Ex Parte ArmstrongDownload PDFPatent Trial and Appeal BoardDec 20, 201612834198 (P.T.A.B. Dec. 20, 2016) Copy Citation 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. 12/834,198 07/12/2010 David Nigel Armstrong 036411-000001 8028 24239 7590 12/22/2016 MOORE & VAN AT .TEN PLLC P.O. BOX 13706 3015 Carrington Mill Boulevard, Suite 400 Research Triangle Park, NC 27709 EXAMINER SOROUSH, LAYLA ART UNIT PAPER NUMBER 1627 NOTIFICATION DATE DELIVERY MODE 12/22/2016 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): iplaw @ mvalaw. com u sptomail @ m valaw. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DAVID NIGEL ARMSTRONG1 Appeal 2015-000966 Application 12/834,198 Technology Center 1600 Before ERIC B. GRIMES, RICHARD J. SMITH, and RACHEL H. TOWNSEND, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35U.S.C. § 134 involving claims to a treatment method, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE “Metronidazole ... is a synthetic antibacterial and antiprotozoan antibiotic .... The antibiotic has been used for many years in its oral or intravenous form, to treat inflammatory conditions.” (Spec. 1:12—14.) The 1 Appellant identifies the Real Party in Interest as S.L.A. Pharma AG. (Appeal Br. 3.) Appeal 2015-000966 Application 12/834,198 Specification also states that “the oral form is used to treat inflammatory conditions of the perianal region or anal canal such as . . . post-surgical wounds.” {Id. at 1:16—18.) The Specification states that “there is no disclosure of the direct application of metronidazole into the rectum or distal colon (as for example a suppository, foam or enema) in the treatment of inflammatory disease.” {Id. at 2:8—10.) Claims 1—11, 17—20, 22, 24, and 26—32 are on appeal. Claim 1 is the only independent claim and reads as follows: 1. A method of relieving pain or promoting wound healing in a patient following a surgical operation to the colon, rectum, anorectum or perianal region of patient, said method comprising: applying directly to the colon, rectum, anorectum or perianal region of patient affected by the surgical operation a topical composition, wherein the topical composition consists essentially of metronidazole in a therapeutically effective concentration of 10 wt % in a pharmacologically acceptable non- aqueous vehicle, wherein metronidazole is the sole active agent in said topical composition for relieving pain or promoting wound healing in the patient. DISCUSSION The Examiner has rejected claims 1—11, 17—20, 22, 24, and 26—30 under 35 U.S.C. § 103(a) as obvious based on Urbanek2 and Wenshan3 (Ans. 2.) The Examiner has rejected claims 31 and 32 under 35 U.S.C. § 103(a) as obvious based on Urbanek, Wenshan, and Romer4 (Ans. 4). The same issue is dispositive for both rejections. 2 Urbanek et al., Vulval Crohn’s disease: difficulties in diagnosis, 21 Clinical and Experimental Dermatology 211—214 (1996). 3 Wenshan, CN 1291484, published Apr. 18, 2001. 4 Romer et al., US 4,784,994, issued Nov. 15, 1988. 2 Appeal 2015-000966 Application 12/834,198 The Examiner finds that Urbanek teaches topical treatment of a patient with Crohn’s disease using metronidazole. {Id. at 2.) The Examiner finds that “[t]he limitations wherein the topical medicament is applied to reduce anorectal operation is rendered obvious over the prior art because the condition of treating Crohn’s disease of the anorectum and perianal region with metronidazole is known.” {Id.) The Examiner finds that Wenshan teaches a topical formulation of metronidazole and Vaseline {id. at 3), and concludes that it would have been obvious “to incorporate the metronidazole into Vaseline and further in the amount of about 10%” because Urbanek and Wenshan both teach topical metronidazole formulations and determining the optimum dosage would have been within the level of skill in the art. {id. at 3 4.) Appellant argues, among other things, that claim 1 is directed to “the use of a topical composition that consists essentially of metronidazole in a very specific concentration of 10% and as the sole active agent in the treatment of pain and healing after a surgical procedure.” (Appeal Br. 9.) Appellant argues that, “[ijmportantly, the composition is applied to a specific area on the body to relieve the symptoms of pain related to the surgery and to help with healing. None of the cited references alone or in combination teach such a composition or method of using such a composition.” {Id.) We agree with Appellant that the Examiner has not shown that a method meeting all of the limitations of claim 1 would have been obvious based on the cited references. Urbanek states that “Crohn’s disease is a chronic inflammatory condition of the gastrointestinal system (GIT) of 3 Appeal 2015-000966 Application 12/834,198 unknown aetiology.” (Urbanek 211, left col.) Urbanek describes a patient with Crohn’s disease presenting with oedema and erythema who was treated with topical metronidazole (id.), but does not describe treatment of a patient with metronidazole following a surgical operation. Wenshan describes a “medicine used for treating prostatic disease [that] contains green chiretta, furantantin, metronidazole and vaseline” and is applied to the prostate gland. (Wenshan, abstract.) Wenshan mentions metronidazole’s use as anti-parisitic noting that it has “strong disinfecting action on trichomonad and amebic protozoacide,” but it does not describe treatment of a patient with metronidazole following a surgical operation. (Wenshan 1.) Thus, neither Urbanek nor Wenshan disclose topically treating, or provide any reason to topically treat, a patient following a surgical operation, with 10% metronidazole. The Examiner has not provided evidence or sound technical reasoning to support the conclusion that topical treatment following a surgical operation would have been obvious based on the prior art description of a topical treatment for Crohn’s disease. The rejection based on Urbanek, Wenshan, and Romer relies on the same reasoning for combining Urbanek and Wenshan. For the reasons discussed above, we conclude that the Examiner has not shown that Urbanek and Wenshan would have made obvious the method of claim 1. We therefore reverse both of the rejections on appeal. REVERSED 4 Copy with citationCopy as parenthetical citation