Appeal No. 2003-1678 Page 8
Application No. 08/722,659
endothelium and basement membrane of said vasculature which decreases said
localized inflammatory response arising from an ischemia/reperfusion injury" as
required by claim 1 on appeal. The finite amounts described in the written description
of this application are in terms of target dose, e.g., 25 µg/ml, specification, page 40, line
6, or a measured heparinase level in the blood of the laboratory animal, e.g., 1.0 IU/ml
(specification, page 37, last full paragraph). It is acknowledged that administering a
given active agent in differing amounts may illicit different affects within a defined
subset of patients. However, appellants have not argued that the finite amount of
heparinase administered to the rabbits in Example 8 of Zimmermann is not a dosage
within the functional dosage statement set forth in claim 1 on appeal.
Rather, appellants argue does not teach that "heparinase acts to decrease
neutrophil transmigration through the activated endothelium and basement membrane."
Appeal Brief, page 12. Appellants also argue that Zimmermann teaches heparinase
enhances neutrophil transmigration which is contrary to the claimed invention. See,
e.g., Appeal Brief, pages 8-9. In essence, appellants' argument is that Zimmermann
does not recognize that the induced ischemia of Example 8 resulted in localized
inflammation and that the heparinase administered to the rabbits would decrease
neutrophil transmigration through activated endothelium and basement membrane
which would decrease the local inflammatory response.
However, "[i]t is a general rule that merely discovering and claiming a new
benefit of an old process cannot render the process again patentable." Id. Here,
appellants' first burden was to distinguish the patient, active agent, mode of
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