Ex Parte Causey, III et al

Patent Trial and Appeal Board

Jul 19, 2013

11684985 (P.T.A.B. Jul. 19, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JAMES D. CAUSEY III, RICHARD E. PURVIS,
and JAMES L. HENKE
__________

Appeal 2011-005917
Application 11/684,985
Technology Center 3700
__________

Before TONI R. SCHEINER, DEMETRA J. MILLS, and ERIC GRIMES,
Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 from the final rejection of
claims 1-22, 24 and 25, directed to a remote handheld medical device for
programming an implantable therapeutic device. The claims have been
rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 Appellants identify the Real Party-In-Interest as Medtronic, Inc. of
Minneapolis, Minnesota. (App. Br. 3.)

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STATEMENT OF THE CASE
The Specification discloses “remote programmers and/or handheld
personal data assistants (PDA) for use with medical devices . . . to facilitate
testing and monitoring of a patient's condition with coordination of data
management and programming through the PDA” (Spec. ¶ 2).
Specifically, the Specification discloses a “medical device module”
that interfaces with a standard PDA interface, and uses the existing hardware
of the PDA to interact with the user, a sensor or monitor, and an implantable
medical device (id. at ¶¶ 23, 91, 98), in order to remotely program and
control the implanted medical device (id. at ¶ 62). For example, the medical
device module can coordinate data from a glucose sensor with data from an
implanted insulin infusion pump, and remotely update and/or program the
delivery parameters of the infusion pump (id. at ¶ 109).
Claims 1-22, 24, and 25 are pending and on appeal. Claim 23 has
been canceled (App. Br. 3). Claim 1, the sole independent claim, is
representative of the subject matter on appeal:
1. A remote handheld medical device programmer comprising:
a medical device module comprising:
a module housing;
a medical device interface coupled to the module housing and
configured to interface with an implantable medical device that
delivers therapy to a patient, the medical device interface including a
receiver to wirelessly receive data from the implantable medical
device; and
a module processor coupled to the medical device interface to
process data from the medical device;
a programmer processor to interface with the module processor;
a programmer housing adapted to removably receive the
module housing and operatively couple the medical device module to
the programmer processor; and
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at least one user interface to at least one of display data received
from the medical device or receive input from a user,
wherein the medical device module is configured to program
the implantable medical device.
The Examiner relies on the following evidence:
Shimada et al. US 4,564,012 Jan. 14, 1986
Brown US 5,307,263 Apr. 26, 1994
Lord et al. US 5,390,671 Feb. 21, 1995
Böcker et al. US 5,507,288 Apr. 16, 1996
Brown US 5,678,571 Oct. 21, 1997
Worthington et al. US 5,822,715 Oct. 13, 1998
Brederveld et al. US 5,898,679 Apr. 27, 1999
Welch US 6,177,905 B1 Jan. 23, 2001
Grant et al. US 7,286,894 B1 Oct. 23, 2007
The claims stand rejected as follows:
I. Claims 1, 2, 4-12, 21, 22, 24, and 25 under 35 U.S.C. § 103(a)
as unpatentable over Brown '263, Shimada, and Lord (Ans. 4-10).
II. Claim 3 under 35 U.S.C. § 103(a) as unpatentable over Brown
'263, Shimada, Lord, and Worthington (Ans. 16-17).
III. Claims 13 and 14 under 35 U.S.C. § 103(a) as unpatentable
over Brown '263, Shimada, Lord, and Brown '571 (Ans. 17-18).
IV. Claim 15 under 35 U.S.C. § 103(a) as unpatentable over Brown
'263, Shimada, Lord, Brown '571, and Brederveld (Ans. 18-19).
V. Claims 16-20 under 35 U.S.C. § 103(a) as unpatentable over
Brown '263, Shimada, Lord, and Böcker (Ans. 21-23).
VI. Claims 1-3, 6-13, 21, 22, 24, and 25 under 35 U.S.C. § 103(a)
as unpatentable over Grant, Shimada, and Lord (Ans. 10-16).
VII. Claims 4 and 5 under 35 U.S.C. § 103(a) as unpatentable over
Grant, Shimada, Lord, and Welch (Ans. 17).
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VIII. Claims 14 and 15 under 35 U.S.C. § 103(a) as unpatentable
over Grant, Shimada, Lord, and Brederveld (Ans. 19).
IX. Claims 16-20 under 35 U.S.C. § 103(a) as unpatentable over
Grant, Shimada, Lord, and Böcker (Ans. 20-21).
FINDINGS OF FACT
The following findings of fact are supported by a preponderance of
