Ex Parte Libbus et al

Patent Trial and Appeal Board

Oct 12, 2017

13792805 (P.T.A.B. Oct. 12, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/792,805 03/11/2013 Imad Libbus 279.763US2 6171
45458 7590 10/16/2017
SCHWEGMAN LUNDBERG & WOESSNER/BSC
PO BOX 2938
MINNEAPOLIS, MN 55402
EXAMINER
ALTER MORSCHAUSER, ALYSSA MARGO
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
10/16/2017 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
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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, ANDREW P. KRAMER, and JULIA MOFFITT
Appeal 2016-001464
Application 13/792,8051
Technology Center 3700
Before ULRIKE W. JENKS, RICHARD J. SMITH, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35U.S.C. § 134 involves claims to a device and
methods for achieving neural stimulation. The Examiner entered final
rejections for anticipation and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-
PART.
1 Appellants identify the Real Party in Interest as Cardiac Pacemakers, Inc.
App. Br. 2. The inventors to the application are listed as Imad Libbus,
Andrew P. Kramer, and Julia Moffitt. Bib. Data Sheet.
Appeal 2016-001464
Application 13/792,805
STATEMENT OF THE CASE
Background
“Neural stimulators are used to treat a variety of disorders, such as
epilepsy, obesity, and breathing disorders. Experimentally, neural
stimulation has been shown to have a significant effect on several
cardiovascular conditions, and has been proposed to treat hypertension, post
myocardial infarction (MI) remodeling and heart failure.” Spec. 1:24—28.
“Neural stimulators that rely on continuous or intermittent open-loop
stimulation do not adapt to physiologic changes during therapy.” Id. at
2:19-20.
The Specification discloses:
Systems and methods are provided for monitoring nerve
traffic for use to deliver appropriate neural stimulation.
Monitored nerve traffic is used to accurately provide autonomic
modulation for accurate and appropriate delivery of neural
stimulation. Thus, the present subject mat[t]er provides a
closed-loop neural stimulation system that allows the neural
stimulation device to monitor nerve traffic and continuously
provide appropriate therapy. A neural sensing lead is used to
record nerve traffic from the peripheral nervous system (such as
baroreceptors, afferent nerves and/or efferent nerves) to guide
neural stimulation therapy, to record physiologic parameters
such as pressure for diagnostic purposes, and/or to guide CRM
therapy.
Id. at 6:3—12.
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Application 13/792,805
The Claims
Claims 1—3 and 5—21 are on appeal. Final Act. I.2 Claim 1 is
illustrative and reads as follows:
I. A device for delivering a closed-loop neural
stimulation therapy with a reflex neural response feedback to a
desired neural target in an autonomic nervous system to elicit a
desired reflex neural response, comprising:
a pulse generator configured to generate a neural
stimulation signal for delivery to the desired neural target in the
autonomic nervous system for eliciting the desired reflex
neural response by the central nervous system;
a nerve sensor configured to sense a nerve traffic signal
in a centrally-mediated reflex pathway;
a signal processor configured to process the nerve traffic
signal into a signal indicative of a detected reflex neural
response to stimulating the neural target; and
a controller connected to the pulse generator and the
signal processor, wherein the controller is configured to control
the pulse generator to generate the neural stimulation signal to
cause a sympathetic or parasympathetic neural response for the
neural stimulation therapy, and use the detected reflex neural
response to adjust at least one stimulation parameter of the
neural stimulation signal based on the detected reflex neural
response to provide the desired reflex neural response to the
neural stimulation therapy.
II. A method, comprising:
delivering a neural stimulation therapy to a neural target
in an autonomic nervous system;
sensing a reflex response to the neural stimulation
therapy, including sensing a nerve traffic signal from the
autonomic nervous system, and processing the sensed nerve
2 Examiner’s Final Action, mailed July 18, 2014.
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Application 13/792,805
traffic signal into a signal indicative of the reflex response to
the neural stimulation therapy; and
adjusting the neural stimulation therapy based on the at
least one feature of the nerve traffic signal to cause the neural
stimulation therapy to elicit a desired reflex neural response to
the neural stimulation therapy.
App. Br. 21—22 (Claims Appendix) (emphases added).
The Issues
The following rejections are before us to review:
Claims 1—3, 5—8, 11—17, and 21 are rejected under pre-AIA
35 U.S.C. § 102(b) as anticipated by King.3 Ans. 2.4
Claim 18 is rejected under pre-AIA 35 U.S.C. § 103(a) as
obvious over King in view of Bourgeois.5 Id. at 7.
Claims 9, 10, 19, and 20 are rejected under pre-AIA 35 U.S.C.
§ 103(a) as obvious over King in view of Hill.6 Id. at 8.
