Appeal 2007-0318
Application 09/766,362
Steiner does not disclose drug delivery systems
suitable for nasal administration nor suggest a composition of
microparticles having an average size between 10 and 20
microns. Steiner does not disclose or suggest modifying the
particles for administration in a dry powder form to the nasal
mucosa. Thus Steiner does not provide the necessary
motivation to one of ordinary skill in the art to modify its
particles so that they are suitable for nasal administration.
Therefore independent claim 1 and dependent claims 2, 4 and
5 are non-obvious over Steiner.
(Second Substitute Appeal Brief (rec’d Dec. 27, 2005) (hereafter “App.
Br.”) 10.)
Appellants’ arguments regarding the patentability of claim 14 track
those made with respect to claim 1:
Independent claim 14 and its dependent claims define
a method for administering a drug to the nasal region of a
patient. Claim 14 specifies that the method requires nasally
administering a dry powder suitable for nasal administration.
Steiner does not disclose or suggest nasally administering a
dry powder. . . . [T]he only reference to the nasal tract
occurs when Steiner mentions that microparticles can include
a diagnostic imaging agent useful for imaging the nasal tract.
However, Steiner does not disclose the form in which the
microparticles are administered to image the nasal tract.
Further, Steiner does not suggest nasal administration of a
dry powder.
(App. Br. 11-12.)
The Examiner responds:
Steiner et al. teach drug delivery systems based on the
formation of diketopiperazine microparticles and
microencapsulation of drugs by derivatives of
diketopiperazine, wherein the microparticles are formed in
the presence of the drug to be delivered and the
microparticles are between 0.1 to 10 microns in diameter and
whereby the microparticles are used for diagnostic
5
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