Appeal No. 2004-0903 Page 4
Application No. 09/008,957
submitting evidence that shows that 1α(OH)D5 possesses key properties
(antiproliferative activity and significantly lower calcemic activity compared to the
closest prior art compounds) that would have been unexpected to a person of
ordinary skill in the art at the time of the invention in view of the prior art.” Id.
Appellants have submitted several declarations, including the declaration
of Dr. Robert Moriarty (Moriarity declaration), see Paper No. 13, which was
supported by the statistical analysis of Dr. Samad Hedeyat provided in
declaration form (Hedeyat declaration), see Paper No. 21, in support of their
assertion of unexpected results. See Appeal Brief, page 8. Appellants assert
that:
The data in the Moriarity declaration . . . shows that,
between 1α(OH)D5 and 1α(OH)D4, two synthetic compounds,
1α(OH)D5 is significantly less calcemic than 1α(OH)D4. This is an
important improvement in properties, because, unlike the other
known vitamin D analogues, the desirable antiproliferative activity of
1α(OH)D5 is not offset by undesirably high calcemic activity. No
one, including Bishop, anticipated that 1α(OH)D5 would have such
a favorable combination of properties.
Id.
The examiner argues in response:
that the data presented . . . is not unexpected because Bishop
teaches that the compounds have a lower tendency or inability to
cause the undesired side effects of hypercalcemia and/or
hypercalcuria and thus, allows said compounds to be administered
as antiproliferative agents etc. without significantly altering calcium
metabolism. Therefore, the ordinary artisan would have the
reasonable expectation that any of the compounds of the genus
taught by the prior art would have these properties. The ordinary
artisan would also have the reasonable expectation that the
favorable properties (i.e. lower adverse hypercalcemic and/or
specifically address each piece of evidence by name.
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