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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/18/2025 has been entered.
Election/Restrictions
Applicant's election with traverse of Group I (claims 17-18, 20, 32-35, 67, 71-79) in the reply filed on 04/15/2026 is acknowledged. The traversal is on the ground(s) that the Applicant amended to incorporate common language into the claims. This is not found persuasive because claim 80 requires the use of the feedback information to therapeutically adjust treatment and provide stimulation to treat migraines based on the feedback, where none of claims of group I require this limitation.
The requirement is still deemed proper and is therefore made FINAL.
To clarify the restriction between the two groupings, Group I is much broader than Group II as Group I obtains biological data from sensors for predicting a migraine and delivering the first and second stimulation (applying stimulation is not done in relation to the prediction of a migraine for treatment) whereas Group II does an analysis of feedback information obtained from biological data obtained during an aberrant state and resting state to provide a “cue to a user” and therapeutically treating the migraine using either the first or second electrical stimulation. In other words, Group I does not actively recite the use of stimulation to treat migraines but instead collects data and applies stimulation while Group II applies stimulation to treat migraines based on data collected.
Claims 80-81 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/15/2026.
Response to Amendment
This Office Action is responsive to the amendment filed on 09/03/2025. As directed by the amendment: Claims 67 and 71 have been amended, claims 1-16, 19, 21-31, 36-66, 68-70, and 82 have been cancelled, and no claims have been added. Claims 80-81 were previously withdrawn due to a Restriction Requirement. Thus, claims 17-18, 20, 32-35, 67, 71-79 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 09/18/2025, with respect to the rejection(s) of the claim(s) under 35 U.S.C. 102/103 have been fully considered and are persuasive. Amendments to the claim obviate the rejection of record. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ganguly et al. (US 20200061378) (WO/2018/093765 IDS) (Hereinafter Ganguly) in view of Bergethon (US 20040267153)(Hereinafter Bergethon).
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-15, 19, 27-29 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 67, the phrase “one or more sensors located on the arm or the wrist” is claiming the mammal subject, as the systems are attached to the mammal. Examiner suggests to amend the claim to recite “one or more sensors configured to be located on the arm or the wrist”.
Claim Rejections - 35 USC § 112
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.
Claims 17-18, 20, 32-35, 67, 71-79 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 67, it is unclear if the “biological data” obtained by the one or more sensors of line 12 is the same or different than the “biological data” obtained from the at least one biomedical sensor of lines 7-8. Further, it is unclear if the “biological data” of line 8 is the same or different than the “biological data” of line 8. Examiner will interpret the biological data as different data.
Regarding claim 79, it is unclear if the sensor of line 2 is the same or different than the “one or more sensors” of claim 67 line 12 and/or the biomedical sensor of claim 67 lines 7-8.
Claims 17-18, 20, 32-35, 67, 71-79 are rejected for being dependent on independent claim 67.
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.
Claim(s) 17-18, 20, 32-33, 35, 67, and 71-78 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ganguly et al. (US 20200061378) (WO/2018/093765 IDS) (Hereinafter Ganguly) in view of Bergethon (US 20040267153)(Hereinafter Bergethon).
Regarding claim 67, Ganguly teaches A wearable device for treating migraines using transcutaneous peripheral nerve stimulation ([0013] “A stimulator may be configured as a wearable stimulator that is configured to be worn on a subject's arm and/or wrist, (e.g., and configured to apply stimulation to one or more of the subject's radial, ulnar and median nerves).” [0105] “Various diseases and conditions may be treated by PNS combined with training and feedback using the devices, systems and algorithms described above. These include … migraines” [0106] “Various nerves may be targeted for treat disease conditions or to enhance performance. These include nerves of the upper limb such as radial nerve (all branches), median nerve”), comprising:
a first peripheral nerve effector configured to be placed on a first skin surface proximate a median nerve of an arm or a wrist of a patient ([0089] “In FIG. 6A-6D the wrist band 250 incorporates one or more electrodes 255 to individually or collectively stimulate the three peripheral nerves of the arm, namely the radial, median and ulnar nerves.” [0134] “For multiple nerve stimulations (e.g., median, ulnar, radial), all nerves may be stimulated simultaneously or may be stimulated using a patterned train (e.g. sequential or any combination with variable temporal lags).”);
a second peripheral nerve effector configured to be placed on a second skin surface proximate a radial nerve or an ulnar nerve of the arm or the wrist of the patient ([0089] “In FIG. 6A-6D the wrist band 250 incorporates one or more electrodes 255 to individually or collectively stimulate the three peripheral nerves of the arm, namely the radial, median and ulnar nerves.” [0134] “For multiple nerve stimulations (e.g., median, ulnar, radial), all nerves may be stimulated simultaneously or may be stimulated using a patterned train (e.g. sequential or any combination with variable temporal lags).”);
