DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/22/2025 has been entered.
Response to Arguments
Applicant’s arguments filed 12/22/2025 with respect to the rejection of Independent Claim 1 under 35 U.S.C. 103 as being unpatentable over US 2021/0085980 A1 to Mora Lopez et al. (“Mora Lopez”) in view of US 2009/0292336 A1 to Nishida et al. (“Nishida”) have been fully considered and are persuasive. The Examiner agrees that the combination of Mora Lopez and Nishida does not teach “an amplifier included in the neural probe,” “at least one flexible signal lead extending from the neural probe,” and “a neural probe configured for placement within a deep brain nucleus” as recited by amended Claim 1. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of US 2018/0185656 A1, US 2006/0195157 A1 and US 2008/0039709 A1.
With particular respect to the Claim 1 recitation “a neural probe configured for placement within a deep brain nucleus,” the Examiner notes that were the outstanding 112 issues to be resolved, prosecution would likely be advanced substantially. Such placement appears to differentiate the claimed invention from a significant number of prior art devices, as is alluded to in Applicant’s Remarks.
Applicant’s arguments regarding the rejection of dependent Claims 2-16, 18-20 and 61-65 are based on Applicant’s arguments regarding Independent Claim 1. Applicant’s arguments have been fully considered and are persuasive for the same reasons as explained above. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of US 2018/0185656 A1, US 2006/0195157 A1 and US 2008/0039709 A1.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1, and Claims 2-16, 18-20 and 61-67 by dependency, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Independent Claim 1, Claim 1 recites “a neural probe configured for placement within a deep brain nucleus of a brain….” The term “deep brain nucleus” does not appear in the Present Specification. The Present Specification discusses various structures that “deep brain region 106 may include,” but does not use the term “deep brain nucleus.” The Present Specification does not appear to support the recited “neural probe” being “configured for placement within a deep brain nucleus of a brain….” Applicant has not provided any citation to the Present Specification where support may be found. The recitation “a neural probe configured for placement within a deep brain nucleus of a brain…” constitutes new matter.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1, and Claims 2-16, 18-20 and 61-67 by dependency, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Independent Claim 1, Claim 1 recites “a neural probe configured for placement within a deep brain nucleus of a brain….” The term “deep brain nucleus” does not appear in the Present Specification. The Present Specification discusses various structures that “deep brain region 106 may include,” but does not use the term “deep brain nucleus.” Among the terms listed are “the subthalamic nucleus, globus pallidus, the thalamus, or any other subcortical brain region,” “the thalamus,” and “the basal ganglia and/or the globus pallidus” as examples of particular structures “deep brain region 106 may include.” It is unclear whether the term “deep brain nucleus” is intended to reference “the subthalamic nucleus” and other similar such species as a broad genus which includes those species, a particular set of “deep brain regions” of which those listed at Para. [0036] are representative examples, or something else.
For purposes of this Office Action, and consistent with Applicant’s use of the term in Applicant’s Remarks dated 12/22/2025, the term “deep brain nucleus” is being interpreted to mean a particular set of “deep brain regions” of which those listed at Para. [0036] are representative examples.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4, 6, 8, 11-12, 16, 20 and 64-66 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0185656 A11 to Shepard et al. (“Shepard”) in view of US 2006/0195157 A1 to Lee et al. (“Lee”) and US 2008/0039709 A1 to Karmarkar (“Karmarkar”).
Regarding Independent Claim 1, Shepard teaches:
A neural interface, comprising: (Abstract, “Systems and methods for providing neural stimulation and recording on a subject using flexible complementary CMOS probes are provided.”);
a neural probe configured for placement … within of a brain in a skull; (Figs. 1A-D, “probe 112;” Para. [0020], “FIG. 1A illustrates a top view of a brain in which probes 112 are inserted;” Para. [0023], “…the probes 112 can cover multiple brain areas simultaneously, such as multiple cortical regions, the hippocampus, and thalamus, and numerous subcortical structures…” (emphasis added));
As explained above, the term “deep brain nucleus” is being interpreted to mean a particular set of “deep brain regions” of which those listed at Para. [0036] are representative examples. Para. [0036] of the Present Specification lists “the subthalamic nucleus, globus pallidus, the thalamus, or any other subcortical brain region” (emphasis added) and “the basal ganglia and/or the globus pallidus” as examples of particular structures “deep brain region 106 may include.” Shepard’s “thalamus” and “numerous subcortical structures” are thus being interpreted as being “within a deep brain nucleus.”
Although Shepard’s probe is configured to perform sensing at Shepard’s “thalamus” and “numerous subcortical structures,” Shepard’s probe does not appear to extend beyond the cerebral cortex (see Shepard at Para. [0024]), which is not as deep within the brain as Shepard’s “thalamus” and “numerous subcortical structures” themselves. Shepard thus does not fairly disclose “a neural probe configured for placement within a deep brain nucleus within of a brain in a skull.” This deficiency is addressed below.
at least one [wireless communication means configured to transfer signals from the neural probe] to a … unit located outside the skull (Para. [0024], “…the circuits in each channel can process information collected by each of the multiple electrodes 208 and prepare that data for transmission to the reader 110 through the antenna 204;” Para. [0020], “…FIG. 1C illustrates a cross-section view of the brain implanted with the disclosed probes 112 and a wireless reader 110 that is positioned above the skull to wireless communicate with the integrated circuits (ICs) in probes 112.”);
The Examiner notes that Shepard differs from the invention of Claim 1 in that rather than “at least one flexible signal lead extending from the neural probe and configured to traverse a portion of the brain outside the deep brain nucleus to a processing unit located outside the skull” as required by Claim 1, (1) Shepard accomplishes the same data transmission wirelessly and (2) Shepard performs processing on circuitry located inside prior to transmission of processed data to a location outside of the skill. Shepard thus does not disclose such an “at least one flexible signal lead…” as claimed. This deficiency is addressed below.
and a sensing assembly included on the neural probe, (Fig. 4, “the circuitry 410” of “probe 406;” Paras. [0033] through [0034]);
The Examiner notes that Shepard’s “probe 406 can correspond to the probe 112 described in connection with FIGS. 1-2” (Shepard at Para. [0032]).
