Revised Interim Guidelines for Examination of Patent Applications Under the 35 U.S.C. Sec. 112, para. 1 ``Written Description'' Requirement; Request for Comments

DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. 991027288-9288-01]

RIN 0651-AB10

Revised Interim Guidelines for Examination of Patent Applications

Under the 35 U.S.C. Sec. 112, para. 1 ``Written Description''

Requirement; Request for Comments

AGENCY: Patent and Trademark Office, Commerce.

ACTION: Notice and request for public comments.

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SUMMARY: The Patent and Trademark Office (PTO) requests comments from

any interested member of the public on the following Revised Interim

Guidelines for Examination of Patent Applications Under the 35 U.S.C.

112, para. 1 ``Written Description'' Requirement (Revised Interim

Guidelines). These Revised Interim Guidelines will be used by PTO

personnel in their review of patent applications for compliance with

the ``written description'' requirement of 35 U.S.C. Sec. 112,para. 1.

This revision supersedes the Interim Written Description Guidelines

which were published contemporaneously in both the Federal Register and

Official Gazette at 63 FR 32,639 (June 15, 1998) and 1212 O.G. 15 (July

7, 1998), respectively. This revision reflects the current

understanding of the PTO regarding the written description requirement

of 35 U.S.C. 112, para. 1 and is applicable to all technologies.

DATES: Written comments on the Revised Interim Guidelines will be

accepted by the PTO until March 22, 2000.

ADDRESSES: Written comments should be addressed to Box 8, Commissioner

of Patents and Trademarks, Washington, DC 20231, marked to the

attention of Stephen Walsh, or to Box Comments, Assistant Commissioner

for Patents, Washington, DC 20231, marked to the attention of Linda S.

Therkorn. Alternatively, comments may be submitted to Stephen Walsh via

facsimile at (703) 305-9373 or by electronic mail addressed to

``[email protected]'' or to Linda Therkorn via facsimile at (703)

305-8825 or by electronic mail addressed to

``[email protected].''

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 Box 8, Commissioner of Patents and Trademarks, Washington,

DC 20231, or by electronic mail at ``[email protected]'; or Linda

Therkorn by telephone at (703) 305-8800, by facsimile at (703) 305-

8825, by mail addressed to Box Comments, Assistant Commissioner for

Patents, Washington, DC 20231, or by electronic mail at

``[email protected].''

SUPPLEMENTARY INFORMATION: The PTO requests comments from any

interested member of the public on the following Revised Interim

Guidelines. As of the publication date of this notice, this revision

will be used by PTO personnel in their review of patent applications

for compliance with the ``written description'' requirement of 35

U.S.C. 112, para. 1. Because this revision governs internal practices,

it is exempt from notice and comment rulemaking under 5 U.S.C.

553(b)(A).

Written comments should include the following information: (1) Name

and affiliation of the individual responding, and (2) an indication of

whether the comments offered represent views of the respondent's

organization or are respondent's personal views. If you believe the PTO

should further amend these revised interim guidelines before they are

made final, you should include the following information in your

comments: (1) The rationale supporting the proposal, including the

identification of applicable legal authority; and (2) a description of

the potential benefits and drawbacks of adopting the proposal. The PTO

is particularly interested in comments relating to the following

topics: (1) The accuracy of the methodology, (2) the legal analysis in

the guidelines, and (3) relevant factors to consider in determining

whether the written description requirement is satisfied.

Parties presenting written comments are requested, where possible,

to provide their comments in machine-readable format in addition to a

paper copy. Such submissions may be provided by electronic mail

messages sent over the Internet, or on a 3.5'' floppy disk formatted

for use in a Macintosh, Windows, Windows for Workgroups, Windows 95,

Windows 98, Windows NT, or MS-DOS based computer.

Written comments will be available for public inspection on or

about April 19, 2000, in Suite 918, Crystal Park 2, 2121 Crystal Drive,

Arlington, Virginia. In addition, comments provided in machine readable

format will be available through the PTO's Website at http://

www.uspto.gov.

Discussion of Public Comments

Comments were received from 13 individuals and 16 organizations in

response to the Request for Comments on the Interim Guidelines for the

Examination of Patent Applications Under the 35 U.S.C. 112, para. 1

``Written Description'' Requirement published contemporaneously in the

Federal Register and Official Gazette at 63 FR 32,639 (June 15, 1998)

and 1212 O.G. 15 (July 7, 1998), respectively; and the Extension of

Comment Period and Notice of Hearing published at 63 FR 50887

(September 23, 1998) and 1214 O.G. 180 (September 29, 1998). The

written comments and the testimony at the public hearing have been

carefully considered.

Overview of Comments

The majority of comments favored issuance of written description

guidelines, with revisions. Several major issues arose in the oral

testimony and written comments submitted in response to the Interim

Guidelines on the Written Description Requirement with respect to the

scope of the Guidelines, the method of analysis, and the content of the

examples. In view of

[[Page 71428]]

the comments and testimony received, the Guidelines have been rewritten

in a technology neutral manner which is broadly applicable to all areas

of technology and to all types of claims (original, new, or amended,

and product, process, or product-by-process). Furthermore, the examples

have been removed from the Guidelines and examples addressing a broad

range of technologies will be incorporated into examiner training

materials. Revised Interim Guidelines are being issued for a second

round of Notice and Comment because the form and content of the

Guidelines are sufficiently different from the previous Guidelines that

additional public comment is desired.

The Extension of Comment Period and Notice of Hearing published at

63 FR 50887 (September 23, 1998) and 1214 O.G. 180 (September 29, 1998)

asked for comments regarding the patentability of Expressed Sequence

Tags (ESTs). Many comments took this opportunity to heavily criticize

the patentability of ESTs, grounding their arguments in fairness and

policy issues. Many comments also expressed the opinion that ESTs

lacked the utility, enablement, and written description necessary to

satisfy title 35 of the U.S. Code. The Revised Interim Guidelines are

not the appropriate vehicle to fully address the patentability of ESTs.

In view of comments and testimony with respect to ESTs and the

enablement and utility requirements, the Office is revising the Utility

Guidelines as published at 60 FR 36263 (July 14, 1995), and will also

be revising the examiner training material with regard to both the

utility and enablement requirements. Comments pertaining to the utility

and enablement requirements will be addressed in the notice revising

the Utility Guidelines. Responses to the comments germane to the

written description requirement are set forth below.

