Appeal No. 1998-1987
Application No. 07/915,783
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.”
(emphasis in original)). See also In re Langer, 503 F.2d 1380, 1391, 183 USPQ
288, 297 (CCPA 1974) (“[A] specification which contains a disclosure of utility
which corresponds in scope to the subject matter sought to be patented must be
taken as sufficient to satisfy the utility requirement of § 101 for the entire claimed
subject matter unless there is reason for one skilled in the art to question the
objective truth of the statement of utility or its scope.”).
“[P]roof of an alleged pharmaceutical property for a compound by
statistically significant tests with standard experimental animals is sufficient to
establish utility.” In re Brana, 51 F.3d 1560, 1567, 34 USPQ2d 1436, 1442 (Fed.
Cir. 1995) (citing In re Krimmel, 292 F.2d 948, 953, 130 USPQ 215, 219 (CCPA
1961)). “‘[O]ne who has taught the public that a compound exhibits some
desirable pharmaceutical property in a standard experimental animal has made a
significant and useful contribution to the art, even though it may eventually
appear that the compound is without value in the treatment of humans.’” Brana,
51 F.3d at 1567, 34 USPQ2d at 1442 (quoting Krimmel, 292 F.2d at 953, 130
USPQ at 219).
In this case, the specification discloses that the claimed compositions
have a significant therapeutic effect when administered to mice. See pages 24-
31. The examiner’s position to the contrary notwithstanding, mice appear to be
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