Ex Parte Johnson et al

Patent Trial and Appeal Board

Jun 29, 2018

14595771 (P.T.A.B. Jun. 29, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/595,771 01/13/2015
25281 7590 07/03/2018
DICKE, BILLIG & CZAJA
FIFTH STREET TOWERS
100 SOUTH FIFTH STREET, SUITE 2250
MINNEAPOLIS, MN 55402
FIRST NAMED INVENTOR
Blake D. Johnson
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.
1618.115.103 8297
EXAMINER
TEJANI, ANKIT D
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
07 /03/2018 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.PA TENTS@dbclaw.com
dmorris@dbclaw.com
DBCLA W-Docket@dbclaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BLAKE D. JOHNSON, MARK CHRISTOPHERSON,
JOHN RONDON!, and QUAN NI
Appeal2017-004143
Application 14/595, 771
Technology Center 3700
Before ULRIKE W. JENKS, RICHARD J. SMITH, and RYAN H. FLAX,
Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant 1 appeals from Examiner's
rejection of the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
STATEMENT OF THE CASE
Claims 12-34 are on appeal, and can be found in the Claims
Appendix of the Appeal Brief. Claims 12, 18, and 26 are representative of
1 Appellant is the Applicant, Inspire Medical Systems, Inc., which,
according to the Brief, is the real party in interest. Appeal Br. 3.
Appeal2017-004143
Application 14/595,771
the claims on appeal, and read as follows:
12. An electrode system, comprising:
an implantable cuff body at least partially self-wrappable
about
a nerve; and a plurality of rows of selectively activatable
electrodes supported by the cuff body and including a first row
and a second row, wherein at least some of the selectively
activatable electrodes of the first row extend generally
perpendicular to at least some of selectively activatable
electrodes of the second row.
18. An electrode system comprising:
an implantable cuff body at least partially self-wrappable
about a nerve;
a plurality of rows of selectively activatable electrodes
supported by the cuff body and including a first row and a
second row, wherein at least some of the selectively activatable
electrodes of the first row extend generally perpendicular to at
least some of selectively activatable electrodes of the second
row; and
an anchor spaced longitudinally from all of the respective
electrodes, with the anchor extending longitudinally from, and
spaced apart from, the cuff body to secure the cuff body relative
to a body structure.
26. A stimulation system comprising:
an electrode system, comprising:
an implantable cuff body at least partially self-wrappable
about a nerve; and
a plurality of rows of selectively activatable electrodes
supported by the cuff body and including a first row and a
second row, wherein at least some of the selectively activatable
electrodes of the first row extend generally perpendicular to at
least some of selectively activatable electrodes of the second
row;
a sensing portion to sense physiologic information
regarding a patient, wherein the sensing portion is separate
from, and independent of, at least the selectively activatable
electrodes.
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Appellant requests review of the following rejections:
I. Claims 12-17, 20, 30 and 31 under 35 U.S.C. § 103(a) as
unpatentable over Ternes2 in view of Guntinas-Lichius. 3
II. Claims 21-25 under 35 U.S.C. § 103(a) as unpatentable over Ternes
in view of Guntinas-Lichius and further in view of Richmond. 4
III. Claims 18, 19, 32, and 33 under 35 U.S.C. § 103(a) as unpatentable
over Ternes in view of Guntinas-Lichius and further in view ofMrva. 5
IV. Claims 26-29 and 34 under 35 U.S.C. § 103(a) as unpatentable over
Ternes in view of Guntinas-Lichius and further in view ofTroosters. 6
I. and II. Obviousness over Ternes and Guntinas-Lichius
Examiner has rejected claims 12-17, 20, 30, and 31 as obvious over
the combination of Ternes and Guntinas-Lichius; and rejected claims 21-25
as obvious over the same references, also adding Richmond. Because both
of these rejections rely on the underlying teachings of Ternes and Guntinas-
Lichius we discuss them together.
