Appeal No. 95-2993
Application 08/019,387
A patent “specification need not disclose what is well known in the art” in order to
satisfy the enablement requirement of 35 U.S.C § 112. Genentech Inc. v. Novo Nordisk
A/S, 108 F.3d 1361, 1366, 42 USPQ2d 1001, 1005 (Fed. Cir. 1997); Hybritech Inc. v.
Monoclonal Antibodies, Inc., 802 F.2d 1367, 1385, 231 USPQ 81, 94 (Fed. Cir. 1986).
To that end, we direct attention to the disclosure in the specification that the claimed
invention is directed to “a group of pharmaceutically acceptable salts of 8,9
dehydroestrone sulfate ester.” Specification, p.1, lines 32-
p. 2, line 6. The specification further discloses that
8,9-Dehydroestrone is a known compound useful as an intermediate in the
synthetic production of estrone by isomerization to 9,11 unsaturation (U.S.
3,394,153) and as an intermediate in the production of 3-cyclopentyloxy-17-ethynyl
derivatives (Example XXVIII, U.S. 3,649,621). In addition, 8,9-dehydroestrone is
known to possess estrogenic activity and to lower blood lipid levels (Examples 11
and 12; US 3,391,169) [Specification, p. 1, lines 23-28].
In addition, we note that the patented parent (U.S. 5,210,081) of the present
application discloses that another member of the group of salts of 8, 9 dehydroestrone
sulfate esters, an alkali metal salt of 8,9 dehydroestrone-3-sulfate ester, possesses
2
estrogenic activity and is useful for the treatment of atherosclerosis. U.S. 5,210,081, col.
4, line 65- col. 5, line 1. Thus, we find that the record establishes that the use of estrogenic
compounds to lower blood lipid levels and to treat atherosclerosis was well
2We point out that the experiments disclosed in the parent application to support
the usefulness of the compounds claimed therein are remarkably similar to the
experiments disclosed in the present application. U.S. 5,210,081, Example 7.
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