Appeal No. 2006-2451 Page 4
Application No. 09/988,150
Almeida is a review of nasal vaccine administration, describing the structure of
the nasal passageway, mechanisms of how proteins are absorbed intransally, and
studies involving the delivery of proteins to the nasal mucosa. Bomberger describes
microparticles which can be loaded with drugs for nasal delivery. Bomberger, column 1,
lines 5-12; column 4, lines 48-51. The patent specifically describes alginate
microparticles loaded with a protein, such as intercellular adhesion molecule ICAM-1.
Id., column 3, lines 62-65.
According to the Examiner, Smith teaches the same composition comprising
protein and microparticles which is recited in claim 11, but does not describe it for
intranasal administration. Answer, page 4. Bomberger and Almeida are cited by the
Examiner for teaching intranasal administration of proteins. Id., page 5. The Examiner
concludes:
[I]t would have been prima facie obvious to one of ordinary skill in the art at the
time the invention was made to include nasal administration of the composition
taught by Smith et al. because nasal administration of microparticles containing
peptides and proteins was well established in the art as taught by Bomberger
et al. (US Patent No. 5,879,712). Further, one would have been motivated to do
so because Almeida et al. teach that nasal delivered vaccines are advantageous
compared to other mucosal surfaces because of the valuable surface area of the
nasal mucosa, the easier accessibility and administration that increases patient
compliance and venous flow that bypasses the portal system, thus preventing
first-pass metabolism in the liver (page 457, 1st column).
Id., pages 5-6.
Appellants challenge the rejection, arguing that there would have been no
motivation with an expectation of success “to perform the claimed method.” Brief,
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