Appeal 2007-0318
Application 09/766,362
applications, especially for imaging of the nasal tract (see
reference col. 4, lines 30-55); (col. 10, lines 25-49); (col. 13,
lines 13-24) and abstract. . . . Appellant's argument that
'Steiner does not disclose dry powder formulations' is not
persuasive since the formulation of Steiner is a
microparticulate (i.e., powder) formulation.
(Answer 7-8.)
With respect to the particle size limitation, the Examiner continues:
It is noted that the particles of Steiner having a particle size
of 10 microns would be retained in the mucosal cavity for
sufficient drug delivery. . . . A review of the instant
specification indicates that formulations I and II on pages 13
and 14, respectively, have particles with micron sizes that are
less than 10 microns. Specifically, Formulation I on page 13
demonstrates that 10% of particles had a particle size of only
3.15 microns. Similarly, Formulation II on page 14
demonstrates that 10% of particles had a particle size of only
2.99 microns. . . . Therefore, this clearly establishes that the
'between 10 microns' claimed by Appellants is not a critical
lower . . . particle size limitation.
(Answer 8-9 (emphasis in original).)
With respect to claims 1 and 14, we frame the § 103(a) issues:
Would the dry powder formulation of claim 1 “comprising
microparticles having an average particle size of between 10 and 20 microns
and comprising the drug and diketopiperazines” have been obvious to the
skilled artisan in view of Steiner’s disclosure of microparticles having a
particle size range between 0.1 and 10 microns and comprising a drug and
diketopiperazines? (Claim 1.)
Would it have been obvious to the skilled artisan to nasally administer
the dry powder formulation of claim 1? (Claim 14.)
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