[Federal Register Volume 66, Number 4 (Friday, January 5, 2001)]
[Notices]
[Pages 1099-1111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-323]


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DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

[Docket No. 991027288-0264-02]
RIN 0651-AB10


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

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Notice.

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SUMMARY: These Guidelines will be used by USPTO personnel in their 
review of patent applications for compliance with the ``written 
description'' requirement of 35 U.S.C. 112, para. 1. These Guidelines 
supersede the ``Revised Interim Guidelines for Examination of Patent 
Applications Under the 35 U.S.C. 112, para. 1 `Written Description' 
Requirement'' that were published in the Federal Register at 64 FR 
71427, Dec. 21, 1999, and in the Official Gazette at 1231 O.G. 123, 
Feb. 29, 2000. These Guidelines reflect the current understanding of 
the USPTO regarding the written description requirement of 35 U.S.C. 
112, para. 1, and are applicable to all technologies.

DATES: The Guidelines are effective as of January 5, 2001.

FOR FURTHER INFORMATION CONTACT: Stephen Walsh by telephone at (703) 
305-9035, by facsimile at (703) 305-9373, by mail to his attention 
addressed to United States Patent and Trademark Office, Box 8, 
Washington, DC 20231, or by electronic mail at 
``[email protected]''; or Linda Therkorn by telephone at (703) 
305-8800, by facsimile at (703) 305-8825, by mail addressed to Box 
Comments, Commissioner for Patents, Washington, DC 20231, or by 
electronic mail at ``[email protected].''

SUPPLEMENTARY INFORMATION: As of the publication date of this notice, 
these Guidelines will be used by USPTO personnel in their review of 
patent applications for compliance with the ``written description'' 
requirement of 35 U.S.C. 112, para. 1. Because these Guidelines only 
govern internal practices, they are exempt from notice and comment 
rulemaking under 5 U.S.C. 553(b)(A).

Discussion of Public Comments

    Comments were received from 48 individuals and 18 organizations in 
response to the request for comments on the ``Revised Interim 
Guidelines for Examination of Patent Applications Under the 35 U.S.C. 
112, para. 1 `Written Description' Requirement'' published in the 
Federal Register at 64 FR 71427, Dec. 21, 1999, and in the Official 
Gazette at 1231 O.G. 123, Feb. 29, 2000. The written comments have been 
carefully considered.

Overview of Comments

    The majority of comments favored issuance of final written 
description guidelines with minor revisions. Comments pertaining to the 
written description guidelines are addressed in detail below. A few 
comments addressed particular concerns with respect to the associated 
examiner training materials that are available for public inspection at 
the USPTO web site (www.uspto.gov). Such comments will be taken under 
advisement in the revision of the training materials; consequently, 
these comments are not specifically addressed below as they do not 
impact the content of the Guidelines. Several comments raised issues 
pertaining to the patentability of ESTs, genes, or genomic inventions 
with respect to subject matter eligibility (35 U.S.C. 101), novelty (35 
U.S.C. 102), or obviousness (35 U.S.C. 103). As these comments do not 
pertain to the written description requirement under 35 U.S.C. 112, 
they have not been addressed. However, the aforementioned comments are 
fully addressed in the ``Discussion of Public Comments'' in the 
``Utility Examination Guidelines'' Final Notice, which will be 
published at or about the same time as the present Guidelines.

Responses to Specific Comments

    (1) Comment: One comment stated that the Guidelines instruct the 
patent examiner to determine the correspondence between what applicant 
has described as the essential identifying characteristic features of 
the invention and what applicant has claimed, and that such analysis 
will lead to error. According to the comment, the examiner may decide 
what applicant should have claimed and reject the claim for failure to 
claim what the examiner considers to be the invention. Another comment 
suggested that the Guidelines should clarify what is meant by 
``essential features of the invention.'' Another comment suggested that 
what applicant has identified as the ``essential distinguishing 
characteristics'' of the invention should be understood in terms of 
Fiers v. Revel, 984 F.2d 1164, 1169, 25 USPQ2d 1601, 1605 (Fed. Cir. 
1993) (``Conception of a substance claimed per se without reference to 
a process requires conception of its structure, name,

[[Page 1100]]

formula, or definitive chemical or physical properties.'').
    Response: The suggestions have been adopted in part. The purpose of 
the written description analysis is to confirm that applicant had 
possession of what is claimed. The Guidelines have been modified to 
instruct the examiners to compare the scope of the invention claimed 
with the scope of what applicant has defined in the description of the 
invention. That is, the Guidelines instruct the examiner to look for 
consistency between a claim and what provides adequate factual support 
for the claim as judged by one of ordinary skill in the art from 
reading the corresponding written description.
    (2) Comment: Two comments urge that Regents of the University of 
California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 
1997), is bad law and should not be followed by the USPTO because it 
conflicts with binding precedent, such as Vas-Cath v. Mahurkar, 935 
F.2d 1555, 19 USPQ2d 1111 (Fed. Cir. 1991). Response: The final 
Guidelines are based on the Office's current understanding of the law 
and are believed to be fully consistent with binding precedent of the 
U.S. Supreme Court and the U.S. Court of Appeals for the Federal 
Circuit. Eli Lilly is a precedential decision by the Court that has 
exclusive jurisdiction over appeals involving patent law. Accordingly, 
the USPTO must follow Eli Lilly. Furthermore, the USPTO does not view 
Eli Lilly as conflicting with Vas-Cath. Vas-Cath explains that the 
purpose of the written description requirement is to ensure that the 
applicant has conveyed to those of skill in the art that he or she was 
in possession of the claimed invention at the time of filing. Vas-Cath, 
935 F.2d at 1563-64, 19 USPQ2d at 1117. Eli Lilly explains that a 
chemical compound's name does not necessarily convey a written 
description of the named chemical compound, particularly when a genus 
of compounds is claimed. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 
1405. The name, if it does no more than distinguish the claimed genus 
from all others by function, does not satisfy the written description 
requirement because ``it does not define any structural features 
commonly possessed by members of the genus that distinguish them from 
others. One skilled in the art therefore cannot, as one can do with a 
fully described genus, visualize or recognize the identity of the 
members of the genus.'' Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 
Thus, Eli Lilly identified a set of circumstances in which the words of 
the claim did not, without more, adequately convey to others that 
applicants had possession of what they claimed.
    (3) Comment: Several comments urged that the Guidelines do not 
recognize the inconsistency between the original claim doctrine and the 
written description requirement as set out in Fiers and Eli Lilly. On 
the other hand, another comment asserts that there is no strong 
presumption that an originally filed claim constitutes an adequate 
written description of the claimed subject matter. Several comments 
indicate that in haec verba support should be sufficient to comply with 
the written description requirement. Two comments urge that the concept 
of constructive reduction to practice upon filing of an application has 
been ignored. Response: As noted above, the USPTO does not find Fiers 
and Eli Lilly to be in conflict with binding precedent. An original 
claim may provide written description for itself, but it still must be 
an adequate written description which establishes that the inventor was 
in possession of the invention. The ``original claim doctrine'' is 
founded on cases which stand for the proposition that originally filed 
claims are part of the written description of an application as filed, 
and thus subject matter which is present only in originally filed 
claims need not find independent support in the specification. See, 
e.g., In re Koller, 613 F.2d 819, 824, 204 USPQ 702, 706 (CCPA 1980) 
(later added claims of similar scope and wording were adequately 
described by original claims); In re Gardner, 480 F.2d 879, 880, 178 
USPQ 149, 149 (CCPA 1973) (``Under these circumstances, we consider the 
original claim in itself adequate `written description' of the claimed 
invention. It was equally a `written description' * * * whether located 
among the original claims or in the descriptive part of the 
specification.''). However, as noted in the preceding comment, Eli 
Lilly identified a set of circumstances in which the words of the claim 
did not, without more, adequately convey to others that applicants had 
possession of what they claimed. When the name of a novel chemical 
compound does not convey sufficient structural information about the 
compound to identify the compound, merely reciting the name is not 
enough to show that the inventor had possession of the compound at the 
time the name was written. The Guidelines indicate that there is a 
``strong presumption'' that an adequate written description of the 
claimed invention is present when the application is filed, consistent 
with In re Wertheim, 541 F.2d 257, 263, 191 USPQ 90, 97 (CCPA 1976) 
(``we are of the opinion that the PTO has the initial burden of 
presenting evidence or reasons why persons skilled in the art would not 
recognize in the disclosure a description of the invention defined by 
the claims.''). In most cases, the statement that ``an originally filed 
claim is its own written description,'' is borne out because the claim 
language conveys to others of skill in the art that the applicant was 
``in possession'' of what is claimed. The Guidelines emphasize that the 
burden of proof is on the examiner to establish that a description as 
filed is not adequate and require the examiner to introduce sufficient 
evidence or technical reasoning to shift the burden of going forward 
with contrary evidence to the applicant.
    (4) Comment: One comment stated that the Guidelines change the 
substance of the written description requirement to require some level 
of enablement. The comment stated that the Eli Lilly case should not be 
followed because its change in the quality of the description required 
is in conflict with precedent. Another comment suggested that to comply 
with the written description requirement, the description must both (i) 
demonstrate possession of the claimed invention by the applicant; and 
(ii) put the public in possession of the claimed invention. Response: 
As noted in the comment above, the USPTO is bound by the Federal 
Circuit's decision in Eli Lilly. The Guidelines have been revised to 
clarify that an applicant must provide a description of the claimed 
invention which shows that applicant was in possession of the claimed 
invention. The suggestion to emphasize that the written description 
requirement must put the public in possession of the invention has not 
been adopted because it removes much of the distinction between the 
written description requirement and the enablement requirement. 
Although the two concepts are entwined, they are distinct and each is 
evaluated under separate legal criteria. The written description 
requirement, a question of fact, ensures that the inventor conveys to 
others that he or she had possession of the claimed invention; whereas, 
the enablement requirement, a question of law, ensures that the 
inventor conveys to others how to make and use the claimed invention.
    (5) Comment: One comment suggested that the Guidelines should 
provide examples of situations in which the written description 
requirement was met but the enablement requirement was not, and vice 
versa. Another comment stated that examiners often use enablement 
language in making

