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 .
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on May 23, 2025, Aug. 15, 2025, Oct. 20, 2025, and Oct. 28, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Interpretation
Claim 10 “an external device that is communicatively connected to a device” is clarified in the specification as “the external device may be a vehicle, such as a car, a ship, or an airplane, and/or on-board diagnostics (OBD) connected to such a vehicle, a smartphone, a navigation system, a black box, or the like”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of copending Application No. 18/568,912 (“ ‘912 ”) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 1 is broader than application ‘912 claim 8. Below is a reproduction of instant claim 1 (left) and application ‘912 (right).
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Application ‘912 claim 8 differs from instant claim 1 by the rounded box and therefore, application ‘912 claim 8 anticipates instant claim 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,576,273 (“ ‘273 ”) in view of Sharma et al. (US 20200094054 A1, published Mar. 26, 2020, hereinafter referred to as “Sharma”).
Below is a reproduction of instant application claim 1 (left) and Patent ‘273 claim 1 (right).
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Instant claim 1 differs from Patent ‘273 claim 1 as indicated by the rounded boxes. Patent ‘273 claim 1 differs from instant claim 1 as indicated by the square boxes. Instant claim 1 is broader than Patent ‘273 claim 1, but for the exception that is limits the one electrode to be used on the vagus nerve in the auricle to a plurality of electrodes contacting different portions of the vagus nerve.
Sharma teaches a wearable device that has two electrodes contacting the ear. The earpiece can form a tight and/or “snug” fit in the patient's ear to position the electrodes at the target region (e.g., the concha, and in particular cases, the cymba concha) (¶[0039]). Representative targets for the electrical therapy signal, in addition to or lieu of the concha, include the antihelix, tragus, antitragus, helix, scapha, triangular fossa, lobule, and/or a lateral surface of the ear (i.e., the side of the ear facing the patient) (¶[0094]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to position multiple electrodes in different regions of the vagus nerve as taught by Sharma in the device of Patent ‘273 since the device can be tailored to different target regions of the vagus nerve.
Instant claim 2 is broader than Patent ‘273 claim 1 but for the exception that is limits the at least one of the left and right ears both ears and being symmetrical.
Sharma also teaches the two earpieces as at least one earpiece includes a first earpiece shaped to fit the patient's right ear and a second earpiece shaped to fit the patient's left ear. Further, two earpiece links 421 (e.g., in the form of flexible cables) connect the signal generator 410 to corresponding earpieces 420a, 420b, which each carry two electrodes 422 (¶[0032]). Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a symmetrical earpiece as taught by Sharma in the device of Patent ‘273, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Instant claims 3-4 are broader than Patent ‘273 claim 1 and differ for the same reasons as claim 1 above.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,576,273 (“ ‘273 ”) in view of Sharma, as applied to claim 3 above, and further in view of Black et al. (US 20210259879 A1, cited on the May 23, 2025 IDS, published Aug. 26, 2021, hereinafter referred to as “Black”).
Instant claim 6 is broader than Patent ‘273 claim 1 in view of Sharma as applied to claim 3 above, but for the exception of limiting the claim further wherein at least one of the plurality of electrodes is configured to exchange thermal energy to cause a change in a temperature of at least one of three semicircular canals of the wearer.
