Appeal No. 2006-2451 Page 5
Application No. 09/988,150
page 4. They state that Bomberger describes controlled delivery of drugs to the nasal
passageway using microparticles in which “the drug to be delivered is contained within
the microparticle,” not adsorbed onto the microparticle as recited in claim 11. Id.,
page 5. They argue that this would “lead one away from the claimed invention.” Id.
Appellants also contend that “a prima facie case is rebutted by the data of record in the
application which demonstrates greater than 400,000 times more particles absorbed
through the nasal mucosa compared to the intestines.” Id., page 6.
A proper analysis under § 103 requires consideration of whether the prior art
would have suggested to those of ordinary skill in the art that they should make the
claimed subject matter, and whether the prior art would also have revealed that, in
making the claimed subject matter, those of ordinary skill would have a reasonable
expectation of success. In re Vaeck, 947 F.2d 488, 493, 5 USPQ 1529, 1531 (Fed.
Circ. 1988).
We agree with the Examiner that the person of ordinary skill in the art would have
been motivated to have utilized Smith’s composition for intranasal administration. Smith
describes experiments which show that microparticles coated with protein and an
antibody specific for that protein enter intestinal (gut) M cells after oral ingestion “more
readily” than microparticles coated only with the protein. Smith, pages 13-15. The
enhanced uptake was shown to be 2x, 5x, and 10x greater, depending on the particular
protein measured. Id., page 13, lines 21 and 26; page 14, line 3. Almeida expressly
teaches that both oral and nasal uptake are mediated by the M cells in the mucosal
epithelium. Almeida, page 457, column 2-page 458, column 2. It also teaches that the
nasal mucosa tissue (NALT) and gut-associated lymphoid tissue (GALT) system are
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 Next
Last modified: November 3, 2007