Appeal 2007-0318
Application 09/766,362
FINDINGS OF FACT RELATING TO CLAIMS 1 AND 143
Claim Interpretation
1. Claim 1 is to a composition which includes microparticles of a
drug and deketopiperazine wherein the microparticles have “an average
particle size of between 10 and 20 microns.”
2. The claim language “having an average particle size of between 10
and 20 microns” does not restrict the particle size range to a specific or
narrow range and includes the ranges disclosed in Examples 1 and 2 of the
Specification. (Spec. 13-14.)
3. “Drug” is not defined in the Specification. Its broadest reasonable
interpretation includes “a substance intended for use in the diagnosis . . . of
disease” (Webster’s New Collegiate Dictionary (1977) (hereafter
“Webster’s”) 350), and thus includes imaging agents.
The Prior Art
4. Steiner discloses a drug delivery system comprising microparticles
having a particle range from 0.1 to 10 microns and comprising a drug and
diketopiperazine. (Answer 3-4 (citing Steiner, col. 4, ll. 30-55 & col. 10, ll.
25-49).)
5. Steiner’s size range overlaps with and theoretically could be
identical to that of the claims. For example, particles of 10 microns satisfy
the claim limitation and also fall within a range between 0.1 and 10 microns.
(See Answer 9.)
6. Steiner discloses administering “biologically active agents”
including imaging agents, in combination with microparticles of
diketopiperazines without any requirement the agent and/or microparticles
3 Findings of Fact are abbreviated “FF.”
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