[[Page 1101]]

written description rejections. Response: The enablement and written 
description requirements are not coextensive and, therefore, situations 
will arise in which one requirement is met but the other is not. 
Federal Circuit case law demonstrates many circumstances where 
enablement or written description issues, but not both, were before the 
Court. These Guidelines are intended to clarify for the examining corps 
the criteria needed to satisfy the written description requirement. For 
examples applying these Guidelines to hypothetical fact situations, see 
the ``Synopsis of Application of Written Description Guidelines'' 
(examiner training materials available on-line at http://www.uspto.gov/web/menu/written.pdf). These examples, as well as the examination form 
paragraphs and instructions on their proper use, provide the 
appropriate language examiners should use in making written description 
rejections.
    (6) Comment: One comment disagreed with the statement in an endnote 
that ``the fact that a great deal more than just a process is necessary 
to render a product invention obvious means that a great deal more than 
just a process is necessary to provide written description for a 
product invention.'' The comment indicated that the statement is overly 
broad and inconsistent with the ``strong presumption that an adequate 
written description of the claimed invention is present when the 
application is filed.'' As an extreme case, for example, for product-
by-process claims, nothing else would be needed to provide the written 
description of the product. Response: The endnote has been clarified 
and is now more narrowly drawn. However, there is no per se rule that 
disclosure of a process is sufficient to adequately describe the 
products produced by the process. In fact, Fiers v. Revel and Eli Lilly 
involved special circumstances where the disclosure of a process of 
making and the function of the product alone did not provide an 
adequate written description for product claims. Even when a product is 
claimed in a product-by-process format, the adequacy of the written 
description of the process to support product claims must be evaluated 
on a case-by-case basis.
    (7) Comment: Several comments urge that actual reduction to 
practice, as a method of satisfying the written description requirement 
by demonstrating possession, has been over-emphasized. Response: The 
Guidelines have been clarified to state that describing an actual 
reduction to practice is one of a number of ways to show possession of 
the invention. Description of an actual reduction to practice offers an 
important ``safe haven'' that applies to all applications and is just 
one of several ways by which an applicant may demonstrate possession of 
the claimed invention. Actual reduction to practice may be crucial in 
the relatively rare instances where the level of knowledge and level of 
skill are such that those of skill in the art cannot describe a 
composition structurally, or specify a process of making a composition 
by naming components and combining steps, in such a way as to 
distinguish the composition with particularity from all others. Thus, 
the emphasis on actual reduction to practice is appropriate in those 
cases where the inventor cannot provide an adequate description of what 
the composition is, and a definition by function is insufficient to 
define a composition ``because it is only an indication of what the 
[composition] does, rather than what it is.'' Eli Lilly, 119 F.3d at 
1568, 43 USPQ at 1406. See also Amgen Inc. v. Chugai Pharmaceutical 
Co., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991).
    (8) Comment: One comment asserts that the citation to Pfaff v. 
Wells Electronics, Inc., 525 U.S. 55, 48 USPQ2d 1641 (1998) is 
inappropriate and should be deleted because Pfaff is concerned with 
Sec. 102(b) on-sale bar, not written description. Another comment 
suggested that the Guidelines should provide an explanation of how the 
``ready for patenting'' concept of Pfaff should be used in determining 
compliance with the written description requirement. Response: The 
Guidelines state the general principle that actual reduction to 
practice is not required to show possession of, or to adequately 
describe, a claimed invention (although, as noted in the previous 
comment, an actual reduction to practice is crucial in relatively rare 
instances). An alternative is to show that the invention described was 
``ready for patenting'' as set out in Pfaff. For example, a description 
of activities that demonstrates the invention was ``ready for 
patenting'' satisfies the written description requirement. As Wertheim 
indicates, ``how the specification accomplishes this is not material.'' 
541 F.2d at 262, 191 USPQ at 96.
    (9) Comment: One comment stated that the written description of a 
claimed DNA should be required to include the complete sequence of the 
DNA and claims should be limited to the DNA sequence disclosed. 
Response: Describing the complete chemical structure, i.e., the DNA 
sequence, of a claimed DNA is one method of satisfying the written 
description requirement, but it is not the only method. See Eli Lilly, 
119 F.3d at 1566, 43 USPQ2d at 1404 (``An adequate written description 
of a DNA * * * requires a precise definition, such as by structure, 
formula, chemical name, or physical properties.'' (emphasis added, 
internal quote omitted)). Therefore, there is no basis for a per se 
rule requiring disclosure of complete DNA sequences or limiting DNA 
claims to only the sequence disclosed.
    (10) Comment: One comment stated that it is difficult to envision 
how one could provide a description of sufficient identifying 
characteristics of the invention without physical possession of a 
species of the invention, and thus this manner of showing possession 
should be considered as a way to show actual reduction to practice. 
Response: This suggestion has not been adopted. The three ways of 
demonstrating possession as set forth in the Guidelines are merely 
exemplary and are not mutually exclusive. While there are some cases 
where a description of sufficient relevant identifying characteristics 
will evidence an actual reduction to practice, there are other cases 
where it will not. See, e.g., Ralston Purina Co. v. Far-Mar-Co, Inc., 
772 F.2d 1570, 1576, 227 USPQ 177, 180 (Fed. Cir. 1985) (disclosure 
taken with the knowledge of those skilled in the art may be sufficient 
support for claims).
    (11) Comment: One comment stated that the Guidelines should be 
revised to indicate that the test of disclosure of sufficiently 
detailed drawings should be expanded to include structural claiming of 
chemical entities. Response: The suggestion has been adopted.
    (12) Comment: One comment stated that the Guidelines should reflect 
that an inventor is in possession of the invention when the inventor 
demonstrably has at least a complete conception thereof, and that 
factors and attributes which provide proof of written description 
should include evidence typically provided to prove a complete 
conception. Response: The suggestion has not been adopted because the 
conception analysis typically involves documentary evidence in addition 
to the description of the invention in the application as filed. 
However, it is acknowledged that if evidence typically provided to 
prove a complete conception is present in the specification as filed, 
it would be sufficient to show possession. The Federal Circuit has 
stated ``[t]he conception analysis necessarily turns on the inventor's 
ability to describe his invention with particularity. Until he can do 
so, he cannot prove possession

[[Page 1102]]

