Ex Parte Secrist et alDownload PDFPatent Trial and Appeal BoardJul 12, 201613654100 (P.T.A.B. Jul. 12, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/654,100 10/17/2012 10574 7590 07114/2016 POLSINELLI PC (Southern Research Institute) - DC OFFICE 1000 Louisiana Street Fifty-Third Floor HOUSTON, TX 77002 FIRST NAMED INVENTOR John A. Secrist III 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. 21381-00089-US4 2467 EXAMINER BAEK, BONG-SOOK ART UNIT PAPER NUMBER 1621 NOTIFICATION DATE DELIVERY MODE 07/14/2016 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): dcdocketing@novakdruce.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOHN A. SECRIST III, WILLIAM R. WAUD, ZHICAN QU, and XIANGMIN CUI1 Appeal2014-008137 Application 13/654,100 Technology Center 1600 Before ERIC B. GRIMES, JACQUELINE WRIGHT BONILLA, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. NEWMAN, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims to a method for preventing rheumatoid arthritis that have been rejected for obviousness and non-statutory obviousness-type double patenting.2 We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as Southern Research Institute. (App. Br. 2). 2 The rejection under 35 U.S.C. § 112, First Paragraph was withdrawn. Appeal2014-008137 Application 13/654,100 STATEMENT OF THE CASE Rheumatoid arthritis is the most significant form of arthritis and significantly lowers the quality of life of affected individuals. (Spec. Background). Rheumatoid arthritis is an autoimmune disease involving auto-reactive T lymphocytes that cause the disease through delayed-type hypersensitivity. (Id.). Although there are investigative targets, the etiology of rheumatoid arthritis is unclear. (Id.). The Specification discloses a method for preventing rheumatoid arthritis comprising "administering to a host in need of said preventing rheumatoid arthritis, an amount effective for preventing rheumatoid arthritis of at least one compound selected from the group consisting of 1-( 4-thio-B- D-arabinofuranosyl) cytosine and 1-( 4-thio-B-D-arabinofuranosyl) fluorosytosine." (App. Br. 2-3). The dependent claims are directed to individual compounds and specified treatment targets, such as mammals or companion animals. (Id. at 3). Claims 6-10 and 14-16 are on appeal. Claim 14 is illustrative and reads as follows: 14. A method for preventing rheumatoid arthritis which comprises administering to a host in need of said preventing rheumatoid arthritis, an amount effective for preventing rheumatoid arthritis of at least one compound selected from the group consisting of 1-(4-thio-B-D-arabinofuranosyl) cytosine and 1-( 4-thio-B-D-arabinofuranosyl) fluorosytosine. 2 Appeal2014-008137 Application 13/654,100 Claims 6-10 and 14-16 stand rejected under 35 U.S.C. § 103(a) as obvious based on Secrist '621 3 in view of Schinazi4 as evidenced by Tam5 (Final Rej. 6 8). Claims 6-10 and 14-16 stand rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over: Claims 1-21 of Secrist '621 in view of Schinazi; Claims 1-12 of Secrist '385 7 in view of Schinazi; Claims 1-7 of Secrist '8208 as evidenced by Yamazaki9; and Claims 1-15 of Secrist '510. 10 I Issue The Examiner rejected claims 6-10 and 14-16 under 35 U.S.C. § 103(a) as obvious based on Secrist '621 and Schinazi as evidenced by Tam (Ans. 4). The Examiner finds that Secrist '621 "teaches a method for treating a mammalian host suffering from a cancer. .. , which comprises administering an effective anticancer amount of 1-(4-thio-B-D- arabinofuranosyl) cytosine." (Id. at 4-5). The Examiner also finds that 3 U.S. Patent No. 6,576,621 Bl issued June 10, 2003. 4 U.S. Patent No. 6,911,424 B2 issued June 28, 2005. 5 U.S. Patent Application No. 2002/0035077 Al published March 21, 2002 6 Office Action mailed Aug. 14, 2003. 7 U.S. Patent No. 7, 138,385 B2 issued November 21, 2006. 8 U.S. Patent No. 7,691,820 B2 issued April 6, 2010. 9 Ryuta Yamazaki, Aspirin and sodium salicylate inhibit proliferation and induce apoptosis in rheumatoid synovial cells, J. Pharmacy and Pharmacol., 54:1675-1679,2002. 10 U.S. Patent No. 8,178,510 B2 issued May 15, 2012. 