90007684 (B.P.A.I. Mar. 24, 2011)

Ex Parte 6024981 et al

Board of Patent Appeals and InterferencesMar 24, 2011

90007684 (B.P.A.I. Mar. 24, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 90/008,133 09/07/2006 6024981 15514/40037 9856 21832 7590 03/24/2011 MCCARTER & ENGLISH, LLP HARTFORD CITYPLACE I 185 ASYLUM STREET HARTFORD, CT 06103 EXAMINER HUANG, EVELYN MEI ART UNIT PAPER NUMBER 3991 MAIL DATE DELIVERY MODE 03/24/2011 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 90/007,684 08/22/2005 6024981 15514/40037 1442 21832 7590 03/24/2011 MCCARTER & ENGLISH, LLP HARTFORD CITYPLACE I 185 ASYLUM STREET HARTFORD, CT 06103 EXAMINER HUANG, EVELYN MEI ART UNIT PAPER NUMBER 3991 MAIL DATE DELIVERY MODE 03/24/2011 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES ____________ Ex parte CIMA LABORATORIES, INC. Patent Owner and Appellant ____________ Appeal 2009-003071 Reexamination Control Nos. 90/007,684 and 90/008,133 Patent 6,042,981 Technology Center 3900 ____________ Before ROMULO H. DELMENDO, JEFFREY T. SMITH, SALLY G. LANE, MICHAEL P. TIERNEY and RICHARD M. LEBOVITZ, Administrative Patent Judges.1 Opinion for the Board filed by Administrative Patent Judge RICHARD M. LEBOVITZ. Opinion Concurring filed by Administrative Patent Judge MICHAEL P. TIERNEY, joined by SALLY G. LANE. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL2 1 The Board Decision dated September 28, 2009 was rendered by a panel consisting of Administrative Patent Judges Carol A. Spiegel, Delmendo, and Smith. Judge Spiegel has since retired from Federal service. Judges Lane, Tierney, and Lebovitz have now been added to the merits panel. In re Bose Corp., 772 F.2d 866, 869 (Fed. Cir. 1985). 2 The time period for commencing any action in connection with this appeal begins to run from the “MAIL DATE” (paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery mode) shown on the PTOL-90A cover letter attached to this decision. Appeal 2009-003071 Reexamination Control Nos. 90/007,684 and 90/008,133 Patent 6,042,981 2 This is a Request for Rehearing under 37 C.F.R. § 41.52 of the Decision entered September 28, 2009, in the above-identified Merged Re- examination Proceeding of U.S. Patent 6,024, 981 (“the ‘981 patent”) in which the Examiner was affirmed. STATEMENT OF THE CASE CIMA, the real party in interest and assignee of the ‘981 patent, requests a rehearing of the Board Decision entered September 28, 2009 (“Dec.”). CIMA contends that the Board erred in interpreting the claim limitation “nondirect compression filler” and in affirming the anticipation rejections over the Fung, Alkire, and Wehling publications. The request for rehearing is granted, but we enter new grounds of rejection pursuant to our authority under 37 C.F.R. § 41.50(b). Claim interpretation All of the claims on appeal in the reexamination proceeding include the phrase “nondirect compression filler.” We interpreted that phrase as follows: a filler material (i) which lacks adequate flow and compression characteristics to allow its use in direct compression processes and products absent physically modifying the filler, e.g., by granulation prior to compression, and has not been so modified prior to compression; and, (ii) which possesses adequate rapid dissolution/disintegration characteristics which allow the rapidly water soluble material in the product to dissolve sufficiently to allow ingestion as a non-gritty solution or slurry in 90 seconds or less. (Dec. 18.) Appeal 2009-003071 Reexamination Control Nos. 90/007,684 and 90/008,133 Patent 6,042,981 3 CIMA contends that this interpretation was erroneous “to the extent that dissolution and disintegration are used interchangeably.” (Req. Reh’g 6.) CIMA argues that dissolution and disintegration are distinct concepts (id.). To support this position, CIMA cites the ‘981 patent, which expressly states that the “difference between dissolution and disintegration is not a trivial one.” (‘981 patent, col. 15, ll. 32-33.) As explained in the ‘981 patent, disintegration is when the dosage form breaks into smaller pieces, while dissolution is a “process which is conceptually analogous to melting” in which water-soluble ingredients dissolve. (Id. at col. 3, ll. 17-45.) CIMA’s position is supported by a preponderance of the evidence (see Dec. at 12, Findings 7 and 8). Consequently, we