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 .
Response to Arguments
The finality of the last office action is withdrawn.
Applicant's arguments filed 3/9/2026 have been fully considered but they are not persuasive. The applicant argues that the term “real-time” is a term of the art, and yet cannot produce a universally accepted definition of the term, either in their specification or in the art. What it real-time? Is it defined in milliseconds, seconds, minutes? We don’t know because the original specification does not define the metes and bounds of the term. Therefore, the Examiner is required to give the term its plain meaning, as per MPEP 2111.01. Since the specification provides no evidence as to the meaning of the term, the Examiner is required by MPEP 2111.01 to turn to extrinsic evidence to determine the ordinary and customary meaning given to the term by those of ordinary skill in the art. MPEP 2111.01 specifically discloses that it is appropriate to look to how the claim term is used in the prior art, which includes prior art patents, published applications, trade publications, and dictionaries. All of Merriam-Webster, NIST and Gartner.com are evidence of how the phrase is used in the prior art. The Examiner is doing exactly what is required of him to define the plain meaning of a term whose metes and bounds is entirely undefined by the applicant’s original specification.
The National Institute of Standards and Technology defines “real-time” as “Pertaining to the performance of a computation during actual time that the related physical process transpires so that the results of the computation can be used to guide the physical process” (https://csrc.nist.gov/glossary/term/real_time). Additionally, Merriam-Webster defines “real-time” as “the actual time during which something takes place” (https://www.merriam-webster.com/dictionary/real%20time). As a final example, Gartner states that “real-time” describes “an operating system that responds to an external event within a short and predictable time frame…[A] real-time operating system provides services or control to independent ongoing physical processes” (https://www.gartner.com/en/information-technology/glossary/real-time).
Compare these to what is disclosed in Cook in par. 0115:
Adaptive learning controllers can learn from the previous response of a particular patient or similar patients to stimulation settings which helped alleviate conditions being treated, such as tachycardia or atrial fibrillation. For example, in one embodiment, a closed loop device may detect heart rate and adjust the output current or voltage or other parameter to limit heart rate reductions to a prescribed level. In some embodiments, this qualitative and/or quantitative feedback may be used by the system to automatically or otherwise adjust the stimulation parameters in a closed-loop fashion to optimize the clinical effects of the stimulation.
Contrary to the applicant’s arguments, the Examiner is NOT placing their personal belief and opinion into what they want Cook to teach. They are merely using the time frames provided by the prior art definitions since the applicant did not provide any time frame definition of their own. Clearly, Cook discloses that a computation is performed while the heart rate is being detected so that the results of the computation can be used to modify and deliver stimulation that affects the physical process during the actual time the process is occurring (i.e., heart beat/rate). This computation is occurring in a “short and predictable time frame” such that the time frame is short enough to TREAT/AFFECT the heart rate that was just detected. Cook clearly describes processing and responding to events as they happen, such that in order to treat a detected heart rate, the stimulation needs to be delivered quickly enough to limit the detected heart rate before the patient is harmed by the detected arrhythmia. If the system were not “real-time” the patient could die or be placed in a dangerous situation (see par. 0087) before treatment were even applied, or the heart rate may change, and the stimulation applied would not be appropriate for current conditions. Cook even teaches in par. 0115 that the closed loop device detects heart rate and adjusts the current output accordingly to treat THAT SPECIFIC HEART RATE. This closed loop device functions continuously, such that as heart rate changes, the output would be adjusted to treat that heart rate. That is quintessential treatment in real-time. If the system did not operate in a short and predictable time frame in order to treat the detected heart rate as it happens, then the device would not function properly for its intended purpose. As such, the Examiner believes this is a time frame that the user would also sense as “immediate or current.” Therefore, the Examiner maintains that Cook operates in “real-time” as would be understood by one of ordinary skill in the art and as described above and the claims are properly anticipated by Cook.
Furthermore, par. 0115 doesn’t merely disclose a closed-loop system, but also discloses providing self-tuning adaptive feedback control for the neurostimulator including, but not limited to, fuzzy controllers, LQG controllers and artificial neural networks (ANN). If this were not in real-time, why would ANN’s be necessary?
Again, while the applicant argues that the term “real-time” is a term of the art, they cannot produce a universally accepted definition of the term, either in their specification or in the art. Instead, the Examiner has provided a definition/plain meaning of the term (as required by MPEP) based on the prior art that is met by Cook.
