11582846 (B.P.A.I. Aug. 23, 2010)

Ex Parte Bergeron

Board of Patent Appeals and InterferencesAug 23, 2010

11582846 (B.P.A.I. Aug. 23, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte RAYMOND J. BERGERON, JR. __________ Appeal 2010-003929 Application 11/582,846 Technology Center 1600 __________ Before ERIC GRIMES, LORA M. GREEN, and STEPHEN WALSH, Administrative Patent Judges. WALSH, Administrative Patent Judge. DECISION ON APPEAL1 This is an appeal under 35 U.S.C. § 134(a) involving claims to a composition for treating malaria. The Patent Examiner rejected the claims 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 2010-003929 Application 11/582,846 2 on the ground of non-statutory obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE The invention concerns pharmaceutical compositions to treat malaria. (Spec. p. 1). The compounds of the invention are iron-chelating compounds that are effective against the Plasmodium parasite because “[s]uch compounds deprive this parasite of much needed iron for its metabolic process.” (Id. at 14). Claims 1, 3-5, 8, 9, 15-18, 21, 25, 26, 44 and 46-48 are on appeal. Claim 1 is representative and reads, in part, as follows: 1. A pharmaceutical composition comprising an amount of a compound represented by formula (I) sufficient to reduce the population of Plasmodium in a human infested with Plasmodium protozoans and suffering from malaria, in combination with a pharmaceutically acceptable excipient…. The Examiner rejected the claims as follows: • claims 1, 3-5, 8, 9, 15-18, 21, 25, 26, 44 and 46-48 on the ground of non-statutory obviousness-type double patenting as unpatentable over claims 1-36 of Bergeron ‘270;2 and • claims 1, 3, 8, 9, 15, 16, 44 and 46-48 on the ground of non- statutory obviousness-type double patenting as unpatentable over claims 1- 13 of Bergeron ‘904.3 2 US Patent No. 6,864,270 B2 issued to Raymond J. Bergeron, Jr. et al., Mar. 8, 2005. 3 US Patent No. 7,144,904 B2 issued to Raymond J. Bergeron, Jr. et al., Dec. 5, 2006. Appeal 2010-003929 Application 11/582,846 3 Claims 3-5, 8, 9, 15-18, 21, 25, 26, 44 and 46-48 have not been argued separately and therefore stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). DOUBLE PATENTING The Issue The Examiner’s position is that the instant claims are not patentably distinct from the conflicting claims of Bergeron ‘270. (Ans. 3). The Examiner found that the conflicting claims are directed to a pharmaceutical composition comprising the same compound recited in instant claim 1 when variable A represents CH or C(OH) in the instant compounds of formula (I). (Ans. 3). The Examiner also found that Bergeron ‘270 disclosed determining the minimum effective concentrations of the compounds required for cytostatic and cytotoxic effect on malarial parasites in vitro. (Id. at 3-4). According to the Examiner, “it would have been obvious to one skilled in the art to use the pharmaceutical compositions containing amounts of active ingredients sufficient to reduce the population of Plasmodium in a human infested with Plasmodium protozoans with reasonable expectation of success.” (Id. at 4). The Examiner’s position is also that the instant claims are not patentably distinct from the conflicting claims of Bergeron ‘904. (Id.). The Examiner found that these conflicting claims are directed to a pharmaceutical composition comprising the same compound recited in instant claim 1 when variable B represents S in the instant compounds of formula (I). (Id.). The Examiner also found that Bergeron ‘904 disclosed determining the minimum effective concentrations of the compounds Appeal 2010-003929 Application 11/582,846 4 required for cytostatic and cytotoxic effect on malarial parasites in vitro. (Id.). Appellant contends that “the Examiner has insisted that the invention defined by the rejected claims is ‘anticipated’ by the reference patent claims.” (App. Br. 3). Appellant asserts that the invention cannot be said to be “anticipated” because there is a “significant difference between the rejected claims and the reference patent claims.” (App. Br. 3). Specifically, Appellant asserts that only instant claim 1 recites “an amount . . . sufficient to reduce the population of Plasmodium in a human infested with Plasmodium protozoans and suffering from malaria.” (Id.). According to Appellant, because of this difference, the invention cannot be said to be “anticipated.” (Id.). Further, Appellant asserts even if the Examiner “alter[s] the basis of the rejection by now contending that the claimed invention is ‘obvious,’” i.e., a new ground of rejection, the rejection would still be improper. (Id.). In particular, Appellant asserts that an analysis of an obviousness-type double patenting rejection considers only the claims of the patent reference and not the disclosure of the patent as prior art. (Id. at 4-5). Therefore, according to Appellant, because the claims of the reference patents do not recite an amount of the claimed compound “sufficient to reduce the population of Plasmodium in a human infested with Plasmodium protozoans and suffering from malaria,” the instant claims are patentably distinct. (Id. at 7). The issue with respect to these rejections is whether the Examiner properly looked to the patent disclosures to construe the scope of the patented claims. Appeal 2010-003929 Application 11/582,846 5 Findings of Fact 1. We adopt the Examiner’s findings of facts set forth in the Answer. (See Ans. 3-4). 