Appeal No. 1997-0483
Application No. 07/648,900
A specification complies with the enablement requirement of 35 U.S.C. § 112, first
paragraph, if it allows one of ordinary skill in the art to make and use the claimed invention
without undue experimentation and the examiner has the initial burden of establishing lack
of enablement. In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir.
1993).
The test [for undue experimentation] is not merely quantitative, since a
considerable amount of experimentation is permissible, if it is merely
routine, or if the specification in question provides a reasonable amount of
guidance with respect to the direction in which the experimentation should
proceed to enable the determination of how to practice a desired
embodiment of the invention claimed.
PPG. Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564, 37 USPQ2d 1618, 1623
(Fed. Cir. 1996) (quotation and citation omitted); see also In re Wands, 858 F.2d 731,
736-40, 8 USPQ2d 1400, 1403-07 (Fed. Cir. 1988). The determination of what
constitutes undue experimentation in a given case must be decided on the facts of each
particular case and requires the application of a standard of reasonableness, having due
regard for the nature of the invention and the state of the art.
According to the examiner,
appellants have failed to enable the broad scope of the instant claims
(except claims 6, 16 and 20 which are limited in scope to specific
sequences) as the available sequence information of the three mammalian
forms disclosed provides only very limited guidance with regard to what
amino acid modifications could be predictably tolerated, e.g., such as
substitution with those amino acids which differ (i.e., are not conserved) in
particular positions between these mammal species or other conservative
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