Federal Register / Vol. 63, No. 114 / Monday, June 15, 1998 / Notices 32639

FOR FURTHER INFORMATION CONTACT: Dr.

Subhas G. Malghan, FQA Program

Manager, Building 820, Room 306,

NIST, Gaithersburg, MD 20899;

telephone (301) 975–5120, fax (301)

975–5414, E-mail: malghan@nist.gov.

SUPPLEMENTARY INFORMATION: On June 1,

1998, NIST announced in the Federal

Register, (63 FR 29702), that it would be

holding a public meeting on June 16,

1998, to provide details and

interpretations on the regulations

related to the Quality Assurance System

(QAS) of fastener manufacturing

contained in the April 14, 1998, final

regulation under the Fastener Quality

Act. NIST is postponing that meeting

and will issue a future notice

announcing a new date for the meeting.

Dated: June 10, 1998.

Robert E. Hebner,

Acting Deputy Director, National Institute of

Standards and Technology.

[FR Doc. 98–15935 Filed 6–12–98; 8:45 am]

BILLING CODE 3510–13–M

DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. 980605148–8148–01]

Request for Comments on Interim

Guidelines for Examination of Patent

Applications Under the 35 U.S.C. 112

¶ 1 ‘‘Written Description’’ Requirement

AGENCY: Patent and Trademark Office,

Commerce.

ACTION: Notice and request for public

comments.

SUMMARY: The Patent and Trademark

Office (PTO) requests comments from

any interested member of the public on

the following interim guidelines. These

guidelines will be used by PTO

personnel in their review of

biotechnological patent applications for

compliance with the ‘‘written

description’’ requirement of 35 U.S.C.

112 ¶ 1. Although the guidelines are

directed primarily to written

descriptions of biotechnological

inventions, they reflect the current

understanding of the PTO and apply

across the board to all relevant

technologies.

DATES: Written comments on the interim

guidelines will be accepted by the PTO

until September 14, 1998.

ADDRESSES: Written comments should

be addressed to Box 8, Commissioner of

Patents and Trademarks, Washington,

D.C. 20231, marked to the attention of

Scott A. Chambers, Associate Solicitor

or to Box Comments, Assistant

Commissioner for Patents, Washington,

D.C. 20231 marked to the attention of

Linda S. Therkorn. Alternatively,

comments may be submitted to Scott

Chambers via facsimile at (703) 305–

9373 or by electronic mail addressed to

‘‘scott.chambers@uspto.gov’’ or to Linda

Therkorn via facsimile at (703) 305–

8825 or by electronic mail addressed at

‘‘linda.therkorn@uspto.gov.’’

FOR FURTHER INFORMATION CONTACT:

Scott Chambers by telephone at (703)

305–9035, by facsimile at (703) 305–

9373, by mail to his attention addressed

to Box 8, Commissioner of Patents and

Trademarks, Washington, D.C. 20231, or

by electronic mail at

‘‘scott.chambers@uspto.gov’; or Linda

Therkorn by telephone at (703) 305–

8800, by facsimile at (703) 305–8825, by

mail addressed to Box Comments,

Assistant Commissioner for Patents,

Washington, D.C. 20231, or by

electronic mail at

‘‘linda.therkorn@uspto.gov.’’

SUPPLEMENTARY INFORMATION: The PTO

requests comments from any interested

member of the public on the following

interim guidelines. These guidelines

will be used by PTO personnel in their

review of biotechnological patent

applications for compliance with the

‘‘written description’’ requirement of 35

U.S.C. 112 ¶ 1. Although the guidelines

are directed primarily to written

descriptions of biotechnological

inventions, they reflect the current

understanding of the PTO and apply

across the board to all relevant

technologies. Because these guidelines

govern internal practices, they are

exempt from notice and comment

rulemaking under 5 U.S.C. 553(b)(A).

Written comments should include the

following information: (1) name and

affiliation of the individual responding;

and (2) an indication of whether the

comments offered represent views of the

respondent’s organization or are they

respondent’s personal views. The PTO

is particularly interested in comments

relating to: (1) the accuracy of the

methodology; (2) relevant factors to

consider in determining whether the

written description requirement of 35

U.S.C. 112 ¶ 1 is satisfied; (3) whether

the scope of these guidelines should be

limited to certain technologies, such as

biotechnology, or even a particular area

of biotechnology such as nucleic acids,

or encompass all technologies generally;

(4) whether the scope of these

guidelines should be expanded to

include processes and/or product-byprocess claims; and (5) the impact these

guidelines may have on currently

pending applications as well as future

applications.

Parties presenting written comments

are requested, where possible, to

provide their comments in machinereadable format in addition to a paper

copy. Such submissions may be

provided by electronic mail messages

sent over the Internet, or on a 3.5′′

floppy disk formatted for use in either

a Macintosh, Windows, Windows for

Workgroups, Windows 95, Windows

NT, or MS-DOS based computer.

