Appeal No. 2007-1072
Application No. 09/872,250
spotting as well as normal/excessive breakthrough bleeding decreasing
during use, and that the highest incidence of any intermenstrual bleeding
occurred during the first cycle. Id. at 136, col. 1. Endrikat concludes “the
results of this comparative study show that the reduction of EE2 content
from 30 μg to 20 μg neither comprises contraceptive reliability nor leads to
clinically unacceptable cycle control.” Id. at 136, col. 2.
Hodgen relates to a method of oral contraception in which the
incidence of breakthrough bleeding is reduced after the first cycle. Hodgen
teaches a oral contraceptive containing “a combined dosage form of estrogen
and progestin monophasically for 23 to 25 consecutive days of a 28 day
cycle, preferably 24 days of the cycle, in which the daily amounts of
estrogen and progestin are equivalent to about 5-35 mcg of ethinyl estradiol
and about 0.025 to 10 mg or norethindrome acetate, respectively, and in
which the weight ratio of estrogen to progesterone is at least 1:45 calculated
as ethinyl estradiol to norethindrone acetate.” Id. at col. 3, ll. 52-61. Thus,
Hodgen solves the problem of breakthrough bleeding in months subsequent
to the first month through the addition of norethindrome acetate to the oral
contraceptive preparation.
Endrikat is drawn to a clinical study comparing oral contraceptives
containing 20 μg of EE2 and 30 μg of EE2, with spotting and breakthrough
bleeding occurring with both preparations, although admittedly with a
slightly lower incidence with the higher EE2 containing preparation.
Hodgen is drawn to reduction of breakthrough bleeding after the first cycle
of use, wherein norethindrone acetate is included in a preparation containing
a combination of estrogen and progestin. Thus, as noted by Appellant, both
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