Ex Parte Olsen et al

Patent Trial and Appeal Board

Dec 14, 2012

11413820 (P.T.A.B. Dec. 14, 2012)

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.
11/413,820 04/28/2006 James M. Olsen M190.187.101/P0009965.00 3126
25281 7590 12/14/2012
DICKE, BILLIG & CZAJA
FIFTH STREET TOWERS
100 SOUTH FIFTH STREET, SUITE 2250
MINNEAPOLIS, MN 55402
EXAMINER
BOSWORTH, KAMI A
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
12/14/2012 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JAMES M. OLSEN and CHARLES R. ROGERS
__________

Appeal 2010-011744
Application 11/413,820
Technology Center 3700
__________

Before DEMETRA J. MILLS, LORA M. GREEN, and
ERICA A. FRANKLIN, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to
systems for monitoring an implantable medical device. The Patent
Examiner rejected the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b). We reverse.

STATEMENT OF THE CASE
The invention concerns systems for monitoring an implantable
medical device. The Specification states, “[b]ecause the device is implanted
within the patient and cannot be seen directly, care must be taken to ensure
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Application 11/413,820

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that the needle is properly placed into the fill port assembly before
transferring liquids. If the needle is not located within the fill port
assembly…delivery of the infusion media through the needle can result in
immediate delivery of a significant quantity of the drug to the patient, with
potentially dire consequences.” (Spec. [04].)
According to the Specification, following implantation , the
temperature of the delivery device will approximately equilibrate with the
body temperature of the patient. (Id. at [27].) Thus, prior to a reservoir
refilling procedure, a temperature of the port chamber, and thus a
temperature sensed by the temperature sensor, will be greater than at least
90° F. (Id.) Because the temperature of a therapeutic substance injected
into the port chamber is conventionally at a significantly lower temperature,
i.e., room temperature (65-75° F) prior to injection into the delivery device,
when the therapeutic substance is dispensed into the port chamber, the
chamber will experience a reduction in temperature. (Id.) Therefore, a
change, i.e., decrease, in temperature at or in the port chamber is indicative
of the needle having been properly placed through the septum and into the
port chamber prior to injection of the therapeutic substance. (Id.)
Claims 1, 2, 4-17 and 31-33 are on appeal. Independent claims 1 and
31are representative and read as follows:
1. A system for monitoring an implantable medical device, the system
comprising:
an implantable liquid therapeutic substance delivery device for
delivering a therapeutic substance to a delivery site within a patient,
the device including:
a housing maintaining a reservoir for containing the therapeutic
substance,
a fill port assembly defining a port chamber in fluid communication
with the reservoir, the fill port assembly further including a
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Application 11/413,820

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septum fluidly sealing the port chamber relative to an exterior
of the device;
a temperature sensor positioned to sense a temperature of the port chamber;
and
an indicator device for indicating presence of liquid dispensed from a needle
disposed within the port chamber based upon information from the
temperature sensor.

31. A system for monitoring an implantable medical device, the system
comprising:
an implantable liquid therapeutic substance delivery device for delivering a
liquid therapeutic substance to a delivery site of a patient, the delivery
device including:
a housing maintaining a reservoir for containing the therapeutic
substance;
a fill port assembly including a septum exteriorly fluidly sealing a port
chamber otherwise in fluid communication with the reservoir;
an outlet catheter extending from the housing and fluidly connected to
the reservoir;
means carried by the housing for sensing information relating to a
temperature of the port chamber; and
indicator means electronically coupled to the sensing means for selectively
indicating to a clinician information indicative of one of:
absence of a needle in the port chamber, and
presence of a needle and liquid dispensed therefrom in the port
chamber,
based upon information signaled from the sensing means.

The Examiner rejected the claims as follows:
• claims 1, 2, 4-7, 9, 11-17 and 31-33 under 35 U.S.C. § 103(a) as
unpatentable over Ginggen
1
and Frank;
2

1
Patent Application Publication No. US 2006/0089619 A1 by Alec
Ginggen, published Apr. 27, 2006.
2
Patent Application Publication No. US 2005/0081623 A1 by Peter Andrew
Frank, published Apr. 21, 2005.
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• claims 8 and 10 under 35 U.S.C. § 103(a) as unpatentable over
Ginggen, Frank, and Faries.
3