Written comments will be available

for public inspection on or about

September 14, 1998, in Suite 918,

Crystal Park 2, 2121 Crystal Drive,

Arlington, Virginia. In addition,

comments provided in machinereadable format will be available

through anonymous file transfer

protocol (ftp) via the Internet (address:

comments.uspto.gov) and through the

World Wide Web (address:

www.uspto.gov).

Interim Guidelines for the Examination

of Patent Applications Under The 35

U.S.C. 112 ¶1 ‘‘Written Description’’

Requirement

These ‘‘Written Description

Guidelines’’ are intended to assist Office

personnel in the examination of patent

applications for compliance with the

written description requirement of 35

U.S.C. 112, ¶ 1, in view of University of

California v. Eli Lilly 1 and the earlier

cases Fiers v. Revel 2 and Amgen, Inc. v.

Chugai Pharmaceutical Co. 3 These

Interim Guidelines are directed

primarily to determining whether there

is written description support for

product claims and are not intended to

specifically address the description

necessary to support process or productby-process claims. Similarly, these

Guidelines are not intended to directly

address the question of new matter,

which is currently addressed in the

Manual of Patent Examining Procedure

§§ 2163.06–.07. The Final Guidelines

may address these additional issues if

public comment suggests they should be

addressed. These guidelines are based

on the Office’s current understanding of

the law and are believed to be fully

consistent with binding precedent of the

Supreme Court, the Federal Circuit, and

the Federal Circuit’s predecessor courts.

These guidelines do not constitute

substantive rulemaking and hence do

not have the force and effect of law.

They are designed to assist Office

personnel in analyzing claimed subject

matter for compliance with substantive

law. Rejections will be based upon the

substantive law, and it is these

rejections which are appealable.

Consequently, any failure by Office

personnel to follow the guidelines is

neither appealable nor petitionable.
32640 Federal Register / Vol. 63, No. 114 / Monday, June 15, 1998 / Notices

These guidelines are intended to form

part of the normal examination process.

Thus, where Office personnel establish

a prima facie case of lack of written

description for a claim, a thorough

review of the prior art and examination

on the merits for compliance with the

other statutory requirements, including

those of 35 U.S.C. 101, 102, 103, and

112, is to be conducted prior to

completing an Office action which

includes a rejection for lack of written

description.

Office personnel are to rely on these

guidelines in the event of any

inconsistent treatment of issues

involving the written description

requirement between these guidelines

and any earlier guidance provided from

the Office. Although these guidelines

address examples principally drawn

from the biotechnological arts, they are

intended to be equally applicable to all

fields of invention.

I. General Principles Governing

Compliance with the ‘‘Written

Description’’ Requirement for

Applications

The first paragraph of 35 U.S.C. 112

requires that the ‘‘specification shall

contain a written description of the

invention * * *’’ This requirement is

separate and distinct from the

enablement requirement. 4 This written

description requirement has several

policy objectives. ‘‘[T]he ‘‘essential

goal’’ of the description of the invention

requirement is to clearly convey the

information that an applicant has

invented the subject matter which is

claimed.’’ 5 Another objective is to put

the public in possession of what the

applicant claims as the invention. The

written description requirement

prevents an applicant from claiming

subject matter that was not described in

the specification as filed, and the

proscription against the introduction of

new matter in a patent application 6

serves to prevent an applicant from

adding information that goes beyond the

subject matter originally filed.

To satisfy the written description

requirement, a patent specification must

describe the claimed invention in

sufficient detail that one skilled in the

art can reasonably conclude that the

inventor had possession of the claimed

invention. 7 This requirement of the

Patent Act promotes the progress of the

useful arts by ensuring that patentees

adequately describe their inventions in

their patent specifications for the benefit

of the public in exchange for the right

to exclude others from practicing the

invention for the duration of the

patent’s term. 8

II. Evaluate Whether The Application

Complies With the ‘‘Written

Description’’ Requirement

The inquiry into whether the

description requirement is met must be

determined on a case-by-case basis and

is a question of fact. 9 The examiner has

the initial burden of presenting

evidence or reasons why a person

skilled in the art would not recognize in

an applicant’s disclosure a description

of the invention defined by the

claims. 10 Office personnel should

adhere to the following procedures

when reviewing patent applications for

compliance with the written description

requirement of 35 U.S.C. 112, ¶ 1.

