Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices 1099

an asserted utility, unless countervailing

evidence can be provided that shows

that one of ordinary skill in the art

would have a legitimate basis to doubt

the credibility of such a statement.

Similarly, Office personnel must accept

an opinion from a qualified expert that

is based upon relevant facts whose

accuracy is not being questioned; it is

improper to disregard the opinion solely

because of a disagreement over the

significance or meaning of the facts

offered.

Once a prima facie showing of no

specific and substantial credible utility

has been properly established, the

applicant bears the burden of rebutting

it. The applicant can do this by

amending the claims, by providing

reasoning or arguments, or by providing

evidence in the form of a declaration

under 37 CFR 1.132 or a patent or a

printed publication that rebuts the basis

or logic of the prima facie showing. If

the applicant responds to the prima

facie rejection, the Office personnel

should review the original disclosure,

any evidence relied upon in establishing

the prima facie showing, any claim

amendments, and any new reasoning or

evidence provided by the applicant in

support of an asserted specific and

substantial credible utility. It is essential

for Office personnel to recognize, fully

consider and respond to each

substantive element of any response to

a rejection based on lack of utility. Only

where the totality of the record

continues to show that the asserted

utility is not specific, substantial, and

credible should a rejection based on

lack of utility be maintained.

If the applicant satisfactorily rebuts a

prima facie rejection based on lack of

utility under § 101, withdraw the § 101

rejection and the corresponding

rejection imposed under § 112, first

paragraph.

Dated: December 29, 2000.

Q. Todd Dickinson,

Under Secretary of Commerce for Intellectual

Property and Director of the United States

Patent and Trademark Office.

[FR Doc. 01–322 Filed 1–4–01; 8:45 am]

BILLING CODE 3510–16–U

DEPARTMENT OF COMMERCE

United States Patent and Trademark

Office

[Docket No. 991027288–0264–02]

RIN 0651–AB10

Guidelines for Examination of Patent

Applications Under the 35 U.S.C. 112,

¶ 1, ‘‘Written Description’’ Requirement

AGENCY: United States Patent and

Trademark Office, Commerce.

ACTION: Notice.

SUMMARY: These Guidelines will be used

by USPTO personnel in their review of

patent applications for compliance with

the ‘‘written description’’ requirement

of 35 U.S.C. 112, ¶ 1. These Guidelines

supersede the ‘‘Revised Interim

Guidelines for Examination of Patent

Applications Under the 35 U.S.C. 112,

¶ 1 ‘Written Description’ Requirement’’

that were published in the Federal

Register at 64 FR 71427, Dec. 21, 1999,

and in the Official Gazette at 1231 O.G.

123, Feb. 29, 2000. These Guidelines

reflect the current understanding of the

USPTO regarding the written

description requirement of 35 U.S.C.

112, ¶ 1, and are applicable to all

technologies.

DATES: The Guidelines are effective as of

January 5, 2001.

FOR FURTHER INFORMATION CONTACT:

Stephen Walsh by telephone at (703)

305–9035, by facsimile at (703) 305–

9373, by mail to his attention addressed

to United States Patent and Trademark

Office, Box 8, Washington, DC 20231, or

by electronic mail at

‘‘stephen.walsh@uspto.gov’’; or Linda

Therkorn by telephone at (703) 305–

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

mail addressed to Box Comments,

Commissioner for Patents, Washington,

DC 20231, or by electronic mail at

‘‘linda.therkorn@uspto.gov.’’

SUPPLEMENTARY INFORMATION: As of the

publication date of this notice, these

Guidelines will be used by USPTO

personnel in their review of patent

applications for compliance with the

‘‘written description’’ requirement of 35

U.S.C. 112, ¶ 1. Because these

Guidelines only govern internal

practices, they are exempt from notice

and comment rulemaking under 5

U.S.C. 553(b)(A).

Discussion of Public Comments

Comments were received from 48

individuals and 18 organizations in

response to the request for comments on

the ‘‘Revised Interim Guidelines for

Examination of Patent Applications

Under the 35 U.S.C. 112, ¶ 1 ‘Written

Description’ Requirement’’ published in

the Federal Register at 64 FR 71427,

Dec. 21, 1999, and in the Official

Gazette at 1231 O.G. 123, Feb. 29, 2000.

The written comments have been

carefully considered.

Overview of Comments

The majority of comments favored

issuance of final written description

guidelines with minor revisions.

Comments pertaining to the written

description guidelines are addressed in

detail below. A few comments

addressed particular concerns with

respect to the associated examiner

training materials that are available for

public inspection at the USPTO web site

(www.uspto.gov). Such comments will

be taken under advisement in the

revision of the training materials;

consequently, these comments are not

specifically addressed below as they do

not impact the content of the

Guidelines. Several comments raised

issues pertaining to the patentability of

ESTs, genes, or genomic inventions with

respect to subject matter eligibility (35

U.S.C. 101), novelty (35 U.S.C. 102), or

obviousness (35 U.S.C. 103). As these

comments do not pertain to the written

description requirement under 35 U.S.C.

112, they have not been addressed.

However, the aforementioned comments

are fully addressed in the ‘‘Discussion of

Public Comments’’ in the ‘‘Utility

Examination Guidelines’’ Final Notice,

which will be published at or about the

same time as the present Guidelines.

Responses to Specific Comments

(1) Comment: One comment stated

that the Guidelines instruct the patent

examiner to determine the

correspondence between what applicant

has described as the essential

identifying characteristic features of the

invention and what applicant has

claimed, and that such analysis will

lead to error. According to the comment,

the examiner may decide what

applicant should have claimed and

reject the claim for failure to claim what

the examiner considers to be the

invention. Another comment suggested

that the Guidelines should clarify what

is meant by ‘‘essential features of the

invention.’’ Another comment suggested

that what applicant has identified as the

‘‘essential distinguishing

characteristics’’ of the invention should

be understood in terms of Fiers v. Revel,

984 F.2d 1164, 1169, 25 USPQ2d 1601,

1605 (Fed. Cir. 1993) (‘‘Conception of a

substance claimed per se without

reference to a process requires

conception of its structure, name,

1100 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices

formula, or definitive chemical or

physical properties.’’).

Response: The suggestions have been

adopted in part. The purpose of the

written description analysis is to

confirm that applicant had possession of

what is claimed. The Guidelines have

been modified to instruct the examiners

to compare the scope of the invention

claimed with the scope of what

applicant has defined in the description

of the invention. That is, the Guidelines

instruct the examiner to look for

consistency between a claim and what

provides adequate factual support for

the claim as judged by one of ordinary

skill in the art from reading the

corresponding written description.

(2) Comment: Two comments urge

that Regents of the University of

California v. Eli Lilly & Co., 119 F.3d

1559, 43 USPQ2d 1398 (Fed. Cir. 1997),

is bad law and should not be followed

by the USPTO because it conflicts with

binding precedent, such as Vas-Cath v.

Mahurkar, 935 F.2d 1555, 19 USPQ2d

1111 (Fed. Cir. 1991). Response: The

final Guidelines are based on the

Office’s current understanding of the

law and are believed to be fully

consistent with binding precedent of the

U.S. Supreme Court and the U.S. Court

of Appeals for the Federal Circuit. Eli

Lilly is a precedential decision by the

Court that has exclusive jurisdiction

over appeals involving patent law.

Accordingly, the USPTO must follow Eli

Lilly. Furthermore, the USPTO does not

view Eli Lilly as conflicting with VasCath. Vas-Cath explains that the

purpose of the written description

requirement is to ensure that the

applicant has conveyed to those of skill

in the art that he or she was in

possession of the claimed invention at

the time of filing. Vas-Cath, 935 F.2d at

1563–64, 19 USPQ2d at 1117. Eli Lilly

explains that a chemical compound’s

name does not necessarily convey a

written description of the named

chemical compound, particularly when

a genus of compounds is claimed. Eli

Lilly, 119 F.3d at 1568, 43 USPQ2d at

1405. The name, if it does no more than

distinguish the claimed genus from all

others by function, does not satisfy the

written description requirement because

‘‘it does not define any structural

features commonly possessed by

members of the genus that distinguish

them from others. One skilled in the art

therefore cannot, as one can do with a

fully described genus, visualize or

recognize the identity of the members of

the genus.’’ Eli Lilly, 119 F.3d at 1568,

43 USPQ2d at 1406. Thus, Eli Lilly

identified a set of circumstances in

which the words of the claim did not,

without more, adequately convey to

others that applicants had possession of

what they claimed.

(3) Comment: Several comments

urged that the Guidelines do not

recognize the inconsistency between the

original claim doctrine and the written

description requirement as set out in

Fiers and Eli Lilly. On the other hand,

another comment asserts that there is no

strong presumption that an originally

filed claim constitutes an adequate

written description of the claimed

subject matter. Several comments

indicate that in haec verba support

should be sufficient to comply with the

written description requirement. Two

comments urge that the concept of

constructive reduction to practice upon

filing of an application has been

ignored. Response: As noted above, the

USPTO does not find Fiers and Eli Lilly

to be in conflict with binding precedent.

An original claim may provide written

description for itself, but it still must be

an adequate written description which

establishes that the inventor was in

possession of the invention. The

‘‘original claim doctrine’’ is founded on

cases which stand for the proposition

that originally filed claims are part of

the written description of an application

as filed, and thus subject matter which

is present only in originally filed claims

need not find independent support in

the specification. See, e.g., In re Koller,

613 F.2d 819, 824, 204 USPQ 702, 706

(CCPA 1980) (later added claims of

similar scope and wording were

adequately described by original

claims); In re Gardner, 480 F.2d 879,

880, 178 USPQ 149, 149 (CCPA 1973)

(‘‘Under these circumstances, we

consider the original claim in itself

adequate ‘written description’ of the

claimed invention. It was equally a

‘written description’ * * * whether

located among the original claims or in

the descriptive part of the

specification.’’). However, as noted in

the preceding comment, Eli Lilly

identified a set of circumstances in

which the words of the claim did not,

without more, adequately convey to

others that applicants had possession of

what they claimed. When the name of

a novel chemical compound does not

convey sufficient structural information

about the compound to identify the

compound, merely reciting the name is

not enough to show that the inventor

had possession of the compound at the

time the name was written. The

Guidelines indicate that there is a

‘‘strong presumption’’ that an adequate

written description of the claimed

invention is present when the

application is filed, consistent with In re

Wertheim, 541 F.2d 257, 263, 191 USPQ

90, 97 (CCPA 1976) (‘‘we are of the

opinion that the PTO has the initial

burden of presenting evidence or

reasons why persons skilled in the art

would not recognize in the disclosure a

description of the invention defined by

the claims.’’). In most cases, the

statement that ‘‘an originally filed claim

is its own written description,’’ is borne

out because the claim language conveys

to others of skill in the art that the

applicant was ‘‘in possession’’ of what

is claimed. The Guidelines emphasize

that the burden of proof is on the

examiner to establish that a description

as filed is not adequate and require the

examiner to introduce sufficient

evidence or technical reasoning to shift

the burden of going forward with

contrary evidence to the applicant.

