Appeal 2007-0318
Application 09/766,362
range,” i.e., greater than 3.15 to 32.20 and 2.99 to 43.52 microns,
respectively. (Spec. 13-14 (disclosing the particle size ranges for 10 to 90%
of the particles).)
Example 3 compares administration of the dry formulations of
Examples 1 and 2 (according to the claimed invention as filed) with the
same formulations in liquid form. (Spec. 14.) The comments of the three
volunteers suggested the dry formulations at least “markedly reduce[ed] the
bitter taste and after taste associated with the . . . liquid nasal spray of
azelastine.” (Spec. 15.)
Example 4 exemplifies dry powder formulations of chlorpheniramine
“made and tested with similar good results” as Examples 1 and 2. (Id.)
Example 5 (the only example within the scope of the pending claims)
discloses antihistamine formulated in diketopiperazine:
Diketopiperazine particles (10 to 20 microns in diameter)
were suspended in aqueous medium. Antihistamine was
added, the suspension acidified, and the suspension
lyophilized to yield antihistamine powder.
Results of administration to volunteers were similar to
the results obtained in examples 1-4.
(Id.)
The Claims on Appeal
The following claims are representative of each group argued:2
1. A composition for the nasal administration of a drug in a dry
powder form suitable for administration to the nasal region,
2 The following groups of claims are argued: claims 1, 2, 4, and 5; claims 7,
9, 11, and 12; claims 14, 15, 17, and 18; claims 3, 8, 10, and 16; and claims
20 and 21. With respect to each of these groups, we consider the
representative claim (quoted above), pursuant to 37 C.F.R. § 41.37(c)(1)(vii)
(2006).
3
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