Appeal 2007-0526
Application 10/141,032
delivering the composition from the inhaler to the
lungs of the patient during the patient’s inhalation.
Thus, claims 20 and 51 are both directed to methods of using a
passive dry powder inhaler to deliver tobramycin to a patient’s lungs. Both
claims require a dry powder composition containing tobramycin and a
phospholipid. Both claims also require the powder composition to contain
particles having a mass median aerodynamic diameter of less than 5
microns, and a bulk density of less than 0.5 g/cm3.
Claim 20 additionally requires the powder composition to contain
particles having a particle size range from 1 to 30 microns, and requires the
composition to be formulated so that administration of the composition to a
group of individuals at 60 LPM2 results in a “relative standard deviation of
interpatient variability in lung deposition [of] less than 40 percent.” We
interpret this recitation to mean that in a group of individuals receiving the
composition, the amount of lung deposition in each individual does not vary
from the mean deposition amount by more than 40 percent.
2 We understand “60 LPM” to mean an inspiratory flow of 60 liters per
minute. The Specification uses the abbreviations “L/min” and “LPM”
interchangeably (Specification 21 (“peak inspiratory flows” of “29 L/min”
and “44 L/min”), 22 (Table 3 refers to the same rates as “LPM”).
4
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