Appeal No. 2003-1019 Page 7
Application No. 09/524,132
Accordingly, we find that the subject matter of claims 1-5, 8-22 and 25-29 is not
anticipated by the FDA Memorandum, the PDR, or by Townsend, and all three of the
rejections of the claims under 35 U.S.C. § 102 are reversed.
Obviousness
Claims 1-5, 8-22 and 25-48 stand rejected under as unpatentable over the
combined teachings of Townsend, the PDR and the FDA Memorandum. Claims 1-5
and 8-22 are discussed above; claims 47 and 48 are directed to compositions of matter
comprising salts of the same essential conjugated estrogenic compounds present in
naturally derived equine conjugated estrogens, wherein the compositions are
substantially devoid of one or all of the following impurities: indican, sulfated benzyl
alcohol, hippuric acid, benzoic acid and creatinine. Finally, claims 30-46 are directed to
methods of analyzing conjugated estrogen constituents by HPLC using a defined mobile
phase.
According to the examiner, “the claimed composition[s] comprising various
estrogenic compounds with or without additional compounds would be obvious to one
having ordinary skill in the art,” “[b]ased on the combined teachings of the above cited
prior art” (Answer, page 6).
“The PTO has the burden under section 103 to establish a prima facie case of
obviousness. It can satisfy this burden only by showing some objective teaching in the
prior art or that knowledge generally available to one of ordinary skill in the art would
lead that individual to combine the relevant teachings of the references.” In re Fine, 837
F.2d 1071, 1074, 5 USPQ2d 1596, 1598 (Fed. Cir. 1988) (citations omitted). An
adequate showing of motivation to combine requires “evidence that ‘a skilled artisan,
confronted with the same problems as the inventor and with no knowledge of the
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