Ex Parte Zerbe et alDownload PDFPatent Trial and Appeal BoardJan 26, 201713292590 (P.T.A.B. Jan. 26, 2017) 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. 13/292,590 11/09/2011 Horst Georg ZERBE 20111766 3737 513 7590 01/30/2017 WENDEROTH, LIND & PONACK, L.L.P. 1030 15th Street, N.W., Suite 400 East EXAMINER ROBERTS, LEZAH Washington, DC 20005-1503 ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 01/30/2017 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): ddalecki@wenderoth.com eoa@ wenderoth. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte HORST GEORG ZERBE, JIAN-HWA GUO, and ANTHONY SERINO1 Appeal 2015-007223 Application 13/292,590 Technology Center 1600 Before RICHARD J. SMITH, RYAN H. FLAX, and RACHEL H. TOWNSEND, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. § 134(a) involving claims directed to a film comprising a pharmaceutically active ingredient Claims 10-14, 16—28, 30-34, and 36-49 are on appeal as rejected under 35 U.S.C. § 103(a) and for obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 We understand the Real Party in Interest to be LTS LOHMANN THERAPIE-SYSTEME AG. Br. 2. Appeal 2015-007223 Application 13/292,590 STATEMENT OF THE CASE The appealed claims can be found in the Claims Appendix of the Appeal Brief. Claims 10, 28, and 45 are independent claims; claim 10 is representative and reads as follows: 10. A film comprising: i. at least one water-soluble polymer, 11. at least one polyalcohol, and iii. at least one pharmaceutically active ingredient selected from the group consisting of narcotics that are capable of being delivered via the mucous membrane, wherein the at least one pharmaceutically active ingredient is incorporated into the film. Br. 23 (Claims App’x).2 The following rejections are on appeal: Claims 10-20, 22 40, and 42-49 stand rejected under 35 U.S.C. § 103(a) over Majeti,3 Acharya,4 Kizawa,5 and Sunshine.6 Ans. 3. 2 The Claims Appendix does not continue the consecutive pagination of the Appeal Brief of which it is a part. We refer to the Claims Appendix herein by the continued consecutive pagination based on counting. 3 U.S. Patent No. 5,599,554 (issued to Satyanarayana Majeti on Feb. 4, 1997) (hereinafter “Majeti”). 4 U.S. Patent No. 5,686,094 (issued to Ramesh N. Acharya on Nov. 11, 1997) (hereinafter “Acharya”). 5 U.S. Patent No. 4,517,173 (issued to Hidenori Kizawa et al. on May 14, 1985) (hereinafter “Kizawa”). 6 U.S. Patent No. 4,486,436 (issued to Abraham Sunshine on Dec. 4, 1984) (hereinafter “Sunshine”). 2 Appeal 2015-007223 Application 13/292,590 Claims 21 and 41 stand rejected under 35 U.S.C. § 103(a) over Majeti, Acharya, Kizawa, Sunshine, and Hill.7 Id. at 5. Claims 10-14, 16—28, and 30-46 stand rejected on the ground of nonstatutory obviousness-type double patenting over the claims of Zerbe.8 Id. at 6. We adopt the Examiner’s findings of fact, reasoning on scope and content of the prior art, and conclusions set out in the Final Action and Answer. The findings of fact set forth below are provided only to highlight certain evidence of record. FINDINGS OF FACT FF1. Majeti disclosed “a transdermally or transmucosally administrable composition for the treatment o[f] nicotine craving or smoking withdrawal symptoms comprising nicotine and caffeine or caffeine equivalent.” Majeti Abstract; see also Ans. 3—5 and 7—13 (discussing Majeti). FF2. Majeti disclosed a film for “use in with the oral mucosa,” comprising “[wjater soluble or water swellable polymers . . . [including] polyvinyl alcohol [and] cellulose derivatives [such as] . . . hydroxypropyl cellulose,” and “a glycol plasticizer,” such as propylene glycol and polyethylene glycol, which forms a “reservoir layer . . . forming film walls or matrixes which allow the nicotine and 7 U.S. Patent No. 5,032,387 (issued to Ira D. Hill et al. on July 16, 1991) (hereinafter “Hill”). 8 U.S. Patent No. 5,948,430 (issued to Horst Georg Zerbe et al. on Sept. 7, 1999) (hereinafter “Zerbe”). 