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 .
Drawings
The drawings are objected to because the mobile control device should be labeled as reference character “2” and the server device should be labeled as reference character “3” in Figure 1. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 8 is objected to because of the following informality: “the ear of the user” in line 6 should read “an ear of the user”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Brantigan et al. (WIPO Pub. No. 2024/086209) in view of Chiang et al. (TW-201625330).
Regarding claim 1, Brantigan teaches a feedback-based (Paragraph 0004, lines 6-
8) neural electrical stimulation system (Paragraph 0003, lines 2-4) comprising a wearable
(Paragraph 0096, lines 20-21) feedback-based (Paragraph 0004, lines 6-8) neural
electrical stimulation device (Fig. 1C-1F, Paragraph 0095, line 1, 100), wherein the feedback-based neural electrical stimulation device comprises: a sensing module (Fig. 8A-C, Paragraph 0135, line 1, 812), for measuring physiological feedback signals from a user (Paragraph 0108, lines 1-2), comprising: a photoplethysmography (PPG) sensor for measuring PPG signals (Paragraph 0108, line 3); and an electrodermal activity (EDA) sensor for measuring EDA signals (Paragraph 0135, lines 4-5); an electrical stimulator (Paragraph 0096, line 20), for providing electrical stimulation to the user (Paragraph 0096, lines 20-21), comprising: a tragus electrode (Paragraph 0094, lines 1-3) configured to attach to a tragus of the user (Paragraph 0056, lines 1-3) for providing transcutaneous auricular vagus nerve stimulation (taVNS) (Paragraph 0096, lines 21-22); and a digital controller (Fig. 8C, Paragraph 0155, line 1, 880) electrically connected to both the sensing module and the electrical stimulator (Fig. 8A-8B, Paragraph 0155, lines 1-2 and 5-6) for receiving the physiological feedback signals from the sensing module (Paragraph 0156, lines 1-6) and outputting electrical stimulation control signals to the electrical stimulator so as to control the electrical stimulation (Paragraph 0158, lines 1-3 and Paragraph 0160, lines 13-16).
Brantigan teaches that neural electrical stimulation device can include multiple electrodes that attach to the skin of a user (Paragraph 0096, lines 21-23). Brantigan does not teach that one of the electrodes is a concentric electrode comprising a center electrode and a ring electrode, and that the concentric electrode is configured to attach to the skin of the user for providing transcranial direct current stimulation (tDCS).
Chiang, however, teaches an electrical stimulation system that uses a concentric silicone electrode (Fig. 1, Paragraph 00036, line 1, 1), wherein the concentric electrode comprises a center electrode (Fig. 1, Paragraph 00037, lines 4-5, 111) and a ring electrode (Fig. 1, Paragraph 00037, lines 5-6, 112). Chiang also teaches that the concentric electrode is configured to attach to skin of a user (Paragraph 00037, lines 1-2) in order to provide neural electrical stimulation (Paragraph 00037, lines 9-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brantigan to incorporate the teachings of Chiang to include that one of the electrodes is a concentric electrode comprising a center electrode and a ring electrode, and that the concentric electrode is configured to attach to the skin of the user. Doing so would allow nerves to be selectively stimulated (Paragraph 00037, lines 9-11), and would ensure that a user does not develop burns on their skin (Paragraph 00044, lines 3-4), as recognized by Chiang.
In addition to structural limitations, claim 1 recites functional limitations drawn toward the intended use or manner of operating the claimed apparatus. The functional limitations are: “for providing transcutaneous auricular vagus nerve stimulation (taVNS)” and “for providing transcranial direct current stimulation (tDCS)”. When the cited prior art teaches all of the positively recited structure of the claimed apparatus, it will be held that the prior art apparatus is capable of performing all of the claimed functional limitations of the claimed apparatus. The courts have held that: (1) "apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990), and (2) a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). MPEP § 2114. In this instance, the prior art is capable of meeting the claimed intended use recitations since the devices disclosed by Brantigan and Chiang both comprise electrodes that can “attach to a tragus” or “attach to skin”, and can provide “taVNS” or “tDCS”.
