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 species a, e, and g (claims 1-8) in the reply filed on 05/18/2026 is acknowledged. The traversal is on the ground(s) that, on pages 7-8, “Applicant has amended claim 13 to recite a controller circuit being used to perform various recited steps (including delivering electrostimulation, comparing the ERs to acceptance criteria, and displaying the comparison results on a user interface). The recited steps of delivering electrostimulation, sensing evoked responses from a group of selected sensing electrodes selected from the plurality of electrodes on the at least one lead, comparing sensed ERs to acceptance criteria, displaying a comparison result, and providing a recommendation to reposition the lead or adjust the stimulation setting are the same operations that the controller circuit of claim 1 is "configured to" perform. The Examiner's reference to "external or internal leads" does not identify a materially different apparatus, because both external and implanted leads fall within the scope of "at least one lead coupled [to the electrostimulator]" as recited in claim 1. Similarly, the assertion that the system "can be used to determine diseases relating to movement disorders" does not identify a materially different process distinct from the recited method steps.”.
This is not found persuasive because the method (Group II) does not require the ERs to be sensed in response to the electrostimulation of the group of electrodes, which the device of Group I requires. Furthermore, the method (Group II) requires the additional step of providing a recommendation which is not required by the device of Group I.
Applicant then argues on pages 9-10 that “First, only option (a) corresponds to a pending claim. Claim 5 recites a lead having both ring electrodes and segmented electrodes. Option (b), directed to a ring-only lead, is drawn from disclosure in the specification (Fig. 3A) but is not the subject of any pending claim. A species election under MPEP 806.04 presupposes that the claims are directed to distinct species; here, the claim set does not include a claim limited to a ring-only lead.
Second, claims 1-4 and 6-12 are generic to both options. These claims recite "a plurality of electrodes" without specifying whether the electrodes are ring electrodes, segmented electrodes, or combination. Under MPEP 806.04(d) and 809, generic claims that read on multiple species are examined regardless of the species election when an allowable generic claim is identified. Applicant respectfully submits that claims 1-4 and 6-12 are generic and should be examined on the merits irrespective of the species election.
Prior art directed to deep brain stimulation leads commonly addresses both ring and segmented electrode configurations within the same references, and the Examiner has not identified any reason why the search for one configuration would not substantially encompass the other. Under MPEP 808.02, a restriction requirement must be supported by specific reasons demonstrating a serious search burden, not by generic recitations.”
Examiner disagrees because the two species are separate embodiments, and shown in the specification as different embodiments. Having ring electrodes only or both ring and segmented electrodes are different embodiments requiring a different search for each of their implementations in the art. Both embodiments are mutually exclusive from one another. Examiner further notes that the species needs not to be claimed for a species election requirement. Paragraph 8.02 under MPEP 809.02(a) allows an Examiner to make a species election with no species claim present.
Applicant then argues on page 10 that “The three options are not mutually exclusive species but are overlapping and cumulative aspects of an integrated signal processing pipeline disclosed in the specification. As described, for example, in paragraph [0101] and the accompanying disclosure of FIGS. 11A-11D and 12A-12D, the sensed ERs are filtered to remove or attenuate stimulation artifacts (option c), signal features are then extracted from the filtered ERs (option d), and a spatial distribution of those features may be generated across sensing locations (option e). Determining a spatial distribution of signal features (option e) presupposes that signal features have been extracted (option d), which in turn presupposes that the underlying ER signals have been processed (option c). These are not alternative embodiments; they are sequential operations on the same data.
Forcing an election among c, d, and e improperly fragments a unified processing approach. The Examiner has not demonstrated that the species are patentably distinct under MPEP 806.04(f), nor that the prior art search for any one of these aspects would not substantially encompass the others. Searching prior art directed to ER-based feedback for neurostimulation will routinely address signal conditioning, feature extraction, and spatial distribution analysis together.
In addition, claims 1-7 are generic with respect to options C, d, and e. These claims recite the comparison of sensed ERs to acceptance criteria without specifying whether the comparison operates on filtered ERs as such, on extracted features, or on a spatial distribution. Applicant respectfully submits that claims 1-7 should be examined on the merits regardless of the species election.”
