Appeal 2007-0741
Application 09/313,625
DISCUSSION
The present invention “relates to a method of using a SERM . . .
postmenopausally, e.g., in hormone replacement therapy to prevent
osteoporosis, cardiovascular disease and breast cancer . . . [while] preventing
the hypothalamus and pituitary from operating in a deranged manner . . .
[by] super[im]posing upon the use of a selective estrogen receptor
modulator, the co-administration of a [ ] progestationally active [compound]
to [post-menopausal] women” (Spec. 4: 8-19), in an amount effective to
modulate the bleeding side effects of the SERM.
Claim 1 is representative of the claimed subject matter:
1. In a method of hormone replacement therapy comprising
administering an effective amount of a selective estrogen
receptor modulator to a woman in need of such therapy
in order to control and regulate estrogenic impact on
estrogen sensitive tissues and organs, the improvement
which comprises additionally administering an agent
which exhibits progestogenic activity in the woman in an
amount which is effective to modulate the bleeding side
effects of the selective estrogen receptor modulator.
According to the Specification, the “progestationally active” or
“progestogenic” compound may be “progesterone, a synthetic progestin
analog or even an anti-progestin having agonistic activity” and may further
“exhibit both androgenic and progestogenic activity simultaneously[,]” like
levonorgestrel (Spec. 7: 31 to 8: 14).
3
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