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 .
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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 15, the limitation “the device wearer” lacks proper antecedent basis as there is no previous recitation of a device or a wearer. For the purpose of furthering examination, the phrase is being interpreted as “a wearer of the system”.
Claims not explicitly rejected above are rejected due to their dependence on the above claims.
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, 5-13, 15-17, 19-20, and 85 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of Claim 1 follows.
STEP 1
Regarding Claim 1, the claim recites a series of components, including a control circuit, a microphone in electrical communication with the control circuit, a power supply in electrical communication with the control circuit, a sensor package in electrical communication with the control circuit, and a processor to detect clinical symptoms of hydration levels and issue an alert when hydration level clinical symptoms cross a threshold value. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The function of detecting clinical symptoms of hydration levels can be performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites issuing an alert when hydration level clinical symptoms cross a threshold, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The issuance of the alert does not provide an improvement to the technological field, the system does not effect a particular treatment or effect a particular change based on the issued alert, nor is a particular machine used to perform the Abstract Idea. The Abstract Idea is performed by a computer – a processor. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, Claim 1 recites a monitoring system comprising the following generically recited components: a control circuit, a microphone, a power supply, and a sensor package. The claim fails to recite any particular function of the individual elements. While the claim recites that the system is configured to process signals of one or more sensors of the sensor package, the processing function is recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g., mere data gathering steps necessary to perform the Abstract Idea, and the element configured to perform this function is recited at a high level of generality. The claim additionally recites a generic system configured to issue an alert when hydration level clinical symptoms cross a threshold, but the issuing function is recited at a high level of generality such that it amounts to insignificant extra-solution activity. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional function that distinguishes it from well-understood, routine, and conventional data gathering or extra-solution activity engaged in by medical professionals prior to Applicant's invention.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding Claim 85, the system recited in the claim is a generic system comprising generic components configured to perform the abstract idea. The recited control circuit, microphone, power supply, and sensor package are all generic data gathering and transmission components configured to perform pre-solutional data gathering activity. The recited processor is a generic computing device configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
Dependent Claims 5-13, 15-17 and 19-20 fail to add something more to the abstract independent claim as they generally recite structural components. Claim 7 recites generic structures, an external sensor, used to receive data from an external sensor. Claim 9 recites generic structures used to process signals of the microphone and detect signs of hydration levels. Claim 16 recites generic structures used to identify drinking events based on signals from a microphone. Claim 17 recites generic structures used to issue an alert when a number of drinking events cross a threshold. Claim 19 recites generic structures, a first and second unit, used to exchange signals between a first and second unit. Claim 20 recites generic structures used to classify observed patterns into a scale of hydration levels. However, the functions recited in each claim are stated at such a high generality that they amount to nothing more than pre-solution data gathering and post-solution data activity that do not use a particular machine to perform the Abstract Idea. It is noted that Claim 8 uses an external sensor, but these are generic devices configured to act as an additional element for pre-solution data gathering.
The processing, detecting, and issuing functions recited in the independent claims, Claims 1 and 85, maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 102
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, 7-9, 15-16, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steven Goldstein'671 (U.S. Patent Publication 20170112671 – previously cited).
