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 .
Status of Claims
Applicant's arguments, filed 12/17/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 12/17/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1, 27, and 28.
Applicants have introduced new claim 29
Applicants have left claims 2-4, 10-11, and 13-22 as originally filed/previously presented.
Applicants have canceled/previously cancelled claims 5-9, 12, and 23-26.
Claims 1-4, 10-11, 13-22, and 27-29 are the current claims hereby under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Warnings - Maintained
Applicant is advised that should claim 27 be found allowable, claim 18 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Response to Arguments
Applicant’s arguments filed 12/17/2025 did not address this claim warning. The Examiner cannot find a reason to withdraw it.
Claim Objections - Newly Applied Necessitated by Applicant’s Amendments
Claims 15-16 are objected to because of the following informalities:
Regarding claim 15, line 2 recites “predetermined ranges”, however it appears it should read --the predetermined ranges-- (emphasis added).
Regarding claim 16, line 2 recites “predetermined ranges”, however it appears it should read --the predetermined ranges-- (emphasis added).
Claim Rejections - 35 USC § 112 - Withdrawn
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.
Response to Arguments
Applicant’s arguments, see page 11 of Remarks, filed 12/17/2025, with respect to claims 1-4, 10-11, 13-22, and 27-28 have been fully considered and are persuasive. Applicants have amended the claims, rendering the 112(b) rejections moot. The 112(b) rejection of claims 1-4, 10-11, 13-22, and 27-28 has been withdrawn.
Claim Rejections - 35 USC § 101 - Withdrawn
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.
Response to Arguments
Applicant’s arguments, see pages 11-12 of Remarks, filed 12/17/2025, with respect to the 101 rejection of claims 1-4, 10-11, 13-22, and 27 have been fully considered and are persuasive. Applicants have amended the claims, rendering the 101 rejection moot. The 101 rejection of claims 1-4, 10-11, 13-22, and 27 has been withdrawn.
Claim Rejections - 35 USC § 103 - Maintained and Newly Applied Necessitated by Applicant’s Amendments
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 1-4, 10-11, 13-20, 22, and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Robert Kaleal (Pub. No. US 2017/0206795) (cited in the IDS, filed 06/23/2022) (previously cited), hereinafter referred to as Kaleal, in view of Gratzl et al. (US 2004/0180391 A1) (previously cited), hereinafter referred to as Gratzl, in view of Rack-Gomer et al. (Pub. No. US 2015/0289821) (cited in the IDS, filed 02/24/2021) (previously cited), hereinafter referred to as Rack-Gomer, in view of Mensinger et al. (Pub. No. US 2016/0066843) (previously cited), hereinafter referred to as Mensinger, in view of Brockway et al. (US 20060010090 A1) (previously cited), hereinafter referred to as Brockway.
The claims are generally directed towards a health monitoring system for monitoring health of a living creature, the health monitoring system comprising: an implantable sensor for simultaneously measuring a plurality of metabolism analytes in bodily tissue or bodily fluids of the living creature, thus obtaining a metabolic fingerprint for the living creature comprising concentration information of the plurality of metabolism analytes at any given moment in time; the implantable sensor being configured to measure, over a period of time, multiple times the plurality of metabolism analytes simultaneously; a processor programmed for determining for each of the plurality of metabolism analytes whether the obtained concentration information is within a respective predetermined range, wherein the predetermined ranges are based on previously measured metabolism analyte concentrations obtained from the living creature or from a group of living creatures, and further programmed for detecting trends in the concentration information of the plurality of metabolism analytes measured multiple times over a period of time, and programmed for detecting user dependent correlations between said trends; and an output port for providing output to a user, a medical practitioner or medical team and wherein the health monitoring system is programmed for providing personalized recommendations to the user through the output port based on the detected user dependent correlations between said trends, the health monitoring system being configured for triggering additional measurements of one or more of the plurality of metabolism analytes or to alter a frequency of measurements of one or more of the plurality of metabolism analytes based on the determining for each of the plurality of metabolism analytes whether the obtained concentration information is within the respective predetermined range.
Regarding claim 1, Kaleal discloses a health monitoring system for monitoring health of a living creature (Abstract, “system includes a reception component configured to receive bio-chemical information about a physiological state or condition of a user …”, Fig. 1), the health monitoring system comprising:
an implantable sensor (Fig. 1, element 104, “sensor devices”) for measuring a plurality of metabolism analytes in bodily tissue or bodily fluids of the living creature, thus obtaining a metabolic fingerprint for the living creature comprising concentration information of the plurality of metabolism analytes at any given moment in time (para. [0048], “one or more sensor devices can be worn or otherwise attached to the user to capture the physical and physiological data … in real-time or substantially real-time”, para. [0051], “biosensor device can include a blood-testing device that is implanted into the body … detect biochemical information regarding at least one of: glucose level, cortisol, potassium level … creatine kinase, vitamin B12 … electrolytes …”);
a processor (Fig. 2, element 210 and 212, “processing module” and “analysis component”) programmed for determining for each of the plurality of metabolism analytes whether the obtained concentration information is within a respective predetermined range (para. [0088-0090], “analysis component is configured to analyze raw physical and physiological data for a user to determine or infer feature values corresponding to what the raw physical and physiological data represents … occur in real-time … biometric data, biochemical data ….”, para. [0091], “determine whether and to what degree levels of the respective biomarkers are abnormal (e.g., with respect to predefined values or ranges for normal vs abnormal levels)…”, para. [0093]);
an output port for providing output to a user, a medical practitioner or a medical team and wherein the health monitoring system is programmed for providing personalized recommendations to the user through the output port (Fig. 1, element 106, “client device”, para. [0060], “client device can include avatar platform to provide for processing and analyzing of user’s physical and physiological activity data … various visual and/or audible actions of the avatar generated and displayed at client device …”, para. [0087], “processing module is configured to process various input data received to facilitate guiding and assisting the user with performance of a specific program, routine or task … through an avatar …”).
