Appeal No. 2001-1970 Page 9
Application No. 08/260,190
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; we need not
repeat them 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 mainly directed to sources of unpredictability and experimentation
involved in antisense therapy in general, rather than the claimed method in
particular. Granted, the examiner’s references show that (at least as of 1992)
antisense 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.
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