CTNF 18/859,621 CTNF 85932 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 Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 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, 2, 4, 5 and 12 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Mishelevich (2017/0246481) . Regarding claim 1, Mishelevich discloses a method of treating pain in a patient, the method comprising: applying a transdermal stimulation routine to a portion of a spinal cord to treat pain (ultrasound transducer 5470 is pressed against skin 5460 and generates ultrasound beam 5480 that neuromodulates nerves within the spinal cord 5430 – [0624]; fig.54). Regarding claim 2, Mishelevich discloses wherein the patient does not have a spinal cord injury that affects motor function (for any of the parts, in some variations, the disorder treated is…pain – [0037]). Regarding claim 4, Mishelevich discloses determining the transdermal stimulation routine for treating pain in the patient, wherein determining the transdermal stimulation routine comprises changing at least one of a pulse duration, a frequency, or an amplitude of the transdermal stimulation routine based on a pain metric (in the set-up phases the patient/subject physiologic results will include assessment of changes such as…pain threshold – [0676]; use of acute feedback to adjust 6755 that iterates through the ultrasound variables (e.g., position, intensity, frequency, phase/intensity relationships, mechanical perturbations, pulse duration, firing pattern – [0677]). Regarding claim 5, Mishelevich discloses wherein the pain metric is an EGG measurement (feedback mechanism is applied, wherein the feedback mechanism is…electroencephalogram (EEG) – [0038]; [0209]). Regarding claim 12, Mishelevich discloses wherein the stimulation routine comprises a plurality of repetitions, each repetition having a pulse width, each repetition comprising a plurality of frequency modulated pulses provided at a carrier frequency, wherein the repetitions are repeated at a repetition frequency (determine one or more of the carrier wave frequency, the pulse intensity, the pulse energy, the pulse duration, the pulse repetition rate, or the pulse phase – [0253];[0272];[0642]) . 07-15-aia AIA Claim(s) 13, 15-18, 20, 21, 23 and 27 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Lo et al (WO2021/062345) . Regarding claim 13, Lo et al discloses a method of treating pain in a patient, the method comprising: applying, transdermally, by a first electrode, a stimulation routine to a portion of a spinal cord of the patient (a transcutaneous electrical stimulation system, comprising: a plurality of electrodes – claim 1; wherein electrodes are arranged in both longitudinal and transverse direction relative to the spinal cord – claim 5); increasing an intensity of the stimulation routine to a first threshold (delivers incremental ramp up of current intensity in order to classify the minimum current densities requires to reach the targeted neural fibers perception, sensor and motor activation thresholds – [0165]); and applying the stimulation routine at the first threshold during a session ([0162]). Regarding claim 15, Lo et al disclose wherein applying the stimulation routine at the first threshold during the session comprises applying the stimulation routine at the first threshold for an entirety of the session (restrict stimulation intensity to sub-motor threshold levels – [0132]). Regarding claim 16, Lo et al disclose wherein applying the stimulation at the first threshold during the session comprises intermittently reducing the stimulation routine below the first threshold (decreasing frequency at the recorded amplitude while recording measurements from the one or more sensors, recording a frequency at which the one or more detected measurements reaching a second predetermined threshold – [0078]). Regarding claim 17, Lo et al disclose wherein the first threshold is determined by a patient tolerance (dynamically restrict stimulation intensity to sub-motor thresholds. The user’s motor thresholds are determined during the diagnostic or testing phases of therapy and subsequently used as pre-set parameters to minimize the likelihood of the occurrence for painful or twitch-inducing overstimulation – [0132]). Regarding claim 18, Lo et al disclose wherein the stimulation routine is a first stimulation, the method further comprising: applying, transdermally, by a second electrode, a second stimulation routine of a spinal cord (a transcutaneous electrical stimulation system, comprising: a plurality of electrodes – claim 1; wherein electrodes are arranged in both longitudinal and transverse direction relative to the spinal cord – claim 5); increasing an intensity of the second stimulation routine by the second electrode to a second threshold (for each of the two or more transcutaneous stimulation electrodes, delivering a series of pulses of increasing amplitude…reaching a first predetermined threshold…decreasing to a second predetermined threshold – [0078]); and applying the second stimulation routine by the second electrode at the second threshold during the session (the stimulation frequency is automatically decreased until a subject’s perception threshold is reached – [0080]). Regarding claim 20, Lo et al disclose wherein the stimulation routine comprises a plurality of repetition frequency modulated pulses, each