Ex Parte Spadafora et alDownload PDFPatent Trials and Appeals BoardMay 17, 201910500270 - (D) (P.T.A.B. May. 17, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 10/500,270 07/25/2005 26774 7590 05/20/2019 NIXON PEABODY LLP - PATENT GROUP 1300 CLINTON SQUARE ROCHESTER, NY 14604 FIRST NAMED INVENTOR Corrado Spadafora 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. 746210-000100 9338 EXAMINER KANTAMNENI, SHOBHA ART UNIT PAPER NUMBER 1627 MAIL DATE DELIVERY MODE 05/20/2019 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 PATENT TRIAL AND APPEAL BOARD Ex parte CORRADO SPADAFORA, PATRIZIA LA VIA, ELISABETTA MATTEI, GUGLIEMO PALOMBINI, RODOLFO NELLO LORENZINI, and CLARA NERVI Appeal2017-010795 Application 10/500,2701 Technology Center 1600 Before FRANCISCO C. PRATS, ELIZABETH A. LA VIER, and DAVID COTTA Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims to processes of treating certain types of cancers. The Examiner rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 Appellants state that the real party in interest "is the ISTITUTO SUPERIORE DI SANITA, the assignee of record, having its principal place of business at VIALE REGINA ELENA 299, ROMA, ITALY 00161." Appeal Br. 3. Appeal2017-010795 Application 10/500,270 STATEMENT OF THE CASE The following rejections are before us for review: (1) Claims 3-5, under 35 U.S.C. § 103(a), as being unpatentable over Cortes2 (Final Act. 2-4);3 and (2) Claims 8 and 9, under 35 U.S.C. § 103(a), as being unpatentable over Cortes and Bahal4 (Final Act. 10-11). Claim 3 is the sole independent claim before us for review, and reads as follows: 3. A method to treat a subject comprising the step of administering to a subject identified as having a tumor selected from the group consisting of a carcinoma, a fibro-sarcoma and an osteo-sarcoma an effective amount of at least a compound selected from the group consisting of, nevirapine, efavirenz, delavirdine, and corresponding salts of nevirapine, efavirenz, and delavirdine to exhibit an anti-tumor action. Appeal Br. 18. In response to a species election requirement, Appellants elected efavirenz as the administered compound. See Appeal Br. 8 ( citing Evidence App., Ex. B). Claims 3-5, 8, and 9, therefore, have been examined only to the extent they read on the elected species. 2 Jorge Cortes, M.D. et al., Hyperfractionated Cyclophosphamide, Vincristine, Doxorubicin, and Dexamethasone and Highly Active Antiretroviral Therapy for Patients with Acquired Immunodeficiency Syndrome-Related Burkitt Lymphoma/Leukemia, 94 CANCER 1492-1499 (2002). 3 Final Office Action entered October 3, 2016. 4 US 6,235,733 Bl (issued May 22, 2001). 2 Appeal2017-010795 Application 10/500,270 We, therefore, limit our analysis of claims 3-5, 8, and 9 to the patentability of the elected species, and the extent to which the claims read on it. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987). DISCUSSION The Examiner's Prima Facie Case In rejecting claims 3-5, the Examiner cited Cortes as describing a method of treating Burkitt lymphoma and leukemia by administering a chemotherapy regimen, "hyper-CV AD," in combination with "highly active antiretroviral therapy (HAART)," a therapy that used combinations of antiretroviral agents, including efavirenz. Final Act. 2-3 (emphasis removed). The Examiner noted, in particular, Cortes's disclosure that the combination of hyper-CV AD and HAART had favorable outcomes as to a number of patients. Id. at 2-4. The Examiner found that the processes described in Cortes differed from the processes recited in Appellants' claims in that Cortes "does not teach administration of efavirenz to treat a subject identified as having tumors such as carcinoma, hepatoma (liver), a tumor of central nervous system (glioma)." Id. at 3. The Examiner concluded that a skilled artisan would have considered it obvious, nonetheless, to treat patients having cancers encompassed by Appellants' claims, because Cortes teaches that highly active antiretroviral therapy (HAAR T) treats Burkitt lymphoma/leukemia and also teaches that 7 patients treated with HAAR T had stage IV Burkitt lymphoma/leukemia, 4 patients had stage IV disease (liver, three patients), three patients had CNS involvement at diagnosis i.e Cortes teaches treatment of ALL [ acute lymphocytic 3 Appeal2017-010795 Application 10/500,270 Id. leukemia] or cancer of white blood cells, Cortes teaches treatment of abnormal uncontrolled growth of cells. The Examiner reasoned