Appeal No. 1998-0350
Application No. 08/453,937
composition and method are unexpectedly superior to what would have been
expected based on the prior art. Broze shows that when LACI and heparin are
combined in the presence of 65 µg/ml of antithrombin III (AT III), they have a
combined anticoagulant activity that is lower than the anticoagulant activity of
LACI alone in the presence of AT III. See Figure 3 of Broze (compare results
shown as filled squares (LACI + AT III) with those shown as filled upright
triangles (LACI + heparin + AT III)).
Normal plasma contains about 290 µg/ml of AT III. See the Wun
declaration filed June 17, 1994, page 3. Given this level of endogenous AT III
and the teaching of Broze, those skilled in the art would have expected the
combination of LACI and heparin to have a lower anticoagulant activity in whole
plasma than LACI alone.
Contrary to this expected result, however, Appellant’s data show that the
combination of LACI and heparin has a higher anticoagulant activity in whole
plasma than LACI alone. See Figure 4 in the specification. Figure 4 shows that,
in whole plasma,4 LACI alone and heparin alone have roughly equivalent
anticoagulant activities. For example, when LACI was added to plasma at
2.5 µg/ml, coagulation required about 100 seconds, about the same
anticoagulant effect as that caused by heparin at 0.5 U/ml of plasma. However,
when both LACI (at 2.5 µg/ml) and heparin (at 0.5 U/ml) were added, coagulation
4 The plasma was depleted of endogenous LACI. See the specification at page 6. Normal
plasma, however, contains only 0.1 µg/ml of LACI. See the Wun declaration filed December 15,
1994. The plasma used in Figure 4 was supplemented with exogenous LACI at well over 0.1
µg/ml and therefore the experimental results cannot be attributed to removal of the endogenous
LACI.
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