Appeal 2007-0313
Application 10/414,447
5. ANTICIPATION
Claims 1-12, 30-32, 36-39, and 48 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Bühlmayer. The Examiner reasons that
Bühlmayer discloses valsartan in crystalline form and therefore anticipates
the instant claims (Answer 10). See also id. at 8:
Buhlmayer et al. . . . does not provide applicants’ instant X-ray
diffraction data. However, Buhlmayer et al. do name a
crystalline form of valsartan . . . , which puts this product in the
public domain. As these forms differ from the claims in that
the references are [sic] silent on the X-ray diffraction data,
applicants must show that their crystalline forms really are
different.
Appellants argue that the process described in Bühlmayer for making
valsartan is different from the processes described in the instant
Specification for making Form I and Form II valsartan, and the melting point
range disclosed by Bühlmayer is different from the melting point ranges of
Form I and Form II valsartan disclosed in the instant Specification (Br. 7).
Appellants conclude that Bühlmayer “did not provide any X-ray diffraction
or differential scanning calorimetry information, and there is no reason to
expect that their crystalline form, prepared by a different process and having
a different melting point, would have these properties corresponding to the
presently claimed forms of the compound” (id.)
We agree with Appellants that the evidence relied on by the Examiner
is inadequate to justify shifting the burden of proof to Appellants. When the
inherent properties of a prior art product are at issue, “the examiner must
provide some evidence or scientific reasoning to establish the reasonableness
of the examiner’s belief that the functional limitation is an inherent
characteristic of the prior art” before the burden is shifted to the applicant to
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