Appeal No. 2005-1152
Application No. 10/202,616
under 35 U.S.C. 103(a) for obviousness over Hanes in view of Szoka in further view of
Zuckerman.
According to the examiner (Paper No. 6, page 4)
Hanes teaches aerodynamically light particles incorporating a surfactant
on the surface thereof for drug delivery to the pulmonary system, and
methods for their synthesis and administration. The particles have a tap
density Iess than 0.4 g/cm3 and mass mean diameter between 5:m and
30:m. Exemplary surfactants include phosphoglycerides such as
L-"-phosphatidylcholine dipalmitoyl (DPPC) (col. 3, Iine 57 to col. 4, Iine 66) suitable particulat
10, Iines 24-49). Hanes Iacks specific teachings on other suitable lipids.
Szoka teaches a method of stabilizing polynucleotide complexes by
adding a cryoprotectant compound and Iyophilizing the resulting
formulation. Cationic Iipids are useful in forming complexes to be
cryoprotected and Iyophilized. Conventional cationic Iipids suitable for the
formulations include phosphatidylethanolamine, dioleyloxyphosphatidyl-
ethanolamine, 1,2 dimyristoyl-sn-glycero-3-ethylphosphocholine, 1,2
dioleyl-sn-glycero-3-ethylphosphocholine, etc (col. 6, lines 27-46). The
formulations may also include buffers that can be removed during
Iyophilization (col. 6, Iines 14-26). Charge ratios are disclosed in column
6, Iines 1-9.
The examiner concludes (Paper No. 6, page 4) that
[i]t would have been obvious to a person of ordinary skill in the art
at the time the invention was made to have combined the method and
formulations of Hanes on aerosolized, Iiposome associated drug particles
with compositions of Szoka et al because of the disclosed benefits of
various Iipids in forming complexes and delivering therapeutic agents to
respiratory system and because it provides patients and healthcare
providers a wider selection of treatment and better absorption of actives
systematically.
In our view the examiner has not established a prima facie case of obviousness
over Hanes and Szoka. The examiner has not indicated, and we do not find, a charged
lipid in particles for pulmonary delivery in the disclosure of Hanes. Hanes discloses a
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