[Federal Register: December 21, 1999 (Volume 64, Number 244)]
[Notices]
[Page 71427-71440]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21de99-56]

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DEPARTMENT OF COMMERCE

Patent and Trademark Office
[Docket No. 991027288-9288-01]
RIN 0651-AB10


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

AGENCY: Patent and Trademark Office, Commerce.

ACTION: Notice and request for public comments.

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SUMMARY: The Patent and Trademark Office (PTO) requests comments from
any interested member of the public on the following Revised Interim
Guidelines for Examination of Patent Applications Under the 35 U.S.C.
112, para. 1 ``Written Description'' Requirement (Revised Interim
Guidelines). These Revised Interim Guidelines will be used by PTO
personnel in their review of patent applications for compliance with
the ``written description'' requirement of 35 U.S.C. Sec. 112,para. 1.
This revision supersedes the Interim Written Description Guidelines
which were published contemporaneously in both the Federal Register and
Official Gazette at 63 FR 32,639 (June 15, 1998) and 1212 O.G. 15 (July
7, 1998), respectively. This revision reflects the current
understanding of the PTO regarding the written description requirement
of 35 U.S.C. 112, para. 1 and is applicable to all technologies.

DATES: Written comments on the Revised Interim Guidelines will be
accepted by the PTO until March 22, 2000.

ADDRESSES: Written comments should be addressed to Box 8, Commissioner
of Patents and Trademarks, Washington, DC 20231, marked to the
attention of Stephen Walsh, or to Box Comments, Assistant Commissioner
for Patents, Washington, DC 20231, marked to the attention of Linda S.
Therkorn. Alternatively, comments may be submitted to Stephen Walsh via
facsimile at (703) 305-9373 or by electronic mail addressed to
``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

[[Page 71428]]

the comments and testimony received, the Guidelines have been rewritten
in a technology neutral manner which is broadly applicable to all areas
of technology and to all types of claims (original, new, or amended,
and product, process, or product-by-process). Furthermore, the examples
have been removed from the Guidelines and examples addressing a broad
range of technologies will be incorporated into examiner training
materials. Revised Interim Guidelines are being issued for a second
round of Notice and Comment because the form and content of the
Guidelines are sufficiently different from the previous Guidelines that
additional public comment is desired.
    The Extension of Comment Period and Notice of Hearing published at
63 FR 50887 (September 23, 1998) and 1214 O.G. 180 (September 29, 1998)
asked for comments regarding the patentability of Expressed Sequence
Tags (ESTs). Many comments took this opportunity to heavily criticize
the patentability of ESTs, grounding their arguments in fairness and
policy issues. Many comments also expressed the opinion that ESTs
lacked the utility, enablement, and written description necessary to
satisfy title 35 of the U.S. Code. The Revised Interim Guidelines are
not the appropriate vehicle to fully address the patentability of ESTs.
In view of comments and testimony with respect to ESTs and the
enablement and utility requirements, the Office is revising the Utility
Guidelines as published at 60 FR 36263 (July 14, 1995), and will also
be revising the examiner training material with regard to both the
utility and enablement requirements. Comments pertaining to the utility
and enablement requirements will be addressed in the notice revising
the Utility Guidelines. Responses to the comments germane to the
written description requirement are set forth below.

Responses to Specific Comments

    (1) Comment: Several comments criticized the Guidelines for failing
to set out a general, systematic examination of the case law on written
description. Comments mentioned Vas-Cath, Inc. v. Mahurkar, 935 F.2d
1555, 19 USPQ2d 1111 (Fed. Cir. 1991), in particular as important for
summarizing the state of the law as the Federal Circuit sees it. Other
comments particularly urged a general analysis of case law as it
pertains to written description for chemical compounds, and criticized
the fact that the Guidelines relied heavily on only three recent cases.
Response: The suggestion to provide a general, systematic legal
analysis has been adopted. The Revised Interim Guidelines are grounded
more broadly than the three cases heavily relied upon in the original
Interim Guidelines, and cases dealing with a variety of arts are relied
upon.
    (2) Comment: The comments were equally divided with respect to the
issue of whether the Guidelines should be broadly applicable to all
technologies or limited to biotechnology, DNA claims, or unpredictable
arts. Two of the comments urging broad applicability stated that the
law should be articulated in a clear and technology neutral fashion,
and several comments urged that examples and training materials should
illustrate application of the Guidelines in a diverse range of
technologies. One comment suggested that applications in which written
description problems are likely to arise should be identified
generically, rather than requiring a written description analysis in
each application. Response: The suggestion to cover all technologies
and to articulate the law in a clear and technology neutral fashion has
been adopted. While a written description analysis is required in each
case, the Revised Interim Guidelines clearly specify when a written
description issue is most likely to arise, and--for most applications--
the Revised Interim Guidelines will quickly lead the examiner to
determine that, at least for original claims, the written description
requirement has been met. The Revised Interim Guidelines avoid
narrowing the application of the written description requirement to a
single art, and the examiner training materials will illustrate
application of the revision in various technologies.
    (3) Comment: While the majority of comments supported the Interim
Guidelines, eight comments opposed their issuance. Some of those
opposing the guidelines argued that the decision in Regents of the
University of California v. Eli Lilly, 119 F.3d 1559, 43 USPQ2d 1398
(Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998), is a drastic
departure from legal precedent and PTO practice. In particular, two
comments suggested that the Interim Guidelines should be replaced by
Revised Interim Guidelines, and one comment recommended that final
Guidelines be deferred until the U.S. Court of Appeals for the Federal
Circuit or the U.S. Supreme Court hands down decisions that elaborate,
construe, modify, or overrule Eli Lilly and/or decide related issues
not dealt with by that case. See Comments (5) and (9) for more opposing
comments. Response: This revision is based on the Office's current
understanding of the law and is believed to be fully consistent with
binding precedent of the U.S. Supreme Court and the U.S. Court of
Appeals for the Federal Circuit. Guidelines are necessary in this area
to promote uniformity and consistency in the examination process. The
suggestion to issue Revised Interim Guidelines for a second round of
Notice and Comment has been adopted. The revision is written in a
technology neutral manner, and the form is sufficiently different from
the previous guidelines that additional public comment is desired.
    (4) Comment: Six comments were in favor of including process and
product-by-process claims in the analysis, whereas one comment was
opposed. One comment criticized the Guidelines for failing to
acknowledge the ``safe harbor'' product-by-process type claim noted in
Fiers v. Revel, 984 F.2d 1164, 25 USPQ2d 1601 (Fed. Cir. 1993), and
Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016
(Fed. Cir. 1991). One comment observed that process and product-by-
process claims tend not to implicate many written description issues,
and it may be useful to point out possible enablement deficiencies for
such claims. Two comments suggested that the Guidelines should
distinguish between claims to processes whose patentability depends on
the compositions used in them, as opposed to those where patentability
rests in the steps of the process itself. Response: The suggestion to
address process and product-by-process claims has been adopted.
Furthermore, the training materials will analyze claims wherein the
patentability depends on the compositions used therein, as well as
those where the patentability rests in the process steps themselves.
Enablement issues raised by process and product-by-process claims are
outside the scope of these Revised Interim Guidelines.
    (5) Comment: While one comment stated that the Guidelines correctly
present the relationship between written description and enablement, a
number of comments dispute that the statute actually has a written
description requirement distinct from the enablement requirement. One
comment requested that the PTO refrain from issuing any Guidelines in
this area until the U.S. Supreme Court rules on the Federal Circuit's
present position on written description. Several comments urged the PTO
to announce that it will not follow the court decisions applying the
separate written description requirement, while others observed that
the PTO and the practitioners must nevertheless follow the case law.
Some of these comments urged the PTO to

[[Page 71429]]

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

[[Page 71430]]