The issue is: Does the preponderance of the evidence of record
support Examiner's position that the combination of references renders
obvious a plurality of activatable electrodes that are arranged in rows
perpendicular to each other?
2 Ternes et al., US 2010/0121405 Al, publ. May 13, 2010 ("Ternes").
3 Guntinas-Lichius et al., US 2010/0114240 Al, publ. May 6, 2010
("Guntinas-Lichius").
4 Richmond et al., US 2001/0010010 Al, publ. July 26, 2001 ("Richmond").
5 Mrva et al., US 2008/0172116 Al, publ. July 17, 2008 ("Mrva").
6 Troosters et al., US 2010/0222844 Al, publ. Sept. 2, 1010 ("Troosters").
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Application 14/595,771
Findings of Fact
FPL Ternes discloses an implantable medical device (IMD) that includes a
pulse generator. Ternes i-f 17. Figure IA, reproduced below, shows
the various components making up the Ternes IMD:
~
( -------' i.------.i i.-----' lo---' ~
30
Fig. 1 A shows "a system 10 including an implantable medical device (IMD)
12 with a lead 14 having a proximal end 16 and a distal end 18." Id. i-f 1 7.
Further,
The distal end 18 of the lead 14 includes a plurality of
electrodes 20a, 20b, 20c, 20d, 20e, 20/, 20g, and 20h and
a retention cuff 22. . . . The electrodes may be separately
controlled by IMD 12 such that energy having different
magnitude, phase, and/ or timing characteristics may be
delivered to or from each of the electrodes 20.
Id. i-f 18. Further,
The system 10 also includes a converter 30. The
converter 30 includes a converter body 32, cuff
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electrodes 34a and 34b, a strain relief cuff36, and a
securing mechanism 3 8. . . . The cuff electrodes 34a and
34b also include a conductive material (not shown) that is
suitable for carrying electrical energy to the excitable
tissue.
Id. i-f 19, see also id. i-f 22. "When the cuff electrodes ... are secured to
excitable tissue, the IMD 12 can deliver energy having different
characteristics to each of the cuff electrodes. . . . Consequently, different
therapies can be delivered to different parts of the patient's anatomy."
Id. i-f 31.
FF2. Ternes teaches an electrode matrix as shown in Figure 3, reproduced
below:
~78
14
(
72
84f
Figure 3 shows a matrix 7 6 that includes conductive elements 84a -
84g that are arranged substantially perpendicular to conductive
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Application 14/595,771
elements 88a- 88g. Id. i-f 32. A matrix electrode 90 is provided at a
point where conductive element 84 and 88 are connected. Ternes
i-f 33. Figure 3 shows the matrix electrodes 90 arranged in a diagonal
line with respect to the lead 14, however, "the electrode matrix 7 6 can
be configured to include any number of matrix electrodes 90 in any
pattern." Id. i-f 33. "The electrode matrix 76 may be configured to
wrap around excitable tissue, such as a nerve or nerve bundle, to
deliver stimulation energy." Id. i-f 34.
FF3. Guntinas-Lichius teaches a method of stimulating nerves, specifically
facial nerves, with a system having a plurality of contacts. Guntinas-
Lichius, Abstract. Guntinas-Lichius teaches the use of a cuff-
electrode to stimulate around a neural stump of a neuromuscular
transplant. Id. i-f 35.
FF4. Figure 5 of Guntinas-Lichius is reproduced below:
FIG. 5
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"FIG. 5 shows an array electrode in the parotic region in relation to
the branches of the facial nerve." Guntinas-Lichius i-f 20. Guntinas-
Lichius teaches an "electrode 16 has a plurality of contacts 18, which
may be configured in rows and columns. . . . The contacts 18 may be
used to stimulate nerve branches 24 or to record nerve impulses or
potentials from the nerve branches 24." Id. i-f 45. The electrode is
coupled to processor and "[ t ]he processor has program code for
stimulating each of the plurality of contacts separately." Guntinas-
Lichius i-f 11.
