Ex Parte Heckmann

Patent Trial and Appeal Board

Jul 26, 2018

10490244 (P.T.A.B. Jul. 26, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
10/490,244 10/26/2004
51957 7590 07/30/2018
ALLERGAN, INC.
2525 DUPONT DRIVE, T2-7H
IRVINE, CA 92612-1599
FIRST NAMED INVENTOR
Marc Heckmann
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
17836 (BOT) 3489
EXAMINER
BROWN, COURTNEY A
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
07/30/2018 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
patents_ip@allergan.com
pair_allergan@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARC HECKMANN 1
Appeal2017-006867
Application 10/490,2442
Technology Center 1600
Before RICHARD M. LEBOVITZ, MICHAEL J. FITZPATRICK, and
RYAN H. FLAX, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to methods for the therapy of
bromhidrosis comprising administering botulinus toxin by injection. The
Examiner rejected the claims as obvious under 35 U.S.C. § 103. Appellant
appeals the rejection pursuant to 35 U.S.C. § 134(a). We have jurisdiction
under 35 U.S.C. § 6(b). The rejection is affirmed.
STATEMENT OF THE CASE
Claims 1 and 16-18, which are all the pending claims, stand finally
rejected by the Examiner under 35 U.S.C. § 103(a) as obvious in view of
1 The Appeal Brief ("Br.") 3 lists Allergan, Inc. as the real party in interest.
2 The appealed application's written description is referred to as the
"Specification" or "Spec."
Appeal2017-006867
Application 10/490,244
Massimiliano Filosto et al., Acta neural. belg., 2001, 101, 121-123
(hereinafter "Filosto") and Coleman, III, U.S. Patent 7,507,419 B2 (issued
Mar. 24, 2009) (hereinafter "Coleman").
Claim 1 is the only independent claim on appeal. Appellant states that
the claims are argued together. Br. 9. Consequently, the claims stand or fall
together. Claim 1 is reproduced below:
1. A method for the therapy of bromhidrosis compnsmg
administering between 50 and 100 units of a botulinus toxin type
A to an affected armpit of a subject having bromhidrosis due to
scent gland activity, to treat the bromhidrosis, wherein the
botulinum toxin is administered by injection of skin in the area
to be treated.
REJECTION
Claim 1 is directed to a method of therapy of bromhidrosis.
Bromhidrosis is defined in the Specification as "an extremely strong and
unpleasant occurrence" of a body odor emanating from the scent glands.
Spec. 3 :9-31. The method comprises administering "50 and 100 units of a
botulinus toxin type A to an affected armpit of a subject having
bromhidrosis due to scent gland activity." The botulinus toxin is
administered by injection of the skin in the area to be treated.
The Examiner found that Filosto describes injection of botulinus toxin
type A to treat axillary hyperhidrosis, which is excessive production of
sweat in an armpit. Final Office Action ("Final Act.") 4; see also Filosto
121; Spec. 23-28. Filosto teaches that 200 MU (mouse units) botulinum A
toxin were administered by injection into the armpit ("axillary") of a human.
Filosto 122. Filosto injected singles doses of 20 MU botulinum A toxin
into ten different sites in the armpit. Id. Filosto reported that there was "a
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Application 10/490,244
marked reduction in sweating" two weeks after treatment, which persisted
for five months after treatment. Id.
The Examiner found that Filosto does not expressly teach
administering 50 to 100 units of botulinus toxin by injection into "an
affected armpit" to treat bromhidrosis as required by claim 1. Final Act. 5.
Rather, Filosto teaches injection into the armpit for treating hyperhidrosis.
However, the Examiner found the Coleman teaches treating bromhidrosis,
hyperhidrosis, and other glandular disorders by topically applying botulinus
toxin and that 100 units would be sufficient for a one time treatment of a
single axilla (i.e., armpit) or hand. Id.
The Examiner determined it would have been obvious to one of
ordinary skill to treat bromhidrosis by injection
because the substitution of treating one glandular condition (i.e.
hyperhydrosis [sp., hyperhidrosis]) using injection methods for
treating another glandular condition (i.e., bromhidrosis) using
injection would have yielded predictable result[s] to one of
ordinary skill in the art at the time of the invention.
Final Act. 6.
Appellant contends that Coleman "teaches away" from injecting
botulinus toxin because it discloses that injection-based treatments "' have
several significant drawbacks.'" Appeal Br. 10. Appellant also states that
Coleman is not "combinable with Filosto to render the claimed method
obvious" because "'[i]t is improper to combine references where the
references teach away from their combination. In re Grasselli, 713 F .2d
731,743,218 USPQ 769, 779 (Fed. Cir. 1983), emphasis added'§ MPEP
2145." Br. 10-11. Appellant also contends that Examiner did not provide a
reason to combine the publications. Id. at 11.
