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 .
Response to Amendment
The preliminary amendment filed 30 June 2026 has been entered. Claims 56-62, 67-78, and 139-142 are pending and claims 63-66 are newly canceled. Applicant’s amendments to the claims have overcome each and every objection to the claims as well as each and every rejection under 35 U.S.C. 112(b) previously applied in the office action dated 17 March 2026.
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.
Utilizing the two step process adopted by the Supreme Court (Alice Corp vs CLS Bank Int'l, US
Supreme Court, 110 USPQ2d 1976 (2014) and the recent 101 guideline Federal Register Vol. 84, No., Jan
2019)), determination of the subject matter eligibility under the 35 U.S.C. 101 is as follows: Specifically, the Step 1 requires claim belongs to one of the four statutory categories (process, machine, manufacture, or composition of matter). If Step 1 is satisfied, then in the first part of Step 2A (Prong One), identification of any judicial recognized exceptions in the claim is made. If any limitation in the claim is identified as judicial recognized exception, then in the second part of Step 2A (Prong Two), determination is made whether the identified judicial exception is being integrated into practical application. If the identified judicial exception is not integrated into a practical application, then in Step 2B, the claim is further evaluated to see if the additional elements, individually and in combination provide "inventive concept" that would amount to significantly more than the judicial exception. If the element and combination of elements do not amount to significantly more than the judicial recognized exception itself, then the claim is ineligible under the 35 U.S.C. 101.
Claims 56-62, 67-78, and 139-142 are rejected under 35 U.S.C. 101.
Claim 56 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. The claim recite(s) "determining a first subset of the glucose data based on the filtering criteria, wherein the first subset of the glucose data comprises glucose data during a period when the glucose alarm was enabled; determining a second subset of the glucose data based on the filtering criteria, wherein the second subset of the glucose data comprises glucose data during a period when the glucose alarm was disabled". This judicial exception is not integrated into a practical application and the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 56 satisfies Step 1, namely the claim is directed to one of the four statutory classes, machine. Following Step 2A Prong one, any judicial exceptions are identified in the claims. In claim 56, the limitations "determining a first subset of the glucose data based on the filtering criteria, wherein the first subset of the glucose data comprises glucose data during a period when the glucose alarm was enabled; determining a second subset of the glucose data based on the filtering criteria, wherein the second subset of the glucose data comprises glucose data during a period when the glucose alarm was disabled" are abstract ideas as they are directed to a mental process or mathematical concept, as data may be filtered by hand via visual observation and identifying an area of interest or via a simple mathematical operation. With the identification of an abstract idea, the next phase is to proceed Step 2A, Prong Two, wherewith additional elements and taken as a whole, evaluation occurs of whether the identified abstract idea is integrated into a practical application.
In Step 2A, Prong Two, the claim does not recite any additional elements or evidence that amounts to significantly more than the judicial exception. Besides the abstract idea, the claim recites the additional elements ”computer-readable storage medium storing instructions which, when executed by one or more processors, cause the one or more processors to perform operations comprising: receiving, by communication circuitry, glucose data characterizing a glucose level of a user; receiving a filtering criteria selected by the user, wherein the filtering criteria comprises enablement and disablement of a glucose alarm” and “outputting, on a display, a first glucose profile and a second glucose profile on a single graphical user interface, wherein the first glucose profile displays the first subset of the glucose data when the glucose alarm was enabled over a first time period, and wherein the second glucose profile displays the second subset of the glucose data when the glucose alarm was disabled over the first time period”. However, these components may be seen as the use of well-understood, routine, or conventional elements to perform a non-mental process in order to gather data for the mental process step, much like the example given in MPEP 2106.04(d)(2)(c), such that these limitations are extra-solution activity and thus do not integrate the judicial exception into a practical application. The receiving and storing of data leads to the limitation of “determin[ing]” and “display[ing]such that the end result of use of the system is only the generic displayed profiles. As this is not defined as requiring any further action, such as a form of prophylaxis or treatment or an improvement to a computer or other technology, the claim limitations constitute mere generation of data, in this case the measurement of data relating to first and second physiological information, such that the claim does not integrate the judicial exception into any practical application. Regarding “executed by the one or more processors”, the limitation amounts to nothing more than an instruction to apply the abstract idea using a generic computer, which does not render an abstract idea eligible. The steps performed by the one or more processors are, as claimed, capable of being performed in the human mind similar to the examples given in MPEP 2106.04(a)(2)(III)(A)-(C), wherein it is described that “a claim to ‘collecting information, analyzing it, and displaying certain results of the collection and analysis’ where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind” recites a mental process and that claims which merely use a computer as a tool to perform a mental process are not eligible when “there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper” such as “mental processes of parsing and comparing data” when the steps are recited at a high level of generality and a computer is used merely as a tool to perform the processes. Under the broadest reasonable interpretation, the claim elements are recited with a high level of generality (as written, each claimed step of the process may be performed by a person in an undefined manner including excluding data outside of some chosen filter or by using a simple mathematical operation) that there are no meaningful limitations to the abstract idea. Consequently, with the identified abstract idea not being integrated into a practical application, the next step is Step 2B, evaluating whether the additional elements provide "inventive concept" that would amount to significantly more than the abstract idea.
In Step 2B, claim 56 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The limitation of ”computer-readable storage medium storing instructions which, when executed by one or more processors, cause the one or more processors to perform operations comprising: receiving, by communication circuitry, glucose data characterizing a glucose level of a user; receiving a filtering criteria selected by the user, wherein the filtering criteria comprises enablement and disablement of a glucose alarm” and “outputting, on a display, a first glucose profile and a second glucose profile on a single graphical user interface, wherein the first glucose profile displays the first subset of the glucose data when the glucose alarm was enabled over a first time period, and wherein the second glucose profile displays the second subset of the glucose data when the glucose alarm was disabled over the first time period” constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic communication circuitry, display, memory, and processor, which are generically claimed computer components performing basic functions and automating mental tasks. It is clear from the claims themselves and the specification that these additional limitations do not constitute a special machine or an improvement to a computer and instead utilize a generic computer having basic functions to execute the claimed functions of the system. This is further supported by Hayter (US 20180226150 A1) which provides a description of well-understood, routine, or conventional components of a reader device which may be in the form of a smartphone and including each of communication circuitry, memory, processors, and display which can be used for applications related to a diabetes monitoring regime in addition to other commonly used applications (Paragraphs 0050-0058). As discussed above with respect to integration of the abstract idea into a practical application, the present elements amount to no more than mere indications to apply the exception.
In Summary, claim 56 recites abstract idea without being integrated into a practical application, and does not provide additional elements that would amount to significantly more. As such, taken as a whole, the claim and is ineligible under the 35 U.S.C. 101.
Claim 139 is rejected under 35 U.S.C. 101 for similar reasons.
Claims 56-62, 67-78, and 141-142 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. As each of these claims depends from claim 56, which was rejected under 35 U.S.C. 101 in paragraph 5 of this action, these claims must be evaluated on whether they sufficiently add to the practical application of claim 56, or comprise significantly more than the limitations of claim 56.
