Ex Parte Borlongan et al

Patent Trial and Appeal Board

May 21, 2013

10218893 (P.T.A.B. May. 21, 2013)

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.
10/218,893 08/14/2002 Cesario V. Borlongan UTSE:096US 3508
7590 05/22/2013
FULBRIGHT & JAWORSKI L.L.P.
A REGISTERED LIMITED LIABILITY PARTNERSHIP
600 CONGRESS AVENUE, SUITE 2400
AUSTIN, TX 78701-3271
EXAMINER
LOVE, TREVOR M
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
05/22/2013 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte CESARIO V. BORLONGAN,
DONALD E. MOSS, and ISABEL C. SUMAYA
__________

Appeal 2011-009584
Application 10/218,893
Technology Center 1600
__________

Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
JOHN G. NEW, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of treating a mammal for cognitive deficits resulting after an oxygen
deficit in the brain, a method of reducing stroke-induced cognitive deficits,
and a method of reducing stroke-induced loss of function in a tissue distal to
the stroke site in a mammal. The Patent Examiner rejected the claims as
obvious and on the ground of non-statutory obviousness-type double
patenting. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

Appeal 2011-009584
Application 10/218,893

2
STATEMENT OF THE CASE
The invention concerns “methods of improving cognitive deficits
which occur following stroke or other conditions with interfere with the
brain receiving the necessary blood supply or oxygen.” (Spec. 2, ll. 7-10.)
Claims 1, 3-14, 20 and 21 are on appeal. Claim 1 is representative
and reads as follows:
1. A method of treating a mammal for cognitive deficits resulting after
an oxygen deficit in the brain comprising the step of administering to said
mammal, within 24 hours of said deficit, a dose of a sulfonyl fluoride
effective to treat said oxygen deficit in the brain, wherein said sulfonyl
fluoride is selected from the group consisting of methanesulfonyl
fluoride and ethanesulfonyl fluoride.

The Examiner rejected the claims as follows:
• claims 1, 3-14, 20 and 21 under 35 U.S.C. § 103(a) as unpatentable
over Izumi,1 Scremin,2 and Moss;3
• claims 1, 3-14, 20 and 21 on the ground of non-statutory
obviousness-type double patenting as unpatentable over claims 5-13 of
Moss.
OBVIOUSNESS
The Examiner’s position is that the claimed methods would have been
obvious to a person of ordinary skill in the art at the time of the invention
because:
Izumi teaches immediate treatment with pyruvate and

1 US Patent No. 5,395,822 issued to Yukitoshi Izumi et al., Mar. 7, 1995.
2 US Patent No. 5,798,392 issued to Donald Eugene Moss, Aug. 25, 1998.
3 AM Scremin et al., Survival under hypoxia. Age dependence and effect of
cholinergic drugs, 11 STROKE, 548-552 (1980).

Appeal 2011-009584
Application 10/218,893

3
additional additives such as antithrombolytics
and NMDA receptor blockers, Scremin teaches the role
of cholinergic mechanisms in the adaptation of brain
tissue to oxygen related deficiencies, and Moss
teaches the importance of cholinergic function with
regard to cognitive function, wherein Moss further
teaches that 0.15-0.5 mg/kg of methanesulfonyl fluoride
is useful for inhibiting acetylcholinesterase. There would
be a reasonable expectation of success since Izumi,
Scremin, and Moss are all directed to neurological
deficits associated with oxygen deficiency, wherein
Scremin provides clear correlation between the absence
of oxygen (which can be caused by hypoxia or ischemia)
and the cholinergic mechanisms effect.

(Ans. 13.)

Appellants contend “that there is no reasonable basis for combining
[the] references other than improper hindsight.” (Reply Br. 5.) In particular,
Appellants assert that Izumi’s teachings are limited to the use of pyruvate,
and the Examiner has provided no explanation as to why teachings related to
the administration of pyruvate would be instructive with respect to the use of
a cholinesterase inhibitor such as sulfonyl fluoride. (Reply Br. 5; App. Br.
12.) Further, Appellants assert that there would have been “no reason to
draw any expectation of success from the prior art given that (a) Scremin
and Izumi dealt with prevention, not treatment, of hypoxia, and (b) Moss…
dealt with a completely different disease state [i.e., Alzheimer’s and not
stroke].” (Reply Br. 5.)
We agree with Appellants. The Examiner reasoned that a person of
ordinary skill in the art at the time of the invention would have been
motivated to treat a mammal suffering from hypoxia by administering
methanesulfonyl fluoride with a reasonable expectation of success because
Appeal 2011-009584
Application 10/218,893

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Izumi, Scremin, and Moss are all directed to neurological deficits associated
with oxygen deficiency. (Ans. 13.) However, as Appellants have asserted,
the drug described in Izumi is unrelated to a sulfonyl fluoride and the
evidence does not provide any suggestion to substitute sulfonyl fluoride for
Izumi’s drug as a treatment administered after the onset of an event that
triggers neurodegeneration.
Moreover, while Moss disclosed a treatment comprising sulfonyl
fluoride, such treatment was for Alzheimer’s disease. (Moss Abstract.)
Appellants have provided persuasive declaratory evidence that Vascular
Dementia (e.g., secondary to stroke) and Dementia of the Alzheimer Type
are significantly different pathologically, biochemically, and
pharmacologically, such that “there is no predictability that a type of
treatment effective in one condition would also be so in the other.” (See,
e.g., Dec. of Dr. Ruggero G. Fariello, M.D, FAAN, ¶ 2.)
Further, we agree with Appellants that Scremin is concerned with the
effectiveness of administering a cholinesterase inhibitor in mice prior to
subjecting them to hypoxic hypoxia to prolong survival (Scremin 548) rather
than treating the subject with a cholinesterase inhibitor after such an event to
improve cognitive function.
Thus, we find that the Examiner’s cited art is, at best, only
tangentially related and does not provide “some rational underpinning” to
support a motivation to combine their teachings to yield the claimed
invention. See KSR Int’l Co. v. Teleflex Inc., 550 U.S 398, 418
(2007)(quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
Accordingly, we reverse the Examiner’s obviousness rejection.

Appeal 2011-009584
Application 10/218,893

5
NONSTATUTORY OBVIOUSNESS-TYPE DOUBLE PATENTING
The Examiner’s position is that claims 1, 3-14, 20, and 21 are directed
to an invention not patentably distinct from claims 5-13 of Moss, in view of
Izumi and Scremin. (Ans. 3.) The Examiner’s findings relating to Moss,
Izumi, and Scremin are the same as set forth in the obviousness rejection.
(See Ans. 3-5 and 11-14.)
Claims 5 through 13 of Moss are directed to a method of treating
Alzheimer’s disease in a human by administering a therapeutically effective
dose of sulfonyl fluoride. As discussed with respect to the obviousness
rejection, we find that Appellants have provided persuasive declaratory
evidence that Vascular Dementia (e.g., secondary to stroke) and Dementia of
the Alzheimer Type are significantly different pathologically, biochemically,
and pharmacologically, such that “there is no predictability that a type of
treatment effective in one condition would also be so in the other.” (See,
e.g., Dec. of Dr. Ruggero G. Fariello, M.D, FAAN, ¶ 2.) Such differences
between the claimed subject matter render the Moss claims and the claims of
the instant application patentably distinct. See Eli Lilly & Co. v. Barr Labs.,
Inc., 251 F.3d 955, 968 (Fed Cir. 2001).
Accordingly, we reverse the nonstatutory obviousness-type double-
patenting rejection.

SUMMARY
We reverse each of the Examiner’s rejections.

REVERSED
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