# MPEP § 2163: Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph, “Written Description” Requirement

> Federal · Agency guidance · In force

URL: https://www.frixlaw.com/law-library/statutes/MPEP_S2163

## Section

- **Citation:** MPEP § 2163
- **Heading:** Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph, “Written Description” Requirement
- **Jurisdiction:** Federal
- **Kind:** Agency guidance
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** USPTO MPEP / Chapter 2100 - Patentability / MPEP § 2163

## Text

The following Guidelines establish the policies and procedures to be
followed by Office personnel in the evaluation of any patent application for compliance
with the written description requirement of
35 U.S.C. 112
. These 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, as well as the U.S. Court of
Appeals for the Federal Circuit and its predecessor courts.
The Guidelines do not constitute substantive rulemaking and hence do not
have the force and effect of law. They are 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 that 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 that
includes a rejection for lack of written description.
I.
GENERAL PRINCIPLES GOVERNING COMPLIANCE WITH THE “WRITTEN DESCRIPTION”
REQUIREMENT FOR APPLICATIONS
35 U.S.C.
112(a)
and the first paragraph of
pre-AIA 35 U.S.C.
112
require that the “specification shall contain a written
description of the invention ....” This requirement is separate and distinct from the
enablement requirement.
Ariad Pharm., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (
en banc
);
Vas-Cath, Inc. v. Mahurkar,
935 F.2d 1555, 1560, 19 USPQ2d 1111,
1114 (Fed. Cir. 1991); see also
Univ. of Rochester v. G.D. Searle &
Co.,
358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir
the invention ....” This requirement is separate and distinct from the
enablement requirement.
Ariad Pharm., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (
en banc
);
Vas-Cath, Inc. v. Mahurkar,
935 F.2d 1555, 1560, 19 USPQ2d 1111,
1114 (Fed. Cir. 1991); see also
Univ. of Rochester v. G.D. Searle &
Co.,
358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004)
(discussing the history and purpose of the written description requirement);
In
re Curtis,
354 F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)
(“conclusive evidence of a claim’s enablement is not equally conclusive of that claim’s
satisfactory written description”). 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 [inventor] has
invented the subject matter which is claimed.”
In re Barker,
559 F.2d
588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the
public what the applicant claims as the invention. See
Regents of the Univ. of
Cal. v. Eli Lilly,
119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir.
1997),
cert. denied,
523 U.S. 1089 (1998). “The ‘written description’
requirement implements the principle that a patent must describe the technology that is
sought to be patented; the requirement serves both to satisfy the inventor’s obligation
to disclose the technologic knowledge upon which the patent is based, and to demonstrate
that the patentee [inventor] was in possession of the invention that is claimed.”
Capon v. Eshhar,
418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed.
Cir. 2005). Further, the written description requirement 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
he invention that is claimed.”
Capon v. Eshhar,
418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed.
Cir. 2005). Further, the written description requirement 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. See,
e.g.,
Moba, B.V. v. Diamond Automation, Inc.,
325 F.3d 1306, 1319, 66
USPQ2d 1429, 1438 (Fed. Cir. 2003);
Vas-Cath, Inc. v. Mahurkar,
935
F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure
the lack of a written description.
Enzo Biochem, Inc. v. Gen-Probe,
Inc.,
323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For
example, it is now well accepted that a satisfactory description may be found in
originally-filed claims or any other portion of the originally-filed specification. See
In re Koller,
613 F.2d 819, 204 USPQ 702 (CCPA 1980);
In
re Gardner,
475 F.2d 1389, 177 USPQ 396 (CCPA 1973);
In re
Wertheim,
541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not
mean that all originally-filed claims have adequate written support. The specification
must still be examined to assess whether an originally-filed claim has adequate support
in the written disclosure and/or the drawings.
An applicant shows that the inventor was in 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.
Lockwood v. Amer. Airlines, Inc.,
107
F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997)
tten disclosure and/or the drawings.
An applicant shows that the inventor was in 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.
Lockwood v. Amer. Airlines, Inc.,
107
F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a
variety of ways including description of an actual reduction to practice, 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, or by describing
distinguishing identifying characteristics sufficient to show that the inventor was in
possession of the claimed invention. See, e.g.,
Pfaff v. Wells Elecs.,
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;
Amgen,
Inc. v. Chugai Pharm.,
927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir.
1991) (one must define a compound by “whatever characteristics sufficiently distinguish
it”). “Compliance with the written description requirement is essentially a fact-based
inquiry that will ‘necessarily vary depending on the nature of the invention claimed.’”
Enzo Biochem,
323 F.3d at 963, 63 USPQ2d at 1612. An application
specification may show actual reduction to practice by describing testing of the claimed
invention or, in the case of certain biological materials, by specifically describing a
deposit made in accordance with
37 CFR 1.801
et seq.
See
Enzo Biochem,
323 F.3d at 965, 63
USPQ2d at 1614 (“reference in the specification to a deposit may also satisfy the
written description requirement with respect to a claimed material”); see also Deposit
of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 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
65, 63
USPQ2d at 1614 (“reference in the specification to a deposit may also satisfy the
written description requirement with respect to a claimed material”); see also Deposit
of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 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 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 Fed. Reg. 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.”).
A question as to whether a specification provides an adequate written
description may arise in the context of determining whether an original claim is
described sufficiently (see, e.g.,
LizardTech, Inc. v. Earth Resource Mapping,
Inc.,
424 F.3d 1336, 1345, 76 USPQ2d 1724, 1733 (Fed. Cir. 2005);
Enzo Biochem,
323 F.3d at 968, 63 USPQ2d at 1616 (Fed. Cir. 2002);
Eli Lilly,
119 F.3d 1559, 43 USPQ2d 1398)), 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
, e.g.,
LizardTech, Inc. v. Earth Resource Mapping,
Inc.,
424 F.3d 1336, 1345, 76 USPQ2d 1724, 1733 (Fed. Cir. 2005);
Enzo Biochem,
323 F.3d at 968, 63 USPQ2d at 1616 (Fed. Cir. 2002);
Eli Lilly,
119 F.3d 1559, 43 USPQ2d 1398)), 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 or priority to an
earlier filing date under
35 U.S.C. 119
,
120
,
365
, or
386
(see, e.g.,
New
Railhead Mfg. L.L.C. v. Vermeer Mfg. Co.,
298 F.3d 1290, 63 USPQ2d 1843
(Fed. Cir. 2002);
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.,
Martin v.
