Appeal No. 2004-2138 Page 6
Application No. 08/765,324
issue.” Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323, 56 USPQ2d 1481,
1483 (Fed. Cir. 2000). Nonetheless, the disclosure must convey with reasonable clarity
to those skilled in the art that the inventor was in possession of the invention. See id.
The examiner set out five aspects of the claimed method that, in her opinion,
were not adequately explained in the specification. The examiner argues that the
claims contain new matter because they are not limited to monoclonal (as opposed to
polyclonal) antibodies; because they are not limited to the electrophoretic purification
method disclosed in the specification; because they are not limited to the specific
solubilization method used in the specification; because they read on immunizing an
animal with a soluble lipoprotein, in addition to soluble apolipoprotein; and because the
immunogen administered in the specification was not in soluble and reduced form
because it was administered while still in a polyacrylamide gel (and therefore in
insoluble form) and the specification does not disclose that the gel contained a reducing
agent.
We agree with Appellants that none of the claim limitations pointed to by the
examiner renders the specification’s description inadequate. With respect to two of the
examiner’s issues, we agree with Appellants’ argument:
With respect to . . . polyclonal antibodies, immunization of an animal with
an antigen will always produce polyclonal antibodies. One must then
isolate spleen cells and fuse these with immortal cells, which are then
screened, for production of monoclonal antibodies.
With respect to the issue of “lipoprotein” versus “apolipoprotein”, any one
skilled in the art would understand that when one delipidates a lipoprotein,
one by definition obtains an apolipoprotein. It is therefore irrelevant
whether one starts with a lipoprotein or an apolipoprotein, one will utilize
the same material as an antigen.
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