Ex Parte BOLEA

Patent Trial and Appeal Board

Feb 27, 2019

14620131 (P.T.A.B. Feb. 27, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/620,131 02/11/2015 Stephen L. BOLEA
138270 7590 03/01/2019
FOLEY & LARDNER LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
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.
104292-1657 2591
EXAMINER
SO, ELIZABETH K
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
03/01/2019 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte STEPHEN L. BOLEA
Appeal2018-005985
Application 14/620,131 1
Technology Center 3700
Before ANTON W. PETTING, MICHAEL C. ASTORINO, and
BRADLEY B. BAY AT, Administrative Patent Judges.
ASTORINO, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), the Appellant appeals from the
Examiner's decision rejecting claims 1-8. We have jurisdiction over the
appeal under 35 U.S.C. § 6(b ).
We AFFIRM-IN-PART.
1 According to the Appellant, "[t]he real party of interest in this appeal is
Cyberonics, Inc., the assignee of this application." Appeal Br. 2.
Appeal2018-005985
Application 14/620, 131
STATEMENT OF THE CASE
Subject Matter on Appeal
The field of the present invention relates to a method for treating
sleeping disorders, specifically, obstructive sleep apnea. Spec. ,r 2.
Claim 1, the sole independent claim, is representative of the subject
matter on appeal and is reproduced below.
1. A method of providing a sleep apnea nerve stimulation
therapy to a subject, the method comprising:
detecting a respiratory waveform of the subject with a
sensor configured for coupling to the subject, the respiratory
waveform including a plurality of respiratory cycles each
corresponding to at least one of a breath or an attempted breath
of the subject;
identifying a breathing pattern within the respiratory
waveform over a period of time, the breathing pattern comprising
a repeating pattern of a plurality of respiratory cycles followed
by at least one respiratory cycle corresponding to a disordered
breathing event; and
generating a series of stimulation pulses based on the
breathing pattern with an implantable nerve stimulator
configured for coupling to a hypoglossal nerve of the subject, the
series of stimulation pulses coordinated with the breathing
pattern.
Rejections
Claims 1 and 3-8 are rejected under 35 U.S.C. § I02(a)(l)/102(a)(2)
as being anticipated by Tehrani et al. (US 7,979,128 B2, iss. July 12, 2011)
(hereinafter "Tehrani").
Claim 2 is rejected under 35 U.S.C. § 103 as being unpatentable over
Tehrani and Syroid et al. (US 2014/0243629 Al, pub. Aug. 28, 2014)
(hereinafter "Syroid").
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Appeal2018-005985
Application 14/620, 131
ANALYSIS
Independent Claim 1 and Dependent Claims 3-5
The Appellant argues that the Examiner's rejection of claim 1 as
being anticipated by Tehrani is in error. See Appeal Br. 8-11; Reply Br. 3-
4. More specifically, the Appellant argues that the Examiner's reliance of
particular cited portions of Tehrani only generally discloses "detect[ing] the
drop in tidal volume ... below a threshold level" and identifying "various
parts of two sequential integrated waveforms," i.e., "portions of respiratory
cycles," but not "identifying a breathing pattern ... comprising a repeating
pattern of a plurality of respiratory cycles followed by at least one
respiratory cycle corresponding to a disordered breathing event," as
required by claim 1. Appeal Br. 9-10 (citing Tehrani, 8:59-9:10, 14:12-17);
Reply Br. 3 (Tehrani, claim 1). The Appellant's argument is not persuasive
of Examiner error.
Figure 15A of the present application depicts a breathing pattern
within a respiratory waveform including a plurality of respiratory cycles
each corresponding to a number of breaths or attempted breaths of a patient.
