Ex Parte SowdenDownload PDFPatent Trial and Appeal BoardMar 3, 201611043634 (P.T.A.B. Mar. 3, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 111043,634 01/26/2005 27777 7590 03/07/2016 BERNARD F. PLANTZ JOHNSON & JOHNSON ONE JOHNSON & JOHNSON PLAZA NEW BRUNSWICK, NJ 08933-7003 FIRST NAMED INVENTOR Harry S. Sowden 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 ATTORNEY DOCKET NO. CONFIRMATION NO. MCP0242DIV2 8269 EXAMINER LOVE, TREVOR M ART UNIT PAPER NUMBER 1611 NOTIFICATION DATE DELIVERY MODE 03/07/2016 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): jnjuspatent@corus.jnj.com lhowd@its.jnj.com pairjnj@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte HARRY S. SOWDEN Appeal2013-007045 Application 11/043,634 Technology Center 1600 Before JEFFREY N. FREDMAN, JOHN G. NEW, and RICHARD J. SMITH, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal 1 under 35 U.S.C. § 134 involving claims to methods of making dosage forms. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b ). We affirm. 1 Appellant identifies the Real Party in Interest as McNeil-PPC, Inc. (see Br. 1 ). Appeal2013-007045 Application 11/043,634 Statement of the Case Background Capsules are typically manufactured using a two- piece gelatin shell formed by dipping a steel rod into gelatin so that the gelatin coats the end of the rod. The gelatin is hardened into two half-shells and the rod extracted. The hardened half-shells are then filled with a powder and the two halves joined together to form the capsule (Spec. i-f 2). The Specification teaches that "these processes have certain drawbacks. For example, because these systems are batch processes, each of the various apparatuses employed is housed in a separate clean room that must meet FDA standards" (Spec. i-f 4). The Claims Claims 28-36 and 40-46 are on appeal. Claim 28 is representative and is reproduced below: 28. A method of making dosage forms, comprising the steps of: a) compressing a powder into a compressed dosage form in a compression module; b) transferring said compressed dosage form to an injection molding module; c) injecting gelatin under pressure around said compressed dosage form in said injection molding module, wherein said injection molding module and said gelatin are heated prior to said injecting; and d) cooling said gelatin so as to form a hard coating over said compressed dosage form; wherein steps (a) through (d) are linked together such that essentially no interruption occurs between said steps. 2 Appeal2013-007045 Application 11/043,634 The Issues A. The Examiner rejected claims 28-33 and 43--46 under 35 U.S.C. § 103(a) as obvious over GB '081,2 Lehmann, 3 Alt, 4 Conte, 5 and Angell, Jr. 6 (Final Act. 3-11 ). B. The Examiner rejected claims 34--36, 40 and 41under35 U.S.C. § 103(a) as obvious over GB '081, Lehmann, Alt, Conte, Angell, Jr., and Bar-Shalom7 (Final Act. 11-14). A. 35 US.C. § 103(a) over GB '081, Lehmann, Alt, Conte, and Angell, Jr. The Examiner finds it obvious to "utilize the injection molded coating of Lehmann on the composition of [GB] '081. ... Lehmann teaches the clear advantage of utilizing the injection molding coating in order to allow for individual dosages of active to be released in desired sections of the gastrointestinal tract" (Final Act. 6). The Examiner further finds it obvious to "utilize gelatin (a thermoplastic polymer) in combination with the acrylic and/or methacrylic acid coating of Lehmann ... since Alt teaches that gelatin and methacrylic acid are both known in the art as useful coating materials for controlled release compositions" (Final Act. 7). The issue with respect to this rejection is: Does the evidence of record support the Examiner's conclusion that GB '081, Lehmann, Alt, Conte, Angell, Jr., render claim 28 obvious? 2 Stott, F., GB 759,081, published Oct. 10, 1956. 3 Lehmann et al., US 5,705,189, issued Jan. 6, 1998. 4 Alt et al., US 5,788,979, issued Aug. 4, 1998. 5 Conte et al., WO 94/06416 Al, published Mar. 31, 1994. 6 Angell, Jr. et al., US 3,988,403, issued Oct. 26, 1976. 7 Bar-Shalom et al., US 5,213,808, issued May 25, 1993. 3 Appeal2013-007045 Application 11/043,634 Findings of Fact 1. GB '081 teaches "machines for the production of coated tablets" (GB '081 1, 11. 