at least one biomedical sensor configured to provide feedback information, wherein the feedback information comprises biological data of the user at a resting state and biological data of the user at an aberrant state wherein biological data of the user at an aberrant state indicates symptoms that accompany migraines ([0158] “The patient applies the stimulation device to wrist and puts on the headband EEG…Stimulation signals are sent to the control module while EEG data is received from the EEG monitor. The EEG data is used to modulate the stimulation in real time according to algorithm.” [0139] “Clinical experiments were conducted using this system. A relative decrease in ipsilesional resting state low frequency power was observed primarily in the delta band (0-4 Hz) and theta band (4-7 Hz) immediately after PNS when compared to the baseline resting period, as shown in FIG. 17.” Ipsilesional is a migraine on the same side of the brain lesion. The baseline resting period EEG is determined and the ipsilesional resting (aberrant) state EEG is compared.), and
a controller ([0161] “controller”) configured to:
receive biological data relating to the user from one or more sensors located on the arm or the wrist of the user (Examiner notes that the “one or more sensors located on the arm or wrist” is not actively recited and will be interpreted as the biological data from the biomedical sensor. [0082] “However, wearing and removing a glove may be difficult for stroke patients that have limited hand movement. To overcome this limitation, the feedback sensors 112 may be incorporated into stretchable/elastic rings (made from polymers) that incorporate the sensors and detect hand and digit motion.”);
provide a cue to the user of an event associated with migraines based on analysis of the feedback information ([0087] “The device comprises bipolar electrodes 202 as well as vibrotactile feedback sensors 203 to provide real-time feedback regarding (EEG or motor or movement) response to SES stimulation and task-errors during dexterity training. This modular unit also has the capacity to monitor finger movements (using bend sensors 204), ability to electrically stimulate all three nerves at a range of frequencies, and be able to provide vibratory cues based on real-time monitoring of performance.” The glove can be substituted with other embodiments recited in [0082]. See analysis relating to stroke (associated with migraines) in [0147].);
transcutaneously deliver a first electrical stimulation signal to the first peripheral nerve effector to stimulate the median nerve ([0023] “electrical stimulation may be applied transdermally (e.g., through the skin)” [0134] “For multiple nerve stimulations (e.g., median, ulnar, radial), all nerves may be stimulated simultaneously or may be stimulated using a patterned train (e.g. sequential or any combination with variable temporal lags).”); and
transcutaneously deliver a second electrical stimulation signal to the second peripheral nerve effector to stimulate the radial nerve or the ulnar nerve ([0023] “electrical stimulation may be applied transdermally (e.g., through the skin)” [0134] “For multiple nerve stimulations (e.g., median, ulnar, radial), all nerves may be stimulated simultaneously or may be stimulated using a patterned train (e.g. sequential or any combination with variable temporal lags).”).
However, Ganguly does not teach the predicting the onset of a migraine using the biological data. Bergethon, in the same field of endeavor, teaches the stimulation of the median nerve based on ischemic stroke for contralateral migraines ([0014]), and further teaches at least one biomedical sensor configured to provide feedback information, wherein the feedback information comprises biological data of the user at a resting state and biological data of the user at an aberrant state wherein biological data of the user at an aberrant state indicates symptoms that accompany migraines ([0014] “To assess electrical activity, one can record evoked potentials, such as somatosensory evoked potentials (SSEPs).” [0040] “Referring to FIG. 5, ischemia detection system 110 detects and can assess ischemia based on measurements of SSEPs (using, for example, an EEG machine);”), and
a controller ([0037] “Computer 22 includes a processor 52”) configured to:
predict an onset of a migraine based on the biological data relating to the user ([0036] “Process 40 determines (47) whether ischemia is present in the patient's brain using subprocess 47 (see FIG. 4) to compare the response of the tissue on the lateral 32b and contralateral 36b sides of the body.” [0012] “the methods of the invention can be used, alone or in combination with other tests, to diagnose a stroke; to monitor the progression of the stroke; to evaluate a patient's response to medical treatment once stroke is suspected” [0040] “Referring to FIG. 5, ischemia detection system 110 detects and can assess ischemia based on measurements of SSEPs (using, for example, an EEG machine);”) to limit the damage of the disease by providing proper medical attention ([0007]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Gunguly, with the predicting the onset of a migraine using the biological data of Bergethon, because such a modification would allow to limit the damage of the disease by providing proper medical attention.
