Appeal No. 1999-2634
Application No. 08/108,606
does Evans et al teach growing the E. coli to a predetermined density of
about 1010 bacteria/ml.
The examiner relies on Svennerholm for the teaching that candidate
vaccines for enterotoxin-producing bacteria include bacteria which are inactivated with
formalin treatment or colicin E2 treatment. Svennerholm teaches that the inactivation
of bacteria with mild formalin treatment causes complete killing of the bacteria without
significant loss of the antigenicity of the different CFAs and O antigens. In addition,
Svennerholm teach that both anti-enterotoxin and anti-colonization factor antibodies
can, independently of each other, protect against experimental enterotoxin-producing
E. coli infection and when present together, these antibody specificities cooperate
synergistically in protecting against infection, and that for maximal efficacy an ETEC
(enterotoxin producing Escherichia coli) vaccine should ideally invoke an immune
response that would effectively interfere with both colonization and toxin action. Paper
No. 16, page 5.
Soderlind is relied on for its disclosure of commercially available formalin-killed
E. coli vaccine containing 12 strains of E. coli. Gregory discloses bacterins prepared
from formalin-killed E. coli for the vaccination of sheep. Gregory also teaches that the
K99 antigen is a fimbrial adhesive antigen which facilitates colonization of mucosal
surfaces. Myers is relied on for its disclosure of the growth of E. coli strains which
contain K99 antigens in a suitable growth medium with vigorous shaking for twenty to
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