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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/18/2026 has been entered.
Amendment
This action is in response to the Amendment filed on 4/30/2026.
Claims 1, 3, 4, 8, 10-13, 18, 20, 22-26, 49 and 51-58 are pending.
Response to Arguments
Applicant's arguments with respect to claims 1, 3, 4, 8, 10-13, 18, 20, 22-26, 49 and 51-58 have been considered but are moot in view of the new grounds of rejection.
Objections to the Claims
In view of the amendments to claims 22 and 23, the objections have been withdrawn.
Rejections Under 35 U.S.C. § 103
Independent claim 1 (and similarly independent claims 23, 25 and 49) has been amended to recite in the preamble, "a device configured to modulate cerebral blood flow of a user to treat hypertension of the user" and further recite additional limitations of the claim, "a generator configured to produce an electrical stimulation signal that when applied to the user modulates blood flow to the brain to treat hypertension". Accordingly, applicant argues that amended claim 1 is directed to modulation of cerebral blood flow performed to treat hypertension.
Applicants’ arguments with respect to the prior art of Dietrich, Dundovic, or Spinelli and the other references have been considered and therefore the rejections as applied have been withdrawn.
However, upon further search and consideration, the claims are rejected as discussed in the current office action below.
New Claims
New claims 56-58 have been addressed in the current office action as discussed below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 4, 8, 10-13, 18, 20, 22-24, 51-54 and 56 -58 are rejected under 35 U.S.C. 101 because it is drawn to non-statutory subject matter.
Applicant recites part of a human, i.e. "…a stimulating electrode is in position on a respective tragus…” ( claim 1 line 16),””… the stimulating electrode is in contact with a first face of the respective tragus…” ( claim 1, line 17), “… reference electrode is in contact with a second, opposing face of the respective tragus…” claim 1 line 18). Similarly claim 23 recites a part of a human in similar limitations . Further in claim 22 “…the stimulating electrode is in contact with an outer surface of the tragus and the reference electrode is in contact with an inner surface of the tragus.” (claim 22 lines 2-4). Thus, these claims include a human within the scope and are non-statutory.
A claim directed to or including within its scope a human is not considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970). The examiner suggests using the phrase "adapted to be in contact" when referring to the location of the electrode in relation to the tragus.
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 (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.
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.
Claims1, 3, 8, 10-13, 22, 51, 52 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Alataris et al. (International Publication Number: WO 2019/005774 A1, hereinafter “Alataris”- APPLICANT CITED) in view of Dundovic et al (U.S. Patent Application Publication Number: US 2022/0287616 A1, hereinafter “Dundovic”- PREVIOUSLY CITED).
Regarding claims 1, 3, 8, 10-12, 51 and 52, Alataris teaches a device configured to modulate cerebral blood flow of a user to treat hypertension of the user (e.g. [0034],[00125] claim 33), the device comprising:
a generator configured to produce an electrical stimulation signal that when applied to the user modulates blood flow to the brain to treat hypertension; a controller, connected to the generator, configured to determine the form of the electrical stimulation signal (e.g. [00110], [00117]);
wherein the electrical stimulation signal transmitted to the earpieces comprises a series of electrical pulses, each pulse repeating with a frequency of 1 Hz to 100 Hz and each pulse having a duration of 10 microseconds to 500 microseconds and an amplitude of 0.1 mA to 8 mA (e.g. [0019] teaches stimulation parameters (i.e. a pulsed electrical signal having a frequency of from 1 Hz to 50 kHz, a pulse width of from 1-500 microseconds, and a current of from 1 mA to 20 mA) and wherein the controller is configured to transmit an electrical stimulation signal to the stimulating electrode and the reference electrode of each of the first and second earpieces.
