Appeal No. 2004-0250 Page 15
Application No. 09/226,412
Claims 42-44 directed to use of an See the analysis set forth above in
inhalation device such as a nebulizer, regard to claims 37-40.
meter-dosed inhaler, dry powder inhaler
or sprayer.
Claims 45-46 directed to using a dry Gonda ‘250 describes a wide range of
powder inhaler to administer specified dosages. See, e.g., column 31, lines 33-
dosages of the monomeric insulin 45. It is reasonable to shift the burden to
analog. appellants to establish by way of
objective evidence that the dosages
required by claims 45-46 differ from
those described in Gonda ‘250. In re
Best, supra.
Claim 48 directed to Lyspro Gonda ‘250 describes the use of Lyspro
in that method.
Claim 49 is rejected under 35 U.S.C. § 103(a). As evidence of obviousness we
rely upon Gonda ‘250.
Claim 49 is 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 Gonda ‘250.
Independent claims 50 and 59 are rejected under 35 U.S.C. § 102(e) as
anticipated by Gonda ‘250.
Claims 50 and 59 respectively require administration of an effective dose of
monomeric insulin analog for the purpose of treating diabetes or hyperglycemia to a
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