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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/09/2026 has been entered.
Status of the Application
Claims 402-405, 407-415, 423-425, 427-432, and 434-441 are currently pending in this case and have been examined and addressed below.
Claims 402, 408, 409 and 411 are currently amended.
Claims 406 and 433 are cancelled.
Claims 440-441 are added.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/09/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 402-405, 407-415, 423-425, 427-432, and 434-441 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Step 1: Claims 402-405, 407-415, 423-425, 427-432, and 434-441 are drawn to a machine. As such, claims 402-405, 407-415, 423-425, 427-432, and 434-441 are drawn to one of the statutory categories of invention (Step 1: YES).
Step 2A - Prong One: In prong one of step 2A, the claim(s) is/are analyzed to evaluate whether it/they recite(s) a judicial exception.
Independent Claim 402: A glucose monitoring system, comprising:
a sensor control device comprising a glucose sensor, wherein at least a portion of the glucose sensor is configured to be in fluid contact with a bodily fluid of a user;
and a reader device, comprising:
wireless communication circuitry configured to receive glucose levels from the sensor control device;
and one or more processors coupled to a memory, the memory storing instructions that, when executed by the one or more processors, cause the one or more processors to perform operations comprising:
determining one of a plurality of pattern types for each of a plurality of time segments of a day based on at least one of a hypoglycemia risk metric or a hyperglycemia risk metric for each corresponding time segment, wherein the plurality of pattern types comprises a lows pattern, a highs with some lows pattern, or a highs pattern, and wherein the plurality of time segments comprises overnight, morning, afternoon, or evening;
determining a most important pattern type based on the determined pattern types for the plurality of time segments;
and outputting a display to a user interface, the display comprising:
at least one glucose metric determined for a time period based on glucose levels received from the sensor control device;
a time in range display comprising a graph of time in ranges comprising a plurality of graph portions, wherein each graph portion of the plurality of graph portions indicates an amount of time that the user’s glucose level is within a predefined glucose range associated with each graph portion, wherein the plurality of graph portions comprises at least four graph portions;
and a pattern graph comprising a plot of glucose levels of the user across a horizontal representation of the plurality of time segments and an identification of the determined pattern type for each of the plurality of time segments, wherein the pattern graph further comprises an identification of the most important pattern type that is visibly distinct from the identification of the determined pattern type for each of the plurality of time segments, wherein the identification of the most important pattern type comprises a box positioned around glucose data on the plot of glucose levels corresponding to the most important pattern type.
(Examiner notes: The above claim terms underlined are additional elements that fall under Step 2A - Prong Two analysis section detailed below)
These steps amount to methods of organizing human activity which includes functions relating to interpersonal and intrapersonal activities, such as managing relationships or transactions between people, social activities, and human behavior; satisfying or avoiding a legal obligation; advertising, marketing, and sales activities or behaviors; and managing human mental activity (MPEP § 2106.04(a)(2)(II)(C) citing the abstract idea grouping for methods of organizing human activity for managing personal behavior or relationships or interactions between people). Therefore, determining a pattern type, determining the most important pattern type, displaying a glucose metric, displaying a time in range graph, displaying a pattern graph are directed to managing personal interactions or personal behavior.
The dependent claim 403 is directed to a glucose metric including a glucose average.
The dependent claim 404 is directed to a glucose metric including a glucose management indicator.
The dependent claim 405 is directed to display a goal value corresponding to a glucose metric.
The dependent claim 407 is directed to the plurality of graph portions including 4 graph portions consisting of a graph portion below a very low threshold, a portion of the graph in between a very low threshold and a low threshold, a graph portion between a low threshold and a high threshold, a graph portion between a high threshold and a very high threshold, and a portion of the graph above a very high threshold.
The dependent claim 408 is directed to the time in range display including a description of the predefined glucose range associated with each graph portion.
The dependent claim 409 is directed to the time in range display including a value for each graph portion of the plurality of graph portions that relates to the amount of time the glucose level was within a predetermined glucose range.
The dependent claim 410 is directed to the value being a percentage value.
The dependent claim 411 is directed to the time in range display further comprises a combined value for at least two graph portions of the plurality of graph portions that relates to a sum of the amount of time that the user's glucose level was within each of the predefined glucose ranges associated with at least two graph portions during the time period.
The dependent claim 412 is directed to the graph of the time in ranges comprises a histogram.
The dependent claim 413 is directed to graph portion of the histogram arranged in a vertical layout.
The dependent claim 414 is directed to the identification of the determined pattern type for each of the plurality of time segment includes a partial outline of the corresponding time segment on the pattern graph.
The dependent claim 415 is directed to the identification of the determined pattern type for each of the plurality of time segment includes a label of the determined pattern type.
The dependent claim 423 is directed to the identification of the most important pattern type comprises an identification of the lows pattern when the plurality of pattern types includes a lows pattern.
The dependent claim 424 is directed to the identification of the most important pattern type comprises an identification of the highs with some lows pattern when the plurality of pattern types includes a highs with some lows pattern and does not include a lows pattern.
The dependent claim 425 is directed to the identification of the most important pattern type comprises an identification of the highs pattern when the plurality of pattern types includes a highs pattern and does not include a highs with some lows pattern or a lows pattern.
The dependent claim 427 is directed to the identification of the most important pattern type includes a tag.
The dependent claim 428 is directed to the tag for the identification of the most important pattern type is a different color than a tag for the identification of the determined pattern type for each of the plurality of time segments.
The dependent claim 429 is directed to determining a variability of at least one time segment, displaying a statement relating to variability when determined variability is high.
The dependent claim 430 is directed to the statement related to variability including an identification of one or more behaviors that contribute to the glucose variability.
The dependent claim 431 is directed to displaying a statement relating to an excursion below a very low threshold.
The dependent claim 432 is directed to the very low threshold being in between 50mg/dL and about 58 mg/dL.
The dependent claim 434 is directed to displaying one or more recommendations relating to one or more medication considerations.
The dependent claim 435 is directed to one or more recommendations relating to medication consideration includes a recommendation to adjust a medication.
The dependent claim 436 is directed to one or more recommendations relating to medication considerations includes a recommendation related to medications contributing to low glucose levels.
The dependent claim 437 is directed to display one or more recommendations relating to one or more lifestyle considerations.
