Appeal No. 95-1618
Application 08/033,456
required to make and use the claimed invention. In re Scarbrough, 500 F.2d 560, 566, 182 USPQ
298, 303 (CCPA 1974); In re Moore, 439 F.2d 1232, 1235, 169 USPQ 236, 238 (CCPA 1971). The
examiner has not explained how and why appellants’ detailed description of how to make the claimed
compounds described on pages 11-31 and in the 56 examples of the specification would not have
enabled one skilled in the art to make and use the claimed invention without undue experimentation
and why one skilled in the art would find it necessary for applicant to disclose how to make all
tautomers and isomers of formula I in order to comply with the enablement requirement. For the
foregoing reasons, the rejection of claims 1-6 and 8-13 under the first paragraph of 35 U.S.C. § 112
is reversed.
The examiner also rejected claims 5, 6, 12 and 13 under 35 U.S.C. §§ 101 and 112, first
paragraph, for the following reasons (Paper No. 26, pp. 5-6):
There is insufficient data in the specification to show that the claimed
pharmaceutical composition is therapeutically effective in the treatment of the various
complications and diseases disclosed. The specification is devoid of any data for in
vitro or in vivo tests. When [the] disclosed utility is the production of a physiological
response, the dosage effective to achieve this response in a host, whether human or
animal, must be disclosed, In re Gardner et al. (CCPA 1970) 427 F2d [sic, F.2d] 786,
166 USPQ 138. Some showing of empirical results is necessary to establish the utility
of a method of treating or preventing using [sic] applicants' compositions. For
instance the prevention of autoimmune diseases, (i.e. such as AIDS) raises the issue
of prima facie incredible utility. Lack of evidence of the effectiveness of the claimed
method of treating cancer [or autoimmune diseases such as AIDS) coupled with an
experimental paper protocol as the relevant working example can justify a rejection
under both 35 U.S.C. § 101 and § 112. Ex parte Stevens (BPAI 1990) 16 [US]PQ2d
1379. Applicants' claimed invention is sufficiently unusual to warrant requiring
substantiating evidence, Ex parte Busse et al. (BPAI 1986) 1 [US]PQ2d 1908.
It is not clear from the disclosure that [a] useful activity has been determined or
demonstrated in fact for the plurality of possible compounds encompassed by the
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