of the complete mental picture of the invention.'' Burroughs Wellcome 
Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228, 32 USPQ2d 1915, 1919 (Fed. 
Cir. 1994). As further noted by the Federal Circuit, in order to prove 
conception, ``a party must show possession of every feature recited in 
the count, and that every limitation of the count must have been known 
to the inventor at the time of the alleged conception.'' Coleman v. 
Dines, 754 F.2d 353, 359, 224 USPQ 857, 862 (Fed. Cir. 1985).
    (13) Comment: One comment indicated that a ``possession'' test does 
not appear in Title 35 of the U.S. Code and is not clearly stated by 
the Federal Circuit. Therefore, it is recommended that patent examiners 
be directed to use existing judicial precedent to make rejections of 
claims unsupported by a statutory written description requirement. 
Response: While the Federal Circuit has not specifically laid out a 
``possession'' test, the Court has clearly indicated that possession is 
a cornerstone of the written description inquiry. See, e.g., Vas-Cath, 
Inc. v. Mahurkar, 935 F.2d 1555, 1563, 19 USPQ2d 1111, 1116 (Fed. Cir. 
1991); see also Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 
1323, 56 USPQ2d 1481, 1483 (Fed. Cir. 2000) (``[o]ne skilled in the 
art, reading the disclosure, must immediately discern the limitation at 
issue in the claims'') (internal quote omitted). The possession test as 
set forth in the Guidelines is extrapolated from case law in a wide 
variety of technologies and is not intended to be limiting. Any 
rejections made by examiners will be made under 35 U.S.C. 112, para.1, 
with supporting rationale. Final rejections are appealable if applicant 
disagrees and follows the required procedures to appeal.
    (14) Comment: Two comments indicated that if the amino acid 
sequence for a polypeptide whose utility has been identified is 
described, then the question of possession of a class of nucleotides 
encoding that polypeptide can be addressed as a relatively routine 
matter using the understanding of the genetic code, and that the 
endnote addressing this issue should be revised. Response: The 
suggestion of these comments has been incorporated in the Guidelines 
and will be reflected in the training materials. However, based upon In 
re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed. Cir. 1993) and 
In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994), 
this does not mean that applicant was in possession of any particular 
species of the broad genus.
    (15) Comment: One comment disagreed with an endnote which stated 
that a laundry list disclosure of moieties does not constitute a 
written description of every species in a genus. Specifically, the 
comment indicates that if the existence of a functional genus is 
adequately described in the specification, a laundry list of the 
species within that genus must satisfy the written description 
requirement. Response: The suggestion to revise the endnote will not be 
adopted. A lack of adequate written description problem arises if the 
knowledge and level of skill in the art would not permit one skilled in 
the art to immediately envisage the product claimed from the 
disclosure. This was aptly demonstrated in In re Bell and In re Baird 
where possession of a large genus did not put a person of ordinary 
skill in the art in possession of any particular species. See also 
Purdue Pharma, 230 F.3d at 1328, 56 USPQ2d at 1487 (because the 
original specification did not disclose the later claimed concentration 
ratio was a part of the invention, the inventors cannot argue that they 
are merely narrowing a broad invention).
    (16) Comment: One comment suggested that in the majority of cases, 
a single species will support a generic claim, and that the Guidelines 
should emphasize this point. Response: The suggestion has been adopted 
to a limited degree. The Guidelines now indicate that a single species 
may, in some instances, provide an adequate written description of a 
generic claim when the description of the species would evidence to one 
of ordinary skill in the art that the invention includes the genus. 
Note, however, Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829 
(Fed. Cir. 1998), where the species in the parent application was held 
not to provide written description support for the genus in the child 
application.
    (17) Comment: One comment asserted that the Guidelines should focus 
on the compliance of the claims, not the specification, with the 
written description requirement. Response: This suggestion will not be 
adopted. ``The specification shall contain a written description of the 
invention.'' 35 U.S.C. 112. The claims are part of the specification. 
Id., para. 2. If an adequate description is provided, it will suffice 
``whether located among the original claims or in the descriptive part 
of the specification.'' In re Gardner, 480 F.2d 879, 880, 178 USPQ 149 
(CCPA 1973). The entire disclosure, including the specification, 
drawings, and claims, must be considered.
    (18) Comment: One comment asserted that the Guidelines confuse 
``new matter,'' 35 U.S.C. 132, with the written description 
requirement, and that the same standard for written description should 
be applied to both original claims and new or amended claims. Response: 
The Guidelines indicate that for both original and amended claims, the 
inquiry is whether one skilled in the art can reasonably conclude that 
the inventor had possession of the claimed invention at the time the 
application was filed.
    (19) Comment: One comment suggested that the second paragraph of 
the section pertaining to determining what the claim as a whole covers 
should be deleted because it relates more to compliance with Sec. 112, 
second paragraph, than with the written description requirement. 
Response: This suggestion will not be adopted. The claims must be 
construed and all issues as to the scope and meaning of the claim must 
be explored during the inquiry into whether the written description 
requirement has been met. The concept of treating the claim as a whole 
is applicable to all criteria for patentability.
    (20) Comment: One comment suggested a different order for the 
general analysis for determining compliance with the written 
description requirement, starting with reading the claim, then the 
specification, and then determining whether the disclosure demonstrates 
possession by the applicant. Response: This suggestion will not be 
adopted. The claims must be construed as broadly as reasonable in light 
of the specification and the knowledge in the art. See In re Morris, 
127 F.3d 1048, 1054, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997). Then the 
disclosure must be evaluated to determine whether it adequately 
describes the claimed invention, i.e., whether it conveys to a person 
having ordinary skill in the art that the applicant had possession of 
what he or she now claims.
    (21) Comment: Several comments suggested that the Guidelines are 
unclear with regard to how the examiner should treat the transitional 
phrase ``consisting essentially of.'' The comments also suggested that 
the endnote that explains ``consisting essentially of'' does not make 
clear how the use of this intermediate transitional language affects 
the scope of the claim. Several comments stated that the USPTO does not 
have legal authority to treat claims reciting this language as open 
(equivalent to ``comprising''). Another comment suggested that the 
phrase ``clear indication in the specification'' be replaced with 
``explicit or implicit indication.'' Response: The transitional phrase 
``consisting essentially of'' ``excludes

[[Page 1103]]

ingredients that would `materially affect the basic and novel 
characteristics' of the claimed composition.'' Atlas Powder Co. v. E.I. 
DuPont de Nemours & Co., 750 F.2d 1569, 1574, 224 USPQ 409, 412 (Fed. 
Cir. 1984). The basic and novel characteristics of the claimed 
invention are limited by the balance of the claim. In re Janakirama-
Rao, 317 F.2d 951, 954, 137 USPQ 893, 896 (CCPA 1963). However, during 
prosecution claims must be read broadly, consistent with the 
specification. In re Morris, 127 F.3d 1048, 1054, 44 USPQ2d 1023, 1027 
(Fed. Cir. 1997). Thus, for purposes of searching for and applying 
prior art in a rejection under 35 U.S.C. 102 or 103, if the 
specification or the claims do not define the ``basic and novel'' 
properties of the claimed subject matter (or if such properties are in 
dispute), the broadest reasonable interpretation consistent with the 
specification is that the basic and novel characteristics are merely 
the presence of the recited limitations. See, e.g., Janakirama-Rao, 317 
F.2d at 954, 137 USPQ at 895-96. This does not indicate that the 
intermediate transitional language is never given weight. Applicants 
may amend the claims to avoid the rejections or seek to establish that 
the specification provides definitions of terms in the claims that 
define the basic and novel characteristics of the claimed invention 
which distinguish the claimed invention from the prior art. When an 
applicant contends that additional steps or materials in the prior art 
are excluded by the recitation of `consisting essentially of,' 
applicant has the burden of showing that the introduction of additional 
steps or components would materially change the characteristics of 
applicant's invention. In re De Lajarte, 337 F.2d 870, 143 USPQ 256 
(CCPA 1964). The language used in the Guidelines is consistent with PPG 
Industries Inc. v. Guardian Industries Corp., 156 F.3d 1351, 1355, 48 
USPQ2d 1351, 1355 (Fed. Cir. 1998) (``PPG could have defined the scope 
of the phrase `consisting essentially of' for purposes of its patent by 
making clear in its specification what it regarded as constituting a 
material change in the basic and novel characteristics.'').
    (22) Comment: One comment stated that the written description 
should ``disclose the invention,'' including why the invention works 
and how it was developed. Response: This suggestion has not been 
adopted. An inventor does not need to know how or why the invention 
works in order to obtain a patent. Newman v. Quigg, 877 F.2d 1575, 
1581, 11 USPQ2d 1340, 1345 (Fed. Cir. 1989). To satisfy the enablement 
requirement of 35 U.S.C. 112, para.1, an application must disclose the 
claimed invention in sufficient detail to enable a person of ordinary 
skill in the art to make and use the claimed invention. To satisfy the 
written description requirement of 35 U.S.C. 112, para. 1, the 
description must show that the applicant was in possession of the 
claimed invention at the time of filing. There is no statutory basis to 
require disclosure of why an invention works or how it was developed. 
``Patentability shall not be negatived by the manner in which the 
invention was made.'' 35 U.S.C. 103(a).
    (23) Comment: One comment recommended that the phrases ``emerging 
and unpredictable technologies'' and ``unpredictable art'' be replaced 
with the phrase--inventions characterized by factors which are not 
reasonably predictable in terms of the ordinary skill in the art--. 
Response: The suggestion is adopted in part and the recommended phrase 
has been added as an alternative.
    (24) Comment: One comment recommended that the phrase 
``conventional in the art'' be replaced with--part of the knowledge of 
one of ordinary skill in the art--. Response: The suggestion is adopted 
in part and the recommended phrase has been added as an alternative. 
The standard of ``conventional in the art'' is supported by case law 
holding that a patent specification ``need not teach, and preferably 
omits, what is well known in the art.'' See Spectra-Physics, Inc. v. 
Coherent, Inc., 827 F.2d 1524, 1534, 3 USPQ2d 1737, 1743 (Fed. Cir. 
1987); Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 
1384, 231 USPQ 81, 94 (Fed. Cir. 1986). See also Atmel Corp. v. 
Information Storage Devices, Inc., 198 F.3d 1374, 1382, 53 USPQ2d 1225, 
1231 (Fed. Cir. 1999).
    (25) Comment: One comment recommended that the Guidelines be 
amended to state that the appropriate skill level for determining 
possession of the claimed invention is that of a person of ordinary 
skill in the art. Response: The comment has not been adopted. The 
statutory language itself indicates that compliance with the 
requirements of 35 U.S.C. 112, para.1, is judged from the standard of 
``any person skilled in the art.'' It is noted, however, that the 
phrases ``one of skill in the art'' and ``one of ordinary skill in the 
art'' appear to be synonymous. See, e.g., Union Oil Co. v. Atlantic 
Richfield Co., 208 F.3d 989, 997, 54 USPQ2d 1227, 1232 (Fed. Cir. 2000) 
(``The written description requirement does not require the applicant 
`to describe exactly the subject matter claimed, [instead] the 
description must clearly allow persons of ordinary skill in the art to 
recognize that [he or she] invented what is claimed.' Thus, Sec. 112, 
para. 1, ensures that, as of the filing date, the inventor conveyed 
with reasonable clarity to those of skill in the art that he was in 
possession of the subject matter of the claims.'' (citations omitted, 
emphasis added)).
    (26) Comment: One comment stated that an endnote misstates the 
relevant law in stating that, to show inherent written descriptive 
support for a claim limitation, the inherent disclosure must be such as 
would be recognized by a person of ordinary skill in the art. The 
comment recommended that the endnote be amended to delete the reference 
to recognition by persons of ordinary skill and to cite Pingree v. 
Hull, 518 F.2d 624, 186 USPQ 248 (CCPA 1975), rather than In re 
Robertson, 169 F.3d 743, 49 USPQ2d 1949 (Fed. Cir. 1999). Response: The 
comment has not been adopted. Federal Circuit precedent makes clear 
that an inherent disclosure must be recognized by those of ordinary 
skill in the art. See, e.g., Hyatt v. Boone, 146 F.3d 1348, 1354-55, 47 
USPQ2d 1128, 1132 (Fed. Cir. 1998) (``[T]he purpose of the description 
requirement is `to ensure that the inventor had possession, as of the 
filing date of the application relied on, of the specific subject 
matter later claimed by him.' * * * Thus, the written description must 
include all of the limitations of the interference count, or the 
applicant must show that any absent text is necessarily comprehended in 
the description provided and would have been so understood at the time 
the patent application was filed.'' (emphasis added)). See also Reiffin 
v. Microsoft Corp., 214 F.3d 1342, 1346, 54 USPQ2d 1915, 1917 (Fed. 
Cir. 2000) (The ``application considered as a whole must convey to one 
of ordinary skill in the art, either explicitly or inherently, that 
[the inventor] invented the subject matter claimed * * *. See * * * 
Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268, 20 USPQ2d 
1746, 1749 (Fed. Cir. 1991) (descriptive matter may be inherently 
present in a specification if one skilled in the art would necessarily 
recognize such a disclosure)'').
    (27) Comment: Several comments pointed out an inconsistency in the 
Federal Register Notice re: the Revised Interim Written Description 
Guidelines. The inconsistency concerned the treatment of claims 
directed to an isolated DNA comprising SEQ ID NO:1 wherein SEQ ID NO:1 
is an expressed sequence tag. The comments contrasted paragraphs 34 and 
35 of the Response to

