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 amendment filed February 13, 2026 in response to the Office Action of November 14, 2025 has been acknowledged and entered.
Claim Objections
Claim 39 is objected to because of the following informalities:
Claim 39, line 6: “the glucose monitoring system” should read -- a glucose monitoring system--
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 21-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 21-40 are directed to a system and method for monitoring change in insulin resistivity in female patients, which is an abstract idea. Claims 21-40 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 21 is as follows:
Step 1: Claim 21 is drawn to a machine.
Step 2A: Prong One: Claim 21 recites an abstract idea. In particular, claim 21 recites the following limitations:
receiv[ing] information relating to a menstrual cycle of the user, the menstrual cycle comprising a plurality of menstrual phases,
predict[ing] a future change in the user's insulin resistance during a menstrual phase of the plurality of menstrual phases, wherein the prediction is based on the received information relating to the menstrual cycle of the user and historical data comprising a portion of the glucose measurements associated with the user historically being in the menstrual phase; and
present[ing] to the user, at a predetermined period of time with respect to the predetermined menstrual phase, an adjustment to one or more of insulin administration during the predetermined menstrual phase, a diet regimen of the user during the predetermined menstrual phase, and an exercise regimen of the user during the predetermined menstrual phase to counteract the predicted future change in insulin resistance based on an amount of the predicted future change.
These elements of claim 21 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: The “glucose monitoring system” limitations do not integrate the exception into a practical application since they are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
The “present[ing] to the user” limitation in claim 21 does not integrate the exception into a practical application. The display output is merely displaying a variable of an algorithm - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 21 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “glucose monitoring system” does not qualify as significantly more because this limitation is merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well-known elements or simply displaying the results of the algorithm that uses conventional, routine, and well-known elements. In particular, the glucose monitoring system is nothing more than a conventional analyte sensor measuring blood glucose of a user and the sensor electronics module is nothing more than a conventional data transmitter as evidenced by:
Mastrototaro (WO 2014035672) teaches a conventional continuous glucose sensor/transmitter assembly (Paragraph [00388]).
In addition, the use of a processor and a memory circuit does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Also, the “present[ing] to the user” limitation of claim 1 does not amount to significantly more than the judicial exception. The display output is merely displaying a variable of an algorithm - see MPEP 2106.04(d) and MPEP 2106.05(f).
Claims 22-29 depend from claim 21, and recite the same abstract idea as claim 21.
The analysis of claim 30 is as follows:
Step 1: Claim 30 is drawn to a process.
Step 2A: Prong One: Claim 30 recites an abstract idea. In particular, claim 30 recites the following limitations:
receiving… glucose measurements of the user, wherein the glucose measurements are generated by the glucose monitoring system;
receiving….information relating to the menstrual cycle of the user, the menstrual cycle comprising a plurality of menstrual phases;
predicting a future change in the user's insulin resistance during a menstrual phase of the plurality of menstrual phases, wherein the prediction is based on the received information relating to the menstrual cycle of the user and historical data comprising a portion of the glucose measurements associated with the user historically being in the menstrual phase, and
presenting to the user, by the processor, at a predetermined period of time with respect to the predetermined menstrual phase, an adjustment to one or more of insulin administration during the predetermined menstrual phase, a diet regimen of the user during the predetermined menstrual phase, and an exercise regimen of the user during the predetermined menstrual phase to counteract the predicted future change in insulin resistance based on an amount of the predicted future change,
These elements of claim 30 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: The use of a processor does not integrate the system into a practical exception since it is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Further, “a glucose monitoring system” does not integrate the exception into a practical application since it is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Even further, “present[ing] to the user” limitation in claim 21 does not integrate the exception into a practical application. The display output is merely displaying a variable of an algorithm - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 30 does not recite additional elements that amount to significantly more than the judicial exception itself. The use of a processor does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Further, the recitation “a glucose monitoring system” does not qualify as significantly more because this limitation is merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well-known elements or simply displaying the results of the algorithm that uses conventional, routine, and well-known elements. In particular, the glucose monitoring system is nothing more than a conventional blood glucose sensor that measures blood glucose, and a sensor electronics module that transmits sensor data, as evidenced by:
Mastrototaro (WO 2014035672) teaches a conventional continuous glucose sensor/transmitter assembly (Paragraph [00388]).
