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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Objections
Claim 200 is objected to because of the following informalities: the limitation “time correlated data” recited in line 19 of the claim should be recited as “time-correlated data”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
Claims 200-202 and 205-221 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of Claim 200 follows.
Step 1
Regarding Claim 200, the claim recites a series of components, including a wireless communications circuitry configured to receive time-correlated data, a display configured to visually present information, a memory storing instructions, and a processor configured to receive user selection filtering criterion, determine a subset of time-correlated data, generate first and second glucose profiles, and display ambulatory glucose profiles. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
Step 2A, Prong 1
The claim is then analyzed to determine whether it is directed to any judicial exception. Claim 200 recites at least one step or instruction for receiving data and then filtering significant glucose/analyte subsets from that data over a period of time, which is grouped as a mental process under the 2019 PEG. Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Specifically, Claim 200 recites components comprising: “receive time-correlated data characterizing an analyte of the subject and doses of a medication received by the subject over a period of time…”, “visually present information”, “receive a user selection of filtering criterion”, “determine a subset of time-correlated data based on a filtering criterion selected”, “generate a first glucose profile”, “generate a second glucose profile”, and “display ambulatory glucose profiles” which are forms of observation, judgement, and evaluation. Observation, judgement, and evaluation are elements that are grouped as a Mental Process under the 2019 PEG.
Regarding Claim 200, each of the following are considered a mental process, using a computer – processor - as a tool, and insignificant extra-solution activity under the 2019 PEG for the provided reasons:
The “receive time-correlated data characterizing an analyte of the subject and doses of a medication received by the subject over a period of time…” could be accomplished by manually taking analyte levels of the subject, recording these, and then tracking the data on a spreadsheet, in a notebook, etc. The medication received by a subject could be logged manually in a similar fashion to the analyte levels. Additionally, wireless communication circuitry that performs this function is merely using a computer as a tool to perform an abstract idea.
“visually present information” can be created by a person manually via creating charts, graphs, etc. while using the data collected from the subject’s medication doses and analyte levels. Additionally, “a display” that performs this function is merely insignificant extra-solution activity using conventional, routine, well-known elements in the art.
“receive a user selection of filtering criterion” could be accomplished by manually tracking the data on a spreadsheet, in a notebook, etc. Additionally, a processor that performs this function is merely a generic computer used as a tool to perform an abstract idea.
“determine a subset of time-correlated data based on a filtering criterion selected” can be created by a person manually via utilizing a variety of representative tools, charts, graphs, etc. while using the data collected from the subject’s medication doses and analyte levels, which is a mental process used to perform an abstract idea.
“generate a first glucose profile” and “generate second glucose profile” can be created by a person manually via creating charts, graphs, etc. while using the data collected from the subject’s medication doses and analyte levels, which is a mental process used to perform an abstract idea.
“display ambulatory glucose profiles” can be created by a person manually while using the data collected from the subject’s medication doses and analyte levels which is a mental process used to perform an abstract idea.
By recording the above components, “memory” merely uses a computer as a tool to perform an abstract idea.
A person can manually “determine a subject of time-correlated data based on a filtering criterion selected by looking over the data and identifying key elements/areas of focus. The identified portions could then be recorded into a different dataset and presented to a subject.
Accordingly, as indicated above, the above-identified Claim recites an abstract idea.
Step 2A, Prong 2
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 200 recites generating first and second glucose profiles and displaying a first and second ambulatory glucose profile, which are functions that merely add insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The generating and displaying functions do not provide an improvement to the technological field, the system does not effect a particular treatment or effect a particular change based on the issued alert, nor is a particular machine used to perform the Abstract Idea. The Abstract Idea is performed by a computer – a processor. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., “a display” and “processors” as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claim 200 is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claim 200 is directed to an abstract idea under 2019 PEG.
