Ex Parte Starck et al

Board of Patent Appeals and Interferences

Jul 18, 2012

11569605 (B.P.A.I. Jul. 18, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/569,605 08/28/2007 Jean-Philippe Starck 06-926 1657
20306 7590 07/18/2012
MCDONNELL BOEHNEN HULBERT & BERGHOFF LLP
300 S. WACKER DRIVE
32ND FLOOR
CHICAGO, IL 60606
EXAMINER
COUGHLIN, MATTHEW P
ART UNIT PAPER NUMBER
1626
MAIL DATE DELIVERY MODE
07/18/2012 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 JEAN-PHILIPPE STARCK and BENOIT KENDA
__________

Appeal 2011-012332
Application 11/569,605
Technology Center 1600
__________

Before LORA M. GREEN, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for treatment of Parkinson’s disease or dopa-responsive dystonia with
benzoxazolone derivatives. The 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
Background
The Specification teaches that “certain benzoxazolone derivatives
demonstrate therapeutic properties which render them useful in a variety of
pharmaceutical indications, and particularly for the symptomatic and/or
prophylactic treatment of movement disorders and/or motor fluctuations, in
particular in Parkinson’s disease” (Spec. 3, ll. 30-34).
The Claims
Claims 14-18 are on appeal. Claims 14 and 16 are
representative and are reproduced below:
14. A method for the symptomatic treatment of
Parkinson's disease or dopa-responsive dystonia in a patient,
the method comprising administering to the patient an
effective amount of a compound according to formula Ia:

or a pharmaceutically acceptable salt thereof, wherein
R1 is selected from hydrogen or C1-4-alkyl unsubstituted or
substituted by hydroxy;
R2 is selected from hydrogen or C1-4-alkyl unsubstituted or
substituted by hydroxy;
R3 is selected from hydrogen or unsubstituted C1-4-alkyl;
R3a is selected from hydrogen or unsubstituted C1-4-alkyl;
R4 is selected from hydrogen, halogen, or C1-4-alkyl
unsubstituted or substituted by a phenyl group;
R5 is selected from hydrogen, halogen, or C1-4-alkoxy
unsubstituted or substituted by a phenyl group;
R6 is selected from hydrogen, halogen, or C1-4-alkoxy
unsubstituted or substituted by a phenyl group; and
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R7 is selected from hydrogen, halogen, or C1-4-alkoxy
unsubstituted or substituted by a phenyl group;
with the proviso that the compound is not 2-(6-bromo-2-
oxo-1,3-benzoxazol-3(2H)-yl)acetamide.

16. The method according to claim 14 wherein the
compound is selected from
2-(6-bromo-2-oxo-1,3-benzoxazol-3(2H)-yl)-N,N-
dimethylacetamide;
2-(2-oxo-1,3-benzoxazol-3(2H)-yl)acetamide;
2-( 6-chloro-2-oxo-l ,3-benzoxazol-3(2H)-yl)acetamide;
2-( 6-chloro-2-oxo-l ,3-benzoxazol-3(2H)-yl)-N,N-
dimethylacetamide; and
N,N-dimethyl-2-(2-oxo-l,3-benzoxazol-3(2H)-yl)acetamide.

The Issue

The Examiner rejected claims 14-18 under 35 U.S.C. § 103(a) as
obvious over Napper1 (Ans. 4-6).
The Examiner finds that “the preferred structural components for the
genus taught by Napper et al. are the same as those instantly claimed.
Furthermore, Napper et al. teach a compound having the following structure
as compound No.6 on page 12 :”
”
(Ans. 6). The Examiner finds that “Appellant has not established
unexpected properties between the instantly claimed compounds [which] are
the closest prior art homologs” (Ans. 9).

1 Napper et al., US 2005/0250794 A1, published Nov. 10, 2005.
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Appellants contend that “Napper’s teaching of dozens of ‘preferred’
subsets of compounds-only one of which overlaps with the compounds
recited in claim 14-must be considered, and weighs against selecting the
recited subgenus” (App. Br. 3). Appellants contend that “Napper's teaching
of the utilities for the disclosed compounds would not have led one of
ordinary skill in the art to the subgenus of compounds recited in claim 14 for
the use recited in the present claims” (App. Br. 4).
Appellants contend that the “Office Action, however, does not explain
why one of ordinary skill in the art would have selected compound No.6 as a
lead compound in the first place” (App. Br. 5). Appellants contend that
even if a person of ordinary skill in the art would have been
led to select the compounds recited in claim 14 (from among
all of the compounds disclosed in Napper) for use in a
method of treating Parkinson's disease (from among all of
the diseases and disorders disclosed in Napper), one of skill
in the art would not have had a reasonable expectation that
the compounds could be successfully used in a method of
treating Parkinson’s disease.

