Appeal 2006-2945
Application 10/041,958
grouping, we will treat claim 26 as standing or falling alone. Accordingly,
we limit our discussion to representative claims 26, 28, 30, 31, and 32.
Claim 26:
Claim 26 is drawn to a dosage formulation. We interpret the term
“dosage formulation” to be a pharmaceutical composition. According to
Appellants’ Specification,
[t]he pharmaceutical compositions are prepared by
methods known to one of skill in the art. In general, a
monoclonal antibody, a cocktail of monoclonal antibodies or
monospecific polyclonal antibodies are admixed with a carrier
and other diluents necessary to prepare the pharmaceutical
composition, so that it is in a stable and administrable form.
(Specification 10.) The claimed formulation comprising an effective amount
of human or humanized monoclonal antibodies to prevent or treat hemolytic
uremic syndrome (HUS) in a human. Claim 26 requires that the antibodies
have two properties:
(1) they consist of antibodies that neutralize SLT II in vivo; and
(2) they are specifically reactive with a single subunit of the SLT II
produced by Escherichia coli which causes HUS.
The Examiner’s factual findings and conclusion of obviousness based
on these facts are set forth above. In response, Appellants make a number of
assertions as outlined below. We take each of Appellants’ assertions in turn.
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