Ex Parte Bourget et al

Patent Trial and Appeal Board

Sep 28, 2017

13154303 (P.T.A.B. Sep. 28, 2017)

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.
13/154,303 06/06/2011 Duane Bourget 1023-540US05/P0024219.USC 1758
71996 7590 10/02/2017
SHUMAKER & SIEFFERT , P.A
1625 RADIO DRIVE , SUITE 100
WOODBURY, MN 55125
EXAMINER
DINGA, ROLAND
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
10/02/2017 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
medtronic_neuro_docketing @ cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DUANE BOURGET and KEITH A. MIESEL1
Appeal 2016-005071
Application 13/154,303
Technology Center 3700
Before ERIC B. GRIMES, TAWEN CHANG, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method and system for controlling delivery of therapy to a patient via a
medical device, which have been rejected as anticipated. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 Appellants identify the Real Party in Interest as Medtronic, Inc. and
Medtronic pic of Dublin, Ireland. (Appeal Br. 3.)
Appeal 2016-005071
Application 13/154,303
STATEMENT OF THE CASE
Claims 1—20 are on appeal. Claim 1 is illustrative and reproduced
below:
1. A method comprising:
determining a rate of change of a value of a sensed
patient parameter over a first time period, wherein the patient
parameter is sensed via a sensor and is indicative of at least one
of patient posture or patient activity;
comparing the rate of change of the value to a threshold
rate of change; and
controlling delivery of therapy to a patient via a medical
device based on the comparison, wherein at least one of the
determining, comparing, and controlling is performed using one
or more processors.
(Appeal Br. 19 (Claims App’x).)
The Examiner rejects claims 1—20 under pre-AIA 35 U.S.C. § 102(e)
as being anticipated by Heruth.2 (Ans. 2.)
DISCUSSION
Issue
The Examiner finds that Heruth discloses each limitation of the
appealed claims. (Ans. 2—7.) Appellants contend that Heruth does not
disclose “controlling delivery of therapy to a patient via a medical device
based on the comparison” between the rate of change of a sensed patient
parameter and a threshold rate. (Appeal Br. 6.) With respect to dependent
claims 2, 3, 5, 6, 8, 11, 12, 14, 15, and 17, Appellants additionally argue that
Heruth does not disclose the additional dependent limitations of “delivering
therapy to the patient according to default therapy information based on the
2 Heruth et al., US 2005/0209513 Al, published Sept. 22, 2005.
2
Appeal 2016-005071
Application 13/154,303
comparison” (claims 2 & 11, Appeal Br. 9-12); “suspending the delivery of
therapy to the patient for a predetermined period based on the comparison”
(claims 3 & 12, Appeal Br. 12—14); using an accelerometer to sense a patient
parameter (claims 5 & 14, Appeal Br. 14—15); determining the rate of
change of a value of a patient parameter indicative of patient posture (claims
6 & 15, Appeal Br. 15—16); and delivering electrical stimulation therapy,
defined by at least one stimulation parameter, based on the comparison
between the rate of change of a sensed patient parameter and a threshold rate
(claims 8 & 17, Appeal Br. 16—18).
The issue with respect to this rejection is whether a preponderance of
evidence supports the Examiner’s determination that Heruth discloses each
limitation of the claims on appeal.
Findings of Fact
1. Heruth teaches “collecting information that relates to the quality
of patient’s sleep via a medical device,” and determining values for one or
more metrics, such as sleep efficiency, sleep latency, and time spent in
deeper sleep states, all of which indicate the quality of a patient’s sleep.
(Heruth Abstract, || 5, 7.)
2. Heruth teaches that “sleep efficiency may be measured as the
percentage of time while the patient is attempting to sleep that the patient is
actually asleep” and “[sjleep latency may be measured as the amount of time
between a first time when the patient begins attempting to fall asleep and a
second time when the patient falls asleep, and thereby indicates how long a
patient requires to fall asleep.” {Id. 1 8.)
3
Appeal 2016-005071
Application 13/154,303
3. Herath teaches that
[ejxample physiological parameters that the medical device
may monitor include activity level, posture, heart rate,
respiration rate, respiratory volume, blood pressure, blood
oxygen saturation, partial pressure of oxygen within blood,
partial pressure of oxygen within cerebrospinal fluid, muscular
activity, core temperature, arterial blood flow, melatonin level
within one or more bodily fluids, and galvanic skin response.
{Id. | 6; see also id. 52, 72, 79.)