A. Review the Entire Application To

Determine What Applicant has

Invented, the Field of the Invention and

the Level of Predictability in the Art

Prior to determining whether the

claims satisfy the written description

requirement, Office personnel should

review the entire specification,

including the specific embodiments,

figures, sequence listings, and the

claims, to understand what applicant

has invented and the correspondence

between what applicant has described,

i.e., has possession of, and what

applicant is claiming. Such a review

should be conducted from the

standpoint of one of skill in the art at

the time the application was filed and

should include a determination of the

field of the invention and, thus, the

level of predictability in the art.

Predictability of the structure of a

species can be premised upon:

(1) Whether the level of skill in the art

leads to a predictability of structure;

and/or

(2) Whether teachings in the

application or prior art lead to a

predictability of structure.

There is an inverse correlation

between the level of predictability in the

art and the amount of disclosure

necessary to satisfy the written

description requirement. For example, if

there is a well-established correlation

between structure and function in the

art, one skilled in the art will be able to

reasonably predict the complete

structure of the claimed invention from

its function. Thus, in some factual

situations, the written description

requirement may be satisfied through

disclosure of function alone when there

is a well-established correlation

between structure and function. In

contrast, without such a correlation,

prediction of structure from function is

highly unlikely. In this latter case,

disclosure of function alone will not

satisfy the written description

requirement. 11

B. For Each Claim, Determine What the

Claim as a Whole Covers

Each claim must be separately

analyzed and given its broadest

reasonable interpretation. 12 The entire

claim, including its preamble language

and transitional phrase, must be

considered. ‘‘Preamble language’’ is that

language in a claim appearing before a

transitional phase, e.g., before

‘‘comprising,’’ ‘‘consisting essentially

of,’’ or ‘‘consisting of’’. The transitional

term ‘‘comprising’’ (and other

comparable terms, e.g., ‘‘containing’’

and ‘‘including’’) is ‘‘open-ended’’—it

covers the expressly recited subject

matter alone or in combination with

other unstated subject matter. 13 There

must be adequate written description to

support the claimed invention including

the preamble. 14 The claim as a whole,

including all limitations found in the

preamble, the transitional phrase, and

the body of the claim, must be described

sufficiently to satisfy the written

description requirement. 15 For claims of

the form ‘‘A [structure] comprising SEQ

ID NO: 1’’ there may be a written

description problem if the claim as a

whole, including its preamble and

transitional phrase, is directed to an

invention of unpredictable structure

that is not fully described.

For example, when the term ‘‘gene,’’

‘‘mRNA,’’ or ‘‘cDNA’’ is recited in the

preamble, it implies a specific structure

(or a small genus of specific structures)

when used in the traditional sense, i.e.,

to mean the structure having the

naturally occurring sequence. Thus, ‘‘A

gene comprising SEQ ID NO: 1’’; ‘‘A

mRNA comprising SEQ ID NO: 1’’; and

‘‘A cDNA comprising SEQ ID NO: 1’’

implicitly recite specific structures such

as promoters, enhancers, coding regions,

and other regulatory elements in the

preamble which must be sufficiently

described in the specification so as to

show the applicant was in possession of

the claimed inventions.

In contrast, use of less specific,

generic preamble language, such as

‘‘composition,’’ ‘‘nucleic acid,’’ ‘‘DNA,’’

and ‘‘RNA,’’ does not typically present

a written description problem. These

terms are sufficiently general that one

skilled in the art can readily envision a

sufficient number of members of the

claimed genus to provide written

description support for the genus.

A claim such as ‘‘A gene comprising

SEQ ID NO: 1,’’ can be viewed as a

species claim in which the preamble

recites a combination and the body of

the claim recites a subcombination: The

‘‘gene’’ is the combination and ‘‘SEQ ID
Federal Register / Vol. 63, No. 114 / Monday, June 15, 1998 / Notices 32641

NO: 1’’ (which is a fragment of the gene)

is the subcombination. Written

description of only the subcombination

(in this example the fragment SEQ ID

NO: 1) normally does not put one in

possession of the combination (in this

example the gene).

Likewise, generic claims to sequences

can be viewed as a genus of such

combination-subcombination claims.

For example, a claim such as ‘‘A nucleic

acid comprising SEQ ID NO: 1’’ can be

viewed as a genus claim in which each

member of the genus (each species) is

itself a combination-subcombination:

Each member of the genus ‘‘nucleic

acid’’ is a combination containing the

subcombination ‘‘SEQ ID NO: 1’’ (which

is a fragment of the nucleic acid). Again,

the generic term ‘‘nucleic acid’’ does not

typically present a written description

problem because one skilled in the art

can readily envision a sufficient number

of members of the claimed genus to

provide written description support for

the genus. 16

C. For Each Claimed Species, Determine

Whether There is Sufficient Written

Description To Inform a Skilled Artisan

That Applicant was in Possession of the

Claimed Invention at the Time the

Application was Filed

Written description may be satisfied

through disclosure of relevant

identifying characteristics, i.e.,

structure, other physical and/or

chemical characteristics, functional

characteristics when coupled with a

known or disclosed correlation between

function and structure, or some

combination of such characteristics.