Step 2B
The dependent claims of Claim 200 do not include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
Claim 200 requires the additional elements of: “wireless communications circuitry configured to receive time-correlated data characterizing an analyte of the subject and doses of a medication received by the subject over a period of time…”, “a memory storing instructions”, “receive a user selection of filtering criterion”, and “one or more processors…determine a subset of time-correlated data based on a filtering criterion selected”. The receiving functions are merely insignificant pre-solution data gathering. The functions of a memory storing instructions as well as a processor determining a subset of time-correlated data are insignificant extra-solution activity performed by a computer. The recited memory and processor are generic computing devices configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Accordingly, in light of Applicant’s specification, the claimed term “a display” and “processors” are reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “a display” and “processors”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claim 200 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the system of Claim 200 is directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. Claim 200 does not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claim 200 does not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claim amounts to significantly more than the abstract idea itself. Thus, Claim 200 merely applies an abstract idea to a computer and does not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Regarding dependent Claims 201-202 and 205-221, the “filtering” functions in Claims 205-221 are merely insignificant pre-solution data gathering techniques used to understand the data. This does not provide a judicial exception. Additionally, Claims 201-202 contains medicinal components as tangible options to be applied in an earlier step and therefore does not provide a judicial exception.
Therefore, Claims 200-202 and 205-221 do not amount to significantly more than the abstract ideas themselves. Accordingly, Claims 200-202 and 205-221 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 200-202, 205, 209-212, 214, 216-218, and 221 are rejected under 35 U.S.C. 103 as being unpatentable over Hayter et al.’150 (U.S. Patent Publication 20180226150 – previously cited) in view of Mensinger et. al.’169 (WO Patent Publication 2010127169 – previously cited), further in view of Alden et. al.'558 (U.S. Publication 20220375558 - previously cited), and further in view of Steiger et. al.'487 (U.S. Patent Publication 20140068487).
Regarding Claim 200, Hayter et. al.’150 discloses a system comprising:
wireless communications (Paragraph [0043] - the components can be in wireless communication with each other) circuitry configured to receive time-correlated data characterizing an analyte of the subject (Paragraph [0096] - automatic time-of-day period enablement function that determines, e.g., based on the user's analyte level profile) and doses of a medication received by the subject over a period of time (Paragraph [0082] - medication timeline 450 indicating times and amount of rapid acting insulin (top) and long acting insulin (bottom); Figure 4B), and
a display configured to visually present information (Paragraph [0196] - graphical user interface (GUI) screens for the EIS containing visit guide functionality and structure and are displayable on any computing device), and
one or more processors (206) coupled with the wireless communications circuitry, the display (Paragraph [0050] - one or more processors), and
a memory storing instructions (Paragraph [0063] - non-transitory memory of the device… executing the software (e.g., as a plurality of instructions)), time-correlated data charactering an analyte of the subject (Paragraph [0068] - sufficient storage memory (e.g., sufficient for 8, 12, 24, or 48 hours of data, or for the entire lifetime of the sensor control device 102) to hold multiple automatically gathered glucose level measurements until transferred to reader device 120…can include all glucose readings that are stored in memory in sensor control device 102, or a subset, such as those that have not already been transferred to reader device 120, or those that have been collected in a recent period of time), and doses of a glucose level-altering medication received by the subject over a period of time (Paragraph [0082] - medication timeline 450 indicating times and amounts of rapid acting insulin (top) and long acting insulin (bottom) that were administered over the displayed time period; Figure 4B), wherein the instructions, when executed by the one or more processors, cause the one or more processors to:
determine a subject of time-correlated data based on a filtering criterion selected by the subject (Paragraph [0156] - an interactive filter 1810 is located between graph 1806 and table 1807… 1810 allows the user to select which information is displayed in table; Figure 18B); and
generate a first glucose profile associated with the time-correlated data over a first time period (Paragraph [0081] - Glucose graph 457 can display measured glucose level readings over a predetermined time range).
Hayter et. al.’150 fails to disclose causing a processor to receive a user selection of a filtering criterion related to non-adherent medication doses, wherein the filtering criterion comprises one or more of a missed dose, an under-bolused dose, an over-bolused dose, a late dose, or an extra dose. Alden et. al.’558 teaches selecting – as a form of filtering - late and missed bolus (Paragraph [0099] - Contextual factors panel 430 displays a list of exemplary contextual factors, such as upward dose override, downward dose override, late bolus, manual bolus, missed bolus, critical alarm, site change, and suspension; Paragraph [0119] - each panel displays one or more glucose measurements recorded during a time period in which the patient exhibited each of the at least one contextual factors selected at step 306). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system and filtering criterion of Hayter et. al.’150 in view of Mensinger et. al.’169 to include late and missed bolus dosing in order to better understand glucose-related events such as hyperglycemia as seen in Alden et. al.’558 (Paragraph [0048] - the HCP observes that the person's hyperglycemic events tend to be correlated with days where the person has a missed bolus or a late bolus).
