Appeal No. 2000-1717
Application 08/579,731
The examiner argues that claims 1 through 7 and 10 through 16 would have
been prima facie obvious in view of Sohda’s disclosure of benzothiepin racemate
compounds, a method of making those compounds, intermediates useful in making
those compounds, compositions containing the same, and methods of treatment using
the same. Applicants do not controvert the prima facie case of obviousness. Rather,
applicants argue that the Makino declaration serves to rebut the prima facie case
applied against all of the appealed claims. In their Appeal Brief, paragraph bridging
pages 10 and 11, applicants argue that:
The claims of the present application are directed to 2R,4S-isomers that
achieve a level of activity that is five-times greater than the level of activity
demonstrated by an equal concentration of the racemic mixture. The Examiner
has not disputed that the showings of activity differences provided by Appellants
are representative of the claimed genus of 2R,4S-isomers, but has maintained
that the showings are either insufficient or immaterial and irrelevant. Appellants
could not disagree more and respectfully submit that the claimed compounds of
this invention are patentable over the prior art disclosure of Sohda specifically
because of this significant difference in activity of the 2R,4S-isomers over the
racemic compounds.
As described at length in the Makino declaration, the bone formation activity of
applicants’ optically active 2R,4S-isomer is more than five times that of the racemic
mixture. Dr. Makino states that “this surprising result was unexpected and could not
have been predicted” and “I have not been able to understand the reason [for this result]
yet” (Makino declaration, page 15, lines 5 through 7).
The examiner does not argue that the showing in the Makino declaration fails to
compare the claimed invention (2R,4S-isomer) with the closest prior art (racemate
disclosed by Sohda). Nor does the examiner argue that the showing is not sufficiently
representative of the claimed subject matter, i.e., not commensurate in scope with the
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