CTNF 18/671,513 CTNF 100338 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-fti AIA The present application is being examined under the pre-AIA first to invent provisions. Information Disclosure Statement The Information Disclosure Statements (IDS) filed 05/22/2024 and 11/15/2024 have been considered by the Examiner. 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-fti The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made. 07-23-fti The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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. 07-20-02-fti This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a). 07-21-fti Claim s 1-11 and 16-17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ansari et al (US 20210346711 A1) in view of Vysokov et al (US 20210307684 A1) . Regarding claim 1, Ansari teaches a wearable device (1800) for providing a smoking effect, the wearable device comprising: a housing (1880/1885b) ; a first stimulus unit (see Figs. 18-18B; planar micro-coil arrays 1805b) provided on a surface of the housing (see [0230]; micro-coil arrays 1805b positioned in distributed positions around headwear 1885b) and comprising at least one electrode that is disposed on a position corresponding to a first region (see [0236]; one or more arrays positioned between the front of the crown of the headwear 1885b and the right and/or left frontal lobe) of a user and configured to provide electrical stimulation (see Abstract; planar micro-coil arrays are connected to a controller configured to generate an electrical current and transmit that electrical current, in accordance with a particular stimulation protocol, to each of the planar micro-coil arrays.) ; a second stimulus unit (1805b) provided on the surface of the housing and comprising at least one electrode that is disposed on a position corresponding to a second region (see [0236]; one or more arrays positioned between the top side of the crown of the headwear 1885b and the parietal lobe) of the user and configured to provide electrical stimulation; and a controller (1870b) configured to control the first stimulus unit or the second stimulus unit (see [0239]; controller 1870b is in electrical communication with each of the plurality micro-coil arrays 1805b and is programmed to direct an electrical current to each of the arrays) , wherein the first stimulus unit or the second stimulus unit is configured to provide an electrical stimulus signal that induces an alertness state capable of alleviating symptoms associated with nicotine cravings ([0248]; normalization of brain function may thereby enable at least partial alleviation of symptoms associated with addiction to or cravings for nicotine) . Ansari is silent regarding alleviating symptoms associated with nicotine cravings alleviates said symptoms by inducing an alertness state capable of implementing a smoking effect. Vysokov teaches a system for implementing a stimulation protocol that mimics the effects of at least one drug on the brain of a user by measuring the effect of a drug and generating a corresponding stimulation protocol (Vysokov [0040-0043]). It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Ansari’s method for alleviating the symptoms of nicotine cravings by mimicking the state of a user’s brain after smoking as taught by Vyzokov’s drug mimicking stimulation protocol. One of ordinary skill in the art would have been motivated to make this modification in order to assist a user in quitting smoking by providing the mental effects of the drug without having to partake in smoking, thereby satisfying the craving. Regarding claim 2, Ansari in view of Vysokov teaches the wearable device of claim 1, further comprising: a third stimulus unit (1805b) provided on the surface of the housing, wherein the third stimulus unit comprises at least one electrode that is disposed on a position corresponding to a third region of the user (see Ansari [0236]; one or more arrays positioned between the back side of the crown of the headwear 1885b and the occipital lobe) and configured to provide electrical stimulation (see Ansari Abstract; planar microcoil arrays are connected to a controller configured to generate an electrical current and transmit that electrical current, in accordance with a particular stimulation protocol, to each of the planar microcoil arrays). Regarding claim 3, Ansari in view of Vysokov teaches the wearable device of claim 2, wherein the first region is a frontal lobe (see Ansari [0236]; one or more arrays positioned between the front of the crown of the headwear 1885b and the right and/or left frontal lobe), the second region is a parietal lobe (see Ansari [0236]; one or more arrays positioned between the top side of the crown of the headwear 1885b and the parietal lobe) , and the third region is an occipital lobe (see Ansari [0236]; one or more arrays positioned between the back side of the crown of the headwear 1885b and the occipital lobe) . Regarding claim 4, Ansari in view of Vysokov teaches the wearable device of claim 3, wherein the controller is further configured to control at least one of the first stimulus unit, the second stimulus unit, or the third stimulus unit (see Ansari [0253-0254]; the controller is adapted to modify the generation and transmission of current in accordance with the programmatic instructions including parameters such as which micro-coil arrays actually receive the current) so that the first stimulus unit, the second stimulus unit, or the third stimulus unit provides a brain stimulus signal that decreases delta waves or theta waves of the user or increases beta waves of the user (see Ansari [0254]; the treatment may cause