Hayter et. al.’150 further fails to disclose a processor configured to generate a second glucose profile based on the subset of time correlated data over the first time period, wherein the second glucose profile excludes time-correlated data associated with the selected filtering criterion. Steiger et. al.'487 teaches excluding bolus filtering criteria from a user’s profile or graphical window based on selection from the user (Paragraph [0075] - Additionally or alternatively, the view filter tab 248 can comprise a bolus display control 272 that when selected causes the bolus icons 220 to be displayed by the one or more processors automatically in the graphical windows 204, 206, 208. When the bolus display control 272 is deselected, the bolus icons 220 are not displayed by the one or more processors; Paragraph [0094] - When the bolus display control 272 is selected, a plurality of bolus icons 220 can be presented within the event analysis window 200 such that the bolus indication object 222 and the bolus time indication object 224 of each of the bolus icons 220 are plotted within any of the graphical windows 204, 206, 208 and the bolus symbol 226 of each of the bolus icons 220 is plotted outside of the graphical windows 204, 206, 208. When the bolus display control 272 is deselected, the plurality of bolus icons 220 can be removed from and/or disabled for display in the event analysis window 200). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Hayter et. al.’150 in view of Mensinger et. al.’169 and further in view of Alden et. al.’558 to exclude certain bolus-related criteria in order to manage data provided by each graphical display so that the user can visualize trends without certain events as seen in Steiger et. al.'487 (Paragraph - [0071] The event analysis window 200 can comprise a view filter tab 248 for providing controls that are configured to manage the data provided by each of the graphical windows 204, 206, 208).
Regarding Clam 200, Hayter et. al.’150 discloses displaying a first glucose profile and a second glucose profile on a single graphical subject interface (Figures 21 and 58; Paragraphs [0191] and [0289]) wherein the glucose profiles are ambulatory glucose profiles (Paragraph [0179] - FIGS. 19A-B depict example embodiments of a GPI report 1900. Here, GPI report 1900 includes a first region 1902 that displays an ambulatory glucose profile (AGP) of the user and a second region 1904 that displays assessments of the severity of certain conditions related to the user's diabetes), but fails to disclose displaying a first glucose profile and a second glucose profile on a single graphical user interface, wherein the first glucose profile comprises a graph of representative glucose levels vs. time, wherein the second glucose profile comprises a graph of representative glucose levels vs. time. Mensinger et. al.’169 teaches displaying a first glucose profile and a second glucose profile on a single graphical subject interface (Figure 9), wherein the first glucose profile comprises a graph of representative glucose levels vs. time and wherein the second glucose profile comprises a graph of representative glucose levels vs. time (Page 4 Paragraph 2; Page 13 Paragraph 2 - The performance report module 22 may be further configured to generate one or more performance reports; Page 20 Paragraph 3 - pie graphs showing percentage of time that a host was in each of a plurality of predefined blood glucose ranges; Page 23 Paragraph 2 - the performance report module 22, which may reside on the host computing device 20 and/or other suitable computing device, may comprise computer program code configured to analyze sensor historical data, generate one or more performance reports, and implement the user interface 900 of Figure 9; Last 4 lines of Page 23 to the first three lines of Page 24; Page 24 Paragraph 2). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system and display of Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 to include more than one graph of representative glucose levels on a single graphical subject interface in order to compare multiple performance reports across the same or different time periods as seen in Mensinger et. al.’169.
Regarding Claims 201 and 202, Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 discloses the system outlined in Claim 200 above. Hayter et. al.’150 further discloses the medication is insulin which is a glucose level altering medication (Paragraph [0082] - FIG. 4B depicts an example embodiment of glucose graph 457 after depressing zoom button 459. Beneath graph 457 is an medication timeline 450 indicating times and amounts of rapid acting insulin (top) and long acting insulin (bottom) that were administered over the displayed time period, with numerical indicators conveying the respective dose amount and aligned appropriately to convey the associated time of dose administration).
