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 the Claims
The Amendment filed February 6, 2026 has been entered. Claims 1-2, 7-10, 12, and 14-15 have been amended; claims 16-24 are new; and claims 3-6 have been cancelled. Claims 1-2 and 7-24 are currently pending and are examined herein.
Status of the Rejection
Applicant’s amendments to the Claims have overcome each objection previously set forth in the Non-Final Office Action mailed November 6, 2025.
Applicant’s amendments to the Claims have overcome the 35 U.S.C. § 112(b) rejections except claims 13-14 set forth in the previous Non-Final Office Action.
New grounds of claim rejections under 35 U.S.C. § 112(a) and 112(b) are necessitated by the amendment as outlined below.
All 35 U.S.C. § 102 rejections for claims 1-2, 7-9 and 12-15 are maintained and modified in response to amendment as outlined below.
All 35 U.S.C. § 103 rejections for claims 10-11 are maintained and modified in response to amendment as outlined below.
New grounds of rejection for new claims 16-24 under 35 U.S.C. § 102 and under 35 U.S.C. § 103 are necessitated by the amendments as outlined below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2 and 7-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “a second enzyme domain spatially separated from the first enzyme domain and configured to enzymatically interact with ketones to generate ketone measurements”, which is not supported by the specification/drawings. The specification discloses: Other examples of this configuration can include ketone sensing (beta-hydroxybutyrate dehydrogenase electrically coupled enzyme in EZL1 855) and glucose sensing (glucose oxidase in EZL2 856) [para. 0397 in PG-Pub]. Figs. 8C and 8D show a first enzyme domain (856 EZL2) configured to enzymatically interact with glucose to generate glucose measurements; and a second enzyme domain (855 EZL1) configured to enzymatically interact with ketones to generate ketone measurements [para. 0397 in PG-Pub]. However, Figs. 8C-8D show that 856 EZL2 is positioned on 855 EZL1 instead of “spatially separated” from 855 EZL1. Thus, the specification/drawings do not support wherein the second enzyme domain “spatially separated” from the first enzyme domain, recited in the amended claim 1. Therefore, claim 1 and dependent claims 2 and 7-24 are new matters.
Regarding claim 10, amended claim 10 recites “one or more non-analyte sensors physically connected to the sensor electronics module”, which is not supported by the specification/drawings. The specification discloses that the sensor electronics module 204 may also be in wireless communication (e.g., directly or indirectly) with …one or more other non-analyte sensors 206 [para. 0086 in PG-Pub; Fig.2]. Therefore, claim 10 and its dependent claims 11 and 21 are new matters.
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.
Claims 1-2 and 7-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 1, claim 1 recites “a sensor electronics module coupled to the continuous analyte sensor and configured to receive and process the analyte measurements”, and “receive, from the sensor electronics module, the glucose measurements and the ketone measurements”. It is unclear if the analyte measurements refer to one or both of the glucose measurements and the ketone measurements. Furthermore, claim 1 recites “one or more processors configured to execute the executable instructions to process the glucose measurements and the ketone measurements”. If the analyte measurements refer to both the glucose measurements and the ketone measurements, it appears both the sensor electronics module and the one or more processors configured to process the analyte measurements, then it is unclear what is the relationship between the sensor electronics module and the one or more processors since both are configured to process the analyte measurements. Thus, the scope of claim 1 is indefinite. Claims 2 and 7-24 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 1.
Regarding claim 13, claim 13 recites “the user”, which lacks antecedent basis, and it is unclear if it is the same or different than “the patient”. Therefore, the scope of claim 13 is indefinite. Claim 14 is further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of indefinite claim 13.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 7-9, 12-15, 17-20, and 22-24 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Saini et al. (US20180163246A1).
