Appeal 2007-1033
Application 10/091,061
finally [converted] to 5-fluorouracil (5-FU) by dThdPase in tumors, and
should be much safer and more effective than 5-FU, for treating cancers or
various types of tumors” (id. at 7).
We conclude that the Examiner has set forth a prima facie case that it
would have been obvious to administer Compound 1 in combination with
capecitabine to treat cancer. In particular, we agree with the Examiner that
the combination would have been suggested by the known use of various
anti-cancer agents in combination. As recently indicated by the Supreme
Court, “any need or problem known in the field of endeavor at the time of
invention and addressed by the patent can provide a reason for combining
the elements in the manner claimed.” KSR Int’l Co. v. Teleflex Inc., 127 S.
Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007). In addition, we agree with
the Examiner that there would have been a reasonable expectation that
administering capecitabine in combination with Compound 1 would provide
a greater anti-cancer effect than would administering either capecitabine or
Compound 1 alone.
Appellant, however, has provided evidence to rebut the Examiner’s
prima facie case of obviousness. “If a prima facie case is made in the first
instance, and if the applicant comes forward with reasonable rebuttal,
whether buttressed by experiment, prior art references, or argument, the
entire merits of the matter are to be reweighed.” In re Hedges, 783 F.2d
1038, 1039, 228 USPQ 685, 686 (Fed. Cir. 1986).
Appellant relies on the Declaration of Francis Lee (submitted
October 31. 2005). The Declaration describes experiments in which
capecitabine and Compound 1 (referred to in the Declaration as ixabepilone)
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