3 Appeal2014-008137 Application 13/654,100 Secrist '621 "teaches that the compounds are effective for inhibiting DNA replication in mammalian cells and these results suggest [their] ability as immunomodulators, which would render them suitable for treating autoimmune diseases ... " (Id. at 5). The Examiner finds that Schinazi discloses that nucleoside compounds structurally similar to the claimed invention "are useful for treating abnormal cell proliferation such as rheumatoid arthritis and malignant tumor (cancer), including melanoma, lymphoma, breast cancer, and leukemia." (Id. at 6). The compounds of Schinazi differ from those of Secrist '621 only in that a fluoro group is located in the 2' position of the sugar moiety of the nucleoside. (Id). The Examiner finds "it was known in the art that rheumatoid arthritis is an autoimmune disease and nucleoside analogs, which are generally useful for the treatment of autoimmune diseases and cancers, are also suitable for the treatment of rheumatoid arthritis as evidenced by" Tam. (Ans. 7). The Examiner concludes one of ordinary skill in the art would have recognized the claimed compounds as nucleoside analogues of the Schinazi compounds, and "would have been motivated to use [them] for the treatment or prevention of a disease involving abnormal cell proliferations such as rheumatoid arthritis as taught by [Schinazi] on the reasonable expectation that compounds similar in structure as well as function would have similar biological activities and therapeutic utilities." (Id.). Appellants contend that Secrist '621 "does not specifically state rheumatoid arthritis ... [and] is concerned with treating certain disease 4 Appeal2014-008137 Application 13/654,100 states, but does not disclose preventing the onset of a disease." (App. Br. 8). Appellants contend Schinazi likewise does not "disclose or suggest using the nucleosides therein for the purpose of preventing a disease and of course, do not disclose preventing rheumatoid arthritis." (Id. at 9). In addition, Appellants argue "the nucleosides suggested by Schinazi require a fluoro group located in the 2' position of the sugar moiety of the nucleoside, which is not present in the nucleosides according to the present invention" and that use of nucleosides of the present invention "not containing the 2' fluoro group would defeat the purposes of Schinazi" and would be contrary to its disclosure. (Id.). Appellants argue Schinazi's reference to rheumatoid arthritis as one of "a plethora" of common disease targets along with the teachings in Schinazi would not lead persons skilled in the art to select the compounds of the invention or expect they would have the same or all potential uses mentioned by Schinazi. (Id.). Appellants further argue Tam does not "teach or suggest that any and all nucleoside analogs that are useful for treating autoimmune diseases and cancers are also suitable for treating rheumatoid arthritis." (App. Br. 10). Appellants argue Tam's disclosure of certain nucleoside analogs as having desired immunomodulation effects suggests that not all nucleoside analogs might be suitable for even treating rheumatoid arthritis, particularly given the different structure of the nucleosides of the invention. (App. Br. 10-11 ). Finally, Appellants argue the effects of the nucleosides of the invention in preventing and treating rheumatoid arthritis are "significant and unexpected" but not suggested in the cited art. (Id. at 11 ). 5 Appeal2014-008137 Application 13/654,100 The issue with respect to this rejection is whether the Examiner has provided sufficient reasoning to support the conclusion that the method of claim 14 would have been obvious to a person of ordinary skill in the art based on Secrist '621 and Schinazi as evidenced by Tam. Findings of Fact 1. Secrist '621 discloses the synthesis of 1-( 4-thio-B-D-arabinofuranosyl) cytosine as "compound 1 O." (Secrist '621, 10: 19-28). 2. Claim 14 of Secrist '621 reads as follows: 14. A method for treating a mammalian host suffering from a cancer selected from the group consisting of melanoma, prostate cancer, mammary cancer, renal cancer, colon cancer and lung cancer, which comprises administering to said host an effective anticancer amount of 1-( 4-thio-B-D-arabinofuranosyl) cytosine, thereby treating the mammalian host. (Id. at 22:3-10). 3. Secrist '621 discloses " ... thioarobinofuranosyl compounds according to the present invention can be used to inhibit DNA replication in mammalian cells. These results tend to suggest their ability as immunomodulators, which would render them suitable for treating autoimmune diseases." (Id. at 18:66-19:4). 4. Schinazi discloses 2 '-a-fluoronucleosides (Schinazi, Abstract). 5. The nucleosides disclosed in Schinazi differ from the compounds of Secrist only in that a fluoro group is located in the 2' position of the sugar moiety of the nucleoside. (Ans. 6). Appellants do not dispute this finding, nor do they identify additional differences in structure or biological function between the nucleosides disclosed in Schinazi and those of the claimed invention. (See App. Br. 8-9). 6 Appeal2014-008137 Application 13/654,100 6. Schinazi teaches the disclosed nucleosides "can be administered specifically to treat abnormal cell proliferation, and in particular, cell hyperproliferation" such as benign and malignant cancers, viruses and rheumatoid arthritis. (Schinazi, 63 :33-65). 