Appeal No. 2005-0126
Application No. 09/967,791
coexist in the blood stream. Naito, col. 3, lines 46-50. This is because the site of action
of the hypertonic sugar composition is in the bloodstream; said composition does not
cross the blood-brain barrier. Naito, col, 3, lines 38-39. In addition, Naito discloses that
the base material2 can enter the blood stream either by ingestion or by direct
introduction. Id., lines 35-38.
In my view, the aforementioned teachings of Keep and Naito would have
suggested to one of ordinary skill in the art that any art-recognized method of inserting
the hypertonic sugar solution into the blood stream (circulatory system) is acceptable for
increasing the permeability of the blood-brain barrier. That is, it would have been
obvious to one of ordinary skill in the art at the time of the present invention to employ
any convenient route of administering the hypertonic sugar composition to increase the
permeability of the blood brain barrier for passage by a therapeutic compound. In this
regard, Keep demonstrates that there were many alternative routes known in the art by
which pharmaceutical compositions could be introduced into the circulatory system,
other than enterally or by intravenous injection, and that the various routes of
pharmaceutical administration are interchangeable. See, e.g., Keep, col. 5, line 64-
col. 6, line 62. Keep describes the use of alternative routes of administration with
respect to the therapeutic drug as well as with the hypertonic sugar composition and a
formulation comprising a therapeutic drug and sugar composition. See, col. 6,
2 Naito defines the base composition as “a combination of the hypertonic sugar
and amino acid which is effective to permit transportation of other materials into the glia
of the brain past the blood brain barrier.” Naito, col. 3, lines 18-21.
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