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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 30th, 2026 has been entered.
Claims 1-3, 5-10, and 12-16 remain pending in the application.
Response to Arguments
Applicant's arguments filed March 30th, 2026, with respect to the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive.
At page 9, Applicant argues that the that the claims no longer fall under an abstract idea because the claims recite additional elements (i.e. a first analyte sensor that generates a first set of glucose readings … and a second analyte sensor that generates a second set of glucose readings) that are not capable of being performed in the human mind. Examiner respectfully disagrees. The steps of pre-process[ing], determin[ing] … frequency, assign[ing] … group … frequency of measurements, determin[ing] … first … second evaluation parameter, determin[ing] … plurality of first … second evaluation values, determin[ing] … total risk score, determin[ing] the relative risk, describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion) and/or describe mathematical concepts (including mathematical relationships, mathematical formulas or equations, and mathematical calculations). Thus, the claim is drawn to a Mental Process and/or Mathematical Concepts, which is an Abstract Idea. The steps of providing a first analyte sensor that generates a first set of glucose readings and a second analyte sensor that generates a second set of glucose readings are additional elements that add mere insignificant pre-solution activity (i.e. data gathering steps) necessary to perform the Abstract Idea (MPEP 2106.05(g)). Furthermore, the first analyte sensor that generates a first set of glucose readings and second analyte sensor that generates a second set of glucose readings are well-understood, routine and conventional sensors - as evidenced by the Non-Patent Literature of record (Freckmann G, Pleus S, Link M, Zschornack E, Klötzer H-M, Haug C. Performance Evaluation of Three Continuous Glucose Monitoring Systems: Comparison of Six Sensors Per Subject in Parallel. Journal of Diabetes Science and Technology. 2013;7(4):842-853. doi:10.1177/193229681300700406; Bonora, B., Maran, A., Ciciliot, S. et al. Head-to-head comparison between flash and continuous glucose monitoring systems in outpatients with type 1 diabetes. J Endocrinol Invest 39, 1391–1399 (2016). https://doi.org/10.1007/s40618-016-0495-8) - configured to perform pre-solutional data gathering activity.
Claim Rejections - 35 USC § 101
Claims 1-3, 5-10, and 12-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claims 1 and 14 follows.
STEP 1
Regarding claims 1 and 14, the claim recites a series of steps or acts and/or a series of structural elements, including a system. Thus, the claims are directed to a process and/or a machine, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claims are then analyzed to determine whether it is directed to any judicial exception. The steps of:
pre-processing the first and second sets of glucose readings;
using the pre-processed first and second sets of glucose readings to determine a first frequency of measurements for the first set of glucose readings and a second frequency of measurements for the second set of glucose readings;
assigning the first patient to the first group of similar patients based on the first frequency of measurements and the second patient to the second group of similar patients based on the second frequency of measurements;
determining a first evaluation parameter from the plurality of evaluation parameters
determining a second evaluation parameter from the plurality of evaluation parameters …;
determining, from the first set of glucose readings, a plurality of first evaluation values …;
determining, from the second set of glucose readings, a plurality of second evaluation values …;
determining a first total risk score and a second total risk score by summing first and second risk scores …;
determining the relative risk for lack of glycemic control by comparing …;
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion) and/or mathematical concepts (including mathematical relationships, mathematical formulas or equations, and mathematical calculations). Thus, the claim is drawn to a Mental Process and/or Mathematical Concepts, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claims 1 and 14 recite a first analyte sensor and a second analyte sensor that generate glucose readings / a physiological data input device which acquires a first and second set of glucose readings and a storing/ providing to a storage device which is merely adding insignificant pre-solution activity to the judicial exception (MPEP 2106.05(g)).The generating/acquiring and providing/storing does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the glucose readings, nor does the method use a particular machine to perform the Abstract Idea.
The recited analyte sensors, system, and physiological data input device are generic sensors configured to perform pre-solutional data gathering activity, the data storage device is configured to perform insignificant pre-solution activity, and the processor is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
providing a first analyte sensor that generates a first set of glucose readings assigned to a first patient at a first frequency of measurements;
providing a second analyte sensor that generates a second set of glucose readings assigned to a second patient at a second frequency of measurements different from the first frequency of measurements;
a physiological data input device which acquires a first set of glucose readings … and a second set of glucose readings …;
providing a plurality of evaluation parameters in a data storage device …/ a data storage device storing a plurality of evaluation parameters …;
a processor in communication with the physiological data input device … and in communication with the data storage device.
The providing/generating/acquiring and providing/storing steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the providing/generating/acquiring and providing/storing steps are each recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the providing/generating/acquiring and providing/storing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 1, the analyte sensors are generic sensors configured to perform pre-solutional data gathering activity and regarding claim 14, the system recited in the claim is a generic system comprising generic components configured to perform the abstract idea - as evidenced by the Non-Patent Literature of record (Freckmann G, Pleus S, Link M, Zschornack E, Klötzer H-M, Haug C. Performance Evaluation of Three Continuous Glucose Monitoring Systems: Comparison of Six Sensors Per Subject in Parallel. Journal of Diabetes Science and Technology. 2013;7(4):842-853. doi:10.1177/193229681300700406; Bonora, B., Maran, A., Ciciliot, S. et al. Head-to-head comparison between flash and continuous glucose monitoring systems in outpatients with type 1 diabetes. J Endocrinol Invest 39, 1391–1399 (2016). https://doi.org/10.1007/s40618-016-0495-8). The recited system and physiological data input device are generic sensors configured to perform pre-solutional data gathering activity, the data storage device is configured to perform insignificant pre-solution activity, and the processor is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims. Claims 2-3, 5-10, 13 are directed to more abstract ideas and claims 15-16 are directed to generic sensors – as evidenced by the non-patent literature of record - configured to perform pre-solutional data gathering activity and using a computer as a tool to perform the abstract idea, which does not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: McMahon (US 20180272066 A1) directed to a method of monitoring a physiological condition of a patient and computing a risk score (para. [0022]); Heinemann L, Stuhr A, Brown A, Freckmann G, Breton MD, Russell S, Heinemann L. Self-measurement of Blood Glucose and Continuous Glucose Monitoring - Is There Only One Future? Eur Endocrinol. 2018 Sep;14(2):24-29. doi: 10.17925/EE.2018.14.2.24; Martina Montagnana, Marco Caputo, Davide Giavarina, Giuseppe Lippi, Overview on self-monitoring of blood glucose, Clinica Chimica Acta, Volume 402, Issues 1–2, 2009, Pages 7-13, ISSN 0009-8981, https://doi.org/10.1016/j.cca.2009.01.002.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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