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 .
Response to Amendment
This Action is in response to the Amendment filed July 7, 2025.
In view of the Amendment, the objections to the drawings and the specification and the rejection of claims 13 and 15, as set forth in the Office Action dated 04/08/2025, are withdrawn.
Claims 1, 13, and 15 are amended.
Claims 1-15 are pending.
Response to Arguments
Applicant’s arguments, see bottom of page 11 to end of page 12 of the Amendment, filed 07/07/2025, with respect to the rejection(s) of claim(s) 1-15 under 35 USC 102 and 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 Therefore, the rejection has been withdrawn.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 US Patent Application Publication No. 2021/0169364 to Han et al. (hereinafter referred to as “Han”.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2009/0287035 to Dietrich et al. (hereinafter referred to as “Dietrich”) in view of US Patent Application Publication No. 2021/0169364 to Han et al. (hereinafter referred to as “Han”).
Referring to claim 1, Dietrich discloses a method for the treatment of a patient suffering or recovering from a critical illness (e.g., paragraph [0020]: method may be used with neurological and/or neuropsychiatric disorders and/or symptoms resulting sleep disorders, cardiovascular disorders) using a device comprising a generator configured to produce an electrical stimulation signal (e.g., paragraph [0045]: Oscillating signals are needed for transdermal stimulation and the signals are generated by an oscillator 12 located in the control unit 4) and a controller (e.g., Fig. 1, control unit 4), connected to the generator (see Fig. 1, oscillator 12 and paragraph [0045]) and configured to determine the form of the electrical stimulation signal (e.g., paragraphs [0045]: stimulation frequency and stimulation strength are predetermined and generated by the control unit 4 and [0009]: electrical stimuli signals may have the form of either unipolar or bipolar signals and are controlled by an open loop or closed loop control and Fig. 3D), the method comprising: (i) producing an electrical stimulation signal from the generator (e.g., paragraph [0045]), and determining the form of the electrical stimulation signal using the controller connected to the generator (e.g., paragraphs [0023]: for stimulation, a stimulation pulse with at least one plateau pulse width of adjustable duration, a rising and decaying trailing phase of adjustable duration and [0047]-[0048]); and (ii) transmitting the electrical stimulation signal to an electrode in contact with a tragus of the patient (e.g., paragraphs [0052]: stimulation electrodes 2,3 lie on an inner face of the tragus; [0062]: Fig. 3A; and [0068]: tVNS was performed at the inner side of the left tragus (Fig. 3A)).
Dietrich differs from the claimed invention in that it does not expressly disclose determining an electrical impedance of the tragus based on measurements of a current, voltage, and phase relationship of the electrical stimulation signal. However, Han, in a related art: skin measuring apparatus, teaches that it was known to those skilled in the art that a signal detecting unit that detects the amount of current from the skin through an electrode can be used to calculate an impedance signal where the impedance measurement is based on a current, voltage and phase relationship of the electrical signal at an electrode which is on the skin of a patient (e.g., paragraph [0030] of Han). Accordingly, one of ordinary skill in the medical electrical stimulation arts would have recognized the benefits of measuring the skin impedance in view of the teachings of Han. Consequently, one of ordinary skill in the art would have modified the method of Dietrich to produce an electrical stimulation signal and a controller, as well as to determine skin impedance at the tragus in order to measure the skin moisture level as taught by Han, and because the combination would have yielded a predictable result.
With respect to claim 2, Dietrich in view of Han teaches the method for the treatment of a patient suffering or recovering from a critical illness according to claim 1, wherein the electrical stimulation comprises a series of electrical pulses (e.g., paragraphs [0023]: for stimulation, a stimulation pulse with at least one plateau pulse width of adjustable duration, a rising and decaying trailing phase of adjustable duration and [0048]: control unit 4 regulates the frequency of the stimulation signal where the signals follow one another in rapid succession).
As to claim 3, Dietrich in view of Han teaches the method for the treatment of a patient suffering or recovering from a critical illness according to claim 2, wherein each electrical pulse repeats with a frequency of 1 Hz to 100 Hz (e.g., paragraph [0050]: the frequency of the current is between 20 and 30 Hz, which is within the claimed range; also paragraph [0063]).
With respect to claim 5, Dietrich in view of Han teaches the method for the treatment of a patient suffering or recovering from a critical illness according to claim 2, wherein each pulse has an amplitude of 0.1 mA to 8 mA (e.g., paragraphs [0050]: applied current/signal is between 0.25 mA and 1.5 mA; and [0068]: electrical current amplitude was varied between 4 and 8 mA).