Also, the “present[ing] to the user” limitation of claim 1 does not amount to significantly more than the judicial exception. The display output is merely displaying a variable of an algorithm - see MPEP 2106.04(d) and MPEP 2106.05(f).
Claims 31-38 depend from claim 30 and recite the same abstract idea as claim 30.
The analysis of claim 39 is as follows:
Step 1: Claim 39 is drawn to a machine.
Step 2A: Prong One: Claim 39 recites an abstract idea. In particular, claim 39 recites the following limitations:
receiving… glucose measurements of the user, wherein the glucose measurements are generated by the glucose monitoring system;
receiving….information relating to the menstrual cycle of the user, the menstrual cycle comprising a plurality of menstrual phases;
predicting a future change in the user's insulin resistance during a menstrual phase of the plurality of menstrual phases, wherein the prediction is based on the received information relating to the menstrual cycle of the user and historical data comprising a portion of the glucose measurements associated with the user historically being in the menstrual phase, and
presenting to the user, at a predetermined period of time with respect to the predetermined menstrual phase, an adjustment to one or more of insulin administration during the predetermined menstrual phase, a diet regimen of the user during the predetermined menstrual phase, and an exercise regimen of the user during the predetermined menstrual phase to counteract the predicted future change in insulin resistance based on an amount of the predicted future change,
These elements of claim 39 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: The use of a processor does not integrate the system into a practical exception since it is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Also, the recitation “a non-transitory computer-readable storage medium comprising program instructions” does not integrate the exception into a practical application because this limitation is merely an instruction to embody the algorithm on a computer.
Further, “a glucose monitoring system” does not integrate the exception into a practical application because this glucose monitoring system is not part of the claimed machine but merely describes the nature of the blood glucose measurements.
The “present[ing] to the user” limitation in claim 21 does not integrate the exception into a practical application. The display output is merely displaying a variable of an algorithm - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 39 does not recite additional elements that amount to significantly more than the judicial exception itself. The use of a processor does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Also, the recitation “a non-transitory computer-readable storage medium comprising program instructions” does not qualify as significantly more because this limitation is merely an instruction to embody the algorithm on a computer.
Further, “a glucose monitoring system” does not qualify as significantly more because this glucose monitoring system is not part of the claimed machine but merely describes the nature of the blood glucose measurements.
Even further, the “present[ing] to the user” limitation of claim 1 does not amount to significantly more than the judicial exception. The display output is merely displaying a variable of an algorithm - see MPEP 2106.04(d) and MPEP 2106.05(f).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually.
Thus, independent claim 39 fails to recite patent-eligible subject matter under 35 U.S.C. 101.
Claims 40 and recite the same abstract idea as claim 39.
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 21-22, 24, 27-28, 30-31, 33, 36-37 and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Budiman (US 20100298765) in view of Barata, et al., The Effect of the Menstrual Cycle on Glucose Control in Women With Type 1 Diabetes Evaluated Using a Continuous Glucose Monitoring System. Diabetes Care 1 May 2013; 36 (5): e70. https://doi.org/10.2337/dc12-2248.
Regarding claim 21, Budiman teaches a system for personalizing diabetes treatment (Fig. 1) based on a menstrual cycle of a user, (Paragraphs [0059]-[0060]), the system comprising: a glucose monitoring system (30, 32) configured to generate glucose measurements of the user (Paragraph [0054]); a memory (16) comprising executable instructions (Paragraph [0051]); and a processor (12) in data communication with the glucose monitoring system and the memory, (Paragraph [0050]), wherein the processor is configured to execute the executable instructions to: receive information relating to the menstrual cycle of the user, the menstrual cycle comprising a plurality of menstrual phases (Paragraphs [0054], [0059]-[0060]);
predict a future change in the user's insulin resistance during the plurality of menstrual phases, wherein the prediction is based on the received information relating to the menstrual cycle of the user (Paragraph [0073]) and historical data comprising a portion of the glucose measurements associated with the user(Paragraph [0102] user’s stored insulin history); and present to the user, (Paragraphs [0051]-[0052]), at a predetermined period of time, an adjustment to one or more of insulin administration, a diet regimen of the user, and an exercise regimen of the user to counteract the predicted future change in insulin resistance based on an amount of the predicted future change. (Paragraphs [0059]-[0060], [0073]).
