Ex Parte Beck

Board of Patent Appeals and Interferences

Mar 28, 2011

10473525 (B.P.A.I. Mar. 28, 2011)

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.
10/473,525 05/04/2004 Jurgen K. Beck 20392-00046-US 7231
30678 7590 03/29/2011
CONNOLLY BOVE LODGE & HUTZ LLP
1875 EYE STREET, N.W.
SUITE 1100
WASHINGTON, DC 20006
EXAMINER
JEAN-LOUIS, SAMIRA JM
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
03/29/2011 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JURGEN K. BECK
__________

Appeal 2011-000007
Application 10/473,525
Technology Center 1600
__________

Before ERIC GRIMES, LORA M. GREEN, and STEPHEN WALSH,
Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for treatment of extrapyramidal movement disorders in the form of
levodopa-induced dyskinesias by administering an effective amount of
flibanserin. The Patent Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.

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STATEMENT OF THE CASE
Claims 1, 18, and 39-41 are on appeal. Claim 1 is representative and
reads as follows:
1. A method for the treatment of extrapyramidal movement disorders in
the form of levodopa-induced dyskinesias which comprises administering to
an idiopathic Parkinson's disease patient in need thereof an amount effective
for treating extrapyramidal movement disorders in the form of levodopa-
induced dyskinesias of 2H-Benzimidazol-2-one, 1, 3-dihydro-
1- (2- {4- [3- (trifluoromethyl) phenyl]-1-] [piperazinyl}ethyl) (flibanserin)
or a physiologically acceptable acid addition salt thereof.

The Examiner rejected the claims under 35 U.S.C. § 103(a) as
unpatentable over Borsini1 and Graybiel.2

OBVIOUSNESS
The Issues
The Examiner’s position is that Borsini taught administering
flibanserin to reduce drug-induced motor activity. (Ans. 5.) The Examiner
found that dosages of 4 and 8 mg/kg in mice and 8 mg/kg in rats antagonized
drug-induced hypermotility (i.e., increased motor activity) and stereotypy.
(Id.) The Examiner found that Borsini demonstrated that flibanserin was
able to affect motor activity depending on the test performed and stereotypy.
(Id.) However, the Examiner found that Borsini did not specifically teach a

1 Franco Borsini et al., Behavioral Effects of Flibanserin (BIMT 17), 64
PHARM. BIOCHEM. AND BEHAVIOR 137-146 (1999).
2 Ann M. Graybiel et al., Levodopa-induced dyskinesias and dopamine-
dependent stereotypies: a new hypothesis, 23 TRENDS NEUROSCI. S71-77
(2000).

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method of treating extrapyramidal movement disorders in the form of
levodopa-induced dyskinesia. (Id. at 6.)
The Examiner found that Graybiel taught that differential plasticity in
the striatum and extrastriosomal matrix in the basal ganglia may contribute
to the development of levodopa-induced dyskinesia under Parkinsonian
conditions and dopamine receptor agonist induced sterotypies under normal
conditions. (Id.) The Examiner found that although Graybiel taught that
levodopa induced dyskinesia and stereotypies due to dopamine-receptor
agonists are considered different types of movements, levodopa-induced
dyskinesia and dopamine-dependent stereotypies involve common features
and common pathways. (Id.)
According to the Examiner, a person of ordinary skill in the art at the
time the invention was made would have found it obvious to try flibanserin,
as Borsini taught that flibanserin was effective in antagonizing stereotypies
induced by drugs and Graybiel taught that levodopa-induced dyskinesia and
stereotypies, which can also be present in Parkinson’s Disease patients,
involve common pathways. (Id. at 7.) The Examiner explained that based
on the teachings of Borsini and Graybiel, the artisan would have been
motivated to try flibanserin for the treatment of levodopa-induced dyskinesia
with a reasonable expectation of providing an effective treatment method.
(Id.)
Appellant contends that “the testing reported by Borsini et al. is by no
means relevant to levodopa induced dyskinesia.” (App. Br. 20, citing a
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Declaration by Dr. Johannes Schwarz.3) Appellant also contends that
Graybiel does not overcome the deficiency of Borsini. (App. Br. 22.)
According to Appellants, the disclosure that levodopa-induced dyskinesias
share some common features with dopamine-dependent stereotypies does
not extinguish the fundamental difference between these separate symptoms.
(Id.) Appellant asserts that Graybiel’s disclosure only hypothesized, without
any confirmation, that the shared features of these movement disorders may
suggest that common or overlapping pathway(s) exist. (Id. at 23, 24.)
Further, Appellant asserts that even if Graybiel’s hypothesis on
common pathways is accepted, this does not mean that levodopa-induced
dyskinesias and stereotypies share the same treatment approach. (Id. at 25.)
For example, Appellant asserts that amantadine, an antidyskinetic widely
used in levodopa-induced dyskinesia, provokes stereotypies as side effects.
(Id.) Therefore, Appellant asserts that even if both disorders share some
common pathways, it does not follow that a drug that reduces one will
necessarily reduce the other. (Id. at 27.)
The issue with respect to this rejection is whether the record supports
the Examiner’s conclusion that the cited references would have made the
claimed method of treating levodopa-induced dyskinesias with flibanserin
prima facie obvious.
Findings of Fact
1. We agree with the Examiner’s specific findings regarding the scope
and content of Borsini. (See Ans. 5-7.)

