Appeal No. 2006-0624 Page 3
Application No. 10/096,127
Specification, page 1.
According to the specification, “the autoimmune diseases share a
common underlying pathogenesis,” id. at 2, and that “it now appears that gamma
[interferon] . . . plays a pathogenic role [in such diseases],” id. at 4.
Upon observation of the diverse clinical pictures manifested
in patients with various autoimmune disease, which includes
hypersensitivity of the immediate type (e.g., bronchial asthma,
which is also an autoimmune condition), and AIDS (a viral disease
with autoimmune components), it becomes apparent that these
diseases have in common a large number of similar laboratory
characteristics. This suggests that a similar disease mechanism is
occurring in each autoimmune disease, but in different target cells.
Thus, it is the unique target (e.g., skin, joints, liver, and the like) of
each autoimmune disease that leads to its characterization in terms
of clinical manifestations. For example, an autoimmune attack
destroying the insulin producing beta-cells of the islets of
Langerhans of an individual would be diagnosed as diabetes (Type
I), whereas autoimmune destruction of the conducting fibers of the
nervous system is characteristic of multiple sclerosis, or
autoimmune destruction of the joint lining tissue is characteristic of
rheumatoid arthritis. Likewise in the case of skin transplantation,
the skin area can be damaged. Yet, in each case, the mechanism
underlying the immune response is similar; a high level of IFNs, a
detectable level of TNF, an elevated level of HLA class II antigens
in the blood or on the surface of the cells, and antibodies to target
cells. In addition, cells taken from autoimmune patients show a
decreased production of IFNs in vitro, even after stimulation with an
interferogen. Consequently, the method of treatment of the various
autoimmune diseases is similar in principle, despite the apparent
clinical differences among the diseases.
Id. at 9-10.
The instant invention thus “includes a method of treating an autoimmune
disease in a patient, where the autoimmune disease is caused by the
disturbance of the synthesis of gamma interferon (IFN) causing damage to the
patient’s immune system thereby having a direct pathological action on the
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