Appeal No. 93-3114
Application 07/825,465
Applicant prepared his test vaccines in a manner which
appears to be identical or substantially the same as the
vaccine preparation method described at pages 101-102 of Maas;
i.e. the fermented cultures are cooled to a temperature of
about 4 to 7 C (Spec., p. 5, lines 3-6), the cooled culturesO
are inactivated with BPL (0.11% v/v)(Spec. p. 5, lines 6-9),
the culture is maintained at about 4 to 7 C during theO
inactivation stage (Spec., p. 5, lines 13-15), the BPL-
containing culture is heated to about 36 to 38 C for 3 to 5O
hours to remove or inactivate BPL (Spec., p. 5, lines 15-22),
preservatives such as gentamicin (30 micrograms/ml) are
preferably added (Spec., p. 5, lines 23-28), and adjuvants
such as 10% aluminum hydroxide gel are particularly preferred
(Spec., p. 5, lines 29-34). While Maas vaccinated test
calves, applicant vaccinated adult cattle.
In Example 1 (Spec., pp. 6-9), applicant reports that
3.3% of control cattle developed cases of acute foot rot when
challenged. However, 1.4% of the vaccinated cattle developed
cases of acute foot rot (Spec., p. 8, lines 11-19). According
to applicant, “[a] 64.1% reduction in clinical index was
observed among vaccinated cattle” (Spec., p. 8, lines 24-25).
Example 1 is the only reported example of immunization trials
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