Ex Parte HeckmannDownload PDFPatent Trial and Appeal BoardJul 26, 201810490244 (P.T.A.B. Jul. 26, 2018) Copy Citation 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 2 Appeal2017-006867 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. 3 Appeal2017-006867 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 4 Appeal2017-006867 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. 5 Appeal2017-006867 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 6 Copy with citationCopy as parenthetical citation