Ex Parte Bär et alDownload PDFPatent Trial and Appeal BoardDec 27, 201613062591 (P.T.A.B. Dec. 27, 2016) 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. 13/062,591 05/25/2011 Hans Bar 376065US99PCT 5734 22850 7590 12/29/2016 OBLON, MCCLELLAND, MAIER & NEUSTADT, L.L.P. 1940 DUKE STREET ALEXANDRIA, VA 22314 EXAMINER CHICKOS, SARAH J ART UNIT PAPER NUMBER 1619 NOTIFICATION DATE DELIVERY MODE 12/29/2016 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): patentdocket @ oblon. com oblonpat @ oblon. com ahudgens@oblon.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte HANS BAR, THOMAS FURST, GERHARD RENNER, and MICHAEL GOTTSCHALK Appeal 2014-007258 Application 13/062,591 Technology Center 1600 Before DONALD E. ADAMS, JOHN G. NEW, and DAVID COTTA, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL1 This appeal under 35 U.S.C. § 134(a) involves claims 1, 3, 5, 7—13, 15—20 and 25 (Final Act. I).2 Examiner entered rejections under 35 U.S.C. § 103(a) and obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellants identify “the real party in interest [as] Evonik Degussa GmbH” (App. Br. 1). 2 Pending claims 2, 4, 6, 14, and 22—24 stand withdrawn from consideration (see Appellants’ Amendment received May 28, 2013 9). Appeal 2014-007258 Application 13/062,591 STATEMENT OF THE CASE Appellants disclose “a pH-dependent controlled release pharmaceutical composition for narcotic drugs (opioids) with decreased susceptibility to the influence of ethanol on the release of active compound” (Spec. 1: 6—8). Claims 1 and 25 are representative and reproduced below: 1. A pH-dependent controlled release pharmaceutical composition, comprising a core, comprising at least one pharmaceutical active ingredient, which is an opioid, wherein the core is coated by at least one coating layer, controlling release of the pharmaceutical composition, wherein the at least one coating layer comprises: (A) a polymer mixture of (Ai) 40 - 95 % by weight, based on a dry weight of the polymer mixture, of at least one water insoluble essentially neutral vinyl polymer or copolymer, and (Aii) 5-60 % by weight, based on the dry weight of the polymer mixture, of at least one anionic polymer or copolymer, which is insoluble in a buffered medium below pH 4.0 and soluble at least in a pH range from 7.0 to 8.0; (B) 110 to 250 % by weight of a non-porous inert lubricant; (C) 1 to 35 % by weight of at least one neutral cellulosic compound; and (D) 1 to 25 % by weight of at least one emulsifier, wherein (B) through (D) are calculated on the dry weight of the polymer mixture, and wherein the at least one active ingredient is released to a degree of 75% or less after 12 hours in simulated gastric fluid pH 1.2 for a first 2 hours and in buffered medium pH 6.8 for a 2 Appeal 2014-007258 Application 13/062,591 remaining time with or without an addition of 40 % ethanol (v/v) in the media. (App. Br. i.) 25. The controlled release pharmaceutical composition of claim 1, wherein component (C) comprises a hydroxypropylmethyl cellulose and component (D) comprises a polyoxyethylene sorbitan monoleate. (App. Br. iv.) In response to Examiner’s restriction requirement, Appellants’ elected naloxone as the opioid, EUDRAGIT® NE as the water insoluble essentially neutral vinyl polymer or copolymer (Ai), EUDRAGIT® FS as the anionic polymer or copolymer (Aii), talc as the non-porous inert lubricant (B), hydroxypropylmethyl cellulose as the neutral cellulosic compound (C), and polyoxyethylene sorbitan monooleate as the emulsifier (D) (see Examiner’s August 27, 2012 Restriction Requirement; Appellants’ September 14, 2012 Response to Restriction Requirement; and Examiner’s February 28, 2013 Office Action 6 (finalizing Examiner’s Restriction Requirement and Appellants’ corresponding election); Final Act. 2). Therefore, we limit the scope of our review to Appellants’ elected invention. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987). 