Appeal No. 2002-2030 Page 5
Application No. 09/294,663
members of the genus, which features constitute a substantial
portion of the genus.
Id.
The Federal Circuit recently revisited this issue. See Enzo Biochem, Inc.
v. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002). The Enzo
court clarified that a description of DNA need not, necessarily, disclose its
structure. The court adopted the standard that
the written description requirement can be met by “show[ing] that
an invention is complete by disclosure of sufficiently detailed,
relevant identifying characteristics . . . i.e., complete or partial
structure, other physical and/or chemical properties, functional
characteristics when coupled with a known or disclosed correlation
between function and structure, or some combination of such
characteristics.”
Id. at 1324, 63 USPQ2d at 1613 (emphasis omitted, ellipsis and bracketed
material in original).
This standard, of course, applies to describing a single compound. The
Enzo court did not decide whether broader genus claims could be described by
three deposited DNA sequences; that issue was left for the district court on
remand. See id.
Thus, the instant specification can provide an adequate description of
claim 1’s genus of IIM genes, per Lilly, by describing “structural features common
to the members of the genus, which features constitute a substantial portion of
the genus.” Alternatively, the specification can describe the genus by describing
a “representative number” of IIM genes, where the representative species are
described according to the standard of either Lilly or Enzo.
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