Timmerman, Robert David.

Patent Trials and Appeals Board

Feb 13, 2020

12620202 - (D) (P.T.A.B. Feb. 13, 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.
12/620,202 11/17/2009 Robert David Timmerman 26285 US
(15878A-147-US)
1098
98067 7590 02/13/2020
Harness Dickey (Roche)
5445 Corporate Drive, Suite 200
Troy, MI 48098-2683
EXAMINER
JANG, CHRISTIAN YONGKYUN
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
02/13/2020 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):
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PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ROBERT DAVID TIMMERMAN

Appeal 2019-003690
Application 12/620,202
Technology Center 3700
____________

Before MICHAEL L. HOELTER, MICHAEL J. FITZPATRICK, and
PAUL J. KORNICZKY, Administrative Patent Judges.

FITZPATRICK, Administrative Patent Judge.

DECISION ON APPEAL

Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
final decision rejecting claims 1, 2, 4–7, 9, and 12–22. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.

1 Appellant is the “applicant” under 37 C.F.R. § 1.42(a) and identifies Roche
Diabetes Care, Inc., as the sole real party in interest. Appeal Br. 3.
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STATEMENT OF THE CASE
The Specification
The Specification’s disclosure “relates generally to hypoglycemic
treatment methods and systems.” Spec. ¶1.
The Claims
Claims 1, 2, 4–7, 9, and 12–22 are rejected. Final Act. 1. No other
claims are pending. Id. Claim 1 is illustrative and reproduced below.
1. A method of treating hypoglycemia of a diabetic
patient, comprising:
detecting a hypoglycemic condition of the diabetic
patient using a continuous glucose monitor, wherein the
continuous glucose monitor is arranged subcutaneously in the
diabetic patient and measures actual glucose levels in interstitial
fluid of the diabetic patient on a continuous basis over a period
of time;
providing a first alarm to alert the diabetic patient of the
hypoglycemic condition in response to an actual glucose level
of the diabetic patient being detected by the continuous glucose
monitor above a predetermined lower glucose level of the
diabetic patient but below a predetermined upper glucose level
of the diabetic patient, wherein the lower and upper glucose
levels define a range of hypoglycemia of the diabetic patient in
which the hypoglycemic condition of the diabetic patent has not
reached a dangerous level;
providing a second alarm different from the first alarm to
alert the diabetic patient that the hypoglycemic condition has
reached the dangerous level in response to the actual glucose
level of the diabetic patient being detected by the continuous
glucose monitor below the predetermined lower glucose level,
wherein said second alarm starts a predetermined time period;
providing the first alarm to alert a caregiver of the
hypoglycemic condition of the diabetic patient when the actual
glucose level of the diabetic patent is above the predetermined
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lower glucose level of the diabetic patient but below the
predetermined upper glucose level of the diabetic patient;
providing the second alarm to alert the caregiver that the
hypoglycemic condition of the diabetic patient has reached the
dangerous level;
detecting acknowledgement of the second alarm within
the predetermined time period;
discontinuing the second alarm in response to detecting
an acknowledgement of the second alarm within the
predetermined time period; and
delivering glucagon automatically to the diabetic patent
using an alarm and injector apparatus comprising a glucagon
delivery mechanism for delivering glucagon to the diabetic
patient in response to absence of an acknowledgement of the
second alarm within the predetermined time period.
Appeal Br. 23–24.
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The Examiner’s Rejections
The following rejections, both pursuant to 35 U.S.C. § 103(a), are
before us:
1. claims 1, 2, 4–7, and 22 as unpatentable over Houben,2 Fox,3
Asomani,4 Brister,5 and Lebel6 (id. at 2); and
2. claims 9 and 12–21 as unpatentable over Houben, Fox,
Asomani, and Brister (id. at 5).
DISCUSSION
Rejection 1
Appellant argues the rejection of claims 1, 2, 4–6, and 22 together.
Appeal Br. 12–19. For these claims, we select claim 1 as representative.
See 37 C.F.R. § 41.37(c)(1)(iv).
Appellant separately presents additional arguments with respect to
claim 7. Appeal Br. 19–20.
Claims 1, 2, 4–6, and 22
Houben is titled “SYSTEM AND METHOD FOR MONITORING
AND CONTROLLING THE GLYCEMIC STATE OF A PATIENT.”
Houben, [54]. The Examiner found that Houben teaches much of the subject
matter of claim 1. Final Act. 2 (citing Houben 5:8–15, 5:60–63, 11:32–24,
19:35–40, 21:41–60). One difference between Houben and claim 1 is that
Houben indirectly measures (or “correlates”) blood glucose levels via
measured ECG and EKG signals (see Houben 14:42–59), whereas claim 1