the evidence of record.
1. Brown '263 discloses a “self-care health monitoring
arrangement[]” (Brown '263, col. 1, ll. 6-7) comprising:
[A] peripheral device to (or incorporat[ing]) a small handheld
microprocessor-based unit of the type that includes a display
screen, buttons or keys that allow a user to control the operation
of the device and a program cartridge or other arrangement that
can be inserted in the device to adapt the device to a particular
application or function. The invention in effect converts the
handheld microprocessor device into a healthcare monitoring
system that has significant advantages over systems such as the
currently available blood glucose monitoring systems. To
perform this conversion, the invention includes a
microprocessor-based healthcare data management unit, a
program cartridge and a monitoring unit. When inserted in the
handheld microprocessor unit, the program cartridge provides
the software necessary (program instructions) to program the
handheld microprocessor unit for operation with the
microprocessor-based data management unit. Signal
communication between the data management unit and the
handheld microprocessor unit is established by an interface
cable. A second interface cable can be used to establish signal
communication between the data management unit and the
monitoring unit or, alternatively, the monitoring unit can be
constructed as a plug-in unit having an electrical connector that
mates with a connector mounted within a region that is
configured for receiving the monitoring unit.
(Id. at col. 4, l. 68 - col. 5, l. 26.)
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2. Lord teaches that
[G]lucose sensors have been developed for use in obtaining an
indication of blood glucose levels in a diabetic patient. Such
readings can be especially useful in monitoring and/or adjusting
a treatment regimen which typically includes regular
administration of insulin to the patient. In this regard, blood
glucose readings are particularly useful in conjunction with
semiautomated medication infusion pumps of the external type
. . . or automated implantable medication infusion pumps[.]
(Lord, col. 1, ll. 15-26.)
REJECTIONS I-V
These five rejections are based, in whole or in part, on the combined
teachings of Brown '263, Shimada, and Lord.
Issue
The Examiner finds, in relevant part, that Brown '263 discloses a data
management system 10 that is “capable of interfacing with implantable
devices because it has plug-in regions where devices can plug in with a
wire” (Ans. 4-5), and therefore meets the claims’ requirement for “a medical
device interface . . . configured to interface with an implantable medical
device that delivers therapy to the patient” (id. at 4). In addition, the
Examiner cites Shimada as evidence that “wired and wireless connections
are known to be substitutable . . . for connecting two electronic
components/devices and communicating signals” (id. at 6).
The Examiner further finds that Lord teaches that “blood glucose
readings are particularly useful in conjunction with semi-automated medical
infusion pumps of the external type or automated implantable infusion
pumps for adjusting insulin treatment of diabetes patients” (id.). The
Examiner concludes that it would have been obvious to “modify the system
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of Brown ['263]” to include an implantable infusion pump “because Brown
['263] discloses connections for additional devices for diabetes care . . . and
glucose level readings are especially useful in conjunction with medical
infusion pumps for adjusting diabetes patients’ insulin treatment” (id.).
Appellants contend that the claims include features that “result in
structural differences between the claimed invention and the cited art” (App.
Br. 11) that the Examiner has not adequately addressed or otherwise
accounted for. Moreover, Appellants contend that “modifying Brown '263
in view of Lord would merely result in a system in which the self-care health
monitoring system disclosed by Brown '263 includes an infusion pump” (id.
at 9). That is, Appellants contend that “[t]he resulting system would not
include a data management unit 10 that is configured to interface with an
infusion pump” (id.).
The issue raised by all five rejections is the same:
Has the Examiner established that a handheld medical device
programmer that includes a medical device module configured to wirelessly
