Appeal No. 2005-1535
Application No. 10/049,379
do not expressly teach the exact concentration for the oxaliplatinurn nor
does the reference teach other solvents for the solution.
Schlipalius teaches that active agents can be in solution with glycerol
and can be administered by injection or infusion (col. 7, claims 1-5; and
col. 3, line 15 - col. 14, line 36).
At the time the invention was made, it would have been obvious to a
person of ordinary skill in the art to use a suitable solvent to prepare
injection or infusion solution for administration that includes oxaliplatinum
and glycerol in differing concentrations.
While the reference does not teach the complete concentration range,
differences in concentration will not support the patentability of subject
matter encompassed by the prior art unless there is evidence indicating
such concentration is critical. Where the general conditions of a claim are
disclosed in the prior art, it is not inventive to discover the optimum or
workable ranges by routine experimentation. In re Aller, 220 F.2d 454,
105 USPQ 233, 235 (CCPA 1955). The Examiner does not see the
criticality in the particular concentrations for oxaliplatinum compound. The
prior art teaches the compound to have the same activity in a
concentration close of the claimed concentration. Any difference is a
matter of degree and not of kind.
Answer, page 4.
Upon review of the Examiner’s Answer, we do not find the evidence before us
supports a prima facie case of obviousness of the invention, as claimed. In particular,
as indicated in the background section above, Ibrahim describes oxaliplatinum in water
delivered by the parenteral route in a concentration of 1 to 5 mg/ml. Col. 2, lines 9-18.
Schlipalius describes a method and composition for the treatment of melanoma
including beta carotenoid and a water soluble dispersible component which may be
glycerol. Claims 1-4.
The examiner argues that “[w]hile the reference does not teach the complete
concentration range, differences in concentration will not support the patentability of
subject matter encompassed by the prior art unless there is evidence indicating such
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