[[Page 1104]]

Public Comments with the statement in the text of the Guidelines that a 
genus must be supported by a representative number of species (as 
analyzed in Example 7 of the training materials). Response: The USPTO 
acknowledges that there was an inconsistency. The Office notes that a 
claim reciting a nucleic acid comprising SEQ ID NO:1 may be subject to 
a rejection for lack of an adequate written description where 
particular identifiable species within the scope of the claim lack an 
adequate written description. The training materials as amended 
exemplify an appropriate analysis.
    (28) Comment: One comment stated that the USPTO should respond to 
the issue of whether the U.S. is meeting its TRIPs obligations. This 
comment noted that the USPTO did not address an earlier comment 
regarding the ``Interim Guidelines for the Examination of Patent 
Applications under the 35 U.S.C. 112, para. 1, `Written Description' 
Requirement,'' 63 FR 32,639, June 15, 1998, which questioned whether 
the written description requirement is truly different from the 
enablement requirement, and indicated that such a requirement may be 
contrary to the TRIPs provisions of the World Trade Organization 
(Article 27.1). Article 27.1 requires WTO Members to, inter alia, make 
patents available, with limited exceptions, for products and processes 
in all fields of technology so long as those products and processes are 
new, involve an inventive step, and are capable of industrial 
application. The comment further suggested a response. Response: TRIPs 
Article 27 does not address what must be included in a patent 
application to allow WTO Member officials to determine whether 
particular inventions meet the standards for patentability established 
in that Article. TRIPs Article 29, which is more relevant to this 
comment, states that Members ``shall require'' patent applicants to 
disclose their invention ``in a manner sufficiently clear and complete 
for the invention to be carried out by a person skilled in the art.'' 
If the written description is not clear and complete, the applicant may 
not have been in possession of the invention. This may support both 
written description and enablement standards. In addition, Article 29 
expressly authorizes Members to require patent applicants to disclose 
the best method the inventor knows at the time of filing an application 
for carrying out the invention.
    (29) Comment: Two comments commended the USPTO for eliminating the 
Biotechnology Specific Examples in the Revised Interim Written 
Description Guidelines and providing separate training materials. One 
comment indicated a need to reconfirm the examples set forth in the 
Interim Written Description Guidelines published in 1998. Response: The 
current training materials reflect the manner in which the USPTO 
interprets the Written Description Guidelines.
    (30) Comment: Several comments addressed specific concerns about 
the examiner training materials. Response: The comments received with 
respect to the training materials will be taken under advisement as the 
Office revises the training materials in view of the revisions to the 
Guidelines. The specific comments will not be addressed herein as they 
do not impact the language of the Guidelines.

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

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

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

    The first paragraph of 35 U.S.C. 112 requires that the 
``specification shall contain a written description of the invention * 
* *.'' This requirement is separate and distinct from the enablement 
requirement.\1\ The written description requirement has several policy 
objectives. ``[T]he `essential goal' of the description of the 
invention requirement is to clearly convey the information that an 
applicant has invented the subject matter which is claimed.'' \2\ 
Another objective is to put the public in possession of what the 
applicant claims as the invention.\3\ The written description 
requirement of the Patent Act promotes the progress of the useful arts 
by ensuring that patentees adequately describe their inventions in 
their patent specifications in exchange for the right to exclude others 
from practicing the invention for the duration of the patent's term.
    To satisfy the written description requirement, a patent 
specification must describe the claimed invention in sufficient detail 
that one skilled in the art can reasonably conclude that the inventor 
had possession of the claimed invention.\4\ An applicant shows 
possession of the claimed invention by describing the claimed invention 
with all of its limitations using such descriptive means as words, 
structures, figures, diagrams, and formulas that fully set forth the 
claimed invention.\5\ Possession may be shown in a variety of ways 
including description of an actual reduction to practice,\6\ or by 
showing that the invention was ``ready for patenting'' such as by the 
disclosure of drawings or structural chemical formulas that show that 
the invention was complete,\7\ or by describing distinguishing 
identifying characteristics sufficient to show that the applicant was 
in possession of the claimed invention.\8\ A question as to whether a 
specification provides an adequate written description may arise in the 
context of an original claim which is not described sufficiently, a new 
or amended claim wherein a claim limitation has been added or removed, 
or a claim to entitlement of an earlier priority date or effective 
filing date under 35 U.S.C. 119, 120, or 365(c).\9\ Compliance with the 
written description requirement is a question of

[[Page 1105]]

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

A. Original Claims

    There is a strong presumption that an adequate written description 
of the claimed invention is present when the application is filed.\11\ 
However, the issue of a lack of adequate written description may arise 
even for an original claim when an aspect of the claimed invention has 
not been described with sufficient particularity such that one skilled 
in the art would recognize that the applicant had possession of the 
claimed invention.\12\ The claimed invention as a whole may not be 
adequately described if the claims require an essential or critical 
feature which is not adequately described in the specification and 
which is not conventional in the art or known to one of ordinary skill 
in the art.\13\ This problem may arise where an invention is described 
solely in terms of a method of its making coupled with its function and 
there is no described or art-recognized correlation or relationship 
between the structure of the invention and its function.\14\ A lack of 
adequate written description issue also arises if the knowledge and 
level of skill in the art would not permit one skilled in the art to 
immediately envisage the product claimed from the disclosed 
process.\15\

B. New or Amended Claims

    The proscription against the introduction of new matter in a patent 
application \16\ serves to prevent an applicant from adding information 
that goes beyond the subject matter originally filed.\17\ Thus, the 
written description requirement prevents an applicant from claiming 
subject matter that was not adequately described in the specification 
as filed. New or amended claims which introduce elements or limitations 
which are not supported by the as-filed disclosure violate the written 
description requirement.\18\ While there is no in haec verba 
requirement, newly added claim limitations must be supported in the 
specification through express, implicit, or inherent disclosure. An 
amendment to correct an obvious error does not constitute new matter 
where one skilled in the art would not only recognize the existence of 
the error in the specification, but also recognize the appropriate 
correction.\19\ Deposits made after the application filing date cannot 
be relied upon to support additions to or correction of information in 
the application as filed.\20\
    Under certain circumstances, omission of a limitation can raise an 
issue regarding whether the inventor had possession of a broader, more 
generic invention.\21\ A claim that omits an element which applicant 
describes as an essential or critical feature of the invention 
originally disclosed does not comply with the written description 
requirement.\22\
    The fundamental factual inquiry is whether the specification 
conveys with reasonable clarity to those skilled in the art that, as of 
the filing date sought, applicant was in possession of the invention as 
now claimed.\23\