4. Herath teaches that a processor
may compare one or more parameter or parameter variability
values to thresholds stored in memory ... to detect when [the]
patient. . . falls asleep or awakes. The thresholds may be
absolute values of a physiological parameter, or time rate of
change values for the physiological parameter, e.g., to detect
sudden changes in the value of a parameter or parameter
variability. In some embodiments, a threshold used by [the]
processor ... to determine whether [the] patient... is asleep
may include a time component. For example, a threshold may
require that a physiological parameter be above or below a
threshold value for a period of time before [the] processor . . .
determines that patient is awake or asleep.
{Id. 1 80; see also id. 1 88 (stating that a “processor . . . may detect an
arousal based on . . . [a] sudden increase in one or more of heart rate, heart
rate variability, respiration rate, respiration rate variability, blood pressure,
or muscular activity as the occurrence of an arousal,” and that the
“[m]emory . . . may store thresholds used by process ... to detect arousals
and apneas”).)
5. In particular, Herath teaches that
the medical device may determine the time at which the patient
begins attempting to fall asleep based on the level of melatonin
within one or more bodily fluids, [because] increased levels of
melatonin during evening hours may cause physiological
4
Appeal 2016-005071
Application 13/154,303
changes in the patient, which, in turn, may cause the patient to
attempt to fall asleep.
{Id. 110; see also id. H 55, 95.) Heruth further teaches that, for example,
the medical device
may compare the . . . rate of change in the melatonin level to a
threshold level, and identify the time that threshold value is
exceeded. [The implantable medical device] IMD . . . may
identify the time that [a] patient... is attempting to fall asleep
as the time that the threshold is exceeded, or some amount of
time after the threshold is exceeded.
{Id. | 56; see also id. 178.)
6. Heruth teaches that, in embodiments where the processor is
determining when a patient is attempting to fall asleep based on the level of
melatonin in a bodily fluid, the sensor “may take the form of a chemical
sensor that is sensitive to the level of melatonin or a metabolite of melatonin
in the bodily fluid, and estimate the time that patient. . . will attempt to fall
asleep based on the detection.” {Id. 178.)
7. Heruth teaches that, in one embodiment,
the invention is directed to a method in which at least one
physiological parameter of a patient is monitored via a medical
device that delivers a therapy to the patient. A value of a metric
that is indicative of sleep quality is determined based on the at
least one physiological parameter. A current therapy parameter
set is identified, and the sleep quality metric value is associated
with the current therapy parameter set.
{Id. 120; see also id. 113.)
8. Heruth teaches that
[a] clinician . . . may use the presented sleep quality information
to evaluate the effectiveness of therapy delivered to the patient
by the medical device, to adjust the therapy delivered by the
medical device, or to prescribe a therapy not delivered by the
5
Appeal 2016-005071
Application 13/154,303
medical device in order to improve the quality of the patient’s
sleep.
{Id. 1 5; see also id. H 18, 28 (teaching that “[u]sing the sleep quality
information provided by the system, the clinician and/or patient can . . .
make changes to the therapy provided by a medical device”), 41, 65
(describing how clinician can use the sleep quality information to “identify
effective or ineffective therapy parameter sets”).)
9. Heruth teaches that for purposes of its invention the medical
device may be “an implantable neurostimulator that delivers
neurostimulation therapy in the form of electrical pulses to patient.” {Id.
142; see also id. 1116 (stating that “the invention may be embodied in a
trial neurostimulator, which is coupled to percutaneous leads implanted
within the patient to determine whether the patient is a candidate for
neurostimulation, and to evaluate prospective neurostimulation therapy
parameter sets”).) Heruth further teaches that, “in embodiments in which the
medical device is a neurostimulator, a therapy parameter set may include a
pulse amplitude, a pulse width, a pulse rate, a duty cycle, and an indication
of active electrodes.” {Id. 113.)
Analysis
Claims 1,10, and 20
Heruth teaches a method of determining a rate of change of a value of
a sensed patient parameter (e.g., the rate of change in the melatonin level),
where the parameter is (a) sensed via a sensor (e.g., using a chemical sensor
to sense melatonin) and (b) indicative of an activity of the patient (e.g.,
attempting to fall asleep). (FF4—FF6.) Heruth teaches comparing the rate of
6
Appeal 2016-005071
Application 13/154,303
change of the value (e.g., rate of change in melatonin level) to a threshold.
