Appeal No. 2005-0224
Application No. 08/878,146
case of obviousness on the facts before us. What is missing from the examiner’s
analysis is evidence of a direct relationship between fine particle fraction and the actual
amount of drug delivered.
Maa, column 5, lines 57-65 states that the fine particle fraction is a measure of
the aerosol performance of a powder, with the higher the fraction the better. Maa does
not reasonably appear to disclose how the aerosol performance of a powder may be
correlated to the amount of active agent actually delivered. It would also appear from
Maa that delivery of an amount of active agent may depend on the presence of a carrier
or excipient. Thus, Maa does not teach or suggest that there is a direct relationship
between the amount of agent or protein present in a powder prior to delivery and the
efficiency of delivery (FPF).
The examiner concludes in the Final Rejection that “even if some properties are
not disclosed in the prior art, they are ultimately met [by Maa].” Final Rejection, page 6.
The examiner also states that, “Maa et al disclose a wide range of proteins for the said
composition and it is concluded that one or more of the said bioactive agents would
deliver more than 5 milligrams to the pulmonary system of the subject.” Id. However,
the examiner fails to provide evidence of a correlation or a relationship between any
disclosed aspect of delivery of the particles of Maa or property of the particles delivered
in Maa and the amount of drug ultimately delivered. Patent examiners, in relying on
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