However, Kaleal does not explicitly disclose the implantable sensor simultaneously measures the plurality of metabolism analytes; and the implantable sensor being configured to measure, over a period of time, multiple times the plurality of metabolism analyte simultaneously.
Gratzl teaches an analogous system of monitoring chemical and biochemical species with a sensor probe (Abstract, para. [0009]). Gratzl further teaches the system and probe are configured to measure, over a period of time, multiple times the plurality of metabolism analyte simultaneously (para. [0010], [0023], [0075-0080], [0089], [0179]). 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 implantable sensor and health monitoring system disclosed by Kaleal to additionally be configured to measure, over a period of time, multiple times the plurality of metabolism analyte simultaneously, as taught by Gratzl. This is because Gratzl teaches simultaneously measuring a plurality of metabolism analytes over a period of time, multiple times, allows for a single probe to obtain multiple different concentrations, while determining a relationship between the concentrations (para. [0023], [0089-0095]).
However, modified Kaleal does not explicitly disclose wherein the predetermined ranges are based on previously measured metabolism analyte concentrations obtained from the living creature or from a group of living creatures.
Rack-Gomer teaches of an analogous system for obtaining several factors in order to determine an urgency index, or range, for a patient (Abstract, para. [0007]). Rack-Gomer teaches a continuous analyte sensor (Fig. 3, element 10) configured to be implanted in the body to measure concentration of analytes within the host, which can include a plurality of analytes (para. [0073], para. [0113], para. [0213]) and user information (para. [0026]). Rack-Gomer teaches that based on a plurality of measurements, an urgency index can be calculated (Fig. 7, element 252, and para. [0140]). Rack-Gomer further teaches the urgency index is based on previously measured metabolism analyte concentrations obtained from the living creature or from a group of living creatures (Fig. 7, element 256, para. [0140-0141], para. [0306-0309]). 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 predetermined ranges taught by modified Kaleal to explicitly be based on previously measured metabolism analyte concentrations obtained from the living creature or from a group of living creatures, as taught by Rack-Gomer. This is because Rack-Gomer teaches that by using historical analyte concentrations, more accurate current trending analyses can be determined for the specific living creature, therefore increasing the accuracy (para. [0140-0141]).
However, modified Kaleal does not explicitly disclose the processor is further programmed for detecting trends in the concentration information of the plurality of metabolism analytes measured multiple times over the period of time, and programmed for detecting user dependent correlations between said trends, and providing personalized recommendations to the user through the output port, based on the detected user dependent correlations between said trends.
Mensinger teaches an analogous system for monitoring health of a living organism (Abstract) by measuring a plurality of metabolism analytes of the living creature with sensors (Fig. 1, element 102, para. [0057], para. [0076], Fig. 2, element 216, para. [0079], Fig. 3). Mensinger further teaches a processor is programmed for detecting trends in the concentration information of the plurality of metabolism analytes measured multiple times over the period of time, and providing personalized recommendations to the user through an output port, based on the detected user dependent correlations between said trends (para. [0063-0064], “therapy recommendations … send alerts, warnings …”, para. [0077], “CGM module processes the inputs … produce one or more outputs … output may be to a trend graph displayed”, trends are calculated for the inputs, para. [0159], “rate of change, trend, and/or directional information”, and para. [0076]). Mensinger further teaches the processor is configured to detect correlations between the trends are determined (para. [0078], “correlative algorithms and/or pattern recognition algorithms may be used to process the various inputs and to provide outputs … correlate and/or identify relationships between the various inputs …”). 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 processor disclosed by modified Kaleal to additionally detect trends in the concentration information of the plurality of metabolism analytes measured multiple times over the period of time and detect user dependent correlations between said trends, as taught by Mensinger. This is because Mensinger teaches that determining trends and correlating the trends, relationships between the inputs can be determined (para. [0078]), which allows for a more informative output than an output solely based on the sensor data (para. [0008]).
However, modified Kaleal does not explicitly disclose the health monitoring system being configured for triggering additional measurements of one or more of the plurality of metabolism analytes or to alter a frequency of measurements of one or more of the plurality of metabolism analytes based on the determining for each of the plurality of metabolism analytes whether the obtained concentration information is within the respective predetermined range.
Brockway teaches of an analogous system of using a plurality of sensors to facilitate diagnosis and medical decision making for a patient (Abstract, Fig. 1, Fig. 2, para. [0011-0012]). Brockway further teaches triggering additional measurements of one or more of the plurality of metabolism analytes or to alter a frequency of measurements of one or more of the plurality of metabolism analytes based on the determining for each of the plurality of metabolism analytes whether the obtained concentration information is within the respective predetermined range (para. [0035], “frequency of monitoring a physiological or device parameter is changed based on an instruction received …”, para. [0063], “data derived from one data source can be used to modify data derived from another sensor … one sensor indicates a particular condition … a threshold value exceeded, then the frequency of data sampling of a particular sensor is adjusted …”). 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 system disclosed by modified Kaleal to additionally be configured for triggering additional measurements of one or more of the plurality of metabolism analytes or to alter a frequency of measurements of one or more of the plurality of metabolism analytes based on the determining for each of the plurality of metabolism analytes whether the obtained concentration information is within the respective predetermined range, as taught by Brockway. This is because Brockway teaches by adjusting a frequency of measurements based on trends, the system can tailor the analysis of the data and reporting of detected conditions (para. [0063]), thereby improving the detecting of patient conditions based on a plurality of sensors.