II. Methodology for Determining Adequacy of Written Description

A. Read and Analyze the Specification for Compliance With 35 U.S.C. 
112, 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;\24\ however, with 
respect to newly added or amended claims, applicant should show support 
in the original disclosure for the new or amended claims.\25\ 
Consequently, rejection of an original claim for lack of written 
description should be rare. The inquiry into whether the description 
requirement is met is a question of fact that must be determined on a 
case-by-case basis.\26\
1. For Each Claim, Determine What the Claim as a Whole Covers
    Claim construction is an essential part of the examination process. 
Each claim must be separately analyzed and given its broadest 
reasonable interpretation in light of and consistent with the written 
description.\27\ The entire claim must be considered, including the 
preamble language \28\ and the transitional phrase.\29\ The claim as a 
whole, including all limitations found in the preamble,\30\ the 
transitional phrase, and the body of the claim, must be sufficiently 
supported to satisfy the written description requirement.\31\
    The examiner should evaluate each claim to determine if sufficient 
structures, acts, or functions are recited to make clear the scope and 
meaning of the claim, including the weight to be given the 
preamble.\32\ The absence of definitions or details for 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 How Applicant Provides 
Support for the Claimed Invention Including Each Element and/or Step
    Prior to determining whether the disclosure satisfies the written 
description requirement for the claimed subject matter, the examiner 
should review the claims and the entire specification, including the 
specific embodiments, figures, and sequence listings, to understand how 
applicant provides support for the various features of the claimed 
invention.\33\ The analysis of whether the specification complies with 
the written description requirement calls for the examiner to compare 
the scope of the claim with the scope of the description to determine 
whether applicant has demonstrated possession of the claimed invention. 
Such a review is conducted from the standpoint of one of skill in the 
art at the time the application was filed \34\ and should include a 
determination of the field of the invention and the level of skill and 
knowledge in the art. Generally, there is an inverse correlation 
between the level of skill and knowledge in the art and the specificity 
of disclosure necessary to satisfy the written description requirement. 
Information which is well known in the art need not be described in 
detail in the specification.\35\
3. Determine Whether There is Sufficient Written Description to Inform 
a Skilled Artisan That Applicant was in Possession of the Claimed 
Invention as a Whole at the Time the Application Was Filed
    a. Original claims. Possession may be shown in many ways. For 
example, possession may be shown, inter alia, by describing an actual 
reduction to practice of the claimed invention. Possession may also be 
shown by a clear depiction of the invention in detailed drawings or in 
structural chemical formulas which permit a person skilled in the art 
to clearly recognize that applicant had possession of the claimed 
invention. An adequate written description of the invention may be 
shown by any description of sufficient, relevant, identifying 
characteristics so long as a person skilled in the art would recognize 
that the inventor had possession of the claimed invention.\36\
    A specification may describe an actual reduction to practice by 
showing

[[Page 1106]]

that the inventor constructed an embodiment or performed a process that 
met all the limitations of the claim and determined that the invention 
would work for its intended purpose.\37\ Description of an actual 
reduction to practice of a biological material may be shown by 
specifically describing a deposit made in accordance with the 
requirements of 37 CFR 1.801 et seq.\38\
    An applicant may show possession of an invention by disclosure of 
drawings \39\ or structural chemical formulas\40\ that are sufficiently 
detailed to show that applicant was in possession of the claimed 
invention as a whole. The description need only describe in detail that 
which is new or not conventional.\41\ This is equally true whether the 
claimed invention is directed to a product or a process.
    An applicant may also show that an invention is complete by 
disclosure of sufficiently detailed, relevant identifying 
characteristics \42\ which provide evidence that applicant was in 
possession of the claimed invention,\43\ i.e., complete or partial 
structure, other physical and/or chemical properties, functional 
characteristics when coupled with a known or disclosed correlation 
between function and structure, or some combination of such 
characteristics.\44\ What is conventional or well known to one of 
ordinary skill in the art need not be disclosed in detail.\45\ If a 
skilled artisan would have understood the inventor to be in possession 
of the claimed invention at the time of filing, even if every nuance of 
the claims is not explicitly described in the specification, then the 
adequate description requirement is met.\46\
    (1) For each claim drawn to a single embodiment or species: \47\
    (a) Determine whether the application describes an actual reduction 
to practice of the claimed invention.
    (b) If the application does not describe an actual reduction to 
practice, determine whether the invention is complete as evidenced by a 
reduction to drawings or structural chemical formulas that are 
sufficiently detailed to show that applicant was in possession of the 
claimed invention as a whole.
    (c) If the application does not describe an actual reduction to 
practice or reduction to drawings or structural chemical formula as 
discussed above, determine whether the invention has been set forth in 
terms of distinguishing identifying characteristics as evidenced by 
other descriptions of the invention that are sufficiently detailed to 
show that applicant was in possession of the claimed invention.
    (i) Determine whether the application as filed describes the 
complete structure (or acts of a process) of the claimed invention as a 
whole. The complete structure of a species or embodiment typically 
satisfies the requirement that the description be set forth ``in such 
full, clear, concise, and exact terms'' to show possession of the 
claimed invention.\48\ If a complete structure is disclosed, the 
written description requirement is satisfied for that species or 
embodiment, and a rejection under 35 U.S.C. 112, para. 1, for lack of 
written description must not be made.
    (ii) If the application as filed does not disclose the complete 
structure (or acts of a process) of the claimed invention as a whole, 
determine whether the specification discloses other relevant 
identifying characteristics sufficient to describe the claimed 
invention in such full, clear, concise, and exact terms that a skilled 
artisan would recognize applicant was in possession of the claimed 
invention.\49\
    Whether the specification shows that applicant was in possession of 
the claimed invention is not a single, simple determination, but rather 
is a factual determination reached by considering a number of factors. 
Factors to be considered in determining whether there is sufficient 
evidence of possession include the level of skill and knowledge in the 
art, partial structure, physical and/or chemical properties, functional 
characteristics alone or coupled with a known or disclosed correlation 
between structure and function, and the method of making the claimed 
invention. Disclosure of any combination of such identifying 
characteristics that distinguish the claimed invention from other 
materials and would lead one of skill in the art to the conclusion that 
the applicant was in possession of the claimed species is 
sufficient.\50\ Patents and printed publications in the art should be 
relied upon to determine whether an art is mature and what the level of 
knowledge and skill is in the art. In most technologies which are 
mature, and wherein the knowledge and level of skill in the art is 
high, a written description question should not be raised for original 
claims even if the specification discloses only a method of making the 
invention and the function of the invention.\51\ In contrast, for 
inventions in emerging and unpredictable technologies, or for 
inventions characterized by factors not reasonably predictable which 
are known to one of ordinary skill in the art, more evidence is 
required to show possession. For example, disclosure of only a method 
of making the invention and the function may not be sufficient to 
support a product claim other than a product-by-process claim.\52\ 
Furthermore, disclosure of a partial structure without additional 
characterization of the product may not be sufficient to evidence 
possession of the claimed invention.\53\
    Any claim to a species that does not meet the test described under 
at least one of (a), (b), or (c) must be rejected as lacking adequate 
written description under 35 U.S.C. 112, 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 to practice (see (1)(a), above), reduction 
to drawings (see (1)(b), above), or by disclosure of relevant, 
identifying characteristics, i.e., structure or other physical and/or 
chemical properties, by functional characteristics coupled with a known 
or disclosed correlation between function and structure, or by a 
combination of such identifying characteristics, sufficient to show the 
applicant was in possession of the claimed genus (see (1)(c), 
above).\54\
    A ``representative number of species'' means that the species which 
are adequately described are representative of the entire genus. Thus, 
when there is substantial variation within the genus, one must describe 
a sufficient variety of species to reflect the variation within the 
genus. On the other hand, there may be situations where one species 
adequately supports a genus.\55\ What constitutes a ``representative 
number'' is an inverse function of the skill and knowledge in the art. 
Satisfactory disclosure of a ``representative number'' depends on 
whether one of skill in the art would recognize that the applicant was 
in possession of the necessary common attributes or features of the 
elements possessed by the members of the genus in view of the species 
disclosed. For inventions in an unpredictable art, adequate written 
description of a genus which embraces widely variant species cannot be 
achieved by disclosing only one species within the genus.\56\ 
Description of a representative number of species does not require the 
description to be of such specificity that it would provide individual 
support for each species that the genus embraces.\57\ If a 
representative number of adequately described species are not disclosed 
for a genus, the claim to that genus must be rejected as lacking 
adequate written description under 35 U.S.C. 112, 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. 
119, 120, or

[[Page 1107]]

365(c). The examiner has the initial burden of presenting evidence or 
reasoning to explain why persons skilled in the art would not recognize 
in the original disclosure a description of the invention defined by 
the claims.\58\ However, when filing an amendment an applicant should 
show support in the original disclosure for new or amended claims.\59\ 
To comply with the written description requirement of 35 U.S.C. 112, 
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,\60\ implicitly,\61\ or inherently \62\ supported in the 
originally filed disclosure.\63\ Furthermore, each claim must include 
all elements which applicant has described as essential.\64\
    If the originally filed disclosure does not provide support for 
each claim limitation, or if an element which applicant describes as 
essential or critical is not claimed, a new or amended claim must be 
rejected under 35 U.S.C. 112, 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.\65\ The examiner, therefore, 
must have a reasonable basis to challenge the adequacy of the written 
description. The examiner has the initial burden of presenting by a 
preponderance of evidence why a person skilled in the art would not 
recognize in an applicant's disclosure a description of the invention 
defined by the claims.\66\ In rejecting a claim, the examiner must set 
forth express findings of fact regarding the above analysis which 
support the lack of written description conclusion. These findings 
should:
    (1) Identify the claim limitation at issue; and
    (2) Establish a prima facie case by providing reasons why a person 
skilled in the art at the time the application was filed would not have 
recognized that the inventor was in possession of the invention as 
claimed in view of the disclosure of the application as filed. A 
general allegation of ``unpredictability in the art'' is not a 
sufficient reason to support a rejection for lack of adequate written 
description.
    When appropriate, suggest amendments to the claims which can be 
supported by the application's written description, being mindful of 
the prohibition against the addition of new matter in the claims or 
description.\67\

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

    Upon reply by applicant, before repeating any rejection under 35 
U.S.C. 112, 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 the 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. When a rejection is maintained, any affidavits relevant to the 
112, para. 1, written description requirement,\68\ must be thoroughly 
analyzed and discussed in the next Office action.

