Appeal 2006-2945
Application 10/041,958
supported by Krivan’s teaching that “[t]he actual amount of IgG or
antibodies to be administered for a prophylactic or therapeutic effect will
depend upon the particular disorder being treated and the size and/or age of
the human or animal” (Krivan, col. 10, ll. 48-51). For the same reasons we
are not persuaded by Appellants’ assertion that “[t]he art . . . fails to suggest
using an appropriate animal model that would lead one of skill in the art to
determine an effective dosage” (Br. 30) or that while “Williams defines a
‘therapeutic amount’ . . . as ‘that amount of antitoxin required to neutralize
the pathologic effects of E. coli toxin in a subject’ [t]here is no indication of
what this actually constitutes . . .” (Reply Br. 7).
We also recognize Tzipiri’s statement that “polyclonal antibodies
made in animals, however purified, cannot be injected into the blood stream
of humans, either for treatment or prevention”; that Krivan provides no
evidence that the antibodies are effective when orally administered; and that
Krivan provides no evidence that the administration of “antibody might
safely and effectively protect, ameliorate, or prevent Stx-mediated systemic
disease” (Tzipiri Declaration ¶ 7). We are not persuaded by these statements
for a number of reasons:
1. There is no requirement in Appellants’ claim 26 that the antibody
be injected into the blood stream of a human or administered orally.
Appellants fail to address Kirvan’s teaching that pharmaceutical
preparations may be administered by injection or topical application,
intravenously, orally, intradermally, subcutaneously, intraoccularly,
subconjunctively, intramuscularly, and intrathecally (Krivan, col. 11, ll. 15-
20),
21
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