Further Alatrais teaches providing stimulation to the tragus (e.g. [00114], claim 46) and also teach providing bilateral stimulation (e.g. [00119]) via first and second earpieces, connected to the generator and controller, each of the first and second earpieces comprising:
a stimulating electrode configured to provide an electrical stimulation produced by the generator signal to the nerves innervating a tragus of the user, and a reference electrode, wherein the stimulating electrode is a positive electrode and the reference electrode is a negative electrode (i.e. anode and cathode e.g. [00114]) (as claimed in claim 52) and wherein the first earpiece is configured to be placed in contact with the left tragus of the user and the second earpiece is configured to be placed in contact with the right tragus of the user, and wherein each of the first and second earpieces is configured such that, when the stimulating electrode is in position on the respective tragus of the user and that the electrodes are configured to provide the respective electrical stimulation signal transcutaneously to the user (e.g. [00114]).
While Alataris teaches providing stimulation via C shaped cross section interface member to the tragus and also bilateral stimulation as discussed above, they do not specifically teach the stimulating electrode is in contact with a first face of the respective tragus and the reference electrode is in contact with a second, opposing face of the respective tragus and wherein each of the first and second earpieces comprises a clip to secure the stimulating electrode and the reference electrode to the tragus of the user, wherein the clip has a first gripping portion and a second gripping portion which are biased into contact with each other and the stimulating electrode is located on the first gripping portion and the reference electrode is located on the second gripping portion (as claimed in dependent claims 8 and 10-12) .
In a similar field of endeavor, Dundovic teaches a device that comprises a clip configured to be attached to a tragus of the subject on an outward and an inward facing surface of a tragus, the clip including opposing arms configured so that a distal end of the arms are biased towards each other and electrodes positioned proximate a distal end of the arms on opposing faces so that the electrodes are urged into engagement with opposing faces of the tragus and a signal generator electrically connected to the electrodes, the signal generator being configured to generate at least one therapy signal that is applied to a vagus nerve within the tragus via the electrodes (e.g. abstract).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the electrode holder in the teachings of Alataris to be clippable about the tragus as taught by Dundovic in order to provide the predictable results of ensuring proper and comfortable contact with the tissue.
Regarding claim 13, Alataris in view of Dundovic teaches the claimed invention as discussed above and Alataris further teaches a physiological sensor configured to measure a value of a physiological parameter and store the value in a memory portion of the device, wherein the value stored in the memory portion is used by the controller to determine the form of the electrical stimulation signals transmitted to the first and second earpieces (e.g. [0083], [0093], [00120]).
Regarding claim 22, Alataris in view of Dundovic teach the claimed invention as discussed above, but does not specifically teach that each of the first and second earpieces comprises a marking or shape to indicate to the user a correct orientation of the earpiece such that the stimulating electrode is in contact with an outer surface of the tragus and the reference electrode is in contact with an inner surface of the tragus.
Dundovic teaches that earpiece comprises a marking or shape to indicate to the user a correct orientation of the earpiece (e.g. [00116], [00126]) such that the stimulating electrode is in contact with an outer surface of the tragus (e.g. Figs. 1C and 1D, which show an electrode 121 attached to an outward facing surface of the tragus 101, [00108]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the each of the earpieces in the teachings of Alataris to have a marking or shape to indicate to the user a correct orientation of the earpiece and that the electrode is configured to be placed in contact with an outward facing surface of the tragus as taught by Dundovic in order to provide the predictable results of guiding the positioning of the device and to ensure that the electrodes are aligned with the target region in turn optimising the effect of the applied therapy signals and ensure good electrical contact with the tragus and maximize the effectiveness of modulation.
Regarding claim 54, Alataris in view of Dundovic teaches the claimed invention as discussed above and they teach a pulsed electrical stimulation between the electrodes where one electrode is an anode and the other is a cathode (e.g. [00114]) and therefore they teach that the controller selects the electrical stimulating signal such that over the course of a series of repeating pulses, a net electrical current flow is from the stimulating electrode to the reference electrode (Note: current flows from an anode to a cathode).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Alataris et al. (International Publication Number: WO 2019/005774 A1, hereinafter “Alataris”- APPLICANT CITED) in view of Dundovic et al (U.S. Patent Application Publication Number: US 2022/0287616 A1, hereinafter “Dundovic”- PREVIOUSLY CITED) and further in view of Cartledge et al (U.S. Patent Application Publication Number: US 2019/0351230 A1, hereinafter “Cartledge”- PREVIOUSLY CITED).