However, Budiman does not explicitly teach to “predict a future change in the user's insulin resistance during a predetermined menstrual phase of the plurality of menstrual phases, wherein the prediction is based on the received information relating to the menstrual cycle of the user (Paragraph [0073]) and historical data comprising a portion of the glucose measurements associated with the user historically being in the predetermined menstrual phase (Paragraph [0102] user’s stored insulin history); and present to the user, (Paragraphs [0051]-[0052]), at a predetermined period of time with respect to the predetermined menstrual phase, an adjustment to one or more of insulin administration during the predetermined menstrual phase, a diet regimen of the user during the predetermined menstrual phase, and an exercise regimen of the user during the predetermined menstrual phase to counteract the predicted future change in insulin resistance based on an amount of the predicted future change”.
Barata, in a related field of endeavor, teaches a glucose monitoring system indicating the different insulin resistances for different phases of the menstrual cycle (i.e., the predetermined menstrual phase). (Col. 1-2).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Budiman to teach to “predict a future change in the user's insulin resistance during a predetermined menstrual phase of the plurality of menstrual phases, wherein the prediction is based on the received information relating to the menstrual cycle of the user and historical data comprising a portion of the glucose measurements associated with the user historically being in the predetermined menstrual phase; and present to the user, at a predetermined period of time with respect to the predetermined menstrual phase, an adjustment to one or more of insulin administration during the predetermined menstrual phase, a diet regimen of the user during the predetermined menstrual phase, and an exercise regimen of the user during the predetermined menstrual phase to counteract the predicted future change in insulin resistance based on an amount of the predicted future change” as taught by Barata. Doing so provides women physiological information regarding the effect of their menstrual cycle on glucose levels, which helps when predicting insulin resistance and planning insulin therapy. (Col. 2).
Regarding claim 22, Budiman teaches to predict a future glucose level of the user based on the received information (Paragraph [0073]) and the historical data, (Paragraph [0102]), wherein the adjustment presented to the user is further based on the predicted future glucose level and a target glucose. (Paragraphs [0059]-[0060], [0073]).
However, Budiman does not explicitly teach to predict a future glucose level of the user “during the predetermined menstrual phase”.
Barata, in a related field of endeavor, teaches a glucose monitoring system indicating the different glucose levels for different phases of the menstrual cycle (i.e., the predetermined menstrual phase). (Col. 1-2).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Budiman to teach to predict a future glucose level of the user “during the predetermined menstrual phase”, as taught by Barata. Doing so provides women physiological information regarding the effect of their menstrual cycle on glucose levels, which helps when predicting insulin resistance and planning insulin therapy. (Col. 2).
Regarding claim 24, Budiman teaches wherein the adjustment presented to the user is predicted to maintain the user's glucose levels within a predetermined target range in view of the predicted future change in insulin resistance. ((Paragraphs [0059], [0073]).
Regarding claim 27, Budiman teaches wherein the presentation comprises providing, to the user, a recommendation indicative of the adjustment. (Paragraphs [0051]-[0052], [0061]).
Regarding claim 28, Budiman does not teach “wherein the predetermined menstrual phase comprises at least one of a luteal phase of the menstrual cycle of the user or a sub-phase of the luteal phase.”
Barata teaches a glucose monitoring system wherein the predetermined menstrual phase comprises at least one of a luteal phase of the menstrual cycle of the user or a sub-phase of the luteal phase. (Col. 1-2).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Budiman as modified to provide “wherein the predetermined menstrual phase comprises at least one of a luteal phase of the menstrual cycle of the user or a sub-phase of the luteal phase” as taught by Barata. Doing so provides information about glucose level for the luteal phase, which is important when planning insulin therapy because it the luteal phase is reported to have an increase in frequency of hyperglycemia. (Col. 2).
