Appeal 2007-3216
Application 10/271,433
“S. aureus is found in the vagina of approximately 16% of healthy
women of menstrual age. Approximately 25% of the S. aureus isolated from
the vagina are found to produce TSST-1,” the causative agent of TSS in
humans (Spec. 3: 22-25). “[A]s S. aureus grows and multiplies, it can
produce TSST-1. Only after entering the bloodstream does TSST-1 toxin
act systemically and produce the symptoms attributed to TSS” (Spec. 3: 31-
34).
“There have been numerous attempts to reduce or eliminate
pathogenic microorganisms and menstrually occurring TSS by incorporating
into a tampon pledget one or more biostatic, biocidal, and/or detoxifying
compound[s]” (Spec. 4: 20-23). See, e.g., U.S. Pat. Nos. 5,679,369,
5,685,872, 5,618,554, and 5,612,045 (Spec. 4: 27-31). “Despite the
aforementioned attempts, there continues to be a need for compounds that
will effectively inhibit the production of TSST-1 from Gram positive
bacteria, and maintain activity even in the presence of the enzymes lipase
and esterase which can have adverse effects on potency and which may also
be present in the vagina” (Spec. 4-5).
The claims in this appeal are directed to a method of inhibiting the
production of TSST-1 from gram positive bacteria comprising “exposing the
Gram positive bacteria located in and around the vagina . . . to a liquid
vaginal formulation comprising . . . an effective amount of a first active
ingredient” selected from a list of compounds that includes
hexachlorophene.
Appellants appeal from the Examiner’s final rejection of claims 1, 4,
5, and 41-43 – which are all the pending claims – under 35 U.S.C. § 103(a)
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