Appeal No. 2005-1169 Page 6
Application No. 09/900,063
In claims to genetic material, however, 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. 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.
Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
In Enzo-Biochem, the court refined the approach advanced by Eli Lilly,
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. Thus, 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, 323
F.3d at 967, 63 USPQ2d at 1615.
Claim 1 is drawn to a method of screening for animals that are more likely
to produce large litters comprising the step of “assaying for the presence of a
genotype in the prolactin receptor gene as set forth in SEQ ID NO:3 or a region
thereof in said sample, wherein said genotype is comprised of a polymorphism in
the prolactin receptor gene associated with increased litter size.” Similarly, claim
36 is drawn to a method of screening for pigs that are more likely to produce a
large litter, comprising the steps of “determining the alleles of prolactin receptor
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