Appeal No. 2004-0250 Page 14
Application No. 09/226,412
1997. Since the application from which Gonda ‘250 issued was filed on November 22,
1996, it is apparent that the Rule 131 declarations are ineffective.
Claims 31, 32, 34-46, and 48 which depend from claim 30 are also described in
Gonda ‘250 as discussed in the following table:
Table 1
Claims 31-32 directed to delivering the Gonda ‘250, column 3, lines 59-60 (“[I]t is
monomeric insulin analog to a lower desirable to get the aerosolized insulin
airway of the patient, specifically the formulation deeply into the lung.”) In view
alveoli. of this disclosure it is reasonable to shift
the burden to appellants to establish
through objective evidence that the
method described in Gonda ‘250 does
not deliver the insulin to the lower airway
of the patient, e.g., the alveoli. In re
Best, 562 F.2d 1252, 1255, 195 USPQ
430, 433 (CCPA 1977).
Claims 34-36 directed to administering Gonda ‘250, column 4, lines 6-10,
the monomeric insulin analog by way of (“systemic delivery of insulin is obtained
an aerosol with the analog being in a by by releasing an aerosolized dose at a
pharmaceutical carrier such as an prescribed point in a patient’s respiratory
aqueous medium. cycle.”) Gonda ‘250, column 40, lines
52-56 (“[T]he insulin may be an aqueous
solution of the drug....”)
Claims 37-40 directed to administering ‘Gonda ‘250, column 40, lines 58-64 (The
the monomeric insulin analog as a dry drug may be in powder form having
powder having specified particle sizes, particle size in the range of 0.5-12
e.g., less than 10 microns. microns.)
Claim 41 directed to at least 10% of the See the analysis set forth above in
monomeric insulin analog delivered is regard to claims 31-32. It is again
deposited in the lung. reasonable to shift the burden to
appellants to provide objective evidence
that the method of Gonda ‘250 does not
meet this claim limitation.
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