See Spec. ,r,r 14, 41, 122. Figure 15A is reproduced below:
!,"!-.<~: \,:.;:,j
.--~; _________ . ..l ..... _,
(
t
FIG. 15A
3
\.i \
Appeal2018-005985
Application 14/620, 131
Figure 15A depicts respiratory waveforms 5501 and 5511, which "show a
breathing pattern that is initially ordered and then degrades to a disordered
breathing pattern as time (t) progresses." Id. ,r 122. Also, the Specification
describes: "[t]he characterizing of the normal breathing pattern for the
patient may involve evaluating a baseline level of effort or work required for
the patient to achieve a necessary level of respiration, which can be
measured as an air volume"; and "[ f]urther evaluation may be performed to
identify a threshold value or level ... at which the breathing can be
characterized as labored or deficient, or at which the breathing can be
considered insufficient to maintain adequate blood oxygen levels." Id. ,r 126
( emphasis added); id. ,r 124 ( explaining that a significant value for
respiratory effort, such as an impedance peak value M or airflow peak
value P, may surpass a threshold 5502 or 5512 to determine disordered
breathing).
Similar to Figure 15A of the present application, Tehrani's Figure 4A
"illustrates a breathing pattern where a decrease in tidal volume ultimately
ends in an obstructive sleep apnea event." Tehrani 13:62---64. Tehrani's
Figure 4A is reproduced below:
"
Figure 4A shows a patient's breathing pattern where the tidal volume of
breaths 411--415 crosses threshold 450 and gradually decreases until the
patient's airway narrows ultimately leading to an airway obstruction, i.e., an
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Appeal2018-005985
Application 14/620, 131
obstructive respiratory event. Id. at 13:64--14:10; see Final Act. 4 (citing
Tehrani 4:54--5:29, 8:59-9: 10, 13: 18-14:39).
The Examiner finds "Tehrani discusses using physiological
information that includes a movement pattern and a respiratory activity
pattern, therefore showing detecting a breathing pattern from the
physiological information" and "tracking the breathing cycle, which is a
breathing pattern and not detection of a single breath." Final Act. 2-3. In
support of this finding, we note that Tehrani describes:
FIGS. 16A-16D illustrate monitoring or detection of various
aspects or parameters of respiration on a breath by breath basis.
Tidal volume is monitored and a decrease in tidal volume
characteristic (FIG. 4A) or an erratic breathing pattern (FIG. 4B)
in an obstructive sleep apnea patient is detected. (Monitored
tidal volume as used herein may also include a monitored tidal
volume correlated signal).
Tehrani 13:30-37.
In view of the foregoing, we determine that the Appellant fails to
persuasively explain using evidence or technical reasoning why one of
ordinary skill in the art, upon reading the Specification, would fail to
understand Tehrani as disclosing a step of "identifying a breathing pattern
... comprising a repeating pattern of a plurality of respiratory cycles
followed by at least one respiratory cycle corresponding to a disordered
breathing event," as required by claim 1. See Final Act. 2--4; Ans. 6.
The Appellant also argues that the Examiner's rejection of claim 1 is
in error because the cited portions of Tehrani fail to disclose "generating a
series of stimulation pulses based on the breathing pattern with an
implantable nerve stimulator configured for coupling to a hypoglossal nerve
of the subject, the series of stimulation pulses coordinated with the breathing
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Appeal2018-005985
Application 14/620, 131
pattern," as required by claim 1. Reply Br. 4---6; see Appeal Br. 10-12. The
Appellant's argument is not persuasive of Examiner error.
To the extent that the Appellant's argument refers back to the
arguments provided for the "identifying a breathing pattern" step of claim 1,
those arguments are not persuasive for the reasons discussed above.
As for the remainder of the Appellant's argument, we note that the
Examiner cites to a number of portions of Tehrani' s disclosure to teach the
"generating a series of stimulation pulses" step of claim 1. Final Act. 4
(citing Tehrani 4:50-56; 5:30-59; 6:4--25; 12: 23--43; 13:18-14:39); Ad.
