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 .
Claim Rejections - 35 USC § 101
Claims 110-129 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 110 follows.
STEP 1
Regarding claim 110, the claim recites a series of structural elements, including a system. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
calculate one or more metrics using the received data indicative of the glucose level of the subject for a predetermined time period, wherein the calculated one or more metrics comprises a corresponding one or more raw values;
normalize the corresponding one or more raw values for each of the one or more calculated metrics;
weigh each of the normalized corresponding one or more raw values, wherein the each of the weighted normalized corresponding raw value is provided a sub- score;
calculate an overall score for the predetermined time period based on a function of the sub-scores
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion) and/or mathematical concepts
(including mathematical relationships, mathematical formulas or equations, and mathematical calculations). Thus, the claim is drawn to a Mental Process and/or Mathematical Concepts, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 110 recites a sensor control device comprising a glucose sensor, wherein at least a portion of the glucose sensor is configured to be positioned under a skin surface and in fluid contact with a bodily fluid of a subject; and a reader device, comprising: wireless communication circuitry configured to receive data indicative of a glucose level of the subject from the sensor control device; and one or more processors coupled to a memory, the memory storing an analyte monitoring software application and output, to a graphical user interface, at the end of the predetermined time, information related to the overall score, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The received data, stored analyte monitoring software application, and output to a graphical user interface does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the received data, stored analyte monitoring software application, and output to a graphical user interface, nor does the method use a particular machine to perform the Abstract Idea.
Regarding claim 110, the system recited in the claim is a generic system comprising generic components configured to perform the abstract idea. The recited sensor control device comprising a glucose sensor and reader device are generic components configured to perform pre-solutional data gathering activity, the interface is configured to perform insignificant extra-solution activity, and the processor coupled to the memory storing the analyte monitoring software application is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
a sensor control device comprising a glucose sensor, wherein at least a portion of the glucose sensor is configured to be positioned under a skin surface and in fluid contact with a bodily fluid of a subject;
a reader device, comprising: wireless communication circuitry configured to receive data indicative of a glucose level of the subject from the sensor control device;
one or more processors coupled to a memory, the memory storing an analyte monitoring software application;
output, to a graphical user interface, at the end of the predetermined time, information related to the overall score.
The receiving, storing, and outputting steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the receiving, storing, and outputting steps are each recited at a high level of generality such that it amounts to insignificant pre-solution activity and insignificant extra-solution activity, e.g., mere data gathering and mere data outputting steps necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the receiving and outputting steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 110, the system recited in the claim is a generic system comprising generic components configured to perform the abstract idea – as evidenced by David Olczuk, Ronny Priefer, A history of continuous glucose monitors (CGMs) in self-monitoring of diabetes mellitus, Diabetes & Metabolic Syndrome: Clinical Research & Reviews, Volume 12, Issue 2, 2018, Pages 181-187, https://doi.org/10.1016/j.dsx.2017.09.005; Valdes (US 20120108934 A1) in para. [0004, 0088,0101] discloses a conventional CGM system and conventional communication circuits; Nam (US 20240415420 A1) in para. [0003-0004] discloses a conventional continuous glucose monitoring system including a continuous glucose meter and a user terminal device; Tankiewicz (US 20140350359 A1) in para. [0003] discloses conventional continuous analyte (e.g., glucose) monitoring systems include a sensor, a transceiver worn on the user and configured for communication with the sensor, and a receiver, separate from the transceiver and configured to receive data transmissions from the transceiver and to provide notifications and feedback to the user. The recited sensor control device comprising a glucose sensor and reader device are generic components configured to perform pre-solutional data gathering activity, the interface is configured to perform insignificant extra-solution activity, and the processor coupled to the memory storing the analyte monitoring software application is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims. Claims 111, 120, and 124 are directed to more abstract ideas and claims 112-119, 121-123, 125-129 merely define what the metric and/or the score is, which does not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 110, 116-118, 120, and 122 are rejected under 35 U.S.C. 103 as being unpatentable over Shah (US 20170325749 A1) in view of Ohnemus (US 20140135592 A1).
