Appeal No. 2001-1589 Page 3
Application No. 08/769,077
DISCUSSION
Claim 1, which represents the invention in its broadest aspect, requires
contacting a patient sample (suspected of containing troponin from damaged heart
muscle) with exogenous troponin C, and a Asurface.@ There are two provisos regarding
the exogenous troponin C in the claims: it cannot be labeled, and it cannot be bound to
the surface. In addition, there are four possible scenarios for the contacting step(s): (1)
the troponin C and the patient sample can be contacted initially, and then with the
surface; (2) the troponin C and the surface can be contacted initially, and then with the
patient sample; (3) the patient sample and the surface can be contacted initially, and
then with the troponin C; and finally (4) the patient sample, the surface and the troponin
C can be contacted simultaneously.
The examiner maintains that claims 1-6, 8 and 10 are anticipated by Larue, and
that claims 7 and 18 are unpatentable over the combined teachings of Larue and
Wicks. The examiner=s interpretation of Larue=s teachings is central to both rejections,
so we will discuss them together.
Larue describes calibration reagents for troponin immunoassays, prepared by
adding a known amount of troponin I or troponin T, obtained from isolated human heart,
to a buffer (which may comprise normal human plasma). In addition, troponin C is
included in the calibration reagent to stabilize the troponin I or T. Page 2, lines 20-29;
page 3, lines 4-10 and 32-33; and page 4, lines 3-4. The calibration reagent is intended
for use as a standard in serum or blood plasma troponin immunoassays, to be run in
parallel with a sample containing an unknown amount of troponin I or T. Page 3, lines
20-29 and page 5, lines 12-17.
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