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

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).