Appeal No. 1997-2336
Application No. 08/256,065
the examiner's determination that a prima facie case of unpatentability has been
established sufficient to support the rejections of claims 27-35 under 35 U.S.C. § 112, first
paragraph. Having met her initial burden, the burden shifts to the appellants to rebut the
basis for the rejection.
Appellants, initially, argue that the amount of direction or guidance present in the
application is adequate for those skilled in this art to practice the invention and cites the
article by Thun I, published in 1991, as evidence that aspirin has been shown to reduce the
risk of colon cancer and reduce mortality caused by colonic cancer. (Principal Brief,
paragraph bridging pages 7-8). However, as appellants acknowledge, the article is
limited to the discussion of colon cancer and "fails to provide further information as to the
manner and form of administration and dosage." (Principal Brief, page 8). Also, as
pointed out by the examiner (Answer, page 4):
In the article by Thun, it is clearly stated as a conclusion that
"regular aspirin use at low dosages may (emphasis added)
reduce the risk of fatal colon cancer. Whether this is due to a
direct effect of aspirin . . . or to other factors is unclear." The
results of this one study, are therefore, inconclusive as to the
efficacy of aspirin in reducing the risk of fatal colon cancer,
(sic, .) Moreover, however, even if aspirin was shown to be
indisputably effective in reducing the risk of fatal colon cancer,
that finding would not be predictive of aspirin preventing any
and all cancers in general. Finally, "reducing the risk" is not
equivalent to "prevention of".
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