Besides the abstract idea of claim 56: claims 57-60 recite limitations which amount to further details of the abstract idea of claim 56 which may themselves be considered abstract (where details of the filtering criteria may be mere considerations for a human making judgments of the data); claims 61-62 and 70-74 recite limitations which recite extra-solution activity which is not sufficient to integrate the judicial exception into a practical idea, namely the use of well-understood, routine, or conventional elements to perform mere data gathering and/or output; claims 67-69, 75-78 and 141-142 recite additional abstract ideas and details thereof which are directed toward mental processes or mathematical concepts (see limitations relating to determining recommended doses, determining metrics, determining statistics, determining risk, comparing profiles, identifying patterns each of which may rely upon human judgment of received data or mathematical operations applied to received data) similarly to the limitations of claim 56 as well as limitations which recite extra-solution activity which is not sufficient to integrate the judicial exception into a practical idea, namely the use of well-understood, routine, or conventional elements to perform mere data gathering and/or output.
The claim element of claim 56 of a system for displaying metrics relating to a subject is recited with a high level of generality (as written, the actions of the processing circuitry may be carried out by a person alone or with a generic computer in any undefined manner). This limitation provides no practical application, nor does it provide meaningful limitations to the abstract idea.
Claim 140 is rejected for similar reasons to claim 67.
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.
Claim(s) 56-62, 67-70, 74-78, and 139-140 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayter (US 20180226150) in view of Mensinger (US 20170143251 A1).
Regarding claim 56, Hayter teaches a computer-readable storage medium storing instructions (Paragraph 0042, 0063—non-transitory memory of the device…) which, when executed by one or more processors (206), cause the one or more processors to perform operations (Paragraph 0042, 0050, 0063, 0068) comprising:
Receiving, by communication circuitry (Paragraph 0043—components can be in wireless communication) glucose data characterizing a glucose level of a user (Paragraph 0096—determines, e.g., based on the user’s analyte level profile);
Receiving a filtering criteria selected by the user (Paragraph 0173-0178—an interactive filter 1810 is located between graph 1806 and table 1807…1810 allows the user to select which information is displayed in table…Filter 1810 can be included with any graph or other representation of data described herein having an associated table, such as table 1807 listing episodes; Fig. 18A-B) wherein the filtering criteria comprises enablement and disablement of a glucose alarm (Paragraph 0091-0093, 0096, 0140-0141--On screen 901 the type of episodes to be detected can be chosen by selecting check boxes 987 corresponding to the type of episode desired… On screen 902, the user can choose the times of day that episode detection can occur by selecting fields 988 (e.g., check boxes) corresponding to the times of day…Episode detection can be highly configurable and include many options. Episode detection can be enabled for one or more of selected time of day periods, certain days of the week, specific days, weeks, or months, or elapsed time; Figs. 8-15; paragraph 0173-0178--Here, the indicia are the episode indicators 1712, and the information displayed in table 1807 is the date and time of each episode, the type of each episode, and the responses recorded with respect to questions posed about the episode…Filter 1810 can therefore serve to reduce the amount of information displayed in table 1807, and also to allow the user to focus on only those episodes occurring during a particular time of day…Filter 1810 is not limited to use with analyte level graphs and episode indicators, but rather can be used to filter based on any type of information presented in the reports, such as exercise indicators, meal indicators, sleep indicators, medication dose indicators (e.g., LA insulin and/or RA insulin), textual notes or comments, or even segments of data display in graph 1806 without any overlying indicator (e.g., the analyte data itself)…);
determining a first subset of the glucose data based on the filtering criteria, wherein the first subset of the glucose data comprises glucose data during a period when the glucose alarm was enabled (Paragraph 0091-0093, 0096, 0140-0141, 0173-0178; Figs. 8-15, 17A-18B);
determining a second subset of the glucose data based on the filtering criteria, wherein the second subset of the glucose data comprises glucose data during a period when the glucose alarm was disabled (Paragraph 0091-0093, 0096-0115-- the type of episodes to be detected can be chosen by selecting check boxes 987 corresponding to the type of episode desired… the user can choose the times of day that episode detection can occur by selecting fields 988 (e.g., check boxes) corresponding to the times of day… When episode detection is enabled, data from the selected time of day periods are used for episode detection, however, prior data outside the selected time of day period can be used to determine if and/or when an episode occurred… the EIS can have an automatic time-of-day period enablement function that determines, e.g., based on the user's analyte level profile and/or historical times when episode occurrences are relatively high, whether to enable the EIS to detect one or more types of episodes; paragraph 0230-0232-- Selection of one of these fields 3511 can enable or disable the generation of notifications for that episode type and time-of-day.; paragraph 0173-0178-- This placement serves to filter from inclusion in table 1807 all episodes, notes and other information that occurred before 2 pm and after 6 pm in the daily graph 1806. Thus, only those episodes and notes occurring between 2 pm and 6 pm (inclusive or exclusive of those end times) are displayed in table 1807, which in this embodiment is two episodes. Filter 1810 can therefore serve to reduce the amount of information displayed in table 1807, and also to allow the user to focus on only those episodes occurring during a particular time of day; It is noted that in describing specific periods of time where episode detection is enabled, the periods of time outside of those specific periods would correspond to periods where the episode detection is disabled. Furthermore, if the EIS can automatically enable episode detection based on historical occurrences or based on the user’s analyte profile, it may further be seen that a subset of data is monitored while the episode detection is disabled in order to allow for the system to override the episode detection disablement. Because episode detection may be enabled in particular time periods, and thus disabled in other time periods, and the filter may be utilized to display data limited to any selected time period, the filter may be used to select a subset of data where the episode detection is disabled and a user did not receive episode alerts); and
outputting, on a display (Paragraph 0074, 0213—graphical user interface (GUI) screens for the EIS containing visit guide functionality and structure and are displayable on any computing device), a first glucose profile and a second glucose profile on a single graphical user interface (Figs. 21 and 58; Paragraphs 0191, 0289).
Hayter also generally teaches that graphs and reports may include any indicator or detail of another graph (Paragraph 0202, 0386).
However, Hayter does not explicitly disclose wherein the first glucose profile displays glucose levels associated with the time-correlated data over a first time period, and wherein the second glucose profile displays the subset of the time-correlated data over the first time period.
Mensinger, in the same field of endeavor of systems for providing health management capabilities for a user, discloses a system which can display a first glucose profile and a second glucose profile on a single graphical subject interface, wherein the first glucose profile displays glucose levels associated with the time-correlated data over a first time period, and wherein the second glucose profile displays the subset of the time-correlated data over the first time period (Fig. 9—a first time period and a second time period may be selected and the corresponding glucose profiles displayed within the same interface; paragraph 0094--the user interface 900 includes fields 910 and 920 for inputting respective first and second analysis time periods upon which statistical values, performance indicators, and/or performance reports are desired…if a different analysis time period is desired, a user can input a different analysis time period by selecting a desired analysis time period via drop down menu 930. The drop down menu 930 can allow the user to select one of a variety of analysis time periods, such as days, months, quarters, or years, or other custom time periods).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the computer-readable storage medium of Hayter with the displaying details of Mensinger in order to predictably improve the ability of a user to compare a subset of data against the data as a whole to monitor critical periods or periods of increased variability while still monitoring overall health and behaviors of a user. The combination is further supported by Hayter disclosing that the reports and graphs of the system may be modified to utilize the various arrangements of other graphs of the system (such as the dual-profile arrangement of Figs. 21 and 58) as desired (Paragraphs 0202, 0386).
