DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in Application 17/449,661 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicants’ submission filed on 08/19/2026 has been entered.
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 .
Claim Rejections - 35 USC § 112(b)
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.
Claims 13-21 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 13 in line 11 recites “user feedback” which renders this claim unclear. More specifically, it is unclear as to whether claim 13 line 11 “user feedback” is the same as different than or in addition to that recited in claim 13 line 5 and if different in what way the two differ.
Claim 13 in line 14 recites “the user feedback” which renders this claim unclear. More specifically, it is unclear as to whether claim 13 line 14 “the user feedback” is referencing “user feedback” in claim 13 line 5 and/or “user feedback” in claim 13 line 11.
Claim 13 recites “user feedback related to the anxiety level or the general mood of the user before, during, and/or after the treatment session” which renders this claim unclear. More specifically, it is unclear as to how the user feedback is actually “related” to the anxiety level or the general mood of the user i.e. the nature of the relationship is not clear or what is meant by “related” in this context. Additionally, it is unclear as to what is meant by “general mood” or how the “anxiety level” is determined i.e. subjective, objective, based on EEG measurements or something else. In the interest of furthering prosecution, the term “user feedback” in this limitation in the context used is being interpreted in light of instant application specification para. [0042] as [i] user feedback/user data used to set a parameter of the treatment session and/or [ii] as user provided feedback/data on the effectiveness of a treatment and/or [iii] as user feedback/data used to adjust a treatment protocol which (i.e. each of [i-iii]) is indirectly/directly related to anxiety level or the general mood of the user before, during, and/or after the treatment session.
Dependent claims 14-21 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 14-21 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification para. [0002], [0042], [0081], [0097], [0102-0103], [0115-0118].
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
The claimed term “general mood” is being interpreted as user state of mind (Webster’s New World College Dictionary, 5th Digital Edition. Copyright © 2025 HarperCollins Publishers.).
The claimed term “user feedback” is being interpreted in light of instant application specification para. [0042] as user feedback/user data used to set a parameter of the treatment session and/or a user provided feedback/data on the effectiveness of a treatment or user feedback/data used to adjust a treatment protocol indirectly/directly related to anxiety level or the general mood of the user before, during, and/or after the treatment session.
Claim Rejections - 35 USC § 103
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 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.
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 of this title, 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.
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 13-21 are rejected under 35 U.S.C. 103 as being unpatentable over Charles et al. (Pub. No.: US 20180214710 A1, hereinafter referred to as “Charles”) in view of Helekar (Pub. No.: US 20220168585 A1, hereinafter referred to as “Helekar”) as evidenced by Zis et al. (Pub: Athena Michaelides & Panagiotis Zis (2019): Depression, anxiety and acute pain: links and management challenges, Postgraduate Medicine, DOI: 10.1080/00325481.2019.1663705, hereinafter referred to as “Zis”).
As per independent Claim 13, a mobile device (Charles in at least fig. 1, fig. 7-8, fig. 11, [0003-0007], [0032], [0034], [0043], [0067], [0094-0100], [0106], [0122-0124], [0126], [0131], [0136], [0139], [0146-0148], [0150], [0165-0166], [0174-0175], [0177-0179] for example discloses relevant subject-matter. More specifically, Charles in at least fig. 1, 7-8, 11, [0042], [0067], [0094-0095], [0099], [0123] for example discloses a mobile device such as mobile smartphone. See at least Charles [0067] “adjustment of the magnets within the helmet … are automatically controlled by the controller having a digital processing device”; [0099] “controller is a hand held unit or any other suitable unit that is portable. The controller includes one or more selected from: a digital processing device, non-transitory computer readable/writeable storage medium, a software module, a processor, a computer program, or any suitable software or hardware”; [0123] “suitable digital processing devices include… handheld computers… mobile smartphones, tablet computers, personal digital assistants… Those of skill in the art will recognize that many smartphones are suitable for use in the system described herein”) comprising:
a wireless communication interface configured to communicate with a head-mounted device (HMD) (Charles in at least fig. 1, 7-8, 11, [0007], [0042], [0067], [0094], [0096], [0099], [0123-0124] for example discloses a wireless communication interface configured to communicate with a head-mounted device (HMD). See at least Charles [0007] “a device comprising a helmet for applying a magnetic field to a head of a subject …the device comprises a connection to a controller…connection is … a wireless connection”; [0042] “the motors and magnets reside in the headset 10, 1200 but the motor controllers and other system electronics reside external to the headset, for example, in the system controller”; [0067] “adjustment of the magnets within the helmet … are automatically controlled by the controller having a digital processing device”; [0094] “devices and methods disclosed herein include a controller… controller 20 includes …an interface to electronically … connect to a helmet”; [0099] “controller is a hand held unit or any other suitable unit that is portable. The controller includes one or more selected from: a digital processing device…a processor, a computer program, or any suitable software or hardware”; [0123] “suitable digital processing devices include… mobile smartphones … Those of skill in the art will recognize that many smartphones are suitable