Ex Parte Yang et al

Board of Patent Appeals and Interferences

Nov 1, 2010

10741434 (B.P.A.I. Nov. 1, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/741,434 12/19/2003 Kaiyuan Yang KCX-727 (19353) 2332
22827 7590 11/01/2010
DORITY & MANNING, P.A.
POST OFFICE BOX 1449
GREENVILLE, SC 29602-1449
EXAMINER
YU, MELANIE J
ART UNIT PAPER NUMBER
1641
MAIL DATE DELIVERY MODE
11/01/2010 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte KAIYUAN YANG, XUEDONG SONG,
and ROSANN KAYLOR
__________

Appeal 2010-005036
Application 10/741,434
Technology Center 1600
__________

Before ERIC GRIMES, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to an assay
device. The Examiner rejected the claims as obvious. We have jurisdiction
under 35 U.S.C. § 6(b). We reverse.

1 The two-month time period for filing an appeal or commencing a
civil action, as recited in 37 C.F.R. § 1.304, or for filing a request
for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from
the “MAIL DATE” (paper delivery mode) or the
“NOTIFICATION DATE” (electronic delivery mode) shown on
the PTOL-90A cover letter attached to this decision.
Appeal 2010-005036
Application 10/741,434

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Statement of the Case
The Claims
Claims 53-60, 64, and 66-74 are on appeal. Claims 53 and
57 read as follows:
53. An assay device for detecting the presence
or quantity of an analyte residing in a test sample,
the assay device comprising:
a first substrate onto which is printed a
detection working electrode capable of generating
a measurable detection current and a calibration
working electrode capable of generating a
measurable calibration current, wherein the
detection working electrode has a thickness of less
than about 100 micrometers, the detection working
electrode comprising an immobilized
immunoreactive specific binding capture ligand for
the analyte, the calibration working electrode
being generally configured to not specifically bind
the analyte;
a second substrate onto which is printed an
auxiliary electrode selected from the group
consisting of a counter electrode, a reference
electrode, and combinations thereof;
a multi-channel potentiostat, the multi-
channel potentiostat capable of receiving the
detection current from the detection working
electrode and the calibration current from the
calibration working electrode; and
wherein the first and second substrates are
laminated together so that the auxiliary electrode is
positioned adjacent to the detection working
electrode and the calibration working electrode,
wherein the detection current calibrated by the
calibration current is proportional to the amount of
the analyte within the test sample.

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57. The assay device of claim 53, wherein the
assay device contains a redox label for directly or
indirectly binding to the analyte.

A. The Examiner rejected claims 53-56, 59, 66, and 68-74 under 35
U.S.C. § 103(a) as obvious over Feldman,2 Oberhardt,3 and Giaquinta4 (Ans.
5-10).
B. The Examiner rejected claims 57, 58, 64, 66, and 67 under 35 U.S.C.
§ 103(a) as obvious over Feldman, Oberhardt, Giaquinta, and Zhang5 (Ans.
10-11).
A. 35 U.S.C. § 103(a) over Feldman, Oberhardt, and Giaquinta
The Examiner finds
it would have been obvious to one having ordinary skill in
the art at the time the invention was made to include in the
device of Feldman et al., a calibration working electrode that
is configured not to bind to analyte as taught by Oberhardt et
al., in order to provide an accurate and precise assay
measurement.

(Ans. 7.) The Examiner finds that it would have been obvious to include “a
multi-channel potentiostat capable of receiving a plurality of currents as
taught by Giaquinta et al., in order to provide a simple correlation of target
analyte and background signal by comparing separate signals in a single
device” (id.).