Regarding claim 1, Saini teaches a monitoring system (a system comprising an apparatus for processing data from a test device. The system further comprises a test device comprising a first working electrode having first sensing chemistry for detecting the first analyte; and a second working electrode having second sensing chemistry for detecting the second analyte [para. 0024-0025]; a system comprising a meter 600 [apparatus for processing data from a test device] in Fig.6 and electrochemical test device [para. 0153]), comprising:
a continuous analyte sensor configured to generate analyte measurements associated with analyte levels of a patient (an electrochemical test device for determining concentrations of multiple analytes in a fluid sample [para. 0025]; the electrochemical test device may comprise a continuous monitoring device [para. 0323]; an electrochemical test device in the form of electrochemical test strip 100 [para. 0122]), wherein the continuous analyte sensor comprises:
a first enzyme domain configured to enzymatically interact with glucose to generate glucose measurements ( Reagent layer 460 comprises a glucose oxidase for reacting with glucose in the sample [para. 0141]; the second working electrode 420 may correspond to the second working electrode 118 of Fig.1 [para. 0139]; reagent layer 460 disposed on the second working electrode 118 is deemed as the first enzyme domain configured to enzymatically interact with glucose to generate glucose measurements);
a second enzyme domain spatially separated from the first enzyme domain and configured to enzymatically interact with ketones to generate ketone measurements (Reagent layer 440 comprises suitable reagents for reacting with a ketone in the sample. For example, reagent layer 440 comprises β-hydroxybutyrate dehydrogenase for reacting with β-hydroxybutyrate [para. 0140]; The first working electrode 410 may correspond to the first working electrode 114 of Fig.1 [para. 0139]; Fig.4 shows the respective reagent layers 460/440 applied to the electrodes 420/410 (corresponding to the working electrodes 118/114 in Fig.1) of an electrochemical test device [para. 0139], and the respective reagent layers 460/440 are spatially separated from each other since the workings electrodes 118 and 114 are spatially separated from each other as shown in Fig.1. The Reagent layer 440 is deemed as the second enzyme domain); and
a sensor electronics module (meter 600 in Fig.6 [para. 0153]) coupled to the continuous analyte sensor and configured to receive and process the analyte measurements (a system may comprise an apparatus for processing data from a test device [para. 0024]; a test strip-meter 600 suitable for processing data from one or more electrochemical test devices; and the meter 600 further comprises a port 622 for receiving an electrochemical test device which may be provided with a fluid sample to be analyzed [para.0152-0153]);
a memory comprising executable instructions (a memory 616 in Fig.6 [para. 0153-0154]; The processor 614 is configured to receive data, access the memory 616, and to act upon instructions received either from said memory 616, from communications module 620 or from user input device 612 [para. 0154]; a memory storing instructions [claim 47]; a memory storing instructions to perform a method as disclosed herein [para. 0022]); and
one or more processors ( processor 614 in Fig.6 [para. 0153]) in data communication with the memory and configured to execute the executable instructions ( the processor 614 is configured to receive data, access the memory 616, and to act upon instructions received either from said memory 616, from communications module 620 or from user input device 612 [para. 0154]; a processor which may be configured to perform the instructions stored in the memory [para. 0022]) to:
receive, from the sensor electronics module, the glucose measurements and the ketone measurements (the processor is further configured to control the application of potential differences across electrodes of an electrochemical test device when an electrochemical test device is docked in port 622, to receive output signals, such as transient current data, from the docked electrochemical test device [para. 0154]; an apparatus or test meter for use with a multi-analyte electrochemical test device in order to monitor glucose and ketone levels [para. 0050]);
process the glucose measurements and the ketone measurements to determine analyte metrics including glucose metrics and ketone metrics (the processor is further configured to analyse said received output signals [para. 0154]; the processor may then analyse the first and second output signals to determine a concentration of the first analyte in the blood sample and a concentration of the second analyte in the blood sample [para. 0156]; The processor is configured to determine glucose metrics and ketone metrics based on the determined concentrations of glucose and ketone [Fig.8; para. 0166-0174] and Background Settings [para. 0176-0185], and Table in [para. 0194] shows the determined analyte metrics including both the glucose metrics and ketone metrics based on thresholds of glucose and ketone and glucose and ketone values [para. 0194-0195]); and
generate a treatment recommendation based, at least in part, on the analyte metrics (based on the condition accessed obtained from the analyte metrics [para. 0215-0216], the system will report and advise the user appropriately, as shown in the table of [para. 0217]; the last column in table of [para. 0217] shows a treatment recommendation. Recommendation made by meter in the last column of the table in [para. 0235] also shows a treatment recommendation based on glucose result, ketone result, condition assessed, and whether transient risk was absent, present or not assessed [para. 0224-0229]), wherein the treatment recommendation comprises at least one of a change in dosage of a pharmacologic agent or a change in frequency of administration of the pharmacologic agent (“consider increase in SGLT2 dose” and “consider reduced SGLT2 dose” in the last column of Table of [para. 0235]; enable medication [e.g. insulin, SGLT2 inhibitors, biguanides such as metformin and SGLT2/metformin combinations] to be titrated and dose adjusted and/or dose and time adjusted appropriately to ensure that adverse DKA events or lactic acidosis events can be avoided [para. 0039]).
