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 .
Election/Restrictions
Applicant’s election with traverse of Group I (claims 1-12), see pg. 7 of remarks filed 06/03/2026, is acknowledged. The traversal is on the grounds that claim 12 has been amended to remove the “providing a recommendation” limitation. Applicant’s arguments have been fully considered and are persuasive. The restriction requirement has been withdrawn.
Claims 1-20 are examined.
Claim Objections
Claims 2 and 14 are objected to because of the following informalities: “immediate” in line 2 should be changed to “immediately”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 3 is 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.
The term “more favorably” in claim 3 is a relative term which renders the claim indefinite. The term “more favorably” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what “favorable” means in the context of the claims and how similar the ERs would need to be to the acceptance criterion to be considered “more favorable”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 3-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, and 8 of copending Application No. 18/782,807 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other (see below).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18/784,365 (Instant Application)
18/782,807 (Reference Application)
Claim 1: A medical-device system, comprising:
at least one lead including a plurality of electrodes;
an electrostimulator configured to provide electrostimulation to a neural target of a patient;
a sensing circuit configured to sense an evoked response (ER) to the electrostimulation; and
a controller circuit operably connected to the electrostimulator and the sensing circuit, the controller circuit configured to:
deliver the electrostimulation to the neural target in accordance with a stimulation setting via a stimulating electrode selected from the plurality of electrodes on the at least one lead;
collect sensed ERs to the electrostimulation from each of a group of sensing electrodes selected from, and less than an entirety of, the plurality of electrodes on the at least one lead, the group of selected sensing electrodes located within a specific proximity to the selected stimulating electrode; compare the ERs sensed from the group of selected sensing electrodes to an acceptance criterion to produce a comparison result; and
display the ERs and the comparison result on a user interface.
Claim 1: A neuromodulation system, comprising:
at least one lead including a plurality of electrodes;
an electrostimulator configured to provide electrostimulation to a neural target of a patient;
a sensing circuit configured to sense an evoked response (ER) to the electrostimulation; and
a controller circuit operably connected to the electrostimulator and the sensing circuit, the controller circuit configured to:
deliver the electrostimulation to the neural target in accordance with a stimulation setting via a stimulating electrode selected from the plurality of electrodes on the at least one lead;
collect sensed ERs to the electrostimulation from each of a group of sensing electrodes distinct from the stimulating electrode and selected from the plurality of electrodes on the at least one lead;
compare the ERs sensed from the group of selected sensing electrodes to acceptance criteria to produce a comparison result; and
display the comparison result on a user interface.
Claim 3: wherein the controller circuit is further configured to, based at least in part on the comparison result, provide a recommendation on the user interface to reposition the at least one lead or to adjust the stimulation setting to cause the sensed ERs from the group of selected sensing electrodes to compare more favorably to the acceptance criterion.
Claim 2: wherein the controller circuit is further configured to, based at least in part on the comparison result, provide a recommendation on the user interface to reposition the at least one lead or to adjust the stimulation setting to cause the sensed ERs from the group of selected sensing electrodes to compare more favorably to the acceptance criteria.
Claim 4: wherein the at least one lead includes a deep brain stimulation (DBS) lead, and wherein the electrostimulator is configured to provide DBS to a brain target of the patient.
Claim 3: wherein the at least one lead includes a deep brain stimulation (DBS) lead, and wherein the electrostimulator is configured to provide DBS to a brain target of the patient in accordance with a stimulation setting based on the sensed ERs.
Claim 5: wherein the plurality of electrodes include one or more ring electrodes disposed at respective longitudinal positions along a length of the at least one lead, or one or more rows of segmented electrodes where each row comprises segmented electrodes disposed about a circumference of the at least one lead at a specific longitudinal position, wherein the stimulating electrode and the group of selected sensing electrodes are each selected from the one or more ring electrodes or the one or more rows of segmented electrodes.
Claim 5: wherein the at least one lead includes (i) one or more ring electrodes disposed at respective longitudinal positions along a length of the at least one lead and (ii) two or more segmented electrodes disposed about a circumference of the at least one lead at a specific longitudinal position, wherein the stimulating electrode and the group of selected sensing electrodes are each selected from the one or more ring electrodes or the two or more segmented electrodes.
Claim 6: wherein the acceptance criterion includes a target distribution of ERs across the group of selected sensing electrodes, wherein the controller circuit is configured to:
determine a spatial distribution of the sensed ERs across the group of selected sensing electrodes; and
provide a recommendation on the user interface to reposition the at least one lead or to adjust the stimulation setting based at least in part on a comparison of the determined spatial distribution of the sensed ERs and the target distribution.