2 Feldman et al., US 6,461,496 B1, issued Oct. 8, 2002.
3 Oberhardt et al., US 4,280,815, issued Jul. 28, 1981.
4 Giaquinta et al., US 6,758,951 B2, issued Jul. 6, 2004.
5 Honghua Zhang, US 6,670,115 B1, issued Dec. 30, 2003.
Appeal 2010-005036
Application 10/741,434

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Appellants contend that “the mechanism of analyte detection in
Feldman et al. is based on coulometric and non-coulometric assays in which
the analyte is electrolyzed for measurement” (App. Br. 6). Appellants
contend that “Feldman et al. provides no support for combining an
immunoreactive specific binding capture ligand with the system described
therein and, indeed, it is unclear what impact such a capture ligand would
have on the system of Feldman et al.” (Id.)
Appellants contend that the ordinary artisan “would have been led
away from looking to the so-called calibration working electrode of
Oberhardt et al. for a calibration working electrode that is located on the
same substrate as a detection working electrode because such a
configuration would completely change the principle of operation of the
device” (id. at 7-8).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that it would have been obvious to
incorporate the calibration electrode with non-specific capture ligand of
Oberhardt into the assay device of Feldman?
Findings of Fact
1. Feldman teaches that one method of “forming a sensor . . .
includes forming at least one working electrode on a first substrate and
forming at least one counter or counter/reference electrode on a second
substrate” (Feldman, col. 3, ll. 19-22).
2. Feldman teaches that “[c]arbon or other electrode material . . .
is formed on the substrate to provide a working electrode for each sensor.
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The carbon or other electrode material can be deposited by a variety of
methods including printing” (Feldman, col. 31, l. 65 to col. 32, l. 2).
3. Feldman teaches that:
One example of a multiple electrode sensor that can
be used to accurately determine the volume of the
measurement zones of the electrode pairs and that is also
useful in reducing noise is presented herein. In this example,
one of the working electrodes 42 is prepared with a non-
leachable redox mediator and a non-leachable second
electron transfer agent (e.g., an enzyme). Sorbent material
may be disposed between that working electrode 42 and its
corresponding counter electrode. Another working electrode
44 includes non-leachable redox mediator, but no second
electron transfer agent on the electrode. Again, this second
electrode pair may have sorbent material between the
working electrode 44 and the corresponding counter
electrode.

(Feldman, col. 49, ll. 16-28.)
4. Feldman teaches that the “small charge passed between the
electrodes in this second electrode pair can be subtracted from the charge
passed between the first electrode pair to substantially remove the error due
to the oxidation state of the redox mediator and/or to remove the background
current caused by a diffusible redox mediator” (Feldman, col. 49, ll. 56-61).
5. Feldman teaches an “approximately 12 micron thick carbon pad
having a diameter of about 1 cm was screen printed on the Mylar™ film.
The carbon electrode was overlaid with a water-insoluble dielectric insulator
(Insulayer) having a thickness of 12 μm, and a 4 mm diameter opening in the
center” (Feldman, col. 52, ll. 45-50).
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6. Feldman teaches that the “sensor reader may include a
potentiostat or other component to provide a potential and/or current for the
electrodes of the sensor. The sensor reader may also include a processor
(e.g., a microprocessor or hardware) for determining analyte concentration
from the sensor signals” (Feldman, col. 37, ll. 54-58).
7. The Examiner finds that Feldman teaches that the “detection
working electrode is capable of generating a measurable detection current
that is proportional to the amount of analyte within the test sample (col. 57,
lines 1-17)” (Ans. 6).
8. Figure 3a of Oberhardt is reproduced below:

“FIG. 3a shows a reactive mixture being introduced between a pair of
modified electrodes” (Oberhardt, col. 3, ll. 53-54).
9. Oberhardt teaches that:
FIGS. 3a through 3f illustrate still another
embodiment of the invention which eliminates the need for a
wash or separation step. The surface 17 of electrode 11
comprises immobilized antibodies 14a, which are not
specific to the antigens 21 and 21a in solution 23. However,
the antibodies 14a are selected to present a similar surface
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Application 10/741,434

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profile to the antigens 21 and 21a in solution 23 as do the
antibodies 14 on surface 16 of electrode 10.