Responses to Specific Comments

(1) Comment: Several comments criticized the Guidelines for failing

to set out a general, systematic examination of the case law on written

description. Comments mentioned Vas-Cath, Inc. v. Mahurkar, 935 F.2d

1555, 19 USPQ2d 1111 (Fed. Cir. 1991), in particular as important for

summarizing the state of the law as the Federal Circuit sees it. Other

comments particularly urged a general analysis of case law as it

pertains to written description for chemical compounds, and criticized

the fact that the Guidelines relied heavily on only three recent cases.

Response: The suggestion to provide a general, systematic legal

analysis has been adopted. The Revised Interim Guidelines are grounded

more broadly than the three cases heavily relied upon in the original

Interim Guidelines, and cases dealing with a variety of arts are relied

upon.

(2) Comment: The comments were equally divided with respect to the

issue of whether the Guidelines should be broadly applicable to all

technologies or limited to biotechnology, DNA claims, or unpredictable

arts. Two of the comments urging broad applicability stated that the

law should be articulated in a clear and technology neutral fashion,

and several comments urged that examples and training materials should

illustrate application of the Guidelines in a diverse range of

technologies. One comment suggested that applications in which written

description problems are likely to arise should be identified

generically, rather than requiring a written description analysis in

each application. Response: The suggestion to cover all technologies

and to articulate the law in a clear and technology neutral fashion has

been adopted. While a written description analysis is required in each

case, the Revised Interim Guidelines clearly specify when a written

description issue is most likely to arise, and--for most applications--

the Revised Interim Guidelines will quickly lead the examiner to

determine that, at least for original claims, the written description

requirement has been met. The Revised Interim Guidelines avoid

narrowing the application of the written description requirement to a

single art, and the examiner training materials will illustrate

application of the revision in various technologies.

(3) Comment: While the majority of comments supported the Interim

Guidelines, eight comments opposed their issuance. Some of those

opposing the guidelines argued that the decision in Regents of the

University of California v. Eli Lilly, 119 F.3d 1559, 43 USPQ2d 1398

(Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998), is a drastic

departure from legal precedent and PTO practice. In particular, two

comments suggested that the Interim Guidelines should be replaced by

Revised Interim Guidelines, and one comment recommended that final

Guidelines be deferred until the U.S. Court of Appeals for the Federal

Circuit or the U.S. Supreme Court hands down decisions that elaborate,

construe, modify, or overrule Eli Lilly and/or decide related issues

not dealt with by that case. See Comments (5) and (9) for more opposing

comments. Response: This revision is based on the Office's current

understanding of the law and is 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. Guidelines are necessary in this area

to promote uniformity and consistency in the examination process. The

suggestion to issue Revised Interim Guidelines for a second round of

Notice and Comment has been adopted. The revision is written in a

technology neutral manner, and the form is sufficiently different from

the previous guidelines that additional public comment is desired.

(4) Comment: Six comments were in favor of including process and

product-by-process claims in the analysis, whereas one comment was

opposed. One comment criticized the Guidelines for failing to

acknowledge the ``safe harbor'' product-by-process type claim noted in

Fiers v. Revel, 984 F.2d 1164, 25 USPQ2d 1601 (Fed. Cir. 1993), and

Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016

(Fed. Cir. 1991). One comment observed that process and product-by-

process claims tend not to implicate many written description issues,

and it may be useful to point out possible enablement deficiencies for

such claims. Two comments suggested that the Guidelines should

distinguish between claims to processes whose patentability depends on

the compositions used in them, as opposed to those where patentability

rests in the steps of the process itself. Response: The suggestion to

address process and product-by-process claims has been adopted.

Furthermore, the training materials will analyze claims wherein the

patentability depends on the compositions used therein, as well as

those where the patentability rests in the process steps themselves.

Enablement issues raised by process and product-by-process claims are

outside the scope of these Revised Interim Guidelines.

(5) Comment: While one comment stated that the Guidelines correctly

present the relationship between written description and enablement, a

number of comments dispute that the statute actually has a written

description requirement distinct from the enablement requirement. One

comment requested that the PTO refrain from issuing any Guidelines in

this area until the U.S. Supreme Court rules on the Federal Circuit's

present position on written description. Several comments urged the PTO

to announce that it will not follow the court decisions applying the

separate written description requirement, while others observed that

the PTO and the practitioners must nevertheless follow the case law.

Some of these comments urged the PTO to

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withdraw the Guidelines on the grounds that they are premature because

the case law has not developed sufficiently. Others urged the PTO to

limit application of the Guidelines to the narrow subject matter of the

Fiers, Amgen, and Eli Lilly cases. Response: A separate written

description requirement has long been a part of the U.S. patent law.

See, e.g., In re Ruschig, 379 F.2d 990, 154 USPQ 118 (CCPA 1967). The

Federal Circuit has recognized the distinct and separable nature of

this requirement. See Vas-Cath. Although the interpretation of the law

is always evolving, the PTO is obliged to follow the law as currently

interpreted by the court. As noted above, the suggestion to limit the

application of the Revised Interim Guidelines to certain subject matter

has not been adopted.

(6) Comment: While several of the comments stated that the

Guideline's explanation of the purpose of the written description

requirement is accurate, a number of comments suggested that the

concept of ``possession'' should be more fully explained or developed.

One comment urged that the meaning of ``possession of the invention''

is different for written description than enablement, whereas another

observed that an ``in possession of the invention'' test for compliance

with the written description requirement does not appear in 35 U.S.C.

112, and its definition and application are not clearly stated in the

Federal Circuit cases to date. Another comment urged that descriptive

attributes which provide proof of written description should include

evidence typically provided to prove a complete and enabling

conception. One comment stated that the meaning of ``has invented'' is

unclear and queried if actual reduction to practice is required. The

same comment asked for clarification on what kind of description

equates with possession of a claimed species. One comment stated that a

question left unanswered in the Guidelines is that if one has ``made''

an invention, is one necessarily in possession of it, or are there some

further criteria? Two comments observed that physical possession is not

necessary: one must have complete conception of the invention in mind.

These comments suggested that the possession analysis incorporate the

Supreme Court's statements in Pfaff v. Wells Electronics, Inc., 525

U.S. 55, 48 USPQ2d 1641 (1998) (the word ``invention'' must refer to a

concept that is complete: one can prove that an invention is complete

and ready for patenting before it has been reduced to practice). One of

these comments elaborated that the doctrine of simultaneous conception

and reduction to practice should remain applicable to only a very small

number of cases, including biotechnology cases. Response: The Revised

Interim Guidelines expand the explanation of possession by discussing

decisions that offer some guidance as to how possession may be shown.

