Ex Parte Bunick et alDownload PDFPatent Trial and Appeal BoardSep 21, 201613030273 (P.T.A.B. Sep. 21, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/030,273 02/18/2011 27777 7590 09/23/2016 JOSEPH F. SHIRTZ JOHNSON & JOHNSON ONE JOHNSON & JOHNSON PLAZA NEW BRUNSWICK, NJ 08933-7003 FIRST NAMED INVENTOR Frank J. 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. MCP0262USCNT1 2407 EXAMINER CHANNA V AJJALA, LAKSHMI SARADA ART UNIT PAPER NUMBER 1611 NOTIFICATION DATE DELIVERY MODE 09/23/2016 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 J. BUNICK and JOSEPH LUBER Appeal2015-003941 Application 13/030,273 1 Technology Center 1600 Before DONALD E. ADAMS, TIMOTHY G. MAJORS and DAVID COTTA, Administrative Patent Judges. COTT A, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of improving the stability of a tablet comprising a pharmaceutically active ingredient. The Examiner rejected the claims on appeal as obvious under 35 U.S.C. § 103(a). We affirm. 1 According to Appellants, the real party in interest is McNeil-PPC, Inc., a wholly owned subsidiary of Johnson & Johnson. App. Br. 2. Appeal2015-003941 Application 13/030,273 STATEMENT OF THE CASE Claims 15-26 are on appeal. Claim 15 is illustrative and reads as follows: 15. A method of improving the stability of a tablet, wherein the tablet comprises a pharmaceutically active ingredient, the method comprising the step of: combining the pharmaceutically active ingredient in a matrix comprising directly compressible dextrose monohydrate and sucralose; wherein the improvement in stability is evidenced by a reduction in browning or discoloration in the tablet. The Examiner rejected claims 15-26 under 35 U.S.C. § 103(a) as unpatentable over the combination of Boissonneault,2 Brouillard3 and Olmo4 or over the combination of Boissonneault, Valentine, 5 Brouillard and Olmo. The Examiner also rejected claims 15-26 on the ground of obviousness-type double patenting over claims 1-14 of U.S. Patent No. 6,814,978 in view of Boissonneault and Valentine. Appellants do not address the Examiner's double patenting rejection. We therefore summarily affirm the obviousness-type double patenting rejection. See Manual of Patent Examining Procedure § 1205.02. 2 Boissonneault et al., U.S. Patent No. 6,667,050 Bl, issued Dec. 23, 2003 ("Boissonneault") 3 Brouillard et al., U.S. Patent No. 3,619,292, issued Nov. 9, 1971 ("Brouillard") 4 Olmo et al., Evaluation of Two Dextrose-Based Directly Compressible Excipients, 24(8) DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY 771- 778 (1998) ("Olmo"). 5 Valentine, U.S. Patent No. 4,684,534, issued Aug. 4, 1987 ("Valentine"). 2 Appeal2015-003941 Application 13/030,273 ANALYSIS Appellants address the Examiner's obviousness rejections. Because the issues raised on appeal are the same with respect to both combinations of prior art, we will address both obviousness rejections together as well. Appellants argue claims 15-26 as a group. We designate claim 15 as representative of the group. The Examiner found that Boissonneault taught a chewable tablet composition comprising, inter alia, an active ingredient, dextrose, and sucralose. Ans. 5. Boissonneault, however, does not disclose the use of dextrose monohydrate in its chewable tablet. Id. The Examiner found that Brouillard taught that dextrose hydrate, when employed in direct compression, "produces a cooling effect when dissolved in the mouth, which is highly desirable for a tableted food or a pharmaceutical and can also enhance the flavor in the tablet (col. 2, L 10- 35); particularly chewable dn1g tablets ( coL 5; []L 55-58)." Id at 5---6. The Examiner also found that Olmo taught that tablets prepared with Emdex (hydrated dextrose) had higher mechanical strength and faster disintegration than tablets prepared with Maltrin (fine granules of maltodextrine ). Id. at 6. Finally, the Examiner found that Valentine taught that dextrose and dextrose monohydrate were "equally effective for compressibility." Id. at 7. Based on these teachings, the Examiner concluded: It would have been obvious for one of an ordinary skill in the art at the time of the instant invention was made [] to include the particulate agglomerated carbohydrates or granules such as dextrose monohydrate (of Valentine or []Brouillard or Olmo et al) in the composition of Boissonneault for preparing directly compressed tablets because Valentine teach that dextrose and dextrose 3 Appeal2015-003941 Application 13/030,273 Id. monohydrate are equally effective for compressibility, the