Ex Parte Shishilla et al

Patent Trial and Appeal Board

Sep 7, 2018

14396659 (P.T.A.B. Sep. 7, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/396,659 10/23/2014
71996 7590 09/11/2018
SHUMAKER & SIEFFERT, P.A
1625 RADIO DRIVE, SUITE 100
WOODBURY, MN 55125
FIRST NAMED INVENTOR
John Shishilla
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
l 123-086US01/P041871.USN4 9047
EXAMINER
FAIRCHILD, MALLIKA DIPAYAN
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
09/11/2018 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):
pairdocketing@ssiplaw.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 JOHN SHISHILLA, KATHRYN A. PEDERSON,
MUKUL JAIN, and NICHOLAS S. MAIRS 1
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Application 14/396,659
Technology Center 3700
Before DEMETRA J. MILLS, RICHARD M. LEBOVITZ, and
JOHN G. NEW, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state that the real party-in-interest is Medtronic, Inc. App. Br.
3.
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SUMMARY
Appellants file this appeal under 35 U.S.C. § I34(a) from the
Examiner's Final Rejection of claims 1-24. Specifically, claims 1, 8, 10, 13,
15-17, and 23 2 stand rejected under 35 U.S.C. § I02(b) as being anticipated
by Bennett et al. (US 2008/0161874 Al, July 3, 2008) ("Bennett")
Claims 2 and 3 stand rejected as unpatentable under 35 U.S.C.
§ I03(a) as being obvious over Bennett and Sakai et al. (US 2010/0036445
Al, February 11, 2010) ("Sakai").
Claim 4 stands rejected as unpatentable under 35 U.S.C. § I03(a) as
being obvious over Bennett, Sakai, Thorpe et al. (US 7,120,499 B2, October
10, 2006) ("Thorpe"), and Roushey III et al. (US 2009/0182216 Al, July 16,
2009) ("Roushey").
Claims 5, 6, 20, and 21 stand rejected as unpatentable under 35 U.S.C.
§ I03(a) as being obvious over Bennett and Schotzko et al. (US
2012/0123496 Al, May 17, 2012) ("Schotzko").
Claims 7 and 22 stand rejected as unpatentable under 35 U.S.C.
§ I03(a) as being obvious over Bennett, Schotzko, and Thompson et al. (US
2003/0018369 Al, January 23, 2003) ("Thompson").
2 Appellants state that, in the Final Office Action, the Examiner appeared to
reject claim 23 on the same grounds asserted with respect to claim 15, but
did not identify claim 23 as being rejected in the heading of the
corresponding section. App. Br. 5, fn.25 ( citing Final Act. 4, 6). We
consequently include claim 23 on this ground of rejection. See also
Advisory Act., November 9, 2016, 3--4.
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Claims 9, 12, and 19 stand rejected as unpatentable under 35 U.S.C.
§ I03(a) as being obvious over Bennett and Erickson et al. (US 7,359,751
B 1, April 15, 2008) ("Erickson").
Claim 11 stands rejected as unpatentable under 35 U.S.C. § I03(a) as
being obvious over Bennett and Gray et al. (US 2011/0208123 Al, August
25, 2011) ("Gray").
Claim 14 stands rejected as unpatentable under 35 U.S.C. § I03(a) as
being obvious over Bennett and Carson et al. (US 5,669,790, September 23,
1997) ("Carson").
Claims 18 and 24 stand rejected as unpatentable under 35 U.S.C.
§ I03(a) as being obvious over Bennett and Jensen et al. (US 7,680,540 B2,
March 16, 2010) ("Jensen").