Mayer,
823 F.2d 500, 503, 3 USPQ2d 1333, 1335 (Fed. Cir. 1987);
Fields v. Conover,
443 F.2d 1386, 170 USPQ 276 (CCPA 1971)).
Compliance with the written description requirement is a question of fact which must be
resolved on a case-by-case basis.
Vas-Cath, Inc. v. Mahurkar,
935
F.2d at 1563, 19 USPQ2d at 1116 (Fed. Cir. 1991).
A.
Original Claims
There is a presumption that an adequate written description of the
claimed invention is present when the application is filed.
In re
Wertheim,
541 F.2d 257, 263, 191 USPQ 90, 97 (CCPA 1976) (“[W]e 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.”)
presumption that an adequate written description of the
claimed invention is present when the application is filed.
In re
Wertheim,
541 F.2d 257, 263, 191 USPQ 90, 97 (CCPA 1976) (“[W]e 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.”). However, as discussed in subsection I,
supra,
issues of adequate written description may arise even
for original claims, for example, 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 inventor had possession of the claimed invention at the time of
filing. 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 or known in the art. Consider the
claim “A gene comprising SEQ ID NO:1.” The claim may be construed to include specific
structures in addition to SEQ ID NO:1, such as a promoter, a coding region, or other
elements. Although SEQ ID NO:1 is fully disclosed, there may be insufficient
description of other structures embraced by the claim (e.g., promoters, enhancers,
coding regions, and other regulatory elements). For guidance on subject matter
eligibility of such claims, see
MPEP § 2106
.
An invention described solely in terms of a method of making and/or
its function may lack written descriptive support where there is no described or
art-recognized correlation between the disclosed function and the structure(s)
responsible for the function. For example, the amino acid sequence of a protein along
with knowledge of the genetic code might put an inventor in possession of the genus
of nucleic acids capable of encoding the protein, but the same information would not
place the inventor in possession of the naturally-occurring DNA or mRNA encoding the
protein
between the disclosed function and the structure(s)
responsible for the function. For example, the amino acid sequence of a protein along
with knowledge of the genetic code might put an inventor in possession of the genus
of nucleic acids capable of encoding the protein, but the same information would not
place the inventor in possession of the naturally-occurring DNA or mRNA encoding the
protein. See
In re Bell,
991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir.
1993);
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
). (For guidance on subject matter eligibility of claims to
naturally-occurring compositions, see
MPEP § 2106
.) The Federal Circuit
has pointed out that, under United States law, a description that merely renders a
claimed invention obvious may not sufficiently describe the invention for the
purposes of the written description requirement of
35 U.S.C. 112
.
See
Eli Lilly,
119 F.3d at 1567, 43 USPQ2d at 1405; compare
Fonar Corp. v. Gen. Elec. 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.”).
Written description issues may also arise if the knowledge and level
of skill in the art would not have permitted the ordinary artisan to immediately
envisage the claimed product arising from the disclosed process. See, e.g.,
Fujikawa v. Wattanasin,
93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed.
Cir
source code listings are not a requirement for adequately disclosing the functions of
software.”).
Written description issues may also arise if the knowledge and level
of skill in the art would not have permitted the ordinary artisan to immediately
envisage the claimed product arising from the disclosed process. 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 necessarily
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) (“[T]he 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”).
B.
New or Amended Claims
The proscription against the introduction of new matter in a patent
application (
35
U.S.C. 132
and
251
) serves to prevent an
applicant from adding information that goes beyond the subject matter originally
filed
en description requirement was
satisfied because the disclosure revealed a broad invention from which the
[later-filed] claims carved out a patentable portion”).
B.
New or Amended Claims
The proscription against the introduction of new matter in a patent
application (
35
U.S.C. 132
and
251
) serves to prevent an
applicant from adding information that goes beyond the subject matter originally
filed. See
In re Rasmussen,
650 F.2d 1212, 1214, 211 USPQ 323, 326
(CCPA 1981); see also
MPEP §§ 2163.06
through
2163.07
for a more
detailed discussion of the written description requirement and its relationship to
new matter. 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). 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 that are not supported by the as-filed disclosure
violate the written description requirement. 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)
(an adequate description of a genus may not support claims to a subgenus or species
within the genus).
While there is no
in haec verba
requirement,
newly added claims or 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 the ordinary artisan would not only
recognize the existence of the error in the specification, but also recognize the
appropriate correction
enus).
While there is no
in haec verba
requirement,
newly added claims or 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 the ordinary artisan would not only
recognize the existence of the error in the specification, but also recognize the
appropriate correction.
In re Oda,
443 F.2d 1200, 170 USPQ 268
(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., David Laehnemann
et al.,
Denoising DNA deep sequencing data—high-throughput
sequencing errors and their correction, 17
Briefings in
Bioinformatics
154–1791 (2016); Peter Richterich, Estimation of Errors
in ‘Raw’ DNA Sequences: A Validation Study, 8
Genome Research
251-59 (1998). For example, if an application as filed includes incorrect nucleic
acid sequence information and references a deposit of the sequenced material made in
accordance with the requirements of
37 CFR 1.801
et seq.,
an amendment to correct the nucleic acid sequence may be
permissible where the amendment conforms the sequence information to the compound
described in the specification and covered by the claims. See
Cubist Pharm.,
Inc. v. Hospira, Inc.,
805 F.3d 1112, 1118, 117 USPQ2d 1054, 1059 (Fed.
Cir. 2015)(“The fact that the inventors were mistaken as to one aspect of the
structure of daptomycin at the time the application [ ] was filed does not render the
specification inadequate to satisfy the written description requirement. It was
enough that the specification disclosed relevant identifying characteristics that
distinguished daptomycin from other compounds and thus showed that the inventors had
possession of daptomycin, even though they may not have had an accurate picture of
the entire chemical structure of that compound.”