Examiner disagrees. The comparison analysis is different between one another as noted by each “or” of [0101] because each require different steps for the recommendation of repositioning, as each would yield a different result from the determination calculated, as the steps for each comparison differs based on what is being compared, thereby being a species. Applicant’s arguments that the spatial distribution is extracted from signal features, which is all extracted from filtered ERs is not what is being claimed. Examiner disagrees with Applicant’s remarks that “the comparison of sensed ERs to acceptance criteria without specifying whether the comparison operates on filtered ERs as such, on extracted features, or on a spatial distribution” because an ER feature is an extracted feature which is compared with a target ER extracted feature, which is different than the spatial distribution compared with the target distribution. Examiner notes this in claims 10-12 as the target feature will differ (species) based on the specific feature that is used, which also means that the target distribution will also be different because spatial distribution is based on a collection of extracted featured (see [0100]).
Applicant then argues on page 11 that “Options f, g, and h are all amplitude-based features extracted from the same evoked response waveform. They represent variations of a single feature category, namely amplitude or peak measurement of the decaying-oscillation evoked potential, rather than patentably distinct species. The specification describes these as alternative ways of characterizing ER magnitude (see, for example, the discussion of "max P2P" and "N1-P2 P2P" amplitudes in the disclosure of FIG. 7). Each is computed from the same sensed signal using related peak-detection operations.
The Examiner has not identified any divergence in classification, search query, or field of art among these three feature types. Prior art directed to ERNA or ER-based neuromodulation feedback regularly discusses multiple amplitude metrics within the same reference, and a search for any one of these features would substantially overlap with the others. The boilerplate burden statement does not satisfy the specificity required by MPEP 808.02.
In addition, claim 9 is generic to options f, g, and h, reciting "a target ER feature" without specifying which feature. Applicant respectfully submits that claim 9 should be examined on the merits regardless of the species election.”
Examiner disagrees. As noted in the previously, a spatial distribution comparison may yield a different result than a signal feature. Applicant, while suggesting that the features extracted are known in the art, has provided different signal features in which the comparison between specific features and their targets would each represent its own different species, as the results of the comparison between different species of signal features may also vary. This would be a search burden for the Examiner because these specific features outlined in claims 10-12 would each require their own searches for determining that specific features input in comparison to the target.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/18/2026.
Claims 1-8 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/24/2024 and 05/18/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 2-3 and 6 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.
The term “more favorably” in claim 2 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 unknown what makes the acceptance criteria “more favorable” when a recommendation of adjustment or reposition is provided.
Regarding claim 3, it is unclear of the “stimulating setting” of line 3, is the same or different than the “stimulation setting” of claim 1 line 8.
Regarding claim 6, it is unclear of the “electrostimulation” of line 3, is the same or different than the “stimulation setting” of claim 1 line 3.
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject
matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claim 1 is directed to a system (i.e. machine) and thus meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claim 1, the following step is an abstract idea:
“compare the ERs sensed from the group of selected sensing electrodes to acceptance criteria to produce a comparison result”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could compare sensed ER to an acceptance criteria and making a determination.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claim 1, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “controller circuit”, “user interface”, and “sensing circuit” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “electrodes” and “lead” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “evoked response (ER)”, “acceptance criteria”, “comparison result” and “neural target” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)];
- “electrostimulator configured to provide electrostimulation” is nominal or insignificant relationship to the judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.04(d)(2).
While step (a) administers vaccines to the cats, this administration is performed in order to gather data for the mental analysis step, and is a necessary precursor for all uses of the recited exception. It is thus extra-solution activity, and does not integrate the judicial exception into a practical application. See MPEP 2106.04(d)(2)(c).
-The instant claims apply stimulation followed by the mental process and gathering of data regarding the delivery of electrostimulation. Therefore, all the data gathered following the electrostimulation applied is extra-solution activity, as noted above.
Step 2B – significantly more/inventive concept
The following claim elements do not add any meaningful limitation to the abstract idea:
- “controller circuit”, “user interface”, and “sensing circuit” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “electrodes” and “lead” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “evoked response (ER)”, “acceptance criteria”, “comparison result” and “neural target” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)];
- “electrostimulator configured to provide electrostimulation” is nominal or insignificant relationship to the judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.04(d)(2).
While step (a) administers vaccines to the cats, this administration is performed in order to gather data for the mental analysis step, and is a necessary precursor for all uses of the recited exception. It is thus extra-solution activity, and does not integrate the judicial exception into a practical application. See MPEP 2106.04(d)(2)(c).
