Appeal No. 2005-1171
Application No. 09/469,485
col. 7, lines 61-63; col. 9, lines 53-59 (Scheme 1); col. 12, lines 34-57. Since denatured
proteins are not biologically active, Builder discloses, inter alia, a method of refolding
the protein by incubating it in the presence of a redox buffer “at about 0° C to 37° C,
depending on the protein, 4-24 hours, preferably overnight.” Id., col. 16, lines 50-55;
see also, col. 17, lines 43-50. We find no teaching or suggestion in Builder to use the
methods described therein for treating soluble, biologically-active proteins. Thus, we do
not find Builder would have suggested to one of ordinary skill in the art to incubate the
soluble, biologically-active (immunogenic) HBsAg taught by Valenzuela II in the manner
recited in the claims. Rather, on this record, the only suggestion we find to incubate
soluble, sterile-filtered rHBsAg with a redox buffer at “about 34° C to about 38° C for
about 40 to about 240 hours” is in the appellants’ disclosure. Thus, we find that the
examiner has engaged in impermissible hindsight to arrive at the conclusion that the
claimed invention would have been obvious over Builder and Valenzuela I (or II). In re
Fritch, 972 F.2d 1260, 1266, 23 USPQ2d 1780, 1784 (Fed. Cir. 1992); Interconnect
Planning Corp. v. Feil, 774 F.2d 1132, 1138, 227 USPQ 543, 547 (Fed. Cir. 1985); W.L.
Gore & Assocs. v. Garlock, Inc., 721 F.2d 1540, 1553, 220 USPQ 303, 312-313 (Fed.
Cir. 1983) cert. denied 469 U.S. 851 (1984)(“To imbue one of ordinary skill in the art
with knowledge of the invention in suit, when no prior art reference or references of
record convey or suggest that knowledge, is to fall victim to the insidious effect of a
hindsight syndrome wherein that which only the inventor taught is used against its
teacher”).
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