(4) Comment: One comment stated

that the Guidelines change the

substance of the written description

requirement to require some level of

enablement. The comment stated that

the Eli Lilly case should not be followed

because its change in the quality of the

description required is in conflict with

precedent. Another comment suggested

that to comply with the written

description requirement, the description

must both (i) demonstrate possession of

the claimed invention by the applicant;

and (ii) put the public in possession of

the claimed invention. Response: As

noted in the comment above, the

USPTO is bound by the Federal

Circuit’s decision in Eli Lilly. The

Guidelines have been revised to clarify

that an applicant must provide a

description of the claimed invention

which shows that applicant was in

possession of the claimed invention.

The suggestion to emphasize that the

written description requirement must

put the public in possession of the

invention has not been adopted because

it removes much of the distinction

between the written description

requirement and the enablement

requirement. Although the two concepts

are entwined, they are distinct and each

is evaluated under separate legal

criteria. The written description

requirement, a question of fact, ensures

that the inventor conveys to others that

he or she had possession of the claimed

invention; whereas, the enablement

requirement, a question of law, ensures

that the inventor conveys to others how

to make and use the claimed invention.

(5) Comment: One comment suggested

that the Guidelines should provide

examples of situations in which the

written description requirement was

met but the enablement requirement

was not, and vice versa. Another

comment stated that examiners often

use enablement language in making

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices 1101

written description rejections.

Response: The enablement and written

description requirements are not

coextensive and, therefore, situations

will arise in which one requirement is

met but the other is not. Federal Circuit

case law demonstrates many

circumstances where enablement or

written description issues, but not both,

were before the Court. These Guidelines

are intended to clarify for the examining

corps the criteria needed to satisfy the

written description requirement. For

examples applying these Guidelines to

hypothetical fact situations, see the

‘‘Synopsis of Application of Written

Description Guidelines’’ (examiner

training materials available on-line at

http://www.uspto.gov/web/menu/

written.pdf). These examples, as well as

the examination form paragraphs and

instructions on their proper use, provide

the appropriate language examiners

should use in making written

description rejections.

(6) Comment: One comment disagreed

with the statement in an endnote that

‘‘the fact that a great deal more than just

a process is necessary to render a

product invention obvious means that a

great deal more than just a process is

necessary to provide written description

for a product invention.’’ The comment

indicated that the statement is overly

broad and inconsistent with the ‘‘strong

presumption that an adequate written

description of the claimed invention is

present when the application is filed.’’

As an extreme case, for example, for

product-by-process claims, nothing else

would be needed to provide the written

description of the product. Response:

The endnote has been clarified and is

now more narrowly drawn. However,

there is no per se rule that disclosure of

a process is sufficient to adequately

describe the products produced by the

process. In fact, Fiers v. Revel and Eli

Lilly involved special circumstances

where the disclosure of a process of

making and the function of the product

alone did not provide an adequate

written description for product claims.

Even when a product is claimed in a

product-by-process format, the

adequacy of the written description of

the process to support product claims

must be evaluated on a case-by-case

basis.

(7) Comment: Several comments urge

that actual reduction to practice, as a

method of satisfying the written

description requirement by

demonstrating possession, has been

over-emphasized. Response: The

Guidelines have been clarified to state

that describing an actual reduction to

practice is one of a number of ways to

show possession of the invention.

Description of an actual reduction to

practice offers an important ‘‘safe

haven’’ that applies to all applications

and is just one of several ways by which

an applicant may demonstrate

possession of the claimed invention.

Actual reduction to practice may be

crucial in the relatively rare instances

where the level of knowledge and level

of skill are such that those of skill in the

art cannot describe a composition

structurally, or specify a process of

making a composition by naming

components and combining steps, in

such a way as to distinguish the

composition with particularity from all

others. Thus, the emphasis on actual

reduction to practice is appropriate in

those cases where the inventor cannot

provide an adequate description of what

the composition is, and a definition by

function is insufficient to define a

composition ‘‘because it is only an

indication of what the [composition]

does, rather than what it is.’’ Eli Lilly,

119 F.3d at 1568, 43 USPQ at 1406. See

also Amgen Inc. v. Chugai

Pharmaceutical Co., 927 F.2d 1200,

1206, 18 USPQ2d 1016, 1021 (Fed. Cir.

1991).

(8) Comment: One comment asserts

that the citation to Pfaff v. Wells

Electronics, Inc., 525 U.S. 55, 48

USPQ2d 1641 (1998) is inappropriate

and should be deleted because Pfaff is

concerned with § 102(b) on-sale bar, not

written description. Another comment

suggested that the Guidelines should

provide an explanation of how the

‘‘ready for patenting’’ concept of Pfaff

should be used in determining

compliance with the written description

requirement. Response: The Guidelines

state the general principle that actual

reduction to practice is not required to

show possession of, or to adequately

describe, a claimed invention (although,

as noted in the previous comment, an

actual reduction to practice is crucial in

relatively rare instances). An alternative

is to show that the invention described

was ‘‘ready for patenting’’ as set out in

Pfaff. For example, a description of

activities that demonstrates the

invention was ‘‘ready for patenting’’

satisfies the written description

requirement. As Wertheim indicates,

‘‘how the specification accomplishes

this is not material.’’ 541 F.2d at 262,

191 USPQ at 96.

(9) Comment: One comment stated

that the written description of a claimed

DNA should be required to include the

complete sequence of the DNA and

claims should be limited to the DNA

sequence disclosed. Response:

Describing the complete chemical

structure, i.e., the DNA sequence, of a

claimed DNA is one method of

satisfying the written description

requirement, but it is not the only

method. See Eli Lilly, 119 F.3d at 1566,

43 USPQ2d at 1404 (‘‘An adequate

written description of a DNA * * *

requires a precise definition, such as by

structure, formula, chemical name, or

physical properties.’’ (emphasis added,

internal quote omitted)). Therefore,

there is no basis for a per se rule

requiring disclosure of complete DNA

sequences or limiting DNA claims to

only the sequence disclosed.

(10) Comment: One comment stated

that it is difficult to envision how one

could provide a description of sufficient

identifying characteristics of the

invention without physical possession

of a species of the invention, and thus

this manner of showing possession

should be considered as a way to show

actual reduction to practice. Response:

This suggestion has not been adopted.

The three ways of demonstrating

possession as set forth in the Guidelines

are merely exemplary and are not

mutually exclusive. While there are

some cases where a description of

sufficient relevant identifying

characteristics will evidence an actual

reduction to practice, there are other

cases where it will not. See, e.g., Ralston

Purina Co. v. Far-Mar-Co, Inc., 772 F.2d

1570, 1576, 227 USPQ 177, 180 (Fed.

Cir. 1985) (disclosure taken with the

knowledge of those skilled in the art

may be sufficient support for claims).

(11) Comment: One comment stated

that the Guidelines should be revised to

indicate that the test of disclosure of

sufficiently detailed drawings should be

expanded to include structural claiming

of chemical entities. Response: The

suggestion has been adopted.

(12) Comment: One comment stated

that the Guidelines should reflect that

an inventor is in possession of the

invention when the inventor

demonstrably has at least a complete

conception thereof, and that factors and

attributes which provide proof of

written description should include

evidence typically provided to prove a

complete conception. Response: The

suggestion has not been adopted

because the conception analysis

typically involves documentary

evidence in addition to the description

of the invention in the application as

filed. However, it is acknowledged that

if evidence typically provided to prove

a complete conception is present in the

specification as filed, it would be

sufficient to show possession. The

Federal Circuit has stated ‘‘[t]he

conception analysis necessarily turns on

the inventor’s ability to describe his

invention with particularity. Until he

can do so, he cannot prove possession

1102 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices

of the complete mental picture of the

invention.’’ Burroughs Wellcome Co. v.

Barr Labs., Inc., 40 F.3d 1223, 1228, 32

USPQ2d 1915, 1919 (Fed. Cir. 1994). As

further noted by the Federal Circuit, in

order to prove conception, ‘‘a party

must show possession of every feature

recited in the count, and that every

limitation of the count must have been

known to the inventor at the time of the

alleged conception.’’ Coleman v. Dines,

754 F.2d 353, 359, 224 USPQ 857, 862

(Fed. Cir. 1985).

(13) Comment: One comment

indicated that a ‘‘possession’’ test does

not appear in Title 35 of the U.S. Code

and is not clearly stated by the Federal

Circuit. Therefore, it is recommended

that patent examiners be directed to use

existing judicial precedent to make

rejections of claims unsupported by a

statutory written description

requirement. Response: While the

Federal Circuit has not specifically laid

out a ‘‘possession’’ test, the Court has

clearly indicated that possession is a

cornerstone of the written description

inquiry. See, e.g., Vas-Cath, Inc. v.

Mahurkar, 935 F.2d 1555, 1563, 19

USPQ2d 1111, 1116 (Fed. Cir. 1991); see

also Purdue Pharma L.P. v. Faulding

Inc., 230 F.3d 1320, 1323, 56 USPQ2d

1481, 1483 (Fed. Cir. 2000) (‘‘[o]ne

skilled in the art, reading the disclosure,

must immediately discern the limitation

at issue in the claims’’) (internal quote

omitted). The possession test as set forth

in the Guidelines is extrapolated from

case law in a wide variety of

technologies and is not intended to be

limiting. Any rejections made by

examiners will be made under 35 U.S.C.

112, ¶1, with supporting rationale. Final

rejections are appealable if applicant

disagrees and follows the required

procedures to appeal.

(14) Comment: Two comments

indicated that if the amino acid

sequence for a polypeptide whose

utility has been identified is described,

then the question of possession of a

class of nucleotides encoding that

polypeptide can be addressed as a

relatively routine matter using the

understanding of the genetic code, and

that the endnote addressing this issue

should be revised. Response: The

suggestion of these comments has been

incorporated in the Guidelines and will

be reflected in the training materials.

