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
Claim Rejections 35 U.S.C. 101
Applicant’s arguments (AA) filed on 09/11/2025 have been fully considered but are not persuasive.
Applicant argues that claim 1 does not recite a mental process “because the steps are not practically performed in the human mind” (AA, pg. 10, ¶ 1). Examiner acknowledges that the human mind alone is not capable of performing sensor-based measurement of biometric quantities. However, as discussed in MPEP 2106.04(a)(2)(III), the courts consider a mental process thinking that “can be performed in the human mind, or by a human using a pen and paper” to be an abstract idea. The action of “providing an early warning score” is an example of a mental process that requires a human to use a physical aid (i.e., sensors to obtain biometric quantities). For this reason, Examiner maintains that the claim is directed to a mental process. Applicant also argues that “the instant claim 1 does not recite any of the judicial exceptions enumerated in the 2019 Guidance”. Examiner respectfully disagrees, as discussed above instant claim 1 recites a mental process performed with the use of a physical aid. The 2019 Guidance specifically states that use of a physical aid does not “negate the mental nature” of a limitation.
Applicant argues that similar to reasoning provided in CardioNet, LLC v. InfoBionic, Inc. No. 2019-1149 (Fed. Cir. Apr. 17, 2020), claim 1 is directed to patentable eligible subject matter because the claim focuses on a specific method that improves hearing aid technology (AA, pg. 10, ¶ 3). Examiner acknowledges that the claims of CardioNet were determined to be directed to patentable eligible subject matter because, as stated by Applicant, they were focused on a specific method that improved cardiac monitoring technology. However, Examiner asserts that the claims examined by CardioNet are not related to Applicants claims, therefore it would be inappropriate to apply court decisions from CardioNet to Applicants claimed invention.
Regarding Applicants argument that the claims focus on a specific method that improves hearing aid technology (AA, pg. 10, ¶ 3), Examiner is not disputing that the invention could be considered by one of ordinary skill in the art as an improvement to hearing aid technology, however, this improvement is not reflected in the claims or supported by the specification. As written, neither the claims nor the specification provides any indication of how the early warning score improves existing hearing aid technology. As discussed in MPEP 2106.04(d)(1), “The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology.” In the instant case, Applicant describes determining an early warning score as an “additional advantage” (Applicants specification, [0032]) but does not provide any additional detail such that one of ordinary skill in the art would reasonably be able to determine that this “additional advantage” amounts to a technological improvement.
Applicant argues that even if the claims are considered to be directed to a judicial exception, the claims as a whole are integrated into practical application because they provide a technological solution to address the problems of conventional hearing aid systems (AA, pg. 10, ¶ 5- pg. 11, ¶ 1). Examiner respectfully disagrees, as discussed above, neither the claims nor specification describe a way in which deriving an early warning score improves existing technology.
For these reasons, the rejection of claims 1-4 and 7-19 under 35 U.S.C. 101 is maintained.
Claim Rejections 35 USC 103
Applicant’s arguments filed on 09/11/2025 do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections (AA, pg. 12, [4]).
However, in the interest of compact prosecution, Examiner has responded to Applicant’s assertion that the cited references alone or in combination do not teach or suggest the following features from amended claim 1:
wherein a preliminary warning score is derived from criticality values corresponding to at least some biometric quantities other than the level of consciousness,
wherein the level of consciousness is assessed when the preliminary warning score exceeds a critical preliminary value, and
wherein the early warning score is derived based on the preliminary warning score and the level of consciousness.
