Roche Diagnostics International AG

Patent Trials and Appeals Board

Aug 7, 2020

2020000034 (P.T.A.B. Aug. 7, 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.
14/310,462 06/20/2014 Andreas Geipel ROJ0215PA/31049US 1110
67491 7590 08/07/2020
DINSMORE & SHOHL, LLP
FIFTH THIRD CENTER
ONE SOUTH MAIN STREET
SUITE 1300
DAYTON, OH 45402
EXAMINER
SWANSON, LEAH JENNINGS
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
08/07/2020 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):
daytonipdocket@dinsmore.com
jackie.pike@roche.com
pair_roche@firsttofile.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ANDREAS GEIPEL

Appeal 2020-000034
Application 14/310,462
Technology Center 3700
____________

Before BRETT C. MARTIN, MICHAEL J. FITZPATRICK, and
MICHELLE R. OSINSKI, 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 1–11, 13–15, and 20–23. 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 sole real party in
interest. Appeal Br. 2.
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Application 14/310,462

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STATEMENT OF THE CASE
The Specification
The Specification “is directed towards dosing units for ambulatory
infusion systems and towards ambulatory infusion systems including a
dosing unit.” Spec. ¶2.
The Claims
Claims 1–11, 13–15, and 20–23 are rejected. Final Act. 1. Claims
17–19 are withdrawn from consideration. Id. No other claims are pending.
Id. Of the rejected claims, claims 1, 20, 21 are independent. Claims App.
2–9.2 Claim 1 is representative and reproduced below.
1. A dosing system comprising a dosing unit for an
ambulatory infusion system, the ambulatory infusion system
designed for the infusion of a liquid drug into a patient’s body
over an extended time period, the dosing unit comprising:
an inlet port;
an outlet port, the outlet port being configured to couple
to the patient’s body; and
a pump kernel, the pump kernel comprising a kernel
body, the kernel body forming a limiting surface of a stepwise
or continuously variable dosing volume;
a control valve, the control valve configured to couple
the variable dosing volume of the pump kernel alternatively, in
a filling state, to the inlet port such that the pump kernel is
configured to fill or refill the dosing unit by an increase of the
dosing volume, or, in an infusing state, to the outlet port such
that the pump kernel is configured to dose the liquid drug out of
the dosing unit by a decrease of the dosing volume;

2 Appellant filed, on March 6, 2019, an Appeal Brief, which we cite as
“Appeal Br.” In response to a Notice of Defective Appeal Brief, Appellant
filed, on April 4, 2019, a Corrected Appeal Brief consisting solely of a
corrected Claims Appendix, which we cite as “Claims App.”
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Application 14/310,462

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wherein the inlet port is configured to be repeatedly
manually attached to and detached from an external liquid drug
container, wherein the external liquid drug container is a drug
reservoir that comprises a total volume configured to store the
liquid drug, thus configured to enable a repeated sequence in
which the external liquid drug container attaches to the inlet
port, the liquid drug fills the dosing unit with the control valve
in the filling state, the external liquid drug container detaches
from the inlet port, and the liquid drug infuses from the dosing
unit with the control valve in the infusing state, wherein the
dosing unit comprises a maximum filling volume that is smaller
than the total volume of the drug reservoir of the external liquid
drug container and is configured to allow volumetric dosing and
incremental infusion of the liquid drug into the patient’s body
when detached from the drug reservoir of the external liquid
drug container;
wherein the dosing unit is coupled to a base unit, the base
unit comprising:
a drive unit, the drive unit being designed to
releasable couple to the dosing unit,
an electronic control unit, the electronic control
unit being coupled to the drive unit for controlling
operation of the infusion system alternatively in a filling
mode by use of the increase of the dosing volume to fill
the dosing unit with the liquid drug from the external
liquid drug container, and in an infusing mode by use of
the decrease of the dosing volume to infuse the liquid
drug into the patient's body, and
a coupling detector, the coupling detector being
coupled to the control unit to generate a signal indicating
whether or not the external liquid drug container is
coupled to the inlet port, wherein the electronic control
unit is further configured to control the drive unit to
increase the variable dosing volume, to draw the liquid
drug from the external liquid drug container into the
dosing unit, only if the signal is indicative of the external
liquid drug container being coupled to the inlet port.
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Claims App. 2–3.
The Examiner’s Rejections
The rejections before us, all pursuant to 35 U.S.C. § 103, are the
following:
1. claims 1–9, 12, 15, and 20–23 as unpatentable over Haueter,3
O’Connor,4 and Kuo5 (Final Act. 3);
2. claim 10 as unpatentable over Haueter, O’Connor, Kuo, and
Haueter ’1276 (id. at 297);
3. claim 11 as unpatentable over Haueter, O’Connor, Kuo, and
Mounce8 (id. at 30); and
4. claims 13 and 14 as unpatentable over Haueter, O’Connor,
Kuo, and Murphy9 (id. at 31).
DISCUSSION
Rejection 1
Appellant argues the rejection of all claims together. Appeal Br. 9–
15. We choose claim 1 as representative. See 37 C.F.R. § 41.37(c)(1)(iv).
Haueter discloses “dosing units for ambulatory infusion devices.”
Haueter ¶2. The Examiner found that Haueter teaches most of the subject