The dependent claim 438 is directed to one or more recommendations relating to one or more lifestyle considerations including a recommendation relating to a missed meal, a missed medication dose, carbohydrates, an activity level, alcohol, or medication.
The dependent claim 439 is directed to the time period being 14 days.
The dependent claim 440 is directed to adjusting one or more glucose level thresholds of the pattern graph associated with the most important pattern type and updating the identification of the most important pattern type based on the adjusted one or more glucose level thresholds.
The dependent claim 441 is directed to the one or more glucose level thresholds comprises a low glucose threshold, a high glucose threshold, or both.
Each of these steps of the preceding dependent claims 403-405, 407-415, 423-425, 427-432, and 434-441 only serve to further limit or specify the features of independent claim 402 accordingly, and hence are nonetheless directed towards fundamentally the same abstract idea as the independent claim and utilize the additional elements analyzed below in the expected manner.
As such, the Examiner concludes that the preceding claims recite an abstract idea (Step 2A – Prong One: YES).
Step 2A - Prong Two: In prong two of step 2A, an evaluation is made whether a claim recites any additional element, or combination of additional elements, that integrate the exception into a practical application of that exception. An “additional element” is an element that is recited in the claim in addition to (beyond) the judicial exception (i.e., an element/limitation that sets forth an abstract idea is not an additional element). The phrase “integration into a practical application” is defined as requiring an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
Claim 402 recites the use of an glucose monitoring system, a reader device, a wireless communication circuitry configured to receive analyte levels from the sensor control device, one or more processors coupled to a memory, the memory storing instructions that, when executed by the one or more processors, cause the one or more processors to perform operations, in this case determining one of a plurality of pattern types for each of a plurality of time segments of a day based on a hypoglycemia or hyperglycemic risk metric for each corresponding time segment, determining a most important pattern type, displaying a glucose metric, displaying a time in range graph, and displaying a pattern graph. The claim only recites an analyte monitoring system, a reader device, a wireless communication circuitry configured to receive analyte levels from the sensor control device, one or more processors, and a memory as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
Claim 402 further recites a sensor control device comprising an glucose sensor, wherein at least a portion of the glucose sensor is configured to be in fluid contact with a body fluid of a user, only as a tool which only serves to input data for use by the abstract idea (MPEP § 2106.05(g)) - insignificant pre/post-solution activity that amounts to mere data gathering to obtain input) and is therefore not a practical application of the recited judicial exception.
Claims 402, 405, 429, 431, 434, 437, and 440 recite he use of a outputting a display to a user interface, in this case to display a glucose metric, display a time in range graph, display a pattern graph, display a statement relating to variability when variability is high, display a statement relating to an excursion below a very low threshold, display a recommendation, adjusting the glucose level thresholds of the pattern graph associated with the most important pattern type, and updating the identification of the most important pattern type based on the adjusted glucose level thresholds, only recites the outputting a display to a user interface as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2)).
The Examiner has therefore determined that the additional elements, or combination of additional elements, do not integrate the abstract idea into a practical application. Accordingly, the claim(s) is/are directed to an abstract idea (Step 2A – Prong two: NO).
Step 2B: In step 2B, the claims are analyzed to determine whether any additional element, or combination of additional elements, is/are sufficient to ensure that the claims amount to significantly more than the judicial exception.
As discussed above in “Step 2A – Prong 2”, the identified additional elements, such as the glucose monitoring system, sensor control device comprising an glucose sensor, wherein at least a portion of the glucose sensor is configured to be in fluid contact with a body fluid of a user, reader device, wireless communication circuitry configured to receive glucose levels from the sensor control device, one or more processors coupled to a memory, the memory storing instructions that, when executed by the one or more processors, cause the one or more processors to perform operations, and outputting a display to a user interface in independent claim 402 and dependent claims 403-405, 407-415, 423-425, 427-432, and 434-441 are equivalent to adding the words “apply it” on a generic computer. Each of these elements is only recited as a tool for performing steps of the abstract idea, such as the use of the computer and data processing devices to apply the algorithm. These additional elements therefore only amount to mere instructions to perform the abstract idea using a computer and are not sufficient to amount to significantly more than the abstract idea (MPEP 2016.05(f) see for additional guidance on the “mere instructions to apply an exception”). Each additional element under Step 2A, Prong 2 is analyzed in light of the specification’s explanation of the additional element’s structure. The claimed invention’s additional elements are directed to generic computer component and functions being used to perform the abstract idea.
Applicant’s own disclosure in paragraph [00781] acknowledges that the “analyte monitoring system includes: a sensor control device comprising an analyte sensor, wherein at least a portion of the analyte sensor is configured to be in fluid contact with a bodily fluid of a subject; and a reader device.” Paragraph [0082] discloses that the “SCD 102 can be implemented in a highly interconnected fashion, where power supply 111 is coupled with each component shown in FIG. 2B and where those components that communicate or receive data, information, or commands (e.g., AFE 110, processing circuitry 112,memory 114,timing circuitry 115, and communication circuitry 116), can be communicatively coupled with every other such component over, for example, one or more communication connections or buses 118”. Paragraph [0081] discloses “Sensor electronics 104 can be implemented in one or more semiconductor chips (e.g., an application specific integrated circuit (ASIC), processor or controller, memory, programmable gate array, and others). In the embodiment of FIG. 1B, sensor electronics 104 includes high-level functional units, including an analog front end (AFE) 110 configured to interface in an analog manner with sensor 101 and convert analog signals to and/or from digital form (e.g., with an A/D converter), a power supply 111 configured to supply power to the components of SCD 102, processing circuitry 112,memory 114,timing circuitry 115 (e.g., such as an oscillator and phase locked loop for providing a clock or other timing to components of SCD 102), and communication circuitry 116 configured to communicate in wired and/or wireless fashion with one or more devices external to SCD 102, such as display device 120 and/or MDD 152.” Additionally, in paragraph [00119] the disclosure acknowledges that the “Display device 120 can be dedicated for use with system 100 (e.g., an electronic device designed and manufactured for the primary purpose of interfacing with an analyte sensor and/or a medication delivery device), as well as devices that are multifunctional, general purpose computing devices such as a handheld or portable mobile communication device (e.g., a smartphone or tablet), or a laptop, personal computer, or other computing device…Display devices, and variations thereof, can be referred to as "reader devices", "readers", "handheld electronics" (or handhelds), "portable data processing" devices or units, "information receivers", "receiver" devices or units (or simply receivers), "relay" devices or units, or "remote" devices or units, to name a few”. Paragraph [0086] discloses that the “Communication circuitry 116 can be implemented as one or more components (e.g., transmitter, receiver, transceiver, passive circuit, encoder, decoder, and/or other communication circuitry) that perform the functions for communications over the respective communications paths or links. Communication circuitry 116 can include or be coupled to one or more antenna for wireless communication.”. Paragraph [0083] discloses the “Processing circuitry 112 can include one or more processors, microprocessors, controllers, and/or microcontrollers, each of which can be a discrete chip or distributed amongst (and a portion of) a number of different chips. Processing circuitry 112 can include on-board memory. Processing circuitry 112 can interface with communication circuitry 116 and perform analog-to-digital conversions, encoding and decoding, digital signal processing and other functions that facilitate the conversion of data signals into a format (e.g., in-phase and quadrature) suitable for wireless or wired transmission”. Furthermore, paragraph [0085] acknowledges that the “Memory 114 is non-transitory, and can be volatile (e.g., RAM, etc.) and/or non-volatile memory (e.g., ROM, flash memory, F-RAM, etc.).”. Paragraph [00120] discloses a “display device 120 includes a user interface 121 and a housing 124 in which display device electronics 130 (FIG. 4B) are held. User interface 121 can be implemented as a single component (e.g., a touchscreen capable of input and output) or multiple components (e.g., a display and one or more devices configured to receive user input)”.
