Ex Parte Leven

Patent Trial and Appeal Board

Jul 30, 2018

14325176 (P.T.A.B. Jul. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/325,176 07/07/2014
50638 7590 07/31/2018
Boston Scientific Neuromodulation Corp.
c/o Lowe Graham Jones
701 Fifth Avenue
Suite 4800
Seattle, WA 98104
FIRST NAMED INVENTOR
Jacob B. Leven
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.
BSNC-1-314.1 5748
EXAMINER
DINGA, ROLAND
ART UNIT PAPER NUMBER
3762
MAIL DATE DELIVERY MODE
07/31/2018 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 JACOB B. LEVEN 1
Appeal2017-008017
Application 14/325, 176
Technology Center 3700
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
JOHN G. NEW, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellant states that the real party-in-interest is Boston Scientific
Neuromodulation Corporation. App. Br. 2.
Appeal2017-008017
Application 14/325, 176
SUMMARY
Appellant files this appeal under 35 U.S.C. § I34(a) from the
Examiner's Final Rejection of claims 1-20. Specifically, claims 1-5, 9-16,
and 20 stand rejected as unpatentable under 35 U.S.C. § I03(a) as being
obvious over the combination of McDonald (US 2010/0094364 Al, April
15, 2010) ("McDonald") and Neubauer et al. (US 5,423,873, June 13, 1995)
("Neubauer").
Claims 6-8 and 17-19 stand rejected as unpatentable under 35 U.S.C.
§ I03(a) as being obvious over the combination of McDonald, Neubauer,
and Goedeke et al. (US 2011/0270362 Al, November 3, 2011) ("Goedeke").
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellant's invention is directed to implantable electrical stimulation
leads using superposition signals for delivering neuromodulation signals, as
well as methods of making and using the leads and electrical stimulation
systems. Spec. 1.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. An electrical stimulation lead, comprising:
at least one lead body having a distal end portion, a proximal end
portion, and a longitudinal length;
a plurality of electrodes disposed along the distal end portion of
the at least one lead body;
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at least one terminal disposed along the proximal end portion of
the at least one lead body;
wherein the lead has more electrodes than terminals;
a signal separator disposed along the lead between the plurality
of electrodes and the at least one terminal;
at least one terminal conductor, each terminal conductor
electrically coupling a one of the at least one terminal to
the signal separator; and
a plurality of electrode conductors, each electrode conductor
electrically coupling the signal separator to a different
one of the plurality of electrodes,
wherein the lead has more electrode conductors than terminal
conductors;
wherein the signal separator is configured and arranged to
receive signals from the at least one terminal conductor
and to separate the signals by frequency into electrode
signals,
wherein each electrode signal is directed along a pre-determined
one of the electrode conductors to a corresponding one of
the electrodes based on the frequency of the electrode
signal.
App. Br. 14.
ISSUES AND ANALYSES
We are persuaded by, and expressly adopt, the Examiner's findings
and conclusions establishing that Appellant's claims are primafacie
anticipated by, or obvious over, the combined cited prior art. We address
the arguments raised by Appellant below.
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A. Claims 1-5, 9-16, and 20 over McDonald and Neubauer
Issue
Appellant argues these claims together. App. Br. 6. Appellant
contends that the Examiner erred because the combined cited prior art
neither teaches nor suggests the limitations of claim 1 reciting: "wherein the
signal separator is configured and arranged to receive signals from the at
least one terminal conductor and to separate the signals by frequency into
electrode signals" and "wherein each electrode signal is directed along a pre-
determined one of the electrode conductors to a corresponding one of the
electrodes based on the frequency of the electrode signal." App. Br. 6.