-The instant claims apply stimulation followed by the mental process and gathering of data regarding the delivery of electrostimulation. Therefore, all the data gathered following the electrostimulation applied is extra-solution activity, as noted above.
The additional elements of claim 1, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the implantable medical device, processing circuitry, and storage devices, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The sensing circuit that uses electrodes for obtaining ERs are claimed very generically and are used only to gather the data they are designed for. These are well-understood, routine and conventional structure since the diagnostic art in Self et al (US 20190388695) teaches the use of electrodes for obtaining ECAP (Fig. 2A and Fig. 3).
Dependent claims 2-8 do not integrate the abstract idea into a practical application
and do not add significantly more to the abstract idea of claim 1 and 10. The dependent claim limitations are directed to the extra-solution activity (claims 2-4, 11, and 6-8) and to generic gathering structure (claim 5), which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional.
In summary, claims 1-8 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3 and 5-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dinsmoor et al. (US 20190388695)(Hereinafter Dinsmoor).
Regarding claim 1, Dinsmoor teaches A neuromodulation system (Fig. 2A (200)), comprising:
at least one lead including a plurality of electrodes (Fig. 2A (232 and 234));
an electrostimulator configured to provide electrostimulation to a neural target of a patient (Fig. 2A (211));
a sensing circuit configured to sense an evoked response (ER) to the electrostimulation (Fig. 2A (212)); and
a controller circuit operably connected to the electrostimulator and the sensing circuit (Fig. 2A (214)), 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 ([0100] “FIG. 3 is a graph 390 of an example evoked compound action potentials (ECAPs) sensed for respective stimulation pulses. As shown in FIG. 3, graph 390 shows example ECAP signal 392 (dotted line) and ECAP signal 394 (solid line). Each of ECAP signals 392 and 394 may be sensed from control pulses that were delivered from a guarded cathode and bi-phasic pulses including an interphase interval between each positive and negative phase of the pulse. The guarded cathode of the stimulation electrodes may be located at the end of an 8-electrode lead while two sensing electrodes are provided at the other end of the 8-electrode 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 ([0100] “FIG. 3 is a graph 390 of an example evoked compound action potentials (ECAPs) sensed for respective stimulation pulses. As shown in FIG. 3, graph 390 shows example ECAP signal 392 (dotted line) and ECAP signal 394 (solid line). Each of ECAP signals 392 and 394 may be sensed from control pulses that were delivered from a guarded cathode and bi-phasic pulses including an interphase interval between each positive and negative phase of the pulse. The guarded cathode of the stimulation electrodes may be located at the end of an 8-electrode lead while two sensing electrodes are provided at the other end of the 8-electrode lead” Examiner notes that an ECAP is a type of ER signal.);
compare the ERs sensed from the group of selected sensing electrodes to acceptance criteria to produce a comparison result ([0083] “determine the representative amplitude of at least one respective ECAP signal and compare the representative amplitude of a series of ECAP signals to a target ECAP adjustment window (e.g., the target ECAP amplitude plus and minus a variance which is stored in patient ECAP characteristics 222)… the lower-bound amplitude value is less than the target ECAP amplitude, and the upper-bound amplitude value is greater than target ECAP amplitude.” [0084] “If the representative amplitude of the at least one respective ECAP signal (e.g., an amplitude of a single ECAP signal or an average of two or more ECAP amplitudes) is greater than the upper-bound amplitude value, processing circuitry 214 may adjust one or more of therapy stimulation programs 217” A target ECAP is the acceptance criteria because it is the target level that is acceptable amplitude for the ECAP. The comparison result is the stimulation adjustment for control pulse that can be displayed.); and
display the comparison result on a user interface ([0094] “User interface 351 may be configured to display any information related to the delivery of electrical stimulation, identified patient behaviors, sensed patient parameter values, patient behavior criteria, or any other such information.”).
Regarding claim 2, Dinsmoor teaches 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 ([0085] “Processing circuitry 214, in one example, may change the amplitude of the informed pulses and the control pulses following the at least one respective ECAP inversely proportional to the difference between target ECAP amplitude and the representative amplitude of the at least one respective ECAP. For instance, if the representative amplitude of the at least one respective ECAP is 20% lower than target ECAP amplitude, then processing circuitry 214 may update therapy programs 217 and 218 such that the amplitude of informed pulses and the control pulses is increased by 20%.” [0094] “User interface 351 may be configured to display any information related to the delivery of electrical stimulation, identified patient behaviors, sensed patient parameter values, patient behavior criteria, or any other such information…the input may request a new spatial electrode movement pattern or a change to an existing spatial electrode movement pattern, of the input may request some other change to the delivery of electrical stimulation.”).
