Ex Parte Aoki et al

Board of Patent Appeals and Interferences

Mar 30, 2011

10726904 (B.P.A.I. Mar. 30, 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.
10/726,904 12/02/2003 Kei Roger Aoki 16952CON1CIP3 (BOT) 4172
7590 03/30/2011
STEPHEN DONOVAN
ALLERGAN, INC.
T2-7H
2525 Dupont Drive
Irvine, CA 92612
EXAMINER
GUPTA, ANISH
ART UNIT PAPER NUMBER
1654
MAIL DATE DELIVERY MODE
03/30/2011 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 KEI ROGER AOKI, MICHAEL W. GRAYSTON,
STEVEN R. CARLSON, and JUDITH M. LEON
__________

Appeal 2009-010021
Application 10/726,904
Technology Center 1600
__________

Before TONI R. SCHEINER, DONALD E. ADAMS, and ERIC GRIMES,
Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING
Appellants request reconsideration of the Decision on Appeal entered
May 21, 2010, which affirmed the rejection of claims 1, 2, 4, 5, 29, 47, and
63 on the ground of obviousness.
We have reconsidered our Decision in light of Appellants’ position,
and have modified our Decision only to the extent that we designate our
affirmance a new ground of rejection.
Appeal 2009-010021
Application 10/726,904

2
BACKGROUND
The claimed invention is directed to a method for treating strabismus
by administering a therapeutically effective amount of the neurotoxic
component of a botulinum toxin to a patient, wherein the neurotoxic
component has a molecular weight of about 150 kilodaltons (see claim 1).
The Examiner rejected the claims as obvious over the combined
teachings of Balkan1 or Han2 in view of Kohl,3 Tse,4 and Aoki ‘915.5 The
Examiner took the position that the Han, Kohl and Aoki ‘915 references
were available as prior art against the claimed invention because the claims
in the present application were not enabled as of the December 28, 1993
filing date of abandoned parent application 08/173,996 (Ans. 4-8), largely on
the basis of the teachings of the Schantz reference.6
We determined that the Examiner’s findings and rationale regarding
enablement of the claimed method were not supported by the evidence, and

1 Robert J. Balkan & Taylor Poole, A Five-Year Analysis of Botulinum Toxin
Type A Injections: Some Unusual Features, 23 ANN OPHTHALMOL 326-333
(1991).
2 Sueng Han Han et al., Effect of Botulinum Toxin A Chemodenervation in
Sensory Strabismus, 38 JOURNAL OF PEDIATRIC OPHTHALMOLOGY AND
STRABISMUS 68-71 (2001).
3 A. Kohl et al., Comparison of the effect of botulinum toxin A (Botox ®)
with the highly-purified neurotoxin (NT 201) in the extensor digitorum
brevis muscle test, 15(Suppl 3) MOV DISORD 165 (2000).
4 Chun K. Tse et al., Preparation and Characterisation of Homogeneous
Neurotoxin Type A from Clostridium botulinum, 122 EUR. J. BIOCHEM. 493-
500 (1982).
5 US 6,113,915, issued Sep. 5, 2000 to Aoki et al.
6 Edward J. Schantz & Eric A. Johnson, Properties and Use of Botulinum
Toxin and Other Microbial Neurotoxins in Medicine, 56 MICROBIOLOGICAL
REVIEWS 80-99 (1992).

Appeal 2009-010021
Application 10/726,904

3
therefore, the Han, Kohl and Aoki ‘915 references were not available as
prior art (see Decision 8).
However, we determined that the claimed invention was nevertheless
unpatentable over the two remaining references, Balkan, which discloses
treating strabismus by administering complexed botulinum toxin to humans,
and Tse, which discloses that pure neurotoxin produces paralysis in rat
muscles, and inhibits release of acetylcholine at the vertebrate
neuromuscular junction, just like the corresponding complexed neurotoxin
(see id. at 9). Therefore, we affirmed the rejection of claims 1, 2, 4, 5, 29,
47, and 63 as unpatentable over the combined teachings of Balkan and Tse.
REQUEST FOR REHEARING
Appellants request reconsideration of our decision affirming the
Examiner’s rejection of claims 1, 2, 4, 5, 29, 47, and 63 on the ground of
obviousness.
Appellants contend that the Decision raised a new ground of rejection
without designating it as such, and also misapprehended and overlooked
certain matters of fact and law (Req. Reh’g 1), specifically Appellants’
contention that the Schantz reference taught away from the claimed
invention (id. at 8). Appellants request that the Board either reverse the
obviousness rejection, or formally designate our affirmance a new ground of
rejection and remand the application to the Examiner so that Appellants may
have an opportunity to react to the thrust of the new rejection by submitting
an amendment and/or a showing of additional facts or evidence (id. at 2).
Appeal 2009-010021
Application 10/726,904