2 US 6,572,542 B1, issued June 3, 2003 (“Houben”).
3 US 2003/0125612 A1, published July 3, 2003 (“Fox”).
4 US 7,261,691 B1, issued Aug. 28, 2007 (“Asomani”).
5 US 2008/0306444 A1, published Dec. 11, 2008 (“Brister”).
6 US 2003/0055406 A1, published Mar. 20, 2003 (“Lebel”).
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recites “measure[ing] actual glucose levels in interstitial fluid of the diabetic
patient on a continuous basis over a period of time.” See Final Act. 3
(acknowledging this difference). Additionally, “Houben fails to teach a first
alarm that is provided when the glucose level is between predetermined
upper and lower levels, and a second, different, alarm if the glucose level is
below the predetermined lower level, detecting actual blood glucose levels,
and the delivery of glucagon if the alarm is not acknowledged.” Id.
The Examiner relies on Fox for teaching a continuous glucose
monitoring device placed subcutaneously to directly measure actual glucose
levels in the interstitial fluid that has several thresholds (proportional to
urgency) and distinct alarms pertaining to the different thresholds. Id.
(citing Fox ¶¶ 53, 54, 56, 89, 90, Fig. 4). The Examiner relies on Asomani
for teaching a glucose monitoring device that automatically administers
glucose upon failure of the patient to acknowledge an alarm condition within
a predetermined time period. Id. at 4 (citing Asomani 2:51–60). The
Examiner relies on Brister for teaching a diabetes monitoring device wherein
information can be monitored remotely by the patient’s physician using a
portable device. Id. (citing Brister ¶276). The Examiner relies on Lebel for
teaching a medical communications device, wherein alarms are set to go off
for a predetermined time period, until it is acknowledged. Id. (citing Lebel
¶¶356–358, 368). The Examiner provides reasons for why a person of
ordinary skill in the art would have incorporated each of these features into
Houben. Id. at 3–5.
Appellant argues that “the Examiner wholly failed to explain how or
why the method for measuring glucose levels in interstitial fluid using a
subcutaneously arranged sensor as taught by Fox would be incorporated into
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a system that monitors glucose levels by processing ECG and EEG signals
as seen in Houben.” Appeal Br. 14. Appellant specifically challenges that a
person of ordinary skill in the art would have incorporated Fox’s “more
invasive” manner of measuring blood glucose levels, particularly in light of
Houben’s statement that “ideally, glucose monitoring would be continuous
and non-invasive.” Id. at 14–15 (quoting Houben 2:25–26). The Examiner
responds that, despite Houben’s stated ideal, its teachings explicitly extend
to using “subcutaneous electrodes, or intracardiac or intracranial electrodes.”
Ans. 4–5 (quoting Houben 11:32–35). Accordingly, Appellant’s argument
does not apprise us of error.7
Appellant also argues that
the Examiner’s reasoning focusing solely on the subsequent
alarms and automatic corrective actions is inapposite when Fox
is silent regarding the application of the automated and semi-
automated medication infusion devices. See Fox, para. [0053].
As such, the skilled artisan would have no basis for determining
a relationship between the multiple alarms and the automated and
semi-automated medication infusion devices and as noted above
obviousness cannot be based on the hindsight combination of
components selectively culled from the prior art to fit the
parameters of the claimed invention.

