a claim resultin there being no common special technical feature. Broad consideration should begiven to the special technical feature – alternatives could be linked by different
properties: this could be composition, structure, function or other manner.

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D.

Assessment of unity of inventioni.

Lack of unity a priori

6.21

Unity of invention requires that the claims have the same or corresponding “special
technical features” that provide the contribution over the prior art. A lack of unity of
invention a priori should be self-evident and an assessment can be made with little indepth analysis. A simple example of claims lacking unity a priori is as follows:

6.22

1.

A+X

2.

B+Y

There is a lack of unity a priori as there is no common or corresponding technical feature
between the two independent claims. Similarly, the following three independent claims
lack unity a priori as there is no subject matter common or corresponding to all claims:

6.23

1.

A+X

2.

A+Y

3.

Y+X

An objection to lack of unity may be taken by grouping the inventions having a common
special technical feature – in this case on the assumption that each of A, X and Y is a
special technical feature, the claims are grouped as follows and each group is considered
to constitute an invention:
Invention 1: A + X and A + Y (A is the special technical feature in common);Invention 2: A + Y and Y + X (Y is the special technical feature in common);Invention 3: A + X and Y + X (X is the special technical feature in common).
The examination report will be based on the first mentioned invention only.

6.24

In the following example, the two independent claims which have a common feature A
may lack unity a priori when the common feature A is well known in the art. Before
considering the prior art, it is clear that feature A is already disclosed in the state of theart, and the ‘real’ inventions relate to features X and Y, respectively. An a priori lackof unity objection in such a circumstance supported by a reference to a citation may be

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raised, unless the feature A is so generic in the art that it requires no documentary
evidence.

6.25

1.

A+X

2.

A+Y

In some cases the claims may be drafted in a manner that makes it difficult to identify
the special technical feature. One approach to dealing with such cases is to consider the
problem that the application addresses and how the application seeks to solve thatproblem. The solution will most likely be the general inventive concept which can beconsidered to be the special technical feature, and if this is present in all of the claims
then there will be unity (sub-section v of Section D in this Chapter).

6.26

Complex claim sets, chemical intermediates and Markush claims also involve special
considerations. These are discussed in later sections.

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ii.

Lack of unity a posteriori

6.27

Unity of invention will be present when the claims all have the same or corresponding“special technical feature” that provides the contribution over the prior art. However, insome cases it may be apparent that the common or corresponding feature does notprovide a contribution over the prior art. This will most often occur where a preliminary
search identifies documents that disclose the common or corresponding feature. In suchcases, an objection to lack of unity may be applicable on the basis that the claims haveno common or corresponding technical feature that makes a contribution over the priorart (that is, a posteriori – after taking the prior art into account).

6.28

In many cases the lack of unity will be apparent to the Examiner from an initialconsideration of the claims, and the key consideration will be as to whether an a priori
approach is the most appropriate or whether an a posteriori approach should be taken.
Where an a posteriori approach is considered appropriate, an initial search can be
carried out to target the matter in common between the claims.

6.29

A posteriori lack of unity may be illustrated as follows:
1.

A+X

2.

A+Y

In the case of independent claims A + X and A + Y which have feature A in common,
if it is established after a search that A is not novel or is obvious, there may be a lack ofunity a posteriori, since A (be it a single feature or a group of features) is not a technicalfeature that defines a contribution over the prior art. Each of these groups is taken to bea separate invention.
6.30

However, there will be instances whereby the Examiner discovers, only after a search,that the common feature is well known in the art. In such cases, an a priori lack of unity
objection may be raised. It is noted that the tests for assessing unity, whether a priori ora posteriori, are meant to assist Examiners in performing the unity assessment andformulating its associated reasoning. When raising a unity objection in the written
opinion or in the examination report, the Examiner may specify whether the lack ofunity occurs a priori or a posteriori, although he need not do so.

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6.31

The a posteriori approach is most applicable in situations where the “real” inventions
are unrelated but the manner in which the claims are drafted introduces a common
feature that is not essential to each. A simple example of this is the following:1.

Automobile characterised by a new and novel exhaust system.

2.

Automobile characterised by a new and novel engine cooling system.

In this case, the “real” inventions relate to the exhaust system and the cooling system
respectively. If a search identifies prior art documents that disclose the common featureof the automobile, an objection of lack of unity a posteriori may be taken. This isconsistent with the policy intention that unity is intended to assist with the efficientadministration of the patent system: the two real inventions would require entirely
separate searches and examinations, and would be subject to entirely different
infringement and revocation actions. On the other hand, if it is determined, whether or
not such determination involved a search of the prior art, that the common feature of theautomobile is well known, an objection of lack of unity a priori may be appropriate.
6.32

Some other examples of these types of situations would be:
1.

A batch stirred tank reactor comprising Catalyst X for use in the preparationof compound Z.

2.

A batch stirred tank reactor comprising Catalyst Y for use in the preparationof Polymer A.

If Catalyst X and Y and/or compound Z and Polymer A were unrelated, then the only
feature in common would be the batch stirred tank reactor. If a search identifies priorart documents that disclose the common feature of the batch stirred tank reactor, thenan objection of lack of unity a posteriori may be taken. On the other hand, if this typeof reactor is well known in the art, then an objection of lack of unity a priori may betaken.
6.33

If an independent claim is new and inventive (i.e. a special technical feature is definedin the claim), then it follows that dependent claims will be unified. This will be the caseeven if the additional features defined in the appended claims are prima facie routine or
obvious by themselves or are prima facie directed to different inventive concepts. For

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example, in the following claims, if A + B is found to be novel and inventive and the
combination of these features represents a special technical feature, then Claims 2 and3 will have unity with Claim 1 even if features C and D are well known in the art.

6.34

1.

A+B

2.

A+B+C

3.

A+B+D

If the combination of A + B was not novel, then an a posteriori lack of unity could
result. In this sort of situation, the decision to raise unity would take into account all
circumstances of the case. If, in the opinion of the Examiner, the separate combination
with C and D results in different inventions, then a unity objection may be raised.
However, if the combination of A + B was known in the art and there was clearly no
inventive step in adding either of the features C and D, then the unity objection may be
a mere technicality.

6.35

For the combination of A + B, an a posteriori lack of unity in view of a combination of
documents is generally not recommended unless the motivation for combining the
documents is absolutely clear. Otherwise raising an objection to a lack of unity may
lead the applicant to argue an absence of motivation to combine the documents, which
is better dealt with in the inventive step assessment.

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iii.

Avoid literal or over-technical approaches

6.36

In addition to the actual tests applied in the unity consideration, there is significant
variation in the “strictness” of approach applied by Examiners. The PCT Guidelines
provide some general examples of where unity may or may not arise, but in practice theunity determination is largely a matter of individual judgment based on the facts of thecase. In this regard, the Guidelines set out that:
Although lack of unity of invention should certainly be raised in clear cases, it
should neither be raised nor persisted on the basis of a narrow, literal or academic
approach. There should be a broad, practical consideration of the degree ofinterdependence of the alternatives presented, in relation to the state of the art asrevealed by the international search or, in accordance with Article 33(6), by any
additional document considered to be relevant. If the common matter of the
independent claims is well known and the remaining subject matter of each claim
differs from that of the others without there being any unifying novel inventive
concept common to all, then clearly there is lack of unity of invention. If, on theother hand, there is a single general inventive concept that appears novel andinvolves inventive step, then objection of lack of unity does not arise. For
determining the action to be taken by the Examiner between these two extremes,
rigid rules cannot be given and each case is considered on its merits, the benefit ofany doubt being given to the applicant.

6.37

Lack of unity a posteriori is particularly open to a “narrow, literal or academic
approach” since in theory any novelty or inventive step objection could potentiallyresult in a further objection on lack of unity for any further variations not covered by
the novelty/inventive step objection. In such cases each and every further variation
could be considered a further invention (in the chemistry area this could amount tothousands of additional inventions). This is clearly not the intention of the unity
requirement. If an a priori consideration of the claims has determined that the claims
have unity, then careful consideration needs to be made as to whether the prior art
significantly impacts on that decision.

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6.38

Notably, the PCT Guidelines set out two extremes – situations where the common
feature is well known and unity clearly is lacking and those where there is clearly a novel
and inventive feature in common and unity is evident. Between these the situation isless clear, but it could be considered that unity might be raised if a feature is not wellknown, but rather is disclosed in a document that might not ordinarily constitutecommon general knowledge (essentially the feature is public knowledge rather thancommon general knowledge). Situations where unity would be unlikely to be raised,
except in exceptional circumstances, would be where a document provides only ageneric disclosure of the feature, or where the features are obvious in view of a
combination of documents.

6.39

As noted in the PCT Guidelines the applicant should be given the benefit of doubt. An
objection of lack of unity can potentially lead to the applicant filing divisional
applications for additional inventions. This can be costly for the applicant, who willneed to pay significant additional costs to prosecute these divisional applications.

6.40

Furthermore as set out in the PCT Guidelines, there should be a broad, practicalconsideration of the degree of interdependence of the alternative inventions. Dependingon the specific circumstances of the case, a lack of unity may be “technical”, and the
key issue may instead lie in whether the claims are inventive, fully supported or clear
in scope. Thus, a practical approach might be to consider inventive step, full support orclarity rather than unity. For example, if an initial consideration of the dependent claims
does not identify any feature that would confer inventive step then a “broad brush”
approach can be taken under inventive step rather than taking a “technical” objection oflack of unity. Another example would be if the claims have an unduly broad scope andare only partially supported by the disclosure, the Examiner adopting a practical
approach may limit the search to the supported subject matter instead of raising a unity
objection. More examples are provided below to further illustrate the consideration forlack of unity.

6.41

In some cases the common technical feature may not be readily apparent and can result
from different properties of the invention. For example:
A polypeptide having activity X comprising SEQ ID No: 1 wherein the sequence
possesses mutations at one or more of the positions 4, 19, 143 and 244.

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In this case the different point mutations are at quite different and remote positions of
the peptide. Prima facie, these are different inventions. However, the activity of thepeptide may relate to the binding at a particular receptor site. Proteins may adopt a
tertiary structure where an active site comprises quite distant amino acids. In this casethe mutations may be related to a single binding site where mutations of the amino acids
result in changes to the same binding site, which has a technical effect not previously
disclosed in the art. This could therefore be the special technical feature the different
proteins have in common.
6.42

Similarly, if the invention relates to a new property of a related group of articles (someof which are known and some of which are new), then the group will comprise a single
inventive concept based on the new property. An a posteriori lack of unity does notarise as a result of some of the articles being known. Such situations are likely to arisein the chemical area. For example, if a group of related chemical compounds comprising
a number of known compounds as well as a number of unknown compounds is usefulin treating a certain disease, then claims to the new use, compositions for the particularuse, claims to any novel compounds and methods for the preparation of the novelcompounds would constitute a single invention.

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iv.

Claims that are unduly complex

6.43

Occasionally an application may contain a large number of claims with overlapping
scope, which may relate to separate inventions. In some cases the claims may be unduly
complex or broad in scope. In approaching such cases there may be different strategies
that may be employed. Some of the key considerations are as follows.
1.

6.44

Is there a lack of unity?

This is likely to be a consideration in combination claims (including methods) where
each feature may itself comprise a large number of alternatives such as where theindividual features are defined in generic terms.

6.45

The considerations set out in previous sections should be taken into account in the unity
determination. Moreover the objection should clearly identify the different inventions.
Admittedly this may be difficult if the claim is relatively broad, but must be done inorder for the applicant to determine the nature of the amendments that they need to
make. Following the guidance of the PCT, the consideration may take into account thedescription and figures to identify groups of inventions.
2.

6.46

Is inventive step or novelty the key issue?

In many cases concerning a posteriori lack of unity, the key issue may instead relate tonovelty and/or inventive step. In this regard the nature of the citation should be taken
into account before raising a lack of unity.

6.47

As discussed in previous sections, whether the common matter is well known is aconsideration. Furthermore, whether the broad inventive concept or merely a specificembodiment within the scope of the claim is disclosed in the prior art should be taken
into account.
3.

6.48

Are the claims supported?

Another consideration is whether the claims are in fact supported by the disclosure. The
usual considerations of support should be taken into account, such as whether, for

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example, the inventive concept is a principle of general application which is supportedby the description.
6.49

It should be noted that a divisional application filed for any additional invention(s)which were not supported by the description would be invalid. Accordingly unity isclearly not the only issue here. An objection to lack of unity may be raised together witha support objection, with a warning to the applicant against filing a divisional
application.

6.50

Example 1:
A method for the diagnosis of prostate cancer comprising the measurement of one
or more of the 2000 markers shown in Table 1.
In this case, the markers have no significant structural or functional feature in common.
The description describes the analysis, identification (using commercial Affymetrix
microarrays) and comparison of markers in cancerous and non-cancerous cells. The
description states that the up- or down-regulation of a group of 20 markers may be used
to determine the presence of prostate cancer.
A literal approach to the claim would be to identify each of the 2000 individual markers,
and each and every combination of such as a single invention. This would result in an
indeterminate number of inventions. However, a consideration of the specification as awhole indicates that the invention relates to the particular group of markers that can beused to diagnose cancer. In this case, a lack of support could be considered if thespecification provides no support for the claim to each and every combination of thenamed markers being used for this purpose.
Furthermore, a search of the broad inventive concept of fingerprinting the genetic
markers produced in prostate cancer cells could be carried out. Any document found bysuch a search could be used as a novelty and/or inventive step objection (even if thespecific markers are not identified since it would be a matter of routine to determine theidentity of such markers).
Nevertheless, in case a lack of unity objection is not raised in the first instance, it may
still be necessary to raise such an objection once the claims are amended to overcome

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the other objections such as inventive step/support. In such cases the applicant should
be warned in the first instance that there is a potential for lack of unity, but that fullconsideration is being deferred pending amendment of the claims.
6.51

Example 2:
A method for the diagnosis of prostate cancer comprising the measurement of one
or more of the (2000) markers shown in Table 1.
As in the above example, the markers have no significant structural or functional featurein common. The description describes the analysis, identification (using commercial
Affymetrix microarrays) and comparison of markers in cancerous and non-cancerous
cells.
The description states that a group of 20 markers may be used to diagnose lethal prostatecancer. A second group of different markers may be used to diagnose benign prostate
disease. A third set of markers may be used to determine the likelihood thatchemotherapy will be successful.
In this case a similar approach as taken in Example 1 may be taken to the broad claimon the ground of lack of support. Furthermore a lack of unity may be appropriate,
identifying the three inventions as noted above.

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v.

Combinations of claims of different categories or of interrelated
products

6.52

Generally, unity will extend to claims of different categories or of interrelated products
related to the same inventive concept, where the claims have corresponding special
technical features. The term “interrelated” means different objects that complement
each other or work together. Some of the following are examples of where this will bea consideration, and are based on the guidance given in the examples in 10.20-10.59 of
the PCT Guidelines.

6.53

Example 1:
In the following example, despite the claims relating to different articles, they relate to
the same inventive concept which provides them with unity. Similarly, there may also
be unity between different articles provided they are specifically adapted to have aworking inter-relationship. For example, the claims are:1.

Plug characterised by feature A.

2.

Socket characterised by having an aperture designed to receive feature A.

In this case, the plug and socket interact in operation using the feature A, and areinterrelated products. This inventive concept therefore provides unity between the twodifferent articles.
This would also be the case with separate claims directed to two parts of an electricalor other coupling, or to a housing and to contacts to be mounted in the housing, provided
they were specifically adapted for one another and have no further obvious application.
In particular, separate claims may be justified to parts which may be manufactured orsold separately, such as a rupturable container of fuel and a burner specifically adapted
to pierce the container when mounted on it; or a container of chemicals to be sprayedwhich is specifically adapted to be mounted on a carrier, and such a carrier specially
adapted for receiving the container; or to a new form of cable and to a sheath stripper
particularly adapted to deal with this cable.

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6.54

Example 2:
In most cases, an article or product per se will be the special technical feature incommon between different aspects of the invention. For instance, in the following
example, the compound of Formula X will be the common feature of the claims:
1.

A compound of formula X.

2.

A herbicidal composition comprising the compound of Formula X as definedin Claim 1, comprising …

3.

A method for preparing the compound of Formula X as defined in claim 1
wherein …

4.

The use of the compound of Formula X as defined in Claim 1 as a herbicide…

6.55

Example 3:
In the biotechnology area, this may extend to different embodiments related to the same
inventive concept even though they are distinct entities. For example, in the case of agene and protein, claims in a single application may include the protein, the use of theprotein, nucleic acids encoding the protein, vectors comprising the nucleic acid,transgenic organisms etc. For example,
1.

An Fc binding protein, containing amino acids at positions 35 to 90 of anamino acid sequence described in SEQ ID NO: 1.

2.

A polynucleotide, encoding the Fc binding protein according to claim 1.

3.

An expression vector, containing the polynucleotide according to claim 2.

4.

A transformant obtained by transforming a host with the expression vector
according to claim 3.

5.

A method for manufacturing an Fc binding protein, comprising culturing thetransformant according to claim 4 to produce the Fc binding protein; andrecovering the produced Fc binding protein from its culture.

In this case, the protein is the unifying inventive concept. In the case of nucleic acids,
unity may exist between the nucleic acid and antisense even though they are different
structurally.

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6.56

Example 4:
In the case of processes and apparatus, unity will generally rely on the apparatus being“specially adapted” for use in the specific process. In order to be considered as specially
adapted, the claim must define the apparatus in a manner that clearly embodies theinventive features of the process.
1.

Process of preparing Compound X comprising the steps of:(a)

In a first reactor, selectively hydrogenating Compound Y using catalyst
Z;(b)

In a second reactor, selectively oxidising the product of step (a) using
permanganate under elevated pressure of at least 5 atmosphere.

2.

Apparatus specially adapted for use in the process of Claim 1.

3.

Use of Compound X for …

If the apparatus has been defined to be specially modified in such a way as to provide
the inventive outcomes of the process (automation, operatively linked, catalysts,
pressure system, etc.), the apparatus is considered “specially adapted” for use in theprocess. The claims would have unity in such cases.
However, if the apparatus is defined in a way that merely requires that it is capable ofcarrying out the process, the claim would not sufficiently embody the inventive concept
and an objection of lack of unity may be applicable. Novelty may also be an appropriate
consideration in this case since the arrangement of reactor vessels may be interpreted insuch a way as to have no distinguishing features over and above the prior art.
It should also be noted that the construction of claims directed to apparatus “specially
adapted” needs to be dealt with on a case-by-case basis (sub-section vii of Section F in
Chapter 2).

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vi.

Markush claims

6.57

A Markush claim is a claim that defines multiple “functionally equivalent” alternative
entities for one or more of the features of the invention. This type of claim is mainly
encountered in the chemistry field.

6.58

Generally, there will be a consistent core structure that provides the activity of acompound. However even relatively straightforward Markush structures might
comprise several thousand compounds, while more complex structures have been
estimated to include in the order of 1061 compounds. By way of reference, the numberof actual known compounds number in the order of 107.

6.59

As previously noted, guidance can be taken from the PCT Guidelines, where the key
consideration for unity is whether there is a common or corresponding special technicalfeature between alternatives. In the case of a Markush structure this requirement is met
when the alternatives (that is the compounds defined by the claim) are of a similar
nature.

6.60

The PCT Guidelines also set out that compounds are regarded as being of a similar
nature where the following criteria are fulfilled:(a)

all alternatives have a common property or activity, and(b)(1) a common structure is present, that is, a significant structural element isshared by all of the alternatives, or(2) in cases where the common structure cannot be the unifying criteria, allalternatives belong to a recognized class of chemical compounds in the art towhich the invention pertains.

6.61

In paragraph (b)(1), “significant structural element is shared by all of the alternatives”
means that the compounds share a common chemical structure which occupies a large
portion of their structures. Where the compounds have only a small portion of theirstructures in common, the commonly shared structure must constitute a structurally
distinctive portion in view of existing prior art, and the common structure must be
essential to the common property or activity. The structural element may be a single
component or a combination of individual components linked together.

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6.62

In paragraph (b)(2), “recognized class of chemical compounds” means that there is an
expectation from the knowledge in the art that members of the class will behave in thesame way in the context of the claimed invention. In other words, each member could
be substituted one for the other, with the expectation that the same intended result would
be achieved.

6.63

An objection of lack of unity should not be taken only on the basis that the alternativesof a Markush grouping belong to different IPC classes. If at least one Markush
alternative is not novel over the prior art, an a posteriori lack of unity may be aconsideration. However, it should be noted that the mere existence of compound(s)falling within the scope of a claim is not unusual and will rarely result in an objectionof lack of unity. This may be an over-technical approach which at its most extreme
would result in an objection of lack of unity. When in such cases, a novelty objection
will be taken that will generally result in the applicant amending the claim to remove
the prior art compound(s). The Examiner should take a broad consideration of therelationship between the alternatives. In these situations the issue may be closely linked
to inventive step. On the other hand, lack of unity of a Markush grouping may arise if
the requirements as set out in paragraphs 6.59 to 6.62 above are not met.

6.64

Example 1:
The invention relates to novel compounds of the following formula:wherein R1 is selected from the group consisting of phenyl, pyridyl, thiazolyl,
triazinyl, alkylthio, alkoxy, and methyl; R2-R4 are methyl, benzyl, or phenyl. The
compounds are useful as pharmaceuticals for the purpose of enhancing the capacityof the blood to absorb oxygen.
In this case, there is a common activity or property and a common structure is present
that appears to be essential to the activity. Accordingly, the Markush grouping has unity.

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6.65

Example 2:
The following Markush group does not represent a single invention:
A-B-C-D-E
wherein:
A is selected from C1-C10 alkyl or alkenyl or cycloalkyl, substituted or
unsubstituted aryl or C5-C7 heterocycle having 1-3 heteroatoms selected from O
and N;
B is selected from C1-C6 alkyl or alkenyl or alkynyl, amino, sulfoxy, C3-C8 ether
or thioether;
C is selected from C5-C8 saturated or unsaturated heterocycle having 1-4
heteroatoms selected from O, S or N or is a substituted or unsubstituted phenyl;
D is selected from B or a C4-C8 carboxylic acid ester or amide; andE is selected from substituted or unsubstituted phenyl, naphthyl, indolyl, pyridyl, or
oxazolyl.
The key issue here is that the different combinations encompassed by the claim can leadto a large diversity of different compounds having no common structural feature.
Furthermore, all of the circumstances of the case should be taken into account. For
example, if the specification provides only one specific group of compounds, then there
may be an issue of whether the claims are supported and such an objection could betaken instead of, or in addition to, the unity objection.

6.66

In chemical cases, a claim directed to a genus expressed as a group consisting of certain
specified materials is allowable, provided it is clear from the known nature of thealternative materials or from the prior art that the materials in the group possess at least
one property in common which is mainly responsible for their function in the claimed
relationship. Therefore, a Markush claim will generally be construed with a genericexpression covering a group of two or more different materials (elements, radicals,
compounds) as illustrated in the following examples:“A solvent selected from the group consisting of alcohol, ether and acetone …”“A strip of a conductive metal selected from the group consisting of copper, silver
and aluminium …”

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6.67

Occasionally, the Markush format may be used in claims directed to subject matter inthe mechanical or electrical fields in a manner such as that illustrated in the example
below:“A means for attaching a wall panel to a framework wherein the attaching means
is selected from group consisting of nails, rivets and screws …”

6.68

While an objection should be as detailed as possible, in more extreme cases such as this,
there is little benefit in detailing every permutation that falls within the scope of theclaim. If there are only a limited number of classes specifically exemplified, then these
may be identified in the objection and only a general comment made as to the others.
Moreover, the examination should attempt to be of as much benefit as possible to theapplicant, as well as avoiding unnecessary or wasted effort through examining
embodiments that the applicant ultimately may not pursue. To this end, if the description
is directed primarily to one particular group of compounds, then examination should be
carried out on that group.

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vii.

Intermediate and final products

6.69

In some cases claims will be directed towards novel intermediates that are used for the
preparation of the final products of the invention. There are special rules that apply insuch cases and these are set out in the PCT Guidelines.

6.70

Unity of invention is considered to be present in the context of intermediate and final
products where the following two conditions are fulfilled:(A) the intermediate and final products have the same essential structuralelement, in that:(1)

the basic chemical structures of the intermediate and the final products
are the same, or(2)

the chemical structures of the two products are technically closelyinterrelated, the intermediate incorporating an essential structuralelement into the final product, and(B)

the intermediate and final products are technically interrelated, this meaningthat the final product is manufactured directly from the intermediate or isseparate from it by a small number of intermediates all containing the sameessential structural element.

6.71

Unity may exist between different intermediates provided the different intermediates
collectively satisfy the above requirements. However, if two different intermediates
incorporate a different structural element into the final product, they will not meet theabove requirements. A simple example of this is in the following multi-step reaction:
A+B

A–B

A–B+C

A–B–C

Assuming A, B and C are not relatively simple structural units, the claims are as follows:1.

Compounds having formula A – B – C

2.

Compounds having formula A – B

3.

Compounds having formula A

4.

Compounds having formula C

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In this case Claims 1 to 3 would have unity. Compounds of these claims have the samestructural element A, and providing this is a relatively significant essential element thatis related to the activity of the final compounds, this group of inventions would meetthe requirements, taking guidance from the PCT Guidelines.
On the other hand there would not be unity between Claims 3 and 4 since these do notincorporate the same structural element into the final compound. Accordingly, theclaims could be divided into two possible groups: Invention 1 comprising Claims 1 to
3, and Invention 2, comprising Claim 1 and Claim 4.
6.72

Other considerations set out in the PCT Guidelines are as follows, but it should be notedthat in all cases a pragmatic approach should be adopted as to whether or not a unity
objection should be taken:(a)The intermediate and final products should not be separated in the process bya known compound (in which case the inventive concept of the intermediate
would lie in the preparation of the known intermediate rather than the novel
final product).

(b)

It is possible for a compound to be claimed as an intermediate in the
preparation of a final product and to also have other uses. The claims could
be drafted in that case to define the final products, and/or compositions
containing such, their preparation and their use, as well as claims to the novel
intermediates and their preparation and use.

(c)

If the intermediate and final products are families of compounds, eachintermediate compound must correspond to a compound claimed in thefamily of the final products. However, some of the final products may haveno corresponding compound in the family of the intermediate products sothat the two families need not be absolutely congruent.

6.73

The intermediate may have the same use as the final product, or it may have any otheruse. Any other use of this intermediate may be considered a further invention.
Furthermore, the final product should be manufactured directly from the intermediateor from the intermediate via a small number of other intermediates having similar
structure.

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E.

Biotechnology examples

6.74

Biosequences can generally be considered using the same principles as used forchemical inventions (for examples point mutations in a protein can be viewed as being
analogous to Markush structures), or using the general principles (different categories
relating to the same underlying inventive concept). However, there are somecircumstances that require further detail.

6.75

One of the issues most often encountered in this technology is how to deal with claims
to sequences. There are a number of different circumstances that can arise, and whilesome guidance may be provided there is still a need to consider the entire circumstances
and avoid too technical an approach:1)

If a claim is directed to peptides or proteins having a significant structuralsimilarity and the same activity, then there will be a single inventive concept.
This can include sequences where there may be mutations at different andremote parts of a molecule. Note that both structure and function are required.
If the claims relate to different mutations (such as SNPs) on the same
nucleotide and a common function is stated, then the claim will have unity.
However, if no function is stated then there prima facie will be no unity.

2)

Nucleotides/Peptides having different sequences will generally not be
considered a single invention. This type of situation might arise where
screening of a library may identify certain members having desirable
activities. Consistent with the principles relating to a Markush grouping, thesequences would need to possess a significant structural homology and acommon activity. In practice, the sequences would be grouped according to
any homology members of the group may possess (including conservative
substitution and the like) and an objection of lack of unity taken on the basisof these groupings following the form objection given under Markush
groupings.

3)

Applications may claim different structurally distinct epitopes from a single
receptor. If the parent protein is novel, then it may be appropriate to consider
these as a single invention since they relate to the same activity and the same
protein. However if the search identifies that epitopes from the same protein

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having this activity are already known, then the invention may lie in
identification of further epitopes and each different sequence would
constitute a different invention (a posteriori).
4)

If the only common structural feature of a claim is known then an a posteriorilack of unity may be a consideration. However this will only be appropriate
where the structural element is known for the same purpose. For example aclaim to various sequences having a common catalytic domain may not
constitute a single invention if the catalytic domain was previously known
for that purpose.

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F.

ICT examples

6.76

Example 1:
Consider the following claims:
1.

Transmitter provided with time axis expander for video signals.

2.

Receiver provided with time axis compressor for video signals received.

3.

Transmission equipment for video signals comprising a transmitter provided
with time axis expander for video signals and a receiver provided with time
axis compressor for video signals received.

Here the special technical features are: in claim 1 the time axis expander, and in Claim
2 the time axis compressor, which are corresponding special technical features. Unity
exists between Claims 1 and 2. Claim 3 includes both special technical features and has
unity with Claims 1 and 2. The problem to be solved by these inventions is common,
which lies in enabling transmission of video signals through a narrow frequency band.
However, if the transmitter and a receiver were merely suitable for the defined purpose
then they may be regarded as separate inventions (for example had the claims defined“transmitter/receiver for use with a time axis expander for video signals”). Nevertheless,in such cases the objection may relate to novelty (if such transmitters and receivers are
known in the art and the claim does not define that they are specially adapted for theparticular use), and a simple amendment may be possible to restore unity.
6.77

Example 2:
Consider the following claims:
1.

Control circuit A for a d.c. motor.

2.

Control circuit B for a d.c. motor.

3.

An apparatus including a d.c. motor with control circuit A.

4.

An apparatus including a d.c. motor with control circuit B.

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Control circuit A is a special technical feature and control circuit B is another unrelated
special technical feature. Unity exists between Claims 1 and 3 or between Claims 2 and4, but not between Claims 1 and 2 or 3 and 4.

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G.

Search and examination of additional inventions

6.78

Rule 45(1) states that:If during the preparation of a report under Section 29(1)(a) or (b)3 it appears thatan application relates to 2 or more inventions, but they are not so linked as to forma single inventive concept, the search may be restricted to one in relation to the firstinvention specified in the claims of the application, and the Registrar shall notify
the applicant of that fact.
Here, the first invention means the invention first mentioned in the claims. In otherwords, as a general rule the division of subject matter follows the order of appearanceof the different inventions in the claims. Notably, the different inventions may occur inseparate claims or as alternatives within a single claim (Rule 25). The content of thedependent claims should be taken into account when determining the first invention.

6.79

The applicant may pay a fee for a search of the second or subsequent invention(s) to be
conducted (Rule 45(2)). This must be done within 2 months of the date of the search
report.

6.80

In addition, during the preparation of a search report under Section 29(1)(a) where it isconsidered there is a lack of unity, there is possibility for a search to be conducted of
second (or subsequent) invention(s) in the case that there is little additional effort
required to undertake such a search.

6.81

In such cases, a lack of unity may be raised, but the applicant is informed that theadditional invention(s) have been searched as a matter of courtesy. Additional search
can be costly in terms of Examiners’ effort and costs associated with database andsupply of citations. As such, additional search should be limited to where there is little
additional cost and effort involved. The approach under the PCT should be followed indetermining whether little additional effort is required. For example, if it is a relatively

3

The corresponding provisions in the Patents Act in effect immediately before 14/02/2014 are Section 29(2)(a)and (b), respectively.

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straightforward claim set and the two inventions can be readily searched in a single
search statement, then there may little additional work to cover all of the inventions.
6.82

During the preparation of a search and examination report under Section 29(1)(b) where
it is considered there is a lack of unity, in exceptional circumstances (e.g. when theinventions are conceptually very close), it is possible to search and examine second (orsubsequent) invention(s) when there is little additional effort required to undertake
both search and examination.

6.83

In such cases, an objection to lack of unity may be raised, but the applicant is informedthat the additional invention(s) have been searched and examined as a matter ofcourtesy. In considering the amount of work involved, the Examiner should take into
account the time taken to conduct the examination through to the establishment of theexamination report as well as that needed to perform the search, since even when theanalysis involved with regards to the search is negligible, the opposite may be the casefor the examination.

6.84

Likewise, Rule 45(1A) stipulates that:If during the preparation of an examination report under Section 29(1)(c), it appears thatan application relates to 2 or more inventions, but they are not so linked as to form asingle inventive concept, the examination may be restricted to one in relation to the firstinvention specified in the claims of the application, and the Registrar shall notify theapplicant of that fact.
Therefore, when the Examiner considers that there is a lack of unity of invention during
the preparation of an examination report under Section 29(1)(c), examination should
generally be directed only to the first invention. An objection to lack of unity should beraised and the invention(s) present other than the first mentioned would not be examinedin the same request under Section 29(1)(c).

6.85

Applicants may address a unity objection raised during the preparation of a report under
Section 29(1)(b) or (c) as follows:(1)

Limit the claims to the first invention as specified in the Examiner’s written
opinion by deleting claims to the second or subsequent invention(s), which

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can be further pursued by requesting for additional search or filing divisional
application(s);(2)

Amend the claims to include a same special technical feature from the firstinvention that joins the claims in a single general inventive concept;(3)

Provide arguments as to why the claims are unified in compliance with
Section 25(5)(d).

6.86

Pertaining to point (1) above, amendments to address the unity objection must limit theclaims to the first invention, and cannot re-direct the claims to the invention(s)present other than the first mentioned, even though these inventions may have been
covered in the search report. Patents for these other invention(s) should be pursued indivisional application(s) filed under Section 26(11).

6.87

In the event that the applicant files a divisional application, the applicant may request
an examination of that divisional application by relying on any search or supplementary
search report established for the parent application (if the search for the parent
application covers the invention claimed in the divisional application) or alternatively
relying on a search report established in another office for that invention (Section
29(1)(c) and Rule 45(3)4). Such search or supplementary search reports relied on may
include those where the examining office has taken an objection of lack of unity but has
undertaken a search of the additional inventions (for example, where additional searchfees were paid during the International phase of the application).

6.88

Pertaining to point (2) above, notably, if as a result of the claim amendments, there is a
shift of the special technical feature of the invention(s) from that of the first invention
searched in the earlier search report, the Examiner is not obliged to carry out anadditional search for the unsearched subject matter. This is because even if the claims
have been amended such that they are joined by a single inventive concept by the
introduction of a common special technical feature, there would have been no reason
for the Examiner to search the specific subject matter of that inventive concept during

4

According to Section 29(1)(c) and Rule 45(3), reliance of search is allowed on (a) any search report or
supplementary search report established in the parent application; or (b) where the parent application is aninternational application for a patent (Singapore) that has entered the national phase in Singapore under Section
86(3), any international search report or international supplementary search report established during theinternational phase of the parent application; or (c) a search in one corresponding application, corresponding
international application or related national phase application.

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the initial search. In other words, if the applicant’s amendment results in an inventive
concept that was not reasonably apparent at the time of the initial search, then additional
search and examination would not be carried out because it would result in the searchand examination of two different inventive concepts.
6.89

Pertaining to point (3) above, if a lack of unity objection has been raised, andsubsequently the applicant provides arguments showing that the lack of unity objection
is not justified, the Examiner shall carry out an additional search and/or examination forthe subject matter that the Examiner initially did not search and/or examine based on
the incorrect lack of unity objection.

6.90

An outstanding lack of unity objection needs to be resolved before the grant of a patent.
Pursuant to such a grant, there is no ground for revocation in relation to the patent being
for more than one invention.

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H.

Divisional applications (Section 26(11)/Rule 27)

6.91

According to Section 26(11) and Rule 27, an applicant can file a new application for apatent in respect of any part of the matter contained in the originally filed application,i.e., parent application, where the new application, i.e., divisional application, shall betreated as having, as its date of filing, the date of filing of the earlier application. The
said new application must not contain any additional matter extending beyond that
disclosed in the original application to satisfy the requirements under Section 84(1).

6.92

The divisional application can be filed at any time after the filing date of the parent
application but before all the grant conditions in Section 30 are met for the parent
application, or before the parent application has been refused, withdrawn or treated ashaving been abandoned.

6.93

A divisional application may serve as the original application of a further divisional
application. However, the immediate predecessor must be pending at the time thefurther divisional application is filed. The original application need not be pending inorder to file a second (or later) generation divisional application from the first (previous)
divisional application.

6.94

Example:Take the case of application “A” with three inventions described therein. A firstdivisional application “B” can be filed with two inventions “divided”, or taking basis,from application “A”. A further divisional application “C” can be filed with subject
matter divided from the divisional application “B” and relying upon this divisional as
its original application. In this case, divisional “C” would have the same filing date as
the divisional “B”, which would be the same as the filing date of the application “A”.
Hence, if all three applications proceed to grant, they would result in patents that would
expire on the same date. However, the time limit for the filing of application “C” isbefore all the grant conditions in Section 30 are met for divisional “B” or before
divisional “B” has been refused, withdrawn or treated as having been abandoned. This
time limit is not dependent on the progress of application “A”, which may have been
granted before the Examiner makes the requisition to restrict to one invention indivisional application “B”.

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6.95

One consequence of prescribing a divisional application with the filing date of the parent
application is that for the purposes of examination, a separate and individual treatment
applies when the divisional is examined. There is no need to examine a divisional
application with the parent, since the exclusive rights begin with the filing date (whichis that of the parent) and end 20 years later on the same date as those of the parent. Of
course, the Examiner may find it more efficient to examine the two together.

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I.

