Appeal No. 2004-2319 Page 4
Application No. 09/915,694
The Court of Appeals for the Federal Circuit, our reviewing court, has
addressed the issue of what constitutes adequate written description for a claim
drawn to a nucleic acid. In Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d
1316, 63 USPQ2d 1602 (Fed. Cir. 2002), the court adopted a portion of the
Guidelines proffered by the United States Patent and Trademark Office
(USPTO). The court stated that:
The written description requirement can be met by “showing 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 characteristics.
Enzo Biochem, 296 F.3d at 1324, 63 USPQ2d at 1613 (citations omitted).
In Enzo-Biochem, the court refined the approach advanced by The
Regents of The University of California v. Eli Lilly and Co., 119 F.3d 1559, 43
USPQ2d 1398 (Fed. Cir. 1998), 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. Adequate written description may be
present for a genus of nucleic acids based on their hybridization properties, “if
they hybridize under highly stringent conditions to known sequences because
such conditions dictate that all species within the genus will be structurally
similar.” Enzo Biochem, 296 F.3d at 1327, 63 USPQ2d at 1615.
In the case before us, the complete structure of the polynucleotide of SEQ
ID NO: 2 has been described, and the genus limited to a polynucleotide
comprising a naturally occurring polynucleotide sequence at least 95% identical
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