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to a trial stimulation system may
include a disposable trial stimulator that is sterilized for a single use in a
stimulation trial of one patient and which may function to improve the
durability of the system during the trial period and reduce the risk of damage
to or malfunction of the system. Spec. 2.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
Claim 1: A medical system comprising:
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a disposable trial electrical stimulator comprising a single
user interface integral with the disposable trial electrical
stimulator;
at least one percutaneous stimulation lead connected to the
disposable trial electrical stimulator; and
an electronic programming device configured to
wirelessly communicate with the disposable trial electrical
stimulator to program the disposable trial electrical stimulator to
deliver stimulation therapy via the at least one percutaneous
stimulation lead,
wherein the single user interface is configured to cause the
disposable trial electrical stimulator to be capable of wireless
communications with the electronic programming device and to
tum off stimulation being delivered by the disposable trial
electrical stimulator.
App. Br. 29.
ISSUES AND ANALYSES
We are persuaded by, and expressly adopt, the Examiner's findings
and conclusions establishing that Appellants' claims are prima facie
anticipated by, or obvious over, the combined cited prior art. We address
the arguments raised by Appellants below.
A. Claims 1, 8, 10, 13, 15-17, and 23 under 35 U.S.C. § 102(b)
Issue 1
Appellants argue that the Examiner erred in finding that Bennett
discloses a single user interface integral with a disposable trial electrical
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stimulator and configured to cause the disposable trial electrical stimulator
to be capable of wireless communications with an electronic programming
device. App. Br. 6.
Analysis
The Examiner finds that Bennett discloses an electronics pod of a trial
stimulator that has an interface with an electronics pod, a power source in a
power source bay, a display, and clinician controls 29. Final Act. 5 ( citing
Bennett Fig. 1. The Examiner finds that Bennett further discloses that the
electronics pod is configured to receive RF based wireless commands for
wireless programming or wireless patient control. Id. ( citing Bennett ,r 71)
The Examiner finds that Bennett discloses that the patient may remove the
power source from the power source bay, which results in the stimulator
being turned off, and thus stopping the stimulation signals from being
delivered by the disposable trial stimulator. Id. ( citing Bennett ,r 22). The
Examiner therefore concludes that Bennett discloses that the interface of the
trial stimulator is capable of wireless communication with the electronic
programming device and turning off the stimulation, as recited in claim 1.
Id.
Appellants argue that the Examiner has failed to show that Bennett's
disclosure that the electronics pod 26 can "accept wireless RF based
commands" suggests that the controls 29 cause electronics pod 26 to be
capable of wireless communication. App. Br. 6. According to Appellants,
the Examiner has not shown that Bennett describes the controls 29 as being
in any way able to control whether or not the electronics pod 29 can "accept
wireless RF based commands." Id. Appellants assert, therefore, that
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Bennett's disclosure that a device can accept wireless commands does not
provide any indication regarding whether or not the device includes a user
interface configured to cause the device to be capable of accepting wireless
commands. Id. Appellants therefore argue that the Examiner has failed to
provide any disclosure of Bennett of a "single user interface [] configured to
cause the disposable trial electrical stimulator to be capable of wireless
communications with the electronic programming device." Id. at 6-7
(Appellants' emphasis).
Appellants argue further that Bennett fails to disclose a single user
interface configured to cause the disposable trial electrical stimulator
configured to tum off stimulation being delivered by the disposable trial
electrical stimulator, as recited by claim 1. App. Br. 7. According to
Appellants, Bennett fails to describe the controls 29 as being configured to
tum off stimulation. Id.
Appellants dispute the Examiner's interpretation of Bennett's
disclosures to mean that "removing the power source results in interrupting
... the stimulation." App. Br. 7 (quoting Advisory Act. November 9, 2016,
3). Appellants assert that the Examiner has thus characterized removing the
power source as a user interface. Id. Appellants argue that the Examiner's
reliance on removing a power source from the device as the claimed "single
user interface" is unreasonable. Id. Appellants contend, by way of example,
that the Examiner has failed to show that the claimed single user interface
can be reasonably characterized as "controls 29" and a removable battery.
Id. Appellants therefore argue that the Examiner has failed to show that one
of ordinary skill in the art would have considered a removable power source
as a "single user interface," particularly in view of Bennett's disclosure of
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controls 29. This is particularly so, argue Appellants, because Bennett
describes power source 34 as a "small, lightweight, self-contained, limited
life, disposable smart power source [], which can be released and replaced as
prescribed." Id. at 8 (quoting Bennett ,r 72).
