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 .
Response to Amendment
This Action is in response to the Amendment filed March 9, 2026.
In view of the Amendment, the objections to the drawings and claims 4, 11, 15, 19 and 32 and the rejection of claims 9, 15-20, and 29-34, as set forth in the Office Action mailed 10/10/2025, are withdrawn.
Claims 1, 4, 8-9, 11, 15, 19, 29, and 32 are amended.
Claims 1-4, 8-11, 15-20, and 29-34 are pending.
Response to Arguments
Applicant's arguments filed March 9, 2026 have been fully considered but they are not persuasive.
Applicant amended independent claims 1, 8, and 15 to recite that a subject is being treated using alternating electric fields “to either treat a tumor in the subject’s body or to increase permeability of the subject’s blood-brain barrier” (claims 1, lines 2-3, 8, lines 2-3, and 15, lines 3-4) and that the selective deactivating/reducing of different electrode(s) occurs while alternating electric fields/current are/is applied to the subject’s body at a frequency between 50 kHz and 1MHz (claim 1, lines 4-6, claim 8, lines 4-6, and 15, line 5). However, US Patent Application Publication No. 2021/0069503 to Tran is directed to methods for reducing the viability of cancer cells by applying an alternating electric field with a frequency between 100 and 500kHz, which overlaps with 50kHz to 500kHz of the now claimed range of 50khz to 1 Mhz (e.g., paragraph [0010] of Tran).
In response to Applicant’s argument that US Patent No. 8,918,184 to Torgenson is not analogous, the Examiner disagrees. Torgenson is directed to applying electrical fields in a subject using different electrode combinations to determine the most likely efficacious treatment (e.g., column 29, lines 42-64). That is, it was known in the medical arts to selectively deactivate one or more different electrode elements while alternating electric fields are being applied to the subject as taught by Torgenson. While Torgenson does not disclose the type of treatment and the frequency of the applied electric fields/current, it is relevant medical treatments using alternating electric fields/current. Both the delivery of electrical stimulation and the delivery of electrical fields using electrode combinations to treat tumors are well-known medical treatments.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 8,918,184 to Torgerson et al. (hereinafter referred to as “Torgerson”) in view of US Patent Application Publication No. 2021/0069503 to Tran et al. (hereinafter referred to as “Tran”).
Referring to claim 1, Torgerson discloses a method of ameliorating electrosensation in a subject that is being treated using alternating electric fields (e.g., abstract: one or more efficacious electrode combinations for delivering electrical stimulation based on delivery of electrical stimulation to the patient … the transition between electrode combinations is achieved by incrementally adjusting amplitudes; column 29, lines 42-64: selected electrode combinations result in therapy fields including an electrical field model that is generated upon patient anatomy), the method comprising: selectively deactivating one or more different electrode elements during respective different periods of time while alternating electric fields are being applied (e.g., Fig. 4A, control IMD to deliver electrical stimulation with selected electrode combination and corresponding sections including column 25, line 59-column 26, line 27, Figs. 4A-b, 82: Receive user input? – the user input received by processor 60 (82) may indicate that the electrode combination should be paused or stopped indefinitely; Fig. 4-B, 84: take responsive action and column 32, lines 17-32: amplitude adjustments can be made to selected electrode combinations and/or deactivation/termination of selected electrode combination); accepting feedback that indicates whether electrosensation is occurring during each of the respective different periods of time (e.g., column 25, lines 29-51: user input may include input marking an electrode combination, efficacy information, input requesting an electrode combination be eliminated from the set of electrode combination – where electrosensation is met by user’s perceived sensation that the electrode combination works or does not work and needs to be eliminated); and determining whether deactivating a given one or more of the electrode elements ameliorates the electrosensation (e.g., column 25, lines 29-51, as above – the user makes a determination that deactivating electrode elements will reduce the perceived electro sensation). Torgenson differs from the claimed invention in that the subject is being treated using alternating electric fields for a tumor in the subject’s body and the selectively deactivating occurs while the alternating electric fields are applied to the subject’s body at a frequency between 50kHz and 1MHz. However, Tran, in a related art: methods for reducing the viability of cancer cells with an alternating electric field (abstract), teaches that it was known in the medical arts to treat cancer/tumors with alternating electric fields at a frequency between 50 kHz and 1 Mhz (e.g., paragraph [0010] of Tran).
