Parminder Singh et al.Download PDFPatent Trials and Appeals BoardMay 19, 202014746758 - (D) (P.T.A.B. May. 19, 2020) 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. 14/746,758 06/22/2015 Parminder Singh 091500-0550/8008.US20 7850 108547 7590 05/19/2020 McDermott Will & Emery LLP 500 North Capitol Street NW Washington, DC 20001 EXAMINER GHALI, ISIS A D ART UNIT PAPER NUMBER 1611 NOTIFICATION DATE DELIVERY MODE 05/19/2020 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): mweipdocket@mwe.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte PARMINDER SINGH, ADRIAN FAASSE, GARY W. CLEARY, SRI MUDUMBA, MIKHAIL M. FELDSTEIN, and DANIR F. BAYRAMOV ____________ Appeal 2019-001674 Application 14/746,758 Technology Center 1600 ____________ BEFORE DONALD E. ADAMS, RICHARD M. LEBOVITZ, and DEBORAH KATZ, 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 27 and 30–56 (Appeal Br. 1).2 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 “A.V. Topchiev Institute of Petrochemical Synthesis, Russian Academy of Sciences and Corium International, Inc.” (Appellant’s May 21, 2018 Appeal Brief (Appeal Br.) 1). 2 This Appeal is related to Appeal 2019-001618, Application 14/246,983 (cf. Appeal Br. 1). Appeal 2019-001674 Application 14/746,758 2 STATEMENT OF THE CASE Appellant’s disclosure “relates to hydrogel compositions useful as wound dressings and for administering a wide variety of active agents to mucosal tissue such as the mouth, including tooth whiteners” (Spec. ¶ 2). Appellant’s independent claims 27 and 56 are reproduced below: 27. A method for preparing a system, the method comprising: (i) providing a hydrogel comprising a water-swellable, water-insoluble polymer, a blend of a hydrophilic polymer and a complementary oligomer capable of hydrogen bonding or electrostatic bonding to the hydrophilic polymer, and (ii) depositing the hydrogel on an erodible backing member comprised of a polymeric component that erodes in a moist environment of a mucosal body surface at a slower rate than the hydrogel; wherein the system comprises an active agent in the hydrogel either by (i) incorporating the active agent with the water-swellable, water-insoluble polymer and the blend or (ii) loading the active agent onto the hydrogel after said depositing step. (Appeal Br. 8.) 56. A method for preparing a system, the method comprising: (i) providing a hydrogel comprising a water-swellable, water-insoluble polymer, a blend of a hydrophilic polymer and a complementary oligomer capable of hydrogen bonding or electrostatic bonding to the hydrophilic polymer, and (ii) depositing the hydrogel on an erodible backing member comprised of a polymeric composition that erodes in a moist environment of a mucosal body surface at a slower rate than the hydrogel, wherein the polymer composition comprises a polymer is selected from the group consisting of acrylate polymers, cellulose derived polymers, cellulose esters, starches, alginic acid, alginates, polyamino acids, and blends thereof; wherein the system comprises an active agent in the hydrogel either by (i) incorporating the active agent with the Appeal 2019-001674 Application 14/746,758 3 water-swellable, water-insoluble polymer and the blend or (ii) loading the active agent onto the hydrogel after said depositing step. (Id. at 11.) Grounds of rejection before this Panel for review: Claims 27, 30–46, 49–51, and 53–56 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Biegajski3 and Sanvordeker.4 Claims 47 and 48 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Biegajski, Sanvordeker, and Polymethacrylates.5 Claim 52 stands rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Biegajski, Sanvordeker, and Chalykh.6 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? ANALYSIS Examiner finds that Biegajski discloses Appellant’s claimed invention, but for a “hydrogel comprising water swellable polymer and blend of hydrophilic polymers as . . . [required by Appellant’s independent claims] 27 and 56” and relies on Sanvordeker to make up for this deficiency 3 Biegajski et al., US 5,700,478, issued Dec. 23, 1997. 4 Sanvordeker et al., US 4,900,552, issued Feb. 13, 1990. 