Appeal No. 2005-0192 Page 7
Application No. 09/809,021
[0002]. Therefore, we will accept, for argument’s sake, Appellants’ position that the
claimed preparation must be in a form that can be directly administered to a patient.
In addition, since the uses disclosed in the specification rely on thrombin’s
enzymatic activity as part of the blood-clotting process, the claimed preparation must
apparently contain enzymatically active thrombin in order to be suitable for therapeutic
purposes. We do not, however, interpret the claim to require that the preparation be
stable when stored in liquid form, or that it be virus-free, or that it be sterile. While those
properties may be desirable for a commercial product, the absence of such properties
would not render the preparation therapeutically ineffective. Therefore, they are not
required by the phrase “suitable for therapeutic purposes” when that phrase is given its
broadest reasonable interpretation in light of the specification.
Based on this interpretation of the claim language, the prior art preparations
reasonably appear to be “suitable for therapeutic purposes.” Lorne discloses that the
thrombin in the eluate had a specific activity of “1450 NIH units/mg”; therefore, the
thrombin was enzymatically active. Although Lorne suggests that the thrombin- and
benzamidine-containing eluate should be subjected to a two-step dialysis procedure,
those dialyses are intended “to place the protein in good conditions to lyophilize it.”
Page 15. Lorne does not disclose or suggest that the dialyses are required in order to
make the thrombin-containing solution therapeutically effective.
In fact, Lorne provides evidence that the standard for therapeutic efficacy is
rather low. Lorne teaches that the standard thrombin used in fibrin glues “is of animal
origin, specifically equine or bovine.” Page 3. Thus, a thrombin-containing preparation
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