The concepts in Pfaff v. Wells Electronics that are pertinent to an

analysis of compliance with the written description requirement have

been incorporated in this revision. At this time, the Federal Circuit

has not indicated that reduction to practice is necessary for

conception or written description of a biotechnological invention. The

Office does not intend to impose a written description requirement that

is more robust than that set forth by the courts. Accordingly, the

Revised Interim Guidelines do not impose a per se requirement for

reduction to practice in any technology to satisfy the written

description requirement. However, the Federal Circuit has recognized

that in some instances an inventor may only be able to establish a

conception (and therefore possession) by pointing to a reduction to

practice through a successful experiment. See Amgen Inc. v. Chugai

Pharmaceutical Co., 927 F.2d at 1206, 18 USPQ2d at 1021. 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.

(7) Comment: Other comments on ``possession'' urged that possession

is to be evaluated by looking to the claims; that the possession

question is to be assessed as set forth in In re Alton, 76 F.3d 1168,

1176, 37 USPQ2d 1578, 1584 (Fed. Cir. 1996); and that compliance must

be assessed on a case-by-case basis given that the question of

compliance with the written description requirement is one of fact. One

comment stated that the test should be whether the inventor had

envisioned the embodiments, not that one of skill in the art can now

envision the embodiments. Another comment stated that the Guidelines

should take a position with regard to their application to the analysis

of declarations submitted under 37 CFR 1.131. Response: The Revised

Interim Guidelines require the examiner to determine whether there is

sufficient written description to inform a skilled artisan that the

applicant was in possession of the claimed invention as a whole at the

time the application was filed. The revision also indicates that

compliance with the written description requirement is a question of

fact which must be resolved on a case-by-case basis. While this

revision addresses the analysis of possession only in the context of

the written description requirement, similar principles apply in

determining whether an inventor has met his or her burden of

demonstrating possession of the claimed invention in an affidavit or

declaration submitted under 37 CFR 1.131.

(8) Comment: Several comments suggested that the Guidelines should

address questions of support for claims added or amended by the

applicant during prosecution (or during an interference). Two comments

suggested that the Guidelines should address the ``omitted element''

prong of the written description requirement. One comment indicated the

Guidelines should harmonize chemical and nonchemical case law on when

an applicant may amend to broaden or change a definition based on an

original disclosure. Another comment stated that the Guidelines should

acknowledge that it is proper to amend the claims to excise prior art.

Response: The suggestions to address questions of support for new or

amended claims and to address the ``omitted element'' test have been

adopted.

(9) Comment: Several comments indicated that case law such as In re

Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980), hold that original

claims constitute their own written description, or that a statement in

ipsis verbis is a sufficient description, and that those cases should

be adhered to. Three comments pointed out that the Guidelines fail to

distinguish between original claims and added/amended claims, arguing

that the original claim doctrine should exempt originally filed claims

from further requirements. Response: The Revised Interim Guidelines

emphasize that a description as filed is presumed to be adequate,

unless or until the examiner introduces sufficient evidence or

technical reasoning to the contrary. The original claim doctrine

continues to be viable, but the court has indicated that every claim

must be supported by sufficient

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evidence of possession, and that, under certain circumstances, claim

language may not provide an adequate written description of itself.

There are no per se rules, since the analysis must be done on a case-

by-case basis. While original claims have an initial presumption of

descriptive support, the applicant should show support for new or

amended claims. See, e.g., Manual of Patent Examining Procedure (MPEP)

Secs. 714.02 and 2163.06 (7th Ed., July 1998) (``Applicant should * * *

specifically point out the support for any amendments made to the

disclosure.'').

(10) Comment: One comment indicated that written description

problems may arise where there is an inadequate description or

demonstration of possession of a genus or where there is an improper

genus (no common structure and function that is linked to the practical

utility disclosed by the specification). Another comment stated that

the Guidelines should address the informational nature of nucleic acid

sequences and amino acid sequences. One comment urged that ``[a]

written description of a genus is sufficient when it is described in

enough detail that possession is understood,'' and that the number of

species relates more to enablement. Response: The Revised Interim

Guidelines indicate that the written description requirement for a

claimed genus may be satisfied through sufficient description of a

representative number of species. The revision does not require a

particular number of species to support a genus, but rather requires

that the species adequately described be representative of the claimed

genus.

(11) Comment: A comment urged that the Guidelines should explicitly

state that the maturation of the technology will increase the

understanding of one skilled in the art, and ease the predictable scope

of the claimed invention beyond the exemplified embodiments, as

recognized in the applicant's specification. Response: The Revised

Interim Guidelines emphasize that in a mature art with a high level of

knowledge and skill, less evidence of possession is required.

(12) Comment: One comment objected to the requirement for an

assessment of predictability as a touchstone for written description.

The comment described this inquiry as new and lacking case law support.

Several comments stated that predictability is an inquiry relating to

the enablement requirement, but not to the written description

requirement. Others commented generally that the Guidelines conflate

what should be separate enablement and written description analyses. On

the other hand, at least one comment stated that the distinctions

between these elements converge when lack of enablement results from

undue breadth of claims. One comment stated that a review of the

application is insufficient to establish the level of predictability in

an art. Another queried if the review is to be done after a search in

the art and assessment of the art. Another comment stated that the lack

of guidance for distinguishing between predictable and unpredictable

areas within the field of biotechnology leads to confusion. Response:

The Revised Interim Guidelines reduce the emphasis on predictability

because of the confusion with enablement. Instead, the Guidelines

emphasize the knowledge in the art and the skill of the practitioner

considered in the totality of the circumstances. With respect to the

comment regarding biotechnology, this sliding scale will permit broader

claims as the knowledge and skill in this art improve. The Guidelines

discuss how the general knowledge in the art may be relied on as

evidence of how much description may be needed in particular cases.

(13) Comment: Several comments criticized the methodology of the

Guidelines because the analytic steps set out by the court in In re

Moore, 439 F.2d 1232, 169 USPQ 236 (CCPA 1971) (first determine what

the claims cover, then review the specification for support) were

reversed. Response: The Revised Interim Guidelines restate the analytic

sequence so it is clearly consistent with In re Moore. The revision

also makes it clear that each claim must be separately analyzed and

given its broadest reasonable interpretation in light of and consistent

with the written description. See, e.g., In re Morris, 127 F.3d 1048,

1054, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997).

(14) Comment: One comment suggested that the Guidelines should

provide more instruction on the different amount of description needed

to support an essential feature of an invention in contrast to a

nonessential feature. The comment explained that contrasting the amount

of description needed to support a novel or nonobvious feature of an

invention with the amount of description needed for features of an

invention that were known in the prior art would be helpful. Response:

The Revised Interim Guidelines distinguish between novel and old

elements in a claim to clarify that the amount of written support

needed in an application can vary depending on the general knowledge

that was readily available in a particular art.

