Appeal 2007-1033
Application 10/091,061
were administered to tumor-bearing mice, alone or in combination
(Declaration ¶¶ 10-13). The results show that the combination of
capecitabine and ixabepilone resulted in slower tumor growth and greater
anti-tumor efficacy (id. at ¶ 14). Dr. Lee declared that the results
“demonstrated [that] a synergistic effect is obtained in preclinical studies
involving the administration of ixabepilone and capecitabine, in
combination, and that [he] found this effect to be surprising” (id. at ¶ 15).
“Synergism, in and of itself, is not conclusive of unobviousness in that
synergism might be expected.” In re Kollman, 595 F.2d 48, 55 n.6, 201
USPQ 193, 198 n.6 (CCPA 1979). “[H]owever, when an applicant
demonstrates substantially improved results . . . and states that the results
were unexpected, this should suffice to establish unexpected results in the
absence of evidence to the contrary.” In re Soni, 54 F.3d 746, 751, 34
USPQ2d 1684, 1688 (Fed. Cir. 1995) (emphases in original).
The Examiner does not dispute that the data in the Declaration show
synergism, or that a synergistic effect was unexpected. Rather, the
Examiner argues that “the Declaration is not relevant because it is not
commensurate with the scope of the claims” (Answer 10). In particular, the
Examiner argues that: (a) “the claims are drawn [to] various cancers, of
which the Declaration has support for only colon cancer”; (b) “there is only
one data point in the Declaration drawn to 10 mg/kg of compound (1) and
250 mg/kg/adm of capecitabine, whereas the claims are drawn to all dosage
ranges of both compound (1) and capecitabine”; and (c) “the results of the
Declaration clearly provide only a delay in tumor growth, while the claims
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