Regarding Claim 205, Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 discloses the system outlined in Claim 200 above but fails to disclose filtering criterion as missed doses, and wherein the subset of time-correlated data based on the filtering criterion comprises analyte data associated with at least one dose of medication that was not received during a dosing window. Alden et. al.’558 teaches selecting – as a form of filtering – missed bolus (Paragraph [0099] - exemplary panel 430 through which the user may provide input selecting at least one of a plurality of contextual factors. Contextual factors panel 430 displays a list of exemplary contextual factors, such as upward dose override, downward dose override, late bolus, manual bolus, missed bolus). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system and filtering criterion of Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 to include late and missed bolus dosing in order to better understand glucose-related events such as hyperglycemia as seen in Alden et. al.’558 (Paragraph [0048] - the HCP observes that the person's hyperglycemic events tend to be correlated with days where the person has a missed bolus or a late bolus).
Regarding Claim 209, Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 discloses the system outlined in Claim 205 above but fails to disclose the dosing window for a basal dose is 1 hour from a prescribed basal dosing time. Alden et. al.’558 teaches a dosing window for a basal dose is 2 hours from a prescribed basal dosing time (Paragraph [0103] - the person has not taken an insulin bolus within a predetermined bolus-consideration time period (T.sub.B, e.g., 2 hours) of the current time; Paragraph [0104] - Increasing the bolus-consideration time window (T.sub.B) would decrease the sensitivity, while decreasing T.sub.B would increase the sensitivity). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 to include a dosing window of less than 2 hours – including 1 hour - to increase the sensitivity in bolus-consideration time period in order to better classify other glucose-level related events such as missed or late doses as seen in Alden et. al.’558 (Paragraph [0114] - used to detect late boluses than to detect missed boluses).
Regarding Claim 210, Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 discloses the system outlined in Claim 200 above but fails to disclose filtering criterion as the filtering criterion is under-bolused doses, and wherein the subset of time-correlated data based on the filtering criterion comprises analyte data associated with at least one dose of medication that was received during a dosing window, wherein an amount of the at least one dose of medication received is lower than a recommended dose of the medication. Alden et. al.’558 teaches selecting – as a form of filtering – under-bolused doses wherein a dose of medication is lower than a recommended dose of medication (Paragraph [0092] - A downward dose override indicator 634 positioned on top of a particular bolus dose block indicates that a computing device (e.g., a device having a bolus advisor or bolus calculator implemented thereon) had recommended that the person take more insulin on a particular bolus based on various factors, such as the person's glucose levels, carb intake, and/or amount of active insulin from previous boluses—however, the person took less insulin on that bolus than recommended (e.g., the device had recommended the person take 12 units of insulin, but the person only took 10 units)). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system and filtering criterion of Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 to include under-bolused dosing in order to better understand glucose-level related events and behaviors as seen in Alden et. al.’558.
Regarding Claim 211 Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 discloses the system outlined in Claim 200 above but fails to disclose the filtering criterion is over-bolused doses, and wherein the subset of time-correlated data based on the filtering criterion comprises analyte data associated with at least one dose of medication that was received during a dosing window, wherein an amount of the at least one dose of medication received is the higher than a recommended dose of the medication. Alden et. al.’558 teaches selecting – as a form of filtering – over-bolused doses wherein an amount of a dose of medication received is higher than a recommended dose of medication (Paragraph [0092] - An upward dose override indicator 638 positioned on top of a particular bolus dose block indicates that the computing device had recommended that the person take less insulin on a particular bolus (again based on various factors), but the person took more insulin on that bolus than recommended (e.g., the device had recommended the person take 10 units of insulin, but the person took 12 units)). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system and filtering criterion of Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 to include over-bolused dosing in order to better understand glucose-level related events and behaviors as seen in Alden et. al.’558.
