Gary W. Cleary et al.Download PDFPatent Trials and Appeals BoardMay 19, 202014264983 - (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. 14/264,983 04/29/2014 Gary W. Cleary 091500-0517/8008.US17 6796 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 GARY W. CLEARY, SHOREH PARANDOOSH, MIKHAIL M. FELDSTEIN, ANATOLY E. CHALYKH, NICOLAI A. PLATÈ, and VALERY G. KULICHIKHIN ____________ Appeal 2019-001618 Application 14/264,983 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 84–91 and 93–101 (Appeal Br. 2).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 “Corium International, Inc. and A.V. Topchiev Institute of Petrochemical Synthesis, Russian Academy of Sciences” (Appellant’s July 3, 2018 Appeal Brief (Appeal Br.) 1). 2 This Appeal is related to Appeal 2019-001674, Application 14/746,758 (see Appeal Br. 1). Appeal 2019-001618 Application 14/264,983 2 STATEMENT OF THE CASE Appellant’s disclosure relates “to hydrogel composition” (Spec.3 ¶ 2). Claim 84 is reproduced below: 84. A delivery system for topical administration of a locally active agent to the skin, the system comprising: a body-surface contacting layer comprised of an adhesive hydrogel composition positioned on a backing layer, the adhesive hydrogel composition comprising: (i) a water-swellable, water-insoluble polymer in an amount ranging from about 2 weight percent to about 15 weight percent of the hydrogel composition, wherein said polymer is insoluble in water within a selected pH range and is an acrylate copolymer comprising monomers selected from the group consisting of acrylic acid, methacrylic acid, methyl acrylate, ethyl acrylate, methyl methacrylate, and ethyl methacrylate, and wherein the acrylate copolymer has a ratio of free carboxyl groups to ester groups in a range of about 1:1 to 1:2; (ii) a blend of a hydrophilic polymer and a complementary oligomer, where the hydrophilic polymer is a poly(N-vinyl lactam), the complementary oligomer is a low molecular weight polyalkylene glycol having a molecular weight of 300 to 600 daltons, and the hydrophilic polymer represents about 75 weight percent to about 25 weight percent of the hydrophilic polymer-complementary oligomer blend, (iii) a permeation enhancer, and (iv) a locally active agent. (Appeal Br. 14.) 3 Appellant’s April 29, 2014 Specification. Appeal 2019-001618 Application 14/264,983 3 Claims 84–91 and 93–101 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Murray,4 Chalykh,5 Roreger,6 Sanvordeker,7 Kolter,8 and Polymethacrylate.9, 10 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Murray discloses a hydrogel-forming wound dressing or skin coating material consisting substantially entirely of wound-compatible and skin- compatible ingredients and comprising a first hydrophilic polymer, selected from[, inter alia,] polymers and copolymers of acrylic acid, polymers or copolymers of methacrylic acid, . . . or combinations thereof; a second hydrophilic polymer which is capable of interacting with the first polymer to produce, upon drying, a hydrogel of improved water resistance and film- forming properties relative to the first hydrophilic polymer 4 Murray et al., US 4,920,158, issued Apr. 24, 1990. 5 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). 6 Roreger et al., US 5,456,745, issued Oct. 10, 1995. 7 Sanvordeker et al., US 4,900,552, issued Feb. 13, 1990. 8 Kolter et al., WO 98/05360, published Feb. 12, 1998. 9 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. 10 The obviousness-type double patenting rejections and provisional rejection on this record are moot, in view of the terminal disclaimers submitted by Appellant, and will not be discussed further (see Examiner’s January 3, 2018 Final Office Action (Final Act.) 2–8; see also Examiner’s October 17, 2018 Answer (Ans.) 3). Appeal 2019-001618 Application 14/264,983 4 alone; and water, the material being film-forming and substantially transparent or translucent although capable of being made opaque. (Murray 3:46–62; see Final Act. 10). FF 2. Murray discloses that its second hydrophilic polymer are “selected from polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP),[11] polyethylene oxide (PEO), copolymer combinations of propylene oxide and