Id
oes not render the
specification inadequate to satisfy the written description requirement. It was
enough that the specification disclosed relevant identifying characteristics that
distinguished daptomycin from other compounds and thus showed that the inventors had
possession of daptomycin, even though they may not have had an accurate picture of
the entire chemical structure of that compound.”
Id.
at 1120, 117
USPQ2d at 1060.) Deposits made after the filing date may be relied upon to provide
support for the correction of sequence information only if applicant submits a
statement in compliance with
37 CFR 1.804
stating that the
biological material which is deposited is the biological material specifically
defined in the application as filed.
Under certain circumstances, omission of a limitation can raise an
issue regarding whether the inventor had possession of a broader, more generic
invention. See, e.g.,
PIN/NIP, Inc. v. Platte Chem. Co.,
304 F.3d
1235, 1248, 64 USPQ2d 1344, 1353 (Fed. Cir. 2002) (Claim for a method of inhibiting
sprout growth on tubers by treating them with spaced,
sequential
application of two chemicals was held invalid for lack of adequate written
description where the specification indicated that invention was a method of applying
a
"composition"
containing the two chemicals.);
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 Assoc. v. Zebco Corp.,
175
F.3d 985, 993, 50 USPQ2d 1607, 1613 (Fed. Cir
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 Assoc. v. Zebco Corp.,
175
F.3d 985, 993, 50 USPQ2d 1607, 1613 (Fed. Cir. 1999) (stating that, 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,
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.’”); see also
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 parent application stating
the advantages and importance of the conical shape.). A claim that omits an element
that applicant describes as an essential or critical feature of the invention
originally disclosed does not comply with the written description requirement. 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))
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(a)
or
pre-AIA 35 U.S.C. 112
, first
paragraph, as not enabling, or under
35 U.S.C. 112(b)
or
pre-AIA
35 U.S.C. 112
, second paragraph. See
In re
Mayhew,
527 F.2d 1229, 188 USPQ 356 (CCPA 1976);
In re
Venezia,
530 F.2d 956, 189 USPQ 149 (CCPA 1976); and
In re
Collier,
397 F.2d 1003, 158 USPQ 266 (CCPA 1968). See also
MPEP
§ 2172.01
.
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, the inventor was in possession of the invention as now claimed. See, e.g.,
Vas-Cath, Inc.,
935 F.2d at 1563-64, 19 USPQ2d at 1117.
II.
METHODOLOGY FOR DETERMINING ADEQUACY OF WRITTEN DESCRIPTION
A.
Read and Analyze the Specification for Compliance with 35 U.S.C. 112(a)
or Pre-AIA 35 U.S.C. 112, first paragraph
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(a)
or
pre-AIA 35 U.S.C. 112
, first
paragraph
1117.
II.
METHODOLOGY FOR DETERMINING ADEQUACY OF WRITTEN DESCRIPTION
A.
Read and Analyze the Specification for Compliance with 35 U.S.C. 112(a)
or Pre-AIA 35 U.S.C. 112, first paragraph
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(a)
or
pre-AIA 35 U.S.C. 112
, first
paragraph. There is a presumption that an adequate written description of the claimed
invention is present in the specification as filed,
Wertheim,
541
F.2d at 262, 191 USPQ at 96, thus 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 the written
description of the invention as providing adequate support for the claimed invention.
To make a
prima facie
case, it is necessary to identify the claim
limitations that are not adequately supported, and explain why the claim is not fully
supported by the disclosure. For example, in
Hyatt v. Dudas,
492
F.3d 1365, 1371, 83 USPQ2d 1373, 1376-1377 (Fed. Cir. 2007), the examiner made a
prima facie
case by clearly and specifically explaining why
applicant’s specification did not support the particular claimed combination of
elements, even though applicant’s specification listed each and every element in the
claimed combination. The court found the “examiner was explicit that while each
element may be individually described in the specification, the deficiency was lack
of adequate description of their combination” and, thus, “[t]he burden was then
properly shifted to [inventor] to cite to the examiner where adequate written
description could be found or to make an amendment to address the deficiency.”
Id.;
see also
Stored Value Solutions, Inc. v. Card
Activation Techs.,
499 Fed.App’x 5, 13-14 (Fed. Cir
ally described in the specification, the deficiency was lack
of adequate description of their combination” and, thus, “[t]he burden was then
properly shifted to [inventor] to cite to the examiner where adequate written
description could be found or to make an amendment to address the deficiency.”
Id.;
see also
Stored Value Solutions, Inc. v. Card
Activation Techs.,
499 Fed.App’x 5, 13-14 (Fed. Cir. 2012)
(non-precedential) (Finding inadequate written support for claims drawn to a method
of processing debit purchase transactions requiring three separate authorization
codes because “the written description [did] not contain a method that include[d] all
three codes” and “[e]ach authorization code is an important claim limitation, and the
presence of multiple authorization codes in [the claim] was essential”.).
