Appeal 2007-2212
Application 10/667,472
Appellants further argue that if a prima facie case of obviousness has
been established, it has been rebutted with evidence of unexpected results.
(Br. 4.) In particular, Appellants argue that
Example 1 of the specification describes the preparation of a
nanoparticulate beclomethasone composition . . . and compares
it to a conventional beclomethasone composition. The
specification states that “only about 7% of the
[beclomethasone] presented as a suspension or raw drug
substance reaches the impactor.” On the other hand, "the use of
nanoparticles led to a significantly higher fraction reaching the
impactor." In addition, a greater fraction of beclomethasone
remained in the nebulizer when raw drug substance rather than
the nanoparticulate form was used. Thus, the experimental
results demonstrate that the nanoparticulate form of
beclomethasone results in less waste and more effective
delivery. (Id. at 9.)
We are not persuaded by Appellants’ presentation of alleged
unexpected results. Liversidge discloses that "extremely small effective
average particle size can be prepared by wet milling in the presence of
grinding media in conjunction with a surface modifier, and that such
particles are stable and do not appreciably flocculate or agglomerate due to
interparticle attractive forces". (Liversidge, col. 3, ll. 15-31). These
particles “can be formulated into pharmaceutical compositions exhibiting
unexpectedly high bioavailability.” (Liversidge, col. 3, ll. 15-31).
Liversidge further teaches surface modified nanoparticles of corticosteroids.
(Liversidge, col. 11, l. 40 to col. 12, l. 25.)
We do not find that Appellants have compared the nanoparticles of
the claimed invention with the closest prior art, Steroid A of Liversidge.
When relying on comparative testing, the applicant is under a duty to
compare his claimed invention with the closest prior art (i.e., steroid A of
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