Regarding claim 2, Saini teaches the monitoring system of claim 1, further comprising one or more electrodes (a second electrode 420 and a first electrode 410 in Fig.4 correspond, respectively to the second working electrode 118 and the first working electrode 114 in Fig.1 [para. 0139]; counter/reference electrode 116 in Fig.1 [para. 0126]) disposed operatively coupled to the first enzyme domain (reagent layer 460 in Fig.4 [para. 0141]) and the second enzyme domain (reagent layer 440 in Fig.4 [para. 0140]), wherein the one or more electrodes comprise at least one working electrode (working electrodes 114/118 corresponding to the electrodes 410/420) and at least one reference electrode (counter/reference electrode 116), and wherein the glucose measurements and the ketone measurements are generated electrochemically at the one or more electrodes based on enzymatic interactions occurring at the first enzyme domain and the second enzyme domain, respectively ( Reagent layer 440 comprises suitable reagents for reacting with a ketone in the sample. For example, reagent layer 440 comprises β-hydroxybutyrate dehydrogenase for reacting with β-hydroxybutyrate, and a cofactor for the β-hydroxybutyrate dehydrogenase such as NAD(P)+ [para. 0140]; Reagent layer 460 comprises a glucose oxidase for reacting with glucose in the sample [para. 0141]).
Regarding claim 7, Saini teaches the monitoring system of claim 1, wherein the pharmacologic agent is an SGLT-2 inhibitor (“consider increase in SGLT2 dose” and “consider reduced SGLT2 dose” in the last column of Table of [para. 0235]; enable medication [e.g. insulin, SGLT2 inhibitors, biguanides such as metformin and SGLT2/metformin combinations] to be titrated and dose adjusted and/or dose and time adjusted appropriately to ensure that adverse DKA events or lactic acidosis events can be avoided [para. 0039]; the SGLT2 inhibitor class of drugs [for example Dapagliflozon, Canagliflozin and Empagliflozin] have recently been licensed for use in diabetes management [para. 0012]) and the treatment recommendation comprises a change in at least the frequency or dosage of the SGLT-2 inhibitor (“consider increase in SGLT2 dose” and “consider reduced SGLT2 dose” in the last column of Table of [para. 0235]; enable medication [e.g. insulin, SGLT2 inhibitors, biguanides such as metformin and SGLT2/metformin combinations] to be titrated and dose adjusted and/or dose and time adjusted appropriately to ensure that adverse DKA events or lactic acidosis events can be avoided [para. 0039]).
