Appeal No. 2006-3290 Page 11
Application No. 10/072,823
Regarding Exhibit 4, Appellant asserts that “combinations of anti-cancer
agents can in fact have negative effects.” Brief, page 5. According to Appellant,
Exhibit 4 reports that “antimitotic agents such as paclitaxel and G1-S arresting
agents such as 5-fluorouracil have antagonistic effects.” From this Appellant
argues that since the “references provided by Examiner provide no suggestion as
to the mechanism of action of lupulone and oridonin . . . there is no motivation to
combine and no expectation of success for this combination.” Reply Brief,
bridging paragraph, pages 5-6. We are not persuaded by Appellant’s argument.
Despite Appellant’s emphasis on the antagonistic effects of paclitaxel and
5-fluorouracil in the treatment of cancer, we note that Exhibit 4 teaches that as of
the publication date of the reference clinical trials were being performed with
combinations of paclitaxel and 5-fluorouracil. Exhibit 4, page 2559, column 2,
first full paragraph. Therefore, the teachings of the reference itself run counter to
the emphasis Appellant places on the reference. Further, contrary to Appellant’s
intimation, the antagonistic effects discussed in Exhibit 4 are not as absolute as
Appellant would lead us to believe. See e.g, Exhibit 4’s conclusion that “[o]ur
results demonstrate that both 5-FU [5-fluorouracil] and HU [hydroxyurea] could
interfere with the cytotoxic effects of antimitotic agents on mitotic arrest and
apoptosis.” Exhibit 4, page 2564, second column, first paragraph, emphasis
added.
In our opinion the evidence relied upon by Examiner provides a
reasonable expectation of formulating a composition comprising lupulone and
oridonin. That Exhibit 4 suggests the possibility that some compounds could
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