Regarding claim 4, Alataris in view of Dundovic teaches the claimed invention as discussed above except for the stimulating electrode and the reference electrode of each of the first and second earpieces being configured to provide the electrical stimulation signal percutaneously to the user.
In a similar field of endeavor, Cartledge teaches an electrostimulation device and methods of electrical stimulation of anatomic structures such as nerves, blood vessels, muscles, connective tissue, glands, individual organs, and organ systems that use transcutaneous and percutaneous methods of stimulating nerves (e.g.[0003]), and further teaches that the stimulating electrode and the reference electrode are configured to provide the electrical stimulation signal percutaneously to the user (e.g. [0272]), ([0417]).
It would have been obvious to person having ordinary skill in the art at the time of the invention to modify the teachings of Altaris in view of Dundovic so that each of the first and second earpieces being are configured to provide the electrical stimulation signal percutaneously to the user as taught by Cartledge in order to provide the predictable results of providing a more targeted stimulation.
Claim 18, 20, 53 are rejected under 35 U.S.C. 103 as being unpatentable over Alataris et al. (International Publication Number: WO 2019/005774 A1, hereinafter “Alataris”- APPLICANT CITED) in view of Dundovic et al (U.S. Patent Application Publication Number: US 2022/0287616 A1, hereinafter “Dundovic”- PREVIOUSLY CITED) and further in view of Spinelli et al (U.S. Patent Number: US 9415220 B1, hereinafter “Spinelli”- PREVIOUSLY CITED).
Regarding claim 18, Alataris in view of Dundovic teach the claimed invention as discussed above except for the device being configured to determine the electrical impedance of the tragus based on measurements of current, voltage and phase relationship of the electrical stimulation signal stored in a memory portion of the device.
In a similar field of endeavor, Spinelli teaches an auricular stimulation device that is configured to determine the electrical impedance of the tragus (e.g. Col. 22, lines 13-18) based on measurements of current, voltage and phase relationship of the electrical stimulation signal are stored in a memory portion of the device (e.g. Col. 7, lines 33-43, Col. 22, lines 13-16) Note: since the stimulation profile, which is continuously updated, is stored in a storage/memory circuit and includes a voltage and current level that are necessarily stored in the memory. Further since the measured ratio of the voltage and current is also determined, a phase relationship is determined and stored since the relationship between voltage and current is a type of phase relationship.) and are used to determine an electrical impedance of the tragus (e.g. Col. 22, lines 13-18).
Therefore, it would have been obvious to person having ordinary skill in the art at the time of the invention to further modify the teachings of Alataris in view of Dundovic to include determining the electrical impedance of the tragus based on measurements of current, voltage and phase relationship of the electrical stimulation signal stored in a memory portion of the device and using the data to determine the electrical impedance of the tragus as taught by Spinelli in order to provide the predictable results of ensuring that the stimulation electrode has an adequate electrical connection with the patient.
Regarding claims 20 and 53, Alataris in view of Dundovic teach the claimed invention as discussed above and while they teach providing a pulsed stimulation (e.g. [0019] teaches stimulation parameters (i.e. a pulsed electrical signal having a frequency of from 1 Hz to 50 kHz, a pulse width of from 1-500 microseconds, and a current of from 1 mA to 20 mA) as discussed above they do not specifically teach that the pulsed electrical stimulation signal comprises a series square electrical pulses, wherein the pulse waveform is one of: a monophasic waveform; a symmetrical biphase waveform; an asymmetrical monophasic waveform; or an asymmetrical biphase waveform.
Spinelli teaches providing a pulsed electrical stimulation signal is a pulse waveform comprising a series of substantially square electrical pulses (e.g. Col. 5, lines 51-52, where “a first stimulation profile may include a series of square wave pulses having a voltage or current level ‘X’”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the pulsed electrical stimulation signal in Alatrais in view of Dundovic teachings of to be a series of substantially square electrical pulses as taught by Spinelli in order to provide the predictable results of achieve and maintain the stimulation profile within an acceptable level.