Regarding claim 57, the combination of Hayter and Mensinger teaches the computer-readable storage medium of claim 56. Hayter additionally teaches wherein the glucose alarm is a low glucose alarm (Paragraph 0091-0093--Episodes can include…actual or impending low episodes (low glucose levels, e.g., less than a predetermined value)…and actual or impending rapid fall episodes (e.g., glucose levels are decreasing at a rate greater than a predetermined rate, e.g., 1 mg/dl or 2 mg/dl per minute)…).
Regarding claim 58, the combination of Hayter and Mensinger teaches the computer-readable storage medium of claim 57. Hayter additionally teaches wherein the low glucose alarm has a threshold of 70 mg/dL (See Figs. 7, 11, 12A-12C, 15, 18A-B—a normal glucose range is shown between horizontal threshold lines on the graph, where the horizontal lines occur at about 70mg/dL and about 180mg/dL; paragraph 0090-0093).
Regarding claim 59, the combination of Hayter and Mensinger teaches the computer-readable storage medium of claim 56. Hayter additionally teaches wherein the glucose alarm is a high glucose alarm (Paragraph 0091-0093-- Episodes can include…actual or impending high episodes (high glucose levels, e.g., greater than a predetermined value), and actual or impending rapid rise episodes (e.g., glucose levels are rising at a rate greater than a predetermined rate, e.g., 1 mg/dl or 2 mg/dl per minute), …).
Regarding claim 60, the combination of Hayter and Mensinger teaches the computer-readable storage medium of claim 59. Hayter additionally teaches wherein the high glucose alarm has a threshold of 180 mg/dL (See Figs. 7, 11, 12A-12C, 15, 18A-B—a normal glucose range is shown between horizontal threshold lines on the graph, where the horizontal lines occur at about 70mg/dL and about 180mg/dL; paragraph 0090-0093).
Regarding claim 61, the combination of Hayter and Mensinger teaches the computer-readable storage medium of claim 56. Hayter additionally teaches wherein the operations further comprise: displaying occurrences of the glucose alarm in the first time period on at least one of the first and second glucose profiles (Paragraph 0168-0177-- Daily report 1800 can include a graph 1806 including one or more of a glucose trace 1710 and color-coded markers 1712 for episodes occurring during the time period plotted, typically 24 hours or less…indicia for the information in time within graph 1806. Here, the indicia are the episode indicators 1712…).
Regarding claim 62, the combination of Hayter and Mensinger teaches the computer-readable storage medium of claim 56. Hayter additionally teaches wherein the operations further comprise:
receiving, by the communication circuitry, medication dosing data characterizing doses of a medication received by the user over the first time period; and displaying instances of doses of the medication received in the first time period on at least one of the first and second glucose profiles (Paragraph 0082, 0084, 0086, 0169, 0177-- Various icons 1804 representing notes entered during that day (such as those described with respect to FIG. 6B) are shown along glucose trace 1710. As described already, each note icon 1804 can indicate one or more of exercise, the consumption of food and/or fluids, the administration of medication (e.g., rapid acting (RA) insulin or long acting (LA) insulin)… Filter 1810 is not limited to use with analyte level graphs and episode indicators, but rather can be used to filter based on any type of information presented in the reports, such as…medication dose indicators (e.g., LA insulin and/or RA insulin); Fig. 18A-B).
Regarding claim 67, the combination of Hayter and Mensinger teaches the computer-readable storage medium of claim 56. Hayter additionally teaches wherein the operations further comprise:
receiving, by the communication circuitry, medication dosing data characterizing doses of a medication received by the user over the first time period (Paragraph 0082, 0084, 0086, 0169, 0177-- the administration of medication (e.g., rapid acting (RA) insulin or long acting (LA) insulin)…), and
wherein the filtering criteria further comprises dose concordance of a dose of the medication (Paragraph 0168-0177-- each note icon 1804 can indicate one or more of exercise, the consumption of food and/or fluids, the administration of medication (e.g., rapid acting (RA) insulin or long acting (LA) insulin… Filter 1810 is not limited to use with analyte level graphs and episode indicators, but rather can be used to filter based on any type of information presented in the reports, such as exercise indicators, meal indicators, sleep indicators, medication dose indicators (e.g., LA insulin and/or RA insulin), textual notes or comments, or even segments of data display in graph 1806 without any overlying indicator (e.g., the analyte data itself). Furthermore, filter 1810 can be used in any instance, including non-medical applications, where it is desired to focus the display of information in one data structure or visual representation (e.g., table 1807) on one portion or part of another data structure or visual representation (e.g., graph 1806); Paragraph 0006-- There are many possible reasons for the glucose excursions that make up glycemic variability: missing bolus and basal dosing, improper bolus timing, missing or improper correction bolus dosing, improper bolus amounts to cover meals; Fig. 58, paragraph 0298—"most frequent episodes” shows that episodes may include overbolusing (“Bolus too large”) or underbolusing (“Highs after breakfast”)).
Hayter additionally generally discloses the one or more processors may determine at least one recommendation (Paragraph 0322-- expert system 6102, runs a model for the patient that relates all of the inputs to future glucose levels. As more data becomes available, expert system 6102 updates the model and some of the relationships in the model become certain enough that they can be used to predict future glucose levels for that patient based on certain values of the inputs. Once these relationships are deemed to be adequately certain, then expert system 6102 can provide recommendations to the EIS mobile platform).
However, Hayter does not explicitly disclose the recommendation is at least one recommended dose.
Mensinger discloses that the system may receive doses of a medication received by the subject over a period of time, and wherein the memory further stores doses of a glucose-altering medication received by the subject over a period of time, wherein instructions cause the one or more processors to determine at least one recommended dose (Paragraph 0030, 0074--recommendations/advice that may be aimed at improving overall glucose control, diabetes management, modified timing, and/or amount of pre-prandial insulin dose information… if criteria for a particular clinical/therapy recommendation are met, such as if a particular trend in glucose variability is met by a host, the particular clinical/therapy recommendation may be displayed). It is noted that as Mensinger discloses that recommendations/advice may be aimed at providing modified timing and/or amounts of insulin dose information, the existing timing and/or amounts must be known and thus received by the system.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the computer-readable storage medium of Hayter to additionally include the at least one recommended dose of Mensinger in order to predictably improve the ability of the system to not only visualize and analyze data but to provide meaningful outputs such as recommendations from this data and analysis to further enable a user to control their blood glucose levels.
Regarding claim 68, the combination of Hayter and Mensinger teaches the computer-readable storage medium of claim 67. Hayter additionally teaches wherein the medication dosing data comprises a dose regimen for the user (Paragraph 0082, 0084, 0086, 0169, 0177-- the administration of medication (e.g., rapid acting (RA) insulin or long acting (LA) insulin)…).
