Appeal No. 2005-1422 Page 16
Application No. 09/997,522
Our appellate reviewing court revisited the issue of describing DNA. See
Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964, 63 USPQ2d 1609,
1613 (Fed. Cir. 2002). The Enzo court held that a claimed DNA could be
described without, necessarily, disclosing 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.’” See id. at 1324, 63 USPQ2d at 1613 (emphasis omitted,
ellipsis and bracketed material in original).
Our appellate review court has also noted that “Eli Lilly did not hold that all
functional descriptions of genetic material necessarily fail as a matter of law to
meet the written description requirement; rather, the requirement may be
satisfied if in the knowledge of the art the disclosed function is sufficiently
correlated to a particular, known structure.” Amgen, Inc. v. Hoechst Marion
Roussel, Inc., 314 F.3d 1313, 1332, 65 USPQ2d 1385, 1398 (Fed. Cir. 2003).
As discussed above, there is no requirement in claim 12, or evidence on
this record, that the claimed polynucleotide variant exhibit a particular “common
structural feature” or function. On reflection, it is our opinion that appellants have
failed to adequately describe the genus of polynucleotides encompassed by
claim 12. Accordingly, we affirm the rejection of claim 12 under the written
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