Appeal 2007-0185
Application 10/305,281
When the x-axis of the graph gets shortened and the y-axis stays the
same, the slope of the curve will inevitably getting [sic] steeper. When
the x-axis is proportional in normal scale and not in log scale, the
"steep" increase of the slope would be disappeared. When employing
80mg and 160mg, the LDL reduction are 37% and 45% respectively.
When employing 40mg of pravastatin, the LDL reduction is 34%. It is
clear that the increase is not really significant because by increasing
the dosage by 4-fold (40mg to 160mg), the increase in LDL reduction
is only better by about 10%. By doubling the dose, the increase in
LDL reduction is only by 3%. Therefore, the alleged "substantial"
benefit is actually considered as an expected benefit.
(Answer 8.)
The Examiner also notes that the duration of the trails were different, one
being 6 wks and one being 8 wks. (Answer 8-9.)
We agree with the Examiner that discrepancies in Appellants' data exist.
The Examiner noted that the PDR and Appellants’ data differs by 5% for the same
donsage amount, 40 mg. (Answer 13.) Furthermore, it is unclear from Appellants’
data whether missing data points at 60, 100, 120, and 140 mg would have resulted
in a linear data progression, evidencing an expected decrease in LDL-C. (Id.) The
Examiner further argues there is no statistical error measurement in the results
Appellants have provided, and thus, a determination of statistical significance of
the results cannot me made. (Id.) While we do not entirely agree with the
Examiner's statements that Appellants' data is not statistically significant,3 we do
not find on the evidence of record that Appellants have addressed, explained, or
resolved the indicated discrepancies in the data they rely upon to show unexpected
results.
3 Note "SD" or standard deviation, (Specification 9) and "p-value" (Specification
10).
- 5 -
Page: Previous 1 2 3 4 5 6 7 8 Next
Last modified: September 9, 2013