Appeal No. 2004-0276
Application No. 09/787,438
determinations which follow.
35 U.S.C. § 103
Claims 2-15 and 20 stand rejected under 35 U.S.C. 103(a) for obviousness over
Noda. Claims 16-19 stand rejected under 35 U.S.C. 103(a) for obviousness over Noda
in view of Savastano.
In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden
of presenting a prima facie case of obviousness. See In re Rijckaert, 9 F.3d 1531,
1532, 28 USPQ2d 1955, 1956 (Fed. Cir. 1993). It is well-established that the
conclusion that the claimed subject matter is prima facie obvious must be supported by
evidence, as shown by some objective teaching in the prior art or by knowledge
generally available to one of ordinary skill in the art that would have led that individual to
combine the relevant teachings of the references to arrive at the claimed invention. See
In re Fine, 837 F.2d 1071, 1074, 5 USPQ2d 1596, 1598 (Fed. Cir. 1988).
It is the examiner’s position that (Answer, page 3):
Noda teaches [a] controlled release composition comprising [an]
active core and polymer coating layer. ... The core containing theophylline
as active agent, excipient, binder, lubricant, and solubilizer, e.g. organic
acids (column 3). ... Noda does not expressly teach the claimed amounts
of organic acid, and of polymer in the coating layer. However, [the]
differences in concentration will not support the patentability of subject
matter encompassed by the prior art unless there is evidence indicating
such concentration is critical.
Savastano is relied on by the examiner for the disclosure of a “controlled release
formulation comprising active core, and delayed jacket coated over core...” The core
may include inorganic and organic acids, or acid salts. Answer, page 4.
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