Appeal 2007-0313
Application 10/414,447
DISCUSSION
1. CLAIMS
Claims 1-12, 30-32, 36-39, and 48 are on appeal. Claims 13-29, 33,
and 40-47 are also pending but have been withdrawn from consideration by
the Examiner.
Claims 1 and 7 are representative and read as follows:
1. A crystalline Form-I of (S)-N-(1-carboxy-2-methyl-prop-1-yl)-N-
pentanoyl-N-[2’-(1H-tetrazol-5-yl)-biphenyl-4-yl methyl] amine.
7. A crystalline Form-II of (S)-N-(1-carboxy-2-methyl-prop-1-yl)-N-
pentanoyl-N-[2’-(1H-tetrazol-5-yl)-biphenyl-4-yl methyl] amine.
Claims 1 and 7 are respectively directed to Form I and Form II
crystalline Valsartan (cf. Specification, ¶ 2).
2. PRIOR ART
The Examiner relies on the following reference:
Bühlmayer US 5,399,578 Mar. 21, 1995
3. ENABLEMENT
Claims 1-12, 30-32, 36-39, and 48 stand rejected under 35 U.S.C.
§ 112, first paragraph, on the basis that “the specification, while being
enabling for a crystalline Form-I of valsartan having an x-ray pow[d]er
diffraction peak at 2 e value of 5.415, does not reasonably provide
enablement for a crystalline Form-I of valsartan having an x-ray pow[d]er
diffraction peak at 2 e value of 40” (Answer 4.)
Appellants argue that the
invention relates to only two specific crystalline forms of the
single previously known compound, valsartan. These specific
crystalline forms have well-defined X-ray diffraction patterns
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