What is well known to one skilled in the

art need not be disclosed. If a skilled

artisan would have understood the

inventor to be in possession of the

claimed invention at the time of filing,

even if every nuance of the claims is not

explicitly described in the specification,

then the adequate description

requirement is met.

For each claimed species:

(1) Determine whether a complete

structure is disclosed. The complete

structure of a species typically satisfies

the requirement that the description be

set forth in ‘‘such full, clear, concise and

exact terms’’ to show possession of the

claimed invention. If a complete

structure is disclosed, the written

description requirement is satisfied for

that species, and a rejection under 35

U.S.C. 112 ¶ 1 for lack of written

description must not be made.

For example, consider the following

claim:

A probe for use in detecting nucleic acid

sequences coding for enzyme Q from the

genus Bacillus consisting of SEQ ID NO: 16.

Considering the claim as a whole, it

is a species claim covering the probe

SEQ ID NO: 16. The specification

discloses the complete sequence for

SEQ ID NO: 16. Thus, this claim falls

into the ‘‘safe harbor’’ described under

C(1).

(2) If the complete structure is not

disclosed, determine whether the

specification discloses other relevant

identifying characteristics, i.e., physical

and/or chemical characteristics and/or

functional characteristics coupled with

a known or disclosed correlation

between function and structure,

sufficient to describe the claimed

invention in such full, clear, concise

and exact terms that a skilled artisan

would recognize applicant was in

possession of the claimed invention.

Disclosure of any combination of such

identifying characteristics that would

lead one of skill in the art to the

conclusion that the applicant was in

possession of the claimed species is

sufficient. In such a case, a rejection for

lack of written description under 35

U.S.C. 112 ¶ 1 must not be made.

For example, consider the following

claim:

An isolated double-stranded DNA

consisting of (1) a single-stranded DNA

which has a molecular size of 2.57 Kb and

is derived from golden mosaic virus, and (2)

a DNA complementary to said singlestranded DNA, giving the restriction

endonuclease cleavage map shown in

FIG.2(a) and having no Mbo I restriction

endonuclease site.

Although the specification does not

disclose the complete structure for the

claimed DNA, it does disclose sufficient

identifying characteristics, i.e., size,

cleavage map, and source from which

the DNA is derived. Thus, while this

claim does not meet the C(1) criteria

because the complete sequence is not

disclosed, it does meet the C(2) criteria

because one skilled in the art would

recognize from the characteristics, e.g.,

size, map, source, that applicant was in

possession of the claimed material at the

time of filing.

The following protein claim also falls

within the C(2) criteria:

An isolated alginate lyase enzyme wherein

said enzyme lyses alginate in the mucous

substance produced in a patient with cystic

fibrosis and wherein said enzyme has the Nterminal amino acid sequence SEQ ID No. 1,

obtained from Flavobacterium pepermentium

and has the following physicochemical

properties: (1) Activity: lyses alginate to

saccharides having a non-reducing end C4–C5

double bond and ultimately to 4-deoxy-5-

ketouronic acid; (2) Molecular weight: 60,000

daltons; (3) Optimal pH: 8.0; (4) Stable pH:

6.0–8.0; (5) Optimal temperature: 70 degrees

C; and (6) Substrate specificity: alginate.

In this example, the specification

discloses the molecular weight, origin,

activity, and specificity but does not

disclose the complete structure for the

claimed enzyme. Thus, this claim

would not meet the C(1) criteria because

the complete sequence is not disclosed.

However, the claim meets the C(2)

criteria because, although the complete

structure is not disclosed, one skilled in

the art would recognize from the

disclosed physical characteristics—e.g.,

molecular weight, origin, activity, and

specificity—that applicant was in

possession of the claimed material at the

time of filing.

In contrast, consider the following

claim:

An isolated nucleotide sequence

consisting of the sequence of the reverse

transcript of a human mRNA, which

mRNA encodes insulin.

The specification in this example

provides the coding sequence for rat

insulin but not that for human insulin.

The description for the reverse

transcript of human mRNA is limited to

its function, encoding human insulin,

and to a method for isolating the

claimed sequence from its natural

source. A sequence described only by a

purely functional characteristic, without

any known or disclosed correlation

between that function and the structure

of the sequence, normally is not a

sufficient identifying characteristic for

written description purposes, even

when accompanied by a method of

obtaining the claimed species. In this

case, even though a genetic code table

would correlate a known insulin amino

acid sequence with a genus of coding

nucleic acids, the same table cannot

predict the native, naturally occurring

nucleic acid sequence of human mRNA

or its corresponding cDNA. Thus, the

specification in this example does not

provide adequate written description,

either under the C(1) or C(2) criteria.

