Appeal No. 2004-2138 Page 4
Application No. 08/765,324
The spleen cells of mice that were immunized using the soluble and
electrophoretically purified Apo B, were then used to produce hybridomas according to
standard hybridoma methods.” Id. One of the resulting monoclonal antibodies was
designated HB3cB3. Id. “HB3cB3 binds to the epitope near the T2 carboxy terminal
region of B-100, exclusively, and does not recognize B-48. The epitope recognized by
HB3cB3 may be conformationally changed or masked by lipids and/or other
apolipoproteins present in VLDL.” Id. Thus, monoclonal antibody HB3cB3 binds
exclusively to LDL.
Discussion
Claim 48, the only independent claim, is directed to a method for making
antibodies that will react with a lipoprotein regardless of lipid content and conformation
of the lipoprotein, by treating a lipoprotein or apolipoprotein to delipidate, reduced,
carboxymethylate, and solubilize it with a reducing or denaturing agent, removing all
self-aggregated and degraded material, and immunizing an animal with the treated
apolipoprotein.
The examiner rejected claim 48, together with dependent claims 49-52, as
containing new matter, i.e., lacking an adequate description in the specification. The
examiner summarized her position as follows:
The entire written description support for these method claims [is]
provided for on page 27, lines 5-16 (Example 2) and page 47, lines 15-
34. . . . These passages do not provide for conception and written
description support for that which is now broadly claimed because [they]
do not provide conception by way of written description for (a) immunizing
with lipoproteins or generic apolipoproteins so treated; (b) antibodies in
general/polyclonal antibodies; (c) subgenus of reducing or denaturing
agents; (d) immunization [with] soluble lipoprotein or apolipoprotein
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