    Dated: December 29, 2000.
Q. Todd Dickinson,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.

Endnotes

    \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. 132. The ``written description'' question similarly 
arises in the interference context, where the issue is whether the 
specification of one party to the interference can support the newly 
added claims corresponding to the count at issue, i.e., whether that 
party can ``make the claim'' corresponding to the interference 
count. See, e.g., Martin v. Mayer, 823 F.2d 500, 503, 3 USPQ2d 1333, 
1335 (Fed. Cir. 1987).
    In addition, early opinions suggest the Patent and Trademark 
Office was unwilling to find written descriptive support when the 
only description was found in the claims; however, this viewpoint 
was rejected. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 
1980) (original claims constitute their own description); accord In 
re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); accord In re 
Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (accord). It is now 
well accepted that a satisfactory description may be in the claims 
or any other portion of the originally filed specification. These 
early opinions did not address the quality or specificity of 
particularity that was required in the description, i.e., how much 
description is enough.
    \5\ Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 
USPQ2d 1961, 1966 (Fed. Cir. 1997).
    \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. See also Deposit of 
Biological Materials for Patent Purposes, Final Rule, 54 FR 34,864 
(August 22, 1989) (``The requirement for a specific identification 
is consistent with the description requirement of the first 
paragraph of 35 U.S.C. 112, and to provide an antecedent basis for 
the biological material which either has been or will be deposited 
before the patent is granted.'' Id. at 34,876. ``The description 
must be sufficient to permit verification that the deposited 
biological material is in fact that disclosed. Once the

[[Page 1108]]

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, 68, 119 S.Ct. 
304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 
43 USPQ2d at 1406.
    \8\ See Amgen, Inc. v. Chugai Pharmaceutical, 927 F.2d 1200, 
1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a 
compound by ``whatever characteristics sufficiently distinguish 
it'').
    \9\ 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 1971)).
    \10\ Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 
1116 (Fed. Cir. 1991).
    \11\ In re Wertheim, 541 F.2d 257, 263, 191 USPQ 90, 97 (CCPA 
1976) (``we are of the opinion that the PTO has the initial burden 
of presenting evidence or reasons why persons skilled in the art 
would not recognize in the disclosure a description of the invention 
defined by the claims'').
    \12\ See endnote 4.
    \13\ 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.
    \14\ 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.
    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.'').
    \15\ See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 
USPQ2d 1895, 1905 (Fed. Cir. 1996) (a ``laundry list'' disclosure of 
every possible moiety does not constitute a written description of 
every species in a genus because it would not ``reasonably lead'' 
those skilled in the art to any particular species); In re Ruschig, 
379 F.2d 990, 995, 154 USPQ 118, 123 (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.'') (emphasis in original); Purdue Pharma L.P. v. 
Faulding Inc., 230 F.3d 1320, 1328, 56 USPQ2d 1481, 1487 (Fed. Cir. 
2000) (``the specification does not clearly disclose to the skilled 
artisan that the inventors * * * considered the [] ratio to be part 
of their invention * * *. There is therefore no force to Purdue's 
argument that the written description requirement was satisfied 
because the disclosure revealed a broad invention from which the 
[later-filed] claims carved out a patentable portion'').
    16 35 U.S.C. Secs. 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., Rev. 1, Feb. 2000) for a more detailed discussion of the 
written description requirement and its relationship to new matter.
    17 The claims as filed in the original specification 
are part of the disclosure and, therefore, if an application as 
originally filed contains a claim disclosing material not found in 
the remainder of the specification, the applicant may amend the 
specification to include the claimed subject matter. In re Benno, 
768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
    18 See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 
795 (CCPA 1971) (subgenus range was not supported by generic 
disclosure and specific example within the subgenus range); In re 
Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a 
subgenus is not necessarily described by a genus encompassing it and 
a species upon which it reads).
    19 In re Oda, 443 F.2d 1200, 170 USPQ 260 (CCPA 
1971). With respect to the correction of sequencing errors in 
applications disclosing nucleic acid and/or amino acid sequences, it 
is well known that sequencing errors are a common problem in 
molecular biology. See, e.g., Peter Richterich, Estimation of Errors 
in `Raw' DNA Sequences: A Validation Study, 8 Genome Research 251-59 
(1998). If an application as filed includes sequence information and 
references a deposit of the sequenced material made in accordance 
with the requirements of 37 CFR Sec. 1.801 et seq., amendment may be 
permissible.
    20 Corrections of minor errors in the sequence may be 
possible based on the argument that one of skill in the art would 
have resequenced the deposited material and would have immediately 
recognized the minor error. Deposits made after the filing date can 
only be relied upon to provide support for the correction of 
sequence information if applicant submits a statement in compliance 
with 37 CFR Sec. 1.804 stating that the biological material which is 
deposited is a biological material specifically defined in the 
application as filed.
    21 See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 
134 F.3d 1473, 45 USPQ2d 1498 (Fed. Cir. 1998) (claims to a 
sectional sofa comprising, inter alia, a console and a control means 
were held invalid for failing to satisfy the written description 
requirement where the claims were broadened by removing the location 
of the control means.); Johnson Worldwide Associates v. Zebco Corp., 
175 F.3d 985, 993, 50 USPQ2d 1607, 1613 (Fed. Cir. 1999) (In Gentry 
Gallery, the ``court's determination that the patent disclosure did 
not support a broad meaning for the disputed claim terms was 
premised on clear statements in the written description that 
described the location of a claim element--the `control means'--as 
`the only possible location' and that variations were `outside the 
stated purpose of the invention.' Gentry Gallery, 134 F.3d at 1479, 
45 USPQ2d at 1503. Gentry Gallery, then, considers the situation 
where the patent's disclosure makes crystal clear that a particular 
(i.e., narrow) understanding of a claim term is an `essential 
element of [the inventor's] invention.' ''); Tronzo v. Biomet, 156 
F.3d at 1158-59, 47 USPQ2d at 1833 (Fed. Cir. 1998) (claims to 
generic cup shape were not entitled to filing date of parent 
application which disclosed ``conical cup'' in view of the 
disclosure of the

[[Page 1109]]