Any claim to a species that does not

meet the test described under C(1) or

C(2)must be rejected as lacking adequate

written description under 35 U.S.C. 112

¶ 1.
32642 Federal Register / Vol. 63, No. 114 / Monday, June 15, 1998 / Notices

D. For Each Claimed Genus, Determine

Whether There is Sufficient Written

Description to Inform a Skilled Artisan

That Applicant was in Possession of the

Claimed Genus at the Time the

Application was Filed

The written description requirement

for a claimed genus may be satisfied

through sufficient description of a

representative number of species by

relevant identifying characteristics, i.e.,

structure or other physical and/or

chemical characteristics, by functional

characteristics coupled with a known or

disclosed correlation between function

and structure, or by a combination of

such identifying characteristics,

sufficient to show the applicant was in

possession of the claimed genus. A

‘‘representative number of species’’

requires that the species which are

expressly described be representative of

the entire genus. Thus, when there is

substantial variation within the genus, it

may require a description of the various

species which reflect the variation

within the genus. For example, a

broadly drawn claim to a specific gene

from ruminant mammals may require a

representative species from cattle,

buffalo, bison, goat, deer, antelope,

camel, giraffe and llama.

What constitutes a ‘‘representative

number’’ is an inverse function of the

predictability of the art, as determined

in IIA above. The number must be

sufficient to reasonably identify the

other members of genus. In an

unpredictable art, adequate written

description of a genus cannot be

achieved by disclosing only one species

within the genus. In fact, if the members

of the genus are expected to vary widely

in their identifying characteristics, such

as structure and activity, written

description for each member within the

genus may be necessary.

Generalized descriptions alone, such

as ‘‘vertebrate insulin cDNA’’ or

‘‘mammalian insulin cDNA,’’ fail to

satisfy the written description

requirement because they do not

describe any members of the genus

except by function without any known

or disclosed correlation between

function and structure.24 If the

correlation between structure and

function in the art would not have been

known to one skilled in the art and the

specification does not describe the

correlation, the written descriptive

support cannot depend on that

correlation.

For each claim to a genus:

(1) Determine whether a

representative number of species have

been described by complete structure as

in C(1) above. If a representative number

have been so described, then the

applicant has written description

support for the claimed genus and a

rejection under 112 ¶ 1 for lack of

written description must not be made.

For example, consider the following

claim to a genus:

An isolated DNA probe for detecting HIV–

X, wherein said DNA probe hybridizes to the

nucleotide sequence set forth in SEQ ID NO:1

under the following conditions:

hybridization in 7% sodium dodecyl sulfate

(SDS), 0.5M NaPO 4 pH 7.0, 1mM EDTA at

50° C.; and washing with 1% SDS at 42° C.

In this case, the specification

discloses the sequence of the isolated

DNA molecule consisting of SEQ ID NO:

1 and discloses several sequences that

hybridize to SEQ ID NO: 1.

Hybridization under the stringent

conditions specified here requires that

the claimed nucleic acid probes be

structurally similar to the complement

of the nucleic acid sequence disclosed

as SEQ ID NO: 1. In this case, the

description as a whole is sufficient to

evidence possession of the claimed

genus because the genus is defined by

relation to the structure of the sequence

provided as SEQ ID NO: 1, and because

several species are disclosed that

possess the hybridization property

which further defines the genus. Thus,

this claim to a genus meets the D(1)

criteria.

(2) For each claim to a genus not

supported as described under D(1),

determine whether there is a

representative number of adequately

described species, as analyzed under

C(2). The representative number must

permit one skilled in the art to

reasonably identify the remaining

members of the genus. If a

representative number are so described,

then the written description

requirement is satisfied and, again, a

rejection under 112 ¶ 1 for lack of

written description must not be made.

For example, consider the following

claim to a genus:

A monoclonal antibody which specifically

binds to the novel cancer associated TAG–31

antigen but which does not substantially

bind normal adult human tissues, wherein

said monoclonal antibody has a binding

affinity of greater than 3 times 10 9 M–-1 for

TAG–31.

Considering the claim as a whole, it

is drawn to a genus of monoclonal

antibodies. Although the specification

does not disclose the complete structure

of a representative number of species to

support the claimed genus of antibodies,

it does disclose multiple monoclonal

antibodies which have the isotype

claimed as well as the binding

specificity and binding affinity

characteristics recited in the claims. In

this well-developed art, additional

identifying characteristics for a

substantial portion of the genus are

well-known (e.g., number of chains,

disulfide bonds, constant and variable

regions, etc.). Thus, applicant’s

disclosure combined with what was

known in the art are sufficient to

describe the claimed genus of

monoclonal antibodies in such full,

clear, concise and exact terms to show

applicant was in possession of the

claimed antibodies. Thus, the claim

meets the D(2) criteria.