modify the interpretation of “non-direct compression filler,” as suggested by CIMA, by deleting the term “disintegration” from the interpretation of non-direct compression filler (Req. Reh’g 7). Anticipation The following rejections, inter alia, were on review in the previous Decision (Dec. 7-8): (F) claims 1, 2, 4, 6-10, 14-23, 26-34, 36, 41-60, and 78-82 under 35 U.S.C. § 102(b) as anticipated by or, in the alternative, under 35 U.S.C. § 103(a) as obvious over Fung,3 as evidenced by Mallinckrodt;4 3 Ho-Leung Fung, S. K. Yap and C.T. Rhodes, “Development of a Stable Sublingual Nitroglycerin Tablet II: Formulation and Evaluation of Tablets Containing Povidone,” 65 J. Pharm. Sci. 558-560 (1976). Appeal 2009-003071 Reexamination Control Nos. 90/007,684 and 90/008,133 Patent 6,042,981 4 (H) claims 1-36, 41-65, and 78-82 under 35 U.S.C. § 102(a) and (e) as anticipated by or, in the alternative, under 35 U.S.C. § 103(a) as obvious over Alkire,5 as evidenced by Kanig;6 and (J) claims 1-36, 41-63, and 78-82 under 35 U.S.C. § 102(b) as anticipated by or, in the alternative, under 35 U.S.C. § 103(a) as obvious over Wehling,7 as evidenced by Alkire and Kanig. All three rejections were affirmed under section 102 as anticipated, and under section 103 because lack of novelty is the epitome of anticipation. CIMA contends that we misapprehended the teachings of the cited references: Fung, Alkire and Wehling. CIMA argues: None of the cited references state that a non-direct compression filler was used in formulation of the tablets described in the references. Moreover, the secondary references cited to support the anticipation rejection are insufficient to establish that a person skilled in the art would reasonably understand or infer from the references' teachings that a non-direct compression filler was used in the tablets described in Fung, Alkire and Wehling. (Req. Reh’g 2.) This case is related to the inter partes reexamination 95/000,160 of U.S. Patent 6,221,392 (“the ‘392 patent”). The ‘392 patent claims benefit to provisional application No. 60/043,242, filed April 16, 1997, as does the ‘981 patent, and is descended from Application No. 09/057,884, the 4 Mallinckrodt Chemicals, Product Catalog, available at http: //mallchem.com/catalog.asp?searchdata=lactose&searchfor=&image l.x… accessed on July 27, 2005. 5 U.S. Patent 5,607,697 issued March 4, 1997. 6 J.L. Kanig, “Properties of Fused Mannitol in Compressed Tablets,” 53 J. Pharm. Sci. 2 188-192 (1964). 7 U.S. Patent 5,178,878 issued January 12, 1993. Appeal 2009-003071 Reexamination Control Nos. 90/007,684 and 90/008,133 Patent 6,042,981 5 application upon which the ‘981 patent is based. The ‘392 patent is a “continuation” application of the ‘981 patent and therefore also shares the same written description as the ‘981 patent. The claims at issue in this reexamination proceeding are similar to those in the ‘392 reexamination. The ‘392 patent claims involve compressed tablets comprising a non-direct compression sugar or sugar alcohol. The claims of the ‘981 patent are broader, involving a non-direct compression filler – a broader genus that includes the sugar and sugar alcohols of the ‘392 claims. The Decision in the ‘392 patent reexamination is attached (“the ‘392 decision”). The claims were rejected over the same Fung, Alkire, and Wehling references under § 102, or alternatively, under § 103, as were the claims in the ‘981 patent reexamination. In the ‘392 decision, we reversed the § 102 rejections, but affirmed the § 103 rejections. The key difference in the two cases was the evidence relied upon. In the ‘392 reexamination, we cited Banker,8 Wade,9 and Shangraw,10 and a declaration of Dr. Larry L. Augsburger11 – evidence that was not relied upon in the ‘981 patent reexamination Decision. Because the ‘981 and ‘392 patents arise from the 8 Gilbert S. Banker, Garnet E. Peck and George Baley, “Tablet Formulation and Design” in Pharmaceutical Dosage Forms: Tablets Vol. 1, 61-80 (Herbert A. Lieberman and Leon Lachman, eds., 2d ed. 1980). 9 Ainley Wade and Paul J. Weller, “Mannitol,” in Handbook of Pharmaceutical Excipients, Am. Pharm. Ass’n 294-98 (2d ed. 1994). 10 Ralph F. Shangraw, “Compressed Tablets by Direct Compression”, in Pharmaceutical Dosage Forms, Vol. 1, 195-219 (Herbert A. Lieberman, Leon Lachman & J.B. Schwartz, eds., 1989). 