Appeal No. 2005-0192 Page 5
Application No. 09/809,021
Lorne describes the results of the experiment:
Benzamidine at the concentration of 15 mmol/l also led to elution of the
thrombin. The results are comparable to those obtained with arginine
methylester in terms of specific activity (1450 NIH units/mg), yield
(approximately 78%), and electrophoretic purity. . . .
Regardless of the elution method selected, the final recovery of this
thrombin obtained by chromatography must be done via a preliminary
dialysis or ultrafiltration in an NaCl 1 M medium in order to dissociate the
complex formed with the elution agent. Next, the salt will be eliminated by
dialysis against water and glucose at 10 g/l in order to place the protein in
good conditions to lyophilize it.
Page 15.
Thus, the initial eluate described by Lorne (i.e., the eluate prior to the two dialysis
treatments described in the last paragraph of the above quote) reasonably appears to
be a thrombin preparation comprising enzymatically active thrombin as a complex with
benzamidine.
Appellants do not dispute that Lorne’s preparation comprises a complex of
thrombin and benzamidine, but they argue that the preparation does not anticipate claim
18 because “[r]eview of the full documents shows that . . . neither Lorne nor Allary
teaches a preparation comprising both ‘thrombin’ and a ‘noncovalently binding inhibitor
of thrombin activity’ such that the overall composition with both ingredients is ‘suitable for
therapeutic purposes.’” Id., page 17. The phrase “suitable for therapeutic purposes,”
Appellants argue “mean[s] that it can be directly administered to a patient.” Id., page 16.
translations to the Board. See the Appeal Brief, page 17 (footnote 2). Since both Appellants and the
examiner apparently considered and relied upon the full-text references, we will do so as well.
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