(FF4, FF5.) Heruth teaches that the medical device used to collect
information relating to the sensed patient parameter may also deliver therapy
to the patient. (FF7.) Heruth teaches controlling (i.e., adjusting or
prescribing) delivery of therapy based on the comparison. (FF8.) Finally,
Heruth teaches using a processor to perform determining rate of change
and/or comparing such rate with a threshold (FF4, FF6), which meets the
limitation of claim 1 that one or more processors perform at least one of the
determining rate of change, the comparing such rate with a threshold, and
the controlling delivery of therapy steps recited. Accordingly, we agree with
the Examiner that Heruth anticipates claim 1.
Appellants argue that Heruth does not describe controlling delivery of
therapy to a patient via a medical device based on a comparison between the
rate of change of melatonin and a threshold.3 Instead, Appellants argue that
3 Appellants no longer appear to argue that “attempting to fall asleep” is not
a “patient activity.” (Appeal Br. 6 (“assuming, arguendo, that the monitored
physiological parameters referenced by Heruth . . . include a patient
parameter that is indicative of at least one of patient posture or patient
activity”); Reply Br. 4 (stating that, “[cjontrary to the Examiner’s
characterization of Appellant’s position, Appellant’s position does not rely
on the assertion that melatonin level or rate of change of melatonin level
does not constitute a patient parameter sensed via a sensor that is indicative
of at least one of patient posture or patient activity”).) To the extent
Appellants continue to advance this argument, however, we are not
persuaded. The Specification describes sleeping, for instance, as a patient
activity or posture. (Spec. 142 (discussing “patient undertaking an activity
or posture, such as running, golfing, taking medication, sleeping, sitting,
bending over, transitioning from sitting to standing, or some particular
activity or posture related to an occupation of patient”).) We find attempting
to do something is an action and thus attempting to fall asleep is a patient
activity.
7
Appeal 2016-005071
Application 13/154,303
Heruth only teaches using such comparison to determine whether a patient is
(a) falling asleep, (b) awake, or (c) attempting to fall asleep. (Appeal Br. 6—
7.) Appellants argue that Heruth at most describes a clinician making an
adjustment to delivered therapy “based on sleep quality information
presented by a programming device to the clinician rather than the
identification of when a patient is attempting to fall asleep as determined
based [on] a comparison of the rate of change of melatonin level of a patient
to a threshold rate of change.” (Reply Br. 5.) Finally, Appellants argue that
Heruth’s description of allowing the patient to control therapy delivered by
the medical device by, e.g., selecting or adjusting a particular
preprogrammed therapy parameter set does not suggest either that such
preprogrammed therapy sets are configured to control delivery of therapy
based on the comparison of melatonin rate of change to a threshold, or that
the patient’s selection or adjustment of a preprogrammed therapy parameter
set is based on such comparison. (Reply Br. 5.)
We are not persuaded. As Appellants acknowledge, Heruth teaches
that a clinician, rather than the patient, may adjust or prescribe therapy
delivered by the medical device based on sleep quality information. (Id.)
Furthermore, as to those activities performed by a clinician, Heruth teaches
that sleep quality information is derived in part from information relating to
when a patient is attempting to fall asleep. (FF2.) For instance, sleep
quality information includes sleep efficiency, which relates to the percentage
of time while a patient is attempting to sleep that the patient is actually
asleep, and sleep latency, which is the amount of time between when a
patient attempts to fall asleep and when he or she falls asleep. (Id.) Heruth
also teaches, however, that “the time that [a] patient... is attempting to fall
8
Appeal 2016-005071
Application 13/154,303
asleep” may be identified by comparing “the . . . rate of change in the
melatonin level to a threshold level.” (FF5.) Thus, both the sleep quality
metrics of sleep efficiency and sleep latency, which depend on determining
when a patient is attempting to fall asleep, ultimately depend on the
comparison of the rate of change of melatonin level of a patient to a
threshold rate of change.
For the reasons set forth above, we affirm the Examiner’s rejection of
claim 1 as anticipated by Heruth. Claims 4 and 9, which are not separately
argued, fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv). Likewise, Appellants
rely on the same arguments for claims 10 and 20 that they made for claim 1.
(Appeal Br. 9.) We therefore affirm the Examiner’s rejection of claims 10
and 20 as anticipated by Heruth for the same reasons. Claims 13, 18, and
19, which are not separately argued, fall with claim 10. 37 C.F.R.
§ 41.37(c)(l)(iv). Finally, Appellants did not include claims 7 and 16 in any
of the claim groups. Because Appellants thus did not separately argue
claims 7 and 16, claims 7 and 16 also fall with claims 1 and 10.
Claims 2 and 11
Claims 2 and 11 depend from claims 1 and 10 respectively and further
recite that “delivering therapy to the patient. . . comprises delivering therapy
to the patient according to default therapy information based on the
comparison.” (Appeal Br. 19,21 (Claims App.).)