the user's brain to decrease or increase beta wave generation, to decrease or increase delta wave generation, to decrease or increase theta wave generation). Regarding claims 5, 7, and 9, Ansari in view of Vysokov teaches the wearable device of claim 3, wherein the controller is further configured to activate (see Ansari [0253-0254]; the controller is adapted to modify the generation and transmission of current in accordance with the programmatic instructions including parameters such as which micro-coil arrays actually receive the current) the second stimulus unit or the third stimulus unit to decrease delta waves of the user (see Ansari [0254]; the treatment may cause the user's brain to decrease or increase delta wave generation); activate the first stimulus unit or the third stimulus unit to decrease theta waves of the user (see Ansari [0254]; the treatment may cause the user's brain to decrease or increase theta wave generation) ; or activate at least one of the first stimulus unit, the second stimulus unit, or the third stimulus unit to increase beta waves of the user (see Ansari [0254]; the treatment may cause the user's brain to decrease or increase beta wave generation). Regarding claim 6 Ansari in view of Vyzokov teaches the wearable device of claim 3, wherein the controller is further configured to activate the second stimulus unit or the third stimulus unit (see Ansari [0253-0254]; the controller is adapted to modify the generation and transmission of current in accordance with the programmatic instructions including parameters such as which micro-coil arrays actually receive the current) , and the second stimulus unit or the third stimulus unit is configured to provide electrical stimulation that causes power spectral density (PSD) of electroencephalogram (EEG) of the user (see Ansari [0269]; EEG sensors capture data indicative of the varying magnitude of electric fields originating from the brain including, but not limited to, delta brain waves, theta brain waves, alpha brain waves, and beta brain waves) to decrease in a frequency range of 1 Hz to 4 Hz (see Ansari [0254]; the treatment may cause the user's brain to decrease or increase beta wave generation, to decrease or increase delta wave generation, to decrease or increase theta wave generation, [0269]; delta brain waves may be between 0.5 to 3Hz and theta brain waves may be between 3 to 8 Hz, [0271]; the data generated by the EEG sensors is used to modulate, change, or otherwise modify one or more of the stimulation parameters including when to activate, how long to operate, and when to terminate). Ansari is silent regarding wherein the electrical stimulation provided by the second stimulus unit or the third stimulus unit causes the PSD of the EEG of the user to decrease by 0.3 to 0.9 dB in the desired frequency range. However, Ansari does teach the application of electrical stimulation to vary brain waves in a desired frequency range and measuring said changes in brain waves via an EEG (Ansari [0271]). It has been held that when the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Therefore, it can be appreciated that it would have been within the ordinary skill in the art to determine the optimum amount by which to decrease the PSD of the EEG of the user in order to achieve the desired effects. See MPEP 2144.05(II), In re Aller, 220 F.2d 454. Regarding claim 8, Ansari in view of Vysokov teaches the wearable device of claim 3, wherein the controller is further configured to activate the first stimulus unit or the third stimulus unit (see Ansari [0253-0254]; the controller is adapted to modify the generation and transmission of current in accordance with the programmatic instructions including parameters such as which micro-coil arrays actually receive the current) , and the first stimulus unit or the third stimulus unit is configured to provide electrical stimulation that causes PSD of EEG of the user (see Ansari [0269]; EEG sensors capture data indicative of the varying magnitude of electric fields originating from the brain including, but not limited to, delta brain waves, theta brain waves, alpha brain waves, and beta brain waves) to decrease in a frequency range of 4 Hz to 8 Hz (see Ansari [0254]; the treatment may cause the user's brain to decrease or increase beta wave generation, to decrease or increase delta wave generation, to decrease or increase theta wave generation, [0269]; theta brain waves may be between 3 to 8 Hz, [0271]; the data generated by the EEG sensors is used to modulate, change, or otherwise modify one or more of the stimulation parameters including when to activate, how long to operate, and when to terminate). Ansari is silent regarding wherein the electrical stimulation provided by the first stimulus unit or the third stimulus unit causes the PSD of the EEG of the user to decrease by 0.2 to 0.5 dB in the desired frequency range. However, Ansari does teach the application of electrical stimulation to vary brain waves in a desired frequency range and measuring said changes in brain waves via an EEG (Ansari [0271]). It has been held that when the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Therefore, it can be appreciated that it would have been within the ordinary skill in the art to determine the optimum amount by which to decrease the PSD of the EEG of the user in order to achieve the desired effects. See MPEP 2144.05(II), In re Aller, 220 F.2d 454. Regarding claim 10, Ansari in view of Vysokov teaches the wearable device of claim 3, wherein the controller is further configured to activate at least one of the first stimulus unit, the second stimulus unit, or the third stimulus unit, (see