Further, Dundovic teaches that the pulse waveform is one of: a monophasic waveform (e.g. [0133]); a symmetrical biphase waveform (e.g. 0227]), an asymmetrical monophasic waveform (e.g. [0133]); or an asymmetrical biphase waveform (e.g. [0227]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Alataris in view of Dundovic and Spinelli with the claimed waveforms as taught by Dundovic in order to provide the predictable results improved tolerance and reduced pain since an asymmetrical balanced biphasic square waveform can be better tolerated by users with less chance of causing a pain response and can be more effectively focused to specific nerve fibers and since symmetrical balanced biphasic square waveforms can be used to reduce charge build-up, thereby resulting in reduced skin irritation for the user.
Claims 57 and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Alataris et al. (International Publication Number: WO 2019/005774 A1, hereinafter “Alataris”- APPLICANT CITED) in view of Dundovic et al (U.S. Patent Application Publication Number: US 2022/0287616 A1, hereinafter “Dundovic”- PREVIOUSLY CITED) and further in view of Parnis et al (U.S. Patent Application Publication Number: US 2007/0021786 A1, hereinafter “Parnis”) OR Hamner (International Publication Number: WO 2020/185601 A1, hereinafter “Hamner”).
Regarding claim 57 and 58, Alataris in view of Dundovic teaches the claimed invention as discussed above and while Alatarais teaches providing bilateral stimulation comprising a first and second electrical signal to a first and opposing ear respectively (e.g. [0019]), they do not specifically teach that the controller is configured to transmit the same or different electrical stimulation signal to the first earpiece and the second earpiece.
Parnis teaches that it is well known to provide bilateral stimulation wherein the stimulation parameters are the same or different (e.g. [0063]).
Hamner is another teaching that teaches that it is well known to provide bilateral stimulation to a first and second target region with same or different stimulation parameters (e.g. [0204]: The first target nerve and the second target nerve can be stimulated with either the same or different parameters, and can be stimulated simultaneously or in alternating or other fashion… bilateral stimulation could involve, for example, stimulation of the left auricular vagus nerve and another nerve proximate the left ear or facial region, for example, alternating or concurrent with stimulation of the right auricular vagus nerve).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the bilateral stimulation parameters in the teachings of Alataris in view of Dundovic to be the same or different as taught by Parnis OR Hamner in order to provide the predictable results of providing a more effective therapy.
Claims 23, 24 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Alataris et al. (International Publication Number: WO 2019/005774 A1, hereinafter “Alataris”- APPLICANT CITED) in view of Dundovic et al (U.S. Patent Application Publication Number: US 2022/0287616 A1, hereinafter “Dundovic”- PREVIOUSLY CITED) and further in view of Sharma et al (U.S. Patent Application Publication Number: US 2020/0094054 A1, hereinafter “Sharma”- PREVIOUSLY CITED).
Regarding claim 23, Alataris in view of Dundovic teach the claimed invention as discussed above for claim 1. However claim 23 adds “a system for modulating cerebral blood flow of a user to treat a circulatory system disease, the system comprising: a transceiver connected to the controller of the device, configured to send information from the device to an external computer system and to receive information from the external computer system, and the information received from the external computer system is used by the controller to determine the form of the electrical stimulation signal.”
While Alataris does teach that the first and second electrical stimulation modules each include a transceiver, which are used to wirelessly couple the first and second electrical signal modules. The transceivers may allow the first and second electrical stimulation modules to synchronize the delivery of the pulses of the first and second electrical signals wherein the first and second electrical stimulation modules operate to provide bilateral stimulation to target structures on the left and right ears of the patient (e.g. [0119] claim 48), they do not specifically teach the system comprising: a transceiver connected to the controller of the device, configured to send information from the device to an external computer system and to receive information from the external computer system, and the information received from the external computer system is used by the controller to determine the form of the electrical stimulation signal.
Sharma teaches auricular nerve stimulation techniques for addressing patient disorders and associated systems and methods (e.g. Abstract) comprising a transceiver connected to the controller of the device, configured to send information from the device to an external computer system and to receive information from the external computer system (e.g. [0027]), and the information received from the external computer system is used by the controller (e.g. [0029]) to determine the form of the electrical stimulation signal (e.g. [0027] and optionally, receiving feedback or other communications from the earpieces 120 ( e.g. [0092]). Note: the therapy signal is an electrical stimulation signal, and therapy signal is determined since the therapy signal is being transmitted to the earpieces and being utilized as feedback.)