The Examiner responds that claim 1 does not provide any structure for
the "single user interface." Ans. 4. The Examiner finds that Bennett
discloses a trial stimulator that has a user interface: the Examiner points to
Figure 1 of Bennett that depicts the top surface of the user interface, which
comprises a display, two buttons 29, and a power source (i.e., battery 34),
inserted into a power input, i.e., a battery bay. Id. The Examiner finds that
this user interface is integral to the disposable trial stimulator since it is part
of the housing of the trial stimulator. Id.
The Examiner finds that Bennett also discloses that when the battery
34 is inserted into the battery bay, it powers up the electronics pod which
includes controls, a processor, and a wireless communication systems. Id. at
4--5 (citing Bennett ,r,r 71-72). Furthermore, the Examiner finds, Bennett
discloses that placing the power source/battery 34 into the battery bay is the
method by which the patient initiates a stimulation session and that
removing the battery from the bay stops the session. Id. at 5 ( citing Bennett
,r 74). The Examiner therefore concludes that Bennett expressly discloses a
single user interface that is integral with the disposable trial electrical
stimulator and that is configured to cause the disposable trial electrical to be
capable of wireless communications with the electronic programming device
and to tum off the stimulation being delivered by the disposable trial
electrical stimulator.
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We find the Examiner has the better position. Figure 1 of Bennett is
reproduced below:
Figure 1 of Bennett depicts perspective view of a trial system
for testing the efficacy of electrical stimulation
Element 26 of Figure 1 is an: "electronics pod 26 [that] may include
user and/or clinician controls 29, or the electronics pod may be configured to
couple to a programming/control device, or if desired, to accept wireless RF
based commands for both wireless programming and wireless patient
control, or any combination control options." Bennett ,r 71. We agree with
the Examiner that the electronics pod 26, which contains a means by which
the stimulation may be controlled, either directly or wirelessly, by the user
or the clinician, corresponds to a "single user interface," as recited in claim
1.
Bennett further discloses that:
The electronics pod 26 further includes a power input bay
32, to receive a small, lightweight, self-contained, limited life,
disposable smart power source 34, which can be released and
replaced as prescribed[ ... ] . The power source 34 may provide
power and data to the electronics pod 26. The disposable power
source 34 may include circuitry 36 to electronically store
information about the power source 34.
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Id. at ,r,r 72-73. Bennett further discloses that:
The replacement of the power source 34 is the method by
which the patient initiates another session of use or episode of
treatment. Sessions or episodes of usage/treatment may be
interrupted by removing the power source 34, and re-inserting
the same power source will resume stimulation; but the total
duration of stimulation from that one power source 34 is still
limited to the value defined for that power source, e.g., one hour
of use, or eight hours, or twelve hours, or twenty-four hours.
Id. at ,r 74. Finally, Bennett discloses:
With the prescribed power source replacement regime ( as with a
prescribed pill-based medication regime), a caregiver or clinician
or physician instructs the patient to remove and replace the
disposable power source 34 on a repeated or periodic basis (like
taking a dose of medication in pill form) to administer to the
circuitry a dose of power so the circuitry can generate a dose of
neurostimulation. In this way, the prescribed power sources
replacement regime has the effect or flavor of administering a
"pill" under a prescribed pill-based medication regime, and not
an end-of-life battery timeout.
Id. at ,r 7 6. Bennett thus discloses that inserting and removing the power
source 34 at the single user interface is the means by which the electronics
pod 26 is, respectively, powered up and powered down. Furthermore,
powering up the electronics pod 26 enables the wireless communication
capability of the electronics pod, and removing the battery back causes the
device to cease delivery of the stimulation. We therefore agree with the
Examiner that Bennett discloses the limitation of claim 1 reciting: "wherein
the single user interface is configured to cause the disposable trial electrical
stimulator to be capable of wireless communications with the electronic
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programming device and to tum off stimulation being delivered by the
disposable trial electrical stimulator."