that a skilled artisan would have had motivation for, and a reasonable expectation of success in, using HAAR T to treat cancers encompassed by Appellants' claims "since Cortes et al. teach administration of HAAR T to a patient with stage IV Burkitt lymphoma/leukemia (which involves CNS, liver) remained alive and [in] CR [ complete remission] after a median of 29 months." Id. at 4. The Examiner found, in particular, that "administration of efavirenz to treat a subject identified as having tumors counteracts the loss of cellular differentiation and treats cell proliferation in tumor pathologies such as carcinomas, reconverts the differentiated cells into phenotypically normal cells." Id. Analysis As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden ... of presenting a primafacie case ofunpatentability .... After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. In KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), although the Supreme Court emphasized "an expansive and flexible approach" when analyzing the issue of obviousness (id. at 415), the Court also reaffirmed the importance of determining "whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue." Id. at 418. Thus, even under the flexible analysis outlined in KSR, it remains true that "[i]n 4 Appeal2017-010795 Application 10/500,270 determining whether obviousness is established by combining the teachings of the prior art, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal quotations and citations omitted). In other words, even post-KSR, "obviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention." Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015). In the present case, having carefully considered all of the arguments and evidence advanced by Appellants and the Examiner, Appellants persuade us that preponderant evidence does not support the Examiner's conclusion of obviousness. In particular, Appellants persuade us that the Examiner has not explained sufficiently why Cortes would have suggested using efavirenz to treat subjects with cancerous tumors encompassed by Appellants' claims. As noted above, Appellants' claim 3 recites administering efavirenz to treat a subject identified as having a tumor selected from the group consisting of a carcinoma, a fibro-sarcoma, and an osteo-sarcoma. See Appeal Br. 18. The Examiner concedes that none of the cancers treated in Cortes involves a cancerous tumor encompassed by claim 3. See Final Act. 3. The Examiner contends, however, that because the cancers treated in Cortes involve abnormal uncontrolled cell growth, and because the cancerous tumors recited in Appellants' claim 3 also involve uncontrolled cell growth, a skilled artisan would have extrapolated Cortes's teachings 5 Appeal2017-010795 Application 10/500,270 regarding cancer treatment to other cancers, including cancerous tumors encompassed by Appellants' claim 3. See, e.g. Ans. 4-5 ("Cortes teaches treatment of abnormal uncontrolled growth of cells employing HAART."). We are not persuaded. Cortes discloses a study of the "feasibility and efficacy of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (hyper-CV AD), a dose-intensive chemotherapy regimen in patients with AIDS-associated Burkitt lymphoma/leukemia, as well as the possible impact of highly active antiretroviral therapy (HAAR T) in these patients." Cortes 1492. As explained in Cortes, the study involved "[t]hirteen patients with AIDS-associated Burkitt lymphoma (six patients) or leukemia (acute lymphoblastic leukemia [ALL]; seven patients)." Id. All thirteen patients in the study were treated with the hyper-CV AD chemotherapy regimen, with nine of those patients also receiving HAART, "from the start of induction chemotherapy ( seven patients) or later in the course of chemotherapy (two patients)." Id. Cortes discloses that, in one patient, the HAAR T protocol included efavirenz, the elected species of therapeutic agent recited in Appellants' claims. Id. at 1493. Of the thirteen patients in the study, [t]welve patients (92%) achieved a complete remission (CR) and one achieved a partial response (PR). Eight patients continued in CR after a median of 31 months (range, 7-45) at the time of writing. Five patients were alive and in CR over two years later. The median survival was 12 months, with 48% of patients alive after 2 years. Id. at 1492. 