University of Massachusetts

Patent Trials and Appeals Board

Jun 16, 2021

2020005737 (P.T.A.B. Jun. 16, 2021)

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.
15/063,446 03/07/2016 Craig Joseph Ceol 579613: UM9-202 8607
12779 7590 06/16/2021
Lathrop GPM LLP
28 State Street
7th Floor
Boston, MA 02109
EXAMINER
HALVORSON, MARK
ART UNIT PAPER NUMBER
1642
NOTIFICATION DATE DELIVERY MODE
06/16/2021 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):
bostonpatent@lathropgage.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte CRAIG JOSEPH CEOL and
ARVIND MURALI VENKATESAN
____________

Appeal 2020-005737
Application 15/063,446
Technology Center 1600
____________

Before DONALD E. ADAMS, ERIC B. GRIMES, and
JOHN E. SCHNEIDER, 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 1–7 and 55–60 (see Appeal Br. 5).2 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 “University
of Massachusetts” (Appellant’s April 1, 2020, Appeal Brief (Appeal Br.) 3).
2 Appellant’s pending claims 8–11 stand withdrawn from consideration
(Appeal Br. 5).
Appeal 2020-005737
Application 15/063,446

2
STATEMENT OF THE CASE
Appellant discloses “methods of treating melanoma by modulating an
activity of GDF6 in melanoma cells” (Spec.,3 Abstract). Appellant’s
independent claim 1 is reproduced below:
1. A method of treating a melanoma in a subject, the method
comprising administering to a subject in need thereof an
effective amount of an inhibitor of at least one GDF6 activity.
(Appeal Br. 19.) In response to Examiner’s July 10, 2017, Restriction
Requirement, “Appellant elected the species, antibodies, as the inhibitor of
at least one GDF6 activity” (Ans.4 4 (citing Appellant’s October 6, 2017
Response to Restriction Requirement)). When the Examiner has required
the applicant to elect a chemical species for examination, the issue on appeal
is the patentability of the elected species. It is appropriate for the Board to
limit discussion to that single issue and take no position respecting the
patentability of the non-elected species. See Ex parte Ohsaka, 2 USPQ2d
1460, 1461 (BPAI 1987).

Claims 1–7 and 55–60 stand rejected under the written description
provision of 35 U.S.C. § 112(a).

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?

3 Appellant’s March 7, 2016, Specification.
4 Examiner’s June 2, 2020, Answer.
Appeal 2020-005737
Application 15/063,446

3
ANALYSIS
Appellant’s claim 1 is representative and reproduced above. As
discussed above, we limit the scope of our review of Appellant’s elected
invention, wherein the method of Appellant’s claim 1 comprises the
administration of an effective amount of an antibody, as the inhibitor of at
least one GDF6 activity, to treat melanoma in a subject. Therefore, we are
not persuaded by Appellant’s contentions regarding the full scope of its
claimed invention (see Appeal Br. 11).
Examiner finds that Appellant’s Specification does not disclose: “any
anti-GDF6 antibodies that were capable of inhibiting GDF6 activity and
capable of treating melanoma” or “sufficient information on the structural
function relationship to identify the claimed genus of antibodies that inhibit
at least one GDF6 activity and is capable of treating melanoma” (Ans. 9).
Appellant acknowledges that its Specification “does not identify which of
the disclosed commercial anti-GDF6 antibodies were capable of inhibiting at
least one GDF6 activity for the purpose of treating melanoma” (Appeal Br.
13; see also Reply Br.5 3). In sum, Appellant fails to: Identify which
commercially available antibodies would exhibit the functions recited in
Appellant’s claims, describe the structural features common to members of
the genus that would allow a skilled artisan to distinguish antibodies
encompassed by the claim language from other antibodies, and disclose any
correlation between the structure and function of the antibodies
encompassed by the claim language. Thus, Appellant’s Specification fails to
describe the antibodies required to practice the claimed method in a manner