It would have been obvious to a person having ordinary skill in the art at the time of the invention to further modify Alataris in view of Dundovic with the transceiver connected to the controller of the device, configured to send information from the device to an external computer system and to receive information from the external computer system, and the information received from the external computer system is used by the controller to determine the form of the electrical stimulation signal as taught by Sharma in order to provide the predictable results of providing more control and a desired effect on the target neural population and provide communication between the signal generator and the external controller.
Regarding claim 24, Alataris in view of Dundovic and Sharma teaches the claimed invention as discussed above, however they do not specifically teach information from the device received by the external computer system is compared to a secondary set of information stored on the external computer system to determine a set of actions to be performed by at least one of the device or the external computer.
In another embodiment, Sharma teaches that information from the device received by the external computer system is compared to a secondary set of information stored on the external computer system to determine a set of actions to be performed by at least one of the device or the external computer (e.g. [0032]-[0033], 108 FIG. 2). (Note: information received by the external computer system, here the external controller and backend, is compared to a secondary set of information stored on the external computer system to determine a set of actions to be performed by the device. The external controller teaches adjustment of the signal delivery parameters, which is a set of actions to be performed by the device, here the signal generator. Additionally, the external controller receives updated information from the backend, and this information can then be utilized to control the signal generator. The information processed through the external controller and backend is compared with other data, which implies a secondary set of information stored in the backend as there will need to be data to compare the incoming data to, and determines a set of actions, through task allocation, as the data is utilized by the external device to control the signal generator.).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the invention to further modify the teachings of Alataris in view of Dundovic and Sharma with the teaching that information from the device received by the external computer system is compared to a secondary set of information stored on the external computer system to determine a set of actions to be performed by at least one of the device or the external computer as taught by the embodiment of Sharma in order to provide the predictable results of being able to exchange data and select processing tasks that suit the preferences of the patient, practitioner, and/or others.
Regarding claim 56, Alataris in view of Dundovic and Sharma teaches the claimed invention as discussed above and Alataris also teaches additional features including the ability to he ability to modify therapeutic doses of stimulation through a software application (an "app") for a mobile electronic device (such as an iPhone or an Android-based mobile device) based on clinician guidelines and patients' adherence to the app and based on the responses the physician can, in the initial office visit, determine whether the patient has responded positively to the first treatment. The physician can adjust the level of stimulation and/or pharmacotherapy accordingly (e.g. [00102], [00103]). Additionally, Sharma also teaches that the external controller 430 can also communicate with a backend device 440 (e.g., a server or other suitable device located on the cloud or other medium) via a backend link 441. Accordingly, the external controller 430 can exchange data with the backend 440. For example, the external controller 430 can provide the backend 440 with information about the patient's condition (e.g., obtained from feedback sensors included in the system 400), and/or a schedule of the signal delivery parameters selected by the patient or practitioner over the course of time (e.g. [0033]) and therefore they teach the information sent from the device to the external computer system is used to determine compliance by the user with a prescribed treatment plan as claimed.
Claims 25-26 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Alataris et al. (International Publication Number: WO 2019/005774 A1, hereinafter “Alataris”- APPLICANT CITED) in view of Dundovic et al (U.S. Patent Application Publication Number: US 2022/0287616 A1, hereinafter “Dundovic”- PREVIOUSLY CITED) and Sharma et al (U.S. Patent Application Publication Number: US 2020/0094054 A1, hereinafter “Sharma”- PREVIOUSLY CITED) and further in view of Brown et al (U.S. Patent Application Publication Number: US 2017/0296807 A1, hereinafter “Brown”- PREVIOUSLY CITED).
