Appeal No. 2001-0869 Page 16
Application No. 08/453,347
monocyte mediated tumoricidal activity,” the method is the same; the preamble
does not imply any difference in the patient treated or in the method’s
manipulative steps, and therefore does not change the scope of the claim. Cf.
Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1372, 58
USPQ2d 1508, 1513 (Fed. Cir. 2001) (Preamble language reciting “a method for
treating a cancer patient to effect regression of a taxol-sensitive tumor, said
method being associated with reduced hematologic toxicity” was “only a
statement of purpose and intended result. The expression does not result in a
manipulative difference in the steps of the claim.”).
Claims 7-16 depend from claims 1 or 3 and add limitations on the form of
the JE expressed by the cells.5 However, in every case, the claimed method is
based on the monocyte chemoattractant activity of naturally occurring JE/MCP-1.
Thus, even in claims that recite a “mutation” in the naturally occurring sequence,
or a “replacement, insertion or deletion of one or more amino acids,” the claims
implicitly require that the protein expressed in the genetically engineered cells
retains the same monocyte chemoattractant activity of wild-type JE/MCP-1.
Thus, the limitations of claims 7-16 do not patentably distinguish these claims
from the claims corresponding to the count lost in the ‘998 interference.
order to be a “method of suppressing tumor formation,” the claimed method would necessarily
require administering a therapeutically effective amount of JE/MCP-1-expressing cells.
5 For example, claim 7 is directed to “[t]he method of claim 1 wherein the JE/monocyte
chemoattractant protein-1 comprises an amino acid sequence from about amino acid #30 to
amino acid #99 of human MCP-1, a biologically active fragment or mutation thereof,” and claim 9
adds the further limitation that “the mutation is characterized by the replacement, insertion or
deletion of one or more amino acids of the amino acid sequence from about amino acid #30 to
amino acid #99 of human MCP-1.”
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