Claim 8: wherein the acceptance criteria includes a target distribution of ERs across the group of selected sensing electrodes, wherein the controller circuit is configured to:
determine a spatial distribution of the sensed ERs across the group of selected sensing electrodes; and
provide a recommendation on the user interface to reposition the at least one lead or to adjust the stimulation setting based at least in part on a comparison of the determined spatial distribution of the sensed ERs and the target distribution.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C 101 because the claimed invention is directed to non-statutory subject matter of abstract ideas under the mental processes and mathematical concepts groupings, without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Step (1)
The claimed invention in claims 1-20 are directed to a system and method, and thus, the claims all fall under one of the four patent eligible categories.
Step (2a) Prong 1 (Judicial Exception)
Regarding claims 1-20, the recited steps are directed towards mental processes of performing concepts in a human mind or by a human using a pen and paper and utilizing mathematical concepts (See MPEP 2106.04(a)(2) subsections (I) and (III)).
Independent claims 1 and 13 recite:
collect sensed ERs to the electrostimulation from each of a group of sensing electrodes selected from, and less than an entirety of, the plurality of electrodes on the at least one lead,
compare the ERs sensed from the group of selected sensing electrodes to an acceptance criterion to produce a comparison result.
Under the broadest reasonable interpretation, these limitations require comparing evoked responses (ERs) to an acceptance criterion. These limitations are processes that, as drafted, cover that which can be wholly performed in a person’s mind via a series of mental observations and judgements and utilizing mathematical concepts. In particular, a person can take an observed/measured neural signal and compare it to an expected neural signal or acceptance criteria. These are data gathering and processing steps (collect, compare) that reflect mental processes and mathematical concepts.
Accordingly, claims 1 and 13 are directed to a judicial exception including one or more abstract ideas, specifically mental processes and mathematical concepts.
Independent claims 1 and 13 recite the corresponding apparatus associated with the system/method, including a medical device system, a lead with electrodes, electrostimulator, sensing circuit, and controller. Under the broadest reasonable interpretation, these claims also recite a judicial exception including one or more abstract ideas under the mental processes and mathematical concepts buckets.
The additional limitations in dependent claims 2-12 and 14-20 comprise additional abstract ideas and/or further limit the abstract ideas of claims 1 and 13:
Claims 2 and 14: sensing electrodes are adjacent to stimulating electrode
Claim 3: recommend the user repositions lead/adjusts stimulation settings
Claim 4: DBS lead
Claim 5: ring or segmented electrodes
Claims 6 and 15: recommendation is based on spatial distributions of ERs
Claims 7 and 16: recommendation is based on target ER feature
Claims 8 and 17: filter ERs
Claims 9 and 18: subtract parametric model artifact component from ER
Claims 10 and 19: model is polynomial exponential decay
Claims 11 and 20: subtract parametric model artifact component from time-reversed signal
Claim 12: collect ERs during pause of electrostimulation delivery
Step (2a) Prong 2 (Integration into a Practical Application)
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d).
For claims 1-20, the judicial exception is not integrated into a practical application.
Regarding claims 1 and 13, the additional element of collecting sensed ERs from sensing electrodes amount to recitation of a generic sensing electrode. Under the broadest reasonable interpretation, these elements are nothing more than the pre-solution activity of mere data gathering using generic components.
Regarding claims 1 and 13, the additional element of displaying the ERs and comparison result on a user interface amounts to recitation of a generic display. Under the broadest reasonable interpretation, these elements are nothing more than the post-solution activity of providing results using generic components.
Regarding claims 1 and 13, the additional elements of a medical device system, lead with electrodes, and an electrostimulator amount to recitation of a generic DBS system/lead. Merely stating that the abstract idea will be for "providing electrostimulation to a neural target of a patient" is an instruction to apply the abstract idea in a particular technological environment. As in Alice Corp. v. CLS Bank, 573 U.S. 208, 223 (2014), limiting an abstract idea to a field of use or adding generic hardware does not integrate the exception into a practical application.
Regarding claims 1 and 13, the additional elements of sensing and controller circuits amount to recitation of a generic controller. This additional element merely defines the field of use of the current claim. This additional element does not practically integrate the judicial exception because this element does not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Furthermore, when the claims, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it is still in the mental processes grouping unless the claim limitation cannot practically be performed in the mind. Likewise, performance of a claim limitation using generic computer components does not preclude the claim limitation from being in the mental processes grouping.
