Appeal No. 2004-0276
Application No. 09/787,438
The examiner summarizes (Answer, page 4):
it would have been prima facie obvious for one of ordinary skill in the art to
modify the controlled release composition of Noda using the organic acid
salts in view of the teaching of Savastano to obtain similar invention since
the references teach the advantageous results in the use of organic acids
as part of the core.
The appellants argue “[of] all the exemplified additives in Noda et al. none is a
salt of an organic acid. The examiner refers to organic acids, which are disclosed in
Noda et al as examples of solubilizers ... but organic acids are not the same as salts
thereof. Thus, Noda et al alone do not render any of the present claims unpatentable.”
Brief, page 5.
We agree with appellants that the examiner has failed to provide sufficient
evidence to support a prima facie case of obviousness. We do not find Noda describes
the required pharmaceutical formulation containing a salt of an organic acid, as claimed.
Nor do we find that Savastano makes up the deficiencies of Noda et al.
In one respect we find Savastano to be a better reference than Noda at first blush.
Savastano describes a core containing an active agent which can also include salts of
organic acids. See column 7, lines 10-47. The core of Savastano is surrounded by a
core delay jacket which also may include salts of organic acids. Column 8, lines 36-65.
The delay jacket can be about 10 to 100% of the core weight. Column 9, lines 33-45.
This is consistent with appellants’ invention in which the “organic acid can be applied on
the core” (Specification, page 5) and can represent 10 to 50% of the core weight. Id. In
addition, Savastano indicates that the outer membrane or coating of its formulation may
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