11 Decl. of Dr. Larry L. Augsburger, Ph.D. made of record on November 19, 2007. Appeal 2009-003071 Reexamination Control Nos. 90/007,684 and 90/008,133 Patent 6,042,981 6 same priority application filing, have the same disclosures, and claim similar subject matter, the patents are intimately intertwined and the reexamination proceedings should involve the same prior art considerations. Accordingly, we have reviewed this Request for Rehearing in light of the additionally cited prior art in the ’392 patent reexamination Decision. For completeness, all evidence cited in the Request for Rehearing is listed in the attached PTO- 892 form. In this Request for Rehearing, CIMA contends that persons of ordinary skill in the art would not have reasonably inferred nor understood that the lactose in Fung and the mannitol in Alkire and Wehling was an unmodified nondirect compression filler. Consequently, CIMA argues that the anticipation rejections should be reversed. On reconsideration, we vacate our affirmance of the anticipation and obviousness rejections over Fung, Alkire, and Wehling in the prior decision. We do not reach the anticipation rejections any further in this Request for Rehearing, but enter new grounds of rejection under 35 U.S.C. § 103(a). The Fung, Alkire, and Wehling publications, coupled with the scope and content of the prior art and the level of ordinary skill, provided sufficient reasons for a person of ordinary skill in the art to have utilized an unmodified nondirect compression filler in tablets produced by compression. Accordingly, we conclude that the claimed subject matter would have been obvious to persons of ordinary skill in the art. Specifically, the reasoning and factual basis for this conclusion is set forth in the Decision in the ‘392 patent Reexamination Control No. 95/000,160, which is incorporated by reference into this Request for Rehearing and designated as new grounds of Appeal 2009-003071 Reexamination Control Nos. 90/007,684 and 90/008,133 Patent 6,042,981 7 rejection under 37 CFR § 41.50(b). The reasoning and factual basis for this determination is summarized below. Obviousness over Fung & Banker Although the evidence is insufficient to establish that Fung described the claimed tablet comprising a nondirect compression filler in the manner required by 35 U.S.C. § 102, there are adequate facts to establish the obviousness of it. Under 37 CFR § 41.50(b), we enter a new ground of rejection of claims 1, 2, 4, 6-10, 14-23, 26-34, 36, 41-60, and 78-82 under 35 U.S.C. § 103(a) as unpatentable over the combined teachings of Fung and Banker. With regard to the rejection, we incorporate by reference the findings and analysis in our Decision in Reexamination Control No. 95/000,160. Banker disclosed that various forms of lactose monohydrate were available and had been used in pharmaceutical formulations as fillers. Banker described hydrous lactose, anhydrous lactose, and spray-dried lactose (FF30-3212). Thus, while there would have been a reasonable basis to have utilized the spray-dried compression lactose form in Fung’s tablet as a filler, other forms were available that had been used in tablet formations. Persons of ordinary skill in the art would have had reason to use one of these forms, such as nondirect compression anhydrous lactose, as the latter had been incorporated in tablets and was said to have “fast disintegration” and “good friability.” (FF33.) Consequently, it would have been obvious to the 12 Findings of Fact (FF) cited in this Request for Rehearing are those cited Appeal No. 2010-009240 (Reexamination Control 95/000,160). Appeal 2009-003071 Reexamination Control Nos. 90/007,684 and 90/008,133 Patent 6,042,981 8 person of ordinary skill in the art to have utilized a nondirect compression lactose as shown in Banker to make Fung’s nitroglycerin tablet – an embodiment within the scope of claim 1. As to the additional characteristics recited in the claims, as indicated in the earlier Decision (e.g., Dec. 33), a tablet made according to Fung with nondirect compression lactose would have reasonably been expected to have the same ingredients recited in the claims. Because the ingredients and compression process are the same, it would reasonably be believed that Fung’s tablet would also have possessed the same properties as claimed. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Obviousness over Alkire and Wehling The Examiner alternatively rejected the claims under section 103 as obvious in view of Alkire or Wehling individually. We vacate these rejections and enter new grounds of rejection pursuant to 37 CFR § 41.50(b) to additionally include the Banker publication: claims 1-36, 41-65, and 78-82 under § 103(a) as obvious over Alkire and Banker, as evidenced by Kanig; and claims 1-36, 41-63, and 78-82 under 35 U.S.C. § 103(a) as obvious over Wehling and Banker, as evidenced by Alkire and Kanig. The disclosures in Alkire and Wehling are overlapping, with both patents describing microparticles made with the filler mannitol, and both cited for the same table describing a pharmaceutical tablet made with mannitol (Alkire, Tbl. A at col. 10, ll. 45-53; Wehling, Tbl. 1 at col. 10, ll. Appeal 2009-003071 Reexamination Control Nos. 90/007,684 and 90/008,133 Patent 6,042,981 9 23-29). Consequently, we shall only address specifically Alkire, but conclude that such determination is applicable to Wehling, as well. The obviousness rejection does not require that Alkire, expressly or inherently, describe unmodified mannitol as a filler to meet the limitations of the claim. Rather, there must be a preponderance of the evidence that the prior art reasonably suggested unmodified mannitol – the nondirect compression form – in the tablets made from the components in Table A and Example V. Both Table A and Example V are directed to a final dosage form in which drug microparticles (comprising mannitol and made by a granulation process) (FF46) are combined with glidant (silicon dioxide), lubricant (magnesium stearate), and mannitol (FF50 & FF51). Table A states that the mixture is tableted in a conventional tableting press (Alkire, col. 10, ll. 54- 56) (FF52). Both Table A and Example V are directed to a final dosage form in which drug microparticles (comprising mannitol and made by a granulation process) (FF46) are combined with glidant (silicon dioxide), lubricant (magnesium stearate), and mannitol (FF50 & FF51). Table A states that the mixture is tableted in a conventional tableting press (Alkire, col. 10, ll. 54- 56) (FF52). Table A does not identify the form or type of mannitol that is utilized in the tablet. However, Banker indicated that unmodified mannitol (i.e., nondirect) had been used in the tableting process (FF6 & FF7). The presence of lubricant and glidant in these examples would be consistent with unmodified mannitol, since Banker reported that usually lubricant and Appeal 2009-003071 Reexamination Control Nos. 90/007,684 and 90/008,133 Patent 6,042,981 10 glidant were required in greater amounts to improve the flow properties of this unmodified form (FF6). Thus, Alkire’s disclosure reasonably suggests incorporating nondirect compression mannitol into the example shown in Table A. Alkire discloses that its dosage forms “can be produced generally by the teachings of Wehling” (col. 10, ll. 17-21) (FF53). Wehling teaches: Materials to be incorporated in the tablets, other than the microparticles and the effervescent disintegration agent, may be pretreated to form granules that readily lend themselves to tableting. (Col. 8, ll. 25-28) (FF54). Thus, while granulation “may be” used to form granules, it is not required. (Augsburger Decl. ¶ 28) (FF55). The teachings in Alkire and Wehling therefore do not restrict the filler to only the direct compression form (i.e., as modified by granulation In sum, the cited prior art reasonably suggested to a person of ordinary skill in the art using nondirect compression mannitol, combined with the microparticles, to produce the tablets described in Table A. As to the additional characteristics recited in the claims, a tablet made according to Alkire (or Wehling) with nondirect compression mannitol would have had the same ingredients recited in the claims. Because the ingredients and compression process are the same, it is reasonable that such tablet would also have possessed the same properties as claimed. In re Best, 562 at 1255. SUMMARY We vacate our decision to affirm the rejection of claims 1, 2, 4, 6-10, 14-23, 26-34, 36, 41-60, and 78-82 under 35 U.S.C. § 102(b) as anticipated by Fung, as evidenced by Mallinckrodt, but enter