Appeal No. 1997-4138
Application No. 08/384,681
f. washing away unbound conjugate;
g. applying onto said discrete location a drop of a second fluid
comprising a substrate reactable with said enzyme at room temperature to form within
about five minutes a colored precipitate visually detectable against said opaque carrier;
and
h. visually ascertaining the presence or absence of the colored
precipitate as indicative of the presence or absence of said at least one component to be
detected.
56. An analytical device for use in a sandwich enzyme immunoassay for
detecting the presence in a body fluid of at least one component to be detected selected
from the group consisting of antigens, antibodies and haptens, consisting essentially of an
inert, opaque plastic carrier having a flat, hydrophobic surface that is non-absorbent to
said antibodies, antigens and haptens and to enzymes having deposited directly thereon
an insolubilized specific binding partner of the at least one component to be detected in
the form of spots of from 1 to 4 mm in diameter in discrete, visually locatable locations.
1
The references relied upon by the examiner are:
Fish et al. (Fish) 5,126,276 Jun. 30, 1992
Towbin et al. (Towbin), "Immunoblotting and Dot Immunobinding -- Current Status and
Outlook," Journal of Immunological Methods, vol. 72, pp. 313-340, 1984
1At page 11 of the Examiner's Answer, the examiner cites U.S. Patent 4,594,225 to
Arai et al. Since this reference was not included in the list of references relied upon and
not included in the statement of the rejection, it is not clear whether the reference is relied
upon to establish the state of the prior art. If it is relied upon to establish the state of the art
relative to a rejection under 35 U.S.C. § 103, the record should clearly indicate that it is so
relied upon and appellants given ample opportunity to respond thereto. In view of the
confusion as to the status of the examiner's reliance on this reference, we have not
considered it in considering the issues raised by this appeal. When a reference is relied
on to support a rejection even in a "minor capacity," ordinarily that reference should be
positively included in the statement of rejection. In re Hoch, 428 F.2d 1341, 1342, n.3, 166
USPQ 406, 407, n. 3 (CCPA 1970).
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