Ex Parte Hayashi et alDownload PDFBoard of Patent Appeals and InterferencesSep 14, 201110534423 (B.P.A.I. Sep. 14, 2011) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte YASUO HAYASHI, KAZUYA YANO, TSUTOMU AWAMURA, and KAZUYOSHI SUDEJI __________ Appeal 2010-010640 Application 10/534,423 Technology Center 1600 __________ Before TONI R. SCHEINER, ERIC GRIMES, and FRANCISCO C. PRATS, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method and apparatus for making an edible film, which the Examiner has rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE Claims 39-76 are on appeal. Each of the independent method claims includes the steps of taking two edible agent layers formed on resin film and joining them by pressing them together, then removing one of the resin films Appeal 2010-010640 Application 10/534,423 2 from the laminated layers (see claims 39, 49, 56, and 62, reproduced in the Claims Appendix of the Appeal Brief). Similarly, the independent apparatus claim requires a pair of press rolls arranged to press together two edible agent layers formed on resin films and “a delamination roll . . . disposed at a position forward of said pair of press rolls in a conveying direction; [and] a winding shaft arranged to draw and delaminate only one of said two resin films sandwiching said orally administrable edible agent layers conveyed from said pair of press rolls” (see claim 69, reproduced in the Claims Appendix of the Appeal Brief). The Examiner has rejected claims 39-76 under 35 U.S.C. § 103(a) as obvious based on Roreger1 and Nogami2 (Answer 4). The Examiner finds that Roreger discloses a method and apparatus that meets the limitations of the claims on appeal except that Roreger does not use an edible film (id. at 5-7). The Examiner finds that Nogami discloses “a layered edible film composition for administering an active agent” (id. at 7) and concludes that it would have been obvious “to make the edible, layered, active agent- containing composition of Nogami by using the films in Nogami as the base layers in the laminate composition-producing method and apparatus as taught by Roreger et al. and produce the instant invention” (id. at 9). Appellants argue that Roreger teaches removing a protective layer from its base material layers before laminating those layers together, not afterward as required by the claims (see, e.g., Appeal Br. 10). Appellants conclude that 1 Roreger et al., US 6,618,087 B1, Nov. 16, 2004 2 Nogami, US 2004/0137040 A1, July 15, 2004 Appeal 2010-010640 Application 10/534,423 3 as none of the Roreger and Nogami references discloses or suggests delaminating only one of the two resin films by conveying the two resin films sandwiching the bonded orally administrable edible agent layers in a substantially tangential direction at a pressurization zone of the pair of press rolls, as required by independent claims 39 and 56, the combination of the Roreger and Nogami references does not disclose or suggest delaminating only one of the two resin films by conveying the two resin films sandwiching the bonded orally administrable edible agent layers in a substantially tangential direction at a pressurization zone of the pair of press rolls, as required by independent claims 39 and 56. (Appeal Br. 12-13; see also id. at 18, 21-22 (same argument with respect to the other independent claims).) We agree with Appellants that the Examiner has not established that Roreger and Nogami would have made obvious the step of (or mechanism for) delaminating one of the protective layers of Roreger’s base material after bonding its two layers together. Roreger describes bonding two layers of matrix base material together to form “a single-layer matrix, containing active substance” (Roreger col. 3, ll. 18-19). Roreger discloses that each of the strips of base material has a layer of protective material on both sides (id. at col. 4, ll. 38-40). In Roreger’s process, one of the protective layers is removed from each strip of base material (id. at col. 4, ll. 45-48), active substance is applied to one of the strips (id. at col. 5, ll. 7-13), and the two strips are bonded together by a pair of rollers (id. at col 5, l. 62 to col. 6, l. 5; see also Fig. 1). Thus, the product of Roreger’s process is a bonded layer of base material, containing active substance, sandwiched between layers of protective material (id. at col. 6, ll. 35-40; see also Fig. 2). Roreger Appeal 2010-010640 Application 10/534,423 4 discloses that this product is stored, or “matured,” for a period of time to allow the active substance to diffuse throughout the base material layers and achieve a uniform distribution (id. at col. 6, ll. 35-43). Roreger does not describe its process as including the removal of either of the protective layers after the layers of base material are bonded together, nor does it provide any reason to expect that an advantage would be gained by removing one of the protective layers. The Examiner reasoned that “it would have been obvious to remove none, one, or both protective films depending on the desired further processing (storage, cutting, direct patient administration, etc.)” (Answer 12). However, the Examiner has not identified any reason a skilled worker would remove one of the protective films in order to facilitate any of these subsequent processing steps. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418-19 (2007) (“[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does . . . because inventions in most, if not all, instances rely upon building blocks long since uncovered, and claimed discoveries almost of necessity will be combinations of what, in some sense, is already known.”). Therefore, we agree with Appellants that the Examiner has not adequately shown that the claimed process and apparatus would have been obvious based on the disclosures of Roreger and Nogami. Appeal 2010-010640 Application 10/534,423 5 SUMMARY We reverse the rejection of claims 39-76 as obvious based on Roreger and Nogami. REVERSED lp Copy with citationCopy as parenthetical citation