Appeal 2007-1633
Application 09/480,236
provide an enabling description of “a recombinant immunotoxin polypeptide
comprising an antibody having a variable region which is at least about 90%
identical to the variable region of UCHT-1 and is at least about 90% as
effective as UCHT-1 for binding human CD3” (Answer 4-5).
Accordingly, we affirm the rejection of claim 51 under the
enablement provision of 35 U.S.C. § 112, first paragraph. According to
Appellants, “[t]he claims stand or fall together as to each ground of
rejection” (Br. 3). Accordingly, claim 50 falls together with claim 51.
Obviousness:
Claims 35-54 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Neville, Kreitman ’95, and Kreitman ’94. Claim 35
is drawn to a recombinant immunotoxin polypeptide or a pharmaceutically
acceptable salt thereof. The recombinant immunotoxin polypeptide
comprises a CD3-binding domain and a Pseudomonas exotoxin (PE) mutant.
Appellants’ Specification defines CD3-binding domain as “an amino acid
sequence capable of binding or otherwise associating with mammalian, and
more preferably primate, and even more preferably, human, CD3 antigen on
T cells or lymphocytes” (Specification 14).
Claim 35 requires that the PE mutant has ADP-ribosylating and
translocation functions but substantially diminished cell-binding ability.
According to Appellants’ Specification “[d]isruption or deletion of all or
substantially all of cell-binding Domain Ia has been found to substantially
reduce the cell-binding capability and thus the non-specific toxicity of the
native PE molecule” (Specification 24). Examples of PE mutants within the
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