Ex Parte Alfano

Patent Trial and Appeal BoardMar 3, 2017

13842414 (P.T.A.B. Mar. 3, 2017)

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. 13/842,414 03/15/2013 Kenneth Mimnaugh Alfano 8036 109138 7590 03/06/2017 Kenneth Alfano 41635 Copper Creek Drive Canton, MI 48187 EXAMINER JAVIER, MELISSA L ART UNIT PAPER NUMBER 1611 MAIL DATE DELIVERY MODE 03/06/2017 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte KENNETH MIMNAUGH ALFANO ____________ Appeal 2015-008028 Application 13/842,414 Technology Center 1600 ____________ Before DONALD E. ADAMS, DEMETRA J. MILLS, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL1 This appeal under 35 U.S.C. § 134(a) involves claims 11 and 16 (App. Br. 3; see also id. at 1 (“This brief is submitted in support of pending independent claims 11 and 16”)).2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM–IN–PART. 1 Appellant identifies the real party in interest as “Kenneth Alfano (Applicant/Inventor), owner of Tailorpill Technologies, LLC.” (App. Br. 1 2 Pending claims 12–15 and 17–20 stand rejected and withdrawn from Appeal (App. Br. 1–3). Appeal 2015-008028 Application 13/842,414 2 STATEMENT OF THE CASE Appellant’s “application relates to pharmaceuticals, and more particularly, relates to patient-specific drug products having high drug loads achievable by ‘micro-dosing’ dispensing technology with filler-free capability for reducing diluent used” (Spec. ¶ 2). Appellant limits the issues presented in this Appeal to whether: (1) claim 11 is anticipated by Kirsh or Clarke and (2) claim 16 is anticipated by Komorowski (App. Br. 3).3 Claims 11 and 16 are reproduced below: 11. A customized multiple-unit-dose drug product, comprising: two or more drug substances whose respective identities and dose levels are customized for a particular patient and combined in a single ingestible or otherwise orally- administrable drug product comprising a capsule shell, wherein at least one of said drug substances is not in formulation with any non-therapeutic excipient, said non-therapeutic excipient being any ingredient that essentially does not facilitate pharmacokinetics or pharmacodynamics in vivo, and wherein said at least one of said drug substances is not on a sheet or other substrate; and a barrier for limiting in vitro contact between at least two of said two or more drug substances. (App. Br. 9.) 16. A customized multiple-unit-dose drug product, comprising: Two or more drug substances at dose levels essentially as prescribed for a particular patient, combined in one capsule drug product having an enteral or otherwise non-intravenous route of administration, wherein at least one drug substance is 3 Appellant waived any appeal of the pending rejections under 35 U.S.C. § 112, second paragraph, 35 U.S.C. § 103(a) and the anticipation rejection of claims 12, 14, 15, 18, and 19 (see Ans. 2–10). In addition, Appellant waived any appeal of the pending rejections of claims 12, 14, 15, 18, and 19. Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii). Appeal 2015-008028 Application 13/842,414 3 present without significant functional or non-functional excipient, said at least one drug substance not having been deposited as a liquid onto an intermediary substrate; and a barrier for restricting contact between at least two drug substances. (App. Br. 10.) The claims stand rejected as follows: Claim 11 stands rejected under 35 U.S.C. § 102(b) as anticipated by Kirsh4 or Clarke.5 Claim 16 stands rejected under 35 U.S.C. § 102(e) as anticipated by Komorowski.6 ISSUE Does the preponderance of evidence on this record support Examiner’s finding that Kirsh, Clarke, or Komorowski teaches Appellant’s claimed invention? FACTUAL FINDINGS (FF) FF 1. Kirsh “relates to a method for providing individualized, customized, combined doses of two or more drugs to an individual” (Kirsh ¶ 1; Ans. 3– 4). FF 2. Kirsh discloses a pharmaceutical dosage form compris[ing] a plurality of drug- containing sub-units connected together in the assembled dosage form and being retained together by the connection at least prior to administration to a patient, at least one of the 4 Kirsh et al., US 2009/0149507 A1, published June 11, 2009. 5 Clarke et al., US 2007/0087049 A1, published Apr. 19, 2007. 6 Komorowski, US 2010/0158956 A1, published June 24, 2010. Appeal 2015-008028 Application 13/842,414 4 subunits being a solid sub-unit comprising a solid matrix of a polymer which contains a drug substance, the polymer being soluble, dispersible or disintegrable in the patients gastrointestinal environment to thereby release the drug substance, and wherein the connection is provided by a weld between parts of the assembled dosage form. (Kirsh ¶ 84; see Ans. 4.) FF 3. Clarke “relates to pharmaceutical formulations, being a dosage form comprising two or more connected sub-units, particularly for oral dosing” (Clarke ¶ 1; see Ans. 5). FF 4. Clarke discloses a multi-component dosage form [] which comprises a plurality of drug substance––containing sub-units each selected from capsule compartments which can release their drug substance in the gastro-intestinal environment, and solid sub-units comprising a solid matrix of a polymer which contains a drug substance, the polymer being soluble, dispersible or disintegrable in the patient’s gastro-intestinal environment to thereby release the drug substance, the sub-units being connected together in the assembled dosage form and being retained together by the connection at least prior to administration to a patient, wherein the connection is provided by a weld between parts of the assembled dosage form. (Clarke ¶ 7; see also id. ¶ 23; Ans. 5.) FF 5. Kirsh and Clarke both disclose that “[p]harmaceutical dosage forms are [] known which comprise a matrix of a solid polymer,” such as “a