3 Appeal 2014-007258 Application 13/062,591 The claims stand rejected as follows:3 Claims 1, 3, 5, 7—13, 15—20, and 25 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Chen4 and Petereit.5 Claims 1, 3, 5, 7—13, 15—20, and 25 stand provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1—7 and 9-14 of copending Application No. 12/678,429 in view of Chen. Claims 1, 3, 5, 7—13, 15—20, and 25 stand provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1—32 and 35 of copending Application No. 13/256,694 in view of Petereit. Claims 1, 3, 5, 7—13, 15—20, and 25 stand provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1—21 of copending Application No. 13/120,112 in view of Chen. Claims 1, 3, 5, 7—13, 15—20, and 25 stand provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1—7 and 9-14 of copending Application No. 12/678,406. Provisional Obviousness-type Double Patenting'. Appellants withdrew the provisional obviousness-type double patenting rejections from Appeal (see Oral Hearing Transcript 4: 8—11). 3 Application No. 13/203,760 stands abandoned. Therefore, all provisional double patenting rejections based on the foregoing Application are moot. 4 Chen et al., US 2003/0077297 Al, published Apr. 24, 2003. 5 Petereit et al., US 2006/0204576 Al, published Sept. 14, 2006. 4 Appeal 2014-007258 Application 13/062,591 Accordingly, we summarily affirm, and will not further discuss, the provisional obviousness-type double patenting rejections on this record. Obviousness: ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Chen discloses a composition comprising “one or more coatings on a[] . . . core,” wherein the core comprises at least one pharmaceutically active ingredient, such as an opioid (Chen H 91, 112, and 230; Final Act. 4). FF 2. Chen discloses that Delayed release formulations . . . enable drug release at some generally predictable location in the lower intestinal tract more distal to that which would have been accomplished if there had been no delayed release feature. The preferred method of delay of release is coating. Such coating should be applied at sufficient thickness such that the entire coating does not dissolve in the gastrointestinal fluids at pH below about 5, but does dissolve at pH about 5 and above. It is expected that any anionic polymer exhibiting a pH-dependent solubility profile can be used as an enteric coating in the practice of the present invention to achieve delivery to the lower gastrointestinal tract. (Chen | 301; see Final Act. 6.) FF 3. Chen discloses “[preferred coating materials [that] include shellac, acrylic polymers, cellulosic derivatives, polyvinyl acetate phthalate, and mixtures thereof. More preferred materials included inter alia,] Eudragit series E, L, S, RL, RS, NE, L, L300, S, and 100-55” (Chen 1309; see Final Act. 4; see also Chen 1308 (exemplifying a coating comprising Eudragit S and Eudragit L-30-D; see generally Ans. 8). 5 Appeal 2014-007258 Application 13/062,591 FF 4. Chen discloses that “[t]he coating can, and usually does, contain . . . other coating excipients such as . . . talc” and “surfactants” (Chen || 305— 306; id. 1151 (“A variety of PEG-sorbitan fatty acid esters are .. . suitable for use as surfactants[, wherein,] preferred hydrophilic surfactants include . . . PEG-20 sorbitan monooleate (Tween-80)”); Final Act. 4—5; see Appellants’ claim 3 (“the non-porous inert lubricant (B)[, of Appellants’ claim 1,] is talc”); Spec. 32: 30 —33: 2 (“Preferably the emulsifier is . . . Tween® 80”)). FF 5. Examiner finds that Chen does not disclose Appellants’ elected species of: (1) opioid (naloxone) or (2) anionic polymer or copolymer (Eudragit FS) and relies on Petereit to make up for the foregoing deficiencies in Chen (Final Act. 6). FF 6. Petereit discloses “a multilayer dosage form composed of a) a neutral core, b) an inner coating of methacrylate copolymer, [and] c) an outer coating of a copolymer which . . . ha[s] an anionic group in the alkyl radical,” wherein “the inner coating consists substantially of a methacrylate copolymer which is composed of at least 90% by weight of (meth)acrylate monomers having neutral radicals” (Petereit || 1, 22—25, and 27; see Final Act. 6-7). ANALYSIS Based on the combination of Chen and Petereit, Examiner concludes that, at the time Appellants’ invention was made, it would have been prima facie obvious “to use Eudragit FS and naloxone in the composition of Chen because of the advantages that Chen and Petereit teach” (Final Act. 7; see Ans. 8 (Chen discloses, intra alia, “that Eudragit NE and Eudragit S and mixtures