CTNF 18/222,114 CTNF 91939 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Objections 07-29-01 AIA Claim s 1-2, 6, 8 and 19 are objected to because of the following informalities: Regarding claim 1, the claim states “at least one of rhythm, harmonic element or melodic element…”; however, this should read “at least one of a rhythm element, a harmonic element or a melodic element…”. Regarding claim 2, 8 and 19, “the motor cortex region of the brain” should be “a motor cortex region of a brain”. Regarding claim 6, “an electromyographic equipment” should read “electromyographic equipment” Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claims 9, 12-14 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 9, claim 9 is a method claim which depends off of claim 7. The claim states “wherein the acoustic stimulation can be subsequently performed…”. However, using the language “can be” renders the claim indefinite as it is unclear if the subsequently performed stimulation is actively part of the claimed method or an optional part of the method that needs not be performed. Regarding claim 12-14 are rejected similar to claim 9 due to their dependency. Regarding claim 18, claim 18 sets forth that the phase offset for the audio waveform to synchronize with the TMS can be done dependent off of claim 17 which does the opposite. This appears to be in error as the specification sets forth these two different synchronizations as different embodiments. Therefore, this is seen as indefinite. For examination purposes, this is seen as separate from each other. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 1-5, 7-13, 15-16 and 17-19 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Ewers, “Classical conditioning of paired-pulse TMS induced intracortical facilitation – a proof of concept”, herein referred to as “Ewers” . Regarding claim 1, Ewers teaches: A system comprising: a transcranial magnetic stimulation (TMS) device configured to generate a localized magnetic field waveform at a brain region (page 8; Transcranial magnetic stimulation; the TMS pulses applied via a figure-of-eight coil connected to two serially linked TMS devices and applied at the skull thus for a region of the brain) ; and an acoustic controller configured to generate an audio waveform having at least one of rhythm, harmonic element, or melodic element synchronized to the localized magnetic field waveform (page 8; Conditioning phase: specifically the acoustic stimuli being applied together with the TMS and Experimental setup: controlled by a laptop computer for paired auditory-TMS stimulations) . Regarding claim 7, Ewers teaches: A method to perform a transcranial magnetic stimulation treatment, the method comprising: generating, via a transcranial magnetic stimulation (TMS) device, a localized magnetic field stimulation at a brain region of a patient; and concurrent with the localized magnetic field stimulation (Fig. 1 and page 8; specifically TMS) , generating, via an acoustic controller, an acoustic stimulation having at least one of rhythm, harmonic element, or melodic element synchronized to the localized magnetic field stimulation (Fig. 1 and page 8; specifically conditioning phase) . Regarding claim 15, Ewers teaches: A non-transitory computer-readable medium having instructions stored thereon (page 8; Experimental Setup) , wherein execution of the instructions by a processor causes the processor to: cause, a transcranial magnetic stimulation (TMS) device, to generate a localized magnetic field waveform at a brain region (page 8; Experimental setup; paired auditory-TMS stimulations are controlled by a laptop using data acquisition unit and “signal” software and TMS) ; and cause, an acoustic controller, to generate an audio waveform having at least one of rhythm, harmonic element, or melodic element synchronized to the localized magnetic field waveform (page 8; Experimental setup; paired auditory-TMS stimulations are controlled by a laptop using data acquisition unit and “signal” software and Conditioning phase) . Regarding claims 2, 8 and 19, Ewers teaches: wherein the brain region is the motor cortex region of the brain (page 8; specifically TMS is applied over the skull at the motor cortex) . Regarding claim 3 , Ewers teaches: further comprising: a TMS controller, wherein the TMS controller is configured to generate a TMS waveform from a TMS waveform file, wherein the TMS waveform is amplified and subsequently applied to one or more TMS coils to generate the localized magnetic field waveform (page 8; specifically Experimental setup; paired auditory-TMS stimulations as well as MEP recording were controlled by a laptop computer which uses data acquisition unit with Signal software and TSM/Conditioning phase on how the signals are applied) . Regarding claim 4, Ewers teaches: wherein the TMS controller is configured to adjust a phase offset of the TMS waveform to synchronize the TMS waveform with the audio waveform (page 8-9; specifically synchronizing TMS and audio which is seen as adjusting a phase offset of both TMS and audio in order to synchronize with one another in conditioning and testing phase) . Regarding claim 5, Ewers teaches: wherein the acoustic controller is configured to adjust a phase offset of the audio waveform to synchronize the audio waveform with the TMS waveform (page 8-9; specifically synchronizing TMS and audio which is seen as adjusting a phase offset of both TMS and audio in order to synchronize with one another in conditioning and testing phase) . Regarding claim 9, Ewers teaches: further comprising: repeating the localized magnetic field stimulation and the concurrent and synchronized acoustic stimulation over a plurality of treatment sessions to establish entrainment or conditioning, wherein the acoustic stimulation can be subsequently performed to invoke a conditioned response or entrainment response without presence of the localized magnetic field