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 .
The amendment filed on February 4, 2026 has been received and considered. By this amendment, claims 1, 5, 50, and 61 are amended, claims 9 and 53 are cancelled, and claims 1, 2, 5-8, 10, 12, 16, 17, 19, 20, 22, 25, 29, 30, 50-52, 54, 58, and 60-63 are now pending in the application.
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.
Claims 1, 7, 8, 10, 12, 16, 17, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Maschino (U.S. Patent No. 7,532,935, previously cited) in view of Von Novak (US 2019/0059832, previously cited) and Panken (U.S. 2009/0082829, previously cited).
1. (Currently Amended) A closed-loop method for treating a neuropsychiatric disorder in a subject, the method comprising: (Maschino teaches a closed loop system that treats, for example depression; see at least col. 9:10-20 and col. 7:14-20)
mapping a brain of a subject to identify an optimal location in a first brain region for positioning a first electrode for delivery of electrical stimulation to treat the neuropsychiatric disorder;
mapping the brain of the subject to identify an optimal location in a second brain region for positioning a second electrode for detection of an electroencephalographic signal from neural activity associated with a symptom of the neuropsychiatric disorder; (Although Maschino is considered to inherently use mapping to find the various locations of the brain for the electrodes, Von Novak is used to more explicitly teach that such mapping is old and well known in the art, see at least ¶37-43. It would have been obvious to use mapping to find the optimal locations for the electrodes since it would yield better results in a predictable manner)
positioning the first electrode at the optimal location in the first brain region to deliver electrical stimulation to the first brain region of the subject; (see at least figure 1 of Maschino which shows stimulating electrode 36 at a first location)
positioning the second electrode at the optimal location in the second brain region to detect the electroencephalographic signal from the neural activity associated with the symptom of the neuropsychiatric disorder; (see at least figure 1 of Maschino which shows sensing electrode 38 at a second location)
detecting the electroencephalographic signal at the second region of the brain of the subject using the second electrode; (see at least col. 8:62-col.9:7 of Maschino)
applying electrical stimulation to the first brain region using the first electrode in a manner effective to treat the neuropsychiatric disorder in the subject when power of the electroencephalographic signal from the gamma frequency neural activity associated with the symptom of the neuropsychiatric disorder that is detected using the second electrode exceeds a threshold level. (see at least col. 8:40-61 and col. 9:8-19 of Maschino and at least ¶121 of Panken teaches sensing power of gamma frequency band in the eeg. It would have been obvious to sense power in such band since it is well known in the art to reveal important information regarding the patient’s condition)
7. (Previously Presented) The method of claim 1, wherein the first brain region comprises a ventral capsule/ventral striatum (VC/VS) region, a subgenual cingulate (SGC) region, or an orbitofrontal cortex (OFC) region of the brain. (see at least col. 15:62 of Maschino)
8. (Previously Presented) The method of claim 1, wherein the second brain region comprises a right amygdala region, a left amygdala region, a right orbitofrontal cortex region, a left subgenual cingulate region, or a right hippocampus region. (see at least col. 12:7-35 which teaches many different regions including amygdala)
10. (Previously Presented) The method of claim 1, wherein the first electrode is placed on a surface of the first brain region or within the first brain region, and wherein the second electrode is placed on a surface of the second brain region or within the second brain region. (see at least col. 14:7:44-50 of Maschino)
12. (Previously Presented) The method of claim 1, wherein the first electrode or the second electrode is a non-brain penetrating surface electrode array or a brain- penetrating electrode array. (see at least col. 14:7:44-50 of Maschino. As is well known, DBS can use electrode inside the brain or on the surface thereof)
16. (Previously Presented) The method of claim 1, wherein the neuropsychiatric disorder is Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Post-Traumatic Stress Disorder (PTSD), Addiction, Anorexia, Obsessive-Compulsive Disorder (OCD), or Bipolar Disorder (BD) or chronic pain. (see at least col. 7:14-20 of Maschino)
17, (Previously Presented) The method of claim 1, wherein the electrical stimulation is applied unilaterally or bilaterally. (stimulating the brain unilaterally or bilaterally is considered to have been obvious in order to best treat the patient in an effective manner, and would yield only predictable results. Bilateral and unilateral stimulation are the two options available to stimulate a patient.)
19, (Previously Presented) The method of claim 1, further comprising monitoring the subject for a period of time, wherein increasing numbers of the electroencephalographic signals exceeding the threshold level detected by the second electrode within a later recording period compared to an earlier recording period indicate increasing severity of the symptom of the neuropsychiatric disorder; and decreasing numbers of electroencephalographic signals exceeding the threshold level detected by the second electrode within a later recording period compared to an earlier recording period indicate decreasing severity of the symptom of the neuropsychiatric disorder. (at least col. 9:8-19 of Maschino teaches recording and monitoring brain state, and adapting treatment to a change in state. It would have been obvious to change the stimulation if the severity of the patient’s condition changes over time. Doing so would provide adaptive therapy and a more optimal treatment for the patient)
20. (Original) The method of claim 19, wherein the subject is monitored continuously or intermittently. (continuous and intermittent covers the range of monitoring possible. Further, it would have been obvious to use either type of monitoring in order to best provide treatment for the patient, depending upon patient conditions, and minimize drain on battery)
Claim(s) 2,5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino et al (7,532,935), Von Novak et al (2019/0059832), and Panken (U.S. 2009/0082829), and further in view of Blum et al (2018/0104500).
