Appeal No. 2005-0139 Page 3
Application No. 10/227,433
York is cited for teaching “salmeterol and lactose particles of controlled
size and shape.” Id. at 4. In particular, the reference is cited for teaching the use
of supercritical fluids to produce particles having improved flow characteristics,
and for teaching “that the inhalation particles (both drug and carrier) should have
low dynamic bulk density because a lower dynamic bulk density results in
particles with low cohesive force, less static charge and particles with good
fluidisability.” Id. York is also cited by the rejection for teaching lactose carrier
crystals having different shapes, such as a blade-like shape with reduced
elongation and more needle like elongated particle. See id.
The rejection concludes:
Neither reference teaches the claimed elongation ratio of
lactose particles. However, both [York] and Staniforth recognize
that the flow properties of the inhalation drugs and ultimately their
dispersion in the respiratory tract is a function of low cohesive
forces, high fluidisability and which in turn depend on the shape and
structure of the particles. Therefore, it would have been obvious for
one of an ordinary skill in the art to prepare inhalation drug such as
salbutamol (of Staniforth) containing lactose carrier where the
carriers have a suitable size and shape (including whether the
particle is round or elongated) such that the drug composition has
optimum fluidisability, good flow characteristics and good drug
deposition upon inhalation. The expected result would be an
inhalation formulation containing drug and lactose particles, where
the particles do not agglomerate or stick to the walls of the inhaler
and at the same time possess good flow properties so as to be
deposited in the respiratory tract.
Id.
Appellants argue that the examiner has used hindsight to combine
Staniforth and York to arrive at the claimed invention. See Appeal Brief, page
12. We agree.
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