Appeal No. 1997-2336
Application No. 08/256,065
We read Thun I to reflect caution on the part of the authors in describing the
potential use of aspirin in the prevention of cancer in stating (page 1323, column 1, first full
paragraph):
The risk of all fatal cancers combined was somewhat lower
among persons who used aspirin than in nonusers; this
difference was of borderline statistical significance except in
women in the highest category of use. No dose-response
trend was seen for all cancers.
Thun I, also, states (page 1324, column 1, first paragraph):
However, until the findings can be replicated, they should be
interpreted cautiously, given the observational nature of our
study and the important differences in the biology and
epidemiology of these cancers.
Thus, appellants' evidence appears to urge caution with respect to the potential
usefulness of aspirin in reducing the risk or prevention of cancer in a subject. In addition,
the article provides little guidance which would assist those skilled in this art in practicing
the presently claimed prevention of cancers in general and would not remove the need for
experimentation to obtain the claimed prevention of cancer.
Appellants point to page 6, lines 22-25 of the present specification as disclosing
that in the prophylaxis against cancer, a therapeutically effective amount of acetyl-salicylic
acid and/or acetylsalicylic acid salts in the blood corresponds to blood level values of
acetylsalicylic acid of between 0.1 and 1.0 µg/ml. (Principal Brief, page 11). The
examiner acknowledges this disclosure, but urges that there are no working examples
indicating prevention of any kind of cancer by transdermally delivering a sufficient quantity
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