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 .
Status of Claims
Claims 1, 4, 5, 9-13, 48, 51-53, 55, and 63-69 were previously pending and subject to a non-final Office Action having a notification date of March 27, 2026 (“non-final Office Action”). Following the non-final Office Action, Applicant filed an amendment on August 10, 2026 (the “Amendment”), amending claims 1, 55, and 67-69 and canceling claim 48.
The present Final Office Action addresses pending claims 1, 4, 5, 9-13, 51-53, 55, and 63-69 in the Amendment.
Response to Arguments
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §101
The 35 USC 101 rejection of claims 1, 4, 5, 9-13, 51-53, and 63-66 is withdrawn in view of the Amendment because independent claim 1 has been amended to incorporate and require the limitations of dependent claim 48 which was indicated as reciting patent-eligible subject matter in the non-final Office Action at pages 19-20. Therefore, independent claim 1 and its respective dependent claims are patent-eligible for at least the same reasons supporting patent-eligibility of claim 48.
However, the 35 USC 101 rejection of claims 55 and 67-69 is maintained as set forth in the rejection below. On pages 8-9 of the Amendment, Applicant takes the position that claims 55 and 67-69 have been amended to incorporate the patent eligible features of claim 48 which renders the rejection moot. The Examiner disagrees.
Initially, claims 55 and 67-69 do not require the features of claim 48 because the incorporated features are merely recited as one of two alternative options along with the recommended insulin dose merely including a decrease when the hypoglycemia risk is high.
Furthermore, claim 48 was indicated as reciting patent-eligible subject matter due to the manner in which the claim as a whole determined whether a hypoglycemia risk based on a glucose central tendency value from the post-prandial glucose data from a post-prandial time period associated with the selected menu item and a variability value for the plurality of meal records associated with the selected menu item, determined the recommended insulin dose based on the glucose central tendency value and the determination of the hypoglycemia risk for the plurality of meal records, and administered the recommended insulin dose including an increase when the determined hypoglycemia risk is low and the glucose central tendency value is above a central tendency threshold value. Similar to the particular manner in which a glaucoma patient identified as high risk for post implant inflammation (PI) (i.e., based on a weighted polygenic risk score generated from SNPs in the genotype dataset by a model that uses multiplication to weight corresponding alleles in the dataset by their effect sizes to sum the weighted values to provide the score) being administered Compound X eye drops (which is particular to the high risk PI population) was found to be a particular treatment for a medical condition such that the claim as a whole integrates the judicial exception into a practical application in Example 49 of the USPTO Patent Eligibility Examples, the particular manner in which a hypoglycemia risk of a user is determined (based on a glucose central tendency value determined from the post-prandial glucose data from a post-prandial time period associated with the selected menu item and a variability value for the plurality of meal records if a predetermined hypoglycemia risk threshold is exceeded for the selected menu item based on information from the database corresponding to the meal records related to the menu item) and a recommended insulin dose is administered to the patient including an increase in insulin when the hypoglycemia risk is determined to be low and the glucose central tendency value is above a central tendency threshold value in independent claim 1 also amounts to a particular treatment for a medical condition such that the claim as a whole integrates the judicial exception into a practical application.
In contrast, independent claims 55 and 67 merely call for receiving/retrieving a glucose level and menu item selection, retrieving meal records based on the selected menu item that each include an insulin dose administered to the user and post-prandial glucose data for a previously consumed meal, determining an insulin dose recommendation including an increase when a hypoglycemia risk is low and a glucose central tendency value is above a threshold or a decrease when the hypoglycemia risk is high, and administering the recommendation which merely has an insignificant relationship to the exception (and thus does not amount to a “particular treatment or prophylaxis”) because it does not use the exception in any meaningful way.
Specifically, part of the abstract idea in independent claims 55 and 67 is receiving glucose level data from the sensor control device; receiving a selection of a menu item from a plurality of menu items on a user interface; and retrieving information relating to post-prandial glucose data and insulin dose data associated with the selected menu item from a database, wherein the database comprises a plurality of meal records, an insulin dose administered to the user for each meal record of the plurality of meal records, and post-prandial glucose data associated with each meal record of the plurality of meal records, wherein each meal record corresponds to a meal previously consumed by the user, and wherein each meal record does not comprise quantitative information of the meal.
However, the administration of the recommended insulin dose (i.e., increased insulin dose when the hypoglycemia risk is low and the glucose central tendency value is above a central tendency threshold value or a decreased insulin dose when the hypoglycemia risk is high) in claims 55 and 67 does not use the above exception in any meaningful way other than to generically recite that the glucose central tendency value and hypoglycemia risk are “of the plurality of meal records classified as the selected menu item.” In this regard, generically administering the recommended insulin dose does not have more than a nominal or insignificant relationship to the exception under MPEP 2106.04(d)(2)(b).
