Appeal No. 1996-0944
Application No. 08/181,259
that particular antibacterial agent. Here, purpurmycin and rifaximin are structurally unrelated. The
examiner has failed to establish why one of ordinary skill in the art would have reasonably expected
purpurmycin and rifaximin to be effective against at least one common microorganism. Neither Parenti
nor Merck disclose or suggest that rifaximin is effective against Gardnerella vaginalis, Bacteroides
bivius-disiens, the species Mobiluncus and Lactobacillus, Neisseria gonorrhoeae, Haemophilus
ducreyi or Chlamydia trachomatis. The only place we find such a teaching is in appellants’
specification. Furthermore, the particular target body area(s) is relevant both to the type of
microorganisms expected to be found there and to the pharmacokinetics of the active agent, e.g.,
delivery means, stability, clearance rate, etc. As noted by appellants, the prior art discloses using
rifaximin to treat intestinal infections caused by totally unrelated bacteria, e.g., Escherichia coli,
Salmonella, Enterococcus, etc. (brief, pages 10-11, 16). Thus, while the examiner is correct that only
a reasonable expectation of success, not absolute predictability, is required to establish a prima facie
case of obviousness, the examiner has failed to establish the requisite reasonable expectation of success
on this record. Moreover, the examiner has not rebutted appellants’ arguments that whether a known
antibiotic will be effective against bacterial vaginitis is unpredictable, even with related antibiotics such
as rifampin and rifabutin, (see e.g., Exhibits C and F) and that effective antibiotics may be
contraindicated because of the target body area (see e.g., Exhibits D and E) (brief, pages 12-14 and
reply brief, page 2).
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