Ex Parte Kucharczyk et alDownload PDFPatent Trial and Appeal BoardSep 16, 201311386394 (P.T.A.B. Sep. 16, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 11/386,394 03/22/2006 John Kucharczyk 511.004US1 2631 97462 7590 09/16/2013 Mark A. Litman & Associates, P.A. 7001 Cahill Road, Ste. 15A Edina, MN 55439 EXAMINER LE, LONG V ART UNIT PAPER NUMBER 3768 MAIL DATE DELIVERY MODE 09/16/2013 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 JOHN KUCHARCZYK and MICHAEL E. MOSELEY1 __________ Appeal 2011-011474 Application 11/386,394 Technology Center 3700 __________ Before JENNIFER D. BAHR, ERIC GRIMES, and CHARLES N. GREENHUT, 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 for detecting tumor cells, which have been rejected for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 Appellants identify the Real Parties in Interest as The Regents of the University of Minnesota and Stanford University (Appeal Br. 3). Appeal 2011-011474 Application 11/386,394 2 STATEMENT OF THE CASE “Studies have demonstrated that the symptoms of Parkinson’s disease (PD) can be improved by transplanting dopaminergic (DA) stem cells into the brain of PD patients” (Spec. 1:19-21). However, the clinical utility of this therapy is “limited by the fact that the incidence of teratoma tumor formation from implanted embryonic stem cells remains high” (id. at 3:1-3). The Specification discloses “an imaging means for distinguishing between normal cell proliferation and angiogenesis following a cell implant versus abnormal tumor growth and neovascularization associated with teratoma-inducing implanted cells” (id. at 9:4-6). More specifically, “[a]s with the detection of specific local chemical indicators that cell viability is not performing at expected levels . . . it has been found that the early stages of tumor growth associated with cell implantation can be determined by similar techniques” (id. at 13:19-23). Claims 1-9 and 18-20 are on appeal. Claim 1 is the only independent claim and reads as follows (emphasis added): 1. A method for providing an indirect indication to a medical observer of tumor cells in a region where cell implantation has occurred comprising: implanting cells into a region of a patient; observing with magnetic resonance imaging or spectroscopy methods in that region of a patient into which cells have been previously implanted; detecting with the magnetic resonance imaging or spectroscopy methods a quantitative change in chemical content or chemical concentration in the region of the cell implant; and identifying from the quantitative change quantitative magnetic resonance indicators that are diagnostic for the presence of tumor cells in advance of being able to visualize a tumor with clinical magnetic resonance imaging. Appeal 2011-011474 Application 11/386,394 3 The claims stand rejected under 35 U.S.C. § 103(a) as follows: • Claims 1, 2, 7, 8, 18, and 20 based on Major2 and Bell3 (Answer 5); • Claim 3 based on Major, Bell, and Bhujwalla4 (Answer 7); • Claims 4 and 6 based on Major, Bell, and Howe5 (Answer 8); • Claim 5 based on Major, Bell, and Judd6 (Answer 9); • Claim 9 based on Major, Bell, and Sherry7 (Answer 10); and • Claim 19 based on Major, Bell, and Weiss8 (Answer 11). Analysis Each of the rejections on appeal is premised on combining the teachings of Major and Bell. The Examiner finds that “Major discloses a method for treating a patient by implanting cells in a region of a patient using an immortalized human neuron-derived fetal cell line” (Answer 5), and also discloses that such cells are predisposed to causing tumor formation after transplantation into a patient (id.). The Examiner finds that Bell discloses a method comprising the “observing,” “detecting,” and “identifying” steps recited in claim 1 (id.) and concludes that it would have been obvious to combine the methods taught by 2 Major et al., 5,869,463, issued Feb. 9, 1999. 3 J.D. Bell and K.K. Bhakoo, Metabolic changes underlying 31P MR spectral alterations in human hepatic tumours, 11 NMR BIOMED. 354-359 (1998). 4 Bhujwalla et al., MR Studies of Tumors: Relationship between Blood Flow, Metabolism, and Physiology, in NMR IN PHYSIOLOGY AND BIOMEDICINE, Academic Press, Inc., pp. 311-328 (1994). 5 Howe et al., Proton Spectroscopy In Vivo, 9 MAGNETIC RESONANCE QUARTERLY 31-59 (1993). 6 Judd et al., 5,910,112, issued June. 8, 1999. 7 Sherry et al., 5,951,473, issued Sept. 14, 1999. 