Ex Parte Bunick et alDownload PDFPatent Trial and Appeal BoardJun 14, 201612824311 (P.T.A.B. Jun. 14, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/824,311 06/28/2010 27777 7590 06/16/2016 JOSEPH F SHIRTZ JOHNSON & JOHNSON ONE JOHNSON & JOHNSON PLAZA NEW BRUNSWICK, NJ 08933-7003 FIRST NAMED INVENTOR Frank Bunick 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. MCP5185USNP 9694 EXAMINER ROBINSON, LISBETH C ART UNIT PAPER NUMBER 1611 NOTIFICATION DATE DELIVERY MODE 06/16/2016 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 FRANK BUNICK, LEO B. KRIKSUNOV, JOSEPH LUBER, and HARRY SOWDEN Appeal2013-009165 Application 12/824,311 Technology Center 1600 Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and JOHN G. NEW, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL 1 This appeal under 35 U.S.C. § 134(a) involves claims 1-11 and 21-30 (App. Br. 2).2 Examiner entered a rejection under 35 U.S.C. § 103. We have jurisdiction under 35 U.S.C. § 6(b ). We AFFIRM. 1 Appellants identify the Real Party in Interest as "McNeil-PPC, Inc., a wholly owned subsidiary of Johnson & Johnson" (see App. Br. 1). 2 "Claims 12-20 [stand] withdrawn from consideration due to a restriction requirement" (App. Br. 2). Appeal2013-009165 Application 12/824,311 STATEMENT OF THE CASE Appellants' invention features a tablet including a compressed core and a liquid filled capsule, wherein the compressed core includes a first pharmaceutically active agent, the compressed core has a cavity exposed on the surface of the core, and the capsule is contained within the cavity such that a portion of the capsule is visible on the surface of the tablet, wherein the capsule has a diameter of at least 500 microns. (Spec. 1.) Claim 1 is representative and reproduced in the Claims Appendix of Appellants' Brief. Claims 1-11 and 21-30 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Li3 and Budich.4 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Li "relates to dosage forms having two or more cores surrounded or covered at least in part by a shell that is translucent" (Li i-f 1; see also i-f 21 ("[t]he dosage form comprises at least two cores, e.g., a first core and a second core"); see generally Final Rej. 4--5). FF 2. Li discloses that "[e]ach core or compressed portion may be any solid form. As used herein, 'core' or 'compressed portion' refers to a part of the dosage form that is at least partially enveloped or surrounded by another material" (Li i-f 20; see Final Rej. 4). 3 LI et al., US 2008/0075766 Al, published Mar. 27, 2008. 4 Budich, DE 103 37 814 Al, published Apr. 7, 2005. 2 Appeal2013-009165 Application 12/824,311 FF 3. Li discloses that "[t]he active ingredient or ingredients may be present in the dosage form in any form" including "in the form of particles," wherein "the particles (whether coated or uncoated) typically have an average particle size of about 1-2000 microns" (Li i-f 19; Final Rej. 4 (Li suggests "cores being at least about 50 to 2000 microns because the contents have that size")). FF 4. "[E]ach [of Li's] core is a self-contained unitary object" that is "[t]ypically a solid," however, "a core or a portion thereof may be in the form of a "liquid" (Li i120; see Final Rej. 4). FF 5. Li's "cores can have the same or different compositions, comprise the same or different active ingredients, excipients ... , and the like" (Li i121; Final Rej. 4--5). FF 6. Li's "core may[] comprise a multilayer tablet," wherein "the cores may be oriented one on top of the other such that their upper or lower faces are adjacent to and in contact with the interior wall" (Li i1i123 and 26; see also i1 51 ("Cores ... may be single or multi-layer, for example bi-layer, tablets"); see Final Rej. 4--55). FF 7. Budich's Figure 3 is reproduced below: 3 2 Figur 3 1 Examiner finds that Budich's Figure 3 "depicts a capsule nearly completely embedded within [a] compressed tablet" (Ans. 6). 