Appeal No. 2003-1019 Page 5
Application No. 09/524,132
1235, 169 USPQ 236, 238 (CCPA 1971)(footnote omitted).
Each of claims 1-5 and 8-22 is directed to 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,” and
“wherein said composition of matter is present in chemically pure form” (see, e.g.,
claims 1, 11, 15 and 19). Claims 25-29 are directed to methods of treating mammals
using the composition of claim 1. According to the specification, “[a]s used herein,
‘chemically pure form’ means substantially devoid of impurities present in naturally
derived equine conjugated estrogens products” (specification, page 4). As discussed
above, indican, sulfated benzyl alcohol, hippuric acid, benzoic acid, and creatinine were
all identified as non-estrogenic impurities in Premarin®, a naturally derived equine
conjugated estrogen product.
Interpreting these claims in “light of the of . . . the particular application disclosure
as it would be interpreted by one possessing the ordinary level of skill in the pertinent
art,” it is clear that the claimed compositions must minimally contain conjugates (or salts
of conjugates, in the case of claims 1-10 and 19-22) of the ten “essential estrogenic
compounds” (estrone; equilin; )8,9-dehydroestrone; 17"-estradiol; 17"-dihydroequilin;
17$-dihydroequilin; 17$-estradiol; equilenin; 17"-dihydroequilenin; and 17$-
dihydroequilenin), and the claimed compositions must be “substantially devoid of
impurities present in naturally derived equine conjugated estrogens products,” i.e., they
must be “in chemically pure form,” as that term is defined in the specification.
Anticipation
“[E]very limitation of a claim must identically appear in a single prior art reference
for it to anticipate the claim.” Gechter v. Davidson, 116 F.3d 1454, 1457, 43 USPQ2d
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