Appeal No. 2004-2201 Page 3
Application No. 09/788,476
human hepatocellular carcinoma tissue or tissue from pancreatic adenocarcinoma
relative to other tissue in the subject and/or in subjects not diagnosed with this
condition.
Discussion
1. Written Description.
The Federal Circuit discussed the application of the written description
requirement to inventions in the field of biotechnology in University of California v. Eli
Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997), stating
that “[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.” Id. at 1567, 43 USPQ2d at 1405. The court also stated 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 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.
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