ethylene oxide [P(EO/PO)], and gelatin” (Murray 4:63–66; see Final Act. 10 (alteration original); see also Final Act. 10–11 (Examiner finds that polyethylene glycol (PEG) is a PEO)). FF 3. Murray discloses that “[i]t is preferred although not strictly necessary in all embodiments, that at least one suitable plasticizer be added to the hydrogel-forming material,” wherein “[p]referred plasticizers for use in this invention are[, inter alia,] propylene glycol” (Murray 5:9–11 and 6:3– 4; see Final Act. 1012). FF 4. Murray discloses: Due to the permeability and biological inertness of the hydrogel-forming material, the novel materials of this invention are particularly suited for the incorporation therein of a wide variety of chemotherapeutic agents, medicinal agents and additives. For instance, the dressing can contain topical keratolytics such as salicylic acid and the like, or agents which 11 Appellant discloses that PVP is a poly(N-vinyl lactam) within the scope of Appellant’s claimed invention (see Spec. ¶ 73; cf. Appeal Br. 14). 12 Although Examiner correctly finds that Murray discloses that a plasticizer, “such as propylene glycol,” may be added to Murray’s hydrogel material, Examiner incorrectly finds that Murray discloses that its plasticizer may be “polypropylene glycol” (see Final Act. 10–11). Appeal 2019-001618 Application 14/264,983 5 accelerate healing, or agents with antimicrobial or hemostatic activity. (Murray 10: 8–15; see Final Act. 10 (Examiner finds that Murray’s “dressing can contain active agent for delivery from the hydrogel such as antimicrobial agents”).) FF 5. Examiner finds that although Murray discloses a “combination of acrylate polymer, PVP and plasticizer,” Murray does not disclose an “amount of acrylate polymer in the composition,” “the amount of the hydrophilic polymer in the combination of hydrophilic polymer and complementary oligomer,” “acrylate copolymers,” or the “backing layer” required by Appellant’s claim 84 (see Final Act. 11). FF 6. Chalykh discloses a PVP-PEG hydrogel pressure sensitive adhesive (PSA) “prepared by dissolving PVP (Mw = 1,000,000) and PEG 400 in ethyl alcohol followed by casting the solution on a . . . backing film and drying,” wherein “[t]he PEG content in the blends varied from 25 to 50 wt %” (Chalykh 456; see Final Act. 11 (Examiner finds that Chalykh’s “PEG content in the blend varies from 25-50%, which implies PVP content would be 75-50%”)). FF 7. Chalykh discloses that “PEG accounts for the PVP blends’ adhesive properties, affecting critically the height and position of the peel force maximum along the axis of PEG and water content” (Chalykh 456; see generally Final Act. 11). FF 8. Chalykh discloses that “[a]lthough neither PVP nor PEG per se demonstrate any pressure sensitive adhesion, their blends exhibit adhesion and absorbed water can influence adhesive behaviour of the PVP·PEG hydrogels in a complicated manner,” wherein “[o]nly the blends in very narrow range of PEG content (in vicinity of 36 wt. %) provide high Appeal 2019-001618 Application 14/264,983 6 adhesion, whereas both PEG underloaded and overloaded blends reveal no adhesion, demonstrating that both initial polymers are non-adhesive” (Chalykh 456; see generally Final Act. 11 (Examiner finds that “[t]he maximum strength of . . . [Chalykh’s] hydrogel obtained by PEG content of 36%, i.e. PVP content of 64%”)). FF 9. Roreger discloses: [A] hydrophilic, flexible gel film which, without the need to use cross-linking agents, exhibits a mechanical stability in swollen condition and has a high water absorption capacity, said stability enabling easy handling, and the gel film being produced of components having optimum skin and mucous membrane tolerance, and which may be loaded with active substance, if needed[, wherein the gel film comprises:] (a) 0.5 to 30%-wt of at least one water-soluble polymer being anion-active at neutral pH (b) 0.5 to 50%-wt of at least one water-soluble polymer being cation-active at neutral pH (c) 0.1 to 20%-wt of at least one moisturizer and (d) 0.1 to 70%-wt of water [wherein] . . . the gel film may contain, (e) 0 to 75%-wt of water-soluble or water-dispersible auxiliaries and (f) 0 to 50%-wt of active substance (Roreger 2:11–31; see Final Act. 11 (Examiner finds that “[t]he high water absorption capacity reads on hydrogel” and the active substance or “[p]harmaceutical active agents include various substances to treat acne, i.e. cosmetic agent” (citing Roreger 1:15–23, 7:6–8:20)); see generally Final Act. 11–12.) FF 10. Roreger discloses that the water-soluble polymer being anion-active at neutral pH may be “Eudragit L/S®”, the water-soluble polymers being Appeal 2019-001618 Application 14/264,983 7 cationic at neutral pH may be “Eudragit E®” or “Eudragit RL/RS®”, and the moisturizer may be “low molecular [weight] polyethylene glycols” (Roreger 2:32–67; see Final Act. 11–12; Final Act. 12 (citing Roreger 13– 14:Examples 3, 7 and 12) (Examiner finds that Roreger exemplifies “Eudragit in an amount of 4%, 10% and 15%”)). FF 11. Roreger discloses that “[t]he gel film may contain as penetration accelerator, e.g. alkyl sulphates, alkyl sulphonates, alkali soaps, fatty acid salts of multivalent metals, betaine, amine oxides, fatty acid esters, mono-, di- or triglycerides, long-chain alcohols, sulphoxides, nicotinic acid esters, salicylic acid, N-methylpyrrolidone, 2-pyrrolidone, or urea” (Roreger 4:19– 24; see Final Act. 12). FF 12. Sanvordeker discloses A buccal dosage form which is a trilaminate film segment capable of delivering an active ingredient within the buccal cavity while attached to a wall of that cavity. The trilaminate film segment includes a hydratable mucoadhesive base layer, a non-adhesive reservoir layer and a water-impermeable barrier sandwiched between and bonded to the base layer and the reservoir layer. The mucoadhesive base layer comprises a hydratable mucoadhesive polymeric matrix. The reservoir layer includes a plasticized film-forming cellulose ester, a dehydrated hydrogel and an active ingredient. The water-impermeable barrier film includes a cellulose ester film. (Sanvordeker 1:38–51; id. at 3:46–48 (Sanvordeker discloses that “the non- adhesive reservoir layer is constituted by a plasticized film-forming cellulose ester and a dehydrated hydrogel); see generally Final Act. 12). FF 13. Kolter “relates to the use of (Meth) acrylic acid copolymers to increase the permeability of the Mucosa” (Kolter 1; see generally Final Act. 12). Appeal 2019-001618 Application 14/264,983 8 FF 14. Examiner finds that Kolter discloses that Kollicoat® MAE 30D, a 1:1 ethyl acrylate/methacrylic acid polymer that is soluble at a pH above 5.5, enhanced permeation at “a concentration up to 3%” (Final Act 12–13 (citing Kolter 1 and 6–7; Polymethacrylate 402–404)). ANALYSIS Based on the combination of Murray, Chalykh, Roreger, Sanvordeker, Kolter, and Polymethacrylate, Examiner concludes that, at the time Appellant’s invention was made, it would have been prima facie obvious to provide hydrogel composition comprising polymers or copolymers of acrylic acid or methacrylic acid, PVP that can be mixed with PEG, and plasticizer as taught by Murray, and use PVP mixed with PEG as a plasticizer wherein the . . . mixture of PVP and PEG comprises 36% PEG and 64% PVP as taught by Chalykh . . . because Chalykh teaches such a mixture provides adhesive hydrogel having maximum strength and because PEG is significant potent plasticizer to PVP, and their plasticizing effect is additive and complement each other. (Final Act. 13.) With respect to the amount of acrylic and hydrophilic polymers required by Appellant’s claimed invention, Examiner finds that “Roreger, Sanvordeker and [Kolter] teach amounts of acrylic polymer falling within the claimed amount, and Chalykh teach amounts of hydrophilic polymer falling within the claimed amount” (id. at 14). In this regard, Examiner reasons that one having ordinary skill in the art would have been motivated to use between 0.5-50% and particularly 4%, 10% and 15% of the acrylic or methacrylic polymers as taught by Roreger, or 3% or 6% polyacrylic acid taught by Sanvordeker in the hydrogel composition taught by the combination of Murray and Chalykh because Roreger teaches gel film comprising such an amount of acrylate polymer is flexible and exhibits mechanical stability in swollen condition and has a high water absorption capacity, handling stability