Appeal No. 2006-2644 Page 6
Application No. 10/047,945
in saliva, which is what is measured in the working examples, correlates to the level of
free IgE in serum.
The specification shows that IgE can be measured in saliva but provides no
evidence to show that the level measured in saliva is indicative of the level of free IgE in
serum. Nor have Appellants pointed to any other evidence of record or known to those
skilled in the art that supplies the missing correlation. In fact, the specification states
that “[f]or humans, immunoglobulins and other proteins are almost always assayed from
serum. . . . There is no published data reporting the use of saliva for assay of IgE and
other proteins.” Page 3. Thus, the evidence of record is not adequate to support the
assertion that saliva levels of IgE provide an accurate measure of free serum levels of
IgE.
Finally, Appellants have pointed to no evidence showing that any fragments of
SEQ ID NO:2 smaller than 10 amino acids have any effect on IgE levels. The working
examples in the specification were carried out with LT-10, a peptide ten amino acids
long. No data are presented for any other peptide. Appellants have acknowledged that
“[f]ree-IgE reduction with a peptide is not known.” Appeal Brief, page 7. Thus, those
skilled in the art would not assume, based on the state of the art, that fragments of LT-
10 would also bind to IgE.
For these reasons, we agree with the examiner that the specification does not
provide adequate guidance to enable those skilled in the art to practice the claimed
method – reducing the serum level of IgE in a human by administering a peptide
comprising the first four amino acids of SEQ ID NO:2 – without undue experimentation.
We therefore affirm the rejection for lack of enablement.
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