Black’s invention relates to neurostimulation, and in particular, to neurostimulation systems, devices, and methods (¶[0002]). A neurostimulation device may include first and second electrodes, first and second thermoelectric devices thermally coupled, respectively, to first and second earpieces configured to be insertable into respective ear canals of a patient. The controller may be configured to deliver a modulated electric signal to the patient through galvanic vestibular stimulation (GVS) using the first and second electrodes and to deliver a time varying thermal waveform to the patient through caloric vestibular stimulation (CVS) using the first and second earpieces simultaneous with the delivery of the modulated electrical signal through GVS (¶[0027]). The modulated electrical signal and/or the time varying thermal waveform may be configured to reduce symptoms of migraine headache (¶[0042]). The earphones may further include thermal electric devices, “TEDs,” attached to the earpieces 550A, 550B. The controller 510A may include a galvanic waveform generator 581A that may be similar to the waveform generator 281 of FIGS. 1-4. The controller 510A may also include a caloric waveform generator 581B. The caloric waveform generator 518B may be configured to activate the TEDs attached to the earpieces 550A, 550B. In this configuration, caloric vestibular stimulation may be administered to a subject via the subject's ear canal (¶[0137]). Subjects may be treated with the present invention for any reason. In some embodiments, disorders for which treatment may be carried out include, include, but are not limited to, migraine headaches (acute and chronic), depression, anxiety (e.g. as experienced in post-traumatic stress disorder (“PTSD”) or other anxiety disorders), spatial neglect, Parkinson's disease, seizures (e.g., epileptic seizures), diabetes (e.g., type II diabetes), etc. Headaches that may be treated by the methods and apparatuses of the present invention include, but are not limited to, primary headaches (e.g., migraine headaches, tension-type headaches, trigeminal autonomic cephalalgias and other primary headaches, such as cough headaches and exertional headaches) and secondary headaches. Migraine headaches that may be treated by the methods and apparatuses of the present invention may be acute/chronic and unilateral/bilateral. The migraine headache may be of any type, including, but not limited to, migraine with aura, migraine without aura, hemiplegic migraine, ophthalmoplegic migraine, retinal migraine, basilar artery migraine, abdominal migraine, vestibular migraine and probable migraine. As used herein, the term “vestibular migraine” refers to migraine with associated vestibular symptoms, including, but not limited to, head motion intolerance, unsteadiness, dizziness and vertigo (¶[0086]-[0088]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to exchange thermal energy to cause a change in a temperature of at least one of three semicircular canals of the wearer as taught by Black in the device of Patent ‘273 and Sharma in order to reduce symptoms of vertigo which the instant spec defines as a symptom of motion sickness.
Claims 7-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,576,273 (“ ‘273 ”) in view of Sharma, as applied to claim 2 above, and further in view of Kim (KR 101218203 B1, cited on the May 23, 2025 IDS, published Oct. 10, 2012, hereinafter referred to as “Kim”).
Instant claim 7 is broader than Patent ‘273 claim 1 in view of Sharma as applied to claim 2 above, but for the exception of limiting the claim further wherein the plurality of electrodes further comprises a plurality of electroencephalogram (EEG) electrodes to measure an EEG of the wearer, wherein the plurality of EEG electrodes is arranged in a symmetrical array shape between the first set and the second set.
Kim’s invention relates to a sensor set, and more particularly, to a body-mounted sensor set device comprising a sensor for obtaining various signals transmitted from the human body to the machine for human-machine interaction and a stimulus element transmitted from the machine to the human body. Another approach is to measure user movement, one of the major sources of biosignal contamination, to determine the degree and location of contamination of the biosignal. Biological signals mainly used as human-machine interface signals include bioelectrical signals, biomechanical signals, or body temperature. The bioelectrical signal may be an electroencephalogram (EEG). The first measurement electrode 461a is disposed on one surface of the first sheath 434. The second measuring electrode 461b is disposed on one surface of the second sheath 436. As shown in Fig. 7, these electrodes are in a symmetrical shape between the wearers ears.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have EEG electrodes to measure the EEG of the wearer as taught by Kim in the device of Patent ‘273 and Sharma in order to measure human movement which is one of the major sources of biosignal contamination to determine the degree and location of the movement.
Instant claim 8 is broader than Patent ‘273 claim 1 in view of Sharma and Kim as applied to claim 7 above, but for the exception of limiting the claim further wherein the processor is configured to: calculate a first acceleration vector a1 corresponding to a change in visual information of the wearer using measurement signals of the plurality of EEG electrodes; change a frequency or intensity of each of the plurality of electrodes so that a difference between the first acceleration vector a1 and a second acceleration vector a2, which is applied to the wearer and the device, is reduced.