Furthermore, administering a "recommended insulin dose" that is somehow based on a glucose central tendency value and hypoglycemia risk of the plurality of meal records classified as the selected menu item is not "particular" under MPEP 2106.04(d)(2)(a) because it encompasses all applications of the judicial exception (where the judicial exception already includes, inter alia, retrieving information relating to meals previously consumed by the user). In other words, because part of the abstract idea includes retrieving information relating to meals previously consumed by the user, then administering a "recommended insulin dose" that is somehow based on such some of such retrieved meal records encompasses all applications of the abstract idea(s).
Still further, the administration step just appears to be insignificant extra-solution activity under MPEP 2106.04(d)(2)(c) and MPEP 2106.05(g) and amounts to generic instructions to “apply” the abstract idea under MPEP 2106.05(f) because it is similar to a method of assigning hair designs to balance head shape with a final step of actually cutting the hair based on the determined hair designs, In re Brown, 645 Fed. App’x 1014, 1017 (Fed. Cir. 2016)).
Furthermore, the Examiner has reevaluated this limitation and determined it to not be unconventional as it is similar to immunizing a patient against a disease, Classen Immunotherapies, Inc. V. Biogen IDEC, 659 F.3d 1057, 1063 (Fed. Cir. 2011). MPEP 2106.07(a)(III)(B). Furthermore, [0009] of Applicant’s specification in the Background discloses “When consuming meals, many diabetics must administer a dose of medication such as insulin to compensate for the anticipated glycemic rise that occurs” which amounts to indicating that the additional elements (administering insulin) 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). MPEP 2106.07(a)(III)(B).
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 55 and 67-69 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more:
Subject Matter Eligibility Criteria - Step 1:
Claim 55 is directed to a method (i.e., a process) and claims 67-69 are directed to a computer-readable storage medium (i.e., a manufacture, as the computer-readable storage medium is necessarily non-transitory per [0284] of the present specification). Therefore, the claims are all within at least one of the four statutory categories. 35 USC 101.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test (which collectively includes the guidance in the January 7, 2019 Federal Register notice and the October 2019 update issued by the USPTO as now incorporated into the MPEP, as supported by relevant case law), the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 67 includes limitations that recite an abstract idea.
Specifically, independent claim 67 recites:
A computer-readable storage medium storing instructions which, when executed by one or more processors, cause the one or more processors to perform operations comprising:
receiving glucose data of a user from a sensor control device and a selection of a menu item from a plurality of menu items on a user interface;
retrieving information relating to post-prandial glucose data and insulin dose data associated with the selected menu item from a database, wherein the database comprises a plurality of meal records, an insulin dose administered to the user for each meal record of the plurality of meal records, and post-prandial glucose data associated with each meal record of the plurality of meal records, wherein each meal record corresponds to a meal previously consumed by the user, and wherein each meal record does not comprise quantitative information of the meal;
determining a recommended insulin dose based on a glucose central tendency value and a hypoglycemia risk of the plurality of meal records classified as the selected menu item; and
causing administration, by a medication delivery device, of the recommended insulin dose, wherein the recommended insulin dose comprises:
an increase in an insulin dose when the hypoglycemia risk is low and the glucose central tendency value is above a central tendency threshold value; or
a decrease in an insulin dose when the hypoglycemia risk is high.
The Examiner submits that the foregoing underlined limitations constitute (a) “certain methods of organizing human activity” because determining an insulin dose to be administered with a meal by way of receiving a user glucose level and menu item (e.g., meal, food) selection, retrieving information relating to post-prandial glucose data and insulin dose data for previously-consumed meals by a user that are associated with the presently selected meal/menu item, and determining and visually outputting a recommendation for the insulin dose based on a glucose central tendency value and a hypoglycemia risk for the plurality of meal records relates to manners of managing personal behavior and relations between people similar to what has been done by humans for many years. For instance, diabetic patients and their medical providers have for many years considered the patient’s risk of hypoglycemia when determining which foods to eat based on post-prandial BG levels (e.g., averages, how the BG levels are changing, etc.) associated with eating the same type of foods in the past and determined recommended insulin dosages based on such BG levels and hypoglycemia risk after consuming similar foods in the past (e.g., decreasing the insulin dose when the hypoglycemia risk is high or the hyperglycemia risk is low, or increasing the dose when it is low, etc.). Furthermore, as part of caring for diabetic patients, medical providers are known to calculate and present various metrics in preparation for or during follow-up appointments with patients as part of managing the patient’s glucose and insulin levels to avoid hypoglycemia and the like. These limitations are similar to a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982). MPEP 2106.04(a)(2)(II)(C).
