Appeal No. 2007-1072
Application No. 09/872,250
Claims 1-11 stand rejected under 35 U.S.C. § 103(a) as being obvious
over the combination of Endrikat,1 Hodgen2 and Katzung.3 We reverse.
DISCUSSION
Claim 1 is drawn to a kit, wherein at least two cycle packs are
packaged together to be given to a patient, wherein one pack has an effective
dosage of steroid that is greater than the effective dosage of steroid in the
second pack, wherein the cycle pack having the lower effective dosage of
steroid has no more than about 20 μg estrogen per dosage unit.
Endrikat is relied upon by the Examiner for teaching that oral
contraceptives having 30 μg of ethinylestradiol have less breakthrough
bleeding in the first three cycles than those having 20 μg of ethinylestradiol
(Answer 3). The examiner also cites Endrikat for its teaching that the
pattern of breakthrough bleeding in the first month may be due to the fact
that the adaptation of the endometrium to the exogenous hormones takes
some time. Id.
Hodgen is cited for teaching “a method of reducing breakthrough
bleeding in the menstrual cycles except for the first cycle employing ultra-
low dose of ethinylestradiol,” wherein the dose is 3-35 μg. Id.
Katzung is relied upon for teaching the various claimed progestins.
Id. at 4. The examiner acknowledges that the “primary references do not
1 Endrikat et al. (Endrikat), A Twelve-Month Comparative Clinical
Investigation of Two Low-Dose Oral Contraceptives Containing 20 μg
Ethinylestradiol/75 μg Gestodene and 30 μg Ethinylestradiol/75 μg
Gestodene, with Respect to efficacy, Cycle Control, and Tolerance,
Contraception, Vol. 55, pp. 131-137 (1997).
2 Hodgen, U.S. Pat. No. 5,552,394, issued September 3, 1996.
3 Katzung, Basic & Clinical Pharmacology, p. 120 (6th Ed. 1995).
2
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