Regarding claim 17, Ganguly teaches wherein the first electrical stimulation signal and the second electrical stimulation signal comprise burst stimulation signals ([0016] “a controller may be configured to adjust the electrical stimulation by adjusting one or more of: intensity, current amplitude, frequency, duration, duty cycle, times/day, pulse duration, burst frequency, burst duration, or total treatment period.” See Fig. 15D).
Regarding claim 18, Ganguly teaches wherein the device is not configured to stimulate the upper arm of the patient ([0013] “A stimulator may be configured as a wearable stimulator that is configured to be worn on a subject's arm and/or wrist, (e.g., and configured to apply stimulation to one or more of the subject's radial, ulnar and median nerves).” Since the device can be wrist worn, it is not stimulating the upper arm.).
Regarding claim 20, Ganguly teaches wherein the first peripheral nerve effector and the second peripheral nerve effector are coupled together on a wearable band ([0013] “A stimulator may be configured as a wearable stimulator that is configured to be worn on a subject's arm and/or wrist, (e.g., and configured to apply stimulation to one or more of the subject's radial, ulnar and median nerves).” [0089] “the wrist band 250 incorporates one or more electrodes 255 to individually or collectively stimulate the three peripheral nerves”).
Regarding claim 32, Ganguly teaches wherein the feedback information comprises real-time feedback information ([0087] “The device comprises bipolar electrodes 202 as well as vibrotactile feedback sensors 203 to provide real-time feedback regarding (EEG or motor or movement) response to SES stimulation and task-errors during dexterity training.”).
Regarding claim 33, Ganguly teaches wherein the feedback information comprises autonomic nervous system activity of the patient (Abstract “Methods and apparatuses for sensory electrical stimulation of the peripheral nervous system [part of the ANS] to improve human motor function” [0087] “The device comprises bipolar electrodes 202 as well as vibrotactile feedback sensors 203 to provide real-time feedback regarding (EEG or motor or movement) response to SES stimulation [part of PNS] and task-errors during dexterity training.”).
Regarding claim 35, Ganguly teaches wherein the feedback information comprises EEG data of the patient ([0087] “The device comprises bipolar electrodes 202 as well as vibrotactile feedback sensors 203 to provide real-time feedback regarding (EEG or motor or movement) response to SES stimulation and task-errors during dexterity training.”).
Regarding claim 71, Ganguly wherein the controller is further configured to adjust at least one of the first electrical stimulation signal and the second electrical signal stimulation signal based on the feedback information ([0087] “The device comprises bipolar electrodes 202 as well as vibrotactile feedback sensors 203 to provide real-time feedback regarding (EEG or motor or movement) response to SES stimulation and task-errors during dexterity training.” [0044] “wherein the program causes a processor to measure a delta wave or theta wave component of an EEG from the biomarker monitor; and adjust the stimulation parameters based on the measured biomarker; and transmit the adjusted stimulation parameters to the stimulator”).
Regarding claim 72, Ganguly teaches wherein the at least one biomedical sensor or data input source comprises motion data relating to the patient ([0085] “software enables real-time feedback on motion during dexterity training.” [0108] “using analysis of phones integrated with motion sensors to analyze gait and provide feedback, placing motion sensors in critical locations along the lower extremities using adhesives or integrated into girdle/sleeves or using motion capture (using e.g., Microsoft Kinect).”).
Regarding claim 73, Ganguly teaches wherein the second peripheral nerve effector is configured to stimulate a radial nerve ([0106] “one embodiment may simultaneously stimulate the median, ulnar and/or radial nerves.”).
Regarding claim 74, Ganguly teaches wherein the EEG data comprises a first set of EEG data prior to a therapy session wherein the controller is configured to adjust at least one of the first electrical stimulation signal and the second electrical stimulation signal based on the first set of EEG data ([0138] “EEG recordings before/during/after stimulation [therapy session] are used to assess response to PNS” [0130] “This may be further modulated and optimized based on how people with similar EEG profiles and responses performed in the past.”).
Regarding claim 75, Ganguly teaches wherein the EEG data comprises a second set of EEG data during or after the therapy session, wherein the controller is configured to adjust at least one of the first electrical stimulation signal and the second electrical stimulation signal based on the second set of EEG data ([0158] “The phone communicates using Bluetooth low energy with the EEG monitor and the electrode control module. Stimulation signals are sent to the control module while EEG data is received from the EEG monitor. The EEG data is used to modulate the stimulation in real time according to algorithm.”).