for use in the system described herein”);an application defining a user interface, the user interface configured to at least prompt a user for user feedback relating to an anxiety or a general mood before, during, and/or after a treatment session (Here, the claim limitation is being interpreted broadly yet reasonably as encompassing both indirect/direct interactions, arrangement, associations, linkages, operation, functions and results, and thus, a broad yet reasonable interpretation of the limitation in light of the instant specification would also include the interpretation “user interface configured to at least prompt a user for user feedback at least indirectly relating to an anxiety or a general mood before, during, and/or after a treatment session”. Additionally, the “and/or” encompassing limitation is broadly yet reasonably interpreted as requiring just one of the enumerated elements in the list i.e. [i] one of an anxiety or a general mood and [ii] one of before, during, or after a treatment session. Further, “prompt a user” in the context used is being broadly yet reasonably interpreted as a user interface that is presented to the user (i.e. prompts a user) on the mobile device to obtain user input. Additionally, the recited term “general mood” is being interpreted as user state of mind in light of specification which is silent as to what is meant by or encompassed by “general mood” (Webster’s New World College Dictionary, 5th Digital Edition. Copyright © 2025 HarperCollins Publishers). Furthermore, the term “user feedback” in this limitation in the context used is being interpreted in light of instant application specification para. [0042] as user feedback/user data used to set a parameter of the treatment session and/or as user provided feedback/data on the effectiveness of a treatment and/or as user feedback/data used to adjust a treatment protocol each of which is at least indirectly related to anxiety or the general mood of the user before, during, and/or after the treatment session. Charles in at least fig. 7-8, 11, [0094], [0096], [0097-0098], [0100], [0146-0166] for example discloses an application defining a user interface/input interface, the user interface configured to at least prompt a user for user feedback/input such as user inputs in [0096] (user input(s) at the input interface, such as a treatment plan number or a target frequency… a user manually inputs a target intrinsic frequency at the input interface, a user inputs an application protocol number, a user enters an intrinsic frequency of the subject, a frequency of movement, number of repetitions for each procedure, and/or duration of procedure from a user, treatment plan or application protocol generated by the device based on inputs at the user input interface) used to derive the treatment protocol and thus at least indirectly relate to treatment for anxiety ([0150], [0165], [0167]) or general mood (mental state associated with any of mental disorders listed in [0146-0166]) which are at least indirectly related to an anxiety when directed to treating anxiety in a subject ([0165]) or a general mood (i.e. state of mind) when directed to treating any of the mental disorders listed in [0146-0166] before, during, or after a treatment session. See Charles [0094] “devices and methods … include …controller 20 includes one or more selected from…an input interface; a button array 202”; from a user…controller is used to select a pre-programmed procedure(s) of the device. Such selection is manual from a user at the input interface”; [0097] “input interface enables user input to be received by the controller and thus controls various parameters”; [0098] “control includes a digital processor and a computer executable
a processor communicatively coupled to the wireless communication interface (Charles in at least fig. 1, fig. 11, [0007],[0067], [0099], [0123], [0136] for example disclose a processor communicatively coupled to the wireless communication interface. See at least Charles [0007] “a device comprising a helmet for applying a magnetic field to a head of a subject …the device comprises a connection to a controller…connection is … a wireless connection”; [0067] “adjustment of the magnets within the helmet … are automatically controlled by the controller having a digital processing device”; [0099] “controller is a hand held unit or any other suitable unit that is portable. The controller includes one or more selected from: a digital processing device…a processor, a computer program, or any suitable software or hardware”; [0123] “suitable digital processing devices include… mobile smartphones … Those of skill in the art will recognize that many smartphones are suitable for use in the system described herein”; [0136] “digital processing device 1101 includes a central processing unit (CPU, also “processor” and “computer processor” herein) 1105”), the processor configured execute the application to:
receive, at the mobile device from the wireless communication interface to the HMD, an electroencephalogram (EEG) signal comprising EEG data (Charles in at least [0005-0006], [0098], [0099-0100] for example discloses receive, at the mobile device from the wireless communication interface to the HMD, an electroencephalogram (EEG) signal comprising EEG data. See at least Charles [0005] “device comprises a connection to a controller… connection is a … a wireless connection …controller comprises a second processor and computer readable media executable by the second processor configured to: … receive the EEG data of the subject”; [0094] “devices and methods disclosed herein include a controller… controller 20 includes …a connection to receive or process EEG data 50… interface to electronically … connect to a helmet”),
receive, from the user interface, user feedback related to the anxiety or the general mood of the user before, during, and/or after the treatment session(Charles in at least fig. 7-8, 11, [0094], [0096], [0097-0098], [0100], [0146-0166] for example discloses receive, from the user interface, user feedback such as user inputs in [0096] that are at least indirectly related to the anxiety ([0150], [0165], [0167]) or the general mood (mental state associated with any of mental disorders listed in [0146-0166]) of the user before, during, or after the treatment session),
