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 .
Status of the Claims
The status of the claims as of the response filed 2/19/2026 is as follows: Claims 3-6, 11-16, 20-21, 23, 25, 32-33, 50, 54, and 56-58 remain cancelled. Claim 1 is currently amended. Claims 2, 7-10, 17-19, 22, 24, 26-31, 34, 36-49, 51-53, 55, and 59 are as previously presented. Claim 35 is original. Claims 1-2, 7-10, 17-19, 22, 24, 26-31, 34-49, 51-53, 55, and 59 are currently pending and have been considered below.
Response to Amendment
Rejections Under 35 USC 112(a)
The claims have been amended to remove the unsupported limitations identified in paras. 5-6 of the non-final rejection mailed 12/2/2025 such that the corresponding 35 USC 112(a) rejections are withdrawn.
Response to Arguments
Regarding 35 USC 101
On page 18 of the response filed 2/19/2026 Applicant argues that claim 1 integrates any recited abstract idea into a practical application because it “improves the medical measuring technique by using GA levels to determine when the invasive and burdensome Continuous Glucose Monitoring (CGM) is necessary” which “avoids unnecessary medical procedures and optimizes the usage of the CGM device” and “represents a technological improvement because it allows a user to more accurately determine the blood glucose level and ambulatory glucose profile (AGP) of a patient, which not only allows the user to determine a better course of treatment, but also alleviates the patient’s burden.” Applicant’s arguments are fully considered, but are not persuasive. Examiner submits that determining when invasive and burdensome CGM measurements are necessary based on evaluating past patient measurements, making inferences about their clinical indications, and comparing them to a threshold is part of the abstract idea itself, because these steps represent steps that a human actor such as a clinician could perform when managing their personal behavior and/or interactions with a patient to make clinically-relevant recommendations about diabetes monitoring frequency. Merely outputting indications to a user to let them know whether or not another CGM measurement should be performed does not improve the underlying technology of the CGM device or another technical field, but rather represents improvements to the abstract idea itself which may have the intended result of avoiding unnecessary medical procedures and optimizing usage of a CGM device if the user decides to act on the output recommendations, but does not guarantee such outcomes in a technological manner. See MPEP 2106.05(a): “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.” See also 2106.05(a)(II): “it is important to keep in mind that an improvement in the abstract idea itself… is not an improvement in technology.”
On pages 18-19 Applicant argues that no prior art rejections have been made, which “supports a finding that the technical features as claimed are not conventional or known in the art; which, in turn, suggests that the claimed invention is patent eligible.” Applicant’s arguments are fully considered, but are not persuasive. Examiner notes that issues of patentability over the prior art are a separate consideration to the question of eligibility under 35 USC 101; MPEP 2106.05(I) states that:
Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting "the Government’s invitation to substitute §§ 102, 103, and 112 inquiries for the better established inquiry under § 101 "). As made clear by the courts, the "‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter." Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9).
Accordingly, whether the claims are found to be novel and/or non-obvious over the prior art has no bearing on analysis of patent eligibility under 35 USC 101. Further, Examiner maintains that the additional elements of the claims, when considered both individually and in combination, do not provide “significantly more” than the abstract idea itself or an unconventional arrangement, as explained in detail in paras. 14-17 below.
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 1-2, 7-10, 17-19, 22, 24, 26-31, 34-49, 51-53, 55, and 59 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
In the instant case, claims 1-2, 7-10, 17-19, 22, 24, 26-31, 34-49, 51-53, and 59 are directed to a method (i.e. a process) and claim 55 is directed to a non-transitory storage medium (i.e. a manufacture). Thus, each of the claims falls within one of the four statutory categories. Nevertheless, the claims fall within the judicial exception of an abstract idea.
