MEDTRONIC, INC.

Patent Trials and Appeals Board

Jun 24, 2020

13953108 - (D) (P.T.A.B. Jun. 24, 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.
13/953,108 07/29/2013 Michael C. Schmitz 134.07490101/
C00003993.US
4313
64619 7590 06/24/2020
MEDTRONIC, INC. (NEURO/MRG)
710 MEDTRONIC PARKWAY NE
MS-LC340
MINNEAPOLIS, MN 55432-5604
EXAMINER
DARB, HAMZA A.
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
06/24/2020 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):
ptodocketing@mrgs.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MICHAEL C. SCHMITZ,
DALE F. SEELEY, and
KEITH R. HILDEBRAND

Appeal 2019-006659
Application 13/953,108
Technology Center 3700
____________

Before STEFAN STAICOVICI, MICHAEL L. HOELTER, and
LEE L. STEPINA, Administrative Patent Judges.

HOELTER, 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, 3–11, 18, 20, 21, 25, and 26, which

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. We understand the real party in interest is “Medtronic,
Inc. of Minneapolis, Minnesota, the assignee of record, and Medtronic plc of
Dublin, Ireland, the ultimate parent entity of Medtronic. Inc.” Appeal Br. 3.
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constitute all the claims pending in this application. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.
CLAIMED SUBJECT MATTER
The disclosed subject matter “generally relates to, among other things,
titration of dosing of medicaments delivered by medical infusion devices
and systems and methods associated therewith.” Spec. ¶ 1. Apparatus claim
1 and method claim 18 are the sole independent claims. Claim 1 is
representative of the claims on appeal and is reproduced below.
1. A medical infusion device, comprising:
a reservoir for housing a liquid composition comprising a
medicament;
a pump mechanism configured to drive the liquid
composition from the reservoir to a patient;
input apparatus configured to receive input indicative of
a patient side effect of the medicament; and
control electronics operably coupled to the pump
mechanism and to the input apparatus, wherein the control
electronics are configured to:
(a) cause the pump mechanism to drive the liquid
composition from the reservoir to the patient at an initial rate;
(b) automatically cause the pump mechanism to drive
the liquid composition from the reservoir to the patient for a
predetermined period of time at a rate increased relative to a
preceding rate if no input indicative of a patient side effect has
been received during a period of time in which the pump
mechanism drove the liquid composition from the reservoir to
the patient at the preceding rate; and
(c) repeat step (b) until a maximum predetermined
rate has been achieved or until input indicative of a patient side
effect is received, wherein if input indicative of a patient side
effect is received, the control electronics cause the pump
mechanism to drive the liquid composition from the reservoir to
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the patient at a decreased rate relative to a rate in a time period
in which the input indicative of a patient side effect is received
but at a rate equal to or greater than the initial rate if no input
indicative of a patient side effect was received during a period
of time in which pump mechanism drove the liquid composition
from the reservoir to the patient at the initial rate.
EVIDENCE
Name Reference Date
Spencer US 6,010,483 Jan. 4, 2000
Bui et al. (“Bui”) US 6,231,560 B1 May 15, 2001
Dang et al. (“Dang”) US 2003/0069318 A1 Apr. 10, 2003
Flaherty et al. (“Flaherty”) US 2005/0203461 A1 Sept. 15, 2005
REJECTIONS
Claims 1, 3–7, 18, 20, 21, 25, and 26 are rejected under 35 U.S.C.
§ 103 as unpatentable over Spencer and Bui.
Claims 8 and 9 are rejected under 35 U.S.C. § 103 as unpatentable
over Spencer, Bui, and Dang.
Claims 10 and 11 are rejected under 35 U.S.C. § 103 as unpatentable
over Spencer, Bui, and Flaherty.
ANALYSIS
The rejection of claims 1, 3–7, 18, 20, 21, 25, and 26
as unpatentable over Spencer and Bui
Appellant argues claims 1, 3–7, 18, 20, 21, 25, and 26 together. See
Appeal Br. 10–22.2 We select claim 1 for review, with the remaining claims

