Appeal No. 2005-0731 Page 10
Application No. 09/974,712
an in vivo utility.” Id. On the facts of that case – successful in vitro testing
supplemented by similar in vitro and in vivo activities of structurally similar compounds –
the court held that in vitro activity was sufficient to meet the requirements of § 101. Id.
The Federal Circuit confirmed in In re Brana, 51 F.3d 1560, 34 USPQ2d 1436
(Fed. Cir. 1995), that human testing is not necessary to establish utility for a method of
treatment. The invention claimed in Brana was a group of compounds disclosed to
have antitumor activity. See id. at 1562, 34 USPQ2d at 1437-38. The claimed
compounds were disclosed to have higher antitumor activity than related compounds
known to have antitumor activity, and the applicants provided declaratory evidence of in
vivo activity against tumors in a mouse model. See id., 34 USPQ2d at 1438. The court
held that these data were sufficient to satisfy § 101; usefulness in patent law does not
require that the invention be ready to be administered to humans. See id. at 1567, 34
USPQ2d at 1442.
Several lessons can be drawn from Brenner and its progeny. First, § 101’s
requirement that an invention be “useful” is not to be given its broadest reach, such that
little or nothing of a chemical nature would be found to lack utility. See Brenner, 383
U.S. at 530, 148 USPQ at 694. Thus, not every “use” that can be asserted will be
sufficient to satisfy § 101. For example, the steroid compound in Brenner was useful as
an object of scientific inquiry, and the polypropylene in Ziegler was useful for pressing
into a flexible film, yet both lacked sufficient utility to satisfy § 101. See Brenner, 383
U.S. at 529, 148 USPQ at 696; Ziegler, 992 F.2d at 1203, 26 USPQ2d at 1605.
Rather than setting a de minimis standard, § 101 requires a utility that is
“substantial”, i.e., one that provides a specific benefit in currently available form.
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