Regarding Claim 1, Steven Goldstein'671 discloses an ear-wearable hydration level monitoring system (Paragraph [0163] - In another case, acoustical energy, including ultrasonic energy, can be passed from one earpiece module to the other, with acoustic absorption and reflection being used to gauge various physiological states. For example, this technique can be used to gauge hydration level in the head or brain by estimating the acoustical energy absorption rate and sound velocity through the head of the user) comprising:
a control circuit (Paragraph [0041] - The term processor has generally replaced the term central processing unit (CPU) and can further refer to a microprocessor, a digital signal processor, a programmable logic device, an application specific integrated circuit or ASIC or any number of other logic devices);
a microphone, wherein the microphone is in electrical communication with the control circuit (Paragraph [0170] - The end cap 75 encloses a number of components within the main housing 73 including a speaker housing 77 (having a speaker port 77A), an ear canal microphone 77B, a memory 83, a digital signal processor 86, a first ambient microphone 82A, a second ambient microphone 82B, an LED 89 and a flex circuit 88 that couples the various electronic components);
a power supply, wherein the power supply is in electrical communication with the control circuit (Paragraph [0064] - In some embodiments, an fully integrated system or device 1 can include an earpiece having a power source 2 (such as button cell battery, a rechargeable battery, or other power source); Paragraph [0075] - In another example, the processor 4 can control a level of battery charging to optimize charging time or optimize battery life in consideration of other factors such as temperature or safety in view of the rechargeable battery technology used); and
a sensor package, wherein the sensor package is in electrical communication with the control circuit (Paragraph [0063] - The wearable device can include one or more sensors that can optionally include sensors on, embedded within, layered, on the exterior or inside the expandable element or balloon. Sensors can also be operationally coupled to the monitoring device either locally or via wireless communication; Paragraph [0064] - The sensor(s) can also be environmental including, but not limited to, ambient microphones, temperature sensors, humidity sensors, barometric pressure sensors, radiation sensors, volatile chemical sensors, particle detection sensors, or other chemical sensors. The sensors 5 can be directly coupled to the processor 4 or wirelessly coupled via a wireless communication system 6A); wherein the ear-wearable hydration level monitoring system is configured to:
process signals of one or more sensors of the sensor package in order to detect clinical symptoms of hydration levels (Paragraph [0163] - The sensor(s) can also be environmental including, but not limited to, ambient microphones, temperature sensors, humidity sensors, barometric pressure sensors, radiation sensors, volatile chemical sensors, particle detection sensors, or other chemical sensors. The sensors 5 can be directly coupled to the processor 4 or wirelessly coupled via a wireless communication system 6A); and
issue an alert when hydration level clinical symptoms cross a threshold value (Paragraph [0083] - Each physiological sensor can be configured to detect and/or measure one or more of the following types of physiological information…breathing rate, blood flow…physical and/or psychological stress levels and/or stress level indicators…position and/or balance…blood pressure; Paragraph [0131] - The communication module may utilize audible or visible alerts if the user is meeting their physiological targets or exceeding safe physiological limits).
Regarding Claim 7, Steven Goldstein'671 discloses the system outlined in Claim 1 above as well as the ear-wearable hydration level monitoring system is configured to receive data from at least one external sensor (Paragraph [0111] - The illustrated wearable monitoring device 20 includes one or more of the following: a sensor 5A in the form of at least one physiological sensor or at least one environmental sensor (which can include an acoustical sensor or a motion sensor) (and in some instances can also be referred to as an external energy sensor) housed on or within a housing of the device 20 (and optionally or additionally houses external thereto)).
Regarding Claim 8, Steven Goldstein'671 discloses the system outlined in Claim 7 above as well as wherein the external sensor is selected from the group consisting of a humidity sensor, an ambient temperature sensor, a weight sensor, and a sensor disposed on a charging device for the ear-wearable hydration level monitoring system (Paragraph [0113] - An external energy sensor (5A), serving primarily as an environmental sensor, can be any compact sensor for monitoring the external environment in the vicinity of the body, such as, but not limited to, sensors for monitoring: climate, humidity).
Regarding Claim 9, Steven Goldstein'671 discloses the system outlined in Claim 1 above as well as wherein the ear-wearable hydration level monitoring system is configured to process signals of the microphone to detect signs of hydration levels (Paragraph [0072] - The device 1 can include one or more processors 4 that can process a number of acoustic channels and process such channels for situational awareness and/or for keyword or sound pattern recognition, as well as daily speech the user speaks, coughs, sneezes, etc…The sensors can also include transducers or microphones for sensing acoustic information; Paragraph [0135] - an ear canal microphone 39; Paragraph [0163] - In another case, acoustical energy, including ultrasonic energy, can be passed from one earpiece module to the other, with acoustic absorption and reflection being used to gauge various physiological states. For example, this technique can be used to gauge hydration level in the head or brain by estimating the acoustical energy absorption rate and sound velocity through the head of the user).
