Commonwealth Scientific and Industrial Research Organisation

Patent Trials and Appeals Board

May 20, 2020

2019005436 (P.T.A.B. May. 20, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
15/197,541 06/29/2016 Tara D. Sutherland RICE-088CON 6906
24353 7590 05/20/2020
BOZICEVIC, FIELD & FRANCIS LLP
BOZICEVIC, FIELD & FRANCIS
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
EXAMINER
BURKHART, MICHAEL D
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
05/20/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docket@bozpat.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte TARA D. SUTHERLAND, VICTORIA SHIRLEY HARITOS,
HOLLY TRUEMAN, ALAGACONE SRISKANTHA,
SARAH WEISMAN, and PETER M. CAMPBELL
____________

Appeal 2019-005436
Application 15/197,541
Technology Center 1600
____________

Before DONALD E. ADAMS, ERIC B. GRIMES, and
TAWEN CHANG, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 54–58, 64, 65, and 70–75. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as
“Commonwealth Scientific and Industrial Research Organization”
(Appellant’s October 8, 2018 Appeal Brief (Br.) 3).
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STATEMENT OF THE CASE
Appellant’s disclosure “relates to silk proteins, as well as nucleic
acids encoding such proteins,” methods of making silk proteins, and “to
recombinant cells and/or organisms which synthesize silk proteins” (Spec.2
1:4–6). Claim 54 is representative and reproduced below:
54. A recombinant host cell comprising a polynucleotide which
encodes a silk polypeptide, wherein at least a portion of the
polypeptide has a coiled coil structure, and wherein the silk
polypeptide comprises an amino acid sequence which is at least
40% identical to at least any one or more of SEQ ID NO:40,
SEQ ID NO:41, SEQ ID NO:5, SEQ ID NO:6, SEQ ID NO:26,
or SEQ ID NO:27; and wherein
a) the polynucleotide is operably linked to a heterologous
promoter, and/or
b) the recombinant host cell is a bacterial, yeast or plant cell.
(Br. 16.)
Grounds of rejection before this Panel for review:
Claims 54–58, 64, 65, and 70–75 stand rejected under the written
description provision of 35 U.S.C. § 112, first paragraph.
Claims 54–58, 64, 65, and 70–75 stand rejected under the enablement
provision of 35 U.S.C. § 112, first paragraph.

Written Description:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Appellant’s Specification fails to provide written
descriptive support for the claimed invention?

2 Appellant’s June 29, 2016 Specification.
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ANALYSIS
Examiner finds that Appellant’s “claims read on a broad genus of
potential DNA and protein sequences (not limited to any particular source or
sequence) and variants, such as any variant with as little as 40% homology
to the recited SEQ ID NOs” (Ans. 4). Examiner further finds that
Appellant’s disclosure fails to provide a correlation between a polypeptide’s
structure and function, i.e. silk polypeptide and variants thereof that are
commensurate in scope with Appellant’s claimed invention may be
reasonably identified. In this regard, Examiner finds that although
one of skill in the art can readily envision numerable [sic]
species of nucleic acid or protein sequences that are at least a
given % identity to a reference sequence and that encode a
polypeptide at least a given % identity to a recited reference
amino acid sequence, one cannot envision which of these also
encode a polypeptide with a specified activity or function.
(Ans. 6.) As Examiner explains,
if one skilled in the art were to make a synthetic sequence that
encoded a polypeptide with 90% identity to the reference amino
acid sequence, he would be no more able to say whether it
encoded a silk protein than if the nucleotide sequence encoded a
polypeptide that was only 10% identical to the reference
polypeptide sequence.
(Id.; see id. at 12 (Examiner finds that Appellant’s Specification fails to
provide “guidance to vary the disclosed sequences such that the claimed
invention is produced, i.e. silk polypeptides. The fact remains there is no
predictable way to vary the claimed nucleotides/polypeptides such that a silk
polymer or polypeptide is produced”).)
In response, Appellant contends “that the unifying feature of [its]
claims is a tertiary structure of the silk polypeptide –– namely, the coiled-
coil structure” (Br. 4; see also id. at 4–5 (Appellant contends that “[t]he
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sequences recited in . . . [its] claims are explicitly limited by their structure
which confers their biological function)). In this regard, Appellant directs
attention to, inter alia, Kohn3 to support Appellant’s contention “that the
coiled-coil structure is simple, well understood, easy to predict and can be
generated by sequences that are completely different to one another. Thus, a
skilled person would have been able to design or envision variants across the
entire scope of the claims at the time of filing” (id. at 5).
Appellant’s contention is not persuasive. As Examiner explains, with
reference to Kohn:
It is stipulated that the coiled-coil structure found in proteins is
reasonably well-studied, however, such coiled-coils are found
in proteins as diverse as the HIV gp41 envelope protein and
well-known DNA-binding motifs (zinc fingers) and DNA-
binding proteins (oncoproteins such as c-Fos). . . . The
situation is thus not as simple as [Appellant] assert[s]: merely
forming a coiled-coil does not lead to a silk polypeptide, but
could be any one of many unrelated possibilities known in the
art.
(Ans. 12 (emphasis added).)
We agree with Examiner’s finding that Appellant’s Specification fails
to provide an adequate written description of Appellant’s claim 1 (see Ans.
4). “[T]he test for sufficiency [of the written description] is whether the
disclosure of the application relied upon reasonably conveys to those skilled
in the art that the inventor had possession of the claimed subject matter as of
the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351
(Fed. Cir. 2010) (en banc). A “sufficient description of a genus . . . requires
the disclosure of either a representative number of species falling within the

