Appeal No. 2005-0258 Page 8
Application No. 09/768,877
According to the examiner (Answer, page 8, emphasis removed),
[o]nly one human and one mouse gene have been disclosed as
encoding calpain 10 polypeptides and only two completely
functional calpain 10 polypeptides have been disclosed. The
specification fails to provide the structures of all the calpain 10
polypeptides … [encompassed by] the claimed method, or the
structural elements which are common to all calpain 10 proteins
from any organism. In addition, the specification fails to disclose …
the critical structural elements in the human and mouse calpain 10
polypeptides disclosed which are required in any polypeptide to
display calpain 10 activity.
As we understand it, the method of claim 51 is open to the use of a
calpain 10 polypeptide of any structure from any source. Therefore, the method
of claim 51 reads generically on the use of any calpain 10 polypeptide from any
source. Thus, the specification must adequately describe the genus of calpain
10 polypeptides encompassed by the method of claim 51. As a matter of logic, a
method of using a product cannot be adequately described without describing the
product. For the following reasons, we agree with the examiner that the
specification does not adequately describe this genus of calpain 10 polypeptides.
“A written description of an invention involving a chemical genus, like a
description of a chemical species, ‘requires a precise definition, such as by
structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to
distinguish it from other materials.” University of California v. Eli Lilly and Co.,
119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997), provides the appropriate
analysis. The claims in Lilly were directed generically to vertebrate or
mammalian insulin cDNAs. See id. at 1567, 43 USPQ2d at 1405. The court held
that a structural description of a rat cDNA was not an adequate description of
these broader classes of cDNAs, because a “written description of an invention
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