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 .
Amendment Entered
This Office action is responsive to the Amendment filed on July 1st, 2026. The examiner acknowledges the amendments to claims 1, 8, and 15, as well as the cancellation of claims 2, 5, 12, 13, 19, and 20. Claims 1, 3-4, 6-11, and 14-18 remain pending in the application.
Response to Arguments
Applicant's arguments, filed July 1st, 2026, with respect to the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive.
At pages 6-7, Applicant argues that the claims are not directed to a mental process because the claims are directed to a method for noise reduction in analyte data and these operations as a whole are not observations, evaluation, judgments or opinions, but rather processor-implemented operations performed on sampled analyte-sensor data. Examiner respectfully disagrees. “It is essential that the broadest reasonable interpretation (BRI) of the claim be established prior to examining a claim for eligibility.” MPEP 2106 II. In light of Applicant’s specification, the claim encompasses raw analyte data. See, for example, [0026]. “The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea.” MPEP 2106.04(a)(2) III. The claimed steps can be performed using raw analyte data in the human mind or by using a pen and paper.
At page 7, Applicant argues that the presence of mathematical relationships within the signal-processing technique does not make the claims directed to a mathematical concept because the claims apply processor-implemented filtering, variance estimation, profiling, smoothing, and boundary-condition handling operations to produce a noise-reduced smoothed signal trace. Examiner respectfully disagrees. 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. “It is essential that the broadest reasonable interpretation (BRI) of the claim be established prior to examining a claim for eligibility.” MPEP 2106 II. Applicant’s specification clearly explains that the noise variance and smoothing algorithm is a mathematical relationship. See, for example, [0057, 0063]. “A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” The single smoothed signal trace generated based on the construction of the noise variance profile and applying of the smoothing algorithm is “a relationship between variables or numbers” that is “expressed in words.” Id.
At pages 7-8, Applicant argues that the claims integrate the abstract idea into a practical application because the claims recite a specific sequence of operations that improves analyte-sensor signal processing. Examiner respectfully disagrees. The improvement cannot be found in the abstract idea itself. “[I]t is important to keep in mind that an improvement in the abstract idea itself ... is not an improvement in technology.” MPEP 2106.05(a) Il. The claims recite steps for processing of data. The claims do not integrate the processing into a practical application. Rather, the alleged improvement lies solely within the processing steps performed by the processor. “Merely adding generic computer components to perform the method/steps is not sufficient. Thus, the claim must include more than mere instructions to perform the method/steps on a generic component or machinery to qualify as an improvement to an existing technology." Id.
At page 9, Applicant argues that in addition to the processor, memory, analyte sensor system, and display, the claims recite a specific analyte-sensor denoising pipeline and when considered as an ordered is directed to a particular way of improving analyte-sensor data quality. Examiner respectfully disagrees. The claims as a whole are analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself. The claims fail to recite an additional element or 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. The claim recites additional elements of: a processor, memory, analyte sensor system, and display. When considered in combination, the additional elements do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. “Merely adding generic computer components to perform the method/steps is not sufficient. Thus, the claim must include more than mere instructions to perform the method/steps on a generic component or machinery to qualify as an improvement to an existing technology." Id. Furthermore, the additional elements of: a processor, memory, analyte sensor system, and display are generic and well-known in the industry - as evidenced by Sugimoto (US 5706423 A), in col. 1 lines 24-33, discloses a conventional data processor; Chang (US 20050114570 A1), in para. [0003-0004], discloses conventional data storage devices; Hasan (US 20160358439 A1) in para. [0028], discloses conventional non-transitory computer-readable media; Bohm (US 20120078071 A1) in para. [0013] discloses conventional continuous analyte sensor systems; Freund (US 20020029979 A1) in para. [0022-0023] conventional measurements and a general purpose computer system of conventional construction, that may include a programmable processor running a signal processing program; Bidarahalli et al., "Noise Reduction in Continuous Blood Glucose Sensor using Physiology based Kalman Filter for Artificial Pancreatic System," 2018 3rd International Conference on Circuits, Control, Communication and Computing (14C), Bangalore, India, 2018, pp. 1-4, doi: 10.1109/CIMCA.2018.8739339.
