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.
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. 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
``stephen.walsh@uspto.gov'' or to Linda Therkorn via facsimile at (703)
305-8825 or by electronic mail addressed to ``linda.therkorn@uspto.gov.''
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 ``stephen.walsh@uspto.gov'; or Linda
Therkorn by telephone at (703) 305-8800, by facsimile at (703) 305-
8825, by mail addressed to Box Comments, Assistant Commissioner for
Patents, Washington, DC 20231, or by electronic mail at
``linda.therkorn@uspto.gov.''
SUPPLEMENTARY INFORMATION: The PTO requests comments from any interested
member of the public on the following 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 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 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 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 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.
(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 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 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
application15 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
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 language26 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 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 inherently56 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 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 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).
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 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).
December 16, 1999 Q. TODD DICKINSON
Assistant Secretary of Commerce and
Commissioner of Patents and Trademarks