I
The Examiner rejects claims 1—3, 5—8, 11—17, and 21 as anticipated
by King. The Examiner finds that King discloses a device meeting all of the
limitations of independent claims 1,11, and 21. Ans. 2—A. Specific to the
issues on appeal, the Examiner finds:
King discloses a device for delivering a closed-loop neural
stimulation therapy with a reflex neural response feedback (The
examiner considers a response of the nerve to stimulation to be
a “reflex neural response”. Thus, since the electrical
3 US 5,913,882, issued June 22, 1999 (“King”).
4 Although claim 4 is included in the Examiner’s statement of rejection,
claim 4 is not on appeal. App. Br. 21 (Claims Appendix).
5 US 5,836,994, issued November 17, 1998 (“Bourgeois”).
6 US 2002/0165586 Al, published November 7, 2002 (“Hill”).
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Application 13/792,805
stimulation to the nerves of King cause a response by the
nerves, that is then recorded by the recoding electrodes, the
examiner considers King to disclose providing stimulation to
elicit a desired reflex neural response.) to a desired neural target
in an autonomic nervous system (ANS is the part of the
peripheral nervous system. Thus, stimulation of a peripheral
nerve (part of the peripheral nervous system) would necessarily
stimulate the autonomic nervous system[)]. Therefore, since
King stimulates a peripheral nerve (see col. 3, lines 19-26, for
example), King stimulates the autonomic nervous system) to
elicit a desired neural response (e.g., col. 1, lines 45-59).
Ans. 2—3.
Appellants argue that King does not anticipate because King’s device
“does not account for” an Autonomic Nervous System reflex circuit, unlike
the claimed subject matter. App. Br. 12.
According to Appellants, a “reflex response is a response from the
central nervous system to a stimuli [that is] ... . mediated through the
central nervous system” and the claimed subject matter “does not sense the
same action potentials that are produced by the stimulation electrode” but
instead relies on a different feedback signal than King discloses. Id. “[A]
control system configured to detect the same action potentials on the same
nerve will be different than a control system configured to detect a reflex
response.” Id. at 8.
The central nervous system does not simply reflect the same
action potential as was received. Therefore, the reflex response
to neural stimulation is not the same action potentials as were
generated by the neural stimulation. As such, the feedback
signals to the control systems are different which require
Appellant’s control system ... to be different than King’s
control system ... in order to process the different feedback
signal.
Reply Br. 3.
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Does the preponderance of the evidence of record support the
Examiner’s finding that King anticipates the device and methods as
claimed?
Claims 11—17
We agree with Appellants that King’s device does not meet the
limitations of method claims 11—17. Claim 11 requires “sensing a reflex
response to the neural stimulation therapy” and “adjusting the neural
stimulation therapy based on the at least one feature of the nerve traffic
signal to cause the neural stimulation therapy to elicit a desired reflex neural
response to the neural stimulation therapy.” App. Br. 22.
King discloses a stimulating lead “positioned so that stimulating
electrodes 18-21 are at the optimal sites adjacent electrically excitable tissue
for control of conscious paresthesia into the painful area of a patient.” King
3:16—18. King discloses:
the positions of stimulating electrodes 18-21 and recording
electrodes 25-26 must be fine-tuned to obtain the correct
paresthesia and extra-cellular recordings. Recordings of
potentials evoked in the nerve fibers adjacent lead 10 are picked
up at the recording sites and analyzed to see if there is sufficient
potential received from large diameter afferents in the dorsal
columns or peripheral nerve.
Id. at 3:63—4:3 (emphasis added). Accordingly, we agree with the
Appellants’ characterization of King’s device as eliciting “action potentials
using an electrode, and [recording] these same action potentials in the
nerve.” Reply Br. 7. Indeed, the Examiner acknowledges that King’s
disclosure does not involve mediation through the central nervous system,
but finds that while a “reflex response” can be mediated through the central
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nervous system, the Specification does not support exclusive mediation
through the central nervous system. Ans. 11.
We are persuaded by Appellants’ argument that the skilled artisan
“understands that reflex response is, by definition, a response from the
central nervous system[,] .... that a baroreflex is a reflex response mediated
through the central nervous system, and that central mediated reflex
pathways refer to pathways that are mediated by the central nervous
system.”7 Reply Br. 5. Positioning of the electrode alongside the peripheral
nerves in King would not inherently result in induction of a reflex response
that must be mediated through the central nervous system. “[T]he examiner
must provide some evidence or scientific reasoning to establish the
reasonableness of the examiner’s belief that the functional limitation is an
inherent characteristic of the prior art” before the burden is shifted to
Applicants to disprove the inherency. Ex parte Skinner, 2 USPQ2d 1788,
1789 (BPAI 1986). Here, the Examiner has not established how placing the
electrodes adjacent to the lead and recording the potentials evoked in the
7 See, e.g., the definition of “reflex”:
a :an automatic and often inborn response to a stimulus that
typically involves a nerve impulse passing inward from a
receptor to the spinal cord and then passing outward from the
spinal cord to an effector (such as a muscle or gland) without
reaching the level of consciousness and often without passing to
the brain; the knee-jerk reflex
b :the process that culminates in a reflex and comprises
reception, transmission, and reaction — called also reflex action
(https://www.merriam-webster.com/dictionary/reflex, last visited
October 3, 2017).