Examiner respectfully disagrees that the cited references alone or in combination do not teach or suggest the listed features from amended claim 1. As discussed in the Non-Final Rejection (filed on 06/11/2025, see In re claim 5 and In re claim 6), Freeman discloses a preliminary warning score (pg. 63, lines 16-19: “modified early warning score”) that is derived from a set of biometric quantities other than the level of consciousness including respiratory rate (RR), tidal volume (TV) and minute ventilation (MV). This preliminary warning score is then used to trigger an alarm or actuate an external system to control medical intervention. Examiner notes that in the case of Freeman it is apparent that the “preliminary value” is the modified warning score that when reached, triggers the alarm. As discussed in Freeman, triggering of the alarm can be used to help initiate or modify patient treatment. Regarding the limitation “level of consciousness is assessed”, it is apparent that consciousness of a patient is assessed given that the alarm functions to initiate or modify patient treatment. However, in so far that this is not explicitly stated, it would have been obvious to use the alarm to alert a clinician to assess consciousness both because the alert identifies changes in patient state (pg. 63, lines 17-19) and because consciousness information (AVPU) must be input by the clinician (pg. 62, lines 16-18). Examiner also notes that Freeman discloses the early warning score being derived based on consciousness level in addition to the same biometric quantities (MV, TV, RR) used to determine the preliminary early warning score (pg. 62, lines 9-18).
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 1-4, and 7-19 are rejected under 35 U.S.C 101 because the claimed invention is directed to an abstract idea (mental process of deriving an early warning score) without significantly more.
STEP 1
In re claim 1 and 13, the claims are directed to statutory subject matter as the claims recite a method and system. (STEP 1: YES)
STEP 2A PRONG 1:
In re claims 1 and 13 the limitations, “a criticality value is assigned” and “an early warning score is derived” and “a preliminary warning score is derived”, are processes capable of being performed in the human mind (including observation, judgement, evaluation, and opinion) under the broadest reasonable standard. These limitations are nothing more than a doctor recording vital signs and determining a patient’s risk of clinical deterioration. For example, a doctor can record a patient’s vital signs, assign a level of criticality, and use that information to calculate a score indicative of the patient’s well-being. (STEP 2A PRONG 1: YES)
STEP 2A PRONG 2:
In re claims 1 and 13 the judicial exception is not integrated into practical application. The requirements to measure the biometric quantities using “a number of sensors” and “wearable system” merely invoke using a computer as a tool to perform an existing process. These additional elements do not impose any meaningful limits on practicing the abstract idea and therefore do not integrate the abstract idea into practical application. See MPEP 2106.05 (f). (STEP 2A PRONG 2: NO)
STEP 2B:
In re claims 1 and 13, the claims do not include any additional elements that are sufficient to amount to more than the judicial exception. As discussed above in “STEP 2A PRONG 2”, the additional elements amount to no more than using a computer as a tool to perform an abstract idea (See, e.g., Versata Development Group v. SAP America, 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015)). Additionally, viewing the limitations in combination show that they fail to ensure the claims amount to significantly more than the abstract idea. When considered as an ordered combination, the additional elements of the claims add nothing that is not already present when considered separately. (STEP 2B: NO)
Regarding the dependent claims, claims 2-4, 7-12, and 14-19 are either directed to steps that are also abstract, are additional data output, or further recite additional elements at a high level of generality which are conventional in the art.
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.
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 1, 2, 4, 11-16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Freeman (WO 2018/085563) in view of Marsh (US 2019/0212198).
In re claim 1, Freeman discloses a method for providing an early warning score by means of a wearable system (abstract) comprising a device (pg. 22, Lines 30-31 : “computing device”),
wherein by means of a number of sensors of the…device (pg. 60, line 27- pg. 61, line 1) at least three biometric quantities of a user of the wearable system are assessed out of:
a heart rate (pg. 60, line 30)
an oxygen saturation of the blood (pg. 60, line 30),
a blood pressure and (pg. 60, line 30)
a respiratory rate (pg. 60, line 30 ; where “RR” stands for respiratory rate),
wherein to each of the at least three biometric quantities, a criticality value is assigned (pg. 59, lines 10-12 ; Table 1 row “Score”)
wherein from said criticality values, an early warning score is derived (pg. 59, lines 4-13 : “composite score”; as known in the art, an early warning score is often referred to as a composite score).
