Ex Parte Haase

Board of Patent Appeals and Interferences

May 22, 2012

11412464 (B.P.A.I. May. 22, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/412,464 04/27/2006 James Martin Haase 134.02550101 7471
26813 7590 05/23/2012
MUETING, RAASCH & GEBHARDT, P.A.
P.O. BOX 581336
MINNEAPOLIS, MN 55458-1336
EXAMINER
SHUMATE, VICTORIA PEARL
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
05/23/2012 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JAMES MARTIN HAASE
__________

Appeal 2011-001536
Application 11/412,464
Technology Center 3700
__________

Before TONI R. SCHEINER, ERIC GRIMES, and ERICA A. FRANKLIN,
Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 1-11 and 24-34, directed to an implantable infusion device. The
claims have been rejected as obvious. We have jurisdiction under 35 U.S.C.
§ 6(b).
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Application 11/412,464

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STATEMENT OF THE CASE
The present invention is directed to “an implantable infusion device
including a bolus pump delivering a therapeutic substance through a passive
check valve and an active check valve” (Spec. ¶ 1). According to the
Specification:
The combination of a passive check valve arranged to
allow flow in the downstream direction and prevent flow in the
upstream direction provided in series with an active check valve
provided downstream of the passive check valve to allow flow
in the downstream direction when activated, but prevent flow in
the downstream direction when closed may provide an infusion
device in which energy efficiency and safety may be improved.
(Id. at ¶ 12.)
In certain embodiments, a so-called “back-closing” active check valve
is used to increase sealing pressure as the reservoir pressure increases,
improving containment even at relatively high differential pressures (id. at ¶
11).
Claims 1-11 and 24-34 are pending and on appeal. Claims 1 and 6 are
representative of the subject matter on appeal:
1. An implantable therapeutic substance infusion device comprising:
a therapeutic substance reservoir;
control electronics operably connected to a power source;
a bolus pump operably connected to the power source and the control
electronics, the bolus pump further operably connected to the reservoir and
configured to pump a therapeutic substance from the therapeutic substance
reservoir in a downstream direction from the bolus pump to an infusion port
in response to a pump signal received from the control electronics;
a passive check valve located in a fluid pathway between the infusion
port and the bolus pump, the passive check valve comprising a normally
closed valve that opens in response to fluidic pressure generated by
operation of the bolus pump; and
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an active check valve located in the fluid pathway between the passive
check valve and the infusion port, wherein the active check valve comprises
a normally closed valve that opens in response to an open signal from the
control electronics, and wherein fluid flow in the downstream direction
through the active check valve is prevented when the active check valve is
closed.
6. A device according to claim 1, wherein fluid pressure on an upstream
side of the active check valve increases the energy required to open the
active check valve.
Claims 1-11 and 24-34 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Portner (WO 80/01755, September 4, 1980) in view of
Varrichio (US 2005/0187515 A1, August 25, 2005).
We affirm in part.
FINDINGS OF FACT
1. Portner discloses an implantable infusion device capable of
“selectively releasing precisely regulated dosages of a drug to the body of a
patient from a reservoir implanted within the body . . . in response to a signal
generated or applied externally of the body” (Portner 5: 23-27).
2. An embodiment of Portner’s implantable infusion device is
depicted in Figure 1, reproduced immediately below:

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Application 11/412,464

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Figure 1 depicts an embodiment of Portner’s implantable infusion
device 10.
3. The interior of Portner’s device is divided into three general
regions: a reservoir portion 16; a pumping chamber portion 18; and an outlet
portion 20 in communication with a catheter 22 (Portner 6: 3-15). Outlet
chambers 32, 34, and 36 provide serial communication between the pumping
chamber and the catheter, with outlet chamber 36 in direct communication
with the catheter (id. at 6: 34 - 7: 4).
A separate outlet check valve respectively regulates
communication of a drug from the pumping chamber into the
first outlet 32, from the outlet chamber 32 into the next
chamber 34 and from the chamber 34 into the final outlet
chamber 36 and accordingly into the catheter 22. The check
valves are indicated respectively at 38, 40 and 42. Preferably,
one of the check valves, indicated at 40, is of a separate type or
design in order to better assure operation of the serial
arrangement of check valves under all conditions.
(Id. at 7: 4-14.)
4. “[T]o assure that operation of the infusion device takes place
only when properly intended . . . safety latch assembly 48 is provided which
prevents operation of the device unless separate externally generated or
applied signals are caused to operate both the safety latch assembly 48 and
the plunger 44” (Portner 7: 31 - 8: 1). In the embodiment depicted in Figure
1 of Portner, the safety latch assembly is a mechanical latching unit, but
Portner discloses an alternative embodiment in which the safety latch
assembly is “in the form of a valve blocking communication from the final
outlet chamber 36 into the catheter” (id. at 8: 3-5).
5. Varrichio discloses an implantable infusion device comprising a
bolus pump and “one or more controllable valves operative under control of
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[a] controller . . . to control delivery of infusate” (Varrichio ¶ 24). The
valves “may comprise one or more [of a] micro-electromechanical system
(MEMS) valve, piezeo-electric valve, magnetic valve, solenoid valve,
constriction valve, and/or the like” (id. at ¶ 25). The valves may “require
application of power only when a change of state is desired” (id.), for
example, “a solenoid valve, which is normally closed and us[es] power to
maintain an open state” (id. at ¶ 32).
DISCUSSION
The Examiner finds that Portner discloses an implantable infusion
device that meets all the requirements of claim 1, except that Portner “fail[s]
to explicitly teach or disclose . . . that the second check valve is an active or
solenoid check valve” (Ans. 4). However, the Examiner finds that Varrichio
discloses a similar infusion device “comprising one or more active valves,
which can be solenoid valves” (id.). The Examiner concludes that it would
have been obvious “to substitute the second check valve of Portner . . . with
an active check valve . . . because doing so is a simple substitution of one
valve for another, having [a] predictable result” (id.), especially as Portner
discloses an embodiment with a safety latch comprising “‘a valve blocking
communication from the final outlet chamber . . . into the catheter’” (id. at
6), which, like Varricio’s “active check valve . . . would offer an additional
safe guard against accidental or premature injection of the drug through the
system” (id.).
We agree with the Examiner that it would have been obvious for one
of ordinary skill in the art to use an active check valve (e.g., a solenoid
check valve, as taught by Varrichio) in the fluid pathway between one of
Portner’s passive check valves and the infusion port, not least of all because
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Portner’s device includes a safety latch assembly which prevents the flow of
the drug from the final outlet chamber into the catheter “unless separate
externally generated or applied signals are caused to operate both the safety
latch assembly . . . and the plunger” (Portner 7: 33 - 8: 1; FF4). Since
Portner discloses an embodiment in which this safety latch function is
performed by “a valve blocking communication from the final outlet
chamber . . . into the catheter” (Portner 8: 3-5; FF4), it is reasonable to infer
that the valve will open only in response to an externally generated or
applied signal, and is therefore an active check valve.
Appellant contends that the mere assertion that substituting one of
Varrichio’s active check valves for one of Portner’s passive check valves
would be simple and predictable “does not provide a ‘recognized reason’
why one of ordinary skill in the art would create the arrangement of an
active check valve/solenoid check valve in relation to a passive check valve
and an infusion port as required for a prima facie case of obviousness”
(Reply Br. 5).
Appellant further contends that:
[R]eplacing a passive check valve of the device of Portner et al.
with an active check valve of Varrichio et al. would involve
additional complexity beyond what is described in Portner et al.
For example, the device of Portner et al. only uses mechanical
plunger 44 as the sole actuating force to pressurize the pumping
chamber causing the flow of a drug through the check valves
38-42 and into the catheter. If an active valve were added to the
device of Portner et al., additional steps (e.g., providing a
control system, providing a power source, opening the valve,
etc.) would be required to control the flow of a drug through the
device.
(Id. at 4.)
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Finally, Appellant contends that “the alleged additional safety
functionality that an active check valve may provide does nothing to rebut
the fact that the proposed modification would change the principle of
operation of the device of Portner” (id. at 6).
Appellant’s arguments are not persuasive. As noted by the Examiner,
Portner’s device includes a safety latch assembly downstream from check
valves 38, 40, and 42 to ensure that the drug is infused into the patient “only
when properly intended” (Portner 7: 32; FF4) - i.e., the drug can only enter
the catheter from the last outlet chamber when “separate externally
generated or applied signals are caused to operate both the safety latch
assembly . . . and the plunger” (Portner 7: 33 - 8: 1; FF4). Portner’s safety
latch assembly can be a valve - i.e., an active valve that opens in response to
a separate, externally generated or applied signal (FF4). Therefore, one of
ordinary skill in the art would have had ample reason to incorporate an
active valve, like Varrichio’s solenoid check valve, in Portner’s device,
downstream from a passive check valve, in the manner required by the
claims.
The rejection of claim 1 as unpatentable over Portner and Varrichio is
affirmed. Claims 2-5, 7-10, and 30-34 have not been argued separately, and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
Claims 6, 11, and 24-29
Claims 6, 11, and 24-29 stand on a different footing. As Appellant
points out, these claims “explicitly recite that fluid pressure on an upstream
side of the active check valve . . . increases the energy required to open the
active check valve” (App. Br. 25).
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We agree with Appellant that the Examiner has not adequately
explained where either of the references suggests this feature, or why it
would have been obvious for one of ordinary skill in the art to incorporate it
into the prior art devices.
The rejection of claims 6, 11, and 24-29 as unpatentable over Portner
and Varrichio is reversed.
SUMMARY
The rejection of claims 1-11 and 24-34 as unpatentable over Portner
and Varrichio is affirmed with respect to claims 1-5, 7-10, and 30-34, and
reversed with respect to claims 6, 11, and 24-29.
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).

AFFIRMED-IN-PART

DM