Act. 2 (citing Tehrani 5:39--44; 6:22-25); Ans. 6 (citing Tehrani 5:18-30,
39--44, 54---6:3, 7:52---61 ). The Appellant argues individual portions of some,
but not all, of the cited portions of Tehrani. See Appeal Br. 10-12; Reply
Br. 4---6. One notable exception is to Tehrani's disclosure at column 13, line
18 through column 14, line 39. In this cited portion, Tehrani discloses
Figures 4A-D of which Figures 4C-D "are schematic illustrations
respectively of respiration response and stimulation waveforms illustrating a
stimulation method using a stimulation device according to the invention in
which the obstructive sleep apnea event illustrated in FIG. 4A is treated with
deep inspiration stimulation." Tehrani 3:12-17. And, Figure 4D shows
pacing pulse 434, which stimulates deep inspiration breath 424, during
breath 414, i.e., the breath after a stimulator detects a drop in tidal volume
(breath 413) below a threshold; similar pacing pulse(s) 439 may be provided
as needed. See id. at 13:18-14:39; see also id. at 5:39--44 ("Electrodes may
be placed at or near the hypoglossal nerve in accordance with a variation of
the invention where stimulation of the diaphragm is coordinated with
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Appeal2018-005985
Application 14/620, 131
activation of upper airway muscles to open the airway passage just prior to
stimulating the diaphragm muscles.").
In view of the foregoing, we determine that the Appellant fails to
persuasively explain using evidence or technical reasoning why one of
ordinary skill in the art would fail to understand Tehrani as disclosing
"generating a series of stimulation pules" step of claim 1.
Thus, we sustain the Examiner's rejection of independent claim 1, as
well as claims 3-5, which are not argued separately by Appellant.
Dependent Claim 6
Claim 6 depends from claim 1 and recites, "wherein the breathing
pattern is determined from a detection of at least one of a signal peak, a
signal minimum, an expiration detection, and an inspiration detection."
Appeal Br., Claims App.
The Examiner finds that Tehrani's disclosure of tracking a breathing
cycle and comparing tidal volume to a threshold value corresponds to a
detection of signal peak or signal minimum. See Ans. 6, 7-8 ( citing Tehrani
13:41---61); Final Act. 5 (citing Tehrani 13:41-14:39). The Examiner does
not find that Tehrani discloses an expiration detection or an inspiration
detection. The Examiner explains:
By definition a threshold shows a m1mmum or peak value,
wherein Tehrani shows that the threshold used is to ensure a
minimum is met for analyzing the respiration data when
determining the breathing pattern for application of the proper
stimulation treatment ( col. 13, lines 41---61 ), showing that the
detected waveform of Claim 1 is identified as a breathing pattern
based on detection of these signal peak or signal minimum based
on a comparison with the set threshold.
Ans. 7-8.
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Application 14/620, 131
The Appellant argues:
Even if the Examiner is correct that "Tehrani shows that the
threshold used is to ensure a minimum is met for analyzing the
respiration data," an assertion with which Appellant does not
necessarily agree, this does not show that "the breathing pattern
is determined from detection of at least one of a signal peak [or]
a signal minimum" because ensuring a minimum using a
threshold is not the same as a "signal minimum."
Reply Br. 7 (alteration and emphasis in original); see Appeal Br. 12-13.
The Appellant's argument is not persuasive. The Appellant addresses error
with respect to the Examiner's finding that Tehrani discloses determining a
breathing pattern from a detection of signal minimum, but fails to
sufficiently explain error in the Examiner's finding that Tehrani discloses
determining a breathing pattern from a detection of signal peak. Moreover,
we agree with the Examiner's finding that tracking a breathing cycle and
comparing tidal volume to a threshold value corresponds to a detection of
signal peak.
Thus, we sustain the Examiner's rejection of claim 6 as anticipated by
Tehrani.
Dependent Claim 7
Claim 7 depends from claim 1 and recites, "wherein the breathing
pattern includes a trend defined by at least one of the plurality of respiratory
cycles." Appeal Br., Claims App.
