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 .
Notice of Amendment
In response to the amendment filed on 4/12/2024, cancelled claims 1-52, 73, and 75-201 are acknowledged. Claims 53-72 and 74 remain pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 53-72 and 74 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 53 recites the limitation "each glucose episode” in line 9. There is insufficient antecedent basis for this limitation in the claim. Further, the claim does not adequately describe what is included and/or excluded by the limitation “each glucose episode” (i.e. what constitutes a glucose episode vs. what does not) such that one can reasonably ascertain the scope of the claim language.
Claims 54-72 and 74 are rejected based on their dependence from claim 53.
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 53-72 and 74 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Specifically, claim 53 recite(s) an abstract idea of “assign a count value for each glucose episode based at least on an area under a curve of the each glucose episode in a dataset of time-correlated glucose data and calculate a running sum of count values for a plurality of glucose episodes in a time period”. Under the broadest reasonable interpretation, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper. These steps amount to an evaluation or judgement that can be performed wholly mentally and/or with pen and paper based on the received time-correlated measured glucose data. (step 2A: Prong One).
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because:
The “wireless communications circuitry”, “display” and “one or more processors” are merely generic computer components performing generic computer functions which are well-understood, routine, and conventional in the art; as such, they do not meaningfully limit the claim to be more than just the abstract idea.
The limitation “display a progress indicator representative of the running sum of the count values relative to a target count goal for the time period” is merely insignificant extra-solution activity, such as outputting the result of the claimed algorithm, recited at a high level of generality and/or in a well-understood, routine, and conventional way (step 2A: Prong Two).
Moreover, the judicial exception is not integrated into a practical application because the claim does not recite any limitations that amount to an improvement in the functioning of a computer, or an improvement to other technology or technical field, apply or use the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement the judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception (step 2B).
Regarding dependent claims 54-72 and 74, the limitations of these dependent claim(s) merely add details to the algorithm which forms the abstract idea and/or add details to how the information is displayed, but do not contain any further “additional elements”. Thus, the dependent claim(s) are not significantly more than the extended abstract idea.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 53-57 and 74 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cole et al. (US Publication No. 2021/0000415 A1) (cited by Applicant).
Regarding claim 53, Cole et al. discloses a system for monitoring metrics relating to a user, the system comprising:
wireless communications circuitry configured to receive time-correlated measured glucose data (see [0030] – “Sensor control device 102 is further described with respect to FIGS. 3A and 3B, and can communicate with reader device 120 via a communication path 140 using a wired or wireless technique. Example wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC), Wi-Fi, and others” and [0031] – “Reader device 120 can communicate with local computer system 170 via a communication path 141 using a wired or wireless technique. Local computer system 170 can include one or more of a laptop, desktop, tablet, phablet, smartphone, set-top box, video game console, or other computing device and wireless communication can include any number of applicable wireless networking protocols including Bluetooth, Bluetooth Low Energy (BTLE), Wi-Fi or others. Local computer system 170 can communicate via communications path 143 with a network 190, similar to how reader device 120 can communicate via a communications path 142 with network 190 by wired or wireless technique as described previously. Network 190 can be any of a number of networks, such as private networks and public networks, local area or wide area networks, and so forth. Network 190 can be the cloud. A trusted computer system 180 can include a server and can provide authentication services and/or secured data storage and can communicate via communications path 144 with network 190 by wired or wireless technique”);
a display configured to visually present information (see [0042] – “Described herein are example embodiments of graphical user interfaces for displaying analyte metrics on reader device 120”); and
one or more processors (222, 224) coupled with the wireless communications circuitry, the display, and a memory (223, 225) storing instructions that, when executed by the one or more processors, cause the system to:
