DETAILED ACTION
Applicant’s arguments, filed on 01/28/2026, 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 on 01/28/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-5, 7-12, 14-16, 18-36, 38-40, and 42-57 are pending wherein claims 1-5, 7-12, 14-16, and 18-29 are withdrawn, therefore claims 30-36, 38-40, and 42-57 are the current claims hereby under examination.
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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 30-36, 38-40, 42-51 and 53-57 are rejected under 35 U.S.C. 103 as being unpatentable over Xu (WO 2020086934) in view of Mears (US 20160047771) and Weinstock (US 20190295700).
Regarding independent claim 30, Xu teaches a glucose monitoring system ([0018]: “The present disclosure generally describes methods, devices, and systems for determining physiological parameters related to the kinetics of red blood cell glycation, elimination, and generation and reticulocyte maturation within the body of a subject. Such physiological parameters can be used, for example, to calculate a more reliable calculated HbA1c and/or a personalized target glucose range, among other things.”) comprising:
a sensor control device comprising an analyte sensor coupled with sensor electronics ([0168]: “The in vivo analyte monitoring system 860 comprises a sensor control device 862 (which may be at least a portion of the glucose monitor 324 of FIG. 3) and a reader device 864 (which may be at least a portion of the health monitoring device 320 of FIG. 3) that communicate with each other over a local communication path”), the sensor control device configured to transmit data indicative of an analyte level of a subject ([0166]: “the in vivo analyte monitoring system may only produce output signals that correspond to glucose levels”); and
a reader device ([0168]: “The in vivo analyte monitoring system 860 comprises a sensor control device 862 (which may be at least a portion of the glucose monitor 324 of FIG. 3) and a reader device 864”) comprising:
a wireless communication circuitry configured to receive the data indicative of the analyte level and a glycated hemoglobin level for the subject ([0168]: “The in vivo analyte monitoring system 860 comprises a sensor control device 862 (which may be at least a portion of the glucose monitor 324 of FIG. 3) and a reader device 864 (which may be at least a portion of the health monitoring device 320 of FIG. 3) that communicate with each other over a local communication path (or link) 866, which can be wired or wireless” Abstract: “A method of calculating at least one physiological parameter using a reticulocyte production index (RPI) value including: measuring a plurality of first glucose levels over a first time period; measuring a first glycated hemoglobin”);
a non-transitory memory; at least one processor communicatively coupled to the non-transitory memory and the analyte sensor and configured to ([0194]: “a system comprising: an analyte sensor configured to measure a glucose level in a bodily fluid; and a monitoring device comprising: one or more processors; and a memory operatively coupled to the one or more processors and having instructions stored thereon”; [0069]: “A "machine-readable medium", as the term is used herein, includes any mechanism that can store information in a form accessible by a machine (a machine may be, for example, a computer, network device, cellular phone, personal digital assistant (PDA), manufacturing tool, any device with one or more processors, and the like). For example, a machine-accessible medium includes recordable/non- recordable media (e.g., read-only memory (ROM), random access memory (RAM), magnetic disk storage media, optical storage media, flash memory devices, and the like).”):
determine an apparent glycation value for the subject ([0187]: “determining (e.g., calculating) at least one physiological parameter selected from the group consisting of: … an apparent glycation constant (K)”), wherein the apparent glycation value represents a subject-specific relationship between a hemoglobin glycation rate (
k
g
l
y
) for the subject and a red blood cell elimination value (
k
a
g
e
) for the subject ([0025]: “Equation 3 defines the apparent glycation constant K (typically with units of dL/mg) as the ratio of
k
g
l
y
and
k
a
g
e
”. The apparent glycation constant is subject-specific, as it is dependent on the values of
k
g
l
y
and
k
a
g
e
, which are calculated for the specific subject.);
calculate a plurality of personalized glucose metrics for the subject using a physiological parameter and at least one of the received data indicative of the analyte level or the received glycated hemoglobin level ([0068]: “the instructions include receiving inputs 216 (e.g., one or more RPI values, one or more glucose levels, one or more HbA1c levels, one or more physiological parameters (k.sub.giy, k.sub.age, and/or K) previously determined, or more other subject-specific parameters, and/or one or more times associated with any of the foregoing), determining outputs 218 (e.g., one or more physiological parameters (k.sub.giy, k.sub.age, and/or K), an error associated with the one or more physiological parameters, one or more parameters or characteristics for a subject's personalized diabetes management (e.g., cHbA1c, a personalized-target glucose range, an average-target glucose level, a supplement or medication dosage, among other parameters or characteristics), a matched group of participants, and the like), and communicating the outputs”. The outputs 218 are the plurality of personalized glucose metrics, the physiological parameter is included in the inputs 216, the received data indicative of the analyte level is the glucose levels, and the received glycated hemoglobin level is the one or more HbA1c level.), wherein the physiological parameter includes the apparent glycation value that is specific to the subject, such that the plurality of personalized glucose metrics are scaled according to the apparent glycation value and such that identical analyte levels for different subjects correspond to different personalized glucose metrics for those different subjects (The inputs 216 includes the K value (the apparent glycation value), and the K value is subject-specific, therefore the plurality of personalized glucose metrics that are calculated from the K value will be different for different subjects.); and
display, on a display of the reader device ([0068]: “communication of the inputs 216 may be via a user-interface (which may be part of a display)”), a report comprising a plurality of interfaces including the calculated plurality of personalized glucose metrics, which are scaled according to the apparent glycation value, and at least one or more of: (i) the received data indicative of the analyte level or (ii) the received glycated hemoglobin level ([0098]: “a personalized-target glucose range report that may be generated as an output 218 by a physiological parameter analysis system 211 of the present disclosure. The illustrated example report includes a plot of glucose level over a day relative to the foregoing personalized-target glucose range (area between the dashed lines). Alternatively, other reports may include, but are not limited to, an ambulatory glucose profile (AGP) plot, a numeric display of the personalized-target glucose range with the most recent glucose level measurement, and the like, and any combination thereof.” [0087]: “a cHbA1c report that may be generated as an output 218 by a physiological parameter analysis system 211 of the present disclosure. The illustrated example report includes a plot of average glucose level over time. Also included on the report are the most recently measured RPI value (open circle), the most recently measured HbA1c level (cross), and cHbA1c levels (asterisks) calculated by the physiological parameter analysis system 211.”. The different plots are the plurality of interfaces.).
