Appeal No. 2005-0126
Application No. 09/967,791
While other modes of administration mentioned in Keep may be ready alternatives for
administration of drugs or treatment compounds (distinguished and distinct from the
hypertonic sugar solution) to other parts of the body, it would appear clear from the
record that the blood brain barrier is recognized by those of ordinary skill in the art as
being unique and distinct from other body tissues. Contrary to the dissent's
characterization of Keep, we do not find Keep states that the hypertonic sugar
composition may be administered by any mode of administration.
Furthermore, we note that unlike enteral absoprtion, contact is usually too brief
with the oral mucosa, even for drugs in solution, for appreciable absorption to occur.
Moreover, it is known from evidence of record that even with intravenous injection, the
blood brain barrier may be open from as little as 20 minutes to 2 hours. Keep, column
5, line 45. While the dissent views the statement from the Merck Manual as
demonstrating that persons having ordinary skill in the art understood that
administration of a pharmaceutical composition to the sublingual, buccal and nasal
mucosa was simply an alternative route of administering a composition to the blood
stream, we do not find that the statement provides acknowledgment that any
composition entering the blood stream by such routes would necessarily be of sufficient
chemical composition or nature or in sufficient amounts to open the blood-brain barrier
for a sufficient amount of time to allow entry of a therapeutic drug, administered by
another means. Therefore, we disagree with the dissent on this point and do not view
the evidence of record, without more, readily supports imposing a regulatory new
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