Additionally, the identified additional element such as the sensor control device comprising an analyte sensor that is in fluid contact with bodily fluid in independent claim 402 is well-understood, routine, and conventional. The applicant’s specification discloses in paragraphs [0071-0073] that the analyte monitoring functionality of dose guidance system, wherein the analyte monitoring functionality includes devices that utilize a sensor placed partially or wholly within a user’s body are described in Int'l Publ. No. WO 2018/152241 and U.S. Patent Publ. No. 2011/0213225. Additionally, U.S. Patent Publ. No. 9/237,865 B2 discloses in the “Description of Related Art” subsection that “Analyte sensors such as biosensors include devices that use biological elements to convert a chemical analyte in a matrix into a detectable signal. There are many types of biosensors used for a wide variety of analytes. The most studied type of biosensor is the amperometric glucose sensor, which is crucial to the successful glucose level control for diabetes”. Therefore, the sensor control device comprising an analyte sensor that is in fluid contact with bodily fluid is not sufficient to amount to significantly more than the recited judicial exception.
The Examiner has therefore determined that no additional element, or combination of additional claims elements is/are sufficient to ensure the claim(s) amount to significantly more than the abstract idea identified above (Step 2B: NO).
Therefore, claims 402-405, 407-415, 423-425, 427-432, and 434-441are not eligible subject matter under 35 USC 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 402-405, 407-411, 414, 423-425, 427-430, and 440-441 are rejected under 35 U.S.C. 103 as being unpatentable over Mayou et al. (US-20130035871-A1)[hereinafter Mayou], in view of Advani (“Positioning time in range in diabetes management”)[hereinafter Advani].
As per Claim 402, Mayou discloses a glucose monitoring system in paragraphs [0009] and [0113-0114] (an analyte concentration monitoring system, wherein the analyte includes glucose), comprising: a sensor control device comprising a glucose sensor, wherein at least a portion of the glucose sensor is configured to be in fluid contact with a bodily fluid of a user in paragraphs [0009] and [0113-0114] and [0160] and [0168] (a continuous analyte sensor system (synonymous to the sensor control device) comprising a continuous analyte sensor, wherein the sensor is an implantable glucose sensor (Examiner notes that an implantable device has fluid contact with bodily fluids of a user)); and a reader device in paragraphs [0151] and [0163] (key fob display device, wherein the key fob display device is configured to be automatically readable by a network system and display sensor information), comprising: wireless communication circuitry configured to receive glucose levels from the sensor control device in paragraphs [0128] and [0160-0163] and [0175-0177] (direct wireless communication between a sensor electronics module and a display device to receive sensor information, wherein the sensor electronics module is a part of the continuous analyte sensor system that transmits sensor information or glucose levels (synonymous to the analyte levels), wherein the display device includes a key fob display device that receives the glucose levels (Examiner notes that the direct wireless communication happens due to the wireless communication circuitry pictured in FIG.3 of the reference specification, wherein the continuous analyte sensor system and the display device are both coupled to transceiver circuits that allow communication functions for a standardized communication protocol)); and one or more processors coupled to a memory, the memory storing instructions that, when executed by the one or more processors, cause the one or more processors to perform operations in paragraph [0009] (one or more processors and a memory, the memory storing the one or more programs, wherein the one or more programs are instructions configured to be executed by the one or more processors to perform instructions):
comprising: determining one of a plurality of pattern types for each of a plurality of time segments of a day based on at least one of a hypoglycemia risk metric or a hyperglycemia risk metric for each corresponding time segment, wherein the plurality of pattern types comprises a lows pattern, a highs with some lows pattern, or a highs pattern, and wherein the plurality of time segments comprises overnight, morning, afternoon, or evening in paragraphs [0032] and [0180] and [0184] and [0187] and [0304] (determine one or more patterns (synonymous to the one of a plurality of pattern types) for each of a plurality of time segments of a day based on hypoglycemic and hyperglycemic patterns for each corresponding time segment, wherein the plurality of patterns may include hyperglycemic patterns (synonymous to a highs pattern) or hypoglycemic patterns (synonymous to a lows pattern) and the plurality of time segments includes overnight, morning, afternoon, or evening (Examiner notes that the hyperglycemic pattern and hypoglycemic patten are pattern types based on a hyper risk metric and a hypo risk metric, respectively. Additionally, the times displayed on the x-axis of the pattern chart in Figure 11 indicate the plurality of time segments corresponding to overnight, morning, afternoon, or evening)); determining a most important pattern type based on the determined pattern types for the plurality of time segments in paragraphs [0015] and [0304-0306] (determine a most significant pattern (synonymous to a most important pattern type) based on the determined patterns for the plurality of time segments); and outputting a display to a user interface, the display in paragraphs [0009] [0051] [0178] (outputting or displaying information on a user interface) comprising: at least one glucose metric determined for a time period based on glucose levels received from the sensor control device in paragraphs [0165-0166] [0180] [0184-0185] (display the patterns of high variability of glucose data (synonymous to the at least one glucose metric), wherein a pattern in glucose data occurs when glucose values are associated with similar time periods, based on the glucose levels received from the continuous analyte sensor system (Examiner notes according to Cardiovascular Diabetology, variability of glucose data or glycemic variability measures the amplitude and frequency of glucose levels, wherein the amplitude measures how much the glucose levels change and frequency measures how often they change)); and a pattern graph comprising a plot of glucose levels of the user across a horizontal representation of the plurality of time segments and an identification of the determined pattern type for each of the plurality of time segments, wherein the pattern graph further comprises an identification of the most important pattern type that is visibly distinct from the identification of the determined pattern type for each of the plurality of time segments in paragraphs [0188] and [0200] and [0204] and [0284] and [0304-0306] (a pattern graph of glucose levels (synonymous to analyte levels) of the patient across a horizontal representation of a plurality of time segments and a detection of a hypoglycemic event, wherein the hypoglycemic event is a hypoglycemic pattern for each of the plurality of time segments, wherein the pattern graph includes an identification of the most significant pattern that is highlighted from the identification of the hypoglycemic pattern for each of the plurality of time segments), wherein the identification of the most important pattern type comprises a box positioned around glucose data on the plot of glucose levels corresponding to the most important pattern type in paragraphs [0284] and [0304-0306] (wherein the identification of the most significant pattern is outlined with a border (synonymous to a box positioned around glucose data) on the chart of glucose levels corresponding to the most significant pattern type).