Double patenting (Rule 46(1)(f)5)

6.96

As set out in Section 80(1)(g), the Registrar may, on the application of any person, byorder revoke a patent for an invention on the ground that the patent is one of 2 or more
patents for the same invention having the same priority date and filed by the same partyor his successor in title. This ground is often referred to as double patenting.

6.97

The Examiner is empowered to determine the matter of double patenting (amongst othermatters) when conducting an examination or supplementary examination, under Section
2(1) (see definition of “examination” and “supplementary examination”), Rule 2A(1)(d)and Rule 2A(3)(e).

6.98

According to Section 2(1), “examination” means an examination conducted by an
Examiner in relation to an application for a patent to determine such matters as may beprescribed, and “supplementary examination” means a supplementary examination
conducted by an Examiner in relation to an application for a patent to determine sub
matters as may be prescribed.

6.99

Rule 2A(1)(d) and Rule 2A(3)(e) respectively set out that for the purposes of thedefinition of “examination” or “supplementary examination” in Section 2(1), thematters to be determined by an Examiner when conducting an examination or
supplementary examination in relation to an application for a patent includes:
Whether there is –(i)any other application for a patent for the same invention, with the samepriority date, filed by the same applicant or his successor in title; and(ii)

any earlier grant of a patent for the same invention, with the samepriority date, to the same applicant or his successor in title.

6.100 An Examiner, in determining a positive finding of double patenting, shall notify theRegistrar accordingly in his written opinion (Rule 46(1)(f) or Rule 46(1A)(e)). A
positive finding of double patenting is considered by the Registrar to be an objection.

5

In the Patents Act with effect immediately before 14/02/2014, Section 30(3)(e) sets out that it is one of theconditions for grant of a patent that a patent application has no double patenting issue.

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6.101 If such a positive finding (i.e. an objection) under Patents Rule 46(1)(f) or Rule
46(1A)(e) is left unresolved, it shall be contained in the examination report or the
supplementary examination report issued by the Examiner. Consequently, the Registrar
shall not issue a notice of eligibility under Section 29A(1). It follows that Section 30(b)would not be satisfied, and hence the patent application would not proceed to grant6.
6.102 It follows from Rule 2A(1)(d) or Rule 2A(3)(e) that double patenting only applies to thesituation where the same applicant (or their successor in title) makes the two
applications. If the applications are made by two different applicants, then theapplications are allowed to proceed.
6.103 It should be noted that double patenting is different from Section 14(3) where a
Singapore application which is not published at the time of filing of the application insuit may constitute part of the state of the art for novelty purposes. In the case of Section
14(3), the two applications do not share the same priority date and accordingly one isprior art against the other.
6.104 The law applies to both pending applications, as well as granted patents for the same
invention. When dealing with co-pending patent applications for the same invention,
Examiners should flag any potential double patenting issues to the applicant while
continuing with the examination of both applications. It will be up to the applicant how
they wish to proceed with the applications in order to avoid double patenting. When
responding (via Patents Form 13A) to the Examiner’s double patenting objection in theapplication in suit, the applicant may state his preference to instead address the double
patenting issue in the co-pending application(s) that has not yet been granted. If such astatement is present, the Examiner may allow the application in suit to proceed to grant,
and the double patenting issue may then be dealt with in the examination of the copending application(s).

6In contrast, under the Patents Act with effect immediately before 14/02/2014, when there is double patenting,the Examiner does not raise an objection but should include a note indicating the potential double patenting issue
in the written opinion. If the written opinion is otherwise clear, an examination report will issue with the note andthe Registrar is also advised of the potential double patenting issue. In other words, under the Patents Act witheffect immediately before 14/02/2014, the note is not taken to be an unresolved objection but rather an observation.
The law did not require the Examiner to examine double patenting under Sections 29(5) and (6), though it is acondition for the application to be granted to have no double patenting issue as per Section 30(3)(e).

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6.105 Double patenting will apply if two claims are identical in scope. In most cases, this will
occur if the claims are coterminous. Double patenting will also apply if the claims use
different terminology but are otherwise identical in substance. This will include
situations where different terminology is used to define the same invention.
6.106 Double patenting may apply as well in situations where two claims differ in as much as
one contains a specific feature while the other defines a more generic group for thecorresponding feature. For example, claim 1 in application “A” and claim 1 ofapplication “B” define identical features, except that claim 1 in application “A” further
defines a specific feature and claim 1 in application “B” further defines a more genericgroup of corresponding feature. An objection of double patenting may arise between
applications “A” and “B” in such situations if the specific feature is the only one
disclosed in the specification of application “B” and there is no basis for reading thespecification as constituting a more generic group. However, if application “B”
discloses that there is more than one means of performing a particular step or the specificfeature may be selected from a group, then no objection should be taken.
6.107 In the case of claims that do not have unity (i.e. they do not share a single inventive
concept), they would not be the same invention and double patenting will not occur.
Therefore, there should not be double patenting between a parent application and its
divisional applications if they relate to claims that were objected to for lack of unity inthe first place.
6.108 Double patenting has yet to be considered by the Singapore Courts but given thesimilarity in the law some guidance may be taken from UK precedent.
6.109 In Koninklijke Philips Electronics n.v. v Nintendo of Europe GmbH [2014] EWHC 1959
(Pat), Birss J, on the matter of a post-grant amendment, found that if two independentclaims in two separate patents have different scope, there is no reason to object even if
the two patents contain dependent claims with the same scope. If an objection arose inwhich both patents are before the Court, then it can be cured by an amendment oramendments to either patent.
6.110 Although this case dealt with conflict in relation to post-grant amendments, the sameconsiderations are expected to apply when assessing conflict pre-grant. Accordingly,

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Examiners should focus on independent claims when assessing applications for double
patenting.
6.111 In Arrow Electric Switches Ltd’s Applications [1944] 61 RPC 1, the Patents Appeal
Tribunal considered a parent application claiming an electric switch A. The specification
also contained a claim to the switch when operated with an overload device B – in essencea claim to A + B. The divisional application claimed overload device (B). The UKIntellectual Property Office considered that double patenting existed because the patentto B per se would encompass its use with device A – thus including A + B (that is, aclaim to the item per se is a claim to the item in all environments), even if not explicitly
defined. They sought that the applicants include a disclaimer in the divisional application
to avoid overlap.
6.112 On appeal, Morton J questioned the logic of this approach. Taken to its full extent, theclaim to A per se in one would always include within its scope the combination of A +B, and a claim to B per se in the other would always include within its scope the
combination of A + B. As a consequence, the divided patent to B per se would always
need a disclaimer, regardless of whether or not the parent application contained a claim
to the combination of A + B. If for any reason the parent patent to A per se wassubsequently made void, the patentee would then have no protection at all over the useof A + B in combination because they had disclaimed it.
6.113 The subsequent UK Patents Act 1977 codified the exclusion to double patenting, as did
the Singapore Act. Moreover, the UK Act forbids double patenting for UK national
applications and those originating under the EPC and designating the UK. Several
decisions have considered the term “same invention” in relation to these provisions
which can provide guidance as to the application of the double patent provision in
Singapore.
6.114 In Marley Roof Tile Co. Ltd.’s Patent [1994] RPC 231, the Court of Appeal found thata claim to a product will conflict with a claim to the same product as produced by aspecific process. This is consistent with the approach that a product-by-process claim is
indistinguishable from a claim directed to the product per se (and made by a different
process).

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6.115 Several other relevant hearings decisions have issued from the UK Intellectual Property
Office. In general, the approach is taken that an objection of double patenting will arise
where the claims explicitly include all of the same features (that is they arecoterminous), but also where the claims differ in wording but not in substance.
6.116 Kimberley-Clark Worldwide Inc. BL O/279/04 involved a situation wherein (in short) a
European patent covered A + B, while the UK patent covered only A. In accordancewith the UK examination guidelines, the hearing officer noted that some overlap ofclaims was allowable. In this case, he considered it useful to consider whether the
integer B was an invention in its own right – since the conclusion could then be readilyreached that the two patents were for different inventions. Furthermore, he noted that
the European patent had been amended to remove claims to A in isolation as a result of
opposition proceedings and had been allowed to proceed with claims to the
combination. He considered this highly persuasive since the patent would not have been
allowed to proceed had it still been to the same invention.
6.117 In SeeReal Technologies SA BL O/261/12, the hearing officer noted that the fact that aclaimed invention in a second patent could have been included as a dependent claim in
the first patent does not automatically mean there is double patenting. An absence ofplurality does not necessarily mean the presence of conflict. Applying this to the casein hand, the hearing officer considered there was a feature that made a substantial
difference between some of the objectionable claims and therefore they constituted
different inventions. A second difference between the claims was considered implicit
since this was the only way described to carry out the particular feature.
6.118 The permissible degree of overlap was also considered in Optinose AS BL O/026/12,
wherein the hearing officer stated:“But even if the divisional application has a claim that falls clearly within the scopeof a claim in the parent then it is not necessarily fatal to the divisional application.
This is clear from Arrow Electric Switches Ltd’s Applications and Kimberley-Clark
Worldwide Inc’s Patent. However, if the two claims are coterminous or the like, in
Maag, if in substance they relate to the same invention then there would be
conflict.”

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In this case, the hearing officer considered the claim of the parent patent included
method A, method B and various combinations of the two (these being the various
methods disclosed in the specification, but were not specifically defined in the claims).
The divisional was limited specifically to method B. The hearing officer therefore
concluded that there was no double patenting because the claims were not coterminous,
nor did they in substance relate to the same invention. However, this may be consideredon a case by case basis. For example, if a claim clearly defined a method using A or B
and the divisional application claims were identical but limited only to the method using
B, an objection may be appropriate since the scope of the divisional is identical to oneof the alternatives in the first granted patent.

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7.

AMENDMENTS AND CORRECTIONSA.

Statutory requirements

7.1

Note: Amendments and Corrections are dealt with under different sections of the Patents
Act.

7.2

Amendment of an application or amendment of the specification of a patent mustcomply with the requirements of Section 84. Section 84(3) requires that pre-grant
amendments do not result in the application disclosing any matter extending beyond
that disclosed in the application as filed. Section 84(4) requires that post-grant
amendments do not result in the specification disclosing any additional matter or extend
the protection conferred by the patent. The same principles apply for deciding whether
a new application filed under Section 20(3), Section 26(11) or Section 47(4) of this Act
or an application for which a filing date has been secured upon satisfying the conditions
referred to in Section 26 (1)(a), (b) and (c)(ii) discloses any added matter as well.
Section 84(1) requires that if an application filed under Section 20(3), Section 26(11)or Section 47(4) of this Act discloses matter extending beyond the earlier application
made under this Act as filed, the application shall not be allowed to proceed unless it isamended to exclude that matter. Section 84(1)(A) requires that if an application having
made a Section 17(2) priority declaration contains an incorporation by reference
statement to an earlier relevant application under Section 26(1)(c)(ii) and the descriptionof the invention later filed under Section 26(7)(b) discloses matter extending beyond
the earlier relevant application, the application shall not be allowed to proceed unless it
is amended to exclude that matter.

7.3

In contrast, correction of an application or the specification of a patent or of any
document filed in connection therewith is governed by Section 107. In short, correctionis the alteration of a document so that it may better express the intention the drafter had
at the time of drafting, including where an agent drafting a document has misconstrued
his given instructions. Once it has been established that the change is indeed acorrection, the question of whether subject matter is added or the protection conferred
is extended is not a relevant consideration.

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7.4

It is important that Examiners examine the correct specification of the application, andaccordingly all relevant amendments or corrections must be identified and taken into
account during examination. This will include any amendments made (PCT Article 19
and 34) or rectifications authorized (PCT Rule 91) in the international phase, as well as
any amendments or corrections made by the applicant during the national prosecution.

7.5

A pre-grant amendment, once accepted, takes effect from the date the amendment was
filed, whereas an amendment of the specification of a patent post-grant, once allowed,
shall have effect and be deemed always to have had effect from the date of grant of thepatent (Section 38(3)). A correction, once accepted, takes effect from the date of filing,as if the error has never been made in the first place.

7.6

How amendments made (PCT Article 19 and 34) and rectifications authorized (PCT
Rule 91) in the international phase should be dealt with during the national phase are
discussed in detail in later sections.

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B.

General power to amend before grant

7.7

Section 31 sets out that:(1)

Subject to subsections (2), (3) and (4), the applicant may, of his own volitionor otherwise, amend the application or the specification thereof.

(2)

The applicant shall not be entitled to amend the application or specification
unless —
(a)

(b)
(3)

he has made a request to do so to the Registrar —(i)in the prescribed manner; and(ii)

within the prescribed period; andthe request is accompanied by the prescribed documents.

The applicant may only amend the application or specification in accordancewith the prescribed conditions and subject to section 84.

(4)

If the applicant fails to comply with any requirement under subsection (2) or(3), the Registrar shall —(a)refuse the applicant’s request to amend the application or specification;
and

(b)
7.8

inform the applicant of the refusal.

Pre-grant amendments under Section 31 shall be made within the prescribed time frames
according to Rule 49 and in the prescribed manner according to Rule 48.

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General process for amendments before grant
7.9

Rule 49 sets out the time frames within which that an applicant may make different
types of pre-grant amendments:(1)

The applicant may, of his own volition, amend the request for the grant of apatent at any time before payment of the fee for the grant of the patent.

(2)

Subject to paragraph (3), the applicant may, unless the Registrar otherwise
requires, of his own volition, amend the description, claims, drawings andabstract at any time before payment of the fee for the grant of a patent.

(3)

Subject to section 29B(2), an amendment shall not be made under paragraph
(2) —
(a)

at any time after the filing of a request for a search report under section
29(1)(a) and before the receipt of that report by the applicant;(b)at any time after the filing of a request for a search and examination
report under section 29(1)(b), unless the amendment is contained in a
response filed under rule 46(3) in respect of that report;(c)

at any time after the filing of a request for an examination report under
section 29(1)(c) or (3), unless the amendment is contained in a response
filed under rule 46(3) in respect of that report;(d)at any time after the filing of a request for a supplementary examination
report under section 29(1)(d), unless the amendment is contained in a
response filed under rule 46(3) in respect of that report; or

(e)
7.10

at any time after a request for a review under section 29B(1) is made.

Taking a search and examination request as an example, amendments to the application(that is, description, claims, any drawings and abstract) can only be made either prior to
or at the filing of the request or during a response to the Examiner’s written opinion
under Rule 46(3). In other words, apart from at the time of filing the response, there isno other opportunity for the applicant to make amendments to the application during
the period after the filing of the request and before payment of the fee for the grant of apatent, unless the Registrar requires such amendments.

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7.11

The identification of the afore-mentioned different types of pre-grant amendments canbe facilitated by an understanding of the governing rules and prescribed forms used fortheir filing as follows:•

Applications for amendment of the request for the grant of a patent on Patents
Form 1 or applications for amendment of the description, claims, drawings
and abstract prior to or at the filing of a request for a search or any type of
examination should be made on Patents Form 13 (Rule 48(1)).

•

Amendments to the specification (that is, description, claims and any
drawings) in response to a written opinion should be made on Patents Form
13A (Rule 46(3)).

•

Amendments to the specification (that is, description, claims and any
drawings) at the time of requesting for an examination review should be madeon Patents Form 13 (Rule 46A(3)).

•

Within the prescribed period of putting the application in order for grant, theapplicant is required to provide clean copies of the specification including
the amended pages, but these clean copies are not forwarded for checking by
the Examiner. Only amendments in order to comply with the formal
requirements made on Patents Form 13 are allowed to be introduced at thisstage (Rule 47(6)).

7.12

Formality requirements would be checked by the Registry prior to forwarding theapplication to the Examiners, so the Examiners need not routinely check these details.
However, if the Examiner notices that the application may not fulfil the formality
requirements, the matter should be referred to the Registry.

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ii.

Amendments made in response to written opinions (Rule 46(3))

7.13

For a search and examination request or an examination only request, Section 29(9)provides that an applicant may respond to at least one written opinion that has been
issued under Section 29(7), and subject to Section 84, amend the specification of theapplication. Rule 46(3) states that the response to the written opinion may contain
written submissions on the Examiner’s opinion, an amendment of the specification of
the application or both.

7.14

Given the time frames associated with the examination process, it is foreseeable that
there may be several rounds of communication between the Examiner and the applicant.
When the deadline for issuing the examination report is approaching and the applicant
still fails to resolve all the issues with the application, it will be at the discretion of the
Examiner whether to issue a further written opinion according to Rule 46(6). Factorsthat may be taken into account at this juncture would include: whether sufficient timeremains for the applicant to respond, which generally depends on the nature of theoutstanding issues, and whether sufficient time remains for the Examiner to draw up an
examination report. However, if the prosecution of the case has reached a stalemate andis unlikely to progress further, where Section 29(7) applies and the Examiner has
already issued at least one written opinion before, the Examiner may issue an adverse
examination report rather than issue a further opinion. In such circumstances, theExaminers should discuss the case with a Senior Examiner.

7.15

Under Rule 46(7), an Examiner’s further opinion or report need not take into accountany response filed by the applicant after the Examiner has commenced drawing up theopinion or report.

7.16

For a supplementary examination request, Section 29(8) mandates that the Examiner
issue the applicant only one written opinion. An applicant’s written submissions to thewritten opinion and/or amendments to the specification under section 29(9) will be
forwarded to the Examiner for consideration, and subsequent establishment of a
supplementary examination report. If the Examiner considers that the written
submissions and/or amendments do not overcome the objections, an adverse
examination report will be established.

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7.17

Rule 46(3) sets out that, in all the types of examination requests aforementioned,
amendments to the specification (that is, the description, the claims and any drawings)
in response to the written opinion issued by the Examiner should be made on Patents
Form 13A. The amendments filed may be in response to the issues raised by the
Examiner, and may include other amendments that are not in response to the Examiner’s
objections.

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iii.

Amendments made in response to an invitation to amend (Rule 46AA)

7.18

Section 29(7A) provides the option for the Examiner to ask the Registrar to give theapplicant an invitation to amend the specification of the application in circumstanceswhere the Examiner is of the opinion that a matter prescribed for a search andexamination request or an examination only request can be resolved by the invitation toamend instead of a written opinion. The invitation to amend may be given where awritten opinion has not yet been issued under Section 29(7), or after the Examiner has
reviewed the applicant’s response to an earlier written opinion (Section 29(7B)).

7.19

Under Section 29(7C), the applicant may respond to the invitation to amend by
amending (subject to Section 84) the specification of the application. Rule 46AA sets
out that amendments in response to the invitation to amend may be filed within 2 months
after the date of the invitation to amend and in Patents Form 13A.

7.20

Generally, Examiners may consider issuing an invitation to amend in the following
circumstances: (i) where the only remaining unresolved objections require minor
amendments to address; or (ii) where there is prior communication between theapplicant and the Examiner regarding what amendments are needed in order to advancethe prosecution. Upon receiving the amendments filed by the applicant, the Examiner
can then proceed with the next office action based on the amendments filed, which could
be a positive examination report if no unresolved objections remain.

7.21

In respect of unresolved objections requiring minor amendments to address, such minor
amendments may include (but are not limited to):•Addressing inconsistent terms used to describe the same feature in the claims.

•

Removing from dependent claims features that have already been deleted in
the independent claim.

•

Aligning the corresponding independent method claim to the features of the
independent apparatus claim that has been acknowledged to be inventive(where the applicant may have omitted to do so in response to the previous
written opinion).

In the case where the invitation to amend is issued due to unresolved objections
requiring such minor amendments, the invitation to amend should mention the
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unresolved objections requiring the minor amendments. Notably, issuing of aninvitation to amend in this circumstance is at the discretion of the Examiner, taking into
account various considerations, including whether the deadline for issuing theexamination report is approaching.
7.22

A possible situation where there is prior communication regarding what amendments
are needed in order to advance the prosecution is when an interview has taken place
between the applicant and the Examiner discussing said amendments. After theinterview, the Examiner may issue the invitation to amend to allow the applicant tosubmit the discussed amendments.

7.23

Section 29(7C) and Rule 46AA provide the option for the applicant to reject theinvitation to amend, and in doing so the applicant may optionally include an explanation
for the rejection. It may also be possible that the applicant does not file amendments
within the 2 months prescribed in Rule 46AA. In such situations, the Examiner may
determine whether or not to issue a written opinion (Section 29(7E)), and theconsiderations for doing so are the same as those detailed in paragraph 7.14. Notably,
where the applicant has already been given a number of written opinions and unresolved
objections remain (Section 29(7)), the Examiner may issue an adverse examination
report rather than a further written opinion.

7.24

Where the Examiner has issued an invitation to amend but the applicant has withdrawn
the search and examination request or the examination only request, the applicant need
not respond to the invitation to amend. There may be situations where the applicant
responds to an invitation to amend well within the prescribed period of 2 months andthe Examiner then goes on to issue the search and examination report or the examination
report shortly. In such a case, even though the prescribed period may not have expired,
the applicant cannot submit further responses to the invitation to amend, since the searchand examination report or the examination report has already been issued (Section
29(7D)).

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C.

Allowability of pre-grant amendments (Section 84(3))

7.25

Pre-grant amendments (Section 84(3)):(2)

No amendment of an application for a patent shall be allowed under
section 31 if it results in the application disclosing any matter extending
beyond that disclosed in the application as filed.

7.26

Section 84(3) requires that no added matter beyond that disclosed in the application as
filed is to be incorporated into the application during any pre-grant amendments (seesub-section i of Section J in this Chapter). This consideration applies to amendments
made of the applicant’s own volition, amendments made by the applicant in response toa written opinion, or amendments required by the Registrar. The test and considerations
for added subject matter are discussed in later sections.

7.27

There is no pre-grant restriction on the applicants broadening the scope of their claims
provided the amendment does not include matter extending beyond that disclosed in theapplication as filed. That is, if the disclosure in the specification as filed is broader thanthe claims as filed, the applicant may make amendments before grant to bring the claims
into alignment with the specification.

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D.

General power to amend after grant (Section 38)

7.28

Section 38 sets out that:(a)

Subject to this section and section 84, the Registrar may, on an application
made by the proprietor of a patent, allow the specification of the patent to beamended subject to such conditions, if any, as he thinks fit.

(b)

No such amendment shall be allowed under this section where there are
pending before the court or the Registrar proceedings in which the validityof the patent may be put in issue.

(c)An amendment of a specification of a patent under this section shall haveeffect and be deemed always to have had effect from the grant of the patent.

(d)

A person may give notice to the Registrar of his opposition to an application
under this section by the proprietor of a patent, and if he does so the Registrar
shall notify the proprietor and consider the opposition in deciding whether togrant the application.

7.29

The Examiner should refer to Section E in this Chapter to determine whether such
amendments are allowable. As compared to pre-grant amendments, post-grant
amendments have the further restriction that the scope of the claims cannot be
broadened.

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General process for amendments after grant (Rule 52)
7.30

An application to the Registrar for leave to amend the specification of a patent following
grant (i.e., post-grant amendment) may be filed by the proprietor of the patent using
Patents Form 17.

7.31

If the Registrar is satisfied that the application may be allowed, the application and thereasons for proposed amendment are advertised for opposition. Interested parties have
2 months to oppose the proposed amendment. If the proposed amendments are opposed,
the proprietor may, within 2 months, file a counter-statement setting out fully thegrounds upon which the opposition is resisted, if he wishes to continue with the request
for amendment. In the event of such an opposition, the Registrar may refer the matterto an Examiner for an opinion on whether the amendment is allowable, taking into
account the application for leave to amend, together with the notice of opposition, theaccompanying statement setting out fully the facts upon which the opponent relies andany counter-statement, where applicable.

7.32

If no opposition is filed within the prescribed period, or the opposition filed is notaccompanied by the said required statement and the Registrar is satisfied with thereasons for the proposed amendment, the amendment of the patent will be allowed.

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E.

Allowability of post-grant amendments (Section 84(4))

7.33

Post-grant amendments (Section 84(4)):(3)

No amendment of the specification of a patent shall be allowed under section
38(1), 81 or 83 if it —

7.34

(a)

results in the specification disclosing any additional matter; or(b)extends the protection conferred by the patent.

Guidance on the assessment of post-grant amendments have been provided in two recent
Singapore High Court decisions: Ship’s Equipment Centre v Fuji Trading [2015] SGHC
159 and Warner-Lambert v Novartis [2016] SGHC 106 (upheld on appeal in WarnerLambert v Novartis [2017] SGCA 45).

7.35

For the determination of condition (a) whether the proposed amendment discloses
additional matter, the same test that applies for pre-grant amendments as set down in
the UK case Bonzel and Schneider (Europe) AG v Intervention Ltd [1991] RPC 553
applies essentially for post-grant amendments. The Bonzel test was accordingly
followed in Ship’s Equipment Centre v Fuji Trading and Warner-Lambert v Novartis.

7.36

The proposed amendment was from a method of treatment claim to a “Swiss-type”
claim in Warner-Lambert v Novartis. Specifically, the granted claims were directed
towards methods of treating pain by administering a therapeutically effective amount of
the disclosed compound. The proprietor proposed to amend the granted claims to claims
directed to the use of the same compound to prepare a medicament (i.e. thetherapeutically effective amount of the disclosed compound) for treating pain.
Following the Bonzel test, Wei J concluded the amendment does not disclose any“added matter”, taking into account the skilled addressee would appreciate that the“Swiss-type” claims were conceived to protect specific medical indications.

7.37

After considering condition (a), it is then necessary to determine condition (b) whether
the proposed amendment extends the protection conferred by the patent. The cruxof the inquiry is whether the ambit of the protection conferred by the patent will be
extended by the proposed amendment. As such, it is important not to be unnecessarilyside-tracked by the change in the category or subject matter of the claims in the patent.

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For example, it would be permissible to reformulate an apparatus claim by way ofamendment to a claim covering only a use of the product, if the result is to cut down thescope of protection. In this sense, the decision as to whether the scope of protection has
been extended cannot be decided on a formalistic basis (see Ship’s Equipment Centre v
Fuji Trading and Warner-Lambert v Novartis).
7.38

A good test is to ask whether something that fell outside the scope of the [granted]
claims (properly interpreted) and hence not an infringing act on its own now falls within
the [proposed amended] claims such that it becomes an infringing act (“the Infringement
Test”) (Terrell on the Law of Patents, Richard Miller et al, Sweet & Maxwell, 17th Ed,
2011 at para 15.41). In properly applying the test, a “purposive approach” should firstbe applied to construing the patent claims. It is then necessary to compare the totalityof protection established by the patent before and after the amendment, and not thescope of protection within the wording of each single claim as granted. For example,
the extension of the scope of an individual claim per se is not objectionable, if it does
not result in the extension of the protection of the patent (see Warner-Lambert v
Novartis and Ship’s Equipment Centre v Fuji Trading).

7.39

Based on these considerations, Wei J concluded in Warner-Lambert v Novartis [2016]
SGHC 106 (upheld on appeal in Warner-Lambert v Novartis [2017] SGCA 45 at paras
67-78) that the amendment sought by Warner-Lambert had broadened the scope ofprotection to include manufacture of a medicament, which represents a shift away fromthe granted claims directed to the method of treatment, and hence fails condition (b).
“Whilst broadly connected by the same final objective (of treating pain), thegranted claims and the amended claims are targeted at different activities — thelatter covers the making of the compound for the purposes of administration (totreat pain) whereas the former covers only the follow-on act of administration of
the compound to treat pain.”

7.40

On appeal in Warner-Lambert v Novartis [2017] SGCA 45, the Court of Appeal further
considered that when a granted patent is “obviously invalid” in its totality and suchinvalidity is attributed solely to the patentee, it would be artificial to even consider
whether any proposed amendments extend the protection conferred by that patent. Thisis because the granted patent confers no protection whatsoever and the amendment

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application is seeking to validate that which was not valid from the beginning. In sucha case, the Court should exercise its discretion to disallow the amendment. The same
approach applies to the obviously invalid claims in cases where the patent contains somevalid and some obviously invalid claims.
7.41

The Court of Appeal also made a clear distinction between the situation where a patentis “obviously invalid” and a situation where a patent is potentially invalid on the groundthat it may have been anticipated by prior art or otherwise. In the latter scenario, theamendment application is sought to clarify the claims to ensure their continued validity.
Therefore, potential invalidity of the patent should not be an impediment to amendment
because the granted claims in the patent are, on their face, deserving of at least somedegree of protection.

7.42

As the claims in Warner-Lambert’s patent, which was granted under the self-assessment
system, were directed to a method of treatment, they were “obviously invalid” under
Section 16(2), and the Court of Appeal disallowed the amendments sought by WarnerLambert on this ground.

7.43

Therefore, in assessing post-grant amendments, the Examiner should first consider
whether any of the proposed amendments are to claims which are “obviously invalid”.
If so, the amendment to said obviously invalid claims may be rejected without further
consideration of whether the proposed amendment discloses additional matter orwhether it extends the protection conferred by the patent. At present, a patentcomprising method of treatment claims would be the clearest instance of claims that are“obviously invalid”. It is noted that while obviously invalid claims may occur in patents
granted under the self-assessment system, they would be rare in patents granted under
the positive-grant system.

7.44

Apart from the requirements under Section 84(4), the proposed amendments must alsosatisfy the requirements under Sections 25(5)(b) and (c) of the Patents Act, i.e., the[amended] claim or claims must be ‘clear and concise’ and ‘supported by thedescription’. These are the “base-line criteria” that any claim amendments must satisfy
as set out in Trek Technology (Singapore) Pte Ltd v FE Global Electronics Pte Ltd andothers and other suits [2005] 3 SLR(R) 389, as affirmed in Ship’s Equipment Centre v
Fuji Trading and Warner-Lambert v Novartis.

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7.45

The Registry issued a Circular No. 1/2016 on 30 June 2016 which takes effect from its
issuance date and applies to all pending and future requests. In addition to therequirements under Section 84(4), it is made clear in the Circular that any post-grant
amendments under Section 38 will also be assessed based on the following criteria:(1)

Whether relevant matters are sufficiently disclosed;(2)

Whether there was any unreasonable delay in seeking amendments; and(3)

Whether the patentee has gained an unfair advantage obtained by delaying
amendments which are known to be needed.

7.46

As required by criterion (1) of the Circular, any application for post-grant amendment
should set out fully the reason(s) for amendments, including the circumstances leading
to the amendments and any evidence in support thereof to facilitate the assessment. As
such, relevant matters, i.e. the reason(s) for amendments, should be disclosed to theextent that said disclosure would be sufficient for the Examiner to establish a prima
facie case of allowability for the proposed amendments. In the situation where the
Examiner deems that the evidence in support of the reason(s) for amendment is not
sufficient, a request may be made, via the Registry of Patents, for the applicant toprovide further evidence.

7.47

Guidance for consideration of criterion (2) Whether there was any unreasonable delay
in seeking amendments may be found in Warner-Lambert v Novartis [2016] SGHC 106
at paras 101-104:“First and foremost, for the delay to be considered undue, the period of the delay
need not be long provided that there is no plausible explanation for the delay.”“Second, a delay may not be held against the applicant if it is able to provide a
reasonable explanation for the delay.”“Third, the appropriate juncture to question whether the amending party has been
guilty of an unreasonable delay is the time it was first made aware of the need toamend.”

7.48

In Warner-Lambert v Novartis [2017] SGCA 45, Tay J reiterated, at paras 40-52, theneed to consider whether the patentee had delayed in seeking amendments when

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exercising the Court’s discretion to refuse an amendment application. In respect of therequisite level of knowledge of the need to amend, he agreed, at para 48, that
constructive knowledge of a patent’s potential invalidity is sufficient, and reiterated thefollowing from para 105 of the High Court decision: “[a] patentee who has been exposed
to facts from which it was, or reasonably ought to have been, apparent to him or her thata claim might well be invalid unless amended, but nonetheless brings a late application
to amend, is in no position to say that there was, on the earlier occasion, no ‘need’ toamend simply because it had not then been conclusively established that the claim wasin fact invalid”.
7.49

Guidance for consideration of criterion (3), whether the patentee has gained an unfair
advantage obtained by delaying amendments which are known to be needed, may also
be found in in Warner-Lambert v Novartis [2016] SGHC 106 at paras 117-121.

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F.

Consideration of PCT amendments in the national phase(Section 86(5))

7.50

Amendments during the international phase of PCT applications may be made under
Article 19 or, if the applicant demands Chapter II examination, Article 34. In most cases
these will need to be taken into account during the national prosecution. They will
always be superseded by amendments made to the same claim(s) in the national phaseby using Patents Form 13 or Patents Form 13A, where applicable.

7.51

The provisions relating to the manner in which such amendments are dealt with in thenational phase are set out in Section 86(5) as follows:(5)

Where, during the international phase, the application is amended inaccordance with the Patent Co-operation Treaty, the amendment shall betreated as made under this Act if, and shall be disregarded unless –(a)when the prescribed period expires, where –(i)the amendment is not in English; and(ii)

if any copy of the amendment has been communicated to theRegistry in accordance with the Treaty, that copy is in a language
other than English, an English translation of the amendment has
been filed at the Registry; or(b)where the applicant expressly requests the Registrar to proceed earlier
with the national phase of the application, there is filed at the Registry–(i)a copy of the amendment, if none has been communicated to theRegistry in accordance with the Treaty; and(ii)

an English translation of the amendment, if –(A) the amendment is not in English; and(B)

where any copy of the amendment has been communicatedto the Registry in accordance with the Treaty, that copy isin a language other than English.

7.52

In most cases, the Registry will process Article 19 and 34 amendments communicatedfrom International Bureau and translations thereof in accordance with the Rules, and the

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application received from the Registry should have all the necessary documents. As
such, the Examiners need not routinely check these details. However, if the Examiner
discovers any irregularity in the documentation that may affect the scope of theapplication (e.g. if there is doubt over whether any Article 19 and 34 amendments havebeen made in the international phase), then the Examiner may, after checking theavailable databases such as Patentscope and the EP Register, refer the matter to theRegistry.
7.53

Where the amendments made under the PCT are in a foreign language, the applicant
shall file at the Registry an English translation of the amendments accompanied by acopy of a verification document upon entry into the national phase or request theInternational Bureau to send an English translation of the amendments under the PCT
to the Registry after entry into the national phase. If the Registry does not receive therequired translation at filing, a notice is issued under Rule 86(6) and the applicant isgiven 2 months to provide a translation. If the Registry considers that the translation
filed at the Registry is inaccurate, a notice is issued and the applicant is given 2 months
to provide another translation. In the event that any prescribed requirement for the
English translation filed at the Registry has not been met, the amendments under the
PCT will be disregarded and the application will proceed in its unamended form.

7.54

Where the applicant expressly requests a PCT application to enter the national phaseearly, the applicant shall file at the Registry a copy of the amendments, if no such
amendments have been communicated to the Registry. The applicant shall also file atthe Registry an English translation, if the amendments filed at the Registry are in aforeign language or amendments in a foreign language are communicated to theRegistry. In the event that any prescribed requirement for the English translation filed
at the Registry has not been met, the amendments under the PCT will be disregarded
and the application will proceed in its unamended form.

7.55

The Examiner should refer to Section G in this Chapter to determine whether the Article
19 and 34 amendments are allowable.

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G.

Allowability of PCT amendments in the national phase

7.56

When amendments are made under the PCT, a consideration is given at that stage as tothe allowability of the amendments. These are set out in the PCT Guidelines at 20.09.
Notably, the considerations are analogous to the considerations made under theSingapore law:
20.09 The examiner makes sure that amendments filed do not add to the content of
the application as filed, thus violating Article 19(2) or 34(2)(b). Furthermore, theymust not itself cause the international application as amended to be objectionable
under the PCT; for example, the amendment should not introduce obscurity. The
examiner should consider as acceptable restriction of the scope of the claims oramendments that improve the clarity of the description or amendments to theclaims in a manner clearly desirable, without changing their subject matter content
or scope.

7.57

If the International Authority has considered an amendment to add subject matter, thiswill be indicated in Box I of the International Report on Patentability II (IPRP II). It
should be noted that a consideration of the allowability of amendments in theinternational phase is done only if the application has demanded Chapter II examination.
This will include a consideration of both Article 19 and Article 34 amendments filed
before expiry of the prescribed time limit. The opinion of the International Authority is
not binding, and Examiners are not bound to follow it if they disagree. However, if the
Examiner considers that the amendments are in fact allowable, they generally should
review the search to ensure that the matter of the amendments is adequately searched.

7.58

If the applicant has not demanded Chapter II examination and has made Article 19
amendments, then there will have been no examination of these amendments during theinternational phase. Accordingly, Article 19 amendments will need to be checked
carefully to ensure that they are allowable.

7.59

It should also be noted that practices differ between international authorities as to what
constitutes added matter. For example, intermediate generalizations may not berecognized by all authorities. As a consequence, Examiners will need to consider

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whether all amendments made during the international phase of the application meet
Singapore requirements.
7.60

In the event that amendments are considered to incorporate added matter, then thisshould be indicated at Box I.3, with a detailed explanation provided in a supplementalbox.

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H.

Added matter in divisional applications (Section 84(1))

7.61

Divisional applications that are filed in respect of matter disclosed in an earlier
application and claim the filing date of the earlier application under Section 20(3),Section 26(11) or Section 47(4) could possibly introduce added matter, that is, matterextending beyond that disclosed in the earlier application.