Appellants argue claims 1, 8, 10, 13, and 15 together (Group 1) and,
for the reasons explained supra, we consequently affirm the Examiner's
rejection of those claims. Furthermore, Appellants argue claims 16 and 17
together (Group 2) but rely upon the same arguments presented with respect
to Group 1. App. Br. 10. For the same reasons explained supra, we affirm
the Examiner's rejection of claims 16 and 17.
Issue 2
Appellants argue claim 23 separately (Group 3). App. Br. 10. Claim
23 recites: "The system of claim 1, wherein the single user interface
comprises a button, the button being the single user interface integral with
the disposable trial electrical stimulator." Id. at 35. Appellants argue the
Examiner erred because Bennett does not disclose the limitation of claim 23.
Analysis
Pointing to Bennett's Figure 1, Appellants argue that the Examiner's
interpretation of Bennett's "controls 29, described by Bennett in the plural
form and comprising two buttons 29, does not reflect the plain meaning of
claim 23's recitation that "a button ... [is] the single user interface." App.
Br. 11. Appellants assert that the Examiner's construction of Bennett's
"controls 29" as being a "a button" is inconsistent with the plain meaning of
claim 23 as would have been understood by one of ordinary skill in the art
and that disclosing controls 29 as including at least two buttons does not
disclose or suggest that "a button is the single user interface." Id. at 11-12.
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Appellants point next to their Specification, which discloses that, in an
exemplary embodiment: "[t]rial stimulator 16 does include, however, a
single user interface, button 30 integral with the stimulator. Button 30 is
conveniently located on one of the two larger faces of trial stimulator 16."
App. Br. 11 (quoting Spec. 13). Appellants also note that the Specification
further describes that: "button 30 may include structural features to make it
easier to locate, like a raised edge around the perimeter of the button or a
surface finish or coating or texture that differs from the other surfaces of trial
stimulator 16." Id. Appellants therefore contend that a person of ordinary
skill in the art would have understood the phrase "a button, the button being
the single user interface" to mean one button; an interpretation that
Appellants contend is consistent with Appellant's description that "[t]he user
interface may include a keypad." Id. (quoting Spec. 11).
We are not persuaded by Appellants' arguments. Claim 23 recites
that: "the single user interface comprises a button, the button being the
single user interface integral with the disposable trial electrical stimulator."
Appellants do not dispute the Examiner's finding that Bennett discloses, in
Figure 1, at least two buttons that are integral to the single unit interface 26.
The transitional term "comprises" in claim 23, however, does not
preclude the presence of other buttons on the single unit interface. As
Bennett expressly discloses. See Crystal Semiconductor Corp. v. TriTech
Microelectronics Int'!, Inc., 246 F.3d 1336, 1348 (Fed. Cir. 2001) ("Use of
the transition "comprising" in the language of a claim creates a presumption
... that the claim does not exclude additional, unrecited elements"). This is
consistent with Appellants' admission that the claim term "button" is
consistent with: "a keypad and a display ( e.g., an LCD display). The keypad
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may take the form of an alphanumeric keypad or a reduced set of keys
associated with particular functions of programmer 24." Spec. 11; see also
Spec. 20.
Appellants appear to be trying to persuade us that the claim term
"single" used in the limitation reciting: "the button being the single user
interface integral with the disposable trial electrical stimulator," should be
interpreted to mean that a single button constitutes the sole or only interface
element, exclusive of any other. We disagree. Claim 1, from which claim
23 depends, recites, in relevant part: "a disposable trial electrical stimulator
comprising a single user interface integral with the disposable trial electrical
stimulator." We find that the use of the claim term "single" modifies the
term "user interface" ( as opposed to multiple user interfaces) that is integral
to the disposable trial electrical stimulator. Claim 23, upon which it
depends, further recites: "wherein the single user interface comprises a
button, the button being the single user interface integral with the disposable
trial electrical stimulator." Thus, the plain language of the claim, because of
the recitation of the open-ended term "comprising," permits additional
elements in the single interface, such as additional buttons or, indeed, an
alphanumeric keypad. See Spec. 11, 20. We consequently affirm the
Examiner's rejection of claim 23.