(15) Comment: One comment criticized the analysis for setting out

conclusions before the analytic method and for distorting or bypassing

the analysis. The same comment said that some of the examples yield

illogical results. Response: The examples have been deleted from the

Guidelines, and the analytical method has been clarified.

(16) Comment: The Guidelines were heavily criticized in ten

comments for overemphasizing the importance of the preamble and for

indicating that generic preamble terms such as ``nucleic acid'' would

need less descriptive support than narrower terms such as ``cDNA.'' One

comment objected to the proposition that one may have an adequate

written description of a genus of DNA when one does not disclose what

gene product the DNA encodes and what that gene product does. This

comment recommended deletion of the example bridging F.R. 32640-41 (``a

gene comprising SEQ ID NO: 1'') as inconsistent with the rest of the

Guidelines. Response: The Revised Interim Guidelines clarify that the

examiner must consider the claim as a whole and that the preamble may

be a limitation of the claim. Preamble language is discussed in the

context of determining what the claim as a whole encompasses within its

scope. However, the Revised Interim Guidelines maintain that any term

may trigger a need for more descriptive support because of usage or

context. The revision clarifies that during examination claim terms are

given their broadest reasonable interpretation consistent with the

specification. See In re Morris, 127 F.3d 1048, 44 USPQ2d 1023 (Fed.

Cir. 1997). The examples have been removed from the text of the

revision.

(17) Comment: Four comments objected to the Guidelines' definitions

for the terms gene, mRNA, and cDNA, stating that the art often refers

only to the coding portion of the molecules and does not necessarily

imply the presence of regulatory elements or recite specific

structures. One comment further indicated that adoption of the PTO's

new definition of these terms for purposes of written description

considerations could potentially destabilize the economic

infrastructure of the biotechnology community because innumerable

patents have issued claiming such molecules without regard to the PTO's

new interpretation of claim language. The Guidelines were said to use

two inconsistent meanings for the term gene that differed in scope and

confused the distinction between

[[Page 71431]]

genus and species. Response: The Revised Interim Guidelines no longer

define the term ``gene.''

(18) Comment: One comment indicated that the PTO has the

opportunity to emphasize the written description requirement as an

anti-submarine patent device; this comment and another observed that

two parties could obtain claims which would be almost identical in

scope in hindsight, based on completely different paths to the claim.

Response: In Hyatt v. Boone, 146 F.3d 1348, 1353, 47 USPQ2d 1128, 1131

(Fed. Cir. 1998), the Federal Circuit addressed the submarine patent

issue in finding that the appellant's parent application lacked written

descriptive support for a later added claim. 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.'' Id.

(19) Comment: A comment stated that the Guidelines give too much

emphasis to claim structure, as if the claim is the sole source of the

written description. Another comment had a different view, stating that

the Guidelines fail to focus on the invention being claimed, and noting

that in some circumstances, failure to provide the structure of a gene,

enzyme, etc. should not result in finding that a claim containing it

fails to meet the written description requirement. Response: The Office

gives a claim its broadest reasonable interpretation during

examination. If the claim taken as a whole requires a limitation not

set forth in the original disclosure it may raise an issue of lack of

proper written description. As noted in In re Hiniker Co., 150 F.3d

1362, 1369, 47 USPQ2d 1523, 1529 (Fed. Cir. 1998), ``the name of the

game is the claim.''

(20) Comment: One comment indicated that there was not enough

emphasis on transitional phrases and their impact on the adequacy of

the written description. Response: As with the preamble, the

transitional phrase is discussed in the context of the scope of the

claimed invention as a whole.

(21) Comment: The Extension of Comment Period and Notice of Hearing

requested comments as to how the transition terms ``having'' and

``consisting essentially of'' should be treated within the context of

nucleotide and amino acid sequence claims. Two comments observed that

transitional phrases in the context of nucleotide and amino acid

sequence claims should have the same treatment as in chemical cases.

Another comment stated that ``consisting essentially of'' language in

DNA or vector claims should not be rejected as per se improper under 35

U.S.C. 112, para. 2. Two comments stated that lacking an art-accepted

meaning or a definition in the specification, ``having'' would imply an

open claim format; another comment stated that ``having'' is understood

to mean ``comprising.'' The term ``consisting essentially of'' was

defined by one comment as a closed claim format that is essentially

limited to the compound or composition defined explicitly following the

transitional phrase, and by two other comments as having the stated

sequence and excluding any alterations which materially change the

structure and/or function of the specified sequence. One comment opined

that ``A DNA consisting essentially of SEQ ID NO: 1'' would be limited

to DNAs having the nucleotide sequence set forth in SEQ ID NO: 1 plus

minor additions at the 5'-- and/or 3' --ends of the recited sequence.

Another comment observed that the meaning of ``consisting essentially

of'' depends on how the specification defines its usage. Response:

During examination, the claim as a whole is given the broadest

reasonable interpretation consistent with the specification.

Transitional phrases should be given the same treatment in all cases.

The Revised Interim Guidelines set forth legally recognized definitions

for transition language in an endnote. ``Consisting essentially of'' is

acceptable transition language in nucleic acid and protein claims. The

impact of the transition language on enablement and practical utility

will not be dealt with in this forum.

(22) Comment: One comment criticized the use of the taxonomic terms

``genus'' and ``species.'' The comment explained that because the

terminology is well established in biology, it should not be applied to

chemical compounds. Two comments described the Guidelines as deficient

in analyzing the proper relationship of preamble, transitional phrase

and claim body for distinguishing genus from species claims. According

to another comment, the Guidelines confuse genus and species claims.

Response: The Revised Interim Guidelines refer to the terms ``genus''

and ``species'' in their well accepted legal sense as widely used

patent terms of art that are recognized as distinct from their use as

taxonomic terms. The revision clarifies what is meant by genus and

species.

(23) Comment: Several comments found the explanations for the

examples deficient because they do not clarify what would constitute a

sufficient disclosure. One comment urged that there is no guidance

provided as to what would constitute sufficient identifying

characteristics, and the Guidelines do not set forth the number of the

examples needed for sufficient written description. Another comment

urged that structure, or function plus partial structure, or function

plus ``some characteristics'' (e.g., 2 or more), is sufficient to meet

the written description requirement. Yet another comment urged that

uncertainties and potential problems exist because it is unclear how

``relevant'' or ``sufficient'' identifying characteristics are

established; that it is unclear how functional properties fit into the

analysis; and that problems exist with the level of uncertainty when

the complete structure is not disclosed or the structure is not

disclosed and only a few identifying characteristics are disclosed.

