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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Choi et al. (Choi: Pub. No. 2023/0123383).
Regarding claim 1, Choi discloses a deep brain stimulation algorithm system (see par. 0093), comprising: a deep brain stimulation device (see Fig. 10 or Fig. 27), configured to generate an electrical stimulation signal to a subject (neurostimulation), wherein the deep brain stimulation device comprises: a signal sensing module 1026 (or the like in Fig. 27, 2704), configured to sense a local field potential signal from the subject after the subject receives the electrical stimulation signal (see pars. 0109 and 0136); a control module 1012/2702, configured to generate a stimulation parameter (through pulse generator 1010/2703); a personalization module, configured to generate a prediction result based on a medical data and the local field potential signal (see pars. 0112, 0120, 0136, 0195 and 0196; multi-dimensional medical data); and an adjustment module (that portion of the control system responsible for adjusting neurostimulation as disclosed), configured to compare the local field potential signal and the prediction result by using a full spectrum analysis (pars. 0188, 0190; frequency bands low theta, high theta, alpha, beta and gamma), so as to generate an adjustment parameter to the control module (pars. 0194, 0195; stimulation parameters, including pulse amplitude, pulse width, pulse or burst frequency, etc.), wherein the control module is further configured to adjust the stimulation parameter based on the adjustment parameter (par. 0195; parameters may be varied accordingly) and the deep brain stimulation device is further configured to adjust the electrical stimulation signal based on the stimulation parameter (par. 0195 neurostimulation therapy may accordingly be varied).
Regarding claim 2, see at least par. 0113 which discloses that disease statistics and patient data may be stored and accessed via a server. Regarding the generation of a personalization adjustment signal (i.e., stimulation tailored to the individual) and prediction adjustment, note the comments above.
Regarding claim 3, see pars. 0051, 0054, 0087, 0106, 0112, 0113, 0195, etc. and communications module 1024, where wireless communication between the stimulation device and the server may be established to allow transmission of medical data and the personalization adjustment signal to allow control of the neurostimulation.
Regarding claim 4, see pars. 0188 and 0190.
Regarding claim 5, the adjustment parameters are considered to be inherently adjusted during each adjustment cycle (i.e., that period of time where adjustment is desired). Further, the initiation of communication between programmer unit(s) and the neurostimulation device (i.e., the initiation of a programming session) is considered to be an “adjustment command” (see for example par. 0074).
Regarding claim 6, see electrical stimulation module 1010/2703 which is coupled between the control module 1012/2702 and the subject through the lead system. Electrical stimulation is generated based on the stimulation parameters as discussed above.
The rejection of patentably indistinct claims 7-18 directly mirrors the discussion above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Saab discloses a deep brain or spinal cord stimulator where local field potentials are sensed and converted to the frequency spectrum for analysis in theta, alpha, beta and gamma bands in order to control neurostimulation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached 2nd Monday of the biweek and W-F.
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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
August 6, 2026