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Application 10/490,244
DISCUSSION
Coleman teaches that hyperhidrosis has been treated by injecting
botulinus toxin into the armpit (Coleman 2:5-9), the same disclosure found
in Filosto. Coleman also teaches, as discussed by Appellant, that injection-
based treatments "have significant drawbacks" because of the pain
associated with the injection, the need for numerous sticks, and "having a
medical practi[ti]oner administer each follow-up injection can be time-
consuming, costly, and inconvenient." Coleman 2:9-17. Coleman teaches
that topical administration of botulinus toxin avoids these problems and that
such topical administration can be used to treat various glandular disorders,
including hyperhidrosis and bromhidrosis. Id. at 2:24--48. Thus, one of
ordinary skill in the art upon reading Coleman would have known that
botulinus toxin is effective to treat bromhidrosis (Coleman 2:47--48), but
would have understood that Coleman administers it topically to avoid
painful injection.
However, based on Coleman's teaching that topical application of
botulinus toxin is effective to treat bromhidrosis, one of ordinary skill in the
art would have had reason to believe that injecting botulinus toxin would
also be effective in treating bromhidrosis because injection had been shown
to be effective for treating another sweat gland disorder, namely
hyperhidrosis (Coleman 2:5-9). Appellant did not provide evidence to the
contrary or dispute that injection would have been effective to treat
bromhidrosis as found by the Examiner. Rather, Appellant's principal
argument is that one of ordinary skill in the art would not have administered
botulinus toxin by injection because of the drawbacks (e.g., discomfort and
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Application 10/490,244
inconvenience) mentioned by Coleman, allegedly teaching away from the
claimed invention. Br. 10.
We are not persuaded by Appellant's arguments that Coleman
"teaches away" from injecting botulinus toxin to treat bromhidrosis. While
it is true that injection is less preferred and less desirable, it would have been
expected to work, a fact undisputed by Appellant. That is, Coleman teaches
that botulinus toxin works to treat hyperhidrosis and bromhidrosis, albeit
topically; both Filosto and Coleman teach that injection of botulinus toxin
works to treat hyperhidrosis (Filosto 122; Coleman 2:5-11). Thus, botulinus
toxin would have been expected to work by either topical application or
when injected.
As held by the Court of Appeals for the Federal Circuit:
[A] motivation to use the teachings of a particular prior art
reference need not be supported by a finding that that feature be
the "preferred, or the most desirable." [In re] Fulton, 391 F.3d
[1195] at 1200. Indeed, we have found a reference to not teach
away when, for example, it described a particular composition
"as somewhat inferior to some other product for the same use."
In re Gurley, 27 F.3d 551, 553 (Fed.Cir.1994).
Apple Inc. v. Samsung Electronics Co., Ltd., 816 F.3d 788, 801-802 (Fed.
Cir. 2016).
Consequently, even if injection is considered inferior and not the most
preferred or desirable route of administration, because injection was
expected to work, Coleman does not teach away from administering
botulinus toxin by injecting it into the armpit to treat bromhidrosis.
Appellant contends that the Filosto and Coleman disclosures cannot
be combined because the teachings are conflicting and teach away from the
combination. Br. 10-11.
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Application 10/490,244
This argument does not persuade us that the Examiner erred. First,
Filosto's teaching about the efficacy of treating hyperhidrosis by injection of
botulinus toxin into the armpit is also reported in Coleman. Coleman 2:5-9.
Thus, the argument that the publications cannot be combined is not
persuasive because Coleman contains both teachings.
We also do not agree that the teachings conflict. Coleman describes
an alternative method to treat glandular disorders by topical administration
of botulinus toxin to avoid painful injections. Coleman 2:24--48. It is not a
conflict to use another alternative route of administration, namely injection,
to treat the same disorder with the same drug, i.e., bromhidrosis with
botulinus toxin. "[J]ust because better alternatives exist in the prior art does
not mean that an inferior combination is inapt for obviousness purposes." In
re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012). A reference may be relied
upon for all that it would have reasonably suggested to one having ordinary
skill in the art, including nonpreferred embodiments. See Merck & Co. v.
Biocraft Laboratories, 874 F.2d 804, 807 (Fed. Cir. 1989).
For the foregoing reason, the obviousness rejection of claim 1 and
dependent claims 16-18 is affirmed.
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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