Appeal 2007-0313
Application 10/414,447
disprove the inherency. Ex parte Skinner, 2 USPQ2d 1788, 1789 (BPAI
1986). See also In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (“[W]hen
the PTO shows sound basis for believing that the products of the applicant
and the prior art are the same, the applicant has the burden of showing that
they are not.” (emphasis added)).
Here, it is true that Bühlmayer discloses valsartan “in crystalline
form” (Bühlmayer, col. 49, ll. 35-51). The instant claims, however, are
limited to only Form I and Form II crystalline valsartan.
The instant Specification states that Form I and Form II crystalline
valsartan are made by dissolving valsartan in a ketone solvent and
precipitating with an aliphatic hydrocarbon. Bühlmayer obtains valsartan by
extraction from aqueous solution with ethyl acetate and crystallization in
ethyl acetate (an ester, not a ketone or hydrocarbon).
The instant Specification also discloses that Form I valsartan has a
melting point range of 80-91°C, while Form II valsartan has a melting point
range of 91-102°C (Specification at ¶¶ 30, 44). Bühlmayer discloses that its
crystalline valsartan has a melting point range of “105°C – 1150°C [sic,
presumably 105°C – 115°C]” (Bühlmayer, col. 49, ll. 50-51).
Thus, the evidence of record shows that the prior art product was
made by a different method and has different physical properties than the
claimed Form I and Form II crystalline valsartan. The evidence does not
support the Examiner’s conclusion that it is reasonable to expect the prior art
product to contain either of the claimed crystalline forms of valsartan. We
therefore reverse the rejection under 35 U.S.C. § 102(b).
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