3 US 2011/0224644 A1, published Sept. 15, 2011 (“Haueter”).
4 US 2009/0143732 A1, published June 4, 2009 (“O’Connor”).
5 US 2012/0059349 Al, published Mar. 8, 2012 (“Kuo”).
6 US 2010/0049127 A1, published Feb. 25, 2010 (“Haueter ’127”).
7 The rejection of claim 10 does not list O’Connor. However, we understand
that omission to be inadvertent as claim 10 depends from claim 1 and the
rejection of claim 10 references the rejection 1. See Final Act. 29 (“as
applied in claim 1 above”).
8 US 2008/0051709 A1, published Feb. 28, 2008 (“Mounce”).
9 US 2011/0300001 Al, published Dec. 8, 2011 (“Murphy”).
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matter of claim 1. Final Act. 3–5 (citing Haueter ¶¶5, 28, 34, 36, 96, 108
134, 170, 171, Figs. 1, 4). The Examiner conceded that Haueter’s inlet port
(charging connector port 72) is not disclosed as meeting all of the following
claim recitations:
wherein the inlet port is configured to be repeatedly manually
attached to and detached from an external liquid drug container,
wherein the external liquid drug container is a drug reservoir that
comprises a total volume configured to store the liquid drug, thus
configured to enable a repeated sequence in which the external
liquid drug container attaches to the inlet port, the liquid drug
fills the dosing unit with the control valve in the filling state, the
external liquid drug container detaches from the inlet port, and
the liquid drug infuses from the dosing unit with the control valve
in the infusing state, wherein the dosing unit comprises a
maximum filling volume that is smaller than the total volume of
the drug reservoir of the external liquid drug container and is
configured to allow volumetric dosing and incremental infusion
of the liquid drug into the patient’s body when detached from the
drug reservoir of the external liquid drug container,
as recited in claim 1. Id. at 5.10
The Examiner, however, found that O’Connor teaches an infusion
pump having an inlet port configured to be repeatedly manually attached to
and detached from an external liquid drug container, i.e., O’Connor’s
prefilled syringe 300. Final Act. 6–7 (citing O’Connor ¶¶27, 30, 36, Figs.
4C–4D). The Examiner further found that O’Connor’s syringe 300 met the
additional claim recitations of the external liquid drug container, including
that it may be reused and that its reservoir volume exceeds that of the dosing