wherein a level of consciousness of the user is assessed as a further biometric quantity (pg. 59, Table 1 : row “APVU”), and a respective criticality value is assigned to the assessed level of consciousness (pg. 59 Table 1: row “Score”), and
wherein the early warning score is further derived from said criticality value corresponding to the level of consciousness (pg. 15, line 31 – pg. 16, lines 1-2).
wherein a preliminary warning score (pg. 63, lines 16-19: “modified early warning score”) is derived from criticality values corresponding to at least some biometric quantities other than the level of consciousness (pg. 63, lines 16-29 : examples of biometric quantities include “MV, TV, and RR”)
wherein the level of consciousness is assessed (pg. 63, lines 16-22: “initiate or modify patient care”) when the preliminary warning score exceeds a critical preliminary value, and (pg. 63, lines 16-19; Note: It is apparent that the preliminary value is the score at which the alarm is triggered.)
wherein the early warning score is derived based on the preliminary warning score and the level of consciousness (pg. 62, lines 9-18: Note: level of consciousness in addition to physiological parameters (ex. MV, TV, RR, etc.) is used to determine the early warning score.)
Freeman does not disclose
an ear warn device
Marsh discloses an analogous wearable device, with several sensors used to measure a variety of biometrics including heart rate, oxygen saturation of the blood, blood pressure, and respiratory rate [0101].
Marsh further discloses the device being an ear-worn device (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable system of Freeman to be ear-worn, as taught by Marsh. One would have been motivated to make this modification because an ear-worn device would allow for continuous non-invasive monitoring of various physiological parameters in a variety of different environments (Marsh, [0002-0018]).
Regarding the limitation “level of consciousness is assessed”, it is apparent that consciousness of a patient is assessed given that the alarm functions to initiate or modify patient treatment. However, in so far that this is not explicitly stated, it would have been obvious to use the alarm to alert a clinician to assess consciousness both because the alert identifies changes in patient state (pg. 63, lines 17-19) and because consciousness information (AVPU) must be input by the clinician (pg. 62, lines 16-18).
In re claim 2, Freeman discloses
wherein the early warning score is compared to a first threshold (pg. 60, lines 12-14), and
wherein an alert signal is *transmitted to a remote medical monitoring server or to a medical service person when the early warning score exceeds the first threshold (pg. 60, lines 13-14: “alarm”)
*As stated above, in pg. 60, lines 13-14, the alarm is generated in response to the early warning score exceeding the first threshold. Although not specifically disclosed, it would have been obvious to have the alert signal (alarm) transmitted to a medical professional in response to the early warning signal exceeding the first threshold for the following reasons: a) the system can use the alarm to alert a medical professional response to a different physiological indication (pg. 55, lines 7-8) b) the system contains a communications interface that is responsible for controlling the system output (pg. 24, lines 4-9) and c) Freeman states that other uses of the invention will be apparent to those skilled in the art (pg. 80, lines 21-22)).
In re claim 4, Freeman discloses
wherein as a further biometric quantity of the user,
a body temperature is assessed by means of a temperature sensor of the wearable system (pg. 60, lines 8-10 ; Table 1 : row “Temperature (C)”), and
a respective criticality value (Table 1 : row “Score”) is assigned to the assessed body temperature, and
wherein the early warning score is further derived from said criticality value corresponding to the body temperature (pg. 60, lines 8-13).
In re claim 11, Freeman discloses
wherein the preliminary warning score is compared to a second threshold (pg. 63, lines 16-22; It is apparent that the preliminary value would be the score at which the alarm is triggered.), and
wherein alert information is presented to the user by means of the wearable system when the preliminary warning score exceeds the second threshold (pg. 63, lines 16-22 ; Note: under the broadest reasonable interpretation (BRI) the “triggering of the alarm” is considered alert information indicating to the patient that something is abnormal).
