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 Next
Last modified: November 3, 2007