Regarding claim 8, Saini teaches the monitoring system of claim 1, wherein the one or more processors are further configured to:
generate a euglycemic diabetic ketoacidosis prediction using the analyte metrics and patient treatment data (The “Condition Assessed” in Table of [para. 0199] is determined based on the ‘Condition Indicated’ along with the background information contained within the meter from initial set up [para. 0197-0200]. The “condition indicated” in Table of [para. 0199] is determined using the analyte metrics of glucose and ketone [para. 0194-0195]; and the background information is received as input by the patient [para. 0176-0185]. Thus, the euglycemic diabetic ketoacidosis prediction as shown in the last column of Table of [para. 0199] is generated using the analyte metrics [to obtain the “condition indicated”] and patient treatment data [the background information from “Background Settings”]).
Regarding claim 9, Saini teaches the monitoring system of claim 8, wherein the one or more processors are further configured to generate an alert or alarm based on at least one of the euglycemic diabetic ketoacidosis prediction or the treatment recommendation (Based on the “condition assessed”, the system will report and advise the user appropriately, see the last column of “Advice to user” in Table of [para. 0217]; a user may be alerted to conditions such as euglycaemic DKA [para. 0021]; alert such as “Are you still taking your SGLT2 correct? Is your dose too high?” in the column of “Recommendation by meter” in Table of [para. 0235 on page 17]).
Regarding claim 12, Saini teaches the monitoring system of claim 1, wherein the one or more processors are further configured to generate a euglycemic diabetic ketoacidosis prediction based, at least in part, on the analyte metrics (The “Condition Assessed” in Table of [para. 0199] is determined based on the ‘Condition Indicated’ along with the background information contained within the meter from initial set up [para. 0197-0199]. The “condition indicated” in Table of [para. 0199] is determined according the analyte metrics of glucose and ketone [para. 0194-0195]. Thus, the euglycemic diabetic ketoacidosis prediction as shown in the last column of Table of [para. 0199] is generated on the basis, at least in part, of the analyte metrics [to obtain the “condition indicated”]).
Regarding claim 13, Saini teaches the monitoring system of claim 12, wherein the euglycemic diabetic ketoacidosis prediction comprises at least one of a likelihood or a risk that the patient is experiencing euglycemic diabetic ketoacidosis, or a severity of euglycemic diabetic ketoacidosis experienced by the patient (risk or severity of euglycemic DKA such as “euglycemic mild DKA risk” and “euglycemic moderate DKA risk” is shown in the column of condition assessed in Table of [para. 0199]).
Regarding claim 14, Saini teaches the monitoring system of claim 13, wherein the euglycemic diabetic ketoacidosis prediction is determined by a rules-based model (“Condition Assessed” Boolean Logic Table [para. 0199]; Boolean Logic is a rules-based model).
Regarding claim 15, Saini teaches the monitoring system of claim 1, wherein the analyte metrics comprise at least one of ketone level maximum, ketone level minimum, ketone trends, or glucose trends (“condition indicated” in Table of [para. 0194] is determined based on thresholds of glucose and ketone values [para. 0194-0195], and glucose and ketone trends [this is achieved by the system looking at the weekly, fortnightly or monthly averages and events logs compared across for example, a 3 week, 6 week or 3 month period, to establish the trends; para. 0225-0233]).
Regarding claim 17, Saini teaches the monitoring system of claim 1, wherein the first enzyme domain and the second enzyme domain are arranged on different regions of a substrate to enable independent sensing of glucose and ketones (first working electrode 114 and second working electrode 118 disposed on the substrate 110 as shown in Fig.1 [para. 0126]; Fig.4 shows the first working electrode 410 may correspond to the first working electrode 114 of Fig.1. Similarly, the second working electrode 420 may correspond to the second working electrode 118 of Fig.1 [para. 0139]. Fig.4 shows the first enzyme domain 460 and the second enzyme domain 440 are arranged on different regions of a substrate [working electrodes 420 and 410 corresponding to the electrodes 118 and 114 disposed on substrate 110 in Fig.1] to enable independent sensing of glucose and ketones [para. 0140-0141]).
Regarding claim 18, Saini teaches the monitoring system of claim 1, wherein the glucose measurements and the ketone measurements are used together to determine the analyte metrics (Table in [para. 0194] shows the determined analyte metrics including both the glucose metrics and ketone metrics based on thresholds of glucose and ketone and glucose and ketone values [para. 0194-0195]).
