DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 22, 2025 has been entered.
Response to Amendment
The amendment filed December 22, 2025 has been entered. Claims 16, 27-29 have been amended. Claims 36-37 are new. Claims 1-15 were previously canceled. Currently, claims 16-37 are pending for examination.
Response to Arguments
Applicant’s arguments, see pages 8-10, filed December 22, 2025, with respect to the 35 U.S.C. 112 and 101 rejections have been fully considered and are persuasive. The 35 U.S.C. 112 rejection of claim 28 and the 35 U.S.C. 101 rejections of claims 27, 29-35 have been withdrawn.
Applicant’s arguments, see page 11, filed December 22, 2025, with respect to the rejection(s) of claim(s) 16-37 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mishra et al. (US 2019/0001139).
Additionally the wording of claim 16 currently states, “apply a plurality of electrical stimuli, including at least a first electrical stimulus and a second electrical stimulus” (lines 5-6), “detect, for each of the plurality of electrical stimuli, a resonant response” (lines 13-14), and “determine a change in one or more common waveform characteristics between two or more of the detected resonant responses” (lines 17-18). The claim does limit the plurality of electrical stimuli to just the first electrical stimulus and the second electrical stimulus- other stimuli not having the specific amplitude relationship of the first and second electrical stimuli can be delivered. Additionally the claim does not require specifically detecting a resonant response for the first electrical stimulus and a resonant response for the second electrical stimulus; and determining a change in one or more common waveform characteristics between the resonant response for the first electrical stimulus and the resonant response for the second electrical stimulus. Other resonant responses from the other stimuli not having the specific amplitude relationship of the first and second electrical stimuli can be detected and a change in one or more common waveform characteristics between the resonant responses for these other stimuli can be determined.
Applicant argues (p. 11-12) Sinclair et al. (WO 2018/027259) does not disclose resonant responses evoked by discrete electrical stimuli. Claim 16 recites “a first electrical stimulus and a second electrical stimulus”. This limitation does not require them to be discrete.
Applicant argues (p. 12) Sinclair et al. does not compare responses to stimuli having differing stimulus amplitudes at the same position. In addition to what is explained above that claim 16 does not require comparison of responses to stimuli having differing stimulus amplitudes, the limitation “at the same position” is not currently recited. Claim 16 recites, “apply a plurality of electrical stimuli… via at least one electrode at a first position in a brain of a patient”. It does not require the responses to be detected at a same position, or require the application of the plurality of stimuli to be delivered to the same position. For example, dependent claim 24 further states “wherein the plurality of electrical stimuli are applied at the first position by two or more electrodes of the at least one electrode”. This “first position” can be interpreted as an implanted first position, where two or more electrodes are positioned adjacent to their own respective tissues, and not as a specific position adjacent one singular electrode.
Specification
The disclosure is objected to because of the following informalities: paragraph [0066] recites, “The depth scale on the x-axis of each graph in Figure 3 represents a position of the electrode relative to a surgical target”. This should instead state, “The depth scale on the y-axis of each graph in Figure 3 represents a position of the electrode relative to a surgical target”, as the horizontal x-axis (as is commonly known in the art) currently describes time (ms) of delivered stimulation.
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.
Claims 18 and 31 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.
Claim 18 recites the limitation "differing amplitudes" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation "differing amplitudes" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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.
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.
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) 16-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sinclair et al. (WO 2018/027259) in view of Mishra et al. (US 2019/0001139).
Regarding claim 16, Sinclair et al. discloses a neurostimulation system 90 (fig. 10), comprising: at least one electrode 72a-d adapted for implantation in or near a target neural structure in the brain; a signal generator 94 selectively coupled to one or more of the at least one electrode (“the multiplexer 98 is provided to control whether the electrodes 72a, 72b, 72c, 72d are connected to the signal generator 94” [0155]) and configured to apply a plurality of electrical stimuli, including at least a first electrical stimulus and a second electrical stimulus (“the patterned signal may be repeated a predetermined number of times, such as 10 times” [0161]; “The process 130 of Figure 12 may be repeated using different stimulation parameters (e.g. using different stimulation amplitudes or frequencies)” [0172]) having differing amplitudes ([0071], [0131]) via the at least one electrode at a first position in a brain of a patient (“DBS at different stimulation amplitudes was applied to the implanted electrode array” [0139]), each electrical stimulus comprising a plurality of pulses ([0071], [0131]); a measurement device 96 selectively coupled to the one or more of the at least one electrode (“the multiplexer 98 is provided to control whether the electrodes 72a, 72b, 72c, 72d are connected to… the measurement circuit 96” [0155]) and configured to detect, for each of the plurality of electrical stimuli, a resonant response from the target neural structure, each resonant response evoked by a respective one of the plurality of electrical stimuli (“the evoked response from a target neural structure is measured at one or more of the electrodes in the array at step 134. In the case of the lead tip 70, for example, the evoked response may be measured at the second, third and fourth electrodes 72b, 72c, 72d when the first electrode 72a is being stimulated.” [0166]; fig. 13); and a processing unit 92 coupled to the measurement device and configured to: determine a change in one or more common waveform characteristics between two or more of the detected resonant responses (“different ERNA features, including relative differences between or spatial derivatives of amplitude, rate of decay, rate of change” [0167]); and determine an effectiveness of delivering therapeutic stimulation at the first position based on the change (“a preferred electrode to use for therapeutic stimulation may be chosen…If the process has been performed during surgery, the results of the ERNA processing may also be used to determine which electrodes are within the target neural structure and whether to reposition the electrode array” [0168]); and deliver therapeutic stimulation at the first position or another position based on the determined effectiveness of delivering therapeutic stimulation at the first position ([0168]).