Analysis
The Examiner finds McDonald teaches all of the limitations of claim
1, with the exceptions of the limitations recited supra. Final Act. 2-3. The
Examiner finds Neubauer teaches a signal separator, in which the signal
separator is capable of receiving signals from the at least one terminal
conductor and separating the signals by frequency into electrode signals, by
which each electrode signal is directed along a pre-determined one of the
electrode conductors to a corresponding one of the electrodes based on the
frequency of the electrode signal. Id. at 3 (citing Neubauer Figs. 1-3, 7, 9;
col. 3 11. 48---66; col. 4, 11. 10-55; col.5, 11. 14--55).
The Examiner concludes that it would have been obvious to a person
of ordinary skill in the art to modify McDonald to incorporate a signal
separator, as taught by Neubauer, in order to yield the predictable result of
separating signals to different electrodes. Final Act. 3.
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Appellant argues that Neubauer discloses a switching device that
receives a stimulation pulse superimposed upon a control signal. App. Br. 6.
According to Appellant, the switching device separates the stimulation pulse
from the control signal, and the control signal changes the state of the
switching device in such a way that the stimulation pulse is sent to one of the
electrodes in the electrode system. Id. (citing Neubauer col. 3, 11. 61-67).
Appellant asserts, however, that Neubauer neither teaches nor suggests a
signal separator which separates the signals by frequency into electrode
signals, and by which each electrode signal is directed along a
predetermined one of the electrode conductors to a corresponding one of the
electrodes based on the frequency of the electrode signal, as recited in the
claims. Id.
Specifically, Appellant argues that Neubauer teaches that the control
signal directs the switching device of Neubauer to send the stimulation pulse
to a specific electrode. App. Br. 7 (citing Neubauer col. 4, 11. 55---62).
Appellant contends that Neubauer teaches that the selection of which
electrode is to receive the stimulation pulse is determined by the control
signal regardless of the frequency characteristics of the stimulation pulse.
Id. According to Appellant, the switching device of Neubauer does not
direct the electrode signal to a corresponding electrode based on the
frequency of the electrode signal. Id.
We do not find Appellant's argument persuasive. We interpret
Appellant's claims in light of the disclosures of Appellant's Specification, as
it would be interpreted by one of ordinary skill in the art. Phillips v. AWH
Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005). Appellant's Specification does
not provide an express definition of the claim term "the frequency of the
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Application 14/325, 176
electrode signal," but it does provide an exemplary embodiment.
Appellant's Specification discloses that:
In at least some embodiments, the IPG [implantable pulse
generator] 402 generates pulses of stimulation energy at a low
frequency pulse rate (for example, in a range from 1 Hz to 100
KHz). The IPG 402 is capable of generating such pulses for any
of the electrodes. To accomplish the superposition of signals, the
energy pulses have an underlying AC signal which has a high
frequency (for example, in the 200 KHz to 1 GHz range). The
signal for each electrode is associated with a different frequency
or frequency range which are spaced apart sufficient to be
reliably separated by the signal separator 450. It will be
understood that the signals can be multiplexed using signal
characteristics other than frequency according to know
multiplexing methods.
Spec. 10-11. We consequently interpret the claim term "the frequency of
the electrode signal" to mean the frequency components of the overall
electrical signal in the lead comprising the combination of the lower-
frequency range stimulation pulse multiplexed with the high-frequency
signal that is the determining signal of which electrode the low-frequency
pulse is to be sent.
Neubauer teaches:
Stimulation pulses can be modulated with control signals
in a modulator 16 .... In the switching device 4, as shown in FIG.
3, the signals in the switching device 4 are sent via a signal input
socket 20 to a signal discriminator 21 which demodulates the
control signal and feeds it to a control element 22 for controlling
a switch 23. The switch 23 has four output positions 23A-D
respectively connected to the first tip electrode 7, the second tip
electrode 8, the third tip electrode 9 and the fourth tip electrode
10.
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Neubauer col. 4, 11. 14--32. Neubauer thus teaches that the stimulation
pulses are multiplexed (modulated) by a control signal that are subsequently
separated at the switching device, with the control signal determining to
which electrode the stimulus pulse will be sent.