However, Xu does not teach at least one of the plurality of interfaces includes a comparison using the received data indicative of the analyte level with the plurality of personalized glucose metrics, at least another one of the plurality of interfaces includes a comparison using the received data indicative of the analyte level without the plurality of personalized glucose metrics.
Mears discloses a blood glucose meter. Specifically, Mears teaches at least one of the plurality of interfaces includes a comparison using the received data indicative of the analyte level with the plurality of personalized glucose metrics and at least another one of the plurality of interfaces includes a comparison using the received data indicative of the analyte level without the plurality of personalized glucose metrics ([0018]: “The current blood glucose measurement is compared to a standard target glucose range such as 70 mg/dL to about 160 mg/dL or a personalized target glucose range based upon the specific characteristics and therapy for the person with diabetes”). Xu and Mears are analogous arts as they both relate to monitoring glucose of a user and displaying the result.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the multiple comparisons from Mears into the system from Xu as it allows the device to display the measured data in different formats, which can provide more information to the user and create a more detailed analysis.
However, the Xu/Mears combination does not teach the plurality of interfaces comprising the report are dynamically selected and presented based on a user type.
Weinstock discloses a system for managing patient data including glucose levels of a patient. Specifically, Weinstock teaches the plurality of interfaces comprising the report are dynamically selected and presented based on a determined type of a user who is accessing the report ([0057]-[0058]: “The term “patient life medical record (PLMR)” is used herein to refer to a completed PLMT that has been saved on the patient's smartphone and/or elsewhere. The term “physician patient medical record (PPMR)” is used herein to refer to a completed PPMT that has been digitally signed by a physician. The PPMR may be saved to the patient's PLMR and/or the physician's database.”; [0083]: “the records circuitry 212 may generate a first record (e.g., PLMR), based on the first template (e.g., PLMT), the first patient data. In some embodiments, the records circuitry 212 may generate a second record (e.g., PPMR), based on the second template (e.g., PPMT) and the second patient data”; [0099]: “The PLMR comprises patient personal medical data. PPMTs may be unique to the physician's medical specialty and used to record the patient's examination, tests, diagnosis and treatment procedures”. The system has different reports for different user types, wherein one report type is the PLMR, which is accessed when the patient is the user type, and another report type is the PPMR, which is accessed when the physician is the user type. The different record types are determined based on the type of user accessing the report and selects the patient data (the plurality of interfaces) to display based on this user type.). Xu, Mears, and Weinstock are analogous arts as they both relate to determining patient’s health parameters by analyzing and managing patient data.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the plurality of interfaces based on user type from Weinstock into the system from the Xu/Mears combination, as it allows multiple users to have access to the data. Both the patient and their healthcare provider or others can access the patient’s data with different data available depending on the user.
The Xu/Mears/Weinstock combination teaches such that when the user is determined to be classified as belonging to a first user type, the report includes a first combination of interfaces that include the comparison using the received data indicative of the analyte level with the plurality of personalized glucose metrics, and when the user is determined to be classified as belonging to a second user type, the report includes a second combination of interfaces that include the comparison using the received data indicative of the analyte level without the plurality of personalized glucose metrics (Mears, [0018]: “The current blood glucose measurement is compared to a standard target glucose range such as 70 mg/dL to about 160 mg/dL or a personalized target glucose range based upon the specific characteristics and therapy for the person with diabetes”; Weinstock, [0057]-[0058]: “The term “patient life medical record (PLMR)” is used herein to refer to a completed PLMT that has been saved on the patient's smartphone and/or elsewhere. The term “physician patient medical record (PPMR)” is used herein to refer to a completed PPMT that has been digitally signed by a physician. The PPMR may be saved to the patient's PLMR and/or the physician's database.”; [0083]: “the records circuitry 212 may generate a first record (e.g., PLMR), based on the first template (e.g., PLMT), the first patient data. In some embodiments, the records circuitry 212 may generate a second record (e.g., PPMR), based on the second template (e.g., PPMT) and the second patient data”; [0099]: “The PLMR comprises patient personal medical data. PPMTs may be unique to the physician's medical specialty and used to record the patient's examination, tests, diagnosis and treatment procedures”. The system has different reports for different user types, wherein one report type is the PLMR, which is accessed when the patient is the user type, and another report type is the PPMR, which is accessed when the physician is the user type. The different record types are determined based on the type of user accessing the report and selects the patient data (the plurality of interfaces) to display based on this user type.. The two different types of interfaces from Mears can be selected, and Weinstock discloses showing different interfaces for different user types.).