With respect to newly added or amended claims,
applicant should show support in the original disclosure for the new or amended
claims. See, e.g.,
Hyatt v. Dudas,
492 F.3d 1365, 1370, n.4, 83
USPQ2d 1373, 1376, n.4 (Fed. Cir. 2007) (citing
MPEP § 2163.04
which provides that a “simple statement such as ‘applicant has not pointed out where
the new (or amended) claim is supported, nor does there appear to be a written
description of the claim limitation ‘___’ in the application as filed’ may be
sufficient where the claim is a new or amended claim, the support for the limitation
is not apparent, and applicant has not pointed out where the limitation is
supported.”); see also
MPEP §§ 714.02
and
2163.06
(“Applicant should ..
d out where
the new (or amended) claim is supported, nor does there appear to be a written
description of the claim limitation ‘___’ in the application as filed’ may be
sufficient where the claim is a new or amended claim, the support for the limitation
is not apparent, and applicant has not pointed out where the limitation is
supported.”); see also
MPEP §§ 714.02
and
2163.06
(“Applicant should ...
specifically point out the support for any amendments made to the disclosure.”); and
MPEP §
2163.04
(“If applicant amends the claims and points out
where and/or how the originally filed disclosure supports the amendment(s), and the
examiner finds that the disclosure does not reasonably convey that the inventor had
possession of the subject matter of the amendment at the time of the filing of the
application, the examiner has the initial burden of presenting evidence or reasoning
to explain why persons skilled in the art would not recognize in the disclosure a
description of the invention defined by the claims.”). The inquiry into whether the
description requirement is met is a question of fact that must be determined on a
case-by-case basis.
AbbVie Deutschland GmbH & Co., KG v. Janssen
Biotech, Inc.,
759 F.3d 1285, 1297, 111 USPQ2d 1780, 1788 (Fed. Cir.
2014) ("Whether a patent claim is supported by an adequate written description is a
question of fact.");
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).
1.
For Each Claim, Determine What the Claim as a Whole Covers
Claim construction is an essential part of the examination
process
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).
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. See, e.g.,
In re Katz Interactive Call Processing Patent Litigation,
639 F.3d 1303, 1319-1320, 97 USPQ2d 1737, 1750 (Fed. Cir. 2011) (stating that
“[t]he construction of the claims [is] important to the written description
analysis” and patent holder’s failure “to point to a genuine factual dispute over
whether the specification disclosed” the claimed subject matter made summary
judgment proper on that issue.);
In re Morris,
127 F.3d 1048,
1053-54, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997). The entire claim must be
considered, including the preamble language and the transitional phrase. “Preamble
language” is that language in a claim appearing before the transitional phase,
e.g., before “comprising,” “consisting essentially of,” or “consisting of.” The
transitional term “comprising” (and other comparable terms, e.g., “containing,”
and “including”) is “open-ended” in that 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”); see also
MPEP § 2111.03
613 (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”); see also
MPEP § 2111.03
. “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 Indus. v. Guardian Indus.,
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
AK Steel Corp. v. Sollac,
344 F3.d 1234, 1239-1240, 68
USPQ2d 1280, 1283-84 (Fed. Cir. 2003);
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 the claimed invention
283-84 (Fed. Cir. 2003);
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 the claimed invention.
In re De Lajarte,
337
F.2d 870, 143 USPQ 256 (CCPA 1964); see also
MPEP § 2111.03
.
The claim as a whole, including all limitations found in the preamble (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)), the
transitional phrase, and the body of the claim, must be sufficiently supported to
satisfy the written description requirement. An applicant shows that the inventor
was in 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.
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. 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.”). 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(a)
or
pre-AIA 35
U.S.C
ation 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.”). 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(a)
or
pre-AIA 35
U.S.C. 112
, first paragraph, 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 provides adequate
written description 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. The disclosure of an element may be
critical where those of ordinary skill in the art would require it to understand
that inventor 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 Pharm.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”). 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
that the inventor was in possession of the claimed invention
entor be able to
define it so as to distinguish it from other materials, and to describe how to
obtain it”). 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
that the inventor was in possession of the claimed invention. Such a review is
conducted from the standpoint of one of ordinary skill in the art at the time the
application was filed (see, e.g.,
Wang Labs., Inc. v. Toshiba
Corp.,
993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and
should include a determination of the field of the invention and the level of
skill and knowledge in the art. For some arts, 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. See, e.g.,
Hybritech, Inc. v. Monoclonal Antibodies,
Inc.,
802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986).
However, sufficient information must be provided to show that the inventor had
possession of the invention as claimed.
3.
Determine Whether There is Sufficient Written Description to Inform a
Skilled Artisan That Inventor was in Possession of the Claimed Invention as a
Whole at the Time the Application Was Filed
Monoclonal Antibodies,
Inc.,
802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986).
However, sufficient information must be provided to show that the inventor had
possession of the invention as claimed.
3.
Determine Whether There is Sufficient Written Description to Inform a
Skilled Artisan That Inventor 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 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 inventor 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. See, e.g.,
Purdue Pharma L.P. v.
Faulding Inc.,
230 F.3d 1320, 1323, 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 Elec.,
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.”)
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.”).
A specification may describe an actual reduction to practice
by showing that the inventor constructed an embodiment or performed a process
that met all the limitations of the claim and determined that the invention
would work for its intended purpose.
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). 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.,
especially
37 CFR 1.804
and
1.809
; see also subsection I.
supra.
An applicant may show that the inventor was in possession of
an invention by disclosure of drawings or structural chemical formulas that are
sufficiently detailed to show that the inventor was in possession of the
claimed invention as a whole
ally describing a deposit made in accordance with the requirements of
37 CFR
1.801
et seq.,
especially
37 CFR 1.804
and
1.809
; see also subsection I.
supra.
An applicant may show that the inventor was in possession of
an invention by disclosure of drawings or structural chemical formulas that are
sufficiently detailed to show that the inventor was in possession of the
claimed invention as a whole. 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 Am. 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.”);
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.”). The description need only
describe in detail that which is new or not conventional. See
Hybritech v. Monoclonal Antibodies,
802 F.2d at 1384, 231
USPQ at 94. This is equally true whether the claimed invention is directed to a
product or a process
and can identify many of the
species that the claims encompass. Accordingly, such a formula is normally an
adequate description of the claimed genus.”). The description need only
describe in detail that which is new or not conventional. See
Hybritech v. Monoclonal Antibodies,
802 F.2d at 1384, 231
USPQ at 94. 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 which
provide evidence that inventor was in possession of the claimed invention,
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.