However, based upon In re Bell, 991

F.2d 781, 785, 26 USPQ2d 1529, 1532

(Fed. Cir. 1993) and In re Baird, 16 F.3d

380, 382, 29 USPQ2d 1550, 1552 (Fed.

Cir. 1994), this does not mean that

applicant was in possession of any

particular species of the broad genus.

(15) Comment: One comment

disagreed with an endnote which stated

that a laundry list disclosure of moieties

does not constitute a written description

of every species in a genus. Specifically,

the comment indicates that if the

existence of a functional genus is

adequately described in the

specification, a laundry list of the

species within that genus must satisfy

the written description requirement.

Response: The suggestion to revise the

endnote will not be adopted. A lack of

adequate written description problem

arises if the knowledge and level of skill

in the art would not permit one skilled

in the art to immediately envisage the

product claimed from the disclosure.

This was aptly demonstrated in In re

Bell and In re Baird where possession of

a large genus did not put a person of

ordinary skill in the art in possession of

any particular species. See also Purdue

Pharma, 230 F.3d at 1328, 56 USPQ2d

at 1487 (because the original

specification did not disclose the later

claimed concentration ratio was a part

of the invention, the inventors cannot

argue that they are merely narrowing a

broad invention).

(16) Comment: One comment

suggested that in the majority of cases,

a single species will support a generic

claim, and that the Guidelines should

emphasize this point. Response: The

suggestion has been adopted to a limited

degree. The Guidelines now indicate

that a single species may, in some

instances, provide an adequate written

description of a generic claim when the

description of the species would

evidence to one of ordinary skill in the

art that the invention includes the

genus. Note, however, Tronzo v. Biomet,

Inc., 156 F.3d 1154, 47 USPQ2d 1829

(Fed. Cir. 1998), where the species in

the parent application was held not to

provide written description support for

the genus in the child application.

(17) Comment: One comment asserted

that the Guidelines should focus on the

compliance of the claims, not the

specification, with the written

description requirement. Response: This

suggestion will not be adopted. ‘‘The

specification shall contain a written

description of the invention.’’ 35 U.S.C.

112. The claims are part of the

specification. Id., ¶ 2. If an adequate

description is provided, it will suffice

‘‘whether located among the original

claims or in the descriptive part of the

specification.’’ In re Gardner, 480 F.2d

879, 880, 178 USPQ 149 (CCPA 1973).

The entire disclosure, including the

specification, drawings, and claims,

must be considered.

(18) Comment: One comment asserted

that the Guidelines confuse ‘‘new

matter,’’ 35 U.S.C. 132, with the written

description requirement, and that the

same standard for written description

should be applied to both original

claims and new or amended claims.

Response: The Guidelines indicate that

for both original and amended claims,

the inquiry is whether one skilled in the

art can reasonably conclude that the

inventor had possession of the claimed

invention at the time the application

was filed.

(19) Comment: One comment

suggested that the second paragraph of

the section pertaining to determining

what the claim as a whole covers should

be deleted because it relates more to

compliance with § 112, second

paragraph, than with the written

description requirement. Response: This

suggestion will not be adopted. The

claims must be construed and all issues

as to the scope and meaning of the claim

must be explored during the inquiry

into whether the written description

requirement has been met. The concept

of treating the claim as a whole is

applicable to all criteria for

patentability.

(20) Comment: One comment

suggested a different order for the

general analysis for determining

compliance with the written description

requirement, starting with reading the

claim, then the specification, and then

determining whether the disclosure

demonstrates possession by the

applicant. Response: This suggestion

will not be adopted. The claims must be

construed as broadly as reasonable in

light of the specification and the

knowledge in the art. See In re Morris,

127 F.3d 1048, 1054, 44 USPQ2d 1023,

1027 (Fed. Cir. 1997). Then the

disclosure must be evaluated to

determine whether it adequately

describes the claimed invention, i.e.,

whether it conveys to a person having

ordinary skill in the art that the

applicant had possession of what he or

she now claims.

(21) Comment: Several comments

suggested that the Guidelines are

unclear with regard to how the

examiner should treat the transitional

phrase ‘‘consisting essentially of.’’ The

comments also suggested that the

endnote that explains ‘‘consisting

essentially of’’ does not make clear how

the use of this intermediate transitional

language affects the scope of the claim.

Several comments stated that the

USPTO does not have legal authority to

treat claims reciting this language as

open (equivalent to ‘‘comprising’’).

Another comment suggested that the

phrase ‘‘clear indication in the

specification’’ be replaced with

‘‘explicit or implicit indication.’’

Response: The transitional phrase

‘‘consisting essentially of’’ ‘‘excludes

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices 1103

ingredients that would ‘materially affect

the basic and novel characteristics’ of

the claimed composition.’’ Atlas Powder

Co. v. E.I. DuPont de Nemours & Co.,

750 F.2d 1569, 1574, 224 USPQ 409,

412 (Fed. Cir. 1984). The basic and

novel characteristics of the claimed

invention are limited by the balance of

the claim. In re Janakirama-Rao, 317

F.2d 951, 954, 137 USPQ 893, 896

(CCPA 1963). However, during

prosecution claims must be read

broadly, consistent with the

specification. In re Morris, 127 F.3d

1048, 1054, 44 USPQ2d 1023, 1027

(Fed. Cir. 1997). Thus, for purposes of

searching for and applying prior art in

a rejection under 35 U.S.C. 102 or 103,

if the specification or the claims do not

define the ‘‘basic and novel’’ properties

of the claimed subject matter (or if such

properties are in dispute), the broadest

reasonable interpretation consistent

with the specification is that the basic

and novel characteristics are merely the

presence of the recited limitations. See,

e.g., Janakirama-Rao, 317 F.2d at 954,

137 USPQ at 895–96. This does not

indicate that the intermediate

transitional language is never given

weight. Applicants may amend the

claims to avoid the rejections or seek to

establish that the specification provides

definitions of terms in the claims that

define the basic and novel

characteristics of the claimed invention

which distinguish the claimed

invention from the prior art. When an

applicant contends that additional steps

or materials in the prior art are excluded

by the recitation of ‘consisting

essentially of,’ applicant has the burden

of showing that the introduction of

additional steps or components would

materially change the characteristics of

applicant’s invention. In re De Lajarte,

337 F.2d 870, 143 USPQ 256 (CCPA

1964). The language used in the

Guidelines is consistent with PPG

Industries Inc. v. Guardian Industries

Corp., 156 F.3d 1351, 1355, 48 USPQ2d

1351, 1355 (Fed. Cir. 1998) (‘‘PPG could

have defined the scope of the phrase

‘consisting essentially of’ for purposes

of its patent by making clear in its

specification what it regarded as

constituting a material change in the

basic and novel characteristics.’’).

(22) Comment: One comment stated

that the written description should

‘‘disclose the invention,’’ including why

the invention works and how it was

developed. Response: This suggestion

has not been adopted. An inventor does

not need to know how or why the

invention works in order to obtain a

patent. Newman v. Quigg, 877 F.2d

1575, 1581, 11 USPQ2d 1340, 1345

(Fed. Cir. 1989). To satisfy the

enablement requirement of 35 U.S.C.

112, ¶1, an application must disclose

the claimed invention in sufficient

detail to enable a person of ordinary

skill in the art to make and use the

claimed invention. To satisfy the

written description requirement of 35

U.S.C. 112, ¶ 1, the description must

show that the applicant was in

possession of the claimed invention at

the time of filing. There is no statutory

basis to require disclosure of why an

invention works or how it was

developed. ‘‘Patentability shall not be

negatived by the manner in which the

invention was made.’’ 35 U.S.C. 103(a).

(23) Comment: One comment

recommended that the phrases

‘‘emerging and unpredictable

technologies’’ and ‘‘unpredictable art’’

be replaced with the phrase—inventions

characterized by factors which are not

reasonably predictable in terms of the

ordinary skill in the art—. Response:

The suggestion is adopted in part and

the recommended phrase has been

added as an alternative.

(24) Comment: One comment

recommended that the phrase

‘‘conventional in the art’’ be replaced

with—part of the knowledge of one of

ordinary skill in the art—. Response:

The suggestion is adopted in part and

the recommended phrase has been

added as an alternative. The standard of

‘‘conventional in the art’’ is supported

by case law holding that a patent

specification ‘‘need not teach, and

preferably omits, what is well known in

the art.’’ See Spectra-Physics, Inc. v.

Coherent, Inc., 827 F.2d 1524, 1534, 3

USPQ2d 1737, 1743 (Fed. Cir. 1987);

Hybritech Inc. v. Monoclonal

Antibodies, Inc., 802 F.2d 1367, 1384,

231 USPQ 81, 94 (Fed. Cir. 1986). See

also Atmel Corp. v. Information Storage

Devices, Inc., 198 F.3d 1374, 1382, 53

USPQ2d 1225, 1231 (Fed. Cir. 1999).

(25) Comment: One comment

recommended that the Guidelines be

amended to state that the appropriate

skill level for determining possession of

the claimed invention is that of a person

of ordinary skill in the art. Response:

The comment has not been adopted.

The statutory language itself indicates

that compliance with the requirements

of 35 U.S.C. 112, ¶1, is judged from the

standard of ‘‘any person skilled in the

art.’’ It is noted, however, that the

phrases ‘‘one of skill in the art’’ and

‘‘one of ordinary skill in the art’’ appear

to be synonymous. See, e.g., Union Oil

Co. v. Atlantic Richfield Co., 208 F.3d

989, 997, 54 USPQ2d 1227, 1232 (Fed.

Cir. 2000) (‘‘The written description

requirement does not require the

applicant ‘to describe exactly the subject

matter claimed, [instead] the description

must clearly allow persons of ordinary

skill in the art to recognize that [he or

she] invented what is claimed.’ Thus,

§ 112, ¶ 1, ensures that, as of the filing

date, the inventor conveyed with

reasonable clarity to those of skill in the

art that he was in possession of the

subject matter of the claims.’’ (citations

omitted, emphasis added)).

(26) Comment: One comment stated

that an endnote misstates the relevant

law in stating that, to show inherent

written descriptive support for a claim

limitation, the inherent disclosure must

be such as would be recognized by a

person of ordinary skill in the art. The

comment recommended that the

endnote be amended to delete the

reference to recognition by persons of

ordinary skill and to cite Pingree v.