6 Appeal2017-010795 Application 10/500,270 As to the patients that received HAAR T during chemotherapy, "[ s ]ix of seven patients who received HAAR T from the start of chemotherapy were alive and in CR after a median of 29 months (range, 7-45). The four patients who did not receive HAAR T died." Id. Based on those results, the Cortes investigators concluded that hyper- CV AD "is an effective regimen for patients with AIDS-associated Burkitt lymphoma/leukemia, with acceptable toxicity. The combination of hyper- CV AD and HAART is associated with long-term survival in patients with the two diseases, which, until recently were both considered invariably fatal and almost futile to treat medically." Id.; see also id. at 1498 ("We conclude that hyper-CV AD is a highly effective regimen for the treatment of HIV- associated Burkitt lymphoma/leukemia. The use of HAAR T concomitant with the chemotherapy is feasible and may be associated with a favorable outcome."). Cortes highlights the importance of HAAR T in the treatments studied: The most important finding in the current study is the potential benefit of HAAR T given during chemotherapy. Six of 7 patients who received HAAR T throughout their chemotherapy (i.e., started prior to or at the start of induction chemotherapy) remained alive and in CR after a median of 29 months (range, 7-45 months). One of 2 patients who started HAAR T late in the course of the chemotherapy remained alive and in CR after 33 months. All four patients who did not receive HARRT died (three had performance status 4 at the start of therapy). . . . [ A ]lthough the current series is small, the favorable results in this subgroup of patients (i.e., patients who received HAAR T with hyper-CV AD; 78% alive and in CR with a median follow-up of more than 2 years) suggest that this strategy is effective. Id. at 1498 (emphasis added). 7 Appeal2017-010795 Application 10/500,270 We thus acknowledge the teachings in Cortes identified by the Examiner that, when using a dose-intensive chemotherapy regimen to treat AIDS-associated Burkitt lymphoma and leukemia in patients infected with HIV, therapeutic outcomes of the chemotherapy may be improved when a highly active anti-retroviral protocol, which can include efavirenz, is administered during the chemotherapy treatment. The Examiner, however, does not identify, nor do we discern, any teachings in Cortes that specifically suggest administering the disclosed hyper-CV AD/HAAR T combination therapy to patients other than the group described in the study-HIV positive patients with AIDS-associated Burkitt lymphoma or leukemia. We agree with Appellants, therefore, that Cortes would not have suggested administering efavirenz to treat a subject identified as having a cancerous tumor encompassed by Appellants' claims. We acknowledge Cortes's teaching, identified by the Examiner, that administration of HAAR T to treat HIV infection has also "led to a decrease in the incidence of Kaposi sarcoma and possibly primary CNS lymphoma .... " Cortes 1493. We acknowledge also that under the flexible standard of obviousness mandated in KSR, a reference is not limited to its express teachings, but instead must be read in light of the reasonable inferences a skilled artisan would make in view of those teachings. KSR, 550 U.S. at 418. The Examiner does not dispute that Appellants' claims do not encompass treating the cancers treated in Cortes, and the Examiner cites no prior art that identifies a patient with both HIV and a cancerous tumor encompassed by Appellants' claims that Cortes might suggest treating with the disclosed hyper-CVAD/HAART combination therapy. Accordingly, we 8 Appeal2017-010795 Application 10/500,270 agree with Appellants that preponderant evidence does not support the Examiner's conclusion of obviousness. We, therefore, reverse the Examiner's rejection of claims 3-5 for obviousness over Cortes. In rejecting claims 8 and 9 over Cortes and Bahal, the Examiner cited Bahal as evidence that, when treating a patient with a cancerous tumor encompassed by Appellants' claims, the formulations recited in claims 8 and 9 would have been obvious. Final Act. 10-11. Because the Examiner does not identify, nor do we discern, any teachings in Bahal that remedy the deficiencies of Cortes discussed above in relation to claim 3, from which claims 8 and 9 depend, we also reverse the Examiner's rejection of claims 8 and 9 over Cortes and Bahal. CONCLUSION For the reasons discussed, we reverse both of the Examiner's obviousness rejections. REVERSED 9 Copy with citationCopy as parenthetical citation