7.62

The provisions relating to the manner in which such divisional applications that haveintroduced added matter are dealt with are set out in Section 84(1) as follows:(1)

An application for a patent which —(a)

is made in respect of matter disclosed in an earlier application, or in thespecification of a patent which has been granted; and(b)discloses additional matter, that is, matter extending beyond that
disclosed in the earlier application made under this Act or in theapplication made under the United Kingdom Patents Act 1977 or theapplication under the European Patent Convention designating theUnited Kingdom filed at the European Patent Office from which thefiling date and right of priority is sought to be derived, as filed, or theapplication for the patent, as filed, may be filed under section 20(3) or
47(4) or section 116(6) of the Patents Act (Cap. 221, 1995 Ed.), or as
mentioned in section 26(11), but shall not be allowed to proceed unless
it is amended so as to exclude the additional matter.

7.63

In deciding whether a divisional application comprises additional matter, the Examinershould take into account the same test and considerations that apply for added subject
matter in application and patent specifications discussed in the previous sections.

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I.

Added matter in applications having declared a priority due
to later filed description (Section 84(2))

7.64

According to Section 26(1), an applicant for a patent can secure a date of filing at theearliest time when the documents filed at the Registry to initiate the application satisfy
the following conditions: (a) the documents indicate that a patent is sought; (b) the
documents identify the applicant; and (c) the documents contain something which is orappears to be a description of the invention sought. In the event where the application
contains a priority declaration under Section 17(2), the description of the invention
sought in condition (c) may be substituted by:(A) a reference to an earlier relevant application specified in the declaration under
section 17(2) made in or in connection with the application;(B)such information on the earlier relevant application as may be prescribed; and(C)a statement that the description of the invention for which the patent is sought
is incorporated in the application by reference to, and is completely containedin, the earlier relevant application, as filed.

7.65

In such an event, within the prescribed period after the filing, the applicant is required
under Section 26(7) to file: (a) a written notice confirming the above statement (C); (b)the description of the invention for which the patent is sought; and (c) other prescribeddocuments in relation to the application. Failing to do so will cause the application to
be treated as having been abandoned according to Section 26(12).

7.66

The afore-mentioned later filed description under Section 26(7)(b) could possibly
introduce added matter, that is, matter extending beyond that disclosed in the earlier
relevant application as specified in the Section 17(2) declaration. Such applications
shall not be allowed to proceed unless amended so as to exclude the additional matter.

7.67

In deciding whether such applications having made a Section 17(2) priority declaration
would introduce additional matter due to the later filed descriptions, the Examinershould take into account the same test and considerations that apply for added subject
matter in patent applications and patent specifications as discussed in the previous
sections.

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J.

The test for added subject matter

7.68

In FE Global Electronics Pte Ltd and others v Trek Technology (Singapore) Pte Ltd[2006] 1 SLR 874 at [24], Martek Biosciences Corp v Cargill International Trading Pte
Ltd [2011] 4 SLR 429 at [81], and Main-Line Corporate Holdings Ltd v DBS Bank Ltd[2012] 4 SLR 147 at [73], the Singapore Courts have followed the test set down in the
UK case Bonzel and Schneider (Europe) AG v Intervention Ltd [1991] RPC 553. The
Court in Novartis AG and another v Ranbaxy (Malaysia) Sdn Bhd [2012] SGHC 253 at[8] followed a further elaboration of this test as provided in European Central Bank v
Document Security Systems Incorporated [2007] EWHC 600 at [97]-[102].

7.69

The Court in Bonzel set down that in order to determine whether an amendment to thedescription had the result that a patent as granted disclosed matter which extended
beyond that disclosed in the application a three-step test is applied —1)

to ascertain through the eyes of the skilled addressee what is disclosed, both
explicitly and implicitly in the application;2)

to do the same in respect of the patent as granted;

3)

to compare the two disclosures and decide whether any subject matterrelevant to the invention has been added whether by deletion or addition.

7.70

The comparison is strict in the sense that subject matter will be added unless such matteris clearly and unambiguously disclosed in the application either explicitly or
implicitly (emphasis added).

7.71

In European Central Bank, the Bonzel test was further elaborated as follows:“97. A number of points emerge from [the Bonzel] formulation which have aparticular bearing on the present case and merit a little elaboration. First, it
requires the Court to construe both the original application and specification todetermine what they disclose. For this purpose the claims form part of thedisclosure … though clearly not everything which falls within the scope of theclaims is necessarily disclosed.
98. Second, it is the Court which must carry out the exercise and it must do sothrough the eyes of the skilled addressee. Such a person will approach theVersion: Oct 2023

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documents with the benefit of the common general knowledge.
99. Third, the two disclosures must be compared to see whether any subject matterrelevant to the invention has been added. This comparison is a strict one. Subject
matter will be added unless it is clearly and unambiguously disclosed in theapplication as filed.
100. Fourth, it is appropriate to consider what has been disclosed both expressly
and implicitly. Thus the addition of a reference to that which the skilled person
would take for granted does not matter: DSM NV’s Patent [2001] R.P.C. 25 at[195]-[202]. On the other hand, it is to be emphasised that this is not an
obviousness test. A patentee is not permitted to add matter by amendment which
would have been obvious to the skilled person from the application.
101. Fifth, the issue is whether subject matter relevant to the invention has been
added. In case G1/93, Advanced Semiconductor Products, the Enlarged Board of
Appeal of the EPO stated (at paragraph [9] of its reasons) that the idea underlying
Art. 123(2) is that an applicant should not be allowed to improve his position byadding subject matter not disclosed in the application as filed, which would givehim an unwarranted advantage and could be damaging to the legal security ofthird parties relying on the content of the original application. At paragraph [16]it explained that whether an added feature which limits the scope of protection iscontrary to Art 123(2) must be determined from all the circumstances. If it provides
a technical contribution to the subject matter of the claimed invention then it
would give an unwarranted advantage to the patentee. If, on the other hand, thefeature merely excludes protection for part of the subject matter of the claimed
invention as covered by the application as filed, the adding of such a featurecannot reasonably be considered to give any unwarranted advantage to theapplicant. Nor does it adversely affect the interests of third parties.
102. Sixth, it is important to avoid hindsight. Care must be taken to consider thedisclosure of the application through the eyes of a skilled person who has not seen
the amended specification and consequently does not know what he is looking for.
This is particularly important where the subject matter is said to be implicitly
disclosed in the original specification.”

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Basis of the consideration: the application as filed
7.72

The Examiner must construe the document through the eyes of the person skilled in theart and with the benefit of the common general knowledge of such a person. As withthe construction of any document, Examiners should take a purposive approach toconstruction.

7.73

Notably the legislation sets out that consideration of post-grant amendments is done on
the “specification” rather than the “application” as is set out in the legislation for pregrant amendments (the application includes both the specification and the abstract as
per Section 25(3)). However, the same consideration applies to both pre- and post-grant
amendments: that is, the whole of the description, any drawings and claims may beconsidered. The comparison is done between the specification as filed and thespecification as proposed to be amended.

7.74

The abstract is not taken into account when determining what the application disclosed
at filing (Abbott Laboratories Ltd. v Medinol Ltd [2010] EWHC 2865 (Pat)). The
purpose of the abstract is to provide technical information about the invention (Section
25(7)). The abstract should therefore be consistent with the specification. If it is, then it
adds nothing in the way of disclosure. If it is not, then it is incorrect. Examiners should
therefore disregard the content of the abstract in determining whether an amendment
adds matter.

7.75

Similarly, a priority document does not form part of the application, and any matter
disclosed in the priority document but omitted from the specification as filed may not
be subsequently added. For example, if figures, sequence listings or the like aredisclosed in the priority documents but omitted from the application, the applicant may
not rely on the priority document as a basis for amending the application (see T 260/85
Coaxial Connector and VEB Kombinat Walzlager [1987] RPC 405).

7.76

In cases where a listing of biological sequences was included after the date of filing of
the original application, the determination of the allowability of such a sequence listing
will be decided depending on the facts of the case.

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ii.

Incorporation by reference

7.77

The specification may refer to another document, which should be unambiguously
identified and should have been published at the date of filing the Singapore applicationin question, to provide additional background material or further information about theinvention, often as an “incorporation by reference” (see sub-section iv of Section K in
Chapter 5). However, the specification must provide a clear and complete disclosure of
the invention at the date of filing (see Section K in Chapter 5). Incorporation byreference of an entire document without indication of the specific features to beincorporated generally will not be permitted. For analogous reasons, features whichhave not been included in the specification as originally filed but are only described in
the document incorporated by reference may subsequently be introduced into the claimsof the application by way of amendment as essential features of the invention only
under particular conditions (see T6/84 Amendment of claims and T 689/90 Eventdetector).

7.78

In the case of T6/84, it was considered that the structural features that were included
into the main claim by way of amendment were indeed those which unequivocallyformed part of the specification and the amendment is thus acceptable. The originally
filed Claim 1 had the following wording:“1. A process for catalytic dewaxing a waxy hydrocarbon oil which comprises
contacting said oil with a catalyst at dewaxing conditions, characterised in that thecatalyst is synthetic offretite.”

7.79

The text in the original description which identified the features disclosed by reference
was worded:“Synthetic offretite is a well-defined zeolite, with a known X-ray diffraction pattern
and a proposed crystal structure … The synthetic offretite useful in the present
invention and its method of preparation are disclosed in Canadian patent 934130
…”

7.80

It is thus clear that the catalyst “synthetic offretite” referred to in the characterising
portion of the main claim as originally filed was an identified material, and that further

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characterising parameters of such material were stated in the specification as originally
filed to be set out in the cross-referenced Canadian patent.
7.81

The further characterising parameters of such synthetic offretite that were incorporated
into the main claim from the Canadian patent during the amendment were the mole ratioof the oxides contained in synthetic offretite and the X-ray powder diffraction pattern.
The Board considered that such parameters were already implicitly present in the main
claim, and the amendment simply defined in greater detail the synthetic offretite. In
other words, the amendment simply introduced that which was already an essential
feature of the invention as described and claimed in the specification as originally filed.

7.82

However, the Board also cautioned that all the essential structural features thus
disclosed which belong together must be incorporated into the claim during theamendment; it is not permissible to single out a particular essential structuralfeature.

7.83

It was further established by the Board in T 689/90 that incorporating information byreference is permissible only if the description of the application as filed leaves a skilled
reader in no doubt that:(a)protection is or may be sought for features which are only disclosed in thereference document;(b)the features contribute to achieving the technical aim of the invention and arethus comprised in the solution of the underlying technical problem of theinvention;(c)the features, implicitly, clearly belong to the description of the invention
contained in the application as filed; and(d)such features are precisely defined and identifiable within the total technicalinformation within the reference document.

7.84

The determination of whether an amendment that sought to incorporate matter from thereference document introduces added matter should take into account all circumstancesof the case.

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iii.

Comparing disclosures: clearly and unambiguously disclosed

7.85

Some EPO decisions have adopted a “novelty test” when assessing the allowability ofamendments. These decisions may provide useful guidance when considering whether
a document provides a clear and unambiguous disclosure of matter proposed to beincorporated by an amendment. For example, as set out in the “Lead Alloys” decision
T 0201/83:“The test for compliance with Article 123(2) EPC is basically a novelty test, i.e. no
new subject-matter must be generated by the amendment. Normally the test for
novelty calls for an inquiry whether or not a document, or article in use, contains
sufficient information so that the person skilled in the art could derive the subjectmatter in question from it directly and unambiguously, including any features
implicit therein … When this maxim is applied to patent applications in order totest the propriety of proposed amendments, the first condition must be that thefeature of the amendment should be contained within the same document or would
have to come from the relevant background art to be incorporated in that
disclosure in consequence of Rule 27(1)(d) EPC. It is, nevertheless, also the viewof the Board that the requirement is not satisfied unless the skilled man could
directly recognise the same as a combination of features available from the
document.”

7.86

The third step set out in Bonzel has been acknowledged as being substantially the sametest as that applied in this case (CIPA Guide to the Patents Act, Seventh Edition at
76.18).

7.87

The “novelty test” is applied only to the matter which is added by the amendment. That
is to say, the matter disclosed in specification after amendment is compared with thematter disclosed in the specification as filed in order to determine the subject matter
generated by the amendment. If the subject matter generated by the amendment would
constitute a novelty-destroying disclosure for a hypothetical claim whereas the original
matter would not, then the amendment would not be allowable.

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7.88

For example, in EPO decision T 194/84 the invention involved the use of natural
cellulosic fibres in the electrode of a storage battery cell. An amendment was proposed
to broaden the claim to the use of cellulosic fibres in general. The applicant argued thatthe amendment was allowable as the original application could be cited against thenovelty of a more generic claim to cellulose fibres. However, the Court noted that theconsideration should be based on the difference in matter between the specification prior
to amendment and the specification after amendment, in this case the use of non-natural
cellulosic fibres. Thus the original matter would not constitute a novelty-destroying
disclosure against a hypothetical claim to the use of non-natural cellulose, andaccordingly the amendment was not allowable.

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iv.

Express and implicit disclosures

7.89

The Examiner must consider what has been disclosed both explicitly and implicitly. The
addition of matter to that the person skilled in the art would take for granted or consider
implicit would generally be allowable (DSM NV’s Patent [2001] RPC 25 at [195][202]). For example, an amendment is made to explicitly include a feature that theskilled person would consider an intrinsic part of the invention would probably beallowable.

7.90

A simple example of this type would be an amendment to include the term “wheels” ina specification relating to a bicycle incorporating a new steering assembly would beallowable.

7.91

In Keith’s Application BL O/455/99, the Comptroller stated that matter is only implicitly
disclosed if the person skilled in the art would inevitably consider that such matter was
included in the application:“In his judgment, Aldous, J stated in terms that the test for added subject-matter isa strict one and that in order to be acceptable the matter in question must be‘clearly and unambiguously disclosed [in the application as filed] either explicitly
or implicitly’. I believe that is clear as it stands, but in the face of Mr Keith’sargument to the contrary, I confirm that I interpret the expression ‘disclosed …
implicitly’ as meaning that the skilled addressee would recognise that the matterin question, though not actually mentioned, must inevitably be present.”

7.92

It is not sufficient that the added matter was one of several possibilities that could bederived from the original disclosure. This approach is consistent with the approach in anovelty consideration, where a feature may only be considered inherent if the workingof the invention would inevitably provide that result.

7.93

It must be noted that this is not an obviousness consideration. Amendments
incorporating matter which would have been obvious to the person skilled in the art
from the application are not allowable. For example, in Flexible Direction Indicators
Ltd’s Application [1994] RPC 207 the invention related to a traffic bollard characterisedby its flexibility. The specification originally disclosed that the bollard was made froma compound of two polymers. The applicants sought an amendment to include the use

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of a single polymer, arguing that it would be obvious to the skilled person that it could
provide the desired flexibility. Aldous J noted in this case that the consideration ofwhether the matter extends beyond the original disclosure “is concerned with what is
disclosed, not with that which the skilled reader might think could be substituted or what
had been omitted”.

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v.

Matter which extends beyond the original disclosure

7.94

The reference in Section 84(3) to “any matter extending beyond that disclosed in theapplication as filed” refers to matter directly in relation to the invention.

7.95

The underlying principle of whether matter relevant to the invention has been added isthat an applicant should not be allowed to improve their position by adding subject
matter not disclosed in the application as filed. A key consideration is “whether a skilled
man would, upon looking at the amended specification, learn anything about theinvention which he could not learn from the unamended specification.” (Jacob J in
Richardson-Vicks Inc.’s Patent [1995] RPC 568).

7.96

One approach taken by the Courts has been:“If it provides a technical contribution to the subject matter of the claimed
invention then it would give an unwarranted advantage to the patentee. If, on theother hand, the feature merely excludes protection for part of the subject matter ofthe claimed invention as covered by the application as filed, the adding of such a
feature cannot reasonably be considered to give any unwarranted advantage to theapplicant.(European Central Bank v Document Security Systems Incorporated at[101]).”

7.97

The addition of prior art information or other material not directly related to theinvention would generally be considered an allowable amendment. However, if theamendment changes the way in which the person skilled in the art would understand theinvention from what was originally indicated or changes the nature of the problem to besolved, then it may not be allowable.

7.98

For example, inclusion of prior art which shows the invention possesses certain
advantages will be allowable only if the advantage would have been apparent to a person
skilled in the art in possession of that prior art (Palmaz’s European Patents (UK) [1999]
RPC 47).

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vi.

Data submitted after the filing date

7.99

Under Singapore Patents Act, the specification of an application or a patent cannot be
amended in a manner which would result in added subject matter. Therefore, if
experimental data is to form part of the specification, it should be included at the dateof filing.

7.100 The Applicant may submit data or evidence after the date of filing in order to address
objections (e.g. an inventive step, sufficiency or industrial applicability objection)raised by the Examiner. Whether the data or evidence will be admitted depends on thetechnological field and individual case. Usually, as long as support could be found in
the original disclosure (no new teaching), the submitted data may be considered by the
Examiner.
7.101 Generally, in the assessment of sufficiency, the applicant cannot rely on data or evidence
submitted after the filing date itself to establish sufficiency of disclosure and overcome
a sufficiency objection.
7.102 When assessing inventive step, advantages in association with the invention (e.g.
substantiated by experimental data) that are not disclosed in the specification as filed
but submitted after the filing date may be considered by the Examiner. However, if thedata or evidence submitted after the filing date provides new teaching, e.g. a selection
invention for which support cannot be found in the application as filed, then it would
not be allowable to claim a specific compound/composition by merely providing its
advantages at a later stage.

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vii.

Intermediate generalisation

7.103 The claims form part of the disclosure but as noted in European Central Bank noteverything which falls within the scope of the claims is necessarily disclosed.
7.104 For example, amendments may limit the scope of a claim by the introduction of one ormore features from the description or claims, but add matter through what is known as“intermediate generalisation”. This was described by Pumfrey J in Palmaz’s European
Patents (UK) [1999] RPC 47 in the following way:
“If the specification discloses distinct sub-classes of the overall inventive concept,
then it should be possible to amend down to one or other of those sub-classes,
whether or not they are presented as inventively distinct in the specification before
amendment. The difficulty comes when it is sought to take features which are only
disclosed in a particular context and which are not disclosed as having any
inventive significance and introduce them into the claim deprived of that context.
This is a process sometimes called ‘intermediate generalisation’.”
7.105 The applicability of intermediate generalisations in Singapore has been specificallyaddressed by the Singapore Courts. Most recently, Lee Seiu Kin J in Novartis AG andanother v Ranbaxy (Malaysia) Sdn Bhd [2012] SGHC 253 noted that the concept isfirmly entrenched as part of the UK law, but noted that “the policy-oriented rules
applicable in England by virtue of the European Patent Convention should not be
unthinkingly adopted in Singapore without an examination of its compatibility with thelocal statutory regime”. At [39] he went on to state:“I am of the view that the principle of intermediate generalization appears to be
subsumed under the test of added matter. This is because the question which thetest of intermediate generalization seeks to answer is simply whether a person
skilled in the art would learn something new which has not hitherto been disclosed
in the patent specifications … the ‘right question is whether the proposed
amendment would result in the specification disclosing additional matter’ … Thisis precisely the test which the court has to apply under s 84(3) of the Act.”

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7.106 An intermediate generalisation will add matter if the person skilled in the art is presented
with information that they could not have derived from the application as originally
filed. This will occur where a particular feature that is present in only one embodiment(or in only a limited number of the embodiments) is imported into the broader invention
as a defining feature of the invention, without importing the other features of theembodiment(s). Unless the application suggests that this feature has a broader
significance, then it may be taken to constitute an impermissible intermediate
generalisation (see for example, Datacard Corp. v Eagle Technologies Ltd. [2011] RPC
17).
7.107 For example, in Teva UK Ltd v Merck & Co. Inc. [2010] FSR 17, the Court found thatan amendment of a claim to limit a formulation to a particular pH range was notallowable on the basis that:“given the paucity of the disclosure about pH generally, the only disclosure thatthe skilled person would take out of the application as filed for combinations of
dorzolamide and timolol would be gellan gum at pH 5.5 to 6.0 and HEC at pH 6.
To claim a range of pH 5.5 to 6.0 for dorzolamide irrespective of viscosifier
amounts to an impermissible intermediate generalisation.”
7.108 An intermediate generalisation may also occur by the deletion of matter to placeemphasis on certain features. For example, in the decision of the Court of Appeals in
Merck & Co Inc’s Patents [2004] FSR 16, the applicant sought to limit the claim to asingle pill comprising 70 mg of alendronate by deleting other tablet dosages andcombinations. This amendment was considered to place particular emphasis on thisspecific dosage form, when no such importance was indicated in the application as filed,and as a consequence the amendment was not allowable.
7.109 In contrast, in Novartis, an amendment to a claim to limit the scope specificformulations comprising valsartan in free form as the only active agent, and where thecomposition comprised 2-10% of crospovidone (a disintegrant used widely inpharmaceuticals) was found to be allowable. The Court found that both these features
had been clearly and unambiguously disclosed in the application as filed, including inexamples of preferred embodiments and specific examples. Moreover, on the questionof whether the limitation of the claims constituted an impermissible intermediate

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generalisation, since the claim did not include other components which were describedin “typical” compositions of the invention, the Court considered that nothing turned on
this point. The omitted components were considered to have no inventive significanceto the person skilled in the art since they were merely coloring and film coating agentsthat had no effect on the performance of the invention.

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viii. Generic disclosure as a basis for amendment to a specific feature
7.110 If a generic term can be regarded as applying only to a limited number of alternatives
then amendment to one of those alternatives may be allowable. This would be restrictionof subject matter rather than addition of subject matter.
7.111 For example, disclosure of a pump for use with a fluid would be contemplated as being
used for liquid or gas. Restriction to one of these alternatives would probably bepermissible.
7.112 However, this will depend on the facts of the case. In Noxell Ltd’s Application BL
O/137/92, the hearing officer did not allow amendment to limit the term layer to “nonpeelable layer” despite submissions from the applicant that “layer” included peelable
and non-peelable.

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ix.

Addition and deletion of features

7.113 Addition or deletion of text, particularly when it relates to the features of the invention,
can result in a specification including additional matter. Disclaimers are a similar
amendment that can result in the addition of matter. Disclaimers are separately dealt
with below. Care should be taken during examination whenever such changes are made,and similar considerations will apply in relation to divisional applications.
7.114 Deletion of a feature will often result in a broadening of the scope of a claim, but priorto acceptance the key consideration will be whether it results in a disclosure of added
matter that was not in the specification as filed. In Protoned’s Application [1983] F.S.R.
110 the invention involved the use of a gas spring and a mechanical compression spring
to adjust the seat and back of a chair. An amendment to change the definition of a“mechanical compression spring” to a “mechanical spring” was refused as it resulted in
the application disclosing added matter inasmuch as it included the use of mechanicalsprings not referred to in the specification as filed.
7.115 An amendment which deletes or adds features may be allowable provided the invention
is disclosed in the application when read as a whole. In particular, if the feature that has
been deleted would be understood by the skilled person to be arbitrary or unnecessarythen its deletion may be allowable. However, deletion of a feature from a claim will not
be allowable if the original specification is construed as teaching that the feature isessential (see for example the “AMP/ Coaxial connector” decision T 0260/85).
7.116 Similarly, in Glatt’s Application [1983] RPC 122, the application as filed described anarticle for conditioning fabrics in a laundry dryer which comprised a flexible woven or
non-woven air-permeable web. Amendment to omit the feature of air-permeability was
not allowed as this was considered to be an essential feature of the invention.
7.117 Raychem Ltd’s Application [1986] RPC 547, dealt with divisional applications in whicha cross-linking step from the parent application was omitted from the claims of thedivisional applications. This step was held by the Patent Court to be an essential featureof the invention described, and therefore claims to an intermediate product without thecross-linking step were considered to constitute additional matter. In the corresponding
European applications, claims in which the intermediate was limited to containing

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cross-linkable groups, thereby incorporating the inventive concept, were foundallowable.
7.118 In International Playtex Corporation’s Application [1969] RPC 362, the omission of afeature that was essential to fulfil the purpose of the invention was not allowable. In
particular, the specification as filed stated that the object of the invention was to designa brassiere with maximum resistance to riding over derived from its built-in differential
stretch patterns. The applicant sought to replace this text with one referring to “atriangular insert” based on a feature defined in the claims (“a triangular piece ofstretchable fabric”), but the Court considered that this was not an allowable amendment.
7.119 There may also be situations where an invention is claimed in a different manner but isstill the same inventive concept. In Southco Inc. v Dzus Fastener Europe Ltd [1990]
RPC 587 at [616], Aldous J:“There is no definition in the Act of what is meant by the word ‘matter’ and I
believe that this word is wide enough to cover both structural features of themechanism and inventive concepts … What the Act is seeking to prevent is apatentee altering his claims in such a way that they claim a different invention fromthat which is disclosed in the application. Thus, provided the invention in theamended claim is disclosed in the application when read as a whole, it will notoffend against section 76 …”
7.120 If a claim does not define a particular feature, it does not necessarily follow that thisfeature must be absent. As a consequence, amendment of a claim to specifically define
the absence of a feature could in fact lead to additional matter (T 170/87 “SULZER/
Hot gas cooler”).

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x.

Ranges

7.121 Amendments to the ranges shall be allowed if the amended range is clearly andunambiguously disclosed in the application either explicitly or implicitly. If thespecification as filed merely discloses a range in general, and the applicant later onamends to a narrower range to overcome a piece of prior art, such amendment may not
introduce added matter as long as there was support within the specification as filed
demonstrating to the person skilled in the art there was clear justification to claiming
the narrower range. However, such amendment may still face an inventive step
objection.
7.122 In the case of a disclosure of both a general and a preferred range, a combination of thepreferred disclosed narrower range and one of the part ranges within the disclosed
general range on either side of the narrower range may be allowable. In T 2/81, theamended range from 180°C to 300°C was allowed as the Board deemed that it was
directly derivable by combination of the disclosed general range from 150°C-300°C andthe disclosed preferred temperature range from 180°C-240°C. In T 925/98, theoriginally filed documents had disclosed a general range of 30% to 60% and a preferred
range of 35% to 50%, and hence, an amendment to introduce the range of 30% to 50%
in claim 1 was not added matter. In T 249/12, the claimed range of “10-50 mass %” wasallowed as the Board viewed it was directly derivable from the application as filed,which disclosed “1-50 mass %, preferably 2.5-40 mass %, more preferably 5-30 mass
% and still more preferably 10-20 mass %”.

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xi.

Disclaimers

7.123 Applicants may use disclaimers as a means to overcome novelty and inventive step
objections during amendments. These are generally in the form of a proviso or similarstatement excluding specific embodiments or groups from the original claim. For
example, the claim as originally filed defines “a composition comprising metal”,
whereas a subsequent amendment may introduce the feature that “the metal is not iron”.
Such an amendment may be illustrated as follows:

7.124 Amendments to incorporate disclaimers will generally be allowable if the disclaimer
itself is clearly disclosed. In the above illustration, this would be where “metal – iron”
is specifically mentioned in the specification as filed. Disclaimers not disclosed in theapplication as filed require further consideration.
Subject matter to be excluded is not disclosed in the application as filed (“undisclosed”
disclaimers)
7.125 Of particular concern in this regard are so-called “undisclosed” disclaimers. An
undisclosed disclaimer is one that is not disclosed as such and the subject matterexcluded by it is not disclosed in the original specification. Referring to the illustration
above, an undisclosed disclaimer is where there is no mention at all of “metal – iron”
and of iron in the specification as filed.

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7.126 Whether or not the incorporation of an undisclosed disclaimer is to be considered as
added matter depends on the circumstances of the individual case. Generally, an
undisclosed disclaimer is not allowable if:(i)

it is used to exclude embodiments that do not work or in order to address anobjection of lack of sufficiency;(ii)

it makes a technical contribution.

7.127 If the incorporation of an undisclosed disclaimer, although limiting the subject-matterclaimed in the original application, provides a technical contribution to the working of
the invention thereby giving an unwarranted advantage to the applicant, it would beconsidered to constitute added matter (see G1/93 “Advanced Semiconductor
Products”).
7.128 Examples of an undisclosed disclaimer that makes a technical contribution and may besubjected to an added matter objection include:1)

one that excludes a feature, the exclusion of which makes a technicalcontribution to the working of the invention;2)

one that leads to a selection invention of compounds or sub-classes ofcompounds not disclosed in the application as filed or otherwise derivable
therefrom; or3)

an intermediate generalization, which is not explicitly mentioned or
implicitly disclosed in the application as filed.

7.129 If, on the other hand, the incorporated undisclosed disclaimer merely excludes part ofthe subject-matter from the originally claimed invention, which does not provide any
unwarranted advantage to the applicant or adversely affect the interests of third parties
relying on the content of the original application, it would be allowable (see G1/93“Advanced Semiconductor Products”).
7.130 In particular, the EPO Enlarged Board of Appeal set out several specific criteria underwhich an undisclosed disclaimer would be considered allowable in G1/03“Disclaimer/PPG”. When applied to the Singapore context, this would be set up as
follows:

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(a)Avoiding a document cited under section 14(3): namely, a conflicting
Singapore patent application published after the priority date.
Different applicants may be entitled to different aspects of an invention basedon their respective priority dates and the matter in each claim. A disclaimer
in this situation merely reflects the respective rights of each applicant in thisregard.

(b)

Avoiding an accidental anticipation in an unrelated field that the person
skilled in the art would never take into consideration because it relates to an
unrelated field or the skilled person would not consider the subject matter
helpful to the invention.
This is typical in the area of chemistry, where searches of claims to a broadchemical class useful for a particular treatment will uncover prior art
compounds having a different unrelated use. Thus a disclaimer to exclude
one or more specific compounds would be allowable.

(c)

Avoiding subject matter that is excluded from patentability, including
inventions that are considered non-industrially applicable such as methods oftreatment of the human body, or inventions that are considered offensive,
immoral or anti-social.
For example, where a particular treatment could be used for medical
treatment but also for cosmetic, non-medical treatments, a disclaimer to
exclude the medical treatment would generally be allowable (see Section C
in Chapter 8).

7.131 The Enlarged Board in G1/16 “Disclaimer III” endorsed that the assessment of theallowability of a claim amendment by an undisclosed disclaimer is governed exclusively
by the criteria laid down in G1/03 (paragraph 44 of the Reasons). Consistent with theprinciples in G1/93, the Enlarged Board further reiterated that the introduction of suchan undisclosed disclaimer may not provide a technical contribution to the subject-matter
disclosed in the application as filed. In particular, it may not be or become relevant for
the assessment of inventive step or for the question of sufficiency of disclosure. The
undisclosed disclaimer may not remove more than necessary either to restore novelty or
to disclaim subject-matter excluded from patentability.

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Subject matter to be excluded is disclosed in the application as filed
7.132 Another possible scenario is where the disclaimer as such is not disclosed but the subject
matter excluded by it may be found in the original specification. With reference to theillustration above, this is where there is no mention of “metal – iron”, but there is anembodiment in the specification as filed of the metal being iron. In this case, the test to
be applied is whether the subject matter remaining in the claim after the introduction of
the disclaimer is clearly and unambiguously disclosed in the application, either
explicitly or implicitly, to the skilled person using his common general knowledge at
the filing date. This was the approach set out by the Enlarged Board in G2/10“Disclaimer/SCRIPPS”.
7.133 This test is not dissimilar to that applied when determining the allowability of anamendment to include the limitation of a positively defined feature in a claim. However,
the allowability of the introduction of the disclaimer cannot be decided solely by
establishing that the disclaimed subject matter is disclosed in the application as filed.
What is required is a technical assessment of the overall technical circumstances of theindividual case under consideration, taking into account the nature and extent of thedisclosure in the application as filed, the nature and extent of the disclaimed subject
matter and its relationship with the subject matter remaining in the claim after theamendment, in order to determine whether or not said subject matter remaining in theclaim is clearly and unambiguously disclosed in the application as filed (see G2/10).
7.134 To illustrate the above principle, G2/10 had provided the following example: “in theapplication as filed an invention has been disclosed and claimed in general terms anddifferent specific embodiments or groups thereof have also been disclosed, and one ofthese is later excluded from the requested protection by the disclaimer, the remaining
subject-matter, i.e. the remaining general teaching, will normally not be modified by thedisclaimer. This contrasts with the situation in which, for instance, the disclaimer would
have the effect of confining the subject-matter remaining in the claim to a subgroup of
the originally claimed subject-matter, which subgroup could not be regarded as
disclosed in the application as filed, even taking into account what the skilled person,
using common general knowledge, would regard as implicit in the contents of theapplication as filed.” In the latter situation, there would be added matter.

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7.135 As clarified by the Enlarged Board in G1/16, the approach in G2/10 does not apply toundisclosed disclaimers as mentioned above.

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K.

Corrections (Section 107)

7.136 Examiners will generally only be dealing with corrections to the specification, and as aconsequence this section provides procedural guidance only in that regard.
7.137 Section 107 sets out the law in relation to corrections of errors:(1)

The Registrar may, subject to any provision of the rules, correct any error oftranslation or transcription, clerical error or mistake in any specification of apatent or application for a patent or any document filed in connection with apatent or such an application.

(2)

Where the Registrar is requested to correct such an error or mistake, any
person may in accordance with the rules give the Registrar notice of
opposition to the request and the Registrar shall determine the matter.

7.138 Rule 91 provides for some of the procedural matters associated with Section 107. A
request to correct an error should be made on Form CM47.
7.139 Once corrected, a document is deemed always to have been in the state in which it isafter the correction. Corrections are not subject to the same considerations ofallowability as set out in Section 84 that apply to amendments. As a consequence, acorrection can potentially result in the specification disclosing added matter or theprotection conferred by the claims being extended (Rock Shing Industrial Ltd v Braun
AG BL O/138/94). The implications of such changes for the public and potential
competitors are quite significant, and care should be taken to ensure that all relevant
considerations are taken into account. Importantly if a specification is being corrected,
care should be taken to ensure that the changes are in the nature of a correction.
However, once this has been established there is no impediment in relation to theallowability of the changes.
7.140 Generally, replacement sheets for rectifications of obvious errors in an international
application authorized by the competent International Authority are deemed to be partof the international application as originally filed (PCT Rule 91) and will be taken into
account accordingly during examination. Only in the rare case when it is found that such
7

The prescribed form under the Patents Rules in effect immediately before 14/02/2014 is Form 23.

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rectifications would not have been authorized under Rule 91 if IPOS had been thecompetent authority, and the applicant is given an opportunity to make observations on
the intention to disregard the rectification within a reasonable time limit under thecircumstances, the Examiner may disregard a rectification authorized under the PCT(PCT rule 91.3f).

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The “two-step test”
7.141 Section 107 confers on the Registrar the power to correct errors in patent applications.
Specifically, Rule 91(2) sets out the requirements for a correction as follows:
Where such a request relates to a specification, no correction shall be made therein
unless the correction is obvious in the sense that it is immediately evident that
nothing else would have been intended other than what is offered as the correction.
7.142 The General Division of the High Court in Nippon Shinyaku Co, Ltd v Registrar of
Patents [2022] SGHC 164 (“Nippon Shinyaku”) has observed that Rule 91(2)demonstrates that a strict approach is taken to the correction of errors in specifications.
The applicant seeking the exercise of the Registrar’s powers to make the correction
bears the burden of proof to show that the correction is justified (at [30]-[31]).
7.143 Notably this provision applies only to corrections that are made to the specification.
The assumption is therefore that the correction of other documents, including theabstract, is not subject to the same requirement that the error be obvious and it be
immediately evident that nothing else would have been intended. Nevertheless,evidence may be required in order to establish that an error had occurred.
7.144 As held in Nippon Shinyaku, the applicable test in deciding whether a correction should
be made under Rule 91(2) is the two–step test in Dukhovskoi’s Application [1985] RPC
8 (“Dukhovskoi”) (at [32], citing Lonza Biologics Tuas Pte Ltd v GenpharmInternational Inc [2014] SGIPOS 9 (“Lonza”) with approval). The two steps are as
follows:(a)

Is it clear that there is an error, and(b)

If so, is it clear what is now offered is what was originally intended?