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nerve fibers will necessarily capture a reflex neural response, or how the
device in King could “cause the neural stimulation therapy to elicit a desired
[reflex] neural response to the neural stimulation therapy.” In short, King
does not disclose the claimed method. We reverse the rejection of claims
11-17 under 35 U.S.C. § 102(b).
Claims 1—3, 5—8, and 21
We agree with the Examiner that King’s device anticipates claims 1—
3, 5—8, and 21. Claims 1 and 21 require “a device for delivering a closed-
loop neural stimulation therapy” comprising a pulse generator, nerve sensor,
signal processor, and controller. King discloses a neural stimulation and
recording device comprising these elements. Ans. 2-4; King 1:45—59;
2:62:3—2, 3:26—29 and Figure 1.
To distinguish over the prior art, the limitations of a device must
recite a structural difference between the claimed subject matter and the
prior art. See In re Lowry, 32 F.3d 1579, 1583—84 (Fed. Cir. 1994) (finding
the claim limitations regarding organization of data in memory distinguished
over the prior art); In re Noll, 545 F.2d 141, 148 (CCPA 1976) (“[T]he
[claimed invention] . . . comprises physical structure, including storage
devices and electrical components uniquely configured to perform specified
functions through the physical properties of electrical circuits to achieve
controlled results. Appellants’ programmed machine is structurally different
from a machine without that program.”).
Appellants do not identify any structural limitation required by claims
1—3, 5—8, and 21 that is not disclosed in King. Rather, Appellants’ argument
focuses on the difference in the type of response to the neural stimulation
effected by and recorded by King. App. Br. 11—16. Notably, Appellants do
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not argue that the pulse generator of King cannot induce a reflex response,
only that it does not “necessarily” do so because “King does not expressly
refer to the autonomic nervous system.” Id. at 11.
Moreover, we are not persuaded that the preamble of claims 1 or 21 is
essential to interpretation of the claims. “Where a patentee uses the claim
preamble to recite structural limitations of his claimed invention, the PTO
and courts give effect to that usage. . . . Conversely, where a patentee defines
a structurally complete invention in the claim body and uses the preamble
only to state a purpose or intended use for the invention, the preamble is not
a claim limitation.” Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). Here,
the preamble “for delivering a closed-loop neural stimulation therapy with a
reflex neural response feedback to a desired neural target in an autonomic
nervous system to elicit a desired reflex neural response” does not contain
structural limitations, but instead recites an intended use. Accordingly, we
affirm the rejection of claims 1 and 21.
Claims 2, 3, and 5—8 have not been argued separately and therefore
fall with claims 1 and 21. 37 C.F.R. § 41.37(c)(l)(iv).
II
The Examiner rejected claim 18 as obvious based on King in view of
Bourgeois. This rejection, however, is based on the Examiner’s finding that
King anticipates claim 11. See Ans. 7—8. The rejection therefore suffers
from the same deficiency discussed above with respect to King’s
anticipation of claims 11—17, and is reversed for the same reason.
III
The Examiner rejected claims 9, 10, 19, and 20 as obvious based on
King in view of Hill. The Examiner finds that King discloses all of the
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limitations of claims 9, 10, 19, and 20 “but does not explicitly disclose the
neural stimulation therapy is an anti-hypertension therapy or heart failure
therapy.” Ans. 8. The Examiner finds that Hill “discloses that it is well
known to apply stimulation to the spinal cord, vagus and other nerves for
providing heart failure treatment (e.g., page 1, paragraph 12) and
antihypertension treatment (e.g., page 1, paragraph 15), as well as providing
paresthesia (e.g., page 8, paragraph 88).” Id. The Examiner concludes it
would have been obvious to the skilled artisan “to modify the paresthesia
neural stimulation of King with the ability to also provide anti-hypertension
therapy or heart failure therapy as disclosed by Hill et al. in order to provide
the predictable results of modifying the treatment to meet specific patient
therapeutic needs and requirements.” Id. at 8—9.
We adopt as our own the Examiner’s findings of fact and conclusions
regarding the teachings of King and Hill with regard to claims 9, 10, 19, and
20. Ans. 8—9. Appellants do not advance any arguments regarding this
rejection. Accordingly, we affirm the rejection. See 37 C.F.R.
§ 41.37(c)(l)(iv) (2015).
SUMMARY
We affirm the rejection of claims 1—3, 5—8, and 21 under pre-AIA 35
U.S.C. § 102(b) as anticipated by King.
We reverse the rejection of claims 11—17 under pre-AIA 35 U.S.C.
§ 102(b) as anticipated by King.
We reverse the rejection of claim 18 under pre-AIA 35 U.S.C.
§ 103(a) as obvious over King in view of Bourgeois.
We affirm the rejection of claims 9—10 and 19—20 under pre-AIA 35
U.S.C. § 103(a) as obvious over King in view of Hill.
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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
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