Appeal No. 2004-0250 Page 20
Application No. 09/226,412
Claims 49, 53, and 62 are rejected under 35 U.S.C. § 103(a). As evidence of
obviousness, we rely upon Rubsamen and Chance.
Claims 49, 53, and 62 are directed to the use of AspB28 human insulin in the
claimed method. As set forth in Declaration III, it was “well known” at the time of filing
this application that AspB28 human insulin and Lyspro had “similar biochemical and
biophysical properties.” Dec. III, paragraph 2. Thus, it would have been obvious to one
of ordinary skill in the art at the time of the present invention to use AspB28 human
insulin as the monomeric insulin analog of Rubsamen.
Other Issue
We direct attention to that part of Chance that describes intranasal
administration of Lyspro. See, e.g., column 52, line 35-column 53, line 62. Lyspro was
adminstered to the nasal cavity of dogs by way of a nebulizer. The issue this disclosure
creates is whether the intranasal administration of Lyspro in Chase is an equivalent to
the pulmonary means required by the claims on appeal under 35 U.S.C. § 112, sixth
paragraph. Chase reports data obtained from those experiments and compares the
data with that obtained by administering Lyspro subcutaneously and intravenously. It
may be that a comparison of that data with the data set forth in the present specification
obtained by administering Lyspro by way of pulmonary means will lead to the
conclusion that administering Lyspro to the nasal cavity using a nebulizer and through
“pulmonary means” are equivalents.
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