Ex Parte Libbus et al

Patent Trial and Appeal Board

Jan 13, 2017

13867778 (P.T.A.B. Jan. 13, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/867,778 04/22/2013 Imad Libbus 279.I49US3 9192
45458 7590 01/18/2017
smwfPtMan t t tndrf.ro & wofnnnfr/rnf EXAMINER
PO BOX 2938 PATEL, NATASHA
MINNEAPOLIS, MN 55402
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
01/18/2017 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte IMAD LIBBUS, QUAN NI, and KENT LEE
Appeal 2015-002740
Application 13/867,778
Technology Center 3700
Before EDWARD A. BROWN, BRANDON J. WARNER, and
ARTHUR M. PESLAK, Administrative Patent Judges.
PESLAK, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Imad Libbus et al. (“Appellants”) appeal under 35 U.S.C. § 134(a)
from the Examiner’s decision rejecting claims 2—21.1 We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART and enter a NEW GROUND OF
REJECTION pursuant to our authority under 37 C.F.R. § 41.50(b).
1 Appellants submit the real party in interest is Cardiac Pacemakers, Inc.
Appeal Br. 2.
Appeal 2015-002740
Application 13/867,778
THE CLAIMED SUBJECT MATTER
Claims 2, 12, and 21 are the independent claims on appeal. Claim 2,
reproduced below, is illustrative of the claimed subject matter.
2. A method for using an implantable system implanted
within a congestive heart failure patient, comprising:
monitoring pulmonary congestion, wherein monitoring
pulmonary congestion includes sensing a physiologic parameter
using a sensor implanted within the patient; and
delivering a congestive heart failure therapy using a
stimulator implanted within the patient, wherein delivering the
congestive heart failure therapy includes delivering electrical
stimulation to the patient using the sensed parameter to control
the congestive heart failure therapy, the congestive heart failure
therapy including a neural stimulation therapy.
REJECTIONS
1) Claims 2, 4—7, 9—12, 14—16, and 19—21 are rejected under 35
U.S.C. § 103(a) as unpatentable over Pitts Crick (US 6,104,949,
issued Aug. 15, 2000) and Terry (US 2003/0040774 Al, published
Feb. 27, 2003).
2) Claims 3, 8, 13, and 17—18 are rejected under 35 U.S.C. § 103(a)
as unpatentable over Pitts Crick, Terry, and Park (US
2003/0153953 Al, published Aug. 14, 2003).
DISCUSSION
Rejection 1
Independent claim 2
The Examiner finds that Pitts Crick discloses all the limitations of
claim 2, except it “discloses myocardial stimulation . . . but no
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neurostimulation.” Final Act. 3. The Examiner finds that Terry “discloses a
similar CHF [“Congestive Heart Failure”] treatment that delivers a
neurostimulation therapy towards increasing baroreflex sensitivity.” Id.
(citing Terry, claim 36). The Examiner concludes it would have been
obvious “to apply baroreceptor therapy [in Pitts Crick] since Terry teaches
that doing so helps provides the heart with adequate parasympathetic
support.” Id. (citing Terry 111).
Appellants contend that Pitts Crick discloses sensing the “degree of
CHF,” which is “a longer term disease state, and does not quickly change
like a heart rate change in response to vagal nerve stimulation [as in Terry]”.
Appeal Br. 12. Appellants next contend the Examiner fails to show “the
control of a congestive heart failure therapy, including a neural stimulation
therapy (the ‘baroreceptor therapy’), using the sensed parameter from the
implanted sensor that is used in the monitoring of pulmonary congestion.”
Id. at 14. Appellants next contend that Terry teaches away from the claimed
subject matter. Id. In support of this contention, Appellants assert that
Terry “rel[ies] on heart rate, as a quick response to vagal stimulation above
the cardiac branch, to control the neural stimulation, in contrast to a slow
and indirect response when the vagus nerve is stimulated below the superior
cardiac branch.” Id. Appellants next contend that “simple substitution”
does not support the Examiner’s conclusion of obviousness. Id. In support
of this contention, Appellants assert that “[o]ne cannot simply substitute the
sensed degree of CHF [Pitts Crick] in place of heart rate [Terry], For
example, vagal stimulation controlled using heart rate is not the same as a
CHF therapy controlled using the sensed degree of CHF,” such a
substitution “would improperly change the intended purpose of Terry,” and
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would “improperly change the principle of operation of Terry.” Id. at 15.
