Appeal 2006-2945
Application 10/041,958
strains 7 were reactive with monoclonal antibody 11E10 and 6 were reactive
with monoclonal antibody 2E1 (Perera, page 2130, Table 2). Of these 10
strains, only 3 strains did not react in a colony ELISA with any of the
neutralizing MAbs to SLT-II (Perera, page 2131, ll. 11-13). According to
Perera, “[t]hese three strains may produce SLTs more like the SLT-IIv of pig
edema disease strains. In support of this possibility is the observation that
none of the nine SLT-IIv-producing edema disease strains were detected by
the MAbs to SLT-II in colony ELISA” (Perera, page 2131, col. 1, ll. 17-20).
Therefore, contrary to Appellants’ intimation, 70% of the SLT-II strains
tested reacted with Perera’s neutralizing MAbs. According to Perera, “[a]ll
the neutralizing MAbs generated in the present study recognized the A
subunit of SLT-II” (Perera, page 2130, col. 1, ll. 34-35). Therefore, we are
not persuaded by Appellants’ assertion that a person of ordinary skill in the
art “would not be led by Perera to use these antibodies in therapy, nor one
would [sic] have a reasonable expectation of success using just an antibody
to Stx2, much less to a single subunit of Stx2” (Br. 19). To the contrary, we
find that Perera’s teaching that 70% of the SLT-II strains tested reacted with
Perera’s neutralizing MAbs provides more than a reasonable expectation of
success in using a neutralizing MAb as a therapeutic agent in a dosage
formulation for the treatment or prevention of hemolytic uremic syndrome in
a human when taken in view of the combination of reference relied upon by
the Examiner. For obviousness under §103, all that is required is a
reasonable expectation of success. In re O’Farrell, 853 F.2d 894, 904, 7
USPQ2d 1673, 1681 (Fed. Cir. 1988). In our opinion, when taken in the
context of the prior art relied upon, Perera provides a reasonable expectation
that a formulation comprising antibodies to SLT II α-subunit would be
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