Appeal 2007-0913
Application 09/888,126
composition, such as the insulin and the DPPC, and that such an interaction
could not have been predicted.
The Specification teaches “[f]ormulations having particles
comprising, by weight, approximately 40% to 60% DPPC, approximately
30% to about 50% insulin and approximately 10% sodium citrate.”
(Specification 3). The Specification does not disclose the criticality of
formulations of approximately 60% DPPC, approximately 30% insulin and
approximately 10% sodium citrate.
PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532, 28
USPQ2d 1955, 1956 (Fed. Cir. 1993) (citations omitted).
The burden of demonstrating unexpected results rests on the party
asserting them, and “it is not enough to show that results are obtained which
differ from those obtained in the prior art: that difference must be shown to
be an unexpected difference.” In re Klosak, 455 F.2d 1077, 1080, 173
USPQ 14, 16 (CCPA 1972). “Mere improvement in properties does not
always suffice to show unexpected results.” In re Soni, 54 F.3d 746, 751, 34
USPQ2d 1684, 1688 (Fed. Cir. 1995). Moreover, it has been long held that
“even though applicant’s modification results in great improvement and
utility over the prior art, it may still not be patentable if the modification was
within the capabilities of one skilled in the art, unless the claimed ranges
‘produce a new and unexpected result which is different in kind and not
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