Ex Parte Denison et al

Patent Trial and Appeal Board

Feb 22, 2019

14732408 (P.T.A.B. Feb. 22, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/732,408 06/05/2015
71996 7590 02/26/2019
SHUMAKER & SIEFFERT, P.A
1625 RADIO DRIVE, SUITE 100
WOODBURY, MN 55125
FIRST NAMED INVENTOR
Timothy J. Denison
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.
l 123-024US02/P37124.USC1 1058
EXAMINER
DOWNEY, JOHN R
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
02/26/2019 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):
pairdocketing@ssiplaw.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TIMOTHY J. DENISON, KUN ALP ARALIKAR,
GORDON ORVIS MUNNS, WESLEY A. SANTA,
PENG CONG, CHRISTIANS. NIELSEN,
JOHN D. NORTON, and JOHN G. KEIMEL 1
Appeal2018-003897
Application 14/732,408
Technology Center 3700
Before JENNIFER D. BAHR, BRETT C. MARTIN, and
RICHARD H. MARSCHALL, Administrative Patent Judges.
BAHR, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner's
decision rejecting claims 1-21. We have jurisdiction under 35 U.S.C.
§ 6(b ). We AFFIRM.
1 Medtronic, Inc. (Appellant) is the applicant as provided in 37 C.F.R.
§ 1.46. The Appeal Brief identifies Medtronic, Inc. of Minneapolis,
Minnesota and Medtronic plc of Dublin, Ireland (the ultimate parent entity
of Medtronic, Inc.) as the real parties in interest. Appeal Br. 3.
Appeal2018-003897
Application 14/732,408
THE CLAIMED SUBJECT MATTER
Appellant's invention "relates to optical stimulation therapy."
Spec. ,r 3. Claim 1, reproduced below, is illustrative of the claimed subject
matter.
1. A medical system comprising:
an implantable optical stimulation device comprising a
light source that generates light;
an optical light guide configured to transmit the light
from the light source to a target tissue remote from the
implantable optical stimulation device, wherein the optical light
guide comprises a non-galvanic material; and
a sense electrode implantable proximate the target tissue,
wherein the implantable optical stimulation device is
configured to sense bioelectrical signals via the sense electrode,
and wherein the sense electrode comprises a material that
produces no induced current in an electromagnetic field created
by a magnetic resonance imaging device.
REJECTIONS
I. Claims 1-5, 11-15, and 21 stand rejected under 35 U.S.C. § I03(a)
as unpatentable over deCharms (US 2006/0155348 Al, published
July 13, 2006), Karmarkar (US 2008/0039709 Al, published
Feb. 14, 2008), DeLonzor (US 2007/0055173 Al, published
Mar. 8, 2007), and Bonmassar (US 2009/0254146 Al, published
Oct. 8, 2009). 2
II. Claims 7 and 17 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over deCharms, Karmarkar, DeLonzor, Bonmassar,
and Francis (US 2008/0125838 Al, published May 29, 2008).
2 The Examiner does not list DeLonzor or Bonmassar in the statements of
the rejections (see Non-Final Act. 5, 9, 10, 11, 12, 13), but cites them as
evidence of the art-recognized meaning of "MRI compatibility" (id. at 8).
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III. Claims 8 and 18 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over deCharms, Karmarkar, DeLonzor, Bonmassar,
and Lee (US 2006/0195157 Al, published Aug. 31, 2006).
IV. Claims 6 and 16 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over deCharms, Karmarkar, DeLonzor, Bonmassar,
and Surgenor (US 2006/0049957 Al, published Mar. 9, 2006).
V. Claims 9 and 19 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over deCharms, Karmarkar, DeLonzor, Bonmassar,
and Kopell (US 2009/0054955 Al, published Feb. 26, 2009).
VI. Claims 10 and 20 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over deCharms, Karmarkar, DeLonzor, Bonmassar,
Kopell, and Chen (US 5,827,186, issued Oct. 27, 1998).
DISCUSSION
Claim Construction
Appellant raises issues in this appeal that focus on the limitation in
each of independent claims 1, 11, and 21 that "the sense electrode comprises
a material that produces no induced current in an electromagnetic field
created by a magnetic resonance imaging device." See Appeal Br. 5-18;
Reply Br. 2-10. Thus, we begin our analysis by construing this claim
language.