3 Appeal2013-009165 Application 12/824,311 FF 8. Examiner finds that Budich's "capsule is fixed into the [tablet's] recess by means of [an] elastic and deformable shell and does not require adhesive" (Ans. 6). FF 9. Lee5 "relates to composite dosage forms such as pharmaceutical compositions" (Lee i-f 2). FF 10. Lee discloses that "[t]he incorporation of molded portions into delivery systems has been used in the household products industry to achieve an additional degree of versatility" and "[a]ssembled forms comprising a mixture of compressed and molded portions are known for example for delivery of detergents" (Lee i-f 14; see Final Rej. 10-11 ). FF 11. Lee discloses that "[ o ]ne limitation of such [detergent] assemblies is the propensity for the two portions to become detached due to inadequate adherence and minimal surface area of contact between them" (Lee i-f 14). ANALYSIS Based on the combination of Li and Budich, Examiner concludes that, at the time Appellants' invention was made, it would have been prima facie obvious "to arrange the cores taught by Li [] into a two-layered tablet by laminating two tablets as shown in figure 3 of Budich, oriented back to back" (Ans. 8; see FF 1-8). We recognize, but are not persuaded by, Appellants' contention that Budich is non-analogous art and, as such, a person of ordinary skill in this art would not look to the detergent composition of Budich to formulate a pharmaceutical dosage form (Br. 4--5). As Examiner explains, "Budich is directed to solving the problem of providing a convenient dosage form for [] 5 Lee et al., US 2004/0156902 Al, published Aug. 12, 2004. 4 Appeal2013-009165 Application 12/824,311 incompatible, multiphasic active agents" (Ans. 2-3). In this regard, as rebuttal evidence to Appellants' non-analogous art argument, Examiner directs attention to Lee which looks to delivery systems for detergents to aid in the development of Lee's pharmaceutical delivery system (FF 9-1 O; see Ans. 4--5). For the foregoing reasons, we are not persuaded by Appellants' contention that Examiner relied upon "impermissible hindsight (e.g., remodeling the orally administrable tablet of Li [] with the design of Budich[]'s unrelated detergent tablet based on the teachings of Appellant's [sic] [S]pecification" (Br. 6). Notwithstanding Appellants' contention to the contrary, Li suggests a plurality of dosage form configurations (see e.g., FF 6; Final Rej. 4). Budich simply suggests, inter alia, a configuration, wherein a compressed core comprises a cavity exposed on the surface of the core, wherein a capsule is contained within the cavity such that a portion of the capsule is visible on the surface of the tablet (see FF 7; cf Appellants' claim 1 ). Thus, Examiner's rejection is based on the obviousness of utilizing Budich's configuration in Li, not hindsight. See KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) ("if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill"). We recognize, but are not persuaded by, Appellants' contention that Lee teaches away from the combination of Li and Budich, because Lee discusses the "propensity for the two portions [of the formulation] to become detached due to inadequate adherence and minimal surface area of contact between them" (Br. 5). As Examiner explains, however, Budich's Figure 3 "depicts a capsule nearly completely embedded within the compressed 5 Appeal2013-009165 Application 12/824,311 tablet" and "that the capsule is fixed into the [tablet's] recess by means of [an] elastic and deformable shell and does not require adhesive" (Ans. 6; FF 7-8). Thus, as Examiner explains, "a skilled artisan would not expect ... Budich to share the same problems identified by Lee" (Ans. 6). We recognize, but are not persuaded by, Appellants' contention that the combination of Li and Budich fails to account for the benefits disclosed by Appellants' claimed invention (Br. 5---6). Where, as here, Appellants' claimed invention "extends to what is obvious, it is invalid under§ 103," because "[i]n determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim." See KSR, 550 U.S. at 419; see also In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992) ("[T]he law does not require that the references be combined for the reasons contemplated by the inventor."). CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness. The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable over the combination of Li and Budich is affirmed. Claims 2-11and21-30 are not separately argued and fall with claim 1. 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 6 Copy with citationCopy as parenthetical citation