Appeal No. 2005-0126
Application No. 09/967,791
Accordingly, in view of the teachings of Keep and Naito, I conclude that it would
have been obvious to persons having ordinary skill in the art to increase the
permeability of the blood-brain barrier by co-administering, or sequentially
administering, a hypertonic sugar composition using any art-recognized route of
administering a pharmaceutical composition to the bloodstream, which includes non-
enteral 4 and non-injection intravenous routes, such as administration via the sublingual,
buccal or oral mucosa, with a compound of interest. Moreover, in view of the teachings
of Naito that the hypertonic composition is effective when administered orally,5 one
having ordinary skill in the art would have a reasonable expectation that administration
of said composition via the sublingual, buccal, and nasal mucosa would be successful.
4 Claim 10 lists several mucosa as routes of administration which include, inter
alia, the rectal mucosa. According to the definitions of enteral administration found by
the majority, rectal administration is a type of enteral administration which the claims are
said to exclude. See, independent claim 1 on which claim 10 depends.
5 Drugs which are administered orally, and which are absorbed by the
gastrointestinal tract as opposed to the oral mucosa, risk degradation by digestive
enzymes throughout the digestive tract prior to reaching the bloodstream. A hypertonic
sugar composition administered orally in solution form as taught by Naito (col. 5, lines
45-47) must survive the transit time from the mouth throughout the digestive tract as
well as encounters with low pH and potentially degrading enzymes. The Merck Manual,
p. 3. Thus, the time between administration and absorption into the bloodstream of a
hypertonic sugar composition which is administered orally is much greater than the time
for absorption when said composition is administered directly by intravenous injection.
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