Appeal No. 1999-0197
Application 08/054,970
transfectants expressing mutant receptors with deletion of the intercellular amino acids
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405-426 were not responsive to antibodies against the human p55 TNF-R (specification,
page 6). Appellants state at page 7 of the specification that mutant receptors having
amino acids 415-426 deleted confer to the transfected cells high responsiveness to
cytocidal antibodies against the human p55 TNF-R. Appellants go on to say in the third
and fourth paragraph on page 7 of the specification that:
In a third mutant, a single serine residue (amino acid 197) in the
transmembrane domain was exchanged by site directed mutagenesis
against alanine, an amino acid said to be compatible with all known
secondary structures of amino acid sequences. Functional analysis of cells
transfected with this receptor mutant revealed a significant impairment in
these receptors to trigger cell death in response to mimetic antibodies
against the human p55 TNF-R. Yet this functional disruption was not
complete and a small cytocidal effect could still be observed.
Yet, other mutants, in which either amino acids 170-174, 175-179 or both,
i.e., amino acids 170-179 were deleted, abolished shedding of the soluble
extracellular forms of the receptor. This finding demonstrates that the region
of amino acids 170-179 or part thereof, of the receptor, which lies just
outside the transmembrane domain, must be intact in order to allow
formation of the soluble TNF receptors. Therefore, any interference with this
region, or the effector protein interacting therewith, will abolish shedding.
The effector protein, in this case, is believed to be a proteolytic enzyme.
For the purposes of considering the issues raised in this appeal, we believe the
claims should be considered in two groups which we will denominate the use claims and
the screening claims. Claims 34 through 36, 42, 44, 47, 48-50, 56, and 60 are the use
claims. Claims 37, 38, 40, 43, 51, 52, and 54 are the screening claims. As can be seen,
1Appellants explain at page 6 of the specification that monoclonal antibodies
against the human p55 TNF-R mimic TNF action.
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