Hayter does not disclose wherein the at least one recommended dose is at least partly determined from the dose regimen.
Mensinger discloses wherein the at least one recommended dose is at least partly determined from the dose regimen (Paragraph 0030, 0074--recommendations/advice that may be aimed at improving overall glucose control, diabetes management, modified timing, and/or amount of pre-prandial insulin dose information… if criteria for a particular clinical/therapy recommendation are met, such as if a particular trend in glucose variability is met by a host, the particular clinical/therapy recommendation may be displayed). It is noted that as Mensinger discloses that recommendations/advice may be aimed at providing modified timing and/or amounts of insulin dose information, the existing timing and/or amounts must be known and thus received by the system.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the computer-readable storage medium of Hayter to additionally include the at least one recommended dose of Mensinger in order to predictably improve the ability of the system to not only visualize and analyze data but to provide meaningful outputs such as recommendations from this data and analysis to further enable a user to control their blood glucose levels.
Regarding claim 69, the combination of Hayter and Mensinger teaches the computer-readable storage medium of claim 67. Hayter additionally teaches wherein the dose concordance comprises missed doses, under-bolused doses with reference to the at least one recommended dose, over-bolused doses with reference to the at least one recommended dose, late meal doses, or extra meal doses (Paragraph 0168-0177-- each note icon 1804 can indicate one or more of exercise, the consumption of food and/or fluids, the administration of medication (e.g., rapid acting (RA) insulin or long acting (LA) insulin… Filter 1810 is not limited to use with analyte level graphs and episode indicators, but rather can be used to filter based on any type of information presented in the reports, such as exercise indicators, meal indicators, sleep indicators, medication dose indicators (e.g., LA insulin and/or RA insulin), textual notes or comments, or even segments of data display in graph 1806 without any overlying indicator (e.g., the analyte data itself). Furthermore, filter 1810 can be used in any instance, including non-medical applications, where it is desired to focus the display of information in one data structure or visual representation (e.g., table 1807) on one portion or part of another data structure or visual representation (e.g., graph 1806); Paragraph 0006-- There are many possible reasons for the glucose excursions that make up glycemic variability: missing bolus and basal dosing, improper bolus timing, missing or improper correction bolus dosing, improper bolus amounts to cover meals; Fig. 58, paragraph 0298—"most frequent episodes” shows that episodes may include overbolusing (“Bolus too large”) or underbolusing (“Highs after breakfast”)).
Regarding claim 70, the combination of Hayter and Mensinger teaches the computer-readable storage medium of claim 56. Hayter additionally teaches a glucose profile comprises a trace of a median glucose level (Paragraph 0180-0184-- A central tendency (e.g., a median or mean) 1910 is depicted with a trace). As Hayter discloses that a graph may include any indicator or detail of another graph (Paragraph 0202, 0386), it may be seen that the first and second glucose profiles (e.g., the unfiltered and filtered profiles such as the filtered profile discussed in paragraph 0177) may thus include a median glucose level trace.
Regarding claim 74, the combination of Hayter and Mensinger teaches the computer-readable storage medium of claim 56. Hayter additionally teaches a profile comprises a plurality of traces, wherein a trace of the plurality of traces corresponds to a day of the first period of time, and wherein the plurality of traces are displayed in an overlay pattern (Paragraph 0180-0184; Figs. 12A-19B—plurality of traces can include a trace of analyte levels over the course of a day). As Hayter discloses that a graph may include any indicator or detail of another graph (Paragraph 0202, 0386), it may be seen that the first and second glucose profiles (e.g., the unfiltered and filtered profiles such as the filtered profile discussed in paragraph 0177) may thus include a plurality of traces.
Regarding claim 75, the combination of Hayter and Mensinger teaches the computer-readable storage medium of claim 56. Hayter additionally teaches wherein the operations further comprise:
determining a first glucose metric based on the first subset of the glucose data when the glucose alarm was enabled for the first time period; determining a second glucose metric based on the second subset of the glucose data when the glucose alarm was disabled for the first time period (Figs. 18A-18B—the nonfiltered and filtered interfaces can show metrics such as a number of total episodes, number of episodes per type, time spent above or below a threshold glucose level etc.; paragraphs 0168-0177-- Each entry in table 1807 can correspond to a marker 1712 indicating an episode in the graph. Within table 1807, the user can sort episodes and responses by day, episode timestamp, episode type, or response… Filter 1810 can therefore serve to reduce the amount of information displayed in table 1807, and also to allow the user to focus on only those episodes occurring during a particular time of day…). As Hayter discloses that a graph may include any indicator or detail of another graph (Paragraph 0202, 0386), it may be seen that the system may display the first glucose metric and the second glucose metric on the single graphical subject interface.
Mensinger additionally discloses determining a first glucose metric based on the first subset of the glucose data for the first time period; determining a second glucose metric based on the second subset of the glucose data for the first time period; and displaying the first glucose metric and the second glucose metric on the single graphical subject interface (Fig. 9—display includes metrics and statistics for each glucose profile; paragraph 0094-0096-- generate statistical values, performance indicators, and performance reports for display to the host and/or others on a display of a computing device… It should also be understood that user interface 900 can be modified to display any of the other performance statistics (e.g., performance reports, performance indicators, and/or statistical values based on sensor readings) described herein. In addition, more than two time analysis periods can be selected and displayed on user interface 900.).
Regarding claim 76, the combination of Hayter and Mensinger teaches the computer-readable storage medium of claim 56. Hayter additionally teaches wherein the operations further comprise:
determining at least one first glucose statistic based on the first subset of the glucose data when the glucose alarm was enabled for the first time period; determining at least one second glucose statistic based on the second subset of the glucose data when the glucose alarm was disabled for the first time period (Figs. 18A-18B—the nonfiltered and filtered interfaces can show metrics such as a number of total episodes, number of episodes per type, time spent above or below a threshold glucose level etc.; paragraphs 0168-0177-- Each entry in table 1807 can correspond to a marker 1712 indicating an episode in the graph. Within table 1807, the user can sort episodes and responses by day, episode timestamp, episode type, or response… Filter 1810 can therefore serve to reduce the amount of information displayed in table 1807, and also to allow the user to focus on only those episodes occurring during a particular time of day…). As Hayter discloses that a graph may include any indicator or detail of another graph (Paragraph 0202, 0386), it may be seen that the system may display the at least one first glucose statistic and the at least one second glucose statistic on the single graphical subject interface.
Mensinger additionally discloses determining at least one first glucose statistic based on the first subset of the glucose data for the first time period; determining at least one second glucose statistic based on the second subset of the glucose for the first time period; and displaying the at least one first glucose statistic and the at least one second glucose statistic on the single graphical subject interface (Fig. 9—display includes metrics and statistics for each glucose profile; paragraph 0094-0096-- generate statistical values, performance indicators, and performance reports for display to the host and/or others on a display of a computing device… It should also be understood that user interface 900 can be modified to display any of the other performance statistics (e.g., performance reports, performance indicators, and/or statistical values based on sensor readings) described herein. In addition, more than two time analysis periods can be selected and displayed on user interface 900.).
