Appeal 2007-0746
Application 10/139,496
STATEMENT OF THE CASE
Sensorineural hearing loss (SNHL) “is the result of damage to either
the sensory system within the inner ear or the nerves that carry information
from the sensory system to the brain.” (Specification (“Spec.”) 1.)
“Autoimmunity is suspected to be a cause of some cases of sudden onset,
rapidly progressive or fluctuating hearing loss, particularly when bilateral
involvement occurs.” (Spec. 2.)
“Currently there is general consensus among researchers in the field
that the target antigen of the hearing loss antibody is a 68 kDa protein found
in the inner ear. It has been postulated that the 68 kDa protein is HSP-70,”
but “the correlation between the Western blot [for HSP-70] and patient
[response] to steroid treatment is low . . . .” (Spec. 3.)
The claimed invention in this case “generally relates to a purified
novel antigen, Inner Ear Supporting Cell Antigen (IESCA) reactive with an
autoantibody associated with autoimmune sensorineural hearing loss
(AISNHL), and to methods for predicting the response of AISNHL patients
to therapeutic treatment.” (Id.) According to Appellants, the “present
invention represents a major improvement over existing tests for AISNHL,
which identify antibodies to a universally distributed substance [HSP-70]
that is not unique to the inner ear and has never been linked to hearing loss.”
(Spec. 4.) The specific autoantibody reactive to IESCA required by the
claims is KHRI-3 monoclonal antibody.
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Last modified: September 9, 2013