Regarding claim 2, modified Kaleal discloses the health monitoring system according to claim 1, wherein the processor furthermore is programmed for deriving from said determination a homeostatic and/or alleostatic condition of the living creature (para. [0091], “determine whether and to what degree levels of the respective biomarkers are abnormal … ranges for normal vs abnormal … further determine or infer conditions or disease of the body that are attributed to the abnormal levels of the respective biomarkers …”, para. [0092-0111] - the analysis component is configured to determine a condition of a user based on the determination biomarkers are within or out of a predetermined range).
Regarding claim 3, modified Kaleal discloses the health monitoring system according to claim 1, wherein the plurality of metabolism analytes comprises at least three different metabolism analytes (para. [0089], “biochemical information can include information regarding presence and/or concentration of various biomarkers … biochemical information regarding at least one of: glucose level, cortisol level … creatine kinase, vitamin B12 … electrolytes …”, para. [0091], and para. [0097-0103] - Kaleal discloses the analysis component is configured to analyze levels from a plurality of different biomarkers to obtain a determination about the user’s health).
Regarding claim 4, modified Kaleal discloses the health monitoring system according to claim 1, wherein the plurality of metabolism analytes is a selection of two or more of glucose, ketones, lactate, lactic acid, acetic acid, nitrite, creatinine, hormones, vitamin B11, vitamin B12, acetate, propionic acid, propionate, butyric acid, butyrate, phenyl sulfate, urea, pyruvate, ethanol, sugar, pH, uric acid, lactate dehydrogenase, fasting glucose, sodium, potassium or cholesterol (para. [0051], “biosensor device can include a blood-testing device that is implanted into the body … detect biochemical information regarding at least one of: glucose level, cortisol, potassium level … creatine kinase, vitamin B12 … electrolytes …”, para. [0089], “biochemical information can include information regarding presence and/or concentration of various biomarkers … biochemical information regarding at least one of: glucose level, cortisol level … creatine kinase, vitamin B12 … electrolytes …”, para. [0091], and para. [0097-0103]).
Regarding claim 10, modified Kaleal discloses the health monitoring system according to claim 1, the health monitoring system further comprising an input port for obtaining information regarding one or more physiological parameters of the living creature at the time of measurement of the plurality of metabolism analytes in bodily tissue or bodily fluids of the living creature (para. [0048], “a client device configured to receive and/or capture physical and physiological activity data about the user … sensor devices can be worn or otherwise attached to the user ...”, and para. [00087-0088], “processing module process user physical and physiological information and context information as it is received and in view of user profile information … analyze raw physical and physiological data for a user to determine or infer feature values corresponding to what the raw physical and physiological data represents …”).
Regarding claim 11, modified Kaleal discloses the health monitoring system according to claim 10, wherein the input port of the health monitoring system is configured for receiving the information regarding one or more physiological parameters from a wearable, worn by the living creature (Fig. 1, element 104, “sensor devices”, and para. [0048], “client device configured to receive and/or capture physical and physiological activity data … one or more sensor devices can be worn or otherwise attached to the user …”), or wherein the health monitoring system is configured for receiving user input from a user or for prompting a user for input when one or more of the plurality of metabolism analyte concentrations outside the predetermined range is detected (para. [0074], “received input for a user … determinations and inferences can be made …”, para. [0076], “input can also include profile information … contextual information …”, para. [0149]).
Regarding claim 13, modified Kaleal discloses the health monitoring system according to claim 10, wherein the health monitoring system is configured for deriving from the one or more physiological parameters a stress condition and for identifying that the measured plurality of metabolism analytes are determined under the stress condition (para. [0095], “determine a degree of inflammation experienced by a user … inflammation is a natural reaction to stress …”, para. [0107], para. [0114], “user can select a specific activity or program … stress reduction program …”, para. [0119], para. [0227]).
Regarding claim 14, modified Kaleal discloses the health monitoring system according to claim 1, wherein the health monitoring system comprises an input port for obtaining information regarding one or more of the living creature’s location, hobbies, ethnic background, age, gender, and socio-economical status. (para. [0080-0082], “avatar guidance platform with updated profile information … health history, preferences, demographics … social affiliations … reception component can receive information regarding a user’s location … environment …”, para. [0128], “user demographic information can define … gender, age, nationality …”).
Regarding claim 15, modified Kaleal discloses the health monitoring system according to claim 1.
However, modified Kaleal does not explicitly disclose wherein the processor is configured for comparing with predetermined ranges for the metabolism analyte concentrations, whereby the predetermined ranges are based on previously measured metabolism analyte concentrations from the living creature.
Rack-Gomer further teaches the predetermined ranges are based on previously measured metabolism analyte concentrations from the living creature (Fig. 7, element 256, para. [0140-0141]). 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 system disclosed by modified Kaleal to explicitly use predetermined ranges are based on previously measured metabolism analyte concentrations from the living creature, as taught by Rack-Gomer. This is because Rack-Gomer teaches that by using historical analyte concentrations, more accurate current trending analyses can be determined for the specific living creature, therefore increasing the accuracy (para. [0140-0141]).