evidence of possession, and that, under certain circumstances, claim
language may not provide an adequate written description of itself.
There are no per se rules, since the analysis must be done on a case-
by-case basis. While original claims have an initial presumption of
descriptive support, the applicant should show support for new or
amended claims. See, e.g., Manual of Patent Examining Procedure (MPEP)
Secs. 714.02 and 2163.06 (7th Ed., July 1998) (``Applicant should * * *
specifically point out the support for any amendments made to the
disclosure.'').
    (10) Comment: One comment indicated that written description
problems may arise where there is an inadequate description or
demonstration of possession of a genus or where there is an improper
genus (no common structure and function that is linked to the practical
utility disclosed by the specification). Another comment stated that
the Guidelines should address the informational nature of nucleic acid
sequences and amino acid sequences. One comment urged that ``[a]
written description of a genus is sufficient when it is described in
enough detail that possession is understood,'' and that the number of
species relates more to enablement. Response: The Revised Interim
Guidelines indicate that the written description requirement for a
claimed genus may be satisfied through sufficient description of a
representative number of species. The revision does not require a
particular number of species to support a genus, but rather requires
that the species adequately described be representative of the claimed
genus.
    (11) Comment: A comment urged that the Guidelines should explicitly
state that the maturation of the technology will increase the
understanding of one skilled in the art, and ease the predictable scope
of the claimed invention beyond the exemplified embodiments, as
recognized in the applicant's specification. Response: The Revised
Interim Guidelines emphasize that in a mature art with a high level of
knowledge and skill, less evidence of possession is required.
    (12) Comment: One comment objected to the requirement for an
assessment of predictability as a touchstone for written description.
The comment described this inquiry as new and lacking case law support.
Several comments stated that predictability is an inquiry relating to
the enablement requirement, but not to the written description
requirement. Others commented generally that the Guidelines conflate
what should be separate enablement and written description analyses. On
the other hand, at least one comment stated that the distinctions
between these elements converge when lack of enablement results from
undue breadth of claims. One comment stated that a review of the
application is insufficient to establish the level of predictability in
an art. Another queried if the review is to be done after a search in
the art and assessment of the art. Another comment stated that the lack
of guidance for distinguishing between predictable and unpredictable
areas within the field of biotechnology leads to confusion. Response:
The Revised Interim Guidelines reduce the emphasis on predictability
because of the confusion with enablement. Instead, the Guidelines
emphasize the knowledge in the art and the skill of the practitioner
considered in the totality of the circumstances. With respect to the
comment regarding biotechnology, this sliding scale will permit broader
claims as the knowledge and skill in this art improve. The Guidelines
discuss how the general knowledge in the art may be relied on as
evidence of how much description may be needed in particular cases.
    (13) Comment: Several comments criticized the methodology of the
Guidelines because the analytic steps set out by the court in In re
Moore, 439 F.2d 1232, 169 USPQ 236 (CCPA 1971) (first determine what
the claims cover, then review the specification for support) were
reversed. Response: The Revised Interim Guidelines restate the analytic
sequence so it is clearly consistent with In re Moore. The revision
also makes it clear that each claim must be separately analyzed and
given its broadest reasonable interpretation in light of and consistent
with the written description. See, e.g., In re Morris, 127 F.3d 1048,
1054, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997).
    (14) Comment: One comment suggested that the Guidelines should
provide more instruction on the different amount of description needed
to support an essential feature of an invention in contrast to a
nonessential feature. The comment explained that contrasting the amount
of description needed to support a novel or nonobvious feature of an
invention with the amount of description needed for features of an
invention that were known in the prior art would be helpful. Response:
The Revised Interim Guidelines distinguish between novel and old
elements in a claim to clarify that the amount of written support
needed in an application can vary depending on the general knowledge
that was readily available in a particular art.
    (15) Comment: One comment criticized the analysis for setting out
conclusions before the analytic method and for distorting or bypassing
the analysis. The same comment said that some of the examples yield
illogical results. Response: The examples have been deleted from the
Guidelines, and the analytical method has been clarified.
    (16) Comment: The Guidelines were heavily criticized in ten
comments for overemphasizing the importance of the preamble and for
indicating that generic preamble terms such as ``nucleic acid'' would
need less descriptive support than narrower terms such as ``cDNA.'' One
comment objected to the proposition that one may have an adequate
written description of a genus of DNA when one does not disclose what
gene product the DNA encodes and what that gene product does. This
comment recommended deletion of the example bridging F.R. 32640-41 (``a
gene comprising SEQ ID NO: 1'') as inconsistent with the rest of the
Guidelines. Response: The Revised Interim Guidelines clarify that the
examiner must consider the claim as a whole and that the preamble may
be a limitation of the claim. Preamble language is discussed in the
context of determining what the claim as a whole encompasses within its
scope. However, the Revised Interim Guidelines maintain that any term
may trigger a need for more descriptive support because of usage or
context. The revision clarifies that during examination claim terms are
given their broadest reasonable interpretation consistent with the
specification. See In re Morris, 127 F.3d 1048, 44 USPQ2d 1023 (Fed.
Cir. 1997). The examples have been removed from the text of the
revision.
    (17) Comment: Four comments objected to the Guidelines' definitions
for the terms gene, mRNA, and cDNA, stating that the art often refers
only to the coding portion of the molecules and does not necessarily
imply the presence of regulatory elements or recite specific
structures. One comment further indicated that adoption of the PTO's
new definition of these terms for purposes of written description
considerations could potentially destabilize the economic
infrastructure of the biotechnology community because innumerable
patents have issued claiming such molecules without regard to the PTO's
new interpretation of claim language. The Guidelines were said to use
two inconsistent meanings for the term gene that differed in scope and
confused the distinction between

[[Page 71431]]

genus and species. Response: The Revised Interim Guidelines no longer
define the term ``gene.''
    (18) Comment: One comment indicated that the PTO has the
opportunity to emphasize the written description requirement as an
anti-submarine patent device; this comment and another observed that
two parties could obtain claims which would be almost identical in
scope in hindsight, based on completely different paths to the claim.
Response: In Hyatt v. Boone, 146 F.3d 1348, 1353, 47 USPQ2d 1128, 1131
(Fed. Cir. 1998), the Federal Circuit addressed the submarine patent
issue in finding that the appellant's parent application lacked written
descriptive support for a later added claim. When an explicit
limitation in a claim ``is not present in the written description whose
benefit is sought it must be shown that a person of ordinary skill
would have understood, at the time the patent application was filed,
that the description requires that limitation.'' Id.
    (19) Comment: A comment stated that the Guidelines give too much
emphasis to claim structure, as if the claim is the sole source of the
written description. Another comment had a different view, stating that
the Guidelines fail to focus on the invention being claimed, and noting
that in some circumstances, failure to provide the structure of a gene,
enzyme, etc. should not result in finding that a claim containing it
fails to meet the written description requirement. Response: The Office
gives a claim its broadest reasonable interpretation during
examination. If the claim taken as a whole requires a limitation not
set forth in the original disclosure it may raise an issue of lack of
proper written description. As noted in In re Hiniker Co., 150 F.3d
1362, 1369, 47 USPQ2d 1523, 1529 (Fed. Cir. 1998), ``the name of the
game is the claim.''
    (20) Comment: One comment indicated that there was not enough
emphasis on transitional phrases and their impact on the adequacy of
the written description. Response: As with the preamble, the
transitional phrase is discussed in the context of the scope of the
claimed invention as a whole.
    (21) Comment: The Extension of Comment Period and Notice of Hearing
requested comments as to how the transition terms ``having'' and
``consisting essentially of'' should be treated within the context of
nucleotide and amino acid sequence claims. Two comments observed that
transitional phrases in the context of nucleotide and amino acid
sequence claims should have the same treatment as in chemical cases.
Another comment stated that ``consisting essentially of'' language in
DNA or vector claims should not be rejected as per se improper under 35
U.S.C. 112, para. 2. Two comments stated that lacking an art-accepted
meaning or a definition in the specification, ``having'' would imply an
open claim format; another comment stated that ``having'' is understood
to mean ``comprising.'' The term ``consisting essentially of'' was
defined by one comment as a closed claim format that is essentially
limited to the compound or composition defined explicitly following the
transitional phrase, and by two other comments as having the stated
sequence and excluding any alterations which materially change the
structure and/or function of the specified sequence. One comment opined
that ``A DNA consisting essentially of SEQ ID NO: 1'' would be limited
to DNAs having the nucleotide sequence set forth in SEQ ID NO: 1 plus
minor additions at the 5'-- and/or 3' --ends of the recited sequence.
Another comment observed that the meaning of ``consisting essentially
of'' depends on how the specification defines its usage. Response:
During examination, the claim as a whole is given the broadest
reasonable interpretation consistent with the specification.
Transitional phrases should be given the same treatment in all cases.
The Revised Interim Guidelines set forth legally recognized definitions
for transition language in an endnote. ``Consisting essentially of'' is
acceptable transition language in nucleic acid and protein claims. The
impact of the transition language on enablement and practical utility
will not be dealt with in this forum.
    (22) Comment: One comment criticized the use of the taxonomic terms
``genus'' and ``species.'' The comment explained that because the
terminology is well established in biology, it should not be applied to
chemical compounds. Two comments described the Guidelines as deficient
in analyzing the proper relationship of preamble, transitional phrase
and claim body for distinguishing genus from species claims. According
to another comment, the Guidelines confuse genus and species claims.
Response: The Revised Interim Guidelines refer to the terms ``genus''
and ``species'' in their well accepted legal sense as widely used
patent terms of art that are recognized as distinct from their use as
taxonomic terms. The revision clarifies what is meant by genus and
species.
    (23) Comment: Several comments found the explanations for the
examples deficient because they do not clarify what would constitute a
sufficient disclosure. One comment urged that there is no guidance
provided as to what would constitute sufficient identifying
characteristics, and the Guidelines do not set forth the number of the
examples needed for sufficient written description. Another comment
urged that structure, or function plus partial structure, or function
plus ``some characteristics'' (e.g., 2 or more), is sufficient to meet
the written description requirement. Yet another comment urged that
uncertainties and potential problems exist because it is unclear how
``relevant'' or ``sufficient'' identifying characteristics are
established; that it is unclear how functional properties fit into the
analysis; and that problems exist with the level of uncertainty when
the complete structure is not disclosed or the structure is not
disclosed and only a few identifying characteristics are disclosed.
Another comment urged that the methodology is incomplete as to how many
identifying characteristics are required and what characteristics are
relevant for description of a species. This comment applied the same
reasoning to the number of species required for describing a genus. One
comment urged that functional characteristics in combination with
certain objectively defined physical characteristics can serve to
characterize the compound sufficiently to establish possession, even in
less developed arts. One comment urged that the ability to predict
structure from function is given as a standard for the written
description requirement without any citation to authority. Response:
The Revised Interim Guidelines do not include examples within the text.
The test for whether sufficient identifying characteristics have been
disclosed is not a bright-line test, but rather requires weighing
various factors including the level of skill and knowledge in the art,
and the extent to which relevant identifying characteristics are
described. The revision provides more guidance to the examiners by
citing as examples cases involving mature arts with a high level of
skill and knowledge (e.g., Pfaff v. Wells Electronics, Fonar Corp. v.
General Electric Co., 107 F.3d 1543, 1549, 41 USPQ2d 1801, 1805 (Fed.
Cir. 1997) and Vas-Cath v. Mahurkar), as well as cases in emerging
technologies where more description is necessary (e.g., Eli Lilly,
Amgen v. Chugai, and Fiers v. Revel). The test remains whether one of
skill in the art, provided with the disclosure, would recognize that
the applicant was in possession of the claimed subject matter when the
application was filed.

