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
Applicants’ election with traverse of Invention I and Subspecies 1A, 2A, 3A, 4A, and 5A in the reply filed on 06/30/2026 is acknowledged.
The traversal of the restriction requirement is on the ground(s) that the restriction requirement does not compare independent claims of each group and only identifies features present only in dependent claims of one group and that the independent claims are only different in their statutory category (apparatus vs method) in that claim 1 has structural elements specifically adapted to perform the method of claim 12 and claim 12 performs these recited functions. Examiner respectfully disagrees. As discussed in the “Requirement for Restriction/Election” filed on 05/19/2026, Invention II, which encompasses claims 12-20, is distinct from Invention I, which encompasses claims 1-11, because it can be practiced with another materially different product, on that does not require features that Invention I requires. For these reasons, the Restriction requirement is maintained.
The traversal of the species election requirement is on the ground(s) that a species election requirement is proper only when the claims are directed to the patentably distinct species with no generic claim reading on all species and not proper among embodiments disclosed in the specification. That the independent claims and dependent claims do not recite any particular electrode arrangement, lead type, number of leads, number of electrodes, or electrode geometry for species 1; that independent claim 1 is generic and reads on all sub-species of species 2 and that while the subspecies are present in dependent claims 7 and 8, these are dependent claims and do not render claim 1 non-generic or make the claims separately electable species; and traverses species 3-5 in a similar manner to claim 1, asserting that none of the respective subspecies appear in the claims. Examiner respectfully disagrees. As discussed in the “Requirement for Restriction/Election” the species are independent and distinct due to their mutually exclusive characteristics. Regarding species 2, each is indicative of a different process for determining an anodic weight and a cathodic weight and are written as exclusive ways of determining the weight (Instant application: [0007, 0014-0015, 00113, 00121-00122]). In addition, a requirement for restriction is permissible if there is a patentable difference between the species as claimed and there would be a serious search and/or examination burden on the examiner if restriction is not required, see MPEP 808.01(a). For these reasons, the election of species requirement of Species 1-5 is maintained.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-9 and 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected species claims, respectively, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/30/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/26/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 1810 in Fig. 18. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to because the following reference sign(s) mentioned in the description is not present in the drawings: 1800 in [00114].
Claim Interpretation
In re claim 1, the limitation “an anodic weight and a cathodic weight” is interpreted under broadest reasonable interpretation in light of the specification to mean a weight or metric of the electrodes for purposes of determining current distribution to the electrodes, wherein the electrodes can be positively or negatively charged, which is based on pain site information and paresthesia information.
In re claim 1, the limitations “an electrostimulator configured to provide electrostimulation therapy to a patient via a plurality of electrodes” and “generate a control signal to the electrostimulator to deliver electrostimulation therapy in accordance with the determined or adjusted stimulation setting” are interpreted to mean that the electrostimulation therapy is positively recited as being delivered in response to the process the controller is configured to perform, in addition to the abstract ideas of “determine, for each of the plurality of electrodes, an anodic weight and a cathodic weight by applying the received pain site information and the received paresthesia feedback information; determine or adjust a stimulation setting based on anodic weights and cathodic weights determined respectively for the plurality of electrodes” that are recited in the claim.
Claims 4 also recites the limitation “the anodic weight and the cathodic weight” and will be interpreted as in Claim Interpretation, In re claim 1.
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 1-11 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.
In re claim 1, the limitation “pain site information on a body surface of the patient” is unclear. As the word “on” is typically a physical descriptor, limitation could mean that the pain site information that is received by a controller circuit is physically on the body surface of the patient, however this is not supported in the specification. Additionally, the limitation could mean that the pain site information describes, concerns, and/or is about the body of the patient or that the pain site information includes a representation of the body surface of the patient. For purposes of examination, the limitation is interpreted under the broadest reasonable interpretation in light of the specification to mean that the pain site information describes, concerns, and/or is about a body of the patient.
Claim 3 also recites “the body surface”, see above 35 U.S.C. 112(b) rejection, In re claim 1.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 20170209702) in view of Kaemmerer (US 20160144186).
In re claim 1, Lee discloses system (Fig. 3), comprising:
an electrostimulator (Fig. 3: 14) configured to provide electrostimulation therapy to a patient [0046] via a plurality of electrodes (26); and
a controller circuit (Fig. 6: 60) configured to:
receive [0098, 0100]
(i) pain site information on a body surface of the patient ([0072, 0100]; Fig. 10: 192), and
(ii) paresthesia feedback information (Fig. 14: 308) in response to the electrostimulation therapy delivered to the patient via the plurality of electrodes [0016, 0093];
determine, for each of the plurality of electrodes, an anodic weight and a cathodic weight by applying the received pain site information and the received paresthesia feedback information
(Fig. 14: 310-312; [0098-0101, 0103-0108]: determines a threshold score which is a ratio between the anodic and cathodic perception thresholds for each electrode and a coverage score based on a relative match between perceived paresthesia and pain on the body for each electrode and calculates a total score based on threshold score and coverage score to determine (an) effective electrode(s) for stimulation which receives either anodic or cathodic stimulation current, and 0% of cathodic or anodic stimulation current, respectively; note: the total score weighs the effectiveness of each electrode, user can select other electrodes based on the total scores and proximity to the most effective electrode);
determine or adjust a stimulation setting based on anodic weights and cathodic weights determined respectively for the plurality of electrodes
(Fig. 14: 316, 318; [0072, 0106-0110; 0112-0114]: note: controller determines amplitude, width, and rate (i.e. waveform pattern), selects effective electrode, or, when multiple electrodes are selected, selects the current distribution between those electrodes (i.e. current or energy fractionalization) based on manipulation of the controls/pain map); and
generate a control signal to the electrostimulator to deliver electrostimulation therapy in accordance with the determined or adjusted stimulation setting (Fig. 14: 318; [0079, 0089, 0114]).
