Appeal 2006-2945
Application 10/041,958
We are not persuaded by this evidence. The evidence relied upon by
the Examiner, which teaches the use of antibodies to treat HUS in humans, is
not a new therapeutic approach to the disease. Instead, as discussed above,
Krivan expressly teaches the use of antibodies to treat SLT related disease,
including HUS, in humans. Accordingly, while the declaratory evidence
may suggest that a pig model is useful to explore new therapeutic
approaches, the evidence of record has already established that antibodies
are useful in the treatment of SLT related disease in humans.
We are also not persuaded by Tzipiri’s declaration that piglets are the
only model that can be used to determine a therapeutic dose. Krivan
discloses 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. Such dosages will be readily determinable by
those of ordinary skill in the art, given the teachings contained
herein. The usual dose range would be 100 mg to 5 gm of
immunoglobulin.
(Krivan, col. 10, ll. 48-54.) Appellants do not refute that Krivan discloses a
dosage that would be considered by those of ordinary skill in the art to be an
effective dosage. Instead, Appellants assert that while “[t]he dosage Krivan
provides is for oral administration . . . [Krivan’s dosage of] 100 mg to 5
grams, greatly exceeds the amount that would be parenterally administered a
human child” (Br. 30). Not only does claim 26 not require parenteral
administration, claim 26 also does not require treatment of a human child.
Further, as Tzipiri declares, a person of ordinary skill in this art would
recognize that the exact dosage is a results effective variable that is readily
determined in dose-response studies (Tzipori Declaration ¶ 5). This is fully
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