Step 2A – Prong 1
Independent claim 1 recites steps that, under their broadest reasonable interpretations, cover certain methods of organizing human activity, e.g. managing personal behavior, relationships, or interactions between people. Specifically, the claim recites:
continuously measuring blood glucose of a subject for several days to generate a continuous blood glucose measurement;
calculating weekly variation data of glucose levels of the subject from the continuous blood glucose measurement;
measuring, by a sensor, a glycated albumin concentration and an albumin concentration in a body fluid of a subject, for the several days during which the continuous blood glucose measurement was performed and for a period other than the several days;
determining a correlation between a mean value of the variation data of the glucose levels acquired by the continuous blood glucose measurement and a glycated albumin (GA) level;
based on the correlation, estimating, from the GA level obtained for the period other than the several days during which the continuous blood glucose measurement was performed, a mean value of glucose levels for the period other than the several days;
comparing threshold values with a corresponding each of the GA level, the mean value of glucose levels estimated from the GA level obtained for the period other than the several days during which the continuous blood glucose measurement was performed, and ambulatory glucose profile (AGP) of the variation data of the glucose levels during the several days during which the continuous blood glucose measurement was performed to identify if a risk is detected;
if the risk is detected in either one of: (i) the GA level, (ii) the mean value of glucose levels estimated from the GA level obtained for the period other than the several days during which the continuous blood glucose measurement was performed, and (iii) ambulatory glucose profile (AGP) of the variation data of the glucose levels during the several days during which the continuous blood glucose measurement was performed, then generating, by a processor, based on predefined threshold and stored rule-based logic, output information including: (a) the risk, (b) first recommendations regarding lifestyle habits based on the risk and associated thresholds, and (c) second recommendations regarding taking medications determined by referencing a treatment ruleset stored in memory; and
transmitting the output information to a user to notify the user of the risk, the first recommendations, and the second recommendations;
wherein based on a change in GA level acquired after the continuous blood glucose measurement, it is determined whether or not a next continuous blood glucose measurement should be performed, and output information including the determination is generated,
wherein when the change in GA level acquired after the continuous blood glucose measurement is greater than a predetermined value, the processor, in response to determining the change in GA level is greater than the predetermined value, generates output information indicating that the next continuous blood glucose measurement should be performed,
wherein when the change in GA level acquired after the continuous blood glucose measurement is less than or equal to the predetermined value, the processor, in response to determining the change in GA level is less than or equal to the predetermined value, generates output information indicating that the next continuous blood glucose measurement is not required to be performed.
Each of these italicized steps, when considered as a whole, describe instructions that a clinician or other medical professional could follow to manage their personal behavior during an interaction with a patient or colleague for medical analysis. For example, a clinician could examine weekly CGM readings to calculate weekly glucose variation levels, and then correlate such data with measured GA concentration and albumin concentration information for different periods of time. The clinician could then use the correlation to estimate or predict mean glucose variation for a period with no CGM data based on known GA level data and make determinations about risk to a patient by evaluating/comparing the GA level, estimated mean glucose level, and/or an ambulatory glucose profile against respective threshold values for each type of data. The clinician could then generate a report or other output based on predefined thresholds and rules such that the output includes any determined risks and corresponding recommendations for lifestyle and medication treatments, and communicate/transmit the output to a relevant stakeholder like a patient or colleague, e.g. by speaking with them, through written communication, etc. The clinician could further make determinations about whether another continuous blood glucose measurement should be performed or not based on comparing the change in GA level to a predetermined value, and communicate this determination to a relevant stakeholder like the patient. Thus, the steps recited in this claim describe the management of personal behavior and/or various interactions between a patient and one or more medical professionals, and accordingly claim 1 recites an abstract idea in the form of a certain method of organizing human activity.
