Appeal No. 2005-0731 Page 22
Application No. 09/974,712
such that gene expression assays could conceivably be used in their research. For
example, some organisms are of interest to researchers because they have been
historically well-studied (e.g., yeast and Arabidopsis). Others are of interest because
they are used as animal models (e.g., mice and chimpanzees), because they are
commercially valuable (e.g., pigs and tomatoes), because they are pests (e.g., ragweed
and corn borers), or because they are pathogens (e.g., Candida and various bacteria).
Under Appellants’ proposed rule, hybridizable fragment of any gene of any of these
organisms—and probably most other organisms—would be found to have patentable
utility because it could be attached to a chip and used in “research” to see what
happens to expression of that gene under various conditions.
Appellants’ reasoning would also vitiate the enablement requirement, since “[t]he
enablement requirement is met if the description enables any mode of making and
using the invention.” Johns Hopkins Univ. v. CellPro Inc., 152 F.3d 1342, 1361, 47
USPQ2d 1705, 1714 (Fed. Cir. 1998) (quoting Engel Indus., Inc. v. Lockformer Co.,
946 F.2d 1528, 1533, 20 USPQ2d 1300, 1304 (Fed. Cir. 1991)). If we were to agree
with Appellants that any expressed gene and any hybridizable fragment thereof is useful
in a DNA chip, then we would also have to hold that the specification has taught those
skilled in the art one mode of using the invention. Thus, Appellants’ rule of per se utility
would also require a corresponding rule of per se enablement.
Under Appellants’ rule, then, any polynucleotide from an expressed gene would
be patentable if it was adequately described in the specification and was not disclosed
or suggested in the prior art. This standard, however, is not the one set by Congress,
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