compute, at the mobile device, a treatment session parameter comprising a magnetic field frequency value based on the EEG data and the user feedback (Charles in at least fig. 7-8, 11, [0094], [0096], [0097-0098], [0100], [0146-0166] for example discloses compute, at the mobile device, a treatment session parameter comprising a magnetic field frequency value based on the EEG data and the user feedback such as in [0096]), and
compute, at the mobile device, a control instruction to apply the magnetic field frequency value at the HMD (Charles in at least [0005-0006], [0094-0096], [0098], [0099-0100] for example discloses compute, at the mobile device, a control instruction to apply the magnetic field frequency value at the HMD. See at least Charles [0096] “controller controls various aspects of the wearable device 10 and its elements… such control is automatic …including power on, power off, starting a treatment, stopping a treatment, or the like… controller is used to automatically adjust a frequency of movement, number of repetitions for each procedure and/or duration of procedure…automatic adjustment is based on the EEG data received and/or processed at the controller… automatic selection is automatic based on the EEG data of the subject”; [0098] “control includes a digital processor and a computer executable program to derive control command(s) based on at least an input from a user, an automatic feedback from the device, and/or internal program stored in the device”),
wherein the wireless communication interface is further configured to transmit the control instruction to the HMD (Charles in at least [0005-0006], [0094-0096], [0098], [0099-0100] for example discloses wherein the wireless communication interface is further capable of being operable to transmit the control instruction to the HMD. See at least Charles [0006] “method comprises: an EEG measuring the EEG data of the subject; the EEG transmitting the EEG data to a processor… processor calculating the intrinsic frequency … the Q-factor of the intrinsic frequency from the EEG data; and the processor directing the fit mechanism to modify the position of a permanent magnet within the housing”; [0095] “controller controls one or more selected from: duration of movement; repetition pattern of movement; track or trajectory of movement; frequency of movement; time for onset/stop of movement; acceleration of movement; speed of movement; … distance of magnets to one or more motors… control of magnets or motors results in the control of the magnetic field(s) generated thereby…controller controls the frequency of the magnetic field(s); the phase of the of the magnetic field(s); the amplitude of the magnetic field(s); the waveform of the frequency; the amplitude or the phase of the magnetic field, the duration of the magnetic field(s); the direction of the magnetic field(s); the polarity of the magnetic field(s); the properties of the magnetic flux; spatial distribution of the magnetic field; or a combination thereof.”; [0096] “controller controls various aspects of the wearable device 10 and its elements… such control is automatic …including power on, power off, starting a treatment, stopping a treatment, or the like… controller is used to automatically adjust a frequency of movement, number of repetitions for each procedure and/or duration of procedure…automatic adjustment is based on the EEG data received and/or processed at the controller… automatic selection is automatic based on the EEG data of the subject”; [0100] “device as disclosed herein includes a treatment plan, an application protocol, or use of the same… treatment plan or application protocol is generated at the device based on one or more parameters selected from… subject's EEG data…or the like….”).
Charles does not explicitly disclose user interface configured to at least prompt a user for user feedback in the form of mental state level such as anxiety level.
However, in an analogous head mounted device communicating mobile device field of endeavor, Helakar discloses a mobile device (Helekar in at least [0002], fig. 1-4, [0009], [0013], [0019], [0023], [0034], [0054], [0057], [0070] for example discloses relevant subject-matter. More specifically, Helekar in at least [0009] for example discloses a mobile/client device. See at least Helekar [0009] “providing highly individualized Transcranial Magnetic Stimulation (TMS) therapy…generating specialized TMS stimulus parameters for a particular individual using … past TMS session data for this individual, test data such as encephalogram (EEG) readings, feedback regarding relief from pain and other symptoms provided by the individual, etc…a software application (“TMS application”) can execute on a client device such as a laptop computer, a tablet computer, a smartphone, etc. …device that activates a set of stimulators according to a particular pattern (referred to below as “TMS device”)…stimulators are miniaturized for use with a head mount”) comprising:
an application defining a user interface, the user interface configured to at least prompt a user for user feedback in the form of an anxiety level before, during, and/or after a treatment session (Examiner notes that a user experiencing pain would also have an associate anxiety/mental state and thus, the Helekar disclosed pain level correlates/linked with and is representative of recited anxiety mental state level as evidenced in Zis et al (page 3 “pain and anxiety, the link between the two has also been established…. anxiety is positively correlated with pain”). Helekar at least fig. 4, [0009], [0034], [0054, [0070] for example discloses an application defining a user interface, the user interface configured to at least prompt a user for an pain/anxiety level before, during, and/or after a treatment session. see at least Helekar [0034] “user interface 116 can display a screen as illustrated in FIG. 4, through which a user can provide feedback regarding pain experienced during or after the administration of TMS therapy…user selects a region of the scalp (e.g., front right quadrant, back left quadrant, etc.) and a numerical (e.g., 0=no decrease in pain, 10=maximum decrease in pain) or qualitative pain (e.g., “reduced pain,” “no change in pain,” etc.) rating from a list via the user interface 116… user interface 116 provides the user with a first interactive screen prior to treatment, via