assign a count value for each glucose episode based at least on an area under a curve of the each glucose episode in a dataset of time-correlated glucose data (see [0040] – “Each analyte curve, AC1, AC2 and AC3, can have an analyte curve profile, where each profile includes, at least: an area under the analyte curve, as depicted in FIG. 4 by the shaded region bound between the analyte level measurement and the reference analyte level (e.g., fasting blood glucose level), an analyte curve slope, and an analyte curve length” and [0046] – “Referring again to FIG. 6, the numerical score can be a whole number on a scale from one to five, with the whole number being proportional to an area under the analyte curve. A numerical score of three, for example, can reflect the area of a “default” analyte curve that represents an analyte response to a standard default meal. By contrast, a numerical score of five can indicate a food or meal that results in a relatively large analyte response, with an analyte curve having a greater area relative to the default meal. Conversely, a numerical score of one can indicate an ingested food or meal that results in a relatively small analyte response, with an analyte curve having a smaller area relative to the default meal. Moreover, as shown in FIG. 6, in many embodiments, the numerical scores reflect the areas underneath the one or more corresponding analyte curves”);
calculate a running sum of count values for a plurality of glucose episodes in a time period (see [0047] – “Referring still to FIG. 6, three summary metrics 330, 340, 350 are displayed below the numerical scores 320 for breakfast, lunch and dinner. Today's Score 330 can indicate a sum of numerical scores for meals ingested on the current day. The Score for the Week 340 can indicate a sum of numerical scores for the week, up to the current day. The Target Weekly Score 350 can indicate a target numerical score which the subject should aspire to stay under. Additionally, as shown below the summary metrics, a daily tip or instruction 352 can be provided to help the subject to meet his or her Target Weekly Score”); and
display a progress indicator representative of the running sum of the count values relative to a target count goal for the time period (see [0047] – “Referring still to FIG. 6, three summary metrics 330, 340, 350 are displayed below the numerical scores 320 for breakfast, lunch and dinner. Today's Score 330 can indicate a sum of numerical scores for meals ingested on the current day. The Score for the Week 340 can indicate a sum of numerical scores for the week, up to the current day. The Target Weekly Score 350 can indicate a target numerical score which the subject should aspire to stay under. Additionally, as shown below the summary metrics, a daily tip or instruction 352 can be provided to help the subject to meet his or her Target Weekly Score”).
Regarding claim 54, Cole et al. discloses the count value is assigned based on a comparison to a distribution of a glucose metric determined from a predetermined population (see [0054] – “Similarly, in some embodiments, GUI 400 can retrieve data from a food database regarding the impact of a specific food or meal for a population, or a portion of a population. The population data can reflect, for example, mean or median values, weighted averages, standard deviations and other statistical parameters for analyte metrics which can reflect the impact of a specific food or meal for a population (or portion thereof), and can be used to normalize and/or be compared to an individual's response to the same specific food or meal. In addition, population data collected from individual users can be made accessible to authorized individuals, groups, public health officials and/or payors”).
Regarding claim 55, Cole et al. discloses the dataset comprises a graph of glucose data vs. time (see Figures 4-5 and 7-9).
Regarding claim 56, Cole et al. discloses the time period is about one day (see [0063] – “According to another aspect of the embodiment, instructions stored in memory on sensor control device 102 and/or reader device 120 can be executed by one or more processors of the respective device to perform periodic monitoring (e.g., daily, weekly, monthly) of carbohydrate intake in order to establish a carbohydrate intake profile for a specific user”)
Regarding claim 57, Cole et al. discloses the progress indicator comprises a display of a fraction comprising the running sum of count values in a numerator (340) and the target count goal (350) in a denominator (see Figure 6).
Regarding claim 74, Cole et al. discloses the instructions, when executed by the one or more processors, further cause the system to:
determine a slope for a line formed by count values determined for a plurality of periods of time (see [0046] – “In other embodiments, however, a numerical score can also be a function of other metrics of an analyte curve profile, such as the slope of the analyte curve and/or the length of the analyte curve. In some embodiments, for example, the numerical score can be a function of the length of the analyte curve, where the length of the analyte curve is associated with the duration of an analyte response. The numerical score can also reflect an analyte curve profile for a specific type of food and/or meal. For example, in some embodiments, a relatively high numerical score can reflect an analyte curve characterized by a sharp spike, which can reflect a food or meal with refined carbohydrates (e.g., white-flour pasta). Conversely, in other embodiments, a relatively low numerical score can reflect an analyte curve characterized by a gradual slope, which can reflect a food or meal that is high in fiber or complex carbohydrates (e.g., whole-wheat pasta). Likewise, in other embodiments, the numerical score can also be a function of the rate of change of an analyte level”);
