Appeal No. 1996-3791
Application 08/028,087
page 3) to which appellants responded by way of Reply Brief (Paper No. 22).
BACKGROUND
The present invention is directed to pulmonary administration of pegylated
G-CSF (specification, page 5). The claimed invention is based on the “broad discovery
that a protein to which a polyethylene glycol molecule has been attached may be
absorbed by the lung into the bloodstream” (specification, page 5). According to
appellants, pulmonary administration of pegylated proteins has not been previously
demonstrated (specification, page 4). Appellants also state that polyethylene glycol
(PEG) is not expected to cross hydrophobic membranes to any significant degree
because it is a large hydrophilic molecule (specification, page 6). Finally, appellants
also argue in page 5 of the Reply Brief that:
One would have expected delivery directly to the heart to
result in more immediate biological activity [i.e., proliferation
of total circulating white blood cells] because of delivery
directly to the bloodstream, than delivery to the lung, where
the transport across the lung was necessary. Figure 17
shows that for pegylated G-CSF, lung delivery and heart
delivery were very comparable.
THE REJECTION UNDER 35 U.S.C. § 103
The examiner relies on the combination of Ishikawa, Platz and Takada as
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