Mayou does not disclose the following limitations. However, Advani discloses a time in range display comprising a graph of time in ranges comprising a plurality of graph portions, wherein each graph portion of the plurality of graph portions indicates an amount of time that the user’s glucose level is within a predefined glucose range associated with each graph portion, wherein the plurality of graph portions comprises at least four graph portions in paragraphs Figure 1 on pg. 245 (a time in range represented by a stacked bar graph with a plurality of graph portions showing the percentage of time (synonymous to the amount of time) the blood glucose level (synonymous to the user's analyte level) is within the predefined blood glucose range associated with each graph portion, wherein the plurality of graph portions includes 5 graph portions which are level 1 hypoglycaemia, level 2 hypoglycaemia, level 1 hyperglycaemia, level 2 hyperglycaemia, and TIR or normoglycemia (Examiner notes that normoglycemia is the normal concentration of blood sugar)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou, to be combined with a time on range display graph, as disclosed by Advani, for the purpose of providing guidance to individuals with diabetes who wish to make use of the time in ranges metrics [Abstract].
As per Claim 403, Mayou and Advani disclose the system of claim 402, Mayou also discloses wherein the at least one glucose metric comprises a glucose average in paragraphs [0304] and FIG. 11 (the glucose statistics include the glucose average of 100 mg/dL).
As per Claim 404, Mayou and Advani disclose the system of claim 402.
Mayou does not disclose the following limitations. However, Advani discloses wherein the at least one glucose metric comprises a glucose management indicator in Figure 3 on pg. 246 ( displays glucose statistics, wherein the glucose statistics include the glucose management indicator (GMI) of 7.1%).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou, to be combined with a glucose metric including a glucose management indicator, as disclosed by Advani, for the purpose of providing guidance to individuals with diabetes who wish to make use of the time in ranges metrics [Abstract].
As per Claim 405, Mayou and Advani disclose the system of claim 402.
Mayou does not disclose the following limitations. However, Advani discloses wherein the operations further comprise outputting a display to the user interface comprising a goal value corresponding to the at least one glucose metric in paragraphs Figure 3 on pg. 246 (displays the target glucose variability of <= 36% (synonymous to the goal value), wherein the glucose variability of 50.9% is a glucose statistic).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou, to be combined with displaying a goal value for a corresponding glucose metric, as disclosed by Advani, for the purpose of providing guidance to individuals with diabetes who wish to make use of the time in ranges metrics [Abstract].
As per Claim 407, Mayou and Advani disclose the system of claim 402.
Mayou does not disclose the following limitations. However, Advani discloses wherein the plurality of graph portions comprises at least four graph portions selected from a group consisting of: a graph portion below a very low threshold, a graph portion between a very low threshold and a low threshold, a graph portion between a low threshold and a high threshold, a graph portion between a high threshold and a very high threshold, and a graph portion above a very high threshold in Figure 1 on pg. 245 (wherein the plurality of graph portions includes 5 graph portions which are level 1 hypoglycaemia, wherein level 1 hypoglycaemia corresponds to the graph portion below a blood glucose level of 3.0mmol/l (synonymous to the very low threshold), level 2 hypoglycaemia, wherein level 2 hypoglycaemia corresponds to the graph portion between the blood glucose level of 3.0mmol/l and 3.9mmol/l (synonymous to the low threshold), normoglycemia, wherein the normoglycemia corresponds to the graph portion between the blood glucose level of 3.9mmol/l and 10.0mmol/l (synonymous to the high threshold), level 1 hyperglycaemia, wherein the level 1 hyperglycaemia corresponds to the graph portion between the blood glucose level 10.0mmol/l and 13.9mmol/l (synonymous to the very high threshold), and level 2 hyperglycaemia, wherein the level 2 hyperglycaemia corresponds to the graph portion above the blood glucose level of 13.9mmol/l).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou, to be combined with a plurality of graph portions including at least four graph portions, as disclosed by Advani, for the purpose of providing guidance to individuals with diabetes who wish to make use of the time in ranges metrics [Abstract].
As per Claim 408, Mayou and Advani disclose the system of claim 402.
Mayou does not disclose the following limitations. However, Advani discloses wherein the time in range display further comprises a description of the predefined glucose range associated with each graph portion in Figure 1 on pg. 245 (the time in range graph shows a legend that describes the blood glucose range associated with each graph portion (Examiner notes that the legend uses a color scheme to associate the blood glucose levels with the ranges of time that correlate to level 2 hypoglycaemia with a blood glucose range of 13.9mmol/l and above corresponds with the color orange , level 1 hypoglycaemia with a blood glucose range from 10.0-13.9mmol/l corresponds to the color yellow, level 2 hyperglycaemia with a blood glucose range of 3.0mmol/l and below corresponds to the color red, level 1 hyperglycaemia with a blood glucose range of 3.0-3.9mmol/l corresponds to the color pink, and normoglycemia with a blood glucose range of 3.9-10.0mmol/l corresponds to the color green)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou, to be combined with a time in range display graph including a predefined analyte range associated with each graph portion, as disclosed by Advani, for the purpose of providing guidance to individuals with diabetes who wish to make use of the time in ranges metrics [Abstract].
