Medtronic MiniMed, Inc.

Patent Trials and Appeals Board

Jul 2, 2020

2019005070 (P.T.A.B. Jul. 2, 2020)

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.
14/632,731 02/26/2015 Daniel E. Pesantez G&C 130.119-US-01 9217
12813 7590 07/02/2020
Gates & Cooper LLP - Minimed
6060 Center Drive
Suite 830
Los Angeles, CA 90045
EXAMINER
ROSENWALD, STEVEN ERIC
ART UNIT PAPER NUMBER
1795
NOTIFICATION DATE DELIVERY MODE
07/02/2020 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
rs.patents.one@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DANIEL E. PESANTEZ, JIA YAO, BRADLEY C. LIANG,
and RAJIV SHAH
Appeal 2019-005070
Application 14/632,731
Technology Center 1700
Before BEVERLY A. FRANKLIN, N. WHITNEY WILSON, and
JANE E. INGLESE , Administrative Patent Judges.
FRANKLIN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 3–5, 8, 25, and 30. Claims 2, 6, 7, 9–
24, and 26–29 have been cancelled (Appeal Br. Claims Appendix). We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as Medtronic
MiniMed, Inc. Appeal Br. 2.
Appeal 2019-005070
Application 14/632,731

2
CLAIMED SUBJECT MATTER
Claim 1 is illustrative of Appellant’s subject matter on appeal
and is set forth below:
1. An amperometric glucose sensor system comprising:
a base;
a plurality of electrodes disposed on the base including:
a working electrode, wherein the working electrode:
is coated with glucose oxidase to sense glucose; and
is adapted to sense changes in pH at the working electrode;
a counter electrode;
a reference electrode;
a processor; and
a computer-readable program having instructions which cause the
processor to assess signal data obtained from the working electrode;
wherein:
the working electrode and the processor are coupled so that the
working electrode monitors glucose within the sensor system;
the working electrode and the processor are coupled so that the working
electrode monitors pH within the sensor system; and
the processor uses a first algorithm to calculate a concentration of
glucose when the pH of the sensor system is at or above pH 7.1; and
the processor uses a second algorithm to calculate a concentration of
glucose when the pH of the sensor system is below pH 6.9.

Appeal 2019-005070
Application 14/632,731

3
REFERENCES
The prior art relied upon by the Examiner is:

Name Reference Date
Rauh US 5,922,183 July 13, 1999
Shah US 2012/0097554 A1 Apr. 26, 2012
Masao2 JPH10227756 (A) Aug. 25, 1998
REJECTIONS
1. Claims 1, 5, and 8 are rejected under 35 U.S.C. § 103 as being
unpatentable over Masao in view of Rauh and Shah.
2. Claims 3, 4, 25, and 30 are rejected under 35 U.S.C. § 103 as
being unpatentable over Masao in view of Rauh as applied to claim 1 above,
and further in view of Shah.
OPINION
We review the appealed rejections for error based upon the issues
Appellant identifies, and in light of the arguments and evidence produced
thereon. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential)
(cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011)
(“[I]t has long been the Board’s practice to require an applicant to identify
the alleged error in the examiner’s rejections.”). After considering the

2 The Examiner refers to this reference as “Goto,” but we use the inventor’s
last name (“Masao”) as identification.
Appeal 2019-005070
Application 14/632,731

4
argued claims and each of Appellant’s arguments, we are not persuaded of
reversible error in the appealed rejections.
Appellant does not make separate arguments in support of
patentability of any particular claim or claim grouping. Accordingly, the
claims subject to each ground of rejection will stand or fall with claim 1. See
37 C.F.R. § 41.37(c)(iv). We can focus on the Masao reference in making
our determinations herein because it is the teachings of Masao which are
dispositive for the issues raised in the record. Also, our determination with
regard to Rejection 1 is dispositive for Rejection 2 (Appellant relies upon the
same arguments for each rejection (Appeal Br. 6)).
Upon consideration of the evidence and each of the respective
positions set forth in the record, we find that the preponderance of evidence
supports the Examiner’s findings and conclusion that the subject matter of
Appellant’s claims is unpatentable over the applied art. Accordingly, we
sustain each of the Examiner’s rejections on appeal essentially for the
reasons set forth in the Final Office Action and in the Answer, and affirm,
with the following emphasis.
We refer to 3–7 of the Answer regarding the statement of the rejection
for Rejection 1.
Appellant first argues that the applied art fails to teach a sensor system
whereby a processor uses a first algorithm to calculate a concentration of
glucose when the pH of the sensor system is at or above pH 7.1, and uses a
second algorithm to calculate a concentration of glucose when the pH of the
sensor system is below pH 6.9. Appeal Br. 3. Appellant also argues that
Appeal 2019-005070
Application 14/632,731

