Appeal No. 2000-1783 Page 5
Application No. 08/817,719
Thus, the dispositive issue here is not whether appellant has established that the
disclosure is broadly enabling for the scope of the claims, rather, the issue is whether
the PTO has met its Ainitial burden of setting forth a reasonable explanation as to why@
it is not. Keeping this in mind, we consider the specific reasons provided by the
examiner in support of her position.
With respect to the unpredictability associated with treatment of autoimmune
diseases, the examiner argues that A[n]umerous and variable parameters contribute in
determining the extent to which CD23 binding agents such as anti-CD23 antibody [ ] will
function in vivo, including cross-reactivity with related antigens, affinity constant,
isotype, rate of clearance from the blood, bioavailability, localization, and distribution of
antibody within the body.@ Answer, pages 4-5. This argument is not persuasive. Even
assuming that all of these parameters contribute to therapeutic efficacy, the examiner
has not begun to establish (as by an analysis in keeping with that set forth in Wands)
that their optimization would have required undue experimentation.
With respect to CD23 binding agents, the examiner argues that Athere is no
evidence in the specification . . . that the enormous number of functionally defined
CD23 binding agents can be readily obtained without undue experimentation because
the specification does not provide guidance as to critical structural characteristics of
CD23 binding agents.@ Answer, page 4. However, the specification does provide
guidance: on page 12, the specification teaches that determining whether an agent may
be useful in the treatment of autoimmune diseases Acomprises whether or not the agent
is capable of blocking the interaction between CD23 and CD11b, or the interaction
between CD23 and CD11c, or the interaction between CD23 and CD21, or the
interaction between CD23 and a 70 to 85 KDa . . . or a 115 KDa protein expressed on
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