Roche Diagnostics Operations, Inc.

Patent Trials and Appeals Board

Oct 1, 2021

2020006651 (P.T.A.B. Oct. 1, 2021)

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.
14/242,953 04/02/2014 Eric S. Carlsgaard 31574 US1 (15878A-124) 7507
98067 7590 10/01/2021
Harness Dickey (Roche)
5445 Corporate Drive, Suite 200
Troy, MI 48098-2683
EXAMINER
LAM, ELIZA ANNE
ART UNIT PAPER NUMBER
3686
NOTIFICATION DATE DELIVERY MODE
10/01/2021 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):
meg.ward@roche.com
pair_roche@firsttofile.com
troymailroom@hdp.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ERIC S. CARLSGAARD, PAUL J. GALLEY,
MARK G. MEARS, BENOIT P. MENEZ, HEMLATA NAYEE, and
JOSE SALAZAR-GALINDO

Appeal 2020-006651
Application 14/242,953
Technology Center 3600
____________

Before BIBHU R. MOHANTY, CYNTHIA L. MURPHY, and
ROBERT J. SILVERMAN, Administrative Patent Judges.

MURPHY, Administrative Patent Judge.

DECISION ON APPEAL
The Appellant1 appeals from the Examiner’s rejections of claims 1–8,
11–17, 20, and 21 under 35 U.S.C. § 103. We REVERSE.2

1 The Appellant is the “applicant” as defined by 37 C.F.R. § 1.42 (e.g., “all
of the joint inventors”). “The real party in interest in the present application
is Roche Diabetes Care, Inc.” (Appeal Br. 3.)
2 We have jurisdiction under 35 U.S.C. §§ 6(b) and 134(a).
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THE APPELLANT’S INVENTION
The Appellant’s invention relates to techniques for “transferring data
from a handheld glucose meter.” (Spec. ¶ 2.) More particularly, the
Appellant’s invention relates to techniques for “time keeping between a
glucose meter and a patient’s portable communication device.” (Id. ¶ 6.)
The Appellant discloses a system of time keeping that comprises a
medical device 12 and a “diabetes management application 14” which
resides on a computing device 16. (Spec. ¶ 23; see also id. ¶ 24, Fig. 1.)
The medical device 12 is a glucose meter which includes a “measurement
module 22” that determines a glucose measurement from a sample of blood
on a test strip. (Id. ¶ 45.) The glucose measurement is transmitted from the
medical device 12 to the computing device 16, and thus to the diabetes
management application 14. (See id. ¶ 54.)
As indicated above, the Appellant is concerned with “time keeping”
between the medical device 12 and the computing device 16. (Spec.¶ 6.) To
this end, the medical device 14 includes “a real-time clock (RTC)” so that it
can associate a measurement time with the glucose measurement it transmits
to the diabetes management application 14. (Id. ¶ 30.) The computing
device 16 includes a “time counter” allowing the diabetes management
application 14 to store “a snapshot time” which is “a reference time based on
a trusted time source.” (Id. ¶ 32.) The diabetes management application 14
synchronizes these time values and associates a timestamp with the glucose
measurement transmitted by the medical device 12. (See id. ¶¶67–74.)
The diabetes management application 14 determines “a bolus
calculation based on the blood glucose measurement” (Spec. ¶ 75) and
generates “a bolus recommendation based on the bolus calculation” (id.
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¶ 76). However, “[i]n order for the diabetes management application 14 to
recommend an effective bolus recommendation,” this recommendation
“must occur within a predetermined period” following the time of the blood
glucose measurement. (Id.) For example, the recommendation must occur
within a ten minute window following the time of the blood glucose
measurement. (See Spec. ¶ 77, Fig. 8.)
The Appellant’s diabetes management application 14 therefore checks
to make sure it is basing a bolus recommendation on a current blood glucose
measurement. (See Spec. ¶¶77–78.) Specifically, the diabetes management
application 14 “generates a request” to the medical device 12 “to
communicate a current RCT time.” (Id. ¶ 76.) The diabetes management
application 14 then “determines the difference” between the measurement
time and the requested current RCT time. (Id. ¶ 77.) And, “when the
difference is greater than the predetermined period, the diabetes management
application does not generate a bolus recommendation.” (Id.)
ILLUSTRATIVE CLAIM
1. A system for time keeping between multiple devices used by
a patient to manage diabetes, the system comprising:
a handheld medical device that includes:
a port configured to receive a test strip having a
reaction site for receiving a sample of fluid from a patient;
a real-time clock (RTC); and
a blood glucose (bG) meter, cooperatively operable
with a test strip inserted in the port, configured to measure
glucose in a sample of fluid residing in the test strip and
associate a first measurement time with the glucose
measurement;
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a mobile computing device comprising a processor
configured to execute a diabetes management application stored
on an associated memory and a counter that begins counting
time in response to the mobile computing device being
initiated;
the diabetes management application is operable to:
determine a snapshot time;
set an internal clock of the diabetes management
application equal to the snapshot time and keep time on the
internal clock by using the counter;
determine whether the handheld medical device is
paired with the mobile computing device;
selectively instruct the handheld medical device to
communicate the glucose measurement and the first
measurement time in response to a determination that the
handheld medical device is paired with the mobile computing
device;
request a current device time from the RTC;
determine a first device delta time by determining a
difference between the current device time and a time on the
internal clock;
associate a first timestamp with the glucose
measurement, wherein the first timestamp is equal to the first
measurement time plus the first device delta time;
determine whether a difference between the first
measurement time and another current time of the RTC is less
than a predetermined value, wherein the diabetes management
application requests the another current time from the RTC of
the handheld medical device; and
generate, in response to the determination that the
difference is less than the predetermined value, a
recommendation for a quantity of insulin for the patient, where
the recommendation is based in part on the glucose
measurement.
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REJECTIONS
I. The Examiner rejects claims 1, 2, 4–8, 11, 12, 14–17, and 21
under 35 U.S.C. § 103 as unpatentable over Carlberg,3 Reinke,4 and
Keenan.5 (Final Act. 2.)6
II. The Examiner rejects claims 3 and 13 under 35 U.S.C. § 103 as
unpatentable over Carlberg, Reinke, Keenan, and Kashikar.7 (Final Act. 5.)
III. The Examiner rejects claim 20 under 35 U.S.C. § 103 as
unpatentable over Carlberg, Reinke, Keenan, and Harmon.8 (Final Act. 6.)
ANALYSIS
Claims 1 and 11 are the independent claims on appeal, with the rest of
the claims on appeal depending therefrom. (See Appeal Br., Claims App.)
Independent Claim 1
Independent claim 1 sets forth “[a] system for time keeping between
multiple devices used by a patient to manage diabetes.” (Appeal Br., Claims
App.) The Examiner finds that Carlberg discloses such a system. (See Final
Act. 2.) Carlberg discloses a system “for acquiring patient-related data”
(Carlberg ¶ 14) such as “medical information of patients suffering from
chronic diseases such as diabetes” (id. ¶ 10).

3 US 2012/0310669 A1, published December 6, 2012.
4 US 2011/0124996 A1, published May 26, 2011.
5 US 2014/0066884 A1, published March 6, 2014.
6 We assume that this rejection covers dependent claim 21 because it recites
subject matter similar to that recited in independent claim 11.
7 US 2011/0237237 A1, published September 29, 2011.
8 US 2006/0095225 A1, published May 4, 2006.
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Independent claim 1 sets forth that the system comprises a “medical
device” including a “real-time clock (RTC)” and a “blood glucose (bG)
meter” that is configured to associate a “measurement time with [a] glucose
measurement.” (Appeal Br., Claims App.) The Examiner finds that
Carlberg’s system includes such a medical device. (See Final Act. 2.)
Carlberg discloses an “electronic device 103” (e.g., “a blood glucose meter”)
which comprises a “clock” for “determining the current time.” (Carlberg
¶ 50.) Carlberg’s medical device 103 obtains patient-related data (e.g., a
glucose measurement) and generates a “corresponding time stamp T(acq)
associated with the patient-related data and indicative of the time at which
the patient-related data has been obtained.” (Id. ¶ 61.)
Independent claim 1 sets forth that a diabetes management application
is operable to “instruct the handheld medical device to communicate the
glucose measurement and the first measurement time.” (Appeal Br., Claims
App.) In Carlberg’s system, the medical device 103 “forwards” acquired
patient data (i.e., a glucose measurement) and an associated time stamp (i.e.,
a measurement time) to a host system 101. (Carlberg ¶ 62.) Carlberg’s host
system 101 comprises “a suitably programmed” processing unit 211 (id.
¶ 48) which analyzes the “acquired patient-related data” forwarded thereto
(id. ¶ 63).
Independent claim 1 sets forth that the diabetes management
application is operable to generate “a recommendation for a quantity of
insulin for the patient.” (Appeal Br., Claims App.) The Examiner finds that
Reinke teaches such a recommendation. (See Final Act. 3.) Reinke teaches
that a diabetes management program can include a “therapy module” which
“determine[s] a particular therapy advice message” based on “blood glucose
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measurement values.” (Reinke ¶ 46.) And Reinke teaches that this therapy
advice message “may comprise bolus recommendations.” (Id.)
Independent claim 1 sets forth that the recommendation is generated
“in response to” a determination involving “the measurement time” and
“another current time of the RCT.” (Appeal Br., Claims App.)9 The
Examiner finds that Keenan teaches generating a bolus recommendation in
response to such a determination. (Final Act. 4.) The Examiner relies upon
the following paragraph in Keenan to support this finding:
[T]he PID-IFB control module 906 may utilize an upper insulin
limit, which is a patient-specific parameter. In certain
embodiments, the upper insulin limit may be entered by the
user, a caregiver, or the like. Alternatively, the insulin limit
module 908 may be responsible for calculating or otherwise
managing the upper insulin limit if so desired. The upper
insulin limit imposes an upper limit to the insulin delivery rate
as an additional safety feature to avoid over-delivery of insulin
by the controller 900 due to potential sensor error. Thus, if the
PID-IFB control module 906 recommends a dose higher than
the insulin limit, the insulin limit will constrain the insulin
delivered to the insulin limit value. In addition, the insulin limit
will “freeze” the integral component of the PID to its previous
value to prevent integral windup, which can cause continuous
integrating of the glucose error until it reaches maximum
values. In certain embodiments, the upper insulin limit has a
default value set at five times the patient’s basal rate. Hence, if
the maximum value is reached, the PID-IFB control algorithm
will be fairly aggressive in calculating an insulin dose.
Accordingly, to minimize integral windup, the insulin limit is

9 Specifically, a determination is made “whether a difference between the
first measurement time and another current time of the RTC is less than a
predetermined value, wherein the diabetes management application requests
the another current time from the RTC of the handheld medical device.”
(Appeal Br., Claims App.)
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fed back to the PID-IFB control module 906 (as depicted in
FIG. 49) for use in the next insulin dose calculation.

(Keenan ¶ 402.) As correctly noted by the Examiner, the “PID-IFB
algorithm” mentioned in this paragraph “discusses recommending an insulin
dose.” (Answer 5.) However, this recommendation is based upon an upper
limit to avoid an unsafe recommendation due to potential sensor error, not
upon a determination involving a measurement time and a current time.
Thus, we are persuaded by the Appellant’s position that Keenan does not
show or suggest a recommendation that is generated in response to such time
values. (See Appeal Br. 14.)
The Examiner maintains that Keenan “describes multiple algorithms
that process, control and implement safeguards on an insulin pump/glucose
monitoring device operating in a closed loop mode.” (Answer 5.) And,
according to the Examiner, these algorithms look for “missed data packets
totaling less than a lower threshold of time,” “trigger a fail-safe alert,”
and/or “switch to” a “safe operating mode with reduced insulin delivery.”
(Id., see also Keenan ¶¶ 409, 377, 562.) But the Examiner does not point,
with particularity, to a disclosed algorithm which generates an insulin
recommendation in response to a determination based upon a measurement
time and a current time.
Thus, we do not sustain the Examiner’s rejection of independent
claim 1 as obvious over Carlberg, Reinke, and Keenan (Rejection I).
Independent Claim 11
Independent claim 11 sets forth a method “for determining a
measurement time associated with a blood glucose measure received from a
glucose meter.” (Appeal Br., Claims App.) The method involves a
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“diabetes management application,” determining “whether a difference
between the measurement time and another current time of [a] real-time
clock is less than a predetermined value,” and generating, “in response to”
this determination, “a recommendation for a quantity of insulin for the
patient.” (Id.) The Examiner’s rejection of independent claim 11 is made in
tandem with independent claim 1, whereby it is likewise deficient for the
reasons discussed above. (See Final Act. 2–4.)
Thus, we do not sustain the Examiner’s rejection of independent
claim 11 as obvious over Carlberg, Reinke, and Keenan (Rejection I).
Dependent Claims
The Examiner’s further findings and determinations with respect to
the dependent claims and the additional secondary references do not
compensate for the above-discussed shortcoming in the rejections of
independent claims 1 and 11. (See Final Act. 4–6.)
Thus, we do not sustain the Examiner’s rejection of dependent
claims 2, 4–8, 12, 14–17, and 21 as obvious over Carlberg, Reinke, and
Keenan (Rejection I); the Examiner’s rejection of dependent claim 3 and 13
as obvious Carlberg, Reinke, Keenan, and Kashikar (Rejection II); and the
Examiner’s rejection of dependent claim 20 as obvious over Carlberg,
Reinke, Keenan, and Harmon (Rejection III).
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CONCLUSION
Claims
Rejected
35 U.S.C.
§ 
Reference(s)/Basis Affirmed Reversed
1, 2, 4–8,
11, 12,
14–17, 21
103  Carlberg, Reinke,
Keenan
1, 2, 4–8, 11,
12, 14–17, 21
3, 13 103 Carlberg, Reinke,
Keenan, Kashikar
3, 13
20 103 Carlberg, Reinke,
Keenan, Harmon
20
Overall
Outcome
1–8, 11–17,
20, 21

REVERSED