Appeal No. 2001-0869 Page 7 Application No. 08/453,347 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). “[E]nablement requires that the specification teach those in the art to make and use the invention without ‘undue experimentation.’ 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, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991) (citation omitted, 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. 1988). Those considerations, see id., are well known and need not be repeated here. In this case, we agree with appellants that the examiner has not shown that undue experimentation would have been required to practice the claimed method. The examiner’s concerns, and the evidence cited in support of the rejection, are directed to sources of unpredictability and experimentation involved in gene therapy in general, rather than the claimed method in particular. Granted, the examiner’s references show that (at least as of 1995) gene therapy techniques, as a group, required further experimentation before they would be ready for clinical application. This showing, however, is not enough to support a rejection of the instant claims for nonenablement.Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 NextLast modified: November 3, 2007