7.145 In order to meet the requirements of the first step, it must be obvious on the face of the
document that there is an error. This encompasses relatively clear errors such as
missing pages and the like. The standard of proof in this regard is the balance of
probabilities, i.e., whether on the balance of probabilities the reader would conclude that
there was an error (see R. v the Comptroller-General of Patents ex parte Celltech Ltd[1991] RPC 475, “Celltech”). However, the consideration is made through the eyes of

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the skilled addressee, and as a consequence their knowledge and their understanding of
the document must be taken into account. Thus, while an error in a cited document may
not be readily apparent to the casual reader, it may be apparent to the person skilled in
the art that the cited document is incorrect. Similarly, the skilled person may have regard
to references (such as standard textbooks) in order to confirm that the document is
indeed in error.
7.146 Once it has been determined that there is an error, to meet the requirements of the second
step, the rectification must be “immediately evident” (Lonza at [11], citing Dukhovskoi).
This is a strict requirement – the skilled person must understand that nothing other thanthe proposed correction was intended. The standard in this respect is not “on the balanceof probabilities” or whether the proposed correction is the “most likely” solution to theskilled reader – there must be only one feasible correction. Arguments to the extent thatthe correction would be the “most likely” solution to the skilled reader “on the balanceof probabilities” would be rejected. If alternative corrections may be envisaged, thenthe rectification cannot be considered immediately evident. If the specification makes
technical and linguistic sense, then it will not be immediately evident that only one othermeaning was originally intended (Lonza at [11], citing Celltech).
7.147 In Nippon Shinyaku (at [30]), the Court reiterated the rationale for the strict approach,citing Lonza (at [5]):“Correction is different to amendment. In particular, Section 84 states that an
amendment cannot add subject matter or in the case of a patent, extend theprotection conferred. The limitations of Section 84 apply only to amendments under
sections 31, 38(1), 81 and 83. In contrast Section 107 has no such restriction, andas a consequence a correction can potentially result in the specification
disclosing new matter or extending the scope of protection of a patent (Rock Shing
Industrial Ltd v Braun AG BL O/138/94). Furthermore, once the correction ismade the document is considered to have always been in the state in which it isafter correction. In theory this can change the scope of the granted patent andmake something an infringement that was not an infringement prior to thecorrection, but this is tempered by the requirement that it must be immediately
evident that nothing else would have been intended than what is offered as thecorrection. …” [emphasis in original]
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7.148 In Lonza, the proprietor of the patent sought various corrections. The proposedcorrection to the title of Table 17, to change the reference of “affinity” to “avidity”, wasconsidered allowable by the hearing officer on the basis that the method described in
the relevant part of the description of the patent would immediately be understood by
the skilled person as being a measurement of avidity. However, the other proposedcorrections for the general references to “affinity” to read “avidity” throughout the restof the specification were not allowed as: i) the evidence did not establish that the skilled
person would consider it clear there was an error; or ii) the evidence showed that theskilled person would consider that two corrections were feasible: either the term“affinity constant” was incorrect, or the numerical values in the specification wereincorrect. Hence, the proposed correction of the term in the rest of the specification was
not “immediately evident”.
7.149 The Opponent in Lonza also argued that the Applicant had knowingly and intentionallychosen to delay the corrections in order to exploit the time delay that the proceedings
would cause, and that the corrections should therefore not be allowed. However, thehearing officer considered that there was no apparent discretion for the Registrar to takesuch matters into account in determining whether the corrections were allowable under
Section 107 and Rule 91.
7.150 In Nippon Shinyaku, the Applicant and the Respondent both agreed that the first step of
the two-step test in Dukhovskoi was satisfied, with the Registrar having acknowledgedthat there was a clear error in Table 7 of the verified English translation of the PCT
application. What was in question was the second step, i.e., whether it would be
immediately evident to the skilled person that Table 7 should contain the same
information as that found in the Japanese priority document, i.e., Table 7 of thespecification of the Japanese priority application.
7.151 In considering whether reference can be made to the priority documents in assessing
whether nothing else other than the proposed corrections could have been intended, theCourt, following a survey of some case authorities, held that where the correction
request involves the replacement of the entire specification, no reference can be madeto the priority document to show that it is immediately obvious that nothing else would
have been intended than what was filed as the correction. However, where the proposedcorrection does not involve the replacement of the entire specification, reference can be
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made to the priority documents in determining whether nothing else other than the
proposed correction was intended (Nippon Shinyaku at [43] and [45]).
7.152 After determining that reference may be made to the priority documents on the facts of
Nippon Shinyaku, the Court held that in assessing whether it was immediately obvious
to the skilled observer that nothing else apart from the proposed corrections to Table 7
would have been intended, it was necessary to consider the: (i) nature of the error; and(ii) the relationship between the patent application and the priority application.
7.153 In assessing the proposed corrections to Table 7, the Court (Nippon Shinyaku at [50])considered that the error in Table 7 related to data (instrumental analytical data) thatwas presented in the specification, rather than the substantive content of thespecification. Where the error related to substantive content, it might not be immediately
obvious that the proposed correction was what was initially intended. The Court notedthat in this scenario, any differences between the present specification and the priority
application might be the result of a conscious act of judgement by the drafter, rather
than the result of an error (citing Tragen’s Application BL O/096/90 (“Tragen”)).
However, where the difference related to data included in the specification, the Court
held that it was more likely to be the result of an error. On the facts of Nippon Shinyaku,
the Court found that the error in Table 7 was quite clearly the result of the wrong set ofdata having been copied over than a conscious act of judgement by the drafter (at [51]).
The proposed correction was thus allowed.
7.154 The circumstances of the individual case determine what information should be
provided by the applicant to meet the burden of proof. This includes justifications andsupporting documents demonstrating why it would be obvious to the person skilled in
the art that there is an error and why the correction would be understood to be original
intention.
7.155 In some cases, it will be readily apparent on the face of the document what the correction
should be. For example, in a situation where the correction relates to an erroneous unit
for a physical parameter that is well-known in the art, a statement describing the natureof the error and its occurrences in the specification to be corrected may suffice.
7.156 On the other hand, there will be instances where the correction may not be readily
apparent. Such cases could concern cited prior art or numerical data, or where the error
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requires reference to other documents to determine what was originally intended. Insuch situations, relevant justifications in the form of written submissions, withsupporting documents, where necessary, should be provided by the applicant to address
both steps of the test. General statements in the written submissions indicating that thebasis for the correction can be found throughout the specification are unlikely to be
sufficient.
7.157 There is no restriction on the person skilled in the art having regard to other documents
in order to determine what was intended. Therefore, the applicant, in meeting its burdenof proof, may refer to other documents filed with the application, such as the foreign
language application in the case of a translated document and the priority document,even if filed later than the original application (see Dukhovskoi).
7.158 However, a mere discrepancy between documents may not be sufficient to justify the
proposed correction. It was held in Tragen that while an error in a specification may, inprinciple, be corrected by reference to the priority document, there is a high evidentiary
burden on the applicant to show that nothing else other than the proposed correction
would have been intended. In Tragen, the application for correction was refused
because, upon comparing the specification in the subject application with that of thepriority document, the differences were found to be the result of a conscious act ofjudgement by the drafter rather than the result of an error. In the light of this, and in theabsence of any other evidence, it could only be assumed that the words used in thesubject application accurately reflected the drafter’s intentions (Tragen, as cited in
Nippon Shinyaku at [46]). Therefore, even where the difference relates to data includedin the specification, the assessment on the proposed correction will depend on thejustifications and supporting documents provided by the applicant, based on thecircumstances of the case.
7.159 In the case where the applicant’s justifications rely on documents not presently filedwith the application, supporting documents would need to be provided as well. For
example, if the applicant’s justifications rely on a reference to show that a particularconstruction is well-known in the art and could be assumed to be known to the skilled
person, a copy of the reference showing the relevant portion relied on should be filed asa supporting document with the request for correction. This includes documents inconnection with the application, but which may not have been filed with it, such as the
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priority document. Supporting documents not in English should also be accompanied
by a verified English translation (Rule 112). Where the justifications refer to documents
already filed with the application, such as the description, an indication in the written
submissions identifying the relevant parts to be considered would be sufficient.
7.160 Sometimes, errors in the specification may be identified during examination, but
Examiners should only note the error in the written opinion if it is of a significant enoughnature. If a significant error is discovered late in the process, such as at the point of
establishing the written opinion, then the Examiner may contact the agent or attorney todiscuss the matter. In clear cases (such as where a page has been omitted), the Examinershould indicate in the report that correction of the specification under Section 107 will
be required. In general, a request for a correction will be required if matter has been
omitted or deleted – such as in the case of a missing page or an error in a chemical
structure – and the information cannot otherwise be gleaned from the specification as
filed. However, amendment may be the appropriate course of action if the missing
information can be ascertained from the specification as filed (that is, no additional
matter results from the amendment).

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Errors in translations
7.161 In the absence of clear evidence to the contrary, the Examiner should generally assume
that the translations of the application and amendments are accurate.
7.162 However, if there are obvious errors or omissions in the translated document (e.g.
missing pages or text), then the Examiner should interpret the document by using
available translation tools or in consultation with an Examiner with the appropriate
language skills. The Examiner should raise the issue in Box I, under “Additional
observations”, of the written opinion, with an explanatory comment. In such cases, theapplicant may request to correct the error.
7.163 If the error in the translations is to the extent that it may influence the scope of search
and/or examination, the Examiner may consult a Senior Examiner, and subsequently
refer the matter to the Registry.

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8.

PATENTABLE SUBJECT MATTER AND
INDUSTRIAL APPLICABILITY

A.

Statutory requirements

8.1

Section 13(1) of the Act states as follows:
Subject to subsection (2), a patentable invention is one that satisfies the following
conditions:the invention is new;it involves an inventive step; andit is capable of industrial application.
Section 13(1) contains the word “invention”. Therefore, the subject matter of a patentapplication must be for an invention – with the assessment of whether the invention ispatentable involving a consideration inter alia of whether the subject matter is new,involves an inventive step and is capable of industrial application.

8.2

The primary focus of the inquiry under Section 13 should be on the criteria of novelty,
inventive step and industrial application. In most cases, a finding that the claims do not
fulfil any one or more of the three requirements of novelty, inventive step and industrial
application would be a sufficient basis for an objection under Section 13. Examiners
should begin by properly construing the claims and identifying the claimed inventive
concept (Chapter 2 and Section F in Chapter 4). The Examiner then proceeds to consider
the specific conditions set out in Section 13(1), including novelty, inventive step andindustrial application.

8.3

If there is a residual issue that the claims may relate to subject matter which is not an“invention”, a separate analysis of the claimed subject matter should be undertaken. In
determining whether or not the claims define an “invention”, the Examiner should take
into account the substance rather than the form of the claims in order to identify theactual contribution which is made by the claimed subject matter, having regard to the
problem to be solved, how the claimed subject matter works, and what its advantages

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are. Regard should also be given to the person skilled in the art and the common generalknowledge he possesses.
8.4

The identification of the “actual contribution” referred to here is the second step in the
Aerotel/Macrossan test in Aerotel Ltd v Telco Holdings Ltd & Ors Rev 1 [2007] RPC 7(Aerotel/Macrossan). The critical factors for the Examiner to consider when identifying
the actual contribution can be found at [43] of Aerotel/Macrossan;“The second step – identify the contribution – is said to be more problematical.
How do you assess the contribution? Mr Birss submits the test is workable – it isan exercise in judgment probably involving the problem said to be solved, how theinvention works, what its advantages are. What has the inventor really added tohuman knowledge perhaps best sums up the exercise. The formulation involves
looking at substance not form – which is surely what the legislator intended.”

8.5

An objection should be raised if the actual contribution lies solely in subject matter thatis not an “invention” (for example, if the actual contribution falls within any of the areas
described in sub-sections i, ii, iii, iv or v of this Section in this Chapter).

8.6

In considering the actual contribution of claims directed to computer-implemented
inventions (CIIs), Examiners should determine the extent to which the computer (orother technical features) contributes to the invention defined in the claims. For such
CIIs, it must be established that said computer (or other technical features), as definedin the claims, is integral to the invention in order for the actual contribution to comprisesaid computer (or technical features).

8.7

For example, claims relating to a computer-implemented business method would beconsidered an invention if the various technical features (e.g. servers, databases, user
devices etc.) interact with the steps of the business method (i) to a material extent; and(ii) in such a manner as to address a specific problem. As an example of what is meantby “material extent”, a claim may recite known hardware components for implementing
a business method, but if the overall combination of the hardware provides, for example,
a more secure environment for performing transactions, then the hardware would be
regarded to interact with the business method to a material extent to address a specificproblem. The actual contribution, in this case, is likely to be the use of that combination

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of hardware for the business method, which would be considered an invention.
However, if the technical features recited in the claim are such that they are no morethan the workings of a standard operating system, in particular, the use of a genericcomputer or computer system to perform a pure business method, then such aninteraction would not be considered to be a material extent and it is apparent that no
specific problem is solved. The actual contribution is likely to be the business method,
and the claimed subject matter would not be considered an “invention” by merely
including the term “computer-implemented” or a similar generic term in the claims.
8.8

The following sub-sections provide some guidance as to what “subject matter” are notconsidered to be “inventions”. These are presented in view of the local jurisprudence
and also in view of the public policy considerations, including maintaining consistency
with international patent norms. Generally, major jurisdictions including the US,
Europe, the UK and Australia preclude mental, intellectual, aesthetic and abstract
matters from being patentable. The following sub-sections should not be considered to
be exhaustive as to what “subject matter” are not considered to be “inventions”.

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Discoveries
8.9

The Singapore Court of Appeal has drawn a distinction between discovery andinvention in Merck & Co Inc v. Pharmaforte Singapore Pte Ltd [2000] SGCA 39 at[63], referencing Lane Fox v. Kensington & Knightsbridge Electric Lighting Co [1892]
3 Ch 424:“In this regard, we must also point out that the fact that a discovery is made does
not mean there is an invention. The latter does not necessarily follow from theformer. This distinction was brought out by Lindley LJ in Lane Fox (supra) at page429 where he said:‘An invention is not the same thing as a discovery. When Volta discovered
the effect of an electric current from his battery on a frog’s leg he made agreat discovery, but no patentable invention. Again, a man who discovers
that a known machine can produce effects which no one before him knew
could be produced by it, may make a great and useful discovery; but if hedoes no more, his discovery is not a patentable invention: … He has added
nothing but knowledge to what previously existed. A patentee must do
something more; he must make some addition, not only to knowledge, but topreviously known inventions, and must so use his knowledge and ingenuity
as to produce either a new and useful thing or result, or a new and useful
method of producing an old thing or result.’”

8.10

From the above quotation that was referenced by the Singapore Court of Appeal, it isclear that discoveries are not inventions. As Section 13(1) of the Patents Act provides
for the grant of patents for inventions, discoveries are not patent eligible subject matter
under Section 13(1) of the Patents Act.

8.11

Many inventions are based on a discovery, but there must be “something more” toconstitute an invention. The discovery of a particular property of a material will add tothe stock of knowledge in relation to that particular substance. However, if that property
results in the application of that substance in a new use then it may constitute an
invention.

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8.12

To find a material or microorganism that pre-existed in nature would represent a
discovery and therefore an isolated or purified material or microorganism from nature
is not an invention. However, if a specific use of the isolated or purified material or
microorganism is found, then the specific use of the isolated or purified material or
microorganism is considered an invention.

8.13

In determining whether the claimed subject-matter is an “invention”, the Examinershould take into account the substance of the claim. This determination should include
considering the actual contribution made by the claimed subject matter to humanknowledge (Aerotel Ltd v Telco Holdings Ltd & Ors Rev 1 [2007] RPC 7 at [43]). The
Examiner would also have regard to the problem to be solved, how the claimed subject
matter works, and what its advantages are. Regard should also be given to the person
skilled in the art and the common general knowledge he possesses.

8.14

If the contribution made by the claimed subject-matter goes beyond isolating or
purifying the material or microorganism that pre-existed in nature, such as to include
modification of an isolated natural material or microorganism in order that the isolated
natural material or microorganism can be adapted for a specific use, then both themodified material or microorganism and the specific use of the modified material or
microorganism are considered inventions. The same consideration also applies to aclaim to a composition or a combination comprising an isolated or purified materials or
microorganism that pre-existed in nature. If the contribution made by the claimed
composition or combination resides merely in combining the isolated or purified
material or microorganism that pre-existed in nature with another product (e.g. a
container), then the claim is not considered an invention. However, if the contributionof the claimed composition or combination goes beyond just putting the composition or
combination together, such as resulting in a specific useful application, then the claimed
composition or combination would be an invention.

8.15

Likewise, a claim directed to a process that occurs in nature would not be allowable but
if a specific use of the process is found, then the specific use can be claimed. For
example, a method of digesting milk casein using proteases found in the gut would beconsidered as directed to a natural process. However, it may be possible to claim aprocess of producing fermented beverages comprising digesting milk casein withnatural proteases, which would represent a specific use of the natural process. In the

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same way, an in vitro diagnostic method performed on blood samples obtained from apatient is an invention since this represents a specific application of a discovery whichallows the diagnosis of a disease to be made.
8.16

Similarly, a new compound that has been synthesized might not constitute an invention
in patent law, as it might represent no more than a chemical curiosity. However, if thecompound could be used in an industrial process or a new and useful property was
discovered then it would constitute an invention.

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ii.

Scientific theories and mathematical methods

8.17

A scientific theory or a mathematical method per se is not an invention, but if anapplication of the principle results in a new material or process, then the resulting
product may be considered an invention.

8.18

For example, the theory of relativity would not be an invention, but a Global Positioning
System that makes use of the theory of relativity to more accurately locate the user
would constitute an invention.

8.19

The implementation of a theory or principle does not require an inventive step if thetheory or principle is inventive. Thus, in Hickton’s Patent Syndicate v Patent & Machine
Improvements Co. [1909] 26 RPC 339, Fletcher Moulton LJ stated:“In my opinion invention may lie in the idea and it may lie in the way in which it iscarried out, and it may lie in the combination of the two; but if there is invention
in the idea plus the way of carrying it out, then it is good subject matter for letterspatent.”8.20

This approach has been followed in Genentech’s Patent [1989] RPC 147 and KirinAmgen v Hoechst Marion Roussel [2005] RPC 9.

8.21

However, if the claimed matter merely constitutes a statement of the principle
underlying a known process then it will not be an invention. In such cases an objection
under inventive step should be considered since the mere elucidation of the principle is
not inventive.

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Artificial intelligence and machine learning
8.22

Artificial intelligence and machine learning methods typically utilize computationalmodels and algorithms for classification, clustering, regression and dimensionality
reduction in the performance of various tasks. Neural networks, support vector
machines, discriminant analysis, decision trees, k-means and other such computationalmodels and algorithms applied in machine learning are, by themselves, mathematicalmethods, and are hence not considered to be inventions.

8.23

On the other hand, where the claimed subject matter relates to the application of amachine learning method to solve a specific (as opposed to a generic) problem, theactual contribution of said claimed subject matter is likely considered to go beyond theunderlying mathematical method and thus, could be regarded as an invention. To clarify,
a generic problem, such as using the method in controlling a system, is unlikely to be
sufficient to pass the threshold; the application must be a specific one, such as using themethod in controlling the navigation of an autonomous vehicle.

8.24

Furthermore, the mere fact that a mathematical method may solve a specific problem isunlikely to be sufficient. The claim should be functionally limited to solve the specificproblem, either explicitly or implicitly. This can be achieved by establishing a sufficient
link between the specific problem and the steps of the mathematical method, forexample, by clearly specifying how the input and the output of the sequence ofmathematical steps relate to the specific problem, so that the mathematical method iscausally linked to solve said problem.

8.25

For example, a claim directed to a deep learning method, incorporating bothheterogeneous transfer and multi-task learning such that the method is characterized by
the mathematical steps of the algorithm would be considered a mathematical method
per se, and therefore would not be regarded as an invention. However, said method, forexample, applied to process audio or video data to solve the specific problem ofrecognising human speech or recognising images would likely be considered aninvention.

8.26

Artificial intelligence or machine learning methods may also be claimed with reference
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same considerations at paragraphs 8.23 and 8.24 should apply to determine whether or
not the claimed invention solves a specific problem. Where such a specific problem is
not apparent, and the claimed subject matter appears to involve the mere use of
conventional computer hardware to implement a machine learning method based on acomputation model, it is unlikely that the actual contribution of said claimed subject
matter would be considered to go beyond the underlying mathematical method,
regardless of whether or not the model can be “trained” based on training data. In sucha situation, the underlying mathematical method is also not considered to interact withthe conventional hardware to a material extent and in such a manner as to address a
specific problem.
8.27

It should be mentioned that artificial intelligence and machine learning methods may be
applied across a broad spectrum of industries, and thus care should be taken that theactual contribution of the claims also does not fall within other subject matter notconsidered to be inventions, such as business methods. For such subject matter, theconsiderations at paragraphs 8.6 and 8.7 are applicable.

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iii.

Aesthetic creations: literary, dramatic, musical or artistic works

8.28

A purely aesthetic creation (including written works, photographs, paintings, sculptures,music, speeches, or other artistic works) is not an invention. This includes not only theidea or mental aspects of the creation, but also any physical representation of the work.

8.29

However, there may be certain instances where the actual contribution is more than themere aesthetic creation. For example a design on a surface would likely constitute a
purely aesthetic creation if the design was merely decorative. However, if the actual
contribution of the claimed subject matter is the achievement of improved non-slip
properties as a result of the design, then the design may constitute an invention.

8.30

Similarly, a particular colour may be considered an invention provided the selection ofsaid colour addresses a specific problem that is not merely aesthetic. For example, ablue squash ball was considered patentable since the colour improved its visibility (ITS
Runner Ltd’s Application [1979] RPC 318).

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iv.

Schemes, rules or methods for performing a mental act, playing a gameor doing business

8.31

Methods that are considered mental acts or schemes are generally not inventions. These
include teaching methods (such as a method of learning a language or reading), methodsof mental arithmetic, methods of memorising things or methods of designing a product.

8.32

This practice is applied narrowly – for example, in Halliburton Energy Services Inc v.
Smith International (North Sea) Ltd [2005] EWHC 1623, the Court found that claims
to a method of designing a drill bit were sufficiently broad to also encompass the purely
intellectual content of a design process, and hence the claims were deemed to be directed
to a mental act. However, the Court considered that this deficiency was a matter of formand could have been overcome by the inclusion of a manufacturing step.

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v.

Presentation of information

8.33

Any invention which is characterised solely by the content of the information is not aninvention, even if a physical apparatus is involved in the presentation. In Townsend’s
Application [2004] EWHC 482 (Pat), claims relating to an advent calendar with anadditional indicium on each door were found not to be an invention. Laddie J held thatthe exclusion does not only apply to the expression of information but also to theprovision of information.

8.34

The key consideration in such cases is whether the actual contribution is the presentationof the information as such.
For example, a gaming machine having product names rather thanconventional symbols would represent mere presentation of information(Ebrahim Shahin’s Application BL O/149/95).
A claim defining the choice of how and where to present information would
not be an invention since this still relates to the presentation of information(Autonomy Corp Ltd v. Comptroller General of Patents, Trade Marks &Designs [2008] EWHC 146 (Pat)).
A newspaper layout designed such that folding the paper did not hinder
reading was found to be an invention (Cooper’s Application [1902] 19 RPC53), as was a ticket on which information was presented in such a way that itwas not lost when the ticket was torn (Fishburn’s Application [1940] 57 RPC
245).
An instructional speech course in which text was highlighted in a particular
way to indicate stress and rhythm was not considered an invention (Dixon’sApplication [1978] RPC 687).
A claim to a known product such as a pharmaceutical which is characterisedby the instructions on the package will not generally be allowed, since thecontribution lies solely in the presentation of information (see paragraph8.188).
Claims to software that are characterised only by source code, and not by any
technical features, is unlikely to be considered an invention on the basis thatthe actual contribution would be a mere presentation of information.

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B.

Industrial applicability

8.35

Section 16(1) states that an invention is considered industrially applicable if it can bemade or used in any kind of industry.

8.36“Industry” is understood in its broadest sense and includes any useful and practicalactivity as distinct from intellectual or aesthetic activity. In general there must be
something in which a new and useful effect, be it creation or alteration, may beobserved. It need not be an article or substance nor necessarily involve a manufacturing
process, but it must be useful in practical affairs. In Chiron Corp v Murex Diagnostics
Ltd [1996] RPC 535, industrial application was taken to carry the connotation of tradeor manufacture in its widest sense and whether or not for profit.

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Subject matter contrary to established physical laws
8.37

Processes or articles alleged to operate in a manner which is clearly contrary to wellestablished physical laws, such as perpetual motion machines, are regarded as nothaving industrial application. In considering whether an invention operates in a manner
which is clearly contrary to well-established physical laws, the Examiner should
consider the material present on the balance of probabilities. If there is substantial doubt
about an issue of fact which could lead to patentability, the Examiner should consider
whether the evidence provided by the applicant gives rise to a reasonable prospect thatthe applicant’s theory might turn out to be valid if it were to be fully investigated at atrial with the benefit of expert evidence (Blacklight Power Inc. v The ComptrollerGeneral of Patents [2009] RPC 6). In such a case the application should be allowed toproceed.

8.38

It should be noted that the test set out in Blacklight Power should be applied only where
there is “substantial doubt” on an issue of fact. In the case of a claim to a perpetualmotion machine, there is no substantial doubt, and as pointed out by the judge in thiscase, there would be no reasonable prospect that matters would turn out differently ona fuller investigation at trial. An alternative or additional objection may be that the
specification is not complete enough to allow the invention to be performed under
Section 25(4).

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C.

Methods of medical treatment

8.39

Methods of medical treatment are a specific exclusion under industrial applicability.
The exclusion only applies to methods that are therapy or surgery, as well as diagnostic
methods practised on the human or animal body, as set out in Section 16(2):“An invention of a method of treatment of the human or animal body by surgery or
therapy or of diagnosis practised on the human or animal body shall not be taken
to be capable of industrial application.”

8.40

Section 16(2) is primarily intended to ensure that medical or veterinary practitioners are
not hindered from properly exercising their professional skills by patent rights. This isconsistent with G 05/83 EISAI/Second medical use OJEPO 1985, 64, which highlights
that“The intention of Article 52(4) EPC … is only to free from restraint noncommercial and non-industrial medical and veterinary activities.”

8.41

Section 16(2) corresponds to Article 52(4) EPC 1973, which states that “Methods fortreatment of the human or animal body by surgery or therapy and diagnostic methods
practised on the human or animal body shall not be regarded as inventions which aresusceptible of industrial application …” and similarly to Section 4(2) of the UK Patents
Act prior to the 2004 amendments. In Singapore, the general approach is set out inBristol-Myers Squibb v Baker Norton Pharmaceuticals Inc [1999] RPC 253 by Jacob J
at [51]:“A like approach is indicated in Plant Genetic Systems/Plant Cells (EPO [1995]
545, T0356/93 OJ). There is also the limited purpose of the exception to beconsidered. It is not so broad as to stop doctors using whatever they feel they needto treat patients. If that were the purpose then one would not allow patents for
medicines or medical implements at all. The purpose of the limitation is muchnarrower, merely to keep patent law from interfering directly with what the doctor
actually does to the patient. Patent monopolies are permitted to control what headministers to, or the implements he uses on, the patient. The thinking behind theexception is not particularly rational: if one accepts that a patent monopoly is a

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fair price to pay for the extra research incentive, then there is no reason to supposethat that would not apply also to methods of treatment. It is noteworthy that in the
US any such exception has gone, and yet no-one, so far as I know, suggests that its
removal has caused any trouble.”

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Therapy
8.42

Therapy refers to any treatment designed to cure, alleviate, remove or lessen thesymptoms of, or prevent or reduce the possibility of contracting any disorder ormalfunction of the human or animal body (T 24/91 THOMPSON/Cornea OJEPO 1995,
512; T 58/87 SALMINEN/Pigs III [1989] EPOR 125; T 1599/09 COVIDIEN).

8.43

The following methods will generally constitute methods of therapy, and Examiners
should have particular regard to such claims (Unilever (Davis’s) Application [1983]
RPC 21):(i)Preventative treatment, including vaccination of healthy individuals;(ii)

Methods to alleviate disease symptoms;(iii) Curative treatment; and(iv) Veterinary treatment of a diseased or injured animal, including prophylactic
and immunotherapeutic treatment.
8.44

The key consideration here is if it is possible to establish a direct link between thetreatment and the disease being cured, prevented or alleviated (Commonwealth
Scientific and Industrial Research Organization’s Application BL O/248/04; Pfizer Inc
v Commissioner of Patents [2004] NZCA 104). If a link can be established then amethod falls within the “treatment by therapy”.

8.45

In addition, any medical treatment of a disease, ailment, injury or disability, i.e. anythingthat is ailing a patient and for which a doctor or veterinarian would be consulted would
generally be regarded as therapy. This may be a Western trained doctor/therapist or a
Traditional Chinese Medical physician. Similarly prophylactic or preventative
treatments by such practitioners may be regarded as constituting therapy for the
purposes of Section 16(2).

8.46

However, whether a medical practitioner or a veterinarian performs the method is not
the only consideration. As long as the treatment cures, prevents or alleviates a disease,
the treatment would constitute a method of therapy whether the treatment is performedby the patient (such as the administration of a medicament), by an automated system(see T 1599/09), or by a farmer (such as treatment of farm animals, see T 116/85

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WELLCOME/Pigs I OJEPO 1989, 13). This is also consistent with the Board of Appeal
decision in T 245/87 SIEMENS/Flow measurement OJEPO 1989, 171 a method of
stimulating a limb during blood collection in order to facilitate the flow of blood, where
the Board noted that:“The need for a medical practitioner to perform a measure on the human body or
supervise such an operation is not the sole criterion by which a method step has tobe assessed with regard to the exclusion of subject-matter from patenting under
Art. 52(4) EPC. The purpose and inevitable effect of the step at issue are much
more important.”
8.47

In this regard, it is more important for the Examiner to consider the purpose andinevitable effects of the invention. The Board of Appeal further noted that:“If the claimed subject-matter is actually confined to operating an apparatus for
performing a method with the technical aim of facilitating blood flow towards a
blood extraction point, the operating method has no therapeutic purpose or effectand, therefore, is not excluded from patentability.”

8.48

On the other hand, if a method has no therapeutic purpose or effect, then the mere factthat an invention may be carried out by a medical practitioner does not render it
incapable of industrial application. For example, in Schering A.G.’s Application [1971]
RPC 337 it was held that claims that are directed solely to non-therapeutic medical
treatments will be generally accepted.

8.49

A method claim would also fall under the prohibition of Section 16(2) even if it contains
only one step that defines a therapeutic activity. For instance, including a step of“administering a substance for prophylactic reasons” in a method claim would likely
render the method claim incapable of industrial application (see G 01/04 Diagnostic
methods OJEPO 2006, 334).

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ii.

Claims to both therapeutic and non-therapeutic methods

8.50

In some cases a claim can be construed to include both therapeutic and non-therapeutic
methods, as exemplified by the following claim:“A method for inhibiting the coagulation of blood by contacting the blood with acarrier containing compounds X and Y.”
This claim could be construed as including a method of treating the blood in a patientas part of a therapeutic method, and a method of treating stored blood in a tube, which
is not a method of medical treatment. In such cases, the claim should be carefully
construed to determine its scope.

8.51

Therapeutic and non-therapeutic effects of a claimed method must be clearly
distinguishable. If the non-therapeutic effect is inseparable from the therapeutic effect,
or if it is merely a secondary consequence of the therapy, then regardless of any
disclaimer or a purely formal rewording of the claim, the invention is not capable ofindustrial application under Section 16(2). Both the UK Courts and the EPO have heldthat if a claim encompasses a use comprising a non-therapeutic element that is
associated with a therapeutic element and that latter element is an essential part of theclaimed method, the claim is non-patentable. For example, in T 290/86 ICI/Cleaning
Plaque OJEPO 1992, 414 a claim directed to a cosmetic method for the removal ofplaque from teeth, was considered to also have a therapeutic benefit in preventing tooth
decay and gum disease:“… the claimed use of a lanthanum-containing composition for cleaning plaqueand/or stains from human teeth … will always inevitably have a therapeutic effect(at least in the prophylactic sense) as well as a cosmetic effect. Thus the invention
as here claimed is not directed solely to a cosmetic effect, but is also necessarily
defining ‘a treatment of the human body by therapy’ as well.”
If the effects are separable, then the existence of a possible therapeutic use should notprevent cosmetic or other non-therapeutic methods from being industrially applicable
under Section 16(2) provided the therapeutic use is not part of the claim.

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8.52

Generally, disclaimers to exclude methods of treatment by therapy are allowable.
However, where a disclaimer is employed there must be support in the specification forsuch non-therapeutic methods or else the amendment will constitute added matter (G01/03 PPG/Disclaimer OJEPO 2004, 413; G 02/10 SCRIPPS/Disclaimer OJEPO 2012,376). In ICI (Richardson’s) Application [1981] FSR 609, a claim to a method of
producing an anti-oestrogenic effect in a human and, which excluded any method oftreatment by therapy was rejected since the specification did not describe any
application of the method other than in the treatment of breast cancer or infertility. Any
disclaimer needs to exclude all possible therapeutic methods, not merely those disclosed
in the specification, and the scope of the remaining monopoly should be clear. For
example, the term “cosmetic” in a claim to a method of treatment is generally acceptable
as a sufficient limitation, as long as there is support in the specification for such nontherapeutic method in the application as filed (T 144/83 DU PONT/Appetite
suppressant OJEPO 1986, 30). If there is no such support from the application as filed,then the amended claim will constitute added matter. However, if it is unambiguously
clear from the specification that the claims relate only to non-therapeutic methods, thenno amendment is required.

8.53

The Examiner should take care, where the claim has been limited to exclude therapeutic
methods, to require amendment of the description, so that all references to a therapeutic
effect are removed. It should be clear from both the claims and the description thattherapeutic methods do not fall within the scope of the invention.

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iii.

Surgery

8.54

Surgery refers to the treatment or manipulation of the body using manual, instrumental
and/or robotic surgical techniques.

8.55

A broader interpretation of the definition of “methods of surgery” was considered in T
35/99 GEORGETOWN UNIVERSITY/Pericardial access OJEPO 2000, 447 where it
was held that any surgical activity, irrespective of whether it is carried out alone or in
combination with other medical or non-medical procedures should be excluded:“In contrast to procedures whose end result is the death of the living being ‘under
treatment’, either deliberately or incidentally (e.g. the slaughter of animals or
methods for measuring biological functions of an animal which comprise thesacrificing of said animal, cf. T 182/90 SEE-SHELL/Blood flow OJEPO 1994 – notexcluded), those physical interventions on the human or animal body which,whatever their specific purpose, give priority to maintaining the life or health of
the body on which they are performed, are ‘in their nature’ methods for treatment
by surgery within the meaning of Article 52(4) EPC.” (emphasis added in boldterms)

8.56

However, in G 01/07 MEDI-PHYSICS/Treatment by surgery OJEPO 2011, 134, theEnlarged Board of Appeal held that given the continuous advances in medical
procedures, a more narrow interpretation of what is encompassed by “method ofsurgery” should be given, in which the purpose of the method should be irrelevant anda surgical method is defined by the nature of the method, namely the level of surgicalskill required and health risks involved. Specifically, in G 01/07 paragraph 3.4.2.3 it isstated that:“… thus any definition of the term ‘treatment by surgery’ must cover the kind ofinterventions which represent the core of the medical profession’s activities, i.e.
the kind of interventions for which their members are specifically trained and forwhich they assume a particular responsibility.”

8.57

For example, if a claim is directed to a method of introducing an agent (e.g. apharmaceutical or contrast agent) it is the health risk of the invasive procedure that

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should be assessed. Even if the procedure is not physically performed by a medical
professional, if it is risky enough to be the responsibility of a medical professional, it
may be sufficient to be considered a method of surgery. On the other hand, if theprocedure is a minor intervention which did not imply substantial health risks when
carried out by said qualified paramedical professional with due care and skill, then it
may not be considered to be a surgical method (T 663/02 PRINCE).
8.58

In a subsequent decision, T 1695/07 TRANSONIC SYSTEMS, it was considered thatthe term “medical profession” should not be limited to medical doctors and physicians
and it should cover all health care providers. In this case, it was deemed that the claimed
process comprised steps that qualified as a surgical method due to the substantial healthrisk associated with them, even if performed by paramedical support staff.
Consequently, the level of medical skill needed to perform a method and the health risks
involved in the procedure should be used by the Examiner as a guide to determine ifthat method constitutes a “method of surgery”.

8.59

If a method does not require medical skills or knowledge, such as, for example, a method
for cosmetic ear-piercing, or a method of tattooing the body, then it would not be
considered a method of surgery. Another example is that while the setting of bones iscarried out by medical practitioners and thus considered to be surgical in nature, themaking and applying a plaster cast is usually performed by a technician and so would
not be regarded as surgery. In any case, as aforementioned, the Examiner should always
take into consideration that even if the procedure is performed by a technician, if it is ofsuch a risky nature that it falls under the responsibility of a medical doctor, it would still
be a method of treatment by surgery.

8.60

In addition, a method claim can fall under the exclusion even if it comprises just one
feature defining a physical activity or action that constitutes a method of surgery (G01/07 paragraph 4.3.2). In T 2187/10 Z-KAT independent method claim 1 was
confirmed to be not allowable on the grounds of it being a method of treatment of thehuman or animal body by surgery due to the step of “… performing the surgicalprocedure …”. In this regard, even if a disclaimer is used to omit the surgical step, theclaims still need to adequately define the invention. As such, if the omitted surgical stepis an essential feature of the invention then disclaiming or omitting this from the claim
should be objected to as lacking support.

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8.61

Some examples of “surgical methods” include:(i)Catheterization, endoscopy, incision, excision or centesis (T 182/90 SEESHELL/Blood flow OJEPO 1994, 641);(ii)“Closed surgery” (see T 182/90), such as setting of broken bones orrelocating dislocated joints;(iii) Implantation of an embryo which requires the intervention of a surgeon or aveterinary surgeon (Occidental Petroleum’s Application BL O/35/84);(iv) Dental surgery (T 429/12 DENTAL VISION);(v)

Any implantation or insertion of devices by surgical means (Allen’sApplication BL O/59/92);(vi) Insertion of devices into respiratory cavities (with and without incision) (T05/04 CAMTECH); and(vii) Puncture/injections such as lumbar punctures to deliver epidural injections,venipunctures (T 1075/06 FENWAL).
8.62

On the other hand, a method that is not itself surgical but is useful during surgery byproviding, for example, real-time feedback and enable a surgeon to decide on the courseof action to be taken during a surgical intervention, should not be considered a methodof surgery (see G 01/07). Additionally, claims to methods involving the internal
operation of implanted devices, or the interaction between the implanted device and an
external user or system, should not be considered a surgical method insofar as themethod only concerns the operation of the device, if:there is no functional link to the effects produced by the device on the body(see T 245/87); or
they are not related to the actual implantation of the device (T 09/04
KONONKLIJKE PHILIPS ELECTRONICS and T 1102/02 MAQUETCRITICAL CARE).

