Appeal No. 2004-0250 Page 19
Application No. 09/226,412
Table 3
Claims 31 and 32 directed to delivering The method of Rubsamen provides for
the monomeric insulin analog to a lower delivery of the active agent to the lungs
airway of the patient, e.g., the alveoli. of the patient. Id., column 17, lines 6-10.
In view of this disclosure it is reasonable
to shift the burden to appellants to
establish through objective evidence that
the method described in Rubsamen 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 34-37 and 42-44 directed to Rubsamen describes administering a
formulating the monomeric insulin analog monomeric insulin analog in the form of
with a pharmaceutical carrier, including an aerosol containing the active agent in
suspending the active agent in a non- the form of a powder with or without a
aqueous medium, administering the non-aqueous propellant using an
active agent in the form of an aerosol inhalation device. See column 14, line
and/or a dry powder, using an inhalation 40-column 15, line 30 and column 20,
device such as a metered dose inhaler or line 62-column 21, line 9.
a dry powder inhaler.
Claims 38-40 directed the particle size of The monomeric insulin analog of
the monomeric insulin analog. Rubsamen is used in the form of a
powder. As such, it would have been
obvious to optimize the particle size of
the powder as this is a result effective
variable. In re Boesch, 617 F.2d 272,
276, 205 USPQ 215, 219 (CCPA 1980).
Claims 45-46 directed the amount of Rubsamen, column 5, lines 55-68 In
monomeric insulin analog to be view of this disclosure it is reasonable to
administered. shift the burden to appellants to establish
through objective evidence that the
amounts of the insulin analog delivered in
Rubsamen do not meet those required by
these claims. In re Best, 562 F.2d 1252,
1255, 195 USPQ 430, 433 (CCPA 1977).
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