Regarding claim 16, modified Kaleal discloses the health monitoring system according to claim 1.
However, modified Kaleal does not explicitly disclose wherein the processor is configured for comparing with predetermined ranges for the metabolism analyte concentrations, whereby the predetermined ranges are based on previously measured plurality of metabolism analytes obtained from a group of living creatures.
Rack-Gomer further teaches that the predetermined ranges are based on previously measured plurality of metabolism analytes obtained from a group of living creatures (Fig. 7, element 256, para. [0140-0141], para. [0306-0309]). 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 system disclosed by modified Kaleal to explicitly use predetermined ranges that are based on previously measured plurality of metabolism analytes obtained from a group of living creatures, as taught by Rack-Gomer. This is because Rack-Gomer teaches that by comparing a plurality of analyte information, trends can be better determined in what the margins should be for the analyte information (para. [0308-0309]), which can be used by the urgency index (para. [0140], “external data”).
Regarding claim 17, modified Kaleal discloses the health monitoring system according to claim 16, wherein the system is adapted for obtaining information regarding to any of gender, age, ethnicity or body mass index (para. [0080-0082], “avatar guidance platform with updated profile information … health history, preferences, demographics … social affiliations … reception component can receive information regarding a user’s location … environment …”, para. [0128], “user demographic information can define … gender, age, nationality …”).
However, modified Kaleal does not explicitly disclose wherein the processor furthermore is configured for comparing with predetermined ranges that are based on previously measured metabolism analyte concentrations obtained from a group of living creatures having a same gender, and/or age.
Rack-Gomer further teaches the collection of analyte information from a plurality of users can be grouped with some similarity, for example, geography, doctor, age, gender, and ethnicity (para. [0308-0309]). 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 system disclosed by modified Kaleal to explicitly group the group of living creatures with similar gender and age, as taught by Rack-Gomer. This is because Rack-Gomer teaches that by comparing analyte concentration information with similar people, more accurate margin of errors are able to be compared for use when determining an urgency index (para. [0308-0309]).
Regarding claim 18, modified Kaleal discloses the health monitoring system according to claim 1.
However, modified Kaleal does not explicitly disclose wherein the implantable sensor comprises an optical sensor configured for spectroscopic measurement of the plurality of metabolism analytes in bodily tissue or bodily fluids and the health monitoring system is configured for deriving the simultaneously measured plurality of metabolism analytes in the bodily tissue or the bodily fluids of the living creature from the same spectroscopic measurement.
Rack-Gomer further teaches that the continuous analyte sensor can be measure the concentration or presence of analytes using a spectroscopic technique with optical absorption (para. [0073], para. [0108], and para. [0120]). Rack-Gomer further teaches the system is configured for deriving the simultaneously measured plurality of metabolism analytes in the bodily tissue or the bodily fluids of the living creature from the same spectroscopic measurement (para. [0104-0105], “measures the glucose concentration ... time intervals …” - a measurement is taken over a period of time, and sampled at a set rate). 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 implantable sensor disclosed by modified Kaleal to explicitly use an implantable sensor with an optical sensor for spectroscopic measurements and the health monitoring system is configured for deriving the simultaneously measured plurality of metabolism analytes in the bodily tissue or the bodily fluids of the living creature from the same spectroscopic measurement, as taught by Rack-Gomer. This is because Rack-Gomer teaches that multiple different sensing techniques are known within the art (para. [0108] and para. [0102]). Further, one of ordinary skill in the art would recognize the sensing technique can be selected based on design incentives and constraints. Further, Rack-Gomer teaches continuous glucose sensing can be performed over a period of time at a set time interval (para. [0105]).
Regarding claim 19, modified Kaleal discloses the health monitoring system according to claim 1.
Kaleal suggests measuring and determining a hydration status (para. [0103], and para. [0119]). However, modified Kaleal does not explicitly disclose the system furthermore comprising an impedance spectroscopy sensor for deriving a hydration status.
Rack-Gomer further teaches the urgency index can be based on physiological data information, such as hydration information (para. [0073], and para. [0182]). Rack-Gomer further teaches that the hydration information can be obtained from a spectroscopy sensor (para. [0073], para. [0108], and para. [0120]). 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 system disclosed by modified Kaleal to additionally determine a hydration status of the patient with an impedance spectroscopy sensor, as taught by Rack-Gomer. This is because Rack-Gomer teaches that a hydration status can be used in addition to the plurality of analyte measurements when determining an urgency index for the patient (para. [0194]).
Regarding claim 20, modified Kaleal discloses a health monitoring platform, the health monitoring platform comprising a plurality of health monitoring systems according to claim 1 for use by a plurality of individual users and the health monitoring platform further comprising a central processing unit for processing metabolic fingerprint information obtained from the plurality of health monitoring systems (para. [0060-0061], “some or all of the processing and analysis of the physical and physiological activity data is performed by a remote avatar server …”, para. [0294], “interference component analyze … for a plurality of user’s … machine learning techniques to optimized determinations regarding how a specific user’s appearance will be affected …”, multiple platforms can be combined and used with machine learning to optimize determinations).