As per Claim 409, Mayou and Advani disclose the system of claim 402.
Mayou does not disclose the following limitations. However, Advani discloses wherein the time in range display further comprises a value for each graph portion of the plurality of graph portions that relates to the amount of time that the user's glucose level was within the predefined glucose range associated with the graph portion during the time period in paragraphs Figure 1 on pg. 245 (the time in range graph includes a value, wherein the value is a percentage, for each graph portion of the plurality of graph portions that is associated with the percentage of time (synonymous to the amount of time) the blood glucose level (synonymous to the user's analyte level)is within the predefined blood glucose range associated with each graph portion, wherein the individual has a value of 12% in the level 2 hyperglycaemia, 20% in the level 1 hyperglycaemia, 60% in normoglycemia, 5% in level 1 hypoglycaemia, and 3% in hypoglycaemia).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou, to be combined with a time in range display graph includes a value relating to the amount of time the user’s analyte level is within the predetermined analyte range, as disclosed by Advani, for the purpose of providing guidance to individuals with diabetes who wish to make use of the time in ranges metrics [Abstract].
As per Claim 410, Mayou and Advani disclose the system of claim 409.
Mayou does not disclose the following limitations. However, Advani discloses wherein the value is a percentage value in Figure 1 on pg. 245 (the time in range graph includes a value, wherein the value is a percentage, for each graph portion of the plurality of graph portions that is associated with the percentage of time (synonymous to the amount of time) the blood glucose level (synonymous to the user's analyte level)is within the predefined blood glucose range associated with each graph portion, wherein the individual has a value of 12% in the level 2 hyperglycaemia, 20% in the level 1 hyperglycaemia, 60% in normoglycemia, 5% in level 1 hypoglycaemia, and 3% in level 2 hypoglycaemia).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou, to be combined with the value being a percentage, as disclosed by Advani, for the purpose of providing guidance to individuals with diabetes who wish to make use of the time in ranges metrics [Abstract].
As per Claim 411, Mayou and Advani disclose The system of claim 402.
Mayou does not disclose the following limitations. However, Advani discloses wherein the time in range display further comprises a combined value for at least two graph portions of the plurality of graph portions that relates to a sum of the amount of time that the user's glucose level was within each of the predefined glucose ranges associated with at least two graph portions during the time period in Figure 1 on pg. 245) (the time in range graph includes a combined value for two graph portions of the plurality of graph portions, wherein the combined value is a sum of the percentage of time the blood glucose level is within the predefined blood glucose range associated with at least two graph portion during the time period, wherein the two graph portions are the level 1 and level 2 hyperglycaemia or the level 1 and level 2 hypoglycaemia(Examiner notes that the reference combines percentage values of hyperglycaemia levels to create a TAR or time above range and the hypoglycaemia levels to create a TBR or a time below range. For example, the reference discloses that the individual has a percentage value of 8% in TBR and 32% in TAR)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou, to be combined with a time in range display graph that includes at least two graph portions that relates to a sum of the amount of time that the user’s analyte level was within the predetermined analyte range, as disclosed by Advani, for the purpose of providing guidance to individuals with diabetes who wish to make use of the time in ranges metrics [Abstract].
As per Claim 414, Mayou and Advani disclose the system of claim 402, Mayou also discloses wherein the identification of the determined pattern type for each of the plurality of time segments comprises at least a partial outline of the corresponding time segment on the pattern graph in paragraphs [0188] and [0200] and [0204-0206] and [0304] (a detection of a hypoglycemic event, wherein the hypoglycemic event is a hypoglycemic pattern for each of the plurality of time segments, wherein a segment is defined as a portion of the episode line segment, wherein an episode may include an event, that focuses on the most clinically relevant data points (synonymous to the partial outline) between the 2 time points on the graph).
As per Claim 423, Mayou and Advani disclose the system of claim 402, Mayou also discloses wherein when the plurality of pattern types comprises a lows pattern, the identification of the most important pattern type comprises an identification of the lows pattern in paragraphs [0304] and FIG. 11 (the most significant pattern identifies the pattern of lows due to the plurality of pattern types includes the pattern of lows).
As per Claim 424, Mayou and Advani disclose the system of claim 402.
Mayou does not disclose the following limitations. However, Advani discloses wherein when the plurality of pattern types comprises a highs with some lows pattern and does not comprise a lows pattern, the identification of the most important pattern type comprises an identification of the highs with some lows pattern in Figure 3 on pg. 246 (the plurality of pattern types shown on the Tuesday, June 26 and Friday, June 29th daily glucose profiles includes a highs pattern with some lows pattern, wherein the most important pattern type includes the identified highs with some lows pattern (Examiner notes that each peak and/or valley on the graph is considered a pattern as a pattern is defined as a plurality of measured glucose values over a period of time. Additionally, the most important pattern is identified as the pattern type that is mostly shown during the time period)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou, to be combined with the identification of the most important pattern type as the highs with some lows pattern if the plurality of pattern types only includes the pattern with highs and some lows, as disclosed by Advani, for the purpose of providing guidance to individuals with diabetes who wish to make use of the time in ranges metrics [Abstract].
As per Claim 425, Mayou and Advani disclose the system of claim 402.
Mayou does not disclose the following limitations. However, Advani discloses wherein when the plurality of pattern types comprises a highs pattern and does not comprise a highs with some lows pattern or a lows pattern, the identification of the most important pattern type comprises an identification of the highs pattern in Figure 3 on pg. 246 (the plurality of pattern types shown on the Monday, June 18 and Sunday, June 24 daily glucose profiles includes a highs pattern and not a highs and lows or a lows pattern, wherein the most important type includes the identified highs pattern (Examiner notes that each peak on the graph is considered a pattern as a pattern is defined as a plurality of measured glucose values over a period of time. Additionally, the most important pattern is identified as the pattern type that is mostly shown during the time period)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou, to be combined with the identification of the most important pattern type as the highs pattern if the plurality of pattern types only includes the pattern with highs, as disclosed by Advani, for the purpose of providing guidance to individuals with diabetes who wish to make use of the time in ranges metrics [Abstract].