where the sensing assembly includes: a plurality of … electrodes positioned on the neural probe, (Figs. 1A-D, “electrodes 208;” Fig. 4, “electrodes 430;” Para. [0024], “The probe 112's tail portion 202, also referred to as the shank, can serve a scalable number of electrodes 208;” Para. [0034), “…the circuitry 410 can include multiple (e.g., 1024) electrodes 430 on a probe 406.”);
The Examiner notes that while Shepard states at Para. [0041] that “…the shank of the probe 406 can be capable of electrically stimulating the brain,” Shepard does not specify that Shepard’s electrodes perform such stimulating. Shepard thus does not fairly disclose “a plurality of dual role electrodes” as claimed. This deficiency is addressed below.
wherein each of the … electrodes is configured to: sense … electrical signals generated by one or more neurons in the deep brain nucleus and to convey to the at least [wireless communication means configured to transfer signals from the neural probe] one or more sense signals generated based on the sensed electrical signals; (Para. [0034], “The signal measured from each of the multiple electrodes 430 can be fed into a corresponding front-end amplifier 428, which can amplify the signal collected by the electrodes 430;” Para. [0024], “… the circuits in each channel can process information collected by each of the multiple electrodes 208 and prepare that data for transmission to the reader 110 through the antenna 204.”);
As explained above, Shepard differs from the invention of Claim 1 in that Shepard accomplishes data transmission wirelessly rather than via “at least one flexible signal lead extending from the neural probe and configured to traverse a portion of the brain outside the deep brain nucleus to a processing unit located outside the skull,” and Shepard thus does not disclose such an “at least one flexible signal lead…” as claimed. Accordingly, Shepard does not disclose “convey to the at least one flexible signal lead one or more sense signals generated based on the sensed electrical signals.” This deficiency is addressed below.
Shepard’s electrodes are not “position[ed] within the deep brain nucleus” as required by Claim 1. Instead, Shepard’s electrodes “sense … electrical signals generated by one or more neurons in the deep brain nucleus” from outside of the deep brain nucleus. Shepard thus does not disclose “sense from a position within the deep brain nucleus electrical signals generated by one or more neurons in the deep brain nucleus” as required by Claim 1 (because Shepard’s electrodes do their sensing from outside of the deep brain nucleus). This deficiency is addressed below.
and an amplifier included in the neural probe, (Fig. 4, “amplifier 428” and “amplifier 422;” Para. [0024], “The probe 112's tail portion 202 can also contain the front-end amplifiers;” Para. [0034]; Para. [0035], “…the electrodes 430, front-end amplifiers 428, amplifiers 422, multiplexers 426, multiplexers 424, multiplexer 432, and SAR ADC 420 can be located at the tail portion of the probe 406.”);
the amplifier configured to amplify the one or more sense signals to produce one or more amplified sense signals in the neural probe, wherein the one or more amplified sense signals are relayed through the at least one [wireless communication means configured to transfer signals from the neural probe] from the neural probe … (Para. [0034], “The signal measured from each of the multiple electrodes 430 can be fed into a corresponding front-end amplifier 428, which can amplify the signal collected by the electrodes 430;” Para. [0024], “…the circuits in each channel can process information collected by each of the multiple electrodes 208 and prepare that data for transmission to the reader 110 through the antenna 204.”).
As explained above, Shepard differs from the invention of Claim 1 in that Shepard processes its data inside the skill prior to transmitting it wirelessly, and thus does not disclose such an “at least one flexible signal lead…” as claimed. Accordingly, Shepard does not disclose “wherein the one or more amplified sense signals are relayed through the at least one flexible signal lead from the neural probe to the processing unit” as required by Claim 1. This deficiency is addressed below.
Shepard differs from the invention of Claim 1 in four ways: (1) Shepard accomplishes its data transmission wirelessly rather than via a “flexible signal lead;” (2) neither Shepard’s electrodes nor Shepard’s probe are positioned as deeply as those of Claim 1; (3) Shepard’s electrodes are not (at least not explicitly) “dual role electrodes;” and (4) the entirety of Shepard’s processing is done inside the skill. These differences are elaborated upon above.
Shepard thus does not disclose:
a neural probe configured for placement within a deep brain nucleus within of a brain in a skull
at least one flexible signal lead extending from the neural probe and configured to traverse a portion of the brain outside the deep brain nucleus to a processing unit located outside the skull
a plurality of dual-role electrodes
to convey to the at least one flexible signal lead one or more sense signals generated based on the sensed electrical signals
sense from a position within the deep brain nucleus electrical signals generated by one or more neurons in the deep brain nucleus
and receive, via the at least one flexible signal lead, a stimulation signal selectively delivered from a stimulus generator;
wherein the one or more amplified sense signals are relayed through the at least one flexible signal lead from the neural probe to the processing unit
Lee describes “a method for modulating or regulating levels of a neurochemical in an individual using deep brain stimulation” (Abstract) as well as such an apparatus (Title). Lee is analogous art.
Lee teaches:
a neural probe configured for placement within a deep brain nucleus within of a brain in a skull (Para. [0010], “The stimulation electrode may be placed in the central or peripheral nervous system brain regions such as, but not limited to the diencephalon, subthalamic nucleus (STN), medial forebrain bundle (MFB), nigrostriatal tract, or substantia nigra (SN), dorsal longitudinal fasciculus, hypothalamus, habenula, globus pallidus and pedunculopontine. Preferably, the stimulation electrode is placed in either or both of the STN and MFB;” Para. [0007], “In any of the embodiments of the invention, the stimulation electrode and neurochemical sensor may be present on a single probe.”);
As explained above, the term “deep brain nucleus” is being interpreted to mean a particular set of “deep brain regions” of which those listed at Para. [0036] are representative examples. Para. [0036] of the Present Specification lists “the subthalamic nucleus, globus pallidus, the thalamus, or any other subcortical brain region” (emphasis added) and “the basal ganglia and/or the globus pallidus” as examples of particular structures “deep brain region 106 may include.”
