Appeal No. 2004-1040 Page 11
Application No. 09/770,643
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 at issue in Brenner was
useful as a possible object of scientific inquiry, and the polypropylene claimed 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.
Brenner, 383 U.S. at 534-35, 148 USPQ at 695. This standard has been found to be
met by pharmaceutical compositions shown to be useful in mouse models and in
humans for treating acute myeloblastic leukemia (Jolles, 628 F.2d at 1327-28, 206
USPQ at 891); by evidence showing successful in vitro testing supplemented by similar
in vitro and in vivo activities of structurally similar compounds (Cross, 753 F.2d at 1051,
224 USPQ at 748); and by evidence showing in vivo antitumor activity in mice,
combined with a disclosure that the claimed compounds had higher antitumor activity
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