Appeal No. 2004-2356 Page 5
Application No. 09/833,740
Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613 (citing Guidelines for
Examination of Patent Applications Under the 35 U.S.C. § 112, ¶ 1 “Written
Description” Requirement, 66 Fed. Reg. 1099, 1106 (January 5, 2001)).
The court also addressed the issue of what constitutes an adequate
written description of a claim to a broad genus of sequences. In The Regents of
The University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398
(Fed. Cir. 1997), the court determined that the disclosure of rat cDNA did not
provide adequate written description support for claims drawn to mammalian and
vertebrate DNA. Eli Lilly, 119 F.3d at 1567-68, 43 USPQ2d at 1405. The court
stated:
In claims to genetic material, however, a generic statement such as
“vertebrate insulin cDNA” or “mammalian insulin cDNA,” without
more, is not an adequate written description of the genus because
it does not distinguish the claimed genus from others, except by
function. It does not specifically define any of the genes that fall
within its definition. It does not define any structural features
commonly possessed by members of the genus that distinguish
them from others. One skilled in the art therefore cannot, as one
can do with a fully described genus, visualize or recognize the
identity of the members of the genus. A definition by function, as
we have previously indicated, does not suffice to define the genus
because it is only an indication of what the gene does, rather than
what it is.
Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
In Enzo-Biochem, the court refined the approach advanced by Eli Lilly,
adopting an example offered in the USPTO guidelines having facts that
contrasted with those of Eli Lilly, wherein the written description requirement
would be met. Thus, an adequate written description may be present for a genus
of nucleic acids based on their hybridization properties, “if they hybridize under
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