15234084 - (D) (P.T.A.B. Jul. 20, 2020)

S.L.A. PHARMA AG

Patent Trials and Appeals BoardJul 20, 2020

15234084 - (D) (P.T.A.B. Jul. 20, 2020)

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. 15/234,084 08/11/2016 DAVID NIGEL ARMSTRONG 646-01-CIPCON-022 6217 79683 7590 07/20/2020 OLIVE LAW GROUP, PLLC BENTLEY J OLIVE 125 EDINBURGH SOUTH DRIVE SUITE 220 CARY, NC 27511 EXAMINER SOROUSH, LAYLA ART UNIT PAPER NUMBER 1627 NOTIFICATION DATE DELIVERY MODE 07/20/2020 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): bjolive@olivelawgroup.com docket@OLIVELAWGROUP.COM eofficeaction@appcoll.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte DAVID NIGEL ARMSTRONG and JUSTIN SLAGEL ____________ Appeal 2019-006704 Application 15/234,084 Technology Center 1600 ____________ Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW, Administrative Patent Judges. KATZ, Administrative Patent Judge. DECISION ON APPEAL Appellant1 seeks our review,2 under 35 U.S.C. § 134(a), of the Examiner’s decision to reject claims 1–12 (Appeal Br. 15.) We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the Real Party in Interest as S.L.A. Pharma AG. (See Appeal Br. 3.) 2 We consider the Specification dated August 11, 2016 (“Spec.”), the Final Office Action issued June 14, 2018 (“Final Act.”), the Appeal Brief filed January 10, 2019 (“Appeal Br.”), the Examiner’s Answer issued July 11, 2019 (“Ans.”), and the Reply Brief filed September 10, 2019 (“Reply Br.”). Appeal 2019-006704 Application 15/234,084 2 INTRODUCTION Appellant’s Specification provides a topical composition comprising metronidazole at a concentration of about 10 wt.% in a pharmacologically acceptable non-aqueous vehicle. (Spec. ¶ 18.) The composition, when topically applied, relieves pain and promotes wound healing. (Id.) The Specification explains that metronidazole has both anti-bacterial and anti-inflammatory properties, and has been used for treating several skin diseases. (Id. ¶ 5.) The Specification further explains that topical metronidazole compositions containing alcohol have been used to treat a number of skin conditions, including rosacea. (Id. ¶ 7.) However, the Specification argues there is a need to provide topical metronidazole compositions that do not contain alcohol, which stings and burns damaged skin or wounds. (Id.) Appellant’s claim 1 recites:3 A method of relieving pain and/or promoting wound healing in a patient due to a pilonidal sinus wound, hidradenitis or pressure sore wounds, the method comprising: applying to the damaged skin area a topical composition, wherein the topical composition consists essentially of (a) metronidazole in a therapeutically effective concentration of 10 wt[.]% to treat the pilonidal sinus wound, hidradenitis or pressure sore wounds and (b) a pharmacologically acceptable nonaqueous vehicle. 3 Claim 1 has been modified by adding indentations. Appeal 2019-006704 Application 15/234,084 3 (Appeal Br. 17, Claims App.) ANALYSIS Prior Art Rejections The Examiner rejected claims 1–10 under 35 U.S.C. § 103(a) as obvious over Rao,4 Wenshan,5 and Wahba-Yahav.6 (Ans. 3–5.) The Examiner rejected claims 11 and 12 under 35 U.S.C. § 103(a) as obvious over Rao, Wenshan, Wahba-Yahav, and Romer.7 (Ans. 5–6.) The Examiner cites Rao for teaching topical application of metronidazole to improve wound appearance of infected pressure sores, based on the teaching of topical application of metronidazole (10 mg/g) gel preparations to treat burns and wounds. (Ans. 3–4.) Appellant disputes the Examiner’s findings regarding Rao, contending that Rao does not teach relieving pain and/or promoting wound healing in a patient due to a pilonidal sinus wound, hidradenitis or pressure sore wounds. (Appeal. Br. 7.) Appellant asserts that, instead, Rao concludes that oral metronidazole promoted healing of burn wounds, but that “topical metronidazole retards healing.” (Id., citing Rao Abstract.) Particularly, Appellant cites Table 2 of Rao for showing that topical metronidazole (1 wt.%) compositions depressed the period of epithelization relative to the base composition (containing no metronidazole). (Id. at 8.) Appellant 4 Rao et al., An Appraisal of the Healing Profiles of Oral and External (Gel) Metronidazole on Partial Thickness Burn Wounds, 32 Indian J. Pharmacology 282–287 (2000). 5 Wahba-Yahav, Idiopathic lichen planus: Treatment with metronidazole, 33 J. Am. Acad. Dermatology 301–302 (1995). 6 Wenshan, CN 1291484, published April 18, 2001. 7 Romer et al., US 4,784,994, issued November 15, 1998. Appeal 2019-006704 Application 15/234,084 4 contends that, in view of Rao’s teachings that 1 wt.% metronidazole topical formulations depressed burn wound healing, there would have no reason to expect that a concentration of 10 wt.