Appeal No. 2001-2497 Page 4
Application No. 08/855,744
of the therapeutic agent are confined to the target site and systemic toxicity is
minimized.
Discussion
The claims are directed to a method of treating a patient with either tumor
necrosis factor (TNF) or interleukin-1 (IL-1). In the claimed method, the patient is
first administered a conjugate that consists of two VH-VL binding molecules
connected by a peptide linker. One of the binding molecules in the conjugate
binds specifically to the therapeutic agent (TNF or IL-1) and the other binds to a
target site antigen. After it is administered, the conjugate is allowed to reach
equilibrium between the capillaries and extravascular space. A liposome
conjugated with conjugate-specific antibodies is then administered (one or more
times) to bind circulating conjugate and, finally, the therapeutic agent is
administered.
1. Enablement
The examiner rejected the claims for as nonenabled. The statement of
the rejection in the Examiner’s Answer reads as follows: “Claims 1 and 3 stand
rejected under 35 U.S.C. § 112, first paragraph. . . . This rejection is set forth in
prior Office action, Paper No. 5; please also see the Office action in paper No.
10.” Examiner’s Answer, page 3. Paper No. 5 (mailed July 29, 1992), in turn,
provides the following statement of rejection:
[T]he specification does not provide any probative evidence for the
operability of the claimed methods. . . . [I]t is unclear as to the
operability of the methods since the delivery of the therapeutic
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