Appeal 2007-0913
Application 09/888,126
Edwards is cited for teaching particles “incorporating a surfactant
and/or a hydrophilic or hydrophobic complex of a positively or negatively
charged therapeutic agent and a charged molecule of opposite charge for
drug delivery to the pulmonary system, methods of preparation, and
administration.” (Id.). Surfactants include dipalmitoylphosphatidylcholine
(DPPC), and exemplary hydrophilic or hydrophobic complexes include
insulin and protamine (id.). Moreover, according to the Examiner, the
formulations of Edwards may include one or more excipients such as sugars,
proteins, and surfactants (id. at 4). In addition, “Edwards discloses that
administration of the particles to the lung by aerosolization permits deep
lung delivery of relatively large diameter therapeutic aerosols, for example
greater than 5 micron in mean diameter. The particles can be fabricated with
features which enhance aerosolization via dry powder inhaler devices, and
lead to lower deposition in the mouth, throat and inhaler device.” (Id.).
The Examiner cites Example 9 of Edwards, which discloses particles
containing 60% DPPC, 2% insulin, 19% albumin, and 19% lactose (id.).
The particles are made from solutions of the ingredients, which are
combined and spray dried to produce the particles (id.).
The Examiner concludes:
It would have been obvious to a person of ordinary skill
in the art at the time the invention was made to have modified
the formulations of Patton containing insulin, buffers and
carriers with insulin formulations and methods of delivering the
insulin formulations to the lung as taught by Edwards and to
have implemented DPPC as the carrier, since it was disclosed
that DPPC is an exemplary surfactant, naturally occurring in the
lung.
Id. at 4-5.
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