Appeal No. 1996-3791
Application 08/028,087
evidence of obviousness (Examiner’s Answer, pages 4-5).
Ishikawa discloses that the pegylation of G-CSF results in longer retention of
G-CSF in mice than the natural version (Example II, page 26). The reference is
directed to prolonging the half-life of G-CSF to enhance its effect (Ishikawa, paragraph
bridging pages 2-3). Ishikawa mentions the size of the PEG as being between 500 to
20,000 Da (page 5, last par. of reference). Ishikawa also discloses the use of oral
administration of the pegylated protein (Ishikawa, page 9). There is no express
disclosure of what constitutes oral administration.
Platz (Abstract) discloses the pulmonary administration of unpegylated G-CSF.
While Platz discloses the general method of administration, the reference does not
contemplate the administration of chemically modified G-CSF.
Takada provides a discussion related to the size of the molecules that can be
absorbed from the lungs into the bloodstream. This reference is directed to address
appellants’ argument that administration of the particular pegylated protein as claimed
has not been proven as feasible (Examiner’s Answer, pages 6-7). However, Takada is
directed to a general analysis of the absorption of macromolecular compounds ranging
from 45,000 to 230,000 Da via pulmonary absorption (Takada, pages 284-286). There
is no disclosure of pegylated G-CSF.
It is the examiner’s position that it would have been obvious to a person with
ordinary skill in the art at the time the invention was made to administer pegylated
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