Claims 1-2, 4, 6-8, 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2022/0233860 to Hamner et al. (EFD: 03/20/2020 and hereinafter referred to as “Hamner”) in view of Han.
Referring to claim 1, Hamner discloses a method for the treatment of a patient suffering or recovering from a critical illness (e.g., paragraph [0009]: methods can treat sleep disorders, such as sleep apnea or chronic insomnia) using a device comprising a generator configured to produce an electrical stimulation signal (e.g., paragraph [0215]: pulse generator 10 delivers electrical stimulation to a nerve through one or more target nerves; Fig. 4, 10) and a controller (e.g., paragraph [0215]: A processor and controller 12 receives one or more signals generated by sensors 13 to control timing and parameters of the stimulation; Fig. 4, 12), connected to the generator (see Fig. 4 and paragraph [0215]) and configured to determine the form of the electrical stimulation signal (e.g., paragraphs [0215]:processor 11 uses instructions stored in memory to coordinate receiving signals from sensors 13 and to control stimulation delivered by pulse generator 10; [0207]: stored biological measures can be correlated to set parameters of the stimulation waveform applied by the therapy unit; and [0245]), the method comprising: (i) producing an electrical stimulation signal from the generator (e.g., paragraph [0215]: pulse generator 10 delivers electrical stimulation to a nerve through one or more target nerves), and determining the form of the electrical stimulation signal using the controller connected to the generator (e.g., paragraphs [0245]: stimulation of a nerve can be controlled by adjusting frequency or pulse width of the stimulation waveform; and [0263]: stimulation parameters that may be adjusted automatically may include waveform shape); and (ii) transmitting the electrical stimulation signal to an electrode in contact with a tragus of the patient (e.g., paragraphs [0205]: Fig. 3 illustrates a tragus stimulator 392 with an earbud configuration positioned in the tragus 398 of the ear 390 where stimulator 392 includes a cathode 387 and an anode 388 (electrodes)).
Hamner differs from the claimed invention in that it does not expressly disclose determining an electrical impedance of the tragus based on measurements of a current, voltage, and phase relationship of the electrical stimulation signal. However, Han, in a related art: skin measuring apparatus, teaches that it was known to those skilled in the art that a signal detecting unit that detects the amount of current from the skin through an electrode can be used to calculate an impedance signal where the impedance measurement is based on a current, voltage and phase relationship of the electrical signal at an electrode which is on the skin of a patient (e.g., paragraph [0030] of Han). Accordingly, one of ordinary skill in the medical electrical stimulation arts would have recognized the benefits of measuring the skin impedance in view of the teachings of Han. Consequently, one of ordinary skill in the art would have modified the method of Hamner to produce an electrical stimulation signal and a controller, as well as to determine skin impedance at the tragus in order to measure the skin moisture level as taught by Han, and because the combination would have yielded a predictable result.
With respect to claim 2, Hamner in view of Han teaches the method for the treatment of a patient suffering or recovering from a critical illness according to claim 1, wherein the electrical stimulation comprises a series of electrical pulses (e.g., paragraph [0261]: the stimulator can deliver various signals to target tissue once a trigger signal is generated from the controller including a burst of bi-phasic pulses).
With respect to claim 4, Hamner in view of Han teaches the method for the treatment of a patient suffering or recovering from a critical illness according to claim 2, wherein each pulse has a duration of 10 microseconds to 500 microseconds (e.g., paragraphs [0261]: each pulse may have a pulse width varying from about 100-1000 microseconds, which discloses pulse widths that are within the range (100-500 microseconds); and [0263]: A preferred pulse width may range from 50-500 microseconds).
As to claim 6, Hamner in view of Han teaches the method for the treatment of a patient suffering or recovering from a critical illness according to claim 1, wherein the device is applied to the patient at least once a day (e.g., paragraphs [0208]: patient satisfaction can be logged after each stimulation session or end of a specified period, like a day or week; [0262]: once or twice a day stimulation is provided; and [0300]: sympathetic and parasympathetic activity are assessed prior to initial stimulation to select dosing of stimulation (e.g., number of times per day)).
With respect to claim 7, Hamner in view of Han teaches the method for the treatment of a patient suffering or recovering from a critical illness according to claim 1, wherein the device is applied to the user for a minimum of 5 minutes and a maximum of 2 hours per day (e.g., paragraph [0263]: stimulation may last for approximately 10 minutes to 1 hour, which is within the claimed range).