Hull, 518 F.2d 624, 186 USPQ 248

(CCPA 1975), rather than In re

Robertson, 169 F.3d 743, 49 USPQ2d

1949 (Fed. Cir. 1999). Response: The

comment has not been adopted. Federal

Circuit precedent makes clear that an

inherent disclosure must be recognized

by those of ordinary skill in the art. See,

e.g., Hyatt v. Boone, 146 F.3d 1348,

1354–55, 47 USPQ2d 1128, 1132 (Fed.

Cir. 1998) (‘‘[T]he purpose of the

description requirement is ‘to ensure

that the inventor had possession, as of

the filing date of the application relied

on, of the specific subject matter later

claimed by him.’ * * * Thus, the

written description must include all of

the limitations of the interference count,

or the applicant must show that any

absent text is necessarily comprehended

in the description provided and would

have been so understood at the time the

patent application was filed.’’ (emphasis

added)). See also Reiffin v. Microsoft

Corp., 214 F.3d 1342, 1346, 54 USPQ2d

1915, 1917 (Fed. Cir. 2000) (The

‘‘application considered as a whole

must convey to one of ordinary skill in

the art, either explicitly or inherently,

that [the inventor] invented the subject

matter claimed * * *. See * * *

Continental Can Co. USA v. Monsanto

Co., 948 F.2d 1264, 1268, 20 USPQ2d

1746, 1749 (Fed. Cir. 1991) (descriptive

matter may be inherently present in a

specification if one skilled in the art

would necessarily recognize such a

disclosure)’’).

(27) Comment: Several comments

pointed out an inconsistency in the

Federal Register Notice re: the Revised

Interim Written Description Guidelines.

The inconsistency concerned the

treatment of claims directed to an

isolated DNA comprising SEQ ID NO:1

wherein SEQ ID NO:1 is an expressed

sequence tag. The comments contrasted

paragraphs 34 and 35 of the Response to

1104 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices

Public Comments with the statement in

the text of the Guidelines that a genus

must be supported by a representative

number of species (as analyzed in

Example 7 of the training materials).

Response: The USPTO acknowledges

that there was an inconsistency. The

Office notes that a claim reciting a

nucleic acid comprising SEQ ID NO:1

may be subject to a rejection for lack of

an adequate written description where

particular identifiable species within

the scope of the claim lack an adequate

written description. The training

materials as amended exemplify an

appropriate analysis.

(28) Comment: One comment stated

that the USPTO should respond to the

issue of whether the U.S. is meeting its

TRIPs obligations. This comment noted

that the USPTO did not address an

earlier comment regarding the ‘‘Interim

Guidelines for the Examination of

Patent Applications under the 35 U.S.C.

112, ¶ 1, ‘Written Description’

Requirement,’’ 63 FR 32,639, June 15,

1998, which questioned whether the

written description requirement is truly

different from the enablement

requirement, and indicated that such a

requirement may be contrary to the

TRIPs provisions of the World Trade

Organization (Article 27.1). Article 27.1

requires WTO Members to, inter alia,

make patents available, with limited

exceptions, for products and processes

in all fields of technology so long as

those products and processes are new,

involve an inventive step, and are

capable of industrial application. The

comment further suggested a response.

Response: TRIPs Article 27 does not

address what must be included in a

patent application to allow WTO

Member officials to determine whether

particular inventions meet the standards

for patentability established in that

Article. TRIPs Article 29, which is more

relevant to this comment, states that

Members ‘‘shall require’’ patent

applicants to disclose their invention

‘‘in a manner sufficiently clear and

complete for the invention to be carried

out by a person skilled in the art.’’ If the

written description is not clear and

complete, the applicant may not have

been in possession of the invention.

This may support both written

description and enablement standards.

In addition, Article 29 expressly

authorizes Members to require patent

applicants to disclose the best method

the inventor knows at the time of filing

an application for carrying out the

invention.

(29) Comment: Two comments

commended the USPTO for eliminating

the Biotechnology Specific Examples in

the Revised Interim Written Description

Guidelines and providing separate

training materials. One comment

indicated a need to reconfirm the

examples set forth in the Interim

Written Description Guidelines

published in 1998. Response: The

current training materials reflect the

manner in which the USPTO interprets

the Written Description Guidelines.

(30) Comment: Several comments

addressed specific concerns about the

examiner training materials. Response:

The comments received with respect to

the training materials will be taken

under advisement as the Office revises

the training materials in view of the

revisions to the Guidelines. The specific

comments will not be addressed herein

as they do not impact the language of

the Guidelines.

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. This revision is based

on the Office’s current understanding of

the law and public comments received

in response to the USPTO’s previous

request for public comments on its

Revised Interim Written Description

Guidelines and is believed to be fully

consistent with binding precedent of the

U.S. Supreme Court, as well as the U.S.

Court of Appeals for the Federal Circuit

and its predecessor courts.

This revision does not constitute

substantive rulemaking and hence does

not have the force and effect of law. It

is 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 perceived failure by

Office personnel to follow these

Guidelines is neither appealable nor

petitionable.

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 this revision of the 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.

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.1 The 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.’’ 2 Another objective is to put

the public in possession of what the

applicant claims as the invention.3 The

written description requirement of the

Patent Act promotes the progress of the

useful arts by ensuring that patentees

adequately describe their inventions in

their patent specifications in exchange

for the right to exclude others from

practicing the invention for the duration

of the patent’s term.

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.4 An applicant shows

possession of the claimed invention by

describing the claimed invention with

all of its limitations using such

descriptive means as words, structures,

figures, diagrams, and formulas that

fully set forth the claimed invention.5

Possession may be shown in a variety of

ways including description of an actual

reduction to practice,6 or by showing

that the invention was ‘‘ready for

patenting’’ such as by the disclosure of

drawings or structural chemical

formulas that show that the invention

was complete,7 or by describing

distinguishing identifying

characteristics sufficient to show that

the applicant was in possession of the

claimed invention.8 A question as to

whether a specification provides an

adequate written description may arise

in the context of an original claim

which is not described sufficiently, a

new or amended claim wherein a claim

limitation has been added or removed,

or a claim to entitlement of an earlier

priority date or effective filing date

under 35 U.S.C. 119, 120, or 365(c).9

Compliance with the written

description requirement is a question of

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices 1105

fact which must be resolved on a caseby-case basis.10

A. Original Claims

There is a strong presumption that an

adequate written description of the

claimed invention is present when the

application is filed.11 However, the

issue of a lack of adequate written

description may arise even for an

original claim when an aspect of the

claimed invention has not been

described with sufficient particularity

such that one skilled in the art would

recognize that the applicant had

possession of the claimed invention.12

The claimed invention as a whole may

not be adequately described if the

claims require an essential or critical

feature which is not adequately

described in the specification and

which is not conventional in the art or

known to one of ordinary skill in the

art.13 This problem may arise where an

invention is described solely in terms of

a method of its making coupled with its

function and there is no described or

art-recognized correlation or

relationship between the structure of the

invention and its function.14 A lack of

adequate written description issue also

arises if the knowledge and level of skill

in the art would not permit one skilled

in the art to immediately envisage the

product claimed from the disclosed

process.15

B. New or Amended Claims

The proscription against the

introduction of new matter in a patent

application 16 serves to prevent an

applicant from adding information that

goes beyond the subject matter

originally filed.17 Thus, the written

description requirement prevents an

applicant from claiming subject matter

that was not adequately described in the

specification as filed. New or amended

claims which introduce elements or

limitations which are not supported by

the as-filed disclosure violate the

written description requirement.18

While there is no in haec verba

requirement, newly added claim

limitations must be supported in the

specification through express, implicit,

or inherent disclosure. An amendment

to correct an obvious error does not

constitute new matter where one skilled

in the art would not only recognize the

existence of the error in the

specification, but also recognize the

appropriate correction.19 Deposits made

after the application filing date cannot

be relied upon to support additions to

or correction of information in the

application as filed.20

Under certain circumstances,

omission of a limitation can raise an

issue regarding whether the inventor

had possession of a broader, more

generic invention.21 A claim that omits

an element which applicant describes as

an essential or critical feature of the

invention originally disclosed does not

comply with the written description

requirement.22

The fundamental factual inquiry is

whether the specification conveys with

reasonable clarity to those skilled in the

art that, as of the filing date sought,

applicant was in possession of the

invention as now claimed.23

II. Methodology for Determining

Adequacy of Written Description

A. Read and Analyze the Specification

for Compliance With 35 U.S.C. 112, ¶ 1

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. The examiner has the

initial burden, after a thorough reading

and evaluation of the content of the

application, of presenting evidence or

reasons why a person skilled in the art

would not recognize that the written

description of the invention provides

support for the claims. There is a strong

presumption that an adequate written

description of the claimed invention is

present in the specification as filed;24

however, with respect to newly added

or amended claims, applicant should

show support in the original disclosure

for the new or amended claims.25

Consequently, rejection of an original

claim for lack of written description

should be rare. The inquiry into

whether the description requirement is

met is a question of fact that must be

determined on a case-by-case basis.26

1. For Each Claim, Determine What the

Claim as a Whole Covers

Claim construction is an essential part

of the examination process. Each claim

must be separately analyzed and given

its broadest reasonable interpretation in

light of and consistent with the written

description.27 The entire claim must be

considered, including the preamble

language 28 and the transitional

phrase.29 The claim as a whole,

including all limitations found in the

preamble,30 the transitional phrase, and

the body of the claim, must be

sufficiently supported to satisfy the

written description requirement.31

The examiner should evaluate each

claim to determine if sufficient

structures, acts, or functions are recited

to make clear the scope and meaning of

the claim, including the weight to be

given the preamble.32 The absence of

definitions or details for wellestablished terms or procedures should

not be the basis of a rejection under 35

U.S.C. 112, ¶ 1, for lack of adequate

written description. Limitations may

not, however, be imported into the

claims from the specification.

2. Review the Entire Application to

Understand How Applicant Provides

Support for the Claimed Invention

Including Each Element and/or Step

Prior to determining whether the

disclosure satisfies the written

description requirement for the claimed

subject matter, the examiner should

review the claims and the entire

specification, including the specific

embodiments, figures, and sequence

listings, to understand how applicant

provides support for the various features

of the claimed invention.33 The analysis

of whether the specification complies

with the written description

requirement calls for the examiner to

compare the scope of the claim with the

scope of the description to determine

whether applicant has demonstrated

possession of the claimed invention.

Such a review is conducted from the

standpoint of one of skill in the art at

the time the application was filed 34 and

should include a determination of the

field of the invention and the level of

skill and knowledge in the art.

Generally, there is an inverse correlation

between the level of skill and

knowledge in the art and the specificity

of disclosure necessary to satisfy the

written description requirement.