FF5. Richmond teaches using implanted electrodes to stimulate and control
muscle or nerve tissue. Richmond, Abstract. Richmond teaches using
a bedside controller that is powered from conventional power lines
and sends preprogrammed sequence of stimulation commands to the
implanted device. Id. i-f 47.
Principle of Law
"If a person of ordinary skill can implement a predictable variation [of
a known work], § 103 likely bars its patentability." KSR Int'! Co. v. Teleflex
Inc., 550 U.S. 398, 417 (2007).
Analysis
Examiner finds that Ternes discloses an electrode system that is
partially self-wrappable around a nerve. Ans. 2; FFl, FF2. Examiner finds
that "electrodes 90 [of Ternes] are the elements that are considered
analogous to the recited electrodes. The first [conductive] row 84 and
second [conductive] row 88 merely act as a scaffold on which the electrodes
90 may be housed." Ans. 12; FF2. Examiner does not dispute that Ternes'
Figure 3 shows only "one diagonal row of electrodes." Ans. 13; FF2.
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Examiner acknowledges that Ternes "does not, however, explicitly disclose
wherein the electrodes are selective the activatable." Ans. 2.
Examiner relies on the teachings of Guntinas-Lichius to describe
electrodes, including cuff electrodes. Ans. 2; FF3. Examiner finds that
Guntinas-Lichius electrode has a plurality of contacts that may be
configured in rows and columns and where each of the contacts in the
electrode is stimulated separately. See Ans. 2, 14; FF4.
Based on these teachings of the prior art, Examiner concludes:
As Ternes discloses nerve cuffs including a plurality of
electrodes configured on a matrix, and as Guntinas-Lichius
discloses selectively activating a subset of electrodes on an
electrode matrix for a specific stimulation scheme, regardless of
the location of the electrode matrix, it would have been obvious
to a person having ordinary skill in the art at the time the
invention was made to incorporate a selective stimulation
scheme similar to that described by Guntinas-Lichius into the
nerve cuff described by Ternes, as doing so advantageously
allows a user to tailor the therapy to a particular region of the
patient's body or a particular stimulation scheme which may
provide optimal results.
Ans. 3.
Examiner acknowledges that "neither Ternes nor Guntinas-Lichius
explicitly discloses wherein the controller is an external controller located
external to a patient's body." Id. at 5. Examiner relies on Richmond to
disclose a nerve stimulation system including the use of an external
controller. Ans. 5; FF5. Examiner concludes that based on the combined
teachings of Ternes, Guntinas-Lichius, and Richmond one of ordinary skill
in the art at the time of the invention was made would have found it obvious
to incorporate an external controller discussed in Richmond into the
electrode system discussed in the combination of Ternes and Guntinas-
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Lichius in order to achieve the "known advantage of allowing for patient
stimulation without a separate implantable controller." Ans. 5.
We agree with Examiner that it would have been obvious to one of
ordinary skill in the art to substitute the Guntinas-Lichius electrode array for
the electrode array disclosed in Ternes. See FF1-FF4. "[W]hen a patent
claims a structure already known in the prior art that is altered by the mere
substitution of one element for another known in the field, the combination
must do more than yield a predictable result." KSR, 550 U.S. at 416 (citing
United States v. Adams, 383 U.S. 39, 50-51 (1966)).
As Examiner pointed out, both Guntinas-Lichius and Ternes teach the
use of cuff electrodes to wrap around nerves for the purpose of stimulating
the nerve. See Ans. 2; FFl, FF3. Ternes teaches that the electrode matrix 76
can be configured to include any number of electrodes 90 in any pattern.
FF2. In addition, Ternes electrodes 20, the electrodes that supply energy
through a converter 30 to the cuff electrodes and conductive material of the
IMD, can each be controlled separately such that "different magnitude,
phase, and/or timing characteristics may be delivered to or from each of the
electrodes 20." FPL Based on these disclosures in Ternes, electrodes 90 of
matrix 7 6 can, therefore, be separately controlled as long as the electrodes
are arranged along the conductive elements 84a-84h. Examiner, however
does not end the analysis there, instead Examiner looks to the electrode array
of Guntinas-Lichius to be substituted into the implantable medical device of
Ternes to provide an electrode array having columns and lines; a potentially
larger number of electrodes arranged in columns and rows. See Ans. 3
(obvious to "incorporate a selective stimulation scheme similar to that
described by Guntinas-Lichius into the nerve cuff described by Ternes").