Regarding claim 8, Torgerson discloses a method of ameliorating electrosensation in a subject that is being treated using alternating electric fields (e.g., abstract: one or more efficacious electrode combinations for delivering electrical stimulation based on delivery of electrical stimulation to the patient … the transition between electrode combinations is achieved by incrementally adjusting amplitudes; column 2, lines 44-49: method of selecting electrode combinations; column 29, lines 42-64: selected electrode combinations result in therapy fields including an electrical field model that is generated upon patient anatomy), the method comprising: selectively reducing current that flows through one or more different electrode elements during respective different periods of time while alternating electric fields are being applied (e.g., column 27, lines 40-54: processor 30 controls the shifting of stimulation parameters smoothly from one electrode combination to a second electrode combination where the user can input feedback that the stimulation intensity is uncomfortable and the shifting process is accomplished by reducing stimulation amplitude, which would inherently reduce current flow as V=I R where R (resistance) is constant and the stimulation amplitude is either V (voltage) or I (current)); accepting feedback that indicates whether electrosensation is occurring during each of the respective different periods of time (e.g., column 27, lines 40-54 – user input is feedback and indicates the sensation of the stimulation intensity); and determining whether reducing the current that flows through a given one or more of the electrode elements ameliorates the electrosensation (e.g., column 27-lines 40-54, as above – the user makes a determination whether reducing the current that flows through the given electrode elements will reduce the perceived electrosensation). Torgenson differs from the claimed invention in that the subject is being treated using alternating electric fields for a tumor in the subject’s body and the selectively reducing current that flows through one of more electrodes occurs while the alternating electric fields are applied to the subject’s body at a frequency between 50kHz and 1MHz. However, Tran, in a related art: methods for reducing the viability of cancer cells with an alternating electric field (abstract), teaches that it was known in the medical arts to treat cancer/tumors with alternating electric fields at a frequency between 50 kHz and 1 Mhz (e.g., paragraph [0010] of Tran).
Accordingly, one of ordinary skill in the art would have recognized the benefits of treating a patient with alternating electric fields at a frequency between 50kHz and 1 Mhz in view of the teachings of Tran. Consequently, one of ordinary skill in the art would have modified the above methods of Torgenson to a subject being treated for a tumor using electric fields at a frequency between 50 kHz and 1 Mhz to determine which electrode combinations are efficacious and comfortable to the patient, and because the combination would have yielded a predictable result.
With respect to claims 2 and 9, Torgerson in view of Tran teaches the method of claims 1 and 8, further comprising treating the subject using alternating electric fields while the given one or more electrode elements is deactivated/is operating at a lower current than that prior to the reducing step (e.g., column 29, lines 4-12: processor 60 automatically selects tested electrode combinations and creates one or more therapy programs for chronic therapy delivery).
As to claims 3 and 10, Torgerson in view of Tran teaches the method of claims 1 and 8, wherein the accepting of feedback is implemented by accepting input from the subject (e.g., Figs. 4A-b, 82: Receive user input? and corresponding passages from Torgerson).
Claims 4 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Torgerson in view of US Patent Application Publication No. 2023/0310843 to Wah et al. (EFD 08/30/2021 and hereinafter referred to as “Wah”).
Torgerson in view of Tran teaches the method of claim 1, but does not expressly disclose that the accepting of feedback is implemented by processing electrical signals that represent activity of the subject's nerves from a set of ECAP electrodes. However, Torgerson teaches that incremental modification to the anodic amplitude and/or cathodic amplitude may result in transitions between electrode combinations that minimize discomfort to the patient (e.g., column 2, lines 39-43). Wah, in a related art: neurostimulation, teaches that for effective and comfortable operation, it is necessary to maintain stimuli amplitude or delivered charge below a comfort threshold (e.g., paragraph [0005] of Wah); and that measurement circuitry for recording a neural compound action potential signals sensed at sense electrode (or a set of ECAP electrodes) that measure the evoked neural compound action potential response (e.g., paragraphs [0011]-[0018] and [0055]-[0065]) and can be used to select electrodes of an array (e.g., paragraph [0132] of Wah). Accordingly, one of ordinary skill in the art would have recognized the benefits of processing electrical signals that represent activity of the subject’s nerves from a set of ECAP electrodes in view of the teachings of Wah. Consequently, one of ordinary skill in the art would have modified the method of claims 1 and 8 to include a set of ECAP electrodes in view of the teachings of Wah that such represent activity of the subject’s nerve after stimulation, and because the combination would have yielded the predictable result of a method that does not rely solely on the patient’s input.
Claims 15-16, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 7,565,205 to Palti in view of Torgerson.
