Appeal No. 2006-2644 Page 5
Application No. 10/047,945
We agree with the examiner that the specification does not provide sufficient
guidance to enable the claimed method. In particular, the specification provides
inadequate evidence to show that any fragments of SEQ ID NO:2 in fact reduce serum
levels of IgE.
As the examiner has pointed out, the experimental data in the specification do
not show that LT-10 causes any reduction in the levels of IgE. The ELISA test used in
the specification’s experiments to measure IgE levels is based on antibody binding to
the IgE. See the paragraph bridging pages 9-10. Thus, the assay used is incapable of
measuring whether an analyte is present or absent; all the assay can measure is
whether the analyte is or is not bound by an antibody.
The results reported for the experiments in the specification (quoted at pages 2-3
above) are consistent with this limitation of ELISA tests. In Experiment 1, the data were
reported to show that “the bound IgE is not detected by anti-IgE by ELISA test” and the
results of Experiment 2 were said to show “the binding of LT-10 to IgE in saliva in
mouth.” Specification, page 8. We agree with the examiner that, at best, the data show
that LT-10 binds the same part of the IgE molecule that is bound by the antibody used
in the ELISA test. The data do not show that the binding of LT-10 to IgE results in a
reduction in the amount of IgE present.
In addition, Appellants have pointed to no evidence showing the effect of LT-10
on serum IgE levels. Claim 9 is directed to a “method for reducing free serum IgE in a
human” by administering a peptide “to reduce serum level of free IgE in said human”
(emphases added). The specification provides no evidence to show that the level of IgE
Page: Previous 1 2 3 4 5 6 7 8 9 10 Next
Last modified: November 3, 2007