Regarding claim 76, Ganguly teaches wherein an EEG sensor is located on an EEG headband, the EEG headband configured to transmit the EEG data to the controller ([0158] “The patient applies the stimulation device to wrist and puts on the headband EEG. She then opens an app on the phone which has previously uploaded data from last stimulation session and last training session. The server has revised the stimulation algorithm and pushed it back down to the app. She then starts a monitored stimulation session. The phone communicates using Bluetooth low energy with the EEG monitor and the electrode control module. Stimulation signals are sent to the control module while EEG data is received from the EEG monitor.”).
Regarding claim 77, Ganguly teaches wherein the first electrical stimulation signal and the second electrical stimulation signal are configured to disrupt a thalamocortical dysrhythmia associated with migraine ([0105] “Various diseases and conditions may be treated by PNS combined with training and feedback using the devices, systems and algorithms described above. These include stroke, pain, neuralgia, migraines” [0106] “Various nerves may be targeted for treat disease conditions or to enhance performance. These include nerves of the upper limb such as radial nerve (all branches), median nerve…one embodiment may simultaneously stimulate the median, ulnar and/or radial nerves.”). The mechanism of action does not have a bearing on the patentability of the invention if the invention was already known or obvious. Even though applicant has proposed or claimed the mechanism by which the disruption of thalamocortical dysrhythmia associated with migraines does not appear to distinguish the prior art teaching the same or nearly the same methods to achieve the same end result of stimulating an individual with migraines. Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145(II) and MPEP 2112.01.
Regarding claim 78, Ganguly teaches wherein the controller is configured to stimulate an orexinergic network by transcutaneously delivering the first electrical stimulation signal and the second electrical stimulation signal ([0107] “In the case of stroke, traumatic brain injury or other acquired brain injury with speech, language, dysphagia, upper-limb and lower-limb deficits, or cerebral palsy, the device may stimulate nerves of the upper limb (sensory and motor nerves C3-T2, including ulnar, median, radial,” Orexigenic network is associated with the health condition of eating habits and appetite. In this regard, dysphagia is a health condition associated with poor eating habits and the difficulty of swallowing, and therefore associated with the orexigenic network.). The mechanism of action does not have a bearing on the patentability of the invention if the invention was already known or obvious. Even though applicant has proposed or claimed the mechanism by which the stimulation of orexigenic network does not appear to distinguish the prior art teaching the same or nearly the same methods to achieve the same end result of stimulating dysphagia. Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145(II) and MPEP 2112.01.
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ganguly et al. (US 20200061378) (WO/2018/093765 IDS) (Hereinafter Ganguly) in view of Bergethon (US 20040267153)(Hereinafter Bergethon) and Ziv (US 20180028809)(Hereinafter Ziv).
Regarding claim 34, claim 1 is obvious over Ganguly and Bergethon. However, Ganguly does not teach a feedback information comprising HRV. Ziv, in the same field of endeavor, teaches the neurostimulation of the skin via electrodes ([0008]), similar to the device of Gungly, and further teaches wherein the feedback information comprises heart rate variability ([0098] “According to some embodiments, processing circuitry 126 may comprise loop feedback circuitry (not shown), configured to adjust inputs (e.g. stimulation signals) as a function of outputs (e.g. real-time HRV values).”) to adjust the stimulation in real-time ([0098]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Gunguly, with the feedback information comprising HRV of Ziv, because such a modification would allow to adjust the stimulation in real-time.
Claim(s) 79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ganguly et al. (US 20200061378) (WO/2018/093765 IDS) (Hereinafter Ganguly) in view of Bergethon (US 20040267153)(Hereinafter Bergethon) and Simon et al. (US 20110230701)(IDS)(Hereinafter Simon).
Regarding claim 79, claim 1 is obvious over Ganguly and Bergethon. However, Ganguly does not teach a respiratory cycle to activate stimulation. Simon, in the same field of endeavor, teaches the nerve stimulation for treating migraines and headaches (Abstract), similar to the device of Ganguly, and further teaches wherein the controller is arranged to receive measurements from a sensor that detects events or phases of a respiratory cycle; wherein the controller is configured to activate at least the first electrical stimulation signal or the second electrical stimulation signal in phase with a portion of the respiratory cycle by measurements from the sensor ([0049] “electrical stimulation on the surface of the neck may co-stimulate the phrenic nerve that is involved with the control of respiration, the patient hiccups and does not breathe normally, resulting in "a patient sense of incongruity and displeasure." … to modulate the timing and intensity of the electrical stimulation at the neck as a function of the respiratory phase, in such a way that the undesirable respiratory effects are minimized.”) to minimize undesirable respiratory effects ([0049]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Gunguly, with the respiratory cycle to activate stimulation of Simon, because such a modification would allow to minimize undesirable respiratory effects.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
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