[[Page 71432]]

    (24) Comment: The Extension of Comment Period and Notice of Hearing
requested comments on how the final Guidelines should address the
deposit of a biological material made under 37 CFR 1.801, and comments
on the extent to which a deposit of biological material may be relied
upon to support the addition or correction of sequence information.
Several comments expressed the opinion that deposit of a compound or
biological material can be one means of demonstrating possession of a
specifically claimed compound that has not otherwise been described in
a complete manner in the specification. One comment stated that if a
gene were cloned but not sequenced, and the vector in question were
deposited, the sequence is an inherent property of the deposited vector
and hence the description requirement would be satisfied if the claim
referred to the deposit. One comment urged that the description
requirement may be satisfied by the inherent properties of a disclosed
structure, citing Kennecott Corp. v. Kyocera Int'l Inc., 835 F.2d 1419,
5 USPQ2d 1194 (Fed. Cir. 1987). As for the later addition or correction
of information, several comments indicated that actual possession
established through a deposit with a partial characterization (i.e., to
correlate the physical description to the material that has been
deposited, such as molecular weight, partial sequence) should be
sufficient to avoid problems with new matter where the information
added to a disclosure is an inherent characteristic of the compound or
composition. One comment indicated that correcting a sequence based on
more accurate sequencing of deposited material does not introduce new
matter. One comment stated that present genus-species concepts should
prevent an applicant from obtaining an unfair advantage by depositing a
large amount of material and then relying on inherency; if a variety of
materials are deposited in a single host, the specification must
adequately describe how to isolate the intended molecule(s). Two
comments expressly stated ``no comment'' with regard to the issue of
adding a substantial amount of sequence information. One comment opined
that the date of deposit is not controlling with regard to the issue of
whether the written description requirement is met, and a second
comment observed that In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed.
Cir. 1985), cannot be limited by rule. Response: The Revised Interim
Guidelines indicate that a deposit of a claimed biological material in
accordance with the requirements of 37 CFR 1.801 et seq. is evidence of
actual reduction to practice of the biological material. However, a
deposit is not a substitute for a written description of the claimed
invention. The Revised Interim Guidelines also address the issue of
when a deposit can be relied upon to correct minor sequencing errors.
However, addition of sequence information based on a deposit is not
specifically addressed; these circumstances create issues yet to be
resolved by the courts, and will be resolved on a case-by-case basis in
the PTO. See, e.g., In re Fisher, 427 F.2d 833, 836, 166 USPQ 18, 21
(CCPA 1970).
    (25) Comment: One comment explained that associating taxonomic
groupings with gene sequences is a dated concept because genes are not
distinguishable as to origin. The generic term ``mammal gene'' was said
to be meaningless, absent an implied process limitation that the gene
was obtained from a mammal. Response: The examples have been removed
from the revision. However, the training materials will permit
applicants to use taxonomic modifiers such as ``mammalian'' because the
usage is ubiquitous in the literature and in patents and generally has
an accepted meaning in the art.
    (26) Comment: One comment urged that broad functional claims
lacking defining structure should not be granted on the basis of a
``not easily generalizable disclosure.'' A different comment stated
that functional characteristics can be appropriate in all arts.
Comments differed on hybridization, where some held it is a proper
defining characteristic, and another stated it is insufficient.
Response: The Revised Interim Guidelines do not establish per se rules
regarding functional language. When used appropriately, functional
language may provide an adequate written description of the claims
invention as discussed in the Revised Interim Guidelines.
    (27) Comment: Several comments indicated that the Guidelines
present inadequate guidance with respect to analyzing written
description support for genus claims. One comment stated that the
Guidelines provide inadequate criteria for selection of appropriate
genuses. Another comment stated that the Guidelines do not provide
adequate guidance to determine whether an applicant has presented a
properly formed genus, and suggested that ``a genus designation should
be strictly tied to the disclosed properties of the structures being
claimed.'' Another comment stated that the Guidelines should clarify
that the genus/species distinction is determined by the transitional
phrase and body of the claim, not the preamble. Another comment stated
that the Guidelines provide inadequate guidance as to the number of
species required to meet the written description requirement for a
genus. One comment urged that a relevant factor to consider is whether
the claims cover embodiments broader than the essential elements of the
embodiments described in the specification as in Gentry Gallery Inc. v.
Berkline, 134 F.3d 1473, 45 USPQ2d 1498 (Fed. Cir. 1998). According to
this comment, species rarely, if ever, constitute sufficient support
for generic claims unless accompanied by a general disclosure that is
commensurate in scope with the claims. Response: The Revised Interim
Guidelines follow Federal Circuit case law which requires a
representative number of species to satisfy the written description
requirement for a genus. Written description is a question of fact, and
what constitutes a representative number for a genus is a factual
determination left to a case-by-case analysis by the examiner.
    (28) Comment: One comment urged that general allegations of
``unpredictability in the art'' are insufficient to support a case
against the applicant, and that examiners should be instructed to weigh
applicant's evidence of what the description provides to one of skill
in the art. Response: The suggestion to clarify that a general
allegation of ``unpredictability in the art'' is insufficient to
support a rejection has been adopted. A disclosure as filed is prima
facie adequate. To support a rejection, the PTO has the burden of
showing why the applicant's evidence is insufficient. In any case where
lack of written description is found, the PTO should cite documentary
evidence in support of the finding. Where documentary evidence is not
available, technical reasoning, as distinguished from legal reasoning,
may support the finding when the technical line of reasoning relates to
fact finding regarding possession of the invention.
    (29) Comment: One comment indicated that rejections based on the
enablement and written description requirements of 35 U.S.C. 112 should
be made separately, and the rejections should not mix standards.
Response: Examiners are directed to make separate rejections based on
the enablement and written description requirements of 35 U.S.C. 112.
See, e.g., MPEP Sec. 706.03(c) (explaining when it is appropriate to
use a particular form paragraph for rejecting claims under 35 U.S.C.
112, para.1) and MPEP Sec. 2164 (``limitations must be

[[Page 71433]]

analyzed for both enablement and description using their separate and
distinct criteria'').
    (30) Comment: One comment observed that the Guidelines do not guide
examiners in how to suggest amendments to bring the claims into
compliance. The comment also observed that examiners may be ill-
equipped to deal with evaluating the sufficiency of applicant's
efforts. Response: The training materials will provide guidance as to
how rejections for lack of an adequate written description can be
overcome.
    (31) Comment: One comment stated that the Guidelines should
instruct examiners to pay due regard to the scientific and commercial
realities of each individual invention, such that the scope of the
claims is a fair reflection of the applicant's contribution to the art.
Response: The scientific and commercial realities of each invention are
considered to the extent that they impact analysis of a claimed
invention for compliance with Title 35 of the U.S. Code. The Office is
bound to follow the law and cannot make judgment calls as to what is
``a fair reflection of the applicant's contribution to the art.''
    (32) Comment: While two comments observed that the Guidelines
should not have a significant impact on patents or pending or newly
filed applications because they are only Guidelines which are not
binding on the Board or examiners, three comments were of the opinion
that the Guidelines would impact pending and newly filed cases by
limiting the scope of patent protection. One comment was of the opinion
that the Guidelines should have no impact on issued cases except
reissues, whereas another expected many issued patents to be declared
invalid (more as a result of Eli Lilly than the Guidelines). Another
comment observed that the Guidelines should not impose significant new
burdens on patent applicants in the biotechnology arts or give rise to
a new ``anti-patenting'' posture in the biotechnology examination
group; however, the PTO should not be misled into adapting ``customer-
friendly'' examination standards that do not subject applications to a
thorough and rigorous examination. One comment opined that the
Guidelines will result in a great increase in the number of appeals
until the Federal Circuit makes clear that the law is quite different,
thus delaying commercialization of potentially life improving and life
saving inventions. According to this comment, universities and small
inventors do not have the financial support to provide the exhaustive
kind of work the Guidelines can require for meaningful coverage; this
will mean that many biotechnology inventions will not be
commercialized. One comment stated that the Commissioner indicates that
meaningful patent coverage is required for commercial exploitation of
biotechnological inventions, yet the PTO continues to take a position
that leads away from what the Commissioner espouses. Another comment
felt that the scope of allowed claims would be dependent on the
examiner; a potential applicant would not know what sort of claims
could be obtained based on a particular disclosure. One comment opined
that applications filed after publication of the Guidelines will
probably be much more detailed and longer in length. Response: The
Revised Interim Guidelines clarify that a written description issue
should rarely arise for an original claim because such a claim is
presumed to have adequate descriptive support. The burden is on the
examiner to provide evidence or reasoning in support of any rejection.
Such an approach would not be expected to increase the number of
appeals, nor should it require exhaustive work for meaningful coverage.
The Revised Interim Guidelines are intended to promote uniformity, not
diminish it.
    (33) Comment: One comment indicated it is premature to instruct
examiners in the proposed Guidelines since they may change dramatically
as a result of public comment. Three comments stated that the
Guidelines should not be applied until final Guidelines have been
approved; two of these indicated that the Guidelines should only be
applied to applications filed after implementation. One comment
suggested preparing separate guidance for currently pending
applications. Response: Separate guidance is not required for pending
applications and applications filed after implementation of any final
Guidelines; the Guidelines do not establish new law or rules or impose
any additional requirements on applicants.
    (34) Comment: One comment requested that the PTO address the issue
of open-claim language for EST claims in the final Guidelines because
of their importance to the biotechnology industry. Several comments
stated that permitting open-ended language with respect to an EST claim
contradicts the written description requirement because the common
structural features of the EST do not constitute a ``substantial
portion of the genus'' as required by the Eli Lilly case. According to
these commentators, a claim such as ``a DNA comprising SEQ. ID. NO: 1''
would lack written description when SEQ. ID. NO: 1 was a gene fragment.
Response: The Revised Interim Guidelines maintain the view that use of
such terms as ``gene'' in the preamble of an EST claim may raise a
written description issue if one skilled in the art would understand
that a ``gene'' requires elements which are not sufficiently described.
However, claims to ``a DNA comprising SEQ. ID. NO: 1'' are unlikely to
raise a written description issue. The comments do not explain why
there is a written description problem for a claim such as ``a DNA
comprising SEQ. ID. 1'' when SEQ. ID. 1 is an EST, while there is no
problem when SEQ. ID. 1 is a whole gene or a gene promoter. The only
difference seems to be the utility of the DNA fragment.
    (35) Comment: One comment asserted that the scope and level of
unpredictability of the structure is so large that the person skilled
in the art could not envisage sufficient species to place the genus in
possession of the inventor at the time of filing, and that it should be
a rare disclosure that supports EST claims broader than the specific
SEQ. ID, even for claims such as ``a DNA comprising the EST of SEQ. ID.
NO: 1.'' The comment also suggested that claim language that supports
the introduction of an infinite amount of random sequence would require
an immense number of exemplary species. Several commentators advanced
the position that disclosure of only a small fragment does not convey
that the inventor was in possession of all of the possible molecules or
that the inventor was in possession of the fragment wherever it occurs.
Response: A claim such as ``a DNA comprising the EST of SEQ. ID. NO:
1'' or ``a gene comprising the EST of SEQ. ID. NO: 1'' will be analyzed
for compliance with the written description requirement by determining
whether the partial structure in combination with any other disclosed
relevant identifying characteristics are sufficient to show that a
skilled artisan would recognize that the applicant was in possession of
the claimed invention as a whole. The Office does not agree with the
comment that the scope of such an EST claim is necessarily too large to
satisfy the written description requirement. The PTO has issued
numerous patents in the past directed to nucleic acids that use open-
ended language. Although an applicant presenting an original claim to
an EST using open-ended claim language with disclosure of only the EST
sequence is not in possession of any arbitrary specific possible
molecule that contains the EST, the applicant may

