California Institute of Technology

Patent Trials and Appeals Board

Dec 11, 2020

2020003635 (P.T.A.B. Dec. 11, 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.
14/310,201 06/20/2014 James R. Heath INDI 19.1 9898
23579 7590 12/11/2020
Pabst Patent Group LLP
1545 PEACHTREE STREET NE
SUITE 320
ATLANTA, GA 30309
EXAMINER
JONES, DAMERON LEVEST
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
12/11/2020 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):
docketing@pabstpatent.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JAMES R. HEATH, ROSEMARY DYANE ROHDE,
ARUNDHATI NAG, SAMIR DAS, and AIKO UMEDA
__________

Appeal 2020-003635
Application 14/310,201
Technology Center 1600
__________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL

Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 2, 4–12, 18–21, and 66–68. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

STATEMENT OF THE CASE
The sole rejection before us for review is the Examiner’s rejection of
claims 1, 2, 4–12, 18–21, and 66–68, as failing to comply with the written

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies California Institute of Technology and
Indi Molecular, Inc., as the real parties in interest. Appeal Br. 2.
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description requirement. Final Act. 5–8 (entered October 15, 2018);2 Ans.
3–7.
Appellant’s claim 1 is the sole independent claim on appeal and reads
as follows:
1. A cyclic peptide having the following structure (I):

or a salt, tautomer or stereoisomer thereof, wherein:
L1 and L2 are each individually optionally substituted
linker moieties, each linker moiety optionally comprising a
linkage to a solid support, a linkage to a reporter moiety, a
linkage to a peptide ligand, a linkage to an azide or alkyne
moiety or combinations thereof;
G is a triazole, a carbon-carbon double bond or an amide;
M is methionine;
R is H, -L3-A or-C(=O)-L3-A, wherein L3 is a linker
moiety and A is an alkyne or an azide, or wherein L3 is a linker
moiety comprising triazole and A is a bond to a peptide ligand;
R1 is H or C1-C6 alkyl;
y1 and y2 are each individually 0 or 1; and
SEQ is an amino acid sequence comprising from 2 to 20
amino acids selected from the group consisting of: D-alanine,