7 In its Reply, Appellant ultimately concedes that Houben contemplates
subcutaneous electrodes, but argues that such electrodes do not measure
blood glucose levels of interstitial fluid. Reply Br. 2 (“Although the ECG
and EEG electrodes may be subcutaneous electrodes, such sensors measure
electrical signals and do not measure glucose levels of interstitial fluid.”).
That argument is inapposite, as the Examiner does not rely on Houben for
teaching directly measuring actual glucose levels in the interstitial fluid. For
that limitation, as already discussed above, the Examiner relies on Fox.
Final Act. 3.
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Appeal Br. 15. Appellant’s argument is vague with respect to “the
Examiner’s reasoning focusing solely on the subsequent alarms and
automatic corrective actions.” Id. As best we can discern from this
argument, Appellant is challenging the Examiner’s reason for combining
Houben and Fox—it is not clear from Appellant’s argument—based on the
isolated teachings of Fox. However, the Examiner relies on Fox solely for
teaching a means to monitor blood glucose levels that is an alternative to
Houben’s ECG- and EKG-based means. Final Act. 3. That Fox does not
teach other aspect of the claimed subject matter does not undermine the
rejection. See In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986)
(“Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references. . . . [The reference] must be read, not in
isolation, but for what it fairly teaches in combination with the prior art as a
whole.”). Appellant’s argument does not apprise us of Examiner error.
Appellant points out that, in Houben, certain data within the EKG and
ECG data must be identified and correlated with glucose or insulin levels to
determine if an alarm should be triggered. Appeal Br. 15–16. Thus,
Appellant argues, “the processing method for identifying and delivering
alerts and therapies is necessarily dependent upon the collection method.”
Id. Appellant does not explain how the change in blood glucose collection
method might be nonobvious. Rather, Appellant merely implies that Fox’s
blood glucose collection method could not be substituted into Houben
thoughtlessly (i.e., without also making some changes to the device’s
programming). See id. (“As such, the processing method for identifying and
delivering alerts and therapies is necessarily dependent upon the collection
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method and actual collected data.”). Whatever the specific contours of this
argument, however, it is not persuasive of error. “A person of ordinary skill
is also a person of ordinary creativity, not an automaton.” KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 421 (2007); see also id. at 417 (“[I]f a technique
has been used to improve one device, and a person of ordinary skill in the art
would recognize that it would improve similar devices in the same way,
using the technique is obvious unless its actual application is beyond his or
her skill.”).
Appellant argues that “it is unclear why one having ordinary skill in
the art would be motivated to combine the passive monitoring system of
Asomani (and/or Houben) with the more invasive method as taught by Fox.”
Appeal Br. 17. This argument does not apprise us of error for multiple
reasons. First, its factual premise is erroneous. On the one hand, Appellant
asserts that Fox’s blood glucose collection method in which “the sensor is
subcutaneously placed” (Fox ¶54) is “more invasive” than Asomani. Appeal
Br. 17. But, on the other hand, Appellant concedes that Asomani teaches an
equally invasive method of collecting blood glucose measurements (i.e.,
“through the patient’s skin”). Id. (quoting Asomani 4:30–31). Second, the
Examiner does not rely on Asomani for its collection method. Rather, the
Examiner relies on Asomani for its feature of automatically administering
glucose upon failure of the patient to acknowledge an alarm condition within
a predetermined time period. Final Act. 4 (citing Asomani 2:51–60).
Appellant argues that the Examiner has not shown that a person of
ordinary skill in the art would have “convert[ed] the operational alarms of
Lebel to physiological alarms” in the asserted combination. Appeal Br. 18.
This argument does not apprise us of error. Claim 1 does not recite
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“physiological” alarms, nor does Appellant explain what it means by that.
As best we can discern, Appellant is arguing that Lebel’s alarms are
triggered by an operational status of a device such as a low battery, whereas
the recited alarms of Appellant’s invention must be triggered by detection of
hypoglycemia, either dangerous or non-dangerous. The Examiner responds
to Appellant by pointing out, correctly, that “[o]ne of ordinary skill in the art
would surely recognize that the concept of having an alarm that rings for a
time period or until acknowledgment would not be solely limited to an alarm
associated with glucose levels, as that is how many an alarm clock similarly
functions.” Ans. 6. Appellant’s related argument that a person of ordinary
skill in the art would not have a reasonable expectation of success in creating
an alarm triggered by the detection of hypoglycemia (Appeal Br. 19)
likewise does not apprise us of error. In view of the cited prior art teachings
and the level of skill in the art as reflected in the cited prior art, we are not
dissuaded that a person of ordinary skill would have had a reasonable
expectation of success in combining the prior art teachings as proposed by
the Examiner.
For the foregoing reasons, we affirm the rejection of claim 1, as well
as claims 2, 4–6, and 22, which fall with claim 1, as unpatentable over
Houben, Fox, Asomani, Brister, and Lebel.
Claim 7
Claim 7 ultimately depends from claim 1 and recites “wherein, after
the step of providing the second alarm, said method further comprises the
controller looking for the patient-initiated input signal provided using an
input mechanism within the predetermined time period.” Appeal Br. 25.
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The Examiner relies on Houben for teaching such a patient-initiated input
signal. Final Act. 5 (citing Houben 18:64–19–22).
Appellant argues that Houben does not disclose the “within the
predetermined time period” aspect of the limitation. Appeal Br. 19–20. The
Examiner responds, in part, by noting that “Asomani addresses the
acknowledgment of the predetermined time period, and as Houben allows
for the patient-initiated input signal, the resulting combination addresses this
limitation.” Ans. 6.8 The Examiner is correct. It is claim 1 that first recites
“a predetermined time period,” and, in fact, the Examiner cited Asomani for
that limitation. Final Act. 4 (citing 2:51–60); see also Asomani 2:56–57
(disclosing automatic glucose administration “upon a failure of the patient to
acknowledge an alarm condition within a predetermined time period, e.g.,
three to five minutes, more or less”). For the foregoing reasons, we affirm
the rejection of claim 7 as unpatentable over Houben, Fox, Asomani, Brister,
and Lebel.
Rejection 2
Claims 9, 12–13, and 15–19
Appellant argues against the rejection of claims 9, 12–13, and 15–19
on the basis that they recite (or incorporate by reference through
dependency) “similar features as independent Claim 1,” and therefore are
patentable “[f]or at least the reasons set forth above.” Appeal Br. 20.
However, as discussed above, those arguments do not apprise us of
Examiner error, and Appellant does not present any additional arguments for