Ansari [0253-0254]; the controller is adapted to modify the generation and transmission of current in accordance with the programmatic instructions including parameters such as which micro-coil arrays actually receive the current) , and at least one of the first stimulus unit, the second stimulus unit, or the third stimulus unit is configured to provide electrical stimulation that causes PSD of EEG of the user (see Ansari [0269]; EEG sensors capture data indicative of the varying magnitude of electric fields originating from the brain including, but not limited to, delta brain waves, theta brain waves, alpha brain waves, and beta brain waves) to increase in a frequency range of 12 Hz to 25 Hz (see Ansari [0254]; the treatment may cause the user's brain to decrease or increase beta wave generation, to decrease or increase delta wave generation, to decrease or increase theta wave generation, [0269]; beta brain waves may be between 12 to 38 Hz, [0271]; the data generated by the EEG sensors is used to modulate, change, or otherwise modify one or more of the stimulation parameters including when to activate, how long to operate, and when to terminate). Ansari is silent regarding wherein the electrical stimulation provided by the first stimulus unit or the third stimulus unit causes the PSD of the EEG of the user to increase by 0.1 to 1.1 dB in the desired frequency range. However, Ansari does teach the application of electrical stimulation to vary brain waves in a desired frequency range and measuring said changes in brain waves via an EEG (Ansari [0271]). It has been held that when the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Therefore, it can be appreciated that it would have been within the ordinary skill in the art to determine the optimum amount by which to decrease the PSD of the EEG of the user in order to achieve the desired effects. See MPEP 2144.05(II), In re Aller, 220 F.2d 454. Regarding claim 11, Ansari in view of Vysokov teaches the wearable device of claim 1, wherein the housing is configured to be worn on a head of the user (see Ansari Fig. 18B, [0230]; headwear 1885b). Regarding claim 16, Ansari teaches a wearable device (1800) for providing a smoking effect, the wearable device comprising: a housing (1880/1885b) ; a stimulus unit (see Figs. 18-18B; planar micro-coil arrays 1805b) provided on a surface of the housing, configured to provide a stimulus signal, and comprising a stimulator (Ansari [0239]) ; and a controller (1870b) provided in the housing and configured to control the stimulus unit (see Ansari [0239]; controller 1870b is in electrical communication with each of the plurality micro-coil arrays 1805b and is programmed to direct an electrical current to each of the arrays) , wherein the controller is configured to control the stimulus unit so that the stimulus unit generates a stimulus signal that induces a state of alertness capable of alleviating symptoms associated with nicotine cravings ([0248]; normalization of brain function may thereby enable at least partial alleviation of symptoms associated with addiction to or cravings for nicotine) . Ansari is silent regarding alleviating symptoms associated with nicotine cravings alleviates said symptoms by inducing an alertness state capable of implementing a smoking effect. Vysokov teaches a system for implementing a stimulation protocol that mimics the effects of at least one drug on the brain of a user by measuring the effect of a drug and generating a corresponding stimulation protocol (Vysokov [0040-0043]). It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Ansari’s method for alleviating the symptoms of nicotine cravings by mimicking the state of a user’s brain after smoking as taught by Vyzokov’s drug mimicking stimulation protocol. One of ordinary skill in the art would have been motivated to make this modification in order to assist a user in quitting smoking by providing the mental effects of the drug without having to partake in smoking, thereby satisfying the craving. Regarding claim 17, Ansari in view of Vysokov teaches the wearable device of claim 16, wherein the stimulus unit is configured to perform at least one of electrical stimulation (see Ansari [0239]; an electrical current is directed to each of a plurality of microcoil arrays 1805b and delivered to a user) . 07-21-fti Claim s 16, 17, 19, and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Covalin (US 20200197707 A1) in view of Vysokov et al (US 20210307684 A1) . Regarding claim 16, Covalin teaches a wearable device (200) for providing a smoking effect, the wearable device comprising: a housing (201 and 210) ; a stimulus unit (210) provided on a surface of the housing, configured to provide a stimulus signal, and comprising a stimulator (see Covalin [0098]; the auricular component 201 is connected to an electrical pulse generator 210 which produces the therapy stimulation going to the electrodes on the auricular component 201) ; and a controller provided in the housing and configured to control the stimulus unit (see Covalin [0088]; the treatment device includes a pulse generator or controller having management software for customizing the therapeutic output and receiving confirmation of therapeutic delivery) , wherein the controller is configured to control the stimulus unit so that the stimulus unit generates a stimulus signal that induces a state of alertness capable of reduction of symptoms associated with substance withdrawal (see Covalin [0069]; transcutaneous stimulation of auricular nerve fibers for the reduction of substance consumption, the reduction of symptoms associated with substance withdrawal, and for the long-term maintenance to prevent substance relapse). Covalin is silent regarding wherein the means of reduction of symptoms associated with substance withdrawal comprises inducing a state of alertness capable of implementing a smoking effect. Vysokov teaches a system for implementing a stimulation protocol that mimics the effects of at least one drug on the brain of a user by measuring the effect of a drug and generating a corresponding stimulation protocol (Vysokov [0040-0043]). It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Covalin’s system for the treatment of substance use disorders, which may comprise reduction of withdrawl symptoms, by mimicking the state of a user’s brain after smoking as taught by Vysokov’s drug mimicking stimulation protocol. One of ordinary skill in the art would have been motivated to make this modification in order to assist a user in quitting smoking by providing the mental effects of the drug without having to partake in smoking, thereby satisfying the craving. Regarding claim 17, Covalin in view of Vysokov teaches the wearable device of claim 16, wherein the stimulus unit is configured to perform electrical stimulation which stimulates a brain of a user (see Covalin [0077]; auricular neurostimulation has proven beneficial in treating a number of human disorders, [0098]; the auricular component 201 is connected to an electrical pulse generator 210 which produces the therapy stimulation) . Regarding claim 19, Covalin in view of Vysokov teaches the wearable device of claim 16, further comprising: a verification member comprising a verifier configured to verify a therapeutic effect, wherein the verification member is capable of measuring a heart rate variability (HRV) (see Covalin [0129]; EKG can be used to assess heart rate and heart rate variability, to determine the activity of the autonomic nervous system in general and/or the relative activity of the sympathetic and parasympathetic branches of the autonomic nervous system, and to modulate the therapy). Regarding claim 20, Covalin in view of Vysokov teaches the wearable device of claim 19, wherein the controller is configured to determine a degree of activation of the stimulus unit based on an indicator signal transmitted from the verification member (see Covalin [0126-0129]; the system can record overall therapeutic delivery to measure compliance, the system can utilize feedback to monitor and/or modify the therapy, the feedback may include EKG signals where the signals are used to detect a speed or timing of a symptom and/or therapeutic outcome) . 07-21-fti Claim 18 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ansari et al (US 20210346711 A1) in view of Vysokov et al (US 20210307684 A1) and Boyle et al (US 20160256105 A1) . Regarding claim 18, Ansari in view of Vysokov teaches the wearable device of claim 17. They are silent regarding wherein the stimulus signal is transcranial alternating current stimulation (tACS), which decreases at least one of delta waves or theta waves of electroencephalogram (EEG) of the user or increases beta waves of EEG of the user. Boyle teaches a system for transcranial stimulation that adapts to simultaneously recorded brain activity, thereby providing better control of activity in the cerebral cortex (Boyle [0005]) , wherein the system may be used to treat a substance use disorder such as substance dependence and substance abuse (Boyle [0097]) using a stimulus signal, wherein the stimulus signal is transcranial alternating current stimulation (tACS) (see Boyle [0110]; cortical stimulation devices capable of detecting cortical oscillations and/or coherence may provide transcranial alternating current stimulation) , which decreases at least one of delta waves or theta waves of electroencephalogram (EEG) of the user or increases beta waves of EEG of the user (see Boyle [0095]; methods of the invention may modulate cortical activity in any suitable manner, including, but not limited to, inhibiting cortical oscillations and enhancing cortical oscillation, wherein said cortical oscillations may be in the delta, theta, or beta frequency ranges, [0113]; means of detecting cortical oscillations including electroencephalograms ). It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Ansari’s system for providing a stimulus signal to a user for modulating brain waves at a desired frequency with Boyle’s method of transcranial alternating current stimulation. One of ordinary skill in the art would have been motivated to make this modification in order to utilize the effects of transcranial alternating current stimulation to modulate neuronal network activity by changing the polarization of a large number of neurons (Boyle [0145]). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /A.J.S./Examiner, Art Unit 3792 /Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792 Application/Control Number: 18/671,513 Page 2 Art Unit: 3792 Application/Control Number: 18/671,513 Page 3 Art Unit: 3792 Application/Control Number: 18/671,513 Page 4 Art Unit: 3792 Application/Control Number: 18/671,513 Page 5 Art Unit: 3792 Application/Control Number: 18/671,513 Page 6 Art Unit: 3792 Application/Control Number: 18/671,513 Page 7 Art Unit: 3792 Application/Control Number: 18/671,513 Page 8 Art Unit: 3792 Application/Control Number: 18/671,513 Page 9 Art Unit: 3792 Application/Control Number: 18/671,513 Page 10 Art Unit: 3792 Application/Control Number: 18/671,513 Page 11 Art Unit: 3792 Application/Control Number: 18/671,513 Page 12 Art Unit: 3792 Application/Control Number: 18/671,513 Page 13 Art Unit: 3792 Application/Control Number: 18/671,513 Page 14 Art Unit: 3792
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