Regarding claim 31, the Xu/Mears/Weinstock combination teaches the system of claim 30, wherein the plurality of personalized glucose metrics includes one or more of an adjusted Ale, a calculated Ale, an adjusted calculated Ale, a personalized glucose, a personalized average glucose, or a personalized time in range (Xu, [0008]: “FIG. 4 illustrates an example of a calculated HbA1c (eHbA1c) report that may be generated as an output by a physiological parameter analysis system”; [0011]: “FIG. 6 illustrates an example of a personalized-target average glucose report that may be generated as an output by a physiological parameter analysis system”; [0096]: “A desired intracellular glucose range 532 (e.g., the currently accepted glucose range) having a lower limit 534 and an upper limit 536 can be personalized using one or more determined physiological parameters”).
Regarding claim 32, the Xu/Mears/Weinstock combination teaches the system of claim 31, wherein the at least one processor is further configured to calculate a plurality of personalized glucose targets corresponding to the calculated plurality of personalized glucose metrics (Xu, [0011]: “FIG. 6 illustrates an example of a personalized-target average glucose report that may be generated as an output by a physiological parameter analysis system”).
Regarding claim 33, the Xu/Mears/Weinstock combination teaches the system of claim 32, wherein the plurality of interfaces further includes the plurality of personalized glucose targets (Xu, [0011]: “FIG. 6 illustrates an example of a personalized-target average glucose report that may be generated as an output by a physiological parameter analysis system”).
Regarding claim 34, the Xu/Mears/Weinstock combination teaches the system of claim 32, wherein the plurality of personalized glucose targets includes one or more of a target glucose range or a target average glucose (Xu, [0011]: “FIG. 6 illustrates an example of a personalized-target average glucose report that may be generated as an output by a physiological parameter analysis system”; [0096]: “A desired intracellular glucose range 532 (e.g., the currently accepted glucose range) having a lower limit 534 and an upper limit 536 can be personalized using one or more determined physiological parameters”).
Regarding claim 35, the Xu/Mears/Weinstock combination teaches the system of claim 34, wherein the personalized target glucose range includes a personalized lower glucose limit (Xu, [0096]: “A desired intracellular glucose range 532 (e.g., the currently accepted glucose range) having a lower limit 534 and an upper limit 536 can be personalized using one or more determined physiological parameters”).
Regarding claim 36, the Xu/Mears/Weinstock combination teaches the system of claim 34, wherein the personalized target glucose range includes a personalized upper glucose limit (Xu, [0096]: “A desired intracellular glucose range 532 (e.g., the currently accepted glucose range) having a lower limit 534 and an upper limit 536 can be personalized using one or more determined physiological parameters”).
Regarding claim 38, the Xu/Mears/Weinstock combination teaches the system of claim 30, wherein the plurality of interfaces further includes the physiological parameter for the subject (Xu, Fig. 11 shows K values on the plot (one of the plurality of interfaces)).
Regarding claim 39, the Xu/Mears/Weinstock combination teaches the system of claim 30, wherein the first or second type of the user includes a health care professional (Weinstock, [0058]: “The term “physician patient medical record (PPMR)” is used herein to refer to a completed PPMT that has been digitally signed by a physician. The PPMR may be saved to the patient's PLMR and/or the physician's database.”; [0083]: “the records circuitry 212 may generate a first record (e.g., PLMR), based on the first template (e.g., PLMT), the first patient data. In some embodiments, the records circuitry 212 may generate a second record (e.g., PPMR), based on the second template (e.g., PPMT) and the second patient data”; [0099]: “The PLMR comprises patient personal medical data. PPMTs may be unique to the physician's medical specialty and used to record the patient's examination, tests, diagnosis and treatment procedures”. The system has different reports for different user types, wherein one report type is the PLMR, which is accessed when the patient is the user type, and another report type is the PPMR, which is accessed when the physician is the user type. The different record types are determined based on the type of user accessing the report and selects the patient data (the plurality of interfaces) to display based on this user type.).
Regarding claim 40, the Xu/Mears/Weinstock combination teaches the system of claim 39, wherein the plurality of interfaces includes a glucose monitoring data interface, a glycated hemoglobin interface, a personalized A1c interface, a personalized glucose interface, a personalized average glucose, and a personalized time in range interface (Xu, [0098]: “a personalized-target glucose range report that may be generated as an output 218 by a physiological parameter analysis system 211 of the present disclosure. The illustrated example report includes a plot of glucose level over a day relative to the foregoing personalized-target glucose range (area between the dashed lines). Alternatively, other reports may include, but are not limited to, an ambulatory glucose profile (AGP) plot, a numeric display of the personalized-target glucose range with the most recent glucose level measurement, and the like, and any combination thereof.”; [0087]: “a cHbA1c report that may be generated as an output 218 by a physiological parameter analysis system 211 of the present disclosure. The illustrated example report includes a plot of average glucose level over time. Also included on the report are the most recently measured RPI value (open circle), the most recently measured HbA1c level (cross), and cHbA1c levels (asterisks) calculated by the physiological parameter analysis system 211.”; Fig. 5B shows the glucose monitoring data interface, Fig. 9A shows a glycated hemoglobin interface, Fig. 9C shows the personalized A1c interface, Fig. 7 shows a personalized glucose interface, Fig. 6 shows the personalized average glucose interface, and Fig. 1 shows the personalized time in range interface.).