Step (2b) (Inventive Concept)
The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the judicial exception into a practical application, the additional elements of a medical device system, a lead with electrodes, electrostimulator, sensing circuit, and controller in the field of DBS are well-understood, routine and conventional activities previously known in the industry as indicated in the following reference:
Xiao et al. (US Pre-Grant Publication 2017/0100601) teaches conventional approaches for programming deep brain stimulation systems (see [0010]).
Accordingly, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Claims 1-20 are thus rejected under 35 USC 101 for reciting patent-ineligible subject matter- abstract ideas and mathematical concepts.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-8, 12-13, and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moffitt (US Pre-Grant Publication 2022/0040486), hereinafter ‘Moffitt’.
Regarding claim 1, Moffitt teaches a medical-device system (abstract, systems for implanting stimulation leads in patient’s brain), comprising:
at least one lead (lead 15, Fig. 1A) including a plurality of electrodes (electrodes 16, Fig. 1A);
an electrostimulator (IPG 10, Fig. 1A) configured to provide electrostimulation to a neural target of a patient ([0041], provide therapeutic stimulation to a patient, Fig. 9);
a sensing circuit (sensing/feedback algorithm 140, Fig. 6) configured to sense an evoked response (ER) to the electrostimulation ([0062], senses evoked resonant neural responses (ERNAs)); and
a controller circuit (control circuitry 102, Fig. 6) operably connected to the electrostimulator and the sensing circuit ([0061], IPG includes control circuitry, see Fig. 6), the controller circuit configured to:
deliver the electrostimulation to the neural target in accordance with a stimulation setting via a stimulating electrode ([0035], tissue-stimulating electrodes) selected from the plurality of electrodes on the at least one lead (stimulation circuitry 28, Fig. 6, [0063], stimulation circuitry produces stimulation at the electrodes);
collect sensed ERs to the electrostimulation from each of a group of sensing electrodes (S+, S-, Fig. 6) selected from, and less than an entirety of, the plurality of electrodes on the at least one lead ([0064], multiplexer 108 can select one or more electrodes to operate as sensing electrodes), the group of selected sensing electrodes located within a specific proximity to the selected stimulating electrode ([0078], ER 906 programs stimulation/sensing parameters);
compare the ERs sensed from the group of selected sensing electrodes to an acceptance criterion to produce a comparison result (steps 1106, 1108, Fig. 11, [0084], determine if predicted efficacy at the present location is adequate); and
display the ERs and the comparison result on a user interface (UI 1000, Fig. 10, [0088], display information about optimal lead placement).
Regarding claim 3, Moffitt teaches the system of claim 1, further comprising:
wherein the controller circuit is further configured to, based at least in part on the comparison result, provide a recommendation on the user interface to reposition the at least one lead or to adjust the stimulation setting (step 1111, Fig. 11, [0084], suggest a distance/direction to move the lead) to cause the sensed ERs from the group of selected sensing electrodes to compare more favorably to the acceptance criterion (step 1104, optimize stimulation, Fig. 11, [0084], determine where stimulation provides the best ERNA response).
Regarding claim 4, Moffitt teaches the system of claim 1, further comprising:
wherein the at least one lead includes a deep brain stimulation (DBS) lead ([0077], lead configured for DBS), and wherein the electrostimulator is configured to provide DBS to a brain target of the patient (see Fig. 9).
Regarding claim 5, Moffitt teaches the system of claim 1, further comprising:
wherein the plurality of electrodes include one or more ring electrodes disposed at respective longitudinal positions along a length of the at least one lead (electrodes 16, Fig. 1A, [0035], electrodes are ring-shaped), or one or more rows of segmented electrodes (electrodes E2-E4, Fig. 1B) where each row comprises segmented electrodes disposed about a circumference of the at least one lead at a specific longitudinal position ([0036], split-ring electrodes span less than 360 degrees around the axis), wherein the stimulating electrode and the group of selected sensing electrodes are each selected from the one or more ring electrodes or the one or more rows of segmented electrodes ([0078], ER 906 programs stimulation/sensing parameters).
Regarding claim 6, Moffitt teaches the system of claim 1, further comprising:
wherein the acceptance criterion includes a target distribution of ERs across the group of selected sensing electrodes (Fig. 12B, [0086], ERNA amplitude as a function of stimulation location), wherein the controller circuit is configured to:
determine a spatial distribution of the sensed ERs across the group of selected sensing electrodes (Fig. 12B); and
provide a recommendation on the user interface to reposition the at least one lead or to adjust the stimulation setting based at least in part on a comparison of the determined spatial distribution of the sensed ERs and the target distribution ([0088], UI presents information relating to location of ERNA source and feedback regarding how to move lead).
