Appeal 2007-4007
Application 90/006,954
While DE 29,909,210 U1 [the Probiodrug application] utilizes a
DP IV inhibitor to treat diabetes mellitus, it is specifically silent
as to the use of the DP IV inhibitor mechanism to facilitate the
conversion of epithelial cells in the pancreas to insulin
producing cells. Instead, DE 29,909,210 U1 utilized a DP IV
inhibitor to lower the blood sugar concentrations (page 1) by
suppressing the undesired enzyme activity (page 2,
paragraph 1) as a simple alternative acute treatment of
symptoms. (page 2, paragraph 2) The result is a temporary
decrease in the reduction in GLP-1 [glucagon-like peptide-1],
whereas in the present invention the method, as a result of
maintaining the extended presence of GLP-1, causes cells
present in the pancreas to differentiate into insulin producing
cells.
OSI is correct that Probiodrug does not teach the use of the effectors
to facilitate the conversion of epithelial cells in the pancreas to insulin-
producing cells. It does, however, teach administering the same DP IV
enzyme-specific effectors to the same group of patients as therapy for the
same conditions. Although OSI argues that Probiodrug teaches an "acute
treatment", we find the reference makes clear that it also contemplates daily,
long-term therapy. Indeed, OSI's argument does not really deny as much
since "maintaining the extended presence of GLP-1" would require avoiding
even short-term "reduction in GLP-1".
Claim 3 and the Probiodrug reference differ not in the actual method,
but rather in what is said to be the result of the method. We must start with
the premise that both the Probiodrug reference and the disclosure underlying
claim 3 are enabled. Thus, we presume the method of repeatedly treating a
diabetes patient with DP IV effectors will have both therapeutic effects (i.e.,
both the benefits disclosed in Probiodrug and the benefits now claimed). In
the absence of evidence to the contrary, we find that the benefit that now
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