Appeal No. 2004-2138 Page 9
Application No. 08/765,324
New Grounds of Rejection
Under the provisions of 37 CFR § 41.50(b), we enter the following new ground of
rejection: claims 48-51 are rejected under 35 U.S.C. § 102(b) as anticipated by Lee,
and claim 49 is rejected under 35 U.S.C. § 103 as obvious in view of Lee and Goding.2
Lee teaches a method of making an antibody to LDL. Lee describes the
preparation of the immunogen as follows: “The LDL2 were delipidized wet with ethanol
and diethyl ether, the latter being freed of peroxides before use. The LDL2
apolipoprotein obtained was solubilized totally in 6 M guanidine HCl buffer containing
the reducing agent dithiothreitol. After carboxymethylation, the reduced and
carboxymethylated (RCM) LDL2 apolipoprotein was purified by gel filtration to yield pure
RCM apolipoprotein B.” Abstract. The RCM apolipoprotein B was then used to
immunize a rabbit (page 136, right-hand column).
Thus, Lee teaches a method of making antibodies comprising immunizing an
animal with a desired apolipoprotein that has been delipidated, reduced,
carboxymethylated, and solubilized with a reducing or denaturing agent (guanidine HCl
buffer containing dithiothreitol), where all self-aggregated and degraded material have
been removed from the treated apolipoprotein (by gel filtration). Thus, the method
taught by Lee meets all the limitations of claim 48. Lee’s method also involves making
antibodies to Apo B, which will bind to LDL; Lee’s method therefore meets all the
limitations of claims 50 and 51.
Lee does not teach a method of making monoclonal antibodies, as in instant
claim 49. However, Goding teaches methods of making monoclonal antibodies to a
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