Referring to claims 15-16, and 18, Palti discloses a method of applying electrical signals to a first set of at least four first electrode elements and a second set of at least four second electrode elements positioned on opposite sides of a target region of a subject's body to treat a tumor (e.g., abstract and column 19, lines 64 to column 20, line 42 and Fig. 28: first set of electrode elements A1-A9, second set of electrode elements N1-N9), the method comprising: (a) applying an alternating current (AC) signal at a frequency between 50kHz and 1 MHz between the second set of at least four second electrode elements and a majority of the first electrode elements (e.g., column 7, lines 1-12 and 15-21: applying an alternating electric field that has a frequency from about 50kHz to about 500 KHz enhances the ability to break the membrane of tumor cells; and column 20, lines 17-42: applying AC signal across electrodes A2 and N7 would generate diagonal field lines and applying the AC signal across electrodes A2 and B7 would generate diagonal fields lines in another direction through the body part where multiple pairs of electrodes can be energized simultaneously to induce fields in the desired direction), wherein one or more different members of the first set of at least four first electrode elements are either not used or operate using a reduced current during respective different periods of time (electrodes A2, A3, A8 can be connected to electrodes N7, N3, N8 while the remaining electrodes are not used, and after the field is maintained in that direction for a suitable duration, the next set of electrodes is activated to rotate the field); the subject may experiencing electrosensation during the respective different periods of time (e.g., column 28, lines 14-17: patient can experience discomfort and pain in area 1030 due to strong current and increased heat); and heat can be reduced by applying the electric field intermittently by repeatedly switching the field on and off). Palti differs from the claimed invention in that it does not expressly disclose the step of accepting/providing feedback that the subject is experiencing electrosensation, and the step of determining, based on the feedback, whether an amelioration of electrosensation occurs when one or more given members of the first set of electrode elements is either not used or operates using reduced current. However, Torgerson, in a related art: identification of electrode combination for efficacious electrical stimulation therapy, teaches that a stimulation processor receives user input indicating the efficacy of the electrical stimulation delivered via the selected electrode combination (e.g., column 25, line 62 to column 26, line 5 of Torgerson); that the shifting between electrode combinations should be gradual and that the user can intervene to adjust the stimulation intensity should the sensation become uncomfortable (e.g., column 27, lines 42-54 of Torgerson); and that the electrode combination testing process should be paused or stopped indefinitely (e.g., column 25, line 59-column 26, line 27 and Figs. 4A-B, Receive User Input? of Torgerson). Accordingly, one of ordinary skill in the art would have recognized the benefits of accepting feedback indicating whether the subject is experiencing electrosensation and determining, based on user input feedback, whether an amelioration of the electrosensation occurs when one or more given members of the first set are not used or operates at a reduced current/intensity in view of the teachings of Torgerson. Consequently, one of ordinary skill in the art would have recognized the benefits of accepting feedback whether the subject is experiencing electrosensation and determining, based user input feedback whether an amelioration of electrosensation occurs when one or more given members of the first set of electrode elements is not used in view of the teachings of Torgerson that such were well-known protocols in the electrode combination art in order to reduce discomfort to the user, and because the combination would have yielded a predictable result.
With respect to claim 20, Palti in view of Torgerson teaches the method of claim 15, further comprising controlling an amplitude of the AC signal (e.g., column 14, lines 4-8 of Palti).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Palti in view of Torgerson as applied to claim 15 above, and further in view of Wah.
Palti in view of Torgerson teaches the method of claim 15, but does not expressly teach the accepting of the first feedback being implemented by processing electrical signals that represent activity of the subject's nerves from a set of ECAP electrodes. . However, Torgerson teaches that incremental modification to the anodic amplitude and/or cathodic amplitude may result in transitions between electrode combinations that minimize discomfort to the patient (e.g., column 2, lines 39-43). Wah, in a related art: neurostimulation, teaches that for effective and comfortable operation, it is necessary to maintain stimuli amplitude or delivered charge below a comfort threshold (e.g., paragraph [0005] of Wah); and that measurement circuitry for recording a neural compound action potential signals sensed at sense electrode (or a set of ECAP electrodes) that measure the evoked neural compound action potential response (e.g., paragraphs [0011]-[0018] and [0055]-[0065]) and can be used to select electrodes of an array (e.g., paragraph [0132] of Wah). Accordingly, one of ordinary skill in the art would have recognized the benefits of processing electrical signals that represent activity of the subject’s nerves from a set of ECAP electrodes in view of the teachings of Wah. Consequently, one of ordinary skill in the art would have modified the method of claims 1 and 8 to include a set of ECAP electrodes in view of the teachings of Wah that such represent activity of the subject’s nerve after stimulation, and because the combination would have yielded the predictable result of a method that does not rely solely on the patient’s input.
Allowable Subject Matter
Claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 29-34 are allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792
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