Regarding claim 110, Shah discloses an analyte monitoring system (Abstract, para. [0002]), comprising: a sensor control device (electronics module 102, fig. 1A) comprising a glucose sensor (“glucose sensor”, para. [0010, 0042], sensor array 101 including analytes sensors 101a, figs. 1A-1B-2), wherein at least a portion of the glucose sensor (101, figs. 1A-1B-2) is configured to (Examiner’s Note: functional language, i.e., capable of) be positioned under a skin surface and in fluid contact with a bodily fluid of a subject (“subcutaneous”, para. [0046-0047, 0069]); and a reader device (external monitor 104 & mobile device 128, fig. 1A), comprising: wireless communication circuitry (communication module 116, fig. 1A, “data from the sensor array 101 to a mobile device 128”, para. [0053-0055]) configured to receive data indicative of a glucose level of the subject from the sensor control device (“data from the sensor array 101 is transmitted via the communications module 108 to an external monitor 104”, para. [0053-0055]); and one or more processors coupled to a memory (processor 118 & memory 120, fig. 1A, “smartphone”, para. [0055, 0059-0060]), the one or more processors (“mobile device 128”, para. [0061] & processor 118, fig. 1A) to: calculate one or more metrics using the received data indicative of the glucose level of the subject for a predetermined time period (metrics processing module 300, fig. 3A-1 & 3A-2, “risk metrics”; “measurements over windows of time”; “glycemic control metric”, para. [0071, 0074, 0086, 0089-0090]), wherein the calculated one or more metrics comprises a corresponding one or more raw values (“secondary inputs ... risk metrics”; “time-in-range calculation or a time-out-of-range metric”, para. [0071-0072, 0074, 0089], figs. 3A-1 & 3A-2); normalize the corresponding one or more raw values for each of the one or more calculated metrics (“operation 306 ... transforms and normalizes the various inputs into risk values”, “normalized to a percentage of the evaluated window time”, para. [0074, 0089], figs. 3A-1 & 3A-2); weigh each of the normalized corresponding one or more raw values (operation 303 & operation 310’/350-360, figs. 3A-1 & 3A-2, “ applies relative weights 310 to appropriate risk values”, para. [0073, 0076]), wherein the each of the weighted normalized corresponding raw value is provided a sub- score (“Relative weights 310 are used to modify primary, secondary and other inputs”; “risk values that have been adjusted with either adjusted relative weights or original relative weight”, para. [0073, 0076, 0084]); calculate an overall score for the predetermined time period based on a function of the sub-scores (“operation 304 then calculates a weighted average risk score”; “operation, 304, risk score is determined based on ...”, para. [0076, 0084]); and output, to a graphical user interface, at the end of the predetermined time, information related to the overall score (“display visual representation ... the risk score”, para. [0075, 0081], figs. 3A-1 & 3A-2).
Shah discloses that software algorithms that combine an understanding of disease, artificial intelligence, and machine learning can be embedded in the instrumentation or systems that power and acquires data from a disease specific multi-parameter sensor to assess the cellular and/or systemic progression of condition or disease and processing sensor data on the mobile device 128 (para. [0029, 0061, 0066]).
Shah does not expressly disclose the memory storing an analyte monitoring software application that is executed by the one or more processors.
However, Ohnemus directed to a wearable device configured to provide and transmit user information and health-related information formatted as a health score (para. [0007]) discloses a reader device comprising one or more processors coupled to a memory, the memory storing an analyte monitoring software application that is executed by the one or more processors (“mobile electronic device ... software application, which starts the program running on the device processor”, para. [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shah such that the memory stores an analyte monitoring software application that is executed by the one or more processors, in view of the teachings of Ohnemus, as this would aid processing the sensor data on the mobile device using a software application running on the processor of the mobile device.
Regarding claim 116, Shah, as modified by Ohnemus hereinabove, discloses the analyte monitoring system of claim 110, wherein the one or more metrics comprise an amount of time the glucose level of the user is below a predetermined low glucose threshold value (“threshold values”; “glycemic control ... time-out-of-range metric”; “tight glucose control range of 70-130 mg/dL”, para. [0074, 0089, 0093-0094], fig. 4D).