While it is believed Sinclair et al. discloses all of the claimed limitations in the embodiment corresponding to Figure 13, the prior art further describes other embodiments such as Figure 15, 16 and 17 where a plurality of electrical stimuli (146 and 150 for fig. 15, repeated 162 for fig. 16, repeated 172 for fig. 17) are applied to at least one electrode at a first position in a brain of a patient, each electrical stimulus comprising a plurality of pulses and differing amplitudes ([0071], [0131]); determining a change in one or more common waveform characteristics between two or more of the detected resonant responses ([0177], [0182], [0189]) to determine an effectiveness of delivering therapeutic stimulation at the first position based on the change; and deliver therapeutic stimulation at the first position based on the determined effectiveness of delivering therapeutic stimulation at the first position.
Sinclair et al. does not expressly disclose wherein each of the first electrical stimulus and the second electrical stimulus comprises a plurality of pulses and wherein the first electrical stimulus and the second electrical stimulus each have a stimulus amplitude and the stimulus amplitude of the first electrical stimulus is different from the stimulus amplitude of the second electrical stimulus. Mishra et al. teaches a neurostimulation device also configured to treat the brain ([0178], [0266]) where a plurality of electrical stimuli (fig. 22) includes a first electrical stimulus comprising a plurality of pulses having a stimulus amplitude A1 that is different from the stimulus amplitude A2 of a second electrical stimulus comprising a plurality of pulses ([0417]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sinclair et al. to try applying a plurality of electrical stimuli, including at least a first electrical stimulus and a second electrical stimulus as claimed and taught by Mishra et al. as it is a known stimulation waveform for delivering to neural tissue, the results of such a modification being reasonably predictable.
Regarding claim 17, Sinclair et al. discloses wherein the one or more common waveform characteristics comprises one or more of an amplitude of the resonant response, rate of decay of the resonant response, a frequency of the resonant response ([0167]).
Regarding claim 18, Sinclair et al. discloses wherein the processing unit is further configured to: select an amplitude of the differing amplitudes for therapeutic stimulation of the target neural structure based on the change ([0011], “The process 130 of Figure 12 may be repeated using different stimulation parameters (e.g. using different stimulation amplitudes or frequencies)… Such response characteristics may be used to adjust amplitude, frequency, pulse width, and shape of a stimulation waveform” [0172-0173]).
Regarding claim 19, Sinclair et al. discloses wherein the processing unit is further configured to: select the first position for therapeutic stimulation of the target neural structure based on the change (“Based on the processing of the evoked responses, a preferred electrode to use for therapeutic stimulation may be chosen.” [0168]).
Regarding claim 20, Sinclair et al. discloses the at least one electrode comprises a first electrode at the first position and a second electrode at a second position different from the first position 72a, 72b, 72c, 72d (fig. 10); the signal generator is configured to apply the plurality of electrical stimuli to each of the first and second electrodes ([0165); the measurement device is configured to detect the resonant response from the target neural structure evoked by the plurality of electrical stimuli applied to each of the first and second electrodes (“The profile of evoked responses may include measurements from multiple electrodes” [0162], [0165-0166]); and the processing unit is configured to: determine a change in one or more common waveform characteristics between two or more of the detected resonant responses evoked by each of the plurality of electrical stimuli applied to the second electrode in the second position (“different ERNA features, including relative differences between or spatial derivatives of amplitude, rate of decay, rate of change” [0167]); compare the change in the one or more common waveform characteristics of the two or more of the detected resonant responses at the first electrode to a change in one or more common waveform characteristics between two or more of the detected resonant responses at the second electrode (“the processing may involve, identifying the electrode that measures the largest evoked resonance amplitude for each stimulation condition). The identification of the preferred electrode location may also be based on a comparison with template ERNA activity” [0167]).
Regarding claim 21, Sinclair et al. discloses wherein the processing unit is configured to select one of the first electrode and the second electrode for therapeutic stimulation to the target neural structure based on the comparison (“Based on the processing of the evoked responses, a preferred electrode to use for therapeutic stimulation may be chosen…If the process has been performed during surgery, the results of the ERNA processing may also be used to determine which electrodes are within the target neural structure and whether to reposition the electrode array” [0168]).
Regarding claim 22, Sinclair et al. discloses wherein the plurality of electrical stimuli are applied to a first electrode of the at least one electrode (“a full stimulus pattern may be applied at one electrode” [0165]; [0169], fig. 13; “The process 130 of Figure 12 may be repeated using different stimulation parameters (e.g. using different stimulation amplitudes or frequencies)” [0172]).
Regarding claim 23, Sinclair et al. discloses wherein determining the change in the one or more common waveform characteristics between the two or more of the detected resonant responses comprises determining a rate of change in the one or more of the common waveform characteristics between the two or more of the detected resonant responses (“different ERNA features, including relative differences between or spatial derivatives of amplitude, rate of decay, rate of change, and frequency, at different insertion positions (e.g. the location that produces the largest resonances)” [0167]).
Regarding claim 24, Sinclair et al. discloses wherein the plurality of electrical stimuli are applied at the first position by two or more electrode of the at least one electrode (“Where a patterned stimulation regime is used, sequential bursts of a stimulus pattern may be applied to different ones of the electrodes 72a, 72b, 72c, 72d.” [0165]).
Regarding claim 25, Sinclair et al. discloses wherein at least one of the two or more electrodes is not located at the first position (fig. 10; each of electrodes 72a-d are in different locations based on the structure of lead 70).
Regarding claim 26, Sinclair et al. discloses wherein the resonant response is detected at two or more of the at least one electrode ([0169], fig. 13).
Regarding claim 27, the limitation “wherein the signal generator is configured to apply the plurality of electrical stimuli to the brain of patient while the patient is under general anaesthetic” is not given patentable weight as it does not invoke structural limitations on the invention and is beyond the scope of the invention. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding claim 28, Sinclair et al. discloses wherein the first electrode is configured to be moved to a second position in the brain different from the first position (“If at step 120 a preferred location cannot be identified, the surgeon and/or clinician may choose to remove the electrode and re-implant along a different trajectory” [0164]) and in response to moving of the first electrode to a second position in the brain different from the first position (“If the process has been performed during surgery, the results of the ERNA processing may also be used to determine which electrodes are within the target neural structure and whether to reposition the electrode array.” [0168]), the signal generator is configured to apply the plurality of electrical stimuli to the first electrode in the second position ([0166]); wherein the measurement device is configured to detect the resonant response from the target neural structure evoked by each of the plurality of electrical stimuli applied to the first electrode in the second position ([0169]; fig. 13); and wherein the processing unit is configured to: determine a change in one or more common waveform characteristics between two or more of the detected resonant responses evoked by each of the plurality of electrical stimuli applied to the first electrode in the second position (“different ERNA features, including relative differences between or spatial derivatives of amplitude, rate of decay, rate of change” [0167]); compare the change in the one or more common waveform characteristics between the two or more of the detected resonant responses detected at the first position to a change in the one or more common waveform characteristics between the two or more of the detected resonant responses detected at second position (fig. 14); and determine an optimum electrode position for therapeutic stimulation of target neural structure based on the comparison ([0171]).
Regarding claim 29, Sinclair et al. discloses a computer readable storage medium storing instructions executable by a processor 92 to control a neurostimulation system (fig. 10) to: apply a plurality of electrical stimuli, including at least a first electrical stimulus and a second electrical stimulus (“the patterned signal may be repeated a predetermined number of times, such as 10 times” [0161]; “The process 130 of Figure 12 may be repeated using different stimulation parameters (e.g. using different stimulation amplitudes or frequencies)” [0172]) having differing amplitudes ([0071], [0131]) via the at least one electrode 72a-d at a first position in a brain of a patient (“DBS at different stimulation amplitudes was applied to the implanted electrode array” [0139]), each electrical stimulus comprising a plurality of pulses ([0071], [0131]); for each of the plurality of electrical stimuli, detect a resonant response from the target neural structure, each resonant response evoked by a respective one of the plurality of electrical stimuli (“the evoked response from a target neural structure is measured at one or more of the electrodes in the array at step 134. In the case of the lead tip 70, for example, the evoked response may be measured at the second, third and fourth electrodes 72b, 72c, 72d when the first electrode 72a is being stimulated.” [0166]; fig. 13); determine a change in one or more common waveform characteristics between two or more of the detected resonant responses (“different ERNA features, including relative differences between or spatial derivatives of amplitude, rate of decay, rate of change” [0167]); and determine an effectiveness of delivering therapeutic stimulation at the first position based on the change (“a preferred electrode to use for therapeutic stimulation may be chosen…If the process has been performed during surgery, the results of the ERNA processing may also be used to determine which electrodes are within the target neural structure and whether to reposition the electrode array” [0168]).
