Appeal 2007-2400
Application 10/418,182
5). “Each heavy-chain variable region and each light-chain variable region
includes three hypervariable loops, also called complementarity-determining
regions (CDRs). The antigen-binding site (Fv) region . . . includes these six
hypervariable (CDR) loops.” (Id.).
The Specification discloses immunoglobulin mutants made by “walk-
through mutagenesis” of immunoglobulin CDRs:
In walk-through mutagenesis a set (library) of immunoglobulins
is generated in which a single predetermined amino acid is
incorporated at least once into each position of a defined region
(or several defined regions) of interest in the immunoglobulin
(i.e., into one or more hypervariable loops (CDRs) of the
immunoglobulins). The resultant immunoglobulins (referred to
herein as “mutated immunoglobulins”) differ from the
prototype immunoglobulin, in that they have the single
predetermined amino acid incorporated into one or more
positions within one or more CDRs of the immunoglobulin, in
lieu of the “native” or “wild-type” amino acid.
(Id. at 9-10.)
The Specification also discloses libraries of mutant immunoglobulins
(referred to as “single predetermined amino acid libraries”) made by
performing walk-through mutagenesis on each of the CDRs of an
immunoglobulin of interest, alone and in all possible combinations:
Each single predetermined amino acid library contains 64
subset libraries, in which the predetermined amino acid is
“walked through” each hypervariable loop (CDR) of the
immunoglobulin of interest. . . . The resultant immunoglobulins
include mutated immunoglobulins having the predetermined
amino acid at one or more positions in each CDR, and
collectively having the predetermined amino acid at each
position in each CDR. The single predetermined amino acid is
“walked through” each of the six hypervariable loops (CDR)
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