Finally, Appellants contend that the combination of Pitts Crick and Terry is
improperly based on hindsight because the rejection is not based on facts
gleaned from the prior art. Id. at 16. In support of this contention,
Appellants assert that the Examiner’s reasoning “is silent as to how vagal
nerve stimulation is part of congestive heart failure therapy, and how the
combination controls the congestive heart failure therapy, including the
vagal nerve stimulation therapy, using the sensed parameter from the
implanted sensor that is used in the monitoring of pulmonary congestion.”
Id.
The Examiner responds that Pitts Crick and Terry each disclose
treatment of CHF. Ans. 5 (citing Pitts Crick, col. 1,11. 49—57, Terry 146).
The Examiner also notes that it is well known in the art to combine a
pacemaker with a nerve stimulator to treat heart conditions. Id. The
Examiner reiterates that Terry is relied on for disclosing the use of neural
stimulation to treat CHF, and that CHF is the specific heart condition
disclosed in Pitts Crick. Id.
Pitts Crick discloses a device and method for “the diagnosis and
treatment of congestive heart failure.” Pitts Crick, col. 1.11. 49—50. Pitts
Crick uses the physiology of pulmonary edema “to indicate congestive heart
failure.” Id. col. 2,11. 36—37. Pitts Crick discloses sensing trans-thoracic
impedance “which is dependent on the blood or fluid content of the lungs, to
assist in the detection and quantification of pulmonary edema and thus
congestive heart failure.” Id. col. 2,11. 38-41. Pitts Crick also senses the
patient’s posture which can affect trans-thoracic impedance. Id. col. 2,1. 44,
col. 3,11. 9—11. Pitts Crick’s device may be implemented in various known
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“implantable devices.” Id. col. 3,11. 17—20. Pitts Crick discloses treatment
of a CHF patient by “electrical stimulation of the heart.” Id. col. 6,11. 28—
30.
Terry discloses a “device for treating patients suffering from
congestive heart failure [that] includes an implantable neurostimulator.”
Terry, Abstract. Terry also discloses a method for treating CHF patients that
includes vagus nerve stimulation. Id. 112. Terry also discloses that, as a
result of its therapy, a patient “is expected to improve gradually over a
period of several weeks or longer as a result of increase in the capillaries and
the coronary blood flow.” Id. 1 37.
Appellants’ first contention that Pitts Crick’s CHF therapy is different
than Terry’s CHF therapy because it measures “degree of CHF” is not
persuasive for the following reasons. Appellants do not direct us to any
portion of Pitts Crick, or to any other evidence, to support the assertion that
“degree of CHF” is a longer term disease state. In addition, Terry also
discloses that its therapy results in gradual improvement to the patient over a
period of several weeks indicating that its disclosed therapy is not merely
short term. Terry, 137.
Appellants’ next contention, i.e., the rejection fails to show the recited
control of a congestive heart failure therapy, appears to be based on an
argument that neither Pitts Crick nor Terry, individually, discloses this
limitation. Pitts Crick discloses sensing trans-thoracic impedance in a CHF
patient which is a measure of pulmonary edema or congestion with an
implanted device. Terry discloses stimulating the vagus nerve to treat CHF.
The rejection is based on the combined teachings of Pitts Crick and Terry.
We are not persuaded by this contention because one cannot show non-
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obviousness by attacking the references individually when the rejection is
based on the combined teachings of the references. In re Keller, 642 F.2d
413, 426 (CCPA 1981). Appellants’ contentions do not persuade us that the
combination of Pitts Crick and Terry fails to disclose the recited control of a
congestive heart failure therapy.
We are also not persuaded by Appellants’ contention that Terry
teaches away from the claimed invention for the following reasons. A prior
art reference does not teach away from the claimed subject matter unless the
prior art reference criticizes, discredits, or otherwise discourages the solution
claimed. See Crocs, Inc. v. U.S. Int’l Trade Comm ’n, 598 F.3d 1294, 1308
(Fed. Cir. 2010) (Prior art taught away by specifically discouraging use of
foam straps.); In re Fulton, 391 F. 3d 1195, 1201 (Fed. Cir. 2004). In this
case, Appellants contend that Terry teaches away from the claimed subject
matter because it discloses vagal stimulation above the cardiac branch as
opposed to below the cardiac branch. Appeal Br. 14. We note, however,
that claim 2 recites “neural stimulation” without any limitation to a
particular location of vagal nerve stimulation relative to the cardiac branch.
Appellants, thus, do not provide persuasive argument or evidence why
Terry’s vagal nerve stimulation above the cardiac branch criticizes,
discredits or otherwise discourages the recited “neural stimulation” therapy.
