Appeal No. 2005-0126
Application No. 09/967,791
non-carcinogenic material having apparent utility in connection with the
treatment of the disorder being investigated may be combined with the hypertonic sugar
composition. Id.
According to the examiner, “Naito teaches oral administration of hypertonic sugar
compositions which is but one non-enteral or non-intravascular mode of administration.”
Answer, page 6.
Keep is relied on by the examiner for the disclosure of cyclosporins which cross
the blood-brain barrier with the aid of osmotic agents for example, mannitol and
arabinose and saccharose solutions, which are able to temporarily disrupt the blood-
brain barrier and allow therapeutic delivery of the drug to the brain. Answer, page 6;
Keep, column 5, lines 35-42. According to the examiner, suitable modes of
administration described in Keep are “oral, sublingual, buccal, nasal, inhalation,
parenteral, intraorgan, subcutaneous,” etc. Answer, page 6.
The examiner concludes (Answer, pages 6-7):
It would have been obvious to one of ordinary skill in the art at the time the
invention was made to co-administer or sequentially administer the
hypertonic sugar composition of Naito along with a chemical compound in
order to increase the effectiveness of said compound, to increase the
passage of the compound through or across the blood brain barrier, or to
increase the permeability of the blood-brain barrier by a route other than
enteral or intravascular injection since Keep teaches the use of hypertonic
sugar compositions for passing therapeutic agents across the blood-brain
barrier. The mode of administration is not seen to be a critical limitation
that would lend patentability of the instantly claimed process over the prior
art. The mode of administration is seen to be a choice of experimental
design as the art teaches suitable alternatives. One of ordinary skill in the
art would have been motivated to modify the teachings of Naito in order to
treat traumatic brain damage.
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