a new rejection of the Appeal 2009-003071 Reexamination Control Nos. 90/007,684 and 90/008,133 Patent 6,042,981 11 same claims under 35 U.S.C. § 103(a) as obvious over Fung in view of Banker. We vacate our decision to affirm to the rejection of claims 1-36, 41- 65, and 78-82 under 35 U.S.C. § 102(a) and (e) as anticipated by or, in the alternative, under 35 U.S.C. § 103(a) as obvious over Alkire, as evidenced by Kanig, but enter a new ground of rejection of the same claims as obvious over Alkire and Banker, as evidenced by Kanig. We vacate our decision to affirm the rejection of claims 1-36, 41-63, and 78-82 under 35 U.S.C. § 102(b) as anticipated by or, in the alternative, under 35 U.S.C. § 103(a) as obvious over Wehling, as evidenced by Alkire and Kanig, but enter a new ground of rejection of the same claims as obvious over Alkire and Banker, as evidenced by Kanig. Because the evidence and reasoning in affirming the § 103 rejection of the claims over the Fung, Alkire, and Wehling publications differ from the Examiner’s, we designate these as new grounds of rejection pursuant to 37 C.F.R. § 41.50(b). TIME PERIOD FOR RESPONSE This decision contains a new ground of rejection pursuant to 37 CFR § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960 (August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37 CFR § 41.50(b) provides "[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review." 37 CFR § 41.50(b) also provides that the appellant, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of Appeal 2009-003071 Reexamination Control Nos. 90/007,684 and 90/008,133 Patent 6,042,981 12 the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the proceeding will be remanded to the examiner. . . . (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same record. . . . No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). GRANTED; 37 C.F.R. § 41.50(b) Appeal 2009-003071 Reexamination Control Nos. 90/007,684 and 90/008,133 Patent 6,042,981 13 Administrative Patent Judge TIERNEY, concurring I agree with the majority that the appealed claims are unpatentable. I would however, affirm the § 102 rejections over Alkire and Wehling. bim FOR PATENT OWNER: McCARTER & ENGLISH, LLP CITYPLACE I 185 ASYLUM STREET HARTFORD, CT 06103-3495 FOR THIRD PARTY REQUESTER: ALAN H. NORMAN, ESQ. THOMPSON COBURN, LLP ONE US BANK PLAZA ST. LOUIS, MO 63101 Application/Control Nos. 90/007,684 and 90/008,133 Applicant(s)/Patent Under Reexamination of a Patent Appeal No. 2009-003071 Notice of References Cited Examiner Evelyn Huang Art Unit 3900 Page 1 of 1 U.S. PATENT DOCUMENTS * Document Number Country Code-Number-Kind Code Date MM-YYYY Name Classification A US-5,607,697 03/1997 Todd G. Alkire et al. B US-5,178,878 01/1993 Fred Wehling et al. C US- D US- E US- F US- G US- H US- I US- J US- K US- L US- M US- FOREIGN PATENT DOCUMENTS * Document Number Country Code-Number-Kind Code Date MM-YYYY Country Name Classification N O P Q R S T NON-PATENT DOCUMENTS * Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages) U Ho-Leung, S.K. Yap and C.T. Rhodes, “Development of a Stable Sublingual Nitroglycerin Tablet II: Formulation and Evaluation of Tablets Containing Povidone,” 65 J. Pharm. Sci. 558-560 (1976). V Mallinckrodt Chemicals, Product Catalog, available at http:// mallchem.com/catalog.asp?searchdata=lactose&searchfor=&image l.x… W J.L. Kanig, “Properties of Fused Mannitol in Compressed Tablets,” 53 J. Pharm. Sci. 2 188-192 (1964). X Gilbert S. Banker, Garnet E. Peck and George Baley, “Tablet Formulation and Design” in Pharmaceutical Dosage Forms: Tablets Vol. 1, 61-80 (Herbert A. Lieberman and Leon Lachman, eds., 2d ed. 1980). Y Ainley Wade and Paul J. Weller, “Mannitol,” in Handbook of Pharmaceutical Excipients, Am. Pharm. Ass’n 294-98 (2d ed. 1994). Z Ralph F. Shangraw, “Compressed Tablets by Direct Compression”, in Pharmaceutical Dosage Forms, Vol. 1, 195-219 (Herbert A. Lieberman, Leon Lachman & J.B. Schwartz, eds., 1989). Decl. of Dr. Larry L. Augsburger, Ph.D. made of record on November 19, 2007. *A copy of this reference is not being furnished with this Office action. (See MPEP § 707.05(a).) Dates in MM-YYYY format are publication dates. Classifications may be US or foreign. U.S. Patent and Trademark Office PTO-892 (Rev. 01-2001) Notice of References Cited Part of Paper No.