Regarding Claim 212, Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 discloses the system outlined in Claim 200 above but fails to disclose the filtering criterion is late meal doses, and wherein the subset of time-correlated data based on the filtering criterion comprises analyte data associated with at least one dose of medication that was received after a predetermined period of time after a start of a meal. Alden et. al.’558 teaches selecting – as a form of filtering – late meal dose wherein a dose of medication was received after a predetermined period of time (Paragraph [0100] - A late bolus may include a situation where a person with diabetes that requires meal-time insulin ingests food at a meal event, but takes an insulin bolus too late in time to appropriately compensate for the meal event. This may result in an undesirable spike in the person's glucose levels before the insulin bolus takes effect. Missed boluses and late boluses may be detected by monitoring the person's glucose levels and/or glucose level trends over time and analyzing said glucose levels in conjunction with a log of the person's insulin boluses (e.g., the time and amount of previously administered insulin boluses)). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system and filtering criterion of Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 to include late-meal dosing in order to better understand glucose-related events such as hyperglycemia as seen in Alden et. al.’558 (Paragraph [0048] - the HCP observes that the person's hyperglycemic events tend to be correlated with days where the person has a missed bolus or a late bolus).
Regarding Claim 214, Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 discloses the system outlined in Claim 200 above but fails to disclose the instructions, when executed by the one or more processors, further cause the one or more processors to: determine an additional subset of time-correlated data based on a second filtering criterion selected by the subject; and display a third glucose profile, wherein the third glucose profile displays the additional subset of time-correlated data over the first time period. Mensinger et. al.’169 teaches displaying three glucose profiles based on selected subsets over a period of time (Figure 9; Page 24 Paragraph 2). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system and display of Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 to include more than one graph of representative glucose levels on a single graphical subject interface in order to compare multiple performance reports across the same or different time periods as seen in Mensinger et. al.’169. It is noted that Hayter et. al.’150 also shows more than two glucose-related graphs on a single screen in Figure 21, but the limitation “first time period” for the second and third graph was not addressed.
Regarding Claim 216, Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 discloses the system outlined in Claim 200 above but fails to disclose filtering criterion as missed doses, and wherein the subset of time-correlated data based on the filtering criterion comprises analyte data associated with at least one dose of medication that was not received during a dosing window. Alden et. al.’558 teaches selecting – as a form of filtering – missed bolus (Paragraph [0099] - exemplary panel 430 through which the user may provide input selecting at least one of a plurality of contextual factors. Contextual factors panel 430 displays a list of exemplary contextual factors, such as upward dose override, downward dose override, late bolus, manual bolus, missed bolus). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system and filtering criterion of Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 to include missed bolus in order to better understand glucose-related events such as hyperglycemia as seen in Alden et. al.’558 (Paragraph [0048] - the HCP observes that the person's hyperglycemic events tend to be correlated with days where the person has a missed bolus or a late bolus).
Regarding Claim 217, Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 discloses the system outlined in Claim 200 above. Hayter et. al.’150 further discloses the first time period is selected by the subject or is automatically set (Paragraph [0096] - If the EIS is enable for a particular time of day period (e.g., 8 am-noon, 6 pm-8 pm, etc.), then the EIS can operate to detect the desired episode types every day of the week during that time period).
Regarding Claim 218, Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 discloses the system outlined in Claim 200 above. Hayter et. al.’150 further discloses filtering criterion is selected using a drop-down menu (Paragraph [0090] - From the dropdown menu shown in FIG. 8, selecting the settings button 852 can start a settings wizard and open the daily events settings screen 900 in FIG. 9A. The daily events can include one or more of breakfast, lunch, dinner, bedtime, and other events, and can be displayed along with default times of day for each of these events on corresponding time of day buttons 985).
Regarding Claim 221, Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 discloses the system outlined in Claim 200 above. Hayter et. al.’150 further discloses wherein the first graph of representative glucose levels vs. time of the first glucose profile is associated with a computer set of time-correlated data over the first time period (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; Figure 9B).
Claims 206-208 are rejected under 35 U.S.C. 103 as being unpatentable over Hayter et al.’150 (U.S. Patent Publication 20180226150 – previously cited) in view of Mensinger et. al.’169 (WO Patent Publication 2010127169 – previously cited), further in view of Alden et. al.'558 (U.S. Publication 20220375558 - previously cited), and further in view of Steiger et. al.'487 (U.S. Patent Publication 20140068487) as applied to Claim 205 above, further in view of Stiene et. al.'014 (KR Patent Application 20090087014 - previously cited).