Claim 1, as presented on June 5, 2015, when the present application
was filed, recited that "the sense electrode comprises a material that
produces substantially no induced current in an electromagnetic field." This
limitation of claim 1, and the same limitation in independent claims 11 and
21, which were added later, contained the term "substantially" until the
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Amendment submitted January 18, 2017 (hereinafter "2017 Amendment"),
which was entered upon the filing of a Request for Continued Examination,
on February 21, 2017. In the Remarks submitted with the 2017 Amendment,
Appellant explained that claims 1, 11, and 21 were amended to remove the
term "substantially" in order to overcome a rejection of these claims under
35 U.S.C. § 112, second paragraph, set forth in an earlier Office Action
dated November 18, 2016, which stated that the term "substantially" was a
relative term for which the Specification does not provide a standard for
ascertaining the requisite degree, and, thus, one of ordinary skill in the art
would not be reasonably apprised of the scope of the claimed invention. See
2017 Amendment 6 (Remarks). Appellant stated that "while not agreeing to
the merits of the Examiner's rejection, [the claims] have been amended to
remove the terms alleged by the Examiner to render the claims indefinite in
order to expedite allowance of the application." Id. Appellant added that,
"[ d]espite the amendment, ... one of ordinary skill in the art would
understand that the scope of the claims are not limited by a strict boundary"
and that, "with regard to claims 1, 11, and 21, one of ordinary skill in the art
would understand that the material of the sense electrode is not limited to a
material that produces exactly no induced current in an electromagnetic field
created by [a magnetic resonance imaging (MRI)] device but, e.g., could
include some nominal amount of induced current in the electromagnetic
field." Id. at 6-7. In essence, Appellant has asserted that the limitation "a
material that produces no induced current in an electromagnetic field created
by a magnetic resonance imaging device" in amended claims 1, 11, and 21
should be construed in essentially the same manner that Appellant earlier
asserted the original limitation "a material that produces substantially no
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induced current in an electromagnetic field" should be construed. See
Amendment, submitted Aug. 5, 2016 (hereinafter "2016 Amendment") 7
(Remarks) (stating that "the term 'substantially' is used to clarify that the
material of the sense electrode is not limited to a material that produces
exactly no induced current in an electrical field").
Appellant's Specification discloses repeatedly that the sense electrode
comprises a material that produces "substantially no induced current in an
electromagnetic field." Spec. ,r,r 9, 160-163. The Specification states that
"all structures that are proximate the target tissue, such as ... sensor 154 ...
do not comprise any material that will produce significant induced current
and/ or heating when exposed to an electromagnetic field, such as ... for
example the fields created by MRI or EMI." Id. ,r 162. The Specification
explains that "[ t ]he lack of an induced current results in little to no risk of
tissue capture or excessive heating, even from components that would
traditionally do so, such as sense electrodes and the leads thereto," which,
"in tum allows MRI and other imaging technologies that may create
electromagnetic fields, to be used substantially simultaneously with optical
stimulation such that imaging and analysis of the patient[']s tissue may be
taken and performed at the time of stimulation." Id. ,r 163. "Moreover,"
according to the Specification, "the use of materials that do not produce
induced current in an electromagnetic field from the tissue interface, such as
the materials of ... sensor 154, helps to mitigate MRI interference that is
seen with typical electrical stimulation electrodes and sense electrodes." Id.
The Specification states that "[ e ]xamples of materials that may be used for
sensor 154 include a carbon fiber or a conductive polymer" and incorporates
by reference a co-pending application for "[f]urther examples of sense
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electrodes and/or leads comprising a material having a very low conductivity
that produces substantially no induced current in an electromagnetic field."
Id. ,I,I 161, 163.