As another example, consider the

following claim to a genus:

An isolated mutanase enzyme produced by

Bacillus having the following

physicochemical properties (1) to (9): (1)

action: an ability to cleave alpha-1,3-

glucosidic links of mutan; (2) substrate

specificity: an ability to effectively

decompose mutan; (3) optimum pH: pH 4 to

4.5 when reacting on a mutan substrate at 35

degrees C for 10 minutes; (4) pH range for

stability: pH 4 to 10 when kept at 25 degrees

C for 24 hours; (5) optimum temperature: 50

degrees to 65 degrees C when reacted at pH

5 with mutan as a substrate; (6) thermal

stability: enzyme activity remains stable

below 50 degrees C after incubation at pH 5

for 10 minutes; (7) effect of metal ions:

mercury and silver show inhibitory effect on

a mutan substrate; (8) effect of inhibitors: pchloromercurybenzoic acid shows inhibitory

effect on a mutan substrate; and (9) molecular

weight: about 140,000 to about 160,000 as

determined by SDS-polyacrylamide gel

electrophoresis.

Considering the claim as a whole, it

covers a genus of mutanase enzymes.

Although the specification does not

disclose the complete structure of a

representative number of species to

support the claimed genus of enzyme

compositions, it does disclose 3

mutanase species produced by different

strains of Bacillus (mutanases A, B and

C) which are identified by multiple

relevant identifying characteristics, i.e.,

molecular weight, substrate specificity,

optimum and ranges of temperature and

pH for mutan cleavage activity, etc. In

this well-developed art, these

identifying characteristics are sufficient

for a skilled artisan to recognize

applicant had possession of the species

from the identifying characteristics of

the three mutanase species, to

reasonably predict sufficient identifying

characteristics of the other members of

the genus and, thus, establish

possession of the genus. Thus, the claim

meets the D(2) criteria.

As another example, consider the

following claim to a genus:
Federal Register / Vol. 63, No. 114 / Monday, June 15, 1998 / Notices 32643

A DNA comprising a novel DF3 enhancer

and DNA encoding a heterologous gene but

not encoding DF3 wherein said DF3

enhancer consists of SEQ ID NO: 1.

Considering the claim as a whole, it

covers a genus of DNA. The

specification does not describe a

representative number of members of

the genus by complete structure. Thus,

the claim does not meet the D(1)

criteria. However, there is sufficient

disclosure of identifying characteristics

common to the members of the genus,

i.e., DF3 enhancer, to meet the D(2)

criteria. Because of the nature of the

generic term ‘‘DNA,’’ one skilled in the

art could envision a sufficient number

of the members of the genus to describe

the invention in such full, clear and

concise terms as to show possession of

the invention at the time of filing.

In contrast, consider the claim:

An isolated nucleic acid comprising the

structure of the reverse transcript of a

mammalian mRNA, which mRNA encodes

insulin.

Considering the claim as a whole, the

claim covers the genus of nucleotide

sequences encoding mammalian

insulin. The specification only provides

the coding sequence for rat insulin

cDNA and a method to isolate the

coding sequence from its natural

source.25 This description does not meet

the criteria of D(1) or D(2) and thus does

not satisfy the written description

requirement.

Also contrast the claim ‘‘A gene

comprising SEQ ID NO: 1.’’ Although all

genes encompassed by this claim share

the characteristic of comprising SEQ ID

NO: 1, and as such might appear to meet

the D(2) criteria, there is insufficient

description of the characteristics (e.g.,

promoters, enhancers, coding regions,

and other regulatory elements) which

identify the genes, as opposed to any

DNA comprising SEQ ID NO: 1.

If sufficient identifying characteristics

are not disclosed for a given genus, as

described in D(1) or D(2), the claim to

that genus must be rejected as lacking

adequate written description under 35

U.S.C. 112 ¶ 1.

III. Complete Patentability

Determination Under All Statutory

Requirements and Clearly

Communicate Findings, Conclusions

and Their Bases

The above only describes how to

determine whether the written

description requirement of 35 U.S.C.

112 ¶ 1 is satisfied. Regardless of the

outcome of that determination, Office

personnel must complete the

patentability determination under all

the relevant statutory provisions of the

Patent Act.

Once Office personnel have

concluded analysis of the claimed

invention under all the statutory

provisions, including 35 U.S.C. 101,

112, 102 and 103, they should review all

the proposed rejections and their bases

to confirm their correctness. Only then

should any rejection be imposed in an

Office action. The Office action should

clearly communicate the findings,

conclusions and reasons which support

them.

