Appeal No. 1998-2088
Application 08/372,712
A patient is in need of treatment with an agent which inhibits TNF-a activity,
such as a compound of formulas (I), (II) or (III), where the patient is suffering
from certain autoimmune or other diseases for which elevated activity of
TNF-a is implicated as a contributing factor in the progression of the
disease.
Specification, page 57.
From this passage it is clear that the term “patient in need thereof” includes
mammals in which TNF-a-mediated inflammatory events are implicated as a
contributing factor in the progression of an acute or chronic disease or condition.
The rejection under 35 U.S.C. § 112, second paragraph
The Examiner’s position appears to be that the above passage does not
satisfy the question “who is in need thereof.” Citing the first two paragraphs on
page 57, the Examiner states:
this is a much broader concept than claim 18, and not particularly useful. It
[the term] is not limited to TNF-a, as immunological based disease can be
based on other cytokines such as the interleukin family, as well as other
enzymes such as histamines, etc. Further the “in danger of suffering
from…immunological based disease” would in its broadest sense cover
everyone, since there is no such thing as immunity from such disease. At
any rate, this paragraph is so broad that it would cover e.g. someone with
Asthma….
[T]he claim language is broader than autoimmune diseases [which the
Examiner does not find indefinite]. It also covers “other diseases for which
elevated activity of TNF-alpha is implicated as a contributing factor in the
progression of the disease.” This is openended [sic] and vague…
[o]ne cannot determine who is and who is not in need thereof just by
measuring their TNF-alpha levels.
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