In re claim 12, the proposed combination yields
wherein the heart rate, the oxygen saturation, the blood pressure, or the respiratory rate are assessed by means of a photoplethysmography sensor of the ear-worn device (Marsh, [0101] : “pulse oximetry sensor,” a type of photoplethysmography sensor, measures “pulse rate”, “oxygen saturation”, and “respiration” ), and/or
wherein the respiratory rate is assessed by means of an audio input signal generated from an electroacoustic input transducer (Marsh, [0101] : “microphone”; Note: a microphone is an electroacoustic input transducer) of the ear-worn device.
In re claim 13, Freeman discloses a wearable system comprising a device (abstract),
wherein the…device comprises a number of sensors, each of which is configured to generate a respective sensor signal when the wearable system is worn a user of the wearable system, each sensor signal being representative of at least one vital function activity of said user (pg. 60, lines 8-12),
wherein the wearable system is configured to
derive from said sensor signal or signals at least three biomedical quantities of the user out of the following:
a heart rate (pg. 60, line 30),
an oxygen saturation of the blood (pg. 60, line 30),
a blood pressure and (pg. 60, line 30)
a respiratory rate (pg. 60, line 30), and to
derive an early warning score from the biomedical quantities (pg. 59, lines 4-13 : “composite score”; as known in the art, an early warning score is often referred to as a composite score).
wherein a level of consciousness of the user is assessed as a further biometric quantity (pg. 59, Table 1 : row “APVU”), and a respective criticality value is assigned to the assessed level of consciousness (pg. 59 Table 1: row “Score”),
wherein the early warning score is further derived from said criticality value corresponding to the level of consciousness (pg. 15, line 31 – pg. 16, lines 1-2),
wherein a preliminary warning score is derived from criticality values corresponding to at least some biometric quantities other than the level of consciousness (pg. 15, line 31 – pg. 16, lines 1-2),
wherein the level of consciousness is assessed (pg. 63, lines 16-22: “initiate or modify patient care”) when the preliminary warning score exceeds a critical preliminary value (pg. 63, lines 16-19; Note: It is apparent that the preliminary value is the score at which the alarm is triggered.), and
wherein the early warning score is derived based on the preliminary warning score and the level of consciousness (pg. 62, lines 9-18: Note: level of consciousness in addition to physiological parameters (ex. MV, TV, RR, etc.) is used to determine the early warning score.).
Freeman does not disclose
an ear warn device
Marsh discloses an analogous wearable device, with several sensors used to measure heart rate, oxygen saturation of the blood, blood pressure, and respiratory rate [0101].
Additionally, Marsh discloses the device being an ear-worn device (abstract). Marsh further discloses several configurations of the ear-worn device including one with two earpieces (FIG. 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable system of Freeman to be ear-worn, as taught by Marsh. One would have been motivated to make this modification because an ear-worn device would allow for continuous non-invasive monitoring of various physiological parameters in a variety of different environments (Marsh, [0002-0018]).
Regarding the limitation “level of consciousness is assessed”, it is apparent that consciousness of a patient is assessed given that the alarm functions to initiate or modify patient treatment. However, in so far that this is not explicitly stated it would have been obvious to use the alarm to alert a clinician to assess consciousness both because the alert identifies changes in patient state (pg. 63, lines 17-19) and because consciousness information (AVPU) must be input by the clinician (pg. 62, lines 16-18).
In re claim 14, Freeman discloses
further comprising in said number of sensors a temperature sensor configured to measure a body temperature of the user (pg. 60 , lines 8-10; Table 1 : row “Temperature (C)”),
wherein the wearable system is further configured to derive the early warning score also based on said body temperature (pg. 60, lines 8-13).