In light of this disclosure in Appellant's Specification, a person
having ordinary skill in the art would understand that the sense electrode
( sensor 154) comprises a material ( or materials) that does not produce a
level of induced current in an electromagnetic field created by an MRI
device that would present a risk of tissue capture or excessive heating, or
problematic MRI interference, thereby allowing MRI to be used
substantially simultaneously with optical stimulation. Further, this
disclosure in the Specification conveys that the present application uses the
terminology "substantially no induced current," "no induced current," "lack
of an induced current," and "[no] significant induced current"
interchangeably to denote levels of induced current below that which would
present a risk of tissue capture or excessive heating, or MRI interference, in
an electromagnetic field created by an MRI device to a degree that would
prevent MRI from being used substantially simultaneously with optical
stimulation using Appellant's system. Accordingly, consistent with
Appellant's Specification, we construe the claim language "a material that
produces no induced current in an electromagnetic field created by a
magnetic resonance imaging device" as encompassing materials that do not
produce a level of induced current in an electromagnetic field created by an
MRI device that would present a risk of tissue capture or excessive heating,
or problematic MRI interference, thereby allowing MRI to be used
substantially simultaneously with optical stimulation according to the
claimed invention. This claim language is not limited to materials that
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produce exactly no induced current in an electromagnetic field created by an
MRI device.
Rejection I
Claims 1. 3-5. 11. 13-15. and 21:
The Examiner found that deCharms discloses a medical system
substantially as claimed in claim 1, including an implantable optical
stimulation device comprising a light source that generates light, an optical
light guide configured to transmit light from the light source to target tissue,
and a sense electrode (sensor 130), wherein the implantable optical
stimulation device is configured to sense bioelectrical signals via the sense
electrode. Non-Final Act. 6 (citing deCharms ,r,r 48, 50, 51, 67, 68). The
Examiner finds that one of ordinary skill in the art would understand, from
deCharms's disclosure that "this device may be used in conjunction with
±MRI" and "may be used to provide MRI compatible stimulation of tissue"
not requiring "implantation of metal lead wires that may not be MRI
compatible," that the sense electrode (sensor 130) "comprises a material that
produces substantially no induced current in an electromagnetic field." Id.
( citing deCharms ,r,r 73, 111) (boldface omitted). However, the Examiner
also determines that, even if "deCharms fails to expressly or inherently teach
a sense electrode that is MRI-compatible," it would have been obvious, in
view of Karmarkar' s teaching of a similar probe for deep brain stimulation
that includes sensing electrodes, is MRI-compatible, and can include MRI-
compatible materials, to modify deCharms to use an MRI-compatible
sensing electrode (sensor 130) as required in claim 1. Id. at 7-8. Further,
citing DeLonzor and Bonmassar as "evidence of the definition of 'MRI
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compatibility' understood by those skilled in the art," the Examiner reasons
that the MRI-compatible sensing electrode of the deCharms/Karmarkar
combination would be made of "a material that produces no induced
current in an electromagnetic field created by a magnetic resonance imaging
device," as recited in claim 1. Id. at 8; Ans. 11-13.
Appellant argues that deCharms fails to expressly disclose that sensor
130 comprises a material that produces no induced current in an
electromagnetic field created by an MRI device. Appeal Br. 8. In particular,
Appellant contends that deCharms describes embodiments of the stimulation
device "that provide MRI compatible stimulation of tissue without utilizing
a sense electrode to sense electrical signals," as well as an embodiment of
device 10 including "an external sensor 130 that communicates via wireless
telemetry to implanted device 10, and, thus, may be temporarily
disconnected during an MRI to provide MRI compatibility." Id. Thus,
Appellant argues, in each of these embodiments, the entire device 10 would
be MRI compatible without requiring sensor 130, in particular, to comprise
material that produces no induced current in an electromagnetic field created
by an MRI device. Id. Appellant also submits that deCharms only discloses
that components used to deliver optical stimulation, such as leads 22A, 22B,
may be MRI compatible, and urges that such stimulation components are
different from sensor 130. Id. at 13-14 (citing deCharms ,r 45).
Accordingly, Appellant argues that there would have been no apparent
reason to modify sensor 130 of deCharms to make it of MRI compatible
material. Id.
This line of argument is not persuasive. Appellant's argument
conveniently overlooks deCharms' s disclosure of embodiments in which
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"sensor 130 may take the form of an electrode inserted into the brain" or
"may take the form of a transducer consisting of an electrode with an ion
selective coating applied which is capable of directly transducing the amount
of a particular transmitter substance and its breakdown byproducts found in
the interstitial space of a region of the brain such as the ventral lateral
thalamus," thereby indicating the relative activity of the brain region.
