Ex Parte Baynham et al

Patent Trial and Appeal Board

Jan 17, 2019

14338695 (P.T.A.B. Jan. 17, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/338,695 07/23/2014 Tamara C. Baynham
45458 7590 01/22/2019
SCHWEGMAN LUNDBERG & WOESSNER/BSC
POBOX2938
MINNEAPOLIS, MN 55402
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.
6279.013US 1 1002
EXAMINER
WU,TONGE
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
01/22/2019 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):
uspto@slwip.com
SLW@blackhillsip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TAMARA C BAYNHAM
and JORDI P ARRAMON1
Appeal2018-000675
Application 14/338,695
Technology Center 3700
Before DANIEL S. SONG, JAMES P. CAL VE, and JILL D. HILL,
Administrative Patent Judges.
CAL VE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Office Action
finally rejecting claims 1-3, 6-8, 10-15, 17, 18, 21, and 22. Appeal Br. 1,
23. Claims 4, 5, 9, and 16 are withdrawn. Final Action 1 (Office Action
Summary). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Boston Scientific Neuromodulation Corporation is identified as the real
party in interest (see Appeal Br. 2), and is also the Applicant pursuant to
37 C.F.R. § 1.46.
Appeal2018-000675
Application 14/338,695
CLAIMED SUBJECT MATTER
Claims 1 and 21 are independent. Claim 1 is reproduced below.
1. A method, comprising:
providing a sub-perception therapy to a patient such that
the patient does not perceive stimulation, including delivering
electrical modulation energy to a target tissue site of the patient
at a programmed intensity value;
automatically calibrating the sub-perception therapy to a
perception threshold in response to an event, wherein the
automatically calibrating the sub-perception therapy to the
perception threshold includes:
automatically detecting the perception threshold,
including:
delivering electrical modulation energy using a series of
incrementally increasing intensity values relative to the
programmed intensity value to increase an intensity of the
delivered electrical modulation energy to at least the perception
threshold; and
sensing at least one evoked compound action potential
(eCAP) indicative of the perception threshold in a population of
neurons at the target tissue site of the patient in response to the
delivery of the electrical modulation energy at the series of
incrementally increasing intensity values; and
selecting one intensity value from the series of
incrementally increased intensity values corresponding to the at
least one sensed eCAP indicative of the perception threshold;
and
computing a decreased intensity value as a function of
the selected intensity value; and
delivering electrical modulation energy to the target
tissue site of the patient at the computed decreased intensity
value to provide the sub-perception therapy.
Appeal Br. 24 (Claims App.).
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Application 14/338,695
REJECTIONS
Claims 1-3, 11-15, 17, 18, and 21 are rejected under 35 U.S.C. § 103
as unpatentable over Wacnik (US 2013/0282078 Al, pub. Oct. 24, 2013)
and Parker (US 2014/0236257 Al, pub. Aug. 21, 2014).
Claims 6-8, 10, and 22 are rejected under 35 U.S.C. § 103 as
unpatentable over Wacnik, Parker, and Barreras, Sr. (US 5,941,906, iss.
Aug. 24, 1999) ("Barreras"). 2-8303
ANALYSIS
Claims 1-3, 11-15, 17, 18, and 21
Unpatentable over Wacnik and Parker
The Examiner finds that Wacnik provides sub-perception therapy as
recited in independent claims 1 and 21, except for using evoked compound
action potential ( eCAP) for a perception response automatically for an event.
Final Act. 4--5. The Examiner relies on Parker to teach sensing at least one
eCAP indicative of a perception threshold in order to determine a paresthesia
threshold more accurately and automatically in response to an event. Id. at
5. The Examiner determines that it would have been obvious to modify
W acnik to use eCAP for a perception response automatically in response to
an event, as taught by Parker, to determine a paresthesia threshold more
accurately and to adjust sub-threshold stimulation automatically in response
to changes that affect the perception threshold. Id.
Appellant argues that Wacnik does not teach a process that finds a
perception threshold, use a sensed eCAP to indicate a perception threshold,
or identify an intensity value of electrical modulation energy corresponding
to the sensed eCAP/perception threshold. Appeal Br. 15.
These arguments are not persuasive for several reasons.
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Application 14/338,695
First, the Examiner relies on Parker to teach the use of a sensed eCAP
to indicate a perception threshold (Final Act. 5) as Appellant recognizes (see
Appeal Br. 16).
Second, the Examiner provides detailed findings regarding Wacnik's
automated process for providing sub-perception therapy by automatically
calibrating stimulation therapy parameters to a perception threshold, albeit
without reliance on a sensed eCAP as indicative of a perception threshold.