B. Claims 2-7, 9, 11, 12, 14, 18-22, and 24 under 35 U.S.C. § 103(a)
Issue 1: claims 2 and 3 (Group 4)
Appellants rely upon the same arguments presented supra with
respect to claim 1, and contend that Sakai fails to overcome the alleged
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deficiencies of Bennett. We have explained the reasons why we do not find
Appellants' arguments concerning claim 1 persuasive, and we consequently
affirm the Examiner's rejection of claims 2 and 3.
Appellants likewise rely upon the same arguments in defense of
claims 5 and 6 (Group 7), 3 claims 20 and 21 (Group 8), claim 22 (Group 10),
claims 9 and 12 (Group 11), claim 11 (Group 13), claim 14 (Group 14),
claim 18 (Group 15). See App. Br. 16, 17, 20, 21, 24, 25, 26. We
consequently, and for the same reasons, affirm the Examiner's rejection of
these claims.
Issue 2: Claim 4 (Group 5)
Claim 4 depends ultimately from claim 1 and recites, in relevant part:
[W]herein the disposable trial electrical stimulator comprises a
battery bay comprising a cavity configured to receive one or
more batteries to power the disposable trial electrical stimulator
and a door that forms a portion of the housing, and wherein the
disposable trial electrical stimulator comprises a gasket
interposed between the battery bay door and the housing to resist
ingress of fluids into the battery bay.
App. Br. 30. Appellants argue that a person of ordinary skill in the art
would have had no reason to modify Bennett and Sakai with Roushey to
arrive at the claimed feature of a gasket interposed between a battery bay
door and a housing to resist ingress of fluids into the battery bay. App. Br.
15.
3 Mention of a "Group 6" is omitted by Appellants.
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Analysis
Appellants argue that Sakai teaches a: "neurostinmlation assembly 10
[that] comprises a disposable patch or carrier 16," that "carrier 16 may
further carry an electronics pod 20," and that "power source 32 may be
secured within the electronics pod 20." App. Br. 15 (quoting Sakai ,r,r 53,
61, 78). Appellants further contend that Sakai teaches that: "assembly 10
may be constructed in a manner to conform to the IPX8 standard for water
ingress." Id. (quoting Sakai ,r 46). Appellants assert that a person having
ordinary skill in the art would have understood that the IPX8 standard
indicates that the object is configured to resist water ingress when
submerged in water. Id. Therefore, argue Appellants, Sakai already
describes a system that could be used to ensur[ e] that the battery
compartment is moisture proof." Id. (quoting Final Act. 10). Because Sakai
already solves the problem posed by the Examiner, a person of ordinary skill
in the art would have had no reason, with a rational underpinning, to arrive
at the claimed features. Id.
We do not find Appellants' argument persuasive. We agree with
Appellants that IPX8 is a standard by which the resistance to water ingress
in a submerged compartment is measured. Sakai ,r 46. Sakai teaches that
its claimed device: "may be constructed in a manner to conform to the IPX8
standard for water ingress." Sakai ,r 46. However, Sakai does not teach or
suggest a specific mechanism by which such a standard could be met.
Roushey teaches a monitor attached to a user's skin that needs to be
resistant from the ingress of fluids. Roushey Abstr. Roushey teaches that:
"[t]here is also an Indentation 70 in Cartridge Back 39, which becomes the
cover for Battery 61. The battery compartment is sealed by a Battery Door
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Gasket 40." Id. at ,r 46. Roushey thus teaches a mechanism by which the
standard taught by Sakai as being preferable can be achieved by mounting a
gasket on the door of a battery compartment to keep water from ingressing
into the compartment holding the replaceable battery. We therefore affirm
the Examiner's rejection of claim 4 for the reasons of record. Ans. 8-9.