Lee contemplates placement within both the subthalamic nucleus and the globus pallidus.
at least one [hardwired transmission means] extending from the neural probe and configured to traverse a portion of the brain outside the deep brain nucleus to a processing unit located outside the skull (Para. [0045], “Control module 310 and stimulation module 320 may be connected to each other and to the sensor and stimulation electrode 330 and 340 by suitable means known to those of skill in the art. These include, but not limited to wire, coaxial cable, optical cable, fiber optics, or infrared signals.”);
The Examiner notes that Lee teaches a functionally equivalent “[hardwired transmission means]” which may be implanted “by suitable means known to those of skill in the art,” including “wire, coaxial cable, optical cable, fiber optics, or infrared signals” (see Lee at Para. [0045]), but Lee does not specify a “flexible signal lead.” This deficiency is addressed below.
a plurality of dual-role electrodes (Para. [0046], “It will be appreciated by one of skill in the art that sensor 330 may be adapted to function both as sensor 330 and stimulation electrode 340.”).
sense from a position within the deep brain nucleus electrical signals generated by one or more neurons in the deep brain nucleus (Para. [0010], “The stimulation electrode may be placed in the central or peripheral nervous system brain regions such as, but not limited to the diencephalon, subthalamic nucleus (STN), medial forebrain bundle (MFB), nigrostriatal tract, or substantia nigra (SN), dorsal longitudinal fasciculus, hypothalamus, habenula, globus pallidus and pedunculopontine. Preferably, the stimulation electrode is placed in either or both of the STN and MFB.”);
and receive, via the at least one [hardwired transmission means], a stimulation signal selectively delivered from a stimulus generator; (Para. [0036], “If a change in neurochemical level is detected in step 120, then a signal is sent from the processor used in step 120 to a stimulation module (step 130). The stimulation module is capable of delivering electrical stimulation to the brain of the individual, either directly, or indirectly.”);
The Examiner notes that Lee teaches a functionally equivalent “[hardwired transmission means]” which may be implanted “by suitable means known to those of skill in the art,” including “wire, coaxial cable, optical cable, fiber optics, or infrared signals” (see Lee at Para. [0045]), but Lee does not specify a “flexible signal lead.” This deficiency is addressed below.
wherein the one or more amplified sense signals are relayed through the at least one flexible signal lead from the neural probe to the processing unit (Para. [0036], “For example, the detection of a change in neurochemical levels may be performed using hardware such as a gating or filtering circuit that only permits the transmission of signals indicating that the neurochemical levels detected in step 110 have specified characteristics, such as being at least 10% different from the predetermined amount in step 120. Such circuits are well known in the art. Alternatively, step 120 may utilize a processor programmed with firmware or software to analyze the neurochemical levels detected in step 110 to identify changes in the amounts measured;” Paras. [0044] through [0045];).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Shepard with the teachings of Lee (i.e., to configure Shepard’s probe and electrodes for positioning within the deep brain nucleus in the manner taught by Lee) in order to gain information regarding levels of neurochemicals in hallmark diseases (Lee at Para. [0002])
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Shepard with the teachings of Lee (i.e., to configure Shepard’s electrodes as dual electrodes in the manner of Lee) in order to gain information regarding levels of neurochemicals in hallmark diseases (Lee at Para. [0002]), acquisition of which information requires the application of electrical stimulation to obtain (Lee at Para. [0004] through [0005]), particularly because Lee expressly states that such a modification is within the level of ordinary skill in the art (Lee at Para. [0046]).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Shepard with the teachings of Lee (i.e., to additionally perform such outside-the-skull processor via external processor as taught by Lee) in order to gain information regarding levels of neurochemicals in hallmark diseases (Lee at Para. [0002]), as such additional processing is required to obtain said information (see Lee at Para. [0036]).
Regarding the recitation “at least one flexible signal lead,” Lee teaches a functionally equivalent “[hardwired transmission means]” which may be implanted “by suitable means known to those of skill in the art,” including “wire, coaxial cable, optical cable, fiber optics, or infrared signals” (see Lee at Para. [0045]), but Lee does not specify a “flexible signal lead.”
The combination of Shepard and Lee thus does not disclose:
to convey to the at least one flexible signal lead
and receive, via the at least one flexible signal lead
Karmarkar describes “interventional medical leads [which] may be particularly suitable for MRI compatible implantable Deep Brain Stimulation (“DBS”)” (Para. [0003]) in the context of “in vivo medical stimulation probes” (Para. [0013]). Karmarkar is analogous art.
Karmarkar teaches:
“at least one flexible signal lead” (i.e., to convey to the at least one flexible signal lead; and receive, via the at least one flexible signal lead) (Para. [0014], “The lead may be a flexible lead…”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shepard and Lee with the teachings of Karmarkar (i.e., to use such a “flexible signal lead” as taught by Karmarkar in place of Shepards “[wireless communication means configured to transfer signals from the neural probe]”) in order to “allow[] for increased precision placement” (Karmarkar at Para. [0012]).
Regarding Claim 4, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
Lee additionally discloses:
wherein stimulation signals selectively delivered from the signal generator to corresponding ones of the plurality of electrodes cause activation of at least some of the plurality of electrodes according to a selected stimulation pattern (Para. [0068]; Para. [0076]).
Regarding Claim 6, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
Shepard additionally discloses:
wherein each of the plurality of electrodes comprises at least one conductor (Para. [0024], “The tail portion 202 can include multiple (e.g., 256) channels of analog signal chain circuits with each channel containing multiple circuits in contact with a gold electrode 208. While the gold electrode 208 can interface with the cerebral cortex 124, the circuits in each channel can process information collected by each of the multiple electrodes 208 and prepare that data for transmission to the reader 110 through the antenna 204.”).
Gold is a conductor. See Para. [0050] of the Present Specification in support of this interpretation (“The composition of a conductor may include … gold….”).
Regarding Claim 8, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 8 as explained above.
Shepard additionally discloses
wherein the at least one conductor comprises gold, titanium nitrate or platinum iridium. (Para. [0024]).
Shepard’s conductor comprises gold.
Regarding Claim 11, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
Shepard additionally discloses:
wherein the plurality of electrodes is arranged in at least one array (Para. [0028], “… the RF data and telemetry exchanged between the reader 110 and each probe 112 can be supported by a dense (>7000 mm−2) array of on-chip electrodes on the tail portion 202 of the probe 112.”).