(App. Br. 6).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Napper renders the method of claim
14 obvious?
Findings of Fact
1. Napper teaches:
[T]he compound can be administered in an amount effective
to ameliorate at least one symptom of the disorder. The
disease or disorder can be, e.g., an age associated disorder, a
geriatric disorder, a disorder having an age-associated
susceptibility factor, a neoplastic disorder, a non-neoplastic
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disorder, a neurological disorder, a cardiovascular disorder,
a metabolic disorder, a dermatological disorder, or a
dermatological tissue condition. In one embodiment, the
disease or disorder can be a neurodegenerative disease or
disorder in which the neurodegenerative disorder can be
mediated at least in part by polyglutamine aggregation, e.g.,
Huntington's disease, Spinalbulbar Muscular Atrophy
(SBMA or Kennedy’s Disease) Dentatorubropallidoluysian
Atrophy (DRPLA), Spinocerebellar
Ataxia 1 (SCA1), Spinocerebellar Ataxia 2 (SCA2),
Machado-Joseph Disease (MJD; SCA3), Spinocerebellar
Ataxia 6 (SCA6), Spinocerebellar Ataxia 7 (SCA7), and
Spinocerebellar Ataxia 12 (SCA12). The neurodegenerative
disorder can be Parkinson’s or Alzheimer’s.

(Id. at ¶ 0131.)
2. Napper teaches further that a “compound or library of
compounds described herein can be evaluated in a non-human animal model
of Parkinson’s disease” (Napper 23 ¶ 0317).
3. A portion of Table 2 of Napper is reproduced below:

Table 2 shows Sir2 activity of representative compounds where
“[c]ompounds having activity designated with a B have an IC50 between 1.0
µM and 10.0 µM. Compounds having activity designated with a C have an
IC50 greater than 10.0 µM” (Napper 12 ¶ 0223).
4. Napper teaches that the “term ‘halo’ or ‘halogen’ refers to any
radical of fluorine, chlorine, bromine or iodine” (Napper 9 ¶ 0190).
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5. Napper teaches that in “certain embodiments R42 and R43,
together with the carbons to which they are attached, form phenyl; and are
substituted with halo or C1-C10 alkyl” (Napper 6 ¶ 0123).
6. The Examiner finds that compound 6 has the structure:

The structure shown above is 2-(6-Bromo-2-oxo-benzooxazol-3-yl)-
acetamide.
7. Claim 16 claims a method using the compound 2-(6-chloro-2-
oxo-l ,3-benzoxazol-3(2H)-yl)acetamide (see Claim 16).
Principles of Law
In In re Dillon, 919 F.2d 688, 696 (Fed. Cir. 1990), the Federal
Circuit noted:
In brief, the cases establish that if an examiner considers that
he has found prior art close enough to the claimed invention
to give one skilled in the relevant chemical art the
motivation to make close relatives (homologs, analogs,
isomers, etc.) of the prior art compound(s), then there arises
what has been called a presumption of obviousness or a
prima facie case of obviousness.

In re Dillon, 919 F.2d 688, 696 (Fed. Cir. 1990).

“[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
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with some rational underpinning to support the legal conclusion of
obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
Analysis
We agree with the Examiner that Napper’s disclosure of 2-(6-bromo-
2-oxo-1,3-benzoxazol-3(2H)-yl)acetamide represents a known compound
which would provide motivation to generate homologs, particularly alternate
selections of halogens as disclosed by Napper (FF 3). One such obvious
homolog would be the substitution of chlorine for bromine to result in the
composition in claim 16 of 2-(6-chloro-2-oxo-l ,3-benzoxazol-3(2H)-
yl)acetamide.
However, claims 14-18 are not drawn simply to composition claims,
but rather are drawn to methods of treatment of Parkinson’s disease or dopa-
responsive dystonia by administration of a claimed compound. Napper
never specifically identifies 2-(6-bromo-2-oxo-1,3-benzoxazol-3(2H)-
yl)acetamide, or indeed, any specific compound as useful in the treatment of
Parkinson’s disease. Instead, Napper teaches screening of a library of all of
the compounds, minimally encompassing the 49 diverse compounds of
Tables 2 and 3, and more reasonably encompassing “four broad genera of
compounds, having formula (I), (II), (III) or (IV). . . Only the preferred
subset of formula (IV), with a core shown at paragraph [0221] of Napper,
encompasses any of the compounds recited in claim 14” (App. Br. 3).
We therefore agree with Appellants that there “is nothing in Napper
that would have led one of ordinary skill in the art to use the recited
compounds for treating, in particular, Parkinson’s disease or dopa-
responsive dystonia, as presently claimed” (App. Br. 6).
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Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Napper renders the method of claim 14 obvious.

SUMMARY
In summary, we reverse the rejection of claims 14-18 under 35 U.S.C.
§ 103(a) as obvious over Napper.

REVERSED

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