Appeal No. 2005-0126
Application No. 09/967,791
lines 29-33 and col. 8, lines 59-66. Thus, Keep demonstrates that one of ordinary skill
in the art would have understood at the time of the invention that (i) any pharmaceutical
composition could be administered by any one of numerous alternative routes; and
(ii) routes of administration through the sublingual, buccal or nasal mucosa, etc., are
simply art-recognized alternative routes of inserting a pharmaceutical agent into the
blood stream.3 In sum, since Naito teaches that the site of action of the hypertonic
sugar composition is the blood stream, one of ordinary skill in the art would have
understood that any art-recognized route of administering said composition into the
blood stream would be appropriate. Such persons select the route based on the
condition of the patient (Keep, col. 6, lines 21-22) and the timing necessary to ensure
that said composition and the therapeutic compound of interest are present in the blood
stream at the same time (Naito, col. 3, lines 46-50). Thus, contrary to the majority, I find
that the applied prior art demonstrates both the knowledge available in the art with
respect to the administration of pharmaceutical compositions and how persons with said
knowledge resolved the problems presented with different patients.
3 As further evidence of the knowledge generally available in the art at the time of
the appellants’ invention, I direct attention to the Merck Manual relied upon by the
majority. The manual states that the “oral mucosa is known for its thin epithelium and a
rich vascularity that favors absorption.” See attached, p. 3, para. 2. Thus, the manual
demonstrates that persons having ordinary skill in the art understood that the
administration of a pharmaceutical composition to the sublingual, buccal and nasal
mucosa was simply an alternative routes of administering said composition to the blood
stream.
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