Applicant’s arguments with respect to the single reference 103 rejection of the claims have been fully considered. In response, a teaching reference has been added to better support the obviousness of a closed-loop process being performed in real-time.
Regarding claim 8, “FOR ensuring a consistent stimulation is delivered to different subjects or the same subject at different times” is an intended use of the system. A recitation of the intended use of the claimed invention 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 intended use, then it meets the claim. The claim does NOT require a system that is configured or programmed to ensure a consistent stimulation is delivered
Regarding claim 13, heart rate is a listed parameter. Par. 0115 discloses detecting heart rate.
Regarding claim 14, the physiological parameters detected, such as heart rate, is the claimed “feedback from a subject” in the closed loop system.
Regarding claim 9, the claim requires “measuring an impedance” between the electrodes and “modulating stimulation based upon said impedance.” Tyler clearly states that in par. 0139 that the impedance between the electrodes is checked and then stimulation is started based on the measurement. In that case, the stimulation is modulated from zero to on. The claim does not require detection of impedance and modulation of stimulation DURING stimulation.
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 6-8, 10-14, 18, 23, 24,27 and 29-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cook et al. (US 2014/0135886, hereinafter Cook).
Regarding claims 6, 7, 13, 14, 18, 23, 24 and 27-31, Cook discloses an auricular nerve stimulation system as seen in figures 8A-8C2 (par. 0123). The system includes an auricular stimulation device with first and second electrodes 310/405 that are positioned apart from each other and are configured to electrically contact a subject’s ear and provide electrical stimulation to an auricular branch of the Vagus nerve (par. 0123-0132). A controller (“pulse generator”) controls application of electrical stimulation delivered in response to input parameters (par. 0127, 130). Cook further discloses that an artificial intelligence learning engine (“artificial neural network”) can be utilized in the disclosed embodiments wherein the engine is programmed to aggregate assessment information, such as feedback heart rate from a user, and input parameters from a monitoring system to determine optimal input parameters for the stimulation (par. 0115).
With regards to the limitation(s) of a “controller configured to selectively modify electrical stimulation protocols and apply the stimulation in real-time,” while the phrase “real-time” is not explicitly written in cited par. 0115, the Examiner believes that the paragraph does describe the selective modification of electrical stimulation protocols and application of the stimulation in real-time.
In reviewing the applicant’s original specification, the applicant did not provide any sort of special definition of “real-time”, nor is there even a general discussion of what the term encompasses. Therefore, the Examiner must rely on the plain meaning of the term “real-time” (see MPEP 2111 and 2111.01). As one example, the National Institute of Standards and Technology defines “real-time” as “Pertaining to the performance of a computation during actual time that the related physical process transpires so that the results of the computation can be used to guide the physical process” (https://csrc.nist.gov/glossary/term/real_time). Additionally, Merriam-Webster defines “real-time” as “the actual time during which something takes place” (https://www.merriam-webster.com/dictionary/real%20time). As a final example, Gartner states that “real-time” describes “an operating system that responds to an external event within a short and predictable time frame…[A] real-time operating system provides services or control to independent ongoing physical processes” (https://www.gartner.com/en/information-technology/glossary/real-time). None of these definitions/interpretations are inconsistent with the original specification. Furthermore, the applicant admitted on page 11 of the arguments filed on 4/20/2025 that “real-time refers to processing or responding to events as they happen, often within a defined time window.” However, the applicant’s specification does NOT define a time window.
Compare these to what is disclosed in Cook in par. 0115:
The device may be configured to detect heart rate…to provide self-tuning adaptive feedback control for the neurostimulator including, but not limited to, fuzzy controllers, LQG controllers and artificial neural networks (ANN). Adaptive learning controllers can learn from the previous response of a particular patient or similar patients to stimulation settings which helped alleviate conditions being treated, such as tachycardia or atrial fibrillation. For example, in one embodiment, a closed loop device may detect heart rate and adjust the output current or voltage or other parameter to limit heart rate reductions to a prescribed level. In some embodiments, this qualitative and/or quantitative feedback may be used by the system to automatically or otherwise adjust the stimulation parameters in a closed-loop fashion to optimize the clinical effects of the stimulation.