3 Appeal 2015-007223 Application 13/292,590 caffeine or caffeine equivalent to pass by diffusion.” Majeti 4:55—5:9, 6:51—65 (Example 1); see also Ans. 3—5 and 7—13 (discussing Majeti). FF3. Acharya disclosed “a carrier or coating of active compositions, such as pharmaceuticals and the like . . . having a shape suitable for insertion into the mouth.” Acharya Abstract; see also Ans. 3—5 and 7—13 (discussing Acharya). FF4. Acharya disclosed materials that dissolve or disintegrate after contact with saliva (e.g., tablets, lozenges, candies, suppositories, or the like) that deliver active compositions, “provided as a . . . film or laminate . . . [where] the active composition is contained in an inert matrix,” comprising “cellulose polymers . . . such as . . . hydroxypropyl cellulose, hydroxymethyl cellulose,” and “cosolvents e.g. glycerol, propylene glycol, or polyethylene glycols, in varying proportion to affect the formation of the polymeric hydrogel,” and “medicinal agents includ[ing inter alia] . . . codeine phosphate.” Acharya 1:56-64, 5:1-2, 5:4A-54, 7:39-8:21, 10:2-6, 12:18-22; see also Ans. 3—5 and 7—13 (discussing Acharya). FF5. Kizawa disclosed “[a] mucous membrane-adhering film preparation wherein the film consists of two layers. One layer of the film consists of the pharmaceutical agents and water-soluble high polymer material.” Kizawa Abstract; see also Ans. 3^4 and 13 (discussing Kizawa). FF6. Kizawa disclosed the film includes “[ujseful pharmaceutical agents [such as]. . . narcotic agents such as lidocain and procainehydrochloride, [and] cough curing agents such as codeine phosphate,” and “a water-soluble cellulose derivative such as 4 Appeal 2015-007223 Application 13/292,590 hydroxypropyl cellulose (hereinafter abbreviated as ‘HPC’), methyl cellulose,” a “[copolymer with] . . . poly vinyl [sic] alcohol,” and a “plasticizer [such as] . . . polyethylene glycol (macrogol), propyleneglycol, glycerine.” Kizawa 2:34—58, 3:5—15, 4:3—6; see also Ans. 3^4 and 13 (discussing Kizawa). FF7. Sunshine disclosed “compositions comprising caffeine together with ... a selected narcotic analgesic.” Sunshine Abstract; see also Ans. 3, 5, and 13—14 (discussing Sunshine). FF8. Sunshine disclosed combining “the selected narcotic analgesic . . . with any oral nontoxic pharmaceutically acceptable inert carrier,” which can include “disintegrating agents” and “binders [such as] . . . methylcellulose [and] polyethylene glycol.” Sunshine 21:8— 36; see also Ans. 3, 5, and 13—14 (discussing Sunshine). FF9. Hill disclosed “an oral hygiene preparation,” which could include “Carbowaxes ® (polyethylene glycols)” and “[v]iscosity control agents . . . such as . . . methyl cellulose,” and “conventional flavoring components [such as] . . . vanillin,” and “at least one humectant [such as] . . . glycerine . . . and propylene glycol.” Hill Abstract, 4:17—18, 6:58—60, 7:1—11, 7:41—45; see also Ans. 5—6 and 14 (discussing Hill). FF10. Zerbe claimed, at its originally granted claims 1 and 10, “[a] monolayer film . . . comprising] at least one water-soluble polymer ... a polyalcohol... [a] pharmaceutically ingredient. . . which rapidly softens and completely disintegrates in the oral environment” where “the pharmaceutically active ingredient is ... a narcotic.” Zerbe claims 1 and 10; see also Ans. 6 and 14—15 (discussing Zerbe). 5 Appeal 2015-007223 Application 13/292,590 FF11. Zerbe claims, at its reexamined claims 13 and 16, “[a] monolayer film . . . comprising]... at least one water-soluble polymer ... a polyalcohol... at least one . . . pharmaceutical ingredient. . . which rapidly softens and completely disintegrates in the oral environment” where “the pharmaceutically active ingredient is ... a narcotic.” Zerbe claims 13 and 16; see also Ans. 6 and 14—15 (discussing Zerbe). DISCUSSION Obviousness Rejections Each of Majeti, Acharya, Kizawa, and Hill disclose the combination of a water-soluble polymer and a polyalcohol for the purpose of carrying and delivering a pharmaceutical and that these components can be the same as those disclosed in the Specification (at 3—5) and recited by the appealed claims.9 FF1—FF9. Acharya, Kizawa, and Sunshine disclose that the pharmaceutical component carried by such a polymer combination can be a narcotic, e.g., codeine phosphate. FF4, FF6—FF8. Majeti, Acharya, and Kizawa disclose that the combination of materials can be produced as a film. FF2, FF4—FF6. Acharya is clear that these materials can be fashioned to dissolve or disintegrate (rapidly), e.g., as tablets, lozenges, candies, suppositories, or the like. FF4. Majeti, Acharya, Kizawa, and Sunshine are clear that these materials can be fashioned to deliver the pharmaceutical (e.g., a narcotic) orally and to the mucous membranes. FF1—FF8. 