assign a count trend status for at least one of the plurality of periods of time based on the determined slope (see [0046] – “In other embodiments, however, a numerical score can also be a function of other metrics of an analyte curve profile, such as the slope of the analyte curve and/or the length of the analyte curve. In some embodiments, for example, the numerical score can be a function of the length of the analyte curve, where the length of the analyte curve is associated with the duration of an analyte response. The numerical score can also reflect an analyte curve profile for a specific type of food and/or meal. For example, in some embodiments, a relatively high numerical score can reflect an analyte curve characterized by a sharp spike, which can reflect a food or meal with refined carbohydrates (e.g., white-flour pasta). Conversely, in other embodiments, a relatively low numerical score can reflect an analyte curve characterized by a gradual slope, which can reflect a food or meal that is high in fiber or complex carbohydrates (e.g., whole-wheat pasta). Likewise, in other embodiments, the numerical score can also be a function of the rate of change of an analyte level”); and
display a color representative of the assigned count trend status for the second time period (see [0048] – “In some embodiments, other non-numerical representations can be used in addition to, or in place of, the aforementioned numerical scores. For example, the use of different colored indicators (e.g., red light, yellow light or green light), textual indicators (e.g., good, neutral, bad), graphical indicators (thumbs up, thumbs down, happy face, sad face or other emoticons), letter grades (e.g., A, B, C, D or F), are all within the scope of the present disclosure” and [0060] – “In other embodiments, however, the plotted analyte values can reflect different rates of change in the analyte level. Accordingly, a different color band can be assigned based on the integrated rate of change over a specified time period. For example, when the analyte level is changing more rapidly, the color band can be red. Likewise, when the rate of change decreases, the color band can be green”).
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.
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.
Claim(s) 58-62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cole et al, further in view of Hayter et al. (US Publication No. 2021/0030323 A1).
Regarding claim 58, it is noted Cole et al. does not specifically teach the display of the fraction has a first end, a second end, and a length, and wherein a numerical value of the running sum of count values is displayed at a position along the length of the numerator that is proportional to [the running sum of count values]/[the target count goal] if the running sum of count values is less than or equal to the target count goal. However, Hayter et al. teaches the display of the fraction has a first end, a second end, and a length, and wherein a numerical value of the running sum of count values is displayed at a position along the length of the numerator that is proportional to [the running sum of count values]/[the target count goal] if the running sum of count values is less than or equal to the target count goal (see Figures 15C, 18A-B, and 19A-C and [0251] – “As seen in FIG. 15C, TIR display 1006 may also use bars or other progress indicators to visually depict the user's TIR relative to the TIR goals. TIR display 1006 displays both the TIR goals for the day so far and for the week so far. The length of the bar can represent the total goal and the bar will be filled to represent the percentage of TIR that the user has achieved for that specific time period. The TIR bars for the day and the week can be in different colors” and [0254] – “FIGS. 18A and 18B illustrate further alternative TIR displays using progress bars to show hours in range. A progress bar having a length equal to the goal hour or percentage can have a progress indicator (shaded or colored extension) to illustrate the user's TIR. For example, where the goal is 16 hours of a day in range, and the user had 14 hours in range, the progress indicator (shaded or colored extension) can fill 14/16 of the total bar. The TIR display can indicate the TIR for the day (1050) or can report both the TIR for the day and the week (1054), or other time period (e.g., past week, past month, or current month)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Cole et al. to include the display of the fraction has a first end, a second end, and a length, and wherein a numerical value of the running sum of count values is displayed at a position along the length of the numerator that is proportional to [the running sum of count values]/[the target count goal] if the running sum of count values is less than or equal to the target count goal, as disclosed in Hayter et al., so as to provide a progress indicator having a length that is proportional to the amount of time that the analyte data is determined to be within a goal range for the time period (see Hayter et al.: [0286]).
Regarding claim 59, Hayter et al. teaches the target count goal is displayed in the denominator near the second end (see Figures 15C and 18A-B).
