Appeal No. 2001-1150 Page 4
Application No. 09/767,764
adequate guidance to allow one skilled in the art to practice the claimed
invention. We agree.
The burden is on the examiner to set forth a prima facie case of
unpatentability. See In re Alton, 76 F.3d 1168, 1175, 37 USPQ2d 1578, 1581
(Fed. Cir. 1996). “[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 35 U.S.C. 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.
With respect to pharmaceutical inventions, the Court of Appeals for the
Federal Circuit has stated:
On the basis of animal studies, and controlled testing in a
limited number of humans (referred to as Phase I testing), the Food
and Drug Administration may authorize Phase II clinical studies.
See 21 U.S.C. § 355(i)(1); 5 C.F.R. § 312.23 (a)(5), (a)(8) (1994).
Authorization for a Phase II study means that the drug may be
administered to a larger number of humans, but still under strictly
supervised conditions. The purpose of a Phase II study is to
determine primarily the safety of the drug when administered to a
larger human population, as well as its potential efficacy under
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