[[Page 71434]]

be in possession of a broad genus of DNA where the EST is in any random
nucleic acid sequence. The comment's statement to the contrary would
preclude open-ended claims incorporating any DNA sequence such as gene
or promoter. In fact, such a view would appear to preclude open-ended
language for any other polymer. However, such open-ended EST claims may
not comply with the utility and scope of enablement requirements of 35
U.S.C. 101 and 112.

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

    These revised interim ``Written Description Guidelines'' are
intended to assist Office personnel in the examination of patent
applications for compliance with the written description requirement of
35 U.S.C. 112, para. 1. This revision is based on the Office's current
understanding of the law and public comments received in response to
the PTO's previous request for public comments on its Interim Written
Description Guidelines and is believed to be fully consistent with
binding precedent of the U.S. Supreme Court, as well as the U.S. Court
of Appeals for the Federal Circuit and its predecessor courts.
    This revision does not constitute substantive rulemaking and hence
does not have the force and effect of law. It is designed to assist
Office personnel in analyzing claimed subject matter for compliance
with substantive law. Rejections will be based upon the substantive
law, and it is these rejections which are appealable. Consequently, any
perceived failure by Office personnel to follow the Revised Interim
Guidelines is neither appealable nor petitionable.
    These Revised Interim Guidelines are intended to form part of the
normal examination process. Thus, where Office personnel establish a
prima facie case of lack of written description for a claim, a thorough
review of the prior art and examination on the merits for compliance
with the other statutory requirements, including those of 35 U.S.C.
101, 102, 103, and 112, is to be conducted prior to completing an
Office action which includes a rejection for lack of written
description. Office personnel are to rely on this revision of the
guidelines in the event of any inconsistent treatment of issues
involving the written description requirement between these Revised
Interim Guidelines and any earlier guidance provided from the Office.

I. General Principles Governing Compliance With the ``Written
Description'' Requirement for Applications

    The first paragraph of 35 U.S.C. 112 requires that the
``specification shall contain a written description of the invention. *
* * '' This requirement is separate and distinct from the enablement
requirement.\1\ The written description requirement has several policy
objectives. ``[T]he `essential goal' of the description of the
invention requirement is to clearly convey the information that an
applicant has invented the subject matter which is claimed.'' \2\
Another objective is to put the public in possession of what the
applicant claims as the invention. The written description requirement
of the Patent Act promotes the progress of the useful arts by ensuring
that patentees adequately describe their inventions in their patent
specifications in exchange for the right to exclude others from
practicing the invention for the duration of the patent's term.\3\
---------------------------------------------------------------------------

    \1\ See Endnotes at end of this notice.
---------------------------------------------------------------------------

    To satisfy the written description requirement, a patent
specification must describe the claimed invention in sufficient detail
that one skilled in the art can reasonably conclude that the inventor
had possession of the claimed invention.\4\ An applicant shows
possession of the claimed invention by describing the claimed invention
with all of its limitations.\5\ Possession may be shown by actual
reduction to practice,\6\ or by showing that the invention was ``ready
for patenting'' such as by the disclosure of drawings or other
descriptions of the invention that are sufficiently specific to enable
a person skilled in the art to practice the invention.\7\ A question as
to whether a specification provides an adequate written description may
arise in the context of an original claim which is not described
sufficiently, a new or amended claim wherein a claim limitation has
been added or removed, or a claim to entitlement of an earlier priority
date or effective filing date under 35 U.S.C. 119, 120, or 365(c).\8\
Compliance with the written description requirement is a question of
fact which must be resolved on a case-by-case basis.\9\

A. Original Claims

    There is a strong presumption that an adequate written description
of the claimed invention is present when the application is filed.\10\
However, the issue of a lack of adequate written description may arise
even for an original claim when an aspect of the claimed invention has
not been described with sufficient particularity such that one skilled
in the art would recognize that the applicant had possession of the
claimed invention.\11\ The claimed invention as a whole may not be
adequately described if the claims require an essential or critical
element which is not adequately described in the specification and
which is not conventional in the art.\12\ This problem may arise where
an invention is described solely in terms of a method of its making
coupled with its function and there is no described or art recognized
correlation or relationship between the structure of the invention and
its function.\13\ A lack of adequate written description problem also
arises if the knowledge and level of skill in the art would not permit
one skilled in the art to immediately envisage the product claimed from
the disclosed process.\14\

B. New or Amended Claims

    The proscription against the introduction of new matter in a patent
application \15\ serves to prevent an applicant from adding information
that goes beyond the subject matter originally filed.\16\ Thus, the
written description requirement prevents an applicant from claiming
subject matter that was not adequately described in the specification
as filed. New or amended claims which introduce elements or limitations
which are not supported by the as-filed disclosure violate the written
description requirement.\17\ While there is no in haec verba
requirement, newly added claim limitations must be supported in the
specification through express, implicit, or inherent disclosure. An
amendment to correct an obvious error does not constitute new matter
where one skilled in the art would not only recognize the existence of
the error in the specification, but also the appropriate
correction.\18\
    Under certain circumstances, omission of a limitation can raise an
issue regarding whether the inventor had possession of a broader, more
generic invention.\19\ A claim that omits an element which applicant
describes as an essential or critical feature of the invention
originally disclosed does not comply with the written description
requirement.\20\
    The fundamental factual inquiry is whether the specification
conveys with reasonable clarity to those skilled in the art that, as of
the filing date sought, applicant was in possession of the invention as
now claimed.\21\

[[Page 71435]]