Regarding claim 60, it is noted Cole et al. does not specifically teach the display of the fraction has a first end, a second end, and a length, and wherein a numerical value of the target count goal is displayed at a position along the length of the denominator that is proportional to [the target count goal]/[the running sum of count values] if the running sum of count values is greater than the target count goal. However, Hayter et al. teaches the display of the fraction has a first end, a second end, and a length, and wherein a numerical value of the target count goal is displayed at a position along the length of the denominator that is proportional to [the target count goal]/[the running sum of count values] if the running sum of count values is greater than the target count goal (see Figures 15C, 18A-B, and 19A-C and [0251] – “As seen in FIG. 15C, TIR display 1006 may also use bars or other progress indicators to visually depict the user's TIR relative to the TIR goals. TIR display 1006 displays both the TIR goals for the day so far and for the week so far. The length of the bar can represent the total goal and the bar will be filled to represent the percentage of TIR that the user has achieved for that specific time period. The TIR bars for the day and the week can be in different colors” and [0254] – “FIGS. 18A and 18B illustrate further alternative TIR displays using progress bars to show hours in range. A progress bar having a length equal to the goal hour or percentage can have a progress indicator (shaded or colored extension) to illustrate the user's TIR. For example, where the goal is 16 hours of a day in range, and the user had 14 hours in range, the progress indicator (shaded or colored extension) can fill 14/16 of the total bar. The TIR display can indicate the TIR for the day (1050) or can report both the TIR for the day and the week (1054), or other time period (e.g., past week, past month, or current month)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Cole et al. to include the display of the fraction has a first end, a second end, and a length, and wherein a numerical value of the target count goal is displayed at a position along the length of the denominator that is proportional to [the target count goal]/[the running sum of count values] if the running sum of count values is greater than the target count goal, as disclosed in Hayter et al., so as to provide a progress indicator having a length that is proportional to the amount of time that the analyte data is determined to be within a goal range for the time period (see Hayter et al.: [0286]).
Regarding claim 61, Cole et al. teaches a numerical value of the running sum of count values is displayed at the first end (see Figure 6). Hayter et al. also teaches a numerical value of the running sum of count values is displayed at the first end (see Figures 15C and 18A-B).
Regarding claim 62, Cole et al. teaches when the numerical value of the running sum of count values is zero, the numerical value of the running sum of count values is displayed near the first end (see Figure 6). Hayter et al. also teaches when the numerical value of the running sum of count values is zero, the numerical value of the running sum of count values is displayed near the first end (see Figures 15C and 18A-B).
Claim(s) 63-72 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cole et al, further in view of Lee (US Publication No. 2022/0108805 A1) (cited by Applicant).
Regarding claim 63, it is noted Cole et al. does not specifically teach the instructions, when executed by the one or more processors, further cause the system to: determine a difference between a first count value assigned in a first time period and a second count value assigned in a second time period, wherein the second time period is immediately after the first time period; assign a count trend status for the second time period from a plurality of count trend statuses based on the determined difference; and display a color representative of the assigned count trend status for the second time period. However, Lee teaches the instructions, when executed by the one or more processors, further cause the system to: determine a difference between a first count value assigned in a first time period and a second count value assigned in a second time period, wherein the second time period is immediately after the first time period (see [0067] – “The processor 120 may determine whether a glycemic variability index shows a rising trend or a falling trend over time, and may visualize the determination result. If a change with time in glycemic variability index at a second time compared to a first time, such as a value obtained by subtracting the glycemic variability index at the first time from the glycemic variability index at the second time, is greater than a first threshold value (positive value), the processor 120 may determine that a glycemic variability index “increases.” Alternatively, if the value is greater than or equal to a second threshold value (negative value) and is less than or equal to the first threshold value, the processor 120 may determine that the glycemic variability index “is maintained.” Alternatively, if the value is less than the second threshold value, the processor 120 may determine that the glycemic variability index “decreases.””); assign a count trend status (e.g. rising, falling, or maintained for the second time period from a plurality of count trend statuses based on the determined difference (see [0067] – “The processor 120 may determine whether a glycemic variability index shows a rising trend or a falling trend over time, and may visualize the determination result. If a change with time in glycemic variability index at a second time compared to a first time, such as a value obtained by subtracting the glycemic variability index at the first time from the glycemic variability index at the second time, is greater than a first threshold value (positive value), the processor 120 may determine that a glycemic variability index “increases.” Alternatively, if the value is greater than or equal to a second threshold value (negative value) and is less than or equal to the first threshold value, the processor 120 may determine that the glycemic variability index “is maintained.” Alternatively, if the value is less than the second threshold value, the processor 120 may determine that the glycemic variability index “decreases.””); and display a color representative of the assigned count trend status for the second time period (see Figures 4A-E and [0068] – “In addition, as illustrated in FIG. 4B, the rising intervals 11 and 13 and the falling intervals 12 and 14 may be shown in different colors so that the respective intervals may be distinguishable from each other” and [0069] – “For example, if the glycemic variability index shows a rising trend at the current time compared to a previous time, the processor 120 may display the first visualization object 41 in red and/or in a square shape; if the glycemic variability index shows a falling trend, the processor 120 may display the first visualization object 41 in blue and/or in a triangular shape; and if the glycemic variability index is in a maintaining interval, the processor 120 may display the first visualization object 41 in black and/or in a circular shape”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Cole et al. to include the instructions, when executed by the one or more processors, further cause the system to: determine a difference between a first count value assigned in a first time period and a second count value assigned in a second time period, wherein the second time period is immediately after the first time period; assign a count trend status for the second time period from a plurality of count trend statuses based on the determined difference; and display a color representative of the assigned count trend status for the second time period, as disclosed in Lee, so as to allow a user to easily and visually monitor their health condition, such as glycemic variability and/or diabetes risk, diabetic complication risk, and the like (see Lee: [0056]).
