Appeal No. 2004-0670 Page 4
Application No. 09/276,741
[t]he recitation of the amount of estramustine phosphate does not
lend patentability to said method of administration of estramustine
phosphate. The determination of the amount of estramustine
phosphate given to a patient is dependent on a number of factors
such as the age, sex and weight of the patient as well as the
severity and type of illness. Said determination as well as the
determination of the dose of estramustine phosphate that would
provide maximum effect with minimum adverse effects in a patient
are within the level of skill of the ordinary artisan in the medical art
and is done routinely in the medical art.
The examiner, however, has not addressed appellants’ assertions that the
prior art of record fails to teach a dose of estramustine phosphate in excess of
1300 mg as is required by the claimed invention. To the extent that the examiner
would assert that it is within the skill of the art to simply increase the dose of
estramustine phosphate above that taught in the prior art, we note that Bishop
teach (column 15, lines 12-20):
[A]s a significantly increased growth inhibitory effect is obtained
with the above disclosed combinations utilizing lower
concentrations of the anticancer drugs compared to the treatment
regimes in which the drugs are used alone, there is the potential to
provide therapy wherein adverse side effects associated with the
anticancer drugs are considerably reduced than normally observed
with the anticancer drugs used alone in larger doses.
Accordingly, Bishop teach the use of estramustine phosphate in combination with
another drug, and at a dosage range below the amount set forth in the claimed
invention.
As set forth in In re Dow Chemical Co. 837 F.2d 469, 473, 5 USPQ2d
1529, 1531 (Fed. Cir. 1988), “[t]he consistent criterion for determination of
obviousness is whether the prior art would have suggested to one of ordinary
skill in the art that this process should be carried out and would have a
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