repetition having a pulse width, wherein the plurality of repetitions are repeated at a repetition frequency (the width of each pulse can range from 10 ps to 10 ms, the stimulation frequency can range from 0 to 10 kHz – [0074]). Regarding claim 21, Lo et al disclose wherein the patient does not have a spinal cord injury that affects motor function (the neuromodulation is employed for pain suppression – [0094]). Regarding claim 23, Lo et al disclose further comprises repeating application of the stimulation routine for a plurality of sessions (immediately repeating the preceding steps with the opposite polarity. Examiner interprets “opposite polarity” to be a second session. benchmarks to optimize stimulation parameters for achieving desired patient outcome – [0112]). Regarding claim 27, Lo et al disclose further comprising, prior to increasing the intensity of the stimulation routine to the first threshold, increasing the intensity of the stimulation to a baseline threshold at which the patient can feel the stimulation routine at the skin (method for calibrating a transcutaneous spinal cord stimulation device – [0078]) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 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. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim (s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mishelevich (2017/0246481) in view of Falci (2007/0016264) . Regarding claims 6 and 7, Mishelevich discloses the invention substantially as claimed, but fail to explicitly disclose wherein the pain metric is a blood biomarker which is RNA. However, Falci teach in an analogous field of endeavor, a pain metric is a blood biomarker which is RNA (potential pain effectors include…RNA – [0028]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the pain metric of Mishelevich with a blood biomarker that is RNA as it would provide a well-known and conventional pain effector involved in the transcription and translation of the receptors, ion channels, transcription factors, neurotransmitters, and the like . 07-21-aia AIA Claim (s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mishelevich (2017/0246481) in view of Errico et al (2014/0030334) . Regarding claims 9 and 10, Mishelevich discloses changing at least one of a pulse duration, a frequency, or an amplitude of the transdermal stimulation routine based on a pain metric (in the set-up phases the patient/subject physiologic results will include assessment of changes such as…pain threshold – [0676]; use of acute feedback to adjust 6755 that iterates through the ultrasound variables (e.g., position, intensity, frequency, phase/intensity relationships, mechanical perturbations, pulse duration, firing pattern – [0677]), but fail to explicitly disclose a machine learning algorithm comprising a support vector machine. However, Errico et al teach in the same medical field of endeavor, a machine learning algorithm comprising a support vector machine (in the preferred embodiments, support vector machines are used – [0035]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the changing based on a pain metric of Mishelevich with a support vector machine of Errico et al as it would provide a well-known and conventional machine used to incorporate knowledge of the physiological system’s anatomy and mechanics to create forecasting models . 07-21-aia AIA Claim (s) 25 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lo et al (WO2021/062345) in view of Thieme et al (9,604,054) . Regarding claims 25 and 26, Lo et al disclose the invention substantially as claimed, but fail to explicitly disclose further comprising ceasing provision of additional sessions after pain is reduced by a threshold and ceasing provision of additional sessions upon absence of improvement of pain experience after one or more previous sessions. However, Thieme et al teach in the same medical field of endeavor, ceasing provision of additional sessions after pain is reduced by a threshold and ceasing provision of additional sessions upon absence of improvement of pain experience after one or more previous sessions (repeat delivery of the series of stimuli until the subject’s pain is reduced – fig. 13). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sessions of Lo et al with ceasing provision of additional sessions after pain is reduced by a threshold and ceasing provision of additional sessions upon absence of improvement of pain experience after one or more previous sessions as it would provide stimulation to the patient in the event of pain reduction or relief. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROCHELLE DEANNA TURCHEN whose telephone number is (571)270-7104. 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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. /ROCHELLE D TURCHEN/Primary Examiner, Art Unit 3797 Application/Control Number: 18/859,621 Page 2 Art Unit: 3797 Application/Control Number: 18/859,621 Page 3 Art Unit: 3797 Application/Control Number: 18/859,621 Page 4 Art Unit: 3797 Application/Control Number: 18/859,621 Page 5 Art Unit: 3797 Application/Control Number: 18/859,621 Page 6 Art Unit: 3797 Application/Control Number: 18/859,621 Page 7 Art Unit: 3797 Application/Control Number: 18/859,621 Page 8 Art Unit: 3797 Application/Control Number: 18/859,621 Page 9 Art Unit: 3797 Application/Control Number: 18/859,621 Page 10 Art Unit: 3797