DeCharms ,r,r 50, 51 (emphasis added); see Non-Final Act. 6-7 (citing
deCharms ,r,r 50, 51 with regard to the sense electrode). As pointed out by
the Examiner (Non-Final Act. 6-7), deCharms discloses that "this device
may be used in conjunction with fMRI as a measure of neural activation, or
real time fMRI" and that the "invention may be used to provide MRI
compatible stimulation of tissue," using "MRI compatible optical fibers" to
convey the light without requiring "implantation of metal lead wires that
may not be MRI compatible." DeCharms ,r,r 73, 111. Although this may
not constitute an express or inherent disclosure of using a sense electrode
(sensor 130) comprising an MRI compatible material, the teaching to
provide an optical stimulation system that can be used in conjunction with
fMRI to provide a real time measure of neural activation and to provide MRI
compatible stimulation of tissue would have provided incentive for a person
of ordinary skill in the art to make all components to be implanted into the
brain, including any sensing electrodes, from MRI compatible materials.
We agree with the Examiner that Appellant's interpretation of deCharms's
use of the language "MRI compatible stimulation" as limiting the MRI
compatibility specifically to the components of the system that deliver the
stimulation, but not including components of the system used to measure the
efficacy of the stimulation for feedback control of the stimulation, attempts
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to read deChanns' s disclosure too narrowly without taking into account the
entirety of deChanns's disclosure. See Ans. 19--20.
Appellant argues that, even assuming that it would have been obvious
to modify the system of deCharms in view of the teachings of Karmarkar,
"the modification would not have resulted in a system including a sense
electrode comprising a material that produces no induced current in an
electromagnetic field created by a magnetic resonance imaging device."
Appeal Br. 9. In particular, Appellant contends that Karmarkar teaches
making the probes compatible by providing a plurality of RF chokes on
and/or in the shielding layer of the lead in advance of the electrode(s) "to
inhibit induced RF current from forming and/or traveling along the shielding
layer," but "provides no description that the sense electrodes comprise a
material that produces no induced current in an electromagnetic field created
by a magnetic resonance imaging device." Id. at 10 (emphasis omitted).
Karmarkar's invention relates to leads or probes "particularly suitable
for MRI compatible implantable Deep Brain Stimulation." Karmarkar ,r 3.
Karmarkar's MRI lead/probe 20 or 120 includes, in pertinent part, a plurality
of electrodes, at least one of which can be a sensing electrode, and a
plurality of axially spaced apart RF chokes in a shielding layer of the lead.
Id. ,r,r 17, 48, 53, 55-57, 72. Karmarkar discloses that the probe "can
comprise non-magnetic MRI compatible material(s) and be configured to
operate in a high magnetic field environment." Id. ,r 51. In other words,
Karmarkar teaches using MRI compatible materials for components of the
probe in order to make the probe MRI compatible. Karmarkar also discloses
that "cannula 75 and both probes 120a, 120b are MRI compatible and at
least the probes 120a and 120b may include the RF chokes 64,f." Id. ,r 72
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(boldface omitted). One skilled in the art would appreciate from this
statement that the probes may be made MRI compatible (such as by
comprising components of MRI compatible materials) without the RF
chokes. Thus, Karmarkar adequately supports the Examiner's finding that
Karmarkar teaches making the sensing electrode of MRI compatible
material. See Ans. 16-17. As the Examiner explains, "there would be no
logical reason" for a person of ordinary skill in the art seeking to provide an
MRI compatible probe to make only some components, but not all of the
components, of the probe MRI compatible. Id. at 17.
Appellant argues that "[t]he Examiner has not established that a
'MRI-compatible' sense electrode necessarily refers to a sense electrode
comprising a material that produces no induced current in an
electromagnetic field created by a magnetic resonance imaging device," and
"[t]hus, even assuming ... that it would have been obvious ... to make the
sensor 130 of deCharms 'MRI-compatible' ... , it has not been established
that such a modification ... would result in the subject matter of ... claim
1." Appeal Br. 7. Along these same lines, Appellant argues that deCharms
gives no indication that sensor 130 is a ferromagnetic material in which
large electrical currents are induced when the sensor is subjected to strong
magnetic fields, and, thus, "the Examiner has failed to establish that there
would have been an apparent reason to modify the sensor 130 of deCharms
... to provide for an MRI compatible device compared to the device
described by deCharms." Appeal Br. 11-12; see Reply Br. 6, 9 (asserting
that DeLonzor and Bonmassar only generally describe induced currents as
one factor in evaluating "MRI compatibility" and are concerned with large
induced electrical current).
