Appeal No. 2002-1353 Page 2
Application No. 09/268,353
The examiner relies on the following reference:
Gram et al. (Gram) WO 95/05807 Mar. 2, 1995
Claims 23-35 stand rejected under 35 U.S.C. § 103 as obvious in view of
Gram.
We reverse.
Background
The specification discloses that “[d]rugs with a progesterone and
oestradiol base in the form of tablets are already on the market. However, all the
tablets known to date use synthetic progestagens, which do not have all the
therapeutic effects of synthetic natural progesterone and may even have
undesirable effects.” Page 2.1 Thus, “it would be very attractive to have a tablet
with a natural progesterone and oestradiol base.” Id.
Formulating a tablet containing synthetic natural progesterone, however,
presents certain problems, because “natural progesterone must be used in much
stronger dosages than the synthetic progestagens, i.e. 50 to 60 times more of the
active principle relative to the tablet containing synthetic progestagens.”
Specification, page 3. Because so much more natural progesterone must be
administered, “it is necessary to considerably decrease the excipient content in
view of the constraints in size and weight appropriate to tablets.” Id.
1 The specification defines “synthetic natural progesterone” to mean “a synthesized progesterone
the chemical formula of which corresponds to the ‘natural’ progesterone, such as is found in the
female body.” Page 1. “Synthetic progestagens”, by contrast, are “entirely synthetic molecules
such as trimegestone, norethisterone and others, the structure of which does not correspond to
that of the natural progesterone.” Id.
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