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We find no error with the Examiner's reliance on substituting one known
equivalent electrode array of Guntinas-Lichius for the array in Ternes to
arrive at the claimed invention.
We address Appellant's contentions below:
Claim 12
Appellant contends that conductive elements 88a- 88h of Ternes do
not function as electrodes. "Only when a matrix electrode (e.g. 90a) is
present, does a second conductive element (e.g. 88a) become electrically
connected." Appeal Br. 9. Appellant contends that Ternes does not provide
a second row of selectively activatable electrodes. Appeal Br. 9. Appellant
contends that if an extra electrode was added below electrode 90a as shown
in Figure 3 of Ternes "then both matrix electrodes 90a, and 90extra would
be electrically common to each other by virtue of second conductive element
88a then both matrix electrodes 90a, 90extra would be electrically common
to each other by virtue of second conductive element 88a." Appeal Br. 11.
We are not persuaded. It is the combination of Ternes and Guntinas-
Lichius which renders the alternative structures obvious as known
equivalents. See In re Keller, 642 F.2d 413, 425 (CCPA 1981) ("The test for
obviousness is not whether the features of a secondary reference may be
bodily incorporated into the structure of the primary reference; nor is it that
the claimed invention must be expressly suggested in any one or all of the
references. Rather, the test is what the combined teachings of the references
would have suggested to those of ordinary skill in the art"). Discussing the
shortcomings of the individual references does not address the rejection as
proposed by Examiner, which relies upon a combination of prior art. Here,
Examiner acknowledges that Ternes does not have an electrode array
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arrangement with lines and columns of electrodes that are each individually
activatable as claimed, but relies on the rows and columns of contacts in the
electrode array as disclosed in Guntinas-Lichius for supplying this element
in order to arrive at the claimed invention. See Ans. 2. Specifically,
Guntinas-Lichius teaches an electrode array that has a plurality of contacts
( 18) that are "configured in rows and columns" that are coupled to processor
for stimulating each of the plurality of contacts separately. See Ans. 2; FF4.
Appellant also contends that the electrode array of Guntinas-Lichius
does not wrap around one of the respective nerve branches. Appeal Br. 14.
"[I]t is impermissible for the Examiner to take favorable aspects of Ternes or
Guntinas-Lichius while ignoring the components and structure of Ternes or
Guntinas-Lichius ... that diverge from each other." Id. In other words,
Appellants contend that the references or at least the portion of the reference
relied on by the Examiner are non-analogous and thereby not combinable.
We are not persuaded. Art is analogous if it is ( 1) from the same field
of endeavor, regardless of the problem addressed, or (2) reasonably pertinent
to the particular problem with which the inventor is involved. In re Clay,
966 F.2d 656, 658-59 (Fed. Cir. 1992). Here, Ternes teaches a cuff
electrode for stimulating nerves. FF2. Guntinas-Lichius also teaches the use
of cuff electrode that wraps around a nerve, specifically, a neural stump.
FF3. Guntinas-Lichius suggests arranging contacts of an electrode into rows
and columns, and there is nothing in the reference to suggest that this
electrode arrangement could not be used in the cuff electrodes also
contemplated by the reference. See FF3, FF4. Because both cited prior art
references disclose stimulating nerves using cuff electrodes we find that the
references are from the same field of endeavor and, therefore, are each
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Application 14/595,771
reasonably pertinent to the problem of electrical stimulation of a nerve as
claimed. Accordingly, we are not persuaded that the evidence supports
Appellant's position that the references are non-analogous art.
