Ex Parte Diamond et al

Patent Trial and Appeal Board

May 19, 2017

12777396 (P.T.A.B. May. 19, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/777,396 05/11/2010 Steven Diamond AGAM.P-018-DV 4260
57381 7590
Larson & Anderson, LLC
P.O. BOX 4928
DILLON, CO 80435
05/19/2017 EXAMINER
KESSEL, MARIS R
ART UNIT PAPER NUMBER
1759
MAIL DATE DELIVERY MODE
05/19/2017 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 PATENT TRIAL AND APPEAL BOARD
Ex parte STEVEN DIAMOND, MARTIN FOREST, BAOGUO WEI,
IAN HARDING, and SRIDHAR IYENGAR
Appeal 2016-000826
Application 12/777,3961
Technology Center 1700
Before TERRY J. OWENS, JEFFERY T. SMITH, and
N. WHITNEY WILSON, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
This is an appeal under 35 U.S.C. § 134 from a Final Rejection of
claims 16—27. We have jurisdiction under 35 U.S.C. § 6.
1 The real party in interest is AgaMatrix, Inc. (App. Br. 1).
Appeal 2016-000826
Application 12/777,396
Appellants’ invention generally relates to a method for assessing the
quality of a conductive layer formed during manufacture of an
electrochemical test strip. (Spec. 19). Claim 16 illustrates the subject
matter on appeal and is reproduced from the Appeal Brief below (italics
added to identify disputed claim language):
16. A method for assessing the quality of a conductive layer
formed during manufacture of an electrochemical test strip,
wherein
the electrochemical test strip is a planar test strip formed
from first and second facing substrates, and is elongated for a
length in a first dimension parallel to a first axis and having a
second dimension corresponding to the width of the strip,
the electrochemical test strip has an electrochemical
analysis cell at one axial end and a connection region at the other
axial end,
the electrochemical test strip has a patterned conductive
layer deposited on the first substrate providing a plurality of
conductive regions including
(a) a first conductive region providing a first
conductive path from the connector region to the electrochemical
analysis cell,
(b) a second conductive region providing a part
of a second conductive path, different from the first conductive
path, from the connector region to the electrochemical analysis
cell,
(c) and a first conductive quality test region that
is separate from the first and second conductive regions or
coextensive with the one of the conductive regions, with the
proviso that when the first conductive quality test region is
coextensive with one of the conductive regions it is not a
conductive path for analysis;
said method comprising during the manufacture of the test
strip the steps of applying first and second probes to the first
conductive quality test region; and measuring an electrical
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Appeal 2016-000826
Application 12/777,396
signal between the first and second probes to assess the quality
of the conductive layer,
wherein the first and second probes are applied to the first
conductive quality test region at points that are separated by at
least one-fifth the length or width of the test strip.
Appellants (see App. Br., generally) request review of the following
rejections:
I. Claims 16, 17, 21—23, and 25—27 under 35 U.S.C. § 103(a) as
unpatentable over Ghesquiere et al., (US 2006/0144704 Al; pub. July 6,
2006) (“Ghesquiere”) to in view of McAleer et al. (US 6,241,862 Bl, iss.
June 5, 2001) (“McAleer”). (Final Act. 2—5)
II. Claims 16—27 under 35 U.S.C. § 103(a) as unpatentable over
Kawanaka et al. (US 2003/0150724 Al; pub. Aug. 14, 2003) (Kawanaka) in
view of Kawabata (JP 5-107298 A) (Kawabata) (English translation
provided and referred to herein) and further in view of McAleer. (Final Act.
6-15)
OPINION
Rejection I
The dispositive issue on appeal for this rejection is: Did the Examiner
err in determining that the combination of Ghesquiere and McAleer
discloses or suggests a method for assessing the quality of a conductive layer
formed during manufacture of an electrochemical test strip comprising the
steps of applying first and second probes to the first conductive quality test
region and measuring an electrical signal between the first and second
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Appeal 2016-000826
Application 12/777,396
probes to assess the quality of the conductive layer, as required by
independent claim 16?2
After review of the respective positions provided by Appellants and
the Examiner, we REVERSE the prior art rejection for the reasons presented
by the Appellants and add the following.
Appellants argue Ghesquiere treats all of the test strips in a batch in
exactly the same way, disregarding the defects that may occur in test strips
as a result of an anisotropic screen printing process. (App. Br. 3).
Appellants argue Ghesquiere does not disclose or suggest any quality control
process during the manufacture of the test strips or assessing the quality of
the conductive layer of each test strip. (App. Br. 3). Appellants argue the