Information which is well known in the

art need not be described in detail in the

specification.35

3. Determine Whether There is

Sufficient Written Description to Inform

a Skilled Artisan That Applicant was in

Possession of the Claimed Invention as

a Whole at the Time the Application

Was Filed

a. Original claims. Possession may be

shown in many ways. For example,

possession may be shown, inter alia, by

describing an actual reduction to

practice of the claimed invention.

Possession may also be shown by a clear

depiction of the invention in detailed

drawings or in structural chemical

formulas which permit a person skilled

in the art to clearly recognize that

applicant had possession of the claimed

invention. An adequate written

description of the invention may be

shown by any description of sufficient,

relevant, identifying characteristics so

long as a person skilled in the art would

recognize that the inventor had

possession of the claimed invention.36

A specification may describe an

actual reduction to practice by showing

1106 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices

that the inventor constructed an

embodiment or performed a process that

met all the limitations of the claim and

determined that the invention would

work for its intended purpose.37

Description of an actual reduction to

practice of a biological material may be

shown by specifically describing a

deposit made in accordance with the

requirements of 37 CFR 1.801 et seq.38

An applicant may show possession of

an invention by disclosure of

drawings 39 or structural chemical

formulas40 that are sufficiently detailed

to show that applicant was in

possession of the claimed invention as

a whole. The description need only

describe in detail that which is new or

not conventional.41 This is equally true

whether the claimed invention is

directed to a product or a process.

An applicant may also show that an

invention is complete by disclosure of

sufficiently detailed, relevant

identifying characteristics 42 which

provide evidence that applicant was in

possession of the claimed invention,43

i.e., complete or partial structure, other

physical and/or chemical properties,

functional characteristics when coupled

with a known or disclosed correlation

between function and structure, or some

combination of such characteristics.44

What is conventional or well known to

one of ordinary skill in the art need not

be disclosed in detail.45 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.46

(1) For each claim drawn to a single

embodiment or species: 47

(a) Determine whether the application

describes an actual reduction to practice

of the claimed invention.

(b) If the application does not describe

an actual reduction to practice,

determine whether the invention is

complete as evidenced by a reduction to

drawings or structural chemical

formulas that are sufficiently detailed to

show that applicant was in possession

of the claimed invention as a whole.

(c) If the application does not describe

an actual reduction to practice or

reduction to drawings or structural

chemical formula as discussed above,

determine whether the invention has

been set forth in terms of distinguishing

identifying characteristics as evidenced

by other descriptions of the invention

that are sufficiently detailed to show

that applicant was in possession of the

claimed invention.

(i) Determine whether the application

as filed describes the complete structure

(or acts of a process) of the claimed

invention as a whole. The complete

structure of a species or embodiment

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.48 If a complete structure is

disclosed, the written description

requirement is satisfied for that species

or embodiment, and a rejection under

35 U.S.C. 112, ¶ 1, for lack of written

description must not be made.

(ii) If the application as filed does not

disclose the complete structure (or acts

of a process) of the claimed invention as

a whole, determine whether the

specification discloses other relevant

identifying characteristics 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.49

Whether the specification shows that

applicant was in possession of the

claimed invention is not a single, simple

determination, but rather is a factual

determination reached by considering a

number of factors. Factors to be

considered in determining whether

there is sufficient evidence of

possession include the level of skill and

knowledge in the art, partial structure,

physical and/or chemical properties,

functional characteristics alone or

coupled with a known or disclosed

correlation between structure and

function, and the method of making the

claimed invention. Disclosure of any

combination of such identifying

characteristics that distinguish the

claimed invention from other materials

and would lead one of skill in the art

to the conclusion that the applicant was

in possession of the claimed species is

sufficient.50 Patents and printed

publications in the art should be relied

upon to determine whether an art is

mature and what the level of knowledge

and skill is in the art. In most

technologies which are mature, and

wherein the knowledge and level of

skill in the art is high, a written

description question should not be

raised for original claims even if the

specification discloses only a method of

making the invention and the function

of the invention.51 In contrast, for

inventions in emerging and

unpredictable technologies, or for

inventions characterized by factors not

reasonably predictable which are known

to one of ordinary skill in the art, more

evidence is required to show

possession. For example, disclosure of

only a method of making the invention

and the function may not be sufficient

to support a product claim other than a

product-by-process claim.52

Furthermore, disclosure of a partial

structure without additional

characterization of the product may not

be sufficient to evidence possession of

the claimed invention.53

Any claim to a species that does not

meet the test described under at least

one of (a), (b), or (c) must be rejected as

lacking adequate written description

under 35 U.S.C. 112, ¶ 1.

(2) For each claim drawn to a genus:

The written description requirement

for a claimed genus may be satisfied

through sufficient description of a

representative number of species by

actual reduction to practice (see (1)(a),

above), reduction to drawings (see

(1)(b), above), or by disclosure of

relevant, identifying characteristics, i.e.,

structure or other physical and/or

chemical properties, 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 (see

(1)(c), above).54

A ‘‘representative number of species’’

means that the species which are

adequately described are representative

of the entire genus. Thus, when there is

substantial variation within the genus,

one must describe a sufficient variety of

species to reflect the variation within

the genus. On the other hand, there may

be situations where one species

adequately supports a genus.55 What

constitutes a ‘‘representative number’’ is

an inverse function of the skill and

knowledge in the art. Satisfactory

disclosure of a ‘‘representative number’’

depends on whether one of skill in the

art would recognize that the applicant

was in possession of the necessary

common attributes or features of the

elements possessed by the members of

the genus in view of the species

disclosed. For inventions in an

unpredictable art, adequate written

description of a genus which embraces

widely variant species cannot be

achieved by disclosing only one species

within the genus.56 Description of a

representative number of species does

not require the description to be of such

specificity that it would provide

individual support for each species that

the genus embraces.57 If a representative

number of adequately described species

are not disclosed for a genus, the claim

to that genus must be rejected as lacking

adequate written description under 35

U.S.C. 112, ¶ 1.

b. New claims, amended claims, or

claims asserting entitlement to the

benefit of an earlier priority date or

filing date under 35 U.S.C. 119, 120, or

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices 1107

365(c). The examiner has the initial

burden of presenting evidence or

reasoning to explain why persons

skilled in the art would not recognize in

the original disclosure a description of

the invention defined by the claims.58

However, when filing an amendment an

applicant should show support in the

original disclosure for new or amended

claims.59 To comply with the written

description requirement of 35 U.S.C.

112, ¶ 1, or to be entitled to an earlier

priority date or filing date under 35

U.S.C. 119, 120, or 365(c), each claim

limitation must be expressly,60

implicitly,61 or inherently 62 supported

in the originally filed disclosure.63

Furthermore, each claim must include

all elements which applicant has

described as essential.64

If the originally filed disclosure does

not provide support for each claim

limitation, or if an element which

applicant describes as essential or

critical is not claimed, a new or

amended claim must be rejected under

35 U.S.C. 112, ¶ 1, as lacking adequate

written description, or in the case of a

claim for priority under 35 U.S.C. 119,

120, or 365(c), the claim for priority

must be denied.

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 title

35 of the U.S. Code.

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. When possible, the

Office action should offer helpful

suggestions on how to overcome

rejections.

A. For Each Claim Lacking Written

Description Support, Reject the Claim

Under Section 112, ¶ 1, for Lack of

Adequate Written Description

A description as filed is presumed to

be adequate, unless or until sufficient

evidence or reasoning to the contrary

has been presented by the examiner to

rebut the presumption.65 The examiner,

therefore, must have a reasonable basis

to challenge the adequacy of the written

description. The examiner has the

initial burden of presenting by a

preponderance of evidence why a

person skilled in the art would not

recognize in an applicant’s disclosure a

description of the invention defined by

the claims.66 In rejecting a claim, the

examiner must 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 at

issue; and

(2) Establish a prima facie case by

providing reasons why a person skilled

in the art at the time the application was

filed would not have recognized that the

inventor was in possession of the

invention as claimed in view of the

disclosure of the application as filed. A

general allegation of ‘‘unpredictability

in the art’’ is not a sufficient reason to

support a rejection for lack of adequate

written description.

When appropriate, suggest

amendments to the claims which can be

supported by the application’s written

description, being mindful of the

prohibition against the addition of new

matter in the claims or description.67

B. Upon Reply by Applicant, Again

Determine the Patentability of the

Claimed Invention, Including Whether

the Written Description Requirement Is

Satisfied by Reperforming the Analysis

Described Above in View of the Whole

Record

Upon reply by applicant, before

repeating any rejection under 35 U.S.C.

112, ¶ 1, for lack of written description,

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 the 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.

When a rejection is maintained, any

affidavits relevant to the 112, ¶ 1,

written description requirement,68 must

be thoroughly analyzed and discussed

in the next Office action.

Dated: December 29, 2000.

Q. Todd Dickinson,

Under Secretary of Commerce for Intellectual

Property and Director of the United States

Patent and Trademark Office.

Endnotes

1See, e.g., Vas-Cath, Inc. v. Mahurkar, 935

F.2d 1555, 1560, 19 USPQ2d 1111, 1114

(Fed. Cir. 1991). 2 In re Barker, 559 F.2d 588, 592 n.4, 194

USPQ 470, 473 n.4 (CCPA 1977). 3See Regents of the University of California

v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d

1398, 1404 (Fed. Cir. 1997), cert. denied, 523

U.S. 1089 (1998). 4See, e.g., Vas-Cath, Inc. v. Mahurkar, 935

F.2d at 1563, 19 USPQ2d at 1116. 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. See, e.g., Martin v. Mayer,

823 F.2d 500, 503, 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); accord 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 may

be in 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. 5 Lockwood v. American Airlines, Inc., 107

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

(Fed. Cir. 1997). 6An application specification may show

actual reduction to practice by describing

testing of the claimed invention or, in the

case of biological materials, by specifically

describing a deposit made in accordance

with 37 CFR 1.801 et seq. See also Deposit

of Biological Materials for Patent Purposes,

Final Rule, 54 FR 34,864 (August 22, 1989)

(‘‘The requirement for a specific

identification is consistent with the

description requirement of the first paragraph

of 35 U.S.C. 112, and to provide an

antecedent basis for the biological material

which either has been or will be deposited

before the patent is granted.’’ Id. at 34,876.

‘‘The description must be sufficient to permit

verification that the deposited biological

material is in fact that disclosed. Once the

1108 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices

patent issues, the description must be

sufficient to aid in the resolution of questions

of infringement.’’ Id. at 34,880.). Such a

deposit is not a substitute for a written

description of the claimed invention. The

written description of the deposited material

needs to be as complete as possible because

the examination for patentability proceeds

solely on the basis of the written description.

