Appeal 2007-0320
Application 09/945,339
According to the present Specification,
• “[t]he mononuclear cells are incubated with a sufficient
concentration of [a] cytotoxic drug so as to substantially reduce
their ability to cause graft versus host disease while they retain
their ability to proliferate in the recipient to enhance the
recipient’s ability to fight cancer, leukemia and viral infection”
(Spec. 19: 11-15, emphasis added);
• “[a] ‘sufficient concentration’ [of the cytotoxic drug] is that
which causes greater than 90% inhibition of the proliferation of
treated cells as measured by assays known in the art” (Spec. 19:
15-17);
• “the phrase ‘substantially reduce their ability to cause graft
versus host disease’ means that as a result of treatment
according to the methods of the invention, a given
concentration of treated mononuclear cells administered to a
recipient results in the absence of graft versus host disease,
whereas the same concentration of untreated mononuclear cells
administered to a recipient results in severe graft versus host
disease” (Spec. 15: 24 to 16: 2); and
• “[b]y ‘proliferation’ is meant cell division that leads to an
increase in the number of nucleated cells such that the number
of cells and their progeny at, for example, time T + 1 is greater
than the number of cells at time T” (Spec. 16: 11-13).
• Finally, “[b]y ‘in combination’ is meant the treated
mononuclear cells can be administered to the recipient before,
contemporaneously with, or after the administration of the
hematopoietic cells to the recipient” (Spec. 15: 21-24).
Thus, based on the explicit teachings of the Specification, claim 1
requires that the treated mononuclear cells retain their ability to proliferate,
3
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