Appeal No. 2001-2411
Application No. 08/879,422
McCune, page 1633.2 As a result, SCID mice “have severe combined
immunodeficiency, an inability to mount an effective cellular or humoral immune
response to foreign antigens.” Id.
In contrast, when immunocompetent mice were used, their immune
systems reacted to the allogeneic TALL-104 cells and eventually rejected them.3
The specification discloses that the treatment of these mice, as well as treatment
of dogs having spontaneously arising tumors, included administration of
cyclosporin A “to avoid rejection of the allogeneic TALL-104 effector cells.” Page
2. Thus, the specification suggests that patients having a functional immune
system, a.k.a. immunocompetent patients, are those having an immune system
that would be expected to mount an immune response when administered
allogeneic cells.
Finally, the prosecution history shows that the “functional immune system”
limitation was added in order to distinguish the claimed process from prior art
disclosing administration of TALL-104 cells to immunodeficient animal models.
In Paper No. 17 (mailed Oct. 28, 1999), the examiner rejected claims reciting
administration of TALL-104 cells “in the absence of an immunosuppressive
agent” as anticipated by references disclosing administration of TALL-104 cells to
immunodeficient SCID mice. See page 2. In response, Appellants amended the
2 McCune et al., “The SCID-hu mouse: Murine model for the analysis of human hematolymphoid
differentiation and function, Science, Vol. 241, pp. 1632-1639 (1988) (exhibit A attached to the
Appeal Brief).
3 See Cesano et al., “Antitumor efficacy of a human major histocompatibility complex
nonrestricted cytotoxic T-cell line (TALL-104) in immunocompetent mice bearing syngeneic
leukemia,” Cancer Research, Vol. 56, pp. 4444-4452 (1996). This reference is cited in the
specification (page 2) and was made of record in Paper No. 8, filed Nov. 10, 1998.
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