Enzo Biochem,
323 F.3d at 964, 63 USPQ2d at 1613 (quoting
the Written Description Guidelines, 66 Fed. Reg. at 1106, n. 49, stating that
“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.”
Id.
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
and function.”
Id.
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. As explained by the Federal Circuit, “(1) examples are
not necessary to support the adequacy of a written description; (2) the written
description standard may be met … even where actual reduction to practice of an
invention is absent; and (3) there is no per se rule that an adequate written
description of an invention that involves a biological macromolecule must
contain a recitation of known structure.”
Falkner v. Inglis,
448 F.3d 1357, 1366, 79 USPQ2d 1001, 1007 (Fed. Cir. 2006); see also
Capon v. Eshhar,
418 F.3d at 1358, 76 USPQ2d at 1084
(“The Board erred in holding that the specifications do not meet the written
description requirement because they do not reiterate the structure or formula
or chemical name for the nucleotide sequences of the claimed chimeric genes”
where the genes were novel combinations of known DNA segments.). However, the
claimed invention itself must be adequately described in the written disclosure
and/or the drawings. For example, disclosure of an antigen fully characterized
by its structure, formula, chemical name, physical properties, or deposit in a
public depository does not, without more, provide an adequate written
description of an antibody claimed by its binding affinity to that antigen,
even when preparation of such an antibody is routine and conventional. See
Amgen Inc. v. Sanofi,
872 F.3d 1367, 1378, 124 USPQ2d
1354, 1361 (Fed. Cir. 2017)(“knowledge of the chemical structure of an antigen
[does not give] the required kind of structure-identifying information about
the corresponding antibodies”); see also
Centocor Ortho Biotech, Inc.
v
ed by its binding affinity to that antigen,
even when preparation of such an antibody is routine and conventional. See
Amgen Inc. v. Sanofi,
872 F.3d 1367, 1378, 124 USPQ2d
1354, 1361 (Fed. Cir. 2017)(“knowledge of the chemical structure of an antigen
[does not give] the required kind of structure-identifying information about
the corresponding antibodies”); see also
Centocor Ortho Biotech, Inc.
v. Abbott Labs.,
636 F.3d 1341, 1351-52, 97 USPQ2d 1870, 1877
(Fed. Cir. 2011)(patent disclosed the antigen the claimed antibody was supposed
to bind, but did not disclose any antibodies with the specific claimed
properties).
Other ways of establishing possession of a
claimed invention may include unique cleavage by particular enzymes,
isoelectric points of fragments, detailed restriction enzyme maps, a comparison
of enzymatic activities, or antibody cross-reactivity. See
Lockwood,
107 F.3d at 1572, 41 USPQ2d at 1966 (Stating
that the 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.”). Conversely, describing a composition
by its function alone typically will not suffice to sufficiently describe the
composition. See
Eli Lilly,
119 F.3 at 1568, 43 USPQ2d at
1406 (Holding that description of a gene’s function will not enable claims to
the gene “because it is only an indication of what the gene does, rather than
what it is.”); see also
Fiers,
984 F.2d at 1169-71, 25
USPQ2d at 1605-06 (discussing
Amgen Inc. v. Chugai Pharm.
Co.,
927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991)). An adequate
written description of a chemical invention also requires a precise definition,
such as by structure, formula, chemical name, or physical properties, and not
merely a wish or plan for obtaining the chemical invention claimed. See, e.g.,
Univ. of Rochester v. G.D. Searle & Co.,
358 F.3d
916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir
rm.
Co.,
927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991)). An adequate
written description of a chemical invention also requires a precise definition,
such as by structure, formula, chemical name, or physical properties, and not
merely a wish or plan for obtaining the chemical invention claimed. See, e.g.,
Univ. of Rochester v. G.D. Searle & Co.,
358 F.3d
916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed
a method of selectively inhibiting PGHS-2 activity by administering a
non-steroidal compound that selectively inhibits activity of the PGHS-2 gene
product, however the patent did not disclose any compounds that can be used in
the claimed methods. While there was a description of assays for screening
compounds to identify those that inhibit the expression or activity of the
PGHS-2 gene product, there was no disclosure of which peptides,
polynucleotides, and small organic molecules selectively inhibit PGHS-2. The
court held that “[w]ithout such disclosure, the claimed methods cannot be said
to have been described.”).
If a claim limitation invokes
35 U.S.C.
112(f)
or
pre-AIA 35 U.S.C. 112
,
sixth paragraph, it must be interpreted to cover the corresponding structure,
materials, or acts in the specification and “equivalents thereof.” See
35 U.S.C. 112(f)
or
pre-AIA 35 U.S.C. 112
,
sixth paragraph. See also
B. Braun Medical, Inc. v. Abbott
Labs.,
124 F.3d 1419, 1424, 43 USPQ2d 1896, 1899 (Fed. Cir. 1997).
In considering whether there is
35 U.S.C. 112(a)
or
pre-AIA 35
U.S.C. 112
, first paragraph, 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(a)
or
pre-AIA 35
U.S.C
raph, 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(a)
or
pre-AIA 35
U.S.C. 112
, first paragraph, if: (1) The written
description adequately links or associates adequately described particular
structure, material, or acts to perform 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 disclosed in the specification perform the function recited