Another comment urged that the methodology is incomplete as to how many

identifying characteristics are required and what characteristics are

relevant for description of a species. This comment applied the same

reasoning to the number of species required for describing a genus. One

comment urged that functional characteristics in combination with

certain objectively defined physical characteristics can serve to

characterize the compound sufficiently to establish possession, even in

less developed arts. One comment urged that the ability to predict

structure from function is given as a standard for the written

description requirement without any citation to authority. Response:

The Revised Interim Guidelines do not include examples within the text.

The test for whether sufficient identifying characteristics have been

disclosed is not a bright-line test, but rather requires weighing

various factors including the level of skill and knowledge in the art,

and the extent to which relevant identifying characteristics are

described. The revision provides more guidance to the examiners by

citing as examples cases involving mature arts with a high level of

skill and knowledge (e.g., Pfaff v. Wells Electronics, Fonar Corp. v.

General Electric Co., 107 F.3d 1543, 1549, 41 USPQ2d 1801, 1805 (Fed.

Cir. 1997) and Vas-Cath v. Mahurkar), as well as cases in emerging

technologies where more description is necessary (e.g., Eli Lilly,

Amgen v. Chugai, and Fiers v. Revel). The test remains whether one of

skill in the art, provided with the disclosure, would recognize that

the applicant was in possession of the claimed subject matter when the

application was filed.

[[Page 71432]]

(24) Comment: The Extension of Comment Period and Notice of Hearing

requested comments on how the final Guidelines should address the

deposit of a biological material made under 37 CFR 1.801, and comments

on the extent to which a deposit of biological material may be relied

upon to support the addition or correction of sequence information.

Several comments expressed the opinion that deposit of a compound or

biological material can be one means of demonstrating possession of a

specifically claimed compound that has not otherwise been described in

a complete manner in the specification. One comment stated that if a

gene were cloned but not sequenced, and the vector in question were

deposited, the sequence is an inherent property of the deposited vector

and hence the description requirement would be satisfied if the claim

referred to the deposit. One comment urged that the description

requirement may be satisfied by the inherent properties of a disclosed

structure, citing Kennecott Corp. v. Kyocera Int'l Inc., 835 F.2d 1419,

5 USPQ2d 1194 (Fed. Cir. 1987). As for the later addition or correction

of information, several comments indicated that actual possession

established through a deposit with a partial characterization (i.e., to

correlate the physical description to the material that has been

deposited, such as molecular weight, partial sequence) should be

sufficient to avoid problems with new matter where the information

added to a disclosure is an inherent characteristic of the compound or

composition. One comment indicated that correcting a sequence based on

more accurate sequencing of deposited material does not introduce new

matter. One comment stated that present genus-species concepts should

prevent an applicant from obtaining an unfair advantage by depositing a

large amount of material and then relying on inherency; if a variety of

materials are deposited in a single host, the specification must

adequately describe how to isolate the intended molecule(s). Two

comments expressly stated ``no comment'' with regard to the issue of

adding a substantial amount of sequence information. One comment opined

that the date of deposit is not controlling with regard to the issue of

whether the written description requirement is met, and a second

comment observed that In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed.

Cir. 1985), cannot be limited by rule. Response: The Revised Interim

Guidelines indicate that a deposit of a claimed biological material in

accordance with the requirements of 37 CFR 1.801 et seq. is evidence of

actual reduction to practice of the biological material. However, a

deposit is not a substitute for a written description of the claimed

invention. The Revised Interim Guidelines also address the issue of

when a deposit can be relied upon to correct minor sequencing errors.

However, addition of sequence information based on a deposit is not

specifically addressed; these circumstances create issues yet to be

resolved by the courts, and will be resolved on a case-by-case basis in

the PTO. See, e.g., In re Fisher, 427 F.2d 833, 836, 166 USPQ 18, 21

(CCPA 1970).

(25) Comment: One comment explained that associating taxonomic

groupings with gene sequences is a dated concept because genes are not

distinguishable as to origin. The generic term ``mammal gene'' was said

to be meaningless, absent an implied process limitation that the gene

was obtained from a mammal. Response: The examples have been removed

from the revision. However, the training materials will permit

applicants to use taxonomic modifiers such as ``mammalian'' because the

usage is ubiquitous in the literature and in patents and generally has

an accepted meaning in the art.

(26) Comment: One comment urged that broad functional claims

lacking defining structure should not be granted on the basis of a

``not easily generalizable disclosure.'' A different comment stated

that functional characteristics can be appropriate in all arts.

Comments differed on hybridization, where some held it is a proper

defining characteristic, and another stated it is insufficient.

Response: The Revised Interim Guidelines do not establish per se rules

regarding functional language. When used appropriately, functional

language may provide an adequate written description of the claims

invention as discussed in the Revised Interim Guidelines.

(27) Comment: Several comments indicated that the Guidelines

present inadequate guidance with respect to analyzing written

description support for genus claims. One comment stated that the

Guidelines provide inadequate criteria for selection of appropriate

genuses. Another comment stated that the Guidelines do not provide

adequate guidance to determine whether an applicant has presented a

properly formed genus, and suggested that ``a genus designation should

be strictly tied to the disclosed properties of the structures being

claimed.'' Another comment stated that the Guidelines should clarify

that the genus/species distinction is determined by the transitional

phrase and body of the claim, not the preamble. Another comment stated

that the Guidelines provide inadequate guidance as to the number of

species required to meet the written description requirement for a

genus. One comment urged that a relevant factor to consider is whether

the claims cover embodiments broader than the essential elements of the

embodiments described in the specification as in Gentry Gallery Inc. v.

Berkline, 134 F.3d 1473, 45 USPQ2d 1498 (Fed. Cir. 1998). According to

this comment, species rarely, if ever, constitute sufficient support

for generic claims unless accompanied by a general disclosure that is

commensurate in scope with the claims. Response: The Revised Interim

Guidelines follow Federal Circuit case law which requires a

representative number of species to satisfy the written description

requirement for a genus. Written description is a question of fact, and

what constitutes a representative number for a genus is a factual

determination left to a case-by-case analysis by the examiner.

(28) Comment: One comment urged that general allegations of

``unpredictability in the art'' are insufficient to support a case

against the applicant, and that examiners should be instructed to weigh

applicant's evidence of what the description provides to one of skill

in the art. Response: The suggestion to clarify that a general

allegation of ``unpredictability in the art'' is insufficient to

support a rejection has been adopted. A disclosure as filed is prima

facie adequate. To support a rejection, the PTO has the burden of

showing why the applicant's evidence is insufficient. In any case where

lack of written description is found, the PTO should cite documentary

evidence in support of the finding. Where documentary evidence is not

available, technical reasoning, as distinguished from legal reasoning,

may support the finding when the technical line of reasoning relates to

fact finding regarding possession of the invention.