5 Appellant’s July 31, 2020, Reply Brief.
Appeal 2020-005737
Application 15/063,446

4
that reasonably conveys to those skilled in the art that Appellant was in
possession of the claimed method as of the filing date of the instant
application. Therefore, we agree with Examiner’s finding that Appellant’s
Specification fails to provide an adequate written description of Appellant’s
claim 1 (see Ans. 4–5).
“[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). To be complete, we note that the written
description standard set out in Ariad applies to antibodies. See Amgen, Inc.
v. Sanofi, 872 F.3d 1367, 1376–79 (Fed. Cir. 2017) (applying the Ariad
standard to antibodies claimed based on their binding and blocking
activities); see also AbbVie Deutschland GmbH & Co. v. Janssen Biotech,
Inc., 759 F.3d 1285, 1298–-1300 (Fed. Cir. 2014) (same).
A “sufficient description of a genus . . . requires the disclosure of
either a representative number of species falling within the 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
Appeal 2020-005737
Application 15/063,446

5
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, although Appellant’s claim 1 is directed to a method of
using an antibody inhibitor of at least one GDF6 activity rather than the
antibody itself, we note that the same standard applies with regard to the
written description requirement. 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).
Although those of ordinary skill in this art may understand how to
prepare antibodies, “it is the specification itself that must demonstrate
possession. And while the description requirement does not demand any
particular form of disclosure, . . . or that the specification recite the claimed
invention in haec verba, a description that merely renders the invention
obvious does not satisfy the requirement.” Ariad, 598 F.3d at 1352.
Therefore, we are not persuaded by Appellant’s contention that its
Specification provides an adequate written description of its claimed
invention because its Specification discloses assays that a person of ordinary
skill in this art could use to identify antibodies, including commercially
available antibodies, that would be useful for its claimed method and
“describes methods of making inhibitory anti-GDF6 antibodies” (Appeal Br.
Appeal 2020-005737
Application 15/063,446

6
13; see id. at 13–15; Reply Br. 3–6; see also Ceol Decl.6 ¶¶ 9–18 (Declarant
states that “the GDF6 ligand was well-characterized” at the time of
Appellant’s claimed invention, Appellant’s Specification discloses “methods
of making inhibitory antibodies,” and that Declarant was able to “generate[]
three distinct monoclonal antibodies that bind mature GDF6 ligand . . . and
prevent its activation of BMP signaling in melanoma cells” by utilizing the
methodology set forth in Appellant’s disclosure). As Examiner explains, the
antibodies discussed in the Ceol Declaration “were made after the
Application was filed” and the fact that Appellant generated three antibodies
that inhibit at least one GDF6 activity and are capable of
treating melanoma after the application was filed does not
demonstrate that the genus of antibodies was described in the
specification in such a way as to reasonably convey to one
skilled in the relevant art that the inventor . . . had possession of
the claimed invention at the time the application was filed.
(Ans. 11.)
Appellant explains that “in Capon the claimed chimeric genes were,
‘prepared from known DNA sequences of known function’” (Appeal Br. 17
(citing Capon v. Eshhar, 418 F.3d 1349, 1358 (Fed. Cir. 2005))). As
discussed above, however, in contrast to Capon the evidence on this record
supports a finding that Appellant’s Specification does not describe the
antibodies encompassed by the genus set forth in Appellant’s claimed
method at the time of Appellant’s claimed invention.
Only those arguments timely made by Appellant in the briefs have
been considered; arguments not so presented in the briefs are waived. See
37 C.F.R. § 41.37(c)(1)(iv); see also Ex parte Borden, 93 USPQ2d 1473,

6 Declaration of Craig J. Ceol, Ph.D., signed January 21, 2019.
Appeal 2020-005737
Application 15/063,446

7
1474 (BPAI 2010) (informative) (“Any bases for asserting error, whether
factual or legal, that are not raised in the principal brief are waived.”).
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 1 under the written
description provision of 35 U.S.C. § 112(a) is affirmed. Claims 2–7 and 55–
60 are not separately argued and fall with claim 1.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–7, 55–60 112(a) Written
Description
1–7, 55–60
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