Appeal No. 2004-0903 Page 5
Application No. 09/008,957
hypercalcuria effects) as taught [by] [sic] Bishop would vary
between compounds of the prior art genus. Therefore, applicant’s
data is not unexpected because it shows what the ordinary artisan
would expect between prior art compounds.
Supplemental Examiner’s Answer, pages 6-7.
Appellants have presented data in the Moriarity declaration to
demonstrate that “1α(OH) Vitamin D5 is considerably less calcemic than its
closest known analogs: 1α(OH) Vitamin D3, 1α(OH) Vitamin D4, and 1α, 25(OH)2
Vitamin D3, all run side-by-side in the same laboratory.” Moriarity Declaration,
¶4.
The examiner, however, does not point to any deficiencies in the data; nor
does there appear to be a disagreement that 1α(OH) Vitamin D3, 1α(OH) Vitamin
D4, and 1α, 25(OH)2 Vitamin D3 are not the closest prior art compounds. Rather,
the examiner relies on the following statements in Bishop to refute appellants’
assertion of unexpected results. According to Bishop:
The 1α-hydroxyvitamin D compounds of formula (I) of the
present invention are those that have effective antiproliferative and
cell differentiation activity (i.e., reversal of malignant
transformation), particularly with respect to cells of prostatic
diseases, e.g., prostatic cancer and prostatic hyperplasia, but have
a lower tendency or inability to cause the undesired side effects of
hypercalcemia and/or hypercalcuria. In other words, the
compounds of formula (I) can be administered at dosages that
allow them to act as antiproliferative agents and cell differentiation
agents when exposed to malignant or other hyperproliferative cells
without significantly altering calcium metabolism. This selectivity
and specificity of action makes the 1α-hydroxyvitamin D
compounds of formula (I) useful and preferred agents for safely
inhibiting hyperproliferation and promoting malignant or hyperplastic
cell differentiation. The 1α-hydroxyvitamin D compounds of the
present invention, thus, overcome the shortcomings of the known
active vitamin D3 compounds described above, and can be
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