Appeal No. 2005-1152
Application No. 10/202,616
would have provided sustained release when delivered by pulmonary inhalation.2
In our view, the examiner has not established by a preponderance of the
evidence why one of ordinary skill in the art, with knowledge of Unger, would have been
directed to select the particular negative charge and type of bioactive agent, and
combine it with the a positively charged lipid, to result in a method of sustained release
pulmonary inhalation of the active agent. Nor has the examiner directed our attention to
a specific example within Unger which would inherently result in a sustained release
when delivered via pulmonary inhalation. Thus, we agree with appellants that the
examiner has failed to establish a prima facie case of anticipation on the facts before
us. “Inherency ... may not be established by probabilities or possibilities. The mere fact
that a certain thing may result from a given set of circumstances is not sufficient.”
In re Oelrich, 666 F.2d 578, 581, 212 USPQ 323, 326 (CCPA 1981). The rejection of
the claims for anticipation over Unger is reversed.
35 U.S.C. 103(a)
Claims 1-24, 32-40, 43 and 45-57 stand rejected under 35 U.S.C. 103(a) for
obviousness over Hanes in view of Szoka. Claims 25-31, 41-42 and 44 stand rejected
2 The disclosure of Unger may not even be sufficient to support a prima facie
case of obviousness. It is well settled that the “fact that a claimed compound and/or
subgenus may be encompassed by a disclosed generic formula does not by itself
render that compound or subgenus obvious”. In re Baird, 16 F.3d 380, 29 USPQ2d
1550 (Fed. Cir. 1994).
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