Regarding claim 64, Lee teaches the plurality of count trend statuses comprises a balanced status, a declining in spike status, a flat during spike status, and a rising in spike status (see [0067] – “The processor 120 may determine whether a glycemic variability index shows a rising trend or a falling trend over time, and may visualize the determination result. If a change with time in glycemic variability index at a second time compared to a first time, such as a value obtained by subtracting the glycemic variability index at the first time from the glycemic variability index at the second time, is greater than a first threshold value (positive value), the processor 120 may determine that a glycemic variability index “increases.” Alternatively, if the value is greater than or equal to a second threshold value (negative value) and is less than or equal to the first threshold value, the processor 120 may determine that the glycemic variability index “is maintained.” Alternatively, if the value is less than the second threshold value, the processor 120 may determine that the glycemic variability index “decreases.””).
Regarding claim 65, Lee teaches the first time period and the second time period both occur during a single glucose episode (see [0067] – “The processor 120 may determine whether a glycemic variability index shows a rising trend or a falling trend over time, and may visualize the determination result. If a change with time in glycemic variability index at a second time compared to a first time, such as a value obtained by subtracting the glycemic variability index at the first time from the glycemic variability index at the second time, is greater than a first threshold value (positive value), the processor 120 may determine that a glycemic variability index “increases.” Alternatively, if the value is greater than or equal to a second threshold value (negative value) and is less than or equal to the first threshold value, the processor 120 may determine that the glycemic variability index “is maintained.” Alternatively, if the value is less than the second threshold value, the processor 120 may determine that the glycemic variability index “decreases.””).
Regarding claim 66, Cole et al. teaches the progress indicator is displayed in a graphic user interface (GUI), and wherein the color is displayed as a background color of the GUI (see [0048] – “In some embodiments, other non-numerical representations can be used in addition to, or in place of, the aforementioned numerical scores. For example, the use of different colored indicators (e.g., red light, yellow light or green light), textual indicators (e.g., good, neutral, bad), graphical indicators (thumbs up, thumbs down, happy face, sad face or other emoticons), letter grades (e.g., A, B, C, D or F), are all within the scope of the present disclosure”). Lee also teaches the progress indicator is displayed in a graphic user interface (GUI), and wherein the color is displayed as a background color of the GUI (see Figures 4B-E and [0068] – “[0068] – “In addition, as illustrated in FIG. 4B, the rising intervals 11 and 13 and the falling intervals 12 and 14 may be shown in different colors so that the respective intervals may be distinguishable from each other”).
Regarding claim 67, Lee teaches the color representative of the assigned count trend status is displayed as a background color of a graphic user interface (GUI) (see Figures 4B-E and [0068] – “[0068] – “In addition, as illustrated in FIG. 4B, the rising intervals 11 and 13 and the falling intervals 12 and 14 may be shown in different colors so that the respective intervals may be distinguishable from each other”).