Regarding Claims 206-208, Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 disclose the system outlined in Claim 205 above but fail to disclose the dosing window for breakfast is from 6 am to 11 am, the dosing window for lunch is from 11 am to 4 pm, the dosing window for dinner is from 4 pm to 10 pm. Mensinger et. al.’169 teaches glucose levels obtained during dosing levels at breakfast, lunch, and dinner (Paragraph [0104] - The DGA can be configured to use a real time meal-detection algorithm and the time of the dose to identify the doses additional to basal as breakfast, lunch, and/or dinner bolus doses). Stiene et. al.’014 teaches glucose levels monitored for breakfast from 6 am to 11 am, lunch from 11 am to 3 pm, and dinner from 4 pm to 8 pm (Page 18 Lines 6-8 - Automatic assignment of meal times is based on operating parameters, such as 'morning' from 6 am to 11 am, 'lunch' from 11 am to 3 pm, 'evening' from 3 pm to 8 pm, Others shall be 'night' or 'other'). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 that includes events such as breakfast, lunch, and dinner (as seen in Paragraph [0090] of Hayter et. al.’150) to include times, give or take a couple of hours, of 6am to 11am, 11am to 3pm, and 3pm to 8pm in order to cover the typical meal times as seen in Stiene et. al.’014.
Claim 213 is rejected under 35 U.S.C. 103 as being unpatentable over Hayter et al.’150 (U.S. Patent Publication 20180226150 – previously cited) in view of Mensinger et. al.’169 (WO Patent Publication 2010127169 – previously cited), further in view of Alden et. al.'558 (U.S. Publication 20220375558 - previously cited), and further in view of Steiger et. al.'487 (U.S. Patent Publication 20140068487), as applied to Claim 200 above respectively, further in view of Mensinger et. al.'937 (U.S. Patent Publication 20190392937 - previously cited).
Regarding Claim 213, Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 disclose the system outlined in Claim 200 above but fails to disclose the filtering criterion is extra meal doses, and wherein the subset of time-correlated data based on the filtering criterion comprises analyte data associated with at least one additional dose of medication that was received after a first dose of the medication was received during a dosing window. Mensinger et. al.'937 teaches selecting – as a form of filtering – data related to receiving and additional dose of medication after an initial dose of medication (Paragraph [0104] - The method 700 includes a process 720 to select time period(s) after a glucose correction dose is administered. The method 700 includes a process 730 to exclude period(s) with large BG corrections, significant insulin on board (IOB) or additional doses). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system and filtering criterion of Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 to include receiving an additional dose of medication in order to better understand glucose-level related events and behaviors as well as be able to adjust recommended doses as seen in Mensinger et. al.’937 (Paragraph [0103] - adjusting an insulin dose calculation). It is noted that Hayter et. al.’150 discloses using machine learning to analyze data and generate therapy recommendations – such as medication dosing (Paragraph [0316] - machine learning (referred to collectively herein as “expert systems”) to analyze data of diabetes patients and generate therapy recommendations).
Claim 215 is rejected under 35 U.S.C. 103 as being unpatentable over Hayter et al.’150 (U.S. Patent Publication 20180226150 – previously cited) in view of Mensinger et. al.’169 (WO Patent Publication 2010127169 – previously cited), further in view of Alden et. al.'558 (U.S. Publication 20220375558 - previously cited), and further in view of Steiger et. al.'487 (U.S. Patent Publication 20140068487), as applied to Claim 214 above respectively, further in view of Mensinger et. al.'937 (U.S. Patent Publication 20190392937 - previously cited).
Regarding Claim 215, Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 discloses the system outlined in Claim 214 above but fails to disclose the second filtering criterion is one of recommended doses, missed doses, under-bolused doses, over-bolused doses, late meal doses, or extra meal doses. Mensinger et. al.'937 teaches selecting – as a form of filtering – missed bolus doses as a second selecting technique (Paragraph [0070] - the report 300 can display missed doses in a time period; Paragraph [0102] - The method 500 includes a process 520 to select time period(s) with no meals and no bolus doses (e.g., such as overnight). The method 500 includes a process 530 to exclude periods where basal dose was missed by the patient user). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system and display of Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 to include selecting or filtering a time period by missed bolus dose in order to understand a user’s glucose level susceptibility to the missed dose as seen in Mensinger et. al.’937 (Paragraph [0070] - the report 300 can display missed doses in a time period in a manner that is accountable by the learning dose calculator 220 so that the appropriate dose recommendation can be made, e.g., such as in the case of a missed dose that would not need to be ‘counted’ if the patient didn't eat a meal or undertook other behavior such that the patient's glucose levels stayed within the target range; Paragraphs [0071-0073]).