Regarding claim 3, Dinsmoor teaches 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 ([0049] “system 100 may be configured to provide therapy taking the form of deep brain stimulation (DBS)… any other stimulation therapy capable of treating a condition of patient 105.” [0053] “The tissue targeted by the control stimulation may be the same tissue targeted by the electrical stimulation therapy, but IMD 110 may deliver control pulses via the same, at least some of the same, or different electrodes, and intended to elicit a detectable ECAP signal. This control stimulation may (e.g., therapeutic stimulation) or may not (e.g., non-therapeutic stimulation) contribute to a therapeutic effect for the patient.”).
Regarding claim 5, Dinsmoor teaches 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 ([0045] “The electrodes of leads 130 may be electrode pads on a paddle lead, circular (e.g., ring) electrodes surrounding the body of the lead, conformable electrodes, cuff electrodes, segmented electrodes [two or more] (e.g., electrodes disposed at different circumferential positions around the lead instead of a continuous ring electrode), any combination thereof (e.g., ring electrodes and segmented electrodes) or any other type of electrodes capable of forming unipolar, bipolar or multipolar electrode combinations for therapy.” [0046] “one or more of leads 130 are linear leads having 8 ring electrodes along the axial length of the lead. In another example, the electrodes are segmented rings arranged in a linear fashion along the axial length of the lead and at the periphery of the lead.”),
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 ([0045] “any combination thereof (e.g., ring electrodes and segmented electrodes) or any other type of electrodes capable of forming unipolar, bipolar or multipolar electrode combinations for therapy.” [0069] “to generate and apply the stimulation signals to selected combinations of electrodes 232, 234.”).
Regarding claim 6, Dinsmoor teaches wherein the controller circuit is configured to:
during each of multiple stimulation sessions, deliver electrostimulation in accordance with respective stimulation settings via respective stimulating electrodes, and collect sensed ERs to the electrostimulation from respective groups of selected sensing electrodes ([0128] “processing circuitry 214 may maintain the same amplitude of the control pulses and adjust the amplitude (or other parameter) in response to changes in the representative amplitude of the sensed ECAP signal(s) as compared to the last, or recent, representative amplitude of the sensed ECAP signal(s) to detect a change in the electrode-to-nerve distance.”);
accumulate the sensed ERs collected from the multiple stimulation sessions ([0128] “processing circuitry 214 may maintain the same amplitude of the control pulses and adjust the amplitude (or other parameter) in response to changes in the representative amplitude of the sensed ECAP signal(s) as compared to the last, or recent, representative amplitude of the sensed ECAP signal(s) [accumulated ECAPs] to detect a change in the electrode-to-nerve distance.”); and
compare the accumulated ERs to the acceptance criteria to produce the comparison result ([0126] “determines if the representative amplitude of the one or more respective ECAP is greater than the lower-bound of target ECAP adjustment window. If the representative amplitude of the one or more [accumulated] respective ECAP is less than the lower-bound of target ECAP adjustment window (a “YES” branch of block 960), processing circuitry 214 increases the amplitude of the informed pulses and the control pulses by respective values (970).”).
Regarding claim 7, Dinsmoor teaches wherein the acceptance criteria include acceptance bounds for the ERs sensed from the group of selected sensing electrodes ([0083] “determine the representative amplitude of at least one respective ECAP signal and compare the representative amplitude of a series of ECAP signals to a target ECAP adjustment window (e.g., the target ECAP amplitude plus and minus a variance which is stored in patient ECAP characteristics 222)… the lower-bound amplitude value is less than the target ECAP amplitude, and the upper-bound amplitude value is greater than target ECAP amplitude.”).
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor et al. (US 20190388695)(Hereinafter Dinsmoor) in view of Parker et al. (US 11110270)(Hereinafter Parker).
