Appeal No. 95-3056
Application 07/833,718
The examiner argues (Supp. Ans., p. 2, l. 27, to p. 3,
l. 9):
. . . [P]harmaceuticals are routinely tested for activity
as a function of storage conditions to determine how they
must be processed in preparation for storage (shelf-life
determination). Instability in the presence of retained
solvent, i.e. herein water of hydration, is not unheard
of and as noted in Weygand, readily soluble in several
different ways without undue expense. Therefore, the
instant “purified” product is deemed to have been well
within the perview [sic] of the ordinary practitioner
seeking to optimize storage conditions for
2-octynyladenosine.
We certainly agree that it would have been well within
the ordinary skill of the artisan to optimize a result
effective variable. In re Boesch, 617 F.2d 272, 276, 205 USPQ
215, 219 (CCPA 1980). Moreover, we see no clear error in the
examiner’s finding that purity is considered a result
effective variable for most drugs. However, we do not see
that persons skilled in the art would have necessarily
considered water of hydration to be
an impurity. To the contrary, persons having ordinary skill
in the art reasonably would have been justified in presuming
that Miyasaka and Matsuda had purified their 2-octynyl
adenosine sufficiently for effective use as an
antihypertensive agent and optimum pharmaceutical activity.
Furthermore, the evidence presented in Morozumi’s Declaration
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