Appeal No. 2001-1589 Page 4
Application No. 08/769,077
The examiner bears the burden of establishing a prima facie case of anticipation
or obviousness. See In re Spada, 911 F.2d 705, 708, 15 USPQ2d 1655, 1657 (Fed.
Cir. 1990); In re Fritch, 972 F.2d 1260, 1265, 23 USPQ2d 1780, 1783 (Fed. Cir. 1992).
In our view, that burden has not been carried here. At issue is the examiner=s assertion
that Athe [troponin I] of the standardized solution is obtained from a human heart which
means that the standardized solution comprising [troponin I] is from a patient.@ Answer,
page 5. Appellants argue that Larue does not anticipate the present invention because
Aneither an isolated human heart, nor a dead human, can be considered a patient,@ and
A[t]herefore, the troponin used in the standard solution of [Larue] is not a >patient
sample.=@ Brief, page 12. Further, Athe >normal human plasma= used to dissolve the
troponin I or T to make the standard solution of [Larue] cannot be >a sample suspected
of containing troponin from a damaged heart muscle,=@ either. Rather, it is Aplasma that
is not suspected of containing troponin from damaged heart muscle.@ Id. We agree
with appellants.
The specification does not explicitly describe Aa patient@ or Aa patient sample,@
but it is readily apparent from the context in which patients and patient samples are
mentioned that the term does not, as the examiner insists, encompass a cadaver or an
isolated human heart. Merely by way of example, the specification (pages 17-19)
teaches that:
The assays taught herein provide for the analysis of release patterns
which may allow the physician to diagnose a specific heart failure, for
example, unstable angina as compared to myocardial infarction or to
determine the time that an infarction occurred . . . Generally, in hospital
emergency departments which admit patients believed to have had a
myocardial infarction, a blood sample from the individual will be obtained
again in an hour or two if the first result is negative. In this example, the
patient . . . would not be treated and would continue to accrue damaged
heart muscle during the time before a second sample was analyzed . . .
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