7. Tam teaches a method of treating a patient in need of an immune- modulator or patient suffering from an autoimmune disease comprising administration of nucleosides disclosed in Schinazi (Tam ii 7). 8. Tam discloses rheumatoid arthritis as one of the autoimmune diseases contemplated to be treated with the disclosed nucleosides. (Tam ii 87). 9. Tam teaches that "many autoimmune diseases (e.g., rheumatoid arthritis ... ) and diseases characterized (at least in part) by activation of CD4+ cells have been shown to correlate with a polarized type 1 cytokine expression." (Tam ii 90). 10. Tam teaches" ... it is contemplated that the compounds according to the inventive subject matter may not only be employed to treat Type 1 cytokine bias [and associated diseases], but also to be of prophylactic use (i.e., to prevent or delay onset and/or severity of diseases associated with Type 1 cytokine bias)." (Tam ii 176). Principles of Law In proceedings before the Patent and Trademark Office, the Examiner bears the burden of establishing a prima facie case of obviousness based upon the prior art. "[The Examiner] can satisfy this burden only by showing some objective teaching in the prior art or that knowledge generally available to one of ordinary skill in the art would lead that individual to combine the 7 Appeal2014-008137 Application 13/654,100 relevant teachings of the references." The patent applicant may then attack the Examiner's prima facie determination as improperly made out, or the applicant may present objective evidence tending to support a conclusion of nonobviousness. In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992) (citations omitted). The test for obviousness is what the combined teachings of the references as a whole would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 425 (CCPA 1981). Analysis The Examiner persuades us that a person of ordinary skill in the art would have been motivated to use the compounds disclosed in Secrist '621 for the treatment of rheumatoid arthritis based on the teachings of Schinazi in view of Tam. Secrist '621 discloses synthesis of 1-( 4-thio-B-D- arabinofuranosyl) cytosine (FF 1 ), claims a method of treating cancer in a mammalian host using the compound (FF2), and suggests its use as an immunomodulator for treating autoimmune diseases (FF3). Schinazi discloses compounds structurally similar to the claimed compound (FF 4-5) and teaches their use for treatment of diseases including rheumatoid arthritis (FF6). Tam discloses use of the compounds disclosed in Schinazi for treatment (FF8) and prevention (FF9- l 0) of autoimmune diseases (FF8). Based on these disclosures, the Examiner establishes sufficiently that it would have been obvious to use 1-(4-thio-B-D-arabinofuranosyl) cytosine in an effective amount to treat or prevent rheumatoid arthritis. (Ans. 4-8, 12- 16). Appellants argue that Secrist '621 "does not specifically state rheumatoid arthritis ... [and] is concerned with treating certain disease 8 Appeal2014-008137 Application 13/654,100 states, but does not disclose preventing the onset of disease." (App. Br. 8). Appellants contend Schinazi likewise does not disclose preventing rheumatoid arthritis and does not "disclose or suggest using the nucleosides therein for the purpose of preventing disease." (Id. at 8-9). This argument is unpersuasive as the Examiner's rejection is based on the combined teachings of Secrist '621, Schinazi, and Tam. (See Ans. 4). We agree with the Examiner because nonobviousness cannot be established by attacking the references individually when the rejection is predicated upon a combination of prior art disclosures. In re Merck & Co. Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986); see also In re Keller, 642 F.2d at 426 (CCPA 1981) (finding "one cannot show nonobviousness by attacking references individually where, as here, the rejections are based on combinations of references" (citations omitted)). Thus, whether Secrist '621 or Schinazi individually fails to teach prophylactic use is not germane to the rationale underlying the rejection. As stated by the Examiner, Tam teaches a relevant prophylactic use. (FF 1 O; Ans. 7). The Examiner sufficiently establishes that an ordinary artisan reading Secrist '621, Schinazi, and Tam would have reasonably expected that the compounds of Schinazi would be useful in treatment and prevention of rheumatoid arthritis. Ans. 7. For similar reasons, we are not persuaded by Appellants' argument that Schinazi's reference to rheumatoid arthritis as one of "a plethora" of common disease targets would not lead persons skilled in the art to select the compounds of the invention and expect they would