Appeal No. 2002-1926 Page 3 Application No. 08/693,353 first paragraph of 35 U.S.C. § 112, “because the specification, while being enabling for Micrococcus varians strains CNCM I-1586 and CNCM I-1587, does not reasonably provide enablement for bacteriocin . . . production by any other strain of Micrococcus varians. Answer, page 4. According to the examiner (id., page 5), Appellants have demonstrated a bacteriocin production by the two strains named above, but have not shown that other strains of Micrococcus varians may reliably be used for production of a bacteriocin effective against Listeria monocytogenes . . . neither of the two (unidentified) strains of Micrococcus varians that Cantoni et al. tested for bacteriocin production had activity against Listeria monocytogenes . . . Thus, based on the art, no other known strain of Micrococcus varians may reliably be used for production of a bacteriocin effective against Listeria monocytogenes; likewise, the specification fails to teach other strains that may be used in the claimed invention. “When rejecting a claim under the enablement requirement of section 112, the PTO bears an initial burden of setting forth a reasonable explanation as to why it believes that the scope of protection provided by that claim is not adequately enabled by the description of the invention provided in the specification of the application.” In re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). “[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’” Id. at 1561, 27 USPQ2d at 1513. “That some experimentation may be required is not fatal; the issue is whether the amount of experimentation is ‘undue.’” In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991) (emphasis in original). “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir.Page: Previous 1 2 3 4 5 6 7 NextLast modified: November 3, 2007