parent application stating the advantages and importance of the 
conical shape.).
    22 See Gentry Gallery, 134 F.3d at 1480, 45 USPQ2d at 
1503; In re Sus, 306 F.2d 494, 504, 134 USPQ 301, 309 (CCPA 1962) 
(``[O]ne skilled in this art would not be taught by the written 
description of the invention in the specification that any `aryl or 
substituted aryl radical' would be suitable for the purposes of the 
invention but rather that only certain aryl radicals and certain 
specifically substituted aryl radicals [i.e., aryl azides] would be 
suitable for such purposes.'') (emphasis in original). A claim which 
omits matter disclosed to be essential to the invention as described 
in the specification or in other statements of record may also be 
subject to rejection under 35 U.S.C. 112, 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 MPEP Sec. 2172.01.
    23 See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 
USPQ2d at 1117.
    24 Wertheim, 541 F.2d at 262, 191 USPQ at 96.
    25 See MPEP 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.'').
    26 See In re Smith, 458 F.2d 1389, 1395, 173 USPQ 
679, 683 (CCPA 1972) (``Precisely how close [to the claimed 
invention] the description must come to comply with 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).
    27 See, e.g., In re Morris, 127 F.3d 1048, 1053-54, 
44 USPQ2d 1023, 1027 (Fed. Cir. 1997).
    28 ``Preamble language'' is that language in a claim 
appearing before the transitional phase, e.g., before 
``comprising,'' ``consisting essentially of,'' or ``consisting of.''
    29 The transitional term ``comprising'' (and other 
comparable terms, e.g., ``containing,'' ``including,'' and 
``having'') is ``open-ended--it covers the expressly recited subject 
matter, alone or in combination with unrecited subject matter. See, 
e.g., Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 
1608, 1613 (Fed. Cir. 1997) (`` `Comprising' is a term of art used 
in claim language which means that the named elements are essential, 
but other elements may be added and still form a construct within 
the scope of the claim.''); Ex parte Davis, 80 USPQ 448, 450 (Bd. 
App. 1948) (``comprising'' leaves the ``claim open for the inclusion 
of unspecified ingredients even in major amounts''). ``By using the 
term `consisting essentially of,' the drafter signals that the 
invention necessarily includes the listed ingredients and is open to 
unlisted ingredients that do not materially affect the basic and 
novel properties of the invention. A `consisting essentially of' 
claim occupies a middle ground between closed claims that are 
written in a `consisting of' format and fully open claims that are 
drafted in a `comprising' format.'' PPG Industries v. Guardian 
Industries, 156 F.3d 1351, 1354, 48 USPQ2d 1351, 1353-54 (Fed. Cir. 
1998). For the purposes of searching for and applying prior art 
under 35 U.S.C. 102 and 103, absent a clear indication in the 
specification or claims of what the basic and novel characteristics 
actually are, `consisting essentially of' will be construed as 
equivalent to ``comprising.'' See, e.g., PPG, 156 F.3d at 1355, 48 
USPQ2d at 1355 (``PPG could have defined the scope of the phrase 
``consisting essentially of'' for purposes of its patent by making 
clear in its specification what it regarded as constituting a 
material change in the basic and novel characteristics of the 
invention.''). See also In re Janakirama-Rao, 317 F.2d 951, 954, 137 
USPQ 893, 895-96 (CCPA 1963). If an applicant contends that 
additional steps or materials in the prior art are excluded by the 
recitation of ``consisting essentially of,'' applicant has the 
burden of showing that the introduction of additional steps or 
components would materially change the characteristics of 
applicant's invention. In re De Lajarte, 337 F.2d 870, 143 USPQ 256 
(CCPA 1964).
    30 See Pac-Tec Inc. v. Amerace Corp., 903 F.2d 796, 
801, 14 USPQ2d 1871, 1876 (Fed. Cir. 1990) (determining that 
preamble language that constitutes a structural limitation is 
actually part of the claimed invention).
    31 An applicant shows possession of the claimed 
invention by describing the claimed invention with all of its 
limitations. Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
    32 See, e.g., Bell Communications Research, Inc. v. 
Vitalink Communications Corp., 55 F.3d 615, 620, 34 USPQ2d 1816, 
1820 (Fed. Cir. 1995) (``[A] claim preamble has the import that the 
claim as a whole suggests for it.''); Corning Glass Works v. 
Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257, 9 USPQ2d 1962, 
1966 (Fed. Cir. 1989) (The determination of whether preamble 
recitations are structural limitations can be resolved only on 
review of the entirety of the application ``to gain an understanding 
of what the inventors actually invented and intended to encompass by 
the claim.'').
    33 An element may be critical where those of skill in 
the art would require it to determine that applicant was in 
possession of the invention. Compare Rasmussen, 650 F.2d at 1215, 
211 USPQ at 327 (``one skilled in the art who read Rasmussen's 
specification would understand that it is unimportant how the layers 
are adhered, so long as they are adhered'') (emphasis in original), 
with Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 
1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (``it is well 
established in our law that conception of a chemical compound 
requires that the inventor be able to define it so as to distinguish 
it from other materials, and to describe how to obtain it'').
    34 See, e.g., Wang Labs. v. Toshiba Corp., 993 F.2d 
858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993).
    35 See, e.g., Hybritech, Inc. v. Monoclonal 
Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 
1986).
    36 See, e.g., Purdue Pharma L.P. v. Faulding Inc., 
230 F.3d 1320, ___, 56 USPQ2d 1481, 1483 (Fed. Cir. 2000) (the 
written description ``inquiry is a factual one and must be assessed 
on a case-by-case basis''); see also Pfaff v. Wells Electronics, 
Inc., 55 U.S. at 66, 119 S.Ct. at 311, 48 USPQ2d at 1646 (``The word 
`invention' must refer to a concept that is complete, rather than 
merely one that is `substantially complete.' It is true that 
reduction to practice ordinarily provides the best evidence that an 
invention is complete. But just because reduction to practice is 
sufficient evidence of completion, it does not follow that proof of 
reduction to practice is necessary in every case. Indeed, both the 
facts of the Telephone Cases and the facts of this case demonstrate 
that one can prove that an invention is complete and ready for 
patenting before it has actually been reduced to practice.'').
    37 Cooper v. Goldfarb, 154 F.3d 1321, 1327, 47 USPQ2d 
1896, 1901 (Fed. Cir. 1998). See also UMC Elecs. Co. v. United 
States, 816 F.2d 647, 652, 2 USPQ2d 1465, 1468 (Fed. Cir. 1987) 
(``[T]here cannot be a reduction to practice of the invention * * * 
without a physical embodiment which includes all limitations of the 
claim.''); Estee Lauder Inc. v. L'Oreal, S.A., 129 F.3d 588, 593, 44 
USPQ2d 1610, 1614 (Fed. Cir. 1997) (``[A] reduction to practice does 
not occur until the inventor has determined that the invention will 
work for its intended purpose.''); Mahurkar v. C.R. Bard, Inc., 79 
F.3d 1572, 1578, 38 USPQ2d 1288, 1291 (Fed. Cir. 1996) (determining 
that the invention will work for its intended purpose may require 
testing depending on the character of the invention and the problem 
it solves).
    38 37 CFR 1.804, 1.809. See also endnote 6.
    39 See, e.g., Vas-Cath, 935 F.2d at 1565, 19 USPQ2d 
at 1118 (``drawings alone may provide a `written description' of an 
invention as required by 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) (``In 
those instances where a visual representation can flesh out words, 
drawings may be used in the same manner and with the same 
limitations as the specification.'').
    40 See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d 
at 1406 (``In claims involving chemical materials, generic formulae 
usually indicate with specificity what the generic claims encompass. 
One skilled in the art can distinguish such a formula from others 
and can identify many of the species that the claims encompass. 
Accordingly, such a formula is normally an adequate description of 
the claimed genus.'').

[[Page 1110]]