Regarding claim 2, Brantigan in view of Chiang discloses the claimed invention
of claim 1. Brantigan further discloses the feedback-based (Paragraph 0004, lines 6-8) neural electrical stimulation system (Paragraph 0003, lines 2-4) of claim 1, wherein the digital controller (Fig. 8C, Paragraph 0155, line 1, 880) receives the PPG signals from the sensing module (Paragraph 0156, lines 1-6) and converts the PPG signals to frequency domain (Paragraph 0157, lines 1-6) for obtaining heart rate variability (Paragraph 0185, lines 13-14), analyzes high-frequency components and low-frequency components of the heart rate variability (Paragraph 0185, lines 9-11), determines an activity level of a parasympathetic nerve based on (Paragraph 0185, lines 1-2 and 8-13) an energy ratio between the high-frequency components and the low-frequency components (Paragraph 0185, lines 11-12), and adjusts the electrical stimulation control signals based on the control of the electrical stimulation of the electrical stimulator (Paragraph 0197, lines 7-9).
Regarding claim 3, Brantigan in view of Chiang discloses the claimed invention
of claim 2. Brantigan further discloses the feedback-based (Paragraph 0004, lines 6-8)
neural electrical stimulation system (Paragraph 0003, lines 2-4) of claim 2, wherein the high-frequency components are in a frequency range of 0.15 to 0.40 Hz (Paragraph 0185, lines 9-10), and the low-frequency components are in a frequency range of 0.06 to 0.15 Hz (Paragraph 0185, lines 10-11).
Regarding claim 5, Brantigan in view of Chiang discloses the claimed invention of claim 1. Brantigan further discloses the feedback-based (Paragraph 0004, lines 6-8) neural electrical stimulation system (Paragraph 0003, lines 2-4) of claim 1, wherein the digital controller (Fig. 8C, Paragraph 0155, line 1, 880) determines an activity level of a parasympathetic nerve (Paragraph 0185, lines 1-2) based on the PPG signals (Paragraph 0028, lines 1-2 and Paragraph 0186, lines 1-4) and determines an activity level of a sympathetic nerve based on the EDA signals (Paragraph 0185, lines 1-2), and adjusts the electrical stimulation control signals to control a stimulation frequency and a pulse width of the electrical stimulation (Paragraph 0185, lines 19-20) based on the activity level of the parasympathetic nerve and the activity level of the sympathetic nerve (Paragraph 0185, lines 16-18).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Brantigan et al. (WIPO Pub. No. 2024/086209) in view of Chiang et al. (TW-201625330) as applied to claim 1 above, and further in view of Jumbe et al. (U.S. Patent No. 12,483,815).
Regarding claim 4, Brantigan teaches the feedback-based (Paragraph 0004, lines 6-8) neural electrical stimulation system (Paragraph 0003, lines 2-4) of claim 1, wherein the digital controller (Fig. 8C, Paragraph 0155, line 1, 880) receives the EDA signals from the sensing module (Paragraph 0156, lines 1-6) and adjusts the electrical stimulation control signals based on the control of the electrical stimulation of the electrical stimulator (Paragraph 0197, lines 7-9).
Brantigan does not teach that the digital controller decomposes the EDA signals into a skin conductance level (SCL) component and a skin conductance response (SCR) component. Brantigan also does not teach that the digital controller determines an activity level of a sympathetic nerve based on the SCL component.
Jumbe, however, teaches a variety of sensing systems, such as bioimpedance-based sensor modules. Jumbe discloses that EDA signals are composed of two components: the skin conductance level (SCL) and the skin conductance response (SCR) (Col. 36, lines 29-33). Jumbe further teaches that the SCL and the SCR can be decomposed from an EDA signal by using a low pass filter (used for SCL) and a high pass filter (used for SCR) (Col. 36, lines 38-41). Jumbe teaches that SCL is an indicator of sympathetic nerve activity (Col. 36, lines 19-20).
Brantigan teaches that the digital controller is capable of performing signal processing techniques, such as low pass filtering and high pass filtering (Paragraph 0157, lines 5-6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try performing low pass and high pass filtering on the EDA signals in the system disclosed by Brantigan in order to determine an activity level of a sympathetic nerve. Doing so would yield the predictable result of decomposing EDA signals into the SCL and the SCR components, as taught by Jumbe.
Claims 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Brantigan et al. (WIPO Pub. No. 2024/086209) in view of Chiang et al. (TW-201625330) as applied to claim 1 above, and further in view of Goodall et al. (U.S. PGPub No. 2019/0046794).