Regarding Claim 12, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
Shepard additionally discloses:
wherein the neural probe comprises at least one facet on which at least some of the plurality of electrodes are disposed (Para. [0024], “In some embodiments, as shown by FIG. 2, the extremely scaled, untethered “tissue-paper-like” probe 112 can include a 2-mm-by-2-mm head portion including one or more antennas 204. The antennas 204 can be integrated inductors. The probe 112's tail portion 202, also referred to as the shank, can serve a scalable number of electrodes 208.”).
The claim element “facet” is being interpreted in accordance with Para. [0056] of the Present Specification, which states “A facet refers to any flat surface on an object.” Shepard’s “’tissue-paper-like’ probe 112” is such a facet as claimed, and has electrodes disposed thereon.
Regarding Claim 16, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
Shepard additionally discloses:
wherein the neural probe is non-centric (Figs. 1A-D, “probe 112” is shown as elongate and is thus non-centric)
The term “non-centric” is being interpreted in accordance with Para. [0060] of the Present Specification, which states “Non-centric may refer to a shape having a non-circular profile in any dimension, such as a cross-section. In some examples, the neural probe may be non-centric in the form of a probe with a square or rectangular cross-section.”
Regarding Claim 20, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
Shepard additionally discloses:
further comprising a power assembly configured to be located on the skull of the brain that can be charged via electrodynamic wireless power transmission, inductive power transmission, or resonant power coupling (Para. [0007], “According to aspects of the present disclosure, each CMOS chip includes a probe where the head of the probe can include an antenna to establish a near-field inductive link through the skull. Using the inductive link, the disclosed neural probe can be wirelessly powered with wireless data telemetry and can eliminate the need for percutaneous wires;” Para. [0010], “In some embodiments, the probe can be powered wirelessly from the reader through a near-field inductive link between an inductor on the head portion of the probe and the reader.”).
Regarding Claim 64, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
Shepard additionally teaches:
further comprising a multiplexer included in the neural probe, wherein the multiplexer is configured to multiplex the one or more amplified sense signals to produce one or more multiplexed sense signals in the neural probe (Fig. 4, “multiplexers 426, multiplexers 424, multiplexer 432;” Para. [0034]; Para. [0035], “…the electrodes 430, front-end amplifiers 428, amplifiers 422, multiplexers 426, multiplexers 424, multiplexer 432, and SAR ADC 420 can be located at the tail portion of the probe 406.”);
Regarding Claim 65, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
Shepard additionally teaches:
further comprising an analog-to-digital converter configured to digitize the multiplexed sense signals the multiplexed sense signals are digitized before being the multiplexed sense signals are relayed through the at least one flexible signal lead (Fig.4, “SAR ADC 420;” Para. [0035]).
Regarding Claim 66, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
Karmarkar additionally teaches:
wherein the at least one flexible signal lead comprises an insulative housing, wherein the insulative housing is configured to be in direct contact with brain tissue in the portion of the brain (Para. [0014], “The shielding layer can be discontinuous and can be configured to surround the conductors over at least a major length of the lead and terminate at a lead location that is in advance of the electrodes.”).
Claims 2, 5, 7, 10 and 63 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0185656 A1 to Shepard et al. (“Shepard”) in view of US 2006/0195157 A1 to Lee et al. (“Lee”) and US 2008/0039709 A1 to Karmarkar (“Karmarkar”) as applied to Claim 1 above, and further in view of previously cited US 2021/0085980 A1 to Mora Lopez et al. (“Mora Lopez”).
Regarding Claim 2, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
The combination of Shepard, Lee and Karmarkar does not disclose:
wherein the at least one neural probe includes a plurality of conductors, such that each of the plurality of dual-role electrodes is associated with a single conductor configured to both carry sensed signals from and to deliver a stimulation signal to one of the plurality of dual-role electrodes
Mora Lopez describes “Electrode arrangement for stimulating and recording electrical signals in biological matter, a neural probe, a micro-electrode array and a method for controlling an electrode arrangement” (Title). Mora Lopez is analogous art.
Mora Lopez teaches:
wherein the at least one neural probe includes a plurality of conductors, such that each of the plurality of dual-role electrodes is associated with a single conductor configured to both carry sensed signals from and to deliver a stimulation signal to one of the plurality of dual-role electrodes (Para. [0111], “Each conductor line 140 may be associated with a unique electrode 112, … The stimuli generator 130 may be configured to output stimulation signals on the conductor lines 140 for providing the stimulation signals to the electrodes 112;” Para. [0112], “The conductor lines 140 may also propagate signals recorded by the electrodes 112;” Paras. [0038] through [0041]).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shepard, Lee and Karmarkar with the teachings of Mora Lopez (i.e., to include such a plurality of conductors such that each of the plurality of dual-role electrodes is associated with a single conductor configured to both carry sensed signals from and to deliver a stimulation signal to one of the plurality of dual-role electrodes) in order to “provide a unique stimulation signal to each of the electrodes” (Mora Lopez at Para. [0040]).
Regarding Claim 5, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
The combination of Shepard, Lee and Karmarkar does not disclose:
wherein stimulation signals selectively delivered from the signal generator to corresponding ones of the plurality of electrodes cause activation during a first time period of a first set of the plurality of electrodes to provide a first stimulation pattern and cause activation, during a second time period different from the first time period, of a second set of the plurality of electrodes to provide a second stimulation pattern
Mora Lopez describes “Electrode arrangement for stimulating and recording electrical signals in biological matter, a neural probe, a micro-electrode array and a method for controlling an electrode arrangement” (Title). Mora Lopez is analogous art.