Regarding claim 77, the combination of Hayter and Mensinger teaches the computer-readable storage medium of claim 76. Hayter additionally teaches wherein the at least one first glucose statistic comprises a first glucose management indicator, a first average glucose, a first standard deviation, or a combination thereof, and wherein the at least one second glucose statistic comprises a second glucose management indicator, a second average glucose, a second standard deviation, or a combination thereof (Paragraph 0177-- Filter 1810 is not limited to use with analyte level graphs and episode indicators, but rather can be used to filter based on any type of information presented in the reports, such as exercise indicators, meal indicators, sleep indicators, medication dose indicators (e.g., LA insulin and/or RA insulin), textual notes or comments, or even segments of data display in graph 1806 without any overlying indicator (e.g., the analyte data itself).; Paragraph 0180-- The AGP region 1902 can include a plot of glucose values for the selected days across a time scale of a typical day. A central tendency (e.g., a median or mean) 1910 is depicted with a trace; Paragraph 0241-- In some embodiments, metrics report 3800 will aggregate, for each visit baseline data range, the average number of episodes per day that were prompted (attributes b+c), and the fraction of these prompted episodes that were responded to (attributes b/(b+c)))). As Hayter discloses that a graph may include any indicator or detail of another graph (Paragraph 0202, 0386), it may be seen that the system these statistics may be displayed on the graph of unfiltered or filtered data.
Mensinger additionally discloses wherein the at least one first glucose statistic comprises a first glucose management indicator, a first average glucose, a first standard deviation, or a combination thereof, and wherein the at least one second glucose statistic comprises a second glucose management indicator, a second average glucose, a second standard deviation, or a combination thereof (Fig. 9—display includes metrics and statistics for each glucose profile including mean glucose, standard deviations, percent in target, etc.; paragraph 0094-0096-- generate statistical values, performance indicators, and performance reports for display to the host and/or others on a display of a computing device… It should also be understood that user interface 900 can be modified to display any of the other performance statistics (e.g., performance reports, performance indicators, and/or statistical values based on sensor readings) described herein. In addition, more than two time analysis periods can be selected and displayed on user interface 900.).
Regarding claim 78, the combination of Hayter and Mensinger teaches the computer-readable storage medium of claim 56. Hayter additionally teaches wherein the operations further comprise:
determining a first hypoglycemia risk based on the first subset of the glucose data when the glucose alarm was enabled for the first time period; determining a second hypoglycemia risk based on the second subset of the glucose data when the glucose alarm was disabled for the first time period and displaying the first hypoglycemia risk and the second hypoglycemia risk on the single graphical subject interface (Paragraph 0096-0115-- the EIS can have an automatic time-of-day period enablement function that determines, e.g., based on the user's analyte level profile and/or historical times when episode occurrences are relatively high, whether to enable the EIS to detect one or more types of episodes… The determinations of the severity of a risk or characteristic (e.g., low, medium, or high, or others) can be made by reference to the diabetic” s most recent or other selected glucose profile, to a plurality of selected glucose profiles, and/or other historical glucose data). As Hayter discloses that a graph may include any indicator or detail of another graph (Paragraph 0202, 0386), it may be seen that these statistics may be displayed on the graph of unfiltered or filtered data.
Regarding claim 139, Hayter teaches method for displaying metrics relating to a user (Paragraph 0042, 0050, 0063, 0068), the method comprising:
Receiving, by communication circuitry (Paragraph 0043—components can be in wireless communication) glucose data characterizing a glucose level of a user (Paragraph 0096—determines, e.g., based on the user’s analyte level profile);
Receiving, by at least one processor (206) a filtering criteria selected by the user (Paragraph 0173-0178—an interactive filter 1810 is located between graph 1806 and table 1807…1810 allows the user to select which information is displayed in table…Filter 1810 can be included with any graph or other representation of data described herein having an associated table, such as table 1807 listing episodes; Fig. 18A-B) wherein the filtering criteria comprises enablement and disablement of a glucose alarm (Paragraph 0091-0093, 0096, 0140-0141--On screen 901 the type of episodes to be detected can be chosen by selecting check boxes 987 corresponding to the type of episode desired… On screen 902, the user can choose the times of day that episode detection can occur by selecting fields 988 (e.g., check boxes) corresponding to the times of day…Episode detection can be highly configurable and include many options. Episode detection can be enabled for one or more of selected time of day periods, certain days of the week, specific days, weeks, or months, or elapsed time; Figs. 8-15; paragraph 0173-0178--Here, the indicia are the episode indicators 1712, and the information displayed in table 1807 is the date and time of each episode, the type of each episode, and the responses recorded with respect to questions posed about the episode…Filter 1810 can therefore serve to reduce the amount of information displayed in table 1807, and also to allow the user to focus on only those episodes occurring during a particular time of day…Filter 1810 is not limited to use with analyte level graphs and episode indicators, but rather can be used to filter based on any type of information presented in the reports, such as exercise indicators, meal indicators, sleep indicators, medication dose indicators (e.g., LA insulin and/or RA insulin), textual notes or comments, or even segments of data display in graph 1806 without any overlying indicator (e.g., the analyte data itself)…);
Determining, by the at least one processor, a first subset of the glucose data based on the filtering criteria, wherein the first subset of the glucose data comprises glucose data during a period when the glucose alarm was enabled (Paragraph 0091-0093, 0096, 0140-0141, 0173-0178; Figs. 8-15, 17A-18B);
Determining, by the at least one processor, a second subset of the glucose data based on the filtering criteria, wherein the second subset of the glucose data comprises glucose data during a period when the glucose alarm was disabled (Paragraph 0091-0093, 0096-0115-- the type of episodes to be detected can be chosen by selecting check boxes 987 corresponding to the type of episode desired… the user can choose the times of day that episode detection can occur by selecting fields 988 (e.g., check boxes) corresponding to the times of day… When episode detection is enabled, data from the selected time of day periods are used for episode detection, however, prior data outside the selected time of day period can be used to determine if and/or when an episode occurred… the EIS can have an automatic time-of-day period enablement function that determines, e.g., based on the user's analyte level profile and/or historical times when episode occurrences are relatively high, whether to enable the EIS to detect one or more types of episodes; paragraph 0230-0232-- Selection of one of these fields 3511 can enable or disable the generation of notifications for that episode type and time-of-day.; paragraph 0173-0178-- This placement serves to filter from inclusion in table 1807 all episodes, notes and other information that occurred before 2 pm and after 6 pm in the daily graph 1806. Thus, only those episodes and notes occurring between 2 pm and 6 pm (inclusive or exclusive of those end times) are displayed in table 1807, which in this embodiment is two episodes. Filter 1810 can therefore serve to reduce the amount of information displayed in table 1807, and also to allow the user to focus on only those episodes occurring during a particular time of day; It is noted that in describing specific periods of time where episode detection is enabled, the periods of time outside of those specific periods would correspond to periods where the episode detection is disabled. Furthermore, if the EIS can automatically enable episode detection based on historical occurrences or based on the user’s analyte profile, it may further be seen that a subset of data is monitored while the episode detection is disabled in order to allow for the system to override the episode detection disablement. Because episode detection may be enabled in particular time periods, and thus disabled in other time periods, and the filter may be utilized to display data limited to any selected time period, the filter may be used to select a subset of data where the episode detection is disabled and a user did not receive episode alerts); and
outputting, to a display (Paragraph 0074, 0213—graphical user interface (GUI) screens for the EIS containing visit guide functionality and structure and are displayable on any computing device), a first glucose profile and a second glucose profile on a single graphical user interface (Figs. 21 and 58; Paragraphs 0191, 0289).