We find that claims 2 and 11 are anticipated by Heruth. In particular,
Heruth teaches that the medical device of its invention may provide sleep
quality information to a clinician, which allows the clinician to evaluate and
adjust the therapy delivered by the medical device. (FF8.) Therefore, when
9
Appeal 2016-005071
Application 13/154,303
an evaluation is made and no adjustment is performed, therapy to the patient
is delivered according to the “default” therapy information.
Appellants contend that Heruth does not describe delivering therapy
to the patient according to default therapy information based on the
comparison of melatonin rate of change to threshold level, but only teaches
identifying the time when a patient is attempting to fall asleep based on such
a comparison. (Reply Br. 7—8.) We are not persuaded. As discussed above
with respect to claim 1, Heruth teaches that information regarding when a
patient is attempting to fall asleep is used to determine sleep quality metrics
such as sleep efficiency and sleep latency, which in turn is used to evaluate
and adjust existing therapy delivery. (FF2, FF4, FF5, FF7, FF8.)
Accordingly, Heruth teaches delivering therapy based on comparison of the
melatonin level rate of change to a threshold. Delivering default therapy
information simply means continuing to deliver existing therapy without
adjustment (e.g., when such adjustment is not warranted based on the sleep
quality metric).
Claims 3 and 12
Claims 3 and 12 depend from claim 1 and 10 and further recite that
“delivering therapy to the patient. . . comprises suspending the delivery of
therapy to the patient for a predetermined period based on the comparison.”
(Appeal Br. 19, 21 (Claims App.).) We agree with the Examiner that claims
3 and 12 are anticipated by Heruth. In particular, Heruth teaches that a
clinician may use sleep quality metric values associated with particular
therapy parameter sets to “identify effective or ineffective therapy parameter
sets.” (FF8.) Heruth also teaches that a clinician may use the sleep quality
information provided by its medical device to adjust the therapy delivered by
10
Appeal 2016-005071
Application 13/154,303
the medical device. (Id.) We find that a skilled artisan reading such
disclosures would immediately understand that adjusting the therapy
delivered by the medical device encompasses suspending delivery of therapy
for a period of time when, e.g., a clinician identifies a particular therapy
parameter set as ineffective. Cf. Wm. Wrigley Jr. Co. v. Cadbury Adams
USA LLC, 683 F.3d 1356 (Fed. Cir. 2012) (affirming anticipation rejection
where the number of categories and components in the prior art was not so
large that the claimed combination would not be immediately apparent to a
skilled artisan).
Appellants argue that “prescribing the delivery of therapy not
delivered by a medical device” does not constitute “suspending delivery of a
therapy to a patient for a predetermined period.” (Reply Br. 10.) However,
as noted above, Heruth teaches not only prescribing a therapy not delivered
by the medical device, but also adjusting the therapy delivered by the
medical device, which would include suspending the therapy. (FF8.)
Appellants further argue that any prescription or adjustment of therapy
performed by the clinician in Heruth is “based on sleep quality information
presented by a programming device to the clinician rather than the
identification of when a patient is attempting to fall asleep as determined
based on a comparison of the rate of change of melatonin level of a patient
to a threshold rate of change.” (Reply Br. 11.) We are not persuaded for the
reason already discussed in connection with claim 1: Heruth teaches that the
sleep quality information presented to the clinician, such as sleep efficiency
and sleep latency, is based on information relating to when patient attempts
to fall asleep and thus on the comparison of the rate of change of melatonin
level to a threshold. (FF2, FF4, FF5, FF8.)
11
Appeal 2016-005071
Application 13/154,303
Claims 5 and 14
Claims 5 and 14 depend from claims 1 and 10 respectively and further
recite that “the sensor comprises an accelerometer.” (Appeal Br. 19, 21
(Claims App.).) The Examiner finds that Heruth discloses a sensor
comprising an accelerometer. (Ans. 4, 6.) Appellants argue that, “to the
extent that Heruth describes that sensor 40 may be an accelerometer, Heruth
fails to describe the use of such an accelerometer to measure the level of
melatonin in a patient or rate of change thereof.” (Appeal Br. 14; Reply Br.
12.)
We find the Appellants to have the better argument. Claim 5 depends
from claim 1, as discussed above. The Examiner relies on Heruth’s
disclosure of determining the rate of change of melatonin level as indicative
of a patient attempting to sleep to meet the limitations of claim 1. The
Examiner has not pointed to any disclosure in Heruth, however, that such
rate of change of melatonin level is sensed via an accelerometer.