Mora Lopez teaches:
wherein stimulation signals selectively delivered from the signal generator to corresponding ones of the plurality of electrodes cause activation during a first time period of a first set of the plurality of electrodes to provide a first stimulation pattern and cause activation, during a second time period different from the first time period, of a second set of the plurality of electrodes to provide a second stimulation pattern (Para. [0130], “In addition to controlling current densities of a combined macroelectrode site 114 by varying a magnitude of a stimulation signal, steering of stimulation currents and fields may be achieved by varying waveforms, amplitudes, delays, or phase of the stimulation patterns at each electrode independently. For instance, the control unit 120 may control a phase (for an AC stimulation signal, such as a sinusoid signal) or a time delay (for pulse-based waveforms, such as monophasic, biphasic and triphasic waveforms) in addition to the magnitude (amplitude) in order to control the amount of charge injected in an electrode 112 of the combined macroelectrode site 114 at a given time interval. This opens a possibility of steering the charge or current injected to achieve a “beamforming effect” for controlling a location of injected charges in relation to the location of the combined macroelectrode site 114, in addition to a spatial steering already available by selection of different electrodes 112 that are to form the combined macroelectrode site 114;” see also Paras. [0099] through [0102]).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shepard, Lee and Karmarkar with the teachings of Mora Lopez (i.e., to modify the device of combined Shepard, Lee and Karmarkar such that its stimulation signals provide such first and second patterns as those of Mora Lopez’s configuration) in order to “control the amount of charge injected in an electrode” (Mora Lopez at Para. [0130]).
Regarding Claim 7, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 6 as explained above.
The combination of Shepard, Lee and Karmarkar does not disclose:
wherein the at least one conductor includes a surface comprising a surface area between 25 and 400 square microns
Mora Lopez describes “Electrode arrangement for stimulating and recording electrical signals in biological matter, a neural probe, a micro-electrode array and a method for controlling an electrode arrangement” (Title). Mora Lopez is analogous art.
Mora Lopez teaches:
wherein the at least one conductor includes a surface comprising a surface area between 25 and 400 square microns (Para. [0037], “According to an embodiment, an electrode may be circular with a diameter of a 10-20 μm. However, it should be realized that many other sizes are possible or suitable…”).
Mora Lopez’s disclosed diameter equates to an area that falls within the claimed range. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05. Although Mora Lopez does not discloses the precise range of “between 25 and 400 square microns,” it would have been obvious for a person of ordinary skill in the art to select from Mora Lopez’s circular conductor “with a diameter of a 10-20 μm” any diameter, including such a diameter resulting in an area “between 25 and 400 square microns” because so-doing entails only routine optimization and is likely to result in success. Furthermore, the Present Specification (which discusses the claimed surface area at Para. [0051]) does not describe the range as imparting any sort of criticality or unexpected result.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shepard, Lee and Karmarkar with the teachings of Mora Lopez (i.e., to modify the conductor of combined Shepard, Lee and Karmarkar such that it includes a surface comprising a surface area between 25 and 400 square microns) because such a modification entails a mere change in size/proportion, which is a common practice the court has held normally requires only ordinary skill in the art and hence is considered a routine expedients. See MPEP2144.04(IV)(A).
Regarding Claim 10, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
The combination of Shepard, Lee and Karmarkar does not disclose:
wherein the sensing assembly comprises circuitry operable to switch each of the plurality of electrodes between a sensing mode and a stimulation mode
Mora Lopez describes “Electrode arrangement for stimulating and recording electrical signals in biological matter, a neural probe, a micro-electrode array and a method for controlling an electrode arrangement” (Title). Mora Lopez is analogous art.
Mora Lopez teaches:
wherein the sensing assembly comprises circuitry operable to switch each of the plurality of electrodes between a sensing mode and a stimulation mode (Para. [0097], “The control unit 120 may control functionality of the electrodes 112 in the array 110, by selecting which electrodes 112 are to receive stimulation signals and selecting which electrodes 112 that are to be used for reading a recorded signal.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shepard, Lee and Karmarkar with the teachings of Mora Lopez (i.e., to modify the sensing assembly of combined Shepard, Lee and Karmarkar such that it additionally including such circuitry operable to switch each of the plurality of electrodes between a sensing mode and a stimulation mode as taught by Mora Lopez) in order to more finely control the function of the electrodes (Mora Lopez at Para. [0097]).
Regarding Claim 63, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
The combination of Shepard, Lee and Karmarkar does not disclose:
wherein the neural probe further comprises one or more switches configured to switch the role of each of the dual-role electrodes between sensing and stimulation
Mora Lopez describes “Electrode arrangement for stimulating and recording electrical signals in biological matter, a neural probe, a micro-electrode array and a method for controlling an electrode arrangement” (Title). Mora Lopez is analogous art.
Mora Lopez teaches:
wherein the neural probe further comprises one or more switches configured to switch the role of each of the dual-role electrodes between sensing and stimulation(Para. [0012], “…electrodes in the array are configured to be switchable between stimulating and recording of electrical signals…”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shepard, Lee and Karmarkar with the teachings of Mora Lopez (i.e., to modify the probe of combined Shepard, Lee and Karmarkar such that it additionally includes such switches configured to switch each of the plurality of electrodes between a sensing mode and a stimulation mode as taught by Mora Lopez) in order to more finely control the function of the electrodes (Mora Lopez at Para. [0097]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0185656 A1 to Shepard et al. (“Shepard”) in view of US 2006/0195157 A1 to Lee et al. (“Lee”) and US 2008/0039709 A1 to Karmarkar (“Karmarkar”) as applied to Claim 1 above, and further in view of previously cited US 2011/0270348 A1 to Goetz (“Goetz”).
Regarding Claim 3, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
Karmarkar additionally teaches:
wherein the at least one flexible signal lead includes a plurality of conductors (Fig. 3B, “conductors 26;” Paras. [0054] through [0056]).
The combination of Shepard, Lee and Karmarkar does not disclose:
such that each of the plurality of dual-role electrodes is associated with at least two conductors, wherein a first of the at least two conductors is configured to carry sensed signals from a particular one of the plurality of dual-role electrodes, and a second of the at least two conductors, different from the first of the at least two conductors, is configured to deliver a stimulation signal to the particular one of the plurality of dual-role electrodes
Goetz discloses “A programming system allows a user to program therapy parameter values for therapy delivered by a medical device by specifying a desired therapeutic outcome. In an example, the programming system presents a model of a brain network associated with a patient condition to the user. The model may be a graphical representation of a network of anatomical structures of the brain associated with the patient condition and may indicate the functional relationship between the anatomical structures.” (Abstract). Goetz is thus analogous art.
