DETAILED ACTION
Response to Amendment
This action is in response to the amendment filed on November 14, 2025. Claims 1, 11, and 14 have been amended. Claims 21-22 have been added. Claims 1-22 have been examined and are currently pending.
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 .
Inventorship
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Information Disclosure Statement
The Information Disclosure Statement filed on November 21, 2025 has been considered. An initialed copy of the Form 1449 is enclosed herewith.
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 1-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
ALICE/ MAYO: TWO-PART ANALYSIS
2A. First, a determination whether the claim is directed to a judicial exception (i.e., abstract idea).
Prong 1: A determination whether the claim recites a judicial exception (i.e., abstract idea).
Groupings of abstract ideas enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Mathematical concepts- mathematical relationships, mathematical formulas or equations, mathematical calculations.
Certain methods of organizing human activity- fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions).
Mental processes- concepts performed in the human mind (including an observation, evaluation, judgement, opinion).
Prong 2: A determination whether the judicial exception (i.e., abstract idea) is integrated into a practical application.
Considerations indicative of integration into a practical application enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Improvement to the functioning of a computer, or an improvement to any other technology or technical field
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition
Applying the judicial exception with, or by use of a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception
Considerations that are not indicative of integration into a practical application enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea.
Adding insignificant extra-solution activity to the judicial exception.
Generally linking the use of the judicial exception to a particular technological environment or field of use.
2B. Second, a determination whether the claim provides an inventive concept (i.e., Whether the claim(s) include additional elements, or combinations of elements, that are sufficient to amount to significantly more than the judicial exception (i.e., abstract idea)).
Considerations indicative of an inventive concept (aka “significantly more”) enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Improvement to the functioning of a computer, or an improvement to any other technology or technical field
Applying the judicial exception with, or by use of a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception NOTE: The only consideration that does not overlap with the considerations indicative of integration into a practical application associated with step 2A: Prong 2.
Considerations that are not indicative of an inventive concept (aka “significantly more”) enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea.
Adding insignificant extra-solution activity to the judicial exception.
Generally linking the use of the judicial exception to a particular technological environment or field of use.
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. NOTE: The only consideration that does not overlap with the considerations that are not indicative of integration into a practical application associated with step 2A: Prong 2.
See also, 2019 Revised Patent Subject Matter Eligibility Guidance; Federal Register; Vol. 84, No. 4; Monday, January 7, 2019
Claims 1-22 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.
1: Statutory Category
Applicant’s claimed invention, as described in independent claim 1 is directed to a system and independent claim 11 is directed to a method.
2(A): The claim(s) are directed to a judicial exception (i.e., an abstract idea).
PRONG 1: The claim(s) recite a judicial exception (i.e., an abstract idea).
Mental Processes
Independent claims 1 and 11 recite the limitations, “receive the glucose data from the glucose monitoring device; receive medication data comprising times and amounts of medication doses administered to the user from a medication delivery device, wherein the medication doses comprise a plurality of meal doses; segment the glucose data into a plurality of glucose data segments, wherein each of the plurality of glucose data segments is associated with one of the plurality of meal doses, and wherein a glucose data segment comprises glucose data received in a time period starting at a time of administration of a medication dose and ending at a time of administration of a subsequent medication dose or at a predetermined maximum time after the time of administration of the medication dose; perform a glucose pattern analysis on the glucose data segments associated with each of the plurality of meal doses; perform an event counting analysis by identifying a number of low glucose events in the glucose data segments associated with each of the plurality of meal doses; determine a recommendation to increase, decrease, or maintain an amount of a meal dose of the plurality of meal doses based on the glucose pattern analysis and the event counting analysis for the glucose data segments associated with the meal dose of the plurality of meal doses;” which are directed to the abstract idea of mental processes. Specifically, the claims are directed to concepts performed in the human mind (e.g., observation, evaluation, and judgment). In the currently pending claims, a person can receive information (e.g., glucose data and medication data), analyze the glucose data and medication data for a plurality of meal doses, and determine whether to increase, decrease, or maintain dosage for a plurality of meal doses. A person through observation, evaluation, and judgment of data can determine dosage based on the evaluation of meal dosages and glucose data.