Regarding claim 19, Saini teaches the monitoring system of claim 1, wherein the analyte metrics comprise one or more trends derived from the glucose measurements and the ketone measurements (The Companion Health Management system creates and maintains a time stamped log of, for example, the following parameters for each test: 1. Glucose result; 2. Ketone result; 3. Condition accessed; 4. 4. Whether transient risk was absent, present or not assessed. Trending and Medication Management with Companion Health Management System; In some examples, this is achieved by the system looking at the weekly, fortnightly or monthly averages and events logs compared across for example, a 3 week, 6 week or 3 month period, to establish the trends [para. 0025-0233]; Table in [para. 0236] shows “Glucose Trend” stable, increasing or decreasing, and “Ketones trending” absent, stable or upwards).
Regarding claim 20, Saini teaches the monitoring system of claim 1, wherein the treatment recommendation is generated based, at least in part, on trends in the glucose measurements and the ketone measurements (Trending and Medication Management with Companion Health Management System; In some examples, this is achieved by the system looking at the weekly, fortnightly or monthly averages and events logs compared across for example, a 3 week, 6 week or 3 month period, to establish the trends, conditions assessed, medications being taken and the risk factors (transient or sustained) present for the individual user [para. 0230-0233]; Table in [para. 0236] shows recommendation made by meter comprising glucose trend, ketones trending, and treatment recommendation such as “consider increase SGLT2 dose”).
Regarding claim 22, Saini teaches the monitoring system of claim 1, wherein the one or more processors are further configured to execute the executable instructions to receive patient treatment data corresponding to the patient (the system is set up initially for the patient a series of ‘Background Settings’, which is received as input by the patient [para. 0176-0185]; for example, (ii) whether the user is prescribed insulin, and optionally the dose taken, the type of insulin [fast acting, long acting, single dose, multiple daily injections, pump user etc], as well as optionally the insulin sensitivity factor of the individual; (iii) whether the user is prescribed SGLT2 medication [and optionally the dose taken]; (iv) whether the user is prescribed metformin or SGLT2 inhibitor metformin combination therapy [para. 0179-0181]), wherein the patient treatment data comprises medication information associated with the pharmacologic agent (whether the user is prescribed SGLT2 inhibitor metformin combination therapy [para. 0181]), and wherein the pharmacologic agent is configured to counteract or affect a risk of euglycemic diabetic ketoacidosis (enable medication [e.g. insulin, SGLT2 inhibitors, biguanides such as metformin and SGLT2/metformin combinations] to be titrated and dose adjusted and/or dose and time adjusted appropriately to ensure that adverse DKA events or lactic acidosis events can be avoided [para. 0039]; thus the prescribed SGLT2 inhibitor is configured to perform the claimed function of counteracting or affecting a risk of euglycemic diabetic ketoacidosis).
Regarding claim 23, Saini teaches the monitoring system of claim 22, wherein the one or more processors are further configured to generate a euglycemic diabetic ketoacidosis prediction using the analyte metrics and the patient treatment data (The “Condition Assessed” in Table of [para. 0199] is determined based on the ‘Condition Indicated’ along with the background information contained within the meter from initial set up [para. 0197-0200]. The “condition indicated” in Table of [para. 0199] is determined using the analyte metrics of glucose and ketone [para. 0194-0195]; and the background information is received as input by the patient [para. 0176-0185]. Thus, the euglycemic diabetic ketoacidosis prediction as shown in the last column of Table of [para. 0199] is generated using the analyte metrics [to obtain the “condition indicated”] and the patient treatment data [the background information from “Background Settings”]).
