Ex Parte Wolfe et al

Patent Trials and Appeals Board

Feb 15, 2019

13047431 - (D) (P.T.A.B. Feb. 15, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/047,431 03/14/2011 Katherine T. Wolfe
12813 7590 02/20/2019
Gates & Cooper LLP - Minimed
6060 Center Drive
Suite 830
Los Angeles, CA 90045
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
130.101-US-Ul 6821
EXAMINER
WEARE, MEREDITH H
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
02/20/2019 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docketing-us@gates-cooper.com
gates-cooper@blackhillsip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte KATHERINE T. WOLFE, AMEY AS. KANTAK,
ERIC ALLAN LARSON, DANIELE. PESANTEZ,
DONGJUAN XI, CHIA-HUNG CHIU, and RAJIV SHAH 1
Appeal2017-003883
Application 13/047,431
Technology Center 3700
Before RICHARD M. LEBOVITZ, JOHN G. NEW, and
KRISTI L. R. SA WERT, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to an analyte sensor that
measures glucose. The Examiner rejected the claims as obvious under
35 U.S.C. § 103. Pursuant to 35 U.S.C. § 134, Appellants appeal the
Examiner's determination that the claims are unpatentable. We have
jurisdiction for this appeal under 35 U.S.C. § 6(b). The Examiner's decision
is reversed.
1 The Appeal Brief ("Br."; May 25, 2016) lists Medtronic MiniMed, Inc., as
the real party in interest. Br. 2.
Appeal2017-003883
Application 13/047,431
STATEMENT OF THE CASE
Claims 1-14, 16-18, 20, and 22-33 stand finally rejected (Advisory
Action entered Oct. 23, 2015) by the Examiner as follows:
Claims 1-7, 9-11, 18, 20, 22, 30, and 31 under 35 U.S.C. § I03(a) as
obvious in view of Simpson et al. (US 2007/0213611 Al, published Sept.
13, 2007) ("Simpson") and Crismore et al. (US 6,270,637 Bl, issued Aug. 7,
2001) ("Crismore"). Final Act. 4.
Claims 8, 12-14, 16, 17, 23-29, 32, and 33 over the combination of
Simpson and Crismore, and additionally cited publications. Final Act. 10,
11, 12, 13, 18, 19, 20.
Claims 1 and 3 0 are independent claims, and the remaining claims
depend from them. Appellants did not provide separate arguments for the
dependent claims. Br. 7. The dependent claims stand or fall with claims 1
and 30. 37 C.F.R. 4I.37(c)(l)(iv).
Claim 1 is reproduced below:
1. An analyte sensor comprising:
a plurality of sensor wires having a first end and second
end and each arranged in a substantially common orientation,
the plurality of sensor wires being electrically conductive and
including:
a first sensor wire substantially covered by a first
electrically insulating cover, wherein an aperture in the first
electrically insulating cover defines a working electrode area;
a second sensor wire substantially covered by a second
electrically insulating cover, wherein an aperture in the second
electrically insulating cover defines a reference electrode area;
and
a third sensor wire substantially covered by a third
electrically insulating cover, wherein an aperture in the third
electrically insulating cover defines a counter electrode area;
wherein;
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Application 13/047,431
the plurality of sensor wires has a first side and a second
side opposite to the first side, and wherein the working
electrode area is on the first side and the counter electrode area
and reference electrode areas are on the second side; and
the portion of the first wire exposed at the working
electrode area is coated with an analyte sensing layer
comprising glucose oxidase.
OBVIOUSNESS BASED ON SIMPSON AND CRISMORE
Claim 1 is directed to an analyte sensor ("a plurality of sensor wires")
having a first side and second side.
The analyte sensor comprises three wires: a first sensor wire with an
aperture in its insulating cover defining a working electrode area, a second
sensor wire with an aperture in its insulating cover defining a reference
electrode area, and a third sensor wire with an aperture in its insulating
cover defining a counter electrode area. The working electrode area is on
the first side of the analyte sensor and the counter electrode and reference
areas are on the second side of the analyte sensor. The working electrode
area is coated with glucose oxidase which enables the sensor to detect
glucose.
Claim 30 is directed to a method of using an analyte sensor which has
the same structural limitations of the analyte sensor of claim 1.
The Examiner found that Simpson "appears to disclose at least one
embodiment in which" the analyte sensor has first and second sides:
has a first side (e.g., Fig. 7 A2, the top of the illustrated cross-
section) and a second side opposite to the first side (e.g., Fig.
7 A2, the bottom of the illustrated cross-section), wherein the
working electrode area is one [ sic, on] the first side (e.g., Fig.
7 A2, where E 1 is exposed at the first side/top surface) and the
counter and reference electrode areas are on the second side
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Application 13/047,431
(e.g., Fig. 7 A2, where E2 and E3 are exposed at the second
side/bottom surface).
Ans. 3.
The Examiner further found that Crismore discloses that the
electrodes of a glucose sensor "must be sufficiently separated so that the
electrochemical events at one electrode do not interfere with the
electrochemical events at the other electrode." Ans. 3.
The Examiner found that it would have been obvious to one of
ordinary skill in the art at the time of the invention to modify the sensor of
Simpson by
providing the working electrode area on the first side and the
reference and counter electrode areas on the opposing, second
side (i.e., having the working electrode area only on one side,
and the reference and counter electrode areas only on the
opposing side) as taught/suggested by Crismore in order to
maximize separation of the electrode areas to avoid products of
electrochemical reaction(s) at one electrode from interfering
with those at the other, thereby increasing the accuracy of
measurements obtained with the sensor
Ans. 3--4 ( emphasis added).
Discussion