Regarding claim 117, Shah, as modified by Ohnemus hereinabove, discloses the analyte monitoring system of claim 116, wherein the predetermined low glucose threshold value is 54 mg/dL or 70 mg/dL (“threshold values”; “tight glucose control range of 70-130 mg/dL”, para. [0074, 0089, 0093-0094] (Examiner note: 70 mg/dL would correspond to the predetermined low glucose threshold value), fig. 4D).
Regarding claim 118, Shah, as modified by Ohnemus hereinabove, discloses the analyte monitoring system of claim 110, wherein the one or more metrics comprise an amount of time the glucose level of the user is above a predetermined high glucose threshold value (“threshold values”; “glycemic control ... time-out-of-range metric”, para. [0074, 0089, 0093-0094], figs. 4C-D).
Regarding claim 120, Shah, as modified by Ohnemus hereinabove, discloses the analyte monitoring system of claim 110, wherein weighing the normalized raw value for each of the one or more calculated metrics comprises applying a differing weight to at least one or more calculated metrics (Tables 1-2, para. [0031, 0078-0079]).
Regarding claim 122, Shah, as modified by Ohnemus hereinabove, discloses the analyte monitoring system of claim 110, wherein calculating the overall score for the predetermined time period comprises summing up a total of the sub-scores (“sum ... weighted average risk score”, para. [0076]).
Claims 111 is rejected under 35 U.S.C. 103 as being unpatentable over Shah in view Ohnemus, as applied to claim 110 above, and further in view of Desborough (US 20130102867 A1).
Regarding claim 111, Shah, as modified by Ohnemus hereinabove, discloses the analyte monitoring system of claim 110. Shah further discloses that the glycemic control metric may require hours, or even multiple days' worth of data points instead of the minutes of data required for predictive metrics (para. [0089]). Shah, as modified by Ohnemus hereinabove, does not expressly disclose wherein the predetermined time period is one day, one week, or one month.
However, Desborough directed to a glycemic health metric determination and application discloses a predetermined time period, wherein the predetermined time period is one day, one week, or one month (“blood glucose concentrations obtained over a duration ... week, month”, para. [0078]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shah, as modified by Ohnemus hereinabove, such that the predetermined time period is one day, one week, or one month, in view of the teachings of Desborough, as this would aid in obtaining enough data for calculating the glycemic control metric.
Claims 112 and 123 are rejected under 35 U.S.C. 103 as being unpatentable over Shah in view Ohnemus, as applied to claim 110 above, and further in view of Cole (US 20180256103 A1)
Regarding claim 112, Shah, as modified by Ohnemus hereinabove, discloses the analyte monitoring system of claim 110. Shah further discloses that other embodiments capable of measuring different, alternate or additional analytes or risk metrics to derive a risk score of developing sepsis or other disease or physical condition should be considered within the scope of this disclosure (para. [0080]). Shah, as modified by Ohnemus hereinabove, does not disclose wherein the one or more metrics comprise a meal scoring metric.
However, Cole directed to monitoring and management of an individual's wellness and nutrition using analyte data from an in vivo analyte sensor discloses one or metrics (“analyte metrics”, para. [0044]), wherein the one or more metrics comprise a meal scoring metric (“a numerical score can be presented to the user, with the score reflecting an analyte response to an ingested food or meal”, para. [0024, 0044], fig. 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shah, as modified by Ohnemus hereinabove, such that the one or more metrics comprise a meal scoring metric, in view of the teachings of Cole, as this would aid in monitoring and management of an individual's wellness and nutrition by presenting easy-to-understand analyte metrics to the user by displaying a numerical score reflecting an analyte curve profile for a specific type of food and/or meal.
Regarding claim 123, Shah, as modified by Ohnemus hereinabove, discloses the analyte monitoring system of claim 110. Shah, as modified by Ohnemus hereinabove, does not disclose wherein the overall score is a numerical daily score.