(Oberhardt, col. 6, ll. 47-54.)
10. Oberhardt teaches that a “light output 31 . . . obtained from the
first pulse 30 . . . is due only to any background antigen 21a, i.e., no light
output is generated by bound antigens 21a and antibodies 14a” (Oberhardt,
col. 7, ll. 5-8).
11. Oberhardt teaches that “[o]utput signal 31 is subtracted from
output 33, by conventional techniques, to obtain a measure for any initial
binding minus the background ‘noise.’” (Oberhardt, col. 7, ll. 21-24.)
12. Giaquinta teaches that a “multi-channel potentiostat/galvanostat
is essentially a collection of individual potentiostats/galvanostats bundled
together in a single unit. These individual potentiostats/galvanostats can
precisely control the current or potential applied to each electrode in the
system” (Giaquinta, col. 5, ll. 29-33).
Principles of Law
The Examiner has the initial burden of establishing a prima facie case
obviousness under 35 U.S.C. § 103. In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992).
“[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).

Appeal 2010-005036
Application 10/741,434

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Analysis
The Examiner acknowledges that Feldman does not teach the
calibration working electrode (see Ans. 6), but does not acknowledge that
Feldman also fails to teach “an immobilized immunoreactive specific
binding capture ligand for the analyte” as also required by claim 53. The
Examiner points to a “sensing layer contain[ing] redox mediator
immobilized on working electrode which is specific for an analyte, col. 21,
lines 17-30” for this limitation. However, the cited portion of Feldman at
column 21 provides no teaching of anything “immunoreactive” which
functions as a capture ligand. Rather, Feldman teaches that “redox
mediators of this embodiment can be bound or otherwise immobilized on the
working electrode” (Feldman, col. 21, ll. 25-27).
In response to Appellants’ argument that the “sensors of Feldman et
al. do not include an immunoreactive specific binding capture ligand for an
analyte,” the Examiner finds that Feldman teaches “the working electrodes
have a second electron transfer agent immobilized, wherein the second
electron transfer agents are either glucose oxidase or lactate oxidase . . .
which are specific for glucose and lactate, respectively, and bind to glucose
so they are considered immunoreactive” (App. Br. 10; Ans. 11-12).
We are not persuaded. Appellants’ Specification expressly
distinguishes between immunoreactive capture ligands and redox mediators
(see Spec. 8-9). The Specification states that “[b]esides specific binding
capture ligands, redox mediators may also be applied to the surface of the
detection working electrode” (Spec. 9, ll. 9-11).
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Application 10/741,434

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The Examiner has not identified any teaching that an enzyme is
reasonably interpreted as “immunoreactive,” consistent with the ordinary
meaning of the term or the Specification.
While we recognize that Oberhardt expressly teaches the use of
immobilized antibodies (FF 9), the assay of Oberhardt operates in an entirely
different manner than that of Feldman, where Feldman uses the electrodes to
detect and measure the analyte and Oberhardt uses the electrodes to
stimulate a light output which light output is used to detect and measure the
analyte.
We therefore agree with Appellants that the ordinary artisan would
not have considered it obvious to substitute “the so-called calibration
working electrode of Oberhardt et al. for a calibration working electrode that
is located on the same substrate as a detection working electrode because
such a configuration would completely change the principle of operation of
the device” (App. Br. 7-8).
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that it would have been obvious to incorporate the calibration electrode with
non-specific capture ligand of Oberhardt into the assay device of Feldman.
B. 35 U.S.C. § 103(a) over Feldman, Oberhardt, Giaquinta, and Zhang
The Examiner relies upon the rejection of Feldman, Oberhardt, and
Giaquinta to address the limitations of claim 53, from which the instantly
rejected claims depend. We therefore also reverse this rejection for the
reasons given above.
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Application 10/741,434

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SUMMARY
In summary, we reverse the rejection of claims 53-56, 59, 66, and 68-
74 under 35 U.S.C. § 103(a) as obvious over Feldman, Oberhardt, and
Giaquinta.
We reverse the rejection of claims 57, 58, 64, 66, and 67 under 35
U.S.C. § 103(a) as obvious over Feldman, Oberhardt, Giaquinta, and Zhang.

REVERSED

cdc

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