thereof are particularly preferred coating materials for use in 6 Appeal 2014-007258 Application 13/062,591 enteric delayed release coatings” and Petereit discloses “Eudragit FS and a naloxone containing [an] opioid core”)). Appellants contend that Chen “discloses many materials then known in the art as coatings for delayed release formulations, including many Eudragit® series polymers, including some within the terms of the present components i) and ii), as well as coating excipients such as talc and magnesium stearate” (App. Br. 5; see also id. at 7 (Appellants “do not challenge the fact that polymers and other components of the present claims can be found individually within the four comers of [Chen], But[, instead contend that Chen] neither discloses nor suggests the particular combination” required by Appellants’ claimed invention); Reply Br. 5—6). Appellants further contend that Chen fails to disclose or “suggest[] the combination of two different polymers each having different properties as a coating layer for a delayed release formulation” (App. Br. 5). In this regard, Appellants contend that Petereit fails to make up for the deficiencies in Chen, because an advantage disclosed by Petereit is “based on the particular multilayer dosage form of [Petereit’s] invention [] containing a particular inner coating not required by [Appellants’] invention” (App. Br. 8; Reply Br. 7 (“Other than the fact that naloxone is a known opioid and Eudragit FS is a known polymer component used in delayed release formulations, [Petereit] adds nothing to [Chen]”)). We find that Appellants’ have the better argument. The composition of Appellants’ claimed invention requires a coating layer comprising, inter alia, (Ai) at least one water insoluble essentially neutral vinyl polymer or copolymer and (Aii) at least one anionic polymer or copolymer (see App. Br. i). Although, as Appellants explain, a number of Eudragit series 7 Appeal 2014-007258 Application 13/062,591 polymers and copolymers are known in the art, Examiner failed to establish an evidentiary basis on this record to support a conclusion that the combination of Chen and Petereit suggests a composition comprising a coating layer as is required by Appellants’ claimed invention (see App. Br. 5 and 7; Reply Br. 5—7). Stated differently, Examiner failed to explain why, without the benefit of Appellants’ disclosure, a person of ordinary skill in this art would have selected the specific Eudragit series polymers or copolymers from Chen and Petereit required by Appellants’ claimed invention (see Reply Br. 7 (“Considering the broad objective of [Chen,] why, without the present disclosure as a guide, would one of ordinary skill in the art choose [Appellants’] presently-recited components Ai) and Aii), in the respectively-recited amounts, given the significantly larger universe of delayed release materials disclosed by [Chen]?”)). See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“rejections 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 find that: Obviousness requires more than a mere showing that the prior art includes separate references covering each separate limitation in a claim under examination. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007). Rather, obviousness requires the additional showing that a person of ordinary skill at the time of the invention would have selected and combined those prior art elements in the normal course of research and development to yield the claimed invention. Id. at 421, 127 S.Ct. 1727. Unigene Laboratories, Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011). See In re NTP, Inc., 654 F.3d 1279, 1299 (Fed. Cir. 2011) (Fed. Cir. 2011) (“Care[, however,] must be taken to avoid hindsight reconstruction by 8 Appeal 2014-007258 Application 13/062,591 using ‘the patent in suit as a guide through the maze of prior art references, combining the right references in the right way so as to achieve the result of the claims in suit’”). CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 1, 3, 5, 7—13, 15—20, and 25 under 35 U.S.C. § 103(a) as unpatentable over the combination of Chen and Petereit is reversed. 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 9 Copy with citationCopy as parenthetical citation