8 The Examiner additionally points out that Houben’s patient input would be
useless if there is no time limit on its receipt. Ans. 6.
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these claims. Id. Accordingly, we affirm the rejection of claims 9, 12–13,
and 15–19 as unpatentable over Houben, Fox, Asomani, and Brister.
Claims 21 and 22
Appellant does not present arguments against the rejection of claims
21 and 22. Accordingly, we affirm the rejection of claims 21 and 22 as
unpatentable over Houben, Fox, Asomani, and Brister.
Claim 14
Claim 14 depends from claim 9 and recites “wherein the first alarm
signal and the second alarm signal are provided by a glucose meter receiving
glucose information from the continuous glucose monitor.” Appeal Br. 27.
Appellant points out that “Houben provides that an alarm signal is generated
by the processor and controller (34) and transmitted to the external device
(41).” Appeal Br. 20–21 (citing Houben 13:51–62). The Examiner
responds that “any part of the system that is part of receiving the glucose
information and outputting an alarm can be considered a glucose meter. The
claim does not necessitate the glucose meter be encased in the same housing
or be connected via wires.” Ans. 6. Appellant does not reply to the
Examiner’s response, and we discern no error in the Examiner’s construction
of “glucose monitor.” See generally Reply Br.
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SUMMARY
Claims
Rejected
35 U.S.C. § References/Basis Affirmed Reversed
1, 2, 4–7, 22 103 Houben, Fox,
Asomani, Brister,
Lebel
1, 2, 4–7,
22

9, 12–21 103 Houben, Fox,
Asomani, Brister
9, 12–21
Overall
Outcome
1, 2, 4–7,
9, 12–22

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