Appeal No. 2004-1790 Page 4
Application No. 09/836,971
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. Here, the examiner has not provided
“acceptable evidence or reasoning which is inconsistent” with the specification,
and therefore has not met the initial burden of showing nonenablement.
The rejection appears to be requiring precise predictability as to the time
when the colon or rectal cancer will appear, and also appears to require 100%
prevention. That is not, however, a requirement under 35 U.S.C. § 112, first
paragraph. “Usefulness in patent law, and in particular the context of
pharmaceutical inventions, necessarily includes the expectation of further
research and development. The stage at which an invention in this field
becomes useful is well before it is ready to be administered to humans.” In re
Brana, 51 F.3d, 1560, 1568 34 USPQ2d 1436, 1442-43 (Fed. Cir. 1995)
(citations omitted).
Moreover, as noted by appellants, page 11 of the specification includes a
study of a multiplicity of rats, and results of “extremely substantial inhibition” are
achieved. See Appeal Brief, pages 6-7. The examiner in response to
arguments, however, rejects that showing on the basis that “[a]pplicants . . .
Page: Previous 1 2 3 4 5 6 7 8 9 Next
Last modified: November 3, 2007