8.63

Additionally, claims directed to a technical method for improving the performance of apacemaker without a surgical implantation step, would normally not be considered amethod of surgery. Some examples of procedures generally not considered as “surgicalmethods” under Section 16(2):Version: Oct 2023

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(i)Simple injection methods, either for taking blood samples or introducing
compositions (see T 663/02);(ii)

Cosmetic ear-piercing, or methods of tattooing the body, which does not
represent the core of the medical profession’s activities and does not pose
substantial health risks (see G1/07 para 3.4.2.3);(iii) Methods to measure, make and apply a plaster cast or attaching
exoprostheses to the skin using an adhesive (T 635/08 DOW CORNINGFRANCE);(iv) Methods of making artificial limbs; and(v)

Methods carried out on a dead body or interventions that result in the deathof the subject (e.g. sacrifice of laboratory animals) (see T 35/99).

8.64

It is important to keep in mind that, while a method might not be considered as“surgery”, the said method could be a procedure that falls under the definition of“therapy” or “diagnosis”. In such cases, the method would still not be considered to becapable of industrial application under Section 16(2).

8.65

In general, any operation on the body which requires the skills or knowledge of asurgeon or other medical practitioner is regarded as surgery, whether or not it istherapeutic. In Unilever (Davis’s) Application, Falconer J. stated, as follows:“[S]urgery can be curative of the disease or diseased conditions, or prophylactic,
that is, preventive of diseased conditions, as for example, where an appendix or
tonsils may be removed before any diseased condition starts up, and surgery may
even be cosmetic without being curative or preventive. So that the subsection it
seems to me is saying that any method of surgical treatment whether it is curative,
prophylactic or cosmetic, is not patentable.” (Obiter)

8.66

As stated in G 01/07 “… the meaning of the term ‘treatment by surgery’ is not to beinterpreted as being confined to surgical methods pursuing a therapeutic purpose”. The
Technical Board of Appeal has followed G 01/07 in the recent T 1213/10 SONY wherea method of measuring in vivo enzymatic activity which included a surgical step of using
a “penetration device” (e.g. an endoscope) to introduce a substrate to an organ in the
body was excluded for being a method of surgery despite the Applicant’s argument thatthe method was carried out for analytical rather than therapeutic purpose.

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8.67

Therefore, any methods of surgery, even for non-therapeutic purposes would beconsidered to be not capable of industrial application under Section 16(2).

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iv.

Some specific examples of therapeutic/surgical and non-therapeutic/
surgical methods
Cosmetic treatments

8.68

Purely cosmetic treatments of the skin and hair are considered patentable inventions.
For example a cosmetic treatment for strengthening hair was considered patentable(Joos v Commissioner of Patents [1972] 126 CLR 611, 619). Similarly, a method of
reducing normal hair loss by administration of a composition defined by its active
ingredients was considered a patentable non-therapeutic method once the claims wererestricted to it being carried out as a cosmetic treatment (T 453/95 REDKEN).

8.69

Similarly, in Virulite’s Application BL O/058/10:“A method of cosmetically treating a superficial area of mammalian skin around,
above or below an eye by reducing or alleviating or removing or diminishing
wrinkles that occur as a result of natural aging, the method comprising irradiating
the skin …”
was considered to be a cosmetic method for removing wrinkles by phototherapy, andwas allowed as the removal of wrinkles caused by ageing had no apparent therapeutic
benefits.

8.70

In T 383/03 GENERAL HOSPITAL/Hair removal method OJEPO 2005, 159 it wasalso held that a method to remove body hair was non-therapeutic as the excess of bodyhair is not considered to be a condition that causes pain or discomfort and is directed toan aesthetic purpose, which is clearly distinguishable from a therapeutic purpose. Thus,
an application containing claims directed to a purely cosmetic treatment byadministration of a chemical product may be considered industrially applicable (see also
T 144/83).

8.71

In contrast, a cosmetic treatment that has a therapeutic effect is considered a method oftherapy. For example, the use of a composition for the local treatment of comedones(blackheads) was generally regarded as a cosmetic method of non-medical bodyhygiene. However, when applied for the treatment of acne this might be regarded as amethod of therapy (T 36/83 ROUSSEL-UCLAF/Thenoyl peroxide OJEPO 1986, 295).

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In T 36/83, the Technical Board of Appeal considered that the cosmetic and therapeutic
compositions were similar and consequently a cosmetic use may result in an incidental
therapeutic effect. Nonetheless, they considered that the following claim was allowable
as it was sufficiently limited to the cosmetic use of the compound:“Use as a cosmetic product of thenoyl peroxide.”
The description expressly disclosed two very different properties of a compound usedin the treatment of comedones, i.e. its anti-bacterial and its hygienic action. The
application showed that pharmaceutical and cosmetic preparations could have very
similar, if not identical, forms. The distinction was clearly set out in the description as
filed. The Board decided that the cosmetic application of a product, which also had atherapeutic use, was patentable, since the Applicants had only claimed in respect of “useas a cosmetic product”. The use of the term “cosmetic” was held to be sufficiently
precise, although the cosmetic treatment according to the application might also
incidentally involve a medical treatment.
8.72

Therefore, methods of a purely cosmetic nature, which are not invasive to the humanbody and that do not have a therapeutic purpose are usually allowable, such as, forexample, methods for: deodorization, decoration, or beautification. Nevertheless, acosmetic method comprising one or more surgical steps may be considered to be amethod of surgery.

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Protection of the skin
8.73

Methods of protecting the skin by simply blocking UV radiation are not considered tobe therapeutic, but where a method produces physiological effects then it is considered
to be a non-patentable therapeutic method. For example, in T 1077/93, the EPO
Technical Board considered that claims directed to the use of the cupric complex of 3,5Diisopropyl salicylic acid (CuDIPS) as a cosmetic product for the protection of humanepidermis against ultraviolet radiation, had also to take into consideration themechanism by which CuDIPS acted. The Board then concluded that at least part of theprotective effects did not derive from a simple filtering at the level of the skin surface,
but rather from an interaction with the cellular mechanisms in the epidermis, with the
purpose of preventing a pathological state (erythema); therefore the process is
considered to be a method of therapy.

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Methods of hygiene, including treatment of parasites
8.74

Methods of hygiene will generally be capable of industrial application even though they
may ultimately prevent the occurrence of diseases. However, methods of treating or
preventing infestation of parasites, including the treatment of head lice, will generally
be regarded as methods of therapy. For example, treatment of parasites residing on theskin of a human or animal is considered to be therapy (see T 116/85):“A method for the control of ectoparasitic infestations of pigs comprising theapplication to a localised area of the pig’s body surface of a pesticidal
composition.”
The Technical Board of Appeal considered that the invention was directed to thetreatment of permanent ectoparasites based on the experimental evidence of thedescription of the patent application, and held that since permanent ectoparasites cause
direct harm to the infested host, the control or eradication of permanent ectoparasites isa therapeutic treatment of the animal body. Consequently, the treatment of, for example,
head lice, is considered therapeutic.

8.75

This is further supported in Ciba-Geigy’s Application BL O/35/85, a method ofcontrolling parasitic helminths by the use of an anthelmintic composition wasconsidered a disease requiring medical treatment of the animal and that such treatment,
whether curative or preventative, constituted therapy even if the host animal isunaffected and that it is only the parasites that are being killed. Accordingly, the Hearing
Officer held that the claims in question were not allowable. Nevertheless, the Examinershould always assess if there is a direct link between the treatment and the condition to
be treated or prevented.

8.76

For example, in Commonwealth Scientific & Industrial Research Organization’sApplication BL O/248/04 it was held that a method for reducing parasitic infestations
by destroying the hair follicles in the skin of sheep was allowable since it was notdirectly linked to a disease state.

8.77

To fall within the exclusion of being a method of therapy, there should be a direct link
between the treatment and the condition to be treated or prevented.

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Treatment of stock animals
8.78

The treatment of stock animals in order to improve the quality of meat or increase theproduction of milk, eggs or the like would not be regarded as therapy, even if thesubstances concerned may have therapeutic benefits. However, in such cases the claims
should clearly be limited to the non-therapeutic aspects. For example, in T 774/89
BAYER, the EPO Technical Board allowed claims directed at medication to increasemilk production in cows since the benefits of administering the medication were notlinked to the health of the cow. To establish its decision, the Board assessed if a nontherapeutic method would be expected to show an improvement on the normal conditionof the subject, rather than just return an animal to a normal, healthy condition.

8.79

However, if the industrial benefit (e.g. an increase in meat yield) is a result from
improved health through a therapeutic treatment, then it may not be allowable. For
example, in T 780/89 BAYER/Immunostimulant OJEPO 1994, 797 claims directed tothe use of compounds for immunostimulation or stimulating the animal body’s own
defences were considered to constitute therapy even with the Applicant arguing that
immunostimulation merely increased meat production.

8.80

This was further confirmed in T 438/91 MEIJI/Feeds [1999] EPOR 333, wherein thestep of feeding said animals had the effects of (a) remedying scours (via treatment withbifidobacteria included in the feed) and of (b) weight increase of the animals being bred.
However, since (a) and (b) cannot be separated, the Technical Board of Appeal
considered the claimed method to relate to a method of therapy or prophylactic
treatment of domestic animals and thus not allowable.

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Oral care
8.81

Methods for the removal of dental plaque, or preventing the formation of plaque areconsidered to be therapeutic and thus not allowed as all such methods have the effect oftreating or preventing dental caries (Oral Health Products (Halsteads) Application[1977] RPC 612; Lee Pharmaceuticals’ Applications [1975] RPC 51). The inherent
therapeutic effect of removing plaque cannot be separated from the purely cosmetic
effect of improved appearance of the teeth, and so restriction of such a claim to acosmetic method is not possible (see T 290/86).

8.82

Non-patentable oral care method claims are those that may include, for example,
references to antiseptic action, treatment of abscess, gumboil, gingivitis, inflammationof gums, mouth ulcers, periodontitis, pyorrhoea, periodontal disease, sensitivity,
stomatitis and thrush.

8.83

However, in T 675/11 COLGATE-PALMOLIVE the Technical Board of Appeal
considered that the “for use in the treatment of halitosis” of the claimed dentrificecomposition was not a method of treatment by therapy as only in extreme cases it canbe considered a disease, such as, for example, chronic halitoses.

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Pain, addiction and fatigue
8.84

The relief of pain is considered to be therapeutic, even where the pain has nopathological cause. In the case of T 81/84 RORER/Dysmenorrhoea OJEPO 1988, 202,
the claim:“A method for relieving the discomfort of a human female attendant tomenstruation, which method comprises administering thereto an effective amountof an amidino-urea of the general formula: X.”
was considered a therapeutic method; it was stated that irrespective of the origin of pain,
discomfort or incapacity, its relief, by the administration of an appropriate agent, is tobe construed as “therapy” or “therapeutic use”.

8.85

However, a method to reduce discomfort by cooling (T 385/09 LELY ENTERPRISES),
and a method to reduce the perception of fatigue in healthy individuals (T 469/94 MIT)have been considered non-therapeutic since it is not comparable with the relief of pain,
discomfort or incapacity.

8.86

Methods of treatment of addiction or withdrawal symptoms are considered to be
therapeutic.

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Obesity, appetite suppression and weight reduction
8.87

Treatment of obesity is generally considered to be therapeutic. However, methods ofweight reduction for purely cosmetic reasons are not considered therapeutic and hence
are industrially applicable under Section 16(2). Claims to such methods must be drafted
to clearly relate to cosmetic weight loss only – for example the following would beallowable:−

A claim limited to a purely cosmetic purpose, such as “A method of
improving the body appearance …” (see T 144/83 DU PONT/ Appetite
suppressant OJEPO 1986, 30).

−

A claim limited to healthy subjects, such as “A method of improving theskeletal muscle performance of healthy subjects …” (T 1230/05
BIOENERGY).

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Contraception, abortion and fertility treatment
8.88

In general, methods of contraception are allowed since pregnancy is not an illness or
disorder (Schering A.G.’s Application; T 74/93 BRITISH TECHNOLOGYGROUP/Contraceptive method OJEPO 1995, 712) but may be excluded under Section
16(2) if the method contains a therapeutic element.

8.89

For example, a contraceptive method using one active ingredient with concomitanttreatment to reduce its ill effects by using a second agent would not be allowable (T820/92 GENERAL HOSPITAL/Contraceptive method OJEPO 1995, 113). In this case,even though the use of an oral contraceptive constituted a non-therapeutic method, theTechnical Board of Appeal considered that the claimed concentrations of the hormone
content in the oral contraceptive were specifically selected at low levels in order toprevent or reduce the likely pathological side effects of the contraceptive. Consequently,
the Board held that the claim is intrinsically indistinguishable from the non-therapeutic
contraceptive method since the prevention of side effects is considered to be atherapeutic method.

8.90

Claims to methods of abortion, termination of pregnancy or induction of labour are notallowable regardless of the reasons for treatment (UpJohn (Kirton’s) Application [1976]
RPC 324). Moreover, methods to prevent or cure any diseases that may occur during
pregnancy, but which are not inherently linked to the pregnancy itself, may still beconsidered therapeutic.

8.91

Methods of infertility treatment, including methods of in vitro fertilisation, areconsidered to be therapeutic. Implantation of an in vitro fertilised embryo would
generally involve a surgical process (see Occidental Petroleum’s Application) andtherefore would not be industrially applicable under Section 16(2).

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Methods relating to implanted devices
8.92

Methods relating to implants and the like may be patentable provided the claimed
method does not relate to any therapeutic effect. For example, if the invention were toa method of monitoring the performance of the implanted device without any changes
being made to the output signal then the method would be considered non-therapeutic(T 789/96 ELA MEDICAL/Therapeutic method OJEPO 2002, 364). Similarly, amethod for measuring the flow of a drug from an implant, and which did not control theflow of the drug, was also held to be non-therapeutic (see T 245/87 SIEMENS/ Flowmeasurement OJEPO 1989, 171).

8.93

On the other hand, a method of optimising an artificial respiration system while thesystem is in use was considered by the EPO Technical Board in T 1680/08 BÖHM to
be indistinguishably linked to the therapeutic use of the respiration system in keeping
the patient alive and consequently the claim was not allowable.

8.94

In addition, a method of operating a pacemaker in which its output to the heart was
adjusted was deemed a method of treatment by therapy (T 82/93 TELECTRONICS/
Cardiac pacing OJEPO 1996, 274). In this case, the Applicant’s argument that this wasa “technical operation performed on a technical object” was considered irrelevant.

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Treatments performed outside the body
8.95

In general, a therapeutic treatment of the human or animal body is not capable ofindustrial application under Section 16(2) even if the actual treatment takes placeoutside the body.

8.96

Examples of such treatments include blood dialysis where the blood is returned to thesame body after treatment (Calmic Engineering’s Application [1973] RPC 684 andShultz’s application BL O/174/86); it is necessary that the blood is returned to the same
body for this to be considered to be a method of therapy. Therefore, treatment of bloodfor storage in a blood bank is not regarded as therapeutic treatment.

8.97

Similarly, methods for treating samples that have been extracted from the human body(e.g. blood, urine, skin, hair, cells or tissue) and methods for gathering data by analysing
such samples are generally not considered to be therapeutic, unless the process isperformed on the presumption that the samples are to be returned to the same body (seeT 1075/06 FENWAL). For example, in T 794/06 GAMBRO LUNDIA it was argued
that a method of preparing a dialysis solution carried out while the patient wasconnected to the dialysis system was not therapeutic since the dialysis solution wasnever in contact with the patient’s blood.

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v.

Diagnosis

8.98

Section 16(2) excludes methods of diagnosis practised on the human or animal body.
Diagnosis includes methods identifying a disease state, but also includes methods
identifying the absence of such a disease state (T 807/98 ST JUDE).

8.99

The process of diagnosis involves four steps leading towards identification of acondition (see G 01/04):(1)

The examination and collection of data;(2)

Comparison of the data with normal values;(3)

Recording any deviation from the norm; and finally,(4)

Attributing the deviation to a particular clinical picture.

8.100 This is a narrow interpretation – only methods comprising all four of these steps andwhich will lead to the identification of a clinical state will be excluded from industrial
applicability. Such interpretation is consistent to that of the earlier decision T 385/86
BRUKER/Non-invasive measurement OJEPO 1988, 308 where a method ofdetermining temperature and pH by magnetic resonance imaging that included a step oftaking a sample, or determining internal temperature or pH, without leading to theidentification of a pathological condition and thereby was not considered to be a methodof diagnosis (see also Bio-Digital Sciences’ Application [1973] RPC 668).

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What does “practised on the body” involve?
8.101 Section 16(2) requires that a diagnostic method be carried out on a living human or
animal body. Therefore, if the diagnostic method is not carried out on a living humanor animal body, but on a dead body, for example to determine the cause of death, said
method would not be objectionable (e.g. performing an autopsy).
8.102 The criterion “practiced on the human or animal body” is to be considered only inrespect of method steps of a technical nature (G 01/04). Section 16(2) does not requirea specific type and intensity of interaction with the human or animal body. The criterion“practiced on the human or animal body” is satisfied as long as the step of technicalnature (usually the examination and data collection step) implies any interaction withthe human or animal body, necessitating the presence of the latter.
8.103 When deciding whether a claim defines a method of diagnosis practised on the humanor animal body, the Examiner may use a simplified test. First, the Examiner should
consider whether the method includes a technical step, i.e. a measurement or
examination step (explicitly or implicitly), and a deductive step of determining thedisease or deriving a clinical picture (corresponding to steps (1) and (4) above). If thisis the case, then the second question is whether the technical step is “practised on thebody” – the simple test for this is whether the patient has to be present during this step.
If the answer to both questions is “yes”, an objection should be made.
8.104 In this regard, the Enlarged Board of Appeal in G 01/04 also noted that:“if … some or all of the method steps of a technical nature … are carried out by adevice without implying any interaction with the human or animal body, forinstance by using a specific software program, these steps may not be considered
to satisfy the criterion ‘practised on the human or animal body’, because theirperformance does not necessitate the presence of the latter.”
8.105 Therefore, if a claim to a diagnostic method includes new and inventive technical steps
that are all carried out separately from the body, for example, by being carrying out invitro on a sample of tissue obtained from the body, it will be capable of industrial
application. For example, in T 666/05 UNIVERSITY OF UTAH, claims defining
methods for diagnosing a predisposition for breast cancer by detecting a mutation in the
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BRCA1 gene in a tissue sample from the subject was allowable since the technical stepsof the claimed methods are performed on an in vitro tissue sample. Nonetheless, suchclaims should still be examined to determine whether they fall under the definition of amethod of therapy or surgery.
8.106 Additional, intermediate steps which relate to, for example, the preparation or
adjustment of a device for data collection, may be introduced into a diagnostic method
claim for completeness. However, since these intermediate steps are not part of steps(1) to (4) as described above, which are necessary for making the diagnosis, they are
ignored when assessing the diagnostic character of the method. Thus, even when theperformance of such intermediate technical steps do not require the presence of thehuman or animal body, it would still not overcome a diagnostic method claim that wasin the first place not allowable (see T 1197/02 THE AUSTRALIAN NATIONALUNIVERSITY and T 143/04 BETH ISRAEL HOSPITAL ASSOCIATION).

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Who performs the method?
8.107 The question of whether a claimed method is excluded under Section 16(2) depends onwhether it falls within the definition of a “method of diagnosis”, and whether it is“practised on the human or animal body”. It does not depend on who performs themethod, or if a medical or veterinary practitioner is required.
8.108 In general, a method is “practised on the human or animal body” if it involves any
interaction that requires the presence of the subject. Consequently, as long as the
subject’s presence is required, it will be considered as being “practised in the human or
animal body”.
8.109 In this regard, G 01/04 states that:“… whether or not a method is a diagnostic method within the meaning of Article
52(4) EPC should neither depend on the participation of a medical or veterinary
practitioner, by being present or by bearing the responsibility, nor on the fact that
all method steps can also, or only, be practised by medicinal or nonmedicinal
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Identification of a condition and/or disease to be diagnosed
8.110 A diagnostic method requires a deductive step (4) that must involve the identificationof a “condition”. For example, a method of measuring temperature using magnetic
resonance would be allowable as there is no condition to be diagnosed (see T 385/86).
8.111 Notably the omission of such a step from the claim may overcome an objection under
Section 16(2), but may result in a support objection under Section 25(5)(c) if an essential
feature of the invention is not defined. For example, in decision T 143/04 the claims as
originally filed were directed to a method of diagnosing Alzheimer’s disease. The
Applicant amended the claims to include only the examination phase and remove thereferences to a comparison and diagnosis. However, the EPO Technical Board did notallow this amendment because the invention as filed is not an independent datacollection method, but a method of diagnosis that included those data collection steps.
In addition, it was held that as long as the method can be used to diagnose a disease,
whether the method is reliable is an irrelevant consideration (paragraph 3.4 of T 143/04).
8.112 There may be cases where it is apparent from the description that a claimed method is
in fact a method of diagnosis, even if the words of the claim do not specify a specificdisease. For example, in T 125/02 AEROCRINE the measurement of nitrogenmonoxide levels in exhaled air was used to identify “impaired respiratory function”;
and the description indicated that the method allowed particular course of treatment tobe selected, and so the claimed method was considered to encompass all the steps
leading to a diagnosis.
8.113 In some cases, the method may be useful in diagnosing a disease but does not provide
sufficient information in itself to enable a diagnosis. Thus, a method should not be
considered a method of diagnosis if it merely determines the general health and wellbeing of an individual and is not intended to determine a pathological condition.
8.114 For example, methods such as fitness tests and the like would be considered patentable.
Similarly, if a method is merely for data acquisition or processing and it only provides
intermediate results that may be of diagnostic significance, it could be patentable aslong as no actual diagnosis can be obtained. However, care must be taken in such cases
since if the application indicates that the claimed method of data acquisition or

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processing is an integral part of a method of diagnosis, there may be support issues when
the said data collection/processing method is claimed as an independent method (seeparagraph 2 of T 143/04).
8.115 Examples of techniques that may be allowable include:(i)

Methods of imaging using CT scanning (see T 09/04 KONONKLIJKE
PHILIPS ELECTRONICS);(ii)

Methods of measuring a parameter in a sample, such as blood glucose (T330/03 ABBOTT LABORATORIES);(iii) Methods of assessing tissue viability by measuring total haemoglobin,
oxygen saturation and hydration (T 41/04 NATIONAL RESEARCHCOUNCIL OF CANADA)(iv) Methods of determining ear temperature (T 1255/06 EXERGENCORPORATION);(v)

Methods of imaging an artery in a patient using magnetic resonance imaging(see T 663/02 PRINCE); and(vi) Methods of detecting regional variations in oxygen uptake from the lungs (T990/03 MEDI-PHYSICS INC.).
8.116 Although these are prima facie allowable methods, if the method encompasses
attribution of the result to a clinical condition or disease, then it may still be considereda diagnostic method.

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D.

Medical use
First medical use

8.117 Whilst methods of treatment are excluded from patentability by virtue of Section 16(2),there is some relief for innovators wishing to patent substances or compositions used inmethods of medical treatment. This is specifically provided in Section 16(3), whichstates that:
Subsection (2) shall not prevent a product consisting of a substance or composition
from being treated as capable of industrial application merely because it is invented
for use in any such method.
8.118 Section 16(3) is further supplemented by Section 14(10) which states that a known
substance or composition for use in a method of treatment excluded by Section 16(2)will be new if the use of the substance or composition in any such method does not form
part of the state of the art. Consequently, known substances or compositions which havenot been used previously for medical purposes may be claimed in the form of a first
medical use claim.
8.119 First (and second) medical use claims are often filed for new substances or compositions
that have medical uses, in anticipation of any unforeseen prior disclosure of the claimed
substance or composition that are found only after grant. Known substances orcompositions not previously used for medical purposes may also be claimed in the formof a first (and/or second) medical use.

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Forms of claim
8.120 A claim to the first medical use of a new or known substance or composition may
broadly claim any therapeutic use. Examples of suitably drafted claims include:(i)Compound X for use in therapy.

(ii)

Compound X for use as a medicament.

8.121 It is clear that no single drug is suitable for treating all diseases. However, this broad
form of first medical use claim is allowable on condition that there is support for at least
one medical use of the substance or composition claimed. The permissibility of thisbroad form of first medical use claim was deliberated by the Technical Board of Appeal(T 128/82 HOFFMAN-LA ROCHE/Pyrrolidine-derivatives OJEPO 1984, 164). It was
decided that claims which did not state the specific therapeutic purpose were allowable
if the substance or composition in question had not been previously used for any formof therapy, even if the specification only indicated one therapeutic use. It was further
agreed that an inventor who for the first time discovered the use of a new or known
compound for therapy should be duly given this broad form of protection.
8.122 First medical use claims may also be drafted in the form of a specific medical use claim
and be worded in the form:(iii) Compound X for use in the treatment of disease Y.
Both broad and specific first medical use claims are anticipated by any prior medical
use of the compound. Essentially, regardless of the claim wording, be it in the form ofeither examples (i)-(iii), first medical use claims will lack novelty in view of earlier
known use of the compound for any therapeutic purpose.
8.123 This differs from the UK and European patent practice, whereby specific medical use
claims, in the form of example (iii), are only anticipated by the use of X for the specifictreatment of disease Y. This is because, following the implementation of EPC 2000,
such claims are regarded by UK IPO and EPO as limited to the specific medical uses
claimed. In other words, in proceedings before the UK IPO and EPO, claims of thisform are anticipated only when the use of X for the specific purpose of treating disease
Y is disclosed.

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8.124 Inappropriate first medical use claims include:(iv) Compound X when used in therapy.
The claim of example (iv) is interpreted as a method of medical treatment and would
not be capable of industrial application.
(v)

Compound X for treating disease Y / Compound X for the treatment ofdisease Y.

The claim of example (v) lacks clarity. It is unclear if the claim is directed to compound
X as “suitable for” treating disease Y or whether the intention is to limit compound X
to the medical use of treating disease Y. In this scenario, the Examiner is to adopt thebroader interpretation, wherein “for” is interpreted as “suitable for”. Accordingly, any
disclosure of compound X, regardless of therapeutic inference would anticipate theclaim of example (v) if the compound disclosed is in a form which would be suitable
for the claimed use. For example, a disclosure of compound X used as a moisturizing
agent, will anticipate a claim drafted in the form of (v) wherein disease Y is eczema.
8.125 In general, Section 16(3) is not relevant to substances or compositions that are not used
in a method prohibited by Section 16(2). The meanings given to “surgery”, “therapy”
and “diagnosis” in Section 16(2) is applied equally to Section 16(3). Therefore, Section
16(3) does not apply to substances or compositions that are used purely for cosmetic
purposes since purely cosmetic methods are not considered as methods of treatment of
the human or animal body by surgery or therapy or of diagnosis. Moreover, known
substances or compositions drafted as a first medical use claim do not fall under theremit of Section 16(3) if there is no genuine prophylactic or therapeutic effect beyond,for example, the maintenance of a healthy diet (T 135/98 NORSK HYDRO [2004]
EPOR 14).
8.126 A known substance or composition used as an inactive carrier or excipient for use intherapy cannot be protected by a first medical use claim. In order for a first medical use
of a known substance or composition to be claimed, the substance or composition must
be present as an active agent in a medicine. In T 1758/07 BIOTEC PHARMACON, adisclosure concerning the use of acid-hydrolysed yeast materials for improving the

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palatability of animal feed and the palatability of oral medicaments for administration
to animals was considered to not anticipate a first medical use claim for the same
composition. This was because the yeast hydrolysate in the prior art document was not
used as an active agent for therapy of a disease but was instead used as an inactive
carrier or excipient for a therapeutic agent. Even though this decision was made in
relation to novelty, the same basis may be applied in determining the admissibility of
an inactive carrier or excipient in the form of a first (or second) medical use claim. For
this reason, an inactive carrier or excipient for a therapeutic agent cannot be claimed in
the form of a medical use claim and the claim would lack support if claimed as such.

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Novelty and inventive step assessment of first medical use claims
8.127 Any disclosure of the claimed substance or composition as a therapeutic agent will
anticipate a first medical use of the substance or composition. However, in someinstances, it is not necessary for the compound to have been isolated in the priordisclosure if, by carrying out the methods of the earlier disclosure, the compound would
have been inevitably made. Specifically, in Merrell Dow Pharmaceuticals Inc v H N
Norton & Co Ltd [1996] RPC 76, which centred on a claim to an acid metabolite formedin the liver after administration of terfenadine (itself the subject of an earlier patent), theacid metabolite was held to be anticipated not because of prior use but because it was
the inevitable result of carrying out the instructions as taught in the earlier terfenadine
patent.
8.128 Actual therapeutic use of the claimed substance or composition must be indicated in
non-patent documents for it to be considered an enabling disclosure. Disclosure ofexperiments in non-patent documents demonstrating an activity which would make thesubstance or composition a suitable candidate for use in therapy or disclosure of in vitro
testing for such a use is not considered as an anticipatory document unless actual
therapeutic use can be inferred from the document (implicit disclosure). This document
may of course serve as a basis for an obviousness objection under inventive step.
8.129 However, when the application contains only in vitro experimental data and the only
difference between the application and the prior art document is the assertion of atherapeutic use, then the Examiner may still object to the claim for lacking novelty since
there was no new technical feature provided in the application that confers novelty to
the claim (T 1031/00 SEPRACOR INC.).
8.130 A statement indicating the therapeutic uses of the claimed substance or composition ina patent document without accompanying clinical data may be cited for novelty. This
statement is considered to anticipate the first medical use of the claimed substance orcomposition and the onus is on the Applicant to challenge whether such a document
constitutes an enabling disclosure. As discussed in T 1001/01 SMITHKLINEBEECHAM:“… it is common practice that a patent literature document, in order to be an

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enabling disclosure of a medical indication for pharmaceutically active
compounds … does not necessarily need to include either clinical tests (Phase I, IIor even III) or in vivo human assays.”8.131 As medical use claims are limited to the intentional treatment of a disease, the disclosurethat the substance or composition of interest has previously been administered oringested would not anticipate a first medical use claim if there was nothing in the priorart documents to indicate any therapeutic benefits even though this may have inherently
occurred.

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Support for first medical use claims
8.132 First medical use claims must be supported by evidence of the likely efficacy of thesubstance or composition in therapy. However, the Applicant is entitled to a broad formof claim (such as in examples (i) and (ii)) in the case of a substance or composition,
wherein its use in medicine is previously unknown. Therefore, it is unlikely a first
medical use claim will lack support as long as the Applicant provides credible evidenceof the efficacy of the claimed substance or composition for use in the treatment of any
one, if not more diseases. For a first medical use claim drafted in form of example (iii):“Compound X for use in the treatment of disease Y”, support has to be provided for the
specified use.
8.133 This requirement of support for known substances or compounds is based on thedecision of the Patents Court in Prendergast’s Applications [2000] RPC 446. Although
this case law is pertaining to support for “Swiss-type” claims, it remains nonethelessrelevant to first medical use claims. It was held in Prendergast’s Applications that since
the distinguishing feature of the “Swiss-type” claim from the prior art is its intended
use, this use must in turn, be supported by credible evidence.
8.134 This requirement of support is also mandatory for new and inventive substances orcompositions. This view was held by the Hearing Officer in F. Hoffman - La Roche’s
Application BL O/192/04:“Support is needed for claims to the use of compounds for therapy, regardless ofwhether the compounds are themselves new or inventive.”
8.135 The form of evidence is not critical. In vivo, in vitro and in silico modelling data may
prove sufficient if it is considered a credible form of support of its efficacy in a medical
use. However, the level of evidence provided will be decided upon a case-by-case basis
as it may also be dependent upon the state of the art in relation to a particular application.
In F. Hoffman-La Roche’s Application BL O/192/04, homology comparisons of theclaimed polypeptide were used to determine biological activity by reference to apolypeptide of known activity. It was concluded that although the description provided
support for the function of the Npt2B polypeptide in its native state, this support cannot
be read across to the claimed polypeptide in an isolated, non-naturally occurring

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environment. The Hearing Officer was of the view that it is unlikely the Npt2B
polypeptide will retain its native state structure when isolated in 99% pure form andhence it was also unlikely that the polypeptide retained its function as a sodium
phosphate transporter. Moreover, in the absence of any evidence demonstrating theefficacy of the isolated polypetide in a non-naturally occurring environment, the claims
relating to the therapeutic uses of the isolated form of Npt2B polypeptide wereconsidered to lack support.
8.136 The evidence in support of first medical use claims must be provided in the application
as filed. The absence of this would result in the first medical use as being no more thanmere speculation. In such instances, the Examiner is required to inform the Applicantof the lack of support for the claimed first medical use. This objection cannot be
overcome by later-filed data.
8.137 Moreover, if the application claims priority from an earlier application and the earlier
application does not enable the therapeutic use of the claimed substance or composition,then claims relating to the medical use of the substance or composition would not be
entitled to the priority date based upon the earlier application (see also paragraph 3.91).
The same applies for both first and second or subsequent medical uses.

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ii.

Second medical use

8.138 Second or subsequent medical uses of a substance or composition may only be claimed
in the form of “Swiss-type” claims. This form of claim, first allowed by the Swiss Patent
Office in response to a lack of provision in the legislation for the protection of second
medical uses of a substance or composition, were also deemed allowable by the
Enlarged Board of Appeal in G 05/83, and subsequently by the Patents Court in John
Wyeth’s and Schering’s Applications [1985] RPC 545. As stated in G 05/83:“… it is legitimate in principle to allow claims directed to the use of a substanceor composition for the manufacture of a medicament for a specified new andinventive therapeutic application, even in a case where the process of manufacture
as such does not differ from known processes using the same active ingredient.”
8.139 “Swiss-type” claims are regarded as purpose limited process claims whereby the claim
is directed to the use of the substance for the manufacture of a medicament for a
specified medical use. Hence, “Swiss-type” claims are not restricted to second or
subsequent medical uses of a substance or composition and can be used even when thefirst medical use of a compound is not previously known.
8.140 This practice of using a “Swiss-type” claim format for second medical uses differs fromthat of UK and Europe. Since the implementation of the EPC 2000, Applicants within
contracting member states have been able to protect inventions relating to second andsubsequent medical uses through a more direct claim form: “substance X for use in thetreatment of disease Y”. However, without similar provisions in the Singapore
legislation, such claims cannot be construed as providing the same limitations of being
specifically directed to the treatment of disease Y in Singapore.
8.141 Normally, “for” is interpreted as “suitable for”. However, in a “Swiss-type” claim, “for”
is interpreted as “suitable and intended for” treatment of the indication specified. In
Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Ors (Rev 1) [2015]
EWHC 72, Arnold J. (citing Actavis v Merck and Birss J. in Hospira UK Ltd v
Genentech Inc.), noted that a “Swiss-type” claim is directed at the manufacturer andthat the intention of the manufacturer in the production of the pharmaceutical productis key.

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8.142 Second medical use claims can only derive novelty from their intended use if the use isin a method of treatment excluded under Section 16(2). This means that “Swiss-type”
claims are not allowable for the new use of a known substance in a non-medical method.
In Commonwealth Scientific & Industrial Research Organization’s Application BL
O/248/04, the method of follicle ablation on sheep was considered as a method of
maintaining hygiene, even though the consequence of wool removal results in a
reduction of conditions favourable for balanitis and blowfly strike occurrence.
However, this reduction of favourable conditions was not directly linked to a therapeutic
activity of follicle ablation. Therefore, the method was considered a non-therapeutic
method and consequently was not entitled to protection in the form of a “Swiss-type”
claim.
8.143 An application may include both “Swiss-type” claims and non-therapeutic claims (e.g.
use of the compound for cosmetic purposes) on condition that the therapeutic and nontherapeutic methods are supported and distinct. As stated by the Hearing Officer in
Commonwealth Scientific & Industrial Research Organization’s Application BL
O/248/04:“… an application may include both claims to the second medical use of acompound for therapeutic purposes, and claims to non-therapeutic methods ofusing the compound, providing the therapeutic and non-therapeutic methods are
distinguishable and both methods are fully supported by the application as filed.
On the other hand, if the therapeutic and non-therapeutic aspects cannot be
distinguished, or if the non-therapeutic effect is merely a secondary consequenceof the therapy, then the invention is unpatentable, regardless of the wording used…”
8.144 Although the Enlarged Board of Appeal in G 05/83, referred only to “therapeutic”
methods, second medical use claims may be used to protect the use of a known
substance or composition in any method excluded under Section 16(2) of the Patents
Act, on condition that the specified medical use is new and inventive. In T 655/92
NYCOMED/Contrast agent for NMR imaging OJEPO 1998, 17, a “Swiss-type” claim
was allowed for the use of a known compound, previously used as a medicament, as areagent in a diagnostic method performed on the human body. The allowed claim reads:

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“Use of a magnetically responsive material for the manufacture of a diagnostic
contrast agent for use in a method of in vivo nuclear magnetic resonance imaging
of a subject, said agent comprising particles of a matrix material having a diameterof up to 10 micrometres and having enclosed therein a said magnetically
responsive material the magnetic responsiveness of which is such that said
particles are magnetically localisable and such that said particles in said nuclear
resonance imaging of said subject cause relaxation time changes resulting in avisualisable ‘black hole’ contrast effect.”8.145 The following are examples of suitably drafted second medical use claims:(vi) Use of compound X in the manufacture of a medicament for the treatment ofdisease Y.
(vii) Use of compound X in the manufacture of a pharmaceutical composition fortreating disease Y.
8.146 Unsuitably drafted second medical use claims include, but are not limited to:(viii) Use of compound X for the treatment of disease Y.
(ix) Compound X for use in the treatment of medical condition Y.
Claim (viii) is interpreted as a method of medical treatment and would lack industrial
application.
Claim (ix) is consistent with current second medical use forms accepted by UK IPO andEPO. However, under present Singapore practice, it is construed as a claim to a first
medical use and accordingly, the claim lacks novelty if compound X is a known
medicament as the specific use is not considered to be limiting. Nonetheless, if aprevious medical use is not known then such claims are allowable, provided that thereis evidence in the specification supporting the claimed use.
8.147 T 1075/09 LABORATOIRES SERONO provides a further example of suitably andunsuitably drafted “Swiss-type” claims. In T 1075/09, a claim to the combined use of
two hormones was drafted in a way such that one of the hormones was interpreted as asecond medical use while the other, as a therapeutic method. The claim in question
relates to the new use of luteinising hormone (LH) and included the phrase “wherein
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folliculogenesis is induced by the administration of follicle stimulating hormone(FSH)”. This phrase was considered as a method of administering follicle stimulating
hormone and so the claim was interpreted as encompassing a method of medical
treatment. On the other hand, the claim “The use of FSH and LH in the production of a
medicament for inducing paucifolliculogenesis or unifolliculogenesis … wherein the
FSH is for inducing folliculogenesis and the LH is to be administered subsequent to
FSH …” was found to be allowable. Thus, the wording of claims relating to combined
treatments needs to be checked to ensure that a method of treatment by therapy is notincluded in the scope of the claims.
8.148 Another example of a Swiss-type claim that is not properly formatted is seen in
BGH/Carvedilol II [2006] X ZR 236/01. The claim reads:“Use of carvedilol for the production of a medicament for the reduction ofmortality … wherein the medicament is administered in starting dosage of …”
The phrase “wherein the medicament is administered” was considered a therapeutic
procedure for the treatment of the human body and thus was not considered a proper“Swiss-type” claim.
A suitable rectification would be to replace the phrase “wherein the medicament isadministered” with “wherein the medicament is to be administered” such as in the claim
below:(x)

Use of a compound X in the manufacture of a medicament for the treatment
of disease Y wherein the medicament is to be administered at a daily dosageof Z mg.

