Appeal No. 2004-1040 Page 24
Application No. 09/770,643
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,
which requires that a patentable invention also be useful and fully enabled, nor is it the
standard that has been consistently applied by the courts.
In addition, the flood of DNA patents that would result from adoption of
Appellants’ rule could doom the potential contribution of microarrays to biological
research. Appellants argue that “[g]iven the widespread utility of such ‘gene chip’
methods using public domain gene sequence information, there can be little doubt that
the use of the presently described novel sequences would have great utility in such
DNA chip applications.” Appeal Brief, page 15. “[T]here is an entire industry
established based on the use of gene sequences or fragments thereof in a gene chip
format.” Id.
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