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This line of argument is not persuasive. As pointed out above, the
Examiner cited DeLonzor and Bonmassar as evidence of the meaning of
"MRI compatible" established in the art. Non-Final Act. 8; Ans. 12-13.
DeLonzor teaches that "[ d]etermining the MRI compatibility of
materials requires evaluating materials for ... heating, electric field
induction and operation during exposure to MRI fields," and that "MRI
compatible materials includes materials that do not ... have adverse side
effects ... when exposed to MRI fields" and "do not include ferromagnetic
materials." DeLonzor ,r 10. According to DeLonzor, "MRI compatible
materials can also include materials that create little or no image artifacts
during an MRI procedure," and "[a] sufficient amount of MRI compatibility
is required [for] diagnostic procedures to be performed safely and
successfully." Id. DeLonzor teaches that "MR safe ... materials include
polymers, elastomers, composites, brass, aluminum, and ceramics." Id. ,r 31.
Bonmassar teaches that "copper-containing electrical leads ... are not
compatible with magnetic resonance imaging (MRI) procedures" because,
"[ w ]hile copper is not a ferromagnetic material and thus, the electrodes do
not move or become dislodged when subjected to strong magnetic fields,
large electrical currents may nonetheless be induced resulting in thermal
damage to the brain tissue." Bonmassar ,r 10.
Thus, DeLonzor and Bonmassar establish that, in determining whether
a material would be MRI compatible, those of ordinary skill in the art take
into account the same concerns that Appellant discusses for materials
suitable for the sensing electrode of Appellant's invention. See Spec.
,r,r 162-163; DeLonzor ,r 10; Bonmassar ,r 10. In particular, like Appellant,
skilled artisans consider a material to be suitable (MRI compatible) if, when
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subjected to electromagnetic fields created by an MRI device, the material
does not produce a level of induced current that would present a risk of
tissue damage or excessive heating or image artifacts during an MRI
procedure that would make the MRI procedure unsafe or unsuccessful.
See id. Thus, the Examiner correctly determined that materials that are
"MRI compatible," as that terminology is understood by those of ordinary
skill in the art, would satisfy the claim limitation "a material that produces
no induced current in an electromagnetic field created by a magnetic
resonance imaging device" in claim 1.
For the above reasons, based on the totality of the evidence and
arguments before us, Appellant does not apprise us of error in the
Examiner's conclusion that the subject matter of claim 1, including the
limitation that "the sense electrode comprises a material that produces no
induced current in an electromagnetic field created by a magnetic resonance
imaging device," would have been obvious to one of ordinary skill in the art.
Accordingly, we sustain the rejection of claim 1 under 35 U.S.C. § 103(a).
We also sustain the rejection of claims 3-5, 11, 13-15, and 21, for which
Appellant does not present any separate arguments for patentability ( Appeal
Br. 5-18, 19-20, 21-22), under 35 U.S.C. § 103(a). See 37 C.F.R.
§ 41.3 7 ( c )( 1 )(iv) (permitting the Board to select a single claim to decide the
appeal as to a single ground of rejection of a group of claims argued
together).
Claims 2 and 12:
The Examiner cited deCharms' s discussion of "a feedback mechanism
using the sensor" in paragraph 56 and DeCharms's disclosure of using
sensor 130 with a closed loop feedback system in paragraph 57 as satisfying
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the limitation in claims 2 and 12 of having the sense electrode sense the
bioelectric signals while the optical light guide transmits light from the light
source to the target tissue. Non-Final Act. 9; see Appeal Br. 31, 33 (Claims
App.). Appellant argues that "[t]he Examiner has failed to establish that"
deCharms's description of using sensor 130 with a closed loop feedback
system constitutes the subject matter of claim 2 or claim 12. Appeal Br. 18-
19, 20-21.