Regarding Claim 15, Steven Goldstein'671 discloses the system outlined in Claim 1 above as well as wherein the threshold value is dynamically set based on factors including one or more of an ambient temperature, an ambient humidity, and activity levels of a wearer of the system (Paragraph [0046] - The term “exercise plan” refers to a method of planning or regulating physical activity. In many cases, a diet/exercise plan are used together to improve or reduce health; Paragraph [0107] - According to further embodiments of the present invention, a method of monitoring patients, includes collecting physiological and/or environmental information from each patient via a monitoring device associated with each respective patient, and analyzing the collected information to determine caloric intake, health, and physical activity of each patient).
Regarding Claim 16, Steven Goldstein'671 discloses the system outlined in Claim 1 above as well as wherein the ear-wearable hydration level monitoring system is configured to identify drinking events based at least in part on signals from the microphone and sound records associated with drinking (Paragraph [0081] - Furthermore, the earpiece can use the ear canal microphone to obtain heart rate, heart rate signature, blood pressure and other biometric information such as acoustic signatures from chewing or swallowing; Paragraph [0205] - For example, a sound extraction methodology can be used to extract sounds associated with swallowing, and this can give an indication of total food volume consumed).
Regarding Claim 19, Steven Goldstein'671 discloses the system outlined in Claim 1 above as well as further comprising: a first unit, wherein the first unit is configured to be wearable about a first ear; and a second unit, wherein the second unit is configured to be wearable about a second ear; wherein signals are exchanged between the first unit and the second unit (Paragraph [0163] - In another case, acoustical energy, including ultrasonic energy, can be passed from one earpiece module to the other, with acoustic absorption and reflection being used to gauge various physiological states. For example, this technique can be used to gauge hydration level in the head or brain by estimating the acoustical energy absorption rate and sound velocity through the head of the user).
It is noted by the examiner that although Steven Goldstein’671 discloses different embodiments, the features of these embodiments can be used in a single device as stated by Steven Goldstein’671 (Paragraph [0064] - In some embodiments, a system or device 1 as illustrated in FIG. 1A, can be part of an integrated miniaturized earpiece (or other body worn or embedded device) that includes all or a portion of the components shown; Paragraph [0185] - The embodiments described above are not limited to using or incorporating the sensors described therein. Different sensors can be substituted or existing sensors can be used for different purposes; Paragraph [0228] - Although a few exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the teachings and advantages of this invention).
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.
Claims 5-6 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Steven Goldstein'671 (U.S. Patent Publication 20170112671 – previously cited) as applied to Claim 1 above, and further in view of Frank et. al.'306 (U.S. Patent Publication 20200397306 – previously cited).
Regarding Claim 5, Steven Goldstein'671 discloses the system outlined in Claim 1 above, but fails to disclose wherein the clinical symptoms of hydration levels include one or more of the following: rapid shallow breathing, increased pulse, low blood pressure, dizziness, change in voice quality, and increased temperature. Frank et. al.’306 teaches that dehydration levels are related to increased respiratory rate and changes in the voice (Paragraph [0023] - Dehydration is often associated with an increase in the respiratory rate and a decrease in the speed quotient at low pitch phonation). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Steven Goldstein’671 that utilizes acoustics for determining hydration levels to include using data obtained from sensors that record a user’s change in voice quality and increased breathing in order to account for signs of dehydration since dehydration, voice change, and breathing patterns have been associated with one another as seen in Frank et. al.’306.
Regarding Claim 6, Steven Goldstein'671 discloses the system outlined in Claim 5 above as well as a physiological sensor that monitors voice quality through tone and pitch (Paragraph [0112] - A physiological sensor (5A) can be any compact sensor for monitoring the physiological functioning of the body, such as, but not limited to, sensors for monitoring… voice characteristics, tone, pitch). Frank et. al.’306 further teaches that dehydration levels are related to increased respiratory rate and changes in the voice (Paragraph [0023] - utilizes a machine learning based model to calculate, based on the feature values, level of dehydration of the user. Optionally, for generating the feature values based on the audio recordings, the computer extracts features indicative of the user's respiratory rate and vocal changes. Dehydration is often associated with an increase in the respiratory rate and a decrease in the speed quotient at low pitch phonation). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Steven Goldstein’671 that utilizes acoustics for determining hydration levels to include using data obtained from sensors that record a user’s change in voice quality and increased breathing in order to account for signs of dehydration since dehydration, voice change, and breathing patterns have been associated with one another as seen in Frank et. al.’306.
