Appeal No. 2003-1019 Page 2
Application No. 09/524,132
compounds is a synthetic estrogenic compound, and wherein said mixture comprises
the same essential estrogenic compounds present in naturally derived equine
conjugated estrogens;
wherein said composition of matter is present in a chemically pure form.
15. A composition of matter comprising:
a mixture of estrogenic compounds, wherein said mixture comprises the same
essential estrogenic compounds present in naturally derived equine conjugated
estrogens;
wherein said composition of matter is present in a chemically pure form.
30. A method for analyzing conjugated estrogen constituents comprising the
steps of :
preparing a solution containing conjugated estrogens, said solution comprising:
a mixture comprising estrogenic compounds to be analyzed; and
a mobile phase comprising:
an organic portion comprising between about 0.1% and about 30%
(by volume organic portion) protic solvent and between about 70% and
about 100% (by volume organic portion) polar aprotic solvent; and
an aqueous portion;
and analyzing the conjugated estrogens solution utilizing a HPLC system.
The references relied on by the examiner are:
Townsend et al. (Townsend), “High-Performance Liquid Chromatographic Determination
of Conjugated Estrogens in Tablets,” Journal of Chromatography, Vol. 450, pp. 414-419
(1988)
Physicians’ Desk Reference (the PDR), 46th Edition, pp. 2504-25-18 (1992)
Memorandum from Janet Woodcock, M.D. (The FDA Memorandum), Director for Drug
Evaluation & Research, regarding Approvability of a Synthetic Generic Version of
Premarin (May 5, 1997)
The claims stand rejected as follows:
I. Claims 1-5, 8-22 and 25-29 under 35 U.S.C. § 102 (b) as anticipated by the
FDA Memorandum.
II. Claims 1-5, 8-22 and 25-29 under 35 U.S.C. § 102 (b) as anticipated by the
PDR.
III. Claims 1-5, 8-22 and 25-29 under 35 U.S.C. § 102 (b) as anticipated by
Townsend.
IV. Claims 1-5, 8-22 and 25-48 under 35 U.S.C. § 103 as unpatentable over
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