teachings of McAleer are irrelevant to the patentability of the claimed
invention because the Examiner only relies on McAleer to teach a second
facing substrate. (App. Br. 4).
The Examiner’s statement of rejection and response to arguments do
not adequately address Appellants’ position. The Examiner contends
Ghesquiere describes testing at least one analyte test sensor and adjusting the
remainder of the batch based on those test results. (Ans. 18—19, Ghesquiere
1126, 63 and 81). The Examiner further contends the claim language “for
assessing the quality of a conductive layer formed during manufacture of an
electrochemical test strip” is given negligible patentable weight because the
claims are directed to a method. (Ans. 19-20).
The Examiner’s rejection and response to argument are not well
taken. Claim 16 requires assessing the quality of the conductive layer
formed during the manufacture for each manufactured electrochemical test
2 We limit our discussion to independent claim 16.
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Appeal 2016-000826
Application 12/777,396
strip. The Examiner’s reliance on the analyzation of one sensor for
modification of the remaining members of the batch as rendering obvious
testing of each test strip during manufacture is not well taken. The cited
paragraphs of Ghesquiere did not address the deficiencies in the Examiner’s
rejection. Consequently, we agree with Appellants that Ghesquiere does not
“disclose [ ] or suggest[ ] assessing the quality of the conductive layer of
each test strip, nor does Ghesquiere disclose or suggest any quality control
process during the manufacture of the test strips themselves.” (App. Br. 3).
Rejection II
The dispositive issue on appeal is: Did the Examiner err in
determining that the combination of Kawanaka, Kawabata, and McAleer
discloses or suggests a method for assessing the quality of a conductive layer
formed during manufacture of an electrochemical test strip comprising the
steps of applying first and second probes to the first conductive quality test
region and measuring an electrical signal between the first and second
probes to assess the quality of the conductive layer as required by
independent claim 16?3
After review of the respective positions provided by Appellants and
the Examiner, we REVERSE the prior art rejection for the reasons presented
by the Appellants and add the following.
Appellants argue the combined teachings of Kawanaka, Kawabata and
McAleer would not result in the claimed invention. Appellants argue
Kawanaka fails to teach the assessment of the test strip during manufacture,
and Kawabata has nothing to do with the manufacture of test strips or even
3 We limit our discussion to independent claim 16.
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Appeal 2016-000826
Application 12/777,396
assessing the quality of a conductive layer of material. (App. Br. 5).
Appellants argue Kawabata only discloses an expedited method for testing
electrical connections between transistors. (App. Br. 5) Appellants further
argue Kawabata is not remotely related to test strips or assessing the quality
of the conductive layer of test strips during manufacture. (App. Br. 5). As
stated above, the Examiner only relies on McAleer to teach a second facing
substrate—a feature not recited in any of the claims. (Final Act 8—9).
The Examiner’s rejection and response to argument are not sufficient
to sustain the rejection of independent claim 16. The Examiner
acknowledges Kawanaka fails to teach the assessment during the
manufacture of the test trip. (Ans. 7). The Examiner relies on Kawabata for
teaching inspecting a device comprising electrodes during manufacturing.
Kawabata is directed to a method of inspecting LCD devices for short-
circuits in the wiring during manufacture. . (Ans. 7; Kawabata H 1, 3 and
5). The Examiner has failed to provide an adequate explanation as to why a
person of ordinary skill in the art would have looked to testing methods from
LCD devices for utilization with test strips utilized in concentration
measuring apparatus such as described by Kawanaka. The Examiner has
failed to explain why the teaching of Kawabata would have led to the
assessment of every test strip during their manufacture as required by claim
16.
For the foregoing reasons and those stated in the Briefs, we determine
that the Examiner’s conclusion of obviousness is not supported by facts of
recoed. “Where the legal conclusion [of obviousness] is not supported by
facts it cannot stand.” In re Warner, 379 F.2d 1011, 1017 (CCPA 1967).
Accordingly, the Examiner’s rejections are reversed.
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Application 12/777,396
ORDER
The Examiner’s rejections of claims 16, 17, 21—23, and 25—27 under
35 U.S.C. § 103(a) as unpatentable over the combination of Ghesquiere and
McAleer is reversed.
The Examiner’s rejections of claims 16—27 under 35 U.S.C. § 103(a)
over the combination of Kawanaka, Kawabata and McAleer is reversed.
REVERSED
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