Appellant contends that Ternes and Guntinas-Luchius are divergent
references and one or ordinary skill in the art would not arrive at the subject
matter of independent claim 12 absent improper hindsight reconstruction.
Appeal Br. 14.
Any judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level
of ordinary skill at the time the claimed invention was made
and does not include knowledge gleaned only from applicant's
disclosure, such a reconstruction is proper.
In re McLaughlin, 443 F.2d 1392, 1395, (CCPA 1971). Appellant has not
directed us to any information that could have only been gleaned from
Appellant's own Specification, rather than from the cited prior art
combination, and that was relied on by Examiner in arriving at the claimed
invention based on the prior art combination. Accordingly, we are not
persuaded by Appellant's contention that Examiner improperly relied on
hindsight in rejecting the claims as obvious.
Having considered each of Appellant's arguments and having found
them to be unpersuasive, we affirm Examiner's rejection of claim 12 as
described above and in conjunction with the reasons of record set out in the
Final Office Action 7 and Answer. Claims 13-17, 20, 30, and 31 fall with
claim 12 as not argued separately. 37 C.F.R. § 41.37 (c)(l)(iv).
7 Final Office Action mailed February 19, 2018 ("Final Act.").
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Application 14/595,771
Claim 21
Having found no error in the combination of Ternes and Guntinas-
Lichius as relied upon by Examiner nor a deficiency as alleged by Appellant
(see above claim 12), we are not persuaded by Appellant's argument that the
inclusion Richmond fails to make up for any alleged deficiency in the
combination of Ternes and Guntinas-Lichius. See Appeal Br. 15.
Accordingly, we affirm the rejection of claims 21-25 for the reasons set out
by Examiner in the Final Office Action and Answer. See Ans. 5---6; Final
Act. 6-7.
III. Obviousness over Ternes, Guntinas-Lichius, and Marva
The issue is: Does the preponderance of the evidence of record
support Examiner's conclusion that the combination references renders
obvious an anchor spaced longitudinally from the electrodes and apart from
the cuff body as claimed?
Findings of Fact
FF6. Mrva teaches an implant nerve cuff electrode. Mrva, Abstract. Figure
14 of Mrva, reproduced below, shows a fastener means for anchoring
a cuff to the nerve.
10
\
\
56
.........
Fig.14
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Application 14/595,771
"FIG. 14 is a perspective view of one embodiment of a securing
means coupled to the lead of the nerve cuff ... , the securing means
including an aperture to allow a loop of suture to wrap loosely about
the nerve to aid in maintaining the position of the implant system."
Mrva i-f 32. The Mrva system includes:
molded or overmolded fastener means used to hold or
anchor the distal portion of the lead 12 and cuff(s) 14, 16,
to the target nerve N or other surrounding tissue. . . . The
fastener 52 includes an aperture 54 to allow a length of
suture 56 to pass through ... [and t ]he suture 56 may
also include one or more barbed elements 58 that may
anchor into surrounding tissue to help secure the system
10 to the nerve, in addition to, or in place of tying.
Id. i-f 79. "[T]he lead 12 provides electrical continuity and mechanical
attachment to the mating connector 48 of an implantable pulse
generator 50." Id. at 75.
Analysis
Examiner relies on the combination of Ternes and Guntinas-Lichius to
meet the arrangement of the electrode elements as claimed. Examiner finds
Mrva also teaches nerve cuff electrodes and methods of securing the nerve
cuff electrode to the body structure, i.e. the nerve, using an anchoring means.
Ans. 7; FF6. Examiner finds that "Mrva describes wherein the anchor is
associated with a free standing cuff module." Ans. 9, see also id. at 18-19.
Based on the combined teachings of the references, Examiner concludes that
it would have been obvious "to incorporate a separate anchoring element
similar to that described by Mrva into the electrode system described by
Ternes in view of Guntinas-Lichius, as this advantageously allows the nerve
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cuff electrode to be secured in place and therefore allows for repeated,
reliable stimulation of a desired portion of the subject's nerve." Ans. 7-8.