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Novelty and inventive step assessment of second medical use claims
8.149 As in the case of a first medical use claim, a disclosure of an activity that merely
suggests that a substance or composition can be used for the claimed therapy, or that
discloses in vitro testing for such a use in a non-patent document would not anticipate
a second medical use claim for the same proposed medical use, if the document did not
explicitly or implicitly disclose the use of the substance or composition for the claimed
therapy. Mere assertion or assumption of a therapeutic use of a compound based uponin vitro testing is not sufficient to destroy the novelty of the claim. This is primarily
because the disclosure in the non-patent document may not be enabling, and moreover,following the directions in the document would not necessarily infringe a claim to atherapeutic use. Nonetheless, such documents would form the basis of a strong inventive
step argument. Summarizing the disclosure requirement, Lord Hoffamn in SmithKline
Beecham’s (Paroxethin Methanesulfonate) Patent [2006] RPC 10, stated:“Anticipation requires prior disclosure of subject-matter which, when performed,
must necessarily infringe the patented invention.”
8.150 However, patent documents which disclose the substance or composition for treatmentof the claimed disease, but without providing actual clinical data may still be cited as aprior art for novelty. This is because even if the document does not disclose actual
clinical use, by following the directions in the document, the skilled person would still
infringe the patent. Similar to first medical use, the onus is on the Applicant to challenge
whether the disclosure in the prior art document constitutes an enabling disclosure.
8.151 Likewise, experimental data demonstrating the efficacy of the treatment for the claimed
ailment using the substance or composition on animals would constitute anticipation of
the medical use claim. If, on the other hand, and as pointed out in T 715/03 PFIZER,
the document does not indicate the use of the substance or composition for the treatmentof the claimed disease, but merely mentions the completion of Phase I orcommencement of Phase II trials, without providing any results on therapeutic efficacy,then this will not necessarily constitute evidence of therapeutic use. This is because
Phase I trials merely assess the safety of the drug and Phase II trials indicate the efficacyof the drug but not necessarily its therapeutic effect. Nevertheless, this would again bea strong basis for an argument under inventive step. However, the Examiner should

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consider such disclosure on a case-by-case basis, taking into account the intention of
the trials and what is known regarding the substance or the composition under trial
before making a decision on whether a novelty or an inventive step objection is
warranted.
8.152 In the case whereby the substance or composition has been used to treat a related
condition, the inventiveness of the claim may be questioned. However, T 913/94
EISAI/Medicament for gastritis [2001] EPOR 362 stated that even if the diseases havea common origin, causative factors or mechanism, this may not necessarily mean thatthe claim lacks inventiveness. If the severity of the symptoms of the disease indicatedin the prior art document is greater than the claimed disease, this would strongly imply
that the same agent will similarly be effective for the latter condition. More often thannot, these cases may need to be individually dealt with by the Examiner on a case-bycase basis.
8.153 For a new use of a known substance or composition to be recognized as inventive, thespecification needs to provide reasons not previously known or recognised as to why
the claimed substance or composition is likely to be effective for the new use. It wasstated in Teva v Astrazeneca [2014] EWHC 2873:“Where, as here, a patent is sought in relation to a new use of an existing drug or
combination of drugs, patent protection will only be justified if the patentee
discloses sound reasons, not recognised or known before, for thinking that new use
will be effective to secure the object for which it is put forward.”
8.154 Typically, the answer to the final question of the Windsurfing test determines theinventiveness of new medical uses of known substances or composition. The question
may be along the lines of: Is it obvious to try to use the said substance or composition
for the claimed purpose? In this instance, obviousness is only found where it isconsidered as obvious to try with a reasonable or fair expectation of success. This isparticularly so in the area of pharmaceuticals and biotechnology as a means ofminimizing deterrence to research. The Court of Appeal in MedImmune v Novartis[2010] EWCA Civ 1234, [2013] RPC 27 provides some guidance on this:“Whether a route has a reasonable or fair prospect of success will depend upon

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all the circumstances including an ability rationally to predict a successful
outcome, how long the project may take, the extent to which the field is unexplored,
the complexity or otherwise of any unnecessary experiments, whether such
experiments can be performed by routine means and whether the skilled person
will have to make a series of correct decisions along the way.”
Although this case did not relate to medical use claims, this approach was validated by
the Court of Appeal in Regeneron Pharmaceuticals v Genentech [2013] EWCA Civ 93
in relation to a second medical use claim.

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The new use
Treatment of a new disease or condition
8.155 Typically, a second medical use claim is used to protect the use of a substance orcomposition in the treatment of a different disease. An example of this would be aspirin,
which was originally used as an antipyretic and analgesic, and was subsequently foundto be useful as an anticoagulant, and later as an anti-stroke medication and an antiischaemic. Hence, a claim based on a new medical use of a known substance orcomposition may claim novelty in the form of a “Swiss-type” claim. Guidance on
evaluating novelty for this form of claims may be taken from the decision in Schering
A.G.’s Application [1985] RPC 553:“… a second pharmaceutical use invention, which is also referred to as the second
medical indication, that is to say an invention based on the discovery that a drug
already known for a particular medical activity (or activities) has another useful
medical activity unconnected with the first and which had not previously been
expected.”
8.156 In a scenario where the new use is the treatment of a specific form of a disease, thenovelty of such a second medical use claim may vary depending on the facts of the case.
In most cases, a general disclosure of a class of diseases, does not anticipate a claim toa specific disease within that class. Nonetheless, a novelty objection may be made ininstances where the prior art document discloses a class of diseases which appear toencompass the specific disease claimed, and either the specific disease is referred to in
the prior art document as being treatable with the claimed substance or it may bereasonably implied that the prior art document does disclose the treatment of the specificdisease. The onus will be on the Applicant to argue whether the prior art document
constitutes an enabling disclosure for the specific disease claimed. In T 1001/01, a“Swiss-type” claim to adenocarcinoma of the ovary was judged as novel over the priorart document which disclosed experimental data employing a metastatic reticulum cellsarcoma arising from the ovary of a C57BL/6 mouse. The Technical Board of Appeal
was convinced by the Appellant’s arguments and evidence that the preclinical modelusing metastatic reticulum cell sarcoma could not serve as a model for adenocarcinomaof the ovary which is of epithelial origin and has a glandular growth pattern.

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Additionally, the Board reasoned that the skilled person would be able to distinguishwhen an ovarian cancer is an adenocarcinoma of the ovary and therefore the novelty of
the claim over the prior art document was acknowledged.

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New mode and dosage of administration
8.157 The mode of administration may play a critical role in a medical treatment and can serve
as a distinguishing feature over the prior art documents. In T 51/93 SERONO, theadministration of human chorionic gonadotrophin in the treatment of male sexual
disorders or infertility by a subcutaneous route was considered to confer novelty overthe prior art documents which disclosed administration via an intramuscular route. In
this case, the Applicant demonstrated that the subcutaneous route provided theadvantages of reduced nerve lesions and the option of self-administration. Nevertheless,it should be noted that the claim must be appropriately drafted such that the claimed
mode of administration is directed at the manufacturer and not at the medical
practitioner. If the claim is drafted such that it is deemed to be directed to a medical
practitioner then it will be considered as a medical method of treatment and thus lackindustrial application. Although second medical use claims may be defined in part bytheir modes of administration, defining the use in these terms alone (e.g. for enteraladministration) without further specifying any actual therapy, is not considered to define
a new medical use and so in such cases, the claim would be construed as a substance orcomposition “suitable for” such a use (T 1278/12 N.V. Nutricia).
8.158 Second medical use claims which are distinguished from the prior art documents by thedosage regime used are allowable, on the condition that the claimed dosage regime isnovel and inventive. In Actavis v Merck [2008] RPC 26, the dispute centred around thesecond medical use of finasteride at a new daily dosage of about 0.05 mg to 1.0 mg forthe treatment of androgenic alopecia. Finasteride was a known drug for treating prostate
conditions and had been previously proposed as a treatment for androgenic alopecia at
a dosage of at least 5 mg. Thus, the new feature in the claim was a lowered dosage offinasteride for the treatment of androgenic alopecia. In this case, the Court of Appeal
overturned the decision of the Patents Court in Actavis v Merck [2007] EWHC 1311
and held that a second medical use claim in the form of a new dosage regime wasallowable. Additionally, after much deliberation, Jacob LJ acceded to Merck’s
argument that based on the state of knowledge of the skilled person at the priority dateof the document, it would not have been obvious to the skilled person to reduce thedosage range for the treatment of androgenic alopecia.

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8.159 However, in most cases, a new dosage regime is generally presumed as lacking
inventiveness unless there is a clear technical prejudice pointing away from the claimed
dosage regime. Therefore, typically, such dosage regimes will be considered obvious as
investigation of dosage regime is regarded to be a routine practice in the art. This point
was highlighted in Actavis v Merck [2008] EWCA Civ 444:
“Only in an unusual case such as the present (where … treatment for the condition
with the substance had ceased to be worth investigating with any dosage regime)
could specifying a dosage regime as part of the therapeutic use confer validity on
an otherwise invalid claim.”

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New patient group8.160 A second medical use claim may, for novelty and inventive step purposes, rely solely
on the patient group to be treated. This is despite the known association of the claimed
substance or composition and the disease to be treated.
8.161 The new patient group must consist of a distinctly different group of patients from thosetreated in the prior art. Furthermore, there must be a functional relationship between theparticular physiological or pathological status of this group of patients and thetherapeutic or pharmacological effect achieved. Guidance is provided by the Technical
Board of Appeal in T 233/96 MEDCO RESEARCH:(1)

The new patient group must be clearly distinct from the patient group treatedin the prior art and these 2 groups must not overlap;(2)

The distinction must not be arbitrary and must be based on a functional
relationship between the physiological or pathological characteristics of the
new group and the therapeutic effect.

An example of a non-overlap of the new patient group with the known patient groupwould include the therapeutic application of a vaccine known for the treatment of seronegative pigs, to a new and different class of the same animal, sero-positive pigs in T
19/86 DUPHAR/Pigs II OJEPO 1989, 24. As stated by the Board of Appeal:“… Such a new use is not only valuable in cases where a novel area of therapeuticuse, i.e. a novel medical indication, is provided but also in those cases where anovel class of animals, which previously did not respond to a medicament, is cured
or protected against a disease. The question whether a new therapeutic use is inaccordance with the decision Gr 05/83 should not be answered exclusively on thebasis of the ailment to be cured but also on the basis of the subject (in the present
case the new group of pigs) to be treated.”
8.162 A second medical use claim directed to the use of a substance or composition in the
manufacture of a medicament for the treatment of a disease in a specific patient groupwill not be considered novel if the same substance or composition has already been used
to treat the same group of patients, amongst others. Mere discovery that a treatment is

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particularly effective in one sub-group of patients does not render a claim novel if it isexplicitly or inherently implied from the prior art documents that the same substancehas been used to treat the same disease in this patient group. The identification of thissub-group of patients is considered a mere discovery of an advantage to an alreadyknown treatment. For example, in Bristol-Myers Squibb v Baker Norton
Pharmaceuticals [1999] RPC 253, it was decided that new information of an advantage
or how a treatment worked did not constitute an invention if this information did notlead to a new use. This decision was upheld in the Court of Appeal in Bristol-Myers
Squibb v Baker Norton Pharmaceuticals [2001] RPC 253.

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New mechanism or technical effect
8.163 Second medical use claims distinguished solely by a different mechanism of action or
technical effect, but used for the same therapeutic purpose as the prior art will lacknovelty. The mere discovery of how a treatment works is inconsequential.
8.164 This interpretation is based by the decision of the Patents Court in the earlier discussed
Bristol-Myers Squibb v Baker Norton Pharmaceuticals [1999] RPC 253. As stated by
Jacob J:“All you have is more information about the old use. In due course no doubt more
information about the exact mode of action of Taxol will emerge. No-one could
obtain a patent for its use simply by adding ‘for’ at the end of the claim and thenadding newly discovered details of the exact mode of action.”
8.165 This conclusion was followed by the Patents Court in El-Tawil v The Comptroller
General of Patents [2012] EWHC 185 where the decision of the Hearing Officer in therejection of claims relating to a mechanism of action of a known treatment was upheld.
Furthermore in Actavis UK Ltd v Jassen Pharmaceutica NV [2008] EWHC 1422, a
second medical use claim relating to the use of an agent for potentiating the effects ofblood pressure reducing agents having adrenergic and/or vasodilating activity was
concluded as merely providing more information about the mechanism of action of aknown treatment. It was stated:“I think that all that is done here is to explain why the results that would beobtained with compound 84 are as good as they are.”8.166 The newly discovered mechanism or technical effect is insufficient on its own inconferring novelty to a second medical use claim. As stated by Floyd J in Actavis UK
Ltd v Jassen Pharmaceutica NV [2008] EWHC 1422:“In my judgement, merely explaining the mechanism which underlies a use alreadydescribed in the prior art cannot, without more, give rise to novelty.”
Hence, the discovery of a new technical effect has to be associated with some otherfeature of the treatment which is clearly distinguishable over the prior art document

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such as a new therapeutic use, patient group or clinical situation in order to fulfil
novelty.
8.167 A claim defined in mechanistic terms does not necessarily mean that the claims areunclear. In Regeneron Pharmaceuticals Inc. and Bayer Pharma AG v Genentech Inc.
[2013] EWCA Civ 93, the phrase “non-neoplastic disease or disorder characterised byundesirable excessive neovascularisation” was deliberated. Floyd J held that there wasno difficulty in identifying treatable diseases characterised by undesirable excessive
neo-vascularisation. It was stated:“There was no evidence that the skilled addressee would have any difficulty indetermining whether a given disease would fall within the terms of the claim as I
have construed them.”
8.168 However, this may not always be the case. Therefore, if the examiner is of any doubtthat a skilled person would not know what the claimed medical use means in terms ofthe treatment of specific medical conditions, then an objection of lack of clarity may beraised. It is then for the applicant to show that the skilled person would be able todetermine the scope of the claim without an undue burden. In T 0241/95 SEROTONIN
RECEPTOR/ELI LILLY, the Board of Appeal rejected on grounds of clarity a “Swisstype” claim directed to the use of a compound for the treatment of a condition which
can be improved or prevented by selective occupation of 5-HT1c receptor. In the Board’sview, the claim was unclear because:“... at the filing date of the application no means involving testable criteria existed
to assist the skilled person in assessing whether or not a ‘condition’ improved or
prevented by (R)-fluoxetine was comprised in the functional definition of theclaimed subject-matter.”
8.169 Examiners should therefore consider claims defined in mechanistic terms on a case-bycase basis and in relation to what is generally known about the mechanism of action
being claimed and its relationship with specific medical conditions. Nevertheless, even
if the condition to be treated defined in mechanistic terms is considered to be clear, theExaminer should ensure that such claims are supported and that there is a clear

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indication that all conditions which fall under the scope of such a mechanism would infact be treatable by the claimed composition.

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New advantage to known use
8.170 Claiming an unexpected advantage to a known treatment is not considered as a new
therapeutic use, although it may form the basis of such a use. In Bristol-Myers Squibbv Baker Norton Pharmaceuticals [1999] RPC 253, the invention lay in the unexpecteddiscovery that a shorter infusion time of Taxol of 3 hours versus a 24 hour period led toa lessening of neutropenia (white blood cell count). The court found that the Applicant
was simply seeking to protect new information (i.e. lessening of neutropenia) regarding
the known use of Taxol for treating the same disease over the same infusion duration.
As stated by Jacob J:“… there is a big difference between new information that a prior proposal
previously thought unworkable in fact works and new information to the effect thata prior proposal has an additional advantage.”

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Level of efficacy of treatment
8.171 Generally, the sole feature of an improved level of efficacy over an existing treatment
will not confer novelty to the claim. Moreover, lack of clarity may be raised as the claim
is defined in terms of a desired outcome. In T 315/98 STERLING/ S(+) ibuprofen, 2000,
the “hastened onset” of pain relief was not considered to be a new medical use when thesubstance was already known for its analgesic properties. The fact that the prior art
document did not expressly mention hastened onset did not automatically establish
novelty of the claimed use. Both the patent in suit and prior art document referred to thesame racemate of ibuprofen as a basis for comparing the pharmacological activity of the
S(+)enantiomer. Additionally, both referred to pharmacological activity in the form of
analgesic response. Hence, it was held that the reference in the prior art document to
S(+)ibuprofen in higher concentrations reaching the site of action more quickly with ahigher activity means nothing else than hastened onset of analgesia. Accordingly, it was
concluded that the pharmacological effect of S(+)ibuprofen as claimed was disclosed in
the prior art document.
8.172 Claims defining a level of efficacy of treatment were also discussed in Hospira v
Genentech [2015] EWHC 1796. The patent claimed the use of an antibody in
combination with a taxoid to treat breast cancer wherein the clinical benefit wasmeasured by time to disease progression, which is one of several parameters usedgenerally to determine the efficacy of anti-cancer treatments. It should be noted though
for this case, the claimed level of efficacy of treatment was not critical for theestablishment of novelty as it could not be established from the prior art documents that
this combination of drugs had been used to treat cancer. Thus, the patent was in fact,
revoked on grounds of inventive step. However, in general, if a claim defines a level of
efficacy and the prior art documents disclose the actual treatment with the same agent
for the same purpose applied in the same manner, it would be reasonable to assume thatthe efficacy achieved in the prior art documents would be similar if not the same as thatof the application in question.

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Co-administration
8.173 It is common to combine two or more known substances or compounds for use as a
medicament. Such compositions comprising two or more agents for the treatment of adisease may claim novelty in the form of a second medical use claim on condition thatthe stated combination has not previously been used for the specified disease orcondition. In Actavis UK Ltd v Janssen Pharmaceutica NV [2008] EWHC 1422, the useof one steroisomer of blood pressure drug, nebivolol, to potentiate the blood-pressure
reducing effects of other agents, including one of its other stereoisomers, wasanticipated by the use of a racemic mixture for the treatment of hypertension.
8.174 The inventiveness of claims of this type will require determining whether the claim
relates to a single or a plurality of inventions. If the two (or more) components simply
perform their usual function in the body and there is no synergy between them, then theclaim would be considered as relating to two separate inventions and there is no
inventiveness in combining them. This practice finds support in the judgement by theHouse of Lords in SABAF v MFI Furniture Centres [2005] RPC 10 whereby the judge
held that the design was obvious, involving essentially only the collocation of two
known features. Evidence of this synergistic effect must be provided at the time offiling; any evidence provided post-filing cannot be used to demonstrate inventivenessin this situation. As stated in Glaxo Group’s Patent [2004] RPC 43:“If a synergistic effect is to be relied on, it must be possessed by everything coveredby the claim, and it must be described in the specification. No effect is described in
the present specification that is not the natural prediction from the properties of
the two components of the combination.”
8.175 Moreover, evidence of unexpected synergy between the claimed components does notrender a combination inventive if this combination was obvious to the skilled person.
In particular, if it is known to combine two categories of active agent, it is unlikely thatthe substitution of a newer, more effective agent of one or other category in the
combined preparation be considered as inventive. The patents in both Glaxo Group’s
Patent [2004] RPC 43 and Richardson-Vicks’ Patent [1995] RPC 568 were revoked onthese grounds.

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8.176 If the synergy of the combined components is no greater than the equivalent prior art
combination, then this synergy does not equate to evidence of inventiveness in thiscombination. In T 492/99 NIPRO, it was determined that there was no advantage of the
combined anti-inflammatory agent claimed in the main request over the state of the art
and therefore it was held that the claim in question did not involve an inventive step.
8.177 However, in Schering-Plough Ltd v Norbrook Laboratories Ltd [2005] EWHC 2532,
even though the combination was prima facie obvious, inventiveness was
acknowledged because technical prejudice pointed away from the combination inquestion. The inventive concept was the use of a long-acting anti-microbial with an antiinflammatory in a combination therapy. Combination products are single products
designed to administer two therapeutic agents in the same dose whilst in concurrent
therapy, the two drugs are administered separately but at the same time. The common
general knowledge consisted of (i) a combination treatment of a short-acting antimicrobial with an anti-inflammatory, and (ii) a concurrent therapy of long-acting antimicrobial and an anti-inflammatory. In view of this, the idea of combining the two
products was prima facie obvious. However, the underlying issue was whether thiscombination therapy retained the long-acting effect of the anti-microbial afteradministration which forms the basis of the technical prejudice. On the basis of expert
evidence, the High Court was satisfied that the data in the patent showed that the longacting antimicrobial effect of Norbrook’s long-acting oxytetracycline product was
retained when formulated together with flunixin in a single product and that this was an
unexpected benefit.

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Use in treatments performed outside the body8.178 Therapeutic treatments such as dialysis where blood or tissue is treated outside of the
body and thereafter returned to the patient are considered to be methods of treatment by
therapy and therefore unpatentable. It therefore follows that an invention relating to theuse of a known substance or composition for such an ex vivo treatment could beprotected under a second medical use claim. For example, in T 2003/08 EDWARDSLIFESCIENCES, a “Swiss-type” claim directed the use of an agent for treating apathological condition by removal of immunoglobulins from plasma ex vivo before
reinfusion was allowed.

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Support for second medical use claims
8.179 Second medical use claims have to be supported by adequate evidence in thespecification as filed that it is (or at least likely to be) effective for the specified use.
The second medical use claims in Hoerrmann’s Application [1996] RPC 341 andMcManus’s Application [1994] FSR 558 were rejected for this reason. As stated by the
Hearing Officer in Hoerrmann’s Application [1996] RPC 341:“… unless there is some indication in the description of applications of this type oftests, however rudimentary, demonstrating that the invention has been carried out
in an effective manner then the application must fail for lack of support for theinvention claimed.”
8.180 The mere assertion that tests had been carried out is insufficient. In Consultant Suppliers
Ltd’s Application [1996] RPC 348, a mere statement in the specification that the claimed
invention has been tested in the absence of any details of this test was deemed to lacksupport. Similarly, in Prendergast’s Applications [2000] RPC 446, it was stated that
full, detailed, rigorous and conclusive testing of a drug for its ability to treat a condition
is not necessary but there must be at least some evidence that it would in fact work. It
was held that tests showing that the known substance or composition works in the
proposed new circumstances are an essential part of the description if second medical
use claims are to be adequately supported. As stated by the Patents Court:“… where you have a claim for the use of a known active ingredient in the
preparation of a medicament for the treatment of a particular condition, thespecification must provide, by way of description, enough material to enable therelevantly skilled man to say this medicament does treat the condition alleged …
pure assertion is insufficient.”
8.181 Similar to a first medical use claim, support for a second medical use claim must be
found in the specification as filed. As such, an objection to a lack of support cannot be
overcome by later-filed evidence. As stated in T 0609/02 SALK INSTITUTE FOR
BIOLOGICAL STUDIES:“Sufficiency of disclosure must be satisfied at the effective date of the patent, ie on

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the basis of the information in the patent application together with the common
general knowledge then available to the skilled person. Acknowledging sufficiency
of disclosure on the basis of relevant technical information produced only after thisdate would lead to granting a patent for a technical teaching which was achieved,
and, thus, for an invention which was made, at a date later than the effective dateof the patent.”
It was further added by the Technical Board of Appeal in T 0609/02:“Once this evidence is available from the patent application, then post-published(so-called) expert evidence (if any) may be taken into account, but only to back-up
the findings in the patent application in relation to the use of the ingredient as apharmaceutical, and not to establish sufficiency of disclosure on their own.”
8.182 In Commonwealth Scientific & Industrial Research Organization’s Application BL
O/248/04, the application was not considered to have provided support for the treatmentof both the diseases, blowfly strike and balanitis in sheep and related animals, as
claimed. The tests included in the application relates solely to blowfly strike with nodata provided to demonstrate that balanitis may be treated by a similar method. Thus,
the “Swiss-type” claims relating to balanitis were deemed unsupported by thedescription as filed.
8.183 However, if the evidence in the application shows an effect on a common underlying
mechanism behind a broader class of diseases, then a correspondingly broad claim may
be considered to be supported. In American Home Products v Novartis [2001] RPC 8,
Aldous LJ states:“Thus if the patentee has hit upon a new product which has a beneficial effect but
cannot demonstrate that there is a common principle by which that effect will beshared by either products in that class, he will be entitled to a patent for that
product but not for the class, even though some may subsequently turn out to havethe same beneficial effect … On the other hand, if he has disclosed a beneficial
property which is common to the class, he will be entitled to a patent for all
products of that class (assuming them to be new) even though he has not himself
made more than one or two of them.”

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8.184 Further guidance may be found in Agency for Science, Technology and Research’s
Application BL O/221/13 and G W Pharma’s Application BL O/237/12. Although notdrafted as a “Swiss-type” form of second medical use claim, the decision in Agency for
Science, Technology and Research’s Application in terms of support for second medical
claim is still relevant. In Agency for Science, Technology and Research’s Application,
it was held that experimental data performed solely on breast cancer cells made it
plausible that the claimed agents could treat any cancer characterised by the overexpression of a particular protein called VHZ. On consideration of information
presented, the Hearing Officer concluded that it was credible that at the priority date theskilled addressee could have expected from reading the application that anti-VHZ
agents could be used to treat not only breast cancer but the other claimed cancers.
8.185 On the other hand, in G W Pharma’s Application BL O/237/12, there was no teachingin the application that the provided in vitro evidence was related to the mechanism
underlying prostate cancer, which was the claimed use. Moreover, in view of the stateof the art, there was no teaching that suggested any correlation existed between theprovided in vitro evidence and prostate cancer. Accordingly, the claims were concluded
to lack support.

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Kit of parts/Set of instructions
8.186 Combined preparations of individual components may be protected as a kit of parts,
provided that the components form a functional combination through a purpose directed
application. Such claims may be defined in terms of simultaneous or sequential
administration or at particular time intervals. Claims in this form was discussed in T
09/81 ASTA/Cytostatic combination OJEPO 1983, 372, where the invention related to
a combined preparation containing an oxazaphosphorin cytostatic agent and the sodium
salt of 2-mercapto-ethane-sulphonic acid as therapeutic active ingredients. The coadministration of sodium 2-mercapto-ethane-sulphonate ceased the severe side effects
caused by cytostatic agents. Individually, these two components were known
medicaments, however these two components had never been used together to providea joint effect and were also unknown as a single composition. The claim in question
read:“Products containing an oxazaphosphorin cytostatic agent and the sodium salt of
2-mercapto-ethane-sulphonic acid as a combined preparation for simultaneous,separate or sequential use in cytostatic therapy.”
8.187 As indicated in the claim, the components were not necessarily present as a single
composition, and as such the components may be used separately or sequentially. It washeld by the EPO Board of Appeal that the combined preparation of an oxazaphosphorin
cytostatic agent and the sodium salt of 2-mercapto-ethane-sulphonic acid was novel andinventive but needed to be drafted specifying its purpose in the form of a medical use
claim in order to distinguish it from a medical kit, collection or package containing thetwo agents together for their known independent uses. Hence, such claims are allowableprovided that the pack is stated to be for the method in which the invention resides andthat the pack is novel and not obvious for any other application.
8.188 A claim to a pack containing a known substance with instructions describing the newuse would normally be construed as directed to a pack containing the known substancesince instructions are not considered to make a technical contribution to the claim.
8.189 However, in the case where the actual contribution resides beyond mere instructions,the claim may be patentable. For this, the claim must define the functional relationship

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between integers in the kit that necessarily provides the invention. In Organon
Laboratories’ Application [1970] RPC 574; [1970] FSR 419, a claim in relation to apack containing two types of contraceptive pills arranged in a distinct order with
instructions for its use was granted under the old UK law (1949 Act). Although packs
containing contraceptive pills in a given order were known, the claim was allowed on
the basis that the particular order of arranging the pills in this case was novel and not
obvious from the prior art as it was based on a new and inventive method ofcontraception.

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iii.

Devices

8.190 Claims to a medical device are allowed on the condition that it is novel and inventive.
However, it is not possible to claim the first or second medical use of devices. Contrary
to substances or compositions in Section 16(3) and Section 14(10) of the Patents Act,
which can derive novelty from a novel use in a therapeutic method, there is noequivalent provision in the Patents Act for medical devices. As such, when the device
per se is known, the use of the device in relation to a new medical indication would notrender the claim novel. “Swiss-type” claims relating to a new use of known surgicalapparatus were disallowed in T 775/97 EXPANDABLE GRAFTS/Surgical device[2002] EPOR 24, T 227/91 CODMAN/Second surgical use OJEPO 1994, 491, and in
National Research & Development Corporation’s Application BL O/117/85.
8.191 In T 2003/08 EDWARDS LIFESCIENCES, a “Swiss-type” claim relating to the use of
a substance in the manufacture of a column for removing immunoglobulin from theblood ex vivo before re-infusing the blood back to the patient was allowed. The claim
in question reads:“Use of a specific ligand for human immunoglobulin in the manufacture of acolumn having said ligand coupled thereto for the treatment of a patient sufferingfrom dilated cardiomyopathy, said treatment comprising passing plasma of thepatient over the column under conditions which effect the binding of said specificligand to immunoglobulin in the patient’s plasma, thereby removing a significant
portion of the immunoglobulin from the patient’s plasma, and reinfusing theplasma to the patient.”
In this decision, several factors were recognised: namely the blood was in a closed
circuit connected with the body and thus was considered as a part of the body; thecolumn and ligand were brought into contact with a part of the body, namely blood, andhence was regarded as administered to the patient’s body; the ligand was consumed
during use and hence was regarded as a chemical entity; and lastly, the column was not
instrumental in achieving the therapeutic effect and thus was regarded as merely acarrier for the ligand. Hence, it was held that the means for achieving the treatment liesin that of the ligand and not the column that holds it. Since the ligand was undeniably a
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invention herein lies not in the device (column) per se but in the compound (ligand) andthus, the claim to the second medical use was allowed.

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iv.

Antibodies

8.192 Antibodies are proteins that are produced by the immune system that identify and bindto foreign objects such as a pathogen (known as an antigen). An antibody comprises
specific recognition domains known as complementarity determining regions (CDRs)
that recognise a unique part of the antigen, and hence can have various uses. Examples
of such uses include diagnosis, medical treatment, purification of proteins and sortingof cells.
8.193 In general, the novelty and inventive step of a claim relating to an antibody is assessedin the same way as a claim relating to any substance. Additionally, for an antibody
binding to the same antigen as known antibodies, inventive step is not acknowledged
solely based on the characterisation by its CDR sequences. Arriving at alternative
antibodies by applying techniques known in the art, in particular by animal
immunisation and hybridoma technology, is considered to be obvious to a skilled
person. The mere fact that the structure of antibodies thus obtained, i.e., their aminoacid sequences, is not predictable is not a reason for finding these antibodies as nonobvious when the specific structure does not impart an additional property to theclaimed antibodies which differs from the property screened for and which could be
regarded as surprising (see T 605/14 MEDIUMMUNE/Anti-angiopoietin-2 antibodies,paragraphs 24 and 25). The Examiner should also consider whether the specification as
filed discloses a surprising technical effect associated with the claimed antibody.
Examples of surprising technical effects when compared to known and enabled
antibodies include an improved binding affinity, an improved therapeutic activity, a
reduced cytotoxicity or immunogenicity or an unexpected species cross-reactivity.
8.194 The above considerations will apply for both first and second or subsequent medical
uses of an antibody that are being claimed if the same uses have been demonstrated withanother known and enabled antibody binding to the same antigen.

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E.

Morality

8.195 Section 13(2) states that inventions which would encourage offensive, immoral or antisocial behaviour if published or exploited are not patentable.
8.196 The intention of Section 13(2) is to prevent the grant of patent rights for inventions
which the general public would regard as abhorrent or from which the public need
protection. However, it should be noted that the test relates to public perceptions – moral
beliefs differ between individuals and care should be taken by Examiners to avoid
applying their personal beliefs during examination. As a consequence, any objection
under 13(2) should be referred to a Senior Examiner for discussion.
8.197 Section 13(3) states that for the purposes of Section 13(2), behaviour shall not be
regarded as offensive, immoral or antisocial only because it is prohibited by any law inforce in Singapore. Thus, a law may prohibit the use of an invention in Singapore, but
this does not necessarily exclude it from patentability under Section 13(2). For example,
the product could be manufactured in Singapore for export to a country where suchprohibitions do not apply. Generally, it would be useful to consider the reason(s) behind
any relevant legal prohibition in Singapore, in order to determine whether a Section
13(2) objection should be raised.
8.198 If an invention can be exploited legally albeit in accordance with stringent legal
regulations, then an objection under Section 13(2) should generally not apply. For
example, a pistol could be used inappropriately, but otherwise may have legitimate uses.
In such cases no objection is raised under Section 13(2).
8.199 Section 27(3) states that the Registrar may omit from the specification of a publishedapplication for a patent any matter – (a) which in his opinion disparages any person in
a way likely to damage him; or (b) the publication or exploitation of which would in his
opinion be generally expected to encourage offensive, immoral or antisocial behaviour.
While the Examiner is not required to specifically look for such material in an
application, where he becomes aware of such matter, he should discuss this with a
Senior Examiner and inform Registry. Where this provision is used, the specification
will contain a statement at the place where this has been applied that “certain matter has
been suppressed from publication under Section 27(3)”. Where a specification is so

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riddled with offending material that publication of any text does not make sense, then
the whole specification may be suppressed from publication. It should be noted that any
matter that has been omitted from publication under Section 27(3) will also be closed
to public inspection.
8.200 Section 33 deals with information prejudicial to defence of Singapore or safety of the
public. According to Section 33(1):Where an application for a patent is filed in the Registry (whether under this Act
or any treaty or international convention to which Singapore is a party) and it
appears to the Registrar that the application contains information of a description
notified to him by the Minister as being information the publication of which might
be prejudicial to the defence of Singapore, the Registrar shall give directions
prohibiting or restricting the publication of that information or its communication
to any specified person or description of persons.
Section 33(2) states that:
If it appears to the Registrar that any application so filed contains information the
publication of which might be prejudicial to the safety of the public, he may give
directions prohibiting or restricting the publication of that information or its
communication to any specified person or description of persons until the end of aperiod not exceeding 3 months from the end of a period prescribed for the purposesof section 27.
8.201 Generally, a technology that is of exclusively military application (such as reactive
vehicle armour) is more likely to be considered prejudicial to national security than atechnology that is capable of more general application but also has military application(such as a rocket propulsion engine).
8.202 Where the specification describes a technology that is designed or has the capacity tocause death, bodily harm, an epidemic, or substantial damage to properties, or which in
the Examiner’s opinion may potentially be relevant under Section 33, he should discuss
the application with a Senior Examiner and if necessary refer the application to Patent
Registry for further advice. An objection under Section 13(2) may also be consideredin such cases.
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8.203 Biological agents and toxins are regulated under the Biological Toxins and Agents(BATA) Act (Cap. 24A) in Singapore. Biological agents are classified under the First
to Fourth Schedules and toxins are listed in the Fifth Schedule. The Schedules can be
downloaded from the Ministry of Health website at: https://www.moh.gov.sg/biosafety/
home, and is updated from time to time. Generally, biological agents contained in theFirst and Second Schedules, as well as the toxins listed in the Fifth Schedule areperceived to have greater potential for bioterrorism and/or to cause diseases; andtransportation of any agents or toxins listed in these Schedules within Singapore by mailor public transportation is prohibited. Therefore, Examiners should exercise care when
examining applications relating to these biological agents and toxins, as well as
technologies concerning their transportation. If in doubt, the Examiner should refer to a
Senior Examiner for discussion.