which he or she can indicate an initial pain level or intensity at one or more respective locations”; [0070] “TMS application on a computing device 102 can generate a user interface for collecting user feedback associated with TMS therapy. As shown in FIG. 4, the user interface screen 400 displays a dynamic model of a human scalp which a user can rotate to select areas of increased or decreased pain… a user can rotate any body parts shown to indicate areas of increased or decreased pain…a user can use to indicate a pain level or degree of relief from pain, the user interface screen 400 could include additional or alternative means for rating a pain level or degree of relief from pain… a user could select or enter a number indicating the user's pain level or degree of relief from pain…user can use the user interface screen 400 to indicate an initial location and level or intensity of pain or other symptoms/conditions present prior to treatment, and indicate the locations and intensity level of pain or other symptoms/conditions present after treatment.”); and
receive, from the user interface, user feedback in the form of anxiety level of the user before, during, and/or after the treatment session (Helekar in at least [0009], [0034], [0054, [0070] for example discloses receive, from the user interface, user feedback related to the pain/anxiety level of the user before, during, and/or after the treatment session. Examiner notes that a user experiencing pain would also have an associate anxiety/mental state and thus, the disclosed pain level correlates with and is representative of recited anxiety mental state level as evidenced in Zis et al. See at least Helekar [0034] “user interface 116 can display a screen as illustrated in FIG. 4, through which a user can provide feedback regarding pain experienced during or after the administration of TMS therapy…user selects a region of the scalp (e.g., front right quadrant, back left quadrant, etc.) and a numerical (e.g., 0=no decrease in pain, 10=maximum decrease in pain) or qualitative pain (e.g., “reduced pain,” “no change in pain,” etc.) rating from a list via the user interface 116… user interface 116 provides the user with a first interactive screen prior to treatment, via which he or she can indicate an initial pain level or intensity at one or more respective locations, as well as a second interactive screen after the treatment, via which the user can indicate the pain level or intensity subsequent to the treatment. The TMS application 122 in this manner can generate quantitative metrics indicative of improvement in the user's conditions due to the treatment”; [0054] “receive real-time user feedback data 330, so that the computing device 102 operates …in a closed-loop configuration. The user feedback data 330 can include for example visual feedback 331, audio feedback 332, GUI feedback 333, etc”; [0070] “TMS application on a computing device 102 can generate a user interface for collecting user feedback associated with TMS therapy. As shown in FIG. 4, the user interface screen 400 displays a dynamic model of a human scalp which a user can rotate to select areas of increased or decreased pain… a user can rotate any body parts shown to indicate areas of increased or decreased pain…a user can use to indicate a pain level or degree of relief from pain, the user interface screen 400 could include additional or alternative means for rating a pain level or degree of relief from pain… a user could select or enter a number indicating the user's pain level or degree of relief from pain…user can use the user interface screen 400 to indicate an initial location and level or intensity of pain or other symptoms/conditions present prior to treatment, and indicate the locations and intensity level of pain or other symptoms/conditions present after treatment.”)
compute, at the mobile device, a treatment session parameter comprising a magnetic field frequency value based on the EEG data and the user feedback (Helekar in at least fig. 4, [0009], [0013], [0054, [0057], [0070] for example discloses compute, at the mobile device, a treatment session parameter comprising a magnetic field frequency value based on the EEG data and the user feedback. Examiner notes that a user experiencing pain would also have an associate anxiety/mental state and thus, the disclosed pain level correlates with and is representative of recited anxiety mental state level as evidenced in Zis et al. see at least Helekar [0009] “generating specialized TMS stimulus parameters for a particular individual using … past TMS session data for this individual… feedback regarding relief from pain and other symptoms provided by the individual, etc.” [0013] “TMS application dynamically adjusts at least some of the operational parameters based on real-time feedback”; [0054] “receive real-time user feedback data 330, so that the computing device 102 operates …in a closed-loop configuration. The user feedback data 330 can include for example visual feedback 331, audio feedback 332, GUI feedback 333, etc.”; [0057] “process the GUI feedback 333, the TMS application 122 can pair indications of location and relief from chronic pain, tremor and other symptoms provided by the user via a GUI (e.g., as shown in FIG. 4)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the user input/feedback used by head mounted device communicating mobile device to provide treatment to user as taught by Charles, by further including granularity such as mental state/pain/anxiety levels, as taught by Helakar. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of [a] generating quantitative metrics indicative of improvement in the user's conditions due to the treatment via a user interface for collecting user feedback associated with TMS therapy (Helekar, [0034], [0070]) and also in order to [b] provide highly individualized TMS therapy that is responsive to a particular individual using not only past TMS session data for this individual but also real-time user feedback associated with TMS therapy such as relief from pain/anxiety and other symptoms provided by the individual (Helekar, [0009], [0013], [0023]); and/or [c] to extend the advantages of TMS treatment based on user feedback of pain level/granularity to anxiety as well in order to further fine-tune/optimize TMS treatment to user-feedback.