Hayter also generally teaches that graphs and reports may include any indicator or detail of another graph (Paragraph 0202, 0386).
However, Hayter does not explicitly disclose wherein the first glucose profile displays glucose levels associated with the time-correlated data over a first time period, and wherein the second glucose profile displays the subset of the time-correlated data over the first time period.
Mensinger, in the same field of endeavor of systems for providing health management capabilities for a user, discloses a system which can display a first glucose profile and a second glucose profile on a single graphical subject interface, wherein the first glucose profile displays glucose levels associated with the time-correlated data over a first time period, and wherein the second glucose profile displays the subset of the time-correlated data over the first time period (Fig. 9—a first time period and a second time period may be selected and the corresponding glucose profiles displayed within the same interface; paragraph 0094--the user interface 900 includes fields 910 and 920 for inputting respective first and second analysis time periods upon which statistical values, performance indicators, and/or performance reports are desired…if a different analysis time period is desired, a user can input a different analysis time period by selecting a desired analysis time period via drop down menu 930. The drop down menu 930 can allow the user to select one of a variety of analysis time periods, such as days, months, quarters, or years, or other custom time periods).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the method of Hayter with the displaying details of Mensinger in order to predictably improve the ability of a user to compare a subset of data against the data as a whole to monitor critical periods or periods of increased variability while still monitoring overall health and behaviors of a user. The combination is further supported by Hayter disclosing that the reports and graphs of the system may be modified to utilize the various arrangements of other graphs of the system (such as the dual-profile arrangement of Figs. 21 and 58) as desired (Paragraphs 0202, 0386).
Regarding claim 140, the combination of Hayter and Mensinger teaches the method of claim 139. Hayter additionally teaches the method further comprising:
receiving, by the communication circuitry, medication dosing data characterizing doses of a medication received by the user over the first time period (Paragraph 0082, 0084, 0086, 0169, 0177-- the administration of medication (e.g., rapid acting (RA) insulin or long acting (LA) insulin)…), and
wherein the filtering criteria further comprises dose concordance of a dose of the medication (Paragraph 0168-0177-- each note icon 1804 can indicate one or more of exercise, the consumption of food and/or fluids, the administration of medication (e.g., rapid acting (RA) insulin or long acting (LA) insulin… Filter 1810 is not limited to use with analyte level graphs and episode indicators, but rather can be used to filter based on any type of information presented in the reports, such as exercise indicators, meal indicators, sleep indicators, medication dose indicators (e.g., LA insulin and/or RA insulin), textual notes or comments, or even segments of data display in graph 1806 without any overlying indicator (e.g., the analyte data itself). Furthermore, filter 1810 can be used in any instance, including non-medical applications, where it is desired to focus the display of information in one data structure or visual representation (e.g., table 1807) on one portion or part of another data structure or visual representation (e.g., graph 1806); Paragraph 0006-- There are many possible reasons for the glucose excursions that make up glycemic variability: missing bolus and basal dosing, improper bolus timing, missing or improper correction bolus dosing, improper bolus amounts to cover meals; Fig. 58, paragraph 0298—"most frequent episodes” shows that episodes may include overbolusing (“Bolus too large”) or underbolusing (“Highs after breakfast”)).
Hayter additionally generally discloses the one or more processors may determine at least one recommendation (Paragraph 0322-- expert system 6102, runs a model for the patient that relates all of the inputs to future glucose levels. As more data becomes available, expert system 6102 updates the model and some of the relationships in the model become certain enough that they can be used to predict future glucose levels for that patient based on certain values of the inputs. Once these relationships are deemed to be adequately certain, then expert system 6102 can provide recommendations to the EIS mobile platform).
However, Hayter does not explicitly disclose the recommendation is at least one recommended dose.
Mensinger discloses that the system may receive doses of a medication received by the subject over a period of time, and wherein the memory further stores doses of a glucose-altering medication received by the subject over a period of time, wherein instructions cause the one or more processors to determine at least one recommended dose (Paragraph 0030, 0074--recommendations/advice that may be aimed at improving overall glucose control, diabetes management, modified timing, and/or amount of pre-prandial insulin dose information… if criteria for a particular clinical/therapy recommendation are met, such as if a particular trend in glucose variability is met by a host, the particular clinical/therapy recommendation may be displayed). It is noted that as Mensinger discloses that recommendations/advice may be aimed at providing modified timing and/or amounts of insulin dose information, the existing timing and/or amounts must be known and thus received by the system.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the computer-readable storage medium of Hayter to additionally include the at least one recommended dose of Mensinger in order to predictably improve the ability of the system to not only visualize and analyze data but to provide meaningful outputs such as recommendations from this data and analysis to further enable a user to control their blood glucose levels.
Claim(s) 71-73 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayter in view of Mensinger, further in view of Dunn (WO 2014106263 A2).
Regarding claim 71, the combination of Hayter and Mensinger teaches the computer-readable storage medium of claim 70. Hayter additionally teaches wherein the first glucose profile and the second glucose profile each further comprise an upper trace of hourly 90th percentile of glucose levels and a lower trace of an hourly 10th percentile of glucose levels (Paragraph 0180-0184-- Next to region 1912 is a second region 1914 that corresponds to the values of data that are within a wider percentile range of the central tendency (e.g., the 10.sup.th percentile of data points to the 90.sup.th percentile of date points)). As Hayter discloses that a graph may include any indicator or detail of another graph (Paragraph 0202, 0386), it may be seen that the first and second glucose profiles (e.g., the unfiltered and filtered profiles such as the filtered profile discussed in paragraph 0177) may each include traces.
Hayter does not explicitly disclose an hourly 95th percentile of glucose levels and a lower trace of an hourly 5th percentile of glucose levels.
Dunn, in the same field of endeavor of a system for determining and visualizing glucose data of a user, discloses a graphic may include an hourly 95th percentile of glucose levels and a lower trace of an hourly 5th percentile of glucose levels (Paragraph 0172-- start is identified as the average timestamp of the 5 percentile glucose value in that segment, and the peak is identified as the average timestamp of the 95th percentile glucose value; paragraph 0183-0185, 0196, 0281-0282-- The AGP 104 is a graph of the 10th, 25th, 50th (median), 75th, and 90th percentiles of glucose readings, presented over the "typical" day 116 based on all days within the selected timeframe… Two alternate variability formulas are compared to the S40 in terms of the ability to estimate the risk of hypoglycemia: 1. Interquartile range (IQR), the difference of the 75th and 25th percentiles, and 2. The difference of the 90th percentile and the 10th percentile, colloquially known as the "mid80.").