Regarding claim 42, the Xu/Mears/Weinstock combination teaches the system of claim 30, wherein the plurality of interfaces includes a glucose monitoring data interface, a glycated hemoglobin interface, a mean glucose interface, and a time in range interface (Xu, [0098]: “a personalized-target glucose range report that may be generated as an output 218 by a physiological parameter analysis system 211 of the present disclosure. The illustrated example report includes a plot of glucose level over a day relative to the foregoing personalized-target glucose range (area between the dashed lines). Alternatively, other reports may include, but are not limited to, an ambulatory glucose profile (AGP) plot, a numeric display of the personalized-target glucose range with the most recent glucose level measurement, and the like, and any combination thereof.”; [0087]: “a cHbA1c report that may be generated as an output 218 by a physiological parameter analysis system 211 of the present disclosure. The illustrated example report includes a plot of average glucose level over time. Also included on the report are the most recently measured RPI value (open circle), the most recently measured HbA1c level (cross), and cHbA1c levels (asterisks) calculated by the physiological parameter analysis system 211.”; Fig. 5B shows the glucose monitoring data interface, Fig. 9A shows a glycated hemoglobin interface, Fig. 6 shows the mean glucose interface, and Fig. 1 shows the time in range interface.).
Regarding claim 43, the Xu/Mears/Weinstock combination teaches the system of claim 30, wherein the plurality of interfaces comprising the report are predetermined based on the type of the user (Weinstock, [0057]-[0058]: “The term “patient life medical record (PLMR)” is used herein to refer to a completed PLMT that has been saved on the patient's smartphone and/or elsewhere. The term “physician patient medical record (PPMR)” is used herein to refer to a completed PPMT that has been digitally signed by a physician. The PPMR may be saved to the patient's PLMR and/or the physician's database.”; [0083]: “the records circuitry 212 may generate a first record (e.g., PLMR), based on the first template (e.g., PLMT), the first patient data. In some embodiments, the records circuitry 212 may generate a second record (e.g., PPMR), based on the second template (e.g., PPMT) and the second patient data”; [0099]: “The PLMR comprises patient personal medical data. PPMTs may be unique to the physician's medical specialty and used to record the patient's examination, tests, diagnosis and treatment procedures”. The system has different reports for different user types, wherein one report type is the PLMR, which is accessed when the patient is the user type, and another report type is the PPMR, which is accessed when the physician is the user type. The different record types are determined based on the type of user accessing the report and selects the patient data (the plurality of interfaces) to display based on this user type.).
Regarding claim 44, the Xu/Mears/Weinstock combination teaches the system of claim 30.
However, the Xu/Mears/Weinstock combination does not teach wherein the plurality of interfaces comprising the report can be selected by the user.
Weinstock teaches wherein the plurality of interfaces comprising the report can be selected by the user ([0034]: “The physician may use the ViewDock application to select which section of the electronic index to view.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the user being capable of selecting the interface from Weinstock into the system from the Xu/Mears/Weinstock combination as it allows the user to choose which piece of information to look at, allowing them to see many different pieces of data and choose which one to look at when they need it.
Regarding claim 45, the Xu/Mears/Weinstock combination teaches the system of claim 33, wherein the at least one processor is further configured to output a notification if at least one of the plurality of personalized glucose metrics is at or above the corresponding plurality of personalized glucose target (Xu, [0180]: “Reader device 864 can display the measured biometric data wirelessly received from sensor control device 862 and can also be configured to output alarms (e.g., a visual alarm on a display, an auditory alarm, or a combination thereof), alert notifications, glucose levels, etc., which may be visual, audible, tactile, or any combination thereof.”; Claim 24: “display an alarm when a glucose level from the plurality of second glucose levels is outside the glucose level target.”).
Regarding claim 46, the Xu/Mears/Weinstock combination teaches the system of claim 45, wherein the notification comprises a visual notification (Xu, [0180]: “Reader device 864 can display the measured biometric data wirelessly received from sensor control device 862 and can also be configured to output alarms (e.g., a visual alarm on a display, an auditory alarm, or a combination thereof), alert notifications, glucose levels, etc., which may be visual, audible, tactile, or any combination thereof.”).
Regarding claim 47, the Xu/Mears/Weinstock combination teaches the system of claim 45, wherein the notification comprises an audio notification (Xu, [0180]: “Reader device 864 can display the measured biometric data wirelessly received from sensor control device 862 and can also be configured to output alarms (e.g., a visual alarm on a display, an auditory alarm, or a combination thereof), alert notifications, glucose levels, etc., which may be visual, audible, tactile, or any combination thereof.”).
Regarding claim 48, the Xu/Mears/Weinstock combination teaches the system of claim 45, wherein the notification is an alarm (Xu, [0180]: “Reader device 864 can display the measured biometric data wirelessly received from sensor control device 862 and can also be configured to output alarms (e.g., a visual alarm on a display, an auditory alarm, or a combination thereof), alert notifications, glucose levels, etc., which may be visual, audible, tactile, or any combination thereof.”).