Regarding claim 6, Brantigan teaches the feedback-based (Paragraph 0004, lines 6-8) neural electrical stimulation system (Paragraph 0003, lines 2-4) of claim 1, further comprising: a mobile control device (Fig. 8B, Paragraph 0151, lines 4-6, 850), for wireless communication with the wearable feedback-based neural electrical stimulation device (Fig. 8B, Paragraph 0151, lines 1-4, 830), configured to provide control commands (Paragraph 0151, lines 2-4) to adjust the electrical stimulation control signals (Paragraph 0197, lines 7-9); and a server device (Paragraph 0152, lines 4-5), for wireless communication with the wearable feedback-based neural electrical stimulation device and the mobile control device (Paragraph 0220, lines 2-4), configured to store and analyze the physiological feedback signals and the electrical stimulation control signals (Paragraph 0152, lines 4-5 and Paragraph 0155, lines 4-5 and 10-11).
Brantigan teaches that the mobile control device includes a display (Fig. 8B, Paragraph 0151, line 8, 856). Brantigan does not disclose that the mobile control device is configured to display the physiological feedback signals and the electrical stimulation control signals.
Goodall, however, teaches an analogous system (Fig. 2A, Paragraph 0131, line 1, 200) that includes a wearable neural stimulation device (Fig. 2A, Paragraph 0131, line 2, 202) that comprises one or more sensors (Fig. 2A, Paragraph 0131, lines 58-59, 220 and Paragraph 0327, lines 10-17), an electrical stimulator (Fig. 2B, Paragraph 0134, lines 1-5, 212), and a digital controller (Fig. 2B, Paragraph 0156, line 5, 224).
Goodall also teaches that the system includes a mobile control device (Fig. 2A, Paragraph 0131, lines 10-16, 208) that is in wireless communication with the wearable neural stimulation device (Paragraph 0131, lines 7-9). Furthermore, Goodall teaches that the mobile control device is configured to display (Paragraph 0223, lines 1-2 and 6-8) physiological feedback signals collected from the one or more sensors and electrical stimulation control signals (Paragraph 0222, lines 11-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brantigan to incorporate the teachings of Goodall to include that the mobile control device is configured to display the physiological feedback signals and the electrical stimulation control signals. Doing so would allow the user to partially control the operation of the wearable device (Paragraph 0222, lines 1-6), and reduce the amount of communication needed between the wearable device, mobile control device, and server device (Paragraph 0223, lines 3-6), as recognized by Goodall.
Regarding claim 7, Brantigan in view of Chiang and Goodall discloses the claimed invention of claim 6. Brantigan further discloses the feedback-based (Paragraph 0004, lines 6-8) neural electrical stimulation system (Paragraph 0003, lines 2-4) of claim 6, wherein the wearable feedback-based neural electrical stimulation device (Fig. 1C-1F, Paragraph 0095, line 1, 100) further comprises: a wireless transmission module (Fig. 8A, Paragraph 0138, lines 1-3, 818), for wireless communication with the mobile control device and the server device (Paragraph 0220, lines 2-4), electrically connected to the digital controller (Fig. 8A) to transmit the physiological feedback signals (Paragraph 0152, lines 2-3), the electrical stimulation control signals (Paragraph 0160, lines 13-14), and the control commands (Paragraph 0151, lines 2-4).
Regarding claim 8, Brantigan teaches the feedback-based (Paragraph 0004, lines 6-8) neural electrical stimulation system (Paragraph 0003, lines 2-4) of claim 1, wherein the wearable feedback-based neural electrical stimulation device further comprises: a body (Fig. 2A-2G, Paragraph 0105, lines 7-9, 120a/120b/130/140) configured to accommodate the digital controller (Fig. 8A-8C, Paragraph 0155, line 1, 808/880) with the tragus electrode and the concentric electrode disposed on a surface of the body (Fig. 2A-2G, Paragraph 0104, lines 14-16, 122a/122b); an earplug element (Fig. 2A-2G, Paragraph 0104, line 6, 110) coupled to the body (Fig. 2A-2G) for securing the wearable feedback-based neural electrical stimulation device to the ear of the user (Fig. 2A-2G, Paragraph 0104, lines 6-8); and a sensing element (Paragraph 0108, line 3 and Paragraph 0135, lines 4-5) that includes the PPG sensor (Paragraph 0108, line 3) and the EDA sensor (Paragraph 0135, lines 4-5).
