ARBOR PHARMACEUTICALS, LLC

Patent Trials and Appeals BoardDec 8, 2021

2021001394 (P.T.A.B. Dec. 8, 2021)

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. 15/968,364 05/01/2018 Nicholas Spring 18873.105468 8074 20786 7590 12/08/2021 KING & SPALDING 1180 PEACHTREE STREET , NE ATLANTA, GA 30309-3521 EXAMINER FISHER, MELISSA L ART UNIT PAPER NUMBER 1611 NOTIFICATION DATE DELIVERY MODE 12/08/2021 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): ATLIPDOCKETING@kslaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte NICHOLAS SPRING and GARRY T. GWOZDZ ____________ Appeal 2021-001394 Application 15/968,364 Technology Center 1600 ____________ Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and RACHEL H. TOWNSEND, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s decision to reject claims 41–58 (Appeal Br. 3).2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 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 Arbor Pharmaceuticals, LLC” (Appellant’s September 21, 2020, Appeal Brief (Appeal Br.) 3). 2 This Appeal is related to Appeal 2019-005431 (Application 15/408,924, which application was abandoned January 11, 2021) and Appeal 2020- 000846 (Application 14/572,664, which application was abandoned September 17, 2020). Decisions affirming the rejection of all claims in Appeal 2019-005431 and Appeal 2020-000846 were entered into the records of both Appeals on July 8, 2020. Appeal 2021-001394 Application 15/968,364 2 STATEMENT OF THE CASE Appellant’s disclosure “relates to topical formulations containing avermectin for use in the prophylactic and therapeutic treatment of a head lice infestation in humans” (Spec.3 ¶ 2; see id. ¶ 14 (Appellant discloses that “[i]vermectin is the synthetic dihydro form of avermectin and is an effective insecticide”)). Appellant’s claim 41 is reproduced below: 41. A method for treatment of a lice infestation, the method comprising: (a) applying a an ivermectin-based pediculicidal formulation to a human scalp infested with lice; wherein the pediculicidal formulation is an emulsion that comprises: about 0.1 % to about 2.0% by weight ivermectin; a pharmaceutically acceptable glycol; at least one suspending agent; at least one non-ionic surfactant; and water, (b) maintaining the topical pediculicidal formulation on the scalp for about 1 to about 60 minutes to provide treated lice; and (c) removing the pediculicidal formulation from the scalp, wherein the treated lice have a faster mortality response than lice treated with 0.5% ivermectin in water. (Appeal Br. 17.) 3 Appellant’s May 1, 2018, Specification. Appeal 2021-001394 Application 15/968,364 3 Grounds of rejection before this Panel for review:4 Claims 41–46, 48, 49, and 54–58 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Guzzo.5 Claims 41–58 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Manetta6 and Campbell.7 Claims 41–58 stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1–6, 13–15, 17, 18, 23, and 25-26 of U.S. Patent No. 8,927,595 in combination with Manetta. Claims 41–58 stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1, 5, 6, and 8–10 of U.S. Patent No. 8,791,153 in combination with Manetta and Campbell. Obviousness-type Double Patenting: Appellant does not present arguments for the obviousness-type double patenting rejections on this record (see Ans. 24 (Examiner finds that Appellant requested “that the double patenting rejections be held in abeyance”); see generally Appeal Br. 6, n. 1). The obviousness double patenting rejections are, therefore, summarily affirmed and will not be further discussed. 4 Application 15/408,924 abandoned January 11, 2021. Therefore, the provisional obviousness-type double patenting rejection over the claims of this Application (see Ans. 20–21) is moot and will not be further discussed. 5 Guzzo et al., US 2005/0143325 A1, published June 30, 2005. 6 Manetta et al., WO 2004/093886 A1, published Nov. 4, 2004. 7 Campbell et al., US 2003/0202997 A1, published Oct. 30, 2003. Appeal 2021-001394 Application 15/968,364 4 Obviousness: The rejection over Guzzo: The rejection of claims 41–46, 48, 49, and 54–58 under 35 U.S.C. § 103(a) as unpatentable over Guzzo is cumulative to the rejection of all pending claims under 35 U.S.C. § 103(a) as unpatentable over the combination of Manetta and Campbell. We, therefore, vacate the rejection over Guzzo in favor of the rejection of all claims over the combination of Manetta and Campbell. The rejection over the combination of Manetta and Campbell: ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Manetta discloses a pharmaceutical composition that may be in the form of a cream or gel (Manetta 4:7–14; see id. at 4:13 (Manetta discloses shampoo formulations); Ans.8 13). FF 2. Manetta discloses a composition comprising: a) an oily phase comprising fatty substances; b) at least one surfactant-emulsifier; c) ivermectin; d) one or more solvent(s) and/or propenetrating agent(s) for the active agent; and e) water (see Manetta 6:7–14; Ans. 13). 