Dependent claims 2, 7-10, 17-19, 22, 24, 26-31, 34-49, 51-53, 55, and 59 inherit the limitations that recite an abstract idea from their dependence on claim 1, and thus these claims also recite an abstract idea under the Step 2A – Prong 1 analysis. In addition, claims 2, 7-10, 17-19, 22, 26-31, 34-49, 51-53, and 59 recite further limitations that, under their broadest reasonable interpretations, amount to additional steps/functions in the method of organizing human activity. Specifically, claim 2 specifies that the AGP includes a variation range of the variation data, which a clinician would be capable of evaluating to detect health risks. Claims 7-9 and 22 recite that the data are measured at multiple times over various time periods, which a clinician would be capable of achieving. Claims 9-10, 17-19, 30, 34-46, and 52 recite various types of output information that may be generated or determined, each of which are types of information that a clinician would be capable of gleaning by analyzing various patient information using their medical expertise. Claims 26-29 and 51 recite determining correlations between various data, which a clinician could achieve by analyzing patient data and observing correlations using their medical expertise. Claim 31 recites storing a correlation as third data, which a clinician could achieve by remembering this information about a patient or otherwise storing it in a patient chart, medical record, etc. Claims 47-49 recite notifying a collector of a body fluid that it should be collected at various times, which a clinician could achieve by communicating with a phlebotomist or other collector of a body fluid that a collection is scheduled to occur. Claim 53 specifies that the body fluid is blood, tears, or saliva, each of which are sample types that a clinician would be able to acquire testing results from. Claim 59 specifies various types of user, each of which are types of people that a clinician would be capable of interacting and sharing data with.
However, recitation of an abstract idea is not the end of the analysis. Each of the claims must be analyzed for additional elements that indicate the abstract idea is integrated into a practical application to determine whether the claim is considered to be “directed to” an abstract idea.
Step 2A – Prong 2
The judicial exception is not integrated into a practical application. In particular, independent claim 1 does not include additional elements that integrate the abstract idea into a practical application. Claim 1 includes the additional elements of continuously measuring blood glucose of a subject for several days to generate the continuous blood glucose measurement; measuring, by a sensor, a glycated albumin concentration and an albumin concentration in a body fluid of a subject, for the several days during which the continuous blood glucose measurement was performed and for a period other than the several days; and use of a processor to generate the output information and direct whether a next continuous blood glucose measurement should be performed or prevented. The “measuring” additional elements, when considered in the context of the claim as a whole, amount to insignificant pre-solution activities in the form of necessary data gathering because these types of sensor measurements are merely made as means of obtaining the data about CGM, GA, and albumin levels needed for the main calculation, correlation, and analysis steps, as explained above. See MPEP 2106.05(g), where similar steps for performing clinical tests on individuals to obtain input for an equation and determining the level of a biomarker in blood are provided as examples of mere data gathering insignificant extra-solution activities. The use of a processor to generate output information and determine whether a next measurement should be performed amounts to instructions to “apply” the exception because it merely utilizes a high-level computing component as a tool with which to digitize and/or automate these otherwise-abstract steps (see MPEP 2106.05(f)). Accordingly, claim 1 as a whole is directed to an abstract idea without integration into a practical application.
The judicial exception recited in dependent claims 2, 7-10, 17-19, 22, 24, 26-31, 34-49, 51-53, 55, and 59 is also not integrated into a practical application under a similar analysis as above. Claims 2, 10, 17-19, 26-31, 33-49, 51-53, and 59 are performed without introducing any new additional elements of their own, and accordingly do not provide integration into a practical application. Claims 7-9 further describe measuring the glycated albumin concentration and the albumin concentration in the body fluid, while claim 22 similarly describes the performance of continuous blood glucose measurements to obtain the variation data of glucose levels. Each of these steps amount to insignificant pre-solution activities in the form of necessary data gathering because these types of measurements are merely made as means of obtaining the GA and albumin levels or glucose level variation data needed for the main analysis steps, as explained above for the independent claim. Claim 24 specifies that determining the correlation is performed using machine learning or deep learning, which amounts to instructions to “apply” the exception with a computer because these methods are recited at a high level of generality (i.e. no particular types or techniques, training data, transformations, specific outputs, or other parameters of the machine learning or deep learning are described) and merely serve to digitize or automate the otherwise-abstract analysis steps (see MPEP 2106.05(f)). Claim 55 introduces the additional element of a non-transitory storage medium storing a software for performing the method of claim 1, which also amounts to instructions to “apply” the exception with a computer because a high-level computing component is utilized as a tool with which to automate or digitize the otherwise-abstract steps (see MPEP 2106.05(f)).
