Appeal 2007-0526
Application 10/141,032
particles, or used to prepare particles consisting solely of the agent and
surfactant. . . . The agents to be incorporated can have a variety of
biological activities, such as . . . antibiotics . . .” (id. at 20).
Thus, one of ordinary skill administering tobramycin by inhalation, as
taught by Vaghefi, would have been motivated to use Edwards’ delivery
methods, because Edwards teaches that those methods effectively deliver
therapeutic agents such as antibiotics to the deep lung, avoid phagocytosis
within the lung, improve aerosolization of the drug composition, and
optimize particle-particle interactions. Because Vaghefi describes the
inhaled tobramycin as an “antibacterial” (Vaghefi, col. 12, l. 28), one of
ordinary skill would have reasonably expected tobramycin to be amenable to
Edwards’ methods, which are disclosed as being suitable for administering
“antibiotics” (Edwards 20).
We therefore agree with the Examiner that one of ordinary skill would
have considered it obvious to administer tobramycin via inhalation using
powders having the physical properties recited in claims 20 and 51.
The Examiner also concluded that Edwards’ delivery system provides
a formulation that meets claim 20’s requirement of less than 40 percent
relative standard deviation of interpatient variability when the composition is
administered to a group of individuals at 60 LPM. We agree. The instant
Specification describes tobramycin-containing particles meeting the
interpatient variability limitation of claim 20 that “were prepared using the
same general procedure as set forth in Example 1”; i.e., spray-drying an
emulsion containing the drug and a phospholipid (Specification 23, 19).
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