Sharma does teach the system can include at least one sensor capable of sensing a body signal including exertional level from an accelerometer, gyroscope and/or GPS device coupled to the patient's body. The system can then use the body parameter to adjust one or more parameters in accordance with which the electrical signal is delivered (or not delivered) (¶[0090]). Kim teaches if the primary biosignal is electroencephalogram (EEG), the mounting structure is wearable on the head. The bioelectrode is disposed at an appropriate location of the mounting structure. The acceleration sensor may be located near the living body. The acceleration sensor may detect movement of the bioelectrode due to user movement. The sensor set 100 includes biosignal detection sensors that detect a biosignal from a wearer's head, an acceleration sensor 120 mounted to the sensor set to detect a wearer's head movement.
Regarding the limitation of the processor is configured to: calculate a first acceleration vector a1 corresponding to a change in visual information of the wearer using measurement signals of the plurality of EEG electrodes; change a frequency or intensity of each of the plurality of electrodes so that a difference between the first acceleration vector a1 and a second acceleration vector a2, which is applied to the wearer and the device, is reduced, the recitation of functional language must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim. In this case, the device of Patent ‘273, Sharma and Kim contains all of the structural components of the claim and is capable of altering the frequency of the electrodes based on input from the EEG and accelerometer readings and therefore capable of reducing the difference between the two; see MPEP 2114(I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2s at 1432.
Instant claim 9 is broader than Patent ‘273 claim 1 in view of Sharma as applied to claim 8 above, but for the exception of limiting the claim further comprising: a sensor configured to measure the second acceleration vector a2.
Sharma teaches the system can include at least one sensor capable of sensing a body signal including exertional level from an accelerometer, gyroscope and/or GPS device coupled to the patient's body. The system can then use the body parameter to adjust one or more parameters in accordance with which the electrical signal is delivered (or not delivered) (¶[0090]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to include an additional sensor in order to provide a way to adjust parameters of the electrical signal as taught by Sharma in the device of Patent ‘273 and Kim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 and 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sharma.
Regarding claim 1, Sharma teaches a device for transmitting stimulation in a form of an ear set worn on ears of a wearer (Fig.’s 2, 4, 8A and 8B “system 100” ¶[0027], “system 400” ¶[0032], “system 800 having a signal generator 810, earpieces 820a, 820b” ¶[0041]), the device comprising: a plurality of electrodes configured to transmit electrical stimulation by contacting different portions of a vagus nerve of the wearer (“Representative systems in accordance with the present technology deliver electrical signals transcutaneously to the auricular branch(es) of a patient's vagus nerve. The signals are delivered via electrodes positioned at or partially within one or both of the patient's ears.” ¶[0025]); and a processor configured to control at least one of a frequency or intensity of stimulation by controlling the plurality of electrodes (Fig. 2 “The signal generator 110 can include a housing 111 that encloses or partially encloses signal generating circuitry 114. The signal generating circuitry 114 can be controlled by an internal controller 108, e.g., a processor 113 that accesses instructions stored in a memory 112. The signal generator 110 can include a signal transmission port 115 for communicating with the earpieces 120, e.g., transmitting an electrical therapy signal to the earpieces 120” ¶[0027] “The representative systems described above deliver electrical signals to the patient in accordance with selected signal delivery parameters. The signal delivery parameters can include the characteristics defining or describing the signal, and the location to which the signal is delivered.” ¶[0049]; “the frequency can be varied, while the average frequency remains within the foregoing range of about 15 kHz to about 50 kHz.” ¶[0058]).
Regarding claim 2, Sharma teaches wherein the device comprises a first set configured to contact a left ear of the wearer and a second set configured to contact a right ear of the wearer (Fig. 2 “The system 100 includes a signal generator 110 coupled to one or more earpieces 120 (shown as a left earpiece 120a and a right earpiece 120b)” ¶[0027]; “at least one earpiece includes a first earpiece shaped to fit the patient's right ear and a second earpiece shaped to fit the patient's left ear” claim 10), wherein the first set and the second set each comprise a plurality of electrodes of the same number in a symmetrical structure (Fig. 4 “The housing 411 can in turn include the internal components described above with reference to FIG. 2. Two earpiece links 421 (e.g., in the form of flexible cables) connect the signal generator 410 to corresponding earpieces 420a, 420b, which each carry two electrodes 422.” ¶[0032]).