% metronidazole would promote wound healing. (Id. at 9–10.) With respect to treating pressure sores specifically, Appellant acknowledges that Rao teaches “Rice [Metronidazole use in malodorous skin lesions, 17 Rehabil. Nurs. 244–245 (1992)] reported that topical metronidazole improved wound appearance of infected pressure sores, leg ulcers etc.” (Id. at 10.) Appellant argues, however, that Rao misinterpreted Rice, as Rice teaches “treatment with metronidazole has not been shown to affect the progression of the wound.” (Id. at 12 (emphasis omitted).) The Examiner responds that Rice teaches treating any component of the wound “whether it be pain or odor” and therefore “reads on promoting would healing[] as claimed.” (Ans. 11.) As to Rao’s statement that topical metronidazole retards healing, the Examiner finds Rao teaches that a non- aqueous formulation MGEL-2 showed healing properties. (Id. at 11–12.) Accordingly, the Examiner finds that Rao does not teach away from the claimed invention. (Id. at 12.) We find Appellant’s argument persuasive. Rao states “[t]he results of the present study show that oral metronidazole accelerates healing while external metronidazole depresses it.” (Rao 286.) Rao attributes depressed healing to metronidazole’s known cytotoxicity. (See id.) For example, Rao states “at a dose of 1 mg, topical metronidazole could also be expected to home in, in high amounts, on the reparative cells causing them direct cytotoxicity.” (Id.) As to the healing properties of the MGEL-2 Appeal 2019-006704 Application 15/234,084 5 formulation, Rao explains that the healing effect of the base formulation reversed the “healing-depressant effect of topical metronidazole.” (Id.) Rao’s express teaching that topical metronidazole depressed burn wound healing contradicts the “direct pro-healing property of the drug” attributed to Rice. (See Rao 282.) Rice teaches topically applying metronidazole to treat odor caused by fungating tumors and other anaerobically infected skin lesions. (Rice 245.) However, Rice concludes “treatment with metronidazole has not been shown to affect the progression of the wound.” (Id.) Accordingly, neither Rao nor Rice teach topically applying metronidazole promotes wound healing. Considering the prior art as a whole, neither Wenshan nor Wahba- Yahav teach relieving pain and/or promoting wound healing in a patient due to a pilonidal sinus wound, hidradenitis or pressure sore wounds. Moreover, none of the references cited by the Examiner teaches topical compositions containing 10 wt.% metronidazole. Given that Rao teaches topical compositions containing 1 wt.% metronidazole would have been expected to have cytotoxic effects in healing wound tissue, we do not agree that a person of ordinary skill in the art would have been motivated increase the concentration to 10 wt.% to treat the claimed conditions. Accordingly, we do not sustain the Examiner’s rejection of claims 1–10 as obvious over Rao, Wenshan, and Wahba-Yahav. The rejection of claims 11 and 12 incorporate the teachings of Rao, Wenshan, and Wahba-Yahav, in addition to Romer. For the reasons set forth above, we do not sustain the Examiner’s obviousness rejection of claims 11 and 12. Appeal 2019-006704 Application 15/234,084 6 Obviousness-type Double Patenting The Examiner provisionally rejected “claims 1, 3–8, 11–14, 17–21” under the doctrine of obviousness-type double-patenting over claims 1–25 of U.S. Patent 9,655,883 B2 and claims 1–14 of Application No. 13/834,281. (Ans. 8–9.) After the Examiner’s Answer in this appeal, claims issued in Application 13/834,281 as U.S. Patent 10,653,671 B2. In the event of continued prosecution, the Examiner may wish to revisit a rejection for obviousness-type double-patenting over U.S. Patent 10,653,671 B2. As Appellant notes, the Examiner’s listing of “claims 1, 3–8, 11–14, 17–21” is unclear as only claims 1–12 are pending (Appeal Br. 14–15.) Appellant does not present any substantive arguments with respect to the double-patenting rejections. (See id.) Although the Examiner’s listing of the claims is not accurate, at least pending claim 1 stands provisionally rejected under the doctrine of obviousness-type double patenting. Because the Examiner provisionally rejected the claims on the ground of obviousness-type double-patenting, we conclude that it is premature to address the provisional rejections. See Ex parte Moncla, Appeal No. 2009- 006448 (PTAB June 22, 2010). Accordingly, we do not reach the Examiner’s provisional rejections. CONCLUSION Upon consideration of the record and for the reasons given, we reverse the Examiner’s obvious rejections. In summary: Appeal 2019-006704 Application 15/234,084 7 Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–10 103(a) Rao, Wenshan, Wahba- Yahav 1–10 11–12 103(a) Rao, Wenshan, Wahba- Yahav, Romer 11–12 1 Obviousness-type Double Patenting8 Claims 1–25 of U.S. Patent 9,655,883 B2 1 Obviousness-type Double Patenting9 Claims 1–14 of Application 13/834,281 Overall Outcome 1–12 REVERSED 8 As explained above, we do not reach this rejection per Ex parte Moncla, Appeal No. 2009-006448 (PTAB June 22, 2010) (holding that it is premature to address a provisional rejection) (designated precedential). 9 See footnote 8.