Regarding claim 30, Budiman teaches a method of personalizing diabetes treatment based on a menstrual cycle of a user, (Paragraph [0059]), the method comprising: receiving, at a processor (12) in data communication with a glucose monitoring system (30, 32), glucose measurements of the user, wherein the glucose measurements are generated by the glucose monitoring system (Paragraph [0054]), receiving, at the processor, information relating to the menstrual cycle of the user, the menstrual cycle comprising a plurality of menstrual phases (Paragraphs [0054], [0059]-[0060]);
predicting, by the processor, a future change in the user's insulin resistance during the plurality of menstrual phases, wherein the prediction is based on the received information relating to the menstrual cycle of the user and historical data comprising a portion of the glucose measurements associated with the user (Paragraph [0102] user’s stored insulin history);
presenting to the user, by the processor, at a predetermined period of time, an adjustment to one or more of insulin administration, a diet regimen of the user, and an exercise regimen of the user to counteract the predicted future change in insulin resistance based on an amount of the predicted future change. (Paragraphs [0059]-[0060], [0073]).
However, Budiman does not teach “predicting, by the processor, a future change in the user's insulin resistance during a predetermined menstrual phase of the plurality of menstrual phases, wherein the prediction is based on the received information relating to the menstrual cycle of the user and historical data comprising a portion of the glucose measurements associated with the user historically being in the predetermined menstrual phase;
presenting to the user, by the processor, at a predetermined period of time with respect to the predetermined menstrual phase, an adjustment to one or more of insulin administration during the predetermined menstrual phase, a diet regimen of the user during the predetermined menstrual phase, and an exercise regimen of the user during the predetermined menstrual phase to counteract the predicted future change in insulin resistance based on an amount of the predicted future change”.
Barata, as previously discussed, teaches a glucose monitoring system indicating the different insulin resistances for different phases of the menstrual cycle (i.e., the predetermined menstrual phase). (Col. 1-2).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Budiman to teach “predicting, by the processor, a future change in the user's insulin resistance during a predetermined menstrual phase of the plurality of menstrual phases, wherein the prediction is based on the received information relating to the menstrual cycle of the user and historical data comprising a portion of the glucose measurements associated with the user historically being in the predetermined menstrual phase; presenting to the user, by the processor, at a predetermined period of time with respect to the predetermined menstrual phase, an adjustment to one or more of insulin administration during the predetermined menstrual phase, a diet regimen of the user during the predetermined menstrual phase, and an exercise regimen of the user during the predetermined menstrual phase to counteract the predicted future change in insulin resistance based on an amount of the predicted future change” as taught by Barata. Doing so provides women physiological information regarding the effect of their menstrual cycle on glucose levels, which helps when predicting insulin resistance and planning insulin therapy. (Col. 2).
Regarding claim 31, Budiman teaches predicting a future glucose level of the user based on the received information (Paragraph [0073]) and the historical data, (Paragraph [0102]), wherein the adjustment presented to the user is further based on the predicted future glucose level and a target glucose. (Paragraphs [0059]-[0060], [0073]).
However, Budiman does not explicitly teach predicting a future glucose level of the user “during the predetermined menstrual phase”.
Barata, in a related field of endeavor, teaches a glucose monitoring system indicating the different glucose levels for different phases of the menstrual cycle (i.e., the predetermined menstrual phase). (Col. 1-2).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Budiman to teach predicting a future glucose level of the user “during the predetermined menstrual phase”, as taught by Barata. Doing so provides women physiological information regarding the effect of their menstrual cycle on glucose levels, which helps when predicting insulin resistance and planning insulin therapy. (Col. 2).
Regarding claim 33, Budiman teaches wherein the adjustment presented to the user is predicted to maintain the user's glucose levels within a predetermined target range in view of the predicted future change in insulin resistance. ((Paragraphs [0059], [0073]).