in a means- (or step-) plus- function limitation. See
Aristocrat
Techs. Australia PTY Ltd. v. Int’l Game Tech.,
521 F.3d 1328,
1336-37, 86 USPQ2d 1235, 1242 (Fed. Cir. 2008) (“'consideration of the
understanding of one skilled in the art in no way relieves the patentee of
adequately disclosing sufficient structure in the specification.’ It is not
enough for the patentee simply to state or later argue that persons of ordinary
skill in the art would know what structures to use to accomplish the claimed
function.”), quoting
Atmel Corp. v. Information Storage Devices,
Inc.,
198 F.3d 1374, 1380, 53 USPQ2d 1225, 1229 (Fed. Cir. 1999);
Biomedino, LLC v. Waters Technologies Corp.,
490 F.3d
946, 953, 83 USPQ2d 1118, 1123 (Fed. Cir. 2007) (“The inquiry is whether one of
skill in the art would understand the specification itself to disclose a
structure, not simply whether that person would be capable of implementing a
structure."). Note also that a rejection under
35 U.S.C.
112(b)
or
pre-AIA 35 U.S.C. 112
,
second paragraph, “cannot stand where there is adequate description in the
specification to satisfy
35 U.S.C. 112(a)
or
pre-AIA 35
U.S.C
uiry is whether one of
skill in the art would understand the specification itself to disclose a
structure, not simply whether that person would be capable of implementing a
structure."). Note also that a rejection under
35 U.S.C.
112(b)
or
pre-AIA 35 U.S.C. 112
,
second paragraph, “cannot stand where there is adequate description in the
specification to satisfy
35 U.S.C. 112(a)
or
pre-AIA 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 Fed. Reg. 38510, June 21, 2000; see also
MPEP § 2181
.
However, when a means- (or step-) plus-function claim limitation is found to be
indefinite based on failure of the specification to disclose sufficient
corresponding structure, materials, or acts that perform the entire claimed
function, then the claim limitation necessarily lacks an adequate written
description. Thus, when a claim is rejected as indefinite under
35 U.S.C. 112(b)
or
pre-AIA 35 U.S.C. 112
,
second paragraph because there is no corresponding structure, materials, or
acts, or an inadequate disclosure of corresponding structure, materials, or
acts, for a means- (or step-) plus-function claim limitation, then the claim
must also be rejected under
35 U.S.C. 112(a)
or
pre-AIA 35
U.S.C. 112
, first paragraph, for lack of an adequate
written description.
What is conventional or well known to one of ordinary skill in
the art need not be disclosed in detail. See
Hybritech Inc. v.
Monoclonal Antibodies, Inc.,
802 F.2d at 1384, 231 USPQ at 94. See
also
Capon v. Eshhar,
418 F.3d 1349, 1357, 76 USPQ2d 1078,
1085 (Fed. Cir. 2005) (“The ‘written description’ requirement must be applied
in the context of the particular invention and the state of the knowledge…. As
each field evolves, the balance also evolves between what is known and what is
added by each inventive contribution.”)
onoclonal Antibodies, Inc.,
802 F.2d at 1384, 231 USPQ at 94. See
also
Capon v. Eshhar,
418 F.3d 1349, 1357, 76 USPQ2d 1078,
1085 (Fed. Cir. 2005) (“The ‘written description’ requirement must be applied
in the context of the particular invention and the state of the knowledge…. As
each field evolves, the balance also evolves between what is known and what is
added by each inventive contribution.”). 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. 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”).
A claim which is limited to a single disclosed embodiment or
species is analyzed as a claim drawn to a single embodiment or species, whereas
a claim which encompasses two or more embodiments or species within the scope
of the claim is analyzed as a claim drawn to a genus. See also
MPEP §
806.04(e)
.
i)
For Each Claim Drawn to a Single Embodiment or Species:
(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 inventor was in possession
of the claimed invention as a whole
) 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 inventor 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 inventor was in possession of the claimed
invention.
(1) 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.
35 U.S.C.
112(a)
or
pre-AIA 35
U.S.C. 112
, first paragraph;
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). 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(a)
or
pre-AIA 35
U.S.C. 112
, first paragraph, for lack of
written description must not be made.
ion
because the specification lacked the “full, clear, concise, and
exact written description” which is necessary to support the
claimed invention). 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(a)
or
pre-AIA 35
U.S.C. 112
, first paragraph, for lack of
written description must not be made.
(2) 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 inventor
was in possession of the claimed invention. For example, in the
biotech art, if a strong correlation has been established
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
ly. 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”).
Whether the specification shows that the inventor 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 inventor was in
possession of the claimed species is sufficient. See
Eli
Lilly,
119 F.3d at 1568, 43 USPQ2d at 1406. The description
needed to satisfy the requirements of
35 U.S.C. 112
“varies
with the nature and scope of the invention at issue, and with the scientific
and technologic knowledge already in existence.”
Capon v.
Eshhar,
418 F.3d at 1357, 76 USPQ2d at 1084. 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
needed to satisfy the requirements of
35 U.S.C. 112
“varies
with the nature and scope of the invention at issue, and with the scientific
and technologic knowledge already in existence.”
Capon v.
Eshhar,
418 F.3d at 1357, 76 USPQ2d at 1084. 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 claims present in the application when originally filed, even if
the specification discloses only a method of making the invention and the
function of the invention.
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. See, e.g.,
Fiers v. Revel,
984 F.2d at 1169, 25 USPQ2d at 1605;
Amgen,
927 F.2d at 1206, 18 USPQ2d at 1021. 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. Furthermore, disclosure of a partial structure
without additional characterization of the product may not be sufficient to
evidence possession of the claimed invention
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. Furthermore, disclosure of a partial structure
without additional characterization of the product may not be sufficient to
evidence possession of the claimed invention. See, e.g.,
Amgen,
927 F.2d at 1206, 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 Labs. Inc.,
40 F.3d 1223, 1229, 32 USPQ2d
1915, 1920 (Fed. Cir. 1994)
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 Labs. 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.