It would have been obvious to one having ordinary skill in the art at the time of filing to modify Hayter to include an hourly 95th percentile of glucose levels and a lower trace of an hourly 5th percentile of glucose levels as disclosed by Dunn in order to provide a known measurement of a risk of hypoglycemia called the mid80 and additionally to improve the accuracy of the device in monitoring time-to-peak durations of glucose levels while not being as susceptible to outliers as other metrics (see Dunn, paragraphs 0169-0174, 0196).
Regarding claim 72, the combination of Hayter and Mensinger teaches the computer-readable storage medium of claim 71. Hayter additionally teaches a profile may comprise a second upper trace of an hourly 75th percentile of glucose levels and a second lower trace of an hourly 25th percentile of glucose levels (Paragraph 0180-0184--Surrounding this trace 1910 is a region 1912 that corresponds to the values of the data that are within a percentile range of the central tendency (e.g., the 25.sup.th percentile of data points to the 75.sup.th percentile of date points)). As Hayter discloses that a graph may include any indicator or detail of another graph (Paragraph 0202, 0386), it may be seen that the first and second glucose profiles (e.g., the unfiltered and filtered profiles such as the filtered profile discussed in paragraph 0177) may thus include the traces.
Regarding claim 73, the combination of Hayter and Mensinger teaches the computer-readable storage medium of claim 71. Hayter additionally teaches a profile may comprise an upper trace of an hourly 75th percentile of glucose levels and a lower trace of an hourly 10th or 25th percentile of glucose levels (Paragraph 0180-0184-- Surrounding this trace 1910 is a region 1912 that corresponds to the values of the data that are within a percentile range of the central tendency (e.g., the 25.sup.th percentile of data points to the 75.sup.th percentile of date points). Next to region 1912 is a second region 1914 that corresponds to the values of data that are within a wider percentile range of the central tendency (e.g., the 10.sup.th percentile of data points to the 90.sup.th percentile of date points).). As Hayter discloses that a graph may include any indicator or detail of another graph (Paragraph 0202, 0386), it may be seen that the first and second glucose profiles (e.g., the unfiltered and filtered profiles such as the filtered profile discussed in paragraph 0177) may thus include the traces.
Hayter does not explicitly disclose a lower trace of an hourly 15th percentile of glucose levels.
Dunn, in the same field of endeavor of a system for determining and visualizing glucose data of a user, discloses a graphic may include an hourly 75th percentile of glucose levels and a lower trace of an hourly 5th, 10th, or 25th percentile of glucose levels (Paragraph 0172-- start is identified as the average timestamp of the 5 percentile glucose value in that segment, and the peak is identified as the average timestamp of the 95th percentile glucose value; paragraph 0183-0185, 0196, 0281-0282-- The AGP 104 is a graph of the 10th, 25th, 50th (median), 75th, and 90th percentiles of glucose readings, presented over the "typical" day 116 based on all days within the selected timeframe… Two alternate variability formulas are compared to the S40 in terms of the ability to estimate the risk of hypoglycemia: 1. Interquartile range (IQR), the difference of the 75th and 25th percentiles, and 2. The difference of the 90th percentile and the 10th percentile, colloquially known as the "mid80.").
While Dunn does not explicitly disclose a 15th percentile trace, it would have been obvious to one having ordinary skill in the art at the time of filing to modify Hayter to include 15th percentile trace of glucose levels as Dunn demonstrates that a plurality of lower traces starting at an hourly 5th percentile may be utilized to improve the accuracy of the device in monitoring time-to-peak durations of glucose levels while not being as susceptible to outliers as other metrics (see Dunn, paragraphs 0169-0174, 0196) and to enable a user to more easily visualize the variability of a glucose metric.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 56-62 and 139 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 214 of copending Application No. 17725063 in view of Hayter (US 20180226150 A1).
Claim 200 of the reference application discloses receiving, by communication circuitry, glucose data characterizing a glucose level of a user and doses of a medication received by the user over a period of time; receiving a filtering criteria selected by the user; determining a first subset of the glucose data based on the filtering criteria; determining a second subset of the glucose data based on the filtering criteria; and outputting, on a display, a first glucose profile and a second glucose profile on a single graphical user interface, wherein the first glucose profile displays the first subset of the glucose data, and wherein the second glucose profile displays the second subset of the glucose data. Claim 214 of the reference application discloses determining a second subset of time-correlated data based on the filtering criteria selected by the subject, and displaying a third glucose profile on the single graphical subject interface, wherein the third glucose profile displays the second subset of time-correlated data over the first time period.
However, the reference application fails to disclose wherein the filtering criteria comprises enablement and disablement of at least one alarm of claim 56 and is silent as to the remaining limitations of claims 57-66.
Hayter, in the same field of endeavor of a system for diabetes management including a filter for determining a subset of time-correlated data, discloses wherein the filtering criteria comprises enablement and disablement of a glucose alarm (Paragraph 0091-0093, 0096, 0140-0141--On screen 901 the type of episodes to be detected can be chosen by selecting check boxes 987 corresponding to the type of episode desired… On screen 902, the user can choose the times of day that episode detection can occur by selecting fields 988 (e.g., check boxes) corresponding to the times of day…Episode detection can be highly configurable and include many options. Episode detection can be enabled for one or more of selected time of day periods, certain days of the week, specific days, weeks, or months, or elapsed time; Figs. 8-15; paragraph 0173-0178--Here, the indicia are the episode indicators 1712, and the information displayed in table 1807 is the date and time of each episode, the type of each episode, and the responses recorded with respect to questions posed about the episode…Filter 1810 can therefore serve to reduce the amount of information displayed in table 1807, and also to allow the user to focus on only those episodes occurring during a particular time of day…Filter 1810 is not limited to use with analyte level graphs and episode indicators, but rather can be used to filter based on any type of information presented in the reports, such as exercise indicators, meal indicators, sleep indicators, medication dose indicators (e.g., LA insulin and/or RA insulin), textual notes or comments, or even segments of data display in graph 1806 without any overlying indicator (e.g., the analyte data itself)…).
Hayter also generally teaches that graphs and reports may include any indicator or detail of another graph (Paragraph 0202, 0386).
Hayter additionally teaches wherein the glucose alarm is a low glucose alarm (Paragraph 0091-0093--Episodes can include…actual or impending low episodes (low glucose levels, e.g., less than a predetermined value)…and actual or impending rapid fall episodes (e.g., glucose levels are decreasing at a rate greater than a predetermined rate, e.g., 1 mg/dl or 2 mg/dl per minute)…).
Hayter additionally teaches wherein the low glucose alarm has a threshold of 70 mg/dL (See Figs. 7, 11, 12A-12C, 15, 18A-B—a normal glucose range is shown between horizontal threshold lines on the graph, where the horizontal lines occur at about 70mg/dL and about 180mg/dL; paragraph 0090-0093).