Regarding claim 22, modified Kaleal discloses the health monitoring system according to claim 1, wherein the implantable sensor further comprises one or more of an electrochemical sensing device, an enzymatic sensing device, an electronic impedance sensing device, a resonant electronic circuit sensing device, or an electrical sensing device (para. [0048-0051]).
Regarding claim 27, Kaleal discloses a health monitoring system for monitoring health of a living creature (Abstract, “system includes a reception component configured to receive bio-chemical information about a physiological state or condition of a user …”, Fig. 1), the health monitoring system comprising:
an implantable sensor (Fig. 1, element 104, “sensor devices”) for measuring a plurality of metabolism analytes in bodily tissue or bodily fluids of the living creature, thus obtaining a metabolic fingerprint for the living creature comprising concentration information of the plurality of metabolism analytes at any given moment in time (para. [0048], “one or more sensor devices can be worn or otherwise attached to the user to capture the physical and physiological data … in real-time or substantially real-time”, para. [0051], “biosensor device can include a blood-testing device that is implanted into the body … detect biochemical information regarding at least one of: glucose level, cortisol, potassium level … creatine kinase, vitamin B12 … electrolytes …”);
a processor (Fig. 2, element 210 and 212, “processing module” and “analysis component”) programmed for determining for each of the plurality of metabolism analytes whether the obtained concentration information is within a respective predetermined range (para. [0088-0090], “analysis component is configured to analyze raw physical and physiological data for a user to determine or infer feature values corresponding to what the raw physical and physiological data represents … occur in real-time … biometric data, biochemical data ….”, para. [0091], “determine whether and to what degree levels of the respective biomarkers are abnormal (e.g., with respect to predefined values or ranges for normal vs abnormal levels)…”, para. [0093]);
an output port for providing output to a user, a medical practitioner or a medical team and wherein the health monitoring system is programmed for providing personalized recommendations to the user through the output port (Fig. 1, element 106, “client device”, para. [0060], “client device can include avatar platform to provide for processing and analyzing of user’s physical and physiological activity data … various visual and/or audible actions of the avatar generated and displayed at client device …”, para. [0087], “processing module is configured to process various input data received to facilitate guiding and assisting the user with performance of a specific program, routine or task … through an avatar …”).
However, Kaleal does not explicitly disclose the implantable sensor simultaneously measures the plurality of metabolism analytes; and the implantable sensor being configured to measure, over a period of time, multiple times the plurality of metabolism analyte simultaneously.
Gratzl teaches an analogous system of monitoring chemical and biochemical species with a sensor probe (Abstract, para. [0009]). Gratzl further teaches the system and probe are configured to measure, over a period of time, multiple times the plurality of metabolism analyte simultaneously (para. [0010], [0023], [0075-0080], [0089], [0179]). 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 implantable sensor and health monitoring system disclosed by Kaleal to additionally be configured to measure, over a period of time, multiple times the plurality of metabolism analyte simultaneously, as taught by Gratzl. This is because Gratzl teaches simultaneously measuring a plurality of metabolism analytes over a period of time, multiple times, allows for a single probe to obtain multiple different concentrations, while determining a relationship between the concentrations (para. [0023], [0089-0095]).
However, modified Kaleal does not explicitly disclose wherein the predetermined ranges are based on previously measured metabolism analyte concentrations obtained from the living creature or from a group of living creatures, and wherein the implantable sensor comprises an optical sensor configured for spectroscopic measurement of the plurality of metabolism analytes in the bodily tissue or the bodily fluids and the implantable sensor is configured for deriving the simultaneously measured plurality of metabolism analytes in the bodily tissue or the bodily fluids of the living creature from the same spectroscopic measurement.
Rack-Gomer teaches of an analogous system for obtaining several factors in order to determine an urgency index, or range, for a patient (Abstract, para. [0007]). Rack-Gomer teaches a continuous analyte sensor (Fig. 3, element 10) configured to be implanted in the body to measure concentration of analytes within the host, which can include a plurality of analytes (para. [0073], para. [0113], para. [0213]) and user information (para. [0026]). Rack-Gomer teaches that based on a plurality of measurements, an urgency index can be calculated (Fig. 7, element 252, and para. [0140]). Rack-Gomer further teaches the urgency index is based on previously measured metabolism analyte concentrations obtained from the living creature or from a group of living creatures (Fig. 7, element 256, para. [0140-0141], para. [0306-0309]). Rack-Gomer further teaches that the continuous analyte sensor can be measure the concentration or presence of analytes using a spectroscopic technique with optical absorption (para. [0073], para. [0108], and para. [0120]). Rack-Gomer further teaches the system is configured for deriving the simultaneously measured plurality of metabolism analytes in the bodily tissue or the bodily fluids of the living creature from the same spectroscopic measurement (para. [0104-0105], “measures the glucose concentration ... time intervals …” - a measurement is taken over a period of time, and sampled at a set rate).
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 predetermined ranges taught by modified Kaleal to explicitly be based on previously measured metabolism analyte concentrations obtained from the living creature or from a group of living creatures, as taught by Rack-Gomer. This is because Rack-Gomer teaches that by using historical analyte concentrations, more accurate current trending analyses can be determined for the specific living creature, therefore increasing the accuracy (para. [0140-0141]). It further would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implantable sensor disclosed by modified Kaleal to explicitly use an implantable sensor with an optical sensor for spectroscopic measurements and the health monitoring system is configured for deriving the simultaneously measured plurality of metabolism analytes in the bodily tissue or the bodily fluids of the living creature from the same spectroscopic measurement, as taught by Rack-Gomer. This is because Rack-Gomer teaches that multiple different sensing techniques are known within the art (para. [0108] and para. [0102]). Further, one of ordinary skill in the art would recognize the sensing technique can be selected based on design incentives and constraints. Further, Rack-Gomer teaches continuous glucose sensing can be performed over a period of time at a set time interval (para. [0105]).
