Appeal No. 2006-2466 Page 2
Application No. 09/835,759
“In individuals (both animals and humans) bearing solid nonlymphoid tumors,
tumor progression is associated with a change in the TH1/TH2 balance, in favor of a
predominant TH2 response.” Id., page 3. In fact, in these individuals, there may be a
humoral immune response, referred to as “a pro-tumor immune response,” that “has a
propensity (e.g., as mediated through activated B cells, immune complexes, and
activated immune effector cells) to: selectively drive the immune response, in polarizing
the immune response, to comprise a TH2 response; preserve an immune response
polarized to a TH2 response; and to suppress cell mediated immune response
comprising a TH1 response (as exemplified by a TH2/TH1 imbalance).” Id., pages
21-22.
The specification describes vaccines and methods “to suppress a TH2 response,
and induce a cell mediated immune response to tumor-associated antigen.” Id., page 6.
In particular, the specification describes “a vaccine comprising an immunotherapeutic
composition, and tumor-associated antigen.” Id., page 25. A “tumor-associated antigen”
is “a composition comprising one or more antigens expressed by tumor cells of solid
nonlymphoid tumor origin.” Id., page 16.
An “immunotherapeutic composition” is “a composition (a) comprised of at least
one affinity ligand which selectively (preferentially) binds to at least one determinant
present on nonmalignant B cells, preferably mature B cells and/or memory B cells; and
(b) where[ ]upon contact and binding to such B cells, directly or indirectly results in
(causes and/or enables) B cell depletion when added in an amount effective to cause
the B cell depletion.” Id., pages 8-9. In reference to B cells, “depletion” means “one or
more of: blocking of B cell function; functional inactivation of B cells; cytolysis of B cells;
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