Appeal No. 2002-0546 Page 6
Application No. 08/809,379
Furthermore, the PDR notes that cytotec (misoprostol) “caused partial or
complete expulsion of the uterine contents in 11% of the subjects and increased
uterine bleeding in 41%” in women undergoing an elective termination of their
pregnancy in the first trimester. Thus, appellant asserts that the ability of
misoprostol to decrease uterine bleeding is unexpected because of its known
liability of causing uterine bleeding. See Appeal Brief, page 11.
In response, the examiner asserts that
[t]he liability of misoprostol, noted in the [PDR] to cause uterine
bleeding and miscarriage in some woman (making its use in
pregnant women undesirable) would be reasonably expected to be
avoided by the administration of a dosage of this agent which is
greater than in the prior art.
Examiner’s Answer, page 9. The examiner, however, provides no supporting
documentation or evidence to support the contention that one would expect side
effects of the drug, such as increased uterine bleeding, to decrease at increased
dosages of the drug. See, e.g., In re Lee, 277 F.3d 1338, 1343-44, 61 USPQ2d
1430, 1433-34 (Fed. Cir. 2002) (in reviewing an obviousness rejection, the court
noted that “conclusory statements” as to teaching, suggestion or motivation to
arrive at the claimed invention “do not adequately address the issue.”).
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