In re claim 15, the proposed combination yields (all mapping directed to Marsh)
wherein the ear-worn device comprises, in said number of sensors,
a photoplethysmography sensor or ([0101] : “pulse oximetry sensor”)
an electroacoustic input transducer, and ([0101] : “microphone”)
wherein the wearable system is configured
to derive the heart rate, the oxygen saturation, the blood pressure, or the respiratory rate from a sensor signal of said photoplethysmography sensor, (Marsh, [0101]) or
to derive the respiratory rate from an audio input signal generated by the electroacoustic input transducer from an *environment sound ([0101] : “bone conduction vibrations”, “breath” ; and [0115] : “voice input”)
*Under BRI an environment sound could include any sound that exists outside of the electroacoustic input transducer (microphone). Therefore, under BRI this limitation is met as the microphone records bone conduction vibrations[0101] , breath [0101] and voice input [0115].
In re claim 16, Freeman discloses further configured to assess a level of consciousness of the user (pg. 59, Table 1 : row “APVU”), and to derive the early warning score further based on the assessed level of consciousness (pg. 15, line 31 – pg. 16, lines 1-2).
In re claim 19, the proposed combination yields (all mapping directed toward Marsh)
comprising
a first ear-worn device (FIG. 6 : 100 ; left earpiece) and a second ear-worn device (100; right earpiece)
configured to be worn by the user at different ears (inherent),
wherein
the first ear-worn device comprises at least a first sensor of said number of sensors (105 ; [0157] : “accelerometer sensor”), and
the second ear-word device comprises at least a second sensor of said number of sensors (103 ; [0157] : “ECG sensor” ) measuring a different biometrical quantity than the at least first sensor ([0157] ; Note: accelerometer measures movement of subject’s head, while ECG sensor measures hearts electrical conduction system.)
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Freeman (WO 2018/085563) in view of Marsh (US 2019/212198), and further in view of Hui et al. (US 2019/0197864).
In re claim 3, the proposed combination yields
wherein the alert signal is transmitted from the ear-worn device to the remote medical monitoring server or to the medical service person via a…network (see In re claim 2).
The proposed combination does not yield
wherein the network is a low-power wide area network.
Hui discloses a wearable device that monitors one or more parameters of a user (abstract). Hui further discloses transferring an alert across a low-power wide area network when an emergency state is detected (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device of the proposed combination, to include the ability to transfer an alert via a low-power network. One would have been motivated to make this modification because low power wide area networks provide low power consumption, extended battery life, and long-range communication.
Claims 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Freeman (WO 2018/085563) in view of Marsh (US 2019/212198) and further in view of Husen et al. (US 8,823,527).
In re claim 7, the proposed combination yields
wherein by means of an electroacoustic input transducer of the ear-worn device, an environment sound is picked up and converted into an audio input signal (see In re claim 15),
The proposed combination does not yield
wherein by means of a sound pattern recognition containing an own voice detection, an utterance of the user is recognized in the audio input signal, and
wherein the level of consciousness of the user is assessed upon the detection of the utterance.
Husen discloses a wearable device (Col. 6, Lines 54-57) with a microphone for detecting environmental acoustic stimulus (Col. 9, Lines 29-34). Additionally, Husen discloses using an algorithm to determine whether the acoustic stimulus corresponds to a patient’s voice (Col. 9, Lines 42-45). Husen further discloses using a patient’s vocal response to determine their level of consciousness (Col. 9, Lines 46-51).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ear-worn device of the proposed combination to determine consciousness level using a patient’s voice. One would have been motivated to make this modification because monitoring consciousness level using a patient’s voice is less invasive and more accessible than existing methods (Col. 2, Lines 58-66).
In re claim 10, the proposed combination discloses
wherein an approximation for the level of consciousness is estimated ( Freeman, pg. 15, line 31 – pg. 16, lines 1-2),
wherein…a communication link between the wearable system and a *medical call center is established for communication between a medical service person of the medical call center and the user in order to assess the user's level of consciousness (see * In re claim 1).
*Regarding the limitation “medical call center”, under BRI a clinician is a medical call center, as a medical call center is merely an entity that serves to connect a patient with their medical provider. Notwithstanding, it would have been obvious to direct the alert/system output to a medical call center to establish a connection between the patient and their medical provider.
