Appeal No. 1999-2330
Application No. 08/219,200
First, the examiner provides a reference, Kahan, which generally suggests that
there are no in vitro immune assays which predict or correlate with immunosuppressive
efficacy. However, appellants present in vivo data in Lenschow, a publication more
specific to the technology in question, which showed that CTLA4Ig bound to both
murine and human B7 and inhibited primary xenogeneic mixed lymphocyte reactions in
vitro. Lenschow, page 790, column 1. Moreover, CTLA4Ig in vivo treatment resulted
in prolonged donor specific unresponsiveness to human pancreas islet xenografts.
Lenschow used a xenogeneic transplant in vivo model and indicated that ?one
advantage of the xenogeneic transplant model is the availability of a MAb to human B7
that does not react with mouse B7... Thus, the role of human B7-bearing antigen-
presenting cells (APCs) could be directly examined.” Lenschow, page 790, column 3.
Therefore, it would reasonably appear that appellants have provided in vivo
experimental evidence conducted in a relevant, art accepted model to support
enablement of the pending claims. We also agree with appellants that the examiner
has provided ?no reason to believe that the use of B7 and CD28 antigens would be
unpredictable in view of the successful use of homologous molecules, e.g., CTLA4Ig, in
vivo.” Brief, page 14. In our view, the data and discussion in Lenschow is more
relevant to the enablement issue before us, than the general immunosuppression
publication cited by the examiner, Kahan.
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