Brantigan does not teach that the sensing element is disposed on a surface of an earplug element to contact the ear of the user and accommodate the PPG sensor and the EDA sensor. Goodall, however, teaches an analogous system (Fig. 2A, Paragraph 0131, line 1, 200) that includes a wearable neural stimulation device (Fig. 2A, Paragraph 0131, line 2, 202) that comprises one or more sensors (Fig. 2A, Paragraph 0131, lines 58-59, 220), such as a PPG sensor and EDA sensor (Paragraph 0327, lines 10-17). Goodall also teaches that the sensor (Fig. 4A, Paragraph 0183, line 25, 418) can be disposed on a surface (Fig. 4A) of an earplug element (Fig. 4A-4B, Paragraph 0183, line 23, 416) to contact the ear of the user (Fig. 4A-4B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brantigan to incorporate the teachings of Goodall to include that the sensing element is disposed on a surface of an earplug element to contact the ear of the user. Doing so would ensure that the wearable device and sensors form a secure connection with the external auditory meatus (Paragraph 0183, lines 21-22), which would improve data collection accuracy, as recognized by Goodall.
Regarding claim 9, Brantigan in view of Chiang and Goodall discloses the claimed invention of claim 8. Brantigan further discloses the feedback-based (Paragraph 0004, lines 6-8) neural electrical stimulation system (Paragraph 0003, lines 2-4) of claim 8, wherein the tragus electrode (Paragraph 0094, lines 1-3) is a contact electrode (Paragraph 0056, lines 1-3) or a snap-fit electrode.
Regarding claim 10, Brantigan in view of Chiang and Goodall discloses the claimed invention of claim 9. Brantigan further discloses the feedback-based (Paragraph 0004, lines 6-8) neural electrical stimulation system (Paragraph 0003, lines 2-4) of claim 9, wherein the contact electrode (Paragraph 0056, lines 1-3) is a direct contact electrode (Paragraph 0009, line 3) or a spring-mechanism electrode (Paragraph 0033, lines 7-10).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Brantigan et al. (WIPO Pub. No. 2024/086209) in view of Chiang et al. (TW-201625330) and Goodall et al. (U.S. PGPub No. 2019/0046794) as applied to claim 9 above, and further in view of Goldwasser et al. (WIPO Pub. No. 2017/201525).
Regarding claim 11, Brantigan teaches the feedback-based (Paragraph 0004, lines
6-8) neural electrical stimulation system (Paragraph 0003, lines 2-4) of claim 9 that includes the tragus electrode (Paragraph 0094, lines 1-3). Brantigan does not teach that the tragus electrode is a snap-fit electrode, wherein the snap-fit electrode comprises a male snap and a female snap that are detachably assembled with each other, one of the male snap and the female snap contacts the ear of the user, and the other is disposed on the body.
Goldwasser, however, teaches an apparatus for transdermal electrical stimulation that uses snap-fit (Paragraph 0177, lines 7-10) electrodes (Paragraph 0011, lines 3-7). Goldwasser teaches that the snap-fit electrodes comprise a male snap (Fig. 38A, Paragraph 0177, line 8) and a female snap (Fig. 39B, Paragraph 0177, line 9) that are detachably assembled with each other (Fig. 38A-39B). Goldwasser also teaches that the male snap contacts the skin of the user (Paragraph 0177, lines 1-3), and the female snap is disposed on the body (Paragraph 0177, line 9).
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of the direct contact or spring-mechanism electrode of Brantigan for the snap-fit electrode of Goldwasser. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Lerman et al. (U.S. Patent No. 11,311,724) discloses a system (200) for providing electrical nerve stimulation to the vagus nerve of an ear of a user (Col. 14) that uses at least one physiological sensor (230), to measure heart rate variability using PPG signals (Col. 39) and skin conductance (Col. 40).
Cartledge et al. (U.S. PGPub No. 2015/0360030) discloses a transcutaneous electrostimulation device that positions electrodes in the ear canal (Abstract), and uses physiological feedback such as heart rate and EDA activity to adjust the electrical stimulation parameters (Paragraph 0036).
Synergistic Effects of Simultaneous tDCS and tAVNS on the Brain Responses, 2021 (See PTO 892) discusses a study where transcranial direct current stimulation (tDCS) and transcutaneous auricular vagus nerve stimulation (taVNS) were applied simultaneously, and the study showed that simultaneous stimulation has potential to modulate multiple brain networks in a more effective way.
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/H.A.H./Patent Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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