Appeal No. 2001-1589 Page 2
Application No. 08/769,077
The references relied on by the examiner are:
Larue & Marquet (Larue) GB 2,275,774 Sep. 7, 1994
Wicks (et al.) WO 94/27156 Nov. 24, 1994
Claims 1-6, 8 and 10 stand rejected under 35 U.S.C. ' 102(a) as anticipated by
Larue, while claims 7 and 18 stand rejected under 35 U.S.C. ' 103 as unpatentable
over Larue and Wicks. We reverse both of these rejections.
BACKGROUND
The troponin complex in muscle is comprised of troponin I, C and T . . .
[which] exist as various tissue specific isoforms. Troponin C exists as two
isoforms, one from cardiac and slow-twitch muscle and one from fast-twitch
muscle. Troponin I and T are expressed as different isoforms in slow-twitch,
fast-twitch and cardiac muscle . . . The unique cardiac isoforms of troponin I
and T allow them to be distinguished immunologically from the other
troponins of skeletal muscle. Therefore, the release into the blood of troponin
I and T from damaged heart muscle has been related to cases of unstable
angina and myocardial infarction . . . (Specification, pages 3 and 4).
According to appellants, A[p]rior to the instant invention, troponins I and T were
believed to be >unstable= in aqueous solutions.@ Brief, page 6. AAs a result of this
>instability,= assays for troponin I and/or T in patient samples could report falsely low
concentrations of troponin proteins, resulting in a falsely negative diagnosis for heart
damage. It was unrecognized that a major source of this >instability= is the propensity of
troponins I and T to adsorb tenaciously to glass and other surfaces.@ Id. AHowever,
when bound to troponin C . . . the absorptive characteristics of of troponin I and T may
be dramatically reduced.@ Specification, page 44.
The present invention is based on the premise that pretreating a patient sample
with exogenous troponin C will reduce the incidence of inaccurate assay results by
reducing the tendency of troponin I and troponin T in the patient sample to non-
specifically bind various assay surfaces (e.g., glass, plastic, lipsomes, other blood
components, etc.). Specification, page 43, line 28 through page 44, line 3.
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