As per dependent Claim 14, the combination of Charles and Helakar as evidenced by Zis as a whole further discloses mobile device wherein the processor is further configured to: receive, at the mobile device from the user interface, treatment feedback used to compute the treatment session parameter (Charles in at least fig. 7-8, 11, [0094], [0096-0098], [0100] for example discloses the processor is further configured to: receive, at the mobile device from the user interface, treatment feedback used to compute the treatment session parameter. See at least Charles [0097] “input interface enables user input to be received by the controller and thus controls various parameters of the helmet as disclosed herein”; [0098] “control includes a digital processor and a computer executable program to derive control command(s) based on at least an input from a user, an automatic feedback from the device, and/or internal program stored in the device”; [0100] “treatment plan or application protocol is generated by the device based on inputs at the user input interface… In some embodiments, the user … modifies an existing plan or protocol using the controller”).
As per dependent Claim 15, the combination of Charles and Helakar as evidenced by Zis as a whole further discloses mobile device wherein the processor is further configured to: receive, at the mobile device from the user interface, treatment session input used to control the treatment session using the treatment session parameter (Charles in at least fig. 7-8, 11, [0094-0098], [0100] for example discloses the processor is further configured to: receive, at the mobile device from the user interface, treatment session input used to control the treatment session using the treatment session parameter. See at least Charles [0096] “controller controls various aspects of the wearable device 10 and its elements. Such control requires certain user input(s) at the input interface, such as a treatment plan number or a target frequency. For example, a user manually inputs a target intrinsic frequency at the input interface, and the controller controls the movement of magnet fields at the input target frequency… user inputs an application protocol number, and the controller controls the magnets to carry out the exact protocol including frequency, Q-factor, duration, or other parameters of the device… controller is used for receiving a frequency of movement, number of repetitions for each procedure, and/or duration of procedure from a user”; [0097] “input interface enables user input to be received by the controller and thus controls various parameters of the helmet as disclosed herein”; [0098] “control includes a digital processor and a computer executable program to derive control command(s) based on at least an input from a user, an automatic feedback from the device, and/or internal program stored in the device”; [0100] “the treatment plan or application protocol is generated at the device based on one or more parameters selected from: a …a medical professional's instructions, or the like… treatment plan or application protocol is generated by the device based on inputs at the user input interface… In some embodiments, the user … modifies an existing plan or protocol using the controller.”).
As per dependent Claim 16, the combination of Charles and Helakar as evidenced by Zis as a whole further discloses mobile device wherein the treatment session parameter further comprises one or more of: a treatment session start time, a treatment session stop time, a treatment session pause time, a treatment session duration, a number of treatment sessions, a treatment session payment, a treatment amount, or a treatment session target (Charles in at least [0067], [0095-0096], [0100] for example discloses the treatment session parameter further comprises one or more of: a treatment session start time, a treatment session stop time, a treatment session pause time, a treatment session duration, a number of treatment sessions, a treatment session payment, a treatment amount, or a treatment session target. See at least Charles [0095] “the controller controls the frequency of the magnetic field(s); the phase of the of the magnetic field(s); the amplitude of the magnetic field(s); the waveform of the frequency; the amplitude or the phase of the magnetic field, the duration of the magnetic field(s); the direction of the magnetic field(s); the polarity of the magnetic field(s); the properties of the magnetic flux; spatial distribution of the magnetic field; or a combination thereof”; [0096] “a user inputs an application protocol number, and the controller controls the magnets to carry out the exact protocol including frequency, Q-factor, duration, or other parameters of the device….a target frequency, a treatment plan based on the intrinsic frequency of the patient…a frequency of movement, number of repetitions for each procedure, and/or duration of procedure from a user. … movement, number of repetitions for each procedure and/or duration of procedure”).
As per dependent Claim 17, the combination of Charles and Helakar as evidenced by Zis as a whole further discloses mobile device wherein the processor is further configured to: display a treatment session indication on the mobile device (Charles in at least [0094], [0096], [0126] for example discloses processor is further configured to: display a treatment session indication on the mobile device. See at least Charles [0094] “devices and methods disclosed herein include a controller… controller 20 includes one or more selected from: an electronic display 201”; [0096] “controller controls various aspects of the wearable device 10 and its elements… digital display is used to display status information of the device…digital display is used to display EEG data of a user before, during, or after a procedure. The digital display then displays the progress of a procedure.”; [0126] “the digital processing device includes a display to send visual information to a user”).
As per dependent Claim 18, the combination of Charles and Helakar as evidenced by Zis as a whole further discloses mobile device wherein the treatment session indication comprises one or more of: an HMD status, an HMD energy-emission status, an HMD energy-emission form, an HMD wireless link status, an HMD energy-administration session status, or an HMD session duration (Charles in at least [0094], [0096], [0126] for example discloses treatment session indication comprises one or more of: an HMD status, an HMD energy-emission status, an HMD energy-emission form, an HMD wireless link status, an HMD energy-administration session status, or an HMD session duration. See at least Charles [0096] “digital display is used to display status information of the device. As an example, a magnet height measured by a drop gauge is shown to a user at the display… digital display then displays the progress of a procedure.” [0126] “the digital processing device includes a display to send visual information to a user”).