Hayter additionally teaches wherein the glucose alarm is a high glucose alarm (Paragraph 0091-0093-- Episodes can include…actual or impending high episodes (high glucose levels, e.g., greater than a predetermined value), and actual or impending rapid rise episodes (e.g., glucose levels are rising at a rate greater than a predetermined rate, e.g., 1 mg/dl or 2 mg/dl per minute), …).
Hayter additionally teaches wherein the high glucose alarm has a threshold of 180 mg/dL (See Figs. 7, 11, 12A-12C, 15, 18A-B—a normal glucose range is shown between horizontal threshold lines on the graph, where the horizontal lines occur at about 70mg/dL and about 180mg/dL; paragraph 0090-0093).
Hayter additionally teaches wherein the operations further comprise: displaying occurrences of the glucose alarm in the first time period on at least one of the first and second glucose profiles (Paragraph 0168-0177-- Daily report 1800 can include a graph 1806 including one or more of a glucose trace 1710 and color-coded markers 1712 for episodes occurring during the time period plotted, typically 24 hours or less…indicia for the information in time within graph 1806. Here, the indicia are the episode indicators 1712…).
Hayter additionally teaches wherein the operations further comprise:
receiving, by the communication circuitry, medication dosing data characterizing doses of a medication received by the user over the first time period; and displaying instances of doses of the medication received in the first time period on at least one of the first and second glucose profiles (Paragraph 0082, 0084, 0086, 0169, 0177-- Various icons 1804 representing notes entered during that day (such as those described with respect to FIG. 6B) are shown along glucose trace 1710. As described already, each note icon 1804 can indicate one or more of exercise, the consumption of food and/or fluids, the administration of medication (e.g., rapid acting (RA) insulin or long acting (LA) insulin)… Filter 1810 is not limited to use with analyte level graphs and episode indicators, but rather can be used to filter based on any type of information presented in the reports, such as…medication dose indicators (e.g., LA insulin and/or RA insulin); Fig. 18A-B).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of the reference application to include the particular filtering criteria and displayed indicators disclosed by Hayter in order to predictably improve the ability of the filter to allow a user to easily focus on a particular time of increased concern where a user enabled an alarm, such as a period of historically high glucose variability or frequent episodes of hypo- or hyper-glycemia or a period of normal behavior where an alarm is disabled, such as a period of historically low glucose variability of infrequent episodes, and to observe episodes and behaviors within either time period which may prompt changes in behavior or actions, such as changing a dose or timing of medication based on the patterns shown in the displayed graphics.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 30 June 2026 with respect to the non-statutory obviousness-type double patenting rejection have been fully considered. The rejection has been updated to reflect the cancellation of various claims and the amendments to the claims, wherein the amended claim scope does not appear to overcome the rejection.
Applicant's arguments filed 30 June 2026 regarding the rejection of the claims under 35 U.S.C. 101 have been fully considered but they are not persuasive.
The applicant argues that amended claim 56 cannot practically be performed in the human mind, in particular arguing that such calculations would “involve multiple subsets of continuous glucose data over an extended time period (e.g., 14 days) and visually organizing the large volumes of glucose data into specific subsets based on whether the glucose alarm was enabled or disabled”.
However, at present, the claim language reflects no required timeframe or speed of calculation which would preclude the human mind from performing such observation and organization even when applied to a very large data set, wherein the actual organization of the data would require the same steps to be performed by a user and may simply require more time to parse the data or perform the analysis. Furthermore, the current claim language does not reflect the use of any particular amount of data as it requires only “receiving…glucose data” and is silent as to how many data points would be included in such data, with no details of how frequently the glucose data is measured, how long of a time period the data is measured over, or any other requirements. As a result, the amount of data to be organized may vary and include relatively smaller data sets.
The applicant additionally argues that the claim “is integrated into a practical application that provides an improved user interface that enables comparative visualization of the glycemic impact of selectable glucose alarms thereby improving user interface functionality and providing a specific manner of displaying a limited set of information to the user”. In particular, the applicant argues that “the claims provide improved user interface functionality that transforms large volumes of glucose data into a comparative, clinically actionable visualization” which would improve the functioning of a computer or another technology or technical field.
However, as the claim limitations which serve to transform the volume of glucose data into a smaller subset are those which have been determined to recite the abstract idea the improvement argument is not persuasive. The display step appears merely to provide a generic output of the data after the abstract step transforms the data, such that the display step itself is entirely conventional. Per Genetic Technologies Limited v. Merial LLC (Fed Cir., 2016) the inventive concept of step 2 of the Alice/Mayo analysis cannot be supplied by the abstract idea. The inventive concept necessary at step two of the Mayo/Alice analysis cannot be furnished by the unpatentable abstract idea itself. See Mayo, 132 S. Ct. at 1294; see also Myriad, 133 S. Ct. at 2117; Ariosa, 788 F.3d at 1379. Furthermore, applicant’s arguments that the instant claims are similar to the eligible claims of Core Wireless is unpersuasive as the instant claims recite using conventional user interface methods of outputting a graphical depiction based on a subset of data resulting from applying a filter, as the manner of displaying (producing two visualizations on one display) appears wholly conventional and requires no particular functions of the graphical user interface itself. The “comparative” nature of this display again appears to suggest the abstract idea, wherein the comparison of two graphics is capable of being performed in the mind and would likewise fail to recite an improvement.
Applicant's arguments filed 30 June 2026 regarding the rejection of the claims under 35 U.S.C. 103 have been fully considered but they are not fully persuasive.
The applicant argues that the prior art fails to disclose or suggest filtering glucose data based on whether a glucose alarm is enabled or disabled and then displaying comparative glucose profiles on a common interface.
While the applicant argues that the episode information of Hayter does not teach or suggest filtering data based on whether a glucose alarm was enabled or disabled, additional citations have been provided above which note that the enablement of episode detection includes notification (i.e., alarms) for the selected episodes, such that enablement of episode detection for glucose-related episodes may constitute a glucose alarm. Furthermore, as noted above, in describing specific periods of time where episode detection is enabled, the periods of time outside of those specific periods would correspond to periods where the episode detection is disabled. Additionally, regarding the visualization of these subsets of data, because episode detection may be enabled in particular time periods, and thus disabled in other time periods, and the graphic filter may be utilized to display data limited to any selected time period, the filter may be used to select a subset of data where the episode detection is enabled and the user received alerts or a subset where the episode detection is disabled and a user did not receive episode alerts. As Hayter additionally teaches the graphical features from any particular display may be present on any other display, and Mensinger describes displaying multiple glucose profiles within a single screen for comparison, the combination is sufficient to render obvious the instant claims 56-62, 67-78, and 139-140.
Regarding the new claims, the examiner agrees that the prior art of the record fails to disclose the limitations of claim 141, specifically “identifying one or more patterns in the first and second glucose profiles based on the comparison reflecting glycemic impact of the glucose alarm being enabled or disabled”. As a result, no rejection under 35 U.S.C. 102/103 has been applied to claims 141-142.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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/ANNA ROBERTS/Examiner, Art Unit 3791
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