5 Chang et al., Polymethacrylates, Handbook of Pharmaceutical Excipients, 401–406 (3rd ed., Arther H. Kibbe, ed., 2000). Appellant and Examiner refer to this document as “Polymethacrylate,” therefore we do the same. 6 Chalykh et al., Effects of Composition and Hydration on Adhesive Properties of Poly(N-Vinyl Pyrrolidone)-Poly(Ethylene Glycol) Hydrogels, 81 Polym. Mater. Sci. Eng. 456–457 (1999). Appeal 2019-001674 Application 14/746,758 4 in Biegajski (Final Act.7 5). In this regard, Examiner finds that Sanvordeker discloses a dosage form comprising a “hydratable mucoadhesive layer [that] is [a] hydrogel, and comprises cellulose acetate butyrate, polyacrylic acid polymer and PVP” (id.). Thus, based on the combination of Biegajski and Sanvordeker, Examiner concludes that, at the time Appellant’s invention was made, it would have been prima facie obvious to make a device for application to mucosa comprising drug containing layer comprising blend of hydrophilic polymers and a layer that erodes slower than the drug containing layer as taught by Biegajski, and add water swellable cellulose or polyacrylic polymers taught by Sanvordeker to the drug containing layer to form hydrogel. (Id.) We are not persuaded. Contrary to Examiner’s finding, Sanvordeker does not disclose a mucoadhesive layer that comprises a hydrogel (see Sanvordeker 1: 46–47 (Sanvordeker discloses that “[t]he mucoadhesive base layer comprises a hydratable mucoadhesive polymeric matrix” (emphasis added)); cf. id. at ll. 47–49 (Sanvordeker discloses that its “reservoir layer includes a plasticized film-forming cellulose ester, a dehydrated hydrogel and an active ingredient”) (emphasis added)). As Appellant explains: Sanvordeker discloses a trilaminate film comprising a water- impermeable barrier layer sandwiched between a mucoadhesive base layer and non-adhesive reservoir layer, wherein the barrier layer is bonded to mucoadhesive base layer. Sanvordeker, col. 2, lines 14-18. Sanvordeker discloses that the non-adhesive reservoir layer NOT the mucoadhesive layer is constituted by a plasticized film-forming cellulose ester and a dehydrated hydrogel. Sanvordeker, col. 3, lines 46-48. Sanvordeker further discloses that the water-impermeable barrier inhibits the diffusion of the active ingredient to the base layer. Id., col. 5, 7 Examiner’s November 20, 2017 Final Office Action. Appeal 2019-001674 Application 14/746,758 5 lines 48-50. Sanvordeker further discloses that the water- impermeable barrier inhibits the diffusion of the active ingredient to the base layer. In other words, Sanvordeker does not teach that “such ingredients are capable of delivering active agent to the buccal cavity while attaching to the wall of the cavity” as contended by the Office because no active agent in the dehydrated hydrogel containing non-adhesive layer is delivered to the buccal cavity through base layer. (Appeal Br. 6; see also Reply Br. 4.) We find that Examiner’s assertion that Sanvordeker’s mucoadhesive layer may comprise an active agent misses the point of Appellant’s contentions (see Ans. 7–8 (citing Sanvordeker 3: 44–45)). As Appellant explains, although “Sanvordeker . . . discloses one type of material[] suitable for forming the hydratable mucoadhesive base layer is water-swellable polymers . . . nowhere does Sanvordeker disclose the water-swellable polymers in a hydrogel composition” (Reply Br. 4 (citing Sanvordeker 2: 65–67)). Thus, because Sanvordecker’s mucoadhesive does not comprise a hydrogel, the issue is whether it would have been prima facie obvious to incorporate components, i.e. a hydrogel, of Sanvordecker’s non-adhesive reservoir layer into Biegajski’s mucoadhesive layer. Examiner failed to address this issue. Thus, we find that the evidence of record supports Appellant’s contention that “a skilled artisan would not be motivated to incorporate Sanvordeker’s teachings about a non-adhesive layer into Biegajski’s basal adhesive layer so as to arrive at . . . [Appellant’s] claims” (Appeal Br. 6; see also Reply Br. 4). Examiner failed to establish an evidentiary basis on this record to establish that Polymethacrylates, as applied to claims 47 and 48, or Chalykh, as applied to claim 52, make up for the foregoing deficiency in the combination of Biegajski and Sanvordeker (see Final Act. 8–10; cf. Appeal Appeal 2019-001674 Application 14/746,758 6 Br. 7 (Appellant contends that “Polymethacrylates and Chalykh . . . do not cure the deficiencies of Biegajski and Sanvordeker)). CONCLUSION The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 27, 30–46, 49–51, and 53–56 under 35 U.S.C. § 103(a) as unpatentable over the combination of Biegajski and Sanvordeker is reversed. The rejection of claims 47 and 48 under 35 U.S.C. § 103(a) as unpatentable over the combination of Biegajski, Sanvordeker, and Polymethacrylates is reversed. The rejection of claim 52 under 35 U.S.C. § 103(a) as unpatentable over the combination of Biegajski, Sanvordeker, and Chalykh is reversed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 27, 30–46, 49– 51, 53-56 103 Biegajski, Sanvordeker 27, 30–46, 49–51, 53- 56 47, 48 103 Biegajski, Sanvordeker, Polymethacrylates 47, 48 52 103 Biegajski, Sanvordeker, Chalykh 52 Overall Outcome 27, 30–56 REVERSED Copy with citationCopy as parenthetical citation