Appeal No. 1999-1181
Application 08/480,332
therapeutic agent (i.e. drug) encapsulated inside of the liposomes. Therefore, even though
Klibanov teaches of the attachment of a ligand to the distal ends of PEG chains on a
liposome, there would be no reason to attach the active therapeutic agent to the distal
ends of the PEG chains on the liposomes of Woodle since the active therapeutic agent is
inside the liposomes, not attached on the exterior to the PEG chains.
In addition, the examiner has not shown that the ligand (i.e. antibody) attached to the
distal ends of the PEG chains in Klibanov meets the two criteria for the effector molecules
as set forth in the instant claims. According to the claims on appeal the effector molecule
is a polypeptide or a polysaccharide which “interferes with specific binding between said
first and second binding members and is rapidly removed by renal clearance from the
bloodstream when administered in free form”. The examiner has only shown that the
ligand (i.e., antibody) in Klibanov is a peptide. The examiner has not established that the
antibody on the ends of the PEG chains in Klibanov specifically interferes with the specific
binding between first and second binding members and more importantly, is removed by
renal clearance from the bloodstream when administered in free form. Therefore, even if
Woodle and Klibanov could be properly combined, these criteria as recited in the instant
claims are not accounted for by the examiner.
For these reasons, we reverse the rejection based upon Woodle and Klibanov.
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