2. (Previously Presented) The method of claim 1, further comprising using a control algorithm to automate said applying electrical stimulation when the electroencephalographic signal exceeds the threshold level, wherein the control algorithm comprises a machine learning algorithm, optionally wherein the machine learning algorithm is a supervised machine learning algorithm. (Maschino is considered to teach adaptive learning control algorithm, see at least col. 9:8-20. Blum teaches the use of machine learning, see at least ¶43. It would have been obvious to use machine learning with the device of Maschino since it would yield predictable results such as more efficient stimulation control)
5. (Currently Amended) The method of claim 2, wherein the control algorithm further modulates one or more programmed stimulation parameters based on the level of the gamma frequency power of the electroencephalographic signal. (see at least col. 9:8-19 of Maschino which teaches adaptive learning and sensing changes after stimulation. Such changes are considered to be a change in level of activity of the sensed portion of the brain. It would have been obvious have been obvious to sense changes in level of eeg since if the level increased, the stimulation would be changed to reduce the level, as taught in Maschino)
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino et al (7,532,935), Von Novak et al (2019/0059832), and Panken (U.S. 2009/0082829), and further in view of Gonzalez-Martinez et al (2018/0110972).
6. (Previously Presented) The method of claim 1, further comprising positioning a plurality of electrodes at the second brain region for detection of the electroencephalographic signal by stereoelectroencephalography (sEEG). (sEEG is old and well known in the art, see at least ¶4 of Gonzalez. It would have been obvious to use such with the device of Maschino since it would yield predictable results such as precise placement of the electrodes)
Claim(s) 22,25,29,30,50-52,54, 58, 60, and 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino et al (7,532,935) and Panken et al (2009/0082829).
22. (Previously Presented) A closed-loop method for treating major depressive disorder (MDD) in a subject, the method comprising: (at least col. 7:14-20 of Maschino teaches treating MDD)
positioning a first electrode to deliver electrical stimulation to a first region of the brain of the subject, wherein the first brain region comprises a ventral capsule/ventral striatum (VC/VS) region, a subgenual cingulate (SGC) region, or an orbitofrontal cortex (OFC) region of the brain; (see at least col. 15:6s and col. 12:7-36
positioning a second electrode to detect a gamma frequency electroencephalographic signal from neural activity associated with MDD symptoms at a second region of the brain of the subject, wherein the second brain region comprises a right amygdala, left amygdala region, a right orbitofrontal cortex region, a left subgenual cingulate region, or a right hippocampus region; (see at least col. 12:7-36 of Maschino which teaches various places that can be stimulated or sensed from. Also, col. 12:8 teaches that the sites are not limited to the various mentioned sites. One of ordinary skill in the art would know where to sense or stimulate the patient depending upon his condition, without undue experimentation, yielding predictable results. Further, as mentioned supra, Panken teaches use of sensing gamma frequency. It would have been obvious to sense power in such band since it is well known in the art to reveal important information regarding the patient’s condition)
detecting the gamma frequency electroencephalographic signal using the second electrode; and applying electrical stimulation to the first region of the brain of the subject using the first electrode in a manner effective to treat the MDD symptoms in the subject when the gamma frequency electroencephalographic signal that is detected using the second electrode exceeds a threshold level. (as mentioned supra, Panken teaches use of sensing gamma frequency. It would have been obvious to sense power in such band since it is well known in the art to reveal important information regarding the patient’s condition. See also at least col. 9:8-19 of Maschino)
25. (Previously Presented) The method 22, wherein said applying electrical stimulation comprises applying bipolar electrical stimulation at the VC/VS region of the brain of the subject. (see at least col.12:7:36 of Maschino which teaches various regions of the brain including ventral striatum region. Such regions, as mentioned in Maschino, are not limited to those explicitly set forth in col. 12.)