Regarding claim 36, Budiman teaches wherein the presentation comprises providing, to the user, a recommendation indicative of the adjustment. (Paragraphs [0051]-[0052], [0061]).
Regarding claim 37, Budiman does not teach “wherein the predetermined menstrual phase comprises at least one of a luteal phase of the menstrual cycle of the user or a sub-phase of the luteal phase.”
Barata teaches a glucose monitoring system wherein the predetermined menstrual phase comprises at least one of a luteal phase of the menstrual cycle of the user or a sub-phase of the luteal phase. (Col. 1-2).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Budiman as modified to provide “wherein the predetermined menstrual phase comprises at least one of a luteal phase of the menstrual cycle of the user or a sub-phase of the luteal phase” as taught by Barata. Doing so provides information about glucose level for the luteal phase, which is important when planning insulin therapy because it the luteal phase is reported to have an increase in frequency of hyperglycemia. (Col. 2).
Regarding claim 39, Budiman teaches a computer-program product comprising a non-transitory computer-usable medium having computer-readable program code embodied therein, (Paragraph [0037]), the computer-readable program code adapted to be executed to implement a method of personalizing diabetes treatment based on a menstrual cycle of a user, (Paragraph [0059]), the method comprising receiving glucose measurements of the user, wherein the glucose measurements are generated by the glucose monitoring system (Paragraph [0054]); receiving information relating to the menstrual cycle of the user, the menstrual cycle comprising a plurality of menstrual phases. (Paragraphs [0054], [0059]-[0060]).
predicting a future change in the user's insulin resistance of the plurality of menstrual phases, wherein the prediction is based on the received information relating to the menstrual cycle of the user (Paragraph [0073]) and historical data comprising a portion of the glucose measurements associated with the user (Paragraph [0102] user’s stored insulin history); and presenting to the user, at a predetermined period of time, an adjustment to one or more of insulin administration, a diet regimen of the user, and an exercise regimen of the user to counteract the predicted future change in insulin resistance based on an amount of the predicted future change. (Paragraphs [0059]-[0060], [0073]).
However, Budiman does not teach “predicting a future change in the user's insulin resistance during a predetermined menstrual phase of the plurality of menstrual phases, wherein the prediction is based on the received information relating to the menstrual cycle of the user and historical data comprising a portion of the glucose measurements associated with the user historically being in the predetermined menstrual phase; and presenting to the user, at a predetermined period of time with respect to the predetermined menstrual phase, an adjustment to one or more of insulin administration during the predetermined menstrual phase, a diet regimen of the user during the predetermined menstrual phase, and an exercise regimen of the user during the predetermined menstrual phase to counteract the predicted future change in insulin resistance based on an amount of the predicted future change”.
Barata, as previously discussed, teaches a glucose monitoring system indicating the different insulin resistances for different phases of the menstrual cycle (i.e., the predetermined menstrual phase). (Col. 1-2).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Budiman to teach “predicting a future change in the user's insulin resistance during a predetermined menstrual phase of the plurality of menstrual phases, wherein the prediction is based on the received information relating to the menstrual cycle of the user and historical data comprising a portion of the glucose measurements associated with the user historically being in the predetermined menstrual phase; and presenting to the user, at a predetermined period of time with respect to the predetermined menstrual phase, an adjustment to one or more of insulin administration during the predetermined menstrual phase, a diet regimen of the user during the predetermined menstrual phase, and an exercise regimen of the user during the predetermined menstrual phase to counteract the predicted future change in insulin resistance based on an amount of the predicted future change” as taught by Barata. Doing so provides women physiological information regarding the effect of their menstrual cycle on glucose levels, which helps when predicting insulin resistance and planning insulin therapy. (Col. 2).
Regarding claim 40, Budiman teaches predicting a future glucose level of the user during the predetermined menstrual phase based on the received information (Paragraph [0073]) and the historical data, (Paragraph [0102]), wherein the adjustment presented to the user is further based on the predicted future glucose level and a target glucose. (Paragraphs [0059]-[0060], [0073]).
Claims 23 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Budiman in view of Barata, further in view of Lafon (U.S. 20200000441) (previously cited).