2. We find that Bergeron ‘270 and Bergeron ‘904 expressly disclosed “administering a therapeutically-effective amount of a compound of formula (I) [in a] sufficient quantity to reduce the population of Plasmodium.” (Bergeron ‘270 Abstract; Bergeron ‘904 Abstract). Principles of Law An obviousness-type double patenting analysis entails two steps: (1) construction of the claims of the patent and the claim in the application to identify any differences, and (2) determination of whether the differences in subject matter between the claims render the claims patentably distinct. See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968 (Fed Cir. 2001). In an obviousness-type double patenting analysis, ascertaining the scope of an earlier patent’s claim to a compound requires examining the specification of the earlier patent, including any disclosed utility of the claimed compound. See Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1385 (Fed. Cir. 2003). Analysis Appellant’s assertion that the Examiner improperly rejected the instant claims as being anticipated (App. Br. 3) is misdirected. The Examiner expressly stated that the appealed claims were “rejected on the Appeal 2010-003929 Application 11/582,846 6 ground of non-statutory obviousness-type double patenting as being unpatentable …” and not under 35 U.S.C. § 102. (Ans. 3-4). We are not persuaded by Appellant’s argument that analysis of an obviousness-type double patenting rejection considers only the claims of the patent reference and not the disclosure of the patent. (See App. Br. 4-5). Federal Circuit case law has established that when an obviousness-type double patenting analysis addresses claims to a compound, it is necessary to ascertain the scope of an earlier patent’s claim to the compound by examining the specification of the earlier patent, including any disclosed utility of the claimed compound. See Geneva Pharmaceuticals, Inc, 349 F.3d at 1385. Our reviewing court recently reviewed the law in this area and applied this same principle, stating, “Thus, we have expressly held that, where a patent claims a compound, a court performing an obviousness-type double patenting analysis should examine the specification to ascertain the coverage of the claim.” Sun Pharm. Indus., Ltd., v. Eli Lilly & Co., 2010 WL 2976902, *6 (Fed. Cir. 2010). Thus, an obviousness-type double patenting analysis is not limited to determining whether differences exist between the instant claims directed to a composition comprising a compound and the patent claims. Rather, the analysis also requires consideration of the scope of the patented claims by reviewing the specification of the patent. The Specifications of both Bergeron ‘270 and Bergeron ‘904 expressly disclosed “administering a therapeutically-effective amount of a compound of formula (I) [in a] sufficient quantity to reduce the population of Plasmodium.” (FF-2). Thus, the Examiner properly construed the scope of the patented claims as including an amount sufficient to reduce the population of Plasmodium, as recited in instant claim 1. Consequently, Appeal 2010-003929 Application 11/582,846 7 we agree with the Examiner that the instantly claimed composition is not patentably distinct from the composition defined in the claims of the reference patents. See Eli Lilly & Co., 251 F.3d at 968. Accordingly, we affirm the non-statutory obviousness-type double patenting rejection of claims 1, 3-5, 8, 9, 15-18, 21, 25, 26, 44 and 46-48. CONCLUSIONS OF LAW Instant claims 1, 3-5, 8, 9, 15-18, 21, 25, 26, 44 and 46-48 are not patentably distinct from Bergeron ‘270 claims 1-36. Instant claims 1, 3, 8, 9, 15, 16, 44 and 46-48 are not patentably distinct from Bergeron ‘904 claims 1-13. SUMMARY We affirm the rejection of claims 1, 3-5, 8, 9, 15-18, 21, 25, 26, 44 and 46-48 on the ground of non-statutory obviousness-type double patenting over claims 1-36 of Bergeron ‘270; and we affirm the rejection of claims 1, 3, 8, 9, 15, 16, 44 and 46-48 on the ground of non-statutory obviousness-type double patenting over claims 1-13 of Bergeron ‘904. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED Appeal 2010-003929 Application 11/582,846 8 lp MILES & STOCKBRIDGE PC 1751 PINNACLE DRIVE SUITE 500 MCLEAN VA 22102-3833