Issue 3: Claim 7 (Group 9)
Claim 7 ultimately depends from claim 1 and recites:
The system of claim 6, wherein the processor is configured to
automatically, and without user interaction, select at least one of
a number of stimulation programming options available via the
electronic programming device and one or more stimulation
parameter values according to which the disposable trial
electrical stimulator can deliver stimulation via the at least one
percutaneous stimulation lead based on the type of the at least
one percutaneous stimulation lead
App. Br. 31. Appellants argue the Examiner erred because the combined
cited prior art (Bennett, Schotzko, and Thompson) neither teaches nor
suggests the limitation of claim 7. App. Br. 18.
Analysis
Appellants argue that Thompson teaches that: "data can be used by
the processor to adjust gain/energy control circuitry 348 in a manner that
controls the gains of output amplifier circuit 340 and sense amplifiers 360"
and that "[t]he adjustments may be based on the type of leads and sensors
that are detected in the system." App. Br. 19 (quoting Thompson ,r,r 60, 63).
However, argue Appellants, the Examiner has not shown that adjusting gains
of output circuit 340 or sense amplifiers 360 describes "automatically, and
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without user interaction, select at least one of a number of stimulation
programming options available via the electronic programming device and
one or more stimulation parameter values according to which the disposable
trial electrical stimulator can deliver stimulation via the at least one
percutaneous stimulation lead." Id. According to Appellants, the Examiner
has not established that adjusting output gains discloses or suggests selection
of a stimulation programming option or a stimulation parameter value for
delivering stimulation. Id. Therefore, Appellants contend, the Examiner has
failed to show that one of ordinary skill in the art would have modified the
system of Bennett to arrive at these claimed features. Id. Appellants argue
that the Examiner's proposed reason for modification to Bennett's system
lacks a nexus to the modification actually proposed by the Examiner.
The Examiner finds that Schotzko teaches an implantable medical
device ("IMD") that is used for stimulating the heart and which comprises a
processor and further teaches that it is well known to determine the lead type
by determining the impedance (i.e., input resistance) of the lead and
compare the measured impedance to stored impedance values associated
with a plurality of lead types (i.e., stored identifiers which include
impedance values). Ans. 11-12 (citing Schotzko Figs. 1, 5; ,r,r 68, 80).
The Examiner finds that Thompson teaches that it was well known in
the art that IMDs can be configured to automatically adjust the stimulation
programs based on the lead type determined by the system. Final Act. 12
( quoting Thompson ,r 60). The Examiner concludes that it would have been
obvious to a person having ordinary skill in the art to modify the teachings
of Bennett and Schotzko with the automatic selection of stimulation
programs based on the identified lead type, as taught by Thompson. Id.
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We agree with the Examiner. "[O]ne cannot show non-obviousness
by attacking references individually where ... the rejections are based on
combinations of references." In re Keller, 642 F.2d 413, 426 (C.C.P.A.
1981 ). Schotzko teaches that measurements of the impedance of stimulator
leads can be tested by the internal circuitry to determine a range of valid
values. Schotzko ,r 80. Thompson teaches that:
[T]he signals provided to sense amplifiers 360 may be selected
by selection circuit 361 based on the leads and/or sensors being
used by a particular system. Similarly, the signals that are driven
by output amplifier circuit 340 may be selected by selection
circuit 341 based on whether a lead or a particular electrode is
available within the system, and is being used to provide therapy
for a given patient.
Thompson ,r 63. We find that the automatic control of the output amplifier
circuit in the IMD stimulator taught by Thompson, by a processor and based
upon the leads in use and: "in a manner that controls the gain of output
amplifier circuit," constitutes automatically, and without user input:
"selecting at least one of a number of stimulation programming options ...
and one or more stimulation parameter values ... based on the type of the at
least one percutaneous stimulation lead," as recited in the claims. We
consequently affirm the rejection of claim 1.
Issue 4: Claim 19 (Group 12)
Claim 19 depends from independent claim 16 and recites:
The method of claim 16, further comprising:
monitoring stimulation intensity delivered by the
disposable trial electrical stimulator via the at least one
percutaneous stimulation lead; and
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causing the disposable trial electrical stimulation to cease
delivery of stimulation when the stimulation intensity delivered
by the disposable trial electrical stimulator does not equal a
programmed stimulation intensity.