II. Methodology for Determining Adequacy of Written Description

A. Read and Analyze the Specification for Compliance With 35 U.S.C.
112, para. 1

    Office personnel should adhere to the following procedures when
reviewing patent applications for compliance with the written
description requirement of 35 U.S.C. 112, para. 1. The examiner has the
initial burden, after a thorough reading and evaluation of the content
of the application, of presenting evidence or reasons why a person
skilled in the art would not recognize that the written description of
the invention provides support for the claims. There is a strong
presumption that an adequate written description of the claimed
invention is present in the specification as filed; \22\ however, with
respect to newly added or amended claims, applicant should show support
in the original disclosure for the new or amended claims.\23\
Consequently, rejection of an original claim for lack of written
description should be rare. The inquiry into whether the description
requirement is met is a question of fact that must be determined on a
case-by-case basis.\24\
1. For Each Claim, Determine What the Claim as a Whole Covers
    Claim construction is an essential part of the examination process.
Each claim must be separately analyzed and given its broadest
reasonable interpretation in light of and consistent with the written
description.25 The entire claim must be considered,
including the preamble language 26 and the transitional
phrase.27 The claim as a whole, including all limitations
found in the preamble,28 the transitional phrase, and the
body of the claim, must be sufficiently described in the specification
to satisfy the written description requirement.29
    The examiner should evaluate each claim to determine if sufficient
structures, acts, or functions are recited to make clear the scope and
meaning of the claim, including the weight to be given the
preamble.30 The absence of definitions or details for well-
established terms or procedures should not be the basis of a rejection
under 35 U.S.C. 112, para. 1, for lack of adequate written description.
Limitations may not, however, be imported into the claims from the
specification.
2. Review the Entire Application to Understand What Applicant Has
Described as the Essential Features of the Invention
    Prior to determining whether the disclosure satisfies the written
description requirement for the claimed subject matter, the examiner
should review the claims and the entire specification, including the
specific embodiments, figures, and sequence listings, to understand
what applicant has identified as the essential distinguishing
characteristics of the invention. The analysis of whether the
specification complies with the written description requirement
requires the examiner to determine the correspondence between what
applicant has described as the essential identifying characteristic
features of the invention, i.e., what the applicant has demonstrated
possession of, and what applicant has claimed. Such a review is
conducted from the standpoint of one of skill in the art at the time
the application was filed,31 and should include a
determination of the field of the invention and the level of skill and
knowledge in the art. Generally, there is an inverse correlation
between the level of skill and knowledge in the art and the specificity
of disclosure necessary to satisfy the written description requirement.
Information which is well known in the art does not have to be
described in detail in the specification.32
3. Determine Whether There is Sufficient Written Description To Inform
a Skilled Artisan That Applicant Was in Possession of the Claimed
Invention as a Whole at the Time the Application Was Filed
    a. Original claims.--Possession may be shown in any number of ways.
Possession may be shown by actual reduction to practice, by a clear
depiction of the invention in detailed drawings which permit a person
skilled in the art to clearly recognize that applicant had possession
of the claimed invention, or by a written description of the invention
describing sufficient relevant identifying characteristics such that a
person skilled in the art would recognize that the inventor had
possession of the claimed invention.33
    A specification may show actual reduction to practice by showing
that the inventor constructed an embodiment or performed a process that
met all the limitations of the claim, and determined that the invention
would work for its intended purpose.34 Actual reduction to
practice of a biological material may be shown by specifically
describing a deposit made in accordance with the requirements of 37
C.F.R. Sec. 1.801 et seq.35
    An applicant may show possession of an invention by disclosure of
drawings that are sufficiently detailed to show that applicant was in
possession of the claimed invention as a whole.36 The
description need only describe in detail that which is new or not
conventional.37 This is equally true whether the claimed
invention is directed to a product or a process. Normally a reduction
to drawings will adequately describe the claimed
invention.38
    An applicant may also show that an invention is complete by
disclosure of sufficiently detailed relevant identifying
characteristics which provide evidence that applicant was in possession
of the claimed invention,39 i.e., complete or partial
structure, other physical and/or chemical properties, functional
characteristics when coupled with a known or disclosed correlation
between function and structure, or some combination of such
characteristics.40 What is conventional or well known to one
skilled in the art need not be disclosed in detail.41 If a
skilled artisan would have understood the inventor to be in possession
of the claimed invention at the time of filing, even if every nuance of
the claims is not explicitly described in the specification, then the
adequate description requirement is met.42
    (1) For each claim drawn to a single embodiment or species:
43
    (a) Determine whether the application describes an actual reduction
to practice of the claimed invention.
    (b) If the application does not describe an actual reduction to
practice, determine whether the invention is complete as evidenced by a
reduction to drawings.
    (c) If the application does not describe an actual reduction to
practice or reduction to drawings, determine whether the invention has
been set forth in terms of distinguishing identifying characteristics
as evidenced by other descriptions of the invention that are
sufficiently detailed to show that applicant was in possession of the
claimed invention.
    (i) Determine whether the application as filed describes the
complete structure (or acts of a process) of the claimed invention as a
whole. The complete structure of a species or embodiment typically
satisfies the requirement that the description be set forth ``in such
full, clear, concise, and exact terms'' to show possession of the
claimed invention.\44\ If a complete structure is disclosed, the
written description requirement is satisfied for that species or
embodiment, and a rejection under 35 U.S.C. 112, para. 1 for lack of
written description must not be made.
    (ii) If the application as filed does not disclose the complete
structure (or acts of a process) of the claimed invention as a whole,
determine whether the specification discloses other relevant
identifying characteristics sufficient to

[[Page 71436]]

describe the claimed invention in such full, clear, concise, and exact
terms that a skilled artisan would recognize applicant was in
possession of the claimed invention.\45\ Whether the specification
shows that applicant was in possession of the claimed invention is not
a single, simple factual determination, but rather is a conclusion
reached by weighing many factual considerations. Factors to be
considered in determining whether there is sufficient evidence of
possession include the level of skill and knowledge in the art, partial
structure, physical and/or chemical properties, functional
characteristics alone or coupled with a known or disclosed correlation
between structure and function, and the method of making the claimed
invention. Disclosure of any combination of such identifying
characteristics that distinguish the claimed invention from other
materials and would lead one of skill in the art to the conclusion that
the applicant was in possession of the claimed species is sufficient.
Patents and printed publications in the art should be relied upon to
determine whether an art is mature and what the level of knowledge and
skill is in the art. In most technologies which are mature, and wherein
the knowledge and level of skill in the art is high, a written
description question should not be raised for original claims even if
the specification discloses only a method of making the invention and
the function of the invention.\46\ In contrast, in emerging and
unpredictable technologies, more evidence is required to show
possession. For example, disclosure of only a method of making the
invention and the function may not be sufficient to support a product
claim other than a product-by-process claim.\47\ Furthermore,
disclosure of partial structure without additional characterization of
the product may not be sufficient to evidence possession of the claimed
invention.\48\
    Any claim to a species that does not meet the test described under
at least one of (a), (b), or (c) must be rejected as lacking adequate
written description under 35 U.S.C. 112, para. 1.
    (2) For each claim drawn to a genus:
    The written description requirement for a claimed genus may be
satisfied through sufficient description of a representative number of
species by actual reduction practice (see (1)(a), above), reduction to
drawings (see (1)(b), above), or by disclosure of relevant identifying
characteristics, i.e., structure or other physical and/or chemical
properties, by functional characteristics coupled with a known or
disclosed correlation between function and structure, or by a
combination of such identifying characteristics, sufficient to show the
applicant was in possession of the claimed genus (see (1)(c),
above).\49\
    A ``representative number of species'' means that the species which
are adequately described are representative of the entire genus. Thus,
when there is substantial variation within the genus, one must describe
a sufficient variety of species to reflect the variation within the
genus. What constitutes a ``representative number'' is an inverse
function of the skill and knowledge in the art. Satisfactory disclosure
of a ``representative number'' depends on whether one of skill in the
art would recognize that the applicant was in possession of the
necessary common attributes or features of the elements possessed by
the members of the genus in view of the species disclosed. In an
unpredictable art, adequate written description of a genus which
embraces widely variant species cannot be achieved by disclosing only
one species within the genus.50 Description of a
representative number of species does not require the description to be
of such specificity that it would provide individual support for each
species that the genus embraces.51 If a representative
number of adequately described species are not disclosed for a genus,
the claim to that genus must be rejected as lacking adequate written
description under 35 U.S.C. 112, para. 1.
    b. New claims, amended claims, or claims asserting entitlement to
the benefit of an earlier priority date or filing date under 35 U.S.C.
Secs. 119, 120, or 365(c).--The examiner has the initial burden of
presenting evidence or reasoning to explain why persons skilled in the
art would not recognize in the original disclosure a description of the
invention defined by the claims.52 However, when filing an
amendment an applicant should show support in the original disclosure
for new or amended claims.53 To comply with the written
description requirement of 35 U.S.C. 112, para. 1, or to be entitled to
an earlier priority date or filing date under 35 U.S.C. 119, 120, or
365(c), each claim limitation must be expressly,54
implicitly,55 or inherently 56 supported in the
originally filed disclosure.57 Furthermore, each claim must
include all elements which applicant has described as
essential.58
    If the originally filed disclosure does not provide support for
each claim limitation, or if an element which applicant describes as
essential or critical is not claimed, a new or amended claim must be
rejected under 35 U.S.C. 112, para. 1, as lacking adequate written
description, or in the case of a claim for priority under 35 U.S.C.
119, 120, or 365(c), the claim for priority must be denied.

III. Complete Patentability Determination Under All Statutory
Requirements and Clearly Communicate Findings, Conclusions and
Their Bases

    The above only describes how to determine whether the written
description requirement of 35 U.S.C. 112, para. 1 is satisfied.
Regardless of the outcome of that determination, Office personnel must
complete the patentability determination under all the relevant
statutory provisions of Title 35 of the U.S. Code.
    Once Office personnel have concluded analysis of the claimed
invention under all the statutory provisions, including 35 U.S.C. 101,
112, 102, and 103, they should review all the proposed rejections and
their bases to confirm their correctness. Only then should any
rejection be imposed in an Office action. The Office action should
clearly communicate the findings, conclusions, and reasons which
support them. When possible, the Office action should offer helpful
suggestions on how to overcome rejections.

A. For Each Claim Lacking Written Description Support, Reject the Claim
Under Section 112, para. 1, for Lack of Adequate Written Description

    A description as filed is presumed to be adequate, unless or until
sufficient evidence or reasoning to the contrary has been presented by
the examiner to rebut the presumption.59 The examiner,
therefore, must have a reasonable basis to challenge the adequacy of
the written description. The examiner has the initial burden of
presenting by a preponderance of evidence why a person skilled in the
art would not recognize in an applicant's disclosure a description of
the invention defined by the claims.60 In rejecting a claim,
the examiner must set forth express findings of fact regarding the
above analysis which support the lack of written description
conclusion. These findings should:
    (1) identify the claim limitation at issue; and
    (2) establish a prima facie case by providing reasons why a person
skilled in the art at the time the application was filed would not have
recognized that the inventor was in possession of the invention as
claimed in view of the disclosure of the application as filed. A
general allegation of ``unpredictability

[[Page 71437]]

in the art'' is not a sufficient reason to support a rejection for lack
of adequate written description.
    When appropriate, suggest amendments to the claims which can be
supported by the application's written description, being mindful of
the prohibition against the addition of new matter in the claims or
description.61

B. Upon Reply By Applicant, Again Determine the Patentability of the
Claimed Invention, Including Whether the Written Description
Requirement is Satisfied by Reperforming the Analysis Described Above
in View of the Whole Record

    Upon reply by applicant, before repeating any rejection under 35
U.S.C. 112, para. 1 for lack of written description, review the basis
for the rejection in view of the record as a whole, including
amendments, arguments, and any evidence submitted by applicant. If the
whole record now demonstrates that the written description requirement
is satisfied, do not repeat the rejection in the next Office action. If
the record still does not demonstrate that written description is
adequate to support the claim(s), repeat the rejection under 35 U.S.C.
112, para. 1, fully respond to applicant's rebuttal arguments, and
properly treat any further showings submitted by applicant in the
reply. Any affidavits, including those relevant to the 112, para. 1,
written description requirement,62 must be thoroughly
analyzed and discussed in the next Office action.