Final Action 4--5. The Examiner relies on Parker to teach the use of eCAP
as a proxy or indication of a perception threshold automatically in response
to an event as claimed. Id. at 5. Appellant's arguments do not address the
findings of the Examiner that W acnik teaches the claimed process except for
using a sensed eCAP (see Appeal Br. 14--16; Reply Br. 2-5), and therefore
do not apprise us of Examiner error. See 37 C.F.R. § 4I.37(c)(l)(iv) (the
Appeal Brief must contain the arguments of appellant explaining why the
examiner erred as to each ground of rejection contested by appellant); see
also In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (approving of Board's
long-standing practice of requiring an applicant to identify the alleged error
in an examiner's rejections); Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI
2010) (precedential) ("The panel then reviews the obviousness rejection for
error based upon the issues identified by appellant, and in light of the
arguments and evidence produced thereon.") (cited with approval in Jung,
637 F.3d at 1365).
Wacnik expressly teaches a therapy mode that automatically changes
stimulation intensity to be below the perception threshold of a patient and
then automatically increases the intensity to above the perception threshold
stimulation intensity of the patient. Wacnik ,r,r 33, 34, 62, 135-143.
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Appeal2018-000675
Application 14/338,695
Wacnik discloses an implanted modulation device (IMD 14) that
gradually and automatically increases the stimulation intensity until the
patient or a sensor perceives the stimulation. Id. ,r,r 33-36, 62, 138-140.
The perception may include a perception of paresthesia. Id. ,r,r 7, 35, 137.
Wacnik also teaches that the perception threshold is the minimum
stimulation intensity at which the patient first perceives (e.g., feels) one or
more substantial effects from the electrical stimulation therapy such as a
motor response, a stimulation perception response, a detected physiological
response, or "a nerve action potential." Id. ,r 35.
The Examiner relies on Parker for further teachings on the use of a
detected physiological response such as a nerve action potential or eCAP as
claimed. Final Act. 5. In this regard, Parker teaches that it is well known to
use the eCAP measurements to provide completely automated device fitting
to a patient because the eCAP response provides measurement of the fibers
being stimulated and "[t]he perception threshold corresponds to the
appearance of an evoked response." Parker ,r,r 73, 75, 76. Therefore, the
Examiner correctly reasons that Parker's process uses eCAP ( evoked CAP)
to determine a perception threshold more accurately. Final Act. 5.
Parker records the eCAP measurements during implantation. Parker
,r,r 78, 79. Parker records these measurements for different user postures.
Id. ,r 91, Fig. 19. As a result, these stored measurements also can be used to
determine whether lateral movement of the electrode has occurred and then
change stimulation therapy parameters/electrodes automatically, in real time
in response to automated neural response measurements. Id. ,r,r 153, 154.
Stimulation intensity may be reduced to avoid undesired sensation, and
stimulation location may be shifted to resume the desired response level. Id.
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Application 14/338,695
These adjustments to stimulus parameters based on evoked response
measurements return the neural response to the first, stored neural response
measurement. Id. ,r 159. A table of program parameters can be updated
with new posture and program data determined from neural responses. Id.
Wacnik and Parker automatically calibrate to provide sub-perception
therapy to a patient. They do so by sensing evoked physiological responses
to a series of incrementally increased stimulation intensities to identify the
sensed value that corresponds to a stored value indicative of the perception
threshold. Their automated methods select the intensity that provides this
sensed value. Wacnik ,r,r 5-7, 9-11, 29-36, 62, 135-143; Parker ,r,r 7, 29,
35-37, 75-80, 90-93, 147. Wacnik automatically, incrementally increases
the stimulation intensity from below the perception threshold to just above
the perception threshold to detect the perception threshold. Then, Wacnik
lowers the stimulation intensity to just below the perception threshold. See
Wacnik ,r,r 62. Parker induces paresthesia in response to postural changes to
identify treatment locations and then reduces stimulation to sub-threshold
levels. Parker ,r,r 33, 35-37, 91, 147, 153, 154, 159.
Wacnik and Parker both detect a stimulation perception threshold by
sensing an acute, physiologically significant response while increasing the
stimulation intensity from a low intensity to a higher intensity. For Wacnik,
the response includes a motor response, a stimulation perception response,
or a detected physiological response such as nerve action potential. Wacnik
,r 35. For Parker, the response includes eCAP, which is provided above a
recruitment threshold for neural response and therapeutic effect but below a
comfort threshold to minimize energy expenditure. Parker ,r,r 7, 8, 29, 35.
