Appeal 2007-1152
Application 10/660,924
The Specification in its original disclosure describes a one-step
process of administering a tolerizing dose of insulin-secreting cells. In the
“Summary of the Invention,” it is stated:
One embodiment of the invention is a method of creating
immunological tolerance to foreign cells, tissues or organs in a
mammal, comprising the step of implanting in the mammal a
tolerizing dose of foreign cells or tissue encapsulated in a
biologically compatible permselective membrane. The method
may additionally comprise the step of administering to the
mammal a curative dose.
(Spec. 3-4.)
An original claim of the Specification also describes a single step
method:
1. A method of creating immunological tolerance to foreign
cells, tissues or organs in a mammal, comprising the step of
implanting in said mammal a tolerizing dose of corresponding
foreign cells or tissue which shed antigens contained in or on
said foreign cells [,] tissues or organs, said corresponding
foreign cells or tissue being encapsulated in a biologically-
compatible permselective membrane.
(Spec. 27.)
The tolerizing dose is characterized in the original Specification as
being “one to two orders of magnitude less than the curative dose” (Spec. 4:
26-27) and “one or two orders of magnitude less than a full dose implant”
(Spec. 12: 26-27). It is stated in the Specification that the “amount of cells
. . . necessary for the initial tolerizing implant will vary” (Spec. 12: 24-25)
and “the size of these doses . . . can be optimized” (Spec 12: 30-31). Thus,
the Specification describes a dose of one order of magnitude less than a
curative dose (i.e., the dose recited in clam 2 which is “necessary to achieve
normoglycemia in a mammal of the same species”) and that this amount
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Last modified: September 9, 2013