Claims 219 and 220 are rejected under 35 U.S.C. 103 as being unpatentable over Hayter et al.’150 (U.S. Patent Publication 20180226150 – previously cited) in view of Mensinger et. al.’169 (WO Patent Publication 2010127169 – previously cited), further in view of Alden et. al.'558 (U.S. Publication 20220375558 - previously cited), and further in view of Steiger et. al.'487 (U.S. Patent Publication 20140068487), as applied to Claim 200 above, further in view of Dunn et. al.'263 (WO Patent Publication 2014106263 – previously cited).
Regarding Claim 219, Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 discloses the system outlined in Claim 200, but fails to disclose the representative glucose levels of the first graph comprise hourly percentiles of glucose levels over a 24-hour day period, and the representative glucose levels of the second graph comprise hourly percentiles of glucose levels of the subset over the 24-hour day period. Dunn et. al.’263 teaches representing glucose data over a day’s-worth of time as hourly percentiles (Paragraphs [0182]-[0183]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the displays and graphs of Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 to include hourly percentiles of glucose as a tracking metric in order to more accurately understand time-to-peak durations of glucose levels in a person following routine events such as eating while not being as susceptible to outliers as other forms of metrics as seen in Dunn et. al.’263 (Paragraphs [0169-0174]; Paragraph [0196] - Percentile metrics were favored over other common metrics such as mean and standard deviation because a) percentiles are more robust to outliers that often occur in glucose data, and b) commonality with AGP's use of percentiles).
Regarding Claim 220, Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 discloses the system outlined in Claim 200, but fails to disclose the hourly percentiles of the first graph comprise 5th, 25th, 50th, 75th, and 95th percentiles, and the hourly percentiles of the second graph comprise 5th, 25th, 50th, 75th, and 95th percentiles. Dunn et. al.’263 teaches the hourly percentiles of the graphs 10th, 25th, 50th, 75th, and 90th percentiles (Paragraph [0183] - 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) as well as analyzing glucose at 5th and 95th hourly percentiles (Paragraph [0172] – the start is identified as the average timestamp of the 5th percentile glucose value in that segment, and the peak is identified as the average timestamp of the 95th percentile glucose value in that segment). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the displays and graphs of Hayter et. al.’150 in view of Mensinger et. al.’169, further in view of Alden et. al.’558, and further in view of Steiger et. al.'487 to include hourly percentiles of glucose as a tracking metric in order to more accurately understand time-to-peak durations of glucose levels in a person following routine events such as eating while not being as susceptible to outliers as other forms of metrics as seen in Dunn et. al.’263 (Paragraphs [0169-0174]; Paragraph [0196] - Percentile metrics were favored over other common metrics such as mean and standard deviation because a) percentiles are more robust to outliers that often occur in glucose data, and b) commonality with AGP's use of percentiles).
Response to Arguments
Applicant's arguments filed 16 March 2026 have been fully considered and they are not entirely persuasive.
Applicant’s amendments to the claims have overcome the rejections of claims under 35 U.S.C. 112(b).
Applicant’s amendments to the claims have not overcome previous rejections of claims under 35 U.S.C. 101. Regarding the inability to overcome the 101 rejections, the examiner has noted that the filtering techniques claimed do not seem to be inventive or provide particular improvement over prior art filtering techniques as addressed in the prior art section in Paragraph 5 above. Therefore, the “filtering” functions are seen as mere pre-solution data gathering techniques and are not enough to overcome the Abstract Ideas presented in Claim 200.
As necessitated by amendment, Claims 200-202 and 205-221 are rejected under 35 U.S.C. 103 and have been addressed in Paragraphs 5-9 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Brown'132 (U.S. Patent Publication 20040015132) and Dick et. al.'921 (U.S. Patent Publication 20150205921) disclose a device configured to identify if a user has missed their scheduled dose.
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 SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
Prosecution Insights