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(a)
or
pre-AIA 35 U.S.C. 112
,
first paragraph.
ii)
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 i)(A) above), reduction to
drawings (see i)(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 inventor was in
possession of the claimed genus (see i)(C) above). See
Eli
Lilly,
119 F.3d at 1568, 43 USPQ2d at 1406. See
Juno
Therapeutics, Inc. v. Kite Pharma, Inc.,
10 F.4th 1330, 1337,
2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a
person of ordinary skill in the art to understand that the inventor
possessed the entire scope of the claimed invention
ient to show the inventor was in
possession of the claimed genus (see i)(C) above). See
Eli
Lilly,
119 F.3d at 1568, 43 USPQ2d at 1406. See
Juno
Therapeutics, Inc. v. Kite Pharma, Inc.,
10 F.4th 1330, 1337,
2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a
person of ordinary skill in the art to understand that the inventor
possessed the entire scope of the claimed invention.
Ariad,
598 F.3d at 1353–54 ('[T]he purpose of the
written description requirement is to ensure that the scope of the right to
exclude, as set forth in the claims, does not overreach the scope of the
inventor's contribution to the field of art as described in the patent
specification.' (internal quotation marks omitted).").
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. See
AbbVie Deutschland GmbH & Co., KG v. Janssen
Biotech, Inc.,
759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed.
Cir. 2014) (Claims directed to a functionally defined genus of antibodies
were not supported by a disclosure that “only describe[d] one type of
structurally similar antibodies” that “are not representative of the full
variety or scope of the genus.”). The disclosure of only one species
encompassed within a genus adequately describes a claim directed to that
genus only if the disclosure “indicates that the patentee has invented
species sufficient to constitute the gen[us].” See
Enzo
Biochem,
323 F.3d at 966, 63 USPQ2d at 1615;
Noelle v.
Lederman,
355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir.
2004) (Fed. Cir. 2004) (“[A] patentee of a biotechnological invention cannot
necessarily claim a genus after only describing a limited number of species
because there may be unpredictability in the results obtained from species
other than those specifically enumerated.”)
” See
Enzo
Biochem,
323 F.3d at 966, 63 USPQ2d at 1615;
Noelle v.
Lederman,
355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir.
2004) (Fed. Cir. 2004) (“[A] patentee of a biotechnological invention cannot
necessarily claim a genus after only describing a limited number of species
because there may be unpredictability in the results obtained from species
other than those specifically enumerated.”). “A patentee will not be deemed
to have invented species sufficient to constitute the genus by virtue of
having disclosed a single species when … the evidence indicates ordinary
artisans could not predict the operability in the invention of any species
other than the one disclosed.”
In re Curtis,
354 F.3d
1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) (Claims directed to PTFE
dental floss with a friction-enhancing coating were not supported by a
disclosure of a microcrystalline wax coating where there was no evidence in
the disclosure or anywhere else in the record showing applicant conveyed
that any other coating was suitable for a PTFE dental floss.) On the other
hand, there may be situations where one species adequately supports a genus.
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 corticosteroid 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 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
, 200 USPQ
711, 714 (CCPA 1979) (disclosure of corticosteroid 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 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.). See
Juno,
10 F.4th 1337, 2021 USPQ2d 893 (Fed. Cir. 2021)
(where the claims are directed to species that bind to various selected
targets, it is not fatal that all species are not disclosed as long as the
patent provides other means of identifying which species would possess the
claimed common structural characteristics or shared traits).
The Federal Circuit has explained that a specification
cannot always support expansive claim language and satisfy the requirements
of
35
U.S.C. 112
“merely by clearly describing one
embodiment of the thing claimed.”
LizardTech v. Earth Resource
Mapping, Inc.,
424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed.
Cir. 2005). The issue is whether a person skilled in the art would
understand inventor to have invented, and been in possession of, the
invention as broadly claimed. In
LizardTech,
claims to a
generic method of making a seamless discrete wavelet transformation (DWT)
were held invalid under
35 U.S.C
laimed.”
LizardTech v. Earth Resource
Mapping, Inc.,
424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed.
Cir. 2005). The issue is whether a person skilled in the art would
understand inventor to have invented, and been in possession of, the
invention as broadly claimed. In
LizardTech,
claims to a
generic method of making a seamless discrete wavelet transformation (DWT)
were held invalid under
35 U.S.C. 112
, first
paragraph, because the specification taught only one particular method for
making a seamless DWT and there was no evidence that the specification
contemplated a more generic method.
Id.
; see also
Tronzo v. Biomet,
156 F.3d at 1159, 47 USPQ2d at 1833
(Fed. Cir. 1998)(holding that the disclosure of a species in a parent
application did not provide adequate written description support for claims
to a genus in a child application where the specification taught against
other species).
Satisfactory disclosure of a “representative number”
depends on whether one of skill in the art would recognize that the inventor
was in possession of the necessary common attributes or features 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. See, e.g.,
Eli Lilly,
119 F.3d
at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect
the structural diversity of the claimed genus, either through the disclosure
of sufficient species that are “representative of the full variety or scope
of the genus,” or by the establishment of “a reasonable structure-function
correlation.” Such correlations may be established “by the inventor as
described in the specification,” or they may be “known in the art at the
time of the filing date.” See
AbbVie,
759 F.3d at
1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir
disclosure
of sufficient species that are “representative of the full variety or scope
of the genus,” or by the establishment of “a reasonable structure-function
correlation.” Such correlations may be established “by the inventor as
described in the specification,” or they may be “known in the art at the
time of the filing date.” See
AbbVie,
759 F.3d at
1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to
all human antibodies that bind IL-12 with a particular binding affinity rate
constant (i.e., k
off
) were not adequately supported
by a specification describing only a single type of human antibody having
the claimed features because the disclosed antibody was not representative
of other types of antibodies in the claimed genus, as demonstrated by the
fact that other disclosed antibodies had different types of heavy and light
chains, and shared only a 50% sequence similarity in their variable regions
with the disclosed antibodies.). 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.
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 inventor 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). 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(a)
or
pre-AIA
35 U.S.C
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). 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(a)
or
pre-AIA
35 U.S.C. 112
, first paragraph.