Regarding claim 24, Saini teaches the monitoring system of claim 1, wherein the continuous analyte sensor further comprises a substrate (a substrate 110 in Fig.1 [para. 0123]), and wherein the first enzyme domain and the second enzyme domain are each disposed on a surface of the substrate (The first working electrode 410 may correspond to the first working electrode 114 of Fig.1 . Similarly, the second working electrode 420 may correspond to the second working electrode 118 of Fig.1 [para. 0139]. Fig.4 shows the first enzyme domain 460 and the second enzyme domain 440 are each disposed on a surface of the substrate [460 is disposed on a surface of the WE 420 corresponding the WE 118 disposed on substrate 110, and 440 is disposed on a surface of the WE 410 corresponding the WE 114 disposed on substrate 110]).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 10-11, 16 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Saini, as applied to claim 1 above, and in view of Hayter et al. (US20240206772A1).
Regarding claim 10, Saini teaches the monitoring system of claim 1, and further teaches wherein the one or more processors are further configured to receive non-analyte sensor data for the patient , wherein the treatment recommendation is further based on the non-analyte sensor data ( the transient risk of DKA will be assessed by the system based on the user's response to on screen prompts such as questions on symptoms. For example, Q3. Have you suffered from nausea, vomiting, abdominal pain, shortness of breath, excessive urination, or mental confusion within the previous 12 hours (Y/N); Q4. Have you been undertaking sustained vigorous exercise/exertion within the previous 3 hours? (Y/N), and determine the ‘transient’ risk of DKA on the basis of user inputs in response to prompts such as questions on symptoms [para. 0200-0209]. Subsequently, determine the treatment recommendation based, in part, on the non-analyte sensor data [Action in Table of [para. 0212] is determined based, in part, on the “transient DKA risk assessed”, which is determined based on the non-analyte sensor data]).
Saini is silent to further comprising one or more non-analyte sensors physically connected to the sensor electronic module, wherein the non-sensor data is generated using the one or more non-analyte sensors.
Hayter teaches systems, devices and methods for dual analyte sensor (title). Fig.3 shows dual analyte sensors 104 and 106, and a sensor control device 102 configured to collect data indicative of multiple physiological measurements, including but not limited to, data indicative of a glucose level, lactate level, ketone level, or heart rate measurement, to name only a few. Sensor 104 can be a dual-analyte sensor configured to sense a glucose level and a concentration of another analyte (e.g., lactate, ketone, etc.) [para. 0066 ]. If other sensor data are collected by the mobile application, such as activity data or heart rate or another analyte sensor data that may help predict high ketone occurrences, a probabilistic model can be made between these data and occurrences of high ketone levels, and the model can be used to predict when high ketones may be likely and an appropriate alert is sent to the patient [para. 0163]. The mobile application may automatically titrate the SGLT-2i dose amount for the patient [para.0164 ], and the mobile application may output a recommendation for an increase in the SGLT-2i dose amount [para. 0165]. The monitoring system must have an activity tracker for providing the sensor data of activity data and a heart rate monitor for providing the sensor data of heart rate. Thus, Hayter teaches a monitoring system comprising a dual analyte sensor comprising a glucose sensor and a ketone sensor, one or more non-analyte sensors such as a activity tracker (for activity data), a heart rate monitor (for heart rate data), and a temperature sensor 257 in Fig.3 [para. 0065] connected to a sensor electronics (sensor electronics 250 in Fig.3), wherein a processor (mobile application processor 224 [para. 0053]) is configured to receive non-analyte sensor data generated for the patient using the one or more non-analyte sensors (other sensor data are collected by the mobile application, such as activity data or heart rate [para. 0163]), wherein the treatment recommendation is further based on the non-analyte sensor data (the mobile application may output a recommendation for an increase in the SGLT-2i dose amount [para. 0165]).
