Appeal No. 2005-1452 Page 4
Application No. 09/915,549
during storage. This is achieved by the novel production technology discovered and
disclosed in the present application . . . [] Furthermore, at supersaturation levels, the
claimed invention is able to provide a dose containing far less carrier than the prior art
compositions. Thus, any undesirable effects due to the carrier are substantially
reduced in the present invention.” (Brief, pp. 22-23).
These arguments are not persuasive because the subject matter of claim 1 is
not limited to the scope of these arguments. The subject matter of claim 1 is directed
to a dispersion and not a method of production. Claim 1 also does not specify the
storage characteristics of the dispersion and does not set amounts for the carrier
component.
Appellant argues “the claimed composition provides supersaturated
concentrations of drug, such that the drug crystals do not precipitate out of solution
over time. The Examiner does not provide any evidence or convincing argument that
one of ordinary skill in the art would now ignore the teachings of Davis and go above
the saturation limits of the drug and provide a stable supersaturated drug . . . []
Applicant submits that it is not routine experimentation to ignore teachings of the prior
art and use concentrations outside of the disclosed ranges as alleged by the
Examiner, especially not supersaturation concentrations that are well-known to be
unstable.” (Brief, pp. 23-24).
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