10979399 (B.P.A.I. Jun. 20, 2012)

Ex Parte Zeiher et al

Board of Patent Appeals and InterferencesJun 20, 2012

10979399 (B.P.A.I. Jun. 20, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte ANDREAS ZEIHER, STEFANIE DIMMELER, CHRISTOPHER HEESCHEN, and HARTMUT RUETTEN __________ Appeal 2010-012300 Application 10/979,399 Technology Center 1600 __________ Before ERIC GRIMES, LORA M. GREEN, and JEFFREY N. FREDMAN, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of treating heart disease, which the Examiner has rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE The Specification states that “[r]ecent experimental studies support that progenitor cells obtained from bone marrow or blood contribute to the Appeal 2010-012300 Application 10/979,399 2 regeneration of infarcted myocardium and enhance neovascularization of ischemic myocardium” (Spec. 2: 16-18). “[U]nfortunately the functional activity of the stem and progenitor cells from patients with an ischemic heart disease is impaired and their homing capacity decreased . . . [which] limits their therapeutic potential for clinical cell therapy” (id. at 3: 12-16). The Specification discloses that “the impaired function of stem and progenitor cells from patients with an ischemic heart disease can be improved considerably by incubation with a transcription enhancer of endothelial nitric oxide synthase” (id. at 4: 4-6). Claims 1-8 are on appeal. Claims 1 and 7 are the independent claims and read as follows: 1. A method for treating stem or progenitor cells of a patient suffering from an ischemic heart disease in a cell therapy comprising ex vivo treating stem or progenitor cells of the patient with a transcription enhancer of endothelial nitric oxide synthase. 7. A method for treating a patient suffering from an ischemic heart disease comprising administering to the patient in a cell therapy stem or progenitor cells of the patient wherein the cells were ex vivo treated with a transcription enhancer of endothelial nitric oxide synthase. The Examiner has rejected claims 1-8 under 35 U.S.C. § 103(a) as obvious based on Strobel1 and Reffelmann2 (Answer 4). The Examiner finds that Strobel discloses compounds that “are useful in the upregulation of 1 Strobel et al., Patent Application Publication US 2003/0055093A1, Mar. 20, 2003 2 Thorsten Reffelmann et al., Cellular cardiomyoplasty—cardiomyocytes, skeletal myoblasts, or stem cells for regenerating myocardium and treatment of heart failure?, 58 CARDIOVASCULAR RESEARCH 358-368 (2003) Appeal 2010-012300 Application 10/979,399 3 endothelial nitric oxide synthase (eNOS), and may therefore be useful for the manufacture of medicaments for the treatment of cardiovascular diseases, which would include ischemic heart disease” (id.). The Examiner finds that, while Strobel teaches compounds that “are capable of treating human cells in order to upregulate eNOS in said cells, Strobel does not specifically teach treating patients via cell therapy with said cells” (id. at 4- 5). The Examiner finds that “Reffelmann teaches that stem cells from the bone marrow are used in cardiomyoplasty, and discloses transplantation techniques including injection and infusion” (id. at 5). The Examiner concludes that it would have been obvious “to use eNOS transcription enhancers to treat bone marrow cells harvested from patients suffering from ischemic cardiovascular diseases for use in cardiomyoplasty for said patients . . . because treating via cell therapy provides advantages such as improved functioning and healing, as taught by Reffelmann.” (Id.) Appellants argue that combining the references would not be obvious because “there seems to be no connection between their teachings. Strobel does not teach that eNOS enhancers can have any effect on cell therapy. Reffelmann has no mention of eNOS proteins or enhancers for any purpose. Therefore, it is not seen how these two references can be combined as suggested in the present Action.” (Appeal Br. 4.) We agree with Appellants that the Examiner has not provided an adequate reason for combining Strobel’s treatment with eNOS transcription enhancers with Reffelmann’s cell therapy. Strobel discloses that “[e]ndothelially released NO is of central importance in a number of key Appeal 2010-012300 Application 10/979,399 4 cardiovascular mechanisms” (Strobel 1, ¶ 2) and that “[t]he aim of a therapeutic approach to the treatment of these disorders must accordingly be . . . increasing the endothelial NO expression” (id. at 1, ¶ 7). Strobel discloses compounds that upregulate eNOS expression in endothelial cells (id. at 1, ¶ 10) and suggests treating various cardiovascular diseases (id. at 13, ¶ 205) by administering the compounds to patients (id. at 13, ¶ 209). Reffelmann discloses that one approach to “repairing and rebuilding the failing human heart” (Reffelmann 358, right col.) is “the exogenous delivery of less differentiated cells to the damaged heart, that retain to a certain degree their capacity of proliferation” (id.). Reffelmann teaches that cells that could be used in such treatment include embryonic stem cells (id. at 362) and bone marrow derived mesenchymal stem cells (id. at 363). Reffelmann suggests several ways “how to best improve the results” (id., right col.), including “culturing technique” (id. at 364, right col.), but does not suggest treating the cells ex vivo with an eNOS transcription enhancer. The Examiner has not identified anything disclosed in Reffelmann that would provide a reason to treat cells in culture with an eNOS transcription enhancer in preparation for use in cardiomyoplasty. The Examiner finds that Reffelmann teaches that “treating via cell therapy provides advantages such as improved functioning and healing, as taught by Reffelmann (for example, see page 360, section 2.4)” (Answer 5). The Examiner has not, however, identified any disclosure in either Reffelmann or Strobel that would provide a reason to expect treating cultured cells with an eNOS transcription enhancer to result in any improvement in Reffelmann’s cell therapy method. Appeal 2010-012300 Application 10/979,399 5 In short, we agree with Appellants that the Examiner has not provided an adequate reason for concluding that it would have been obvious to combine the teachings of Strobel and Reffelmann. SUMMARY We reverse the rejection of claims 1-8 as obvious based on Strobel and Reffelmann. REVERSED lp