As per Claim 427, Mayou and Advani disclose the system of claim 402, Mayou also discloses wherein the identification of the most important pattern type comprises a tag in paragraphs [0304-0306] and FIG. 11 (the identified most significant pattern is highlighted (synonymous to a tag) (Examiner notes that the purpose of the highlighted most significant pattern is to visually categorize the pattern of lows by most significant and non-significant, wherein the purpose of the highlighted most significant pattern serves the same purpose of tagging the most significant pattern)).
As per Claim 428, Mayou and Advani disclose the system of claim 427, Mayou also discloses wherein the tag for the identification of the most important pattern type is a different color than a tag for the identification of the determined pattern type for each of the plurality of time segments in paragraph [0304] and FIG. 11 (the highlight of the identified most significant pattern is highlighted a darker shade than the light grey highlight of the identified pattern of lows for each of the plurality of time segments (Examiner notes since the most significant pattern is highlighted a darker shade than the light grey highlight of the identified pattern of lows, then the highlights are different colors)).
As per Claim 429, Mayou and Advani disclose the system of claim 402, Mayou also discloses wherein the operations further comprise: determining a variability of at least one time segment in paragraphs [0183-0184] (detect patterns of high variability of glucose data by the time of day); outputting a display to the user interface comprising a statement relating to variability when the determined variability is high in paragraphs [0184-0185] (output information (synonymous to a statement), wherein the information may include corrective actions in the form of a text message or the like, based on the determined patterns, wherein the determined patterns may include patterns of high variability of glucose data).
As per Claim 430, Mayou and Advani disclose the system of claim 429, Mayou also discloses wherein the statement relating to variability comprises an identification of one or more behaviors that contribute to glucose variability in paragraphs [0183-0185] (wherein the output information relating to the pattern of high variability may include a detailed report of real-time analysis of the inputs an determined patterns or a retrospective analysis, wherein the report may include that a user overcorrected a hypoglycemic event by overly increasing glucose intake causing them to be in an hyperglycemic event (Examiner notes that being in an hyperglycemic event means that patient has a high glucose variability. Additionally, an user overly increasing their glucose intake is an identification of behaviors that contributes to the increase of the glucose variability)).
As per Claim 440, Mayou and Advani disclose the system of claim 402, Mayou also discloses wherein the operations further comprise: adjusting one or more glucose level thresholds of the pattern graph on the user interface associated with the most important pattern type in paragraphs [0309-0310] (modifying the target glucose range (synonymous to one or more glucose level thresholds) of the pattern graph on the user interface associated with the most significant pattern); and updating the identification of the most important pattern type on the display based on the adjusted one or more glucose level thresholds in paragraphs [0309-0310] (updating the identification of the most significant pattern type on the user interface based on the change in target glucose range).
As per Claim 441, Mayou and Advani disclose the system of claim 440, Mayou also discloses wherein the one or more glucose level thresholds comprises a low glucose threshold, a high glucose threshold, or both in paragraphs [0309-0310] and [0321] (the target glucose range includes a low or high glucose threshold (Examiner notes that a glucose concentration above the target glucose range indicates a high glucose threshold and a glucose concentration below the target glucose range indicates a low glucose threshold)).
Claims 412-413, 415, 431-432, and 437-438 are rejected under 35 U.S.C. 103 as being unpatentable over Mayou et al. (US-20130035871-A1)[hereinafter Mayou], in view of Advani (“Positioning time in range in diabetes management”)[hereinafter Advani], in view of Rack-Gomer (US-20150289823-A1)[hereinafter Rack-Gomer].
As per Claim 412, Mayou and Advani disclose the system of claim 402.
Mayou and Advani do not disclose the following limitations. However, Rack-Gomer discloses wherein the graph of the time in ranges comprises a histogram in paragraph [0295] (a histogram that shows the average glucose profile or normal patient pattern that are in hypoglycemic and hyperglycemic ranges for a given time of day (Examiner notes that the histogram of the glucose profile or pattern within the hypoglycemic or hyperglycemic ranges for a given time of day is a graph of the time of ranges)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou and Advani, to be combined with a time in range display graph including a histogram, as disclosed by Rack-Gomer, for the purpose of allowing diabetics to make educated insulin therapy decisions [0004].
As per Claim 413, Mayou and Advani disclose the system of claim 412.
Mayou does not disclose the following limitations. However, Advani discloses wherein a graph portion below a very low threshold is located below a graph portion between a very low threshold and a low threshold, which is located below a graph portion between a low threshold and a high threshold, which is located below a graph portion between a high threshold and a very high threshold, which is located below a graph portion above a very high threshold in Figure 1 on pg. 245 (wherein the plurality of graph portions includes 5 graph portions which are level 1 hypoglycaemia, wherein level 1 hypoglycaemia corresponds to the graph portion below a blood glucose level of 3.0mmol/l (synonymous to the very low threshold), level 2 hypoglycaemia, wherein level 2 hypoglycaemia corresponds to the graph portion between the blood glucose level of 3.0mmol/l and 3.9mmol/l (synonymous to the low threshold), normoglycemia, wherein the normoglycemia corresponds to the graph portion between the blood glucose level of 3.9mmol/l and 10.0mmol/l (synonymous to the high threshold), level 1 hyperglycaemia, wherein the level 1 hyperglycaemia corresponds to the graph portion between the blood glucose level 10.0mmol/l and 13.9mmol/l (synonymous to the very high threshold), and level 2 hyperglycaemia, wherein the level 2 hyperglycaemia corresponds to the graph portion above the blood glucose level of 13.9mmol/l).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou, to be combined with a plurality of graph portions including at least four graph portions, as disclosed by Advani, for the purpose of providing guidance to individuals with diabetes who wish to make use of the time in ranges metrics [Abstract].
The combination of Mayou and Advani disclose a graph and graph portions, but does not disclose a histogram arranged in a vertical layout. However, Rack-Gomer discloses wherein each graph portion of the histogram are arranged in a vertical layout in paragraph [0295] (the histogram is arranged for the glucose values measured over a time period, wherein figure 23 shows bar graphs of the histogram are in a vertical layout).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou and Advani, to be combined with a time in range display graph including a histogram arranged in a vertical layout, as disclosed by Rack-Gomer, for the purpose of allowing diabetics to make educated insulin therapy decisions [0004].