stimulation (Fig. 1 and page 8; specifically conditioning phase) . Regarding claim 10 , Ewers teaches: wherein the localized magnetic field stimulation is used to treat pain (this is seen as the result of using the method and Ewers shows this is possible as seen in the Introduction) . Regarding claim 11, Ewers teaches: wherein the localized magnetic field stimulation is used to treat chronic pain. (this is seen as the result of using the method and Ewers shows this is possible as seen in the Introduction) . Regarding claim 12, Ewers teaches: further comprising: receiving, via the TMS device, a TMS file; receiving, via the acoustic controller, an audio file (page 8; experimental setup) ; and adjusting a phase offset of a TMS waveform generated from the TMS file to synchronize the TMS waveform with the audio waveform, wherein the TMS waveform is amplified and subsequently applied to one or more TMS coils to generate the localized magnetic field waveform (page 8-9; specifically synchronizing TMS and audio which is seen as adjusting a phase offset of both TMS and audio in order to synchronize with one another in conditioning and testing phase and page 5: amplification of amplitudes) . Regarding claim 13, Ewers teaches: further comprising: receiving, via the TMS device, a TMS file; receiving, via the acoustic controller, an audio file (page 8: experimental setup) ; and adjusting a phase offset of the audio waveform generated from the audio file to synchronize the audio waveform to the TMS waveform, wherein the TMS waveform is amplified and subsequently applied to one or more TMS coils to generate the localized magnetic field waveform (page 8-9; specifically synchronizing TMS and audio which is seen as adjusting a phase offset of both TMS and audio in order to synchronize with one another in conditioning and testing phase and page 5: amplification of amplitudes) . Regarding claim 16, Ewers teaches: wherein the instructions further causes the processor to: receive a TMS waveform file; and generate a TMS waveform to be amplified and subsequently applied to one or more TMS coils to generate the localized magnetic field waveform (page 8; specifically Experimental setup; paired auditory-TMS stimulations as well as MEP recording were controlled by a laptop computer which uses data acquisition unit with Signal software and TSM/Conditioning phase on how the signals are applied) . Regarding claim 17, Ewers teaches: wherein the instructions further causes the processor to: adjust a phase offset of the TMS waveform to synchronize the TMS waveform with the audio waveform (page 8-9; specifically synchronizing TMS and audio which is seen as adjusting a phase offset of both TMS and audio in order to synchronize with one another in conditioning and testing phase) . Regarding claim 18, Ewers teaches: wherein the instructions further causes the processor to: adjust a phase offset of the audio waveform to synchronize the audio waveform with the TMS waveform (page 8-9; specifically synchronizing TMS and audio which is seen as adjusting a phase offset of both TMS and audio in order to synchronize with one another in conditioning and testing phase) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 6 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ewers in view of Goldwasser et al., US 20170224990, herein referred to as “Goldwasser” . Regarding claim 6, Ewers does disclose that the system includes recording MEPs for the TMS and audio pairing as seen in Figure 1 during operation of the TMS and acoustic controller. Ewers does not explicitly disclose that EMG was used for recording MEPS. However, Goldwasser discloses: further comprising: an electromyographic equipment configured to acquire an electromyography (EMG) measurement during operation of the system ([0699]; specifically using physiological measurement for controlling functionalities one of which is EMG) . It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the recording of MEPs for the TMS and audio pairing as seen in Ewers to include recording physiological measurements including EMG as seen in Goldwasser. The motivation being replacing one known measurement and recording for MEPS with another known physiological measurement using EMG with the predictable result of measuring signals from musculature. Regarding claim 14, Ewers does disclose that recording MEPs for the TMS and audio pairing as seen in Figure 1 during operation. Ewers does not explicitly disclose that EMG was used for recording MEPS. However, Goldwasser discloses: further comprising: acquiring an electromyography (EMG) measurement during operations of the generation of the localized magnetic field waveform and the acoustic stimulation ([0699]; specifically using physiological measurement for controlling functionalities one of which is EMG) . It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the recording of MEPs for the TMS and audio pairing as seen in Ewers to include recording physiological measurements including EMG as seen in Goldwasser. The motivation being replacing one known measurement and recording for MEPS with another known physiological measurement using EMG with the predictable result of measuring signals from musculature. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOANNE M RODDEN whose telephone number is (303)297-4276. The examiner can normally be reached Monday - Friday 9:00 AM-5:00 PM MST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794 Application/Control Number: 18/222,114 Page 2 Art Unit: 3794 Application/Control Number: 18/222,114 Page 3 Art Unit: 3794 Application/Control Number: 18/222,114 Page 4 Art Unit: 3794 Application/Control Number: 18/222,114 Page 5 Art Unit: 3794 Application/Control Number: 18/222,114 Page 6 Art Unit: 3794 Application/Control Number: 18/222,114 Page 7 Art Unit: 3794 Application/Control Number: 18/222,114 Page 8 Art Unit: 3794 Application/Control Number: 18/222,114 Page 9 Art Unit: 3794