However, Cole directed to monitoring and management of an individual's wellness and nutrition using analyte data from an in vivo analyte sensor discloses an overall score (fig. 6, para. [0047-0048]), wherein the overall score is a numerical daily score (“Today's Score 330”, para. [0047-0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shah, as modified by Ohnemus hereinabove, such that the one or more metrics comprise a meal scoring metric, in view of the teachings of Cole, as this would aid in presenting easy-to-understand analyte metrics to the user without a need for the subject to understand or interpret the underlying analyte level measurements acquired by sensor by presenting a daily summary metric/score.
Claims 113 and 119 are rejected under 35 U.S.C. 103 as being unpatentable over Shah in view Ohnemus, as applied to claim 110 above, and further in view of Chavan (US 20190239784 A1).
Regarding claim 113, Shah, as modified by Ohnemus hereinabove, the analyte monitoring system of claim 110. Shah, as modified by Ohnemus hereinabove, does not expressly disclose wherein the one or more metrics comprise an amount of time the sensor control device is worn by the user.
However, Chavan directed to an analyte monitoring system discloses wherein the one or more metrics comprise an amount of time the sensor control device is worn by the user (compliance information ... an amount of time that the user has used the analyte monitoring system (Wear Time); “compliance metrics 1324”, para. [0057, 0060, 0065], 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 modify Shah, as modified by Ohnemus hereinabove, such that the one or more metrics comprise an amount of time the sensor control device is worn by the user, in view of the teachings of Chavan, as this would aid in monitoring patient compliance information/metrics related to the extent to which a user is using the analyte monitoring system.
Regarding claim 119, Shah, as modified by Ohnemus hereinabove, discloses the analyte monitoring system of claim 118. Shah, as modified by Ohnemus hereinabove, does not expressly disclose wherein the predetermined high glucose threshold value is 180 mg/dL or 250 mg/dL.
However, Chavan directed to an analyte monitoring system discloses wherein the predetermined high glucose threshold value is 180 mg/dL or 250 mg/dL (“an amount of time that the user's calculated analyte level has been within a target analyte level range (e.g., 70-180 mg/dL) (Time in Target) ... amount of time that the user's calculated analyte level has been high (e.g., above 250 mg/dL) (High Time)”, para, [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shah, as modified by Ohnemus hereinabove, such that the one or more metrics comprise an amount of time the sensor control device is worn by the user, in view of the teachings of Chavan, as this would aid in monitoring an amount of time that the user's calculated analyte level has been within a target analyte level range and an amount of time that the user's calculated analyte level has been high.
Claim 114 is rejected under 35 U.S.C. 103 as being unpatentable over Shah in view Ohnemus, as applied to claim 110 above, and further in view of Kumar (US 20210378601 A1).
Regarding claim 114, Shah, as modified by Ohnemus hereinabove, discloses the analyte monitoring system of claim 110. Shah, as modified by Ohnemus hereinabove, does not expressly disclose wherein the one or more metrics comprise an amount of time the sensor control device is active.
However, Kumar directed to improvements to analyte monitoring systems discloses one or more metrics comprising an amount of time the sensor control device is active (“Percentage Time Sensor Active metric 506”, para. [0086, 0088], figs. 5A-5C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shah, as modified by Ohnemus hereinabove, such that the one or more metrics comprise an amount of time the sensor control device is active, in view of the teachings of Kumar, as this would aid in monitoring/indicating the percentage of the predetermined time period that reader device is in communication with the sensor control device and correlating the data with other metrics.
Claim 115 is rejected under 35 U.S.C. 103 as being unpatentable over Shah in view Ohnemus, as applied to claim 110 above, and further in view of Heaton (US 20110053121 A1)
Regarding claim 115, Shah, as modified by Ohnemus hereinabove, discloses the analyte monitoring system of claim 110. Shah, as modified by Ohnemus hereinabove, does not expressly disclose wherein the one or more metrics comprise a glycemic variability.
However, Heaton directed to a system and method for monitoring individual metabolic response discloses wherein the one or more metrics comprise a glycemic variability (“glycemic variability”, para. [0015, 0089]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shah, as modified by Ohnemus hereinabove, such that the one or more metrics comprise a glycemic variability, in view of the teachings of Heaton, as this would aid in predicting health risks for the patient, such as the patient's risk of hypoglycemia.