Regarding claim 7, Moffitt teaches the system of claim 1, further comprising:
wherein the acceptance criterion includes a target ER feature ([0081], example parameters include amplitude, rate of decay, number of pulses, frequency), wherein the controller circuit is configured to:
determine an ER feature from the ERs sensed from the group of selected sensing electrodes (A2Max, Fig. 12B, [0086]); and
provide a recommendation on the user interface to reposition the at least one lead or to adjust the stimulation setting based at least in part on a comparison of the determined ER feature to the target ER feature ([0086], model based on maximum amplitude of response/slope as a function of position on the lead, [0088], provide feedback to user).
Regarding claim 8, Moffitt teaches the system of claim 1, further comprising:
wherein the controller circuit is further configured to filter the ERs sensed from the group of selected sensing electrodes to remove or substantially attenuate an artifact component from each of the ERs ([0100], Kalman filter, [0101], averaging samples to reduce noise), and to compare the filtered ERs to the acceptance criterion to produce the comparison result ([0100], adjust stimulation settings to minimize difference between measured/desired ERNA features).
Regarding claim 12, Moffitt teaches the system of claim 1, further comprising:
wherein the controller circuit is configured to intermittently pause delivery of the electrostimulation (quiescent phase 1408, Fig. 14), and to collect the ERs sensed from the group of selected sensing electrodes during the intermittent pause ([0098], ERNA response sensed during quiescent phase).
Regarding claim 13, Moffitt teaches a method of providing neurostimulation to a neural target of a patient (abstract, methods for implanting stimulation leads in patient’s brain) via a medical-device system that comprises an electrostimulator (IPG 10, Fig. 1A) and at least one lead coupled thereto (lead 15, Fig. 1A), the method comprising:
delivering electrostimulation to the neural target in accordance with a stimulation setting via a stimulating electrode ([0035], tissue-stimulating electrodes) selected from a plurality of electrodes on the at least one lead (electrodes 16, Fig. 1A, stimulation circuitry 28, Fig. 6, [0063], stimulation circuitry produces stimulation at the electrodes);
sensing evoked responses (ERs) from each of a group of sensing electrodes (S+, S-, Fig. 6) electrically connected to a sensing circuit (sensing/feedback algorithm 140, Fig. 6, [0062], senses evoked resonant neural responses (ERNAs)), the group of sensing electrodes selected from, and less than an entirety of, the plurality of electrodes on the at least one lead ([0064], multiplexer 108 can select one or more electrodes to operate as sensing electrodes), and located within a specific proximity to the selected stimulating electrode ([0078], ER 906 programs stimulation/sensing parameters);
comparing the ERs sensed from the group of selected sensing electrodes to an acceptance criterion to produce a comparison result using a controller circuit (steps 1106, 1108, Fig. 11, [0084], determine if predicted efficacy at the present location is adequate); and
displaying the ERs and the comparison result on a user interface (UI 1000, Fig. 10, [0088], display information about optimal lead placement).
Regarding claim 15, Moffitt teaches the method of claim 13, further comprising:
determining a spatial distribution of the sensed ERs across the group of selected sensing electrodes (Fig. 12B, [0086], ERNA amplitude as a function of stimulation location); and
providing a recommendation on the user interface to reposition the at least one lead or to adjust the stimulation setting based at least in part on a comparison of the determined spatial distribution of the sensed ERs and a target distribution of ERs across the group of selected sensing electrodes ([0088], UI presents information relating to location of ERNA source and feedback regarding how to move lead).
Regarding claim 16, Moffitt teaches the method of claim 13, further comprising:
determining an ER feature from the ERs sensed from the group of selected sensing electrodes (A2Max, Fig. 12B, [0086]); and
providing a recommendation on the user interface to reposition the at least one lead or to adjust the stimulation setting based at least in part on a comparison of the determined ER feature to a target ER feature ([0086], model based on maximum amplitude of response/slope as a function of position on the lead, [0088], provide feedback to user).
Regarding claim 17, Moffitt teaches the method of claim 13, further comprising:
filtering the ERs sensed from the group of selected sensing electrodes to remove or substantially attenuate an artifact component from each of the ERs ([0100], Kalman filter, [0101], averaging samples to reduce noise), and comparing the filtered ERs to the acceptance criterion to produce the comparison result ([0100], adjust stimulation settings to minimize difference between measured/desired ERNA features).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Moffitt (US Pre-Grant Publication 2022/0040486) in view of Su et al. (US Pre-Grant Publication 2022/0001176), hereinafter ‘Su’.