The proposed combination does not disclose
establishing the communication link upon estimating a critical level of consciousness
Husen further discloses triggering an alarm in response to estimating a level of consciousness, that summons a medical professional to evaluate a patient (col. 16, lines 23-27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proposed combination to establish a communication link upon measuring a critical level of consciousness, as taught by Husen. One would have been motivated to make this modification because patients experiencing critical consciousness levels would require immediate medical attention.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Freeman (WO 2018/085563) in view of Marsh (US 2019/212198) and further in view of Oksala et al. (US 2017/0360334).
In re claim 9, the proposed combination does not yield
wherein by means of an output speaker of the ear-worn device, at least one acoustic stimulus is presented to a hearing of the user, and
wherein the level of consciousness is assessed by means of measuring a reaction of the user's brain to the at least one acoustic stimulus.
Oksala discloses a wearable device (FIG. 2: 201) configured to determine a patient’s state of consciousness (abstract), that may be located on the chest, wrist, or other parts of the body [0025].
Oksala further discloses determining a patients consciousness level (FIG. 1: 100) by delivering an auditory stimulus (106) and monitoring the patient’s response (108). Additionally, Oksala discloses the auditory stimulus being generated using a sound generator (203) of the wearable device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable device of the proposed combination to use an auditory stimulus to assess consciousness level, as taught by Oksala. One would have been motivated to make this modification because using an auditory stimulus to monitor a patient’s state of consciousness is both simple and non-invasive (Oksala, [0006-0007]).
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Freeman (WO 2018/085563) in view of Marsh (US 2019/212198), in view of Vu et al. (US 2022/0218941) and further in view of Sarén (US 2019/0378620).
In re claim 17, the proposed combination does not yield
wherein the ear-worn device further comprises an electroencephalographic sensor in said number of sensors, and
wherein the level of consciousness is assessed based on a sensor signal of the electroencephalographic sensor.
Vu discloses an analogous ear-worn device that contains a variety of sensors configured to non-invasively measure biosignals (abstract). Vu further discloses one of the sensors being an electroencephalographic (EEG) sensor ([0042] : “EEG”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ear-warn device of the proposed combination to include an EEG sensor, as taught by Vu. One would have been motivated to make this modification because traditional EEG monitoring requires a complicated set up and technicians to operate (Vu, [0003]) and having an EEG sensor in an ear-worn device would create a simpler way to monitor brain activity.
Regarding the limitation
wherein the level of consciousness is assessed based on a sensor signal of the electroencephalographic sensor
Saren discloses a medical device capable of monitoring a patients biosignals to determine an overall condition score (similar to an Early Warning Score) [0014]. Saren further discloses the medical device containing an analytics unit that is configured to determine the level of consciousness based on collected EEG data [0034].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ear-worn device of the proposed combination to assess the level of consciousness based on EEG signals. One would have been motivated to make this modification both because the proposed combination contains an EEG sensor, and using EEG signals to assess consciousness level is a known technique in the art.
In re claim 8, see above (In re claim 17).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Freeman (WO 2018/085563) in view of Marsh (US 2019/212198) and further in view of Stump (US 2021/0000347).
In re claim 18, the proposed combination does not yield,
wherein the ear-worn device is a hearing aid
Stump discloses an analogous wearable monitoring device that includes several sensors for monitoring various physiological parameters (abstract). Stump further discloses the monitoring device being a hearing aid [0125].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ear-worn device of the proposed combination to be given by a hearing aid, as taught by Stump. One would have been motivated to make this modification because using a hearing aid as a monitoring device is known in the art, and the result of the modification is reasonably predictable.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Stroetz et al. (US 2008/0287752) discloses a system for measuring physiological parameters from within an ear canal (abstract).
Chou (US 2020/0121198) discloses a wearable device for monitoring vital signs (abstract).
Solumn et al. (US 2019/0268707) discloses an ear-wearable health monitoring device (abstract).
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796