The Examiner finds "Tehrani shows determining a baseline variance
in the respiration waveform over time (col. 13, lines 53-61), thereby
showing at least determining a trend as defined by the detected plurality of
respiratory cycles." Ans. 8; see Final Act. 5 (citing Tehrani 13:41-14:39).
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Application 14/620, 131
The Appellant acknowledges that Tehrani describes "[o]ther
parameters may be used to identify when tidal volume has dropped below a
predetermined threshold, for example baseline tidal volume rate variance
over a period of time may be monitored and compared to a normal
variance." Reply Br. 8 (citing Tehrani 13:56-59). The Appellant argues
that Tehrani fails to disclose a trend defined by a plurality of respiratory
cycles because "the Examiner provides no explanation as to how baseline
tidal volume rate variance is analogous to 'a trend defined by ... the
plurality of respiratory cycles,' as recited in part in claim 7." Id. The
Appellant's argument is not persuasive of Examiner error.
The Appellant's argument does not explain how tidal volume rate
variance is not a trend or, more specifically, is not a trend defined by a
plurality of respiratory cycles. See also Spec. ,r,r 16, 18, 123 ( describing a
respiratory trend as being based on a comparison of the plurality of peak
magnitudes over the time period). The Appellant's argument does little
more than reiterate and disagree with the Examiner's finding without adding
explanation or technical reasoning explaining the error. See also In re Jung,
637 F.3d 1356, 1365 (Fed. Cir. 2011) ("It has long been the Board's practice
to require an applicant to identify the alleged error in the examiner's
rejections."). Hence, we determine that the Appellant fails to persuasively
explain using evidence or technical reasoning why one of ordinary skill in
the art would fail to understand Tehrani as disclosing "wherein the breathing
pattern includes a trend defined by at least one of the plurality of respiratory
cycles," as recited in claim 7.
Thus, we sustain the Examiner's rejection of claim 7 as anticipated by
Tehrani.
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Appeal2018-005985
Application 14/620, 131
Dependent Claim 8
Claim 8 depends from claim 1 and recites "comparing portions of the
breathing pattern within the respiratory waveform to support an
identification of the disordered breathing event." Appeal Br., Claims App.
( emphasis added).
The Examiner finds that Tehrani discloses "comparing ... portions of
the breathing pattern against thresholds to identify a disordered breathing
event." Ans. 8 (citing Tehrani 13:30-51 (claim 1)); Final Act. 5 (citing
Tehrani 13:41-14:39).
The Appellant argues that Tehrani's use of comparing a portion of a
respiratory waveform against a threshold does not correspond to the further
limitation of claim 8. See Appeal Br. 15; Reply Br. 9. The Appellant's
argument is persuasive.
We determine that the broadest reasonable interpretation of the
limitation of claim 8 - when read by one of ordinary skill in the art in light
of the Specification - requires something distinct from comparing different
portions a waveform to a threshold. Rather, we construe claim 8 to require a
comparison of one portion of a waveform with another portion of the
waveform. See, e.g., Spec. ,r 13 2 ( comparing the time period of two
inspiration periods, where one is longer than the other, may indicate that a
patient is entering a period of disordered breathing).
Thus, we do not sustain the Examiner's rejection of claim 8 as
anticipated by Tehrani.
Dependent Claim 2
The Appellant does not present any arguments for the separate
patentability of dependent claim 2 apart from asserting that Syroid does not
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Application 14/620, 131
cure the alleged deficiencies of Tehrani with respect to claim 1. Appeal
Br. 16. For the reasons discussed above, we are not persuaded that the
Examiner's rejection of claim 1 as being anticipated by Tehrani includes the
alleged deficiencies. Thus, we sustain the Examiner's rejection of claim 2 as
unpatentable over Tehrani and Syroid.
DECISION
We AFFIRM the Examiner's decision rejecting claims 1-7.
We REVERSE the Examiner's decision rejecting claim 8.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED-IN-PART
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