As per dependent Claim 19, the combination of Charles and Helakar as evidenced by Zis as a whole further discloses mobile device wherein the processor is further configured to: compute, at the mobile device, one or more of the treatment session parameter or a treatment session indication using a machine learning algorithm (Here, the claim is broadly yet reasonably interpreted as recited one of the limitations in the enumerated list i.e. “one or more of the treatment session parameter or a treatment session indication “. Charles in at least [0096] and Helekar in at least fig.1-3, [0009], [0013] for example discloses processor is further configured to: compute, at the mobile device, one or more of the treatment session parameter or a treatment session indication using a machine learning algorithm. See at least Charles [0096] “controller controls various aspects of the wearable device 10 and its elements… such control is automatic … including power on, power off, starting a treatment, stopping a treatment, or the like… controller is used to automatically adjust a frequency of movement, number of repetitions for each procedure and/or duration of procedure”; Helekar [0009] “software application then can apply the output of the machine learning model to a device that activates a set of stimulators according to a particular pattern (referred to below as “TMS device”)”; [0013] “apply the output of the machine learning model to the TMS device, the TMS application in some implementations configures a controller operating in the TMS device with the operational parameters for the duration of the session. In other implementations, the TMS application dynamically adjusts at least some of the operational parameters based on real-time feedback”).
As per dependent Claim 20, the combination of Charles and Helakar as evidenced by Zis as a whole further discloses mobile device wherein the processor is further configured to: compute, at the mobile device for communication via the wireless communication interface to the HMD, an additional control instruction configured to control one or more of: a motor activation, a motor deactivation, an energy-emission frequency setting, a recording setting, or an EEG data request (Charles in [0007], [0067], [0095], [0099] for example discloses the processor is further configured to: compute, at the mobile device for communication to the wireless communication interface to the HMD, an additional control instruction configured to control one or more of: a motor activation, a motor deactivation, an energy-emission frequency setting, a recording setting, or an EEG data request. See at least Charles [0007] “a device comprising a helmet for applying a magnetic field to a head of a subject …the device comprises a connection to a controller…connection is … a wireless connection”; [0067] “adjustment of the magnets within the helmet … are automatically controlled by the controller having a digital processing device”; [0095] “controller controls one or more selected from: the motor(s); the magnet(s); and the gear box…controller controls one or more selected from: duration of movement; repetition pattern of movement; track or trajectory of movement; frequency of movement; time for onset/stop of movement; acceleration of movement; speed of movement; direction of movement in two or three dimensions; type of motion; rotation axis of movement in two or three dimensions; distance of movement in two or three directions; distance of magnets to each other or to a determined portion of the head; and distance of magnets to one or more motors. In further cases, the control of magnets or motors results in the control of the magnetic field(s) generated thereby.”; [0099] “controller includes one or more selected from: a digital processing device).
As per dependent Claim 21, the combination of Charles and Helakar as evidenced by Zis as a whole further discloses mobile device wherein the wireless communication interface is configured to: communicate with the HID using one or more of: a direct wireless connection, a local communication device, or a remote communication device comprising a remote server (Charles in at least fig. 1, 7-8, 11, [0007], [0096], [0099], [0123-0124] and Helekar in at least fig. 1-3, [0009], [0028-0029] for example discloses the wireless communication interface is configured to: communicate with the HMD using one or more of: a direct wireless connection, a local communication device, or a remote communication device comprising a remote server. See at least Charles [0007] “a device comprising a helmet for applying a magnetic field to a head of a subject …the device comprises a connection to a controller…connection is … a wireless connection”. Also see Helekar [0009] “providing highly individualized Transcranial Magnetic Stimulation (TMS) therapy…generating specialized TMS stimulus parameters for a particular individual using a machine learning model trained with past TMS session data for this individual, test data such as encephalogram (EEG) readings, feedback regarding relief from pain and other symptoms provided by the individual, etc. As discussed in more detail below, a software application (“TMS application”) can execute on a client device such as a laptop computer, a tablet computer, a smartphone, etc. to train the machine learning model. The software application then can apply the output of the machine learning model to a device that activates a set of stimulators according to a particular pattern (referred to below as “TMS device”)…stimulators are miniaturized for use with a head mount”).
Response to Amendment
According to the Amendment, filed 08/19/2026, the status of the claims is as follows:
Claims 13 is currently amended;
Claims 14-21 are previously presented; and
Claims 1-12 and 22-32 are cancelled.
By the current amendment, as a result, claims 13-21 are now pending in this application and are being examined on the merits as being drawn to elected invention/species.
Response to Arguments
Issues Raised and Arguments/Remarks to Rejections Based On Prior Art presented on Pages 5-11 of Applicant’s Amendment dated 08/19/2026 where Applicant’s’ remarks inter alia that:
35 U.S.C. § 103 Rejection of the Amended Independent Claim 13[A] The cited art does not teach or suggest each element of the pending claims
[B1] In contrast to independent claim 13, which specifies "the user interface configured to at least prompt a user for user feedback relating to an anxiety level or a general mood before, during, and/or after a treatment session", Charles fails to disclose or suggest "the user interface configured to at least prompt a user for user feedback relating to an anxiety level or a general mood before, during, and/or after a treatment session", as recited in claim 13. For at least these reasons, independent Claim 13 is patentable over Charles.