In response, the Examiner reiterates that paragraphs 56 and 57 of
deCharms describe "a closed-loop feedback mechanism for a continuous
process of reevaluating the stimulation parameters," and adds that
"deCharms doesn't teach that the sensor is shut off while the new parameters
are implemented, and one of ordinary skill in the art at the time of the
invention would have had no reason to interpret deCharms in that manner or
to believe that such an interpretation would be correct." Ans. 20-21. The
Examiner also cites Figure 4 of deCharms, and the discussion of Figure 4 in
paragraph 61, as supporting the Examiner's interpretation. Id. at 21. In
particular, the Examiner directs us to deCharms' s disclosure of the device
trying to reduce a parameter in step 413, at the end of the programmed
interval, to determine if control is maintained and, if so, ratcheting parameter
values down until the sensor values again indicate a need to increase the
parameter values. Id. ( citing deCharms ,r 61 ). The Examiner finds that this
disclosure establishes that "the sensor is continuously active while the
various stages of stimulation are occurring, and are thus sensing while the
delivery of light occurs." Id. Appellant does not apprise us of error in the
Examiner's finding or persuasively explain why this would not satisfy the
limitation of claims 2 and 12.
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Accordingly, we sustain the rejection of claims 2 and 12 under
35 U.S.C. § 103(a).
Re} ection II
The Examiner found that deCharms "fails to expressly disclose the
use of a conductive polymer sense electrode," as required in claims 7 and 17.
Non-Final Act. 9. However, the Examiner found that "Francis discloses an
implantable device which can include conductive polymer electrodes," and
determined that it would have been obvious "to use conductive polymer
electrodes as the sense electrodes in deCharms' [ s] device because such a
modification would amount to nothing more than a merely simple
substitution of one known electrode material for another to obtain
predictable results." Id. at 10 (citing Francis ,r 39).
Appellant argues that the Examiner does not specify "the predictable
results that would be obtained by substituting the conductive polymer
electrode allegedly described by Francis for the sensor 130 described by
deCharms" and "has failed to establish that the conductive polymer
electrode ... of Francis would be capable of functioning in the same manner
as described for sensor 130 of deCharms, e.g., as an electrode inserted into
the brain of the patient to detect nerve cell or axon activity." Appeal Br. 23
( citing deCharms ,r 50).
Appellant's argument does not apprise us of error because it is not
responsive to the rejection set forth by the Examiner. The rejection does not
involve substituting the electrode of Francis for the electrode of deCharms.
Rather, the Examiner determined it would have been obvious to substitute
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the material (i.e., conductive polymer) for the unspecified material of sensor
130 of deCharms.
The Examiner explains that Francis teaches the use of a conductive
polymer "in the context of an implantable electrode," which is the type of
component in deCharms that would be modified according to the rejection.
Ans. 22. According to the Examiner, Francis's teaching that conductive
polymer is a known suitable material for an implantable electrode would be
sufficient to motivate one of ordinary skill in the art to consider such a
material for deCharms's implantable electrode as an obvious selection of a
known material based on its suitability for its intended purpose, and
deCharms does not provide any specifications for the sense electrode (sensor
130) that would appear to exclude the conductive polymer taught by Francis
as a suitable material. Id.
Appellant does not specifically identify any error in the Examiner's
findings and reasoning and, in particular, does not give any reason why a
person of ordinary skill in the art would consider the implantable electrode
material (i.e., conductive polymer) taught by Francis to be unsuitable for the
implantable sense electrode (sensor 130) of deCharms. See Reply Br. 14
(merely asserting the Examiner has not established that the conductive
polymer material described by Francis would be suitable for the uses of
sensor 130 described by deCharms). Francis discloses that its teachings are
applicable to implantable medical devices, including "neurological leads for
sensing ... in the brain." Francis ,r 107. Likewise, deCharms teaches that
sensor 130 "may take the form of an electrode inserted into the brain."
DeCharms ,r 50. This is sufficient to establish a reasonable basis that one of
ordinary skill in the art would consider the implantable electrode material
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(i.e., conductive polymer) taught by Francis as suitable for use in the
implantable electrode (sensor 130) of DeCharms.
For the above reasons, Appellant fails to apprise us of error in the
rejection of claim 7, or the rejection of claim 17, for which Appellant relies
on the arguments presented for claim 7. See Appeal Br. 24. Accordingly,
we sustain the rejection of claims 7 and 17 under 35 U.S.C. § 103(a).
Rejection III
The Examiner found that deCharms "fails to expressly disclose the
use of a carbon fiber sense electrode." Non-Final Act. 10. However, the
Examiner found that "Lee discloses a device for brain stimulation that
comprises carbon fiber electrodes as electrochemical sensors," and
determines it would have been obvious "to use carbon fiber electrodes as the
sense electrodes in deCharms' [ s] device because such a modification would
amount to nothing more than a merely simple substitution of one known
electrode material for another to obtain predictable results." Id. at 10-11
( citing Lee ,r 7).