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Methods of human cloning, generation of human embryos and humanstem cell lines
8.204 The prohibition of human reproductive cloning was codified into law as the Human
Cloning and Other Prohibited Practices Act (HCOPPA) in Singapore as it is almost
unanimous from the international community, local scientific and religious groups aswell as our general public that reproductive cloning of human beings is abhorrent andshould not be allowed under any circumstances. Therefore objections under Section
13(2) should be made over such inventions.
8.205 The Bioethics Advisory Committee (BAC) issued a report in 2001 stating that (atparagraph 39, page 31):
“There is consensus from all sectors in opposing reproductive cloning. The BAC
is of the view that the implantation of a human embryo created by any cloning
technology in a womb, known as reproductive cloning, or any other treatment of ahuman embryo intended to result in its development into a viable infant, should beprohibited. There are strong public policy reasons for this position. These include:(a) the view that human reproductive cloning goes against moral ideas that holds
that a human being is not to be treated as a means to an end, but only as an end.
This translates into the fear that a whole human being may be brought into
existence for a utilitarian purpose; (b) that the social and legal implications ofreproductive cloning are very serious, including issues of identity andresponsibility; and (c) the fear that it will result in a reduction in biodiversity.”
8.206 Following the BAC report, the HCOPPA was enacted and it came into force inSingapore on 1st October 2004. In the Second Reading of the Bill as it then was, theSenior Minister of State & Health (Dr Balaji Sadasivan) said that:“There will be no unanimous view on this subject and my Ministry recognises andrespects the diversity of views. But in the area of human reproductive cloning, there
is almost unanimous agreement from the international community, local scientificand religious groups as well as our general public that reproductive cloning of
human beings is abhorrent and should not be allowed under any circumstances.”

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8.207 When dealing with applications involving human embryos and cloning, Examiners
should consider raising a Section 13(2) objection when the invention encompasses
performance of an act that is one of the “Prohibited Practices” in Part III of the
HCOPPA.
8.208 Acts that are prohibited by the HCOPPA include:(i)

placing a human embryo clone in the body of a human or the body of ananimal even if the human embryo clone did not survive or could not havesurvived;(ii)

development of any human embryo that is created by a process other thanfertilisation of a human egg by human sperm, for a period of more than 14days (excluding any period when the development of the embryo issuspended);(iii) development of any human embryo outside the body of a woman for a periodof more than 14 days (excluding any period when the development of theembryo is suspended);(iv) removal of any human embryo from the body of a woman for the purpose ofcollecting a viable human embryo;(v)

placing any human embryo in a non-human animal;(vi) placing any human embryo in the body of a human other than in a woman’s
reproductive tract;(vii) placing any animal embryo in the body of a human for any period ofgestation;(viii) placing any prohibited embryo in the body of a woman;(ix) the import into Singapore or export out of Singapore of any prohibitedembryos; and(x)commercial trading in human eggs, human sperm and human embryos.

A prohibited embryo as defined in Section 2(1) of the HCOPPA, includes among others,
any human embryo that has been developing outside the body of a woman for a periodof more than 14 days (excluding any period when the development of the embryo issuspended) and any human embryo that was removed from the body of a woman by aperson intending to collect a viable human embryo.

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8.209 Generally, methods of generating human embryonic stem cell lines from humanblastocysts will not be objected under Section 13(2) since human blastocysts are lessthan 14 days old post fertilization. Methods of producing human stem cell lines fromadult tissues are normally also allowed. The patenting of parthenote-derived humanembryonic stem cell lines was recently considered by the Australian Patent Office(International Stem Cell Corporation [2016] APO52) and the European Court of Justice(International Stem Cell Corporation v Comptroller General of Patents, Designs andTrademarks [2014], C-364/13), and the decision was a blastocyst formed via
parthenogenic activation of an unfertilized human oocyte cannot develop into a humanbeing, and therefore are also allowable. Accordingly, such inventions will likely not
attract a Section 13(2) objection in Singapore. However, Examiners should still consider
the facts of the case when examining such inventions.
8.210 The Human Biomedical Research Act (HBRA) 2015 prohibits certain kinds of humanbiomedical research activities as a result of ethics concerns. Examiners should consider
raising a Section 13(2) objection when the invention fall within “Prohibited humanbiomedical research” in Section 30 and the Third Schedule of the HBRA.
8.211 The Third Schedule of the HBRA prohibits:(i)human biomedical research involving the development of particular types ofhuman-animal combination embryos beyond 14 days or the appearance ofthe primitive streak, whichever is earlier (these particular types arecytoplasmic hybrid embryos; and human animal combination embryos
created in vitro by using human gametes and animal gametes; or one humanpronucleus and one animal pronucleus);(ii)

human biomedical research involving the implantation of any human-animal
combination embryo into the uterus of a human; or human biomedical
research involving the implantation of: (a) cytoplasmic human-animal hybrid
embryos; or (b) human-animal combination embryos created in vitro byusing: (i) human gametes and animal gametes; or (ii) one human pronucleus
and one animal pronucleus; into the uterus of an animal;(iii) human biomedical research involving the introduction of human stem cells(including induced pluripotent stem cells) or human neural cells into thebrains of living great apes (whether prenatal or postnatal); andVersion: Oct 2023

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(iv) human biomedical research involving the breeding of animals which have
had any kind of pluripotent stem cells (including induced pluripotent stem
cells) introduced into them.
There are strong ethics reasons for prohibiting such research and therefore, when
Examiners encounter applications involving any of the above prohibited research, heshould discuss the application with a Senior Examiner and generally consider raising a
Section 13(2) objection.
8.212 Although human biomedical research activities listed in the Fourth Schedule are notprohibited by HBRA 2015, these should not be construed to indicate that applications
involving these restricted research activities or claims encompassing these restrictedsubject matter are automatically allowable. If in doubt, Examiners who encounter suchapplications should discuss with a Senior Examiner to determine whether raising a
Section 13(2) objection is appropriate.
8.213 In addition, any claim which encompasses a human would be objected to under Section
13(2). This is consistent with the patent practice in other major jurisdictions.

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ii.

Genetically modified organisms

8.214 Inventions relating to transgenic plants and transgenic non-human animals generally do
not raise ethics alarms in Singapore. As acknowledged in paragraph 14 of the Bioethics
Advisory Committee’s (BAC) Consultation Paper on Human-Animal Combinations for
Biomedical Research:“… transgenic animals are already widely used in research. Besides enabling
scientists to understand the causes of diseases, and to develop more effective
treatment for these diseases, they have also been used to test the safety of new
products and vaccines and to study the possibility of producing organs fortransplantation that will not be rejected. As transgenic animals are not thought toraise any new ethical difficulties, they are not considered further in thisConsultation Paper.”8.215 This appears to be the case even if the genome of such transgenic non-human animals
contains human genes. The Bioethics Advisory Committee’s Ethics Guidelines for
Human Biomedical Research (June 2015) stated that:“Transgenic animals are animals in which the genome has been modified toinclude human genes. They have been widely used in laboratory research into theunderstanding and treatment of diseases for many years. In its Human-Animal
Combinations Report and in preparing these Guidelines, the BAC has not explicitly
considered transgenic animals but insofar as these Guidelines are relevant theyshould apply. However, to the extent that research involves the use of transgenic
mice or other small mammals in laboratory conditions, and subject to observanceof provisions for laboratory animal welfare, the BAC does not foresee any ethicaldifficulty in the continued use of such animals.”
8.216 Therefore, in the absence of laws prohibiting the creation of such transgenic non-humananimals coupled with the scientific and medical benefits arising from such research
involving the use of these transgenic non-human animals, mere offence to a section of
the public, in the sense that that section of the public considers such inventions
distasteful, is not enough for Section 13(2) to apply. Section 13(2) will apply only if thegeneral public would regard the grant of patent rights for such inventions as abhorrent.

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8.217 In contrast to the ethics position on the germline genetic modification of non-humananimals, the position is less clear with regards to germline genetic modification ofhumans. There have been recent international deliberations on germline editing of genes
in humans for the treatment of serious genetic diseases. In the Ethics Guidelines for
Human Biomedical Research (June 2015), it was acknowledged that such germline
genetic interventions are still at the experimental stage and there is insufficientknowledge to assess the potential long term consequences of such interventions.
Accordingly, when the invention encompasses germline genetic modification ofhumans, the case should be discussed with a Senior Examiner.
8.218 Inventions relating to genetic manipulations that can cause public safety concerns or
serious environmental hazards should also be discussed with a Senior Examiner. If it isdetermined that publication of the invention may be prejudicial to public safety under
Section 33(2) of the Patents Act, the Examiner should inform and consult Patents
Registry for further advice. An objection under Section 13(2) may also be warranted insuch situations.

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9.

SUPPLEMENTARY EXAMINATION

A.

Overview of supplementary examination

9.1

For the purpose of conciseness, the expression “corresponding or related application” isused hereinafter to refer to:
the corresponding application; orthe corresponding international application; or
the related national phase application.
The term “PCT application” refers to the international phase of an international
application for a patent (Singapore) that has entered the national phase in Singapore
under Section 86(3).

9.2

Under Section 29(1)(d) read with Section 29(12), applicants may rely on the prosecutionof certain foreign or international applications for supplementary examination of apatent application in Singapore. The “prescribed date” mentioned in Section 29(12)(a)and (b) is found in Rule 43(4). Under Section 29(12) read with Rule 43(4), thesupplementary examination route will not be available for patent applications filed on
or after 1 January 20208, and only patent applications filed before 1 January 2020 may
continue to use the supplementary examination route. The basic requirements that makean application suitable for the supplementary examination process are:
There are final results of search and examination as to the substance of acorresponding or related application, or the PCT application; andEach claim in the Singapore application is related to one or more claims in thecorresponding or related application, or the PCT application, as the case may be;
and8

Patent applications filed on or after 1 January 2020 refers to –(a) national applications having a date of filing on or after 1 January 2020;(b) international applications having a date of filing on or after 1 January 2020; and(c) where the application is a new application mentioned in Section 20(3), 26(11) or 47(4)) the actual dateof filing is on or after 1 January 2020.

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According to the final results, each claim of the Singapore application appears tosatisfy the criteria of novelty, inventive step (or non-obviousness) and industrial
applicability (or utility).
9.3

The determination of whether a foreign or international application can be used for
initiating a supplementary examination is performed by the Registry at filing, so
Examiners should not routinely check these details. However if the Examiner notices
that the application may not fulfil the requirements of being corresponding or related,then they should refer the matter to the Registry.

9.4

Supplementary examination considers only a limited number of prescribed mattersunder Rule 2A(3). The presumption is that the quality of the examination carried out inthe foreign offices is such that little or no additional examination is required on theapplication in Singapore. There is no statutory mechanism by which an Examiner may
raise new citations if they become aware of them.

9.5

If the foreign report has a negative indication against a claim for novelty, inventive stepor industrial applicability, then that claim cannot be used for initiating a supplementary
examination. There is no action available to the applicant to amend and/or makesubmissions in order to use any claim that has a negative indication for initiating a
supplementary examination, regardless of how trivial an amendment is required. The
applicant in such cases can only rely upon claims for which there are positive
indications.

9.6

In contrast, it is possible to further limit the scope of a claim for which there is a positive
indication by adding further provisos or additional features that are supported in thespecification. The assumption here is that the positive indication applies to all matterwithin the scope of the claim.

9.7

Furthermore, the reference in the Patents Act and Rules to there being a positive
indication in relation to novelty, inventive step and industrial applicability is restricted
to the consideration (and as a consequence the law and practices) in the foreign offices.
Thus, in theory at least, the outcome of the foreign search and examination could beinconsistent with the Singapore law and practices.

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9.8

As there is no legislative basis on which an Examiner can raise new citations, theyshould strictly apply the existing legislative requirements, and in particular ensure thatthe final results filed in support of the supplementary examination request clearly
establish that the claims are novel, inventive and industrially applicable across the fullscope of the claims. An Examiner should also consider whether the intention definedin each claim of the specification of the application constitutes an invention.

9.9

For example, if the final results indicate that a search and examination has not been
carried out across the full scope of the claims, for example, because of clarity or support
issues, then a supplementary examination can only be requested by relying on thoseclaims that have been examined and given a positive opinion. In such cases the applicant
may file an amendment to limit to those claims qualified for the supplementary
examination either before requesting the examination or in a response to an adverse
written opinion.

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B.

General process

9.10

The general process for supplementary examination is as follows:•

The Registry checks that the request for supplementary examination has been
made within the prescribed period in Rule 43(3). The Registry also checks
that the application for which supplementary examination has been requested
for has a date of filing that is before 1 January 2020, in accordance with
Section 29(12) and Rule 43(4).

•The Registry checks that the prescribed documents to meet the requirementsof Section 29(1)(d) have been filed.

•

If the request and the prescribed documents have been filed and met theprescribed requirements, the Registry will cause the application to be
subjected to a supplementary examination by the Examiner (Section
29(6)(a)).

•

The Examiner determines whether the application meets the prescribed
requirements under Section 29(1)(d) and Rule 2A(3) and advises theRegistrar accordingly (through establishment of either a written opinion or
an examination report).

•

Where a matter is raised in a written opinion, the Registrar will forward thewritten opinion to the applicant and invite them to address the matter within
3 months after the date of the Registrar’s letter forwarding the written opinion(Rule 46(4A)).

•

The applicant has one opportunity to respond to an adverse written opinion
by filing written submissions and/or amendments. These are forwarded to the
Examiner for consideration and subsequent establishment of a supplementary
examination report.

•

If the Examiner establishes a supplementary examination report with nounresolved objections, the Registrar will issue a notice of eligibility toproceed to the grant of a patent (Section 29A(1)). The applicant will thenhave 2 months to meet the requirements for the grant of the patent (Section
29A(2)(a) read with Section 30(a) and (c)).

•

If there are unresolved objections in the supplementary examination report
the Registrar will issue a notice of intention to refuse the application (Section

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29A(3)). The applicant will then have 2 months from the date of theRegistrar’s letter to request an examination review (Section 29B(1) read with
Rule 46A(2)). If the applicant does not request an examination review within
the prescribed period, the application is refused.

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C.

Requirements under Section 29(1)(d)9.11

Section 29(1)(d) sets out the requirements that an applicant shall comply with at thetime of request in order to proceed with a supplementary examination. At filing theRegistry will only ensure that:•

The applicant has filed a request for supplementary examination using
Patents Form 12A (Rule 42A(1)); and•9.12

The applicant has filed the prescribed documents (Rule 42A(2)).

The Registry will not consider the substance of the documents and their compliancewith prescribed requirements. This is left for the Examiner to determine.

9.13

Thus for example, Registry will consider whether a claim correspondence table has been
filed but generally will not consider the contents of the table to determine whether theclaims are indeed related. Similarly, Registry will consider whether a set of final results
have been filed but generally will not determine whether the final results relied on
clearly establish that all claims of the application are novel, inventive and industriallyapplicable. If, for example, the Examiner subsequently finds that the final results havenot provided a positive indication on an independent claim but have indicated that adependent claim is allowable, the Examiner will issue a written opinion, thereby
allowing the applicant to amend claims to incorporate the allowed dependent claim into
the independent claim during supplementary examination.

9.14

If the prescribed documents appear to have been filed, the Registrar will forward theapplication to the Examiner for supplementary examination (Section 29(6)(a)).

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i.

Prescribed documents for a corresponding or related Application

9.15

The applicant must file the following prescribed documents in support of the request fora supplementary examination (Rule 42A(2)(a)):
EITHER:A copy of the patent granted by the patent office in question and its
specification, which is duly certified by that office or which isotherwise acceptable to the Registrar. If the granted patent andspecification are not in English then an English translation (with averification of English translation (VET)) must also be provided; AND
A claim correspondence table showing how the claims of the Singapore
application are related to one or more claims of the corresponding or
related application, as the case may be, which has been subject toexamination for novelty, inventive step and industrial applicability.
OR,
All of the following:
Other documents, to the satisfaction of the Registrar, setting out the
final results of the search and examination. If the document is not inEnglish then an English translation (with a VET) must also be
provided; AND
A copy of the claims referred to in the final results; AND
A claim correspondence table showing how the claims of the Singapore
application are related to one or more claims of the corresponding or
related application, as the case may be, which has been subject toexamination for novelty, inventive step and industrial applicability.

9.16

In the second case described above, the final results of search and examination may beon either a corresponding application or a related national phase application filed in aprescribed office or a corresponding international application which has a search andexamination conducted by any International Searching Authority (ISA) or a further
examination conducted by any International Preliminary Examining Authority(IPEA).

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ii.

Prescribed documents for a PCT Application

9.17

Where the Singapore application is a PCT application designating Singapore that hasentered the national phase in Singapore under Section 86(3), the applicant may rely
upon the International Preliminary Report on Patentability (IPRP) (Rule 42A(2)(b)).
The applicant must provide a copy of the IPRP. If the IPRP is not in English, atranslation must also be provided.

9.18

A claim correspondence table is also required, showing how the claims of theapplication are related to one or more claims of the PCT application which have been
subject to examination and given a positive indication for novelty, inventive step andindustrial applicability.

9.19

If a translation of any document or part of a document is required then this should beaccompanied by a verification of the translation.

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iii.

Certified copies

9.20

The applicant may provide a “certified” copy of a granted patent. This may be a copyof the granted patent which is accompanied by a signed certificate from the prescribed
office confirming that it is a true copy of the granted patent.

9.21

Alternatively the applicant may provide a copy of the granted patent which has been
downloaded from the website of the prescribed office or from another source such as
ESPACENET (https://worldwide.espacenet.com). In this case the document must be
certified to the Registrar’s satisfaction.

9.22

A declaration by the person who downloaded the submitted copy will be sufficient inthis regard. Examiners may assume that the Registry has checked this requirement, but
if there is a clarity issue they may contact the Registry for clarification.

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iv.

Translations

9.23

If a translation of any document or part of a document is required then this should beaccompanied by a declaration by the translator that:(a)States the document being translated; AND(b)

Verifies that the translation corresponds to the original text of the document
or part; AND(c)

States the name of the translator and contains a statement that he/she is wellversed in English and the relevant foreign language.

9.24

Examiners may assume that the translation is accurate and should not routinely checkthe veracity of the document.

9.25

However, if there are clear errors or omissions in the document (for example, missing
pages or text), then the Examiner may check the document using available translation
tools or in consultation with an Examiner with appropriate language skills. The
Examiner should raise the issue as a note in the written opinion. In such cases theapplicant may make an amendment to correct the error.

9.26

If the error or omission is present in the original document then there is no legislative
mechanism to address the issue, unless it results in a deficiency in one of the examinedareas (support, claim relatedness, morality, methods of medical treatment or diagnosis,
double patenting or added matter). The Examiner may include a note in an adverse
written opinion bringing the error to the attention of the applicant. It may be possible toamend the specification and claims to address such issues, but careful consideration of
the amendments will be required to ensure they meet the requirements of claim
relatedness and the like.

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v.

Prescribed offices

9.27

The prescribed patent offices are as follows:•

Australia•

Canada (in respect of applications for a Canadian patent filed in the English
language)

•

Japan

•

New Zealand•Republic of Korea•

United Kingdom•

United States of America•

European Patent Office (in respect of applications for a European patent filed
in the English language)

9.28

Japanese and Korean applications may be relied upon provided an English translation
has been filed. However in the case of corresponding or related Canadian or European
applications, these must have been filed in English, or the procedural language is in
English.

9.29

The language requirements will generally be checked by the Registry at filing of therequest for supplementary examination. If during the examination the Examiner
considers that the corresponding or related application does not meet the language
requirements they would advise the Registry.

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vi.

Final results

9.30

As set out in Section 29(1)(d)(i), supplementary examination may be based on the final
results of a search and examination on:

9.31

•

a corresponding application; or•a corresponding international application; or•a related national phase application; or•a PCT application.

Section 2(1) sets out the definitions for the different foreign or international applications
on which a supplementary examination may be based. These are discussed in later
sections.

9.32

The applicant may rely on the final results for corresponding or related applications
in a prescribed office. According to Rule 42A(2)(a)(i), there is no specific format forthese final results, but they must clearly state the claims in question and give a positive
indication in relation to novelty, inventive step and industrial applicability.

9.33

The indication must be across the full scope of the claim. If the foreign report indicatesthat the search and examination has been limited or truncated in any way then theapplicant will need to restrict their claims to the matter for which a search andexamination has been carried out and a positive indication provided.

9.34

Examples of suitable final results include:•

A notice of intent to grant stating that specific claims are allowable.

•

An examination report stating that certain claims are novel, inventive andindustrially applicable.

•

A notice of refusal stating that certain claims are novel, inventive andindustrially applicable, but that the application is refused on other grounds.

9.35

Rule 42A(4) codifies that in the case of a corresponding international application the
IPRP in the international phase (that is IPRP Chapter I or Chapter II) is the final result.
In the case of a PCT application, Rule 42A(2)(b) codifies that the IPRP is the final
result. If subsequent examinations have been done on the PCT application during its

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national phase in one or more countries, these are not taken into account in the
supplementary examination – the IPRP is still considered the final result and no
additional citations or objections should be raised.
9.36

In the case of an application relying on an IPRP Chapter I, the Examiner should verify
whether the applicant has made any amendments under Article 19 of the PCT sincethese amendments will not be enclosed with the IPRP Chapter I report. The allowabilityof such amendments shall be considered in accordance with the practices set out in
Section 9J of these Guidelines.

9.37

Similarly to the above considerations in relation to corresponding or related applications
in a prescribed office, the positive indication must be across the full scope of the claims
under consideration.

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D.

Corresponding applications

9.38

According to Section 2(1), corresponding applications are those which are filed ortreated as filed in one of the prescribed offices and:•The Singapore application claims priority from the corresponding application
under Section 17; or•The corresponding application claims priority from the Singapore
application; or•The corresponding application and the Singapore application (under Section17) share at least one priority document in common that forms the basis fora priority claim in both applications.

9.39

If one of these conditions is met the final results of a search and examination in theprescribed office may be used as the basis for supplementary examination.

9.40

In its simplest form, a corresponding application refers to the following 3 scenarios(1)(a)-(1)(c) (refer to Diagrams in Section 9J of these Guidelines):•(1)(a): The Singapore application validly claims priority under Section 17(also under Paris Convention) from the prescribed office application being
used as the basis for the supplementary examination request. [See Diagram
1]•(1)(b): The prescribed office application being used as the basis for the
supplementary examination request validly claims priority under the Paris
Convention from the Singapore application. [See Diagram 2]•(1)(c): The Singapore application validly claims priority under Section 17
from an earlier application filed in a Convention country and the prescribed
office application being used as the basis for the supplementary examination
request also validly claims priority under Paris Convention or validly claims
domestic priority from said earlier Convention country application. In otherwords, the Singapore application and the prescribed office application shareat least one priority document in common that forms the basis for a priority
claim in both applications. [See Diagram 3]

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Corresponding applications: Divisional applications
9.41

Divisional applications filed in Singapore are not required to make a priority claim to
the parent application. Generally, a divisional application filed in Singapore is taken to
adopt the filing date of the parent application as its filing date under Section 26(11)rather than making a priority claim in the sense of Section 17 to that application. Where
the parent application in Singapore has a priority claim, the divisional application would
generally inherit priority claims by filing a declaration of priority(s) under Section 17(2)unless the applicant purposely gives up the priority claim or claim fewer priorities. In
comparison, where the parent application in Singapore is a first application having nopriority claim under Section 17(2), the Singapore divisional application is taken to“adopt” the filing date of the parent application as its filing date rather than making apriority claim to that application. Therefore, the presence of a priority claim by theparent application in Singapore to an earlier filed application impacts on whether or not
the divisional application would be considered a corresponding application as definedin Section 2(1).

9.42

In the case of divisional applications filed with a prescribed patent office, suchapplications are regarded in the spirit of the Paris Convention since the definition ofcorresponding applications under Section 2(1) does not delimit priority claims made byapplications filed with any of the prescribed patent offices. Divisional applications are
considered to preserve an earlier filing date comprising the filing date of the parent
application as well as the benefit of the right of priority, if any. Therefore it is acceptedthat a divisional application filed with any of the prescribed patent offices makes apriority claim to its parent application.

9.43

The following scenarios (1)(d)-(1)(l) presented in Section 9J of these Guidelines provide
examples in relation to divisional applications. [See Diagrams 4-12]

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ii.

Corresponding applications: PCT national phase applications

9.44

The Singapore application and the prescribed office application referred to in thedefinition of corresponding applications under Section 2(1) also include PCT
application that has entered the national phase in Singapore or the prescribed office,respectively. Based on the requirements as elaborated above, in the following scenarios(1)(m)-(1)(t) presented in Section 9J of these Guidelines, the final results in theprescribed office may be used as the basis for a supplementary examination of theSingapore application. [See Diagrams 13-20]

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E.

Related national phase applications

9.45

According to Section 2(1), a related national phase application meets the following
criteria:•

There is a national phase application in one of the countries and jurisdictions
the offices of which are the prescribed offices and in Singapore based on thesame PCT application (including a divisional application filed in accordancewith section 26(11) which derived its filing date from the PCT application);and•

The PCT application makes no earlier priority claim (that is, the PCT
application was the first application for the invention).

9.46

In this case the applicant may rely upon the final results of the prosecution of a related
national phase application in a prescribed patent office. Notably the original PCT
application need not necessarily be filed in a prescribed office – that is, it may have been
filed in any Receiving Office and the international search and/or examination may havebeen conducted by any ISA or IPEA. However the related national phase application
derived from that PCT application and used for initiating a supplementary examinationmust be a national phase entry in a prescribed patent office.

9.47

In the following scenarios (2)(a) and (2)(b) presented in Section 9J of these Guidelines,
the final results in the prescribed office may be used as the basis for a supplementary
examination of the Singapore national phase application and any divisionals derived
therefrom. [See Diagrams 21-22]

9.48

However, in the following scenarios (2)(c) and (2)(d) presented in Section 9J of these
Guidelines, the final results of the examination of a divisional application in theprescribed office cannot be used as the basis for a supplementary examination of anyof the applications in Singapore since the said divisional application does not meet thecriteria of being a related national phase application according to Section 2(1). [SeeDiagrams 23-24]

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F.

Corresponding international applications

9.49

According to Section 2(1), a corresponding international application is a PCT
application that:(a)is an international application from which the Singapore application derived
its priority under Section 17; or(b)is an international application which claims priority to the Singapore
application; or(c)is an international application claiming priority from an application in aconvention country that also forms the basis of a priority claim in a Singapore
application.

9.50

The corresponding international application need not have entered the national phase in
Singapore. For example, a supplementary examination may be requested for a
Singapore application that shares a common priority document with a PCT applicationthat has not entered the national phase in Singapore.

9.51

Rule 42A(4) codifies that in the case of a corresponding international application, the
IPRP in the international phase (that is IPRP Chapter I or Chapter II) is the final result.
If subsequent examinations have been done on the PCT application during its national
phase in one or more countries, these are not taken into account in the supplementary
examination – the IPRP is still the final result.

9.52

In its simplest form, a corresponding international application refers to the following 3
scenarios (3)(a)-(3)(c) presented in Section 9J of these Guidelines. [See Diagrams 2527]

9.53

The following scenarios 3(d) and 3(e) presented in Section 9J of these Guidelines
involve divisional applications. [See Diagrams 28 and 29]

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G.

PCT applications entering the national phase in Singapore

9.54

According to Section 29(1)(d)(i)(B), where the Singapore application is a PCT
application for a patent (Singapore) that has entered the national phase in Singapore
under section 86(3), the final results of search and examination in the international phase
may be used as the basis for supplementary examination. [See Diagram 30]

9.55

Rule 42A(2)(b) codifies that in the case of a PCT application, the IPRP in theinternational phase (that is IPRP Chapter I or Chapter II) is the final result. If subsequentexaminations have been done on the PCT application during its national phase in one
or more countries, these are not taken into account in the supplementary examination –the IPRP is still the final result.

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H.

Grounds for examination

9.56

During supplementary examination only the following grounds are subject toexamination according to Rule 2A(3):•Support•Whether the invention defined in each claim of the specification of theapplication constitutes an invention

9.57

•

Relatedness of claims•

Morality•

Methods of medical treatment or diagnosis•

Double patenting•

No added matter

It should be noted that there is no provision for consideration of other grounds, including
unity, clarity and sufficiency. As a consequence it may be possible for the applicant torely upon final results which have negative indications in relation to these grounds, but
a positive determination in relation to novelty, inventive step and industrial
applicability. For example, there is no requirement that the claims be directed to a single
invention. Thus, if the claims lack unity but additional fees have been paid for a searchand examination of the second and subsequent inventions resulting in the final results,then a supplementary examination may be carried out.

9.58

As there is no statutory mechanism by which an Examiner can raise new objections inrelation to other matters, e.g. clarity, there is no room for the applicant to makesubmissions in order to argue against such objection given in the final results and/or
amend to overcome such objection.

9.59

Although there is no provision for consideration of clarity in supplementary
examination, it may be deliberated whether the support requirement has been met in themeantime wherein the applicant will have one opportunity to respond to the objection
raised, if any.

9.60

However, a clarity objection in the final results may nevertheless be referred to by the
Examiner in order to determine how the claims were construed and which claims were

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examined that formed the basis of the positive indication given in the final results. If theforeign report clearly indicates that the search and examination has been limited or
truncated in any way due to the clarity objection, then the applicant should amend theclaims to the matter for which a search and examination has been carried out and apositive indication is provided. The consideration is a strict one – the final results relied
upon must clearly establish that a positive indication is given across the full scope ofthe claims.
9.61

For example, in cases where the foreign office Examiner examined and gave a positive
indication towards the claim “Device comprising X, Y1 and Z” but not “Device
comprising X, Y and Z” based on his interpretation, the applicant may amend the claimin the Singapore application from Y to Y1 either prior to requesting supplementary
examination or in response to an adverse written opinion.

9.62

In comparison, in cases where the foreign office Examiner did not provide any
reasoning for the clarity objection and/or provide any indication as to the extent to which
the claims were examined, the Examiner should issue an adverse written opinion
indicating it cannot be clearly established that a positive indication in relation to novelty,
inventive step and industrial applicability is given across the full scope of the claims.
Assuming that the applicant makes an amendment and there is no added matter as aresult of the amendment, since there has been no indication of the extent of examination
carried out in the foreign report, it is considered that none of the possible amendments
would be justified to be entitled to the positive indication given in the foreign report. In
such cases, the foreign report cannot be used as the basis for a supplementary
examination request and the applicant may consider requesting for an examination
under the local or mixed route instead.

9.63

The considerations in relation to support, whether the invention defined in each claimof the specification of the application constitutes an invention, morality, methods of
medical treatment or diagnosis, double patenting and added matter are the same as those
for applications undergoing other routes of examination and practices as set out in therelevant section should be followed.

9.64

The consideration of whether the invention defined in each claim of the specification of
the application constitutes an invention can vary between foreign patent offices. For

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example, according to current Australian and US patent practice, isolated DNA
sequences that replicate pre-existing DNA sequences found in nature are not consideredinventions, but at the EPO and UKIPO, isolated DNA sequences are deemed patentablesubject-matter. Computer-implemented inventions may also be considered differently
by different foreign patent offices. Chapter 8 of these Guidelines provide further
guidance with respect to the Singapore practice.
9.65

Examination of claim relatedness is specifically dealt with in the following section.

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Claim relatedness
9.66

Examination of claim relatedness is set out in Rule 2A(3)(b) as follows:(b)whether, at the time the prescribed documents referred to in section 29(1)(d)are filed, each claim in the application in suit is related to at least one claim
which —(i)is set out in the prescribed documents relating to the corresponding
application, corresponding international application or related national
phase application referred to in section 29(1)(d), or to the applicationin suit during its international phase; and(ii)

has been examined to determine whether the claim appears to satisfy
the criteria of novelty, inventive step (or non-obviousness) andindustrial applicability (or utility);

9.67

The meaning of claim relatedness is given in Section 2(4) which states that:“For the purposes of this Act —(a)a claim is related to another claim if —(i)the 2 claims are identical; or(ii)each limitation in the second claim —(A) is identical to a limitation in the first claim; or(B)

differs from a limitation in the first claim only in expression
but not in content; and

(b)
9.68

more than one claim may be related to a single claim.”

The consideration in examination is therefore essentially two-fold:•

Are all the claims of the Singapore application identical to the claims of thecorresponding, related application or PCT application or do they differ only
in expression but not in limitation or does each claim at least contain all thelimitations in a claim in the corresponding, related application or PCT
application?

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•Have the claims of the corresponding, related application or PCT application
been examined to determine whether they appear to satisfy the criteria ofnovelty, inventive step and industrial applicability?

Are the claims related?
9.69

The first consideration will be relatively straightforward where the claims of theSingapore application and the corresponding, related application or PCT application are
identical.

9.70

The requirement that each limitation in the claims differs only in expression but not incontent means that the claims do not need to be identical in wording provided each
limitation in the claims defines the same subject matter.

9.71

For example, a claim defining a method of manufacturing an article would not be related
to a claim to using the article in a particular environment. However, a claim to a methodof using an article may be related to a claim defining the same article when used in theparticular method.

9.72

Care should therefore be taken to ensure that the claims are directed to the same subject
matter. This will include cases where there may be differences in how claims areconstrued – for example some offices consider preambles and definitions of purpose tolimit the scope of claims. Where the Examiner is aware of the differences in claim
construction, or where the documents in support of the request suggest a particularconstruction has been taken that is not consistent with the Singapore practice, then an
objection would be raised that the claims are prima facie not related.

9.73

Section 2(4)(b) states that more than one claim may be related to a single claim. Thissuggests that a number of claims of different scope of the Singapore application may berelated to a single claim of the corresponding, related application or PCT application(and vice versa).

9.74

Thus, one or more claims of the Singapore application may be related to a single claimof the corresponding, related or PCT application – the key consideration being that theSingapore claims are entirely within the scope of those claims. It follows that the claimsof the Singapore application may be of a narrower scope than the claims of the

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corresponding, related application or PCT application. For example, the Singapore
claims may include an additional proviso or define a subset of the invention defined inthose claims. The Singapore claims may be amended to be further limited by anadditional feature that is supported in the specification. However, the Singapore claims
may not be broader in scope than those of the corresponding, related application or PCT
application.
9.75

Any objections to claim relatedness raised should be supported with reasoning in a
written opinion. The applicant may remedy the lack of claim relatedness by making
amendments and/or making submissions in rebuttal. However, any amendments mademust be fully supported by the original application, that is, there is no added matter.
Is there a positive indication for the claims?

9.76

The second consideration is whether the claims of the corresponding, related
application or PCT application have been examined to determine whether they appear
to satisfy the criteria of novelty, inventive step and industrial applicability. There is no
statutory basis on which new citations or objections can be raised in relation to theserequirements – the assumption is that these requirements have been determined to besatisfied in the final results provided by the applicant.

9.77

The consideration is therefore a strict one – the final results relied upon must clearly
establish that these criteria are met across the full scope of the claims.

9.78

A positive indication must be made in the final results for the claims that are used as thebasis for a supplementary examination. When requesting for a supplementary
examination, the applicant cannot amend the claims to address the negative indication,
nor can they make submissions arguing the objection. If a negative indication has been
given against the related claims for novelty, inventive step or industrial applicability
then there is no remedy available for the applicant to use these claims for initiating a
supplementary examination.

9.79

Where the applicant relies on final results comprising references to P or E documents,
said final results may or may not be considered to be a positive indication. In the caseof P documents being cited, the Examiner should first check the foreign report for anindication of the validity of the priority claim of the corresponding or related

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application. If the foreign report indicates that said priority claim appears to be invalidor that the priority claim could not be verified, references to P documents should betaken as a prima facie negative indication since verifying the priority claim is not among
the grounds for supplementary examination. An objection would then be raised that theclaims do not appear to satisfy the criteria of novelty, inventive step and industrial
applicability.
9.80

If the foreign report affirms the validity of the priority claim, the Examiner should thenproceed to check the origin of the cited P documents and their respective priority dates.
In the case where a cited P document has an earlier priority date than the Singapore
application and is itself a Singapore application or an international application
designating Singapore that has entered the Singapore national phase, the cited P
document in the final results should be taken as a negative indication since saidreference is relevant for novelty under Section 14(3). An objection would be raised thatthe claims do not appear to satisfy the criteria of novelty, inventive step and industrial
applicability. In the case where the cited P document is an international application
designating Singapore that has not entered the Singapore national phase at the time ofestablishment of the supplementary examination report, the Examiner may proceed toissue a positive supplementary examination report. However, said examination report
should include a statement that the positive indication is conditional, provided that the
P document does not later enter the Singapore national phase. If it is subsequently foundout that the P document has indeed entered the Singapore national phase, Section 81
may be invoked.

9.81

Otherwise, references to P documents may be disregarded and the final results may betaken to be a positive indication despite P documents being raised.

9.82

For final results comprising references to E documents, the Examiner should check if
any of the cited E documents are international applications designating Singapore thathave entered the Singapore national phase. A check of the priority date of the E
document may also be necessary since the E document may have an earlier priority datethan the corresponding or related application. If the cited E document has entered theSingapore national phase and has an earlier priority date, the cited E document in the
final results should be taken as a negative indication. In the case where the cited E
document is an international application designating Singapore that has not entered the

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Singapore national phase at the time of establishment of the supplementary examination
report, the Examiner should similarly issue a positive supplementary examination reportcomprising a conditional statement as detailed above.
9.83

Examiners should not review the positive indications given in the final results to ensure
the corresponding, related application or PCT application used as the basis complies
with the Singapore law and practice. Thus, there may be differences in law and practice
between the prescribed office or ISA/IPEA in question and Singapore but there is no
statutory mechanism by which new citations or objections may be raised. For example,
Singapore examines inventive step according to the “Windsurfing test” while manyother offices adopt different tests. There may be instances where a different outcome
could be obtained using different tests, but no objection can be taken. The same will
apply in industrial applicability, but here there is a basis for raising objection if theclaims define a method of medical treatment or diagnosis.

