Appeal 2007-0543
Application 10/023,182
According to Appellants, the cDNA encoding NY-ESO-1 was originally
isolated from a library prepared from a specimen of squamous cell cancer of the
esophagus (Specification 6: 4-8), and the corresponding mRNA was subsequently
detected in other esophageal tumors, as well as tumors of unrelated lineage,
including melanoma, and breast (id. at 10: 24-26). NY-ESO-1’s overall “pattern of
expression is consistent with other tumor rejection antigen precursors” (id. at 10:
13-14). Moreover, NY-ESO-1 was “found to be reactive with antibodies in the
serum of cancer patients” (id. at 5: 12-13, 16-17).
In order to evaluate T cell response to NY-ESO-1, the amino acid sequence
of the protein encoded by SEQ ID NO: 1 was analyzed, and peptides satisfying the
binding motif for the MHC molecule HLA-A2 were tested in cytotoxicity assays
(id. at 17: 9-11 and 24: 4-11). Of these peptides, three corresponding to SEQ ID
NOS: 4, 5, and 6, with the common amino acid sequence SLLMWIT, “were the
three best stimulators of CTLs” (id. at 25: 1-4). In addition, the deduced protein
was analyzed for peptides satisfying other MHC binding motifs (i.e., various
HLA-A and HLA-B molecules). Of the thirty-eight such peptides listed in the
specification, only a few have sequences overlapping SEQ ID NOS: 3, 4, and 5
(id. at 25: 9 to 26: 40). According to Appellants, complexes between these
additional peptides and their corresponding MHC molecules “should provoke a
cytolytic T cell response” (id. at 25: 12-15), which “could be determined by one
skilled in the art following [conventional] methods” (id. at 25: 16-17).
According to the Examiner, however, “[t]he specification does not provide
an adequate written description of the claimed genus” (Answer 10), because the
peptides corresponding to SEQ ID NOS: 3, 4, and 5 are not representative of a
genus that encompasses “peptides [which] do not have to share the same common
structure SLLMWIT of . . . SEQ ID NO[S]: 4, 5 and 6” (Answer 5). As far as the
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