Appeal Number: 2006-1762
Application Number: 09/848,774
We first note that none of the claims contain limitations specifying structural characteristics
that control the amount of insulin inhaled or actually absorbed. Instead, the claims recite the
results to be achieved, viz. the amount to be inhaled and absorbed, and are consequently broad
enough to embrace any technique for achieving those amounts. We further note that the ranges
specified in the claims for such amounts are very broad, suggesting minimal criticality for any
particular subset of such ranges.
As to the limitation regarding the number of units to be absorbed, we further note that the
appellants’ disclosure supports the examiner’s finding that an absorption of 1-50 units would be
that which a person of ordinary skill in the art would ordinarily use. [See Specification at p. 21].
This recitation confirms the findings of the examiner as to the evidentiary value of Harrison’s
recitation of amounts. Therefore, we find the appellants’ arguments as to the limitation of an
absorption of 1-50 units to be unpersuasive.
As to the limitation regarding the amount of insulin in the aerosolized suspension, we next
note that with inhaled substances, it is known to a person of ordinary skill in the art that not all of
the amount that is inhaled will be absorbed. The fraction that will be absorbed relative to the
total amount inhaled is referred to in the art as the “respirable fraction”. We note that Velasquez
describes the range that such respirable fractions may embrace for the various medicaments it
describes at col. 5 lines 7-15. Velasquez mentions the fraction may be in the range of 10% to
65%. Taking the inverse of this range to determine the amount of medicament that would need
to be inhaled yields a range of 1.54 to 10 times the amount needed to be absorbed, which we note
substantially overlaps the claimed range of 2 to 10 times. Therefore, we find the appellants’
arguments as to the claim limitation of “the aerosolized suspension contains an amount of insulin
that is 2- 10 times higher than the amount needed to be absorbed in the bloodstream of the
patient” to be unpersuasive.
We next note that medicament that is inhaled is absorbed into the blood stream by the lungs.
Therefore, we find the appellants' arguments as to the claim being toward delivery through
inhalation rather than to the bloodstream to be unpersuasive.
We next note that the appellants make much of the argument that the applied art fails to
show how insulin is to be inhaled in controlled delivery. However, we note that, contrary to this
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