Appeal No. 2001-1437
Application No. 08/764,145
formula, undue and exhaustive experimentation would be required. Most
importantly, the data used for each point were NORMALIZED and are in
disagreement by about one order of magnitude (0.2 vs. 0.005). Thus, the
two points from the curves, in the presence of DNQX, and upon which the
Examiner relies as being at or near to the maximum of the control curve
(without DNQX) ARE NOT TRUE MAXIMA because of the nature of their
random selection of points together with the presentation of only data that
had been normalized. These facts clearly demonstrate that the
investigators DID NOT, NOR COULD NOT derive the claimed
formulations that would provide the unique attributes of this invention.
[Emphasis in original.]
Responding to the appellant, the examiner maintains the argument that
optimization of a result (desensitization) effective variable (concentration of the
antagonist) is routine in the absence of unexpected results. Answer, page 9. While we
agree with the examiner that “discovery of an optimum value of a result effective
variable in a known process is ordinarily within the skill of the art,” In re Boesch, 617
F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (citations omitted), our reviewing
court has found an exception to this general rule where “the parameter optimized was
not recognized to be a result effective variable,” In re Antonie, 559 F.2d 618, 621, 195
USPQ 6, 8 (CCPA 1977).
In our view, the examiner has not established that one of ordinary skill in the art
would have been able to determine an optimum dosage of agonist and antagonist to
prevent desensitzation altogether, from the general principle of the dose (concentration)
dependence of desensitization. There is no compelling evidence of record that the
relevant effect was achieved by the prior art. The examiner has not established that
the reference describes a formulation having the specifically claimed amounts of
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