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 Arguments
Applicant’s arguments filed 6/11/2026 have been considered but are not persuasive in view of the new grounds of rejection as necessitated by the applicant’s claim amendments.
Applicant argues on page 6 “The cited prior art fails to disclose or suggest such an arrangement. In Blum, the "contact location" is referring to the lead body, as described in [0154] for example, not to a tissue source or location within a patient”.
The examiner has revised the rejection and the cited paragraphs in Blum to address the new claim language and this related argument. For the prediction step, the examiner is now citing [0066]-[0069], [0117]-[0122]. Note: The physician anticipates the neural target location in [0067], which reads on predicting “a location of an oscillatory neural tissue source”. The claims do not define what neural tissue constitutes “oscillatory neural tissue”. For the determining step, the examiner is citing [0066]-[0069], [0117]-[0122]. Note: The electrode configurations in these paragraphs will read on determining at least one electrode relative to the neural tissue. For the visualizing step, the examiner is citing figure 6A element 603, [0155], which discloses “The data generation tab 601 shows a gauge for optimal contact location 603 and a gauge for optimal amplitude 604. The values for these gauges are determined as a result of running the feedback loop stimulation parameter control system (system 500 in FIG. 5), presented here as an application”. For the programming step, the examiner is citing figure 5 element 500, [0090], [0155].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blum et al. (Pub. No.: US 2018/0104500 A1); hereinafter referred to as “Blum”, in view of Towe et al. (Pub. No.: US 2019/0247668 A1); hereinafter referred to as “Towe”.
Regarding claims 1 and 11, Blum discloses conducting a brain sense survey with at least one lead including a plurality of electrodes (e.g. see figure 5 element 500, [0090]. Note: The first loop of the feedback loop is being interpreted as the “brain sense survey”); developing at least one machine learning model based on the brain sense survey (e.g. see figure 5 element 502, [0093]-[0106]. Note: One of the parameters may be “contact location”); applying the at least one machine learning model to in-vivo patient data (e.g. see figure 5 element 502, [0093]-[0106]) to predict a location of an oscillatory neural tissue source within a patient (e.g. see [0066]-[0069], [0117]-[0122]. Note: The physician anticipates the neural target location in [0067], which reads on predicting “a location of an oscillatory neural tissue source”. The claims do not define what neural tissue constitutes “oscillatory neural tissue”); and determine at least one predicted electrode from the plurality of electrodes relative to the oscillatory neural tissue source (e.g. see [0066]-[0069], [0117]-[0122]. Note: The electrode configurations in these paragraphs will read on determining at least one electrode relative to the neural tissue.); visualizing the at least one predicted electrode (e.g. see figure 6A element 603, [0155], “The data generation tab 601 shows a gauge for optimal contact location 603 and a gauge for optimal amplitude 604. The values for these gauges are determined as a result of running the feedback loop stimulation parameter control system (system 500 in FIG. 5), presented here as an application”); and programming the medical device based on the at least one predicted electrode (e.g. see figure 5 element 500, [0090], [0155]).
Blum discloses the claimed invention but is silent as to conducting the brain sense survey in a simulated environment. Towe teaches that it is known to use such a modification as set forth in figures 6-7, [0049]-[0053], especially [0053], to provide minimized patient discomfort. It would have been obvious to one having ordinary skill in the art at the time the invention was made to conduct the brain sense survey in a simulated environment as taught by Towe in the system/method of Blum, since said modification would provide the predictable results of minimized patient discomfort (Note: [0060] and [0067] of the applicant’s printed application disclose that the simulation occurs in a saline tank like Towe discloses).
Regarding claims 2 and 12, Blum discloses conducting the brain sense survey includes collecting data from all possible channels for the plurality of electrodes (e.g. see [0047]).
Regarding claims 3 and 13, Blum discloses visualizing the at least one predicted electrode includes displaying the at least one lead and the at least one predicted electrode proximate anatomical scan data (e.g. see figure 6, [0154]-[0155]).
Regarding claims 4 and 14, Blum discloses visualizing the at least one predicted electrode includes displaying the at least one lead and the at least one predicted electrode without anatomical scan data (e.g. see figure 6, [0154]-[0155]).
Regarding claims 5 and 15, Blum discloses visualizing the at least one predicted electrode includes displaying the at least one lead and the at least one predicted electrode relative to a heatmap (e.g. see figure 6, [0154]-[0155]).
Regarding claims 6 and 16, Blum discloses applying the at least one machine learning model to in-vivo patient data to determine the at least one predicted electrode includes detecting an electrode furthest from the oscillatory neural tissue source (e.g. see [0066]-[0069], [0117]-[0122]).
Regarding claims 7 and 17, Blum discloses applying the at least one machine learning model to in-vivo patient data to determine the at least one predicted electrode includes detecting an electrode nearest to the oscillatory neural tissue source (e.g. see [0066]-[0069], [0117]-[0122]).
Regarding claims 8 and 18, Blum discloses visualizing the at least one predicted electrode includes displaying at least one longitudinal change associated with disease progression or a therapy change (e.g. see figures 5-6, elements 500 and 600).
Regarding claims 9 and 19, Blum discloses visualizing the at least one predicted electrode includes displaying a change in a location of the oscillatory neural tissue source (e.g. see figures 5-6, elements 500 and 600).
Regarding claims 10 and 20, Blum discloses the claimed invention but is silent as to the simulated environment includes a signal generated using a signal generator in a saline tank. Towe teaches that it is known to use such a modification as set forth in figures 6-7, [0049]-[0053], especially [0053], to provide minimized patient discomfort. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the simulated environment including a signal generated using a signal generator in a saline tank as taught by Towe in the system/method of Blum, since said modification would provide the predictable results of minimized patient discomfort.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Kaemmerer et al. (Pub. No.: US 2016/0144186 A1), Madhavan et al. (Pub. No.: US 2020/0230419 A1), and Panken et al. (Pub. No.: US 2020/0338351 A1).
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 PHILIP C EDWARDS whose telephone number is (571)270-1804. The examiner can normally be reached Mon-Fri, 9:00-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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