Applicant's arguments, filed July 1st, 2026, with respect to the rejections under 35 U.S.C. 103 have been fully considered and are persuasive. The rejections under 35 U.S.C. 103 are withdrawn.
Claim Rejections - 35 USC § 101
Claims 1, 3-4, 6-11, and 14-18 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, 8, and 15 follows.
STEP 1
Regarding claims 1, 8, and 15, 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 claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
Mirroring, by the processor, a portion of the raw analyte data corresponding to at least one of a beginning of the raw analyte data or an end of the raw analyte data to form mirrored data at the beginning or end of the raw analyte data;
Partitioning, by the processor, the raw analyte data into a plurality of partitions;
Applying, by the processor, an adaptive filter separately to each of the plurality of partitions to generate rough filtered partitions having reduced noise;
Determining, by the processor, for each of the plurality of partitions, a noise variance;
Constructing, by the processor, a noise variance profile based on the noise variance determined for each of the plurality of partitions;
Applying, by the processor, a smoothing algorithm across the rough filtered partitions to smooth the rough filtered partitions to generate a single smoothed signal trace; and
Removing, by the processor, a portion of the single smoothed signal trace corresponding to the mirrored data.
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion) (partitioning, determining, constructing) and/or Mathematical Concepts (mirroring, applying an adaptive filter, constructing a noise variance profile, applying a smoothing algorithm, removing). Thus, the claim is drawn to a Mental Process and/or Mathematical Concepts, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claims as a whole are 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, 8, 15 recites receiving raw analyte data corresponding to a noisy signal trace from an analyte sensor, generating a single smoothed signal trace, and displaying the smooth filtered data to the user, which is merely adding insignificant pre-solution and extra-solution activity to the judicial exception (MPEP 2106.05(g)). The received raw analyte data and generated/displayed single smoothed signal trace/smooth filtered data 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 raw analyte data or single smoothed signal trace/smooth filtered data, nor does the method use a particular machine to perform the Abstract Idea.
Regarding claim 8, the system recited in the claim is a generic system comprising generic components configured to perform the abstract idea. The recited system and analyte sensor system are generic sensors configured to perform pre-solutional data gathering activity, and the processor/memory 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:
Receiving, by a processor, raw analyte data corresponding to a noisy signal trace from an analyte sensor;
Analyte sensor system
Memory
Processor
generating a single smoothed signal trace
displaying the smooth filtered data to the user
The receiving steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the receiving, generating, and displaying steps are each recited at a high level of generality such that it amounts to insignificant pre-solution and extra-solution activity, e.g., mere data gathering and data-outputting steps 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 processor, memory, receiving, generating, and displaying 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 8, the system recited in the claim is a generic system comprising generic components configured to perform the abstract idea. The recited system and analyte sensor system are generic sensors configured to perform pre-solutional data gathering activity, and the processor/memory 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. See the prior art of record: Sugimoto (US 5706423 A), in col. 1 lines 24-33, discloses a conventional data processor; Chang (US 20050114570 A1), in para. [0003-0004], discloses conventional data storage devices; Hasan (US 20160358439 A1) in para. [0028], discloses conventional non-transitory computer-readable media; Bohm (US 20120078071 A1) in para. [0013] discloses conventional continuous analyte sensor systems; Freund (US 20020029979 A1) in para. [0022-0023] conventional measurements and a general purpose computer system of conventional construction, that may include a programmable processor running a signal processing program; Bidarahalli et al., "Noise Reduction in Continuous Blood Glucose Sensor using Physiology based Kalman Filter for Artificial Pancreatic System," 2018 3rd International Conference on Circuits, Control, Communication and Computing (14C), Bangalore, India, 2018, pp. 1-4, doi: 10.1109/CIMCA.2018.8739339.
The dependent claims also fail to add something more to the abstract independent claims. Claims 3-4, 6-11, 14, and 16-18 are directed to more abstract ideas, 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
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 ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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