8 Examiner’s October 14, 2020, Answer. Appeal 2021-001394 Application 15/968,364 5 FF 3. Manetta discloses that the “oily phase” of its composition “may comprise, for example, vegetable, mineral, animal or synthetic oils, silicone oils, Guerbert alcohols or other substances, and mixtures thereof” (Manetta 6:24–7:2; see also id. at 7:7–9 (Manetta discloses that the vegetable oil may be “palm oil, soybean oil, sesame oil and sunflower oil”); id. at 7:21–22 (Manetta discloses that “[a]s a silicone oil, mention may be made of a dimethicone”); Ans. 13). FF 4. Manetta discloses “[a]s other fatty substances, mention may be made of fatty acids such as stearic acid, fatty alcohols such as stearyl alcohol, cetostearyl alcohol and cetyl alcohol, or derivatives thereof, waxes such as beeswax, carnauba wax or candelilla wax, and also gums, in particular silicone gums” (Manetta 8:19–22; Ans. 13). FF 5. Manetta discloses that its “composition . . . comprises from 0.001 to 10%[, preferably 0.1 to 5%,] of ivermectin by weight relative to the total weight of the composition” (Manetta 9:20–22; Ans. 13). FF 6. Manetta discloses “[b]y way of example of a solvent and/or propenetrating agent for the ivermectin active agent, mention will preferably be made of propylene glycol, alcohols such as ethanol, isopropanol, butanol, N-methyl-2-pyrrolidone or DMSO, polysorbate 80, phenoxyethanol, and mixtures thereof” (Manetta 9:26–10:4; Ans. 13). FF 7. Manetta discloses that its “composition . . . contains water ranging from 30 to 95%” (Manetta 11:25–26; Ans. 13). Appeal 2021-001394 Application 15/968,364 6 FF 8. Manetta exemplifies a composition comprising: (Manetta 21–22.) Appeal 2021-001394 Application 15/968,364 7 FF 9. Manetta discloses that ivermectin is known as an “antiparasitic medicinal product for veterinary use” and is effective against, inter alia, some lice (Manetta 1:21–27; Ans. 13). FF 10. Manetta “relates to the use of ivermectin for producing a topical pharmaceutical composition intended for the treatment of rosacea” (Manetta 1:3–5; see generally Ans. 13). FF 11. Examiner finds that “although Manetta . . . describe[s] ivermectin as an antiparasitic medicinal product that is effective against lice . . . Manetta's topical compositions are intended for the treatment of rosacea and are not necessarily administered to hosts who are infested with lice” (Ans. 13. FF 12. Campbell discloses “compositions are useful against a variety of ectoparasites that afflict humans, animals, and plants, e.g., head lice, fleas, body lice, crab lice, scabies, ticks, and plant parasites” (Campbell, Abstract; see id. ¶ 15 (Campbell discloses “that ivermectin is able to kill head lice and their eggs when topically applied” and that a “person of ordinary skill in the art will realize that various compounds are available to act as carriers of the ivermectin”); id. at 7 (Campbell’s claims 14–17 disclose a method of using a composition comprising a fatty acid ester and a mectin, i.e. ivermectin, to kill head lice on a human); id. ¶ 19 (Campbell discloses a composition comprising “from about 0.02% to about 1.0%, and preferably . . . about 0.2%” ivermectin); id. ¶ 6 (Campbell makes clear that a “subject” within the scope of its disclosure “includes humans”); Ans. 13–14). FF 13. Campbell discloses: The present invention also provides methods of treating ectoparasite infestation on a mammal by topically administering a composition containing iver[m]ectin to an area on the mammal where lice, fleas, ticks or other ectoparasites are Appeal 2021-001394 Application 15/968,364 8 present. The composition can be any of the compositions of the present invention, or can also be ivermectin and any suitable carrier. (Campbell ¶ 8; see also id. ¶ 15 (Campbell discloses that its “composition will contain ivermectin and will not contain any other agent in an amount sufficient for killing ectoparasites present”); see generally Ans. 13–14.) FF 14. Campbell discloses: [C]ompositions are formulated to be applied to the scalp of a person suffering from a head lice infestation and are left on the treated person for a period of time. The compositions are preferably left on the treated area for about 5-15 minutes, and more preferably for about 10 minutes, with the effect of killing lice and their eggs present within 1 hour or less. (Campbell ¶ 5; see id. ¶¶ 7, 11, 19, and 24; Ans. 13–14). ANALYSIS The evidence on this record establishes that compositions comprising from about 0.02% to about 1.0%, and preferably . . . about 0.2%” ivermectin are effective in treating a lice infestation of a human scalp (see FF 12–14). In addition, the evidence on this record makes obvious a method of treating a human scalp suffering from a lice infestation, wherein: [C]ompositions are formulated to be applied to the scalp of a person suffering from a head lice infestation and are left on the treated person for a period of time. The compositions are preferably left on the treated area for about 5-15 minutes, and more preferably for about 10 minutes, with the effect of killing lice and their eggs present within 1 hour or less. (FF 14.) The evidence of record further makes obvious a composition, in the form of a shampoo, comprising: a) an oily phase comprising fatty Appeal 2021-001394 Application 15/968,364 9 substances; b) at