Saini and Hayter are considered analogous art to the claimed invention because they are in the same field of monitoring system for sensing analytes of glucose and ketone of a patient, and automatically generating treatment based on the measurements. Given the teachings of Saini regarding manually collecting the non-analyte sensor data such as exercise/exertion activity data based on the user's response to on screen prompts such as questions on symptoms for further determining the treatment recommendation, and the teachings of Hayter regarding automatically collecting non-analyte sensor data such as activity data and heart rate data from one or more non-analyte sensors which may help predict high ketone occurrences, and automatically generating a treatment recommendation for the patient, 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 monitoring system in Saini by providing one or more non-analyte sensors comprising an activity tracker and a heart rate monitor connected to the sensor electronics module, wherein the one or more processors are further configured to receive non-analyte sensor data such as activity data and heart rate data generated for the patient using the one or more non-analyte sensors, wherein the treatment recommendation is further based on the non-analyte sensor data, as taught by Hayter, since the added one or more non-analyte sensors would automatically provide the non-analyte sensor data such as activity data and heart rate data, which would help predict high ketone occurrences, and accordingly an appropriate alert and treatment recommendation (i.e., change SGLT-2i dose amount) would be sent to the patient [para. 0163-0165 in Hayter]. Furthermore, to provide a mechanical or automatic means to replace manual activity, which accomplishes the same result, is within the ambit of a person of ordinary skill in the art. See In re Venner, 120 USPQ 192 (CCPA 1958) (see MPEP § 2144.04).
Hayter further teaches sensor control device 102 can include multiple discrete sensors, and is configured to collect data indicative of multiple physiological measurements, including but not limited to, data indicative of a glucose level, lactate level, ketone level, or heart rate measurement, to name only a few [para. 0066]. Fig. 3 shows the sensors 104 and 106 are physically connected to the sensor electronics module (sensor electronics 250).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the one or more non-analyte sensors physically connected to the sensor electronics module in the same way as the analyte sensors physically connected to the sensor electronics module, as taught by Hayter, since Hayter teaches the suitable alternative connection between sensor(s) and sensor electronics such that the sensor electronics is configured to collect data indicative of multiple physiological measurements [para. 0066].
Regarding claim 11, modified Saini teaches the monitoring system of claim 10, wherein the one or more non-analyte sensors comprise at least one of a heart rate monitor or an activity tracker (as outlined in the rejection of claim 10 above, modified Saini teaches one or more non-analyte sensors comprising an activity tracker and a heart rate monitor to provide activity data and heart rate data [para. 0163 in Hayter]).
Regarding claim 16, Saini teaches the monitoring system of claim 1, and is silent to wherein the continuous analyte sensor is configured for continuous monitoring of the patient while positioned on or in the patient.
Hayter teaches systems, devices and methods for dual analyte sensor (title). Fig.3 shows dual analyte sensors 104 and 106 [para. 0066 ]. In this embodiment, the in vivo analyte monitoring circuitry is electrically coupled with one or more analyte sensors 104, 106 that extend through an adhesive patch 105 and projects away from housing 103. The sensors may include a blood glucose sensor 104 and a ketone sensor 106. An adhesive patch 105 may include an adhesive layer (not shown) for attachment to a skin surface of the body of the user. Other forms of body attachment to the body may be used, in addition to or instead of adhesive [para. 0040]. In an alternative, embodiments of the present disclosure may be used with dual-sensor systems for continuous or semi-continuous monitoring of different analytes, for example blood glucose and ketone bodies [para. 0026]. Thus, Hayter teaches a monitoring system comprising a dual analyte sensor comprising a glucose sensor and a ketone sensor, wherein the analyte sensor is configured continuous monitoring of the patient while positioned on the patient (attached to a skin surface of the body of the user).
Saini and Hayter are considered analogous art to the claimed invention because they are in the same field of monitoring system for sensing analytes of glucose and ketone of a patient, 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 analyte sensor in Saini such that the glucose and ketone sensors extend through an adhesive path which includes an adhesive layer for attachment to a skin surface of the body of a user, as taught by Hayter, since it would allow to measure analytes of glucose and ketone from user’s bodily fluid [para. 0040-0041 in Hayter].