Regarding claims 2 and 14, Moffitt teaches the system/method of claims 1 and 13, but does not specifically teach that the sensing electrodes are immediately adjacent to the stimulating electrode.
Su teaches systems for positioning an implantable electrode (abstract), further comprising:
wherein the selected group of sensing electrodes (sensing sites 66, Fig. 3) include two or more electrodes immediate adjacent to the stimulating electrode (stimulation sites 64, Fig. 3) on the at least one lead ([0050], sensing sites may be adjacent to stimulation sites).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Moffitt to incorporate the teachings of Su to include sensing electrodes immediately adjacent to a stimulating electrode. Doing so would allow for the sensing of a maximum response, as recognized by Su [0068].
Claims 9-10 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Moffitt (US Pre-Grant Publication 2022/0040486) in view of Moses et al. (US Pre-Grant Publication 2017/0105645), hereinafter ‘Moses’.
Regarding claims 9 and 18, Moffitt teaches the system/method of claims 8/17, but does not specifically teach generating a parametric model to fit the artifact and subtracting it from the ERs.
Moses teaches a device for brain stimulation (see [0003]), further comprising:
wherein to filter the ERs sensed from the group of selected sensing electrodes, the controller circuit is configured to, for each of the ERs:
generate a parametric model to fit the artifact component in the each of the ERs in accordance with a fitting criterion (decreasing rational function curve 64, Fig. 4A, [0100], created by fitting); and
subtract the parametric model fitted artifact component from the each of the ERs (corrected signal curve 66, Fig. 4A, [0100], subtracting decreasing rational function curve from original curve).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Moffitt to incorporate the teachings of Moses to include generating a parametric model to fit the artifact and subtracting it from the ERs. Doing so would allow for the extraction of the neurological signal from the measured signal, as recognized by Moses [0046].
Regarding claims 10 and 19, Moffitt and Moses teach the system/method of claims 9/18. Moses teaches the system/method further comprising:
wherein the parametric model is a polynomial-exponential decay model ([0083], exponential decay, [0092], polynomial function).
Claims 11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Moffitt (US Pre-Grant Publication 2022/0040486) in view of Moses et al. (US Pre-Grant Publication 2017/0105645), further in view of Väyrynen et al. (US Pre-Grant Publication 2019/0246927), hereinafter ‘Väyrynen’.
Regarding claims 11 and 20, Moffitt teaches the system/method of claims 8/17, but does not teach generating a parametric model to fit the artifact and subtracting it from a time-reversed signal.
Moses teaches a device for brain stimulation (see [0003]), further comprising:
wherein to filter the ERs sensed from the group of selected sensing electrodes, the controller circuit is configured to, for each of the ERs:
generate a parametric model to fit the artifact component in the each of the signals in accordance with a fitting criterion (decreasing rational function curve 64, Fig. 4A, [0100], created by fitting); and
subtract the parametric model fitted artifact component from the each of the signals (corrected signal curve 66, Fig. 4A, [0100], subtracting decreasing rational function curve from original curve).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Moffitt to incorporate the teachings of Moses to include generating a parametric model to fit the artifact and subtracting it from the signals. Doing so would allow for the extraction of the neurological signal from the measured signal, as recognized by Moses [0046].
Moffitt and Moses do not specifically teach a time-reversed signal.
Väyrynen teaches an apparatus with a processing unit for processing brain signals (abstract), further comprising:
generate a time-reversed signal for each of the ERs ([0102-0103], time-reversed signal).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Moffitt and Moses to incorporate the teachings of Väyrynen to include generating a time-reversed signal, then subtracting the parametric model of Moses from the time-reversed signal of Väyrynen. Doing so would allow for the processing of data, as recognized by Väyrynen [0117].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dinsmoor et al. (US Pre-Grant Publication 2019/0388695) teaches systems for controlling electrical stimulation therapy, including sensing an ECAP.
Parker et al. (US Patent No. 11,110,270) teaches a brain neurostimulator electrode array.
Grill et al. (US Pre-Grant Publication 2023/0285755) teaches methods for estimating the response of neurons to stimulation. See [0083], discussion of convolution, sufficient to reject claims 11 and 20 under 35 USC 103.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.L.O./Examiner, Art Unit 3792
/SHIRLEY X JIAN/Primary Examiner, Art Unit 3792
August 18, 2026
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