interface with and program an implantable therapeutic device would have
been obvious to one of ordinary skill in the art, given the teachings of Brown
'263, Shimada, and Lord?
Discussion
The claims are directed to a “handheld medical device programmer”
comprising “a medical device module” which further comprises “a medical
device interface . . . configured to interface with an implantable medical
device that delivers therapy to a patient” (claim 1). Moreover, the claims
explicitly require that “the medical device module is configured to program
the implantable medical device” (see claim 1). This is not simply a
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statement of intended use. While we agree with the Examiner that the
claims do not “require [the] medical device to actually interface with [an]
implantable device” (Ans. 24), the claims explicitly require a physical
component structurally configured to interface with and program an
implantable therapeutic device. Even if we accept the Examiner’s assertion
that the data management system of Brown '263 would be capable of
interfacing with an undisclosed module that can program an implantable
therapeutic device, the Examiner has not established that Brown '263’s
system includes a module configured to do so, as “[a]ll of the devices
disclosed by Brown '263 are monitoring devices” (App. Br. 8-9). Thus, we
agree with Appellants that the system disclosed by Brown '263 does not
meet the claims’ requirement for a medical device module configured to
wirelessly interface with and program an implantable therapeutic device.
That being the case, we agree with Appellants that “modifying Brown
'263 in view of Lord would . . . result in a system in which the self-care
health monitoring system disclosed by Brown '263 includes an infusion
pump” (id. at 9), but “[t]he resulting system would not include a data
management unit 10 that is configured to interface with an infusion pump”
(id.).
Finally, we agree with Appellants that the Examiner’s rationale for
combining the references “merely identifies why it would have been obvious
to use the infusion device disclosed by Lord in conjunction with a blood
glucose monitor” (Reply Br. 9), but does not explain “why it would have
been obvious to modify the data management unit 10 disclosed by Brown
'263 to both program the infusion device disclosed by Lord and receive
information from a blood glucose monitor” (id. at 9-10).
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The Examiner has not established that a handheld medical device
programmer that includes a medical device module configured to wirelessly
interface with and program an implantable therapeutic device would have
been obvious to one of ordinary skill in the art based on Brown '263,
Shimada, and Lord.
Accordingly, Rejections I-V, based in whole or in part on the
combined teachings of Brown '263, Shimada, and Lord, are reversed.
Rejections VI-IX
These four rejections are based, in whole or in part, on the combined
teachings of Grant, Shimada, and Lord.
The Examiner finds, in relevant part, that Grant discloses a handheld
computer device with an “[a]ttachable module [that] has ports where
sensors plug in to via wires therefore it is capable of interfacing with an
implantable device” (Ans. 11), and therefore meets the claims’ requirement
for “a medical device interface . . . configured to interface with an
implantable medical device” (id.).
The Examiner acknowledges that Grant “do[es] not disclose that the
. . . medical device is an infusion device” (id. at 12), and relies on Shimada
and Lord as discussed above. The Examiner concludes that it would have
been obvious to “modify the system of Grant” to include an implantable
infusion pump “because Grant discloses connections for additional devices
. . . and teaches using detected glucose levels to direct administration of
treatment” (id. at 12-13).
Grant’s teachings are similar to those of Brown '263 (discussed
above), and the Examiner relies on them in the same way. Thus, Rejections
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VI-IX are essentially cumulative to Rejections I-V, and suffer from the same
deficiencies.
SUMMARY
Rejections I-V, based in whole or in part on the combined teachings
of Brown '263, Shimada, and Lord, are reversed.
Rejections VI-IX, based in whole or in part on the combined teachings
of Grant, Shimada, and Lord, are reversed.

REVERSED

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