Appeal No. 2004-1761 Page 11
Application No. 10/044,807
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.
In this case, the examiner noted that the specification teaches that the protein
encoded by the claimed polynucleotides shares sequence similarity to a variety of
known proteins, including matrix metalloproteases, zinc-dependent metalloproteases,
collagenases, receptor linked phosphatases, and membrane-associated cell adhesion
proteins. Examiner’s Answer, page 5. “However, the specification fails to identify any
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