Appeal No. 2006-3202 Page 12
Application No. 10/323,592
the claimed invention. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed.
Cir. 1993). In this context, the following issues should be considered:
First, Appellants state in their Brief (page 12), “during their investigations the
inventors came to the important realization that when the methods are carried out in
such a way that blood flows through the vessel at a significant rate (approaching or at
physiological rates), in fact vulnerable plaques are indicated by temperature differences
which are rather low, specifically not more than 0.39°C.” Claim 30, however, is not
limited to carrying out the method in the presence of blood flow. It is not clear from the
record (and possibly inconsistent with it) that, when the method is carried out in the
absence of blood flow, elevated temperatures in the claimed range would be
experienced by inflamed plaques.
Second, it is not apparent whether the data presented in Tables 1 and 2 on
pages 25-26 of the application, which show “results from patients . . . indicative of the
likely presence of inflamed plaques,” support the conclusion that the presence of
inflamed plaques can be diagnosed where the temperature difference is “above zero but
not more than 0.14°C” as required by claim 30. There is no information (e.g., number of
measurements made in particular patient, standard deviation, etc.) to establish the
significance of the data. For example, it is unclear on what basis Appellants have
concluded that these values represent inflamed plaques rather than “biological noise” of
the type described by Casscells ‘261. Column 23, lines 54-57. Similarly, patients 16 to
18 are described as “most at risk of plaque rupture.” These patients show the highest
amount of vessel temperature heterogeneity. In contrast, patients 5, 10, 13, and 14
exhibit about two-fold less heterogeneity. It is not evident how Appellants have ruled
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