Appeal No. 1999-2634
Application No. 08/108,606
coli bacterial strain expressing the colonization factor antigens in a liquid
culture medium to a predetermined density of about A640 of about 0.9: (2)
harvesting the E. coli bacterial strain; (3) resuspending the bacterial strain
in water; (4) treating the cells with colicin E2 at 37EC while agitating; (5)
harvesting and resuspending the bacterial strain in saline (p 10, column 2,
paragraph 2). Evans et al disclose adding a pharmaceutically acceptable
diluent to the bacterial cells. ... Evans et al teach the oral administration of
the inactivated vaccine. ...Evans et al does not teach treating the bacterial
strain with formalin. Evans et al does not teach the administration of the
vaccine with Cholera toxin-b subunit (CTB).1 Evans also does not
specifically teach vigorous agitation during the entire growing step nor
1 Although the examiner suggests that Evans does not does not teach the
administration of the vaccine with Cholera toxin-b subunit (CTB) we note Evans 1 does
teach in the Summary on page 9, that the oral vaccine testing in Evans was (ST+LT+;
078:H11:CFA/1). We further note, Svennerholm indicates that heat labile enterotoxin
(LT) cross reacts with the beta subunit of cholera toxin. Svennerholm, page 196.
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