However, modified Kaleal does not explicitly disclose the processor is further programmed for detecting trends in the concentration information of the plurality of metabolism analytes measured multiple times over the period of time, and programmed for detecting user dependent correlations between said trends, and providing personalized recommendations to the user through the output port, based on the detected user dependent correlations between said trends.
Mensinger teaches an analogous system for monitoring health of a living organism (Abstract) by measuring a plurality of metabolism analytes of the living creature with sensors (Fig. 1, element 102, para. [0057], para. [0076], Fig. 2, element 216, para. [0079], Fig. 3). Mensinger further teaches a processor is programmed for detecting trends in the concentration information of the plurality of metabolism analytes measured multiple times over the period of time, and providing personalized recommendations to the user through an output port, based on the detected user dependent correlations between said trends (para. [0063-0064], “therapy recommendations … send alerts, warnings …”, para. [0077], “CGM module processes the inputs … produce one or more outputs … output may be to a trend graph displayed”, trends are calculated for the inputs, para. [0159], “rate of change, trend, and/or directional information”, and para. [0076]). Mensinger further teaches the processor is configured to detect correlations between the trends are determined (para. [0078], “correlative algorithms and/or pattern recognition algorithms may be used to process the various inputs and to provide outputs … correlate and/or identify relationships between the various inputs …”). 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 processor disclosed by modified Kaleal to additionally detect trends in the concentration information of the plurality of metabolism analytes measured multiple times over the period of time and detect user dependent correlations between said trends, as taught by Mensinger. This is because Mensinger teaches that determining trends and correlating the trends, relationships between the inputs can be determined (para. [0078]), which allows for a more informative output than an output solely based on the sensor data (para. [0008]).
However, modified Kaleal does not explicitly disclose the health monitoring system being configured for triggering additional measurements of one or more of the plurality of metabolism analytes or to alter a frequency of measurements of one or more of the plurality of metabolism analytes based on the determining for each of the plurality of metabolism analytes whether the obtained concentration information is within the respective predetermined range.
Brockway teaches of an analogous system of using a plurality of sensors to facilitate diagnosis and medical decision making for a patient (Abstract, Fig. 1, Fig. 2, para. [0011-0012]). Brockway further teaches triggering additional measurements of one or more of the plurality of metabolism analytes or to alter a frequency of measurements of one or more of the plurality of metabolism analytes based on the determining for each of the plurality of metabolism analytes whether the obtained concentration information is within the respective predetermined range (para. [0035], “frequency of monitoring a physiological or device parameter is changed based on an instruction received …”, para. [0063], “data derived from one data source can be used to modify data derived from another sensor … one sensor indicates a particular condition … a threshold value exceeded, then the frequency of data sampling of a particular sensor is adjusted …”). 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 system disclosed by modified Kaleal to additionally be configured for triggering additional measurements of one or more of the plurality of metabolism analytes or to alter a frequency of measurements of one or more of the plurality of metabolism analytes based on the determining for each of the plurality of metabolism analytes whether the obtained concentration information is within the respective predetermined range, as taught by Brockway. This is because Brockway teaches by adjusting a frequency of measurements based on trends, the system can tailor the analysis of the data and reporting of detected conditions (para. [0063]), thereby improving the detecting of patient conditions based on a plurality of sensors.
Regarding claim 28, Kaleal discloses a health monitoring system for monitoring health of a living creature (Abstract, “system includes a reception component configured to receive bio-chemical information about a physiological state or condition of a user …”, Fig. 1), the health monitoring system comprising:
an implantable sensor (Fig. 1, element 104, “sensor devices”) for measuring a plurality of metabolism analytes in bodily tissue or bodily fluids of the living creature, thus obtaining a metabolic fingerprint for the living creature comprising concentration information of the plurality of metabolism analytes at any given moment in time (para. [0048], “one or more sensor devices can be worn or otherwise attached to the user to capture the physical and physiological data … in real-time or substantially real-time”, para. [0051], “biosensor device can include a blood-testing device that is implanted into the body … detect biochemical information regarding at least one of: glucose level, cortisol, potassium level … creatine kinase, vitamin B12 … electrolytes …”);
a processor (Fig. 2, element 210 and 212, “processing module” and “analysis component”) programmed for determining for each of the plurality of metabolism analytes whether the obtained concentration information is within a respective predetermined range (para. [0088-0090], “analysis component is configured to analyze raw physical and physiological data for a user to determine or infer feature values corresponding to what the raw physical and physiological data represents … occur in real-time … biometric data, biochemical data ….”, para. [0091], “determine whether and to what degree levels of the respective biomarkers are abnormal (e.g., with respect to predefined values or ranges for normal vs abnormal levels)…”, para. [0093]);
an output port for providing output to a user, a medical practitioner or a medical team and wherein the health monitoring system is programmed for providing personalized recommendations to the user through the output port (Fig. 1, element 106, “client device”, para. [0060], “client device can include avatar platform to provide for processing and analyzing of user’s physical and physiological activity data … various visual and/or audible actions of the avatar generated and displayed at client device …”, para. [0087], “processing module is configured to process various input data received to facilitate guiding and assisting the user with performance of a specific program, routine or task … through an avatar …”).
