Appeal No. 1999-1413
Application 08/176,024
Although the examiner considered several scientifically conservative statements
regarding the acceptability of the animal model of record, such as, “this monkey model
system has not been validated” (Hoffman declaration, page 6), and “[w]ith the exception of
the work carried out in man, the validity of all the experimental systems is open to
challenge” (Mitchell, page 2), we do not find that the examiner has reviewed the evidence
of enablement provided by appellants as a whole.
The cases of In re Fouche, 439 F.2d 1237, 1243, 169 USPQ 429, 434 (CCPA
1971) and In re Brana, 51 F.3d 1560, 1563, 34 USPQ2d 1436, 1439 (Fed. Cir. 1995),
recognize that 35 U.S.C. §101 rejections for utility present similar issues as 35 U.S.C.
§112 rejections for nonenablement. Thus, it is appropriate to consider relevant utility case
law to the present enablement issue.
In Brana, the Federal Circuit stated, “Our court's predecessor has determined that
proof 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); In re Krimmel, 292 F.2d 948,
953, 130 USPQ 215, 219 (CCPA 1961). In addition, “...pharmacological testing of
animals is a screening procedure for testing new drugs for practical utility.” Cross v. Iizuka,
753 F.2d 1040, 1051, 224 USPQ 739, 747 (Fed. Cir. 1985); In re Jolles, 628 F.2d 1324,
1327, 206 USPQ 885, 890 (CCPA 1980).
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