Appeal 2007-0313
Application 10/414,447
further purify Bühlmayer’s valsartan by recrystallization. That would not
necessarily lead to the claimed crystalline forms, however. The instant
Specification states that Form I and Form II valsartan are obtained by
dissolving valsartan in a ketone solvent and adding an aliphatic hydrocarbon
solvent to precipitate it.
The only ketone solvent disclosed by Cheronis is acetone, which is
said to be “[o]f limited use as a single solvent; more useful as a pair with
alcohols” (Cheronis 33, Table 5-1). Cheronis states that hydrocarbons,
including hexane, are “[u]seful for many compounds. May be employed
with benzene and toluene to form solvent pairs” (id.). Cheronis does not
disclose that a ketone/hydrocarbon solvent pair was commonly used for
recrystallization. Thus, we cannot agree with the Examiner that Cheronis
would have led those skilled in the art to the recrystallization conditions that
are disclosed in the Specification to be necessary for formation of Form I
and Form II crystalline valsartan.
The Examiner has not adequately shown that the cited references
would have led those skilled in the art to the conditions needed to make the
claimed crystalline forms of valsartan. The rejection under 35 U.S.C. § 103
is reversed.
SUMMARY
We reverse the rejections under 35 U.S.C. § 112, first and second
paragraphs, because the Examiner has not established that the claims are not
enabled throughout their scope or that they are indefinite. We reverse the
rejections under 35 U.S.C. §§ 102(b) and 103 because the Examiner has not
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