Regarding claims 23 and 32, Budiman does not specifically teach wherein the processor is further configured to execute the executable instructions “to predict a future date when the user will enter the predetermined menstrual phase based on the received information relating to the menstrual cycle of the user, the predicted future change corresponding to the predicted future date, and wherein the predetermined period of time with respect to the predetermined menstrual phase is prior to the predicted future date.”
Barata, as previously discussed, teaches a glucose monitoring system indicating the different insulin resistances and glucose levels for different phases of the menstrual cycle (i.e., the predetermined menstrual phase). (Col. 1-2).
Lafon, in a related field of endeavor, as modified by Barata, teaches a menstrual tracking system (Fig. 3 of Lafon) to predict (Fig. 3, step 304 of Lafon) a future date when the user will enter the predetermined menstrual phase (Col. 1-2 of Barata) based on the received information relating to the menstrual cycle of the user, the predicted future change corresponding to the predicted future date and wherein the predetermined period of time with respect to the predetermined menstrual phase (Col. 1-2 of Barata) is prior to the predicted future date. (Paragraphs [0042]-[0043] of Lafon).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Budiman to provide wherein the processor is further configured to execute the executable instructions “to predict a future date when the user will enter the menstrual phase based on the received information relating to the menstrual cycle of the user, the predicted future change corresponding to the predicted future date, and wherein the predetermined period of time with respect to the predetermined menstrual phase is prior to the predicted future date” as taught by the combination of Barata and Lafon. Doing so provides women physiological information regarding the effect of their menstrual cycle on glucose levels, which helps when predicting insulin resistance and planning insulin therapy (Col. 2 of Barata); and helps predict menstrual cycles and related health issues, and the combinations of these metrics and approaches can be used to attempt to improve the accuracy of the predictions. (Paragraph [0044] of Lafon).
Claims 25 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Budiman in view of Barata, further in view of Fischell (US 9171343).
Regarding claims 25 and 34, Budiman as modified does not teach “wherein adjustment includes an adjustment to insulin administration during the predetermined menstrual phase in response to receipt from the user of an indication that the user would not like to engage in any additional exercise or follow any additionally restrictive diet.”
Fischell, in a related field of endeavor, teaches a glycemic control system wherein adjustment includes an adjustment to insulin administration during the predetermined menstrual phase in response to receipt from the user of an indication that the user would not like to engage in any additional exercise or follow any additionally restrictive diet. (Col. 7, lines 2-39, if the patient injects a certain number of units of insulin based upon a meal he/she is about to eat, and if the patient then does not eat that meal, then the GlytApp can provide the information that the patient needs to determine the number of units of insulin that the patient should inject based on other factors that affect the patient's blood glucose level such as exercise, quantity of food ingested by the patient, the time since that last food ingestion, if a meal is about to be eaten, if the patient is about to exercise, having a menstrual period, or any other factor that the remote computer system will determine over a period of time that affects that specific patient's need for insulin.)
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Budiman as modified to provide “wherein adjustment includes an adjustment to insulin administration during the predetermined menstrual phase in response to receipt from the user of an indication that the user would not like to engage in any additional exercise or follow any additionally restrictive diet” as taught by Fischell. Doing so provides an insulin dosage system for optimizing insulin dosages to be administered to a subject. (Col. 4, lines 36-38).
Claims 26 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Budiman in view Barata, further in view of Constantin (WO 2019157102) (previously cited)
Regarding claims 26 and 35, Budiman does not teach to “wherein the historical data on which the prediction is based further comprises data indicating a change in insulin resistance associated with a stratified group of users historically being in the predetermined menstrual phase, wherein the stratified group of users is stratified at least based on menstrual cycle information.”
Barata, as previously discussed, teaches a glucose monitoring system indicating the different insulin resistances and glucose levels for different phases of the menstrual cycle (i.e., the predetermined menstrual phase). (Col. 1-2).
