Appeal No. 2000-1717
Application 08/579,731
claims; nor that declarant failed to test a significant property in this art. Rather, the
examiner argues that:
applicant failed to show that a five -fold increase in activity is outside the norm or
unexpected. There is nothing in the law or facts presented in this case which
show what is the range of expected activity for an isomer over its racemate; this
needs to be established [Examiner’s Answer, page 5, lines 12 through 15].
We disagree.
As stated in the Appeal Brief, page 7, it would have been expected that the
biological response elicited by a given dosage of pure (2R,4S)-isomer would be equal to
twice that elicited by the same dosage of racemate. Put another way, it would have
been expected that when the racemate is administered at a dose two times that of the
(2R,4S)-isomer, its bone formation activity would be equal to that of the (2R,4S)-isomer
(Makino declaration, page 13, last full paragraph). This is the factual basis for the
expected “two-fold” increase in activity of the claimed optical isomer compared with the
closest prior art. The examiner’s position to the contrary, notwithstanding, this
expectation is adequately established by declaration evidence of record.
The uncontroverted facts of record show that a representative (2R,4S)-isomer
possesses bone formation activity more than five times that of the prior art racemate.
Test data reported in the Makino declaration show that the activity of the claimed
optically active compound is not two times that of the racemic mixture (which would
have been expected), but more than five times that of the racemic mixture. On the
strength of this rebuttal evidence establishing unexpectedly superior results, we reverse
the rejection of a ll the appealed claims under 35 U.S.C. § 103.
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