Regarding claim 21, modified Saini teaches the monitoring system of claim 10, wherein the one or more non-analyte sensors operate in coordination with the sensor electronics module (since the sensor electronics module is configured to receive the non-analyte sensor data [para. 0200-0209 in Saini], and the non-analyte sensor data is generated by the one or more non-analyte sensors, as outlined in the rejection of claim 10 above, the one or more non-analyte sensors operate in coordination with the sensor electronics module such that the sensor electronics module reads/receives the non-analyte sensor data generated by the one or more non-analyte sensors).
Response to Arguments
Applicant's arguments, see Remarks Pgs. 6-9, filed 2/6/2026, with respect to the 35 U.S.C. § 102 and 35 U.S.C. § 103 rejections have been fully considered, but are not persuasive.
Applicant’s Argument #1:
Regarding the 102 rejections, Applicant argues at pages 6-8 that Saini is focused on discrete, sample-based test events using a test strip, in contrast to independent claim 1, which requires a "continuous analyte sensor" including spatially separated glucose and ketone enzyme domains configured to generate glucose and ketone measurements, respectively. Saini's detailed embodiments describe a layered electrochemical test strip that receives a single fluid sample via capillary action, generates transient electrochemical currents, and relies on a test meter to determine an analyte concentration for a discrete test event. Saini does not disclose or suggest a continuous analyte sensor having the claimed multi-domain enzyme architecture, the generation of both glucose measurements and ketone measurements as required by amended claim 1, or the above-noted "receive...," "process...," and "generate..." operations executed by one or more processors. Claims 7-9 and 12-15 depend from independent claim 1, directly or indirectly, and include additional features.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are moot in view of the modified rejection for the amended claim 1 above. Saini does teach a continuous analyte sensor having the claimed multi-domain enzyme architecture, the generation of both glucose measurements and ketone measurements, and the above-noted "receive...," "process...," and "generate..." operations executed by one or more processors, as required by amended claim 1, as outlined in the modified rejection of claim 1 above. The disclosed sensor comprises a continuous monitoring device, and there is further disclosed tracking and trending of measurements using such systems over a prolonged duration [para. 0033]. Thus, the disclosed sensor is a continuous analyte sensor.
Applicant’s Argument #2:
Regarding claims 10-11, Applicant argues at pages 8-9 that Claim 10 as amended herein requires "one or more non-analyte sensors physically connected to the sensor electronics module," and further requires that “the one or more processors" receive "non-analyte sensor data generated for the patient using the one or more non-analyte sensors," such that “the treatment recommendation is further based on the non-analyte sensor data." Nothing in Hayter teaches or suggests that such non-analyte sensor hardware is "physically connected to the sensor electronics module." as required by amended claim 10. Claim 11 depends from claim 10 and is patentable for at least the same reasons.
Examiner’s Response #2:
Applicant’s arguments have been fully considered, but are moot in view of the modified rejection for the amended claim 10 above. Firstly, the instant specification/drawings do not support the amended limitations: one or more non-analyte sensors "physically connected to the sensor electronics module”, as outlined in the rejection under 112(a) above. Secondly, the limitation is further rejected in view of Hayter as outlined in the modified rejection for claim 10 above. Note that Hayter teaches the sensors 104/106 physically connected to the sensor electronics module (sensor electronics 250 in Fig.3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the one or more non-analyte sensors physically connected to the sensor electronics module in the same way as the analyte sensors physically connected to the sensor electronics module, as taught by Hayter, since Hayter teaches the suitable alternative connection between sensor(s) and sensor electronics such that the sensor electronics is configured to collect data indicative of multiple physiological measurements [para. 0066].
Examiner suggests applicant to further amend claim 1 by reciting the detailed structure of EZL1 and EZL2 as shown in Figs. 8C-8D, wherein EZL1 855 for sensing ketone is disposed above both working electrodes WE1 and WE2 and EZL2 856 for glucose sensing is arranged on EZL1 of the working electrode WE2.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIZHI QIAN whose telephone number is (571)272-3487. The examiner can normally be reached Monday-Thursday 8:00 am-5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan V Van can be reached on 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIZHI QIAN/Examiner, Art Unit 1795