Clearly, Cook discloses that a computation is performed while the heart rate is being detected so that the results of the computation can be used to modify and deliver stimulation that affects the physical process during the actual time the process is occurring (i.e., heart beat/rate). This computation is occurring in a “short and predictable time frame” such that the time frame is short enough to TREAT/AFFECT the heart rate that was just detected. Cook clearly describes processing and responding to events as they happen, such that in order to treat a detected heart rate, the stimulation needs to be delivered quickly enough to limit the detected heart rate before the patient is harmed by the detected arrhythmia. If the system were not “real-time” the patient could die before treatment were even applied. As such, the Examiner believes this is a time frame that the user would also sense as “immediate or current.” Just because Cook did not use the term “real-time” does not mean that they do not describe a controller process that meets the BRI of “real-time.” Based on the evidence, the Examiner believes that Cook does disclose a “controller configured to selectively modify electrical stimulation protocols and apply the stimulation in real-time.” Alternatively, given the above evidence, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date that the disclosure found in par. 0115 discloses “real-time” modification given the plain meaning of the term as defined above and the complete lack of discussion of the metes and bounds of the term in the applicant’s original specification.
Regarding claim 8, Cook discloses that the learning engine (“stimulation normalization system”) allows for consistent stimulation across different patients when the patients have similar conditions (par. 0115).
Regarding claims 10-12, the electrodes of Cook can be put in contact with the cymba concha of either ear of the patient at different times if so desired by a user (par. 0130), such that one electrode is distal to the other (see figure 8B). A recitation of the intended use of the claimed invention 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 intended use, then it meets the claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6-8, 10-14, 18, 23, 24, 27 and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Cook in view of Panescu et al. (US 8,712,519, hereinafter Panescu).
Regarding claims 6, 7, 13, 14, 18, 23, 24, 27 and 29-31, Cook discloses an auricular nerve stimulation system as seen in figures 8A-8C2 (par. 0123). The system includes an auricular stimulation device with first and second electrodes 310/405 that are positioned apart from each other and are configured to electrically contact a subject’s ear and provide electrical stimulation to an auricular branch of the Vagus nerve (par. 0123-0132). A controller (“pulse generator”) controls application of electrical stimulation delivered in response to input parameters (par. 0127, 130). Cook further discloses that an artificial intelligence learning engine (“artificial neural network”) can be utilized in the disclosed embodiments wherein the engine is programmed to aggregate assessment information, such as feedback heart rate from a user, and input parameters from a monitoring system to determine optimal input parameters for the stimulation (par. 0115).
As described above, Cook discloses a system in par. 0115 that detects heart rate and adjusts the stimulation output accordingly to treat that specific heart rate. This device functions continuously, such that as heart rate changes, the output would be adjusted to treat that heart rate. While the Examiner considers this to be real-time adjustment, Cook does not use the term real-time explicitly. Panescu discloses an analogous closed-loop system for modulating stimulation based on detected parameters in real-time (Col. 23, lines 64-67 and claim 37). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date that the closed loop system of Cook should be operated in real-time, as taught by Panescu since Panescu discloses that real-time adjustment is an ideal way to respond automatically to changes in cardiac performance (Col. 2, lines 26-28).
Regarding claim 8, Cook discloses that the learning engine (“stimulation normalization system”) allows for consistent stimulation across different patients when the patients have similar conditions (par. 0115).
Regarding claims 10-12, the electrodes of Cook can be put in contact with the cymba concha of either ear of the patient at different times if so desired by a user (par. 0130), such that one electrode is distal to the other (see figure 8B). A recitation of the intended use of the claimed invention 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 intended use, then it meets the claim.
Claims 9, 15, 16, 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Cook in view of Tyler et al. (US 2017/0368329, hereinafter Tyler).
Regarding claim 9, Cook, as described above, discloses the applicant’s basic invention, with the exception of measuring an impedance between the electrodes and modulating stimulation based on the impedance. Attention is directed to Tyler, which also discloses an auricular nerve stimulation device, and thus is analogous art with Cook. Tyler discloses an auricular stimulation system comprising an auricular stimulation device comprising first and second electrodes positioned spaced apart from each other, such that at least one electrode is configured to be in contact with the surface of the subject’s ear to provide stimulation to the subject’s Vagus nerve (par. 0061, 0118, 0123, 0124, 0128). The system includes a controller coupled to the stimulation device and configured to control and/or modulate application of electrical stimulation in response to input parameters received from a monitoring system coupled to the controller for providing an assessment that includes the input parameters by measuring physiological properties, such as heart rate or HRV, as feedback in real time (par. 0053-0054, 0058, 0061, 0132, 0161-0162, 0185, 0223). Tyler discloses measuring impedance of the electrodes and modulating (e.g., activating) stimulation based on the impedance (par. 0139). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Cook to measure impedance of the electrodes and modulate (e.g., activate) stimulation based on the impedance in order to ensure the electrodes have the proper impedance values prior to delivering stimulation.