While it is believed Sinclair discloses all of the claimed limitations in the embodiment corresponding to Figure 13, the prior art further describes other embodiments such as Figure 15, 16 and 17 where a plurality of electrical stimuli (146 and 150 for fig. 15, repeated 162 for fig. 16, repeated 172 for fig. 17) are applied to at least one electrode at a first position in a brain of a patient, each electrical stimulus comprising a plurality of pulses and differing amplitudes ([0071], [0131]; 168 for fig. 16); determining a change in one or more common waveform characteristics between two or more of the detected resonant responses ([0177], [0182], [0189]) to determine an effectiveness of delivering therapeutic stimulation at the first position based on the change.
Sinclair et al. does not expressly disclose wherein each of the first electrical stimulus and the second electrical stimulus comprises a plurality of pulses and wherein the first electrical stimulus and the second electrical stimulus each have a stimulus amplitude and the stimulus amplitude of the first electrical stimulus is different from the stimulus amplitude of the second electrical stimulus. Mishra et al. teaches a neurostimulation device also configured to treat the brain ([0178], [0266]) where a plurality of electrical stimuli (fig. 22) includes a first electrical stimulus comprising a plurality of pulses having a stimulus amplitude A1 that is different from the stimulus amplitude A2 of a second electrical stimulus comprising a plurality of pulses ([0417]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sinclair et al. to try applying a plurality of electrical stimuli, including at least a first electrical stimulus and a second electrical stimulus as claimed and taught by Mishra et al. as it is a known stimulation waveform for delivering to neural tissue, the results of such a modification being reasonably predictable.
Regarding claim 30, Sinclair et al. discloses wherein the one or more common waveform characteristics comprises one or more of an amplitude of the resonant response, rate of decay of the resonant response, a frequency of the resonant response ([0167]).
Regarding claim 31, Sinclair et al. discloses to select an amplitude of the differing amplitudes (fig. 16) for therapeutic stimulation of the target neural structure based on the change ([0182-0185]).
Regarding claim 32, Sinclair et al. discloses to select the first position for therapeutic stimulation of the target neural structure based on the change ([0168]).
Regarding claim 33, Sinclair et al. discloses to apply the plurality of electrical stimuli to a first electrode at a first position and a second electrode at a second position (fig. 14); detect the resonant response from the target neural structure evoked by the plurality of electrical stimuli applied to each of the first and second electrodes (fig. 13-14; [0169]); and determine a change in one or more common waveform characteristics between two or more of the detected resonant responses evoked by each of the plurality of electrical stimuli applied to the second electrode in the second position (fig. 13-14); compare the change in the one or more common waveform characteristics of the two or more of the detected resonant responses at the first electrode to a change in one or more common waveform characteristics between two or more of the detected resonant responses at the second electrode (“comparing the measured evoked responses at each electrode in response to stimulation at another electrode, a determination can be made firstly of whether any of the electrodes are positioned within the target neural structure, secondly whether any of the electrodes are positioned at an optimum location within the target neural structure, and thirdly the direction and/or distance of a particular electrode from that target neural structure” [0171]).
Regarding claim 34, Sinclair et al. discloses to select one of the first electrode and the second electrode for therapeutic stimulation of target neural structure based on the comparison ([0171-0172]).
Regarding claim 35, Sinclair et al. discloses to apply the plurality of electrical stimuli to a first electrode of the at least one electrode (“DBS at different stimulation amplitudes was applied to the implanted electrode array” [0139]).
Regarding claim 36, Sinclair et al. in view of Mishra et al. disclose wherein the plurality of pulses in the first electrical stimulus each have a fixed first amplitude A1 and wherein the plurality of pulses in the second electrical stimulus each have a fixed second amplitude A2 and wherein the fixed first amplitude is different from the fixed second amplitude (fig. 22).
Regarding claim 37, Sinclair et al. in view of Mishra et al. disclose wherein the plurality of pulses in the first electrical stimulus each have a fixed first amplitude A1 and wherein the plurality of pulses in the second electrical stimulus each have a fixed second amplitude A2 and wherein the fixed first amplitude is different from the fixed second amplitude (fig. 22).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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/ERICA S LEE/Primary Examiner, Art Unit 3796