9 Except with respect to claims 21, 26, 41, and 43, that we address below, we select claim 10 as representative with the remaining claims falling with claim 10. See 37 C.F.R. § 41.37(c)(l)(iv). 6 Appeal 2015-007223 Application 13/292,590 These references are analogous art as they are each in the same field of endeavor as one another and the claimed invention—polymeric oral or mucous membrane pharmaceutical carriers and delivery systems. See In re Clay, 966 F.2d 656, 658—59 (Fed. Cir. 1992). As the Supreme Court explained in KSR, “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” KSR Int’l v. Teleflex Inc., 550 U.S. 398, 416 (2007); see also id. at 417 (“[W]hen a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.”) (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976)). Furthermore, picking one of a finite number of known solutions to a known problem is obvious. KSR, 550 U.S. at 421. Here the prior art combination cited by the Examiner establishes a prima facie case that the appealed claims would have been obvious. Appellants’ arguments do not persuade us that a preponderance of the evidence fails to support the Examiner’s determination that the film defined by claim 10 would have been prima facie obvious over Majeti, Acharya, Kizawa, and Sunshine, and in the case of claims 21 and 41, also Hill. We address Appellants’ arguments below. Appellants argue the final rejection is premised on improper hindsight reasoning because the Examiner used the Applicants’ disclosure as a guide to pick and choose components from the prior art. This argument is not persuasive. The Examiner relies on the disclosures of the prior art and their suggested materials for a polymeric drug delivery film. No improper 7 Appeal 2015-007223 Application 13/292,590 hindsight was necessary or evidenced in the Examiner’s analysis or reasoning. Appellants argue there would have been no expectation of successfully combining the references because Acharya merely lists codeine as one of many drugs and Majeti requires both nicotine and caffeine and the skilled artisan could not expect to replace both of these with a narcotic. This argument is not persuasive. Even though the Examiner focuses on Acharya, more than one of the references disclosed using a narcotic as the pharmaceutical agent in a polymeric film, made of the materials recited by the appealed claims, for the purpose of delivering the drug to the mouth or mucous membrane. FF3—FF8. There would have been no reason to expect anything other than success in combining such materials and narcotic active ingredients, rather than the caffeine and nicotine active ingredients taught in Majeti, for mucosal delivery by way of a film as taught in Majeti. Appellants argue the Examiner has not used the broadest reasonable interpretation of the claim language in referencing the Specification’s disclosure of a list of drugs suitable for its invention, which includes narcotics and other drugs that overlap with the drug lists of the prior art references. This argument is not persuasive. There is no evidence suggesting the Examiner has not given the claim language its broadest reasonable interpretation. Ans. 12. To the contrary, the Examiner looked to the Specification to understand the meaning and context of the term “narcotic,” and found no special definition was given and determined that lidocaine, labeled by the prior art as a narcotic, would meet the limitation, but even if it did not, Acharya’s (and, we note, Kizawa’s and Sunshine’s) 8 Appeal 2015-007223 Application 13/292,590 disclosure of codeine phosphate would meet the limitation. Adv. Act. 2.10 “[A] claim must be read in view of the specification of which it is a part.” Renishaw PLC v. Marposs