Claim 121, 124, and 129 are rejected under 35 U.S.C. 103 as being unpatentable over Shah in view Ohnemus, as applied to claim 110 above, and further in view of Mcmahan (US 20210321883 A1).
Regarding claim 121, Shah, as modified by Ohnemus hereinabove, discloses the analyte monitoring system of claim 110. Shah, as modified by Ohnemus hereinabove, does not expressly disclose wherein the overall score is a numerical value between 1 and 100.
However, Mcmahan directed to a modular ambulatory health status and performance tracking system discloses an overall score (“normalized aggregate health score”, para. [0133, 0144]), wherein the overall score is a numerical value between 1 and 100 (“score that is normalized on a scale of 0 to 100”, para. [0133, 0144], figs. 14A-C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shah, as modified by Ohnemus hereinabove, such that the overall score is a numerical value between 1 and 100, in view of the teachings of Heaton, as this would aid in obtaining a normalized aggregate health score for indicating a health status.
Regarding claim 124, Shah, as modified by Ohnemus hereinabove, discloses the analyte monitoring system of claim 110. Shah, as modified by Ohnemus hereinabove, does not expressly disclose wherein the one or more processors are further caused to: update, at a predetermined frequency, the overall score, wherein an updated overall score is calculated for a subsequent predetermined time period.
However, Mcmahan directed to a modular ambulatory health status and performance tracking system discloses one or more processors (“processor”, para. [0042]) are further caused to: update, at a predetermined frequency, the overall score (“one or more biometrics of the standard of care biometrics may be updated periodically”; “time periods ... T1, T2, and T3”, para. [0088, 0129, 0143]), wherein an updated overall score is calculated for a subsequent predetermined time period (“health score 1422 is a graph of the user's health score over time”; “aggregated health score results ... T1=80.8, T2=75.8, and T3=71.7 ... trending graph”, para. [0129, 0143-0144, 0146], Table 3, figs. 14A-C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shah, as modified by Ohnemus hereinabove, such that the one or more processors are further caused to: update, at a predetermined frequency, the overall score, wherein an updated overall score is calculated for a subsequent predetermined time period, in view of the teachings of Mcmahan, as this would aid in indicating a trend of the user’s health over time.
Regarding claim 129, Shah, as modified by Ohnemus hereinabove, discloses the analyte monitoring system of claim 110. Shah, as modified by Ohnemus hereinabove, does not expressly disclose wherein the information related to the overall score comprises a trend of the user's historical overall scores over a second predetermined time period.
However, Mcmahan directed to a modular ambulatory health status and performance tracking system discloses an overall score (“normalized aggregate health score”, para. [0133, 0144]), wherein the information related to the overall score comprises a trend of the user's historical overall scores over a second predetermined time period (“health score 1422 is a graph of the user's health score over time ... time periods ... T1 and T2 may be in the past”; “aggregated health score results ... T1=80.8, T2=75.8, and T3=71.7 ... trending graph”, para. [0129, 0143-0144, 0146], Table 3, figs. 14A-C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shah, as modified by Ohnemus hereinabove, such that the information related to the overall score comprises a trend of the user's historical overall scores over a second predetermined time period, in view of the teachings of Mcmahan, as this would aid in indicating a trend of the user’s health over time.
Claim 125 is rejected under 35 U.S.C. 103 as being unpatentable over Shah in view Ohnemus, as applied to claim 110 above, and further in view of Kim (US 20130268292 A1).
Regarding claim 125, Shah, as modified by Ohnemus hereinabove, discloses the analyte monitoring system of claim 110. Shah, as modified by Ohnemus hereinabove, does not expressly disclose wherein the information related to the overall score comprises a congratulatory message in response to the overall score exceeding a predetermined high threshold overall score value.
However, Kim directed to a user health management method and device discloses wherein the information related to the overall score comprises a congratulatory message in response to the overall score exceeding a predetermined high threshold overall score value (“congratulatory message ... evaluation score is greater than a predetermined value”, para. [0274]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shah, as modified by Ohnemus hereinabove, such that the information related to the overall score comprises a congratulatory message in response to the overall score exceeding a predetermined high threshold overall score value, in view of the teachings of Kim, as this would aid in indicating when the user’s health is cared for successfully.