Lee lacks:
determine, for each of the plurality of electrodes, an anodic weight and a cathodic weight by applying the received pain site information and the received paresthesia feedback information to a trained machine-learning model.
Kaemmerer discloses a system for delivering electrical stimulation to a patient [0025] that, like the system disclosed by Lee, comprises a processor (Fig. 2: 60; [0065]) and an implantable medical device (i.e. electrostimulator, Fig. 1: 16) with a plurality of electrodes (24 and 26), wherein each electrode is assigned a respective score (i.e. anodic and cathodic weight) to determine a most likely combination of electrodes that will be beneficial to deliver therapy to a particular patient (Fig. 4; [0085-0086]). In addition, Kaemmerer discloses wherein a machine learning model, such as linear discriminant analysis, k-nearest neighbors classification, classification trees, and support vector machines (SVM), trained based on one or more of the plurality of representations of electrical signals for the plurality of patients [0025, 0084], determines the score of the electrodes [0085-0086].
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system as taught by Lee by providing wherein the controller is configured to determine, for each of the plurality of electrodes, a respective score by applying the received pain site information and the received paresthesia feedback information to a trained machine-learning model as taught by Kaemmer because the machine learning models, such as linear discriminant analysis, k-nearest neighbors classification, classification trees, and support vector machines (SVM), may reduce programming time and improve patient outcomes [0029] and different machine learning models may be used for different scores that they may perform better for, such as using SVM to compare observations within a combination of electrodes to those not in the combination [0103].
In re claim 2, see 35 U.S.C. Rejection, In re claim 1.
In re claim 10, Lee discloses wherein the electrostimulation therapy delivered in accordance with the determined or adjusted stimulation setting includes a paresthesia-free neuromodulation therapy [0012, 0018-0020].
In re claim 11, see 35 U.S.C. Rejection, In re claim 1.
Claims 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 20170209702) in view of Kaemmerer (US 20160144186) in further view of Lee (US 20120296392).
In re claim 3, Lee (‘702) discloses:
wherein the received pain site information includes pain sites on the body surface ([0072, 0100]; Fig. 10: 192: map shows pain on a surface of a body).
Lee (‘702) lacks:
wherein the received paresthesia feedback information includes a dermatomal coverage of paresthesia over one or more dermatomes on the body surface of the patient.
Lee (‘392) discloses a system for use with a neurostimulator coupled to one or multiple electrodes wherein a user selects a set of stimulation parameters (abstract) that, like the system disclosed by Lee (‘702), receives pain information (Fig. 10a-b; [0020, 0039, 0091]) and feedback regarding paresthesia ([0091]: “feedback from the patient can be used to ensure that the electrical energy delivered in accordance with the stimulation parameter set optimally provides the necessary paresthesia for the corresponding pain region”). In addition, Lee discloses wherein superficial tissue on the spinal cord generates a dermatome map that provides visual identification of paresthesia coverage over dermatomes ([011, 0089-0091]; i.e. the received paresthesia feedback information includes a dermatomal coverage of paresthesia over one or more dermatomes on the body surface of the patient, wherein the dermatomal coverage of paresthesia includes paresthesia sites at one or more dermatomes).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system as taught by Lee (‘702) by providing wherein the received paresthesia feedback information includes a dermatomal coverage of paresthesia over one or more dermatomes on the body surface of the patient, wherein the dermatomal coverage of paresthesia includes paresthesia sites at one or more dermatomes as taught by Lee (‘392) because the dermatome map allows the user (or a processor) to steer an ideal target pole over neural locations coincident with estimated regions of activation and paresthesia (Lee (‘392): [0091]).
In re claim 4, Lee (‘702) discloses:
wherein the controller circuit is configured to determine, for each of the plurality of electrodes, the anodic weight and the cathodic weight further using a spatial correspondence between the pain sites and the paresthesia sites (See 35 U.S.C. 103 Rejection, In re claim 1; [0015, 0092]; note: coverage score is based on the overlap between pain map and paresthesia map for each electrode).
Lee (‘392) lacks:
wherein the dermatomal coverage of paresthesia includes paresthesia sites at the one or more dermatomes.
Regarding the limitation “wherein the dermatomal coverage of paresthesia includes paresthesia sites at the one or more dermatomes”, see above 35 U.S.C. 103 Rejection, In re claim 3).
In re claim 5, see above 35 U.S.C. 103 Rejection, In re claim 4.
In re claim 6, Lee (‘702) discloses wherein the pain sites are identified from a pain drawing (Fig. 10: 192), and the paresthesia sites are identified from a paresthesia drawing (Fig. 10: right side; [0016, 0093]; See 35 U.S.C. 103 Rejection, In re claim 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Zhang (US 20180056068) discloses a neuromodulation stimulation system for spatially selecting electrodes for stimulation which receives pain information in the form of a drawing/map and with corresponding dermatomes and determines electrical modulation based on patient feedback and determines the fractionalization of the electrodes.
Zhang (US 20180085583) discloses a neuromodulation stimulation system for selection of neuromodulation target regions which receives pain information in the form of a drawing/map and with corresponding dermatomes and where the patient can highlight the location of experience paresthesia, no paresthesia, and pain without paresthesia and determines the fractionalization of the electrodes.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALLE M WELCH whose telephone number is (571)272-0168. The examiner can normally be reached Mon-Fri, 8:30 am to 5:00 pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HALLE MARGARET WELCH/
Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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