Appeal 2007-0185
Application 10/305,281
10, 20 or 40 mg of pravastatin. (Br. 6.) This argument of Appellants is
unsupported by evidence of record. Appellants have provided no evidence that 80
mg of pravastatin alone lowers LDL cholesterol levels to a greater degree than 80
mg pravastatin and chromium.
Appellants argue that based on the dose response curve (Br. 20),
corresponding to example 1, one of ordinary skill in the art would expect that as a
once daily dosage of pravastatin is increased beyond 40 mg, the percentage
reduction in LDL-cholesterol cholesterol would not be significantly better than that
obtained using 40 mg of pravastatin. (Br. 12.)
Appellants thus rely on data from the Physician's Desk Reference (PDR)
54th, edition (2002) page 846 edition, and 2002 PDR, pages 1-23, as evidence of
unexpected results and of non-obviousness of the claimed invention.2 A
characterization of Table 3 of the PDR 2002 is reproduced at page 7 of the Brief
and incorporated into the standard dose response curve on page 20 of the Brief.
The data from the PDR is indicated in the Brief to reflect the mean percentage
reduction in LDL cholesterol from baseline. In contrast, Appellants’ Data from
Specification, example 1, appears in two forms, an LDL-C actual and LDL-C
calculated. A mean percentage reduction in LDL-C was calculated. (Specifi-
cation 9-10.)
The Examiner finds several deficiencies with Appellants' evidence of
unexpected results. (Answer 8.) The Examiner finds that the scale of the x-axis
is not “proportional” and that there is a perception of unexpected results appears
significant at the higher dosages.
In particular, the Examiner argues
2 Pages 1-23 were not attached to the PTO Copy of the Supplemental Brief. Nor
does the scanned record reflect they were attached to previous amendments.
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