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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/30/2025 has been entered.
Response to Arguments
Applicant’s arguments, see pages 5-8, filed 12/30/2025, with respect to the rejection(s) of claim(s) 1-4, 7, 8, and 10-19 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art.
Applicant argues that the prior art does not disclose the variable pulse intervals. Newly found prior art US 2016/0001096 (Mishelevich) discloses the reasons for using variable pulse intervals in TMS stimulation. Thus, a combination of US 2019/0082990 (Poltorak) in view of US 2016/0001096 (Mishelevich) in view of US 2005/0234286 (Riehl et al., hereinafter Riehl) would meet the limitations specified in claim 1 as shown in the rejection below.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 4, 7, 8, and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0082990 (Poltorak) in view of US 2016/0001096 (Mishelevich) in view of US 2005/0234286 (Riehl et al., hereinafter Riehl).
In regards to claims 1 and 11-14, Poltorak discloses a method and apparatus for neuroenhancement (title and abstract). Of note is paragraphs 173 and 291 which states that TMS can be performed as single pulses or as pairs of pulses separated by a variable time interval or pulses in a repetitive manner (rTMS). Paragraphs 619-635 show the use of TMS on a mammalian subject that modulates brain activity (note that the subjects used in the reference are human brain entrainment subjects). Poltorak discloses in paragraph 386 that transcranial magnetic stimulation is used to treat conditions like pain and depression and paragraph 291 states that transcranial magnetic stimulation modulates brain activity to alter subject behavior. However, Poltorak does not state that the patient has been diagnosed with autism spectrum disorder, Alzheimer’s Disease, Post Traumatic Stress Disorder, Parkinson’s Disease, or Attention Deficit Hyperactivity Disorders.
In a related area, Mischelevich discloses devices and methods for optimized neuromodulation (title and abstract). Mischelevich discloses the use of varied pulse intervals when administering the pulses to eliminate potential problems with habituation (paragraphs 138 and 155). Paragraphs 138 and 656-657 disclose the usage of either ultrasound or TMS stimulation for the relief of various conditions including PTSD. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the method of Poltorak to administer varied pulses for the treatment of PTSD as taught by Mischelevich in order to eliminate problems with habituation and provide relief for PTSD (which can be considered as an improvement in the condition). Poltorak and Mischelevich do not explicitly state that prior to treatment that the patient is diagnosed with autism spectrum disorder, Alzheimer’s Disease, Post Traumatic Stress Disorder, Parkinson’s Disease, or Attention Deficit Hyperactivity Disorders.
In a related area, Riehl discloses methods and an apparatus used to determine TMS coil proximity (title and abstract). Paragraph 48 states that TMS can be used for treatment of various disease states including Alzheimers Disease, Parkinson’s Disease, Attention Deficit Hyperactivity Disorder, Post Traumatic Stress Disorder, pain, and depression. This would require the diagnosis of the presence of the diseases in the patient, which would also meet the limitations of claims 11-14. Thus, it would be obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the method of Poltorak and Mischelevich to be applied to a patient diagnosed with Alzheimers Disease, Parkinson’s Disease, Attention Deficit Hyperactivity Disorder, Post Traumatic Stress Disorder, because they are one of the diseases that can be treated with TMS as taught by Riehl.
In regards to claim 4, Poltorak, Mischelevich, and Riehl disclose the limitations of claim 1. Additionally, Poltorak describes the use of EEG to obtain brain activity information and deliver pulses to a mammal (paragraphs 90, 94-95, 619 and 724-426). Poltorak also discloses various studies where pulses with variable intervals can be used for entrainment and other therapies (paragraph 173 and 291). Poltorak also states that EEG feedback is used to optimize stimuli (paragraphs 592 and 607). Thus, it would be obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the method of Polorak and Riehl to derive variable pulse intervals from mammal’s EEG signal as noted in another method disclosed by Poltorak in order to provide feedback for stimuli optimization.
In regards to claim 7, Poltorak, Mischelevich, and Riehl disclose the limitations of claim 1. Poltorak also discloses in paragraphs 173 and 290 that in another study subthreshold stimulation is used modify the susceptibility of cells to depolarization. Thus, it would be obvious to one of ordinary skill in the art before the claimed invention was filed to modify the method of Poltorak and Riehl to use sub-threshold stimulation in the mammal as taught in another study of Poltorak in order to modify the susceptibility of cells to depolarization.
In regards to claim 8, Poltorak, Mischelevich, and Riehl discloses the limitations of claim 7, which covers the ranges below motor threshold. While Poltorak does not explicitly state the claimed range, Applicant has not disclosed the criticality of the claimed range. It would be obvious to one of ordinary skill in the art to arrive at the claimed range before the filing date of the invention because it is the normal desire to scientist and artisans to improve upon what is already generally known to determine an optimum combination of percentages (MPEP 2144.05 – optimization of ranges).
Claims 2, 3, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0082990 (Poltorak) in view of US 2016/0001096 (Mishelevich) in view of US 2005/0234286 (Riehl et al., hereinafter Riehl) as applied to claim 1 above, and further in view of US 6,488,617 (Katz).