Methods of Organizing Human Activity
Independent claims 1 and 11 recite the limitations, “receive the glucose data from the glucose monitoring device; receive medication data comprising times and amounts of medication doses administered to the user from a medication delivery device, wherein the medication doses comprise a plurality of meal doses; segment the glucose data into a plurality of glucose data segments, wherein each of the plurality of glucose data segments is associated with one of the plurality of meal doses, and wherein a glucose data segment comprises glucose data received in a time period starting at a time of administration of a medication dose and ending at a time of administration of a subsequent medication dose or at a predetermined maximum time after the time of administration of the medication dose; perform a glucose pattern analysis on the glucose data segments associated with each of the plurality of meal doses; perform an event counting analysis by identifying a number of low glucose events in the glucose data segments associated with each of the plurality of meal doses; determine a recommendation to increase, decrease, or maintain an amount of a meal dose of the plurality of meal doses based on the glucose pattern analysis and the event counting analysis for the glucose data segments associated with the meal dose of the plurality of meal doses;” which are directed to the abstract idea of managing personal behavior under methods of organizing human activity. Specifically, the claims are directed to managing a person’s medication regimen during specific meal times based on an analysis of glucose data and medication data during meals. The management of a person’s medication regimen is a form of managing personal behavior.
PRONG 2: The judicial exception (i.e., an abstract idea) is not integrated into a practical application.
The applicant has not shown or demonstrated any of the requirements described above under "integration into a practical application" under step 2A. Specifically, the applicant's limitations are not "integrated into a practical application" because they are adding words "apply it" with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea (see MPEP 2106.05(f)). Additionally, improvements to the functioning of a computer or any other technology or technical field has not been shown or disclosed (see MPEP 2106.05(a)). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Specifically, the applicant’s limitations are not “significantly more” because they are adding words “apply it” with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea (see MPEP 2106.05(f)) and generally linking use of the judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)). The applicant’s claimed limitations do not demonstrate an improvement to another technology or technical field, an improvement to the functioning of the computer itself, effecting a transformation or reduction of particular article to a different state or thing. The current application does not amount to 'significantly more' than the abstract idea as described above. The claim does not include additional elements or limitations individually or in combination that are sufficient to amount to significantly more than the judicial exception. Specifically, the individual elements of a glucose monitoring device, in vivo glucose sensor, sensor electronics, display device, one or more processors, memory, and medication delivery device amount to no more than implementing an idea with a computerized system and they are adding words “apply it” with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea. The additional elements taken in combination add nothing more than what is present when the elements are considered individually. Therefore, based on the two-part Alice Corp. analysis, there are no meaningful limitations in the claims that transform the exception (i.e., abstract idea) into a patent eligible application.
Since the claim(s) recite a judicial exception and fails to integrate the judicial exception into a practical application, the claim(s) is/are “directed to” the judicial exception. Thus, the claim(s) must be reviewed under the second step of the Alice/ Mayo analysis to determine whether the abstract idea has been applied in an eligible manner.
2(B): The claims do not provide an inventive concept (i.e., The claim(s) do not include additional elements, or combinations of elements, that are sufficient to amount to significantly more than the judicial exception (i.e., abstract idea)).
As discussed with respect to Step 2A Prong Two, the additional element(s) in the claim amounts to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
For these reasons, there is no invention concept in the claim, and thus the claim is ineligible.
Dependent claims 2-10 and 12-22 are rejected as ineligible subject matter under 35 U.S.C. 101 based on a rationale similar to the claims from which they depend. Claims 3-4 and 22 recite medication delivery device, claims 3, 5, 13-14, and 21 recite one or more processors, claim 4 recites an injection pen, claims 6 and 16 recites display device and claims 14 and 22 recite a smart pen cap. Claims 3-6, 13-14, 16, and 21-22 do not recite additional elements that amount to significantly more than the judicial exception.
