Appeal 2007-0313
Application 10/414,447
and thermal properties, which have been provided in the
specification. A process for preparing each crystalline form has
been described, and a working example was provided for
preparing each of the forms. . . . There is no lack of enablement,
and this rejection should be reversed.
(Br. 5.)
We agree with Appellants. The Examiner’s concern, as best we
understand it, seems to be that some of the claims do not expressly recite the
X-ray diffraction peaks that are characteristic of Form I crystalline valsartan.
Thus, according to the Examiner’s apparent theory, claim 1 encompasses a
“Form I valsartan” with a X-ray diffraction peak with a 2 θ value of, for
example, 40, rather than the peaks shown in Figure 1.
The problem with the theory apparently underlying the Examiner’s
rejection is that a form of crystalline valsartan with a X-ray diffraction peak
with a 2 θ value of 40 would not be Form I crystalline valsartan. Claims
must be interpreted in light of the Specification. See In re Morris, 127 F.3d
1048, 1054 (Fed. Cir. 1997). Here, the Specification states that the
“Crystalline Form-I of Valsartan has X-ray powder diffraction pattern
essentially as shown in [] Table-1” (Specification ¶ 26). Table 1 does not
show any X-ray diffraction peaks with a 2 θ value of 40. Thus, the
embodiment asserted by the Examiner to be nonenabled is not within the
scope of the claims. The rejection for nonenablement is reversed.
4. DEFINITENESS
Claims 3, 5, 9, and 11 stand rejected under 35 U.S.C. § 112, first
paragraph, as indefinite because they refer to Figures 1, 2, 3, and 4,
respectively: “Claims must stand alone to define invention, and
incorporation into claims by express reference to specification is not
4
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