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DISCUSSION
Appellants acknowledge that relying on fewer references than the
Examiner did in affirming an obviousness rejection, in and of itself, does not
normally constitute a new ground of rejection (Req. Reh’g 3). However,
Appellants contend that “the basic thrusts of the Board’s rejection and the
Examiner’s rejection are different such that Appellant has not had a fair
opportunity to respond to the thrust of the Board’s rejection, thus the
Board’s ‘affirmed’ rejection constitutes a new ground of rejection” (id.).
Appellants contend that:
The basic thrust of the Examiner’s rejection is that
Balk[a]n teaches the treatment of strabismus in humans using
complexed botulinum toxin type A while the combination of
Kohl, Tse, and Aoki ‘915 allegedly suggests, with the legally
required reasonable expectation of success, that a person having
ordinary skill in the art would substitute the purified neurotoxic
component of botulinum toxin for the complexed botulinum
toxin of Balk[a]n. Clearly, any rebuttal of this rejection
directed, for example, toward the reasonable expectation of
success of the suggested substitution allegedly provided by the
combination of Kohl, Tse, and Aoki ‘915 must address the
combination of the Kohl, Tse, and Aoki ‘915 teachings and not
the teachings of any one of these references individually or in
isolation.
(Req. Reh’g 3.)
On the other hand, the basic thrust of the Board’s
rejection . . . is that Balk[a]n teaches the treatment of strabismus
in humans using complexed botulinum toxin type A while Tse
alone allegedly suggests, with the legally required reasonable
expectation of success, that a person of ordinary skill in the art
should substitute the purified neurotoxic component of a
botulinum toxin for the complexed botulinum toxin of Balk[a]n.
(Id. at 4.)
Appeal 2009-010021
Application 10/726,904

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Appellants argue that
[T]he basic thrusts of the Board’s rejection and the Examiner’s
rejection are fundamentally different in that the Board’s
rejection . . . requires an analysis of the prior art from the
perspective of an ordinary skilled artisan as of December 28,
1993 . . . while the Examiner’s rejection required an analysis of
the prior art from the perspective of an ordinary skilled artisan
as of May 21, 2003 . . . As such, Appellant has not had a fair
opportunity to respond to the Board’s new rejection based on
Tse by itself with Balk[a]n from the perspective of an ordinary
skilled artisan as of December 28, 1993.
(Id. at 5.)
At first blush, it is not readily apparent how an argument or evidence
establishing the lack of a reasonable expectation of success based on the art
available in 2003 would not have been equally applicable ten years earlier in
1993. However, the obviousness rejection in this case has the added
complication of incorporating an enablement issue.
That is, the Examiner cited Schantz as evidence of lack of enablement
as of the December 28, 1993 filing date of the parent ‘996 application (Ans.
4-8). Appellants, on the other hand, contended that in relying on Schantz,
the Examiner “failed to consider the evidence as a whole, including the
guidance and working examples in the ‘996 specification” (App. Br. 9), as
supported by several articles addressed in the Smith7 Declaration, some of
which were published before the filing date of the ‘996 application (id. at 9,
11). Appellants discussed the prosecution history of the present application,
and noted that in responding to a previous obviousness rejection, in
discussing the Examiner’s finding of lack of enablement, that “statements in

7 Declaration of Dr. Leonard A. Smith, dated November 20, 2007, and
submitted December 20, 2007 under the provisions of 37 C.F.R. § 1.132.
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Schantz teach away from the claimed invention” (App. Br. 12). We
recognize that, in this context, an analysis of the state of the prior art, as a
whole, from the perspective of the ordinary artisan in 1993 could be very
different from an analysis from the perspective of the ordinary artisan in
2003. Moreover, we are mindful that the Examiner apparently informed
Appellants that the obviousness rejection would be withdrawn if the claims
were determined to be entitled to the priority date of the parent application.8
Therefore, in the interest of procedural fairness, we have modified our
Decision to the extent that we designate our affirmance in the Decision
entered May 21, 2010 a new ground of rejection. We decline to reverse the
obviousness rejection on the basis of Appellants’ argument that we only
considered Schantz’s relevance in terms of enablement, and did not consider
its import as a teaching away, as that issue was not properly raised in the
Appeal Brief.9

8 See Appellants’ Interview Summary (p. 4, ¶ 3) submitted June 4, 2007,
summarizing the substance of an interview conducted with the Examiner on
May 23, 2007.
9 Appellants point to page 12 of their Appeal Brief in arguing that we did
not properly consider the relevance of Schantz as a teaching away.
However, that portion of the Brief is essentially a partial summary of the
prosecution history of this application, and merely states that in an earlier
response dated September 26, 2006, “Appellants argued, in response to an
obviousness rejection, that the statements in Schantz teach away from the
claimed invention.” Appellants have not pointed us to any discussion of the
merits of Schantz as a teaching away which we overlooked or
misapprehended.
Appeal 2009-010021
Application 10/726,904

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TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37
C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review.
37 C.F.R. § 41.50(b) also provides that the appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence
relating to the claims so rejected, or both, and have the
matter reconsidered by the examiner, in which event the
proceeding will be remanded to the examiner . . . .

(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record
. . . .

GRANTED-IN-PART; 37 C.F.R. § 41.50(b)

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