[B2] In an example, a user manually inputs a target intrinsic frequency at Charles' input interface, and a controller controls a movement of magnet fields at the input target frequency. (See Charles, par. [0096]). In another example, a user inputs an application protocol number, and Charles' controller controls magnets to carry out an exact protocol including a frequency, a Q-factor, a duration, or other parameters of the stimulation device. (See Charles, par. [0096]).
[C] Helekar does not remedy these shortcomings; the reference does not mention "anxiety" at all, and the reference's only disclosure of "mood" does not teach or suggest the claimed "prompt a user for user feedback relating to an anxiety level or a general mood before, during, and/or after a treatment session."
[D] For the foregoing reasons, Applicants respectfully submit that the present application is in condition for allowance and earnestly solicit reconsideration of same.
Applicant’s arguments [A-D] with respect to the above claim limitation in Claim 1 have been considered but are not persuasive for the following reasons:
With respect to Applicant’s arguments [A-B] above, the limitation "the user interface configured to at least prompt a user for user feedback relating to an anxiety level or a general mood before, during, and/or after a treatment session", is being interpreted broadly yet reasonably as encompassing both indirect/direct interactions, arrangement, associations, linkages, operation, functions and results, and thus, a broad yet reasonable interpretation of the limitation in light of the instant specification would also include the interpretation “user interface configured to at least prompt a user for user feedback at least indirectly relating to an anxiety or a general mood before, during, and/or after a treatment session”. Additionally, the “and/or” encompassing limitation is broadly yet reasonably interpreted as requiring just one of the enumerated elements in the list i.e. [i] one of an anxiety or a general mood and [ii] one of before, during, or after a treatment session. Further, “prompt a user” in the context used is being broadly yet reasonably interpreted as a user interface that is presented to the user (i.e. prompts a user) on the mobile device to obtain user input. Additionally, the recited term “general mood” is being interpreted as user state of mind in light of specification which is silent as to what is meant by or encompassed by “general mood” based on ordinary and customary meaning of the term as evidenced in the following source: Webster’s New World College Dictionary, 5th Digital Edition. Copyright © 2025 HarperCollins Publishers. Furthermore, the term “user feedback” in this limitation in the context used is being interpreted in light of instant application specification as-filed para. [0042] as user feedback/user data used to set a parameter of the treatment session and/or as user provided feedback/data on the effectiveness of a treatment and/or as user feedback/data used to adjust a treatment protocol each of which is at least indirectly related to anxiety or the general mood of the user before, during, and/or after the treatment session.
In light of the above broad yet reasonable interpretation in light of instant application specification as-filed, Charles in at least fig. 7-8, 11, [0094], [0096], [0097-0098], [0100], [0146-0166] can be seen as disclosing an application defining a user interface/input interface, the user interface configured to at least prompt a user for user feedback/input such as user inputs in [0096] (user input(s) at the input interface, such as a treatment plan number or a target frequency… a user manually inputs a target intrinsic frequency at the input interface, a user inputs an application protocol number, a user enters an intrinsic frequency of the subject, a frequency of movement, number of repetitions for each procedure, and/or duration of procedure from a user, treatment plan or application protocol generated by the device based on inputs at the user input interface (emphasis added)) used to derive the treatment protocol and thus at least indirectly relate to treatment for anxiety ([0150], [0165], [0167]) or general mood (mental state associated with any of mental disorders listed in [0146-0166]) which are at least indirectly related to an anxiety when directed to treating anxiety in a subject as in [0165] or a general mood (i.e. state of mind) when directed to treating any of the mental disorders listed in [0146-0166] before, during, or after a treatment session.
Further Helekar at least fig. 4, [0009], [0034], [0054-0055], [0070] for example discloses an application defining a user interface, the user interface configured to at least prompt a user for an pain/anxiety level before, during, and/or after a treatment session. Examiner notes that a user experiencing pain would also have an associate anxiety/mental state and thus, the Helekar disclosed pain level correlates/linked with and is representative of recited anxiety mental state level as evidenced in Zis et al (page 3 “pain and anxiety, the link between the two has also been established…. anxiety is positively correlated with pain”. Also see at least Helekar [0034] “user interface 116 can display a screen as illustrated in FIG. 4, through which a user can provide feedback regarding pain experienced during or after the administration of TMS therapy…user selects a region of the scalp (e.g., front right quadrant, back left quadrant, etc.) and a numerical (e.g., 0=no decrease in pain, 10=maximum decrease in pain) or qualitative pain (e.g., “reduced pain,” “no change in pain,” etc.) rating from a list via the user interface 116… user interface 116 provides the user with a first interactive screen prior to treatment, via which he or she can indicate an initial pain level or intensity at one or more respective locations”; [0070] “TMS application on a computing device 102 can generate a user interface for collecting user feedback associated with TMS therapy. As shown in FIG. 4, the user interface screen 400 displays a dynamic model of a human scalp which a user can rotate to select areas of increased or decreased pain… a user can rotate any body parts shown to indicate areas of increased or decreased pain…a user can use to indicate a pain level or degree of relief from pain, the user interface screen 400 could include additional or alternative means for rating a pain level or degree of relief from pain… a user could select or enter a number indicating the user's pain level or degree of relief from pain…user can use the user interface screen 400 to indicate an initial location and level or intensity of pain or other symptoms/conditions present prior to treatment, and indicate the locations and intensity level of pain or other symptoms/conditions present after treatment.” (emphasis added). Thus, the combination of applied art, Charles and Helakar as evidenced by Zis as a whole discloses the limitation “the user interface configured to at least prompt a user for user feedback relating to an anxiety level or a general mood before, during, and/or after a treatment session” as now explicitly, positively and specifically recited by the Applicant when broadly yet reasonably interpreted in light of the instant application specification as-filed and as best reasonably understood by one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to Applicant’s arguments [B2] above, user inputs examples that the Applicant lists which when applied to treat anxiety or any of the other mental disorders listed in Charles (see anxiety treatment application ([0150], [0165], [0167]) or general mood treatment application (mental state associated with any of mental disorders listed in [0146-0166]) qualify as user feedback/inputs relating to an anxiety or a general mood before, during, or after a treatment session and thus, read on the limitation "the user interface configured to at least prompt a user for user feedback relating to an anxiety level or a general mood before, during, …or after a treatment session" (emphasis added) as now explicitly, positively and specifically recited by the Applicants when interpreted in light of the instant application as-filed.