Regarding Claims 11-13, Steven Goldstein'671 discloses the system outlined in Claim 9 above, but fails to disclose wherein the signs of hydration levels include pitch tremor, rapid shallow breathing, or dysphonia. Frank et. al.'306 teaches hydration levels are related to increased respiratory rate and changes in the voice (Paragraph [0023] - Optionally, for generating the feature values based on the audio recordings, the computer extracts features indicative of the user's respiratory rate and vocal changes. Dehydration is often associated with an increase in the respiratory rate and a decrease in the speed quotient at low pitch phonation). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Steven Goldstein’671 that utilizes acoustics for determining hydration levels to include using data obtained from sensors that record a user’s change in voice quality and increased breathing in order to account for signs of dehydration since dehydration, voice change, and breathing patterns have been associated with one another as seen in Frank et. al.’306.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Steven Goldstein'671 (U.S. Patent Publication 20170112671 – previously cited) as applied to Claim 9 above, as evidenced by Harper et. al.'879 (U.S. Patent Publication 20220096318 – previously cited).
Regarding Claim 10, Steven Goldstein'671 discloses the system outlined in Claim 9 above as well as obtaining acoustics resulting from motions/movements of the mouth that could be indicative of hydration levels (Paragraph [0057] - Furthermore, as the ear canal is naturally designed for capturing or harvesting acoustical energy, the ear canal provides an optimal location for monitoring internal sounds, such as heartbeat, breathing rate, and mouth motion). Given that the mouth includes lips, smacking and licking of the lips would be commonly received acoustics when in motion and are reflexes to try and maintain hydration as evidence by Harper et. al.'879 (Paragraph [0131] - reflexive lip smacking movements (common in dry mouth syndrome to maintain hydration)).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Steven Goldstein'671 (U.S. Patent Publication 20170112671 – previously cited) as applied to Claim 16 above, and further in view of Chen et. al.'174 (U.S. Patent Publication 20230355174– previously cited).
Regarding Claim 17, Steven Goldstein'671 discloses the system outlined in Claim 16 above as well as providing alerts to a user if their target levels are outside a threshold (Paragraph [0131] - The communication module may utilize audible or visible alerts if the user is meeting their physiological targets or exceeding safe physiological limits), but fails to disclose wherein the ear-wearable hydration level monitoring system is configured to issue an alert if a number of identified drinking events over a defined time period change by at least a threshold value. Chen et. al.'174 teaches issuing an alert or displaying a message to a user if a number of drinking-related events exceeds a certain threshold (Paragraph [0022] - Various embodiments provide methods executed by a processor of an electronic device for tracking hydration of a user. Various embodiments may determine an amount of liquid consumed by the user based on a predetermined baseline consumption rate for the user and a number of at least one of sips or swallows by the user that are detected by a sensor coupled to the processor in response to determining that a received indication of consumption by the user involves drinking a liquid. In addition, a hydration level of the user may be determined based on the determined amount of liquid consumed; Paragraph [0045] - In addition to determining a current hydration level of a user by estimating the amount of water consumed, the user equipment 110 may be configured to provide feedback to the user 5 through the display 115, such as an alert that may read, “ALERT, You have not consumed enough liquids today, drink some fluids!”). It would have been obvious to have modified the system of Steven Goldstein'671 to include an alert that notifies a user that the number of drinks accounted for a predetermined amount of time it outside a threshold value in order to assist the user in obtaining a more favorable physiological state as seen in Chen et. al.’174.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Steven Goldstein'671 (U.S. Patent Publication 20170112671 – previously cited) as applied to Claim 1 above, and further in view of Devries et. al.'585 (WO Publication 2016038585 – previously cited).