Regarding claim 4, Dinsmoor teaches the invention of claim 1. Dinsmoor teaches wherein the sensed ERs to the electrostimulation include ERs sensed … to respective acceptance criteria to produce the comparison result ([0083] “determine the representative amplitude of at least one respective ECAP signal and compare the representative amplitude of a series of ECAP signals to a target ECAP adjustment window (e.g., the target ECAP amplitude plus and minus a variance which is stored in patient ECAP characteristics 222)… the lower-bound amplitude value is less than the target ECAP amplitude, and the upper-bound amplitude value is greater than target ECAP amplitude.”). However, Dinsmoor does not teach the sensed ERs to the electrostimulation include ERs sensed from a left hemisphere region and ERs sensed from a right hemisphere region in the brain, and wherein the controller circuit is configured to compare the ERs sensed from the left hemisphere region and the ERs sensed from the right hemisphere region. Parker, in the same field of endeavor, teaches brain stimulating electrodes to target the cerebral hemisphere (Abstract) for obtaining ECAPs (Col. 4 lines 55-59), and further teaches wherein the sensed ERs to the electrostimulation include ERs sensed from a left hemisphere region and ERs sensed from a right hemisphere region in the brain, and wherein the controller circuit is configured to compare the ERs sensed from the left hemisphere region and the ERs sensed from the right hemisphere region (Col. 4 lines 55-59 “Delivery of an appropriate stimulus to the neural tissue 180 evokes a neural response comprising a compound action potential which will propagate along associated neural pathways both in the ipsilateral (left) and contralateral (right) cerebral hemisphere, for therapeutic purposes.” Col. 6 lines 17-24 “the implantation”) to optimize the implantation ([0088]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Dinsmoor, with the sensed ERs to the electrostimulation include ERs sensed from a left hemisphere region and ERs sensed from a right hemisphere region in the brain, and wherein the controller circuit is configured to compare the ERs sensed from the left hemisphere region and the ERs sensed from the right hemisphere region of Parker, because such a modification would allow to optimize the implantation.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor et al. (US 20190388695)(Hereinafter Dinsmoor) in view of Moffitt (US 20220040486)(IDS)(Hereinafter Moffitt).
Regarding claim 8, Dinsmoor teaches the invention of claim 1. However, Dinsmoor does not teach the acceptance criteria includes a target distribution of ERs across the group of selected sensing electrodes, 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. Moffitt, in the same field of endeavor, teaches implantable stimulation leads to the nerves of a user for evoking a response/potential (Abstract), and further teaches wherein the acceptance criteria includes a target distribution of ERs across the group of selected sensing electrodes ([0045] “The stimulation circuitries described herein provide multiple independent current control (MICC) (or multiple independent voltage control) to guide the estimate of current fractionalization among multiple electrodes and estimate a total amplitude that provide a desired strength [target distribution].” [0086] “the direction and/or distance from the lead to the ERNA source may be determined based on the measured amplitude of the ERNA response. For example, a model can be developed based on clinical data [target distribution of ERs] that uses amplitude data to estimate the distance between the trajectory of the electrode lead and the neural source of the ERNA signal [target].”),
wherein the controller circuit ([0094] “control circuitry 102”) is configured to:
determine a spatial distribution of the sensed ERs across the group of selected sensing electrodes ([0086] “a model for source location using measured ERNA responses may be based on the maximum amplitude of the ERNA response and on the slope of the curve of the amplitude as a function of position on the electrode lead [spatial distribution]. Multiple values for those properties may be determined at different slices in time.”); 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 ([0086] “According to some embodiments, a stimulation optimization routine using MICC, as described above, can be used to determine the stimulation position on the lead 1204 which evokes the greatest ERNA amplitude. The maximum ERNA response may be used for source localization. Likewise, the variation in ERNA response to stimulation at various positions upon the electrode lead may be used for source localization.” [0088] “the system may use a source localization technique, as described above, to determine the relative position of the electrode lead with respect to the ERNA response. The UI of the system, such as UI 1000 (FIG. 10), may present information relating to the location of the ERNA source and/or feedback regarding how to move the electrode lead. For example, the UI may provide a distance and direction to the target.” Examiner notes that MICC is used to compare the ERNA amplitude with the desired strength indicating a location of the electrode with the measured ERNA amplitude obtained.) to optimize the lead placement for optimal stimulation ([0088]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Dinsmoor, with the acceptance criteria includes a target distribution of ERs across the group of selected sensing electrodes, 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 of Moffitt, because such a modification would allow to optimize the lead placement for optimal stimulation.