Allowable Subject Matter
receive medication data comprising times and amounts of medication doses administered to the user from a medication delivery device, wherein the medication doses comprise a plurality of meal doses;
segment the glucose data into a plurality of glucose data segments, wherein each of the plurality of glucose data segments is associated with one of the plurality of meal doses, and wherein a glucose data segment comprises glucose data received in a time period starting at a time of administration of a medication dose and ending at a time of administration of a subsequent medication dose or at a predetermined maximum time after the time of administration of the medication dose;
Response to Arguments
Applicant's arguments filed November 14, 2025 have been fully considered but they are not persuasive.
A. According to applicant’s argument on pages 8-9 of remarks disclose, “Amended claim 1 is patent eligible at Step 2A of the Alice/Mayo test as claim 1 provides a practical application of the alleged abstract idea by providing a system to titrate medication doses based on glucose data collected following the user’s medication dose administration times rather than based on glucose data collected in fixed or predetermined time of day periods as in existing titration systems. The Specification of the present application discloses that existing titration systems may rely on fixed time of day periods to titrate medication doses, such as by dividing a day into breakfast, lunch, dinner and overnight periods. The periods may be predetermined, e.g., a breakfast period from 8AM-12PM, a lunch period from 12PM-6PM, and a dinner period from 6PM- 12AM. Specification, [0183]-[0184]. However, the use of fixed time of day periods for titrating medication doses may be ineffective when the patient’s mealtimes deviate from the fixed time of day periods. Patients’ mealtimes may vary due to work or travel, among other reasons. Specification, [0186], [0204]. Thus, titrating based on fixed time of day periods may result in inaccurate titration of doses which may prevent the user from maintaining glucose levels in a target range and delay optimization of the user’s dose regimen or progression to additional therapies. The claimed invention provides a solution to this problem by titrating mealtime medication doses based on glucose data segments associated with the patient’s actual medication dose administration times. Specification, [0204]. Specifically, the claimed invention determines glucose data segments that start at a time of administration of a dose and that end at a time of administration of another medication dose or after a predetermined period of time. In this way, the claimed titration system can titrate the user’s medication doses based on the user’s specific dose schedule to ensure the glucose data used for titrating the medication doses is associated with the particular dose, and the system titrates the medication doses without requiring manual user input of glucose data or medication data.” The examiner respectfully disagrees.
Under the 2019 Revised Patent Subject Matter Eligibility Guidance, determining whether a claim integrates a judicial exception into a practical application, examiners should consider whether the claimed invention pertains to an improvement in the functioning of the computer itself or any other technology or technical field. Additionally, making this determination, examiners should determine whether there is a technical explanation as to how to implement the invention in the specification and the claim itself reflects the improvement in technology. The recited claims do not recite and reflect an improvement in the technology or technical field as required in the 2019 Revised Patent Subject Matter Eligibility. Specifically, the applicant cites improvements such as titrating mealtime medication doses based on glucose data segments associated with the patient’s actual medication dose administration times and the system titrates the medication doses without requiring manual user input of glucose data or medication. These features are not recited within the body of independent claims 1 and 11. The applicant claims the end result of the invention of titrating medication doses as an improvement, but does not explain how the improvement implemented or executed. The examiner notes the specification and claims do not provide a technical explanation as to how the invention/computer, technical field, or other technology is improved with regards to titrating mealtime medication doses based on glucose data segments associated with the patient’s actual medication dose administration times and the system titrating the medication doses without requiring manual user input of glucose data or medication. The examiner notes the limitation, “segment the glucose data into a plurality of glucose data segments, wherein each of the plurality of glucose data segment comprises glucose data received in a time period starting at a time of administration of a medication dose and ending at a time of administration of a subsequent medication dose or at a predetermined maximum time after the time of administration of the medication dose” is a data collection step of glucose data within a specific time period associated with one or more meal doses. This is not an improvement in the functioning of the computer itself or any other technology or technical field.
