Appeal No. 2005-0139 Page 5
Application No. 10/227,433
an optimization of the shape, size and texture of the particles, among which
shape of the particles is related to the claimed elongation ratio[ ] [sic].” Id. The
above argument, however, is nothing but a restatement of the problem solved by
the inventors, that is, determining a shape of a carrier particle that has optimum
fluidisability, good flow characteristics and good drug deposition upon inhalation.
Furthermore, our review of the record does not reveal any teaching or
suggestion to produce a lactose monohydrate crystal carrier particle having an
elongation ratio in the range of 1.55-2.20. While Staniforth suggests the use of
lactose as a carrier particle, it teaches the use of carrier particles having a
diameter between 50µm and 1000µm, see id. at col. 3, lines 54-55, suggesting a
particle that is basically spherical in shape. With respect to the York reference,
while Figures 17 and 18 are more elongated in shape, those particles are
salmeterol particles, and not crystals of lactose monohydrate. Although Figures
43 and 45 show alpha-lactose monohydrate particles, nothing in the reference
appears to suggest the claimed elongation ratio.
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