Regarding claims 15 and 16, Cook is silent as to the monitoring system being an app on a smart device that poses questions to a user and provides the answers as input parameters. However, Tyler suggests that the controllers can be included on a smartphone (par. 0165) and that questions can be presented to a user to elicit subjective answers that can be used as treatment input parameters (par. 0161). Cook explicitly discloses that the AI engine can learn from “previous responses of a particular patient” (par. 0115). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Cook to have the monitoring system be an app on a smart device that poses questions to a user and provides the answers as input parameters to the learning engine, as taught by Tyler, in order to learn what treatments best alleviated conditions.
Regarding claims 25 and 26, figure 8B-8C of Cook discloses a housing structure of the stimulation device, but is silent as to also providing audio signals to the patient to augment the stimulation. Tyler discloses that audio signals may be applied to the subject’s ear to augment the electrical stimulation treatment to the auricular branch of the Vagus nerve (par. 0028, 0030, 0041, 0143). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Cook such that audio signals may be applied to the subject’s ear to augment the electrical stimulation treatment to the auricular branch of the Vagus nerve, as taught by Tyler.
Claims 9, 15, 16, 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Cook or Cook in view of Panescu and further in view of Tyler et al. (US 2017/0368329, hereinafter Tyler).
Regarding claim 9, Cook, as described above, discloses the applicant’s basic invention, with the exception of measuring an impedance between the electrodes and modulating stimulation based on the impedance. Attention is directed to Tyler, which also discloses an auricular nerve stimulation device, and thus is analogous art with Cook. Tyler discloses an auricular stimulation system comprising an auricular stimulation device comprising first and second electrodes positioned spaced apart from each other, such that at least one electrode is configured to be in contact with the surface of the subject’s ear to provide stimulation to the subject’s Vagus nerve (par. 0061, 0118, 0123, 0124, 0128). The system includes a controller coupled to the stimulation device and configured to control and/or modulate application of electrical stimulation in response to input parameters received from a monitoring system coupled to the controller for providing an assessment that includes the input parameters by measuring physiological properties, such as heart rate or HRV, as feedback in real time (par. 0053-0054, 0058, 0061, 0132, 0161-0162, 0185, 0223). Tyler discloses measuring impedance of the electrodes and modulating (e.g., activating) stimulation based on the impedance (par. 0139). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Cook to measure impedance of the electrodes and modulate (e.g., activate) stimulation based on the impedance in order to ensure the electrodes have the proper impedance values prior to delivering stimulation.
Regarding claims 15 and 16, Cook is silent as to the monitoring system being an app on a smart device that poses questions to a user and provides the answers as input parameters. However, Tyler suggests that the controllers can be included on a smartphone (par. 0165) and that questions can be presented to a user to elicit subjective answers that can be used as treatment input parameters (par. 0161). Cook explicitly discloses that the AI engine can learn from “previous responses of a particular patient” (par. 0115). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Cook to have the monitoring system be an app on a smart device that poses questions to a user and provides the answers as input parameters to the learning engine, as taught by Tyler, in order to learn what treatments best alleviated conditions.
Regarding claims 25 and 26, figure 8B-8C of Cook discloses a housing structure of the stimulation device, but is silent as to also providing audio signals to the patient to augment the stimulation. Tyler discloses that audio signals may be applied to the subject’s ear to augment the electrical stimulation treatment to the auricular branch of the Vagus nerve (par. 0028, 0030, 0041, 0143). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Cook such that audio signals may be applied to the subject’s ear to augment the electrical stimulation treatment to the auricular branch of the Vagus nerve, as taught by Tyler.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892, particularly Rosenbluth et al. (US 2019/0001129) and Pillai et al. (US 7,676,264), both of which disclose real-time closed loop stimulation modulation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eric D. Bertram/Primary Examiner, Art Unit 3796
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