ENDNOTES

    1. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560,
19 USPQ2d 1111, 1114 (Fed. Cir. 1991).
    2. In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4
(CCPA 1977).
    3. See Regents of the University of California v. Eli Lilly, 119
F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert.
denied, 523 U.S. 1089 (1998).
    4. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19
USPQ2d at 1116. Much of the written description case law addresses
whether the specification as originally filed supports claims not
originally in the application. The issue raised in the cases is most
often phrased as whether the original application provides
``adequate support'' for the claims at issue or whether the material
added to the specification incorporates ``new matter'' in violation
of 35 U.S.C. Sec. 132. The ``written description'' question
similarly arises in the interference context, where the issue is
whether the specification of one party to the interference can
support the newly added claims corresponding to the count at issue,
i.e., whether that party can ``make the claim'' corresponding to the
interference count. E.g., see Martin v. Mayer, 823 F.2d 500, 502, 3
USPQ2d 1333, 1335 (Fed. Cir. 1987).
    In addition, early opinions suggest the Patent and Trademark
Office was unwilling to find written descriptive support when the
only description was found in the claims; however, this viewpoint
was rejected. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA
1980) (original claims constitute their own description); In re
Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973) (accord); In re
Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (accord). It is now
well accepted that a satisfactory description may be in the claims
or any other portion of the originally filed specification.
    These early opinions did not address the quality or specificity
of particularity that was required in the description, i.e., how
much description is enough.
    5. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41
USPQ2d 1961, 1966 (Fed. Cir. 1997).
    6. An application specification may show actual reduction to
practice by describing testing of the claimed invention or, in the
case of biological materials, by specifically describing a deposit
made in accordance with 37 CFR 1.801 et seq. 37 CFR 1.804, 1.809.
See also Deposit of Biological Materials for Patent Purposes, Final
Rule, 54 FR 34,864 (August 22, 1989) (``The requirement for a
specific identification is consistent with the description
requirement of the first paragraph of 35 U.S.C. 112, and to provide
an antecedent basis for the biological material which either has
been or will be deposited before the patent is granted.'' Id. at
34876. ``[T]he description must be sufficient to permit verification
that the deposited biological material is in fact that disclosed.
Once the patent issues, the description must be sufficient to aid in
the resolution of questions of infringement.'' Id. at 34,880.). Such
a deposit is not a substitute for a written description of the
claimed invention. The written description of the deposited material
needs to be as complete as possible because the examination for
patentability proceeds solely on the basis of the written
description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90
(Fed. Cir. 1985). See also 54 FR at 34,880 (``As a general rule, the
more information that is provided about a particular deposited
biological material, the better the examiner will be able to compare
the identity and characteristics of the deposited biological
material with the prior art.'').
    7. Pfaff v. Wells Electronics, Inc., 525 U.S. 55,____ , 119
S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998).
    8. A description requirement issue can arise for original claims
(see, e.g., Eli Lilly, 119 F.3d 1559, 43 USPQ2d 1398) as well as new
or amended claims. Most typically, the issue will arise in the
context of determining whether new or amended claims are supported
by the description of the invention in the application as filed
(see, e.g., In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir.
1989)), whether a claimed invention is entitled to the benefit of an
earlier priority date or effective filing date under 35 U.S.C. 119,
120, or 365(c) (see, e.g., Tronzo v. Biomet, Inc., 156 F.3d 1154, 47
USPQ2d 1829 (Fed. Cir. 1998); Fiers v. Revel, 984 F.2d 1164, 25
USPQ2d 1601 (Fed. Cir. 1993); In re Ziegler, 992 F.2d 1197, 1200, 26
USPQ2d 1600, 1603 (Fed. Cir. 1993)), or whether a specification
provides support for a claim corresponding to a count in an
interference (see, e.g., Fields v. Conover, 443 F.2d 1386, 170 USPQ
276 (CCPA 1970)).
    9. Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at
1116 (Fed. Cir. 1991).
    10. In re Wertheim, 541 F.2d at 262, 191 USPQ at 96.
    11. See endnote 4.
    12. For example, consider the claim ``A gene comprising SEQ ID
NO: 1.'' A determination of what the claim as a whole covers may
result in a conclusion that specific structures such as a promoter,
a coding region, or other elements are included. Although all genes
encompassed by this claim share the characteristic of comprising SEQ
ID NO: 1, there may be insufficient description of those specific
structures (e.g., promoters, enhancers, coding regions, and other
regulatory elements) which are also included.
    13. A biomolecule sequence described only by a functional
characteristic, without any known or disclosed correlation between
that function and the structure of the sequence, normally is not a
sufficient identifying characteristic for written description
purposes, even when accompanied by a method of obtaining the claimed
sequence. For example, even though a genetic code table would
correlate a known amino acid sequence with a genus of coding nucleic
acids, the same table cannot predict the native, naturally occurring
nucleic acid sequence of a naturally occurring mRNA or its
corresponding cDNA. Cf. In re Bell, 991 F.2d 781, 26 USPQ2d 1529
(Fed. Cir. 1993), and In re Deuel, 51 F.3d 1552, 34 USPQ2d 1210
(Fed. Cir. 1995) (holding that a process could not render the
product of that process obvious under 35 U.S.C. 103). The Federal
Circuit has pointed out that under United States law, a description
that does not render a claimed invention obvious cannot sufficiently
describe the invention for the purposes of the written description
requirement of 35 U.S.C. 112. Eli Lilly, 119 F.3d at 1567, 43 USPQ2d
at 1405. The fact that a great deal more than just a process is
necessary to render a product invention obvious means that a great
deal more than just a process is necessary to provide written
description for a product invention.
    Compare Fonar Corp. v. General Electric Co., 107 F.3d 1543,
1549, 41 USPQ2d 1801, 1805 (Fed. Cir. 1997) (``As a general rule,
where software constitutes part of a best mode of carrying out an
invention, description of such a best mode is satisfied by a
disclosure of the functions of the software. This is because,
normally, writing code for such software is within the skill of the
art, not requiring undue experimentation, once its functions have
been disclosed * * *. Thus, flow charts or source code listings are
not a requirement for adequately disclosing the functions of
software.'').
    14. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39
USPQ2d 1895, 1905 (Fed. Cir. 1996) (a ``laundry list'' disclosure of
every possible moiety does not constitute a written description of
every species in a genus because it would not ``reasonably

[[Page 71438]]