Regarding claim 49, the Xu/Mears/Weinstock combination teaches the system of claim 45, wherein the notification is a prompt for the subject to take an action (Xu, [0114]: “a subject triage report may simply display the suggested course(s) of action.”).
Regarding claim 50, the Xu/Mears/Weinstock combination teaches the system of claim 30, wherein the reader device wirelessly receives the glycated hemoglobin level for the subject from an electronic medical records system (Xu, [0084]: “HbA1c levels may be measured with a laboratory test where the results are input to the server/cloud 328, the subject interface 320A, and/or a display from the testing entity, a medical professional, the subject, or other user. Then, the HbA1c levels may be received by the one or more of health monitoring device 320, server/cloud 328, and data processing terminal/PC 326 for analysis”).
Regarding claim 51, the Xu/Mears/Weinstock combination teaches the system of claim 30, wherein the reader device wirelessly receives the glycated hemoglobin level for the subject from a cloud-based database (Xu, [0084]: “HbA1c levels may be measured with a laboratory test where the results are input to the server/cloud 328, the subject interface 320A, and/or a display from the testing entity, a medical professional, the subject, or other user. Then, the HbA1c levels may be received by the one or more of health monitoring device 320, server/cloud 328, and data processing terminal/PC 326 for analysis”).
Regarding claim 53, the Xu/Mears/Weinstock combination teaches the system of claim 30, wherein the reader device wirelessly receives the glycated hemoglobin level for the subject from a home test kit (Xu, [0036]: “glucose data collected with ad hoc adjunctive measurements (e.g., a finger stick and test strip) can also be present”).
Regarding claim 54, the Xu/Mears/Weinstock combination teaches the system of claim 30, wherein the wireless communication circuitry is configured to receive the data indicative of the analyte level according to a wireless protocol including at least one: a near field wireless communication protocol, a low energy near field wireless communication protocol, Near-Field Communication, or Radio Frequency Identification protocol (Xu, [0074]: “While the health monitoring device 320, the data processing terminal/PC 326, and the glucose monitor 324 are illustrated as each operatively coupled to the data network 322 for communication to/from the server/cloud 328, one or more of the health monitoring device 320, the data processing terminal/PC 326, and the glucose monitor 324 can be programmed or configured to directly communicate with the server/cloud 328, bypassing the data network 322. The mode of communication between the health monitoring device 320, the data processing terminal/PC 326, the glucose monitor 324, and the data network 322 includes one or more wireless communication, wired communication, RF communication, BLUETOOTH® communication, WiFi data communication, radio frequency identification (RFID) enabled communication, ZIGBEE® communication, or any other suitable data communication protocol, and that optionally supports data encryption/decryption, data compression, data decompression and the like.”).
Regarding claim 55, the Xu/Mears/Weinstock combination teaches the glucose monitoring system of claim 30, wherein the selection and presentation of the interfaces are automatically adapted by the system according to the type of the user (Weinstock, [0057]-[0058]: “The term “patient life medical record (PLMR)” is used herein to refer to a completed PLMT that has been saved on the patient's smartphone and/or elsewhere. The term “physician patient medical record (PPMR)” is used herein to refer to a completed PPMT that has been digitally signed by a physician. The PPMR may be saved to the patient's PLMR and/or the physician's database.”; [0083]: “the records circuitry 212 may generate a first record (e.g., PLMR), based on the first template (e.g., PLMT), the first patient data. In some embodiments, the records circuitry 212 may generate a second record (e.g., PPMR), based on the second template (e.g., PPMT) and the second patient data”; [0099]: “The PLMR comprises patient personal medical data. PPMTs may be unique to the physician's medical specialty and used to record the patient's examination, tests, diagnosis and treatment procedures”. The system has different reports for different user types, wherein one report type is the PLMR, which is accessed when the patient is the user type, and another report type is the PPMR, which is accessed when the physician is the user type. The different record types are determined based on the type of user accessing the report and selects the patient data (the plurality of interfaces) to display based on this user type.).
