Ex Parte Sugiyama et al

Patent Trial and Appeal Board

Nov 19, 2018

13143492 (P.T.A.B. Nov. 19, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/143,492 09/29/2011 Haruo Sugiyama
22852 7590 11/21/2018
FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER
LLP
901 NEW YORK A VENUE, NW
WASHINGTON, DC 20001-4413
UNITED ST A TES OF AMERICA
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
05273.0134 6050
EXAMINER
HUFF, SHEELA JITENDRA
ART UNIT PAPER NUMBER
1643
NOTIFICATION DATE DELIVERY MODE
11/21/2018 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):
regional-desk@finnegan.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HARUO SUGIYAMA and YUSUKE OJI
Appeal2017-010332
Application 13/143,492 1
Technology Center 1600
Before ERIC B. GRIMES, ELIZABETH A. LA VIER, and RYAN H. FLAX,
Administrative Patent Judges.
LA VIER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants seek review of the
Examiner's rejection of claims 20, 22, 24, and 26. We have jurisdiction
under 35 U.S.C. § 6(b ). For the reasons set forth below, we REVERSE.
BACKGROUND
The Specification relates to methods for detecting cancer and
compositions for prevention and treatment of cancer. Spec. ,r 1. Claim 20 is
illustrative:
20. A method for the treatment of a cancer in an HLA-A *0201-
positive subject, comprising administering to said subject an
1 Appellants identify the real party in interest as International Institute of
Cancer Immunology. Br. 2.
Appeal2017-010332
Application 13/143,492
effective amount of an eEF2 peptide consisting of an amino
acid sequence composed of contiguous amino acids of an eEF2
protein, wherein the amino acid sequence is selected from the
group consisting of:
(a) Leu Ile Leu Asp Pro Ile Phe Lys Val (SEQ ID N0:14); and
(b) an amino acid sequence of SEQ ID NO: 14 having a
substitution or substitutions of the amino acid Ile at position 2
with Leu or Met and/or a substitution of the amino acid Val at
position 9 with Leu, wherein the eEF2 peptide retains a binding
ability to the HLA-A *0201 molecule.
Claims Appendix 3. 2
REJECTION MAINTAINED ON APPEAL
Claims 20, 22, 24, and 26 stand rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the enablement requirement. Ans. 3.
DISCUSSION
The appealed claims are directed to a method of treating cancer, but
the Specification's supporting data are derived from in vitro, not in vivo,
studies. In the Examiner's view, the Specification's in vitro data are not
sufficient to enable the appealed claims:
applicant provides a multitude of examples. Some of the
example[s] show the use of SEQ ID NO. 14 and show its
binding to HLA-A *0201 and the peptide[']s ability to increase
cytotoxic activity in vitro and increase IFN-gamma activity in
vitro. Additionally, Table 21 shows that the peptides having
the substitutions of L or M for position 2 and L for position 9
also retain the same activity. The data provided is limited to in
vitro use yet the claims are directed to in vivo use. There is no
2 The Claims Appendix is appended to the Appeal Brief, and is separately
paginated.
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Application 13/143,492
objective evidence to show the correlation of the in vitro data to
use m vivo.
Non-Final Action 3; 3 see also Ans. 10.
As Appellants point out, the Examiner does not challenge the
Specification's enablement of how to make the recited peptides, or how to
administer them. See Br. 6. "Rather the focus of the enablement rejection is
on whether the recited peptides would be reasonably expected to be effective
in treating cancer in an HLA-A*0201-positive subject." Id. As such, the
present appeal presents the same basic question addressed by the Federal
Circuit in In re Brana, 51 F .3d 1560, 1564 (Fed. Cir. 1995): "what must the
applicant prove regarding the practical utility or usefulness of the invention
for which patent protection is sought"? For the Brana court and the present
appeal, this issue of utility is an aspect of the enablement requirement under
§ 112, 4 because "[ o ]bviously, if a claimed invention does not have utility,
the specification cannot enable one to use it." Id. The Brana court made it
clear that evidence of clinical efficacy is not a prerequisite:
Usefulness in patent law, and in particular in the context of
pharmaceutical inventions, necessarily includes the expectation
of further research and development. The stage at which an
invention in this field becomes useful is well before it is ready
to be administered to humans. Were we to require Phase II
testing in order to prove utility, the associated costs would
prevent many companies from obtaining patent protection on
promising new inventions, thereby eliminating an incentive to
3 Non-Final Action dated Oct. 24, 2016.
4 The rejection on appeal in Brana was based on 35 U.S.C. § 112, first
paragraph, not 35 U.S.C. § 101. See Brana, 51 F.3d at 1362.
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Application 13/143,492
pursue, through research and development, potential cures in
many crucial areas such as the treatment of cancer.
Id. at 1568.
The burden of establishing a prima facie case of non-enablement rests
with the Examiner. See In re Wright, 999 F.2d 1557, 1561---62 (Fed. Cir.
1993). Where the asserted lack of enablement is premised on lack of utility,
the PTO has the initial burden of challenging a presumptively
correct assertion of utility in the disclosure. Only after the PTO
provides evidence showing that one of ordinary skill in the art
would reasonably doubt the asserted utility does the burden
shift to the applicant to provide rebuttal evidence sufficient to
convince such a person of the invention's asserted utility.
Brana, 51 F .3d at 1566 ( citations omitted).
The evidence cited by the Examiner in support of the present rejection
(see generally Non-Final Action 4---6) might suffice if absolute predictability
were the standard for enablement. But it is not sufficient to undermine the
reasonable correlation Appellants draw between their in vitro results and in
vivo efficacy, as evinced by the data in the Specification 5 as well as the pre-
filing supporting references offered in support of the August 20, 2015
Declaration of Dr. Sugiyama. Put differently, by requiring Appellants to
support their treatment claims with in vivo evidence specific to the claimed
peptides, or possibly through some sure-fire correspondence between an in
vitro assay and in vivo efficacy (see, e.g., Ans. 10 ("For a true correlation,
the in vitro assay used by appellant should be correlated to in vivo use either
by appellant ( who shows that the peptide can be effective in vivo) or by a
5 Indeed, referring to Appellants' in vitro data, the Examiner acknowledges
the "multitude of examples" provided in the Specification. Non-Final
Action 3.
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Application 13/143,492
showing that the compound ( any compound that is used in the same in vitro
assay as appellant's) can be effective in vivo for the treatment of cancer."),
the rejection appears to rely on the erroneous premise that absolute
predictability is required to satisfy the enablement requirement of§ 112.
Accordingly, on this record, we cannot conclude that the Examiner
has established a prima facie case of non-enablement, and we cannot sustain
the rejection.
CONCLUSION
The rejection of claims 20, 22, 24, and 26 is reversed.
REVERSED
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