Appeal No. 2002-1251 Page 7 Application No. 08/459,340 Appellants argue that the examiner fails to provide any evidence whatsoever that the instant invention would not work for its intended purpose, other tha[n] alleging the unpredictability of in vivo efficacy based on the Antisense ’97 article, or that ribozyme delivery is an unpredictable art based on the Branch article. Appellants, however, have provided ample data and guidance in the specification and indicated teachings in the art that demonstrate the efficacy of modified enzymatic nucleic acid molecules both in vitro and in vivo. . . . In the absence of any technical reasons and/or references to support its reasoning, the Office has failed to establish a prima facie case of lack of enablement. Reply Brief, pages 12-13. “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; this includes, of course, providing sufficient reasons for doubting any assertions in the specification as to the scope of enablement. If the PTO meets this burden, the burden then shifts to the applicant to provide suitable proofs indicating that the specification is indeed enabling.” In re Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). We agree with Appellants that the examiner has not met the burden of providing evidence to support a prima facie case of nonenablement. The examiner provides no Wands-based analysis, based on the particular facts of the application and claims under consideration, supporting a conclusion that undue experimentation would have been required to use the claimed compositionsPage: Previous 1 2 3 4 5 6 7 8 9 10 11 12 NextLast modified: November 3, 2007