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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 6/3/26 has/have been acknowledged and is/are being considered by the Examiner.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the claims have been canceled. New rejections are added based on the newly added claims.
Claim Rejections - 35 USC § 102
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) 21 and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shinba (U.S. Pub. 2014/0058279).
Regarding claims 21 and 31, Shinba discloses a system and method for predicting and treating a neuropsychiatric condition relapse, comprising: a controller (e.g. Fig. 2, “A”), where the controller is configured to: monitor heart rate variability of a patient over time based on heart rate recorded by a heart rate monitor (e.g. Fig. 2 (1); ¶44); identify a potential relapse of a neuropsychiatric condition based on a change in the heart rate variability over time (e.g. ¶¶43, 44); and provide an indicator that the patient is about to relapse (e.g. ¶¶ 25, 43).
Claim Rejections - 35 USC § 103
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) 22-24, 27, 32-34 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shinba as applied to claims 21 and 31 above, and further in view of Mishelevich (U.S. Pub. 2013/0281890).
Regarding claims 23-24 and 33-34, Shinba discloses the claimed invention including the use of theta burst stimulation, but fails to explicitly state that the system uses accelerated theta burst stimulation in both implantable and transcutaneous stimulation. However, Mishelevich teaches a similar system that utilizes accelerated theta burst stimulation in both implantable and transcutaneous stimulation as taught in paragraphs 249, 405 and 671 to provide improved treatment of depression. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the theta burst stimulation as taught by Shinba, with accelerated theta burst stimulation using implanted and/or transcutaneous stimulation as taught by Mishelevich, since such a modification would provide the predictable results of providing a known stimulation technique that improves the treatment for treatment-resistant depression.
Regarding claims 22, 27, 32 and 37, Shinba discloses the use of theta burst stimulation but fails to explicitly state that the has an intersession interval of between 10 and 50 minutes or between 25 and 120 minutes. However, Mishelevich teaches accelerated intermittent theta burst stimulation with a interval of 15 minutes or more between sessions as taught in paragraph 24 and 27 to provide a increase the duration on the effect on motor-evoked potential. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the theta burst stimulation as taught by Shinba, with an interval of 15 minutes or more in between sessions as taught by Mishelevich, since such a modification would provide the predictable results of increasing duration on the effect on motor-evoked potential. Shinba in view of Mishelevich teaches the claimed invention but fails to explicitly state that the system utilizes between 25 and 120 minutes. However, It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the range of 15 minutes or more as taught by Shinba in view of Mishelevich, with 25-120 minutes since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 25, 28, 35 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shinba as applied to claims 21 and 31 above, and further in view of Jain et al. (U.S. Pub. 2017/0249438 hereinafter “Jain”).
Regarding claims 25, 28, 35 and 38, the Shinba discloses claimed system and method, except treating major depressive disorder with a threshold heart rate variability value is selected by; and the relapse prediction application further directs the processor to: obtaining a baseline asymptomatic heart rate variability value for the patient and a baseline symptomatic heart rate variability value for the patient; and determining the midpoint between the asymptomatic heart rate variability value for the patient and the symptomatic heart rate variability value for the patient.
Jain in the same field of endeavor: teaches treating major depression disorder ([130]-[131] including table 2) with sensor assisted evaluation of health treatment, discloses the threshold heart rate variability value is selected by; and the relapse prediction application further directs the processor to: obtaining a baseline asymptomatic heart rate variability value for the patient and a baseline symptomatic heart rate variability value for the patient; and determining the midpoint between the asymptomatic heart rate variability value for the patient and the symptomatic heart rate variability value for the patient (Fig. 3, (330) pars. [0078]: [0080]: the system compares the biological markers, e.g., current or updated states of the biological markers, with the baselines for the biological markers. For example, the system is capable of comparing a biological marker indicative of each dimension with a corresponding baseline biological marker...). This is for the purpose of determining whether deterioration, improvement, or no change in the current state of the HRV biological marker relative to the baseline to indicate a condition (par. [0078]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the method and system for predicting and treating a clinical neurological condition relapse using heart rate variability, as taught by Shinba to include a HRV baseline comparison, as taught by Jain, in order to determine whether there is deterioration, improvement, or no change in the current state of the HRV biological marker relative to the baseline to indicate a condition.
Claim(s) 26 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shinba as applied to claims 21 and 31 above, and further in view of Stubbeman (U.S. Pub. 2016/0008620).
Regarding claims 26 and 36, Shinba discloses all of the limitations in the system and method above, except for explicitly stating that the system further senses EEG. However, Stubbeman in the same field of endeavor: method and systems for therapeutic brain stimulation using EEG sensing and electromagnetic pulses, discloses, where the indicator indicates that the patient will require treatment using a transcranial magnetic stimulation device by applying an accelerated theta burst stimulation protocol where the transcranial magnetic stimulation target is the left prefrontal dorsolateral cortex (pars. [91] and [114]-[118] EEEG monitoring for clustered spike activity;pars. [0036]: ...a brain stimulation device configured to stimulate a patient's brain by emitting an electromagnetic field based on delivery of theta burst pulses, [0037]: ...the brain stimulation device is a transcranial magnetic stimulation device directed to, e.g., the patient's left dorsolateral prefrontal cortex (LDLPFC)). This provides the benefit of effectuating a therapeutic treatment on the patient (par. [0036]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the method and system for predicting and treating a clinical neurological condition relapse using heart rate variability, as taught by Shinba, to include a processor and memory in communication with a EEG Sensor, as taught by Stubbeman, in order enhance the sensing of relapse and to deliver therapy and neural stimulation that may be programmed to detect and/or treat depression; and to effectuating a therapeutic treatment on the patient.
Claim(s) 29-30 and 39-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shinba as applied to claims 21 and 31 above, and further in view of Reeve (U.S. Pub. 2007/0173901).
Regarding claims 29-30 and 39-40, Shinba discloses all of the limitations in the system and method above, except for explicitly stating that the wherein the cardiac monitor is connected to a network via a wireless connection. However, Reeve discloses the cardiac monitor is connected to a network via a wireless connection (Fig. 2, (85) and pars. [0003], [0017]: This disclosure deals with a system for detecting and/or treating depression that may be incorporated into an implantable device such as a cardiac rhythm management device The device may also be interfaced to a patient management network via wireless telemetry...). This is for the purpose of transmitting data and alarm messages to allow clinical personnel to the track the progress of a patient's condition (par. [0017]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the method and system for predicting and treating a clinical neurological condition relapse using heart rate variability, as taught by Shinba to include a cardiac management device with wireless telemetry, as taught by Reeves, in order to transmit data and alarm messages to allow clinical personnel to the track the progress of a patient's condition.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Liao (U.S. Pat. 2014/0206945) – teaches a similar transcranial stimulator for depression disorders.
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 REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/ Primary Examiner, Art Unit 3796
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