Regarding claim 68, Lee teaches the instructions, when executed by the one or more processors, further cause the system to: determine a difference between at least one additional count value in at least one additional time period and the second count value, wherein the at least one additional time period is immediately after the second time period (see [0067] – “The processor 120 may determine whether a glycemic variability index shows a rising trend or a falling trend over time, and may visualize the determination result. If a change with time in glycemic variability index at a second time compared to a first time, such as a value obtained by subtracting the glycemic variability index at the first time from the glycemic variability index at the second time, is greater than a first threshold value (positive value), the processor 120 may determine that a glycemic variability index “increases.” Alternatively, if the value is greater than or equal to a second threshold value (negative value) and is less than or equal to the first threshold value, the processor 120 may determine that the glycemic variability index “is maintained.” Alternatively, if the value is less than the second threshold value, the processor 120 may determine that the glycemic variability index “decreases.””); assign a count trend status for the at least one additional time period from a plurality of count trend statuses based on the determined difference (see [0067] – “The processor 120 may determine whether a glycemic variability index shows a rising trend or a falling trend over time, and may visualize the determination result. If a change with time in glycemic variability index at a second time compared to a first time, such as a value obtained by subtracting the glycemic variability index at the first time from the glycemic variability index at the second time, is greater than a first threshold value (positive value), the processor 120 may determine that a glycemic variability index “increases.” Alternatively, if the value is greater than or equal to a second threshold value (negative value) and is less than or equal to the first threshold value, the processor 120 may determine that the glycemic variability index “is maintained.” Alternatively, if the value is less than the second threshold value, the processor 120 may determine that the glycemic variability index “decreases.””); and display a color representative of the assigned count trend status for the at least one additional time period (see Figures 4A-E and [0068] – “In addition, as illustrated in FIG. 4B, the rising intervals 11 and 13 and the falling intervals 12 and 14 may be shown in different colors so that the respective intervals may be distinguishable from each other” and [0069] – “For example, if the glycemic variability index shows a rising trend at the current time compared to a previous time, the processor 120 may display the first visualization object 41 in red and/or in a square shape; if the glycemic variability index shows a falling trend, the processor 120 may display the first visualization object 41 in blue and/or in a triangular shape; and if the glycemic variability index is in a maintaining interval, the processor 120 may display the first visualization object 41 in black and/or in a circular shape”).
Regarding claim 69, Lee teaches the display comprises a graphic user interface, and wherein the color representative of the assigned count trend status for the at least one additional time period is displayed as a background color of a graphic user interface (GUI) (see Figures 4B-E and [0068] – “In addition, as illustrated in FIG. 4B, the rising intervals 11 and 13 and the falling intervals 12 and 14 may be shown in different colors so that the respective intervals may be distinguishable from each other”).
Regarding claim 70, Lee teaches the color representative of the assigned count trend status for the at least one additional time period is displayed as a background color of a first portion of the GUI, and the color representative of the assigned count trend status for the second time period is displayed in a second portion of the GUI (see Figures 4B-E and [0068] – “In addition, as illustrated in FIG. 4B, the rising intervals 11 and 13 and the falling intervals 12 and 14 may be shown in different colors so that the respective intervals may be distinguishable from each other”).
Regarding claim 71, Lee teaches the first portion of the GUI is a top portion and wherein the second portion of the GUI is a bottom portion (see Figures 4B-E and [0068] – “In addition, as illustrated in FIG. 4B, the rising intervals 11 and 13 and the falling intervals 12 and 14 may be shown in different colors so that the respective intervals may be distinguishable from each other” and [0071] – “As illustrated in FIG. 4D, the fourth visualization object 44 may be displayed in a predetermined area of the user interface 410, such as at positions corresponding to each time at the top of the trend graph of the change. Alternatively, as illustrated in FIG. 4E, the fourth visualization object 44 may be displayed on the first visualization object on the trend graph of the change”).
Regarding claim 72, Cole et a. teaches the color representative of the assigned count trend status for the at least one additional time period and the color representative of the assigned count trend status for the second time period are displayed as blended colors (see Figure 9 and [0059] – “Furthermore, each plotted analyte value can be assigned to one or more ranges, such as a high range, a medium range or a low range, wherein each range can be represented by an indicator such as a colored band extending from the horizontal axis at the bottom portion of the graph up to the plotted value. For example, red-colored band 514 can indicate an analyte value assigned to a high range; yellow-colored band 510 can indicate an analyte assigned to a medium range; and green-colored band 512 can indicate an analyte value assigned to a low range. Although three ranges (high, medium and low) and three corresponding colors (red, green and yellow) are depicted in FIG. 9, other ranges, indicators, colors, visual patterns and gradations can be used, and are thus within the scope of this disclosure”). Lee also teaches the color representative of the assigned count trend status for the at least one additional time period and the color representative of the assigned count trend status for the second time period are displayed as blended colors (see Figures 4B-E).
Conclusion
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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791
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