(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,
365, or 386
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. 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.”). However, when filing an amendment an applicant should
show support in the original disclosure for new or amended claims. See
MPEP §§
714.02
and
2163.06
(“Applicant should ...
specifically point out the support for any amendments made to the
disclosure.”).
To comply with the written description requirement of
35 U.S.C. 112(a)
or
pre-AIA 35 U.S.C. 112
,
first paragraph, or to be entitled to an earlier priority date or filing date
under
35
U.S.C. 119
,
120
,
365
, or
386
, each claim limitation must be expressly,
implicitly, or inherently supported in the originally filed disclosure. 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); see also
Akeva LLC v.
Nike, Inc.,
817 Fed. Appx
ure. 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); see also
Akeva LLC v.
Nike, Inc.,
817 Fed. Appx. 1005, 1012-13, 2020 USPQ2d 10797 (Fed.
Cir. 2020) (The court found that the continuation patents were not entitled to
the benefit of an earlier filing date because the continuation patents removed
a disclaimer that the invention did not cover shoes with conventional fixed
rear soles that was present in the earlier filed patents);
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
.);
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);
Regents of the Univ. of Minnesota v. Gilead Scis., Inc.,
61 F.4th 1350, 1356-58, 2023 USPQ2d 269 (Fed. Cir. 2023) ( The court found the
later-filed patent claims could not receive benefit under
35 U.S.C
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);
Regents of the Univ. of Minnesota v. Gilead Scis., Inc.,
61 F.4th 1350, 1356-58, 2023 USPQ2d 269 (Fed. Cir. 2023) ( The court found the
later-filed patent claims could not receive benefit under
35 U.S.C.
120
, because the earlier-filed applications did not have
ipsis verbis disclosure of the claimed subgenus and did not provide sufficient
blaze marks to provide the later-filed claims with sufficient support under
35 U.S.C. 112(a)
.) ;
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));
Yeda Research and Dev. Co. v. Abbott GMBH &
Co.,
837 F.3d 1341, 120 USPQ2d 1299 (Fed. Cir. 2016) (“Under the
doctrine of inherent disclosure, when a specification describes an invention
that has certain undisclosed yet inherent properties, that specification serves
as adequate written description to support a subsequent patent application that
explicitly recites the invention’s inherent properties.”) (citing
Kennecott Corp. v. Kyocera Int’l, Inc.,
835 F.2d 1419,
1423, 5 USPQ2d 1194 (Fed. Cir. 1987)). Furthermore, each claim must include all
elements which applicant has described as essential. See, e.g.,
Johnson Worldwide Assoc. 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
orp. v. Kyocera Int’l, Inc.,
835 F.2d 1419,
1423, 5 USPQ2d 1194 (Fed. Cir. 1987)). Furthermore, each claim must include all
elements which applicant has described as essential. See, e.g.,
Johnson Worldwide Assoc. 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.
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(a)
or
pre-AIA 35
U.S.C. 112
, first paragraph, as lacking adequate written
description, or in the case of a priority or benefit claim under
35 U.S.C.
119
,
120
,
365
, or
386
, the priority or benefit claim 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(a)
or
pre-AIA 35 U.S.C.
112
, first paragraph, 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 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C
rm 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 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph, 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. See, e.g.,
In re Marzocchi,
439 F.2d
220, 224, 169 USPQ 367, 370 (CCPA 1971). 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.
Wertheim,
541 F.2d at 263,
191 USPQ at 97. 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:
(A) Identify the claim limitation at issue; and
(B) 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. See
Rasmussen,
650 F.2d at 1214, 211 USPQ at 326.
B
llegation 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. See
Rasmussen,
650 F.2d at 1214, 211 USPQ at 326.
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(a)
or
pre-AIA 35 U.S.C. 112
, first
paragraph, 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(a)
or
pre-AIA 35 U.S.C. 112
, first
paragraph, 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
35 U.S.C. 112(a)
or
pre-AIA 35
U.S.C. 112
, first paragraph, written description requirement,
must be thoroughly analyzed and discussed in the next Office action. See
In
re Alton,
76 F.3d 1168, 1176, 37 USPQ2d 1578, 1584 (Fed. Cir. 1996).

## Nearby sections

- [MPEP § 2103 Patent Examination Process](https://www.frixlaw.com/law-library/statutes/MPEP_S2103.md)
- [MPEP § 2104 Requirements of 35 U.S.C. 101](https://www.frixlaw.com/law-library/statutes/MPEP_S2104.md)
- [MPEP § 2104.01 Barred by Atomic Energy Act](https://www.frixlaw.com/law-library/statutes/MPEP_S2104.01.md)
- [MPEP § 2105 Patent Eligible Subject Matter — Living Subject Matter](https://www.frixlaw.com/law-library/statutes/MPEP_S2105.md)
- [MPEP § 2106 Patent Subject Matter Eligibility](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.md)
- [MPEP § 2106.01 [Reserved]](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.01.md)
- [MPEP § 2106.02 [Reserved]](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.02.md)
- [MPEP § 2106.03 Eligibility Step 1: The Four Categories of Statutory Subject Matter](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.03.md)
- [MPEP § 2106.04 Eligibility Step 2A: Whether a Claim is Directed to a Judicial Exception](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.04.md)
- [MPEP § 2106.04(a) Abstract Ideas](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.04(a).md)
- [MPEP § 2106.04(a)(1) Examples of Claims That Do Not Recite Abstract Ideas](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.04(a)(1).md)
- [MPEP § 2106.04(a)(2) Abstract Idea Groupings](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.04(a)(2).md)
- [MPEP § 2106.04(a)(3) Tentative Abstract Ideas](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.04(a)(3).md)
- [MPEP § 2106.04(b) Laws of Nature, Natural Phenomena & Products of Nature](https://www.frixlaw.com/law-library/statutes/MPEP_S2106.04(b).md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/MPEP_S2163. Check the current official text before relying on it. Not legal advice.