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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/23/2025 has been entered.
Response to Arguments
Regarding the previous 112 rejection, the rejection has been withdrawn. In particular, the examiner recognizes the specification in fact discloses what the oscillatory source is. In particular, [0087] discloses “heatmaps can be utilized to indicate one or more optimal electrodes”, [0094] discloses “embodiments can gather montage data from all possible channels of a DBS lead. Subsequently, machine learning algorithm predictions can inform stimulation electrode detection”, and [0105] discloses “FIG. 7C illustrates a three-dimensional visualization of a location prediction for effective stimulation parameters, again without anatomy. As illustrated, a volume of neural activation (VNA) 700 is depicted proximate the lead relative to an oscillatory source 702”. Thus, the oscillatory source appears to be an electrode, typically from a DBS.
Regarding the 103 rejection, the applicant’s arguments submitted 12/23/2025 are not persuasive. The applicant argues Blum fails to teach “applying the at least one machine learning model to in-vivo patient data to predict a location of an oscillatory source within a patient”. The examiner is not persuaded. Figure 5 discloses a “Feedback Loop Stimulation Parameter Control System” that uses Machine Learning (e.g. see figure 5 element 502. Note: One of the parameters may be “contact location”) in vivo (e.g. see figure 5 elements 506/508) to predict contact location (e.g. see [0094], and [0154]-[0155]). [0154] states “In some embodiments the contact location may be a “virtual” contact location, meaning that the stimulation may be split in some fraction between two or adjacent contacts and the resulting stimulation has a centroid that lies between the two contacts, looking as though it's coming from a virtual contact in between the two or more contacts” which seems to be exactly what the applicant is illustrating in Figures 7A-7C. Further, the determined contact location in [0094] and [0154]-[0155] matches what the applicant discloses in [0087], [0094], and [0105] for “predict a location of an oscillatory source within a patient”.
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 source within a patient (e.g. see [0094]-[0095], [0154]-[0155], [0155] discloses “In some embodiments the contact location may be a “virtual” contact location, meaning that the stimulation may be split in some fraction between two or adjacent contacts and the resulting stimulation has a centroid that lies between the two contacts, looking as though it's coming from a virtual contact in between the two or more contacts”); and determine at least one predicted electrode from the plurality of electrodes relative to the oscillatory source (e.g. see [0094], [0154]); 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 programming the medical device based on the at least one predicted electrode (e.g. see figure 5 element 500, [0090]).
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 source (e.g. see [0094], [0154]).
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 source (e.g. see [0094], [0154]).
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 source (e.g. see [0094], [0154]).
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).
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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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792