Appellants’ next contention, that substituting the sensed degree of
CHF from Pitts Crick for the sensed heart rate of Terry is improper because
it would change the intended purpose and/or principle of operation of Terry,
is not persuasive for the following reasons. The rejection is based on
substituting Terry’s neural stimulation therapy for the direct stimulation of
the heart in Pitts Crick. Ans. 5; Final Act. 3. The Examiner, thus, has not
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proposed modifying Terry’s method or device in any way, let alone in a
manner that would change its intended purpose or principle of operation of
Terry.
Appellants’ contention that the rejection is improperly based on
hindsight is also not persuasive. Pitts Crick discloses using an implanted
sensor to sense trans-thoracic impedance to determine pulmonary congestion
and to use the sensed condition to treat a patient suffering from congestive
heart failure. Terry discloses that vagal nerve stimulation is used in CHF
therapy. Thus, all elements of claim 2 are disclosed in the proposed
combination of Pitts Crick and Terry. Appellants do not dispute the
Examiner’s rationale for the combination as quoted above. Appeal Br. 17.
Appellants thus fail to apprise us of error in the Examiner’s rationale for the
combination, which we determine to be reasonable and supported by the
disclosure in the cited references. See KSR Int’l Co. v. Teleflex Inc., 550 US
398, 416 (2007) (“the combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results”); see also In re Cree, 818 F.3d 694, 702, n.3 (Fed. Cir. 2016)
(Impermissible hindsight argument not persuasive when “the proffered
combination is merely a predictable use of prior art elements according to
their established functions.”). We sustain the rejection of claim 2.
Appellants do not argue separately for the patentability of claims 4—6, and
9—10, which depend from claim 2. Appeal Br. 11—23. We also sustain the
rejection of claims 4—6 and 9—10 for the same reasons as stated for claim 2.
Independent claim 12
Claim 12 recites “a controller configured to monitor pulmonary
congestion using the sensed physiologic parameter and use the sensed
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physiologic parameter to control the congestive heart failure therapy.”
Appeal Br. 34 (Claims App.). Appellants contend that the rejection fails to
show the recited controller. Id. at 19. Appellants also raise the same
contentions as discussed above for claim 2. Id. We note that the Examiner
did not make a specific finding concerning the controller recited in claim 12.
Final Act. 3.
Terry discloses a logic/control section 35 “for producing the output
pulse waveform according to the prescribed therapy” in order “to bring the
patient’s detected ventricular rate to a target level.” Terry 129. Pitts Crick
discloses impedance measurement circuit 42 for measuring trans-thoracic
impedance and pace pulse generator 36 for delivering “pace pulses under
influence of control circuitry or control 37, for delivery through lead 32 to
the patient’s heart.” Pitts Crick, col. 1,11. 49—51; col. 3,11. 55—64. Control
37, thus, controls impedance measurement circuit 42 and pace pulse
generator 36 for delivering therapy to the patient. Id. Fig. 2, col. 3,11. 57—
64. Control 37 also controls CHF drug therapy delivery to the patient as an
alternative to electrical stimulation therapy. Id. Fig. 6, col. 6,11. 28—30, col.
6,1. 66-col. 7,1. 3. In light these teachings in Pitts Crick and Terry, we
determine that it would have been obvious to one of ordinary skill in the art
at the time of the present invention to modify Pitts Crick’s control circuitry
to control electrical stimulation of a nerve as disclosed in Terry, rather than
the patient’s heart, in order to provide neural stimulation to treat CHF in the
manner disclosed in Terry.
As discussed above, Appellants’ contentions in connection with claim
2 are not persuasive. Thus, we sustain the rejection of claim 12 for similar
reasons. However, because the Examiner did not make a specific finding
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concerning the recited controller, we designate our affirmance for claim 12
as a new ground of rejection pursuant to 37 C.F.R. § 41.50(b) to provide
Appellants with a fair opportunity to respond. Appellants do not argue
separately for the patentability of claims 14—16 and 19 which depend from
claim 12. We also sustain the rejection of claims 14—16 and 19 for the same
reasons as for claim 12, and likewise designate our affirmance for these
claims as a new ground of rejection.
Independent claim 21
Claim 21 recites, inter alia, that “the sensor is configured to sense
ventricular filling pressure.” Appeal Br. 35 (Claims App.). The Examiner
finds that Pitts Crick discloses this limitation. Final Act. 4 (citing Pitts
Crick, col. 1,11. 10-13, col. 2,11. 30—34.). Appellants contend that Pitts
Crick does not disclose the recited sensing of ventricular filling pressure or
using sensed ventricular filling pressure to control the congestive heart
failure therapy. Appeal Br. 22—23.