29, (Previously Presented) The method of claim 22, further comprising monitoring the subject for a period of time, wherein increasing numbers of gamma frequency electroencephalographic signals exceeding the threshold level detected by the second electrode within a later recording period compared to an earlier recording period indicate increasing severity of MDD symptoms; and decreasing numbers of gamma frequency electroencephalographic signals exceeding the threshold level detected by the second electrode within a later recording period compared to an earlier recording period indicate decreasing severity of MDD symptoms. (at least col. 9:8-19 of Maschino teaches recording and monitoring brain state, and adapting treatment to a change in state. It would have been obvious to change the stimulation if the severity of the patient’s condition changes over time. Doing so would provide adaptive therapy and a more optimal treatment for the patient)
30. (Original) The method of claim 29, wherein the subject is monitored continuously or intermittently. (continuous and intermittent covers the range of monitoring possible. Further, it would have been obvious to use either type of monitoring in order to best provide treatment for the patient, depending upon patient conditions, and minimize drain on battery)
50. (Currently Amended) A system for treating a neuropsychiatric disorder in a subject, the system comprising:
a stimulation electrode adapted for positioning at a first region of the brain of the subject; (see at least figure 1 which shows stimulating electrode 36)
a detection electrode adapted for positioning at a second region of the brain of the subject and for recording an electroencephalographic signal from the second region of the brain of the subject (see at least figure 1 which shows sensing electrode 38, and col. 9:7-18), wherein the electroencephalographic signal comprises gamma frequency neural activity associated with a symptom of the neuropsychiatric disorder; (see at least col. 8:40-61 and col. 9:8-19 of Maschino and at least ¶121 of Panken teaches sensing power of gamma frequency band in the eeg. It would have been obvious to sense power in such band since it is well known in the art to reveal important information regarding the patient’s condition)
a processor programmed to instruct the stimulation electrode to apply an electrical stimulation to the first region of the brain in a manner effective to treat the symptom of the neuropsychiatric disorder in the subject when an electroencephalographic signal that exceeds a threshold level is detected using the second electrode. (see at least col. 9:7-50)
51. (Original) The system of claim 50, wherein the first brain region comprises a ventral capsule/ventral striatum (VC/VS) region, a subgenual cingulate (SGC) region, or an orbitofrontal cortex (OFC) region of the brain. (see at least col. 15:61 and col. 12:7-36)
52. (Previously Presented) The system of claim 50, wherein the second brain region comprises a right amygdala region, a left amygdala region, a right orbitofrontal cortex region, a left subgenual cingulate region, or a right hippocampus region. (see at least ¶12:7-36)
54. (Previously Presented) The system of claim 50, wherein the stimulation electrode or the detection electrode is a non-brain penetrating electrode array or a brain penetrating electrode array. (see at least col. 7:44-50)
58. (Previously Presented) The system of claim 50, wherein the system further comprises a user interface comprising an input electronically coupled to the processor for instructing the stimulation electrode to apply an electrical stimulation to the first region of the brain to treat the neuropsychiatric disorder in the subject, optionally wherein the user interface is password protected and is operable by a health care practitioner. (see at least figure 1 and col 9:20-30)
60. (Previously Presented) The system of claim 50, wherein the neuropsychiatric disorder is Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Post-Traumatic Stress Disorder (PTSD), Addiction, Anorexia, Obsessive-Compulsive Disorder (OCD), or Bipolar Disorder (BD), or chronic pain. (see at least col. 7:14-20)
61. (Currently Amended) The system of claim 50, wherein the processor is further programmed to modulate one or more programmed stimulation parameters according to an algorithm’s control law; and apply the modulated electrical stimulation to the first region of the brain via the stimulation electrode in a manner effective to treat the neuropsychiatric disorder. (see at least col. 9:8-50. The controller is configured to adjust the stimulation by adaptive learning, and thus follows a control law in order to do so)
Claim(s) 62,63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino et al (7,532,935) and Panken et al (2009/0082829), and further in view of Perez et al (2018/0078754).
62. (Previously Presented) The system of claim 50, wherein the processor is further programmed to set a maximum number of electrical stimulations per day. (Perez teaches setting various stimulations per day of amount per day, etc, se at least ¶165. It would have been obvious to limit number of stimulations per day, or amount of time stimulation is delivered per day in order to reduce battery drain and avoid over stimulating the patient which may cause harm)
63. (Previously Presented) The system of claim 50, wherein the processor is further programmed to set a total amount of time of electrical stimulation per day. (Perez teaches setting various stimulations per day of amount per day, etc, se at least ¶165. It would have been obvious to limit number of stimulations per day, or amount of time stimulation is delivered per day in order to reduce battery drain and avoid over stimulating the patient which may cause harm)
Response to Arguments
Applicant's arguments filed February 4, 2026 have been fully considered but they are not persuasive. Regarding the previous rejection of claim 9 as being unpatentable over Maschino in view of Von Novak and Panken, the Applicant argues that Panken fails to identify a neurological biosignal associated with a symptom of disease, but rather only identifies a biosignal used for volitional control and, therefore, Panken does not teach or suggest the closed loop method of treating symptoms of a neuropsychiatric disorder to detecting neural activity associated with symptoms. It is respectfully submitted that Panken is not relied upon to teach identifying a neurological biosignal associated with a symptom of a disease, but rather is utilized to teach sensing power of a gamma frequency band within an EEG. Maschino discloses identifying a neurological biosignal associated with a symptom of a disease, but fails to teach the claimed aspect of sensing power of a gamma frequency band in the EEG, which is why Panken is utilized for this teaching. The sensing of volitional control versus a symptom does not teach away from the combination and, as such, the rejection is considered to stand.
Conclusion
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 TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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