Regarding independent claim 56, Xu teaches a method ([0018]: “The present disclosure generally describes methods, devices, and systems for determining physiological parameters related to the kinetics of red blood cell glycation, elimination, and generation and reticulocyte maturation within the body of a subject. Such physiological parameters can be used, for example, to calculate a more reliable calculated HbA1c and/or a personalized target glucose range, among other things.”) comprising:
determining an apparent glycation value for a subject ([0187]: “determining (e.g., calculating) at least one physiological parameter selected from the group consisting of: … an apparent glycation constant (K)”), wherein the apparent glycation value represents a subject-specific relationship between a hemoglobin glycation rate (
k
g
l
y
) for the subject and a red blood cell elimination value (
k
a
g
e
) for the subject ([0025]: “Equation 3 defines the apparent glycation constant K (typically with units of dL/mg) as the ratio of
k
g
l
y
and
k
a
g
e
”. The apparent glycation constant is subject-specific, as it is dependent on the values of
k
g
l
y
and
k
a
g
e
, which are calculated for the specific subject.);
calculating a plurality of personalized glucose metrics for the subject using a physiological parameter and at least one of an analyte level of the subject or a received glycated hemoglobin level of the subject ([0068]: “the instructions include receiving inputs 216 (e.g., one or more RPI values, one or more glucose levels, one or more HbA1c levels, one or more physiological parameters (k.sub.giy, k.sub.age, and/or K) previously determined, or more other subject-specific parameters, and/or one or more times associated with any of the foregoing), determining outputs 218 (e.g., one or more physiological parameters (k.sub.giy, k.sub.age, and/or K), an error associated with the one or more physiological parameters, one or more parameters or characteristics for a subject's personalized diabetes management (e.g., cHbA1c, a personalized-target glucose range, an average-target glucose level, a supplement or medication dosage, among other parameters or characteristics), a matched group of participants, and the like), and communicating the outputs”. The outputs 218 are the plurality of personalized glucose metrics, the physiological parameter is included in the inputs 216, the received data indicative of the analyte level is the glucose levels, and the received glycated hemoglobin level is the one or more HbA1c level.), wherein the physiological parameter includes the apparent glycation value that is specific to the subject, such that the plurality of personalized glucose metrics are scaled according to the apparent glycation value and such that identical analyte levels for different subjects correspond to different personalized glucose metrics for those different subjects (The inputs 216 includes the K value (the apparent glycation value), and the K value is subject-specific, therefore the plurality of personalized glucose metrics that are calculated from the K value will be different for different subjects.); and
displaying a report comprising a plurality of interfaces that includes the calculated plurality of personalized glucose metrics for the subject and one or more of: (i) the analyte level of the subject or (ii) the received glycated hemoglobin level of the subject ([0098]: “a personalized-target glucose range report that may be generated as an output 218 by a physiological parameter analysis system 211 of the present disclosure. The illustrated example report includes a plot of glucose level over a day relative to the foregoing personalized-target glucose range (area between the dashed lines). Alternatively, other reports may include, but are not limited to, an ambulatory glucose profile (AGP) plot, a numeric display of the personalized-target glucose range with the most recent glucose level measurement, and the like, and any combination thereof.” [0087]: “a cHbA1c report that may be generated as an output 218 by a physiological parameter analysis system 211 of the present disclosure. The illustrated example report includes a plot of average glucose level over time. Also included on the report are the most recently measured RPI value (open circle), the most recently measured HbA1c level (cross), and cHbA1c levels (asterisks) calculated by the physiological parameter analysis system 211.”. The different plots are the plurality of interfaces.).
However, Xu does not teach at least one of the plurality of interfaces includes a comparison using the received data indicative of the analyte level with the plurality of personalized glucose metrics, at least another one of the plurality of interfaces includes a comparison using the received data indicative of the analyte level without the plurality of personalized glucose metrics.
Mears discloses a blood glucose meter. Specifically, Mears teaches at least one of the plurality of interfaces includes a comparison using the analyte level with the plurality of personalized glucose metrics and at least another one of the plurality of interfaces includes a comparison using the analyte level without the plurality of personalized glucose metrics ([0018]: “The current blood glucose measurement is compared to a standard target glucose range such as 70 mg/dL to about 160 mg/dL or a personalized target glucose range based upon the specific characteristics and therapy for the person with diabetes”). Xu and Mears are analogous arts as they both relate to monitoring glucose of a user and displaying the result.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the multiple comparisons from Mears into the system from Xu as it allows the device to display the measured data in different formats, which can provide more information to the user and create a more detailed analysis.
However, the Xu/Mears combination does not teach the plurality of interfaces comprising the report are dynamically selected and presented based on a user type.
Weinstock discloses a system for managing patient data including glucose levels of a patient. Specifically, Weinstock teaches the plurality of interfaces forming the report are dynamically selected and presented based on a determined type of a user who is accessing the report ([0057]-[0058]: “The term “patient life medical record (PLMR)” is used herein to refer to a completed PLMT that has been saved on the patient's smartphone and/or elsewhere. The term “physician patient medical record (PPMR)” is used herein to refer to a completed PPMT that has been digitally signed by a physician. The PPMR may be saved to the patient's PLMR and/or the physician's database.”; [0083]: “the records circuitry 212 may generate a first record (e.g., PLMR), based on the first template (e.g., PLMT), the first patient data. In some embodiments, the records circuitry 212 may generate a second record (e.g., PPMR), based on the second template (e.g., PPMT) and the second patient data”; [0099]: “The PLMR comprises patient personal medical data. PPMTs may be unique to the physician's medical specialty and used to record the patient's examination, tests, diagnosis and treatment procedures”. The system has different reports for different user types, wherein one report type is the PLMR, which is accessed when the patient is the user type, and another report type is the PPMR, which is accessed when the physician is the user type. The different record types are determined based on the type of user accessing the report and selects the patient data (the plurality of interfaces) to display based on this user type.). Xu, Mears, and Weinstock are analogous arts as they both relate to determining patient’s health parameters by analyzing and managing patient data.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the plurality of interfaces based on user type from Weinstock into the system from the Xu/Mears combination, as it allows multiple users to have access to the data. Both the patient and their healthcare provider or others can access the patient’s data with different data available depending on the user.