As to claim 8, Hamner in view of Han teaches the method for the treatment of a patient suffering or recovering from a critical illness according to claim 7, wherein the device is applied to the user for a minimum of 15 minutes and a maximum of 2 hours per day (e.g., paragraph [0263]: stimulation may last for approximately 20 minutes to 40 hour, which is within the claimed range).
With respect to claim 11, Hamner in view of Han teaches the method for the treatment of a patient suffering or recovering from a critical illness according to claim 1, wherein the critical illness is a disease or condition including at least one of COVID-19 infection, post-surgical recovery, trauma, post-traumatic stress disorder (PTSD), sleep apnoea, infection (viral, bacterial and/or fungal infection, including sepsis), organ failure, e.g. failure of the heart, lung, brain, kidneys, bone marrow and/or other major organs, cancer, heart attack, organ transplant (e.g. heart, liver, kidney, lung, bone marrow transplant), coronary bypass surgery and angioplasty (e.g., paragraphs [0009]: some embodiments treat a sleep disorder, such as sleep apnea; [0015]: some embodiments related to the treatment of diseases such as heart failure, post-traumatic stress disorder; and [0216]: alternating stimulation bilaterally can improve the efficiency of accessing experiences associated with PTSD).
As to claim 12, Hamner in view of Han teaches the method for the treatment of a patient suffering or recovering from a critical illness according to claim 1, wherein the method further comprises a step of administering to the patient a pharmaceutically active composition for treatment of the critical illness (e.g., paragraphs [0018]: peripheral nerve stimulation can advantageously have synergistic effects when combined with pharmacotherapy; [0288]; stimulation combined with pharmacotherapy for cardiac disorders).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hamner in view of Han as applied to claim 1 above, and further in view of case law.
With respect to claim 9, Hamner in view of Han teaches the method for the treatment of a patient suffering or recovering from a critical illness according to claim 1, wherein during a first period the method is applied to the user for between 5 minutes and 2 hours each day, the first period comprising a minimum of 3 consecutive days, and a third period where the method is applied to the user between 5 minutes and 2 hours each day (e.g., paragraphs [0300]-[0301]: duration of stimulation session: 20-120 minutes (2 hours) where the number of sessions per day depends on the sympathetic and parasympathetic activity of the patient), but does not expressly disclose a second period where the method is stopped for at least 2 days. However, Hamner does disclose that a patient could receive such therapy three times a week, which if scheduled M, W, F would result in two stopped days (T, Th of the week, or Sat., Sun would be two consecutive days - see paragraph [0301]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Hamner in view of Han with a first period of therapy, a second period of no therapy, and a third period of therapy, 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].
As to claim 10, Hamner in view of Han teaches the method for the treatment of a patient suffering or recovering from a critical illness according to claim 9, wherein the method is applied to the user for between 15 minutes and 2 hours each day (e.g., paragraphs [0300]-[0301]: duration of stimulation session: 20-120 minutes (2 hours)).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Dietrich in view of Han or Hamner in view of Han as applied to claim 1 above, and further in view of International Publication Number WO 2020/086726 (cited by Applicant and hereinafter referred to as WO ‘726).