However, Kaleal does not explicitly disclose the implantable sensor simultaneously measures the plurality of metabolism analytes; and the implantable sensor being configured to measure, over a period of time, multiple times the plurality of metabolism analyte simultaneously.
Gratzl teaches an analogous system of monitoring chemical and biochemical species with a sensor probe (Abstract, para. [0009]). Gratzl further teaches the system and probe are configured to measure, over a period of time, multiple times the plurality of metabolism analyte simultaneously (para. [0010], [0023], [0075-0080], [0089], [0179]). 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 implantable sensor and health monitoring system disclosed by Kaleal to additionally be configured to measure, over a period of time, multiple times the plurality of metabolism analyte simultaneously, as taught by Gratzl. This is because Gratzl teaches simultaneously measuring a plurality of metabolism analytes over a period of time, multiple times, allows for a single probe to obtain multiple different concentrations, while determining a relationship between the concentrations (para. [0023], [0089-0095]).
However, modified Kaleal does not explicitly disclose wherein the predetermined ranges are based on previously measured metabolism analyte concentrations obtained from the living creature or from a group of living creatures.
Rack-Gomer teaches of an analogous system for obtaining several factors in order to determine an urgency index, or range, for a patient (Abstract, para. [0007]). Rack-Gomer teaches a continuous analyte sensor (Fig. 3, element 10) configured to be implanted in the body to measure concentration of analytes within the host, which can include a plurality of analytes (para. [0073], para. [0113], para. [0213]) and user information (para. [0026]). Rack-Gomer teaches that based on a plurality of measurements, an urgency index can be calculated (Fig. 7, element 252, and para. [0140]). Rack-Gomer further teaches the urgency index is based on previously measured metabolism analyte concentrations obtained from the living creature or from a group of living creatures (Fig. 7, element 256, para. [0140-0141], para. [0306-0309]). 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 predetermined ranges taught by modified Kaleal to explicitly be based on previously measured metabolism analyte concentrations obtained from the living creature or from a group of living creatures, as taught by Rack-Gomer. This is because Rack-Gomer teaches that by using historical analyte concentrations, more accurate current trending analyses can be determined for the specific living creature, therefore increasing the accuracy (para. [0140-0141]).
However, modified Kaleal does not explicitly disclose the processor is further programmed for detecting trends in the concentration information of the plurality of metabolism analytes measured multiple times over the period of time, and programmed for detecting user dependent correlations between said trends, and providing personalized recommendations to the user through the output port, based on the detected user dependent correlations between said trends.
Mensinger teaches an analogous system for monitoring health of a living organism (Abstract) by measuring a plurality of metabolism analytes of the living creature with sensors (Fig. 1, element 102, para. [0057], para. [0076], Fig. 2, element 216, para. [0079], Fig. 3). Mensinger further teaches a processor is programmed for detecting trends in the concentration information of the plurality of metabolism analytes measured multiple times over the period of time, and providing personalized recommendations to the user through an output port, based on the detected user dependent correlations between said trends (para. [0063-0064], “therapy recommendations … send alerts, warnings …”, para. [0077], “CGM module processes the inputs … produce one or more outputs … output may be to a trend graph displayed”, trends are calculated for the inputs, para. [0159], “rate of change, trend, and/or directional information”, and para. [0076]). Mensinger further teaches the processor is configured to detect correlations between the trends are determined (para. [0078], “correlative algorithms and/or pattern recognition algorithms may be used to process the various inputs and to provide outputs … correlate and/or identify relationships between the various inputs …”). 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 processor disclosed by modified Kaleal to additionally detect trends in the concentration information of the plurality of metabolism analytes measured multiple times over the period of time and detect user dependent correlations between said trends, as taught by Mensinger. This is because Mensinger teaches that determining trends and correlating the trends, relationships between the inputs can be determined (para. [0078]), which allows for a more informative output than an output solely based on the sensor data (para. [0008]).
However, modified Kaleal does not explicitly disclose the health monitoring system being configured for triggering additional measurements of one or more of the plurality of metabolism analytes or to alter a frequency of measurements of one or more of the plurality of metabolism analytes based on the detected user dependent correlations between said trends.
Brockway teaches of an analogous system of using a plurality of sensors to facilitate diagnosis and medical decision making for a patient (Abstract, Fig. 1, Fig. 2, para. [0011-0012]). Brockway further teaches triggering additionally measurements of a sensor or to alter a frequency of measurements of a sensor based on the detected user dependent correlations between said trends (para. [0035], “frequency of monitoring a physiological or device parameter is changed based on an instruction received …”, para. [0063], “data derived from one data source can be used to modify data derived from another sensor … one sensor indicates a particular condition … a threshold value exceeded, then the frequency of data sampling of a particular sensor is adjusted …”). 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 system disclosed by modified Kaleal to additionally be configured for triggering additional measurements of one or more of the plurality of metabolism analytes or to alter a frequency of measurements of one or more of the plurality of metabolism analytes based on the detected user dependent correlations between said trends, as taught by Brockway. This is because Brockway teaches by adjusting a frequency of measurements based on trends, the system can tailor the analysis of the data and reporting of detected conditions (para. [0063]), thereby improving the detecting of patient conditions based on a plurality of sensors.
Regarding claim 29, modified Kaleal discloses the health monitoring system according to claim 28.