least one surfactant-emulsifier; c) ivermectin; d) one or more solvent(s) and/or propenetrating agent(s) for the active agent; and e) water (FF 1–2; see also FF 12). In the context of Appellant’s claim 41, the evidence of record makes obvious a composition comprising: at least one suspending agent and at least one non-ionic surfactant, i.e. an oily phase comprising, inter alia, mixtures of vegetable and other fatty substances, such as palm oil, soybean oil, sesame oil, sunflower oil, beeswax, cetyl alcohol, and stearyl alcohol (FF 3–4; see also FF 8; cf. Appellant’s claims 41, 44, 45, and 47); about 0.1 to about 1.0% ivermectin (FF 5 and 12; see also FF 8; cf. Appellant’s claim 41); a pharmaceutically acceptable glycol, i.e. a solvent and/or propenetrating agent for the ivermectin active agent, such as propylene glycol (FF 6, see also FF 8; cf. FF 41); and water (FF 7; see also FF 8; cf. FF 41). For the forgoing reasons, we find that the combination of Manetta and Campbell makes obvious a method for the treatment of a lice infestation of a human scalp using a composition falling within the scope of Appellant’s claimed invention. In addition, we find no objective evidence on this record to support a conclusion that the treatment of lice with the composition and method made obvious by the combination of Manetta and Campbell would not have a faster mortality response than lice treated with 0.5% ivermectin in water alone (cf. Reply Br. 5 (Appellant contends that its “composition compris[es] multiple other components and the specific effectiveness, i.e., the treated lice having a faster mortality response than lice treated with 0.5% ivermectin in water”)). Appeal 2021-001394 Application 15/968,364 10 Thus, we find no error in Examiner’s conclusion that the combination of Manetta and Campbell makes obvious Appellant’s claimed invention (see Ans. 14–16). For the foregoing reasons, we are not persuaded by Appellant’s contention that “Examiner has not established a motivation to combine” Campbell with Manetta or that Examiner’s combination is based in improper hindsight (Appeal Br. 13–14 (emphasis omitted); see also Reply Br. 4–5). Campbell discloses “compositions are useful against a variety of ectoparasites that afflict humans . . . e.g., head lice,” “that ivermectin is able to kill head lice and their eggs when topically applied” and that a “person of ordinary skill in the art will realize that various compounds are available to act as carriers of the ivermectin” (FF 12; see also id. (Campbell discloses compositions comprising “from about 0.02% to about 1.0%” ivermectin)). Campbell further discloses that its composition can “be ivermectin and any suitable carrier” (FF 13). Thus, the evidence on this record fails to support Appellant’s characterization of Campbell as “not even directed to ivermectin-based compositions” and does not “teach or suggest that ivermectin in any amount is effective to kill lice” (Appeal Br. 14–15; see also Reply Br. 5 (Appellant questions “How is it possible to find an invention obvious when the cited references fail, alone or in combination, to teach the use of the claimed active for the claimed indication”)). Campbell discloses that a composition comprising “from about 0.02% to about 1.0%” ivermectin is effective to kill head lice when topically applied to a human scalp when the composition is left on the treated area for about 5-15 minutes, and more preferably for about 10 minutes, with the effect of killing lice and their eggs present within 1 hour or less (see FF 12– Appeal 2021-001394 Application 15/968,364 11 14). “[W]here there is a range disclosed in the prior art, and the claimed invention falls within that range, there is a presumption of obviousness.” Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004). Thus, we are not persuaded by Appellant’s contention that Campbell does not “teach or suggest that ivermectin in any amount is effective to kill lice, let alone in an amount between about 0.2 to about 1.0 wt. % as presently claimed” by Appellant (Appeal Br. 14–15). For the foregoing reasons, we are not persuaded by Appellant’s contention that “Examiner has not established a reasonable expectation of success” (Appeal Br. 15). For the same reasons, we are not persuaded by Appellant’s contention that Campbell does not make up for Appellant’s alleged deficiencies in Manetta (Reply Br. 4–5). CONCLUSION The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness. The rejection of claim 41 under 35 U.S.C. § 103(a) as unpatentable over the combination of Manetta and Campbell is affirmed. Claims 42–58 are not separately argued and fall with claim 41. Appeal 2021-001394 Application 15/968,364 12 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 41–46, 48, 49, 54–58 103(a) Guzzo9 41–58 103(a) Manetta, Campbell 41–58 41–58 Obviousness-type Double Patenting U.S. Patent No. 8,927,595, Manetta 41–58 41–58 Obviousness-type Double Patenting U.S. Patent No. 8,791,153, Manetta, Campbell 41–58 Overall Outcome 41–58 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv) (2019). AFFIRMED 9 This rejection stand vacated for the reasons discussed above.