(29) Comment: One comment indicated that rejections based on the

enablement and written description requirements of 35 U.S.C. 112 should

be made separately, and the rejections should not mix standards.

Response: Examiners are directed to make separate rejections based on

the enablement and written description requirements of 35 U.S.C. 112.

See, e.g., MPEP Sec. 706.03(c) (explaining when it is appropriate to

use a particular form paragraph for rejecting claims under 35 U.S.C.

112, para.1) and MPEP Sec. 2164 (``limitations must be

[[Page 71433]]

analyzed for both enablement and description using their separate and

distinct criteria'').

(30) Comment: One comment observed that the Guidelines do not guide

examiners in how to suggest amendments to bring the claims into

compliance. The comment also observed that examiners may be ill-

equipped to deal with evaluating the sufficiency of applicant's

efforts. Response: The training materials will provide guidance as to

how rejections for lack of an adequate written description can be

overcome.

(31) Comment: One comment stated that the Guidelines should

instruct examiners to pay due regard to the scientific and commercial

realities of each individual invention, such that the scope of the

claims is a fair reflection of the applicant's contribution to the art.

Response: The scientific and commercial realities of each invention are

considered to the extent that they impact analysis of a claimed

invention for compliance with Title 35 of the U.S. Code. The Office is

bound to follow the law and cannot make judgment calls as to what is

``a fair reflection of the applicant's contribution to the art.''

(32) Comment: While two comments observed that the Guidelines

should not have a significant impact on patents or pending or newly

filed applications because they are only Guidelines which are not

binding on the Board or examiners, three comments were of the opinion

that the Guidelines would impact pending and newly filed cases by

limiting the scope of patent protection. One comment was of the opinion

that the Guidelines should have no impact on issued cases except

reissues, whereas another expected many issued patents to be declared

invalid (more as a result of Eli Lilly than the Guidelines). Another

comment observed that the Guidelines should not impose significant new

burdens on patent applicants in the biotechnology arts or give rise to

a new ``anti-patenting'' posture in the biotechnology examination

group; however, the PTO should not be misled into adapting ``customer-

friendly'' examination standards that do not subject applications to a

thorough and rigorous examination. One comment opined that the

Guidelines will result in a great increase in the number of appeals

until the Federal Circuit makes clear that the law is quite different,

thus delaying commercialization of potentially life improving and life

saving inventions. According to this comment, universities and small

inventors do not have the financial support to provide the exhaustive

kind of work the Guidelines can require for meaningful coverage; this

will mean that many biotechnology inventions will not be

commercialized. One comment stated that the Commissioner indicates that

meaningful patent coverage is required for commercial exploitation of

biotechnological inventions, yet the PTO continues to take a position

that leads away from what the Commissioner espouses. Another comment

felt that the scope of allowed claims would be dependent on the

examiner; a potential applicant would not know what sort of claims

could be obtained based on a particular disclosure. One comment opined

that applications filed after publication of the Guidelines will

probably be much more detailed and longer in length. Response: The

Revised Interim Guidelines clarify that a written description issue

should rarely arise for an original claim because such a claim is

presumed to have adequate descriptive support. The burden is on the

examiner to provide evidence or reasoning in support of any rejection.

Such an approach would not be expected to increase the number of

appeals, nor should it require exhaustive work for meaningful coverage.

The Revised Interim Guidelines are intended to promote uniformity, not

diminish it.

(33) Comment: One comment indicated it is premature to instruct

examiners in the proposed Guidelines since they may change dramatically

as a result of public comment. Three comments stated that the

Guidelines should not be applied until final Guidelines have been

approved; two of these indicated that the Guidelines should only be

applied to applications filed after implementation. One comment

suggested preparing separate guidance for currently pending

applications. Response: Separate guidance is not required for pending

applications and applications filed after implementation of any final

Guidelines; the Guidelines do not establish new law or rules or impose

any additional requirements on applicants.

(34) Comment: One comment requested that the PTO address the issue

of open-claim language for EST claims in the final Guidelines because

of their importance to the biotechnology industry. Several comments

stated that permitting open-ended language with respect to an EST claim

contradicts the written description requirement because the common

structural features of the EST do not constitute a ``substantial

portion of the genus'' as required by the Eli Lilly case. According to

these commentators, a claim such as ``a DNA comprising SEQ. ID. NO: 1''

would lack written description when SEQ. ID. NO: 1 was a gene fragment.

Response: The Revised Interim Guidelines maintain the view that use of

such terms as ``gene'' in the preamble of an EST claim may raise a

written description issue if one skilled in the art would understand

that a ``gene'' requires elements which are not sufficiently described.

However, claims to ``a DNA comprising SEQ. ID. NO: 1'' are unlikely to

raise a written description issue. The comments do not explain why

there is a written description problem for a claim such as ``a DNA

comprising SEQ. ID. 1'' when SEQ. ID. 1 is an EST, while there is no

problem when SEQ. ID. 1 is a whole gene or a gene promoter. The only

difference seems to be the utility of the DNA fragment.

(35) Comment: One comment asserted that the scope and level of

unpredictability of the structure is so large that the person skilled

in the art could not envisage sufficient species to place the genus in

possession of the inventor at the time of filing, and that it should be

a rare disclosure that supports EST claims broader than the specific

SEQ. ID, even for claims such as ``a DNA comprising the EST of SEQ. ID.

NO: 1.'' The comment also suggested that claim language that supports

the introduction of an infinite amount of random sequence would require

an immense number of exemplary species. Several commentators advanced

the position that disclosure of only a small fragment does not convey

that the inventor was in possession of all of the possible molecules or

that the inventor was in possession of the fragment wherever it occurs.

Response: A claim such as ``a DNA comprising the EST of SEQ. ID. NO:

1'' or ``a gene comprising the EST of SEQ. ID. NO: 1'' will be analyzed

for compliance with the written description requirement by determining

whether the partial structure in combination with any other disclosed

relevant identifying characteristics are sufficient to show that a

skilled artisan would recognize that the applicant was in possession of

the claimed invention as a whole. The Office does not agree with the

comment that the scope of such an EST claim is necessarily too large to

satisfy the written description requirement. The PTO has issued

numerous patents in the past directed to nucleic acids that use open-

ended language. Although an applicant presenting an original claim to

an EST using open-ended claim language with disclosure of only the EST

sequence is not in possession of any arbitrary specific possible

molecule that contains the EST, the applicant may

[[Page 71434]]

be in possession of a broad genus of DNA where the EST is in any random

nucleic acid sequence. The comment's statement to the contrary would

preclude open-ended claims incorporating any DNA sequence such as gene

or promoter. In fact, such a view would appear to preclude open-ended

language for any other polymer. However, such open-ended EST claims may

not comply with the utility and scope of enablement requirements of 35

U.S.C. 101 and 112.