have the same or all potential uses mentioned by Schinazi. (App. Br. 8-9). Schinazi's teachings alone are not germane to the rationale underlying the rejection. Again, it is 9 Appeal2014-008137 Application 13/654,100 the combined teachings of the three references that persuade us that the Examiner's burden is met. Appellants argue "the nucleosides suggested by Schinazi require a fluoro group located in the 2' position of the sugar moiety of the nucleoside, which is not present in the nucleosides according to the present invention" and that use of nucleosides "not containing the 2' fluoro group would defeat the purposes of Schinazi" and would be contrary to its disclosure. (App. Br. 8-9). As discussed above, however, the rejection is based on the combined teachings of Secrist '621, Schinazi, and Tam, not on Schinazi alone. In addition, Appellants provide no evidence in support of this argument. Without evidence, this attorney argument is unpersuasive. See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) ("Attorney's argument in a brief cannot take the place of evidence."). For the same reasons, we reject Appellants' argument that the effects of the nucleosides of the invention in preventing and treating rheumatoid arthritis are "significant and unexpected" (App. Br. 11) as unsupported attorney argument. Finally, Appellants contend Tam does not "teach or suggest that any and all nucleoside analogs that are useful for treating autoimmune diseases and cancers are also suitable for treating rheumatoid arthritis." Appellants suggest Tam's disclosure of "certain pyrrolo[2,3-d]pyrimidine nucleoside analogs" as having desired immunomodulation effects suggests that not all nucleoside analogs might be suitable for even treating rheumatoid arthritis, particularly given the different structure of the nucleosides of the invention. (App. Br. 9-11 ). 10 Appeal2014-008137 Application 13/654,100 This argument is unpersuasive. We find that one of ordinary skill in the art would have a reasonable expectation of success in using the claimed compound for prophylactic treatment of rheumatoid arthritis based on the combined disclosures in Secrist '621, Schinazi, and Tam. "Obviousness does not require absolute predictability of success .... For obviousness under§ 103, all that is required is a reasonable expectation of success." In re O'Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988). Conclusion of Law The evidence of record supports the Examiner's rejection of claims 6- 10 and 14-16 under 35 U.S.C. § 103(a) based on Secrist '621 and Schinazi as evidenced by Tam. II The Examiner has rejected claims 6-10 and 14-16 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over: Claims 1-21 of Secrist '621 in view of Schinazi; Claims 1-12 of Secrist '3 85 in view of Schinazi; Claims 1-7 of Secrist '820 as evidenced by Yamazaki; and Claims 1-15 of Secrist '510. The Examiner finds that, with regard to each rejection, "[a ]lthough the conflicting claims are not identical, they are not patentably distinct from each other" because the claims of the patent and/or art cited in each rejection would render obvious to one of ordinary skill in the art the use of the nucleoside analogue compounds of the cited patents "for the treatment and prevention of rheumatoid arthritis." (Ans. 9-11). 11 Appeal2014-008137 Application 13/654,100 Appellants contend that the claims of the cited patents relate to methods of treating the diseases cited therein or inhibiting DNA replication but do not claim "preventing" rheumatoid arthritis as recited in independent claim 14. (App. Br. 11-14 ). Appellants further argue the cited references do not teach use of the claimed compounds to prevent any disease and, in particular, rheumatoid arthritis. (Id.). We agree with the Appellants that the claims of the patents forming the basis of the rejections do not establish a prima facie case of obviousness- type double patenting. The cited patents claim methods of treating disease or inhibiting DNA replication, and Yamazaki teaches the biological cause of rheumatoid arthritis. (FF 2-4, 10-13). No cited reference, however, addresses preventing rheumatoid arthritis through use of the claimed or similar compounds. Without this teaching, the Examiner has not established a prima facie case of obviousness-type double patenting. Conclusion of Law The evidence of record does not support the Examiner's obviousness- type double patenting rejections. SUMMARY We affirm the rejection for obviousness and reverse the rejections for non-statutory obviousness-type double patenting. 12 Appeal2014-008137 Application 13/654,100 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § l.136(a). AFFIRMED 13 Copy with citationCopy as parenthetical citation