Specific to these guidelines:

A. For Each Claim Lacking Written

Description Support, Reject the Claim

Under Section 112, ¶ 1, for Lack of

Adequate Written Description

In rejecting a claim, set forth express

findings of fact regarding the above

analysis which support the lack of

written description conclusion. These

findings should:

(1) identify the claim limitation not

described; and

(2) provide reasons why a person

skilled in the art at the time the

application was filed would not have

recognized the description of this

limitation in view of the disclosure of

the application as filed.

When appropriate, suggest

amendments to the claims which would

bring the claims into compliance with

the written description in the

specification, bearing in mind the

prohibition against new matter in the

claims and corresponding description

set forth in 35 U.S.C. 112 and 132.

B. Upon Reply by Applicant, Again

Determine the Patentability of the

Claimed Invention, Including Whether

the Written Description Requirement is

Satisfied by Performing the Analysis

Described Above in View of the Whole

Record

Upon reply by applicant, before

repeating any rejection under Section

112 ¶ 1 for lack of written descriptive

basis, review the basis for the rejection

in view of the record as a whole,

including amendments, arguments and

any evidence submitted by applicant. If

the whole record now demonstrates that

the written description requirement is

satisfied, do not repeat the rejection in

the next Office action. If the record still

does not demonstrate that written

description is adequate to support the

claim(s), repeat the rejection under 35

U.S.C. 112 ¶ 1, fully respond to

applicant’s rebuttal arguments, and

properly treat any further showings

submitted by applicant in the reply.

Any affidavits, including those relevant

to the 112 ¶1 written description

requirement, must be thoroughly

analyzed and discussed in the Office

action.

Endnotes

1. 119 F.3d 1559, 43 USPQ2d 1398 (Fed.

Cir. 1997).

2. 984 F.2d 1164, 25 USPQ2d 1601 (Fed.

Cir. 1993).

3. 927 F.2d 1200, 18 USPQ2d 1016 (Fed.

Cir. 1991).

4. E.g., Vas-Cath, Inc. v. Mahurkar, 935

F.2d 1555, 1560, 19 USPQ2d 1111, 1115

(Fed. Cir. 1991).

5. In re Barker, 559 F.2d 588, 592 n.4, 194

USPQ 470, 473 n.4 (CCPA 1977).

6. 35 U.S.C. §§ 132 & 251.

7. E.g., Vas-Cath, Inc. v. Mahurkar, 935

F.2d 1555, 1563, 19 USPQ2d 1111, 1116

(Fed. Cir. 1991). Much of the written

description case law addresses whether the

specification as originally filed supports

claims not originally in the application. The

issue raised in the cases is most often

phrased as whether the original application

provides ‘‘adequate support’’ for the claims at

issue or whether the material added to the

specification incorporates ‘‘new matter’’ in

violation of 35 U.S.C. § 132. The ‘‘written

description’’ question similarly arises in the

interference context, where the issue is

whether the specification of one party to the

interference can support the newly added

claims corresponding to the count at issue,

i.e., whether that party can ‘‘make the claim’’

corresponding to the interference count. E.g.,

see Martin v. Mayer, 823 F.2d 500, 502, 3

USPQ2d 1333, 1335 (Fed. Cir. 1987).

In addition, early opinions suggest the

Patent and Trademark Office was unwilling

to find written descriptive support when the

only description was found in the claims;

however, this viewpoint was rejected. See In

re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA

1980) (original claims constitute their own

description); In re Gardner, 475 F.2d 1389,

177 USPQ 396 (CCPA 1973) (accord); In re

Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA

1976) (accord). It is now well-accepted that

a satisfactory description can be mined from

the claims or any other portion of the

originally filed specification.

These early opinions did not address the

quality or specificity of particularity that was

required in the description, i.e., how much

description is enough.

8. See Eli Lilly, 119 F.3d at 1566, 43

USPQ2d at 1404.

9. See In re Smith, 458 F.2d 1389, 1395,

173 USPQ 679, 683 (CCPA 1972) (‘‘Precisely

how close [to the claimed invention] the

description must come to comply with § 112

must be left to a case-by-case development.’’);

In re Wertheim, 541 F.2d 257, 262, 191 USPQ

90, 96 (CCPA 1976) (inquiry is primarily

factual and depends on the nature of the

invention and the amount of knowledge

imparted to those skilled in the art by the

disclosure).

10. Wertheim, 541 F.2d at 262, 191 USPQ

at 96.

11. See Eli Lilly, 119 F.3d at 1568, 43

USPQ2d at 1406 (written description

requirement not satisfied by merely

providing ‘‘a result that one might achieve if

one made that invention’’); In re Wilder, 736

F.2d 1516, 1521, 222 USPQ 369, 372–73
32644 Federal Register / Vol. 63, No. 114 / Monday, June 15, 1998 / Notices

(Fed. Cir. 1984) (affirming a rejection for lack

of written description because the

specification does ‘‘little more than outline

goals appellants hope the claimed invention

achieves and the problems the invention will

hopefully ameliorate’’).