Regarding claim 4, Sharma teaches further comprising: a communicator communicatively connected to an external device and configured to receive external data (Fig. 2 “The signal generator 110 can include a signal transmission port 115 for communicating with the earpieces 120, e.g., transmitting an electrical therapy signal to the earpieces 120, and optionally, receiving feedback or other communications from the earpieces 120. When the system 100 is in use, the electrical therapy signal is in electrical communication with the target neural population to create a desired effect on the target neural population. A communications transceiver 116 provides for communication between the signal generator 110 and the external controller 130.” ¶[0027]), wherein the processor is configured to adaptively adjust an output of at least one of the plurality of electrodes according to the external data (Fig. 4 “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.” ¶[0033]; “the communication pathways between the earpiece and the signal generator, and between the signal generator and the external controller can be in two directions. Accordingly, the signal generator can receive information from the earpieces and/or other elements of the system and take actions based on that information.” ¶[0089]).
Regarding claim 5, Sharma teaches wherein the electrical stimulation is constant current stimulation (“The amplitude at which the electrical therapy signal is delivered can be provided in the form of a step function that remains constant throughout the duration of the therapy” ¶[0087]) in a predetermined size range (“an amplitude in an amplitude range from about 0.1 mA to about 10 mA” ¶[0099]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma.
Regarding claim 3, Sharma teaches the device for transmitting stimulation of claim 1. Sharma also teaches wherein the plurality of electrodes comprises at least two electrodes (Fig. 4 “Two earpiece links 421 (e.g., in the form of flexible cables) connect the signal generator 410 to corresponding earpieces 420a, 420b, which each carry two electrodes 422.” ¶[0032]) of: 1) a first electrode inserted into an external auditory canal through a cavum concha of the wearer in an in-ear manner and configured to transmit electrical stimulation to the external auditory canal (“As shown in FIG. 1, the target region 195 is positioned primarily at the concha 191 and can extend at least partially into the ear canal 194. Devices configured in accordance with embodiments of the present technology are configured not only to deliver electrical therapy signals to the target region 195, but to provide a comfortable, repeatable, and in at least some embodiments, patient-specific, structures and therapy signals for doing so.” ¶[0026]).
Sharma does not explicitly teach 2) a second electrode configured to contact a cymba concha of the wearer; 3) a third electrode configured to contact a tragus of the wearer.
Sharma also teaches that the earpiece can form a tight and/or “snug” fit in the patient's ear to position the electrodes at the target region (e.g., the concha, and in particular cases, the cymba concha) (¶[0039]). Representative targets for the electrical therapy signal, in addition to or lieu of the concha, include the antihelix, tragus, antitragus, helix, scapha, triangular fossa, lobule, and/or a lateral surface of the ear (i.e., the side of the ear facing the patient) (¶[0094]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to position the electrodes as various positions such as two locations of the concha or in addition to the concha as taught by Sharma since the device is capable of being tailored to different target regions.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma, as applied to claim 3 above, and in further view of Black.
Regarding claim 6, Sharma teaches the device for transmitting stimulation of claim 3. Sharma does not disclose wherein at least one of the plurality of electrodes is configured to exchange thermal energy to cause a change in a temperature of at least one of three semicircular canals of the wearer.