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.
Claim 1-3, 5, and 8 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, and 3-6 of copending Application No. 18/784,365 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the systems recite the same limitation, as shown below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, ‘365 teaches A neuromodulation system (Claim 1 “A medical-device system”), comprising:
at least one lead including a plurality of electrodes (Claim 1 “at least one lead including a plurality of electrodes”);
an electrostimulator configured to provide electrostimulation to a neural target of a patient (Claim 1 “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 (Claim 1 “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 (Claim 1 “a controller circuit operably connected to the electrostimulator and the sensing circuit, the controller circuit configured to”), 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 (Claim 1 “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 (Claim 1 “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 acceptance criteria to produce a comparison result (Claim 1 “compare the ERs sensed from the group of selected sensing electrodes to an acceptance criterion to produce a comparison result”); and
display the comparison result on a user interface (Claim 1 “display the ERs and the comparison result on a user interface”).
Regarding claim 2, ‘365 teaches 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 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.”).
Regarding claim 3, ‘365 teaches 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 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.”).
Regarding claim 5, ‘365 teaches 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 (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 two or more segmented electrodes (Claim 5 “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”).
Regarding claim 8, ‘365 teaches wherein the acceptance criteria includes a target distribution of ERs across the group of selected sensing electrodes (Claim 6 “wherein the acceptance criterion includes a target distribution of ERs across the group of selected sensing electrodes,”),
wherein the controller circuit (Claim 6 “wherein the controller circuit is configured to”) is configured to:
determine a spatial distribution of the sensed ERs across the group of selected sensing electrodes (Claim 6 “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 6 “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 1-3, 5, and 8 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 6, and 10 of copending Application No. 18/784,430 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the systems recite the same limitation, as shown below.
Regarding claim 1, ‘430 teaches A neuromodulation system (Claim 1 “A neuromodulation system”), comprising:
at least one lead including a plurality of electrodes (Claim 1 “at least one lead including a plurality of electrodes”);
an electrostimulator configured to provide electrostimulation to a neural target of a patient (Claim 1 “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 (Claim 1 “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 (Claim 1 “a controller circuit operably connected to the electrostimulator and the sensing circuit, the controller circuit configured to”), 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 (Claim 1 “in response to the electrostimulation delivered to the neural target in accordance with a stimulation setting via a stimulating electrode 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 (Claim 1 “collect sensed ERs from each of a group of sensing electrodes positioned at respective sensing locations, the sensing electrodes 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 (Claim 1 “based at least in part on a comparison of the fitted model to acceptance criteria,
provide a recommendation to a user to reposition the at least one lead or to adjust the stimulation setting to cause the fitted model to compare more favorably to the acceptance criteria.”); and
display the comparison result on a user interface (Claim 6 “wherein the controller circuit is configured to display on a user interface one or more of the sensed ERs, the generated ER features, the fitted model representing the spatial distribution of the generated ER features, or the acceptance criteria.”).
Regarding claim 2, ‘430 teaches 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 1 “based at least in part on a comparison of the fitted model to acceptance criteria, provide a recommendation to a user to reposition the at least one lead or to adjust the stimulation setting to cause the fitted model to compare more favorably to the acceptance criteria.”).
Regarding claim 3, ‘430 teaches 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 2 “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 ER features or the fitted model of the ER features.”).
Regarding claim 5, ‘430 teaches 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 (Claim 3 “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 two or more segmented electrodes (Claim 3 “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.”).
Regarding claim 8, ‘430 teaches wherein the acceptance criteria includes a target distribution of ERs across the group of selected sensing electrodes (Claim 10 “wherein the controller circuit is configured to provide the recommendation to reposition the at least one lead or to adjust the stimulation setting to cause the spatial location of the local peak to fall within a margin of a target location of ER peak.”),
wherein the controller circuit (Claim 10 “controller circuit is configured to”) is configured to:
determine a spatial distribution of the sensed ERs across the group of selected sensing electrodes (Claim 10 “fit the generated ER features to a model to represent a spatial distribution of the generated ER features across the sensing locations”); 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 10 “wherein the controller circuit is configured to provide the recommendation to reposition the at least one lead or to adjust the stimulation setting to cause the spatial location of the local peak to fall within a margin of a target location of ER peak.”).
Conclusion
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/MOUSSA HADDAD/Examiner, Art Unit 3796
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