Appeal No. 2004-0250 Page 8
Application No. 09/226,412
prior art under the two-way test is (1) the claimed subject matter of this application
(which is assumed to be prior art) in combination with (2) other relevant prior art.
Turning to the first difference noted by appellants, i.e., an enhancer, we note that
independent claims 30, 50, and 59 of this application are “comprising” in nature and
thus, are open to the inclusion of other substances. Jensen describes the enhancer in
the following manner:
The expression ‘enhancer’ refers to a substance enhancing the
absorption of insulin, insulin analogue, or insulin derivative through the
layer of epithelial cells lining the alveoli of the lung into the adjacent
pulmonary vasculature, i.e., the amount of insulin absorbed into the
systemic system is higher than the amount absorbed inthe absence of
enhancer.
Jensen, column 2, lines 15 through 21. Jensen states that the enhancer is
“advantageously a surfactant.” Id., column 2, lines 59 through 61. The present
specification states that the monomeric insulin analog compositions administered
according to the claimed method may also include surfactants. See, e.g., Id., page 15.
line 19.
Furthermore, it is known in the art that surfactants assist in the absorption of
monomeric insulin analogs including Lyspro by mucosal surfaces. Chance describes
monomeric insulin analog composition including Lyspro compositions that include
absorption enhancing agents such as oleic acid. See Chance, column 52, lines 35
through 50. Thus, it would have been obvious to one of ordinary skill in the art to use a
surfactant in the compositions administered in present claims 30, 50, and 59 and
expect that the surfactant would serve as an “enhancer,” i.e., enhancing the absorption
of the monomeric insulin analog by the lung.
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Next
Last modified: November 3, 2007