Black’s invention relates to neurostimulation, and in particular, to neurostimulation systems, devices, and methods (¶[0002]). A neurostimulation device may include first and second electrodes, first and second thermoelectric devices thermally coupled, respectively, to first and second earpieces configured to be insertable into respective ear canals of a patient. The controller may be configured to deliver a modulated electric signal to the patient through galvanic vestibular stimulation (GVS) using the first and second electrodes and to deliver a time varying thermal waveform to the patient through caloric vestibular stimulation (CVS) using the first and second earpieces simultaneous with the delivery of the modulated electrical signal through GVS (¶[0027]). The modulated electrical signal and/or the time varying thermal waveform may be configured to reduce symptoms of migraine headache (¶[0042]). The earphones may further include thermal electric devices, “TEDs,” attached to the earpieces 550A, 550B. The controller 510A may include a galvanic waveform generator 581A that may be similar to the waveform generator 281 of FIGS. 1-4. The controller 510A may also include a caloric waveform generator 581B. The caloric waveform generator 518B may be configured to activate the TEDs attached to the earpieces 550A, 550B. In this configuration, caloric vestibular stimulation may be administered to a subject via the subject's ear canal (¶[0137]). Subjects may be treated with the present invention for any reason. In some embodiments, disorders for which treatment may be carried out include, include, but are not limited to, migraine headaches (acute and chronic), depression, anxiety (e.g. as experienced in post-traumatic stress disorder (“PTSD”) or other anxiety disorders), spatial neglect, Parkinson's disease, seizures (e.g., epileptic seizures), diabetes (e.g., type II diabetes), etc. Headaches that may be treated by the methods and apparatuses of the present invention include, but are not limited to, primary headaches (e.g., migraine headaches, tension-type headaches, trigeminal autonomic cephalalgias and other primary headaches, such as cough headaches and exertional headaches) and secondary headaches. Migraine headaches that may be treated by the methods and apparatuses of the present invention may be acute/chronic and unilateral/bilateral. The migraine headache may be of any type, including, but not limited to, migraine with aura, migraine without aura, hemiplegic migraine, ophthalmoplegic migraine, retinal migraine, basilar artery migraine, abdominal migraine, vestibular migraine and probable migraine. As used herein, the term “vestibular migraine” refers to migraine with associated vestibular symptoms, including, but not limited to, head motion intolerance, unsteadiness, dizziness and vertigo (¶[0086]-[0088]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to exchange thermal energy to cause a change in a temperature of at least one of three semicircular canals of the wearer as taught by Black in the device for transmitting stimulation of Sharma in order to reduce symptoms of vertigo which the instant spec defines as a symptom of motion sickness.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Kim.
Regarding claim 7, Sharma teaches the device for transmitting stimulation of claim 2. Sharma does not disclose wherein the plurality of electrodes further comprises a plurality of electroencephalogram (EEG) electrodes to measure an EEG of the wearer, wherein the plurality of EEG electrodes is arranged in a symmetrical array shape between the first set and the second set.
Kim’s invention relates to a sensor set, and more particularly, to a body-mounted sensor set device comprising a sensor for obtaining various signals transmitted from the human body to the machine for human-machine interaction and a stimulus element transmitted from the machine to the human body. Another approach is to measure user movement, one of the major sources of biosignal contamination, to determine the degree and location of contamination of the biosignal. Biological signals mainly used as human-machine interface signals include bioelectrical signals, biomechanical signals, or body temperature. The bioelectrical signal may be an electroencephalogram (EEG). The first measurement electrode 461a is disposed on one surface of the first sheath 434. The second measuring electrode 461b is disposed on one surface of the second sheath 436. As shown in Fig. 7, these electrodes are in a symmetrical shape between the wearers ears.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have EEG electrodes to measure the EEG of the wearer as taught by Kim in the device for transmitting stimulation of Sharma in order to measure human movement which is one of the major sources of biosignal contamination to determine the degree and location of the movement.
Regarding claim 8, Sharma and Kim do not explicitly teach wherein the processor is configured to: calculate a first acceleration vector a1 corresponding to a change in visual information of the wearer using measurement signals of the plurality of EEG electrodes; change a frequency or intensity of each of the plurality of electrodes so that a difference between the first acceleration vector a1 and a second acceleration vector a2, which is applied to the wearer and the device, is reduced.
Sharma does teach the system can include at least one sensor capable of sensing a body signal including exertional level from an accelerometer, gyroscope and/or GPS device coupled to the patient's body. The system can then use the body parameter to adjust one or more parameters in accordance with which the electrical signal is delivered (or not delivered) (¶[0090]). Kim teaches if the primary biosignal is electroencephalogram (EEG), the mounting structure is wearable on the head. The bioelectrode is disposed at an appropriate location of the mounting structure. The acceleration sensor may be located near the living body. The acceleration sensor may detect movement of the bioelectrode due to user movement. The sensor set 100 includes biosignal detection sensors that detect a biosignal from a wearer's head, an acceleration sensor 120 mounted to the sensor set to detect a wearer's head movement.