2 After presenting arguments with respect to independent claim 1, Appellant
states, “[t]he same or similar arguments apply to claim 18.” Appeal Br. 22.
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(i.e., claims 3–7, 18, 20, 21, 25, and 26) standing or falling with claim 1.
See 37 C.F.R. § 41.37(c)(1)(iv).
The Examiner relies primarily on Spencer for teachings the various
limitations of claim 1, including pump operation. See Final Act. 2–3.
However, the Examiner acknowledges that Spencer “fails to specifically
disclose that the control electronics are configured to cause the pump” to
operate as recited. Final Act. 3 (emphasis added). To be clear, Spencer
addresses “a single button for a patient to push when more pain medicine is
needed.” Spencer 2:29–30. The Examiner relies on Bui for disclosing
“control electronics (Fig. 2) . . . configured to cause the pump” to operate,
and to do so “automatically.” Final Act. 3, 4; see also Ans. 3 (“but the
control electronics of Spencer fails to perform step (b) in an automatic
manner”), 4 (“with regards to the word ‘automatically’, a second reference is
used in the action”). The Examiner’s stated reason to combine Spencer and
Bui is that it would have been obvious to a skilled artisan “for the purpose of
automatically adjusting . . . the patient’s medications in [the] absence of [a]
caregiver.” Final Act. 4, Ans. 4 (both referencing Bui 13:30–62) (“The
invention allows the pump to automatically adjust basal rate and/or bolus
rate to alleviate patient pain in the absence of the caregiver’s intervention.”);
see also Bui, Abstract (“automatically adjusts the amount of medication to
optimize the treatment of pain”).
Appellant initially contends, “the Office Action appears to contradict
itself when discussing Spencer.” Appeal Br. 13. Appellant states, “the
Office Action contended that Spencer disclosed step (b) of claim 1 but
simultaneously acknowledged that Spencer failed to disclose step (b) of
claim 1.” Appeal Br. 14. This is not a correct interpretation of the
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Examiner’s rejection. As noted above, the Examiner acknowledged that
Spencer did not specifically disclose that the “control electronics” operate
the pump in a certain manner, and relied on Bui for automatic operation
thereof. Thus, Appellant’s contention that the Examiner issued
contradictory statements regarding step (b) is not a proper reading of the
Examiner’s rejection. Accordingly, we do not find error in the Examiner’s
analysis or conclusion.
Appellant also contends, “Spencer failed to disclose increasing the
pump rate if there is no patient side effect.” Appeal Br. 15. This is not a
correct reading of Spencer. Spencer clearly addresses monitoring “patient
parameters,” and provides such examples as “respiratory rate, respiratory
depth, hemoglobin oxygen saturation, and patient movement.” Spencer
2:54–57. Spencer also states, “such parameters may be used to provide both
sensitive and specific feedback to the pump regarding possible overdose.”
Spencer 2:57–59. Spencer also teaches “having the continuous infusion
flow rate step up to a higher rate” but that patient feedback may also result in
“discontinuation of the infusion.” Spencer 2:31–50. Accordingly,
Appellant’s contention above that Spencer does not disclose increasing
pump rate if there is no patient side effect is not a correct reading of the
teachings of Spencer.3
Appellant also contends that Spencer does not teach the automatic
operation of the pump. See Appeal Br. 16–17. Appellant provides a

3 Appellant also appears to agree that Spencer monitors for side effects
stating, “Although Spencer also described determining an effective baseline
infusion rate if the patient's background pain is controlled without side-
effects, there is no affirmative step to increase in the absence of patient side
effects described.” Appeal Br. 18.
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definition of “automatically” as “(of a device or process) working by itself
with little or no direct human control.” Reply Br. 2. Hence, as per
Appellant, “claim 1 recites to, with little or no direct human control, cause
the pump mechanism to” operate. Reply Br. 2. However, it is clear from the
Examiner’s rejection that Bui was relied on for such automatic operation,
not Spencer. See Final Act. 3–4. This would be the case even abiding by
Appellant’s definition above.4 Accordingly, Appellant’s contentions are not
persuasive of Examiner error.
Appellant further states, “Bui failed to disclose increasing the pump
rate if there is no patient side effect.” Appeal Br. 19. This contention is not
persuasive because Bui was not relied on for this teaching, but instead for
disclosing electronic controls that operate automatically.5 Final Act. 3–4. It
would appear that Appellant is improperly arguing the art individually when
the rejection is predicated upon a combination of prior art disclosures. See
In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
In addition to the above, Appellant seeks to distinguish Bui by stating,
“Bui described a PCA [pain controlled analgesic] modification routine in
which the patient is queried before modifying the PCA. Appeal Br. 19.
Appellant contends that because of such querying, “Bui describes a process
that is not automatic.” Reply Br. 2. In other words, “Bui did not disclose at
least step (b),” which includes the limitation of “automatically” causing the
pump to operate, because Bui queries first. Appeal Br. 19. Appellant does

4 Further, regarding Spencer’s teaching of pushing a button, such action
would also appear to be in accordance with Appellant’s proffered definition
of “little or no direct human control.”
5 However, Bui also teaches adjusting infusion rate based on side effects.
See Bui 2:52–58; 11:34–42; 13:44–49.
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not explain how, because Bui’s pump may be programmed to first ascertain
whether a predetermined value needs modification, this act serves to detract
from Bui’s clear teaching of the automatic operation of the pump to provide
medication. See Appeal Br. 19, Reply Br. 2 (both referencing Bui 13:39–
54); see also Bui, Title, Abstract, 1:6–8; 2:52–58, 4:15–16, etc.
Accordingly, and based on the record presented, we are not persuaded
the Examiner erred in rejecting claims 1, 3–7, 18, 20, 21, 25, and 26 as
unpatentable over Spencer and Bui.
The Examiner’s rejection of (a) claims 8 and 9 as unpatentable over
Spencer, Bui, and Dang and (b) claims 10 and 11 as unpatentable over
Spencer, Bui, and Flaherty
Appellant does not dispute the Examiner’s additional reliance on
Dang or Flaherty in rejecting these claims, but instead relies on the
arguments presented above regarding the combination of Spencer and Bui.
See Appeal Br. 23. Because we are not persuaded by Appellant’s arguments
regarding Spencer and Bui, we sustain (a) the rejection of claims 8 and 9 as
unpatentable over Spencer, Bui, and Dang and (b) the rejection of claims 10
and 11 as unpatentable over Spencer, Bui, and Flaherty.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 3–7, 18,
20, 21, 25,
26
103 Spencer, Bui 1, 3–7, 18,
20, 21, 25,
26

8, 9 103 Spencer, Bui, Dang 8, 9
10, 11 103 Spencer, Bui,
Flaherty
10, 11
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Overall
Outcome
1, 3–11, 18,
20, 21, 25,
26

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