Accordingly, the additional elements of claims 1-2, 7-10, 17-19, 22, 24, 26-31, 34-49, 51-53, 55, and 59 do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Claims 1-2, 7-10, 17-19, 22, 24, 26-31, 34-49, 51-53, 55, and 59 are directed to an abstract idea.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of measuring glucose, GA, and albumin levels in a body fluid with a sensor as in claims 1, 7-9, and 22 amounts to insignificant pre-solution activity in the form of necessary data gathering (see MPEP 2106.05(g)). These types of activities are also nothing more than those recognized as well-understood, routine, and conventional, as evidenced by at least MPEP 2106.05(d)(II) (noting that determining the level of a biomarker, e.g. glucose or albumin, in blood by any means is well-understood, routine, and conventional in the life science arts) as well as Koehler et al. (US 20170215774 A1) paras. [0005]-[0006]; Smith et al. (US 20090042237 A1) para. [0113]; Nagalla et al. (US 20150276723 A1) abstract & [0004]; and Schaefer (US 20140120559 A1) abstract & para. [0008].
The use of a processor to achieve the generating and directing steps as in claim 1 and a non-transitory storage medium storing a software for performing the method as in claim 55 amount to mere instructions to apply the exception using generic computer components. As evidence of the generic nature of the above recited additional elements, Examiner notes para. [0178] of Applicant’s specification, which provides disclosure of generic computer system elements for performing the functions of the invention. The disclosure does not indicate that the elements of the invention are particular machines, and instead provides generic examples of computer hardware, such that one of ordinary skill in the art would understand that any generic computer system including a processor executing stored software instructions could be used to implement the invention.
The use of machine learning or deep learning to perform the analysis steps as in claim 24 also amounts to mere instructions to apply the exception using generic computer components. As evidence of the generic nature of the machine and/or deep learning, Examiner notes at least paras. [0064], [0109], [0112], [0163]-[0164], [0173], [0177] of Applicant’s specification, which provide no specifics regarding the particular types of learning, methods of training the algorithms/models, how particular inputs are transformed to particular outputs, etc. such that they amount to high-level “black box” type elements for automating otherwise-abstract analysis steps. Further, Examiner notes that it is well-understood, routine, and conventional to utilize machine learning and/or deep learning artificial intelligence techniques to analyze patient data to determine health-related outputs, as evidenced by at least Blume et al. (US 20190113520 A1) paras. [0135] & [0155]-[0157]; Cossler et al. (US 20180182475 A1) abstract; and Lewis et al. (US 20180166174 A1) para. [0116].
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually; the overall effect of the processor implementation and sensor-based measuring steps in combination is to digitize and/or automate clinical analysis and determinations of blood-based analytes measured in conventional ways. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Further, the combination of a processor and steps for measuring blood analytes such as glucose, glycated albumin, and albumin via sensors is well-understood, routine, and conventional, as evidenced by at least Schaefer abstract, [0021]-[0022], [0043], & [0048]-[0049]; Kohzuma et al. (WO 2010041439 A1) bottom half of Pg3 & first full paragraph of Pg20; Michelson et al. (US 20140046683 A1) [0152], [0160], [0171], & [0218]; and Paek et al. (US 20190321818 A1) [0013] & [0097]. Thus, when considered as a whole and in combination, claims 1-2, 7-10, 17-19, 22, 24, 26-31, 34-49, 51-53, 55, and 59 are not patent eligible.
Subject Matter Free from Prior Art
The prior art of record fails to expressly teach or suggest, either alone or in combination, each and every feature of independent claim 1 (and thus the claims depending therefrom), as explained in more detail in paras. 27-28 of the final Office action mailed 12/11/2024. Upon completion of an updated prior art search, no additional relevant prior art was discovered.
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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/KAREN A HRANEK/ Primary Examiner, Art Unit 3684