Appeal No. 2001-1933
Application No. 08/940,058
paroxetine crystals of the prior art in solid formulation since it is conventionally taught
that spray drying is expected to give a better absorbed amorphous state of the drug.”
Answer, page 5.
Similar to the argument set forth herein in response to the rejection (I.),
appellants argue that the art (Leonard and Barnes) provides a teaching away from the
use of amorphous paroxetine in pharmaceutical compositions due to its hydroscopicity,
by those of ordinary skill in the art at the time the invention was made. Appellants also
argue that Byron, of record, does not evidence that ?any and all formulations are
suitable for spray drying” to prepare amorphous compounds Brief, pages 45-46.
Byron appears to suggest that ?The amorphous form collected following spray drying of
lactose, trehalose and sucrose was unstable in the solid state at 25°C, reverting to the
crystalline form at relative humidities $ 52%.” Byron, page 109. ?Exposure of spray
dried mannitol to high humidity in a microcalorimeter (9) also failed to induce any
observable recrystallization event leading to a deduction of 100% crystallinity.” Id.
Thus, it would reasonably appear that those of ordinary skill in the art would not have
expected that spray drying would necessarily produce stable, amorphous compounds.
Again, we agree with appellants that the examiner has failed to provide sufficient
motivation for combination of the cited references in view of the teaching away in the
art, discussed herein. Nor has the examiner provided sufficient evidence of a
reasonable expectation of success of obtaining stable, amorphous compounds in view
of the teachings of Byron.
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