lead'' those skilled in the art to any particular species); In re
Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 122-23 (CCPA 1967) (``If
n-propylamine had been used in making the compound instead of n-
butylamine, the compound of claim 13 would have resulted. Appellants
submit to us, as they did to the board, an imaginary specific
example patterned on specific example 6 by which the above butyl
compound is made so that we can see what a simple change would have
resulted in a specific supporting disclosure being present in the
present specification. The trouble is that there is no such
disclosure, easy though it is to imagine it.'').
    15. 35 U.S.C. 132 and 251. See also In re Rasmussen, 650 F.2d
1212, 1214, 211 USPQ 323, 326 (CCPA 1981). See Manual of Patent
Examining Procedure (MPEP) Secs. 2163.06-2163.07 (7th Ed., July
1998) for a more detailed discussion of the written description
requirement and its relationship to new matter.
    16. The claims as filed in the original specification are part
of the disclosure and therefore, if an application as originally
filed contains a claim disclosing material not found in the
remainder of the specification, the applicant may amend the
specification to include the claimed subject matter. In re Benno,
768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
    17. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA
1971) (subgenus range was not supported by generic disclosure and
specific example within the subgenus range); In re Smith, 458 F.2d
1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not
necessarily described by a genus encompassing it and a species upon
which it reads).
    18. In re Oda, 443 F.2d 1200, 170 USPQ 260 (CCPA 1971). With
respect to the correction of sequencing errors in applications
disclosing nucleic acid and/or amino acid sequences, it is well know
that sequencing errors are a common problem in molecular biology.
See, e.g., Richterich, Peter, ``Estimation of Errors in `Raw' DNA
Sequences: A Validation Study,'' Genome Research, 8:251-259 (1998).
If an application as filed includes sequence information and
references a deposit of the sequenced material made in accordance
with the requirements of 37 CFR 1.801 et seq., corrections of minor
errors in the sequence may be possible based on the argument that
one of skill in the art would have resequenced the deposited
material and would have immediately recognized the minor error.
Deposits made after the filing date can only be relied upon to
provide support for the correction of sequence information if
applicant submits a statement in compliance with 37 CFR 1.804
stating that the biological material which is deposited is a
biological material specifically defined in the application as
filed.
    19. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d
1473, 45 USPQ2d 1498 (Fed. Cir. 1998) (claims to a section sofa
comprising, inter alia, a console and a control means were held
invalid for failing to satisfy the written description requirement
where the claims were broadened by removing the location of the
control means.); Johnson Worldwide Associates Inc. v. Zebco Corp.,
175 F.3d 985, 993, 50 USPQ2d 1607, 1613 (Fed. Cir. 1999) (In Gentry
Gallery, the ``court's determination that the patent disclosure did
not support a broad meaning for the disputed claim terms was
premised on clear statements in the written description that
described the location of a claim element--the `control means'--as
`the only possible location' and that variations were `outside the
stated purpose of the invention.' Gentry Gallery, 134 F.3d at 1479,
45 USPQ2d at 1503. Gentry Gallery, then, considers the situation
where the patent's disclosure makes crystal clear that a particular
(i.e., narrow) understanding of a claim term is an `essential
element of [the inventor's] invention.' ''); Tronzo v. Biomet, Inc.,
156 F.3d 1154, 1159, 47 USPQ2d 1829, 1833 (Fed. Cir. 1998) (claims
to generic cup shape were not entitled to filing date of parent
application which disclosed ``conical cup'' in view of the
disclosure of the parent application stating the advantages and
importance of the conical shape.).
    20. See Gentry Gallery, 134 F.3d at 1480, 45 USPQ2d at 1503; In
re Sus, 306 F.2d 494, 134 USPQ 301 (CCPA 1962) (``[O]ne skilled in
this art would not be taught by the written description of the
invention in the specification that any `aryl or substituted aryl
radical' would be suitable for the purposes of the invention but
rather that only certain aryl radicals and certain specifically
substituted aryl radicals [i.e., aryl azides] would be suitable for
such purposes.''). A claim which omits matter disclosed to be
essential to the invention as described in the specification or in
other statements of record may also be subject to rejection under 35
U.S.C. Sec. 112, para. 1 as not enabling, or under 35 U.S.C. 112,
para. 2. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976);
In re Venezia, 530 F.2d 956, 189 USPQ 149 (CCPA 1976); and In re
Collier, 397 F.2d 1003, 158 USPQ 266 (CCPA 1968). See also Reiffin
v. Microsoft Corp., 48 USPQ2d 1274, 1277 (N.D. Cal. 1998) and MPEP
Sec. 2172.01.
    21. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at
1117.
    22. Wertheim, 541 F.2d at 262, 191 USPQ at 96.
    23. See MPEP Secs. 714.02 and 2163.06 (``Applicant should * * *
specifically point out the support for any amendments made to the
disclosure.''); and MPEP Sec. 2163.04 (``If applicant amends the
claims and points out where and/or how the originally filed
disclosure supports the amendment(s), and the examiner finds that
the disclosure does not reasonably convey that the inventor had
possession of the subject matter of the amendment at the time of the
filing of the application, the examiner has the initial burden of
presenting evidence or reasoning to explain why persons skilled in
the art would not recognize in the disclosure a description of the
invention defined by the claims.'').
    24. See In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683
(CCPA 1972) (``Precisely how close [to the claimed invention] the
description must come to comply with Sec. 112 must be left to case-
by-case development.''); In re Wertheim, 541 F.2d at 262, 191 USPQ
at 96 (inquiry is primarily factual and depends on the nature of the
invention and the amount of knowledge imparted to those skilled in
the art by the disclosure).
    25. See, e.g., In re Morris, 127 F.3d 1048, 1053-54, 44 USPQ2d
1023, 1027 (Fed. Cir. 1997).
    26. ``Preamble language'' is that language in a claim appearing
before the transitional phase, e.g., before ``comprising,''
``consisting essentially of,'' or ``consisting of.''
    27. The transitional term ``comprising'' (and other comparable
terms, e.g., ``containing,'' ``including,'' and ``having'') is
``open-ended--it covers the expressly recited subject matter, alone
or in combination with unrecited subject matter. See, e.g., Ex parte
Davis, 80 USPQ 448, 450 (Bd. App. 1948) (``comprising'' leaves the
``claim open for the inclusion of unspecified ingredients even in
major amounts''), quoted with approval in Moleculon Research Corp v.
CBS, Inc., 793 F.2d 1261, 1271, 229 USPQ 805, 812 (Fed. Cir. 1986).
``By using the term `consisting essentially of, ' the drafter
signals that the invention necessarily includes the listed
ingredients and is open to unlisted ingredients that do not
materially affect the basic and novel properties of the invention. A
`consisting essentially of ' claim occupies a middle ground between
closed claims that are written in a `consisting of ' format and
fully open claims that are drafted in a `comprising' format.'' PPG
Industries v. Guardian Industries, 156 F.3d 1351, 1354, 48 USPQ2d
1351, 1353-54 (Fed. Cir. 1998). For search and examination purposes,
absent a clear indication in the specification of what the basic and
novel characteristics actually are, `consisting essentially of '
will be construed as equivalent to ``comprising.'' See, e.g., PPG,
156 F.3d at 1355, 48 USPQ at 1355 (``PPG could have defined the
scope of the phrase `consisting essentially of ' for purposes of its
patent by making clear in its specification what it regarded as
constituting a material change in the basic and novel
characteristics of the invention.'').
    28. See Pac-Tec Inc. v. Amerace Corp., 903 F.2d 796, 801, 14
USPQ2d 1871, 1876 (Fed. Cir. 1990) (determining that preamble
language that constitutes a structural limitation is actually part
of the claimed invention).
    29. An applicant shows possession of the claimed invention by
describing the claimed invention with all of its essential novel
elements. Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
    30. See, e.g., Bell Communications Research, Inc. v. Vitalink
Communications Corp., 55 F.3d 615, 620, 34 USPQ2d 1816, 1820 (Fed.
Cir. 1995) (``[A] claim preamble has the import that the claim as a
whole suggests for it.''); Corning Glass Works v. Sumitomo Elec.
U.S.A., Inc., 868 F.2d 1251, 1257, 9 USPQ2d 1962, 1966 (Fed. Cir.
1989) (The determination of whether preamble recitations are
structural limitations can be resolved only on review of the
entirety of the application ``to gain an understanding of what the
inventors actually invented and intended to encompass by the
claim.'').
    31. See, e.g., Wang Labs. v. Toshiba Corp., 993 F.2d 858, 865,
26 USPQ2d 1767, 1774 (Fed. Cir. 1993).

[[Page 71439]]

