Appeal No. 94-2100
Application 07/902,109
of Alzheimer’s. Thus, there is no need for the specification to
positively demonstrate the successful treatment of Alzheimer’s
patients in order to satisfy the enablement requirement of § 112,
first paragraph.
The examiner’s contends that “scopolamine induced amnesia is
only a screening test which screening test is deemed insufficient
to employ [sic, comply?] with the statute.” Answer, p. 3.
Here, it appears that the examiner is questioning the relevance
of the disclosed in vitro and in vivo screening assays with
respect to the ability of the present compositions to treat
Alzheimer’s. Again, however, the examiner has not provided any
reasons as to why the results of the screening tests do not
correlate with the suggested utility of treating “diseases
involving hypofunction of the cortical cholinergic system,” or
with the treatment of Alzheimer’s. Specification, p. 2, lines
32-33. Moreover, we point out that the Federal Circuit recently
addressed the issue of enablement with regard to screening assays
in animals. In In re Brana, 51 F.3d 1560, 1567, 34 USPQ2d 1436,
1442 (Fed. Cir. 1995), the court stated 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 Krimmel, 292 F.2d 948, 953, 130 USPQ 215, 219 (CCPA
1961); see also In re Bergel, 292 F.2d 958, 130 USPQ 205
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