2 The Final Action included a rejection for obviousness-type double
patenting over copending application 15/211,759. Final Act. 2–4. The
Examiner withdrew that rejection in the Examiner’s Answer. Ans. 14–15.
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glycine, D-leucine, D-isoleucine, D-valine, D-phenylalanine, D-
tryptophan, D-arginine, D-histidine, D-lysine, D-aspartate, D-
glutamate, D-asparagine, D-glutamine, D-serine, D-threonine,
D-tyrosine, D-proline, L-alanine, L-leucine, L-isoleucine, L-
valine, L-phenylalanine, L-tryptophan, L-arginine, L-histidine,
L-lysine, L-aspartate, L-glutamate, L-asparagine, L-glutamine,
L-serine, L-threonine, L-tyrosine, L-proline, hydroxyproline,
carboxyglutamate, O-phosphoserine, homoserine, norleucine,
methionine sulfoxide, and methionine methyl sulfonium.
Appeal Br. 24–25.
DISCUSSION
The Examiner’s Prima Facie Case
In rejecting Appellant’s claims for failure to comply with the written
description requirement, the Examiner determined that Appellant’s
Specification does not provide sufficient descriptive support for the “SEQ”
moiety formula (I) of the cyclic peptide recited in claim 1. Ans. 4.
In addition, the Examiner determined, “the instant invention does not
sufficiently describe the invention as it relates to sequence having 90%
identity to SEQ ID Nos 1-33 (see claim 18).” Ans. 4
Further, the Examiner determined, “the claims do not require that the
sequences possess any particular biological activity or that any particular
portion of the sequence be conserved in order to possess the
characteristics/features necessary to be compatible with the instant invention
and compatible with the structure” of formula (I) of claim 1. Ans. 4.
The Examiner determined that the “SEQ” moiety formula (I) of the
cyclic peptide recited in claim 1 encompasses a multitude of potential
combinations of amino acids. Ans. 4–5. The Examiner determined that, “to
provide evidence of possession of a claimed genus, the specification must
provide sufficient distinguishing identifying characteristics/properties of the
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genus” and noted that “there is not even identification of any particular
portion of the structure that must be conserved and any combination of 2-20
amino acid residues may be utilized.” Id. at 5.
Accordingly, the Examiner reasoned, “the skilled artisan cannot
envision the species encompassed by the genus” and therefore “what the
Reader gathers from the instant application is a desire/plan/first step for
obtaining a desired result.” Ans. 6.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In the present case, having carefully considered all of the arguments
and evidence advanced by Appellant and the Examiner, Appellant persuades
us that a preponderance of evidence does not support the Examiner’s
determination that the rejected claims lack adequate written descriptive
support in the Specification.
As Appellant points out, claim 1 does not recite a genus in terms of a
function. Rather, claim 1 recites a cyclic peptide in terms of the structural
formula (I), which undisputedly recites a specific moiety at every position of
the formula. See Appeal Br. 24–25. As to the “SEQ” moiety that forms the
primary basis of the Examiner’s rejection, claim 1 states expressly that
“SEQ” is an amino acid sequence comprising from 2 to 20 amino acids
selected from a specific list of amino acids. See id.
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Thus, although the SEQ moiety of formula (I) encompasses numerous
distinct amino acid sequences, claim 1 fully explains the structure of every
amino acid sequence encompassed by claim 1, because each of the
components is expressly stated in the claim, and the length of each sequence
is expressly stated in the claim. Moreover, the Examiner does not dispute
that the Specification provides sufficient support for the actual language
used in claim 1 to describe the claimed cyclic peptide, including the SEQ
moiety. Thus, we are not persuaded that the Specification (or claim 1 for
that matter) fails to describe adequately the structure of the claimed cyclic
peptide.
We acknowledge the Examiner’s contention that the Specification
fails to explain which sequences among those encompassed by claim 1 are
“compatible” with the cyclic structure recited in the remainder of formula (I)
the claim. Ans. 4, 8, 10, 12. As our reviewing court has explained,
however, the written description requirement “is about whether the skilled
reader of the patent disclosure can recognize that what was claimed
corresponds to what was described; it is not about whether the patentee has
proven to the skilled reader that the invention works, or how to make it
work, which is an enablement issue.” Alcon Research Ltd. v. Barr Labs.,
Inc., 745 F.3d 1180, 1191 (Fed Cir. 2014) (emphasis added).
Thus, contrary to the Examiner’s suggestion that it is always
necessary for the Specification to provide specific representative working
examples or evidence of an actual reduction to practice, our reviewing court
has stated expressly that “[t]here is no requirement that the disclosure
contain either examples or an actual reduction to practice.” Alcon, 745 F.3d
at 1190 (internal quotations omitted).
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“[R]ather, the critical inquiry is whether the patentee has provided
a description that in a definite way identifies the claimed invention in
sufficient detail that a person of ordinary skill would understand that the
inventor was in possession of it at the time of filing.” Alcon, 745 F.3d at
1190–91 (internal quotations omitted).
In the present case, as discussed above, Appellant’s claim 1 and
Appellant’s Specification undisputedly describe the identity of every
substituent at every position of the cyclic peptide recited in claim 1.
Appellant persuades us, therefore, that it has described the claimed invention
in a definite way, and in sufficient detail, such that a skilled artisan would
understand that Appellant possessed the claimed invention at the time of
filing. See Alcon, 745 F.3d at 1190–91.
We acknowledge the Examiner’s contention that cyclic peptides can
have a variety of diverse biological properties. Ans. 4 (citing Joo).3 As
noted above, however, Appellant’s claim 1 does not recite the claimed cyclic
peptide in terms of any particular functional property. Thus, the fact that
different cyclic peptides might have different biological activities does not
demonstrate that, as claimed, the cyclic peptide of Appellant’s claim 1 lacks
adequate descriptive support.
Lastly, we acknowledge that claim 18 recites that the amino acid
sequence of SEQ has 90% sequence identity to an amino acid sequence
comprising any one of SEQ ID NOS: 1–33. Appeal Br. 26. As Appellant
points out, however, and the Examiner does not dispute, the concept of
percent sequence identity was well known in the art. See Appeal Br. 10

3 Sang Hoon Joo, Cyclic Peptides as Therapeutic Agents and Biochemical
Tools, 20 BIOMOL. THER. 19–26 (2012).
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(citing Spec. 24:12–21). We are not persuaded, therefore, that claim 18
lacks sufficient written descriptive support.
In sum, for the reasons discussed, Appellant persuades us that
a preponderance of the evidence does not support the Examiner’s
determination that claims 1, 2, 4–12, 18–21, and 66–68 lack adequate
descriptive support in the Specification. We therefore reverse the
Examiner’s rejection.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 2, 4–12,
18–21, 66–
68
112(a) or
112, first
paragraph
Lack of Written
Description
1, 2, 4–12,
18–21, 66–
68

REVERSED