Neubauer further teaches that:
FIG. 5 shows a second stimulation pulse 30 which
contains a first control signal in the form of a pulse packet 31, a
first stimulation pulse part 32, a second control signal in the form
of a pulse packet 33 and a second stimulation pulse part 34. The
first control signal 31 can, e.g., cause transmission of the first
stimulation pulse part 31 to the heart 5 via the third tip electrode
9, and the second control signal 33 can set the switch 23 such that
the second stimulation pulse part 34 is delivered to the heart 5
via the fourth tip electrode 10.
FIG. 6 shows a third stimulation pulse 35 in which the
control signal 36 consists of a high-frequency signal 30,
superimposed on the stimulation pulse 35.
Neubauer col. 5, 11. 1-13 (emphasis added). Neubauer thus teaches that
different control signals can direct the stimulus pulses to different electrodes
for delivery to the tissues. Furthermore, Neubauer teaches that the control
signals can comprise a high-frequency signal multiplexed with the
stimulation pulse, as disclosed by Appellant's Specification.
We consequently find that a person of ordinary skill in the art would
have understood from the teachings of Neubauer that the control signal is
part of the frequency of the electrode pulse, as claimed, and can comprise a
high-frequency signal superimposed upon the stimulation pulse. Moreover,
because Neubauer teaches that different control signals determine which
electrodes the stimulus pulses are sent to, we conclude that it would have
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been obvious to a person of ordinary skill in the art that control signals of
different high frequencies could be used to this end. See KSR Int 'l Co. v.
Teleflex Inc., 550 U.S. 398,421 (2007) ("A person of ordinary skill is also a
person of ordinary creativity, not an automaton"). We therefore affirm the
Examiner's rejection of claims 1-5, 9-16, and 20 on this ground.
B. Claims 3 and 14 over McDonald and Neubauer
Issue
Appellant additionally argues these claims together. App. Br. 9.
Appellant contends the Examiner erred because the combined cited prior art
references neither teach nor suggest: "wherein the signal separator is
disposed in the paddle," as recited in the claims. Id.
Analysis
Appellant argues that, whereas McDonald does not teach or suggest
the recited signal separator, Neubauer does not teach the use of a paddle.
App. Br. 9. Therefore, argues Appellant, Neubauer also does not teach that
the recited signal separator is in the paddle, rather, in Neubauer, the
switching device is placed in the lead. Accordingly, Appellant asserts,
neither McDonald nor Neubauer teach or suggest positioning a signal
separator in a paddle.
We are not persuaded. McDonald teaches:
Suitable implantable electrical stimulation systems
include, but are not limited to, an electrode lead ("lead") with one
or more electrodes disposed on a distal end of the lead and one
or more terminals disposed on one or more proximal ends of the
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lead. Leads include, for example, percutaneous leads, paddle
leads, and cuff leads.
McDonald ,r 33 (emphasis added). Appellant acknowledges that Neubauer
teaches that its switching device (i.e., a signal separator) is placed in the
lead. Thus it would have been obvious for a person of ordinary skill in the
art to place the signal separator located in the lead of Neubauer in the paddle
lead taught by McDonald. See In re Keller, 642 F.2d 413,425 (C.C.P.A.
1981 ):
The test for obviousness is not whether the features of a
secondary reference may be bodily incorporated into the
structure of the primary reference; nor is it that the claimed
invention must be expressly suggested in any one or all of the
references. Rather, the test is what the combined teachings of the
references would have suggested to those of ordinary skill in the
art.
We consequently affirm the Examiner's rejection of claims 3 and 14.
C. Claims 6-8 and 17-19 over McDonald, Neubauer, and Goedeke
Issue
Appellant repeats the arguments presented supra with respect to
claims 1-5, 9-16, and 20. App. Br. 10. Additionally, Appellant argues that
the combined cited prior art neither teaches nor suggests the limitations of
claims 6 and 1 7 reciting that the signal separator comprises a plurality of
frequency filters configured and arranged to separate the signals by
frequency into the electrode signals. Id.