Furthermore, the foregoing underlined limitations constitute (b) “mental processes” because they are observations/evaluations/judgments/analyses that can be practically performed in the human mind or with pen and paper at the currently claimed high level of generality. As an example, a medical professional could mentally (e.g., with pen and paper) review a particular proposed menu item (e.g., spaghetti and meat sauce) and a patient’s current BG level, analyze/review the administered insulin dose and post-prandial BG level of the patient in two meal records for the same menu item previously consumed by the patient, and determine and output an insulin dose recommendation based on a glucose central tendency value and a risk of hypoglycemia for the plurality of meal records. For instance, a medical professional could readily determine/observe/review in their mind (e.g., with or without pen and paper) a glucose central tendency value (e.g., average) of the post-prandial BG levels from the two meal records in some post-prandial time period (e.g., 1 hour after meal) and a hypoglycemia risk then mentally determine a recommendation to reduce the meal bolus/insulin dose if the hypoglycemia risk is high or increase the dose when the risk is low.
Claims “directed to collection of information, comprehending the meaning of that collected information, and indication of the results, all on a generic computer network operating in its normal, expected manner,” fail step one of the Alice framework. In re Killian, 45 F.4th 1373, 1380 (Fed. Cir. 2022). Claims directed to “collecting, analyzing, manipulating, and displaying data” are abstract. Univ. of Fla. Research Found., Inc. v. General Elec. Co., 916 F.3d 1363, 1368 (Fed. Cir. 2019). Claims directed to organizing, storing, and transmitting information determined to be directed to an abstract idea. Cyberfone Sys., L.L.C. v. CNN Interactive Grp., Inc., 558 F. App' x 988, 992 (Fed. Cir. 2014).
The present recitations, under their broadest reasonable interpretation, are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQe2d 1739 (Fed. Cir. 2016)).
Accordingly, the claim is directed toward at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the “abstract idea”):
A computer-readable storage medium storing instructions which, when executed by one or more processors, cause the one or more processors to perform operations comprising:
receiving glucose data of a user from a sensor control device and a selection of a menu item from a plurality of menu items on a user interface;
retrieving information relating to post-prandial glucose data and insulin dose data associated with the selected menu item from a database, wherein the database comprises a plurality of meal records, an insulin dose administered to the user for each meal record of the plurality of meal records, and post-prandial glucose data associated with each meal record of the plurality of meal records, wherein each meal record corresponds to a meal previously consumed by the user, and wherein each meal record does not comprise quantitative information of the meal;
determining a recommended insulin dose based on a glucose central tendency value and a hypoglycemia risk of the plurality of meal records classified as the selected menu item; and
causing administration, by a medication delivery device, of the recommended insulin dose, wherein the recommended insulin dose comprises:
an increase in an insulin dose when the hypoglycemia risk is low and the glucose central tendency value is above a central tendency threshold value; or
a decrease in an insulin dose when the hypoglycemia risk is high.
For the following reasons, the Examiner submits that the above identified additional limitations, when considered as a whole with the limitations reciting the at least one abstract idea, do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the computer-readable storage medium storing instructions for execution by one or more processors and the database that stores the information, the Examiner submits that these limitations are instructions to apply the above-noted abstract idea by merely using a computer as a tool to perform the process (see MPEP § 2106.05(f)).
Regarding the additional limitations of the glucose data being received from a sensor control device and the menu item selection being received from a UI, the Examiner submits that these additional limitations do no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the at least one abstract idea (see MPEP § 2106.05(h)).
Regarding the additional limitation of causing administration, by a medication delivery device, of the recommended delivery dose, the Examiner submits that this additional limitation amounts to generic instructions to "apply" the abstract idea and/or insignificant extra-solution activity, similar to a method of assigning hair designs to balance head shape with a final step of using a tool/scissors to cut the hair, In re Brown, 645 Fed. App’x 1014, 1017 (Fed. Cir. 2016)) (see MPEP § 2106.05(f) and (g)).
Thus, taken alone, the additional elements do not integrate the abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the limitations reciting the at least one abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, representative independent claim 67 and analogous independent claim 55 do not recite additional elements that integrate the judicial exception into a practical application.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
-Claims 68 and 69: These claims recite how the medication delivery device is a medication injection pen or portable infusion pump which just amounts to generally linking use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the at least one abstract idea or altering how the abstract idea is carried out (see MPEP § 2106.05(h)).
Thus, when the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, independent claim 67 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitations of the computer-readable storage medium storing instructions for execution by one or more processors and the database that stores the information, the Examiner submits that these limitations are instructions to apply the above-noted abstract idea by merely using a computer as a tool to perform the process (see MPEP § 2106.05(f)).