Societa per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998). Furthermore, we also do not find anything improper in the Examiner’s consulting the Specification to better understand the claimed invention. Adv. Act. 2; Ans. 12. The Examiner determined from the Specification that no specific tailoring was disclosed to make the film especially suited for use with narcotics, as opposed to the many other active ingredients listed in the Specification (Ans. 12; Spec. 5), which supported the Examiner’s conclusion of obviousness in substituting a medicinal agent listed in Acharya, such as lidocaine or codeine phosphate, for the nicotine and caffeine of Majeti into the film of Majeti, that includes the same film ingredients for mucosal delivery of the drug as claimed. We note the Specification evidences a lack of criticality to the particular pharmaceutical used. We also note that the Sunshine reference discloses combining a narcotic with caffeine, which evidences that a narcotic could be added to the film disclosed by Majeti. FF7-FF8. Appellants argue the Examiner has improperly relied on inherency regarding claims 26 and 43 (directed to “rapidly dissolving” limitation) and contend there was no reason to expect the film materials of the prior art references to “rapidly dissolve,” as required by claims 26 and 43. This argument is not persuasive. As the Examiner found, the cited prior art discloses the same water soluble polymers and polyalcohols, in substantially 10 Advisory Action, dated Oct. 9, 2014. 9 Appeal 2015-007223 Application 13/292,590 the same amounts, as disclosed in the Appellants’ Specification as suitable to carry and deliver narcotics. Ans. 12—13. Thus, if the Specification’s disclosed materials rapidly dissolve, those of the prior art would likewise be expected to do so. This expectation is confirmed by the disclosure of Acharya, which indicates that its drug carrier/delivery products composed of water soluble polymers and polyalcohols carrying narcotics can be fabricated as products that dissolve or disintegrate quickly, e.g., as tablets, lozenges, candies, suppositories, or the like. FF4. Appellants argue claims 21 and 41 are patentable for the same reasons argued for other claims. For the same reasons discussed above, this argument is not persuasive. Double Patenting Rejection Appellants’ arguments also do not persuade us that the Examiner was incorrect in determining that the appealed claims 10-14, 16—28, and 30-46 are unpatentable over the claims of Zerbe.11 We address Appellants’ arguments below. Appellants argue that the double patenting rejection fails because the Examiner has not addressed their prior traversal of the rejection. Appellants also argue that the appealed claims do not require a surfactant (which is alleged to be different from a polyalcohol), which is required by the claims of Zerbe. Appellants’ arguments are not persuasive. Zerbe claims a film with a water soluble polymer, a polyalcohol, and a pharmaceutical agent (claim 13). FF10. Zerbe also claims that the 11 Claim 10 is representative with the remaining claims falling therewith. See 37 C.F.R. § 41.37(c)(l)(iv). 10 Appeal 2015-007223 Application 13/292,590 pharmaceutical agent can be a narcotic (claims 10 and 16). FF10-FF11. Whether Zerbe’s claims also include a surfactant is not determinative because the Appellants’ claims are fashioned as inclusive, open-ended claims by nature of their use of the transition term “comprising.” A film having a water soluble polymer, a polyalcohol, and a narcotic, with or without a surfactant, such as defined by the Zerbe claims, renders the appealed claims obvious. SUMMARY The rejection of claims 10-20, 22-40, and 42-49 under 35 U.S.C. § 103(a) over Majeti, Acharya, Kizawa, and Sunshine is affirmed. The rejection of claims 21 and 41 under 35 U.S.C. § 103(a) over Majeti, Acharya, Kizawa, Sunshine, and Hill is affirmed. The rejection of claims 10—14, 16—28, and 30-46 for nonstatutory obviousness-type double patenting over the claims of Zerbe is affirmed. 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). AFFIRMED 11 Copy with citationCopy as parenthetical citation