App. Br. 34. Appellants argue that the Examiner erred because the
combined cited prior art (Bennett and Erickson) fails to teach the limitations
of claim 16. Id. at 22.
Analysis
Appellants argue that the Examiner has not shown that Erickson
discloses or suggests monitoring stimulation intensity delivered by the
disposable trial electrical stimulator or causing the disposable trial electrical
stimulation to cease delivery of stimulation when the stimulation intensity
delivered by the disposable trial electrical stimulator does not equal a
programmed stimulation intensity. App. Br. 22. According to Appellants,
Erickson teaches that: "[a] broken circuit detection circuit ... provides an
alarm or other alert to a user to provide notification of the broken circuit
and/or stops delivering stimulation pulses ... such as to avoid ... over
stimulating the patient when the lead is subsequently reconnected." Id. at
22-23 ( quoting Erickson col. 7, 11. 40-46). Appellants assert that merely
monitoring a circuit to determine whether or not it is broken does not
disclose or suggest monitoring stimulation intensity delivered by a
stimulator. Id. at 23. Appellants therefore assert that the Examiner has
failed to show that merely detecting a broken circuit suggests monitoring
stimulation intensity delivered to the patient. Id.
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Appellants argue further that, even if a person of ordinary skill in the
art had a reason to modify Bennett's method to "improv[ e] the safety of the
device," as the Examiner finds, the Examiner nonetheless has not shown that
such a reason would have led a person of ordinary skill in the art to combine
the teachings of Bennett and Erickson. App. Br. 23 (quoting Final Act. 14).
Appellants contend that the Examiner's proposed reason for modification
only attempts to establish that it would have been obvious to modify
Bennett's method to "have a broken circuit detection circuit ... [to] improv[ e]
the safety of the device," and does not establish that it would have been
obvious to achieve this result by modifying Bennett's method to include the
features of claim 19. Id. ( quoting Final Act. 14 ). Appellants argue that,
even if one of ordinary skill in the art were to modify the Bennett method to
include the broken circuit detector of Erickson, the Examiner has failed to
explain why that modified method would have arrived at the claimed
features of monitoring stimulation intensity or causing a disposable trial
electrical stimulation to cease delivery of stimulation when the stimulation
intensity delivered by the disposable trial electrical stimulator does not equal
a programmed stimulation intensity. Id. Therefore, Appellants argue, the
Examiner's proposed reason for modification to Bennett's method in view of
Erickson lacks a nexus to the modification actually proposed by the
Examiner. Id.
We are not persuaded by Appellants' arguments. Erickson, like
Bennett, is directed to electrical stimulators, which function by applying
current between electrode pairs. Erickson, col. 4, 11. 40-45; col. 1, 11. 42--46.
Specifically, Erickson teaches:
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Trial stinmlators configured according to embodiments of the
invention include a broken circuit detection feature to recognize
when an electrode is not receiving a stimulation pulse. A broken
circuit detection circuit of a preferred embodiment provides an
alarm or other alert to a user to provide notification of the broken
circuit and/or stops delivering stimulation pulses, such as to
avoid a patient or clinician increasing pulse magnitude before
realizing a lead has become disconnected and thereby over
stimulating the patient when the lead is subsequently
reconnected. The aforementioned maximum voltage override of
embodiments of the invention may be utilized in providing a
broken circuit detection feature. For example, when a maximum
voltage override threshold for a particular channel is reached, a
trial stimulator operating program may conclude that a circuit has
been broken with respect to that channel.