Regarding Claim 20, Steven Goldstein'671 discloses the system outlined in Claim 1 above as well as applying pattern recognition and a variety of algorithms to recorded acoustic sounds that can be used for classifying hydration levels (Paragraph [0072] - For simplicity, local or remote memory, local or remote databases, and features for recording can all be represented by the storage device 7 which can be coupled to an analysis module 7D. As before, the device can be powered by a power source 2. The device 1 can include one or more processors 4 that can process a number of acoustic channels and process such channels for situational awareness and/or for keyword or sound pattern recognition, as well as daily speech the user speaks, coughs, sneezes, etc; Paragraph [0145] - It should be noted that algorithms for processing personal health and environmental data, diagnosing medical conditions, assessing health states, and the like do not need to be limited to the illustrated monitoring system 20. Various algorithms can also be integrated into the wearable sensor module 20 or telecommunication device 6D according to embodiments of the present invention), but fails to disclose wherein the ear-wearable hydration level monitoring system is configured to classify an observed pattern representing signals from the microphone and the sensor package into a scale of hydration levels using a machine learning derived algorithm. Devries et. al.'585 teaches using regression models to classify different levels of hydration (Page 35 Lines 16-21 - In an embodiment, the hydration range category (or "class") can be predicted (either by using a classifier for regression model 206 or by binning the output of regression model 206). For example, normohydration can defined as when rel. OH is between the 10th and the 90th percentile for healthy, age- and gender-matched individuals from the reference population, e.g., between 10th percentile (.sup._7%) to 90th percentile (+7%), while volumes below and above this range can be defined as underhydration and overhydration, respectively). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Steven Goldstein'671 to include organizing different levels of hydration in order to better classify and understand a user’s hydration state as seen in Devries et. al.’585.
Claim 85 is rejected under 35 U.S.C. 103 as being unpatentable over Steven Goldstein'671 (U.S. Patent Publication 20170112671 – previously cited) as applied to Claim 1 above, and further in view of Frank et. al.'306 (U.S. Patent Publication 20200397306 – previously cited).
Regarding Claim 85, Steven Goldstein'671 discloses an ear-wearable hydration level monitoring system (Paragraph [0163] - In another case, acoustical energy, including ultrasonic energy, can be passed from one earpiece module to the other, with acoustic absorption and reflection being used to gauge various physiological states. For example, this technique can be used to gauge hydration level in the head or brain by estimating the acoustical energy absorption rate and sound velocity through the head of the user) comprising:
a control circuit (Paragraph [0041] - The term processor has generally replaced the term central processing unit (CPU) and can further refer to a microprocessor, a digital signal processor, a programmable logic device, an application specific integrated circuit or ASIC or any number of other logic devices);
a microphone, wherein the microphone is in electrical communication with the control circuit (Paragraph [0170] - The end cap 75 encloses a number of components within the main housing 73 including a speaker housing 77 (having a speaker port 77A), an ear canal microphone 77B, a memory 83, a digital signal processor 86, a first ambient microphone 82A, a second ambient microphone 82B, an LED 89 and a flex circuit 88 that couples the various electronic components);
a power supply, wherein the power supply is in electrical communication with the control circuit (Paragraph [0064] - In some embodiments, an fully integrated system or device 1 can include an earpiece having a power source 2 (such as button cell battery, a rechargeable battery, or other power source); Paragraph [0075] - In another example, the processor 4 can control a level of battery charging to optimize charging time or optimize battery life in consideration of other factors such as temperature or safety in view of the rechargeable battery technology used); and
a sensor package, wherein the sensor package is in electrical communication with the control circuit (Paragraph [0063] - The wearable device can include one or more sensors that can optionally include sensors on, embedded within, layered, on the exterior or inside the expandable element or balloon. Sensors can also be operationally coupled to the monitoring device either locally or via wireless communication; Paragraph [0064] - The sensor(s) can also be environmental including, but not limited to, ambient microphones, temperature sensors, humidity sensors, barometric pressure sensors, radiation sensors, volatile chemical sensors, particle detection sensors, or other chemical sensors. The sensors 5 can be directly coupled to the processor 4 or wirelessly coupled via a wireless communication system 6A); wherein the ear-wearable hydration level monitoring system is configured to:
process signals of one or more sensors of the sensor package in order to detect clinical symptoms of hydration levels (Paragraph [0163] - The sensor(s) can also be environmental including, but not limited to, ambient microphones, temperature sensors, humidity sensors, barometric pressure sensors, radiation sensors, volatile chemical sensors, particle detection sensors, or other chemical sensors. The sensors 5 can be directly coupled to the processor 4 or wirelessly coupled via a wireless communication system 6A).
