Appeal No. 2001-1576 Page 3
Application No. 08/460,622
DISCUSSION
Fischer in view of Etzioni and Sutherland:
According to the examiner (Answer, page 4), “Fischer discloses that a
directed GBS [Group B Streptococcus]-specific immunoglobulin preparation was
prepared from pooled plasma obtained from volunteers immunized with a
pentavalent GBS vaccine (Sandoglobulin, GBS-IVIG) which had consistent high
titers of antibody to each GBS serotype (p. 522).” We note that in contrast to the
claimed invention that requires immunizing plasma donors with a Staphylococcus
epidermidis vaccine (claim 1, step (a)), Sandoglobulin is a directed group B
Streptococcus specific immunoglobulin preparation. Nevertheless, the examiner
finds (Answer, page 5), with reference to Etzioni, “that Sandoglobulin contains
antibodies against two different Staphyloccus epidermidis strains (page 160,
third full paragraph).”
The examiner also finds (Answer, page 4, emphasis removed), “Fischer
further teaches the preparation and selection of specific donors necessary to
produce highly active IGIV preparations which can be analyzed for functional
activity against staphylococci (p. 529).” We, however, are unable to find such an
affirmative statement in Fischer. Instead, as we read the reference, Fischer
provides nothing more than an invitation to experiment. According to Fischer
(bridging paragraph, pages 528-529, footnotes omitted), “[d]irected
immunoglobulin preparations could be produced by selecting plasma donors with
high levels of pathogen-specific antibody or by immunizing donors prior to
plasmapheresis. … Analysis of IVIG in vitro has shown functional activity for
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