We address Appellant's contentions below:
Claim 18
Appellant contends that, for the same reasons discussed for claim 12,
the combination of Ternes and Guntinas-Lichius with Mrva similarly fails to
render obvious claim 18. Appeal Br. 16. With respect to claim 18,
Appellant further contends that Mrva fails to cure the deficiencies of the
other two references. Id.
Having found no error in the combination of Ternes and Guntinas-
Lichius as relied upon by Examiner nor a deficiency as alleged by Appellant
(see above claim 12), we are not persuaded by Appellant's argument that the
inclusion Mrva fails to make up for any alleged deficiency in the
combination of Ternes and Guntinas-Lichius. See Appeal Br. 15.
Accordingly, we affirm the rejection of claim 18 for the reasons set out by
Examiner in the Final Office Action and Answer. See Ans. 5---6; Final Act.
6-7. Claims 19 and 32 were not argued separately and fall with claim 18.
Claim 33
With respect to claim 33, Appellant contends that Mrva "fails to meet
the recitation of 'the anchor is associated with a freestanding cuff module,
including the cuff body' and, therefore Mrva fails to cure the deficiencies of
Ternes and Guntinas-Lichius." Appeal Br. 17. Appellant contends that "it
would be clear to one skilled in the art that a freestanding cuff module 390 is
not connected to, or part of, a lead." Reply Br. 9.
On this point, we find that Appellant's have the better position. The
term "freestanding cuff module," when read in light of the Specification, is a
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wireless communication cuff module that avoids the need of having a power
unit implanted in the body. See Spec. i-f 52 ("implanted cuff module 310 to
enable wireless communication between the cuff module 310 and the
external support module 312. In one aspect, by housing power unit 338 in
garment 360, the patient avoids having a power unit implanted in their
body"), see also id. i-f 53 ("the anchor portion 382 is implemented on a
freestanding cuff module, such as cuff 390 ... or cuff module 31 O").
Mrva explains that lead 12 provides electrical continuity and
mechanical attachment to an implantable pulse generator. See FF6 ("the
lead 12 provides electrical continuity and mechanical attachment to the
mating connector 48 of an implantable pulse generator 50"). Mrva
electrodes are not "freestanding," as understood in light of the Specification,
because they are attached to an implantable pulse generator, thereby Mrva
does not teach the element of freestanding cuff.
For the reasons discussed above, we agree with Appellant that
Examiner has not persuasively shown that the limitation of "freestanding
cuff," which is missing from Ternes and Guntinas-Lichius, would have been
obvious based on the disclosure of Mrva. Furthermore, because Examiner
has not articulated any other rationale for how the cited combination of
references discloses a freestanding cuff device or would render such a
freestanding cuff obvious we are constrained to reverse the rejection of
claims reciting the element of a "freestanding cuff." We reverse the
rejection of claim 33.
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IV. Obviousness over Ternes, Guntinas-Lichius, and Troosters
The issue is: Does the preponderance of the evidence of record
support Examiner's conclusion that the combination references renders
obvious and electrode system that also contains a sensing portion to obtain
physiologic information about the patient?
Findings of Fact
FF7. Troosters teaches an implanted electrode in contact with neural tissue,
that contains stimulation electrode contacts for applying electrical
stimulation as well as one or more sensing electrode contacts at a
distance from said simulation electrodes. Troosters, Abstract.
Troosters Figure 2, reproduced below, shows the arrangement of the
sensors and electrodes.
30'\
;33~
l
'
Fig.2
Figure 2 above, shows distances between sensing electrodes (33a,
33b, and 33c) and stimulating electrodes (32a and 32b ). Id. i-f 70. The
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sensing electrodes are located at a predetermined axial distance
~e from the stimulation electrode contacts. Id. "[T]he predetermined
distance of ~e is 10 mm, so that the compound action potential
reaches the sensing electrode [] after 1.2 ms," but also recognizes that
different values ~e may also be chosen. Id.
