Appeal No. 2003-1817 Page 4
Application No. 09/501,714
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 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.
Id. at 1568, 43 USPQ2d at 1406. The court concluded that “naming a type of material
generally known to exist, in the absence of knowledge as to what that material consists
of, is not a description of that material.” Id.
Finally, the court addressed the manner by which a genus of cDNAs might be
described. “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 structural features common to the
members of the genus, which features constitute a substantial portion of the genus.” Id.
Claim 45 b) defines a genus of polynucleotides by way of two significant
qualifiers. First, the polynucleotide of claim 45 b) must be “naturally occurring.”
Second, the polynucleotide of claim 45 b) must be “at least 90% identical to the
polynucleotide sequence of SEQ ID NO:1 or SEQ ID NO:3.”1 As explained in Lilly, a
genus of polynucleotides can be described by a representative number of
polynucleotides sharing common structural features which constitute a substantial
portion of the genus. The examiner is correct in her analysis that claims 45 b) and
1 Claim 52 is similar to claim 45 but is directed to the polynucleotides of SEQ ID
NO:2 or SEQ ID NO:4.
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