The Xu/Mears/Weinstock combination teaches such that when the user is determined to be classified as belonging to a first user type, the report includes a first combination of interfaces that include the comparison using the analyte level with the plurality of personalized glucose metrics, and when the user is determined to be classified as belonging to a second user type, the report includes a second combination of interfaces that include the comparison using the analyte level without the plurality of personalized glucose metrics (Mears, [0018]: “The current blood glucose measurement is compared to a standard target glucose range such as 70 mg/dL to about 160 mg/dL or a personalized target glucose range based upon the specific characteristics and therapy for the person with diabetes”; Weinstock, [0057]-[0058]: “The term “patient life medical record (PLMR)” is used herein to refer to a completed PLMT that has been saved on the patient's smartphone and/or elsewhere. The term “physician patient medical record (PPMR)” is used herein to refer to a completed PPMT that has been digitally signed by a physician. The PPMR may be saved to the patient's PLMR and/or the physician's database.”. The two different types of interfaces from Mears can be selected, and Weinstock discloses showing different interfaces for different user types.).
Regarding independent claim 57, Xu teaches one or more hardware storage devices that store instructions that are executable by one or more processors to cause the one or more processors to ([0067]: “The physiological parameter analysis system 211 includes one or more processors 212 and one or more machine-readable storage media 214. The one or more machine-readable storage media 214 contains a set of instructions for performing a physiological parameter analysis routine, which are executed by the one or more processors 212.”):
determine an apparent glycation value for a subject ([0187]: “determining (e.g., calculating) at least one physiological parameter selected from the group consisting of: … an apparent glycation constant (K)”), wherein the apparent glycation value represents a subject-specific relationship between a hemoglobin glycation rate (
k
g
l
y
) for the subject and a red blood cell elimination value (
k
a
g
e
) for the subject ([0025]: “Equation 3 defines the apparent glycation constant K (typically with units of dL/mg) as the ratio of
k
g
l
y
and
k
a
g
e
”. The apparent glycation constant is subject-specific, as it is dependent on the values of
k
g
l
y
and
k
a
g
e
, which are calculated for the specific subject.);
calculate a plurality of personalized glucose metrics for the subject using a physiological parameter and at least one of an analyte level of the subject or a received glycated hemoglobin level of the subject ([0068]: “the instructions include receiving inputs 216 (e.g., one or more RPI values, one or more glucose levels, one or more HbA1c levels, one or more physiological parameters (k.sub.giy, k.sub.age, and/or K) previously determined, or more other subject-specific parameters, and/or one or more times associated with any of the foregoing), determining outputs 218 (e.g., one or more physiological parameters (k.sub.giy, k.sub.age, and/or K), an error associated with the one or more physiological parameters, one or more parameters or characteristics for a subject's personalized diabetes management (e.g., cHbA1c, a personalized-target glucose range, an average-target glucose level, a supplement or medication dosage, among other parameters or characteristics), a matched group of participants, and the like), and communicating the outputs”. The outputs 218 are the plurality of personalized glucose metrics, the physiological parameter is included in the inputs 216, the received data indicative of the analyte level is the glucose levels, and the received glycated hemoglobin level is the one or more HbA1c level.), wherein the physiological parameter includes the apparent glycation value that is specific to the subject, such that the plurality of personalized glucose metrics are scaled according to the apparent glycation value and such that identical analyte levels for different subjects correspond to different personalized glucose metrics for those different subjects (The inputs 216 includes the K value (the apparent glycation value), and the K value is subject-specific, therefore the plurality of personalized glucose metrics that are calculated from the K value will be different for different subjects.); and
display a report comprising a plurality of interfaces that includes the calculated plurality of personalized glucose metrics for the subject and one or more of: (i) the analyte level of the subject or (ii) the received glycated hemoglobin level of the subject ([0098]: “a personalized-target glucose range report that may be generated as an output 218 by a physiological parameter analysis system 211 of the present disclosure. The illustrated example report includes a plot of glucose level over a day relative to the foregoing personalized-target glucose range (area between the dashed lines). Alternatively, other reports may include, but are not limited to, an ambulatory glucose profile (AGP) plot, a numeric display of the personalized-target glucose range with the most recent glucose level measurement, and the like, and any combination thereof.” [0087]: “a cHbA1c report that may be generated as an output 218 by a physiological parameter analysis system 211 of the present disclosure. The illustrated example report includes a plot of average glucose level over time. Also included on the report are the most recently measured RPI value (open circle), the most recently measured HbA1c level (cross), and cHbA1c levels (asterisks) calculated by the physiological parameter analysis system 211.”. The different plots are the plurality of interfaces.).
However, Xu does not teach at least one of the plurality of interfaces includes a comparison using the received data indicative of the analyte level with the plurality of personalized glucose metrics, at least another one of the plurality of interfaces includes a comparison using the received data indicative of the analyte level without the plurality of personalized glucose metrics.
Mears discloses a blood glucose meter. Specifically, Mears teaches at least one of the plurality of interfaces includes a comparison using the analyte level with the plurality of personalized glucose metrics and at least another one of the plurality of interfaces includes a comparison using the analyte level without the plurality of personalized glucose metrics ([0018]: “The current blood glucose measurement is compared to a standard target glucose range such as 70 mg/dL to about 160 mg/dL or a personalized target glucose range based upon the specific characteristics and therapy for the person with diabetes”). Xu and Mears are analogous arts as they both relate to monitoring glucose of a user and displaying the result.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the multiple comparisons from Mears into the system from Xu as it allows the device to display the measured data in different formats, which can provide more information to the user and create a more detailed analysis.
However, the Xu/Mears combination does not teach the plurality of interfaces comprising the report are dynamically selected and presented based on a user type.
