11236038 (B.P.A.I. Aug. 15, 2012)

Ex Parte Bunick et al

Board of Patent Appeals and InterferencesAug 15, 2012

11236038 (B.P.A.I. Aug. 15, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte FRANK J. BUNICK and JEN-CHI CHEN __________ Appeal 2011-011779 Application 11/236,038 Technology Center 1600 __________ Before ERIC GRIMES, FRANCISCO C. PRATS, and STEPHEN WALSH, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a dosage form. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE The Specification discloses that one way to “differentiate one dosage form from another is via application of microreliefs to the dosage form…. A microrelief is a regular pattern of ridges and grooves and the like that may Appeal 2011-011779 Application 11/236,038 2 display a visual effect or optical information when exposed to suitable radiant energy.” (Specification 2:21-25.) The “the microrelief may be a ‘high resolution diffraction grating,’ meaning one that can diffract light and has at least about 100 lines per mm” (id. at 8:21-22) or “a ‘dovid,’ which is a diffractive optical variable image device, such as a hologram” (id. at 8:28- 29). The Specification states that one embodiment “is directed to flakes or ‘glitter’ comprised of film containing microreliefs that may be subsequently cut into smaller desired shapes and sizes. Films suitable for use in this embodiment may be prepared from a polymeric mixture.” (Id. at 35:3-4.) “The resulting flakes may then be added to any media . . . [and the] glitter- containing media may then be applied to dosage forms” (id. at 36:29-37). Claims 8, 10-13, 41, 44, 45, 48, 51, 52, 55, 57, 59, 60, 63, and 65 are on appeal. Claim 8, the only independent claim, reads as follows: 8. A dosage form comprised of: a) a core; and b) an outer layer comprised of the composition comprised of polymeric film flakes having at least one surface wherein the polymeric film flakes possess a microrelief on the at least one surface and wherein the microrelief is a high resolution diffraction grating or dovid. The Examiner has rejected all of the claims on appeal under 35 U.S.C. § 103(a) as obvious in view of Begleiter1 and Sugiyama.2 The Examiner finds that “Begleiter discloses a need to differentiate one pharmaceutical dosage form from another by visual effect … [and] solves said need by 1 Begleiter, US 7,083,805, Aug. 1, 2006 2 Sugiyama, JP (Kokai) No. Hei 6-51682, Feb. 25, 1994 Appeal 2011-011779 Application 11/236,038 3 disclosing a pharmaceutical dosage form[ ] bearing a high resolution diffraction relief” in which “a layer of material that retains the microrelief is coated onto the core” of the dosage form (Answer 5). The Examiner finds that Begleiter does not disclose a microrelief in the form of polymeric flakes (id.). The Examiner finds that Sugiyama “discloses that a microrelief such as hologram base material in a flake form … provides [a] three-dimensional visual effect …, a higher diffraction index and an extremely visually beautiful appearance” (id.). The Examiner concludes that it would have been obvious to substitute Sugiyama’s microrelief-containing polymeric film flakes for Begleiter’s microrelief “in order to provide an enhanced visual effect” (id.). The Examiner reasons that “one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results” (id.). Appellants contend that the cited references would not have made obvious the use of Sugiyama’s flakes on a dosage form because Sugiyama “fails to teach, or suggest, using such flakes in pharmaceutical dosage forms, but rather discloses the use of the flakes for other unrelated uses, such as skincare products and lipsticks” (Appeal Br. 4-5). We agree with Appellants that the Examiner has not adequately explained how the cited references would have made obvious the application of Sugiyama’s flakes to a dosage form. Begleiter discloses “pharmaceutical dosage forms and other edible products bearing a microrelief” (Begleiter, col. 3, ll. 65-67). Begleiter discloses that the dosage forms bear “a high Appeal 2011-011779 Application 11/236,038 4 resolution diffraction relief … [which] is thermoformed in a layer of a suitable material, and once formed, is stable” (id. at col. 3, l. 65 – col. 4, l. 2). Begleiter discloses that food grade materials are used to “receive and retain [the] diffraction relief” (id. at col. 9, ll. 21-24). Begleiter discloses that the use of diffraction reliefs allows for the “production of edible colors without the necessity of adding to the product objectionable materials such as certain dyes,” etc. (id. at col. 4, ll. 17-20). Sugiyama discloses a “Hologram Pigment and Hologram Composition” as a material for cosmetic products, decorations, coatings such as paints and inks, or various types of molding (Sugiyama 1). Sugiyama discloses that the hologram pigment is “obtained by processing a hologram base material having a coating of a high index of refraction to flakes of any desired size, and dispensing it in one or more bonding agents” (id.). Sugiyama discloses that hologram base materials are substances that, for example, form thermoplastic resin layers such as acrylic lacquers (id. at 2, ¶ 0006). Sugiyama discloses that the coating “can be, for example, a metal deposition layer in which TiO2, ZnS or PbCl2 is thinly deposited” (id. at 3, ¶ 0007). Sugiyama discloses that the hologram pigments can be used to produce “materials for cosmetic products [such] as lipstick and manicures, materials for coatings such as paints and inks, materials for decorated molded products or materials for various other types of molded products” (id. at 5, ¶ 0021). We agree with Appellants that the Examiner has not adequately explained why one of ordinary skill in the art would have been led to substitute Sugiyama’s microrelief-containing polymeric film flakes for the Appeal 2011-011779 Application 11/236,038 5 microrelief disclosed by Begleiter. Begleiter discloses that its products are edible, and that the use of microreliefs avoids the necessity of adding objectionable materials to the pharmaceutical dosage forms. Neither the Examiner’s statement of the rejection nor the response to Appellants’ argument (Answer 6-7) adequately explains how Sugiyama’s disclosure of hologram-bearing flakes for use in cosmetics, paints, etc. would have suggested making the flakes using materials that would be suitable for use in a pharmaceutical dosage form or other edible product. SUMMARY We reverse the rejection claims 8, 10-13, 41, 44, 45, 48, 51, 52, 55, 57, 59, 60, 63, and 65 under 35 U.S.C. § 103(a). REVERSED lp