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Analysis
The Examiner finds that Goedeke teaches an implantable lead with
plurality of filters, including band-pass filters. Final Act. 5 ( citing Goedeke
,r 62). The Examiner concludes that it would have been obvious to combine
the teachings of Goedeke to separate control signals of different frequencies
through the use of band-pass filters, which are well-known in the art. Id.
Appellant contends that Goedeke, upon which the Examiner relies,
teaches that the filters of its invention are to reduce or eliminate the negative
effects of an interfering electromagnetic field and other interfering external
fields on the patient or on the circuitry within the implantable medical
device. App. Br. 10 (citing Goedeke ,r 27). According to Appellant,
Goedeke uses a plurality of filters to filter external signals that would
interfere with internal signals of the circuitry of the implantable medical
device. Id. However, argues Appellant, the recited electrode signals of
claims 6 and 17 are internal signals within the electrical stimulation lead and
are also not meant to be reduced or eliminated. Id.
Appellant therefore argues that a person of ordinary skill in the art
would not have found it obvious to modify the filters of Goedeke to separate
electrode signals, because the proposed modification would have changed
the principle of operation of the reference. App. Br. 10-11 (citing MPEP
§ 2143.01).
We are not persuaded by Appellant's argument. We have already
explained our reasoning as to why we find that Neubauer teaches separating
electrode sequence by frequency. Goedeke is cited as teaching band-pass
filters, such as notch filters, and such filters are certainly well-known in the
art. See, e.g., Goedeke ,r 53. We agree with the Examiner that it would have
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been obvious to a person of ordinary skill in the art seeking to separate
control signals on the basis of their frequency, to apply such filters as a
routine solution to this problem, and we affirm the Examiner's rejection of
the claims.
D. Claims 7 and 18 over McDonald, Neubauer, and Goedeke
Appellant also argues these claims together. App. Br. 11. Claim 7 is
representative and recites: "The lead of claim 6, wherein each frequency
filter is disposed adjacent a different one of the electrodes." Id. at 15.
Appellant argues that the combined cited prior art references neither teach
nor suggest the limitation of claim 7. Id. at 11.
Analysis
Appellant argues that Goedeke teaches that lead 124 has two
electrodes; a ring electrode 140 and a tip electrode 142 that is spaced-apart
from the ring electrode. App. Br. 12 (citing Goedeke ,r 45, Fig. 3).
Appellant acknowledges that Goedeke discloses that the active circuit
elements 146a, 146b, and 146c can be filters. Id. ( citing Goedeke ,r,r 60-62).
However, Appellant asserts, as illustrated in Figure 5 of Goedeke, all three
active circuit elements 146a, 146b, and 146c are positioned within the ring
electrode 140. Id. at 11-12 (also citing Goedeke Figure 4). Appellant points
out that none of the three active circuit elements 146a, 146b, or 146c is
adjacent to the tip electrode 142, which protrudes from lead 124, as
illustrated in Figure 3 of Goedeke. Therefore, argues Appellant, Goedeke
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does not teach or suggest that each frequency filter is disposed adjacent to a
different one of the electrodes. Id. at 12.
We do not find Appellant's arguments persuasive. As we have
explained supra, Goedeke teaches the use of band-pass or notch filters, and a
person of ordinary skill would have found it obvious to incorporate such
filters to apply such filters to separate control signals on the basis of their
frequency. Furthermore, because such filters would obviously function to
separate the control signals from the electrode signals, we conclude that it
would be an obvious choice for a person of ordinary skill in the art to locate
the filters adjacent to the electrodes to which they are passing their
respective electrode signals. We consequently affirm the Examiner's
rejection of claims 7 and 18.
DECISION
The Examiner's rejection of claims 1-20 under 35 U.S.C. § 103(a) is
affirmed.
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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