8 Weiss et al., 5,980,885, issued Nov. 9, 1999. Appeal 2011-011474 Application 11/386,394 4 the two references in order to non-invasively detect metabolic changes associated with tumor metabolism to help diagnosis and develop better therapies (id. at 6). Appellants argue that “[c]linical MR [magnetic resonance] methods currently used in human patients can detect formed tumors comprised of large populations of tumor cells, but cannot detect early stage events” (Appeal Br. 15). Appellants argue that “[n]either Bell nor Major disclose the use of quantitative magnetic resonance indicators to detect the small number of cells in early development of tumors, as opposed to the detection of fully developed tumors as done by Bell” (id. at 17). Appellants argue that “[t]hose of ordinary skill in the art, prior to the invention by Appellants, were not aware of the efficacy of the recited process of quantitative measurements in the determination of early growth cancer cells” (id. at 15-16). We agree with Appellants that the Examiner has not provided sufficient evidence or sound technical reasoning to support the finding that Bell discloses identifying, from changes in quantitative chemical content or chemical concentration, “magnetic resonance indicators that are diagnostic for the presence of tumor cells in advance of being able to visualize a tumor with clinical magnetic resonance imaging,” as recited in claim 1. Bell “review[s] the application of in vivo 31P MRS [magnetic resonance spectroscopy] to the study of hepatic tumours” (Bell 354, left col.). Bell discloses that typical in vivo 31P MRS spectra from a patient with hepatocellular carcinoma show a characteristic elevation of phospho- monoester signals, compared to a healthy person (id. at 354, right col.). Bell Appeal 2011-011474 Application 11/386,394 5 concludes that “in vivo 31P MRS can be used to distinguish between normal and neoplastic tissue” (id. at 358, right col.). However, as Appellants have pointed out, the work reviewed in Bell was done on patients who had already been diagnosed as having hepatic tumors (id. at 355, Table 1). Bell expressly states that “MRS studies of hepatic tumours have been limited by the spatial resolution of the technique, concentrating on relatively large tumours. However, liver cancer needs to be detected and treated when tumour bulk is relatively small, which in most cases is well below the relative resolution of MRS.” (Id. at 354-355, right col.) Bell also states that, because MRS cannot be used to distinguish between different types of tumors, “[a] more likely role for in vivo 31P MRS appears to be in the monitoring of response to therapy, although, because of its relatively low spatial resolution, it should again be restricted to large tumour masses” (id. at 355, right col.). Bell’s description of MRS as having a spatial resolution that does not allow it to detect tumors when they are relatively small supports Appellants’ position that Bell does not disclose “magnetic resonance indicators that are diagnostic for the presence of tumor cells in advance of being able to visualize a tumor with clinical magnetic resonance imaging,” as required by claim 1. The Examiner argues that “Bell’s disclosure is not directed to distinguishing between tumor types, but it is directed to detecting if a tumor has formed in a patient” (Answer 14). Bell’s disclosure does not support this position. As discussed above, Bell discloses that the patients studied using MRS had already been diagnosed as having hepatic tumors, Appeal 2011-011474 Application 11/386,394 6 and that the spatial resolution of MRS does not allow detection of tumors when they are relatively small. Thus, while Bell discloses that there are differences between tumor tissue and normal tissue that can be detected using in vivo 31P MRS, it does not disclose using those differences to detect a tumor in a patient who was not already known to have one, nor does it disclose using in vivo 31P MRS to detect tumor cells at a stage earlier than the tumor can be detected by clinical magnetic resonance imaging (MRI). The Examiner also argues that “Bell uses the same apparatus (31P MRS) and the same chemical content and quantitative magnetic resonance indicators (PME, Pi, PDE, ATP) as disclosed by appellant” (Answer 14). Even assuming, however, that Bell discloses using the same technique to quantitate the same chemical compounds as described or claimed by Appellants, it does not disclose or suggest that doing so can be used to detect tumor cells in a patient before the tumor can be visualized using clinical MRI, as required by claim 1. Bell therefore does not provide a reason to carry out the steps of the claimed method in the patient defined by the claim language. SUMMARY We reverse all of the rejections on appeal. REVERSED cdc Copy with citationCopy as parenthetical citation