Appeal No. 2006-1304 Page 10
Application No. 10/214,058
paradox” of reduction of clinical progression without reduction of clinical events may be
influenced by the “remarkable low incidence of events” in the study population, and
expresses an expectation that a beneficial effect on clinical events would be observed
with longer follow-up. See page 429, left-hand column.
Appellant also argues that those skilled in the art would recognize that Jukema’s
retrospective analysis precluded drawing any definitive conclusions. See the Appeal
Brief, pages 11-13. Appellant argues that the tentative nature of Jukema’s conclusions
would support at best an “obvious to try” rationale, not prima facie obviousness under
35 U.S.C. § 103. Id., pages 14-15.
We have considered the full disclosure of Jukema, as it would have been viewed
by a person of ordinary skill in the art at the time the present application was filed. In
our view, the reference would have led those skilled in the art to make the claimed
combination with a reasonable expectation of success, for the reasons discussed in
detail above. “Obviousness does not require absolute predictability of success. . . . For
obviousness under § 103, all that is required is a reasonable expectation of success.”
In re O’Farrell, 853 F.2d 894, 903-04, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988). Jukema
provides the required reasonable expectation of success.
Appellant also argues that Jukema would not have suggested the claimed
composition because “there is no mention or suggestion of atorvastatin at all,” and “only
a small percentage of [the CCBs] (6.5%) was amlodipine.” Thus, the argument goes,
“there is nothing in Jukema that would have motivated one to select a specific CCB
(amlodipine – used in only 6.5% of the patients) and a specific statin (atorvastatin – not
mentioned or suggested at all).” Appeal Brief, page 13.
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