3 Kohn et al., α-Helical Protein Assembly Motifs, 272 J. Biol. Sci. 2583–86
(1997).
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scope of the genus or structural features common to the members of the
genus so that one of skill in the art can ‘visualize or recognize’ the members
of the genus.” Ariad, 598 F.3d at 1350. “[A]n adequate written description
requires a precise definition, such as by structure, formula, chemical name,
physical properties, or other properties, of species falling within the genus
sufficient to distinguish the genus from other materials.” Id. Although
“functional claim language can meet the written description requirement
when the art has established a correlation between structure and function,”
“merely drawing a fence around the outer limits of a purported genus is not
an adequate substitute for describing a variety of materials constituting the
genus and showing that one has invented a genus and not just a species.” Id.
In addition, as the Rochester Court made clear:
Regardless whether a compound is claimed per se or a method
is claimed that entails the use of the compound, the inventor
cannot lay claim to that subject matter unless he can provide a
description of the compound sufficient to distinguish infringing
compounds from non-infringing compounds, or infringing
methods from non-infringing methods.
University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 926 (Fed. Cir.
2004).
As discussed above, the evidence on this record refutes Appellant’s
contention that its disclosure’s “unifying feature,” specifically a “coiled-coil
structure,” is sufficient to establish a correlation between the structure and
function so that one of skill in this art can visualize or recognize the
members of Appellant’s claimed genus (see, e.g., Ans. 12; see id. at 14
(Examiner finds that Appellant’s “rebuttals are completely directed to
coiled-coils when the relevant issue is silk polypeptides”); cf. Br. 4
(Appellant contends “that the unifying feature of [its] claims is a tertiary
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structure of the silk polypeptide –– namely, the coiled-coil structure”); see
generally Br. 5–14).
CONCLUSION
The preponderance of evidence on this record supports Examiner’s
finding that Appellant’s Specification fails to provide written descriptive
support for the claimed invention. The rejection of claim 54 under the
written description provision of 35 U.S.C. § 112, first paragraph is affirmed.
Claims 55–58, 64, 65, and 70–75 are not separately argued and fall with
claim 54.

Enablement:
ISSUE
Does the evidence of record support Examiner’s conclusion that
undue experimentation would be required to practice the claimed invention?
ANALYSIS
“[T]o be enabling, the specification of a patent must teach those
skilled in the art how to make and use the full scope of the claimed invention
without ‘undue experimentation.”’ In re Wright, 999 F.2d 1557, 1561 (Fed.
Cir. 1993).
The enablement requirement ensures that the public knowledge
is enriched by the patent specification to a degree at least
commensurate with the scope of the claims. The scope of the
claims must be less than or equal to the scope of the
enablement. The scope of enablement, in turn, is that which is
disclosed in the specification plus the scope of what would be
known to one of ordinary skill in the art without undue
experimentation.
National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d
1190, 1195–96 (Fed Cir. 1999).
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Examiner and Appellant agree that although “the written description
and enablement requirements are separate and . . . separable requirements,
the instant application fails to meet either requirement for essentially the
same reasons” (Ans. 4; see Br. 4 (Appellant “understand[s] that although
two distinct and separate rejections are made under 35 U.S.C. §112, first
paragraph, the issues that underpin both of the rejections are essentially the
same, and largely relate to the structural and functional characteristics of the
polypeptides and polynucleotides recited in the claims,” thus “Appellant
believes that both rejections can be addressed by a single discussion”)).
On this record, Examiner finds that although Appellant’s
Specification provides an enabling disclosure of “methods and compositions
comprising the biomolecules set forth in SEQ ID NOs: 40, 41, 5, 6, 26 and
27,” Appellant’s Specification fails to provide an enabling disclosure of
“variants” of these biomolecules falling within the scope of Appellant’s
claims (see Ans. 3). In this regard, Examiner finds that Appellant’s
“[S]pecification discloses only a few putative functional amino acid
sequences with little to no sequence homology for a polypeptide having the
necessary activity, and provides no guidance on determining which
polypeptide variants would have an activity or structure as recited in
[Appellant’s] claims” (id. at 10). Thus, finding “the number of possible
sequences having 81 substitutions (i.e. 80% homology as recited in
[Appellant’s] claim 57) is 3.6 x 10187,” Examiner finds that Appellant’s
“claimed genus of potential silk polypeptides to be produced or encoded by
the claimed cell lines is impossibly broad, and . . . [Appellant’s]
[S]pecification lacks any link between the recited function (a silk
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polypeptide) and a structure which would allow predictable variation to the
degree claimed” (Ans. 11). We find no error in Examiner’s findings.
For the reasons discussed above, with respect to the written
description requirement, we are not persuaded by Appellant’s contention its
disclosure of a “coiled-coil structure” “provides the skilled artisan with an
enormous amount of information to enable them to design variants
encompassed by” Appellant’s claims (see Br. 14; see also id. at 4 (Appellant
contends “that the unifying feature of [its] claims is a tertiary structure of the
silk polypeptide –– namely, the coiled-coil structure”); see generally Br. 5–
14; cf. Ans. 14 (Examiner finds that Appellant’s “rebuttals are completely
directed to coiled-coils when the relevant issue is silk polypeptides”)).
CONCLUSION
The evidence of record supports Examiner’s conclusion that undue
experimentation would be required to practice the claimed invention. The
rejection of claim 54 under the enablement provision of 35 U.S.C. § 112,
first paragraph is affirmed. Claims 55–58, 64, 65, and 70–75 are not
separately argued and fall with claim 54.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
54–58, 64,
65, 70–75
112, first
paragraph
Written
Description
54–58, 64,
65, 70–75

54–58, 64,
65, 70–75
112, first
paragraph
Enablement 54–58, 64,
65, 70–75

Overall
Outcome
54–58, 64,
65, 70–75

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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED