Catherine Rougeot

Patent Trials and Appeals Board

Oct 4, 2019

14730396 - (D) (P.T.A.B. Oct. 4, 2019)

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.
14/730,396 06/04/2015 Catherine ROUGEOT DI2008-06-B 1724
76392 7590 10/04/2019
ARRIGO, LEE, GUTTMAN & MOUTA-BELLUM LLP
2200 Pennsylvania Ave NW
Suite 400E
WASHINGTON, DC 20037
EXAMINER
CHERNYSHEV, OLGA N
ART UNIT PAPER NUMBER
1649
NOTIFICATION DATE DELIVERY MODE
10/04/2019 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):
SAL@ARRIGO.US
legaladmin@arrigo.us
scott@arrigo.us
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte CATHERINE ROUGEOT
____________

Appeal 2018-007103
Application 14/730,396
Technology Center 1600
____________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
RYAN H. FLAX, Administrative Patent Judges.

FLAX, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims to a method for treating pain. Appellant1 appeals the Examiner’s
rejection of claims 17–29 for obviousness-type double patenting is
appealed.2 We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 “Appellant” herein refers to the “applicant” as defined by 37 C.F.R. § 1.42.
Appellant identifies itself, “Institut Pasteur,” as the real party-in-interest.
Appeal Br. 3.
2 Oral argument was heard on September 24, 2019; a transcript of the
hearing will be made a part of the record in due course.
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STATEMENT OF THE CASE
The Specification states that “[t]he present invention relates to
peptides derived from human BPLP (Basic Proline-rich Lacrimal Protein)
protein coded by the Prol1 gene, notably opiorphin, for use as
psychostimulanting [sic] agents. The invention also relates to the use of
such peptides for preparing a psychostimulant drug.” Spec. 1:3–6. The
Specification further explains, “[p]sychostimulant agents are psychotropic
substances considered as psychic stimulants, which accelerate the activity of
the nervous system and stimulate the motivation and well-being.” Id. at 1:7–
9. The Specification further explains, “[p]sychostimulants act by stimulating
neurotransmission. They are used for treat[ing] various symptoms including
vigilance drop, narcolepsy, obesity, attention deficit and/or hyperactivity in
children, obsessive-compulsive disorders (OCD), depression, mania and
bipolar disease.” Id. at 1:14–17. To summarize the inventor’s discovery and
the invention’s point of novelty, the Specification states:
The inventors have [sic inventor has] found that,
surprisingly, opiorphin not only has analgesic properties, but also
a psychostimulant effect. Further, this psychostimulant effect is
not associated with any adverse effect of the amnesia, sedation,
hyperactivity or addiction type. Finally, it was found that the
analgesic potency of opiorphin is as powerful as that of morphine
and that its psychostimulant potency is as powerful as that of
imipramine.
Therefore, opiorphin and derived peptides may
advantageously be used as psychostimulants for treating or
preventing diseases such as narcolepsy, hypersomnia, vigilance
drop, attention deficit in adults and in children, hyperactivity in
adults and in children, attention-deficit/hyperactivity disorder
(ADHD), obsessive-compulsive disorders (OCD), and mood
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disorders such as depression, bipolar disease, dysthymic disorder
and cyclothymic disorder.
Id. at 3:4–15; see also id. at 14:1–2 (“the invention relates to peptides
according to the invention, described in the above paragraph, for a use as
psychostimulants.”), id. at 15:31–16:3 (defining “psychostimluant agent”),
id. at 17–18 (describing effective doses for psychostimulation). The
Specification also discloses the use of opiorphin as an analgesic and
discloses examples relating to testing rats’ pain responses after
administration of opiorphin. Id. at 21–37.
Independent claim 17, which is representative, states:
17. A method for treating pain comprising
administering a dose of 10-300 mg/day of a peptide consisting of
the sequence Gln-Arg-Phe-Ser-Arg (SEQ ID NO:2) or Glp-Arg-
Phe-Ser-Arg (SEQ ID NO:55) for 7 days.
Appeal Br. 19 (Claims Appendix).
The following rejection is on appeal:
Claims 17–29 stand rejected on the ground of obviousness-type
double patenting over claims 1, 3, 5, 6, 8, 10, 11, and 14 of U.S. Patent
9,403,871 B2 (issued Aug. 2, 2016) (“the ’871 patent”). Final Action 3;
Answer 4.
DISCUSSION
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability.
[Once] . . . that burden is met, the burden of coming forward with evidence
or argument shifts to the applicant.” In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992). Arguments made by Appellants in the Appeal Brief and
properly presented in the Reply Brief have been considered; arguments not
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so-presented are waived. See 37 C.F.R. § 41.37(c)(1)(iv) (2017); see also Ex
parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative) (“Any
bases for asserting error, whether factual or legal, that are not raised in the
principal brief are waived.”).
“[T]he law of obviousness-type double patenting looks to the law of
obviousness generally. As . . . explained in Amgen, ‘[t]his part of the
obviousness-type double patenting analysis is analogous to an obviousness
analysis under 35 U.S.C. § 103.’” AbbVie Inc. v. The Mathilda and
Terrence Kennedy Inst. of Rheumatology Trust, 764 F.3d 1366, 1378 (Fed.
Cir. 2014); see also In re Braithwaite, 379 F.2d 594, 600 n.4 (CCPA 1967)
(A nonstatutory double patenting rejection is “analogous to the
nonobviousness requirement of 35 U.S.C. 103,” except that only the claims
of, not the disclosure of, the reference patent underlying the double patenting
rejection is considered prior art).
Even though the specification of the applied patent or co-pending
application is not technically considered to be prior art for obviousness-type
double patenting, it may still be used to interpret the applied claims. As held
in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 611 F.3d 1381,
1387 (Fed. Cir. 2010):
In Geneva [Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349
F.3d 1373 (Fed. Cir. 2003)], we acknowledged the general rule
that an earlier patent’s specification is not available to show
obviousness-type double patenting. 349 F.3d at 1385. We have
held, however, that there are “certain instances” where the
specification of an earlier patent may be used in the obviousness-
type double patenting analysis. In re Basell [Poliolefine Italia
S.P.A., 547 F.3d 1371, 1378 (Fed. Cir. 2008).] Specifically, the
specification’s disclosure may be used to determine whether a
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claim “merely define[s] an obvious variation of what is earlier
disclosed and claimed,” “to learn the meaning of [claim] terms,”
and to “interpret [ ] the coverage of [a] claim.” Id. As we
recognized in Geneva, a court considering a claim to a compound
must examine the patent’s specification to ascertain the coverage
of the claim, because a claim to a compound “[s]tanding alone
. . . does not adequately disclose the patentable bounds of the
invention.” 349 F.3d at 1385. In examining the specification of
the earlier patent, the court must consider “the compound’s
disclosed utility.” Id.
With these standards in mind, we address the Examiner’s rejection
and Appellant’s arguments there-over.
The Examiner determined claims 17–29, although not identical to, are
obvious in view claims 1, 3, 5, 6, 8, 10, 11 and 14 of the ’871 patent. Final
Action 3; Answer 4. The Examiner determined that the ’871 patent’s claims
are directed to treating pain by administering the same peptides as the
appealed claims, at a dosage range overlapping the claimed dosage range.
Answer 5. Regarding the ’871 claim term “pain,” the Examiner determined
the scope of this term included acute or chronic pain. Id. (citing ’871 patent
18:45). Regarding the ’871 claim term “administering,” the Examiner
determined that the scope of this term included, inter alia, intravenous
administration. Id. (citing ’871 patent 16:58–60).
The Examiner identified the differences between the appealed claims
and those of the ’871 patent as follows:
the difference between the scope of the instant claims and the
claims for which patent protection has already been granted is as
follows: the patented claims (1) do not recite dose of 10-300
mg/day, (2) do not recite any duration of the treatment, such as
specifically 7 days; and (3) do not recite intravenous
administration.
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Id. Regarding the claimed 7-day treatment duration, the Examiner
determined that, because the claimed treating pain included within its scope
treating chronic pain, it would be obvious, as reasonably expected, to
continue to treat chronic pain until the pain is alleviated, making treating for
a week obvious. Regarding the claimed daily dose of 10–300 mg/day, the
Examiner determined “[i]t is reasonable to interpret that treatment
‘administering a dose of 10-100 mg of the peptide’ occurs at intervals
necessary to alleviate pain, starting with daily administration.” Id. at 6.
We discern no error in the Examiner’s determinations and adopt the
Examiner’s findings of fact and rationale regarding obviousness-type double
patenting. We address Appellant’s arguments below.
Appellant argues “[t]he Examiner does not point to any evidence to
support her conclusions regarding motivation, and does not address
expectation of success at all.” Appeal Br. 8. Appellant further argues,
The Examiner does not point to anything in U.S. Patent No.
9,403,871 that discloses the particular dosing regimen claimed
by Appellant. In addition, the Examiner provides no evidence
supporting her conclusions and does not identify any reason that
would have led the skilled artisan to modify the patented method
to make the claimed method with a reasonable expectation of
success.
Id. at 11. Appellant makes several other points along this same line of
reasoning.3 We do not find Appellant’s arguments persuasive.
As a starting point, the claims of the ’871 patent are directed to “[a]
method for treating pain,” which comprises “administering an effective

3 Appellant does not brief any arguments concerning secondary indicia of
non-obviousness, e.g., unexpected results, in the Appeal Brief. See
generally Appeal Br. and Reply Br.
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amount of” the peptide “Glu-Arg-Phe-Ser-Arg,” which is the same peptide
sequence expressly recited in the appealed claims and corresponding to SEQ
ID NO:2. ’871 patent 41:26–40. The ’871 patent also claims (see, e.g.,
claim 8) that this peptide is administered at a dose of 10–100 mg, again, for
the purpose of treating pain, also as recited by appealed claim 1. Id. at
42:30–31.
As noted above, when analyzing the patentability of claims under the
doctrine of obviousness-type double patenting, the reference patent’s
specification may be examined and considered to ascertain the meaning and
scope of claim language and when analyzing whether a claim in the
application defines an obvious variation of an invention claimed in the
reference patent. Sun Pharmaceutical, 611 F.3d at 1387. As did the
Examiner, we consult the ’871 patent’s disclosure, not as prior art, but for
these purposes.
In determining what the ’871 patent’s claim term “pain” includes
within its scope, we find, as did the Examiner, that it includes at least “acute
pain” and “chronic inflammatory pain such as arthritis or inflammatory
bowel disease.” ’871 patent 18:15–17; see also Answer 5. In determining
what the ’871 patent’s claim term “effective amount of an isolated peptide”
includes within its scope, we find, as did the Examiner, that it includes a
therapeutic mixture including about 0.0001 to 100 milligrams of the peptide,
or, most preferably, 10–100 milligrams per dose, and that “[m]ultiple doses
can also be administered.” ’871 patent 16:49–57; see also Answer 5. For
example, claim 8 of the patent, as pointed out above, expressly claims “a
dose of 10-100 mg of the peptide.” In determining what the ’871 patent’s
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claim term “administering” includes within its scope, we find, as did the
Examiner, that it includes “topical, oral, sublingual, parenteral, intranasal,
intravenous, intramuscular, subcutaneous, transcutaneous or intraocular
administration and the like.” ’871 patent 14:67–15:2; see also Answer 5.
In determining whether a treatment period of 7 days, as claimed,
would be an obvious variant of the method claimed in the ’871 patent, we
consider, as did the Examiner, that the type of pain disclosed and claimed as
being treated in the ’871 patent includes chronic pain, which by its very
persisting or reoccurring nature may last several days. Thus, based on the
claims of the ’871 patent, which encompass treating chronic pain, one of
ordinary skill in the art would have found it obvious to treat such pain for 7
days (and more) because of its persistent nature. See Answer 5 (“It would
have been further obvious for one of ordinary skill in the art to treat chronic
pain by the methods of claims 1, 3, 5, 6, 8, 10, 11 and 14 of the [’]871
patent, which would require treatment for several days, as needed, including
7 days where appropriate.”). Such a conclusion is reasonable because, as
determined by the Examiner, “[i]t is reasonable to interpret that treatment
‘administering a dose of 10-l00 mg of the peptide’ occurs at intervals
necessary to alleviate pain, starting with daily administration” and if pain
persists, chronically, to a second day, treatment should likewise extend to
the second day, and so on to the claimed 7 days (or beyond). See Answer 6.
As noted above, we agree with and adopt the Examiner’s findings of
fact and rationale regarding the obviousness of the claims. We discern no
error in the Examiner’s determinations, which we conclude, after
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considering Appellant’s arguments in their entirety, establish that the
rejected claims are obvious over those of the ’871 patent.
CONCLUSION
In summary, the obviousness-type double patenting rejection of
claims 17–29 is affirmed.
Claims Rejected Basis Affirmed Reversed
17–29
obviousness-
type double
patenting US
9,403,871 B2
17–29

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED