Appeal Number: 2006-1762
Application Number: 09/848,774
OPINION
In reaching our decision in this appeal, we have given careful consideration to appellants’
specification and claims, to the applied prior art references, and to the respective positions
articulated by appellants and the examiner. As a consequence of our review, we make the
determinations that follow.
Claims 22 through 38 rejected under 35 U.S.C. § 103 as obvious over Schenk in
view of Velasquez.
As to claims 22 and 23, the appellants argue that the art fails to show the claim elements 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” and “inhaling the aerosolized
suspension at a flow rate and volume sufficient to allow the patient to absorb in the bloodstream
a controlled dose of insulin that comprises between 1-50 units of insulin.” [See Brief at p. 13].
The appellants go on to argue that the law does not recognize an “obvious to try”/ ”routine
experimentation” standard for proof of obviousness. [See Brief at p. 14].
The examiner responds that the claimed dose of 1-50 units is that which is administered to
patients in typical administration, as evidenced by Harrison. The examiner goes on to argue that
the examiner has not applied an “obvious to try” argument, but has applied the taught application
of Velasquez’ insulin powder to Schenk’s inhaler, and that a person of ordinary skill in the art
would know the standard guidelines for the number of units that are needed to be absorbed and
would adjust the amount inhaled to achieve that amount accordingly. The examiner also
responds that a person of ordinary skill in the art would know that the amount of aerolized
suspension would have to be substantially higher than the amount needed to be absorbed and that
the specification shows no criticality for the range of 2-10 times the amount. [See Answer at p.
5-8]
The appellants responded that neither reference discloses delivery to the bloodstream
through inhalation let alone in controlled doses. [See Reply Brief at p. 5-6]. The appellants
further argue that any guidelines that might be found in the art, including Harrison, refer to
injected rather than inhaled insulin. [See Reply Brief at p. 6].
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