polyethylene glycol (‘PEG’) matrix” (Kirsh ¶ 80; Clarke ¶ 4; see Ans. 11). FF 6. Examiner asserts that “[p]olyethylene glycol is a known laxative material (i.e. a therapeutic excipient)” (Ans. 11). FF 7. Komorowski “relates to a formulation and treatment regime that provides to a patient, in a single dosage form, a combination of a therapeutic Appeal 2015-008028 Application 13/842,414 5 drug and a nutritional component,” which are separated by a barrier layer (Komorowski ¶ 3; see also id. at ¶¶ 8–14; see Ans. 6). Komorowski discloses that [t]he nutritional supplement and therapeutic agent, pharmaceutically acceptable salts of the therapeutic agent and pharmaceutically acceptable solvates of the therapeutic agent can be co-formulated alone but, in human therapy, will generally be administered in admixture with a suitable pharmaceutical excipient[,] diluent or carrier selected with regard to the intended route of administration and standard pharmaceutical practice. (Komorowski ¶ 37; Ans. 12.) ANALYSIS The anticipation rejection of claim 11 over Kirsh or Clarke: Examiner finds that Kirsh or Clarke anticipates Appellant’s claimed invention (Ans. 3–4 and 5; FF 1–4). In this regard Examiner asserts that “[t]he art does not need to specifically teach the general exclusion of a non- therapeutic excipient when the art of record teaches the combination of a drug and a polyethylene glycol matrix,” because “[p]olyethylene glycol is a known laxative material (i.e. a therapeutic excipient)” (Ans. 11–12; FF 6). We are not persuaded. Examiner failed to establish an evidentiary basis on this record to support a finding that PEG is a laxative material in general, or specifically, at the concentration required to serve as a matrix material for a pharmaceutical dosage form (see FF 5; cf. FF 6). Therefore, we are compelled to agree with Appellant’s contention that “[b]ecause Examiner has not explained how Kirsh or Clarke teach avoidance of non-therapeutic excipient, Appellant submits that a prima fascia [sic] case of anticipation has not been made” (App. Br. 5–6). Appeal 2015-008028 Application 13/842,414 6 We recognize, but are not persuaded by, Examiner’s reliance on Xcelodose®S7 to support Examiner’s assertion that “it [was] known in the art to fill API[8] directly into capsules, with no need for excipients with powder micro-dosing systems” (Ans. 12). Examiner failed to establish an evidentiary basis on this record to support a finding that the pharmaceutical formulations of Kirsh or Clarke are or are amenable to powder micro-dosing systems, such that the disclosure of Kirsh or Clarke inherently teaches, or encompasses, Xcelodose®S’ powder micro-dosing systems (see Reply Br. 2– 3 (Xcelodose®S’ “‘microdosing’ dispensing technology had not been directed to pharmaceutical compounding, particularly for customized polypills”)). In order to support an anticipation rejection, a prior art “reference must clearly and unequivocally disclose the claimed [invention] or direct those skilled in the art to the [invention] without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference.” In re Arkley, 455 F.2d 586, 587 (CCPA 1972) (emphasis added). The anticipation rejection of claim 16 over Komorowski: Examiner finds that Komorowski anticipates Appellant’s claim 16 (Ans. 6; FF 7–8). Appellant does not dispute that Komorowski’s disclosure of a formulation comprising a nutritional supplement and a therapeutic agent reads on a multiple-unit-dose drug product, comprising two or more drug substances (see App. Br. 6–8; Reply Br. 3; cf. FF 7–8). To the contrary, 7 Xcelodose®S, New Powder Mirco-dosing System brochure, www.capsugel.com (2008). 8 Appellants’ Specification defines the acronym “API” as “the active pharmaceutical ingredient” (Spec. ¶ 8). Appeal 2015-008028 Application 13/842,414 7 Appellant contends that “Komorowski does not appear to teach excipient avoidance for an API in a compounded polypill” (App. Br. 7). In this regard, Appellant recognizes “the fact cited by Examiner that certain ingredients in Komorowski can be ‘co-formulated alone’,” but finds that this teaching in Komorowski “is distinguishable from teaching that at least one drug substance is present without any significant amount of an excipient” (App. Br. 7; see FF 8). We are not persuaded. Komorowski expressly discloses that “[t]he nutritional supplement and therapeutic agent [] can be co-formulated alone” (FF 8). Notwithstanding Appellant’s contention to the contrary, Komorowski distinguishes between “co-formulated alone” and formulation in the presence of “a suitable pharmaceutical excipient[,] diluent or carrier” (FF 8; cf. App. Br. 7). Therefore, on this record, we find that Examiner has the better position, wherein Examiner finds that Komorowski’s disclosure of “co-formulated alone” means “without significant functional or non- functional excipient” (see Ans. 12). For the foregoing reasons, we are not persuaded by Appellant’s contention that “Examiner has not explained how Komorowski teaches at least one drug substance lacking any significant excipient in a custom polypill capsule (by any standard for significance) [or that] a prima fascia [sic] case of anticipation has not been made” (App. Br. 8; see also Reply Br. 3). CONCLUSION OF LAW The preponderance of evidence on this record fails to support Examiner’s finding that Kirsh or Clarke teach Appellant’s claimed invention. The rejection of claim 11 under 35 U.S.C. § 102(b) as anticipated by Kirsh or Clarke is reversed. Appeal 2015-008028 Application 13/842,414 8 The preponderance of evidence on this record supports Examiner’s finding that Komorowski teaches Appellant’s claimed invention. The rejection of claim 16 under 35 U.S.C. § 102(e) as anticipated by Komorowski 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-IN-PART