See, e.g., In re Lundak, 773 F.2d 1216, 227

USPQ 90 (Fed. Cir. 1985). See also 54 FR at

34,880 (‘‘As a general rule, the more

information that is provided about a

particular deposited biological material, the

better the examiner will be able to compare

the identity and characteristics of the

deposited biological material with the prior

art.’’). 7Pfaff v. Wells Electronics, Inc., 525 U.S.

55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,

1647 (1998); Eli Lilly, 119 F.3d at 1568, 43

USPQ2d at 1406. 8See Amgen, Inc. v. Chugai

Pharmaceutical, 927 F.2d 1200, 1206, 18

USPQ2d 1016, 1021 (Fed. Cir. 1991) (one

must define a compound by ‘‘whatever

characteristics sufficiently distinguish it’’). 9A description requirement issue can arise

for original claims (see, e.g., Eli Lilly, 119

F.3d 1559, 43 USPQ2d 1398) as well as new

or amended claims. Most typically, the issue

will arise in the context of determining

whether new or amended claims are

supported by the description of the invention

in the application as filed (see, e.g., In re

Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed.

Cir. 1989)), whether a claimed invention is

entitled to the benefit of an earlier priority

date or effective filing date under 35 U.S.C.

119, 120, or 365(c) (see, e.g., Tronzo v.

Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829

(Fed. Cir. 1998); Fiers v. Revel, 984 F.2d

1164, 25 USPQ2d 1601 (Fed. Cir. 1993); In

re Ziegler, 992 F.2d 1197, 1200, 26 USPQ2d

1600, 1603 (Fed. Cir. 1993)), or whether a

specification provides support for a claim

corresponding to a count in an interference

(see, e.g., Fields v. Conover, 443 F.2d 1386,

170 USPQ 276 (CCPA 1971)). 10 Vas-Cath, Inc. v. Mahurkar, 935 F.2d at

1563, 19 USPQ2d at 1116 (Fed. Cir. 1991). 11 In re Wertheim, 541 F.2d 257, 263, 191

USPQ 90, 97 (CCPA 1976) (‘‘we are of the

opinion that the PTO has the initial burden

of presenting evidence or reasons why

persons skilled in the art would not

recognize in the disclosure a description of

the invention defined by the claims’’). 12See endnote 4. 13For example, consider the claim ‘‘A gene

comprising SEQ ID NO:1.’’ A determination

of what the claim as a whole covers may

result in a conclusion that specific structures

such as a promoter, a coding region, or other

elements are included. Although all genes

encompassed by this claim share the

characteristic of comprising SEQ ID NO:1,

there may be insufficient description of those

specific structures (e.g., promoters,

enhancers, coding regions, and other

regulatory elements) which are also included. 14A biomolecule sequence described only

by a 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 sequence.

For example, even though a genetic code

table would correlate a known amino acid

sequence with a genus of coding nucleic

acids, the same table cannot predict the

native, naturally occurring nucleic acid

sequence of a naturally occurring mRNA or

its corresponding cDNA. Cf. In re Bell, 991

F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993),

and In re Deuel, 51 F.3d 1552, 34 USPQ2d

1210 (Fed. Cir. 1995) (holding that a process

could not render the product of that process

obvious under 35 U.S.C. 103). The Federal

Circuit has pointed out that under United

States law, a description that does not render

a claimed invention obvious cannot

sufficiently describe the invention for the

purposes of the written description

requirement of 35 U.S.C. 112. Eli Lilly, 119

F.3d at 1567, 43 USPQ2d at 1405.

Compare Fonar Corp. v. General Electric

Co., 107 F.3d 1543, 1549, 41 USPQ2d 1801,

1805 (Fed. Cir. 1997) (‘‘As a general rule,

where software constitutes part of a best

mode of carrying out an invention,

description of such a best mode is satisfied

by a disclosure of the functions of the

software. This is because, normally, writing

code for such software is within the skill of

the art, not requiring undue experimentation,

once its functions have been disclosed. * * *

Thus, flow charts or source code listings are

not a requirement for adequately disclosing

the functions of software.’’). 15See, e.g., Fujikawa v. Wattanasin, 93

F.3d 1559, 1571, 39 USPQ2d 1895, 1905

(Fed. Cir. 1996) (a ‘‘laundry list’’ disclosure

of every possible moiety does not constitute

a written description of every species in a

genus because it would not ‘‘reasonably

lead’’ those skilled in the art to any particular

species); In re Ruschig, 379 F.2d 990, 995,

154 USPQ 118, 123 (CCPA 1967) (‘‘If npropylamine had been used in making the

compound instead of n-butylamine, the

compound of claim 13 would have resulted.

Appellants submit to us, as they did to the

board, an imaginary specific example

patterned on specific example 6 by which the

above butyl compound is made so that we

can see what a simple change would have

resulted in a specific supporting disclosure

being present in the present specification.

The trouble is that there is no such

disclosure, easy though it is to imagine it.’’)

(emphasis in original); Purdue Pharma L.P. v.

Faulding Inc., 230 F.3d 1320, 1328, 56

USPQ2d 1481, 1487 (Fed. Cir. 2000) (‘‘the

specification does not clearly disclose to the

skilled artisan that the inventors * * *

considered the [] ratio to be part of their

invention * * *. There is therefore no force

to Purdue’s argument that the written

description requirement was satisfied

because the disclosure revealed a broad

invention from which the [later-filed] claims

carved out a patentable portion’’). 16 35 U.S.C. §§ 132 and 251. See also In re

Rasmussen, 650 F.2d 1212, 1214, 211 USPQ

323, 326 (CCPA 1981). See Manual of Patent

Examining Procedure (MPEP) §§ 2163.06–

2163.07 (7th Ed., Rev. 1, Feb. 2000) for a

more detailed discussion of the written

description requirement and its relationship

to new matter.

17 The claims as filed in the original

specification are part of the disclosure and,

therefore, if an application as originally filed

contains a claim disclosing material not

found in the remainder of the specification,

the applicant may amend the specification to

include the claimed subject matter. In re

Benno, 768 F.2d 1340, 226 USPQ 683 (Fed.

Cir. 1985). 18 See, e.g., In re Lukach, 442 F.2d 967, 169

USPQ 795 (CCPA 1971) (subgenus range was

not supported by generic disclosure and

specific example within the subgenus range);

In re Smith, 458 F.2d 1389, 1395, 173 USPQ

679, 683 (CCPA 1972) (a subgenus is not

necessarily described by a genus

encompassing it and a species upon which it

reads). 19 In re Oda, 443 F.2d 1200, 170 USPQ 260

(CCPA 1971). With respect to the correction

of sequencing errors in applications

disclosing nucleic acid and/or amino acid

sequences, it is well known that sequencing

errors are a common problem in molecular

biology. See, e.g., Peter Richterich,

Estimation of Errors in ‘Raw’ DNA

Sequences: A Validation Study, 8 Genome

Research 251–59 (1998). If an application as

filed includes sequence information and

references a deposit of the sequenced

material made in accordance with the

requirements of 37 CFR § 1.801 et seq.,

amendment may be permissible. 20 Corrections of minor errors in the

sequence may be possible based on the

argument that one of skill in the art would

have resequenced the deposited material and

would have immediately recognized the

minor error. Deposits made after the filing

date can only be relied upon to provide

support for the correction of sequence

information if applicant submits a statement

in compliance with 37 CFR § 1.804 stating

that the biological material which is

deposited is a biological material specifically

defined in the application as filed. 21 See, e.g., Gentry Gallery, Inc. v. Berkline

Corp., 134 F.3d 1473, 45 USPQ2d 1498 (Fed.

Cir. 1998) (claims to a sectional sofa

comprising, inter alia, a console and a

control means were held invalid for failing to

satisfy the written description requirement

where the claims were broadened by

removing the location of the control means.);

Johnson Worldwide Associates v. Zebco

Corp., 175 F.3d 985, 993, 50 USPQ2d 1607,

1613 (Fed. Cir. 1999) (In Gentry Gallery, the

‘‘court’s determination that the patent

disclosure did not support a broad meaning

for the disputed claim terms was premised

on clear statements in the written description

that described the location of a claim

element—the ‘control means’—as ‘the only

possible location’ and that variations were

‘outside the stated purpose of the invention.’

Gentry Gallery, 134 F.3d at 1479, 45 USPQ2d

at 1503. Gentry Gallery, then, considers the

situation where the patent’s disclosure makes

crystal clear that a particular (i.e., narrow)

understanding of a claim term is an ‘essential

element of [the inventor’s] invention.’ ’’);

Tronzo v. Biomet, 156 F.3d at 1158–59, 47

USPQ2d at 1833 (Fed. Cir. 1998) (claims to

generic cup shape were not entitled to filing

date of parent application which disclosed

‘‘conical cup’’ in view of the disclosure of the

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices 1109

parent application stating the advantages and

importance of the conical shape.). 22 See Gentry Gallery, 134 F.3d at 1480, 45

USPQ2d at 1503; In re Sus, 306 F.2d 494,

504, 134 USPQ 301, 309 (CCPA 1962) (‘‘[O]ne

skilled in this art would not be taught by the

written description of the invention in the

specification that any ‘aryl or substituted aryl

radical’ would be suitable for the purposes of

the invention but rather that only certain aryl

radicals and certain specifically substituted

aryl radicals [i.e., aryl azides] would be

suitable for such purposes.’’) (emphasis in

original). A claim which omits matter

disclosed to be essential to the invention as

described in the specification or in other

statements of record may also be subject to

rejection under 35 U.S.C. 112, ¶ 1, as not

enabling, or under 35 U.S.C. 112, ¶ 2. See In

re Mayhew, 527 F.2d 1229, 188 USPQ 356

(CCPA 1976); In re Venezia, 530 F.2d 956,

189 USPQ 149 (CCPA 1976); and In re

Collier, 397 F.2d 1003, 158 USPQ 266 (CCPA

1968). See also MPEP § 2172.01. 23 See, e.g., Vas-Cath, Inc., 935 F.2d at

1563–64, 19 USPQ2d at 1117. 24 Wertheim, 541 F.2d at 262, 191 USPQ at

96.25 See MPEP §§ 714.02 and 2163.06

(‘‘Applicant should * * * specifically point

out the support for any amendments made to

the disclosure.’’); and MPEP § 2163.04 (‘‘If

applicant amends the claims and points out

where and/or how the originally filed

disclosure supports the amendment(s), and

the examiner finds that the disclosure does

not reasonably convey that the inventor had

possession of the subject matter of the

amendment at the time of the filing of the

application, the examiner has the initial

burden of presenting evidence or reasoning

to explain why persons skilled in the art

would not recognize in the disclosure a

description of the invention defined by the

claims.’’). 26 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 case-by-case development.’’);

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

at 96 (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). 27 See, e.g., In re Morris, 127 F.3d 1048,

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

1997). 28 ‘‘Preamble language’’ is that language in

a claim appearing before the transitional

phase, e.g., before ‘‘comprising,’’ ‘‘consisting

essentially of,’’ or ‘‘consisting of.’’ 29 The transitional term ‘‘comprising’’ (and

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

‘‘including,’’ and ‘‘having’’) is ‘‘open-ended—

it covers the expressly recited subject matter,

alone or in combination with unrecited

subject matter. See, e.g., Genentech, Inc. v.

Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d

1608, 1613 (Fed. Cir. 1997) (‘‘ ‘Comprising’ is

a term of art used in claim language which

means that the named elements are essential,

but other elements may be added and still

form a construct within the scope of the

claim.’’); Ex parte Davis, 80 USPQ 448, 450

(Bd. App. 1948) (‘‘comprising’’ leaves the

‘‘claim open for the inclusion of unspecified

ingredients even in major amounts’’). ‘‘By

using the term ‘consisting essentially of,’ the

drafter signals that the invention necessarily

includes the listed ingredients and is open to

unlisted ingredients that do not materially

affect the basic and novel properties of the

invention. A ‘consisting essentially of’ claim

occupies a middle ground between closed

claims that are written in a ‘consisting of’

format and fully open claims that are drafted

in a ‘comprising’ format.’’ PPG Industries v.

Guardian Industries, 156 F.3d 1351, 1354, 48

USPQ2d 1351, 1353–54 (Fed. Cir. 1998). For

the purposes of searching for and applying

prior art under 35 U.S.C. 102 and 103, absent

a clear indication in the specification or

claims of what the basic and novel

characteristics actually are, ‘consisting

essentially of’ will be construed as equivalent

to ‘‘comprising.’’ See, e.g., PPG, 156 F.3d at

1355, 48 USPQ2d at 1355 (‘‘PPG could have

defined the scope of the phrase ‘‘consisting

essentially of’’ for purposes of its patent by

making clear in its specification what it

regarded as constituting a material change in

the basic and novel characteristics of the

invention.’’). See also In re Janakirama-Rao,

317 F.2d 951, 954, 137 USPQ 893, 895–96

(CCPA 1963). If an applicant contends that

additional steps or materials in the prior art

are excluded by the recitation of ‘‘consisting

essentially of,’’ applicant has the burden of

showing that the introduction of additional

steps or components would materially

change the characteristics of applicant’s

invention. In re De Lajarte, 337 F.2d 870, 143

USPQ 256 (CCPA 1964). 30 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). 31 An applicant shows possession of the

claimed invention by describing the claimed

invention with all of its limitations.

Lockwood, 107 F.3d at 1572, 41 USPQ2d at

1966. 32 See, e.g., Bell Communications Research,

Inc. v. Vitalink Communications Corp., 55

F.3d 615, 620, 34 USPQ2d 1816, 1820 (Fed.

Cir. 1995) (‘‘[A] claim preamble has the

import that the claim as a whole suggests for

it.’’); Corning Glass Works v. Sumitomo Elec.

U.S.A., Inc., 868 F.2d 1251, 1257, 9 USPQ2d

1962, 1966 (Fed. Cir. 1989) (The

determination of whether preamble

recitations are structural limitations can be

resolved only on review of the entirety of the

application ‘‘to gain an understanding of

what the inventors actually invented and

intended to encompass by the claim.’’). 33 An element may be critical where those

of skill in the art would require it to

determine that applicant was in possession of

the invention. Compare Rasmussen, 650 F.2d

at 1215, 211 USPQ at 327 (‘‘one skilled in the

art who read Rasmussen’s specification

would understand that it is unimportant how

the layers are adhered, so long as they are

adhered’’) (emphasis in original), with

Amgen, Inc. v. Chugai Pharmaceutical Co.,

Ltd., 927 F.2d 1200, 1206, 18 USPQ2d 1016,

1021 (Fed. Cir. 1991) (‘‘it is well established

in our law that conception of a chemical

compound requires that the inventor be able

to define it so as to distinguish it from other

materials, and to describe how to obtain it’’). 34 See, e.g., Wang Labs. v. Toshiba Corp.,

993 F.2d 858, 865, 26 USPQ2d 1767, 1774

(Fed. Cir. 1993). 35 See, e.g., Hybritech, Inc. v. Monoclonal

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

USPQ 81, 90 (Fed. Cir. 1986). 36 See, e.g., Purdue Pharma L.P. v.

Faulding Inc., 230 F.3d 1320, ___, 56

USPQ2d 1481, 1483 (Fed. Cir. 2000) (the

written description ‘‘inquiry is a factual one

and must be assessed on a case-by-case

basis’’); see also Pfaff v. Wells Electronics,

Inc., 55 U.S. at 66, 119 S.Ct. at 311, 48

USPQ2d at 1646 (‘‘The word ‘invention’ must

refer to a concept that is complete, rather

than merely one that is ‘substantially

complete.’ It is true that reduction to practice

ordinarily provides the best evidence that an

invention is complete. But just because

reduction to practice is sufficient evidence of

completion, it does not follow that proof of

reduction to practice is necessary in every

case. Indeed, both the facts of the Telephone

Cases and the facts of this case demonstrate

that one can prove that an invention is

complete and ready for patenting before it

has actually been reduced to practice.’’). 37 Cooper v. Goldfarb, 154 F.3d 1321, 1327,

47 USPQ2d 1896, 1901 (Fed. Cir. 1998). See

also UMC Elecs. Co. v. United States, 816

F.2d 647, 652, 2 USPQ2d 1465, 1468 (Fed.

Cir. 1987) (‘‘[T]here cannot be a reduction to

practice of the invention * * * without a

physical embodiment which includes all

limitations of the claim.’’); Estee Lauder Inc.

v. L’Oreal, S.A., 129 F.3d 588, 593, 44

USPQ2d 1610, 1614 (Fed. Cir. 1997) (‘‘[A]

reduction to practice does not occur until the

inventor has determined that the invention

will work for its intended purpose.’’);

Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572,

1578, 38 USPQ2d 1288, 1291 (Fed. Cir. 1996)

(determining that the invention will work for

its intended purpose may require testing

depending on the character of the invention

and the problem it solves). 38 37 CFR 1.804, 1.809. See also endnote

6. 39 See, e.g., Vas-Cath, 935 F.2d at 1565, 19

USPQ2d at 1118 (‘‘drawings alone may

provide a ‘written description’ of an

invention as required by § 112’’); In re

Wolfensperger, 302 F.2d 950, 133 USPQ 537

(CCPA 1962) (the drawings of applicant’s

specification provided sufficient written

descriptive support for the claim limitation at

issue); Autogiro Co. of America v. United

States, 384 F.2d 391, 398, 155 USPQ 697, 703

(Ct. Cl. 1967) (‘‘In those instances where a

visual representation can flesh out words,

drawings may be used in the same manner

and with the same limitations as the

specification.’’). 40 See, e.g., Eli Lilly, 119 F.3d at 1568, 43

USPQ2d at 1406 (‘‘In claims involving

chemical materials, generic formulae usually

indicate with specificity what the generic

claims encompass. One skilled in the art can

distinguish such a formula from others and

can identify many of the species that the

claims encompass. Accordingly, such a

formula is normally an adequate description

of the claimed genus.’’).

1110 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices

41 See Hybritech v. Monoclonal Antibodies,

802 F.2d at 1384, 231 USPQ at 94; Fonar

Corp. v. General Electric Co., 107 F.3d at

1549, 41 USPQ2d at 1805 (source code

description not required). 42 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 may be able

to determine when the gene disclosed is the

same as or different from 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. Similarly, isolation of an mRNA

and its expression to produce the protein of

interest is strong evidence of possession of an

mRNA for the protein.

For some biomolecules, 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 or combinations of

characteristics may 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, 107

F.3d at 1572, 41 USPQ2d at 1966 (‘‘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’’). 43 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 Inc.

v. Chugai Pharmaceutical Co., 927 F.2d 1200,

18 USPQ2d 1016 (Fed. Cir. 1991)). 44 If a claim limitation invokes 35 U.S.C.

112, ¶ 6, it must be interpreted to cover the

corresponding structure, materials, or acts in

the specification and ‘‘equivalents thereof.’’

See 35 U.S.C. 112, ¶ 6. See also B. Braun

Medical, Inc. v. Abbott Lab., 124 F.3d 1419,

1424, 43 USPQ2d 1896, 1899 (Fed. Cir.

1997). In considering whether there is 35

U.S.C. 112, ¶ 1, support for a means- (or step)

plus-function claim limitation, the examiner

must consider not only the original

disclosure contained in the summary and

detailed description of the invention portions

of the specification, but also the original

claims, abstract, and drawings. A means- (or

step-) plus-function claim limitation is

adequately described under 35 U.S.C. 112, ¶

1, if: (1) The written description adequately

links or associates adequately described

particular structure, material, or acts to the

function recited in a means- (or step-) plusfunction claim limitation; or (2) it is clear

based on the facts of the application that one

skilled in the art would have known what

structure, material, or acts perform the

function recited in a means- (or step-) plusfunction limitation. Note also: A rejection

under 35 U.S.C. 112, ¶ 2, ‘‘cannot stand

where there is adequate description in the

specification to satisfy 35 U.S.C. 112, first

paragraph, regarding means-plus-function

recitations that are not, per se, challenged for

being unclear.’’ In re Noll, 545 F.2d 141, 149,

191 USPQ 721, 727 (CCPA 1976). See

Supplemental Examination Guidelines for

Determining the Applicability of 35 U.S.C.

112, ¶ 6, 65 FR 38510, June 21, 2000. 45 See Hybritech Inc. v. Monoclonal

Antibodies, Inc., 802 F.2d at 1384, 231 USPQ

at 94. 46 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 [i.e., ‘‘in the same words’’] to be

sufficient’’). 47 A claim which is limited to a single

disclosed embodiment or species is analyzed

as a claim drawn to a single embodiment or

species, whereas a claim which encompasses

two or more embodiments or species within

the scope of the claim is analyzed as a claim

drawn to a genus. See also MPEP § 806.04(e). 48 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). 49 For example, if the art has established

a strong correlation between structure and

function, one skilled in the art would be able

to predict with a reasonable degree of

confidence the structure of the claimed

invention from a recitation of its function.