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Appellant's arguments that Parker does not automatically calibrate to
a perception threshold and Wacnik does not use sensed eCAP to calibrate
automatically to a perception threshold or event (Appeal Br. 15-16) are not
persuasive because the Examiner relies on Wacnik to teach automatically
calibrating to a perception threshold and Parker to teach the use of sensed
eCAP to identify a perception threshold upon occurrence of an event (i.e., a
posture change) (Final Act. 4--5). Moreover, as discussed above, Wacnik
uses sensed physiological responses to identify a perception threshold, and
Parker uses sensed eCAP to identify a perception threshold automatically
and provide sub-threshold therapy upon occurrence of an event.
We agree with the Examiner that using eCAP, as taught by Parker, in
the method of Wacnik would not alter the principle of operation of Wacnik.
Ans. 7. The Examiner proposes a simple substitution of Parker's sensed
eCAP values as a means to detect a patient's perception threshold and then
to deliver sub-threshold stimulation therapy where Wacnik already teaches
to sense a variety of different physiological responses of a patient in order to
identify a perception threshold and deliver sub-threshold therapy.
Thus, we sustain the rejection of claim 1 and dependent claims 2, 3,
12-15, 17, and 18, which are not argued separately. Appeal Br. 13-19.
Claim 11
The Examiner correctly finds that Parker adjusts stimulation therapy
in response to an event that includes an identified physical activity/posture
of a user, a user-initiated signal, a signal indicating an electrode migration,
or on a periodic basis, as recited in claim 11. Final Act. 6. Appellant argues
that Parker does not automatically calibrate to a perception threshold in
response to an event. Appeal Br. 17-18.
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Application 14/338,695
This argument is not persuasive as the Examiner relies on Wacnik, not
Parker, to teach automatic calibration to a perception threshold and further
relies on Parker to teach the calibration of stimulation therapy in response to
an event that includes the events recited in claim 11. Final Act. 6 ( citing
Parker ,r,r 33, 153, 154, 159). Paragraph 33 of Parker describes the adaptive
control of stimuli in response to user's postural changes, which correspond
to the claimed event. Parker compares measured neural fiber conduction to
desired fiber class recruitment to provide desired pain suppression response.
Parker ,r 34. Parker also identifies a "perception" threshold below which no
evoked response arises from the stimulus and a maximum, comfort threshold
and uses this data to adaptively control the stimuli in response to postural
changes of a user to maintain stimuli at a sub-threshold level. Id. ,r,r 35-37.
Paragraph 153 describes how the system monitors and estimates the
lateral movement of an electrode for a given stimulus intensity and uses the
sensed responses to change the stimulus electrodes, location, and intensity as
needed. These automated neural response measurements adjust the system
in real time. Id. ,r 154. Accelerometer posture measurements can be used
simultaneously with the neural response measurements to adjust stimulus
parameters and to return the neural response measure to the first, desired
neural response measure automatically in a feedback loop. Id. ,r 159.
As discussed above, Wacnik teaches a method that adaptively controls
the stimulation intensity and parameters in a closed feedback loop based on
sensed physiological responses to identify a patient's perception threshold
and then set stimulation to a sub-perception threshold. Parker teaches to run
adaptive, feedback loops in response to events that affect stimulation therapy
such as posture changes and to provide sub-perception stimulation therapy.
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Appeal2018-000675
Application 14/338,695
A skilled artisan would understand that Parker's feedback loop is used
to sense and identify a perception threshold upon occurrence of an event and
then to set stimulation therapy at a sub-perception threshold. In addition,
Wacnik's measures responses to identify a patient's perception threshold and
then provides sub-perception therapy. The Examiner reasonably determines,
and we agree that, it would have been obvious to run Wacnik's method upon
the occurrence of an event, as Parker teaches to do, so the IMD continues to
provide efficacious, sub-perception, stimulation therapy even if the location
of the leads change due to user movement and the like. Final Act. 5, 6.
Thus, we sustain the rejection of claim 11.
Claim 21
Appellant argues the patentability of independent claim 21 based, in
part, on arguments presented for claim 1. Appeal Br. 18. This argument is
not persuasive for the reasons discussed for the rejection of claim 1.
Appellant also recites various limitations of claim 21 and argues that
Wacnik and Parker do not teach or suggest these features. Id. at 18-19.
Merely reciting limitations of a claim and asserting that the prior art
does not teach of suggest these features does not apprise us of Examiner
error and does not constitute effective argument for the separate patentability
of claim 21. See 37 C.F.R. § 4I.37(c)(l)(iv); In re Lovin, 652 F.3d 1349,
1357 (Fed. Cir. 2011) (holding that the Board had reasonably interpreted 37
C.F.R. § 4I.37(c)(l)(vii) (the predecessor to§ 4I.37(c)(l)(iv)) as requiring
"more substantive arguments in an appeal brief than a mere recitation of the
claim elements and a naked assertion that the corresponding elements were
not found in the prior art").