As per Claim 415, Mayou and Advani disclose the system of claim 414.
Mayou and Advani do not disclose the following limitations. However, Rack-Gomer discloses wherein the identification of the determined pattern type for each of the plurality of time segments further comprises a label of the determined pattern type in paragraphs [0165-0166] and [0168] and [0221-0222] and [0234-0235] (the trace of glucose values (synonymous to the pattern) for each of the plurality of time segments is applied to an axis labeled with the pattern types, wherein the pattern types include hyperglycemic and hypoglycemic (Examiner notes since the trace of glucose values are graphed on an axis labeled with the pattern types, the trace of glucose values is subsequently labeled with the corresponding pattern type)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou and Advani, to be combined with the identified pattern type to include a label, as disclosed by Rack-Gomer, for the purpose of allowing diabetics to make educated insulin therapy decisions [0004].
As per Claim 431, Mayou and Advani disclose the system of claim 402.
Mayou and Advani do not disclose the following limitations. However, Rack-Gomer discloses wherein the operations further comprise outputting a display to the user interface comprising a statement relating to an excursion below a very low threshold in paragraphs [0113] and [0134] and [0171] [0223] (the processor displays notifications, results, outputs, and alerts/alarms, wherein the notifications, results, outputs, alerts/alarms can be displayed through text or numerals, relating to hypoglycemic excursion, wherein the hypoglycemic excursion occurs when the glucose level drops to a dangerously low glucose level below 55 mg/dL).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou and Advani, to be combined with displaying a statement in relation to an excursion being below a very low threshold, as disclosed by Rack-Gomer, for the purpose of allowing diabetics to make educated insulin therapy decisions [0004].
As per Claim 432, Mayou and Advani disclose the system of claim 431, Mayou also discloses wherein the very low threshold is between about 50 mg/dL and about 58 mg/dL in paragraphs [0188] and [0301] (the lower threshold value is about 55 mg/dL).
Mayou discloses a lower threshold value, but does not disclose the very low threshold. However, Advani discloses wherein the very low threshold is between about 50 mg/dL and about 58 mg/dL in Figure 1 on pg. 245 (level 1 hypoglycaemia, wherein level 1 hypoglycaemia corresponds to the graph portion below a blood glucose level of 3.0mmol/l (synonymous to the very low threshold) (Examiner notes that the conversion of 3.0mmol/l is 50.054mg/dL which is about 54 mg/dL)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou, to be combined with a very low threshold range, as disclosed by Advani, for the purpose of providing guidance to individuals with diabetes who wish to make use of the time in ranges metrics [Abstract].
As per Claim 437, Mayou and Advani disclose the system of claim 402.
Mayou and Advani do not disclose the following limitations. However, Rack-Gomer discloses wherein the operations further comprise a display to the user interface comprising one or more recommendations relating to one or more lifestyle considerations in paragraph [0281] (output to a display to the user interface a suggestion (synonymous to one or more recommendations) that relates to the one or more lifestyle conditions (Examiner notes as that the reference uses the prompt "We noticed that you are going low…Did you eat yet?", wherein the prompt is recommending that the user considers eating something to increase their glucose level)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou and Advani, to be combined with displaying a recommendation in relation to lifestyle considerations, as disclosed by Rack-Gomer, for the purpose of allowing diabetics to make educated insulin therapy decisions [0004].
As per Claim 438, Mayou and Advani disclose the system of claim 437.
Mayou and Advani do not disclose the following limitations. However, Rack-Gomer discloses wherein the one or more recommendations relating to one or more lifestyle considerations comprises a recommendation relating to at least one of a missed meal, a missed medication dose, carbohydrates, an activity level, alcohol, or a medication in paragraphs [0230] and [0281] and [0328] (suggestions to encourage the user to consider altering their lifestyle, where in altering their lifestyle includes asking if the user has eaten (synonymous to the missed meals), food intake (synonymous to carbohydrates and alcohol), exercise (synonymous to an activity level), insulin intake (synonymous to medication) (Examiner notes that the food intake includes carbohydrates because it is a biomolecule that contains sugars, starch, or cellulose which is makes up certain food items and alcoholic beverages)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou and Advani, to be combined with the recommendation including a missed meal, carbohydrates, activity level, alcohol, and medication, as disclosed by Rack-Gomer, for the purpose of allowing diabetics to make educated insulin therapy decisions [0004].
Claims 434-436 are rejected under 35 U.S.C. 103 as being unpatentable over Mayou et al. (US-20130035871-A1)[hereinafter Mayou], in view of Advani (“Positioning time in range in diabetes management”)[hereinafter Advani], in view of Sjolund (US-20190183434-A1)[hereinafter Sjolund].
As per Claim 434, Mayou and Advani disclose the system of claim 402.
Mayou and Advani do not disclose the following limitations. However, Sjolund discloses wherein the operations further comprise outputting a display to the user interface comprising one or more recommendations relating to one or more medication considerations in paragraph [0160] and Figure 31 (a suggestion (synonymous to one or more recommendations), wherein the suggestion is a message in the mobile application that is displayed on the mobile device, that prompts the user to "consider if a change in insulin is needed" (Examiner notes that the displayed suggestion of considering a change in insulin is an example of a statement relating to medication considerations, wherein the insulin is the medication that is used to treat glucose levels outside of the target range)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou and Advani, to be combined with displaying the recommendation in relation to medication considerations, as disclosed by Sjolund, for the purpose of assisting the user to male appropriate therapy decisions while minimizing the burdens on the user [0006].
As per Claim 435, Mayou and Advani disclose the system of claim 434.
Mayou and Advani do not disclose the following limitations. However, Sjolund discloses wherein the one or more recommendations relating to medication considerations comprises a recommendation to adjust a medication in paragraph [0160] and Figure 31 (a suggestion that prompts the user to "consider if a change in insulin is needed" (Examiner notes that the changing the insulin is an example of a adjusting the medication)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou and Advani, to be combined with the recommendation including a recommendation to adjust the medication, as disclosed by Sjolund, for the purpose of assisting the user to male appropriate therapy decisions while minimizing the burdens on the user [0006].
As per Claim 436, Mayou and Advani disclose the system of claim 434.
