Appeal No. 2006-2451 Page 8
Application No. 09/988,150
which are independent of the physiological similarities, including ease of administration
and increased patient compliance. Answer, page 5. In sum, we find the strong
teachings about the value of intranasal delivery described in Almeida hard to reconcile
with Appellants’ position.
“When the PTO shows prima facie obviousness, the burden then shifts to the
applicant to rebut it. In re Dillon, 919 F.2d 688, 692 [16 USPQ2d 1897] (Fed. Cir. 1990)
(en banc). Rebuttal may take the form of ‘a comparison of test data showing that the
claimed compositions possess unexpectedly improved properties . . . that the prior art
does not have, that the prior art is so deficient that there is no motivation to make what
might otherwise appear to be obvious changes, or any other argument . . . that is
pertinent.’ Id. at 692-93 (citations omitted).” In re Harris, 409 F.3d 1339, 1343, 74
USPQ2d 1951, 1954 (Fed. Cir. 2005). Appellants argue that prima facie obviousness is
rebutted by their showing that 400,000 times more particles are absorbed through the
nasal mucosa than through the intestine. Brief, page 6.
The Examiner dismisses these results for two primary reasons. First, he states
that results obtained by the in vivo intestinal model used by Smith cannot be compared
to the results generated by Appellants using an in vitro nasal model. Answer, page 9.
Secondly, the Examiner argues that Appellants’ higher results in the nasal mucosa
would have been expected from Almeida’s teaching that “the nasal administration of
drugs exploits the high permeability of the nasal mucosa when compared to other
mucosal surfaces.” Id., page 11.
We agree with the Examiner that the results are not sufficient to rebut the prima
facie obviousness of the claimed subject matter, but we rely on different reasoning.
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