Appeal No. 2003-1126 Page 8
Application No. 08/444,285
transgenically expressed one gene under the control of the promoter in one
species of mammal.” Substitute Appeal Brief, page 12.
“[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 not ‘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). “[A] specification disclosure which contains a teaching of the manner
and process of making and using the invention in terms which correspond in
scope to those used in describing and defining the subject matter sought to be
patented must be taken as in compliance with the enabling requirement of the
first paragraph of § 112 unless there is reason to doubt the objective truth of the
statements contained therein which must be relied on for enabling support.” In re
Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971) (emphasis in
original). “[It] is incumbent upon the Patent Office, whenever a rejection on this
basis is made, to explain why it doubts the truth or accuracy of any statement in
a supporting disclosure and to back up assertions of its own with acceptable
evidence or reasoning which is inconsistent with the contested statement.” Id. at
224, 169 USPQ at 370.
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