and optimum skin and mucous membrane Appeal 2019-001618 Application 14/264,983 9 tolerance and because Sanvordeker teaches suitability of such amount of polyacrylic acid to provide adhesive hydrogel. (Final Act. 13–14.) According to Examiner, (a) “Sanvordeker is relied upon for solely teaching polyacrylate in the skin contacting layer in an amount of 3-6%;” (b) “[o]ne having ordinary skill in the art would have used [Roreger’s] acrylic copolymer . . . instead of [Murray’s] acrylic polymer . . . based on [the] suitability of both for hydrogel [formulations] suitable for wound healing;” and (c) “[o]ne having ordinary skill in the art would have replaced the acrylic polymers of Murray with Kollicoat® MAE 30D taught by [Kolter] because [Kolter] teaches the effect of such polymer in lowering transepithelial resistance, hence increase[ing] permeability” (Final Act. 17; see generally Ans.13 7–16). We are not persuaded. The evidence of record supports a finding that Murry fails to disclose an adhesive hydrogel, as required by Appellant’s claimed invention (see Appeal Br. 14). Examiner relies on Sanvordeker and Chalykh to make up for this deficiency in Murray (see FF 6–8 and 12). Sanvordeker’s mucoadhesive, however, does not comprise a hydrogel (see Appeal Br. 6). To the contrary, Sanvordeker discloses that “the non-adhesive reservoir layer,” not the mucoadhesive layer, of its trilaminate (mucoadhesive base layer, non-adhesive reservoir layer, and water-impermeable barrier) film comprises “a dehydrated hydrogel” (FF 12; see also Appeal Br. 6). Chalykh, as relied upon by Examiner, also fails to support a conclusion of obviousness. The adhesive hydrogel composition of Appellant’s claimed invention, comprises four components: (i) an acrylate copolymer, (ii) a blend of a hydrophilic polymer and a complementary 13 Examiner’s October 17, 2018 Answer. Appeal 2019-001618 Application 14/264,983 10 oligomer, (iii) a permeation enhancer, and (iv) a locally active agent (see Appeal Br. 14). Chalykh, however, describes a hydrogel composition comprising PVP and PEG, which according to Examiner corresponds to the hydrophilic polymer and complementary oligomer, respectively, of component (ii) of Appellant’s claimed invention (see Final Act. 11; see also FF 6–8). In this regard, Chalykh discloses that “PEG accounts for the PVP blend’s adhesive properties” and “[o]nly the blends in very narrow range of PEG content (in vicinity of 36 wt. %) provide high adhesion, whereas both PEG underloaded or overloaded blends reveal no adhesion” (FF 7–8). Examiner failed to adequately explain how the evidence on this record supports a conclusion that a person of ordinary skill in this art would have reasonably expected that Chalykh’s, PEG concentration sensitive, PVP-PEG hydrogel composition to retain its pressure sensitive adhesive properties when combined with the other three components of Appellant’s claimed adhesive hydrogel composition. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”). In this regard, we note that in order “to have a reasonable expectation of success, one must be motivated to do more than merely to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1365 (Fed. Cir. 2007) (quoting Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006)). Appeal 2019-001618 Application 14/264,983 11 Examiner further failed to establish that any of Roreger, Kolter, or Polymethacrylate alone or in combination make up for the foregoing deficiencies in the combination of Murray, Chalykh, and Sanvordeker. Having found that Examiner failed to establish an evidentiary basis on this record to support a conclusion of obviousness, we do not address Appellant’s evidence of unexpected results presented to rebut a prima facie case of obviousness (see Appeal Br. 10–13). CONCLUSION The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 84–91 and 93– 101 under 35 U.S.C. § 103(a) as unpatentable over the combination of Murray, Chalykh, Roreger, Sanvordeker, Kolter, and Polymethacrylate is reversed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 84–91, 93–101 103 Murray, Chalykh, Roreger, Sanvordeker, Kolter, Polymethacrylate 84–91, 93–101 REVERSED Copy with citationCopy as parenthetical citation