Appeal No. 2000-1717
Application 08/579,731
(4) the above -cited prior art reference; and
(5) the Makino declaration, filed under the provisions of 37 CFR § 1.132, copy
attached as Appendix B to the Appeal Brief.
On consideration of the record, including the above -listed materials, we reverse
the examiner’s rejection under 35 U.S.C. § 103.
DISCUSSION
Applicants’ invention relates to optically active benzothiepin derivatives useful for
stimulating bone growth in mammals. The invention is based on applicants’ discovery
that the 2R, 4S stereoisomer (“2R, 4S-isomer”) of a benzothiepin racemate, known in
the art at the time the invention was made, possesses significant bone resorption-
suppressing activity. According to applicants, the record establishes that the level of
protein synthesis and bone growth activity shown by a representative 2R,4S-isomer is
greater than the activity demonstrated by twice the dose of racemate.1 Thus, according
to applicants, their invention provides diastereomerically pure active ingredients having
greater bone formation activity than the corresponding prior art racemic ingredients at
lower dosages.
The pending claims are directed to 2R,4S benzothiepin isomeric compounds, a
method of making the same, intermediate compounds useful in making the same,
compositions containing the same, and methods of treatment using the same.
1 As stated in the Makino declaration, filed under the provisions of 37 CFR § 1.132, page 13, the
racemate consists of (2R,4S)-active isomer, and (2S,4R)-inactive isomer. A copy of the Makino
declaration is attached as Appendix B to the Appeal Brief.
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