Claim 126 is rejected under 35 U.S.C. 103 as being unpatentable over Shah in view Ohnemus and Kim, as applied to claim 125 above, and further in view of Bhavaraju (US 20140005509 A1).
Regarding claim 126, Shah, as modified by Ohnemus and Kim hereinabove, discloses the analyte monitoring system of claim 125. Shah, as modified by Ohnemus and Kim hereinabove, does not expressly disclose wherein the predetermined high threshold overall score value is 85, 90, or 95.
However, Bhavaraju directed to devices, systems, and methods for a continuous analyte sensor discloses a score (“quality score ... determined by considering any measured parameters”, para. [0236]) and a predetermined high threshold (high quality score value, para. [0237]) wherein the predetermined high threshold overall score value is 85, 90, or 95 (“high quality score value ... 100 indicates perfect tracking, a high quality score may be any score above 60, 65, 75, 80, 85, 90, or 95”, para. [0236-0237]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shah, as modified by Ohnemus and Kim hereinabove, such that the predetermined high threshold overall score value is 85, 90, or 95, in view of the teachings of Bhavaraju, as this would aid in indicating a high score.
Claims 127-128 are rejected under 35 U.S.C. 103 as being unpatentable over Shah in view Ohnemus, as applied to claim 110 above, further in view of Bhavaraju, and further in view of Schuster (US 20220020499 A1).
Regarding claim 127, Shah, as modified by Ohnemus hereinabove, discloses the analyte monitoring system of claim 110. Shah, as modified by Ohnemus hereinabove, does not expressly disclose wherein the information related to the overall score comprises a recommendation on improving the user's glycemic control in response to the overall score falling below a predetermined low threshold overall score value.
However, Bhavaraju directed to devices, systems, and methods for a continuous analyte sensor discloses a score (para. [0236, 0239-0240]) and information related to the overall score in response to the overall score falling below a predetermined low threshold overall score value (“instructing or notifying the user.... low quality score”, para. [0239-0240]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shah, as modified by Ohnemus hereinabove, such that the information related to the overall score is in response to the overall score falling below a predetermined low threshold overall score value, in view of the teachings of Bhavaraju, as this would aid in instructing or notifying the user based on indicating a low score.
Shah, as modified by Ohnemus and Bhavaraju hereinabove, does not expressly disclose that the information related to the overall score comprises a recommendation on improving the user's glycemic control.
However, Schuster directed to method for determining relative risk for lack of glycemic control discloses a score (“first total risk score and a second total risk score”, Abstract) and information related to the overall score comprises a recommendation on improving the user's glycemic control (“message may comprise one or more of i) teaching material on how to improve glycemic control”, para. [0054]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shah, as modified by Ohnemus and Bhavaraju hereinabove, such that information related to the overall score comprises a recommendation on improving the user's glycemic control, in view of the teachings of Schuster, as this would aid in teaching a subject how to improve glycemic control.
Regarding claim 128, Shah, as modified by Ohnemus and Bhavaraju hereinabove, discloses the analyte monitoring system of claim 127. Shah, as modified by Ohnemus and Bhavaraju hereinabove, does not expressly disclose wherein the predetermined low threshold overall score value is 65, 60, or 55.
However, Bhavaraju directed to devices, systems, and methods for a continuous analyte sensor discloses a score (“quality score ... determined by considering any measured parameters”, para. [0236, 0239]) and a predetermined high threshold (low quality score value, para. [0239]) wherein the predetermined low threshold overall score value is 65, 60, or 55 (“low quality score value ... 100 indicates perfect tracking, a low quality score may be any score below 5, 10, 15, 20, 25, 30, 35, 40, 45, or 50, in some embodiments”, para. [0239]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shah, as modified by Ohnemus and Bhavaraju hereinabove, such that the predetermined high threshold overall score value is 85, 90, or 95, in view of the teachings of Bhavaraju, as this would aid in indicating a low score.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Pauley (US 20210104173 A1) directed to a comprehensive and personalized approach to health and lifestyle coaching; Shah (US 20190183339 A1) directed to a biosensor assembly that measures multiple physical parameters.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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