Constantin, in a related field of endeavor, as modified by Barata, teaches a decision support system for glucose control (Paragraph [00296] of Constantin), wherein the historical data on which the prediction is based further comprises data indicating a change in insulin resistance associated with a stratified group of users historically being in the predetermined menstrual phase (Col. 1-2 of Barata), wherein the stratified group of users is stratified at least based on menstrual cycle information. (Paragraphs [0522], [00524], [00528]-[00529] of Constantin).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Budiman to provide “wherein the historical data on which the prediction is based further comprises data indicating a change in insulin resistance associated with a stratified group of users historically being in the predetermined menstrual phase, wherein the stratified group of users is stratified at least based on menstrual cycle information” as taught by the combination of Barata and Constantin. Doing so provides women physiological information regarding the effect of their menstrual cycle on glucose levels, which helps when predicting insulin resistance and planning insulin therapy (Col. 2 of Barata); and employs population data from a database of similarly characterized patients to determine a person’s glycemic condition and recognize glycemic patterns in relation to a population of similar people. (Paragraphs [00529]-[00531] of Constantin).
Claims 29 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Budiman in view of Barata, further in view of Booth (U.S. 20150217055) (previously cited).
Regarding claim 29, Budiman as modified does not teach “wherein the adjustment comprises an insulin treatment and the processor is further configured to execute the executable instructions to transmit a signal to an insulin delivery device, thereby causing the insulin delivery device to administer insulin to the user based on the insulin treatment.”
Booth, in a related field of endeavor, teaches wherein the adjustment comprises an insulin treatment (subcutaneous insulin treatment program) and the processor (Paragraph [0085], dosing controller 160) is further configured to execute the executable instructions to transmit a signal to an insulin delivery device (Paragraph [0085], administration device 123), thereby causing the insulin delivery device to administer insulin to the user based on the insulin treatment. (Paragraph [0085] The administration device 123 may receive a subcutaneous insulin treatment program selected by and transmitted from the dosing controller 160, while the administration computing device 112a, 112b may execute the subcutaneous insulin treatment program).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Budiman as modified to provide “wherein the adjustment comprises an insulin treatment and the processor is further configured to execute the executable instructions to transmit a signal to an insulin delivery device, thereby causing the insulin delivery device to administer insulin to the user based on the insulin treatment” as taught by Booth. Doing so delivers a personalized dose of insulin to bring and maintain a patient's blood glucose level. (Paragraphs [0054], [0085]).
Regarding claim 38, Budiman as modified does not teach “the adjustment comprises an insulin treatment; and the method further comprises transmitting, by the processor, a signal to an insulin delivery device, thereby causing the insulin delivery device to administer insulin to the user based on the insulin treatment.”
Booth, in a related field of endeavor, teaches wherein the adjustment comprises an insulin treatment (subcutaneous insulin treatment program); and the method further comprises transmitting, by the processor, (dosing controller 160) a signal to an insulin delivery device (administration device 123), thereby causing the insulin delivery device to administer insulin to the user based on the insulin treatment. (Paragraph [0085] The administration device 123 may receive a subcutaneous insulin treatment program selected by and transmitted from the dosing controller 160, while the administration computing device 112a, 112b may execute the subcutaneous insulin treatment program).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Budiman as modified to provide “the adjustment comprises an insulin treatment; and the method further comprises transmitting, by the processor, a signal to an insulin delivery device, thereby causing the insulin delivery device to administer insulin to the user based on the insulin treatment” as taught by Booth. Doing so delivers a personalized dose of insulin to bring and maintain a patient's blood glucose level. (Paragraphs [0054], [0085]).
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 2/13/2026, with respect to the 101 rejection of claims 21-40 have been fully considered. However, upon further consideration the amendments do not overcome the 101 rejection because the “present[ing] to the user” limitation in claims 21, 30, and 39 does not integrate the exception into a practical application. The display output is merely displaying a variable of an algorithm - see MPEP 2106.04(d) and MPEP 2106.05(f).
Applicant’s arguments, see “Remarks”, filed 2/13/2026, with respect to the 103 rejection of claims 21-40 have been fully considered. However, upon further consideration, a new ground of rejection is made under 103. In the new ground of rejection, Budiman and Barata are relied upon for the amended feature.
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.
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/OM PATEL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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