The Examiner found that the embodiment shown in Figure 7 of
Simpson shows an analyte sensor having first and second sides with
electrodes located on both sides. Ans. 3. The rejection is based on the
Examiner's determination that it would have been obvious to have placed
the working electrode on one side only, and the reference and counter
electrodes on the second side only.
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Appeal2017-003883
Application 13/047,431
The Examiner's characterization of Figure 7 of Simpson as showing
an analyte sensor having first and second sides appears to be based on a
misunderstanding of Simpson's disclosure.
Simpson discloses that Figure 7 Al is a "coaxial sensor." Simpson
,r 55. Figure 7A2 is "a side-cutaway view" of the coaxial sensor. Id. ,r 332.
Figure 7 A2 of Simpson, relied upon by the Examiner as showing a sensor
with first and second sides, is reproduced below:
Figure 7 A2, shown above, is "a side-cutaway view" of the coaxial
analyte sensor. Simpson ,r 332. It shows electrodes E 1, E2, and E2 arranged
around axis A-A. The electrodes are separated by insulating layers I.
While Figure 7 A2 appears to show a sensor with two sides, this is a
misunderstanding of the figure because the sensor is "coaxial" and the figure
is a section through the side of it. The term "coaxial" is defined in Simpson
to have "its ordinary and customary meaning to a person of ordinary skill in
the art" and to refer "to having a common axis, having coincident axes or
mounted on concentric shafts." Id. ,r 133. Simpson further describes the
sensor of Figure 7 as having "a coaxial design ... [which] enables a
symmetrical design without a preferred bend radius ... in contrast to prior
art sensors comprising a substantially planar configuration that can suffer
from regular bending about the plane of the sensor." Id. ,r 308. Simpson
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Application 13/047,431
also describes the sensor construction as beginning with a "bulk metal wire
electrode E 1" which is coated with a plurality of layers of electrode material
separated by layers of insulating material. Id. ,r 332. Thus, from Simpson's
description, one of ordinary skill in the art would understand that Figure 7 A2
depicts a side cutaway of a tubular electrode sensor ( e.g., a "wire") with
layers of electrode and insulating materials coating around it.
The finding by the Examiner that "the working electrode area is one
[sic, on] the first side (e.g., Fig. 7A2, where El is exposed at the first side/top
surface) and the counter and reference electrode areas are on the second side
(e.g., Fig. 7 A2, where E2 and E3 are exposed at the second side/bottom
surface)" (Ans. 3) is inconsistent with Simpson's description of a coaxial
analyte sensor in which the electrodes are disposed concentrically around
the A-A axis. The Examiner's finding that E2 and E3 are on one side and
E 1 on the other side of the analyte sensor is not correct since E 1, E2, and E3
completely surround axis A-A. El is, in fact a wire. Simpson ,r 332. While
Figure 7 A2 appears to show the electrodes on either side of the axis A-A,
this is because the 7 A2 is a side-cutaway view of a coaxial sensor. In fact,
the electrodes completely surround common axis A-A.
Based on Crismore' s teaching of maximizing electrode separation, the
Examiner found it would have been obvious to have modified Simpson by
providing the working electrode area on the first side only and the reference
and counter electrode areas on the opposing, second side only. Ans. 3--4.
However, as explained above, the Examiner's rejection appears to be
based on a misinterpretation of Figure 7 A2 of Simpson. Simpson's analyte
sensor is coaxial and has a radial circumference. To the extent a first side is
one half the circumference around the coaxial sensor, and the second side is
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Application 13/047,431
the second half of the circumference, it has not been explained by the
Examiner how electrode separation is achieved by disposing the electrodes
on different regions of the sensor circumference. While Crismore at column
3, lines 37-52, teaches that in its sensor "electrodes must be sufficiently
separated so that the electrochemical events at one electrode do not interfere
with the electrochemical events at the other electrode," the Examiner did not
explain how sufficient separation would be achieved by placing the
electrode working areas on different "sides" of the coaxial sensor of
Simpson. Indeed, Simpson already has insulating layers ("I") between each
electrode which separate the electrode layers from each other. Simpson ,r
332, Fig. 7 A2.
Appellants argue that it would not have been obvious to have put
electrodes on different sides of Crismore' s test strip which shows the
electrodes on one side only. Br. 5. Appellants stated that
if the electrode tracks 5 and 6 were reconfigured to be on
opposite sides of the Crismore device, this would destroy the
ability of artisans to load both electronically conductive tracks
simultaneously via a single opening ( e.g. element 10) on a
single side of the Crismore device ( and would require, for
example, an additional/new opening to be introduced on the
other side of the Crismore device along with the new electrode
track).
Br. 5. We agree with Appellants that the Examiner did not provide a reason
to put the electrodes on opposite sides of Crismore' s device, but rather
incorrectly found that Simpson already had electrodes on the opposite side.
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Application 13/047,431
For the foregoing reasons, the obviousness rejection of claims 1 and
30 are reversed. The Examiner did not identify how any of the additional
publications compensate for the deficiency of Simpson and Crismore.
Consequently, the obviousness rejections of claims 2-14, 16-18, 20, 22-29,
and 31-33 are reversed for the same reasons as claims 1 and 30.
REVERSED
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