Revised Interim Guidelines for the Examination of Patent

Applications Under the 35 U.S.C. Sec. 112, para. 1 ``Written

Description'' Requirement

These revised interim ``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, para. 1. This revision is based on the Office's current

understanding of the law and public comments received in response to

the PTO's previous request for public comments on its 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 the Revised Interim

Guidelines is neither appealable nor petitionable.

These Revised Interim 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 Revised

Interim 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. 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.\3\

---------------------------------------------------------------------------

\1\ See Endnotes at end of this notice.

---------------------------------------------------------------------------

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.\5\ Possession may be shown by actual

reduction to practice,\6\ or by showing that the invention was ``ready

for patenting'' such as by the disclosure of drawings or other

descriptions of the invention that are sufficiently specific to enable

a person skilled in the art to practice the invention.\7\ 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).\8\

Compliance with the written description requirement is a question of

fact which must be resolved on a case-by-case basis.\9\

A. Original Claims

There is a strong presumption that an adequate written description

of the claimed invention is present when the application is filed.\10\

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.\11\ The claimed invention as a whole may not be

adequately described if the claims require an essential or critical

element which is not adequately described in the specification and

which is not conventional in the art.\12\ 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.\13\ A lack of adequate written description problem 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.\14\

B. New or Amended Claims

The proscription against the introduction of new matter in a patent

application \15\ serves to prevent an applicant from adding information

that goes beyond the subject matter originally filed.\16\ 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.\17\ 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 the appropriate

correction.\18\

Under certain circumstances, omission of a limitation can raise an

issue regarding whether the inventor had possession of a broader, more

generic invention.\19\ 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.\20\

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.\21\

[[Page 71435]]

II. Methodology for Determining Adequacy of Written Description

A. Read and Analyze the Specification for Compliance With 35 U.S.C.

112, para. 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, para. 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; \22\ however, with

respect to newly added or amended claims, applicant should show support

in the original disclosure for the new or amended claims.\23\

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.\24\

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.25 The entire claim must be considered,

including the preamble language 26 and the transitional

phrase.27 The claim as a whole, including all limitations

found in the preamble,28 the transitional phrase, and the

body of the claim, must be sufficiently described in the specification

to satisfy the written description requirement.29

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.30 The absence of definitions or details for well-

established terms or procedures should not be the basis of a rejection

under 35 U.S.C. 112, para. 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 What Applicant Has

Described as the Essential Features of the Invention

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

what applicant has identified as the essential distinguishing

characteristics of the invention. The analysis of whether the

specification complies with the written description requirement

requires the examiner to determine the correspondence between what

applicant has described as the essential identifying characteristic

features of the invention, i.e., what the applicant has demonstrated

possession of, and what applicant has claimed. Such a review is

conducted from the standpoint of one of skill in the art at the time

the application was filed,31 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 does not have to be

described in detail in the specification.32

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 any number of ways.

Possession may be shown by actual reduction to practice, by a clear

depiction of the invention in detailed drawings which permit a person

skilled in the art to clearly recognize that applicant had possession

of the claimed invention, or by a written description of the invention

describing sufficient relevant identifying characteristics such that a

person skilled in the art would recognize that the inventor had

possession of the claimed invention.33

A specification may show actual reduction to practice by showing

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.34 Actual reduction to

practice of a biological material may be shown by specifically

describing a deposit made in accordance with the requirements of 37

C.F.R. Sec. 1.801 et seq.35

An applicant may show possession of an invention by disclosure of

drawings that are sufficiently detailed to show that applicant was in

possession of the claimed invention as a whole.36 The

description need only describe in detail that which is new or not

conventional.37 This is equally true whether the claimed

invention is directed to a product or a process. Normally a reduction

to drawings will adequately describe the claimed

invention.38

An applicant may also show that an invention is complete by

disclosure of sufficiently detailed relevant identifying

characteristics which provide evidence that applicant was in possession

of the claimed invention,39 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.40 What is conventional or well known to one

skilled in the art need not be disclosed in detail.41 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.42

(1) For each claim drawn to a single embodiment or species:

43

(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.

(c) If the application does not describe an actual reduction to

practice or reduction to drawings, 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.\44\ 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, para. 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

[[Page 71436]]

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.\45\ Whether the specification

shows that applicant was in possession of the claimed invention is not

a single, simple factual determination, but rather is a conclusion

reached by weighing many factual considerations. 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.

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.\46\ In contrast, in emerging and

unpredictable technologies, 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.\47\ Furthermore,

disclosure of partial structure without additional characterization of

the product may not be sufficient to evidence possession of the claimed

invention.\48\

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, para. 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 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).\49\

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. 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. 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.50 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.51 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, para. 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.

Secs. 119, 120, or 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.52 However, when filing an

amendment an applicant should show support in the original disclosure

for new or amended claims.53 To comply with the written

description requirement of 35 U.S.C. 112, para. 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,54

implicitly,55 or inherently 56 supported in the

originally filed disclosure.57 Furthermore, each claim must

include all elements which applicant has described as

essential.58

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, para. 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, para. 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, para. 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.59 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.60 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

[[Page 71437]]

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.61

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, para. 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 written description is

adequate to support the claim(s), repeat the rejection under 35 U.S.C.

112, para. 1, fully respond to applicant's rebuttal arguments, and

properly treat any further showings submitted by applicant in the

reply. Any affidavits, including those relevant to the 112, para. 1,

written description requirement,62 must be thoroughly

analyzed and discussed in the next Office action.

ENDNOTES

1. See, 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).

3. See 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).

4. See, 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. Sec. 132. The ``written description'' question

similarly arises in the interference context, where the issue is

whether the specification of one party to the interference can

support the newly added claims corresponding to the count at issue,

i.e., whether that party can ``make the claim'' corresponding to the

interference count. E.g., see Martin v. Mayer, 823 F.2d 500, 502, 3

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

In addition, early opinions suggest the Patent and Trademark

Office was unwilling to find written descriptive support when the

only description was found in the claims; however, this viewpoint

was rejected. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA

1980) (original claims constitute their own description); In re

Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973) (accord); In re

Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (accord). It is now

well accepted that a satisfactory description 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).

6. An 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. 37 CFR 1.804, 1.809.

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

34876. ``[T]he description must be sufficient to permit verification

that the deposited biological material is in fact that disclosed.

Once the 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.'').

7. Pfaff v. Wells Electronics, Inc., 525 U.S. 55,____ , 119

S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998).

