Ex Parte KawasakiDownload PDFBoard of Patent Appeals and InterferencesFeb 12, 200809971475 (B.P.A.I. Feb. 12, 2008) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte TOSHISUKE KAWASAKI __________ Appeal 2007-3119 Application 09/971,475 Technology Center 1600 __________ Decided: February 12, 2008 __________ Before TONI R. SCHEINER, DEMETRA J. MILLS, and ERIC GRIMES, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a gene therapy method of treating cancer, which the Examiner has rejected as nonenabled. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. BACKGROUND The Specification discloses that “mannan-binding protein (MBP)” is a known “type C lectin which binds to mannose (Man) or N-acetylglucosamine (GlcNAc) in a calcium-dependent manner” (Spec. 1). The Specification also Appeal 2007-3119 Application 09/971,475 discloses that “the growing ability of cancer cells in . . . tumor bearing animals administered with the gene coding for MBP is clearly suppressed” (id. at 2-3). The Specification provides a working example in which nude mice were inoculated with human colon cancer cells and treated with saline, wild- type vaccinia virus, or a recombinant vaccinia virus encoding MBP (administered either into the tumor or “subcutaneously to non-diseased part”) (id. at 14). The Specification reports that when the MBP recombinant vaccinia virus of the present invention is administered into tumors of the diseased part, the tumors clearly became smaller and that, even when it was subcutaneously administered to the non-diseased part, a significant suppression of growth of cancer cells was observed as compared with the controls where vaccinia virus WR strain of a wild type and physiological saline solution were administered. (Id. at 15.) DISCUSSION 1. CLAIMS Claims 12, 14, and 19 are pending and on appeal. Claim 12 is representative and reads as follows: 12. A method of treating human cancer comprising administering a gene for a mannan-binding protein having an amino acid sequence represented by SEQ ID NO:1, where administering said gene includes injecting said gene directly into a tumor of the diseased part, wherein said gene is integrated in a virus vector. 2. ENABLEMENT Claims 12, 14, and 19 stand rejected under 35 U.S.C. § 112, first paragraph, on the basis that the “specification does not teach how to 2 Appeal 2007-3119 Application 09/971,475 overcome problems with in vivo delivery and expression with respect to the administration of the claimed nucleic acids or viral vectors comprising said nucleic acids” (Answer 3). The Examiner cites several references to support his position that gene therapy generally was highly unpredictable as of this application’s effective filing date (id. at 3-4).1 The Examiner concludes that the “specification does not remedy any of the deficiencies [of] the prior art with regard to gene therapy. Given the lack of any guidance from the specification on any of the above issues pointed out by Verma or Eck or Orkin[, o]ne of skill in the art would be subject to undue experimentation without reasonable expectation of success in order to practice the methods of [the] claims” (id. at 5). Appellant argues that a “specific working example describing the preparation of a recombinant vaccinia virus vector for administering a gene coding for MBP is provided . . . at Example 1 of the specification. Administration of the recombinant vaccinia virus vector is described in Example 2 of the specification.” (App. Br. 4.) Appellant also argues that the state of the art of gene therapy supports the position that the claimed method is enabled (id. at 5-6). Appellant concludes that “[i]n view of the guidance provided . . . for performing the claimed method, in combination with experimental evidence showing anti-cancer activity in human colon 1 The Examiner cites Verma et al., “Gene therapy – promises, problems and prospects,” Nature, Vol. 389, pp. 239-242 (1997); Eck et al., “Gene-based therapy,” in Goodman & Gilman’s The Pharmacological Basis of Therapeutics, 9th edition, pp. 77-101, McGraw Hill (1996); and Orkin et al., “Report and Recommendations of the Panel to Assess the NIH Investment in Research on Gene Therapy,” Nat’l Insts. of Health (1995). 3 Appeal 2007-3119 Application 09/971,475 cancer cells, and the skill and knowledge available to an artisan of ordinary skill,” the claims should be considered enabled (id. at 8). We agree with Appellant that the Examiner has applied an overly stringent standard for enablement in this case. “[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). “That some experimentation may be required is not fatal; the issue is whether the amount of experimentation required is ‘undue.’” In re Vaeck, 947 F.2d 488, 495 (Fed. Cir. 1991) (emphasis in original). Some experimentation, even a considerable amount, is not “undue” if, for example, it is merely routine, or if the specification provides a reasonable amount of guidance as to the direction in which the experimentation should proceed. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). In this case, the claims are relatively narrow, in that they require administration of a gene encoding a known protein with a specific amino acid sequence, and require “injecting said gene directly into a tumor.” Importantly, the Specification provides a working example of one viral vector comprising the gene recited in the claims (Spec. 12-13), and another working example that describes practice of the claimed method to treat tumors in experimental mice (id. at 14-15). In the Specification’s working example, the claimed method caused tumors to shrink from >35 mm in control mice (treated with saline or wild-type virus) to <5 mm in mice treated by the claimed method (id. at 15; Fig. 3). 4 Appeal 2007-3119 Application 09/971,475 We conclude that, in view of the significant guidance provided by the Specification and the prior art of record, and the working example in the Specification, the Examiner has not adequately established that undue experimentation would have been required to practice the claimed method. We disagree with the Examiner’s apparent position that a therapeutic method must be clinically proven to be safe and effective in order to be enabled. When Appellant cited clinical trials showing gene therapy for different diseases, the Examiner responded that those treatments were “under the guise of clinical trials. A treatment is administered by a clinical trial when the result is uncertain, and therefore the method was not enabled, because there was no reasonable expectation of success. Even in the year 2006, . . . an individual suffering from cancer does not go [to] a physician and expect to receive gene therapy for cancer.” (Answer 12-13.) The Examiner’s position “confuses the requirements under the law for obtaining a patent with the requirements for obtaining government approval to market a particular drug for human consumption.” In re Brana, 51 F.3d 1560, 1567 (Fed. Cir. 1995). The Brana court held that “[u]sefulness in patent law, and in particular in the context of pharmaceutical inventions, necessarily includes the expectation of further research and development. The stage at which an invention in this field becomes useful is well before it is ready to be administered to humans.” Id. at 1568. (The court’s reference to “usefulness” was in the context of the how-to-use prong of 35 U.S.C. § 112, first paragraph; the rejection on appeal was for nonenablement. See id. at 1564.) 5 Appeal 2007-3119 Application 09/971,475 The Brana court’s holding is consistent with that of CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1338 (Fed. Cir. 2003) (“Enablement does not require an inventor to meet lofty standards for success in the commercial marketplace. Title 35 does not require that a patent disclosure enable one of ordinary skill in the art to make and use a perfected, commercially viable embodiment absent a claim limitation to that effect.”). See also In re Cortright, 165 F.3d 1353, 1359 (Fed. Cir. 1999) (claims to method of “restoring hair growth” encompassed achieving full head of hair but did not require it). SUMMARY The Examiner’s conclusion that the pending claims are not enabled is based on an overly stringent application of the enablement requirement of 35 U.S.C. § 112, first paragraph. We therefore reverse the rejection of claims 12, 14, and 19 for nonenablement. REVERSED Ssc: KOLISCH HARTWELL, P.C. 520 SW YAMHILL STREET, SUITE 200 PORTLAND, OR 97204 6 Copy with citationCopy as parenthetical citation