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ii.

Medical use claims

9.84

Pharmaceutical applications require specific considerations and care should be taken
where claims include first medical use and “Swiss-type” formats:•First medical use claims are not related to method of medical treatment
claims. As a consequence, if the invention lies in the first medical use of aknown compound and the claims of corresponding, related application or
PCT application are method of medical treatment claims (for example anAustralian or US application), then an objection will be taken that the claims
are not related. The treatment steps are a limitation in a method of medical
treatment claim. A first medical use claim does not include such treatment
steps.

•

Similarly, “Swiss-type” claims are not related to method of medical treatment
claims. “Swiss-type” claims define a method of preparing a pharmaceuticalwhich is intended for a particular treatment – in effect a purpose-limited
process of preparing the pharmaceutical. This is different subject matter to amethod of medical treatment.

•“Swiss-type” claims are not related to European-style second medical use
claims. EPO allows second medical use claims in a format corresponding toa Singapore first medical use claim – that is, substance X for use in treatment
of Y and in effect a purpose-limited product claim. As noted above, “Swisstype” claims are limited by the preparation of a medicament and is a purposelimited process claim. Therefore, a “Swiss-type” claim is not related to a
European-style second medical use claim.

•

First medical use claims are not related to European-style second medical use
claims, since a first medical use claim is not limited by the specific medical
use defined in a European-style second medical use claim. However, if it isclear from the claim wording that the European-style medical use claim
defines the first medical use of a compound or composition (e.g. Compound
X for use in medicine), then an identical first medical use claim in the
Singapore application would be related.

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However, in accordance with paragraphs 9.73 and 9.74 above, where the corresponding,related or PCT application contains a claim to the substance X that has been deemed tosatisfy the criteria of novelty, inventive step and industrial applicability, first medical
use or “Swiss-type” claims for the same substance X in the Singapore application are
considered to be related to the claim to the substance X in the corresponding, related or
PCT application. Notably, despite there being relatedness, the requirement of support
for first medical use and/or “Swiss-type” claims has to be assessed separately.

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iii.

Third party observations

9.85

Third party observations may also be submitted for an application under supplementary
examination. The procedure and timeline for submission of third party observations on
an application undergoing supplementary examination is the same as that for
applications filed undergoing examination or search and examination. However, in thecase of supplementary examination, only observations under one or more of the grounds
for supplementary examination according to Rule 2A(3) may be adopted by the
Examiner. Such observations by third parties must be received by the Registrar before
a copy of the supplementary examination report is sent to the applicant.

9.86

The considerations for third party observations for an application under supplementary
examination are similar to those for applications examined under Sections 29(4) and29(5), as detailed in sub-section i of Section B in Chapter 3.

9.87

Notably, Section 29(8) permits that only one written opinion may be given in a
supplementary examination. Hence, third party observations received after the written
opinion has been issued and which are deemed highly prejudicial to the application on
the grounds for supplementary examination could result in the Examiner issuing anegative supplementary examination report.

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I.

Responding to written opinions

9.88

As set out in Section 29(8), where the Examiner raises one or more matters in a written
opinion, the applicant will have only one opportunity to respond. They may makeamendments to overcome any deficiencies in the specification and/or make submissions
in rebuttal.

9.89

The response must be filed within 3 months of the Registrar’s letter forwarding thewritten opinion. If no response is filed within the prescribed period, the written opinion
is taken to be the supplementary examination report.

9.90

If the Examiner considers that the submissions and/or amendments do not overcome theobjections, an adverse examination report will be established. The Registrar will thenissue a notice of intention to refuse the application under Section 29A(3). The options
for the applicant at that stage are to request an examination review (Section 29B readwith Rule 46A) or to file a divisional application.

9.91

An applicant may withdraw the request for supplementary examination and file arequest for search and examination or examination, but the withdrawal of the request
for supplementary examination must be done within either of the periods stated in
Section 29(11)(a)(i) or 29(11)(a)(ii). Section 29(11)(a)(i) applies where the examiner
has given a written opinion under Section 29(8), and the period stated in Section
29(11)(a)(i) is the period for responding to the written opinion, which is found in Rule
46(4A). Section 29(11)(a)(ii) applies in any other case, and the period stated in Section
29(11)(a)(ii) is before the establishment of the supplementary examination report. The
request for search and examination or examination must be filed within 36 months fromthe earliest priority date (Section 29(11)(b) read with Rule 43(1)).

9.92

Supplementary examination may be requested within 54 months from the earliest
priority date (Rule 43(3)), and if the 36-month period in which the request for searchand examination or examination may be filed has expired, the applicant may consider
requesting an extension of time to request for search and examination or examination.
The applicant may also file a divisional application in such cases.

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J.

Annex

i.

Corresponding applications

9.93

Scenario (1)(a): The Singapore application validly claims priority under Section 17(also under Paris Convention) from the prescribed office application being used as thebasis for the supplementary examination request.

1
9.94

Scenario (1)(b): The prescribed office application being used as the basis for the
supplementary examination request validly claims priority under Paris Convention fromthe Singapore application.

2

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9.95

Scenario (1)(c): The Singapore application validly claims priority under Section 17
from an earlier application filed in a Convention country and the prescribed officeapplication being used as the basis for the supplementary examination request also
validly claims priority under Paris Convention or domestic priority from said earlier
Convention country application. In other words, the Singapore application and theprescribed office application share at least one priority document in common that forms
the basis for a priority claim in both applications.

3

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i(a). Corresponding applications: Divisional applications
9.96

Scenario (1)(d): The Singapore application is a divisional application of the Singapore
application referred to in (1)(a) above, and said divisional application validly claims
priority under Section 17 from the prescribed office application being used as the basis
for the supplementary examination request.

4
9.97

Scenario (1)(e): The prescribed office application being used as the basis for the
supplementary examination request is a divisional application of the prescribed officeapplication referred to in (1)(b) above, and said divisional application validly claims
priority under Paris Convention from the Singapore application.

5

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9.98

Scenario (1)(f): The Singapore application is a divisional application of the Singapore
application referred to in (1)(c) above, and said divisional application validly claims
priority under Section 17 from said earlier Convention country application, and theprescribed office application being used as the basis for the supplementary examination
request also validly claims priority under Paris Convention or domestic priority fromsaid earlier Convention country application.

6

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9.99

Scenario (1)(g): An application is filed in a Convention country. Applications aresubsequently filed both in Singapore validly claiming priority under Section 17 fromsaid earlier Convention country application and in a prescribed office validly claiming
priority under Paris Convention or domestic priority from said earlier Convention
country application. The prescribed office application being used as the basis for the
supplementary examination request is a divisional application of the parent prescribed
office application and also validly claims priority from said earlier Convention country
application.

7

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9.100 Scenario (1)(h): An application is filed in a Convention country. Applications aresubsequently filed both in Singapore validly claiming priority under Section 17 fromsaid earlier Convention country application and in a prescribed office validly claiming
priority under Paris Convention or domestic priority from said earlier Convention
country application. The Singapore application is a divisional application of the parent
Singapore application and validly claims priority under Section 17 from said earlier
Convention country application. The prescribed office application being used as thebasis for the supplementary examination request is a divisional application of the parent
prescribed office application and also validly claims priority from said earlier
Convention country application under Paris Convention.

8

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9.101 Scenario (1)(i): An application is filed in Singapore with no priority claim and an
application is subsequently filed in a prescribed office validly claiming priority fromsaid earlier Singapore application under Paris Convention. The Singapore application isa divisional application of said earlier Singapore application. The Singapore divisional
application in this case is taken to adopt the filing date of the parent application as its
filing date rather than making a priority claim to that application. The prescribed officeapplication and the Singapore divisional application are therefore not corresponding
applications.

99.102 Scenario (1)(j): Similarly, the prescribed office application is a divisional applicationof the prescribed office application referred to in (1)(i) above, the final results of theprescribed office divisional application may not be used as the basis for a supplementary
examination for the Singapore divisional application.

10

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9.103 Scenario (1)(k): An application is filed in a prescribed office with no priority claim andan application is subsequently filed in Singapore validly claiming priority from said
earlier prescribed office application under Paris Convention. The prescribed officeapplication is a divisional application of the parent application in the prescribed office.
The prescribed office divisional application preserves an earlier filing date comprising
the filing date of the parent application as well as the benefit of the right of priority, ifany. Said divisional application is regarded to make a priority claim to its parent
application. The Singapore divisional application and the prescribed office application
are thus corresponding applications.

119.104 Scenario (1)(l): Similarly, the Singapore application is a divisional application of theSingapore application referred to in (1)(k) above, the final results of the prescribed
office divisional application may be used as the basis for a supplementary examination
for the Singapore divisional application.

12

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i(b). Corresponding applications: PCT national phase applications
9.105 Scenario (1)(m)-(1)(t):

13

14

15

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16

17

18

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19

20

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ii.

Related national phase applications

9.106 Scenario (2)(a) and (b): The following scenarios illustrate how the final results in theprescribed office may be used as the basis for a supplementary examination of theSingapore national phase application and any divisionals derived therefrom.

21

22

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9.107 Scenario (2)(c) and (d): However, the final results of the examination of a divisional
application in the prescribed office cannot be used as the basis for a supplementary
examination of any of the applications in Singapore since said divisional application is
not a related national phase application.

23

24

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iii.

Corresponding international applications

9.108 Scenario (3)(a)-(3)(c):

25

26

27

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9.109 Scenario (3)(d): The final results of the PCT application may be used as the basis for a
supplementary examination of the Singapore application. An application is filed in a
Convention country and a PCT application is subsequently filed validly claiming
priority from said earlier Convention country application under Paris Convention. For
the Singapore application which is a divisional application of the Singapore national
phase application in this case, the PCT application will be a corresponding international
application as they share a common priority document (i.e. the convention country
application).

28

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9.110 Scenario (3)(e): An application is filed in Singapore with no priority claim and a PCT
application is subsequently filed validly claiming priority from said earlier Singapore
application under Paris Convention. The Singapore application is a divisional
application of said earlier Singapore application. The Singapore divisional applicationin this case is taken to adopt the filing date of the parent application as its filing daterather than making a priority claim to that application. The PCT application and theSingapore divisional application are therefore not corresponding applications.

29

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iv.

PCT application entering the national phase in Singapore

9.111 Scenario (4): Where the Singapore application is a PCT application for a patent(Singapore) that has entered the national phase in Singapore under section 86(3), thefinal results of search and examination in the international phase may be used as thebasis for supplementary examination.

30

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10. EXAMINATION REVIEWA.

Overview of examination review

10.1

For the purpose of conciseness, unless otherwise specified, the term “examination
report” is used hereinafter in Chapter 10 to refer to:

10.2

(a)

an examination report issued under section 29(4); or(b)a search and examination report issued under section 29(5); or(c)a supplementary examination report issued under section 29(6).

Section 29A(3) prescribes that where an examination report contains one or moreunresolved objections, the Registrar shall issue to the applicant a notice of intention torefuse the application. In such a case, the applicant may, in accordance with Section
29B(1), apply for a review of the examination report within the prescribed period under
Section 29A(4)(a). If the applicant fails to apply for a review of the examination report,
the application shall be refused, in accordance with Section 29A(4)(b).

10.3

Under Section 29B(1), a request for a review of an examination report shall be made byfiling:(a)the prescribed form for the request within the prescribed period; and(b)written submissions to overcome the unresolved objections in theexamination report.

10.4

At the time the request for a review of the examination report is made, the applicant
may also, according to Section 29B(2), amend the specification of the application in theprescribed manner to overcome the unresolved objections in the examination report.
Such amendments are subject to the conditions prescribed in Section 84.

10.5

The examination review process, under Section 29B, is predicated on the assumptionthat the applicant has exhausted all available means to overcome the objections raisedby the Examiner during examination or during supplementary examination, andprovides the applicant with a final opportunity to address any unresolved objections.
During the examination review, matters relating to the examination report under review

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would generally be decided by a different and, if possible, a more senior Examiner. The
examination review process is intended to provide an option for the applicant tocontinue the prosecution of an application that has been the subject of an adverse
examination report. If the examination review report maintains that the application
should be refused, an appeal may be made to the Courts.

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B.

General process

10.6

The general process for an examination review is as follows:•

The Registry shall check that the request for an examination review has been
made within the prescribed period and that the required forms have been
filed. The request for a review of the examination report should be madewithin 2 months after the date of the Registrar’s letter forwarding to theapplicant the notice under Section 29A(3) (Rule 46A(2)), by filing theprescribed Patents Form 12B (Rule 46A(1)). Written submissions to
overcome the unresolved objections in the examination report should also be
filed in order to meet the requirements of Section 29B(1). Optionally, theapplicant may, at the time the request is made, subject to Section 84, amend
the specification of the application to overcome one or more unresolved
objections in the examination report (Section 29B(2) and Rule 46A(3) and
(4)).

•

If the necessary requirements are met Registry then forwards the application
to an Examiner to perform the examination review. Generally, the Examiner
performing the examination review will be different from the Examiner whoestablished the examination report.

•

Upon completing the examination review, the Examiner prepares an
examination review report (Section 29B(3) and Section 29B(4)) which isforwarded to the Registrar.

•

Upon receiving the examination review report, the Registrar sends theapplicant a copy of that report (Section 29B(5)(a)). If the Registrar is satisfied
by the examination review report that there is no unresolved objection, theRegistrar will proceed to issue to the applicant a notice of eligibility toproceed to the grant of a patent (Section 29B(5)(b)(i)). If the Registrar issatisfied by the examination review report that there are one or moreunresolved objections, the Registrar will proceed to issue to the applicant a
notice of refusal of the application (Section 29B(5)(b)(ii)).

•

In accordance with Section 29B, there is no opportunity for the applicant to
respond to an adverse examination review report which contains one or moreunresolved objections.

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•

If a notice of eligibility to proceed to the grant of a patent has been issued,
the applicant will have 2 months to meet the requirements for the grant of thepatent under Section 30(a) and (c) (Section 29B(6)(a) and Rule 47(2)). If theapplicant fails to comply with those requirements within the prescribedperiod, the application shall be treated as abandoned (Section 29B(6)(b)).

•

If a notice of refusal of the application has otherwise been issued, that refusal
shall take effect upon the expiry of 2 months after the date of the Registrar’s
letter forwarding the notice (Section 29B(7), Rule 46A(5)).

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C.

Unresolved objections

10.7

Section 29B refers to “unresolved objections” in relation to the adverse examination
report subject to an examination review. While there is no explicit definition for“unresolved objections” in the Act or the Rules, Rule 46(1) and Rule 46(1A) do
explicitly prescribe the adverse opinions that an Examiner should notify the Registrarof in his written opinion during an examination or a supplementary examination
respectively. Adverse opinions relating to any of the prescribed matters in Rule 46(1)or Rule 46(1A) would be regarded by the Registry to be “objections” for the purposesof an examination or a supplementary examination. When the applicant has exhausted
all available means to overcome the objections during the examination or during the
supplementary examination, these outstanding objections become unresolved
objections in the examination report.

10.8

Hence, for an examination report issued under Section 29(4) or a search andexamination report issued under Section 29(5), an unresolved objection would mean anopinion in relation to any the following matters stated in Rule 46(1)(a)-(f):(a)

the description, claims, or drawings are so unclear, or the claims are so
inadequately supported by the description, that no meaningful opinion can beformed on —

(b)

(i)

the novelty or inventive step of the claimed invention; or(ii)whether the claimed invention is capable of industrial application;

the invention defined in any claim —(i)does not appear novel;(ii)

does not appear to involve an inventive step; or(iii) does not appear to be capable of industrial application;(c)the conditions specified in sections 13 and 25(4) and (5) have not been complied
with;

(d)

the application discloses any additional matter referred to in section 84(1) or(2) or any matter referred to in section 84(3);(e)

a claim relates to an invention in respect of which no search has been
completed, and the Examiner has decided not to carry out the examination in
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(f)there is —(i)any other application for a patent for the same invention, with the samepriority date, filed by the same applicant or his successor in title; or(ii)

any earlier grant of a patent for the same invention, with the samepriority date, to the same applicant or his successor in title.

10.9

For a supplementary examination report issued under Section 29(6), an unresolved
objection would mean an opinion on any the following matters stated in Rule 46(1A)(a)(f):(a)

any claim in the application is not supported by the description of theinvention;(b)at the time the prescribed documents referred to in section 29(1)(d) are filed,
any claim in the application in suit is not related to at least one claim which —(i)is set out in the prescribed documents relating to the corresponding
application, corresponding international application or related national
phase application referred to in section 29(1)(d), or to the applicationin suit during its international phase; and(ii)

has been examined to determine whether the claim appears to satisfy
the criteria of novelty, inventive step (or non-obviousness) andindustrial applicability (or utility);(c)the invention is an invention referred to in section 13(2) that is not patentable;(d)the invention is an invention referred to in section 16(2) that is not to be taken
to be capable of industrial application;(e)there is —(i)any other application for a patent for the same invention, with the samepriority date, filed by the same applicant or his successor in title; or(ii)

any earlier grant of a patent for the same invention, with the samepriority date, to the same applicant or his successor in title; or(f)the application discloses any additional matter referred to in section 84(1) or(2) or any matter referred to in section 84(3).

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D.

Examination review report

10.10 Section 29B(4) provides that:
Subject to subsection (4A), the examination review report shall specify —(a)whether the Examiner agrees or disagrees with the examination report,
search and examination report or supplementary examination report, as
the case may be;(b)where the applicant has amended the specification of the application
under subsection (2), whether each unresolved objection in theexamination report, search and examination report or supplementary
examination report, as the case may be, has been overcome in theamended specification; and(c)the reasons for the Examiner’s decision under paragraph (a) and, whereapplicable, paragraph (b).

Section 29B(4A) further specifies:
The examination review report need not specify whether the Examiner agrees ordisagrees with the examination report, search and examination report or
supplementary examination report (as the case may be) if the applicant had
amended the specification of the application for the purpose of overcoming all
unresolved objections in the report.
10.11 Thus, according to Section 29B(4A), if it is apparent that the amendments to thespecification filed by the applicant under Section 29B(2) are for the purpose ofovercoming all unresolved objections in the examination report, the Examiner need notreview the examination report and specify whether he agrees or disagrees with theexamination report. In such a situation, the Examiner may proceed to consider whether
each unresolved objection in the examination report has been overcome in the amended
specification without specifying whether he agrees or disagrees with the examination
report.
10.12 On the other hand, if the amendments filed by the applicant are not aimed at overcoming
all of the unresolved objections or if no amendments are filed, the Examiner is required

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to review the examination report and state whether he agrees or disagrees with theexamination report. In arriving at his decision of whether he agrees or disagrees withthe examination report, the Examiner should take into account the written submissions
filed by the applicant under Section 29B(1)(b), and consider whether or not said
submissions overcome the unresolved objections in the examination report. The
Examiner may also consider any other relevant documents on record, including earlier
written opinions for the application and responses to the written opinions filed by theapplicant so as to obtain a clearer idea of the proceedings that led to the adverse
examination report, but should note that this is a review of the examination report andnot a review of the previous written opinions.
10.13 Sometimes, in attempting to overcome all the unresolved objections in the examination
report, the amendments filed by the applicant may result in a set of claims that is distinct
from what was examined in the examination report (such as amendments from productclaims to method claims). In such a situation, the Examiner may determine whether areview of the examination report is helpful or necessary.
10.14 With respect to the written submissions filed under Section 29B(1)(b), applicants areadvised to clearly identify the outstanding unresolved objections, and where applicable
the relevant claims, in the examination report that are intended for consideration, and toprovide relevant and well substantiated arguments for said consideration. This would
place the Examiner in a better position to review the examination report.
10.15 It is noted that Section 29B(4)(a) does not limit the Examiner to specify whether heagrees or disagrees with only the unresolved objections in the examination report, andhence the Examiner may disagree in the sense that he considers an objection that shouldhave been raised in the examination report was not raised. This may result from, forexample, a different construction of the claims during the examination review. Hence,an examination review report may comprise unresolved objections, which were notpreviously raised in the earlier examination report, on any of the grounds stated in Rule46(1) (for the review of an examination report or a search and examination report) or in
Rule 46(1A) (for the review of a supplementary examination report).
10.16 For the purposes of an examination review, the Examiner is not expected to actively
perform further searches for additional prior art documents in order to demonstrate that

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a claim, which was acknowledged to be novel and inventive in the earlier examination
report, would lack novelty and/or inventive step. The basis of consideration for novelty
and inventive step during the examination review should only be with respect to those
documents that are connected with the search and examination history of the file at
IPOS.
10.17 Where there are amendments to the specification filed under Section 29B(2), theExaminer should also specify, according to Section 29B(4)(b), whether each unresolved
objection in the examination report has been overcome in the amended specification.
10.18 During consideration of said amendments, the Examiner should also take into accountthe written submissions filed by the applicant in relation to the amendments. Any otherrelevant documents on record may also be considered. Applicants are advised to provide
relevant and well substantiated arguments detailing how the amendments would
overcome the unresolved objections in the examination report under review.
10.19 According to Section 29B(4)(c), the Examiner should specify reasons for his decision.
The reasons provided should clearly set out how the Examiner had arrived at his
decision with respect to each issue. It is worthwhile to note that the examination review
report may potentially serve as a useful reference in the event that a subsequent appeal
is filed at the Courts for an application that has been refused by the Registrar in view ofan adverse examination review report.

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11. EX PARTE RE-EXAMINATIONA.

General process

11.1

After the grant of a patent, any person (the “requester”) may at any time, file a request
under Section 38A for the Registrar to conduct a re-examination of the specification ofa patent for an invention on any one or more of the following grounds prescribed in
Section 38A(1):(a)

the invention is not a patentable invention;(b)

the specification does not disclose the invention clearly and completely for it
to be performed by a person skilled in the art;(c)the matter disclosed in the specification(i)

extends beyond that disclosed in the application for the patent as filed;
or

(ii)

in the case of a patent granted on an application filed under Section
20(3) or 47(4) or Section 116(6) of the Patents Act (Cap. 221, 1995
Ed.) or in accordance with Section 26(11), extends beyond that
disclosed in the earlier application made under this Act; the application
made under the United Kingdom Patents Act 1977; or the application
under the European Patent Convention designating the United
Kingdom filed at the European Patent Office; as the case may be, fromwhich the filing date and the right of priority has been derived, as filed.

(d)an amendment has been made to the specification of the patent under Section
38(1), 81 or 83, which

(e)

(i)

results in the specification disclosing any additional matter; or(ii)extends the protection conferred by the patent;

an amendment has been made to the specification of the application for thepatent under Section 31 which results in the specification disclosing any
matter extending beyond that disclosed in the application as filed;(f)a correction has been made to the specification of the patent or of theapplication for the patent under Section 107 which should not have been
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(g)the patent is one of 2 or more patents for the same invention having the samepriority date and filed by the same party or the party’s successor in tile.

Upon acceptance of the request, the Registrar will cause the specification of the patent
to be re-examined by an Examiner.
11.2

It should be noted that the re-examination is an ex parte process and as prescribed by
Section 38A(15), the requester generally plays no further role after the submission of
the request, unless the requester is also the proprietor of the patent.

11.3

During the re-examination, if the Examiner is of the opinion that the ground(s) specified
in the request, or any other ground(s) prescribed in Section 38A(1) based on the
documents that have been submitted with the re-examination request, is made out, theExaminer will provide a written opinion to the proprietor of the patent in accordancewith Section 38A(8).

11.4

The proprietor may request an interview with the Examiner within 2 months after thedate on which the Registrar sends the proprietor of the patent a copy of the Examiner’s
written opinion (Rule 52A(5)).

11.5

The proprietor must respond to the Examiner’s written opinion within 3 months after
the date on which the Registrar sends to the proprietor of the patent a copy of the written
opinion (Rule 52A(8)). Failure to do so will result in the written opinion being treatedas the re-examination report (Rule 52A(9)(b)).

11.6

The response of the proprietor can include written submissions on the Examiner’s
written opinion and/or an amendment of the specification of the patent. If the proprietor
wishes to make written submissions and amend the specification of the patent, bothmust be done at the same time (Rule 52A(7)).

11.7

At the conclusion of the re-examination process, the examiner will provide a reexamination report. A positive re-examination report will be issued if the Examiner
determines that the patent is valid on all of the grounds prescribed in Section 38A(1),or where the proprietor has filed written submissions on the Examiner’s written opinion
and/or amendment to the specification of the patent under Rule 52A(7), the written
submissions and/or amendment have overcome the objections raised by the Examiner

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in the written opinion. Otherwise, a negative re-examination report will be issued by the
Examiner. If it appears to the Examiner that the proposed amendment would resolve
any objection mentioned in the written opinion, the Examiner must state so in the reexamination report and specify in the report the objection that would be so resolved(Rule 52A(10)). The Registrar will send a copy of the re-examination report to the
proprietor of the patent (Section 38A(10)), and make the report available on the Patents
Open Dossier (POD) website.

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B.

Acceptance of re-examination request

11.8

Section 38A(2) prescribes that a request for re-examination must be:(a)filed in the prescribed manner;(b)

accompanied by the prescribed fee; and(c)accompanied, at the time the request is filed, by(i)reasons to substantiate the ground specified in the request; and(ii)

any document that the person considers to be relevant for the purposesof the re-examination.

The details of how a request should be made are described in Patents Rule 52A(1) and52A(2). The request may be rejected if it does not comply with any requirement in
Section 38A(2) and Patents Rule 52A(1). For documents in a language other thanEnglish, there are additional requirements in Patents Rule 52A(2) to be complied withwithin the time specified by the Registrar. Otherwise, the request will be treated ashaving been abandoned (Patents Rule 52A(3)).
11.9

Patents Rule 52A(1)(b) stipulates that the request must clearly identify each ground on
which the re-examination is to be conducted and explain how the ground (or grounds)
has (or have) been established. The means that the request should identify the claims
relating to each ground, and state the reasons why a particular ground has been
established for each of the claims identified in full. In some instances, this may require
providing a construction of particular claims or identifying differences between
particular claims and prior art documents. Case law may be referred to if relevant tosupport an argument. If a prior art document is relied upon for a particular ground, thereasons should identify the parts of the document the requester thinks most relevant forassessing the particular ground, and match the specific features the requester thinks
relevant in the prior art document to the claims of the specification. Where there aresupporting documents, they should be filed at the same time as the request.

11.10 For a supporting document that is considered by the requester to be part of the state of
the art relevant to the patent, the requester must establish and state the date the document
was made available to the public. Documents that are commonly submitted as
supporting documents include patent documents, book chapters and journal

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publications. Pamphlets, brochures and catalogues may also be used as long as the datethe document was made available to the public can be established. For supporting
documents that are in a language other than English, an English translation of the whole
or any part of that document should be provided, together with a verification of thetranslation (Rule 52A(2)).
11.11 A request for re-examination may also rely on one or more prior art documents thatwere considered by the Examiner during the course of examination of the patentapplication, but only if such prior art documents are presented in a new light, or in adifferent way, as compared with their use during examination, in view of a material newargument or interpretation of the prior art documents presented during the request forre-examination. For avoidance of doubt, even though such prior art documents may beon file at IPOS, they should still accompany the request in accordance with Section
38A(2)(c)(ii).
11.12 Supporting documents are not limited to prior art documents. For example, a document
which provides evidence that the priority claims are not valid, and as a result theinvention is not a patentable invention in view of other prior art documents, may also
be submitted.
11.13 Section 38A(4) prescribes that the Registrar must not grant a re-examination requestthat is frivolous, vexatious, or an abuse of the process. Requests that may be consideredfrivolous, vexatious, or an abuse of the process includes re-submitting a request for reexamination on the same grounds that have previously been rejected by an Examiner,
and/or where the reasons submitted are substantially the same based on the same orequivalent prior art documents. An equivalent document includes family members of apreviously submitted patent document or a non-patent publication whose content issubstantially similar to a previously submitted patent document.
11.14 The Registrar will not accept a request for re-examination of a patent where there areproceedings pending before the Court or the Registrar in which the validity of the patent
may be put in issue (Section 38A(5)). In a situation where proceedings before the Courtor the Registrar in which the validity of the patent may be put in issue are filed after are-examination request, the Registrar has the discretion to deal with the request as theRegistrar thinks fit (Section 38A(6)).

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C.

Grounds for re-examination

11.15 Section 38A(7) stipulates that during re-examination, the Examiner is to determine
whether the grounds specified in the request are made out. Section 38A(8) subsequently
empowers the Examiner to report on both the grounds specified in the request, and on
any other ground prescribed in Section 38A(1) based on the documents submitted withthe re-examination request. Hence, while the requester may have filed his request on thebasis of only some of the grounds in Section 38A(1) and in respect of specific claims inthe specification of the patent, it is possible for re-examination to also be performed on
any part of the specification on any of the grounds in Section 38A(1), if the Examiner
deems the documents submitted with the re-examination request to be relevant to therest of the specification.
11.16 To illustrate, a requester may identify a claim in a patent undergoing re-examination tolack novelty in view of a prior art document submitted under Section 38A(2)(c)(ii). On
the other hand, after considering the requester’s arguments and the submitted prior art
document, the Examiner disagrees with the requester that the claim lacks novelty, butnonetheless finds it to lack inventive step. In such a situation, the Examiner should raise
an inventive step objection for the claim even though this was not one of the grounds
contained in the re-examination request (Section 38A(8)(b)).
11.17 The Examiner may also re-examine claims that have not been identified in the reexamination request in view of any document submitted under Section 38A(2)(c)(ii).
For example, a requester may have only requested claims 1-5 of a patent to be reexamined on the ground that these claims lack an inventive step. However, in the courseof re-examination, if the Examiner finds claims 1-5 to be inventive but claims 6-10 tolack an inventive step in view of any of the documents submitted by the requester under
Section 38A(2)(c)(ii), the Examiner should raise an inventive step objection against
claims 6-10, even though the re-examination of claims 6-10 on the grounds of inventive
step was not specifically requested (Section 38A(8)(b)).
11.18 The Examiner is expected to only rely on the documents submitted by the requester forthe re-examination. However, in order to establish common general knowledge at thetime of filing of the patent undergoing re-examination, the Examiner may cite additional

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documents that the Examiner considers to be useful for establishing common generalknowledge during the re-examination of the specification of the patent.

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Written opinion and re-examination report
11.19 Section 38A(8) prescribes that:
If it appears to the Examiner during the re-examination of the specification of thepatent that —(d)the ground specified in the request; or(e)based on any document submitted under subsection (2)(c)(ii), any otherground mentioned in subsection (1),is made out, the Examiner must provide the proprietor of the patent a written
opinion to that effect, and the Registrar must, upon receiving the written opinion,
send the proprietor a copy of the written opinion.
11.20 Thus, according to Section 38A(8), the Examiner is required to provide the proprietorof the patent that is undergoing re-examination a written opinion if either of theconditions in Section 38A(8)(a) or 38A(8)(b) is met. Otherwise, the Examiner should
prepare a re-examination report stating the reasons why none of the specified grounds
in the re-examination request have been made out i.e. a positive re-examination report.
11.21 The written opinion provided by the Examiner should contain a statement informing the
proprietor of the patent that in the Examiner’s opinion, the reasons one or more of thegrounds mentioned in Section 38A(1) have been made out in respect of any part of thespecification of the patent.
11.22 In accordance with Rule 52A(7), the proprietor of the patent has only one opportunity
to respond to the Examiner’s written opinion by filing written submissions and/or an
application to amend the specification of the patent. This must be done within 3 months
after the date on which the Registrar sends to the proprietor a copy of the Examiner’s
written opinion (Rule 52A(8)). Otherwise, the Examiner’s written opinion will betreated as the re-examination report (Rule 52A(9)(b)).
11.23 Any proposed amendment filed under Rule 52A(7)(b) will be advertised by theRegistrar under Section 83(1), and may be opposed by any person (including therequester) within 2 months from the date of the advertisement (Rule 85(1)). Any

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statements filed by opponents within the specified period will be provided to the
proprietor and the Examiner.
11.24 After the proprietor has responded to the written opinion, the Examiner must draw up
the re-examination report, taking into account the written submissions of the proprietor
and any proposed amendment filed. Where opposition statements have been filed in
respect of the proposed amendment, these will be reviewed as well in determining theallowability of the proposed amendment. As such, it may be more efficient for the
Examiner to only begin drawing up the re-examination report after the 2-month period
for opposing the proposed amendment has expired.
11.25 The proposed amendment must comply with Section 84(4), i.e. that they (i) do notdisclose any additional matter; and (ii) do not extend the protection conferred by thepatent. Discretionary criteria under Section 83(1) also applies: (i) whether the relevant
matters are sufficiently disclosed; (ii) whether there was any unreasonable delay inseeking amendments; (iii) whether the proprietor sought to obtain an unfair advantage;and, generally (iv) whether the conduct of the patentee discourages the amendment of
the patent (Warner-Lambert Company LLC v Novartis (Singapore) Pte Ltd [2017] 2
SLR 707). In addition, the amended claim or claims must satisfy the “baseline criteria”
of being “clear and concise” and “supported by the description” (Trek Technology(Singapore) Pte Ltd v FE Global Electronics Pte Ltd and others and other suits [2005]
3 SLR(R) 389). Essentially, the considerations in respect of these requirements are thesame as for post-grant amendments, as detailed in Section E in Chapter 7. The proposed
amendment may be opposed under Rule 85(1) on any one of the grounds listed above.
The Registrar will give directions with regard to any aspect of the procedure for the
opposition (Rule 85(4)). The Registrar will inform the opponent and the proprietor ofthe decision on the opposition.
11.26 If it appears to the Examiner that the proposed amendment would resolve any objection
mentioned in the written opinion, the Examiner must state so in the re-examination
report and specify in the report the objection that would be so resolved (Rule 52A(10)).
11.27 The re-examination report prepared by the Examiner is forwarded to the Registrar, whowill send the proprietor of the patent a copy of that report, in accordance with Section
38A(10). Rule 52A(11) prescribes that the Registrar may direct the proprietor to file

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with the Registrar within a specified time limit, a specification incorporating theamendment mentioned in Rule 52A(10), which resolves the objection mentioned in thewritten opinion, or in the case of a patent where one or more grounds mentioned in
Section 38A(1) has been established, but only so as to invalidate the patent to a limited
extent, a specification incorporating any amendment to the satisfaction of the Registrar.
11.28 Section 38A(15) sets out that the requester does not become a party to any reexamination proceedings, unless the requester is the proprietor of the patent. However,the Registrar will inform the requester after the re-examination report has been issued
and made available on the Patents Open Dossier (POD) website.

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Request for interview under Rule 52A(5)11.29 Prior to responding to the Examiner’s written opinion during re-examination, theproprietor may request an interview with the Examiner (Rule 52A(5)). Such a request
should be made with the Registrar, who will verify that the request is made with theprescribed time limit of within 2 months after the date on which the Registrar sends the
proprietor a copy of the Examiner’s written opinion under section 38A(8). Rule 52A(6)provides discretion to the Registrar to allow an interview request made after theprescribed time limit.
11.30 The request should be accompanied by an agenda of the items that the proprietor or his
representative wishes to discuss with the Examiner during the interview. Where a
proprietor intends to amend the specification of his patent to address the written opinion,
it is strongly encouraged that the proposed amendment is tabled and discussed at theinterview. If one of the agenda items includes a proposed amendment to thespecification of the patent, the amendment must be provided in the interview request.
11.31 The interview will generally be limited to the items on the agenda and should becompleted within the interview session, which normally should not go beyond 2 hours.
The Examiner has the discretion to decline discussion of items that are not on theagenda. The Registrar is only obliged to grant one interview request (Rules 52A(5) and52A(6)), and therefore, the proprietor should carefully consider the agenda items, andwhere the agenda includes a discussion on proposed amendments, the proprietor should
consider all amendments to be discussed and include them in the request for interview.
11.32 If the proprietor intends to make changes to submitted agenda items prior to theinterview, he should inform the Registrar at least 5 working days before the scheduledinterview date. However, acceptance of changes to the agenda items is subject to theRegistrar’s discretion.

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Conclusion of the re-examination process
11.33 After the issuance of the re-examination report, the patent will either be maintained in
its original form, maintained in an amended form or fully revoked.
11.34 When the re-examination report contains one or more unresolved objections, theRegistrar must make an order to revoke the patent (Section 38A(11)). The order may bean order for the unconditional or conditional revocation of the patent (Section 38A(12)).
A conditional revocation of the patent is ordered when at least one of the grounds in
Section 38A(1) has been established, but only so as to invalidate part of the claims in
the patent, leaving the other parts valid.
11.35 When the proprietor receives an order for conditional revocation of the patent, theproprietor will have a final opportunity to amend the specification under Section 83
within the time limit specified by the Registrar to prevent the full revocation of thepatent. The proposed amendment filed by the proprietor will be assessed in accordancewith the requirements set out in paragraph 11.25 above. Generally, the proprietor may
amend the specification by limiting the claims to those that have been assessed to bevalid in the re-examination report.
11.36 If, as a result of the re-examination request, an order is made by the Registrar to revoke
the patent under Section 38A(11), the proprietor of the patent may appeal to the Court(Section 90(1)).

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