Appeal No. 2003-1019 Page 8
Application No. 09/524,132
claimed invention, would select the elements from the cited prior art references for
combination in the manner claimed.’” Ecolochem, Inc. v. Southern Calif. Edison Co.,
227 F.3d 1361, 1375, 56 USPQ2d 1065, 1075 (Fed. Cir. 2000).
In this case, we cannot agree that the cited references, viewed without the
benefit of the instant specification, would have suggested the specific combinations of
compounds required by the claimed compositions, especially in light of the position
taken by the Center for Drug Evaluation and Research: “The Center’s conclusion is that
because the reference listed drug Premarin is not adequately characterized at this time,
the active ingredients of Premarin cannot now be definitively identified” (see the FDA
Memorandum, page 1).
With respect to claims 30-46, the examiner concludes that “[t]he prior art
[presumably Townsend] also makes obvious the use of a mobile phase consisting of
acetonitrile, methanol and water and tetrabutylammonium hydroxide and adjusting the
pH of the mobile phase to 3.0 in the HPLC analysis of conjugated estrogens” (Answer,
page 6). Nevertheless, according to appellants, claim 30 requires “a mobile phase
comprising an organic portion comprising between about 0.1% and about 30% (by
volume organic portion) protic solvent [e.g., methanol] and between about 70% and
about 100% (by volume organic portion) polar aprotic solvent [e.g., acetonitrile],” but
Townsend uses only “a mobile phase having an organic portion including 46.6%
methanol and 53.3% acetonitrile.” Appellants point out that Townsend states that
“[b]aseline separation was obtained for all compounds,” and argue that the examiner
“offers no particular evidence as to why one . . . would be motivated to modify a method
that achieved baseline separation of all compounds” (Brief, page 24).
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