Appeal No. 2004-1346 Page 12
Application No. 08/971,338
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 than a related compound
known to have antitumor activity (Brana, 51 F.3d at 1567, 34 USPQ2d at 1442).
By contrast, Brenner’s standard has been interpreted to mean that
“vague, general disclosures or arguments of ‘useful in research’ or ‘useful as
building blocks of value to the researcher’” would not satisfy § 101. See Kirk,
376 F.2d at 945, 153 USPQ at 55 (interpreting Brenner). Likewise, a disclosure
of a “plastic-like” polypropylene capable of being pressed into a flexible film was
held to show that the applicant was “at best . . . on the way to discovering a
practical utility for polypropylene at the time of the filing,” but not yet there.
Ziegler, 992 F.2d at 1203, 26 USPQ2d at 1605.
On this record, the examiner finds (Answer, page 5),
[t]he protein products lack patentable utility for the reasons set forth
below. Without knowing how to use the end product, the process
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