Goetz discloses:
such that each of the plurality of dual-role electrodes is associated with at least two conductors, wherein a first of the at least two conductors is configured to carry sensed signals from a particular one of the plurality of dual-role electrodes, and a second of the at least two conductors, different from the first of the at least two conductors, is configured to deliver a stimulation signal to the particular one of the plurality of dual-role electrodes (Para. [0031], “In some examples, lead 10 may also carry one or more sense electrodes to permit implantable stimulator 4 to sense electrical signals from patient 6. Some of the stimulation electrodes may be coupled to function as stimulation electrodes and sense electrodes on a selective basis. In other examples, implantable stimulator 4 may be coupled to one or more leads which may or may not be bifurcated. In such examples, the leads may be coupled to implantable stimulator 4 via a common lead extension or via separate lead extensions.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shepard, Lee and Karmarkar with the teachings of Goetz (i.e., to use such separate conductors for stimulation and sensing as taught by Goetz in the device of combined Shepard, Lee and Karmarkar in place of Karmarkar’s single conductor) because such a modification entails simple substitution of one known element for another to obtain predictable results.
The prior art contains a device (i.e., the device of combined Shepard, Lee and Karmarkar) which differs from the claimed device by the substitution of some components (i.e., a single conductor which both carries senses signals and transmits stimulation signals) with other components (i.e., a lead which uses separate conductors for carrying sensed signals and transmitting stimulation signals).
The substituted components (i.e., a lead which uses separate conductors for carrying sensed signals and transmitting stimulation signals) and their functions were known in the art. For example, Goetz discloses such components at Para. [0031].
One of ordinary skill in the art could have substituted such a single conductor configuration as taught by Shepard, Lee and Karmarkar with such a bifurcated lead as taught by Goetz. The results of the substitution would have been predictable.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0185656 A1 to Shepard et al. (“Shepard”) in view of US 2006/0195157 A1 to Lee et al. (“Lee”) and US 2008/0039709 A1 to Karmarkar (“Karmarkar”) as applied to Claim 1 above, and further in view of previously cited US 2021/0085961 A1 to Ferro et al. (“Ferro”).
Regarding Claim 9, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
The combination of Shepard, Lee and Karmarkar does not disclose:
wherein each of the plurality of electrodes has an impedance of between 1 kOhms and 1 MOhm
Ferro describes “A neural implant is provided for electrical stimulation and recording of brain or nervous system tissue” (Abstract). Ferro is thus analogous art.
Ferro discloses:
wherein each of the plurality of electrodes has an impedance of between 1 kOhms and 1 MOhm (Para. [0028], “The rough Pt or PEDOT-PSS pads at each tip provided low impedance electrodes. For example, the 15 micrometers diameter Pt electrodes exhibited an average impedance of 40 kΩ to 2MΩ at 1 kHz and 100Ω to 2MΩ between 0.1 Hz and 1 MHz.”).
Ferro’s disclosed range overlaps the claimed range. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shepard, Lee and Karmarkar with the teachings of Ferro (i.e., to alter the electrodes of Shepard, Lee and Karmarkar such that each has an impedance between 1 kOhms and 1 MOhm) in order to “provide a superior platform for the low-noise recording of localized electrophysiological activity” (Ferro at Para. [0028]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0185656 A1 to Shepard et al. (“Shepard”) in view of US 2006/0195157 A1 to Lee et al. (“Lee”) and US 2008/0039709 A1 to Karmarkar (“Karmarkar”) as applied to Claim 1 above, and further in view of previously cited US 2015/0112360 A1 to Pellinen et al. (“Pellinen”).
Regarding Claim 13, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 10 as explained above.
The combination of Shepard, Lee and Karmarkar does not disclose:
wherein the neural probe comprises two facets, including a first facet and a second facet on opposing faces of the neural probe, on which at least some of the plurality of electrodes are disposed
Pellinen describes “a neural probe comprising an electrode array of at least one of a stimulation electrode and a recording electrode” (Para. [0003]). Pellinen is thus analogous art.
Pellinen discloses:
wherein the neural probe comprises two facets, including a first facet and a second facet on opposing faces of the neural probe, on which at least some of the plurality of electrodes are disposed (Para. [0043], “The neural probe 16 comprises opposed first and second electrodes 36 and 38 comprising an electrode array supported by a tape-spring-type carrier 40.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shepard, Lee and Karmarkar with the teachings of Pellinen (i.e., to employ such electrodes position on opposing surfaces as taught by Pellinen in the device of combined Shepard, Lee and Karmarkar a) in order to increase probative capacity while minimizing trauma to surrounding tissue (Pellinen at Abstract, Para. [0052]).
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0185656 A1 to Shepard et al. (“Shepard”) in view of US 2006/0195157 A1 to Lee et al. (“Lee”) and US 2008/0039709 A1 to Karmarkar (“Karmarkar”) as applied to Claim 10 above, and further in view of previously cited US 2008/0119711 A1 to Nikumb et al. (“Nikumb”).
Regarding Claim 14, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 10 as explained above.
The combination of Shepard, Lee and Karmarkar does not disclose:
wherein the neural probe comprises three facets on which at least some of the plurality of electrodes are disposed
Nikumb describes a “Neurological Probe And Method Of Using Same” (Title). Nikumb is thus analogous art.
Nikumb discloses:
wherein the neural probe comprises three facets on which at least some of the plurality of electrodes are disposed (Para. [0107], “FIGS. 7C and 7D show eight individual electrode elements 701 (only one labeled) stacked in a staggered fashion such that there is a stimulating/lesioning channel and a recording channel every 0.5 mm along the length of the probe from the tip to a position about 3.5 mm from the tip. Each electrode element comprises first electrode 702 (only one labeled) and second electrode 703 (only one labeled) on a strip of non-conductive substrate. The electrodes of the top four electrode elements face up while the electrodes of the bottom four electrode elements face down, thereby providing fields on opposite sides of the stack;” see Annotated Figs. 7C and 7D, below).
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It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shepard, Lee and Karmarkar with the teachings of Nikumb (i.e., to employ three facets on which electrodes are disposed in the device of combined Shepard, Lee and Karmarkar) in order to make the probe “more compact while having a large number of stimulation/lesioning and recording channels” (Nikumb at Abstract).
Regarding Claim 15, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 10 as explained above.