B. According to applicant’s argument on pages 9-10 of remarks disclose, “While it is not believed to be necessary to proceed to Step 2B of the Alice/Mayo test, amended claim 1 should also be found to be patent eligible under Step 2B. When the claim elements are considered in combination, the claim amounts to significantly more than the alleged judicial exception of managing a person’s medication regimen. See Office Action at p. 6. The claimed invention is directed to an improved medication titration system that uses a specific arrangement of components including an in vivo glucose sensor for determining glucose data continuously over a period of time, a medication delivery device for providing dose amounts and timing information, a display device for displaying titration recommendations, and one or more processors communicating with these components. By using this combination of components, the claimed invention provides a system that improves medication dose titration by using medication timing data determined by a medication delivery device to determine what period of glucose data collected by the in vivo glucose sensor to use for titrating each medication dose. In this way, each dose can be titrated based on the user’s particular dosing schedule and the dose titration is performed without requiring manual user entry of dose information or glucose data. Thus, the claimed invention provides significantly more than the alleged abstract idea and provides an improved medication titration system.” and “Here, the Office has not shown that the components or the claimed arrangement of components are well known or conventional. The Office does not consider the additional elements in combination and alleges generally that “the additional element(s) in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.” See Office Action at p. 8. However, as discussed, the claimed invention does not merely relate to generic computer components and instead includes a specific arrangement and communication of data between a glucose monitoring device comprising an in vivo glucose sensor, a display device, a medication delivery device, and one or more processors.” The examiner respectfully disagrees.
The individual elements of a glucose monitoring device, in vivo glucose sensor, sensor electronics, display device, one or more processors, memory, and medication delivery device amount to no more than implementing an idea with a computerized system and they are adding words “apply it” with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea. The additional elements taken in combination add nothing more than what is present when the elements are considered individually. The combination of elements does not improve the functioning of the computer itself or any other technology or technical field.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Komistek et al. US Publication 20250316358 A1 Diabetic Pump, Application, and Programming
Komistek discloses “The rate of change in glucose levels during a meal event is notably higher compared to regular times of the day governed by basal doses. This serves as the primary discriminator for distinguishing meal events from other times of the day. Moreover, meal events exhibit temporal dependencies. Therefore, to identify mealtimes, the Data Assessment Module relies on both the temporal relationships of meal events with the time of day and the rate of change in glucose levels. For instance, breakfast typically occurs between 7:00 am to 9:00 am, lunch between 11:00 am to 2:00 pm, and dinner between 6:00 pm to 8:00 pm. A dedicated algorithm initiates a search from these time windows to identify meal events. If a meal event cannot be located within these windows, the time windows are expanded, and the search is conducted again. In the rare instance where a patient skips a meal and thus a bolus dose is not administered, the algorithm records this occurrence and generates a report for the patient by the end of the week to encourage and maintain healthy habits. Once the glucose data is partitioned into bolus and basal-controlled segments, meal events are removed from the glucose patterns. Within the remaining basal-controlled glucose patterns, they are further segmented into sub-segments based on the acceleration or deceleration of the rate of change in the glucose level. Although the initial algorithm in this disclosure can refer to analysis of basal data, as mentioned above, the more advanced algorithm can address meal times and subsequently bolus doses can be factored into the algorithm and that amount of insulin can be incorporated into the algorithm when determining optimal, personalized basal rates for a patient.” (paragraph 0106)
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 MATTHEW L HAMILTON whose telephone number is (571)270-1837. The examiner can normally be reached Monday-Thursday 9:30-5:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Marc Jimenez can be reached at (571)272-4530. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW L HAMILTON/Primary Examiner, Art Unit 3681
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