Roche Diagnostics Operations, Inc.

Patent Trials and Appeals Board

May 3, 2021

2020003389 (P.T.A.B. May. 3, 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.
14/172,043 02/04/2014 Eric S. Carlsgaard 31575 US1 (15878A-125) 4873
98067 7590 05/03/2021
Harness Dickey (Roche)
5445 Corporate Drive, Suite 200
Troy, MI 48098-2683
EXAMINER
FRITCHMAN, REBECCA M
ART UNIT PAPER NUMBER
1797
NOTIFICATION DATE DELIVERY MODE
05/03/2021 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):
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. CALSGAARD, DAVID B. MARKISOHN, and
MARK MEARS

____________

Appeal 2020-003389
Application 14/172,043
Technology Center 1700
____________

Before JEFFREY T. SMITH, JENNIFER R. GUPTA,
and JANE E. INGLESE, Administrative Patent Judges.

INGLESE, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 requests review under 35 U.S.C. § 134(a) of the
Examiner’s final rejection of claims 1–7 and 10–13.2 We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.

1 “Appellant” refers to the “applicant” as defined in 37 C.F.R. § 1.42.
Appellant identifies Roche Diabetes Care, Inc. as the real party in interest.
Appeal Brief filed December 3, 2019 (“Appeal Br.”), 3.
2 Final Office Action entered June 19, 2019 (“Final Act.”), 1.
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CLAIMED SUBJECT MATTER
Appellant claims a diabetes management system. Appeal Br. 7–8.
Claim 1 illustrates the subject matter on appeal, and reads as follows:
1. A diabetes management 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 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 identifying information with the
glucose measurement;
a wireless transceiver cooperatively operable with
the bG meter to communicate the glucose measurement
and the identifying information via a wireless data link;
a user interface that selectively instructs the
handheld medical device to initiate a pairing procedure in
response to input received from a user; and
a first processor configured to:
determine whether a test strip is received in
the port;
measure, in response to a determination that
a test strip is received in the port, glucose in the
sample of fluid on the test strip,
determine, in response to a determination
that a test strip is received in the port, whether an
auto-send feature is enabled on the handheld
medical device; and
determine, in response to a determination
that a test strip is received in the port, whether the
handheld medical device is paired with a mobile
computing device; and
in response to a determination (i) that the
auto-send feature is enabled and (ii) the handheld
medical device is paired with the mobile
computing device and (iii) receiving the glucose
measurement from the bG meter, instruct the
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wireless transceiver to establish a wireless
connection and communicate the glucose
measurement and the identifying information to
mobile computing device;
the mobile computing device comprising a second
processor configured to execute a diabetes management
application stored on an associated memory, the diabetes
management application configured to:
process a plurality of glucose measurements and
identifying information associated with each of the
plurality of glucose measurements; and
display, on a user display of the mobile computing
device, a message indicative of at least one glucose
measurement.

Appeal Br. 15–16 (Claims Appendix) (emphasis added and spacing
altered).
REJECTION
The Examiner maintains the rejection of claims 1–7 and 10–13 under
35 U.S.C. § 103 as unpatentable over OneTouch3 in view of Valdes4 and
Elder5 in the Examiner’s Answer entered January 10, 2020 (“Ans.”).

FACTUAL FINDINGS AND ANALYSIS
Upon consideration of the evidence relied upon in this appeal and
each of Appellant’s contentions, we affirm the Examiner’s rejection of
claims 1–7 and 10–13 under 35 U.S.C. § 103 for reasons set forth in the
Final Action, the Answer, and below.
We review appealed rejections for reversible error based on the

3 OneTouch VerioSync: Blood Glucose Monitoring System –Owner’s
Booklet (34 pgs).
4 Valdes et al., US 2011/0320130 Al, published December 29, 2011.
5 Elder et al., US 2014/0238874 Al, published August 28, 2014.
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arguments and evidence the Appellant provides. 37 C.F.R. §
41.37(c)(1)(iv); 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) (explaining that even if the Examiner had failed to make a prima
facie case, “it has long been the Board’s practice to require an applicant to
identify the alleged error in the examiner’s rejections”)).
Appellant presents arguments directed to the subject matter of
independent claim 1 only, to which we accordingly limit our discussion.
Appeal Br. 10–14; 37 C.F.R. § 41.37(c)(1)(iv).
OneTouch discloses a blood glucose monitoring system that includes
a blood glucose meter. OneTouch pp. 1, 16. OneTouch provides
instructions for using the system that involve an initial set-up process with
the following steps: downloading the OneTouch Reveal app onto an Apple
device, pairing the blood glucose meter with the Apple device using
Bluetooth, and syncing the meter and the app. OneTouch pp. 18–27.
OneTouch discloses that after this initial set-up process, the system can be
used for blood glucose testing, which first involves inserting a test strip into
a test strip port on the meter “to turn the meter on.” OneTouch pp. 26, 39.
OneTouch discloses that after applying a blood sample to the test strip, a
blood glucose result appears on the meter display, and the meter then syncs
with the app to send the test result to the app via Bluetooth. OneTouch pp.
42, 45–46. OneTouch cautions not to remove the test strip from the port
until the blood glucose result displays on the meter, or the meter will turn
off. OneTouch p. 44. OneTouch also indicates that a test strip should not be
inserted into the meter during transmission, because doing so “will cancel
the transfer of all results.” OneTouch p. 47.
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The Examiner finds that the OneTouch System thus “reads on” the
diabetes management system of claim 1, including ensuring that a test strip
has been inserted in the port, because the OneTouch System “would not
work if this were not the case.” Final Act. 3–4. The Examiner additionally
relies on Elder “[i]f it is unclear to one of ordinary skill in the art . . . that the
OneTouch System reads on . . . making sure a test strip was received in the
port.” Final Act. 3–4.
Elder discloses blood analyte meter 10 that includes processing
system 140 having processing unit 120, and port 22 for receiving glucose
test strip 24. Final Act. 4–5; Elder ¶ 16, Figs. 1A, 1B. Elder discloses that
processing unit 120 receives a signal from test strip port 22 indicating that a
test strip has been inserted into port 22. Elder ¶ 32.
Appellant argues that “OneTouch does not teach or suggest that
sending glucose measurements occurs in response to a determination that a
test strip is inserted into a port of the meter.” Appeal Br. 11. Appellant
argues that “sending of test results in [the] OneTouch meter is independent
from (and not in response to) insertion of a test strip” because “Bluetooth
can be turned on with or without a strip being inserted into the port of the
device.” Id. Appellant argues that Valdes and Elder both do not cure this
deficiency of OneTouch because neither reference teaches or suggests
sending test results in response to a determination that a test strip is inserted
into a port. Appeal Br. 11–12.
Appellant’s arguments do not identify reversible error in the
Examiner’s rejection, for reasons that follow.
As discussed above, OneTouch explicitly discloses that testing blood
glucose using OneTouch’s meter after an initial set-up process first involves
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inserting a test strip into a test strip port on the meter “to turn the meter on.”
OneTouch p. 39. One of ordinary skill in the art reasonably would have
understood from this disclosure that the remaining steps for testing blood
glucose using OneTouch’s system occur as a result of, or in response to,
inserting a test strip into the test strip port of OneTouch’s blood glucose
meter. The ordinarily skilled artisan would have recognized that the meter
would need to be turned on before the subsequent steps could be conducted,
including the step of sending the glucose test result to the paired app.
Contrary to Appellant’s arguments, one of ordinary skill in the art, therefore,
would have understood that a glucose test result is sent from OneTouch’s
meter to a paired app in response to a determination that a test strip has been
inserted into the test strip port of the meter. KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 418 (2007) ([A]n obviousness analysis “need not seek out
precise teachings directed to the specific subject matter of the challenged
claim, for [an examiner] can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ.”); see also In re
Preda, 401 F. 2d 825, 826 (CCPA 1968) (“[I]t is proper to take into account
not only specific teachings of the reference but also the inferences which one
skilled in the art would reasonably be expected to draw therefrom.”).
Although OneTouch does not explicitly disclose the means for
making this determination, Elder includes such disclosure. As discussed
above, Elder discloses blood analyte meter 10 including processing unit 120
that receives a signal from test strip port 22 indicating that a test strip has
been inserted into port 22. Elder ¶ 32. One of ordinary skill in the art would
have recognized that a processing unit as disclosed in Elder would have been
suitable as the means used in OneTouch’s meter to determine when a test
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strip has been inserted into OneTouch’s test strip port. The ordinarily skilled
artisan would have recognized that a signal could be sent from OneTouch’s
test strip port to a processing unit in OneTouch’s system as disclosed in
Elder, and in response to such a signal, the processing unit could turn
OneTouch’s meter on, and send instructions for carrying out the remaining
steps in OneTouch’s process, including the step of sending the glucose test
result to the paired app, as required by claim 1.
As to Appellant’s argument that Valdes does not teach or suggest
sending test results in response to a determination that a test strip is inserted
into a port, the Examiner does not rely on Valdes for any such disclosure.
Final Act. 3–4. Appellant’s argument, therefore, does not identify reversible
error in the Examiner’s rejection because it does not address the basis for the
Examiner’s reliance on Valdes, discussed below.
Appellant argues that because “OneTouch teaches terminating any
transmission of test results upon detecting insertion of a test strip,” the
Examiner is not correct in finding that OneTouch teaches ensuring that a test
strip has been inserted in the test strip port because the OneTouch System
“would not work if this were not the case.” Appeal Br. 12. Appellant
argues that “OneTouch teaches away from sending test results in a response
to a determination that a test strip is inserted into a port of the meter”
because “[r]ather than transmitting upon insertion of a test strip, OneTouch
teaches terminating any transmission of test results when a test strip is
inserted into a port of the meter.” Appeal Br. 13. Appellant argues that “the
principle of operation of the OneTouch system would change if modified in
the manner suggested by the examiner” because “the OneTouch system
cancels data transmission upon detecting the insertion of a test strip.”
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Appeal Br. 13–14.
Appellant’s arguments do not identify reversible error in the
Examiner’s rejection, for reasons that follow.
As discussed above, OneTouch discloses conducting blood glucose
testing using OneTouch’s system by first inserting a test strip into a test strip
port on the meter “to turn the meter on,” and then applying a blood sample
to the test strip. OneTouch discloses that a blood glucose result then appears
on the meter display, and the meter syncs with a paired app to send the test
result to the app using Bluetooth. OneTouch explicitly cautions against
removing the test strip from the port until the blood glucose result displays
on the meter, because doing so will cause the meter to turn off. OneTouch
p. 44. Contrary to Appellant’s arguments, OneTouch thus discloses turning
on OneTouch’s meter by inserting a test strip into a test strip port in the
meter, and leaving the test strip in the port until a blood glucose result
appears on the meter’s display.
Although OneTouch also indicates that a test strip should not be
inserted into the meter during transmission of the blood glucose result from
the meter to the paired app, because doing so “will cancel the transfer of all
results,” one of ordinary skill in the art would have understood this
disclosure to refer to a situation in which a test strip previously had been
inserted into the test strip port of OneTouch’s meter to turn the meter on,
blood had been applied to the test strip, and a blood glucose test result was
being transmitted from the meter to the paired app. OneTouch indicates that
in such a situation, the test strip should remain in the port during
transmission of the test result to the app, because removing the strip during
transfer of the test result terminates the transmission. OneTouch p. 47.
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Contrary to Appellant’s arguments, this disclosure does not teach away
from, or change the operating principle of, OneTouch’s process, which
involves sending a glucose test result to a paired app as a consequence of, or
in response to, determining that a test strip has been inserted into a port of
OneTouch’s meter, such as through use of a processing unit as disclosed in
Elder (as discussed above). In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994)
(“A reference may be said to teach away when a person of ordinary skill,
upon reading the reference, would be discouraged from following the path
set out in the reference, or would be led in a direction divergent from the
path that was taken by the applicant.”).
Appellant argues that “the examiner’s rationale for combining the
teachings of Valdes with the OneTouch system are [sic] flawed” because
“[t]he OneTouch system does not continuously detect or quantify glucose
measurements.” Appeal Br. 12–13.
As discussed above, however, the Examiner finds that the OneTouch
System “reads on” the diabetes management system of claim 1.
Nonetheless, the Examiner further relies on Valdes “[i]f it is unclear to one
of ordinary skill in the art though that the OneTouch system reads on the
diabetes management application” recited in claim 1. Final Act. 3. The
Examiner finds that Valdes discloses a software application stored on a
mobile computing device that receives data wirelessly from a sensor that
substantially continuously measures glucose, and displays glucose
measurements on the mobile computing device. Final Act. 3. In view of
these disclosures in Valdes, the Examiner concludes that it would have been
obvious to one of ordinary skill in the art to use a software application as
disclosed in Valdes with the OneTouch system to allow transmission of raw
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or minimally processed glucose data for subsequent analysis at a remote
computing device. Final Act. 4 (citing Valdes ¶ 4).
Although Valdes disclosees a glucose sensor that substantially
continuously measures glucose as Appellant argues, this disclosure is not the
basis for the Examiner’s reliance on Valdes. Final Act. 3–4; Valdes ¶ 8.
Rather, although OneTouch explicitly discloses pairing OneTouch’s blood
glucose meter with an app on an Apple device, and syncing the meter with
the app to wirelessly send glucose test results from the meter to the app,
Valdes also discloses sending glucose measurements to an app stored on a
mobile computing device and displaying the test results on the mobile
device. Valdes ¶¶ 8, 9, 12, 14, 16. The Examiner relies on this disclosure in
Valdes to further support the Examiner’s finding that a diabetes management
application stored on a mobile computing device that receives glucose
measurements from a glucose meter as recited in claim 1 was known in the
art at the time of filing. Final Act. 3–4.
Appellant’s arguments, therefore, do not identify reversible error in
the Examiner’s rejection, which we accordingly sustain.
CONCLUSION
Claims

35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–7, 10–13 103 OneTouch, Valdes,
Elder
1–7, 10–13

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

AFFIRMED