Analysis
Examiner finds that "Ternes does not explicitly disclose wherein the
electrodes are selectively activatable and wherein the sensing portion is
separate from and independent of at least the selectively activatable
electrodes." Ans. 9. Examiner relies on Troosters for teaching these
limitations. See Ans. 9--10.
We address Appellant's arguments below:
Claim 26
Appellant contends that claim 26 recites a "cuff body, which supports
the electrodes, [and] is part of the electrode system," and contains sensing
elements separate from the stimulating electrode that are missing from the
references. Reply Br. 10.
Examiner responds that Ternes describes a system that contains both a
sensor and electrode. Ans. 20 (citing Ternes 24 ). "[T]he cuff electrode 34a
[of Ternes] receives the electrical energy delivered to the electrode 20e by
the IMD 12 .... In addition, one or both of the cuff electrodes 34a and 34b
may be employed to sense physiological characteristics of the tissue to
which it is attached. Furthermore, the cuff electrodes 34a and 34b may
provide combined sensing and stimulation capabilities." Ternes i-f 24. We
agree with Examiner that the disclosure relied on in Ternes reasonably
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suggests that the "system" contains both sensing and stimulating electrodes,
and that both are part of the cuff. See Ans. 20. Here, Examiner additionally
relies on Troosters to show both sensor and electrode can be on the same
cuff. See FF7. Figures 2 of Troosters embody "stimulation components 3 2a
and 32b may be electrically and physically separate from sensing
components 33a, 33b, and 33c." Ans. 22; FF7.
For the reasons set out above and those provided by Examiner in the
Final Office Action and Answer, we affirm the rejection of claim 26.
Claims 27-29 were not separately argued and fall with claim 26.
Claim 34
Appellant contends that "Ternes stands in conflict with the recitation
and/or diverges from the recitation of 'a sensing portion to sense physiologic
information regarding a patient, wherein the sensing portion is separate
from, and independent of, at least the selectively activatable electrodes."'
Appeal Br. 19 (emphasis removed). Appellant contends that claim 34 recites
"sensor portion is separate from, and independent of, the electrode system,
then the sensor portion is then by extension separate from, and independent
of, the cuff body (which is part of the electrode system)." Reply Br. 10.
Examiner finds that "[b ]oth Ternes and Guntinas-Lichius contain
electrodes which may be configured to sense nerve properties and electrodes
which may be configured to stimulate nerves." Ans. 20. We agree with
Examiner that the references disclose using sensing electrodes that are
separate from the stimulation electrodes. Here, Guntinas-Lichius discloses
that the "the electrode may be an array electrode and/or a rod electrode. The
system may further include one or more sensors in communication with the
processor." Guntinas-Lichius i-f 12. "The movement of the various facial
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muscles may be measured by sensors 32 placed on the skin or implanted
under the skin." Id. i-f4 7. Here, the sensor that is placed on the skin is at a
different location from Guntinas-Lichius 's electrode that stimulates the
nerve, because those electrodes are implanted. Because Guntinas-Lichius' s
processor obtains information from both stimulating electrode and sensing
electrode we agree with the Examiner's conclusion that combination of
references teach a system where the electrodes and sensors are separate from
each other.
For the reasons set out above and those provided by Examiner in the
Final Office Action and Answer, we affirm the rejection of claim 26.
SUMMARY
We affirm the rejection of claims 12-17, 20, 30 and 31 under
35 U.S.C. § 103(a) over Ternes and Guntinas-Lichius.
We affirm the rejection of claims 21-25 under 35 U.S.C. § 103(a)
over Ternes, Guntinas-Lichius, and Richmond.
We affirm the rejection of claims 18, 19, and 32 under 35 U.S.C.
§ 103(a) over Ternes, Guntinas-Lichius, and Marva.
We reverse the rejection of claim 33 under 35 U.S.C. § 103(a) over
Ternes, Guntinas-Lichius, and Mrva.
We affirm the rejection of claims 26-29 and 34 under 35 U.S.C.
§ 103(a) over Ternes, Guntinas-Lichius, and further Troosters.
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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