Appeal No. 2005-0224
Application No. 08/878,146
evidence, as shown by some objective teaching in the prior art or by knowledge
generally available to one of ordinary skill in the art that would have led that individual to
combine the relevant teachings of the references to arrive at the claimed invention. See
In re Fine, 837 F.2d 1071, 1074, 5 USPQ2d 1596, 1598 (Fed. Cir. 1988).
It is the examiner’s position that (Final Rejection, page 2):
Maa teaches methods of preparing a dry powder composition
comprising spray freeze-drying an aqueous mixture of a protein under
conditions to provide a respirable dry powder. Maa also teaches methods
of administering a therapeutically effective dose of a therapeutic protein to
a patient comprising administering to the alveolar regions of the lungs of
the patient a spray freeze dried therapeutic protein dry powder
composition (col. 2, lines 28-55).
The term “powder” is described as a composition that consists of
finely dispersed solid particles that are relatively free flowing and capable
of being readily dispersed in an inhalation device and subsequently
inhaled by a patient so that the particles can reach the alveoli of the lung.
Thus, the powder is respirable and suitable for pulmonary delivery. The
average particle size ranges from about 5 µm to about 30 µm. [T]he
preferred average particle size is 6-8 µm. The FPF, fine powder fraction,
is preferably at least 10%, and especially preferred at 40-50%. The
particles have a tap density of less than about 0.8 g/cm3, with tap
densities of less than about 0.4 g/cm3 being preferred and less than about
0.1 g/cm3 being especially preferred (see col. 5, line 30 to col. 6, line 33).
The examiner acknowledges that, “Maa does not specifically disclose the mass
of the particles delivered,” however, argues that “it clearly teaches powders dispersed
from the dose chamber of the inhalation device.” Final Rejection, page 3.
The examiner concludes (Final Rejection, pages 3-4) that:
It would have been obvious to one of ordinary skill in the art at the time the
invention was made to have modified the teachings of Maa et al by
concentrating on more specific volume of receptacle and mass of particles
delivered because knowing the specific values regarding dosages in
treating certain disorders is very important and helpful to health care
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