Appeal No. 2004-0761 Page 5
Application No. 09/794,531
the instant specification. In particular, the examiner has pointed to nothing in the
prior art that would have led those of skill in the art to administer first αAED and
then, subsequently, βAED.
The examiner pointed out that Loria teaches that the combination of αAED
and βAED was effective in vitro for inhibiting the growth of breast cancer cells
(Example 2). Loria also teaches, however, that the two epimers have different
activities when used separately. See page 7, lines 4-13: At concentration[s] of
nM or greater, the αAED significantly inhibited the growth of ZR-75-1 [breast
cancer] cells. . . . As opposed to αAED, the βAED alone at 100 nM
concentrations did not have any antiproliferative effect on the growth of the ZR-
75-1 cells.”
The examiner cannot rely on a conclusory statement that “optimization of
therapeutic effect parameters (e.g., dosing regimens) is obvious as being within
the skill of the artisan,” in order to make up for deficiencies in the prior art. It is
true that “discovery of an optimum value of a result effective variable in a known
process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276,
205 USPQ 215, 219 (CCPA 1980). That rule, however, applies only where the
variable being optimized is one that is known to affect the results of the particular
process; i.e., the knowledge that the variable is result-affecting provides the
motivation to optimize it. The examiner has pointed to no evidence of record
showing that those of skill in the art would have been motivated to add a
subsequent step of administering βAED in order to “optimize” the known process
of inhibiting tumor cell growth by administering αAED.
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