13-14) including: a stationary cam 10 employed to raise and lower the punches 7 which are also acted on by a roller (not shown) serving to force the punches 7 into the dies 3 at the appropriate time in order to compress powder fed by means of a stationary hopper 22 to the dies into core tablets. A stationary cam 11 acts on the punches 8 to raise them sufficiently to force the made core tablets out of the dies. (GB '081 2, 1. 130 to 3, 1. 8). 2. Lehmann teaches "thermoplastic materials useful for drug coatings and which dissolve in intestinal juices. There also remains a need for pharmaceutical compositions in which an active agent or drug is coated with such a material" (Lehmann, col. 1, 11. 55-59). 3. Lehmann teaches that an "injection molding method can also be used to coat preshaped drug cores with a polymer sheath. The cores are thereby held centered by means of auxiliary dies, which are withdrawn before the final filling of the mold cavity and before the solidification of the molding composition" (Lehmann, col. 3, 11. 2-7). 4. Lehmann teaches that "[t]ogether with acrylic and/or methacrylic acid and methyl acrylate, other alkyl esters of acrylic and/or methacrylic acid, if desired, can also be used ... The present thermoplastic material copolymer can be mixed with auxiliaries in the melt, which are common in drug coating compositions" (Lehmann, col. 3, 11. 51-64). 5. Alt teaches that "[ s Jome materials suitable for the coating are presently in clinical use for the slow release of drugs, for example, from 4 Appeal2013-007045 Application 11/043,634 capsules, tablets, powders, or other galenic preparations after internal application into the gastrointestinal tract, such as gelatin, cellulose and methacrylic acid" (Alt, col. 3, 11. 47-51 ). 6. Conte teaches that the "availability of pharmaceutical compositions capable of liberating different drugs at successive times would solve a therapeutic problem also involving a serious social impact" (Conte 5, 11. 20-23). 7. Conte teaches "tablet as per the present invention consists of three layers ... a first layer containing one or more drugs with immediate or controlled release formulation ... a second layer containing one or more drugs ... a low-permeability barrier type layer coating ... consisting of polymeric materials ... and if necessary, a drug" (Conte 6, 11. 11-25). 8. Angell, Jr. teaches that the "thermoplastic material immediately adjacent to the inner surface of the mold neither slips or slides along the surface nor does it fracture, as the thermoplastic material flows in the mold cavity" (Angell, Jr., col. 3, 11. 44--47). Principles of Law "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability." Id. at 417. Analysis We adopt the Examiner's findings of fact and reasoning regarding the scope and content of the prior art (Final Act. 3-11; FF 1-8) and agree that 5 Appeal2013-007045 Application 11/043,634 claim 28 is rendered obvious by GB '081, Lehmann, Alt, Conte, and Angell Jr. We address Appellants' arguments below. Appellant contends that "GB759081 does not disclose or suggest a method that employs use of a compression module and an injection molding module as claimed" (Br. 7) and Lehman[ n] et al., which discloses the use of specified amounts of specified thermoplastic materials in dosage forms, Alt et al, which discloses that gelatin is suitable as a coating for a biomaterial, Conte et al., which discloses dosage forms having three layers, and Angell et al., which discloses a process for molding a foamed thermoplastic article, do not disclose injecting gelatin around a compressed dosage form. (Br. 8). Appellant contends that "the references alone or combined would not lead one skilled in the art to a method for injecting gelatin around dosage forms as claimed" (Br. 9). We find these arguments unpersuasive because they fail to combine the teachings of the references. "The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference ... Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 413, 425 (CCPA 1981). Here, Appellant's arguments do not address the combined teachings of GB '081, Lehmann, Alt, Conte, and Angell, Jr., but instead dissects the references into their separate teachings. As the Examiner explains, Conte motivates coating drugs with polymers for controlled drug release (FF 6-7; cf Final Act. 6), which provides a reason for coating the compressed pills of 6 Appeal2013-007045 Application 11/043,634 GB '081 (FF 1) with thermoplastic coatings such as the methacrylic polymers of Lehmann or the equivalent gelatin polymers of Alt (FF 2, 5; cf Final Act. 6-7). The Examiner reasonably relies upon Lehmann to teach injection molding as a known process for coating the compressed pills (FF 3). Appellant provides no reason or evidence explaining why the prior art does not render injection molding of gelatin around drug cores unobvious in view of these teachings. Conclusion of Law The evidence of record supports the Examiner's conclusion that GB '081, Lehmann, Alt, Conte, and Angell, Jr., render claim 28 obvious. B. 35 USC§ 103(a) over GB '081, Lehmann, Alt, Conte, Angell, Jr., and Bar-Shalom The Examiner finds it obvious "utilize the dual injection molded coating method of Bar-Shalom in the invention '081 in view of Lehmann, Alt, Conte, and Angell ... since Bar-Shalom teaches that the layers allow for variation which enables one of ordinary skill to 'prepare compositions having different release profiles"' (Final Act. 13). The issue with respect to this rejection is: Does the evidence of record support the Examiner's conclusion that GB '081, Lehmann, Alt, Conte, Angell, Jr., and Bar-Shalom render claim 34 obvious? 7 Appeal2013-007045 Application 11/043,634 Findings of Fact 9. Figures 1 la-1 le of Bar-Shalom are reproduced below: FtG. ffb FIG.Uc FIG. lld FIG. 11 shows a method for producing a composition ... In step a) a layer comprising an active substance 1 dispersed in, e.g., a molten polyethylene glycol with a molecular weight of about 1.000-10.000, is injected into a central cavity formed by two pistons 3 and 4, after which the molten polyethylene glycol is allowed to solidify. In step b) the two pistons 3 and 4 have moved an equal distance away from the active substance 1 in the central cavity. Two layers 2, each of which comprises a crystalline polymer matrix and a surface active agent, are then injected into the two new cavities which are formed on either side of the active substance 1 by the movement of the two pistons 3 and 4. In step c) the two layers 2 have solidified and the two pistons 3 and 4 have moved forward, thereby pushing a central composite rod comprising the two matrix layers 2 and the active substance 1 into a new cavity into which a coating 5 is injected. In step d) the mold is opened by moving one part 6 of the mold from the other part 7. In step e) the finished composition 8 is ejected from the mold 7 by the movement of piston 4. (Bar-Shalom, col. 21, 11. 24--53). 8 Appeal2013-007045 Application 11/043,634 Analysis We adopt the Examiner's findings of fact and reasoning regarding the scope and content of the prior art (Final Act. 11-14; FF 1-9) and agree that claim 34 is rendered obvious by Bar-Shalom in combination with GB '081, Lehmann, Alt, Conte, and Angell, Jr. Appellant contends that "Bar-Shalom does not disclose embedding an insert in powder prior to compressing the powder into a compressed dosage form as claimed" (Br. 10). The Examiner responds that "Bar Shalom clearly teaches an insert which is embedded prior to compression" (Ans. 6). The Examiner finds that "Bar-Shalom teaches an injection mold as shown in figures 11 a-11 e which forms a first injection molded coating 11 b, which is around component number '1' which comprises the active and an insert made of polyethylene glycol" (Ans. 6). We find that the Examiner has the better position. Bar-Shalom teaches that layer 1 comprising an active substance is placed between two layers 2 composed of a "crystalline matrix" which is reasonably interpreted as a powder (FF 9). The layers 2 are compressed by pistons around layer 1 and so layer 1 is reasonably interpreted as "embedded" within the layers 2 after the compression (FF 9). Appellant does not provide any reasoning to distinguish these teachings of Bar-Shalom. Conclusion of Law The evidence of record support the Examiner's conclusion that GB '081, Lehmann, Alt, Conte, Angell, Jr., and Bar-Shalom render claim 34 obvious. 9 Appeal2013-007045 Application 11/043,634 SUMMARY In summary, we affirm the rejection of claim 28 under 35 U.S.C. § 103(a) as obvious over GB '081, Lehmann, Alt, Conte, and Angell, Jr. Claims 29--33 and 43--46 fall with claim 28. 37 C.F.R. § 41.37(c)(l)(iv). We affirm the rejection of claim 34 under 35 U.S.C. § 103(a) as obvious over GB '081, Lehmann, Alt, Conte, Angell, Jr., and Bar-Shalom. Claims 35, 36, 40 and 41 fall with claim 34. 37 C.F.R. § 41.37(c)(l)(iv). 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 10 Copy with citationCopy as parenthetical citation