To the extent the Examiner is combining Heruth’s disclosure of an
embodiment wherein the rate of change of melatonin level is determined and
compared to a threshold to determine whether a patient is attempting to fall
sleep, and the disclosure of a different embodiment in Heruth wherein an
accelerometer is used to sense activity level or posture of the patient to
determine whether a patient is attempting to fall asleep, such “picking and
choosing” is not permissible in an anticipation rejection. In reArkley, 455
F.2d 586, 587 (CCPA 1972) (holding that for an anticipation rejection to be
proper, the reference must “clearly and unequivocally . . . direct those skilled
in the art to the compound without any need for picking, choosing, and
combining various disclosures not directly related to each other by the
12
Appeal 2016-005071
Application 13/154,303
teachings of the cited reference,” even though “[s]uch picking and choosing
may be entirely proper in the making of a 103, obviousness rejection”).
Accordingly, we reverse the Examiner’s rejection of claim 5 as
anticipated by Heruth. For the same reasons, we also reverse the Examiner’s
rejection of claim 14, which depends from claim 10 but contains the same
limitation that the sensor comprises an accelerometer.
Claims 6 and 15
Claims 6 and 15 depend from claims 1 and 10 respectively and further
recite that “the patient parameter is indicative of patient posture.” (Appeal
Br. 20, 22 (Claims App.).) The Examiner finds that Heruth discloses
embodiments where the patient parameter is indicative of patient posture.
(Ans. 4, 6—7.) Appellants contend that Heruth fails to disclose the method of
claim 1 or the system of claim 10 wherein the patient parameter is indicative
of patient posture, because “the level of melatonin in a patient does not
constitute a patient parameter indicative of patient posture.” (Appeal Br.
15—16; Reply Br. 13.)
We find Appellants to have the better argument for similar reasons
discussed with respect to claim 5. While we agree with the Examiner that
Heruth discloses embodiments wherein the sensor senses a patient parameter
indicative of patient posture (e.g., whether the patient is recumbent), the
Examiner has not shown that these embodiments disclose determining a rate
of change of a value of such a parameter, as required by claim 1 from which
claim 6 depends. Rather, the Examiner relies on Heruth’s disclosure of
determining the rate of change of melatonin level to meet the limitations of
claim 1 without pointing to a teaching in Heruth, or an otherwise well-
known fact, that melatonin level is indicative of a patient’s posture. To the
13
Appeal 2016-005071
Application 13/154,303
extent the Examiner is relying on combining the disclosures of disparate
embodiments to meet all of the limitations of claims 6 and 15, such “picking
and choosing” is inappropriate in the context of anticipation. Arkley, 455
F.2d at 587.
Claims 8 and 17
Claims 8 and 17 depend from claims 1 and 10 respectively and further
recite that “the therapy comprises electrical simulation therapy, and wherein
the therapy is defined by at least one stimulation parameter.” (Appeal Br.
20, 22 (Claims App.).) We agree with the Examiner that claims 8 and 17 are
anticipated by Heruth. As discussed above, Heruth anticipates claims 1 and
10, including the limitation regarding controlling the delivery of therapy to a
patient based on the comparison between the rate of change of a value of a
sensed patient parameter and a threshold. Moreover, Heruth discloses that
the medical device of its invention may “take[] the form of an implantable
neurostimulator that delivers neurostimulation therapy in the form of
electrical pulses to [a] patient” and that a therapy parameter set for a
neurostimulator would include, e.g., pulse amplitude and pulse rate. (FF9.)
Heruth thus discloses each limitation of claims 8 and 17.
Appellants first argue that claims 8 and 17 are patentable over Heruth
for the same reasons discussed with respect to claim 1. (Appeal Br. 17;
Reply Br. 14—15.) We are not persuaded for the reasons already discussed.
Appellants further argue that Heruth fails to disclose “the system of claim 10
[sic], wherein the therapy comprises electrical stimulation therapy, and
wherein the therapy is defined by at least one stimulation parameter, as
recited by claim 8.” (Appeal Br. 17.) We are not persuaded: Appellants do
14
Appeal 2016-005071
Application 13/154,303
not explain why it is that the disclosure discussed above does not meet the
dependent claim limitation of claims 8 and 17.
SUMMARY
For the reasons above, we affirm the Examiner’s rejection of claims
1—4, 7—13, and 16—20 as anticipated by Heruth. We reverse the Examiner’s
rejection of claims 5, 6, 14, and 15 as anticipated by Heruth.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED-IN-PART
15