Appeal No. 2003-1019 Page 6
Application No. 09/524,132
1030, 1032 (Fed. Cir. 1997). According to the examiner, the subject matter of claims 1-
5, 8-22 and 25-29 is anticipated by the FDA Memorandum, and by the PDR, each of
which describes Premarin® and its usefulness in treating various consequences of
menopause.
While we agree with the examiner that “the term ‘comprising’ is inclusive and
does not exclude additional unrecited elements” (Answer, page 6), we cannot agree that
the term is open to elements which eviscerate the express requirement that the claimed
“composition of matter is present in chemically pure form,” i.e., the requirement that the
composition must be “substantially devoid of impurities present in naturally derived
equine conjugated estrogens products.” Inasmuch as Premarin® contains various
impurities found in naturally derived equine conjugated estrogen products (e.g., indican,
sulfated benzyl alcohol, hippuric acid, benzoic acid, and creatinine), neither the FDA
Memorandum, nor the PDR can be said to describe the claimed compositions or
methods.
Claims 1-5, 8-22 and 25-29 also stand rejected under 35 U.S.C. § 102 (b) as
anticipated by Townsend, which describes high-performance liquid chromatographic
(HPLC) analysis of “crushed conjugated estrogens tablets” (page 415). It is unclear
whether the conjugated estrogen tablets contained only synthetic sodium estrone
sulfate, sodium equilin sulfate, and sodium equilenin sulfate, or whether the tablets
contained naturally derived equine conjugated estrogens (see page 414 and Tables I
and II). In either case, however, it does not appear that Townsend describes a
composition that meets all of the limitations of the claims, that is, a composition that
contains the 10 essential estrogenic compounds present in naturally derived equine
conjugated estrogens in chemically pure form.
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