Thus, the written description requirement

may be satisfied through disclosure of

function and minimal structure when there is

a well-established correlation between

structure and function. In contrast, without

such a correlation, the capability to recognize

or understand the structure from the mere

recitation of function and minimal structure

is highly unlikely. In this latter case,

disclosure of function alone is little more

than a wish for possession; it does not satisfy

the written description requirement. 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 (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’’). Compare Fonar, 107

F.3d at 1549, 41 USPQ2d at 1805 (disclosure

of software function adequate in that art). 50 See Eli Lilly, 119 F.3d at 1568, 43

USPQ2d at 1406. 51 See, e.g., In re Hayes Microcomputer

Products, Inc. Patent Litigation, 982 F.2d

1527, 1534–35, 25 USPQ2d 1241, 1246 (Fed.

Cir. 1992) (‘‘One skilled in the art would

know how to program a microprocessor to

perform the necessary steps described in the

specification. Thus, an inventor is not

required to describe every detail of his

invention. An applicant’s disclosure

obligation varies according to the art to

which the invention pertains. Disclosing a

microprocessor capable of performing certain

functions is sufficient to satisfy the

requirement of section 112, first paragraph,

when one skilled in the relevant art would

understand what is intended and know how

to carry it out.’’) 52 See, e.g., Fiers v. Revel, 984 F.2d at 1169,

25 USPQ2d at 1605; Amgen., 927 F.2d at

1206, 18 USPQ2d at1021. Where the process

has actually been used to produce the

product, the written description requirement

for a product-by-process claim is clearly

satisfied; however, the requirement may not

be satisfied where it is not clear that the acts

set forth in the specification can be

performed, or that the product is produced

by that process. 53 See, e.g., Amgen, 927 F.2d at1206, 18

USPQ2d at 1021 (‘‘A gene is a chemical

compound, albeit a complex one, and it is

well established in our law that conception

of a chemical compound requires that the

inventor be able to define it so as to

distinguish it from other materials, and to

describe how to obtain it. Conception does

not occur unless one has a mental picture of

the structure of the chemical, or is able to

define it by its method of preparation, its

physical or chemical properties, or whatever

characteristics sufficiently distinguish it. It is

not sufficient to define it solely by its

principal biological property, e.g., encoding

human erythropoietin, because an alleged

conception having no more specificity than

that is simply a wish to know the identity of

any material with that biological property.

We hold that when an inventor is unable to

envision the detailed constitution of a gene

so as to distinguish it from other materials,

as well as a method for obtaining it,

conception has not been achieved until

reduction to practice has occurred, i.e., until

after the gene has been isolated.’’) (citations

omitted). In such instances the alleged

conception fails not merely because the field

is unpredictable or because of the general

uncertainty surrounding experimental

sciences, but because the conception is

incomplete due to factual uncertainty that

undermines the specificity of the inventor’s

idea of the invention. Burroughs Wellcome

Co. v. Barr Laboratories Inc., 40 F.3d 1223,

1229, 32 USPQ2d 1915, 1920 (Fed. Cir.

1994). Reduction to practice in effect

provides the only evidence to corroborate

conception (and therefore possession) of the

invention. Id. 54 See Eli Lilly, 119 F.3d at 1568, 43

USPQ2d at 1406. 55 See, e.g., Rasmussen, 650 F.2d at 1214,

211 USPQ at 326–27 (disclosure of a single

method of adheringly applying one layer to

another was sufficient to support a generic

claim to ‘‘adheringly applying’’ because one

skilled in the art reading the specification

would understand that it is unimportant how

the layers are adhered, so long as they are

adhered); In re Herschler, 591 F.2d 693, 697,

200 USPQ 711, 714 (CCPA 1979) (disclosure

of corticosteriod in DMSO sufficient to

support claims drawn to a method of using

a mixture of a ‘‘physiologically active

steroid’’ and DMSO because ‘‘use of known

chemical compounds in a manner auxiliary

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices 1111

to the invention must have a corresponding

written description only so specific as to lead

one having ordinary skill in the art to that

class of compounds. Occasionally, a

functional recitation of those known

compounds in the specification may be

sufficient as that description.’’); In re Smythe,

480 F.2d 1376, 1383, 178 USPQ 279, 285

(CCPA 1973) (the phrase ‘‘air or other gas

which is inert to the liquid’’ was sufficient

to support a claim to ‘‘inert fluid media’’

because the description of the properties and

functions of the air or other gas segmentizing

medium would suggest to a person skilled in

the art that appellant’s invention includes the

use of ‘‘inert fluid’’ broadly.). However, in

Tronzo v. Biomet, 156 F.3d at 1159, 47

USPQ2d at1833 (Fed. Cir. 1998), the

disclosure of a species in the parent

application did not suffice to provide written

description support for the genus in the child

application. 56 See, e.g., Eli Lilly. 57 For example, in the molecular biology

arts, if an applicant disclosed an amino acid

sequence, it would be unnecessary to provide

an explicit disclosure of nucleic acid

sequences that encoded the amino acid

sequence. Since the genetic code is widely

known, a disclosure of an amino acid

sequence would provide sufficient

information such that one would accept that

an applicant was in possession of the full

genus of nucleic acids encoding a given

amino acid sequence, but not necessarily any

particular species. Cf. In re Bell, 991 F.2d

781, 785, 26 USPQ2d 1529, 1532 (Fed. Cir.

1993) and In re Baird, 16 F.3d 380, 382, 29

USPQ2d 1550, 1552 (Fed. Cir. 1994). 58 See Wertheim, 541 F.2d at 263, 191

USPQ at 97 (‘‘[T]he PTO has the initial

burden of presenting evidence or reasons

why persons skilled in the art would not

recognize in the disclosure a description of

the invention defined by the claims.’’). 59 See MPEP §§ 714.02 and 2163.06

(‘‘Applicant should * * * specifically point

out the support for any amendments made to

the disclosure.’’). 60 See, e.g., In re Wright, 866 F.2d 422, 425,

9 USPQ2d 1649, 1651 (Fed. Cir. 1989)

(Original specification for method of forming

images using photosensitive microcapsules

which describes removal of microcapsules

from surface and warns that capsules not be

disturbed prior to formation of image,

unequivocally teaches absence of

permanently fixed microcapsules and

supports amended language of claims

requiring that microcapsules be ‘‘not

permanently fixed’’ to underlying surface,

and therefore meets description requirement

of 35 U.S.C. 112.). 61 See, e.g., In re Robins, 429 F.2d 452,

456–57, 166 USPQ 552, 555 (CCPA 1970)

(‘‘[W]here no explicit description of a generic

invention is to be found in the specification

* * * mention of representative compounds

may provide an implicit description upon

which to base generic claim language.’’); In

re Smith, 458 F.2d 1389, 1395, 173 USPQ

679, 683 (CCPA 1972) (a subgenus is not

necessarily implicitly described by a genus

encompassing it and a species upon which it

reads). 62 See, e.g., In re Robertson, 169 F.3d 743,

745, 49 USPQ2d 1949, 1950–51 (Fed. Cir.

1999) (‘‘To establish inherency, the extrinsic

evidence ‘‘must make clear that the missing

descriptive matter is necessarily present in

the thing described in the reference, and that

it would be so recognized by persons of

ordinary skill. Inherency, however, may not

be established by probabilities or

possibilities. The mere fact that a certain

thing may result from a given set of

circumstances is not sufficient.’’’’) (citations

omitted). 63 When an explicit limitation in a claim

‘‘is not present in the written description

whose benefit is sought it must be shown that

a person of ordinary skill would have

understood, at the time the patent

application was filed, that the description

requires that limitation.’’ Hyatt v. Boone, 146

F.3d 1348, 1353, 47 USPQ2d 1128, 1131

(Fed. Cir. 1998). 64 See, e.g., Johnson Worldwide Associates

Inc. v. Zebco Corp., 175 F.3d at 993, 50

USPQ2d at 1613; Gentry Gallery, Inc. v.

Berkline Corp., 134 F.3d at 1479, 45 USPQ2d

at 1503; Tronzo v. Biomet, 156 F.3d at 1159,

47 USPQ2d at 1833. 65 See, e.g., In re Marzocchi, 439 F.2d 220,

224, 169 USPQ 367, 370 (CCPA 1971). 66 Wertheim, 541 F.2d at 263, 191 USPQ at

97.67 See Rasmussen, 650 F.2d at 1214, 211

USPQ at 326. 68 See In re Alton, 76 F.3d 1168, 1176, 37

USPQ2d 1578, 1584 (Fed. Cir. 1996).

[FR Doc. 01–323 Filed 1–4–01; 8:45 am]

BILLING CODE 3510–16–U

CORPORATION FOR NATIONAL AND

COMMUNITY SERVICE

Revision of Currently Approved

Information Collection; Comment

Request

AGENCY: Corporation for National and

Community Service

ACTION: Notice.

SUMMARY: The Corporation for National

and Community Service (hereinafter

‘‘Corporation’’), as part of its continuing

effort to reduce paperwork and

respondent burden, conducts a

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reporting burden (time and financial

resources) is minimized, collection

instruments are clearly understood, and

the impact of collection requirement on

respondents can be properly assessed.

Currently, the Corporation is

soliciting comments concerning the

proposed revision of its Voucher and

Payment Request Form (OMB #3045–

0014).

Copies of the forms can be obtained

by contacting the office listed below in

the address section of this notice.

DATES: Written comments must be

submitted to the office listed in the

ADDRESSES section by March 6, 2001.

ADDRESSES: Send comments to Levon

Buller, National Service Trust,

Corporation for National and

Community Service, 1201 New York

Ave., NW., Washington, DC 20525.

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Levon Buller, (202) 606–5000, ext. 383.

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clarity of the information to be

collected; and

• Minimize the burden of the

collection of information on those who

are to respond, including through the

use of appropriate automated,

electronic, mechanical, or other

technological collection techniques or

other forms of information technology,

e.g., permitting electronic submissions

of responses.

Background

The Corporation supports programs

that provide opportunities for

individuals who want to become

involved in national service. The service

opportunities cover a wide range of

activities over varying periods of time.

Upon successfully completing an

agreed-upon term of service in an

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The National Service Trust is the

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