Appeal No. 98-1591
Application 08/417,625
which showed detection of clavulanic acid by the imidazole
assay in batch 50/6, may be aberrations.
For the above reasons, the data presented in the Elson
declaration (exhibit 16) are not sufficient to show that when
cephamycin C is made by the Lilly process, clavulanic acid is
not necessarily also produced. On the contrary, these data
support the conclusion that clavulanic acid indeed is
inherently produced when the Lilly process is conducted in
such a manner that the products desired by Lilly are produced.
Appellants argue that Lilly’s observation that the minor
factors produced along with his desired A16886I and A16886II
factors are similar to the A16886I and A16886II factors
indicates that the minor factors are penicillin N and
deacetoxycephalosporin C, because these compounds are more
structurally similar than clavulanic acid to A16886I and
A16886II (brief, page 14). Appellants also argue that Lilly
indicates that the A16886I and A16886II factors and the minor
factors can be used as an acid addition salt, whereas
clavulanic acid does not form an acid addition salt (see id.).
These arguments are not well taken because they are not
directed toward the relevant issue which is not whether Lilly
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