Appeal No. 2006-2451 Page 7
Application No. 09/988,150
provided since the 1920’s.” Id., page 458, second column. “Nasal vaccination has
been investigated by administering antigens together with adjuvants.” Id., page 459,
column 1. In particular, microspheres have been utilized to deliver antigens through the
nasal route, either by encapsulating or adsorbing the antigen on the microsphere
surface. Id., page 462, column 2-463, column 1. Almeida states that “[n]asal
immunisation studies carried out by several independent laboratories suggest that the
use of a respiratory mucosal delivery route can be protective from some infections.” Id.
Finally, as discussed above, similarities in the mechanism (e.g., M cells uptake)
between oral and nasal administration would have reasonably suggested that a
composition which works orally would also work nasally. “[A] general, albeit, imperfect
correlation between a drug’s lipophilicity and its colonic absorptivity” was found to be
sufficient to establish a reasonable expectation of success. Alza Corp. v. Mylan Labs,
464 F.3d 1286, 1298, 80 USPQ2d 1286, 1298 (Fed. Cir. 2006). Thus, we conclude that
the Examiner has provided adequate evidence to establish a prima facie case of
obviousness.
Appellants argue that “that the intestinal absorption and nasal absorption are
similar - as opposed to the ‘superior advantages’ espoused by the Examiner in
providing some reason to combine Smith with Almeida.” Reply Brief, page 3. We are
not persuaded by this argument. Almeida expressly states that intranasal immunization
appears to be superior to the oral route “to achieve a comprehensive immune
response.” Almeida, page 463, line spanning columns 1-2. It also states that nasal
mucosa has “higher permeability” when compared to other mucosal surfaces.” Id., page
457, column 1. Furthermore, the Examiner also cited advantages of the nasal route
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