The combination of Shepard, Lee and Karmarkar does not disclose:
“wherein the neural probe comprises four facets on which at least some of the plurality of electrodes are disposed”
Nikumb describes a “Neurological Probe And Method Of Using Same” (Title). Nikumb is thus analogous art.
Nikumb discloses:
wherein the neural probe comprises four facets on which at least some of the plurality of electrodes are disposed” (Para. [0107], “FIGS. 7C and 7D show eight individual electrode elements 701 (only one labeled) stacked in a staggered fashion such that there is a stimulating/lesioning channel and a recording channel every 0.5 mm along the length of the probe from the tip to a position about 3.5 mm from the tip. Each electrode element comprises first electrode 702 (only one labeled) and second electrode 703 (only one labeled) on a strip of non-conductive substrate. The electrodes of the top four electrode elements face up while the electrodes of the bottom four electrode elements face down, thereby providing fields on opposite sides of the stack;” see Annotated Figs. 7C and 7D, above).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shepard, Lee and Karmarkar with the teachings of Nikumb (i.e., to employ four facets on which electrodes are disposed in the device of combined Shepard, Lee and Karmarkar) in order to make the probe “more compact while having a large number of stimulation/lesioning and recording channels” (Nikumb at Abstract).
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0185656 A1 to Shepard et al. (“Shepard”) in view of US 2006/0195157 A1 to Lee et al. (“Lee”) and US 2008/0039709 A1 to Karmarkar (“Karmarkar”) as applied to Claim 1 above, and further in view of previously cited US 2015/0005607 A1 to Cui et al. (“Cui”).
Regarding Claim 18, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
The combination of Shepard, Lee and Karmarkar does not disclose:
wherein in response to a delivered stimulation signal, each of the plurality of electrodes is configured to cause emission of an electrical field extending into the brain by at least 50 microns
Cui describes “neural probes comprising an L1 polypeptide functional fragment thereof on the exterior surface of the probe, devices including such electrodes, and methods of their use. The disclosed embodiments are useful, for example, for in methods of recording and/or stimulating neural signals in a subject.” (Abstract). Cui is thus analogous art.
Cui discloses:
wherein in response to a delivered stimulation signal, each of the plurality of electrodes is configured to cause emission of an electrical field extending into the brain by at least 50 microns (Para. [0189], “Whereas non-modified probes induced persistent glial activation and significant decreases of neuronal and axonal densities (FIG. 14), the immediate area (100 .mu.m) around the L1 coated probe showed no loss of neuronal bodies and a significantly increased axonal density relative to background (FIGS. 14A-14D). In this same region, significantly lower activation of microglia and reaction of astrocytes around the L1 modified probes were found when compared to the control probes (FIGS. 14E-14G) (Azemi et al., Biomaterials, 2011. 32(3): p. 681-92).”).
The limitation “extending into the brain by at least 50 microns” is being interpreted to mean at least 50 microns as measured from the electrode.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shepard, Lee and Karmarkar with the teachings of Cui (i.e., to employ such a coating as taught by Cui in the device of combined Shepard, Lee and Karmarkar, which coating results in emission of electrical field extending 100 microns) in order to “minimize detrimental tissue responses and impairment of neural function throughout the entire implantation life of the implant” (Cui at Para. [0004]).
Regarding Claim 19, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
The combination of Shepard, Lee and Karmarkar does not disclose:
wherein each of the plurality of electrodes is configured to sense electrical signals generated by brain neurons located within a range of up to 200 microns
Cui describes “neural probes comprising an L1 polypeptide functional fragment thereof on the exterior surface of the probe, devices including such electrodes, and methods of their use. The disclosed embodiments are useful, for example, for in methods of recording and/or stimulating neural signals in a subject.” (Abstract). Cui is thus analogous art.
Cui discloses:
wherein each of the plurality of electrodes is configured to sense electrical signals generated by brain neurons located within a range of up to 200 microns (Para. [0038], “Implanted neural probes include electrodes that detect neuronal action potentials by detecting extracellular electrical potential changes (10's to 100's of microvolt) in reference to a ground. The closer the electrode is to a neuron, the better signal strength and quality of neural signals that can be recorded from the electrode. It is reported that 50-100 .mu.m is the maximum distance that a microelectrode can obtain measurable signals from a neuron. For high quality long-term stable recording, the proximity of electrodes to neurons needs to be maintained over time;” Para. [0194], “L1 Coating Improves Chronic Recording Performance[:] The L1 coated arrays detected 120 single-units on day 2 and the unit counts continued to increase to 240 on day 75 (FIG. 17). Remarkably, many channels have more than one and up to 7 well isolated single-units (FIG. 17b). The amplitude of some of the units can be as high as 1 mV (FIG. 17D). The increases continued for extended time periods, with excellent recording performance maintained at 18 months post-implant (FIG. 18A). On some channels, unit waveforms are very stable and signal amplitudes are extraordinarily large even at day 447 (FIG. 18B). This high amplitude suggest that the neuron is directly on the electrode site with very tight cell-electrode seal (Pettersen and Einevoll, Biophys J, 2008. 94(3): p. 784-802.).”).
The limitation “located within a range of up to 200 microns” is being interpreted to mean that the range is up to 200 microns measures from the electrode.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shepard, Lee and Karmarkar with the teachings of Cui (i.e., to employ such a coating as taught by Cui in the device of combined Shepard, Lee and Karmarkar, which coating results in a “very tight cell-electrode seal” and thereby facilitates recording at distances between 50 and 100 microns from the electrode) in order to “minimize detrimental tissue responses and impairment of neural function throughout the entire implantation life of the implant” (Cui at Para. [0004]).
Claim 61 is rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0185656 A1 to Shepard et al. (“Shepard”) in view of US 2006/0195157 A1 to Lee et al. (“Lee”) and US 2008/0039709 A1 to Karmarkar (“Karmarkar”) as applied to Claim 1 above, and further in view of US 20230263456 A1 to Rourk (“Rourk”).
Regarding Claim 61, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
The combination of Shepard, Lee and Karmarkar does not disclose:
wherein the at least one flexible signal lead has a length of at least 40 millimeters
Rourk describes a “Deep brain sensing and stimulation probe” (Title). Rourk is analogous art.