Regarding the additional limitations of the glucose data being received from a sensor control device and the menu item selection being received from a UI, the Examiner submits that these additional limitations do no more than generally link use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the at least one abstract idea (see MPEP § 2106.05(h)).
Regarding the additional limitation of causing administration, by a medication delivery device, of the recommended delivery dose, the Examiner submits that this additional limitation amounts to generic instructions to "apply" the abstract idea and/or insignificant extra-solution activity, similar to a method of assigning hair designs to balance head shape with a final step of using a tool/scissors to cut the hair, In re Brown, 645 Fed. App’x 1014, 1017 (Fed. Cir. 2016)) (see MPEP § 2106.05(f) and (g)). Furthermore, the Examiner has reevaluated this limitation and determined it to not be unconventional as it is similar to immunizing a patient against a disease, Classen Immunotherapies, Inc. V. Biogen IDEC, 659 F.3d 1057, 1063 (Fed. Cir. 2011). MPEP 2106.07(a)(III)(B). Furthermore, [0009] of Applicant’s specification in the Background discloses “When consuming meals, many diabetics must administer a dose of medication such as insulin to compensate for the anticipated glycemic rise that occurs” which amounts to indicating that the additional elements (administering insulin) 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). MPEP 2106.07(a)(III)(B).
The dependent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
-Claims 68 and 69: These claims recite how the medication delivery device is a medication injection pen or portable infusion pump which just amounts to generally linking use of the abstract idea to a particular technological environment or field of use without adding an inventive concept to the at least one abstract idea or altering how the abstract idea is carried out (see MPEP § 2106.05(h)).
Therefore, claims 55 and 67-69 are ineligible under 35 USC §101.
Allowable Subject Matter
Claims 1, 4, 5, 9-13, 50-53, and 63-66 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding independent claim 1, the combination of U.S. Patent No. 9,171,343 to Fischell et al. ("Fischell"), U.S. Patent App. Pub. No. 2014/0350369 to Budiman et al. ("Budiman"), and U.S. Patent App. Pub. No. 2017/0106052 to Spat et al. ("Spat") disclose, as set forth in the non-final Office Action dated May 19, 2023:
A method of determining an insulin dose for the treatment of diabetes, the method comprising:
receiving, by an electronic device, data indicative of a glucose level from a sensor control device and a selection of a menu item from a plurality of menu items, wherein the sensor control device comprises a glucose sensor, and wherein the glucose sensor comprises a portion configured to be in fluid contact with a bodily fluid of a subject and sense the glucose level of the subject;
retrieving, by the electronic device, information relating to post-prandial glucose data and insulin dose data associated with the menu item from a database, wherein the database comprises a plurality of meal records, an insulin dose administered to a user for each meal record of the plurality of meal records, and post-prandial glucose data associated with each meal record of the plurality of meal records, wherein each meal record corresponds to a meal previously consumed by the user;
determining, by one or more processors, a hypoglycemia risk if a predetermined hypoglycemia risk threshold is exceeded for the menu item based on the information retrieved by the electronic device from the database, wherein the information retrieved corresponds to a plurality of meal records related to the menu item, wherein a risk of hypoglycemia is determined based at least on a first instance of a glucose central tendency value and a variability value for the plurality of meal records, wherein the glucose central tendency value is determined from the post-prandial glucose data from a post-prandial time period associated with the menu item;
determining, by the one or more processors, a recommendation for the insulin dose based on a second instance of the glucose central tendency value and the determination of the hypoglycemia risk for the plurality of meal records, wherein the second instance of the glucose central tendency value is compared to a threshold value; and
visually outputting to a display of the electronic device the recommendation for the insulin dose, without reference to a carbohydrate content of the selected menu item.
However, the above references do not further specifically disclose each of the recited meal records of the database used in a particular manner to determine the various metrics (the glucose central tendency value, the variability value, the hypoglycemia risk, etc.) to not include a quantity of the meal as now recited in the claims.
Furthermore, because independent claim 1 has been amended to incorporate the limitations of dependent claim 48 which was indicated as reciting patent-eligible subject matter, independent claim 1 and its respective dependent claims are patent-eligible for at least the same reasons supporting patent-eligibility of claim 48. See non-final Office Action at pages 19-20.
Conclusion
THIS ACTION IS MADE FINAL. 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 JONATHON A. SZUMNY whose telephone number is (303) 297-4376. The examiner can normally be reached on Monday-Friday 7-5.
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/JONATHON A. SZUMNY/ Primary Examiner, Art Unit 3686
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