Pitts Crick discloses CHF “is the inability of the heart to pump blood
at an adequate rate in response to the filling pressure.” Pitts Crick, col. 1,11.
11—12. We acknowledge this citation by the Examiner; however, the
Examiner does not direct us to any portion of Pitts Crick that discloses the
sensing of ventricular filling pressure as recited in claim 21. The
Examiner’s finding is thus not supported by sufficient evidence.
Consequently, we do not sustain the rejection of claim 21.
Dependent claim 7
Claim 7 recites the “therapy includes stimulating a phrenic nerve.”
Appeal Br. 33 (Claims App.). Appellants contend that neither Pitts Crick
nor Terry discloses therapy that includes stimulating a phrenic nerve.
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Appeal Br. 17. The Examiner does not cite to any portion of either Pitts
Crick or Terry that discloses stimulating a phrenic nerve. Final Act. 3. The
Examiner’s finding is, thus, not supported by the disclosure of either Pitts
Crick or Terry. Consequently, we do not sustain the rejection of claim 7.
Dependent claim 11
Claim 11, similarly to claim 21, recites “sensing ventricular filling
pressure.” Appeal Br. 34 (Claims App.). The Examiner relies on Pitts Crick
for disclosure of this limitation. Final Act. 4. However, as with claim 21
discussed above, the Examiner has not identified sufficient evidence that
Pitts Crick discloses sensing ventricular filling pressure. Consequently, we
do not sustain the rejection of claim 11 for the same reasons stated above in
connection with claim 21.
Rejection 2
Dependent claims 3 and 13
Claim 3, which depends ultimately form claim 2, recites “delivering at
least one disordered breathing therapy” that includes “stimulating a
hypoglossal nerve.” Appeal Br. 33 (Claims App.) (emphasis added). Claim
13, which depends ultimately from claim 12, contains a similar limitation as
claim 3. Id. at 34. The Examiner finds that “Park discloses stimulating the
hypoglossal nerve or the phrenic nerve to address breathing disorders.”
Final Act. 4. The Examiner reasons that stimulating the hypoglossal nerve is
one of a “finite number of identified, predictable solutions” for treating
disordered breathing and “it would have been obvious to stimulate
whichever nerve was necessary to address the adverse effects of CHF.” Id.
at 4—5.
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Appellants contend that Park discloses treatment of sleep apnea by
stimulating the hypoglossal nerve to hold open an airway. Appeal Br. 26—
27. Appellants do not dispute the Examiner’s finding that Park discloses
stimulating the hypoglossal or phrenic nerves. Id. Instead, Appellants
contend that treatment of CHF is not equivalent to treatment of sleep apnea
and the rejection is “silent as to how the ‘hypoglossal nerve stimulation’ for
‘sleep apnea’ would be incorporated with Pitts Crick [] and Terry.” Id. at
28. Appellants also contend that the Examiner’s rationale for the
combination of Pitts Crick, Terry, and Park is unsupported because the
Examiner did not identify the problem to be solved, took official notice of
facts, and failed to provide rational underpinnings for the combination. Id.
at 28-29.
Appellants’ Specification describes disordered breathing as a
“disruption of the normal respiratory cycle.” Spec. 1. Further, sleep apnea
is described as “a fairly common form of disordered breathing.” Id. at 2.
The Specification also describes that “[disordered breathing is particularly
prevalent among congestive heart failure patients.” Id. at 7. The
Specification describes hypoglossal nerve stimulation “to provide therapy
for disordered breathing.” Id. at 13.
Appellants’ contention that disordered breathing treatments for CHF
patients are different than the disordered breathing treatments for sleep
apnea is not supported by the Specification, or by any other evidence
identified by Appellants. Both sleep apnea and CHF patients are described
in Appellants’ Specification as suffering from disordered breathing.
Appellants do not direct us to any part of the Specification describing that
the disordered breathing treatments applied to sleep apnea patients are
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different than the disordered breathing treatments applied to CHF patients.
Appellants, thus, do not apprise us of error in the Examiner’s determination
that the breathing disorder therapy recited in claim 3 reads on Park’s
disclosure of stimulating the hypoglossal nerve to treat breathing disorders.
The “problem” the Examiner refers to in the rejection is the problem
solved by the claimed subject matter, i.e., providing at least one disordered
breathing therapy. The Examiner did not take official notice of facts as
asserted by Appellants, but cited to evidence from Park for disclosure of
stimulating the hypoglossal nerve to provide disordered breathing therapy.
Appellants have not apprised us of error in the Examiner’s rationale
for the combination of Pitts Crick, Terry, and Park which is supported by the
disclosure in the cited references. We, thus, sustain the rejection of claims 3
and 13.
Dependent claims 8 and 18
Claim 8, which depends from claim 2, recites “delivering at least two
disordered breathing therapies” including “stimulating at least two of a
baroreflex target... a phrenic nerve, or a hypoglossal nerve.” Appeal Br.
33—34 (Claims App.). Claim 18, which depends from claim 12, contains
similar limitations. Id. at 35. The Examiner finds that Terry discloses
delivering at least two disordered breathing therapies. Final Act. 4 (citing
Terry H 30, 48-49). Appellants contend that Terry discloses only one
therapy, i.e., vagal stimulation therapy. Appeal Br. 29—30.
Terry discloses one mode of disordered breathing therapy, i.e.,
stimulating the vagus nerve. Terry 130. The Examiner has not directed us
to any disclosure in Terry of stimulating either a phrenic nerve or a
hypoglossal nerve. The Examiner’s finding that Terry discloses delivering
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at least two disordered breathing therapies is not supported by the disclosure
in Terry. Therefore, we do not sustain the rejections of claims 8 and 18.
Dependent claim 17
Claim 17, which depends ultimately from claim 12, recites providing
disordered breathing therapy that “wherein the at least one disordered
breathing therapy includes electrical stimulation of the phrenic nerve.”
Appeal Br. 35 (Claims App.). The Examiner finds that Park discloses
stimulating “the phrenic nerve to address breathing disorders.” Final Act. 4.
Appellants’ Specification also discloses phrenic nerve stimulation as a
disordered breathing therapy that is not limited to sleep apnea patients.
Spec. 13. Appellants do not dispute the Examiner’s finding but, similar to
the arguments made in connection with stimulating the hypoglossal nerve as
recited in claims 3 and 13, Appellants contend that Park stimulates the
phrenic nerve to treat sleep apnea, not as part of CHF therapy. Appeal Br.
30. Appellants also interpose the contention from claims 3 and 13 that the
Examiner’s rationale for the combination is not supported by rational
underpinnings. Id. We determine above that none of these contentions are
persuasive. We, thus, sustain the rejection of claim 17 for the same reasons
stated above in connection with claims 3 and 13.
New Ground of Rejection of claim 7
We exercise our discretion under 37 C.F.R. § 41.50(b) and enter a
NEW GROUND OF REJECTION against claim 7 under 35 U.S.C. § 103(a)
as unpatentable over Pitts Crick and Terry as applied by the Examiner to
claim 2 (from which claim 7 ultimately depends) and Park as applied by the
Examiner to claim 17.
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Claim 7, similarly to claim 17, recites “wherein delivering at least one
disordered breathing therapy includes stimulating a phrenic nerve.” Appeal
Br. 33 (Claims App.). Park discloses “phrenic nerve stimulation” as a
disordered breathing therapy. Park | 65. For the reasons stated by the
Examiner in the rejection of claim 17, we determine it would have been
obvious to one of ordinary skill in the art at the time of the present invention
to modify the combination of Pitts Crick and Terry as applied to claim 2 by
the Examiner to use the stimulation of the phrenic nerve as a disordered
breathing therapy for a patient suffering from CHF.
DECISION
The Examiner’s decision rejecting claims 3—6, 9, 12—16, and 19 is
affirmed, with the affirmance for claims 12, 14—16, and 19 being designated
as a new ground of rejection.
The Examiner’s decision rejecting claims 7, 8, 11, 18, and 21 is
reversed.
We enter a new ground of rejection against claim 7.
FINALITY OF DECISION
This decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides:
When the Board enters such a non-final decision, [Appellants], within
two months from the date of the decision, must exercise one of the
following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
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(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence
relating to the claims so rejected, or both, and have
the matter reconsidered by the examiner, in which
event the prosecution will be remanded to the
examiner. The new ground of rejection is binding
upon the Examiner unless an amendment or new
Evidence not previously of Record is made which, in
the opinion of the examiner, overcomes the new
ground of rejection designated in this decision.
Should the examiner reject the claims, [Appellants]
may again appeal to the Board pursuant to this
subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same
Record. The request for rehearing must address any
new ground of rejection and state with particularity
the points believed to have been misapprehended or
overlooked in entering the new ground of rejection
and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to new grounds of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
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; 37 C.F.R, $ 41.50(b)
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