10 It is not clear the extent to which this claim language limits, if at all, the
scope of the claimed dosing system, as the “external liquid drug container”
is not affirmatively recited as part of the dosing system. Nonetheless, the
Examiner treated it as limiting. Accordingly, we will do the same for
purposes of deciding Appellant’s appeal from the Examiner’s rejection.
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system’s filling volume. Id. The Examiner determined it would have been
obvious to one having ordinary skill in the art to modify the dosing system
of Haueter such that its inlet port were configured “based on the teaching of
O’Connor to ensure that the external drug device is held securely to allow
for proper filling in order to allow for multiple steps of refilling the dosing
unit.” Id. at 7 (citing O’Connor ¶¶27, 36).
The Examiner conceded that Haueter/O’Connor does not disclose a
coupling detector, as recited in claim 1. Id. at 7–8; see also id. at 5. For that
limitation, the Examiner turned to Kuo, which discloses an “implantable
drug delivery pump device”/“infusion pump”. Kuo ¶101 (emphasis added).
The Kuo infusion pump, although implanted under the skin, is refillable
across the skin via a needle. Id. ¶250. The Examiner found that Kuo
teaches a coupling detector for detecting coupling of a refill container and a
septum of the implanted infusion pump. Id. at 8 (citing ¶253, Fig. 2). Kuo’s
coupling detector is in the form of a permanent magnet and magnet
proximity sensor alternatively located on the components whose coupling is
detected by magnetic sensor. Id. (citing Kuo ¶253, Fig. 2). The Examiner
determined it would have been obvious to one having ordinary skill in the art
to modify the base unit of Haueter to include a coupling detector based on
the teaching of Kuo “to provide a dosing system with a failsafe refilling
process that prevents infusion while the dosing unit is being refilled.” Id. at
8–9 (citing Kuo ¶¶10, 253).
Appellant first argues that O’Connor “does not teach and rather
teaches away from . . . ‘the electronic control unit [being] further configured
to control the drive unit to increase the variable dosing volume to draw the
liquid drug from the external liquid drug container into the dosing unit.’”
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Appeal Br. 11 (quoting claim 1). Appellant explains that O’Connor’s pre-
filled syringe 300 fills the infusion pump by virtue of the syringe “actively
inject[ing] drug . . . rather than passively hav[ing] liquid drug drawn from
it.” Id. The Examiner responds to Appellant’s argument cogently by
pointing out that O’Connor is not relied on for the manner in which liquid
drug is caused to flow into the dosing unit. Ans. 27. For that feature, the
Examiner relies on Kuo,
which states that “the retraction or backward movement of the
piston draws the refill fluid from the refill container into the first
chamber . . . The refill container is of the ‘passive type’ and does
not have a plunger thereby minimizing the risk of inadvertently
injecting drug into a body cavity.”
Id. (quoting Kuo ¶252).
Appellant next argues that “the infusion pump 106 of O’Connor
(relied upon as teaching a dosing unit) does not teach at least ‘the dosing
unit comprising . . . a kernel body forming a limiting surface of a stepwise or
continuously variable dosing volume,’ as recited in the present claims.”
Appeal Br. 11. The Examiner again responds cogently by pointing out
O’Connor is not relied on in the manner asserted by Appellant. Ans. 28.
Rather, the Examiner relied on Haueter as disclosing this limitation. Id.; see
also Final Act. 3 (“Haueter teaches a dosing system comprising a dosing
unit . . . comprising: . . . a pump kernel (plunger 50, plunger shaft 60,
metering cavity 31), the pump kernel comprising a kernel body (metering
cavity 31), the kernel body forming a limiting surface of a stepwise or
continuously variable dosing volume (Figure 1).”).
Appellant next argues that the asserted coupling detector of Kuo “does
not indicate whether an external liquid drug container is coupled to an inlet
port but rather whether the magnetic field of a magnet 92 mounted on a
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septum 88 of the implanted drug delivery device 10 is disrupted by a refill-
magnet 96.” Appeal Br. 12. In fact, Kuo does both; the two are not
mutually exclusive. Kuo detects a certain change in magnetic field and
treats it as an indication that its refill container is coupled to the inlet port
(septum) of an implanted infusion device.
For the insertion of a refill container needle, magnet 92
attached to septum 88 is preferably a raised ring for guiding the
positioning of the needle through the skin 98. The raised ring 92
may be in a form of ring magnet of a polarity that attracts a ring
magnet 96 of opposite polarity mounted on the needle 80 of the
refill container 84. The attraction between the two magnets 92
and 96 across the skin can facilitate positioning and stabilizing
the needle 80 during injection. . . .
. . . To ensure a readiness for refilling, the refilling process can
start only when an activation detector is activated. The
permanent magnet 92 mounted on septum 88 as shown in FIG. 2
is attached with an internal magnet proximity sensor (not shown)
to function as an activation detector for triggering the controller
and the motor driver in control board 32. . . . [W]hen starting a
refilling process, a specified refill-magnet is placed on top of the
magnet ring 92 across the skin. The refill-magnet is preferably
being magnet 96 attached to the needle or part of the refill
container. Thus the approaching and docking of a refill container
needle can cause the activation detector to activate the pump
device with backward motion of the piston for refilling the drug
chamber.
Kuo ¶¶251, 253.
None of Appellant’s arguments apprise us of error in the Examiner’s
rejection of claim 1. Accordingly, we affirm the rejection of claim 1, as well
as that of claims 2–9, 12, 15, and 20–23, which fall therewith. 37 C.F.R.
§ 41.37(c)(1)(iv).
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Rejections 2–4
Appellant argues against these rejections solely on the basis of the
rejected claims’ dependency from claim 1. See Appeal Br. 16 (regarding
claim 10), 17 (regarding claim 11), 18 (regarding claims 13 and 14). As
Appellant fails to apprise us of error in Rejection 1, it thus likewise fails to
apprise us of error in Rejections 2–4.
Rejections 2–4 are affirmed.
SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–9, 12,
15, 20–23
103 Haueter,
O’Connor, Kuo
1–9, 12, 15,
20–23

10 103 Haueter,
O’Connor, Kuo,
Haueter ’127
10
11 103 Haueter,
O’Connor, Kuo,
Mounce
11
13, 14 103 Haueter,
O’Connor, Kuo,
Murphy
13, 14
Overall
Outcome
1–11, 13–
15, 20–23

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