Ex Parte Hunt

Board of Patent Appeals and Interferences

Jan 25, 2012

11539778 (B.P.A.I. Jan. 25, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte TERRENCE J. HUNT
__________

Appeal 2011-010449
Application 11/539,778
Technology Center 1600
__________

Before ERIC GRIMES, LORA M. GREEN, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to
pharmaceutical compositions comprising botulinum toxin. The Examiner
has rejected the claims as obvious. We have jurisdiction under 35 U.S.C.
§ 6(b). We reverse.
STATEMENT OF THE CASE
The Specification discloses a “botulinum toxin pharmaceutical
composition wherein the primary stabilizer present in the formulation is a
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polysaccharide” (Spec. 29). The Specification discloses “a pharmaceutical
composition comprising a botulinum toxin and a collagen for use to treat a
variety of conditions wherein the botulinum toxin acts to paralyze a muscle
and the collagen acts to provide a dermal filler” (id. at 55).
Claims 12 and 15-30 are on appeal. Claim 12 is representative and
reads as follows:
12. A pharmaceutical composition comprising a collagen, a
polysaccharide and a botulinum toxin.

The Examiner has rejected claims 12 and 15-30 under 35 U.S.C.
§ 103(a) as being obvious in view of Carruthers,
1
Khawaja,
2
Sarno,
3
and
Hussain.
4

The Examiner finds that Carruthers discloses that “marionette lines
are cosmetic effects of loss of collagen … [and] that pharmaceutical
compositions comprising botulinum toxin (Botox®) can be used to treat
downturned mouth or sad mouth” (Answer 4-5). The Examiner finds that
Carruthers suggests “that collagen can be used … as a soft filling treatment
for [a] patient with marionette lines” (id. at 5). The Examiner finds that the
other cited references would have suggested substituting a polysaccharide
for the albumin conventionally used in botulinum toxin compositions (id. at
5-7), and the combination of collagen and botulinum toxin would have been

1
Carruthers et al., US 6,358,917 B1, issued Mar. 19, 2002.
2
Hassan Abbas Khawaja, MD and Enrique Hernandez-Perez, MD, Botox in
dermatology, 40 INTERNATIONAL JOURNAL OF DERMATOLOGY 311-317
(2001).
3
Sarno et al., US 5,945,098, issued Aug. 31, 1999.
4
Hussain et al., US 5,704,297, issued Jan. 6, 1998.
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obvious because “Carruthers et al teach that both botulinum toxin and
collagen can be used to treat cosmetic conditions such as downturned mouth
or sad mouth caused by marionette lines” (id. at 7).
Appellant argues, among other things, that the composition of claim
12 would not have been obvious in view of the cited references because
“Carruthers unambiguously teaches two separate procedures, one involving
the use of botulinum toxin for partial paralysis of muscles, and another
involving the use of collagen” (Appeal Br. 10). Appellant argues that
“Carruthers does not teach or suggest … pharmaceutical compositions
comprising a collagen … and a botulinum toxin” (id.).
We agree with Appellant that the Examiner has not adequately
explained why, based on the cited references, one of ordinary skill in the art
would have considered it obvious to form a pharmaceutical composition that
comprises both botulinum toxin and collagen.
Carruthers discloses that “[m]arionette lines are … often caused by a
loss of dermal collagen in the lower lips and chin area as a result of aging”
(Carruthers, col. 1, ll. 11-13). Carruthers discloses that marionette lines “are
usually accompanied by a downturn at the corners of the mouth” (id. at col.
1, ll. 13-16). Carruthers discloses “the use of Botulinum toxin (BTX) to
cause paralysis of a depressor anguli oris (DAO) musculature in a patient to
alleviate downturn at corners of the patient’s mouth” (id. at col. 2, ll. 38-41).
Carruthers discloses that the “[i]njection may be made into any part of the
DAO musculature. The injection is intramuscular.” (Id. at col. 4, ll. 28-29.)
Carruthers discloses that “[i]n the case of very deep Marionette lines,
performance of this invention may be followed by soft tissue filling treatment
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such as collagen, Hylafor™, Restlyane™ (soft form) or Gore-Tex™
implants” (id. at col. 4, ll. 54-58, emphasis added).
Thus, while Carruthers discloses that collagen injections and
botulinum toxin injections may be used in combination to treat marionette
lines, it expressly discloses that these are separate treatments. Further,
Carruthers discloses that marionette lines are due to the loss of collagen and
can be treated by injection of collagen to achieve soft tissue filling, while
botulinum toxin is administered by intramuscular injection to achieve
muscle paralysis. Since Carruthers suggests that botulinum toxin and
collagen are administered differently – by intramuscular injection and as soft
tissue filling, respectively – the Examiner has not adequately explained why
Carruthers would have made obvious the combination of botulinum toxin
and collagen in the same composition.
Thus, the rejection of claim 12, and dependent claims 15-27, as being
obvious in view of Carruthers, Khawaja, Sarno and Hussain is reversed.
Claims 28 and 30, the only other independent claims, are also directed to
pharmaceutical compositions that comprise both a botulinum toxin and a
collagen. Thus, the rejection of claims 28 and 30, and dependent claim 29,
is also reversed.
SUMMARY
We reverse the rejection of claims 12 and 15-30 under 35 U.S.C.
§ 103(a).

REVERSED
cdc