Regarding claim 25, Alataris teaches a method for modulating cerebral blood flow of a user to treat hypertension of the user (e.g. [0034],[0125] claim 33), the method comprising:
producing, using a generator, first and second electrical stimulation signals (e.g. [00110], [0119]: bilateral) that when applied to the user modulates blood flow to the brain to treat hypertension (e.g. [0034],[0125]);
determining a controller connected to the generator, the form of the first and second electrical stimulation signal (e.g. [00110], [00117]) based on an input provided by the user (e.g. [00102], [00120]: feedback based stimulation);
wherein the electrical stimulation signal comprises a series of electrical pulses, each pulse repeating with a frequency of 1 Hz to 100 Hz and each pulse having a duration of 10 microseconds to 500 microseconds and an amplitude of 0.1 mA to 8 mA (e.g. [0019] teaches stimulation parameters (i.e. a pulsed electrical signal having a frequency of 1 Hz to 50 kHz, a pulse width of from 1-500 microseconds, and a current of from 1 mA to 20 mA).
Further Alataris teaches providing stimulation to the tragus (e.g. [0114], claim 46) and also teach providing bilateral stimulation (e.g. [0119]) via first and second earpieces, connected to the generator and controller, each of the first and second earpieces comprising:
a stimulating electrode configured to provide an electrical stimulation produced by the generator signal to the nerves innervating a tragus of the user, and a reference electrode, wherein the stimulating electrode is a positive electrode and the reference electrode is a negative electrode (i.e. anode and cathode e.g. [0114]) and wherein the first earpiece is configured to be placed in contact with the left tragus of the user and the second earpiece is configured to be placed in contact with the right tragus of the user, and wherein each of the first and second earpieces is configured such that, when the stimulating electrode is in position on the respective tragus of the user and that the electrodes are configured to provide the respective electrical stimulation signal transcutaneously to the user (e.g. [0114]).
While Alataris teaches providing stimulation via C shaped cross section interface member to the tragus and also bilateral stimulation as discussed above, they do not specifically teach the stimulating electrode is in contact with a first face of the respective tragus and the reference electrode is in contact with a second, opposing face of the respective tragus and wherein each of the first and second earpieces comprises a clip to secure the stimulating electrode and the reference electrode to the tragus of the user, wherein the clip has a first gripping portion and a second gripping portion which are biased into contact with each other and the stimulating electrode is located on the first gripping portion and the reference electrode is located on the second gripping portion.
In a similar field of endeavor, Dundovic teaches a device that comprises a clip configured to be attached to a tragus of the subject on an outward and an inward facing surface of a tragus, the clip including opposing arms configured so that a distal end of the arms are biased towards each other and electrodes positioned proximate a distal end of the arms on opposing faces so that the electrodes are urged into engagement with opposing faces of the tragus and a signal generator electrically connected to the electrodes, the signal generator being configured to generate at least one therapy signal that is applied to a vagus nerve within the tragus via the electrodes (e.g. abstract).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the electrode holder in the teachings of Alataris to be clippable about the tragus as taught by Dundovic in order to provide the predictable results of ensuring proper and comfortable contact with the tissue.
While Alataris teaches providing stimulation at least once a day (e.g. claim 88) Alataris in view of Dundovic do not specifically teach that the method is applied to the user at least once a day for at least 3 consecutive days.
Brown teaches a method of stimulating a cranial nerve with an electric signal by administering to the patient a stimulator device that provides the electric signal, where the device may be any device configured to electrically stimulate nerves near the patient's auricular area (e.g. [0014]), and further teaches that the method is applied to the user for at least 3 consecutive days (e.g. [0053]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Alataris in view of Dundovic to provide the stimulation for 3 consecutive days as taught by Brown in order to provide the predictable results of improving therapeutic outcomes.
Regarding claim 26, Alataris in view of Dundovic and Brown teaches the claimed invention as discussed above and Alataris further teaches that modulating cerebral blood flow is applied to the user for any of the following purposes: modulating arterial blood pressure, reducing systemic arterial blood pressure, reducing pulmonary arterial blood pressure (e.g. [0134]: reducing systolic/diastolic blood pressure).
Furthermore, since Alataris in view of Dundovic and Brown teaches the claimed steps as recited in claim 25, the results of the claimed steps would necessarily result in any of the claimed modulation of arterial blood pressure, reduction in systemic arterial blood pressure, reduction in pulmonary arterial blood pressure.
