11219976 (B.P.A.I. Jul. 19, 2010)

Ex Parte Reguri et al

Board of Patent Appeals and InterferencesJul 19, 2010

11219976 (B.P.A.I. Jul. 19, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES ____________ Ex parte BUCHI REDDY REGURI, SATYANARAYANA BOLLIKONDA, VEERA VENKATA NAGA CHANDRA SEKHAR BULUSU, RAVI KUMAR KASTURI, and SANJEEV KUMAR AAVULA ____________ Appeal 2010-004526 Application 11/219,976 Technology Center 1600 ____________ Before SALLY GARDNER LANE, ROMULO H. DELMENDO, and RICHARD M. LEBOVITZ, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL1 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, 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 2010-004526 Application 11/219,976 2 This is a decision on the appeal under 35 U.S.C. § 134 by the Patent Applicant from the Patent Examiner’s rejections of claims 28 and 40 in U.S. Patent Application No. 11/219,976 (filed Sept. 06, 2005). The Board’s jurisdiction for this appeal is under 35 U.S.C. §§ 6(b). We reverse. STATEMENT OF THE CASE The claims are directed to solid montelukast free acid. Montelukast is a leukotriene antagonist used in the treatment of asthma, inflammation, allergies, and other clinical disorders (Spec. 2). Claims 28 and 40 are the only pending claims. The claims stand rejected by the Examiner as follows: Claims 28 and 40 under 35 U.S.C. § 102(b) as anticipated by Bhupathy;2 and Claims 28 and 40 under 35 U.S.C. § 102(b) as anticipated by Liu.3 Claims 28 and 40 read as follows: 28. A solid form of montelukast free acid. 40. Crystalline solid montelukast free acid. CLAIM INTERPRETATION Legal Principles A determination that a claim is anticipated under 35 U.S.C. § 102(b) involves two analytical steps. First, the Board must interpret the claim language . . . . Secondly, the Board must 2 U.S. Patent No. 6,320,052 (issued Nov. 20, 2001) to Bhupathy et al.. 3 Lida Liu et al., Determination of montelukast (MK-0476) and its S- enantiomer in human plasma by stereoselective high-performance liquid chromatography with column-switching, 15 J. PHARM. & BIOMEDICAL ANALYSIS 631-638 (1997). Appeal 2010-004526 Application 11/219,976 3 compare the construed claim to a prior art reference and make factual findings that “each and every limitation is found either expressly or inherently in [that] single prior art reference.” Celeritas Techs. Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354, 1360 (Fed. Cir. 1998). In re Crish, 393 F.3d 1253, 1256 (Fed. Cir. 2004). Analysis Before a claim can be compared to the prior art, its scope must be properly interpreted. Accordingly, we begin our analysis with the interpretation of claims 28 and 40. Claims 28 and 40 are directed to “solid” montelukast free acid. A solid free acid is not explicitly defined in the Specification. However, the Specification’s written description provides guidance as to how it would be interpreted by persons of ordinary skill in the art. The Specification describes the preparation of various montelukast salts, including the tertiary butyl amine and sodium salts (Spec. 14-15, Examples 6 & 7). The synthesis of montelukast free acid, the subject matter of claims 28 and 40, is described in Example 5 (id. at 13-14). In this only working example in which the free acid was made, the montelukast was produced as a solid and the “solid was dried to afford . . . the purified title [montelukast free acid] compound” (id. at 14). Thus, the only solid montelukast described in the Specification is pure and produced separately from the montelukast salts (id. at 14-15). As claims must be interpreted in light of the Specification, persons of ordinary skill in the art would have understood the “solid form” and “crystalline solid” montelukast free acid of claims 28 and 40, respectively, to be free of other montelukast forms, such as the amine and sodium salts described in Examples 6 and 7. Appeal 2010-004526 Application 11/219,976 4 ANTICIPATION BY BHUPATHY Claims 28 and 40 stand rejected under 35 U.S.C. § 102(b) as anticipated by Bhupathy. Issue Does Bhupathy describe the claimed “solid” and “crystalline solid” montelukast free acids? Legal Principles A person shall be entitled to a patent unless . . . (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States. 35 U.S.C. § 102. “[W]hen the PTO shows sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990). Facts (F) 1. Bhupathy describes preparation of a genus of compounds of formula (I) (Bhupathy col. 7, ll. 38-40). Montelukast is a species of formula (I) (Appeal Br. 5:24-27; Ans. 5). 2. At the end of the process, Bhupathy describes steps in which the “reaction solution containing the desired product is then treated with a water soluble carboxylic acid, e.g. acetic acid, oxalic acid, tartaric acid and the like to provide the free acid form of a compound of formula (I)” (Bhupathy col. 7, ll. 59-63). 