tablets are highly compressible and also the tablets readily dissolve in minimal amounts of water in the mouth thus quickly liquefying [] the active agent. Further []Brouillard also teach that dextrose monohydrate particles disintegrate very quickly in the mouth and enhance the flavor of the tablet. Olmo also teaches directly compressible dextrose monohydrate with high strength and faster disintegration. Appellants assert that the claimed method is based on the "discover[y] that when sucralose is used as the high intensity sweetener, sucralose does not react with dextrose in the presence of increased levels of water. As such, tablets formulated with sucralose and dextrose monohydrate do not exhibit discoloration or browning." App. Br. at 6. Appellants contend that prior to this discovery, "[m]any skilled in the art believe[d] that the use of high intensity sweeteners in combination with dextrose monohydrate lead[] to the browning and/or discoloration issue," and that this belief "would have stopped those skilled in the art from combining dextrose monohydrate with a high intensity sweetener." App. Br. at 5. The Examiner has the better position. Boissonneault exemplifies a tablet for delivering an active pharmaceutical ingredient - an oral contraceptive - comprising dextrose and sucralose. Boissonneault col. 11, 11. 27-43 (Example 6). The prior art provides motivation to substitute dextrose monohydrate for dextrose for the reasons discussed by the Examiner. In particular, the prior art teaches that "dextrose hydrate produces a cooling effect when dissolved in the mouth, which can be highly desirable for tableted food or pharmaceutical products," Brouillard col. 2, 11. 4 Appeal2015-003941 Application 13/030,273 29-3 6, and that hydrated dextrose has both higher mechanical strength and faster disintegration than Maltrin maltodextrin. Olmo 777. Appellants contend that the potential for compositions comprised of dextrose monohydrate and high intensity sweeteners to "exhibit discoloration and browning as the tablets age" would have discouraged the use of dextrose monohydrate together with sucralose. 6 We are not persuaded. Given the art recognized benefits of dextrose monohydrate discussed above, we find that a person of ordinary skill in this art would have been motivated to replace dextrose with dextrose monohydrate in formulations that comprise a pharmaceutically active ingredient, dextrose, and sucralose. See e.g., Boissonneault col. 11, 11. 27-43 (Example 6). Therefore, absent persuasive evidence or argument to the contrary, we find that the benefits of dextrose monohydrate taught in the art would have outweighed any potential concerns regarding browning or discoloration. We also find that Appellants reliance on the recitation of some amount of a "reduction in browning or discoloration in the tablet" in claim 15 for patentability is misplaced.7 Ji);; parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) ("The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would 6 We note that the only evidence of discoloration or browning is provided by the Specification, which states: "Conventional high intensity sweeteners, such as aspartame, when combined with dextrose monohydrate, result in age related browning or discoloration." Specification p. 2, 11. 14--15. 1 In this regard, we note that Appellants' claimed method does not require the absence of browning or discoloration of a tablet, but instead merely requires some, however small, degree of a reduction in the browning or discoloration in the tablet. 5 Appeal2015-003941 Application 13/030,273 otherwise be obvious."); see also, In re I-iuai-I-iung Kao, 639 F.3d 1057, 1072 (Fed. Cir. 2011) (''merely discovering and claiming a new benefit of an old process cannot render the process again patentable"); In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990 ("It is a general nde that merely discovering and claiming a new benefit of an old process cannot render the process again patentable."). Accordingly, we affirm the Examiner's rejection of claim 15 as unpatentable over the combination of Boissonneault, Brouillard and Olmo or over the combination of Boissonneault, Valentine, Brouillard and Olmo. Because they were not argued separately, claims 16-26 fall with claim 15. SUMMARY For these reasons set forth in the Examiner's Answer, as emphasized above, the Examiner's final decision to reject claims 15-26 is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l). AFFIRMED 6 Copy with citationCopy as parenthetical citation