    41 See Hybritech v. Monoclonal Antibodies, 802 F.2d 
at 1384, 231 USPQ at 94; Fonar Corp. v. General Electric Co., 107 
F.3d at 1549, 41 USPQ2d at 1805 (source code description not 
required).
    42 For example, the presence of a restriction enzyme 
map of a gene may be relevant to a statement that the gene has been 
isolated. One skilled in the art may be able to determine when the 
gene disclosed is the same as or different from a gene isolated by 
another by comparing the restriction enzyme map. In contrast, 
evidence that the gene could be digested with a nuclease would not 
normally represent a relevant characteristic since any gene would be 
digested with a nuclease. Similarly, isolation of an mRNA and its 
expression to produce the protein of interest is strong evidence of 
possession of an mRNA for the protein.
    For some biomolecules, examples of identifying characteristics 
include a sequence, structure, binding affinity, binding 
specificity, molecular weight, and length. Although structural 
formulas provide a convenient method of demonstrating possession of 
specific molecules, other identifying characteristics or 
combinations of characteristics may demonstrate the requisite 
possession. For example, unique cleavage by particular enzymes, 
isoelectric points of fragments, detailed restriction enzyme maps, a 
comparison of enzymatic activities, or antibody cross-reactivity may 
be sufficient to show possession of the claimed invention to one of 
skill in the art. See Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966 
(``written description'' requirement may be satisfied by using 
``such descriptive means as words, structures, figures, diagrams, 
formulas, etc., that fully set forth the claimed invention'').
    43 A definition by function alone ``does not 
suffice'' to sufficiently describe a coding sequence ``because it is 
only an indication of what the gene does, rather than what it is.'' 
Eli Lilly, 119 F.3 at 1568, 43 USPQ2d at 1406. See also Fiers, 984 
F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen Inc. v. 
Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 
1991)).
    44 If a claim limitation invokes 35 U.S.C. 112, 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). In considering whether there is 35 U.S.C. 112, para. 1, 
support for a means- (or step) plus-function claim limitation, the 
examiner must consider not only the original disclosure contained in 
the summary and detailed description of the invention portions of 
the specification, but also the original claims, abstract, and 
drawings. A means- (or step-) plus-function claim limitation is 
adequately described under 35 U.S.C. 112, para. 1, if: (1) The 
written description adequately links or associates adequately 
described particular structure, material, or acts to the function 
recited in a means- (or step-) 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, material, or 
acts perform the function recited in a means- (or step-) plus-
function limitation. Note also: A rejection under 35 U.S.C. 112, 
para. 2, ``cannot stand where there is adequate description in the 
specification to satisfy 35 U.S.C. 112, first paragraph, regarding 
means-plus-function recitations that are not, per se, challenged for 
being unclear.'' In re Noll, 545 F.2d 141, 149, 191 USPQ 721, 727 
(CCPA 1976). See Supplemental Examination Guidelines for Determining 
the Applicability of 35 U.S.C. 112, para. 6, 65 FR 38510, June 21, 
2000.
    45 See Hybritech Inc. v. Monoclonal Antibodies, Inc., 
802 F.2d at 1384, 231 USPQ at 94.
    46 See, e.g., Vas-Cath, 935 F.2d at 1563, 19 USPQ2d 
at 1116; Martin v. Johnson, 454 F.2d 746, 751, 172 USPQ 391, 395 
(CCPA 1972) (stating ``the description need not be in ipsis verbis 
[i.e., ``in the same words''] to be sufficient'').
    47 A claim which is limited to a single disclosed 
embodiment or species is analyzed as a claim drawn to a single 
embodiment or species, whereas a claim which encompasses two or more 
embodiments or species within the scope of the claim is analyzed as 
a claim drawn to a genus. See also MPEP Sec. 806.04(e).
    48 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).
    49 For example, if the art has established a strong 
correlation between structure and function, one skilled in the art 
would be able to predict with a reasonable degree of confidence the 
structure of the claimed invention from a recitation of its 
function. Thus, the written description requirement may be satisfied 
through disclosure of function and minimal structure when there is a 
well-established correlation between structure and function. In 
contrast, without such a correlation, the capability to recognize or 
understand the structure from the mere recitation of function and 
minimal structure is highly unlikely. In this latter case, 
disclosure of function alone is little more than a wish for 
possession; it does not satisfy the written description requirement. 
See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written 
description requirement not satisfied by merely providing ``a result 
that one might achieve if one made that invention''); In re Wilder, 
736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) 
(affirming a rejection for lack of written description because the 
specification does ``little more than outline goals appellants hope 
the claimed invention achieves and the problems the invention will 
hopefully ameliorate''). Compare Fonar, 107 F.3d at 1549, 41 USPQ2d 
at 1805 (disclosure of software function adequate in that art).
    50 See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 
1406.
    51 See, e.g., In re Hayes Microcomputer Products, 
Inc. Patent Litigation, 982 F.2d 1527, 1534-35, 25 USPQ2d 1241, 1246 
(Fed. Cir. 1992) (``One skilled in the art would know how to program 
a microprocessor to perform the necessary steps described in the 
specification. Thus, an inventor is not required to describe every 
detail of his invention. An applicant's disclosure obligation varies 
according to the art to which the invention pertains. Disclosing a 
microprocessor capable of performing certain functions is sufficient 
to satisfy the requirement of section 112, first paragraph, when one 
skilled in the relevant art would understand what is intended and 
know how to carry it out.'')
    52 See, e.g., Fiers v. Revel, 984 F.2d at 1169, 25 
USPQ2d at 1605; Amgen., 927 F.2d at 1206, 18 USPQ2d at1021. Where 
the process has actually been used to produce the product, the 
written description requirement for a product-by-process claim is 
clearly satisfied; however, the requirement may not be satisfied 
where it is not clear that the acts set forth in the specification 
can be performed, or that the product is produced by that process.
    53 See, e.g., Amgen, 927 F.2d at1206, 18 USPQ2d at 
1021 (``A gene is a chemical compound, albeit a complex one, and it 
is well established in our law that conception of a chemical 
compound requires that the inventor be able to define it so as to 
distinguish it from other materials, and to describe how to obtain 
it. Conception does not occur unless one has a mental picture of the 
structure of the chemical, or is able to define it by its method of 
preparation, its physical or chemical properties, or whatever 
characteristics sufficiently distinguish it. It is not sufficient to 
define it solely by its principal biological property, e.g., 
encoding human erythropoietin, because an alleged conception having 
no more specificity than that is simply a wish to know the identity 
of any material with that biological property. We hold that when an 
inventor is unable to envision the detailed constitution of a gene 
so as to distinguish it from other materials, as well as a method 
for obtaining it, conception has not been achieved until reduction 
to practice has occurred, i.e., until after the gene has been 
isolated.'') (citations omitted). In such instances the alleged 
conception fails not merely because the field is unpredictable or 
because of the general uncertainty surrounding experimental 
sciences, but because the conception is incomplete due to factual 
uncertainty that undermines the specificity of the inventor's idea 
of the invention. Burroughs Wellcome Co. v. Barr Laboratories Inc., 
40 F.3d 1223, 1229, 32 USPQ2d 1915, 1920 (Fed. Cir. 1994). Reduction 
to practice in effect provides the only evidence to corroborate 
conception (and therefore possession) of the invention. Id.
    54 See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 
1406.
    55 See, e.g., Rasmussen, 650 F.2d at 1214, 211 USPQ 
at 326-27 (disclosure of a single method of adheringly applying one 
layer to another was sufficient to support a generic claim to 
``adheringly applying'' because one skilled in the art reading the 
specification would understand that it is unimportant how the layers 
are adhered, so long as they are adhered); In re Herschler, 591 F.2d 
693, 697, 200 USPQ 711, 714 (CCPA 1979) (disclosure of 
corticosteriod in DMSO sufficient to support claims drawn to a 
method of using a mixture of a ``physiologically active steroid'' 
and DMSO because ``use of known chemical compounds in a manner 
auxiliary

[[Page 1111]]

to the invention must have a corresponding written description only 
so specific as to lead one having ordinary skill in the art to that 
class of compounds. Occasionally, a functional recitation of those 
known compounds in the specification may be sufficient as that 
description.''); In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 
285 (CCPA 1973) (the phrase ``air or other gas which is inert to the 
liquid'' was sufficient to support a claim to ``inert fluid media'' 
because the description of the properties and functions of the air 
or other gas segmentizing medium would suggest to a person skilled 
in the art that appellant's invention includes the use of ``inert 
fluid'' broadly.). However, in Tronzo v. Biomet, 156 F.3d at 1159, 
47 USPQ2d at1833 (Fed. Cir. 1998), the disclosure of a species in 
the parent application did not suffice to provide written 
description support for the genus in the child application.
    56 See, e.g., Eli Lilly.
    57 For example, in the molecular biology arts, if an 
applicant disclosed an amino acid sequence, it would be unnecessary 
to provide an explicit disclosure of nucleic acid sequences that 
encoded the amino acid sequence. Since the genetic code is widely 
known, a disclosure of an amino acid sequence would provide 
sufficient information such that one would accept that an applicant 
was in possession of the full genus of nucleic acids encoding a 
given amino acid sequence, but not necessarily any particular 
species. Cf. In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 
(Fed. Cir. 1993) and In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 
1552 (Fed. Cir. 1994).
    58 See Wertheim, 541 F.2d at 263, 191 USPQ at 97 
(``[T]he PTO has the initial burden of presenting evidence or 
reasons why persons skilled in the art would not recognize in the 
disclosure a description of the invention defined by the claims.'').
    59 See MPEP Secs. 714.02 and 2163.06 (``Applicant 
should * * * specifically point out the support for any amendments 
made to the disclosure.'').
    60 See, e.g., In re Wright, 866 F.2d 422, 425, 9 
USPQ2d 1649, 1651 (Fed. Cir. 1989) (Original specification for 
method of forming images using photosensitive microcapsules which 
describes removal of microcapsules from surface and warns that 
capsules not be disturbed prior to formation of image, unequivocally 
teaches absence of permanently fixed microcapsules and supports 
amended language of claims requiring that microcapsules be ``not 
permanently fixed'' to underlying surface, and therefore meets 
description requirement of 35 U.S.C. 112.).
    61 See, e.g., In re Robins, 429 F.2d 452, 456-57, 166 
USPQ 552, 555 (CCPA 1970) (``[W]here no explicit description of a 
generic invention is to be found in the specification * * * mention 
of representative compounds may provide an implicit description upon 
which to base generic claim language.''); In re Smith, 458 F.2d 
1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not 
necessarily implicitly described by a genus encompassing it and a 
species upon which it reads).
    62 See, e.g., In re Robertson, 169 F.3d 743, 745, 49 
USPQ2d 1949, 1950-51 (Fed. Cir. 1999) (``To establish inherency, the 
extrinsic evidence ``must make clear that the missing descriptive 
matter is necessarily present in the thing described in the 
reference, and that it would be so recognized by persons of ordinary 
skill. Inherency, however, may not be established by probabilities 
or possibilities. The mere fact that a certain thing may result from 
a given set of circumstances is not sufficient.'''') (citations 
omitted).
    63 When an explicit limitation in a claim ``is not 
present in the written description whose benefit is sought it must 
be shown that a person of ordinary skill would have understood, at 
the time the patent application was filed, that the description 
requires that limitation.'' Hyatt v. Boone, 146 F.3d 1348, 1353, 47 
USPQ2d 1128, 1131 (Fed. Cir. 1998).
    64 See, e.g., Johnson Worldwide Associates Inc. v. 
Zebco Corp., 175 F.3d at 993, 50 USPQ2d at 1613; Gentry Gallery, 
Inc. v. Berkline Corp., 134 F.3d at 1479, 45 USPQ2d at 1503; Tronzo 
v. Biomet, 156 F.3d at 1159, 47 USPQ2d at 1833.
    65 See, e.g., In re Marzocchi, 439 F.2d 220, 224, 169 
USPQ 367, 370 (CCPA 1971).
    66 Wertheim, 541 F.2d at 263, 191 USPQ at 97.
    67 See Rasmussen, 650 F.2d at 1214, 211 USPQ at 326.
    68 See In re Alton, 76 F.3d 1168, 1176, 37 USPQ2d 
1578, 1584 (Fed. Cir. 1996).

[FR Doc. 01-323 Filed 1-4-01; 8:45 am]
BILLING CODE 3510-16-U