In regards to claims 2 and 3, Poltorak, Mishelevich, and Riehl disclose the limitations of claim 1 but does not state the brain activity modulated. In a related area, Katz discloses a method and device for producing a desired brain state that uses TMS (title; abstract). Of particular note is column 6, line 1-column 9, line 22 which discloses modulating of different frequency bands including the claimed 8-13 Hz bandwidth which is stated to induce relaxation. Thus, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the method of Poltorak, Mishelevich, and Riehl to modulate the 8-13 Hz frequency bandwidth in order to induce the state of relaxation as taught by Katz.
In regards to claim 18, Poltorak, Mishelevich, and Riehl disclose the limitations of claim 1. However they do not recite the additional steps of subjecting the subject to an EEG, using the EEG to program rTMS to deliver the electromagnetic pulses, and subjecting the patient to rTMS wher ethe pulses are derived from the data set. In a related area, Katz discloses a method and device for producing a desired brain state that uses TMS (title; abstract). Of particular note is column 5, line 8-column 9, line 22 which shows subjecting the patient to an EEG, programming the stimulation parameters from the EEG data, and subjecting the patient to TMS where the stimulation parameters are derived from the EEG data set (the disclosed feedback procedures). Katz states that the feedback allows one to minimize the differences between the desired EEG signal and the actual EEG signal (column 7, lines 26-34). Thus, it would be obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the method of Poltorak and Riehl to include the steps of acquiring an EEG data set, programming a TMS device using the EEG data, and subjecting the subject to rTMS with pulses derived from the EEG data as taught by Katz in order to minimize difference between the desired EEG signal and the actual EEG signal using feedback.
Claim(s) 2, 3, and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0082990 (Poltorak) in view of US 2016/0001096 (Mishelevich) in view of US 2005/0234286 (Riehl et al., hereinafter Riehl), as applied to claim 1 above, and further in view of US 2016/0136427 (De Ridder)
In regards to claim 2, 3, and 15-17, Poltorak, Mischelevich, and Riehl disclose the limitations of claim 1. However, they do not state that the brain wave bands being modulated. In a related area, De Ridder discloses methods of treating a neurological disorder. Paragraph 69 and figure 3 disclose the frequency ranges of the frequency bands. Theta waves (4-8 Hz) overlap the 3-7 Hz range, alpha waves (8-12 Hz) are within the claimed range, beta waves (12-30 Hz) encompass the 15-20 Hz range, and gamma waves (greater than 30 Hz) include the 35-45 Hz range. De Ridder states that these bands are associated with various mental, physical, and emotional characteristics. Paragraphs 70-101 show the monitoring of frequencies and modulating the different frequency bands to produce a specific effect such as entrainment training or facilitation of spatial or temporal components of memories. Thus, it would be obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the method of Poltorak, Mischelevich, and Riehl to monitor the claimed frequencies as taught by De Ridder in order to determine current brain states and modulate them to produce a specific effect.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0082990 (Poltorak) in view of US 2016/0001096 (Mishelevich) in view of US 2005/0234286 (Riehl et al., hereinafter Riehl), as applied to claim 1 above, and further in view of US 2009/0105521 (Bentwich).
In regards to claim 10, Poltorak, Mishelevich, and Riehl disclose the limitations of claim 1 but do not state that the patient being treated has been diagnosed with autism spectrum disorder. In a related area, Bentwich discloses systems and methods for assessing and treating conditions related to the central nervous system and enhancing cognitive function (see title and abstract). Paragraphs 74-77 discloses the use of the TMS devices on Alzheimer’s patients (usage of 10-20 Hz stimulation to enhance neuroplasticity). Paragraph 85 in particular discloses the use of TMS with specific stimulation frequencies (in this case 10-20 Hz in one region and 1 Hz in another region to increase cognitive abilities) for the treatment of autism (note that the paragraph states treating individuals having characteristic traits of autism, thus being diagnosed with autism).
Thus, it would be obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the method of Poltorak, Mishelevich, and Riehl to be applied to Alzheimers patients and autism patients as taught by Bentwich in order to increase cognitive abilities of the claimed patient groups.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0082990 (Poltorak) in view of US 2016/0001096 (Mishelevich) in view of US 2005/0234286 (Riehl et al., hereinafter Riehl), as applied to claim 1 above, and further in view of US 2012/0165696 (Arns).
In regards to claim 19, Poltorak, Mishelevich and Riehl disclose the limitations of claim 1 but does not state that the treatment consists of rTMS. In a related area, Arns discloses a method for assessing susceptibility of a human suffering from a psychiatric or neurological disorder to treatment (title and abstract). Of interest are paragraphs 40-59 which disclose treating patients with rTMS to identify patients that respond to rTMS treatment. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the method of Poltorak, Mishelevich and Riehl to only use rTMS on a patient as taught by Arns in order to identify patients that would be responsive to the rTMS treatment.
Conclusion
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791