OBVIOUSNESS
The Examiner‟s position is that Ginggen disclosed a system for
monitoring an implantable medical device, the system comprising an
implantable liquid therapeutic substance delivery device including a housing
maintaining a reservoir for containing the therapeutic substance, a fill port
assembly defining a port chamber in fluid communication with the reservoir,
the fill port assembly further including a septum fluidly sealing the port
chamber relative to an exterior of the device, a sensor positioned to sense a
liquid in the port chamber, and an indicator device for indicating presence of
liquid dispensed from a needle disposed within the port chamber based upon
information from the sensor. (Ans. 4.)
The Examiner found that Ginggen did not disclose that its sensor is a
temperature sensor that senses a temperature of the port chamber and
indicates the presence of liquid based upon information from the
temperature sensor. (Id. at 4-5.) However, the Examiner found that Frank
taught a liquid substance delivery device comprising a temperature sensor
positioned to sense a temperature of a port chamber and to communicate
with an indicator device for indicating the presence of liquid disposed within
the port chamber based upon information from the temperature sensor to
indicate how much fluid remains in the device. (Id. at 5.) According to the
Examiner, it would have been obvious to a person of ordinary skill in the art

3
Patent Application Publication No. US 2004/0249336 A1 by Durward I.
Faries, Jr. et al., published Dec. 9, 2004.
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at the time the invention was made to have modified Ginggen to include a
temperature sensor, as taught by Frank, for the purpose of indicating how
much fluid remains in the device. (Id.)
Appellants contend that a skilled artisan would not have been
motivated to modify Ginggen to include the temperature sensors taught by
Frank. (App. Br. 8.) Appellants assert that Frank‟s device is a liquid level
indicator for use in a liquid propane container and requires two temperature
sensors to be located vertically, i.e., one above the other, and separated by a
distance of about 3 cm, wherein temperature readings from both sensors are
obtained and compared to determine the liquid level remaining in the
container. (Id. at 7.) According to Appellants, a skilled artisan would not
reasonably consider mounting the relatively large level indicator of Frank to
the fill port 12 of Ginggen, because the entire implantable pump of Ginggen
has a height less than or equal to 2.54 cm. (Id. at 8.)
The Examiner responds that even though the fill port of Ginggen is
not of a height capable of incorporating the exact sensor dimensions of
Frank, a skilled artisan would nevertheless be motivated to modify Ginggen
because Frank suggests that the addition of a temperature sensor would aid
in indicating how much fluid remains in the device. (Ans. 14.) According
to the Examiner, “[s]ince the Ginggen port has a height measurement, it
would be capable to place the temperature sensors 16, 18 so that they are
„separated by an appreciable distance.‟” (Id. at 15.)
Appellants additionally assert that even if Ginggen could be modified
to include Frank‟s level indicator to provide an indication of how much fluid
remains in the drug reservoir, the artisan would understand from Frank that
the temperature sensors should be located in the drug reservoir to sense the
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Application 11/413,820

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temperature of the drug reservoir/chamber, rather than being positioned to
sense a temperature of the port chamber, as required by the claimed
invention. (Id. at 8-9.) Further, according to Appellants, Frank does not
provide any suggestion that an indication of the amount of fluid remaining in
the fill port assembly defining a port chamber has any value or would
provide an improvement to the Ginggen pump. (Id. at 9.)
The Examiner responds that “[k]nowledge of the contents of fill port
12 would be an improvement to the Ginggen pump because it would be
providing further information about the functioning and status of the pump.”
(Ans. 15.)
After considering the evidence and arguments, we agree with
Appellants that the Examiner has not articulated reasoning with rational
underpinnings to support a motivation to combine Frank‟s liquid level
indicator for use in a liquid propane container comprising two temperature
sensors with Ginggen‟s system for monitoring an implantable medical
device to sense a temperature of its port chamber and to provide information
relating to the presence of liquid dispensed from a needle disposed within
the port chamber, as required by the claimed invention. See In re Kahn, 441
F.3d 977, 988 (Fed. Cir. 2006). In particular, we do not find that the
Examiner has established that Frank suggested that its temperature sensors
would provide “further information about the functioning and status of the
[Ginggen‟s] pump,” (see Ans. 15) so as to motivate the artisan to include the
sensors in Ginggen‟s system. Nor do we find that Frank suggested a
solution to a problem of determining whether a needle had been properly
inserted into the septum port assembly provided within an implantable
medical device so as to lead an artisan to add its temperature sensors to the
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port chamber of Ginggen‟s system. Pro-Mold and Tool Co. v. Great Lakes
Plastics Inc., 75 F.3d 1568, 1573 (Fed. Cir. 1996) (citations omitted).
Accordingly, we reverse the Examiner‟s obviousness rejection over
Ginggen and Frank. We also reverse the Examiner‟s obviousness rejection
of dependent claims 8 and 10 over Ginggen, Frank and Faries, as this
rejection also failed to provide sound reasoning to support a motivation to
combine Ginggen and Frank to yield the claimed invention.

SUMMARY
We reverse both obviousness rejections.

REVERSED

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