Steven Goldstein'671 fails to disclose wherein the clinical symptoms of hydration levels include one or more of the following: rapid shallow breathing, increased pulse, low blood pressure, dizziness, change in voice quality, and increased temperature. Frank et. al.’306 teaches that dehydration levels are related to increased respiratory rate and changes in the voice (Paragraph [0023] - Dehydration is often associated with an increase in the respiratory rate and a decrease in the speed quotient at low pitch phonation). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Steven Goldstein’671 that utilizes acoustics for determining hydration levels to include using data obtained from sensors that record a user’s change in voice quality and increased breathing in order to account for signs of dehydration since dehydration, voice change, and breathing patterns have been associated with one another as seen in Frank et. al.’306.
Response to Arguments
Applicant's arguments filed 23 March 2026 have been fully considered and they are not entirely persuasive.
Applicant’s arguments regarding the prior drawing objections were found to be persuasive and the examiner has withdrawn the prior drawing objections.
Applicant’s amendments have overcome the prior claim objections.
Applicant’s amendments have overcome some of the prior 35 U.S.C. 112b rejections, but a 112b rejection remains and is addressed in Paragraph 3 above.
Application’s amendments and reasons regarding overcoming the prior 35 U.S.C. 101 rejections were considered, but were found not to be persuasive. The applicant had amended the claims to recite the limitation "issue an alert when hydration level clinical symptoms cross a threshold" as an attempt overcome the Abstract Idea, but as addressed in the Paragraphs above, the examiner notes that this additional limitation is insignificant extra-solution activity. Additionally, the applicant has argued that the limitation “issue an alert when hydration level clinical symptoms cross a threshold” is “an unconventional technical feature”, but this technical feature is not believed to be unconventional given that it does not overcome prior art as recited in Paragraphs 5-9 above. A more detailed analysis of the 101 rejection is in Paragraph 4 above.
Claims 1, 7-9, 15-16, and 19 are rejected under 35 U.S.C. 102 as necessitated by amendments, as discussed in Paragraph 5 above.
Claims 5-6, 10-13, 17, 20, and 85 are rejected under 35 U.S.C. 103 as necessitated by amendments, as discussed in Paragraphs 6-9 above.
The examiner has considered the applicant's arguments regarding Steven Goldstein'671 failing to disclose the limitation “issue an alert when hydration level clinical symptoms cross a threshold value”, but these arguments were found to not be persuasive. It appears that the applicant is arguing that Steven Goldstein'671 discloses physical exertion as the type of “physiological limit” being referred to in Paragraph [0131]. However, it is noted by the examiner that Steven Goldstein'671 is not limited to physical exertion and discloses “physiological information” can include any of the following: breathing rate, blood flow…physical and/or psychological stress levels and/or stress level indicators…position and/or balance…blood pressure as recited in Paragraph [0083] as well as used as a tool to alert a user of any favorable or unfavorable personal health factors in real-time (Paragraph [0132] - Additionally, an entertaining or aggravating sound or song can be used to alert the user to favorable or unfavorable personal health and environmental factors occurring in real-time).
If the applicant intends for an alert to be issued if a clinical symptom threshold value is exceeded and as a result is indicating a hydration level status to a user, the examiner suggests amending the claim to advocate for such.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Myers et. al.'639 (U.S. Patent Publication 20160338639) discloses a wearable device comprising a display indicating hydration-related metrics. Kirenko et. al.'505 (U.S. Patent Publication 20170202505) discloses using first and second combined physiological signals used to indicate levels of hydration. Chase'502 (U.S. Patent Publication 20200253502) discloses a wearable device comprising an alarm and hydration trendline.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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