Ex Parte Beljanski et alDownload PDFPatent Trial and Appeal BoardMay 26, 201611978014 (P.T.A.B. May. 26, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 111978,014 10/26/2007 441 7590 05/31/2016 SMITH, GAMBRELL & RUSSELL, LLP 1055 Thomas Jefferson Street Suite 400 WASHINGTON, DC 20007 FIRST NAMED INVENTOR Sylvie Beljanski 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. 034482.006 3793 EXAMINER SHIN,DANAH ART UNIT PAPER NUMBER 1674 NOTIFICATION DATE DELIVERY MODE 05/31/2016 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@sgrlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SYLVIE BELJANSKI and JOHN HALL Appeal2013-006747 Application 11/978,014 Technology Center 1600 Before JEFFREYN. FREDMAN, ULRIKE W. JENKS, and JOHN G. NEW, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON REQUEST FOR REHEARING 1 Appellants request rehearing of the decision entered March 23, 2016 ("Decision") affirming the rejection of claims 5, 7-10, and 13-16 under 35 U.S.C. § 103(a). We deny the requested relief. 1 Appellants identify the Real Party in Interest as Molecular International Research, Inc. (see App. Br. 1 ). 1 ANALYSIS A "request for rehearing must state with particularity the points believed to have been misapprehended or overlooked by the Board." 37 C.F.R. § 41.52. An applicant dissatisfied with the outcome of a Board decision is entitled to appeal the decision, see 35 U.S.C. §§ 141 and 145, but is not entitled to have the same issue decided multiple times on the same record. Appellants argue that the Decision misapprehended the subject matter sought to be patented, misapprehended the evidence in the Declarations, and utilized an improper legal standard (Req. Reh'g 1). Appellants first contend that the "evidence of record suggests obviousness was found to exist outside the scope of the claims, which requires a subject with a solid tumor. The broadest reasonable interpretation of the claim 5 does not include a human cancer patient having leukemia" (Req. Reh' g 2). We find this argument unpersuasive because the Examiner's reasonably relies on Cole to suggest the obviousness of therapeutic treatment of solid tumors (Decision 7; FF 10-11) as the Examiner explains: At the time of the invention, it was known in the art that rabbits receiving chemotherapy treatment ( cyclophosphamide injections) and also concurrently receiving l mg/kg by intravenous injection of small bacterial RNA fragments "every seventh day" for "2 or 3 months" survived while those receiving chemotherapy only without small bacterial RNA fragments died as reported by [Beljanski] ... wherein cyclophosphamide has long been used for treating solid tumors such as breast cancer as taught by Cole 2 Appeal2013-006747 Application 11/978,014 (Ans. 9-10). Thus, the Examiner reasonably found it obvious to treat human solid tumor patients with a BLR composition because the BLR composition was shown to be effective to improving survival in animals receiving a cyclophosphamide chemotherapeutic used in treatment of solid tumors and the BLR composition was used in a human patient treated with chemotherapy (Decision 5-7; FF 4---6, 11). Appellants next contend that the "ultimate conclusion reached by Dr. Grutsch, a practicing clinical scientist in the chemotherapy area, is set forth in paragraph 11 - the articles merely invited further experimentation and that, to a practicing scientist, there was no certainty in a successful outcome" (Req. Reh'g 6). We find the arguments related to the Grutsch I, Grutsch II, and Hall Declarations unpersuasive for the reasons given in the Decision. In particular, we noted in response to these arguments that the prior art lacked reasonable expectation of success that "Beljanski (1990) does provide specific dosing information for a human patient, a dose of 15 mg per day was administered to a human female undergoing chemotherapy for leukemia" (Decision 10). We also noted that "Beljanski (1990) teaches that the dose of BLRs is optimizable, showing cyclic treatment of rabbits with doses of 1 to 6 mg 'every second day' (FF 4) as well as 1 mg/kg (FF 2) while Cole further evidences that dose optimization is routine in the art (FF 1 O)" (Decision 11 ). Thus, we balanced the evidence regarding the statements by the Declarants against that provided in the cited prior art and we concluded that "an obviousness finding was appropriate where the prior art 'contained 3 Appeal2013-006747 Application 11/978,014 detailed enabling methodology for practicing the claimed invention, a suggestion to modify the prior art to practice the claimed invention, and evidence suggesting that it would be successful.'" In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (citing In re O'Farrell, 853 F.2d 894, 902 (Fed. Cir. 1988) ). Here, Beljanski (1990) provides a detailed enabling methodology for administering the commercially available BLR product to animal patients receiving cyclophosphamide and to human leukemia patients to improve white blood cell levels (Decision 4---6; FF 1-7), Cole evidences that human solid tumor patients treated with cyclophosphamide have reduced white blood cell levels (Decision 7, FF 11 ), and Beljanski (1990) evidences that treatment with BLRs "restores normal circulating leukocyte counts after they have been depleted by high doses of cyclophosphamide (CP)" (Decision 4, FF 1 ). This evidence, balanced against the statements of the Declarants, supports a finding that there would have been a "reasonable expectation of success" and that the claims would have been obvious over the cited prior art. Appellants contend that there is no evidence that the results of the successful clinical trial were properly considered. The differences in the treatment mechanisms between the anti-CIT agents accepted in the art and the RNA platelet genesis primers and the 20 year plus time frame of acceptance suggests a high degree of reluctance and their consideration as outside the finite (and small in the context of the art) number of options associated with obvious to try options (Req. Reh'g 10). 4 Appeal2013-006747 Application 11/978,014 We do not find this argument persuasive. While the Hall2 Declaration states that "[i]t took years to get the clinical trial initiated, in part because, at the time, the oncologists simply did not believe the RNA fragments would boost platelet counts", the Hall Declaration provides no specific details regarding the time frame relative to other clinical trials demonstrating that this trial took longer to organize than other trials, or evidence that the clinicians were aware of the prior art of Beljanski (1990). As we noted in the Decision, the "Hall Declaration (2009) does not explain why clinicians were surprised by the result, given the extensive prior art animal and human data in Beljanski (1990)" (Decision 13). A limited showing that may or may not evidence unexpected results does not overcome a strong prima facie case of obviousness over detailed enabling prior art. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372 (Fed. Cir. 2007) ("[W]e hold that even if Pfizer showed that amlodipine besylate exhibits unexpectedly superior results, this secondary consideration does not overcome the strong showing of obviousness in this case. Although secondary considerations must be taken into account, they do not necessarily control the obviousness conclusion.) SUMMARY We have carefully reviewed the original opinion in light of Appellants' request, but we find no point of law or fact which we overlooked or misapprehended in arriving at our decision. Therefore, Appellants' request is denied with respect to making any modifications to the decision affirming the Examiner's rejection. 2 Declaration of John Hall, dated July 6, 2010. 5 Appeal2013-006747 Application 11/978,014 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. § 1.136(a). REHEARING DENIED 6 Copy with citationCopy as parenthetical citation