Appeal No. 2006-1035 Page 11
Application No. 09/925,140
The critical question then, is this: assuming that the specification’s disclosure is
adequate to describe a genus of DNAs (i.e., those that encode sequences at least 90%
identical to SEQ ID NO:1), is that same disclosure adequate to describe a subset of
those DNAs (i.e., those encoding naturally occurring sequences), even without any
disclosure of which members of the large genus are included in the subgenus?
We conclude that describing a genus of chemical compounds is not necessarily
adequate to support a claim limited to only those compounds that have a desired
characteristic. Rather, the specification must provide guidance regarding which
compounds within the genus have the recited characteristic.
The U.S. Court of Appeals for the Federal Circuit, faced with circumstances
similar to those here, has held claims to lack adequate description. For example, in
University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir.
1997), the court held that claims generically reciting cDNA encoding vertebrate or
mammalian insulin were not adequately described by the disclosure of cDNA encoding
rat insulin. Id. at 1568, 43 USPQ2d at 1406. The court held that
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.
Id. The court described two ways of properly describing a claimed genus:
A description of a genus of cDNAs may be achieved by means of a
recitation of a representative number of cDNAs, defined by nucleotide
sequence, falling within the scope of the genus or of a recitation of
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