Mayou and Advani do not disclose the following limitations. However, Sjolund discloses wherein the one or more recommendations relating to medication considerations comprises a recommendation related to medications contributing to low glucose levels in paragraphs [0160] and Figure 31 (a suggestion that prompts the user to "consider if a change in insulin is needed", wherein the suggestion was made due to the identification of the user having a high glucose pattern (Examiner notes that changing the amount of insulin will treat the high glucose levels which will lead to lower glucose levels)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou and Advani, to be combined with the recommendation relating to medication considerations including a recommendation related to medications contributing to low glucose levels, as disclosed by Sjolund, for the purpose of assisting the user to male appropriate therapy decisions while minimizing the burdens on the user [0006].
Claims 439 are rejected under 35 U.S.C. 103 as being unpatentable over Mayou et al. (US-20130035871-A1)[hereinafter Mayou], in view of Advani (“Positioning time in range in diabetes management”)[hereinafter Advani], in view of Kröger et al. (“Clinical Recommendations for the Use of the Ambulatory Glucose Profile in Diabetes Care”)[hereinafter Kröger].
As per Claim 439, Mayou and Advani disclose the system of claim 402.
Mayou and Advani do not disclose the following limitations. However, Kröger discloses wherein the time period is 14 days in the "Data Quality" Subsection on page 587 (continuous data should be recorded over at least 14 days, wherein the 14 days is the time period).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of an analyte monitoring system, as disclosed by Mayou and Advani, to be combined with the time period being 14 days, as disclosed by Kröger, for the purpose of describing the steps to assess an ambulatory glucose profile (AGP) in detail and provide illustrations of the steps in order to ensure increased treatment satisfaction and adherence, quality of life, and an improvement in metabolic management for people with diabetes [Abstract].
Response to Arguments
Applicant's arguments, see Pages 8-12, “Rejection under 35 U.S.C.§101”, filed 02/09/2026 with respect to claims 402-415, 423-425, and 427-439 have been fully considered but they are not persuasive.
Applicant argues that the amended claim 402 is not an identified method of organizing human activity. Examiner respectfully disagrees. The amended claim limitations are directed to determining a pattern type and displaying the pattern on a graph. The limitations merely recite determining a pattern type, determining the most important pattern type, displaying a glucose metric, displaying a time in range graph, and displaying a pattern graph, which are activities performed by medical staff, which falls into the abstract grouping of certain methods of organizing human activity because it is the business relations of medical staff and patients. Additionally, the claim limitations involve managing personal behaviors or interactions between people.
Applicant argues that the amended claim 402 is integrated into a practical application that provides an improved user interface. Examiner respectfully disagrees. The claims do not recite an improvement to speed and accuracy in insulin management technology. The claims merely recite determining a pattern type, determining the most important pattern type, displaying a glucose metric, displaying a time in range graph, and displaying a pattern graph, which are a part of the abstract idea. An improvement to the abstract ideas of determining a pattern type, determining the most important pattern type, displaying a glucose metric, displaying a time in range graph, and displaying a pattern graph does not amount to an improvement to technology or a technical field (see MPEP § 2106.05(a)(II) stating “it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology."). The courts indicated in TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48, that gathering and analyzing information using conventional techniques and providing the output is not sufficient to show an improvement to technology. The claim language and instant application fails to provide details regarding how a computer aids the method, the extent to which the computer aids the method, or the significance of a computer to the performance of the method. Here, the improvement is to determining a pattern type, determining the most important pattern type, displaying a glucose metric, displaying a time in range graph, and displaying a pattern graph. There is no indication in the disclosure that the involvement of a computer assists in improving the technology for the outlined problem statement. Merely adding generic computer components to perform the method is not sufficient.
Applicant argues that amended claim 402 has a similar conclusion to Core Wireless and Trading Technologies International, Inc. v. CQG, Inc., 675 F. App'x 1001, 1004 (Fed. Cir. 2017). Examiner respectfully disagrees. In Core Wireless, the patent is directed to providing a specific and efficient way to display application data in an un-launched state improving computer functionality. However, the instant claims are directed towards the abstract idea of determining a pattern type and displaying the pattern on a graph. Examiner notes the claims do not recite a specific and efficient way to display data that improves computer functionality. The instant application is distinguishable from Trading Technologies International, Inc. v. CQG, Inc. because the claims are not directed towards improving the accuracy of trader transactions. Instead, the claims are directed towards the abstract idea of analyzing data and displaying the data. The claims merely recite determining a pattern type, determining the most important pattern type, displaying a glucose metric, displaying a time in range graph, and displaying a pattern graph. The use of the outputting a display to a user interface to display the pattern graph that identifies the most important pattern type by placing a box around the pattern on the graph is not an improvement to the user interface but use of the user interface in its ordinary purpose of displaying information, which is mere instructions to apply the abstract idea, as per MPEP 2106.05(f)(2). Therefore, the rejection is maintained.
Regarding remarks to Ex Parte Mears, Appeal No. 2022-004627, at 10 (P.T.A.B. Dec. 11, 2023), Examiner submits that PTAB Decisions of other applications are not legally binding on the instant claims. PTAB decisions are particular to the facts of each individual case, and each case is evaluated individually on its own merits. These remarks are not persuasive.
Applicant’s arguments, see Pages 12-15, “Rejection under 35 U.S.C.§103”, filed 02/09/2026 with respect to claims 402-439 have been fully considered.
With regards to the amended 402 claim, Applicant argues that Mayou, Advani, Rack-Gomer, Sjolund, and Kröger alone or in combination fail to disclose or suggest the limitations recited in the amended claim. Examiner respectfully disagrees and points Applicant to the updated rejection and citations in the 103 rejections above. Mayou discloses in paragraph [0284] that the most significant pattern type is outlined with a border, synonymous to a box being positioned around data. In response to the argument that Mayou and Advani do not establish a prima facie case of obviousness. Examiner respectfully disagrees. It would have been obvious to one of ordinary still in the art to include in the glucose monitoring system that determines the most significant pattern type, displays the most significant pattern type on the pattern graph by outlining the pattern type with a border of Mayou with the time in range display as taught by Advani since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately. One of ordinary skill in the art would have recognized that the results of the combination were predictably a glucose monitoring system that includes a time in range display along side the pattern graph with the most significant pattern type identified by a border being outlined around the pattern.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Choudhary P, “Blood glucose pattern management in diabetes: creating order from disorder” (2013) teaches methods for improved blood glucose pattern management.
Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.N.W./Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682