Regarding the limitation of the processor is configured to: calculate a first acceleration vector a1 corresponding to a change in visual information of the wearer using measurement signals of the plurality of EEG electrodes; change a frequency or intensity of each of the plurality of electrodes so that a difference between the first acceleration vector a1 and a second acceleration vector a2, which is applied to the wearer and the device, is reduced, the recitation of functional language must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim. In this case, the device of Sharma and Kim contains all of the structural components of the claim and is capable of altering the frequency of the electrodes based on input from the EEG and accelerometer readings and therefore capable of reducing the difference between the two; see MPEP 2114(I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2s at 1432.
Regarding claim 9, Sharma teaches the device further comprising: a sensor configured to measure the second acceleration vector a2 (“the system can include at least one sensor capable of sensing a body signal including exertional level from an accelerometer, gyroscope and/or GPS device coupled to the patient's body. The system can then use the body parameter to adjust one or more parameters in accordance with which the electrical signal is delivered (or not delivered)” ¶[0090]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma in view of Kim, as applied to claim 8 above, and in even further view of Stoneman et al. (US 20180344969 A1, published Dec. 6, 2018, hereinafter referred to as “Stoneman”).
Regarding claim 10, Sharma and Kim teach the device for transmitting stimulation of claim 8. Sharma discloses wherein the second acceleration vector a2 is obtained by information received from device that is communicatively connected to a device (“the patient and/or practitioner can 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.” ¶[0093]).
Sharma and Kim do not teach wherein the device that receives the information is an external device.
Stoneman’s invention relates to vehicles and, more particularly, to an in-vehicle system for mitigation motion sickness (¶[0002]). The on board motion sickness detector(s) 112a may include any suitable devices and/or systems for generating signals indicative of an existing or potential motion sickness condition. By way of example and not limitation, on board motion sickness detector(s) 112a may include one or more of a galvanic skin cell sensor (e.g., to detect symptoms of motion sickness such as increased body temperature or sweating of an occupant), an electroencephalogram (EEG) sensor (e.g., to detect brain waves associated with an occupant experiencing motion sickness), an accelerometer (e.g., to detect vehicle dynamics known to cause motion sickness), a speed sensor (e.g., to detect vehicle dynamics known to cause motion sickness), a yaw-rate sensor (e.g., to detect vehicle dynamics known to cause motion sickness), a tilt-sensor (e.g., to detect vehicle dynamics known to cause motion sickness) a GPS system (e.g., to detect whether the vehicle is traveling along a path likely to induce motion sickness), and a clock (e.g., to detect whether the vehicle 106 is likely to be at a location known to induce motion sickness, for example, because the vehicle's route is predetermined) (¶[0036]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to gather information from an external device such as the moving vehicle as taught by Stoneman in the device for transmitting stimulation of Sharma and Kim since the device can detect vehicle dynamics known to cause motion sickness.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Cervette et al. (US 20110029045 A1) – Fig. 9 and a portable stimulation system may be provided for people who have motion sickness, where motion sensors (e.g., accelerometers and/or gyroscopes) may be placed in the portable device and may cause stimulations to be provided to a subject to offset motion sensed by the motion sensors of an airplane or some other vehicle in which the subject is located. For example, a portable box may be mounted to the subject's belt, and a cap or headband containing stimulation electrodes may be placed over the subject's head.
Tass et al. (US 9302069 B2) – EEG and vision
Medford et al. (US 20170259059 A1) – headrest with electrodes and data gathering of vehicle motion
Andersen et al. (WO 2018103861 A1) – electrodes on multiple parts of ear
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/E.N.C./Patent Examiner, Art Unit 3792 /AMANDA L STEINBERG/Examiner, Art Unit 3792
