Appeal No. 2006-3012
Application No. 09/808,878
(Specification 1.) “Estrogen replacement therapy (ERT) is beneficial for
symptomatic relief of hot flushes.” (Id. at 2.)
ERT may increase the relative risk of endometrial cancer. (Id. at 3.)
“There are extensive clinical data showing that the relative risk of
endometrial cancer can be reduced by the addition of a progestin, either
sequentially or continuously.” (Id. at 4.) “Continuous combined hormone
replacement therapy (HRT) . . . has been shown to be effective in relieving
. . . vasomotor symptoms.” (Id.) PREMPRO is a commercially available
combination HRT product (id.) that contains 0.625 mg of conjugated equine
estrogens USP and 2.5 mg of medroxyprogesterone acetate (MPA) (id. at 5).
The specification discloses that administering either 0.45 mg or 0.3 mg
of conjugated equine estrogens (a.k.a. PREMARIN) in combination with 1.5
mg of MPA “reduce[s] the number and severity of hot flushes to the same
extent as the higher dose combination containing 0.625 mg PREMARIN plus
2.5 mg MPA.” (Id. at 9-10.) The specification characterizes this result as
unexpected. (Id. at 9, line 32.)
DISCUSSION
1. CLAIMS
Claims 7, 11, 12, and 69 are pending and on appeal. Claim 7, the only
independent claim, reads as follows:
7. A method of treating or inhibiting vasomotor symptoms in a
perimenopausal, menopausal, or postmenopausal woman in need thereof,
which comprises orally providing to said woman continuously and
uninterruptedly over the treatment period, a combination of conjugated
estrogens, USP and a daily dosage of about 1.5 mg of medroxyprogesterone
acetate, wherein the daily dosage of conjugated equine estrogens is between
about 0.45 mg and about 0.3 mg.
2
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