With respect to claim 13, Dietrich or Hamner in view of Han teaches the method according to claim 1, but does not expressly disclose screening a patient suffering or recovering from a critical illness for treatment including: (i) recording an electrocardiogram of a patient for a minimum period of 1 minute; (ii) analysing the power spectrum of heart rate variability; determining the low frequency (LF) to high frequency (HF) ratio of the power spectrum of heart rate variability (LF/HF); (iii) determining whether the LF/HF ratio of the power spectrum of heart rate variability is greater than a predetermined threshold value, wherein, if the value of the LF/HF ratio of the power spectrum of heart rate variability is greater than the predetermined threshold value, the patient is particularly suitable for treatment according to the method of claim 1. Dietrich discloses that parasympathetic tissue and related structures can be enhanced by a transdermal applied stimulus, such as tragus stimulation (e.g., paragraphs [0007] and [0063] of Dietrich); and Hamner discloses monitoring sympathetic activity in the patient including receiving heart rate variability of the patient and determining a ratio of absolute low frequency to absolute high frequency of heart rate variability of the patient in order to adjust the electrical nerve stimulation signal (e.g., paragraphs [0024]-[0025] of Hamner. WO ‘726 teaches, in a related art: nerve stimulation, that sympathetic and parasympathetic activity can be measured through heart rate, which is recorded by chest straps or finger sensors (e.g., paragraph [0079] of WO ‘726 or electrocardiogram (ECG) electrodes (e.g., paragraph [0130] of WO ‘726) for a minimum period of 1 minute (e.g., paragraph [0121] of WO ‘726; analyzing the power spectrum (frequency-domain, time-domain, and geometric domain analysis) of heart rate variability to separate the heartbeat frequencies into distinct bands: high frequency and low frequency (e.g., paragraph [0079] of WO ‘726); taking/determining the ratio of high frequency to low frequency to yield an approximation of one’s sympathetic tone (e.g., paragraph [0079] of WO ‘726); and determining whether the ratio is greater than a threshold where the determined ratio indicates a change in one, two, or more stimulation modality parameters to module stimulation to one or more nerves using a target desired HRV value or threshold (e.g., paragraph [0079] of WO ‘726). Accordingly, one of ordinary skill in the art would have recognized the benefits of the screening or monitoring of a patient recovering from an illness in order to treat the patient by electrical stimulation by analyzing heart rate variability of the patient in view of teachings of WO ‘726. Consequently, one of ordinary skill in the art would have modified the method of Dietrich in view of Han or Hamner in view of Han to screen or monitor the power spectrum of heart rate variability of a patient as taught by WO ‘726 to determine a patient’s suitability/adjustment for the stimulation treatment disclosed by Dietrich in view of Han or Hamner in view of Han, and because the combination would have yielded a predictable result. With respect to the specific ratio of LF to HF and being greater than a threshold, it is the Examiner’s position that WO ‘726 teaches a HF/LF and senses the increase in HRV with that ratio using a threshold or percentage to make the adjustments to the stimulation therapy and that one of ordinary skill in the art could have taken a LF/HF ratio and used a threshold as such would be within involve routine skill in the art [In re Aller, id.]
As to claim 14, Dietrich in view of Han or Hamner in view of Han and further in view of WO ‘726 teaches the method according to claim 13, but does not expressly teach that the threshold value is about 1. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by the above combination to have a threshold value of about 1, 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].
With respect to claim 15, Dietrich in view of Han or Hamner in view of Han teaches the method according to claim 1, further comprising: screening a patient suffering or recovering from a critical illness for treatment including: (i) recording an electrocardiogram of a patient for a minimum period of 1 minute; (ii) analysing the power spectrum of heart rate variability; determining the low frequency (LF) value and the high frequency (HF) value of the power spectrum of heart rate variability; (iii) determining whether the LF value or the HF value of the power spectrum of heart rate variability is greater than a predetermined threshold value, wherein, if the LF value or the HF value of the power spectrum of heart rate variability is greater than the predetermined threshold value, the patient is particularly suitable for treatment according to the method of claim 1. WO ‘726 teaches, in a related art: nerve stimulation, that sympathetic and parasympathetic activity can be measured through heart rate, which is recorded by chest straps or finger sensors (e.g., paragraph [0079] of WO ‘726 or electrocardiogram (ECG) electrodes (e.g., paragraph [0130] of WO ‘726) for a minimum period of 1 minute (e.g., paragraph [0121] of WO ‘726; analyzing the power spectrum (frequency-domain, time-domain, and geometric domain analysis) of heart rate variability to separate the heartbeat frequencies into distinct bands: high frequency and low frequency (e.g., paragraph [0079] of WO ‘726); and determining/ evaluating the LF value to assess parasympathetic activity/response which can indicates a change in one, two, or more stimulation modality parameters to module stimulation to one or more nerves using a target desired HRV value or threshold (e.g., paragraphs [0079] and [0081] of WO ‘726). Accordingly, one of ordinary skill in the art would have recognized the benefits of the screening or monitoring of a patient recovering from an illness in order to treat the patient by electrical stimulation by analyzing heart rate variability of the patient in view of teachings of WO ‘726. Consequently, one of ordinary skill in the art would have modified the method of Dietrich in view of Han or Hamner in view of Han to screen or monitor the power spectrum of heart rate variability of a patient as taught by WO ‘726 to determine a patient’s suitability/adjustment for the stimulation treatment taught by Dietrich in view of Han or Hamner in view of Han, and because the combination would have yielded a predictable result.
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.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792