8. A 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 1970)).

9. Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at

1116 (Fed. Cir. 1991).

10. In re Wertheim, 541 F.2d at 262, 191 USPQ at 96.

11. See endnote 4.

12. For 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.

13. A 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. 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.

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.'').

14. See, 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

[[Page 71438]]

lead'' those skilled in the art to any particular species); In re

Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 122-23 (CCPA 1967) (``If

n-propylamine 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.'').

15. 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) Secs. 2163.06-2163.07 (7th Ed., July

1998) for a more detailed discussion of the written description

requirement and its relationship to new matter.

16. 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).

17. 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).

18. 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 know

that sequencing errors are a common problem in molecular biology.

See, e.g., Richterich, Peter, ``Estimation of Errors in `Raw' DNA

Sequences: A Validation Study,'' Genome Research, 8:251-259 (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., 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.

19. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d

1473, 45 USPQ2d 1498 (Fed. Cir. 1998) (claims to a section 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 Inc. 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, Inc.,

156 F.3d 1154, 1159, 47 USPQ2d 1829, 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 parent application stating the advantages and

importance of the conical shape.).

20. See Gentry Gallery, 134 F.3d at 1480, 45 USPQ2d at 1503; In

re Sus, 306 F.2d 494, 134 USPQ 301 (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.''). 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. Sec. 112, para. 1 as not enabling, or under 35 U.S.C. 112,

para. 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 Reiffin

v. Microsoft Corp., 48 USPQ2d 1274, 1277 (N.D. Cal. 1998) and MPEP

Sec. 2172.01.

21. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at

1117.

22. Wertheim, 541 F.2d at 262, 191 USPQ at 96.

23. See MPEP Secs. 714.02 and 2163.06 (``Applicant should * * *

specifically point out the support for any amendments made to the

disclosure.''); and MPEP Sec. 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.'').

24. 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 Sec. 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).

25. See, e.g., In re Morris, 127 F.3d 1048, 1053-54, 44 USPQ2d

1023, 1027 (Fed. Cir. 1997).

26. ``Preamble language'' is that language in a claim appearing

before the transitional phase, e.g., before ``comprising,''

``consisting essentially of,'' or ``consisting of.''

27. 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., 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''), quoted with approval in Moleculon Research Corp v.

CBS, Inc., 793 F.2d 1261, 1271, 229 USPQ 805, 812 (Fed. Cir. 1986).

``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 search and examination purposes,

absent a clear indication in the specification 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 USPQ 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.'').

28. 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).

29. An applicant shows possession of the claimed invention by

describing the claimed invention with all of its essential novel

elements. Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.

30. 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.'').

31. See, e.g., Wang Labs. v. Toshiba Corp., 993 F.2d 858, 865,

26 USPQ2d 1767, 1774 (Fed. Cir. 1993).

[[Page 71439]]

32. See, e.g., Hybritech Inc. v. Monoclonal Antibodies, Inc.,

802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986).

33. Pfaff v. Wells Electronics, Inc., 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.'').

34. 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).

35. 37 CFR Secs. 1.804, 1.809. See also endnote 6.

36. 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 Sec. 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) (``[I]n

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.'').

37. 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).

38. This is especially true for the mechanical and electrical

arts. See, e.g. , Pfaff v. Wells Electronics, 119 S.Ct. at 312, 48

USPQ2d at 1647.

39. 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.

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'').

However, a definition by function alone ``does not suffice'' to

sufficiently describe a coding sequence ``because it is only an

indication of what the gene does, rather than what it is.'' Eli

Lilly, 119 F.3 at 1568, 43 USPQ2d at 1406. See also Fiers, 984 F.2d

at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen Inc. v. Chugai

Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991)).

40. If a claim limitation invokes 35 U.S.C. Sec. 112, para. 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, para. 6. See also B. Braun Medical, Inc. v.

Abbott Lab., 124 F.3d 1419, 1424, 43 USPQ2d 1896, 1899 (Fed. Cir.

1997). If the written description fails to set forth the supporting

structure, material or acts corresponding to the means-(or step-)

plus-function, the claim may not meet the requirement of 35 U.S.C.

112, para. 1. A means-(or step-) plus-function claim limitation

satisfies 35 U.S.C. 112, para. 1 if: (1) The written description

links or associates particular structure, materials, or acts to the

function recited in a means-(or step-) plus-function 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,

materials, or acts perform the function recited in a means-(or step-

) plus-function limitation. In considering whether there is 35

U.S.C. Sec. 112, para. 1 support for the 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. See the Interim Supplemental Examination Guidelines for

Determining the Applicability of 35 U.S.C. 112 para. 6, 64 FR 41392

(July 30, 1999).

41. See Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d

at 1384, 231 USPQ at 94.

42. 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'').

43. 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 Sec. 806.04(e).

44. 35 U.S.C. 112, para. 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).

45. 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).

46. 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.'')

47. See, e.g. , Fiers v. Revel, 984 F.2d at 1169, 25 USPQ2d at

1605; Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 1206,

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

48. See, e.g., Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d

1200, 1206, 18

[[Page 71440]]

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

49. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.

50. See, e.g., Eli Lilly.

51. For example, in the genetics arts, it is unnecessary for an

applicant to provide enough different species that the disclosure

will permit one of skill to determine the nucleic acid or amino acid

sequence of another species from the application alone. The

stochastic nature of gene evolution would make such a predictability

nearly impossible. Thus, the Federal Circuit could not have intended

that representative number requires predictability of sequences.

52. 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.''). See also

MPEP Sec. 2163.05.

53. See MPEP Secs. 714.02 and 2163.06 (``Applicant should * * *

specifically point out the support for any amendments made to the

disclosure.'').

54. 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.).

55. 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).

56. 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).

57. 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).

58. 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, Inc.,

156 F.3d at 1159, 47 USPQ2d at 1833; and Reiffin v. Microsoft Corp.,

48 USPQ2d at 1277.

59. See, e.g., In re Marzocchi, 439 F.2d 220, 224, 169 USPQ 367,

370 (CCPA 1971).

60. Wertheim, 541 F.2d at 262, 191 USPQ at 96.

61. See In re Rasmussen, 650 F.2d at 1214, 211 USPQ at 326.

62. See In re Alton, 76 F.3d 1168, 1176, 37 USPQ2d 1578, 1584

(Fed. Cir. 1996).

Dated: December 16, 1999.

Q. Todd Dickinson,

Assistant Secretary of Commerce and Commissioner of Patents and

Trademarks.

[FR Doc. 99-33053 Filed 12-20-99; 8:45 am]

BILLING CODE 3510-16-P