Ex Parte Lee - Page 4
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“is useful in combination with known anti-cancer and cytotoxic agents for
cancer treatment” (Answer 6).
The Examiner relies on Danishefsky for disclosing that a
pharmaceutical composition comprising Compound 1 is useful in methods of
treating cancer (id. at 3). The Examiner argues that Danishefsky discloses
that its compounds can be used in combination with “other cytotoxic agents
or anticancer agents such as 5-fluorouracil (5-FU)” (id. at 4).
The Examiner relies on The Merck Index for teaching that
“fluorouracil (5-FU) is well-known to be used in combination cancer
chemotherapy, i.e., comb[in]ing with other anti-cancer agents as cancer
chemotherapy drug regimens” (id. at 6).
The Examiner relies on Miwa for disclosing that “capecitabine . . . ,
which is finally converted to 5-fluorouracil (5-FU) by dThdPase in tumors,
should be much safer and more effective than 5-FU, for treating cancers or
various types of tumors” (id. at 4-5, 6).
The Examiner concludes that “[i]t would have been obvious to a
person of ordinary skill in the art at the time the invention was made to
employ [Compound 1] in combination with . . . capecitabine in . . . a method
for treating cancer” (id. at 6-7). In particular, the Examiner argues that there
would have been motivation to combine the references in this way and there
would have been a reasonable expectation of success because Compound 1
“is known to be useful in treating various types of cancers or tumors . . . and
also useful in combination with known anti-cancer and cytotoxic agents for
cancer treatment,” “fluorouracil (5-FU) is well-known to be used in
combination cancer chemotherapy,” and “[c]apecitabine . . . is known to be
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Last modified: November 3, 2007