With respect to Applicant’s arguments [C] above, stating reference does not mention "anxiety" at all, Examiner notes that the Applicants recite the anxiety feature as an option using the “or” term, thus arguing limitations not positively recited in the claim. Examiner suggest amending the claims to explicitly, positively and specifically include such features which the Applicant consider are critical, patentably novel, non-obvious and distinguish over prior art. Nonetheless Charles does recite treatment of anxiety in at least ([0150], [0165], [0167]). Further, Examiner notes that a user experiencing pain as disclosed in Helekar would also have an associate anxiety/mental state and thus, the Helekar disclosed pain level correlates/linked with and is representative of recited anxiety mental state level as evidenced in NPL-Zis et al (page 3 “pain and anxiety, the link between the two has also been established…. anxiety is positively correlated with pain”).
For the above reasons, the 35 U.S.C. § 103 rejection of claims 13 over the combination of applied art, Charles and Helekar as evidenced by Zis, is proper and still applies at this time, and thus, claim 13 as now explicitly, positively and specifically recited by the Applicants is not allowable at this time . Please also cross-reference detailed claim 13 interpretation, claim limitation mapping to prior art disclosed features and method steps and detailed explanations above. Examiner suggest amending the claims to explicitly, positively and specifically include such features which the Applicant consider are critical, patentably novel, non-obvious and distinguish over prior art.
Issues Raised and Arguments/Remarks to Rejections Based On Prior Art presented on Pages 12 of Applicant’s Amendment dated 08/19/2026 where Applicant’s’ remarks inter alia that:
35 U.S.C. § 103 Rejection of Dependent Claims 14-21.
[a] Claims 14 to 21 depend from independent claim 13 and therefore inherit the limitations of independent claim 13. As such, dependent claims 14-21 specify "prompt a user for user feedback relating to an anxiety level or a general mood before, during, and/or after a treatment session."
[b]This element is not taught or suggested by the cited art, and Applicant asks that this rejection be withdrawn.
[c] ] For the foregoing reasons, Applicants respectfully submit that the present application is in condition for allowance and earnestly solicit reconsideration of same.
Applicant’s arguments [a-c] above with respect to dependent claims 14-21 solely based on limitations in independent base claim been considered but are not persuasive for the reasons provided above for independent claim 13. Additionally, Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the dependent claims 14-21 define a patentable invention based on their dependency on base claims without specifically pointing out how the language of the dependent claims patentably distinguishes them from the references.
Applicant’s arguments [c] above, for the above reasons, the 35 U.S.C. § 103 rejection of claims 14-21 over the combination of applied art, Charles and Helekar as evidenced by Zis, still applies and is deemed proper at this time and thus, claims 14-21 as now explicitly, positively and specifically recited by the Applicants are not allowable at this time. Please also cross-reference detailed claim 14-21 interpretation, claim limitation mapping to prior art disclosed features and method steps and detailed explanations above. Examiner suggest amending the claims to explicitly, positively and specifically include such features which the Applicant consider are critical, patentably novel, non-obvious and distinguish over prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims.
Prior art US 20100210894 A1 to Pascual-Leone et al. discloses TMS treatment delivery based on user feedback of treatment effectiveness (see fig. 24, [0268]) similar to that disclosed.
Prior art US 20210162216 A1 to Rezai et al. discloses TMS treatment delivery based on user feedback of anxiety/mood (see [0037] “self-reporting questionnaires”, [0071] ‘data gathering application can include a questionnaire application that allows the user to self-report … mood, mental, physical, and emotional states, and stress”) similar to that disclosed and claimed.
Prior art US 20170352283 A1 to Lau discloses use of user mental state feedback (see [0016]) to determine and optimize effectiveness of treatment/training similar to that disclosed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791