However, modified Kaleal does not explicitly disclose wherein the implantable sensor comprises an optical sensor configured for spectroscopic measurement of the plurality of metabolism analytes in the bodily tissue or the bodily fluids and the implantable sensor is configured for deriving the simultaneously measured plurality of metabolism analytes in the bodily tissue or the bodily fluids of the living creature from the same spectroscopic measurement.
Rack-Gomer further teaches that the continuous analyte sensor can be measure the concentration or presence of analytes using a spectroscopic technique with optical absorption (para. [0073], para. [0108], and para. [0120]). Rack-Gomer further teaches the implantable sensor is configured for deriving the simultaneously measured plurality of metabolism analytes in the bodily tissue or the bodily fluids of the living creature from the same spectroscopic measurement (para. [0104-0105], “measures the glucose concentration ... time intervals …” - a measurement is taken over a period of time, and sampled at a set rate). 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 implantable sensor disclosed by modified Kaleal to explicitly use an implantable sensor with an optical sensor for spectroscopic measurements and the implantable sensor is configured for deriving the simultaneously measured plurality of metabolism analytes in the bodily tissue or the bodily fluids of the living creature from the same spectroscopic measurement, as taught by Rack-Gomer. This is because Rack-Gomer teaches that multiple different sensing techniques are known within the art (para. [0108] and para. [0102]). Further, one of ordinary skill in the art would recognize the sensing technique can be selected based on design incentives and constraints. Further, Rack-Gomer teaches continuous glucose sensing can be performed over a period of time at a set time interval (para. [0105]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Robert Kaleal (Pub. No. US 2017/0206795) (cited in the IDS, filed 06/23/2022) (previously cited), hereinafter referred to as Kaleal, in view of Gratzl et al. (US 2004/0180391 A1) (previously cited), hereinafter referred to as Gratzl, in view of Rack-Gomer et al. (Pub. No. US 2015/0289821) (cited in the IDS, filed 02/24/2021) (previously cited), hereinafter referred to as Rack-Gomer, in view of Mensinger et al. (Pub. No. US 2016/0066843) (previously cited), hereinafter referred to as Mensinger, in view of Brockway et al. (US 20060010090 A1) (previously cited), hereinafter referred to as Brockway as applied to claim 1 above, and further in view of Crawshaw et al. (“Ethanol, Body Temperature, and Thermoregulation”) (previously cited 02/23/2024), hereinafter referred to as Crawshaw, and Green et al. (“The Influence of Intravenous Glucose on Body Temperature”) (previously cited 02/23/2024), hereinafter referred to as Green.
Regarding claim 21, modified Kaleal discloses the health monitoring system according to claim 1.
However, modified Kaleal does not explicitly disclose wherein the processor is further configured for determining body temperature from the measurement of the plurality of metabolism analytes.
Crawshaw teaches that an ethanol concentration effects the body temperature (pg. 150, Mechanism of Action of Ethanol, “ethanol administration led to decreases in body temperature”, Fig. 2).
Green teaches that different concentrations of glucose or mannitol causes effects on the core and skin temperature (pg. 465, Introduction, pg. 470-471, Body temperature, “core temperature decreased … after the start of glucose infusion”).
Therefore, 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 processor disclosed by modified Kaleal to additionally determine body temperature from the measurement of the plurality of metabolism analytes, as taught by Crawshaw and Green. This is because Crawshaw and Green teach that different metabolism analytes, such as ethanol and glucose, cause effects on the body, such as a body temperature. One of ordinary skill in the art would recognize that a body temperature can be measured based on a change in the metabolism analytes without the need of an additional temperature sensor, reducing the cost of the system.
Response to Arguments
Applicant's arguments filed 12/17/2025 have been fully considered but they are not persuasive.
Applicants have argued on pages 12-15 of Remarks, filed 12/17/2025, that “Nothing in … Rack-Gomer teaches or suggests that casual chain, per-analyte selectivity, or the use of ranges that are “based on previously measured metabolism-analyte concentrations obtained from the living creature or from a group of living creatures”’.
The Examiner respectfully disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Specifically, Kaleal in view of Gratzl teaches simultaneously measuring a plurality of metabolism analytes and determining if the plurality of metabolism analytes are within a predetermined range (see the rejection of the independent claims above). Rack-Gomer is introduced to teach that predetermined ranges for comparisons and determinations can be based on previously measured metabolism analyte concentrations obtained from the living creature or from a group of living creatures (see the rejection of the independent claims above). Further, Brockway is introduced to teach triggering additional measurements or altering a frequency of measurements based on a determination (see the rejection of the independent claims above). That is, the combination of references teach the elements of the independent claims.
Applicants have argued on pages 15-16 of Remarks, filed 12/17/2025, that “Brockway neither teaches triggering additional measurements of one or more of the plurality of metabolism analytes or to alter a frequency of measurements of one or more of the plurality of metabolism analytes based on the determining for each of the plurality of metabolism analytes whether the obtained concentration is within the respective predetermined range”, and on page 19 of Remarks, filed 12/17/2025, that “Brockway does not disclose or suggest the claimed use of “user-dependent correlations between said trends” to trigger additional measurements or alter measurement frequency”.
The Examiner respectfully disagrees. Brockway explicitly teaches “if one sensor indicates a particular condition may be present, or a threshold value is exceeded, then the frequency of data sampling of a particular sensor is adjusted” (Brockway, para. [0063]). Further, see the response to arguments above regarding the combination of references.
Conclusion
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.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791