Appeal No. 2006-2644 Page 2
Application No. 10/047,945
“[I]mmunoglobulins and other proteins are almost always assayed from serum.
There is a reported data that IgG and IgA were assayed from saliva of BALB/c mice. . . .
There is no published data reporting the use of saliva for assay of IgE.” Id., page 3.
The specification discloses that IgE levels can be determined by assaying saliva. See
id., page 9, line 13 to page 10, line 1.
The specification also reports that “in humans oral administration of a synthetic
Lethal Toxin Neutralizing Factor (LTNF) designated LT-10 lowers IgE level.” Id.,
page 5, lines 9-10.1 LTNF is a protein isolated from opossum serum that neutralizes
venom from a variety of poisonous snakes. See generally Lipps, U.S. Patent 5,576,297
(cited in the specification, see page 5). LT-10 is a peptide that corresponds to the
N-terminal ten amino acids of LTNF. Specification, page 5, lines 16-19.
The specification describes two experiments that form the apparent basis for the
assertion that LT-10 lowers IgE levels. The experiments are described, in their entirety,
as follows:
Experiment 1: The pool of several human salivas was split into two parts.
To one part equal volume of PBS was added and to the second part equal
volume containing 1 mg/ml of LT-10 was added. The mixtures were
incubated at 37 °C for one hour. IgE levels were assayed in both mixtures
by usual ELISA test using anti-IgE. It was revealed that IgE level was
much reduced in the mixture of saliva and LT-10, in comparison to the
mixture of saliva and PBS. This shows the binding of LT-10 to IgE in
saliva, the bound IgE is not detected by anti-IgE by ELISA test.
Experiment 2: I placed one ml of water in my mouth and kept it for 15
minutes, after which the mixture with saliva and water was collected.
Likewise I placed one ml of LT-10 containing 1 mg/ml and the mixture of
saliva and LT-10 was collected. IgE levels were assayed in both mixtures
by usual ELISA test. It was revealed that IgE level was much reduced in
1 Appellants’ “oral” administration appears to be the route usually referred to as “sublingual.” See the
specification, page 6, line 4 (“LT-10 can be given orally under the tongue.”).
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