Thus, we sustain the rejection of claim 21.
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Appeal2018-000675
Application 14/338,695
Claims 6-8, 10, and 2 2
Unpatentable over Wacnik, Parker, and Barreras
Claim 6
The Examiner relies on Barreras to teach comparing a characteristic of
at least one sensed eCAP to a corresponding characteristic of a reference
eCAP that is indicative of a perception threshold to select an intensity value
indicative of a perception threshold as recited in claim 6. Final Act. 6-7.
Appellant argues that Barreras does not teach a reference paresthesia
threshold and establishing stimulation parameters to provoke paresthesia in a
pain patient. Appeal Br. 19--20.
We agree with the Examiner that Barreras teaches a biological sensor
used to recognize an evoked response resulting from stimulating a remote
nerve tissue for the purpose of automatically establishing the stimulation
parameters required to provoke paresthesia. Barreras, 12:30-36. Barreras
also teaches delivering a stimulus pulse and detecting the evoked response
signals, which are compared against a prerecorded morphology for patient
paresthesia. Id. at 12:36-39. Tissue stimulator 12 periodically resets to zero
and then slowly increases the stimulus in very small steps until the desired
evoked potential is detected (by comparison to the prerecorded paresthesia
morphology) to indicate paresthesia is reestablished. Id. at 12:40-44.
In addition, as discussed above, Wacnik senses stimulus responses to
identify a perception threshold (i.e., paresthesia), and Parker also compares
sensed eCAP responses to recorded eCAP values indicative of paresthesia
for this same purpose of identifying a perception threshold. Parker ,r,r 75-
78, 91-93, 153,154,159.
Thus, we sustain the rejection of claim 6.
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Appeal2018-000675
Application 14/338,695
Claim 8
The Examiner finds that Barreras teaches a method that senses two or
more eCAPs in response to the delivery of electrical modulation energy and
determines which sensed eCAPs has the characteristics that best match a
reference eCAP that is indicative of the perception threshold as recited in
claim 8. Final Act. 7 ( citing Barreras, 12:31--44); Ans. 7-8. In this regard,
Barreras uses a sensor to recognize a prerecorded morphology of an evoked
response that resulted from stimulating a remote nerve tissue for the purpose
of automatically establishing the stimulation parameters required to provoke
paresthesia. Barreras, 12:31-36. Tissue stimulator 12 periodically goes into
a "search" mode whereby the amplitude is reset to zero and then increased
slowly in very small steps until the desired evoked potential is detected to
indicate that paresthesia has been reestablished. Id. at 12:40--44.
The Examiner correctly finds that Barreras compares plural sensed
eCAPs of incrementally increased intensity with a stored reference eCAP to
identify which of the sensed eCAP best matches the reference eCAP that is
indicative of paresthesia. Final Act. 7 (citing Barreras, 12:31--44); Ans. 7-8.
Barreras thus teaches determining which of the two or more sensed eCAPs
has characteristics that best match the characteristics of the reference eCAP.
Barreras then selects the intensity value corresponding to the eCAP that best
matches the reference eCAP to reestablish paresthesia. Barreras, 12:31--44.
In view of these teachings of Barreras, which the Examiner sets forth
in the Answer (Ans. 7-8), Appellant's argument that the Office Action does
not address these limitations is not persuasive. See Appeal Br. 20.
Thus, we sustain the rejection of claim 8.
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Claim 10
The Examiner finds that Parker and Barreras store a list of reference
eCAP characteristics indicating a perception threshold for multiple patient
postures and select a reference eCAP from this list to compare to a sensed
eCAP for an identified posture as recited in claim 10. Final Act. 7 ( citing
Parker ,r,r 91, 159, Fig. 19 for storing reference eCAP data and sensing
current posture); Ans. 8. Appellant's argument that the Office does not
address the "specific claim language" of claim 10 (Appeal Br. 21) does not
apprise us of error in the Examiner's findings, which notify Appellant of the
basis of the rejection. Thus, we sustain the rejection of claim 10.
Claim 22
For similar reasons as claim 8, Barreras also compares a characteristic
of a sensed eCAP to a corresponding characteristic of a reference eCAP that
is indicative of the perception threshold to select an intensity value that
corresponds to the sensed eCAP that is indicative of a perception threshold
as recited in claim 22. Final Act. 7 (citing Barreras, 12:31--44). Barreras
uses this process to provoke or reestablish paresthesia, which corresponds to
the claimed perception threshold. See Spec. ,r,r 57, 59.
Thus, we sustain the rejection of claim 22.
DECISION
We affirm the rejections of claims 1-3, 6-8, 10-15, 17, 18, 21, and
22.
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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