3. Bhupathy does not expressly describe the “free acid form” to be a solid. Appeal 2010-004526 Application 11/219,976 5 4. Bhupathy describes making crystalline salts of a formula (I) compound (id. at col. 7, l. 65-col. 8, l. 63). Analysis The burden is on the PTO to establish that each and every limitation of a properly interpreted claim is found expressly or inherently in a single prior art reference. In re Crish, 393 F.3d at 1256. In this case, the Examiner found Bhupathy described a free acid of montelukast, asserting that “the solid form,” as claimed, “would therefore inherently exist.” (Ans. 4.) The Examiner did not meet the burden of establishing that the claimed solid and solid crystalline montelukast free acids were described by Bhupathy. Bhupathy describes treating a “solution” to form the free acid (F2). There is no explicit teaching that this solution comprises a solid or crystalline solid free acid (F3). The Examiner did not provide a sound basis for believing that solid or crystalline free acid would be present in the solution. In re Spada, 911 F.2d at 708. Solid forms of formula (I) compounds are taught by Bhupathy (F4), but these forms comprise salts, and therefore are excluded from the scope of claims 28 and 40 (See supra Claim Interpretation at p. 3). The Examiner found that Bhupathy described free acid dissolved in a solvent and that “if the solvent were removed, the crystalline solid form of montelukast free acid would be present.” (Ans. 5.) The basis of this rejection is under Section 102 which requires a description of the claimed invention. The Examiner acknowledged that the free acid is in solution, not in solid form. Consequently, the claimed solid montelukast free acid is not described by Bhupathy. Whether solvent Appeal 2010-004526 Application 11/219,976 6 removal would result in the claimed invention is not the issue in this rejection because it would require a step that is not described by Bhupathy and therefore is not a proper basis under section 102. ANTICIPATION BY LIU Claims 28 and 40 stand rejected under 35 U.S.C. § 102(b) as anticipated by Liu. Issue Does Liu describe the claimed “solid” and “crystalline solid” montelukast free acids? Facts 5. Liu describes solid dicyclohexylamine and sodium salts of montelukast (Liu, p. 632, col. 1). 6. Stock solutions of the salts were prepared (id. at p. 633, col. 2). 7. Free acid is present in these solutions (id.). Analysis The Examiner found that Liu discloses montelukast as a free acid, but did not provide adequate evidence of a description of a solid free acid (Ans. 4). To the contrary, while Liu expressly describes solid montelukast salts (F5), the free acid is described as in solution (F7). Because the Examiner did not meet the burden of establishing prima facie anticipation, we are compelled to reverse the rejection. Appeal 2010-004526 Application 11/219,976 7 NEW FORMS OF OLD COMPOUNDS The Examiner found that “regardless [of] the form of the montelukast free acid as claimed, ‘new forms of old compounds’ are not patentable over the prior art” (Ans. 6). The Examiner concluded that Appellants did not show that the claimed solid forms had different properties than the prior art compounds of Bhupathy and Liu (id. at 7-9). The Answer mischaracterized the law. There is no per se prohibition of patenting a “new form” of a compound. To the contrary, there are numerous cases in which a new form of a known compound was determined to be patentable. See, e.g., Abbott Labs. v. Sandoz Inc., 566 F.3d 1282 (Fed. Cir. 2009). Under 35 U.S.C. § 102(b), a person is entitled to a patent unless “the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States.” Thus, if a compound were in a physical state or form that had not previously been described in the prior art, the inventor is entitled to patent (unless that form also would have been obvious under 35 U.S.C. § 103 to a person having ordinary skill in the art). It is true that merely recognizing the “unappreciated” property of a compound which was known in the art does not make an “old” compound patentable. Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005); Abbott Labs. v. Baxter Pharm. Prods. Inc., 471 F.3d 1363, 1367- 68 (Fed. Cir. 2006). However, this legal principle is not applicable in this appeal. First, the Examiner did not establish that the “solid” montelukast free acid of claims 28 and 48 was an “old” compound that had been Appeal 2010-004526 Application 11/219,976 8 described in the prior art. Second, a “solid” or “[c]rystalline solid” is a physical state of matter, not an “unappreciated” property of a compound. As we understand it, a “property” as that term is used in Perricone, Abbott, and M.P.E.P.4 § 2112 referenced by the Examiner, refers to an attribute or characteristic of a material – not to the material itself or the physical form of the material. SUMMARY The Examiner had the burden of showing that the claimed montelukast solid free acid of claims 28 and 40 was described in Bhupathy and Liu. This burden was not met. Consequently, the anticipation rejections of claims 28 and 40 under 35 U.S.C. § 102(b) are reversed. REVERSED KMF DR. REDDY'S LABORATORIES, INC. 200 Somerset Corporate Blvd., Seventh Floor Bridgewater, NJ 08807-2862 4 Manual of Patent Examining Procedure (8th ed., U.S. Government Printing Office 2008) (2001).