Ex Parte Donovan

Board of Patent Appeals and Interferences

May 29, 2012

10194805 (B.P.A.I. May. 29, 2012)

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.
10/194,805 07/11/2002 Stephen Donovan 17510 (BOT) 1686
7590 05/30/2012
STEPHEN DONOVAN
ALLERGAN, INC.
2525 Dupont Drive, T2-7H
Irvine, CA 92612
EXAMINER
SHUKLA, RAM R
ART UNIT PAPER NUMBER
1647
MAIL DATE DELIVERY MODE
05/30/2012 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 STEPHEN DONOVAN
__________

Appeal 2011-012070
Application 10/194,805
Technology Center 1600
__________

Before TONI R. SCHEINER, JEFFREY N. FREDMAN,
ERICA A. FRANKLIN, 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
pharmaceutical composition consisting essentially of a therapeutically
effective amount of a botulinum toxin and at least one enhancing agent. The
Patent Examiner rejected the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.

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STATEMENT OF THE CASE
Claims 1-6 are on appeal. Claim 1 is representative and reads as
follows:
1. A pharmaceutical composition suitable for topical administration, the
composition consisting essentially of:
(a) a therapeutically effective amount of a botulinum toxin; and
(b) at least one enhancing agent capable of increasing the
transdermal delivery of the pharmaceutical composition, the enhancing agent
selected from the group consisting of a short chain alcohol, a long chain
alcohol, a polyalcohol, a polyol, an amine, an amide, a pyrrolidone, a
terpene, a macrocyclic compound, a tenside, an ethosome and any
combination thereof
wherein said pharmaceutical composition is for topical administration
for use in the treatment of wrinkles, such as brow furrows, headaches, such
as migraine, headache pain, cervical dystonia, focal hand dystonia,
neurogenic inflammation, hyperhydrosis, blepharospasm, strabismus,
hemifacial spasm, eyelid disorder, cerebral palsy, focal spasticity, limb
spasticity, tics, tremors, bruxism, anal fissure, fibromyalgia, dysphagia,
lacrimation, and pain from muscle spasms.

The Examiner rejected claims 1-6 under 35 U.S.C. § 103(a) as
unpatentable over Pearce
1
and Bauerova.
2

Claims 2-6 have not been argued separately and therefore stand or fall
with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

OBVIOUSNESS
The Examiner’s position is that Pearce taught compositions
comprising botulinum toxins A-G suitable for topical administration. (Ans.
4-5.) However, the Examiner found that Pearce did not teach adding an

1
US Patent No. 6,087,327 issued to L. Bruce Pearce et al., Jul. 11, 2000.
2
K. Bauerova et al., Chemical enhancers for transdermal drug transport, 26
EUROPEAN J. DRUG METABOLISM AND PHARMACOKINETICS, 85-94 (2001).
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enhancing agent as recited in the claimed invention. (Id. at 5.) The
Examiner found that Bauerova taught chemical enhancers include alcohols
that enhance permeation and rapidly pass through the skin. (Id. at 5-6.)
According to the Examiner, it would have been obvious to a person of
ordinary skill in the art at the time the invention was made to modify the
pharmaceutical compositions for topical administration taught by Pearce to
include a chemical enhancer because Bauerova taught that chemical
enhancers facilitate delivery of compounds through the skin. (Id.at 6.)
Appellant contends that the claimed invention is “limited to
pharmaceutical compositions containing a single botulinum toxin, because
the specification and claims clearly define them to be.” (App. Br. 8-
9)(emphasis added). In particular, Appellant asserts that the Specification
and the claims state “a botulinum toxin,” and “the botulinum toxin.” (Id. at
8.) According to Appellant, such disclosures provide a clear indication of
what the basic and novel characteristics actually are, i.e., “pharmaceutical
compositions comprising a neurotoxin, which are able to be transdermally
administered.” (Id. at 7.) Further, relying on Pearce’s teachings that the
addition of a second botulinum toxin “increases specificity, increases
duration and reduces antigenicity of a composition,” Appellant asserts that
“[t]hese characteristics are indeed basic and novel to the claimed single-
toxin compositions.” (Id. at 9.) Therefore, according to Appellant, these
asserted basic and novel characteristics of the claimed invention would be
materially affected by the addition of a second toxin. (Id.)
In the Response to Appellant’s Arguments, the Examiner states that
the transitional phrase “consisting essentially of” does not limit the claimed
“invention . . . to the use of a single botulinum toxin.” (Ans. 11.) According
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to the Examiner, including a second neurotoxin in a composition comprising
a first neurotoxin, as in Pearce, does not materially affect the basic and novel
characteristics of the composition, as the composition is already a neurotoxin
composition. (Id.) Moreover, Appellant has not provided any evidence that
the addition of a second neurotoxin would materially affect the basic and
novel characteristics of the claimed invention. (Id. at 13.)
“For the purposes of searching for and applying prior art under 35
U.S.C. 102 and 103, absent a clear indication in the specification or claims
of what the basic and novel characteristics are, ‘consisting essentially of’
will be construed as equivalent to ‘comprising.’” PPG Industries v.
Guardian Industries, 156 F.3d 1351, 1354 (Fed. Cir. 1998). It is the
Appellant’s burden to establish that the Specification or claims clearly
indicates the basic and novel characteristics of the claimed invention. See In
re DeLajarte, 337 F.2d 870, 873-74 (CCPA 1964). We do not find that
Appellant has satisfied this burden. According to Appellant, “[t]he
specification is replete with disclosure indicating the composition’s basic
and novel characteristics, including its utilization of a single botulinum
toxin.” (App. Br. 7.) In support of this assertion, Appellant does not allege
that they have defined the scope of the phrase “consisting essentially of” in
their Specification. Rather, Appellant refers to portions of the disclosure and
claims reciting “a neurotoxin” and “the neurotoxin.” (See id. at 7-8.)
However, this evidence does not indicate that the claimed invention should
be limited to single toxin compositions. Indeed, we note that the
Specification states, “Although, the composition may only contain a single
type of neurotoxin, such as botulinum toxin type A, as the active ingredient
to suppress neurotransmission, other therapeutic compositions may include
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two or more types of neurotoxins, which may provide enhanced therapeutic
effects of the disorders.” (Spec. 24 at ll. 11-15.) Further, the Specification
states, “For example, a composition administered to a patient may include
botulinum toxin type A and botulinum toxin type B.” (Id. at ll. 15-17.)
Therefore, giving independent claim 1 the broadest reasonable
interpretation, in light of the Specification, as it would be interpreted by one
of ordinary skill in the art, see In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d
1359, 1364 (Fed. Cir. 2004) we interpret the phrase “consisting essentially
of” as “comprising.” Accordingly, we agree with the Examiner, that claim 1
reads on a composition comprising more than one botulinum toxin, as taught
by the combined prior art.
Each of Appellant’s remaining arguments asserting nonobviousness
are based upon Appellant’s contention that the claimed invention excludes
compositions comprising more than one botulinum toxin and that the
rejection required modifying the composition of Pearce to include only a
single botulinum toxin. (See App. Br. 9-12.) Consequently, we are not
persuaded by these arguments based upon our interpretation that the claimed
invention is not limited to the use of a single botulinum toxin.

SUMMARY
We affirm the rejection of claims 1-6 under 35 U.S.C. § 103(a) as
unpatentable over Pearce and Bauerova.

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

AFFIRMED

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