5
Masao does not teach or suggest the use of multiple algorithms. Appeal Br.
4.
We are unpersuaded by the aforementioned arguments. As explained
by the Examiner, Masao recognizes that enzyme activity depends on pH
(Masao, ¶¶ 2, 20) and selects a calibration curve (algorithm) based on
measured pH (Masao, ¶¶ 4, 17, 18, 26 –29). The Examiner states that in
paragraph 18 of Masao, Masao teaches “a calibration curve of a glucose
sensor corresponding to each pH and a pH calibration curve is first stored in
a measuring instrument circuit, a calibration curve corresponding to the
measured pH is selected in the measuring instrument.” Ans 14–15.
The Examiner concludes that it would have been obvious to have used
a different calibration curve (algorithm) when the pH is 6.9 as opposed to
the calibration curve (algorithm) used when the pH is 7.1 because
Masao teaches “a calibration curve of a glucose sensor corresponding to
each pH and a pH calibration curve is first stored in a measuring instrument
circuit, a calibration curve corresponding to the measured pH is selected in
the measuring instrument.” Masao, ¶ 18; Ans. 15. Hence, separate
calibrations curves are provided in Masao for respective pH values, used for
more precise measurement. Masao, Abstract.
Appellant next argues that the rejection lacks a rational underpinning
for the reasons provided on pages 4–6 of the Appeal Brief and on pages 2–5
of the Reply Brief. We are unpersuaded by the arguments therein. As
mentioned supra, based upon the Examiner’s findings, the Examiner
reasonably concludes that it would have been obvious to have used a
different calibration curve (algorithm) when the pH is 6.9 as opposed to the
Appeal 2019-005070
Application 14/632,731

6
calibration curve (algorithm) used when the pH is 7.1 because
Masao teaches “a calibration curve of a glucose sensor corresponding to
each pH and a pH calibration curve is first stored in a measuring instrument
circuit, a calibration curve corresponding to the measured pH is selected in
the measuring instrument.” Masao, ¶ 18. Separate calibrations curves are
provided in Masao for respective pH values, used for more precise
measurement. Masao, Abstract.
Appellant points out that during in vivo operation of such glucose
sensor systems, the accumulation of enzymatic generated products such as
gluconic acid and hydrogen peroxide lower the local pH within the sensor
chemistry layers of the claimed sensors. Appeal Br. 2. Appellant states that
this drop in pH can affect sensor sensitivity, and in view of this, the claimed
sensor systems include a processor that uses a first algorithm to calculate a
concentration of glucose when the pH of the sensor system is at or above pH
7.1; and further a second algorithm to calculate a concentration of glucose
when the pH of the sensor system is below pH 6.9. Appellant states that in
this way, the claimed systems include a pH specific determinations of
amperometric current observed at the glucose oxidase coated working
electrode in the present of glucose. Appeal Br. 2. Appellant argues that
these pH values are important as it is in this range that there is a fluctuation
in the pH. Reply Br. 3–4. We are unpersuaded by this line of argument.
As stated by the Examiner, Masao recognizes that enzyme activity
depends on pH (Masao, ¶¶ 2, 20; Ans. 4), and in an effort to obtain more
precise measurements, Masao teaches to use a respective calibration curve
for a respective pH value. Masao, Abstract. While Appellant states that pH
Appeal 2019-005070
Application 14/632,731

7
values of 7.1 and 6.9 are important (Reply Br. 4–5), Matsuo teaches that
each pH value is important and teaches to use a respective calibration curve
for more accurate measurements for each pH value, so we thus agree with
the Examiner that the applied art makes obvious the claimed subject matter,
and are unpersuaded by Appellant’s arguments in this regard.
In view of the above, we affirm each rejection.
CONCLUSION
We affirm the Examiner’s decision.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 5, 8 103 Masao in view of
Rauh and Shah
1, 5, 8
3, 4, 25, 30 103 Masao in view of
Rauh and Shah
3, 4, 25, 30
Overall
Outcome
1, 3–5, 8,
25, 30

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED