Appeal 2007-0318
Application 09/766,362
likelihood of successfully nasally administering Steiner’s microparticles and
optimizing the method, including the particle size. (FFs 4-12.)
“Unexpected Results”
14. The Specification states “systemic side effects [are] minimized or
eliminated through the selection of a narrow particle size range, between
approximately 10 and 20 microns in diameter.” (Spec. 2 (emphasis added).)
15. The Specification also describes advantages of having an average
particle size between 10 and 20 microns but refers to drug alone as well as
drug and diketopiperazine microparticles. (Spec. 2.)
16. Examples 1 and 2 are to the originally claimed invention
“comprising a drug in dry powder form having an average particle size of
between 10 and 20 microns . . . .” (Spec. 17 (claim 1); see also Spec. 13-14
(Exs. 1 & 2).) Original claim 1 did not recite “microparticles” or
“diketopiperazine.” (Spec. 17 (claim 1).)
17. Example 3 compared the dry powder drug formulation of
Examples 1 and 2 with a liquid formulation of each and concluded the liquid
form resulted in a “bitter taste and after taste” in all cases, while the dry
form did not. (Spec. 14-15.)
18. Example 5 is the only example encompassed by present claim 1,
but even Example 5 does not reflect the full scope of the claim in that the
particles of Example 5 are “10 to 20 microns in diameter” rather than of
“average particle size of between 10 and 20 microns.” (Spec. 15 & claim 1.)
19. The results of Example 5 “were similar to the results obtained in
examples 1-4.” (Spec. 15.)
20. Appellants’ examples do not support their argument that an
“average particle size of between 10 and 20 microns” provides “unexpected
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