Rourk teaches:
wherein the at least one flexible signal lead has a length of at least 40 millimeters (Para. [0023], “The lead can have a suitable cross-sectional diameter sufficient to provide mechanical support for the other components of probe 100, but small enough to minimize trauma to the neural tissue that it will be disposed in, such as the range of 0.75 to 1.5 mm, a length of at least 10 cm or longer, as suitable.”).
Rourk’s “10 cm or longer” is “at least 40 millimeters.”
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shepard, Lee and Karmarkar with the teachings of Rourk (i.e., to modify Shepard, Lee and Karmarkar’s lead such that it has the dimensions described by Rourk) in order to provide sufficient mechanical support (Rourk at Para. [0023]).
Claim 62 is rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0185656 A1 to Shepard et al. (“Shepard”) in view of US 2006/0195157 A1 to Lee et al. (“Lee”) and US 2008/0039709 A1 to Karmarkar (“Karmarkar”) as applied to Claim 1 above, and further in view of US 20190321626 A1 to Fluri et al. (“Fluri”).
Regarding Claim 62, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
Shepard additionally teaches:
wherein the one or more of the plurality of dual-role electrodes are configured to sense electrical signals from individual neurons, or a plurality of neurons, within a … radius from an area of the neural probe on which the one or more of the plurality of dual-role electrodes are located Para. [0023], “…the probes 112 can cover multiple brain areas simultaneously, such as multiple cortical regions, the hippocampus, and thalamus, and numerous subcortical structures…”).
Shepard’s electrodes sense electrical signals in the manner claimed within an unspecified radius.
Shepard does not specify the radius within which its electrodes sense electrical signals.
The combination of Shepard, Lee and Karmarkar thus does not disclose:
a 200-micron radius
Fluri describes “…methods for determining therapeutic efficacy of deep brain stimulation…” (Para. [0010]). Fluri is analogous art.
Fluri teaches:
a 200-micron radius (Para. [0130], “…monopolar stimulation with a current intensity of 40 μA, as used in this experiment, may excite neural elements (i.e., myelinated axons) within a radius of 500 to 700 μm from the electrode tip.33…”).
Fluri teaches that a particular stimulation results in excitement of neural elements within a radius of 500-700 microns.
The claimed range of “within 200 microns” lies inside Fluri’s range of “within a radius of 500 to 700” microns. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I).
Fluri fails to explicitly teach a range of “within 200 microns.” However, based on Fluri’s disclosed overlapping range of “within a radius of 500 to 700” microns, it would have been obvious for a person of ordinary skill in the art to choose any one of the radii disclosed by Fluri, including “within 200 microns” as this is merely choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success or alternatively optimizing a result effective variable.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shepard, Lee and Karmarkar with the teachings of Fluri (i.e., to modify the device of combined Shepard, Lee and Karmarkar such that that the radius within which Shepard’s electrodes sense electrical signals is within a radius of 200 microns) because certain stimulations excited neurons within that radius (Fluri at Para. [0130]) and sensing activity within such a radius of excited neurons is beneficial to assess the impact of an applied stimulation (Fluri at Para. [0006]).
Claim 66 is rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0185656 A1 to Shepard et al. (“Shepard”) in view of US 2006/0195157 A1 to Lee et al. (“Lee”) and US 2008/0039709 A1 to Karmarkar (“Karmarkar”) as applied to Claim 1 above, and further in view of US 2010/0137962 A1 to Moffitt et al. (“Moffitt”).
Regarding Claim 66, the combination of Shepard, Lee and Karmarkar renders obvious the entirety of Claim 1 as explained above.
The combination of Shepard, Lee and Karmarkar does not disclose:
wherein the at least one flexible signal lead has a cross-section diameter of less than 1 millimeter
Moffit describes “…systems and methods for preventing or reducing inadvertent stimulation of tissue adjacent an implantable neurostimulator” (Para. [0002]). Moffitt is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
Moffit teaches:
wherein the at least one flexible signal lead has a cross-section diameter of less than 1 millimeter (Para. [0039], “The stimulation lead 14 is preferably less than 5 mm in diameter, and more preferably less than 1.5 mm in diameter.”).
Moffit’s disclosed range overlaps the claimed range. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05. Although Moffit does not discloses the precise range of “less than 1 mm,” it would have been obvious for a person of ordinary skill in the art to select from Moffitt’s range of “less than 1.5 mm” any diameter, including such a diameter of “less than 1 mm” because so-doing entails only routine optimization and is likely to result in success. Furthermore, the Present Specification (which discusses the claimed surface area at Para. [0103]) does not describe the range as imparting any sort of criticality or unexpected result.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Shepard, Lee and Karmarkar with the teachings of Moffit (i.e., to modify the lead of combined Shepard, Lee and Karmarkar such that its diameter is 1 mm or less) because such a modification entails a mere change in size/proportion, which is a common practice the court has held normally requires only ordinary skill in the art and hence is considered a routine expedients. See MPEP2144.04(IV)(A).
Notice of Art Considered Relevant Although Not Relied Upon
The Examiner makes of record the following prior art, which is made of record although not relied upon in any foregoing rejection:
US 2016/0128588 A1 describes “Deep-Brain Probe And Method For Recording And Stimulating Brain Activity” (Title) and includes electrodes positioned at the subthalamic nucleus at Para. [0042].
US 2006/0265039 A1 describes “Probe Device For Electrical Stimulation And Recording Of The Activity Of Excitable Cells” (Title) and details a multi-electrode positioned in the subthalamic nuclear at Para. [0004].
US 2024/0057943 A1 describes “Spatially expandable probes and scaffolds for spatially expandable probes are provided that allow for interfacing across distant regions of the brain” (Abstract) and describes electrodes positioned in the thalamus at Para. [0036]
US 8,229,539 B1 describes a “Brain Probe And Method For Manufacturing Same” (Title), and teaches positioning of its electrodes within the basal ganglia at Col. 5, Ln. 44-55.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J MUTCHLER whose telephone number is (571)272-8012. The examiner can normally be reached M-F 7:00 am - 4:00 pm.
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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
1 US 2018/0185656 A1 was disclosed by Applicant in the IDS dated 2/4/2025.
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