Weinstock discloses a system for managing patient data including glucose levels of a patient. Specifically, Weinstock teaches the plurality of interfaces forming the report are dynamically selected and presented based on a determined type of a user who is accessing the report ([0057]-[0058]: “The term “patient life medical record (PLMR)” is used herein to refer to a completed PLMT that has been saved on the patient's smartphone and/or elsewhere. The term “physician patient medical record (PPMR)” is used herein to refer to a completed PPMT that has been digitally signed by a physician. The PPMR may be saved to the patient's PLMR and/or the physician's database.”; [0083]: “the records circuitry 212 may generate a first record (e.g., PLMR), based on the first template (e.g., PLMT), the first patient data. In some embodiments, the records circuitry 212 may generate a second record (e.g., PPMR), based on the second template (e.g., PPMT) and the second patient data”; [0099]: “The PLMR comprises patient personal medical data. PPMTs may be unique to the physician's medical specialty and used to record the patient's examination, tests, diagnosis and treatment procedures”. The system has different reports for different user types, wherein one report type is the PLMR, which is accessed when the patient is the user type, and another report type is the PPMR, which is accessed when the physician is the user type. The different record types are determined based on the type of user accessing the report and selects the patient data (the plurality of interfaces) to display based on this user type.). Xu, Mears, and Weinstock are analogous arts as they both relate to determining patient’s health parameters by analyzing and managing patient data.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the plurality of interfaces based on user type from Weinstock into the system from the Xu/Mears combination, as it allows multiple users to have access to the data. Both the patient and their healthcare provider or others can access the patient’s data with different data available depending on the user.
The Xu/Mears/Weinstock combination teaches such that when the user is determined to be classified as belonging to a first user type, the report includes a first combination of interfaces that include the comparison using the analyte level with the plurality of personalized glucose metrics, and when the user is determined to be classified as belonging to a second user type, the report includes a second combination of interfaces that include the comparison using the analyte level without the plurality of personalized glucose metrics (Mears, [0018]: “The current blood glucose measurement is compared to a standard target glucose range such as 70 mg/dL to about 160 mg/dL or a personalized target glucose range based upon the specific characteristics and therapy for the person with diabetes”; Weinstock, [0057]-[0058]: “The term “patient life medical record (PLMR)” is used herein to refer to a completed PLMT that has been saved on the patient's smartphone and/or elsewhere. The term “physician patient medical record (PPMR)” is used herein to refer to a completed PPMT that has been digitally signed by a physician. The PPMR may be saved to the patient's PLMR and/or the physician's database.”. The two different types of interfaces from Mears can be selected, and Weinstock discloses showing different interfaces for different user types.).
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over the Xu/Mears/Weinstock combination as applied to claim 30 above, and further in view of KR 640 (KR 102559640). Citations to KR 102559640 will refer to the English Machine Translation that accompanies this Office Action.
Regarding claim 52, the Xu/Mears/Weinstock combination teaches the system of claim 30.
However, the Xu/Mears/Weinstock combination does not teach wherein the reader device wirelessly receives the glycated hemoglobin level for the user from a QR code.
KR 640 discloses a blood glucose measurement system. Specifically, KR 640 teaches wherein the reader device wirelessly receives the glycated hemoglobin level for the subject from a QR code ([0038]: “Code information is information regarding a code that indicates patient information and/or
prescription information, and can be implemented visually as a two-dimensional shape in the
form of, for example, a barcode or a QR (Quick Response) code”). Xu, Mears, Weinstock, and KR 640 are analogous arts as they all relate to determining patient’s health parameters by analyzing and managing patient data.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include receiving information from a QR code from KR 640 into the system from the Xu/Mears/Weinstock combination as it allows for an easy way to transfer information in the form of a QR code, where the system can simply scan the QR code and receive the information from the user.
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant's arguments filed 01/28/2026 have been fully considered but they are not persuasive. Applicant argues that the prior art does not teach determining an apparent glycation value which is explicitly defined by a subject-specific relationship between
k
g
l
y
and
k
a
g
e
, and scaling the personalized glucose metrics by the apparent glycation value, however Xu teaches on this limitation, as Xu teaches that the apparent glycation value is determined by a ratio of
k
g
l
y
and
k
a
g
e
(0025]: “Equation 3 defines the apparent glycation constant K (typically with units of dL/mg) as the ratio of
k
g
l
y
and
k
a
g
e
”. The apparent glycation constant is subject-specific, as it is dependent on the values of
k
g
l
y
and
k
a
g
e
, which are calculated for the specific subject.), which then is used to calculate the personalized glucose metrics. Since the personalized glucose metrics are calculated using the subject-specific apparent glycation values, then they are scaled by the apparent glycation value, and therefore teaching on this limitation.
Applicant also argues that the prior art does not teach requiring dual analytical pathways from the same analyte data wherein one interface uses the personalized metrics and one does not, however Mears discloses this limitation, which teaches on using either standard target ranges or personalized target ranges for the interfaces ([0018]: “The current blood glucose measurement is compared to a standard target glucose range such as 70 mg/dL to about 160 mg/dL or a personalized target glucose range based upon the specific characteristics and therapy for the person with diabetes”. The target range is either standard (without the plurality of personalized glucose metrics), or with a personalized target range (with the plurality of personalized glucose metrics)).
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 ERIN K MCCORMACK whose telephone number is (703)756-1886. The examiner can normally be reached Mon-Fri 7:30-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at 5712727540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
Prosecution Insights