Erickson col. 7, 11. 37-52. Erickson thus teaches that a broken circuit
detector sets a maximum output voltage threshold and, when that threshold
is exceeded ( as the stimulator attempts to pass the required current) due to a
disconnected lead, the stimulator ceases to deliver stimulation pulses. To do
this, the stimulator must necessarily be monitoring the output voltage. We
consequently agree with the Examiner that Erickson teaches: "monitoring
stimulation intensity delivered by the disposable trial electrical stimulator"
and "causing the disposable trial electrical stimulation to cease delivery of
stimulation when the stimulation intensity delivered by the disposable trial
electrical stimulator does not equal a programmed stimulation intensity [i.e.,
exceeds the maximum voltage override threshold]," as recited in claim 19.
Furthermore, Erickson provides a motivation for a person of ordinary
skill to combine its broken circuit detection feature with the device of
Bennett, viz., "to avoid a patient or clinician increasing pulse magnitude
before realizing a lead has become disconnected and thereby over
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stimulating the patient when the lead is subsequently reconnected," thereby
increasing the safety of the device. Id. We consequently affirm the
Examiner's rejection of claim 19.
Issue 5: Claim 24 (Group 16)
Claim 24 recites: "The system of claim 1, wherein the single user
interface is configured to initiate wireless communication between the
disposable trial electrical stimulator and the electronic programming device
to cause the disposable trial electrical stimulator to be capable of wireless
communications with the electronic programming device." App. Br. 31.
Appellants argue that the combined cited references (Bennett and Jensen)
fail to teach or suggest the limitation of claim 24. App. Br. 27.
Analysis
Appellants argue that the Examiner has failed to show that Jensen
discloses or suggests that "[a] single user interface is configured to initiate
wireless communication between the disposable trial electrical stimulator
and the electronic programming device," as recited in claim 24. App. Br.
27. According to Appellants, Jensen teaches: "a flow diagram [FIG. 3]
illustrating operation of a multiapplication trial stimulator. As shown in FIG.
3, upon power up (52), processor 26 initializes trial stimulator 12 (54) and
initiates communication with an external programmer (56)." Id. (quoting
Jensen col. 11, 11. 17-20). Appellants contend that Jensen thus teaches that a
processor initiates communication. Id. However, argue Appellants, the
cited passages of Jensen do not disclose that a user interface is configured to
initiate wireless communication. Id. Appellants assert that the Examiner
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has therefore not shown that Jensen discloses or suggests that processor is
acting in response to a command received from a user interface. Id.
Appellants argue further that a person of ordinary skill in the art
would not have understood a processor to be a single user interface, much
less a single user interface configured to initiate wireless communication
between a disposable trial electrical stimulator and an electronic
programming device to cause the disposable trial electrical stimulator to be
capable of wireless communications with the electronic programming
device, as recited in claim 24. App. Br. 28-28.
We are not persuaded by Appellants' arguments. As we have
explained supra, Bennett teaches: "electronics pod 26 [that] may include
user and/or clinician controls 29, or the electronics pod may be configured to
couple to a programming/control device, or if desired, to accept wireless RF
based commands for both wireless programming and wireless patient
control, or any combination control options." Bennett ,r 71. We have also
explained how Bennett teaches that powering up the electronics pod
containing the user interface by inserting the battery pack can cause the unit
to be ready to receive those wireless instructions. See Bennett 72-74.
Jensen, in Figure 3, teaches the remaining limitation of claim 24.
Jensen teaches that: "[U]pon power up (52), processor 26 [of the trial
stimulator] initializes trial stimulator 12 ( 54) and initiates communication
with an external programmer (56)." Jensen col. 11, 11. 17-20. The
combined teachings of Bennett and Jensen therefore teach that the processor
that is part of the user interface of Bennett, upon being powered up, initiate
communication with the external programmer, as taught by Jensen.
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We consequently agree with the Examiner that the combined cited
prior art teaches the limitations of claim 24, and we affirm the Examiner's
rejection of the claim.
DECISION
The Examiner's rejection of claims 1, 8, 10, 13, 15-17, and 23 under
35 U.S.C. § 102(b) is affirmed for the reasons herein and of record.
The Examiner's rejection of claims 2-7, 9, 11, 12, 14, 18-22, and 24
under 35 U.S.C. § 103(a) is affirmed for the reasons herein and of record.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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