12. See, e.g., In re Morris, 127 F.3d 1048,

1053–54, 44 USPQ2d 1023, 1027 (Fed. Cir.

1997).

13. See, e.g., Ex parte Davis, 80 USPQ 448,

450 (1948) (‘‘comprising’’ leaves the ‘‘claim

open for the inclusion of unspecified

ingredients even in major amounts’’.), quoted

with approval in Moleculon Research Corp v.

CBS, Inc., 793 F.2d 1261, 1271, 229 USPQ

805, 812 (Fed. Cir. 1986).

14. See Pac-Tec Inc. v. Amerace Corp., 903

F.2d 796, 801, 14 USPQ2d 1871, 1876 (Fed.

Cir. 1990) (determining that preamble

language that constitutes a structural

limitation is actually part of the claimed

invention).

15. An applicant shows possession of the

claimed invention by describing the claimed

invention with all of its limitations.

Lockwood v. American Airlines, Inc., 107

F.3d 1565, 1572, 41 USPQ2d 1961, 1966

(Fed. Cir. 1997).

16. E.g., Eli Lilly, 119 F.3d at 1568, 43

USPQ2d at 1405–06.

17. A ‘‘relevant identifying characteristic’’

is one that would provide evidence that

applicant was in possession of what is

claimed. For example, the presence of a

restriction enzyme map of a gene may be

relevant to a statement that the gene has been

isolated. One skilled in the art could

determine whether the gene disclosed was

the same as or different than a gene isolated

by another by comparing the restriction

enzyme map. In contrast, evidence that the

gene could be digested with a nuclease

would not normally represent a relevant

characteristic since any gene would be

digested with a nuclease.

Examples of identifying characteristics

include a sequence, structure, binding

affinity, binding specificity, molecular

weight and length. Although structural

formulas provide a convenient method of

demonstrating possession of specific

molecules, other identifying characteristics

can demonstrate the requisite possession. For

example, unique cleavage by particular

enzymes, isoelectric points of fragments,

detailed restriction enzyme maps, a

comparison of enzymatic activities, or

antibody cross reactivity may be sufficient to

show possession of the claimed invention to

one of skill in the art. See Lockwood v.

American Airlines, Inc., 107 F.3d 1565, 1572,

41 USPQ2d 1961, 1966 (1997) (‘‘written

description’’ requirement may be satisfied by

using ‘‘such descriptive means as words,

structures, figures, diagrams, formulas, etc.

that fully set forth the claimed invention’’).

However, a definition by function alone

‘‘does not suffice’’ to sufficiently describe a

coding sequence ‘‘because it is only an

indication of what the gene does, rather than

what it is.’’ Eli Lilly, 119 F.3 at 1568, 43

USPQ2d at 1406. See also Fiers, 984 F.2d at

1169–71, 25 USPQ2d at 1605–06 (discussing

Amgen).

18. See Hybritech Inc. v. Monoclonal

Antibodies, Inc., 802 F.2d 1367, 1379–80, 231

USPQ 81, 90 (Fed. Cir. 1986).

19. See, e.g., Vas-Cath, 935 F.2d at 1563,

19 USPQ2d at 1116; Martin v. Johnson, 454

F.2d 746, 751, 172 USPQ 391, 395 (CCPA

1972) (stating ‘‘the description need not be in

ipsis verbis to be sufficient’’).

20. 35 U.S.C. § 112 ¶ 1. Cf. Fields v.

Conover, 443 F.2d 1386, 1392, 170 USPQ

276, 280 (CCPA 1971) (finding a lack of

written description because the specification

lacked the ‘‘full, clear, concise, and exact

written description’’ which is necessary to

support the claimed invention).

21. The examples contained within these

guidelines are not intended to represent the

minimum requirements necessary to comply

with 35 U.S.C. § 112 ¶ 1.

22. See Eli Lilly, 119 F.3d at 1568, 43

USPQ2d at 1406.

23. See id. at 1568, 43 USPQ2d at 1406.

24. Cf. Eli Lilly, 119 F.3d at 1567, 43

USPQ2d at 1405 (stating that ‘‘The name

cDNA is not itself a written description of

that DNA; it conveys no distinguishing

information concerning itself.’’).

25. See id. 1568, 43 USPQ2d at 1406.

Dated: June 9, 1998.

Bruce A. Lehman,

Assistant Secretary of Commerce and

Commissioner of Patents and Trademarks.

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[FR Doc. 98–15777 Filed 6–12–98; 8:45 am]

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