Appellant argues that the Examiner has not specified "the predictable
results that would be obtained by substituting carbon fiber electrodes as [the]
electrochemical sensor allegedly described by Lee for the sensor 130
described by deCharms." Appeal Br. 25. In particular, Appellant submits
that the Examiner has not established that Lee's carbon fiber electrodes
would be capable of functioning in the manner described for sensor 130 by
deCharms. Id. (citing deCharms ,r 50). Appellant's argument does not
apprise us of error because it is not responsive to the rejection set forth by
the Examiner. The rejection does not involve substituting the electrode of
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Lee for the electrode of deChanns. Rather, the Examiner determined it
would have been obvious to substitute the material (i.e., carbon fiber) for the
unspecified material of sensor 130 of deCharms.
The Examiner explains that Lee teaches the use of carbon fiber
material "in the context of an implantable electrode," which is the type of
component in deCharms that would be modified according to the rejection.
Ans. 23-24. According to the Examiner, Lee's teaching that carbon fiber is
a known suitable material for an implantable electrode would be sufficient to
motivate one of ordinary skill in the art to consider such a material for
deCharms's implantable electrode as an obvious selection of a known
material based on its suitability for its intended purpose, and deCharms does
not provide any specifications for the sense electrode (sensor 130) that
would appear to exclude the carbon fiber taught by Lee as a suitable
material. Id. at 24. The Examiner also points out that deCharms discloses
other uses for deCharms's sensor 130 beyond the detection of"nerve cell or
axon activity" discussed by deCharms in paragraph 50. Id.
Appellant notes that "Lee describes an electrochemical sensor, such
as a carbon fiber electrode or other suitable electrochemical sensor, that is
able to detect extracellular levels of neurochemical in the central and
peripheral nervous system," and contends that "[ n Jo where does deCharms
describe the intended purpose of the sensor 130 as functioning in the manner
of the electrochemical sensor of Lee." Reply Br. 16 ( emphases omitted)
( citing Lee ,r,r 7, 9).
Appellant's argument appears to overlook deCharms's disclosure of
using sensor 130 to detect "the amount of a particular transmitter substance
or its breakdown byproducts found in the interstitial space of a region of the
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Application 14/732,408
brain such as the ventral lateral thalamus" to indicate "the relative activity of
the brain region." DeCharms ,r 51 (pointing to a paper discussing
"electrodes for in vivo electrochemical and electrophysiological studies" for
an example of this type of transducer). Lee discloses a carbon fiber
electrode for use as an electrochemical sensor for detecting changes in levels
of neurochemicals, such as neurotransmitters, in a particular region of the
central nervous system, including structures in the brain. See Lee ,r,r 3, 7.
Thus, the use for which Lee discloses carbon fiber electrodes appears to be
the same as, or substantially similar to, the use of sensor 130 disclosed in
paragraph 51 of deCharms. This is sufficient to establish a reasonable basis
that one of ordinary skill in the art would consider the implantable electrode
material (i.e., carbon fiber) taught by Francis as suitable for use in the
implantable electrode (sensor 130) of DeCharms. Appellant does not
provide adequate evidence or technical reasoning to show that this would not
be the case.
For the above reasons, Appellant fails to apprise us of error in the
rejection of claim 8, or the rejection of claim 18, for which Appellant relies
on the arguments presented for claim 8 (Appeal Br. 26-27). Accordingly,
we sustain the rejection of claims 8 and 18 under 35 U.S.C. § 103(a).
Rejections IV-VI
In contesting the rejections of claims 6, 9, 10, 16, 19, and 20,
Appellant relies on the arguments presented for claims 1 and 11. See Appeal
Br. 27-29 (arguing that Surgenor, Kopell, and Chen do not overcome the
asserted deficiencies in the combination of deCharms and Karmarkar). For
the reasons discussed above, these arguments do not apprise us of error in
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Application 14/732,408
the rejection of claims 1 and 11, and, likewise, do not apprise us of error in
the rejections of claims 6, 9, 10, 16, 19, and 20 (Rejections IV-VI) under
35 U.S.C. § 103(a), which we, thus, sustain.
DECISION
The Examiner's decision rejecting claims 1-21 under
35 U.S.C. § 103(a) is AFFIRMED.
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
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