    32. See, e.g., Hybritech Inc. v. Monoclonal Antibodies, Inc.,
802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986).
    33. Pfaff v. Wells Electronics, Inc., 119 S.Ct. at 311, 48
USPQ2d at 1646 (``The word `invention' must refer to a concept that
is complete, rather than merely one that is `substantially
complete.' It is true that reduction to practice ordinarily provides
the best evidence that an invention is complete. But just because
reduction to practice is sufficient evidence of completion, it does
not follow that proof of reduction to practice is necessary in every
case. Indeed, both the facts of the Telephone Cases and the facts of
this case demonstrate that one can prove that an invention is
complete and ready for patenting before it has actually been reduced
to practice.'').
    34. Cooper v. Goldfarb, 154 F.3d 1321, 1327, 47 USPQ2d 1896,
1901 (Fed. Cir. 1998). See also UMC Elecs. Co. v. United States, 816
F.2d 647, 652, 2 USPQ2d 1465, 1468 (Fed. Cir. 1987) (``[T]here
cannot be a reduction to practice of the invention * * * without a
physical embodiment which includes all limitations of the claim.'');
Estee Lauder Inc. v. L'Oreal S.A., 129 F.3d 588, 593, 44 USPQ2d
1610, 1614 (Fed. Cir. 1997) (``[A] reduction to practice does not
occur until the inventor has determined that the invention will work
for its intended purpose.''); Mahurkar v. C.R. Bard Inc., 79 F.3d
1572, 1578, 38 USPQ2d 1288, 1291 (Fed. Cir. 1996) (determining that
the invention will work for its intended purpose may require testing
depending on the character of the invention and the problem it
solves).
    35. 37 CFR Secs. 1.804, 1.809. See also  endnote 6.
    36. See, e.g., Vas-Cath, 935 F.2d at 1565, 19 USPQ2d at 1118
(``drawings alone may provide a `written description' of an
invention as required by Sec. 112''); In re Wolfensperger, 302 F.2d
950, 133 USPQ 537 (CCPA 1962) (the drawings of applicant's
specification provided sufficient written descriptive support for
the claim limitation at issue); Autogiro Co. of America v. United
States, 384 F.2d 391, 398, 155 USPQ 697, 703 (Ct. Cl. 1967) (``[I]n
those instances where a visual representation can flesh out words,
drawings may be used in the same manner and with the same
limitations as the specification.'').
    37. See Hybritech v. Monoclonal Antibodies, 802 F.2d at 1384,
231 USPQ at 94; Fonar Corp. v. General Electric Co., 107 F.3d at
1549, 41 USPQ2d at 1805 (source code description not required).
    38. This is especially true for the mechanical and electrical
arts. See, e.g. , Pfaff v. Wells Electronics, 119 S.Ct. at 312, 48
USPQ2d at 1647.
    39. For example, the presence of a restriction enzyme map of a
gene may be relevant to a statement that the gene has been isolated.
One skilled in the art may be able to determine when the gene
disclosed is the same as or different from a gene isolated by
another by comparing the restriction enzyme map. In contrast,
evidence that the gene could be digested with a nuclease would not
normally represent a relevant characteristic since any gene would be
digested with a nuclease. Similarly, isolation of an mRNA and its
expression to produce the protein of interest is strong evidence of
possession of an mRNA for the protein.
    Examples of identifying characteristics include a sequence,
structure, binding affinity, binding specificity, molecular weight,
and length. Although structural formulas provide a convenient method
of demonstrating possession of specific molecules, other identifying
characteristics or combinations of characteristics may demonstrate
the requisite possession. For example, unique cleavage by particular
enzymes, isoelectric points of fragments, detailed restriction
enzyme maps, a comparison of enzymatic activities, or antibody
cross-reactivity may be sufficient to show possession of the claimed
invention to one of skill in the art. See Lockwood, 107 F.3d at
1572, 41 USPQ2d at 1966 (``written description'' requirement may be
satisfied by using ``such descriptive means as words, structures,
figures, diagrams, formulas, etc., that fully set forth the claimed
invention'').
    However, a definition by function alone ``does not suffice'' to
sufficiently describe a coding sequence ``because it is only an
indication of what the gene does, rather than what it is.'' Eli
Lilly, 119 F.3 at 1568, 43 USPQ2d at 1406. See also Fiers, 984 F.2d
at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen Inc. v. Chugai
Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991)).
    40. If a claim limitation invokes 35 U.S.C. Sec. 112, para. 6,
it must be interpreted to cover the corresponding structure,
materials, or acts in the specification and ``equivalents thereof.''
See 35 U.S.C. 112, para. 6. See also  B. Braun Medical, Inc. v.
Abbott Lab., 124 F.3d 1419, 1424, 43 USPQ2d 1896, 1899 (Fed. Cir.
1997). If the written description fails to set forth the supporting
structure, material or acts corresponding to the means-(or step-)
plus-function, the claim may not meet the requirement of 35 U.S.C.
112, para. 1. A means-(or step-) plus-function claim limitation
satisfies 35 U.S.C. 112, para. 1 if: (1) The written description
links or associates particular structure, materials, or acts to the
function recited in a means-(or step-) plus-function claim
limitation; or (2) it is clear based on the facts of the application
that one skilled in the art would have known what structure,
materials, or acts perform the function recited in a means-(or step-
) plus-function limitation. In considering whether there is 35
U.S.C. Sec. 112, para. 1 support for the claim limitation, the
examiner must consider not only the original disclosure contained in
the summary and detailed description of the invention portions of
the specification, but also the original claims, abstract, and
drawings. See the Interim Supplemental Examination Guidelines for
Determining the Applicability of 35 U.S.C. 112 para. 6, 64 FR 41392
(July 30, 1999).
    41. See Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d
at 1384, 231 USPQ at 94.
    42. See, e.g., Vas-Cath, 935 F.2d at 1563, 19 USPQ2d at 1116;
Martin v. Johnson, 454 F.2d 746, 751, 172 USPQ 391, 395 (CCPA 1972)
(stating ``the description need not be in ipsis verbis [i.e., ``in
the same words'] to be sufficient'').
    43. A claim which is limited to a single disclosed embodiment or
species is analyzed as a claim drawn to a single embodiment or
species, whereas a claim which encompasses two or more embodiments
or species within the scope of the claim is analyzed as a claim
drawn to a genus. See also  MPEP Sec. 806.04(e).
    44. 35 U.S.C. 112, para. 1. Cf.  Fields v. Conover, 443 F.2d
1386, 1392, 170 USPQ 276, 280 (CCPA 1971) (finding a lack of written
description because the specification lacked the ``full, clear,
concise, and exact written description'' which is necessary to
support the claimed invention).
    45. For example, if the art has established a strong correlation
between structure and function, one skilled in the art would be able
to predict with a reasonable degree of confidence the structure of
the claimed invention from a recitation of its function. Thus, the
written description requirement may be satisfied through disclosure
of function and minimal structure when there is a well-established
correlation between structure and function. In contrast, without
such a correlation, the capability to recognize or understand the
structure from the mere recitation of function and minimal structure
is highly unlikely. In this latter case, disclosure of function
alone is little more than a wish for possession; it does not satisfy
the written description requirement. See Eli Lilly, 119 F.3d at
1568, 43 USPQ2d at 1406 (written description requirement not
satisfied by merely providing ``a result that one might achieve if
one made that invention'') ; In re Wilder, 736 F.2d 1516, 1521, 222
USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of
written description because the specification does ``little more
than outline goals appellants hope the claimed invention achieves
and the problems the invention will hopefully ameliorate''). Compare
Fonar, 107 F.3d at 1549, 41 USPQ2d at 1805 (disclosure of software
function adequate in that art).
    46. See, e.g., In re Hayes Microcomputer Products Inc. Patent
Litigation, 982 F.2d 1527, 1534-35, 25 USPQ2d 1241, 1246 (Fed. Cir.
1992) (``One skilled in the art would know how to program a
microprocessor to perform the necessary steps described in the
specification. Thus, an inventor is not required to describe every
detail of his invention. An applicant's disclosure obligation varies
according to the art to which the invention pertains. Disclosing a
microprocessor capable of performing certain functions is sufficient
to satisfy the requirement of section 112, first paragraph, when one
skilled in the relevant art would understand what is intended and
know how to carry it out.'')
    47. See, e.g. , Fiers v. Revel, 984 F.2d at 1169, 25 USPQ2d at
1605; Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 1206,
18 USPQ2d 1016, 1021 (Fed. Cir. 1991). Where the process has
actually been used to produce the product, the written description
requirement for a product-by-process claim is clearly satisfied;
however, the requirement may not be satisfied where it is not clear
that the acts set forth in the specification can be performed, or
that the product is produced by that process.
    48. See, e.g., Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d
1200, 1206, 18

[[Page 71440]]

USPQ2d 1016, 1021 (Fed. Cir. 1991)(``A gene is a chemical compound,
albeit a complex one, and it is well established in our law that
conception of a chemical compound requires that the inventor be able
to define it so as to distinguish it from other materials, and to
describe how to obtain it. Conception does not occur unless one has
a mental picture of the structure of the chemical, or is able to
define it by its method of preparation, its physical or chemical
properties, or whatever characteristics sufficiently distinguish it.
It is not sufficient to define it solely by its principal biological
property, e.g., encoding human erythropoietin, because an alleged
conception having no more specificity than that is simply a wish to
know the identity of any material with that biological property. We
hold that when an inventor is unable to envision the detailed
constitution of a gene so as to distinguish it from other materials,
as well as a method for obtaining it, conception has not been
achieved until reduction to practice has occurred, i.e., until after
the gene has been isolated.'')(citations omitted). In such instances
the alleged conception fails not merely because the field is
unpredictable or because of the general uncertainty surrounding
experimental sciences, but because the conception is incomplete due
to factual uncertainty that undermines the specificity of the
inventor's idea of the invention. Burroughs Wellcome Co. v. Barr
Laboratories Inc., 40 F.3d 1223, 1229, 32 USPQ2d 1915, 1920 (Fed.
Cir. 1994). Reduction to practice in effect provides the only
evidence to corroborate conception (and therefore possession) of the
invention. Id.
    49. See  Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
    50. See, e.g., Eli Lilly.
    51. For example, in the genetics arts, it is unnecessary for an
applicant to provide enough different species that the disclosure
will permit one of skill to determine the nucleic acid or amino acid
sequence of another species from the application alone. The
stochastic nature of gene evolution would make such a predictability
nearly impossible. Thus, the Federal Circuit could not have intended
that representative number requires predictability of sequences.
    52. See  Wertheim, 541 F.2d at 263, 191 USPQ at 97 (``[T]he PTO
has the initial burden of presenting evidence or reasons why persons
skilled in the art would not recognize in the disclosure a
description of the invention defined by the claims.''). See also
MPEP Sec. 2163.05.
    53. See MPEP Secs. 714.02 and 2163.06 (``Applicant should * * *
specifically point out the support for any amendments made to the
disclosure.'').
    54. See, e.g., In re Wright, 866 F.2d 422, 425, 9 USPQ2d 1649,
1651 (Fed. Cir. 1989)(Original specification for method of forming
images using photosensitive microcapsules which describes removal of
microcapsules from surface and warns that capsules not be disturbed
prior to formation of image, unequivocally teaches absence of
permanently fixed microcapsules and supports amended language of
claims requiring that microcapsules be ``not permanently fixed'' to
underlying surface, and therefore meets description requirement of
35 U.S.C. 112.).
    55. See, e.g., In re Robins, 429 F.2d 452, 456-57, 166 USPQ 552,
555 (CCPA 1970) (``[W]here no explicit description of a generic
invention is to be found in the specification * * * mention of
representative compounds may provide an implicit description upon
which to base generic claim language.''); In re Smith, 458 F.2d
1389, 1395, 173 USPQ 679, 683 (CCPA 1972)(a subgenus is not
necessarily implicitly described by a genus encompassing it and a
species upon which it reads).
    56. See, e.g., In re Robertson, 169 F.3d 743, 745, 49 USPQ2d
1949, 1950-51 (Fed. Cir. 1999)(``To establish inherency, the
extrinsic evidence `must make clear that the missing descriptive
matter is necessarily present in the thing described in the
reference, and that it would be so recognized by persons of ordinary
skill. Inherency, however, may not be established by probabilities
or possibilities. The mere fact that a certain thing may result from
a given set of circumstances is not sufficient.' '') (citations
omitted).
    57. When an explicit limitation in a claim ``is not present in
the written description whose benefit is sought it must be shown
that a person of ordinary skill would have understood, at the time
the patent application was filed, that the description requires that
limitation.'' Hyatt v. Boone , 146 F.3d 1348, 1353, 47 USPQ2d 1128,
1131 (Fed. Cir. 1998).
    58. See, e.g., Johnson Worldwide Associates Inc. v. Zebco Corp.,
175 F.3d at 993, 50 USPQ2d at 1613; Gentry Gallery, Inc. v. Berkline
Corp., 134 F.3d at 1479, 45 USPQ2d at 1503; Tronzo v. Biomet, Inc.,
156 F.3d at 1159, 47 USPQ2d at 1833; and Reiffin v. Microsoft Corp.,
48 USPQ2d at 1277.
    59. See, e.g., In re Marzocchi, 439 F.2d 220, 224, 169 USPQ 367,
370 (CCPA 1971).
    60. Wertheim, 541 F.2d at 262, 191 USPQ at 96.
    61. See In re Rasmussen, 650 F.2d at 1214, 211 USPQ at 326.
    62. See In re Alton, 76 F.3d 1168, 1176, 37 USPQ2d 1578, 1584
(Fed. Cir. 1996).

    Dated: December 16, 1999.
Q. Todd Dickinson,
Assistant Secretary of Commerce and Commissioner of Patents and
Trademarks.
[FR Doc. 99-33053 Filed 12-20-99; 8:45 am]
BILLING CODE 3510-16-P