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Alataris et al. (International Publication Number: WO 2019/005774 A1, hereinafter “Alataris”- APPLICANT CITED) in view of Dundovic et al (U.S. Patent Application Publication Number: US 2022/0287616 A1, hereinafter “Dundovic”- PREVIOUSLY CITED) and Brown et al (U.S. Patent Application Publication Number: US 2017/0296807 A1, hereinafter “Brown”- PREVIOUSLY CITED) and further in view of Sharma et al (U.S. Patent Application Publication Number: US 2020/0094054 A1, hereinafter “Sharma”- PREVIOUSLY CITED).
Regarding claim 55, Alataris in view of Dundovic and Brown teaches the claimed invention as discussed above except for application of the stimulation to the user for a minimum of 5 minutes per day and a maximum of 2 hours per day.
Sharma teaches applying therapy to a user for a minimum of 5 minutes per day and a maximum of 2 hours per day (e.g. [0060]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Alataris in view of Dundovic and Brown with application of the therapy to the user for a minimum of 5 minutes per day and a maximum of 2 hours per day as taught by Sharma since according to In re Wertheim, where the claimed ranges “overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”
Furthermore, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine Alataris in view of Dundovic and Brown with the above-described teachings of Sharma in order to provide the predictable results of an effective therapy to the patient without causing paresthesia and/or other potentially undesirable sensory responses in the patient.
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Alataris et al. (International Publication Number: WO 2019/005774 A1, hereinafter “Alataris”- APPLICANT CITED) in view of Dundovic et al (U.S. Patent Application Publication Number: US 2022/0287616 A1, hereinafter “Dundovic”- PREVIOUSLY CITED) in view of Brown et al (U.S. Patent Application Publication Number: US 2017/0296807 A1, hereinafter “Brown”- PREVIOUSLY CITED) and Sharma et al (U.S. Patent Application Publication Number: US 2020/0094054 A1, hereinafter “Sharma”- PREVIOUSLY CITED) and further in view of Terry, Jr. et al ( U.S. Patent Number: US 5707400 A, hereinafter “Terry”- PREVIOUSLY CITED).
Regarding claim 49, see the rejection of claims 1 and 25 above. However, claim 49 adds “a method of treating hypertension, left ventricular hypertrophy, heart failure and/or atrial fibrillation in a patient, the method comprising: operating a device for modulating cerebral blood flow of a user, the device comprising: administering to the patient a pharmaceutically active composition for the treatment of hypertension, heart failure and/or atrial fibrillation.”
Sharma further teaches administering to the patient a pharmaceutically active composition (e.g. [0081]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the teachings of Alataris in view of Dundovic and Brown and Sharma with administering to the patient a pharmaceutically active composition as taught by Sharma since utilizing a pharmacological/biological supplement increases the efficacy and/or duration of the electrical therapy and since the electrical therapy can improve on the results obtained via a pharmacological treatment.
Further none of the teachings teach pharmaceutically active composition for the treatment of hypertension, heart failure and/or atrial fibrillation.
Terry teaches a method of treating patients suffering from refractory hypertension includes identifying a patient suffering from the disorder and applying a stimulating electrical signal to the patient's vagus nerve predetermined to modulate the electrical activity of the nerve and to alleviate the hypertension (e.g. Abstract), and further teaches a pharmaceutically active composition for the treatment of hypertension, heart failure and/or atrial fibrillation (e.g. Col. 1, lines 41-43, 47-50).
Therefore it would have been obvious to a person having ordinary skill in the art at the time of the invention to modify the teachings with the teachings of Terry which teaches a pharmaceutically active composition for the treatment of hypertension, heart failure and/or atrial fibrillation in order to provide the predictable results of decreasing the systemic vascular resistance by interfering with the sympathetic nervous system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Goodall et al (U.S. Patent Application Publication Number: US 2017/0113057 A1, hereinafter “Goodall”) teaches providing bilateral stimulation via earpieces (e.g. [0032],[0033]) to treat hypertension (e.g. [0208]).
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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