3 “Declaration under 37 CFR § 1[.]132,” dated August 4, 2008, signed by
Professor Dr. Med. Johannes Schwarz.
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2. Graybiel disclosed that levodopa-induced dyskinesias and dopamine-
dependent stereotypies share common features such as similarities in the
neural events that provoke the two behavioral conditions. (Graybiel, S73.)
3. Graybiel stated that “[t]hese shared features suggest that the forms of
neuroplasticity in the two situations – one leading to dyskinesia and the
other to stereotypy – might, actually, be similar.” (Id.)
Principles of Law
“Obviousness does not require absolute predictability of success. . . .
[A]ll that is required is a reasonable expectation of success.” In re
O'Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988). In the absence of a
reasonable expectation of success, one is left with only an “obvious to try”
situation which is not the standard of obviousness under 35 U.S.C. § 103.
Id. at 903.
“[P]atents are not barred just because it was obvious ‘to explore a new
technology or general approach that seemed to be a promising field of
experimentation, where the prior art gave only general guidance as to the
particular form of the claimed invention or how to achieve it.”’ Procter &
Gamble Co. v. Teva Pharmaceuticals USA, Inc., 566 F.3d 989, 997 (Fed.
Cir. 2009) (quoting O'Farrell, 853 F.2d at 903).
Analysis
We agree with Appellant that the evidence of record does not support
the Examiner’s position that an ordinary artisan would have considered it
obvious to treat levodopa-induced dyskinesias with flibanserin. We
acknowledge that Graybiel taught that levodopa-induced dyskinesias and
dopamine-dependent stereotypies share common features such as similarities
in the neural events that provoke the two behavioral conditions. (FF-2.) We
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also acknowledge that Graybiel stated that “[t]hese shared features suggest
that the forms of neuroplasticity in the two situations … might, actually, be
similar.” (FF-3, emphasis added.) However, Graybiel did not state that
dyskinesias and stereotypies “share a common pathway.” Moreover,
Graybiel did not teach that if such a shared common pathway for the
dyskinesias and stereotypies was found to exist, that this result would
suggest that the treatment used for one condition could effectively be used to
treat the other. Thus, the Examiner’s reasoning that while these “movement
disorders are distinct, the fact that Graybiel teaches that they possess
common pathways, effect on one pathway should also affect the L-Dopa
induced pathway” (Ans. 10) is not supported by the record.
At best, the Examiner’s rejection establishes that the combined prior
art would have made it obvious “to explore a new technology or general
approach that seemed to be a promising field of experimentation, where the
prior art gave only general guidance as to the particular form of the claimed
invention or how to achieve it.” Procter & Gamble Co., 566 F.3d at 997,
quoting O'Farrell, 853 F.2d. at 903. However this “obvious to try”
situation is not the standard of obviousness under 35 U.S.C. § 103. See
O'Farrell, 853 F.2d at 903.
Accordingly, we are not persuaded that the Examiner has established
a prima facie case of obviousness, and therefore reverse the rejection.

CONCLUSION OF LAW
The record does not support the Examiner’s conclusion that the cited
references would have made the claimed method of treating levodopa-
induced dyskinesias with flibanserin prima facie obvious.
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SUMMARY
We reverse the rejection of claims 1, 18 and 39-41 under 35 U.S.C.
§ 103(a) as unpatentable over Borsini and Graybiel.

REVERSED

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