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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/16/2026 has been entered.
Status of Claims
Applicant's arguments, filed 01/16/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 01/16/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1, 5, 29, and 55.
Applicants have canceled/previously canceled claims 4 and 8.
Applicants have left claims 2-3, 6, 10-15, 17-28, 49, and 51-52 as originally filed/previously presented.
Claims 7, 9, 16, 30-48, 50, 53, and 54 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/28/2025.
Claims 1-3, 5-6, 10-15, 17-29, 49, 51-52, and 55 are the current claims hereby under examination.
Claim Objections - Newly Applied
Claim 22 is objected to because of the following informalities:
Regarding claim 22, line 1 recites “the enzyme is glucose oxidase”, however it appears it should read along the lines of --an enzyme of the enzyme reaction is glucose oxidase-- (emphasis added).
Claim Rejections - 35 USC § 112 - Newly Applied Necessitated by Applicant’s Amendments
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 5-6, 10-15, 17-29, 49, 51-52, and 55 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites “the sensor” in line 4. However, claim 1 has been amended to recite “an analyte sensor” and “an enzyme-based electrochemical sensor”, in line 3. In light of the specification, it is currently unclear if “the sensor”, recited in line 4 is referring to “an analyte sensor” as a whole, “an enzyme-based electrochemical sensor”, or both. For the purposes of examination, “the sensor” is being interpreted as referring to either “an analyte sensor” or “an enzyme-based electrochemical sensor”. It is recommended to the Applicant to amend the claims to clearly define what “the sensor” encompasses.
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claim 1, the claim recites “the sensor” in line 5. However, claim 1 has been amended to recite “an analyte sensor” and “an enzyme-based electrochemical sensor”, in line 3. In light of the specification, it is currently unclear if “the sensor”, recited in line 5 is referring to “an analyte sensor” as a whole, “an enzyme-based electrochemical sensor”, or both. For the purposes of examination, “the sensor” is being interpreted as referring to either “an analyte sensor” or “an enzyme-based electrochemical sensor”. It is recommended to the Applicant to amend the claims to clearly define what “the sensor” encompasses.
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claim 1, the claim recites “the sensor” in line 9. However, claim 1 has been amended to recite “an analyte sensor” and “an enzyme-based electrochemical sensor”, in line 3. In light of the specification, it is currently unclear if “the sensor”, recited in line 9 is referring to “an analyte sensor” as a whole, “an enzyme-based electrochemical sensor”, or both. For the purposes of examination, “the sensor” is being interpreted as referring to either “an analyte sensor” or “an enzyme-based electrochemical sensor”. It is recommended to the Applicant to amend the claims to clearly define what “the sensor” encompasses.
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claim 1, the claim recites “the sensor” in line 16. However, claim 1 has been amended to recite “an analyte sensor” and “an enzyme-based electrochemical sensor”, in line 3. In light of the specification, it is currently unclear if “the sensor”, recited in line 16 is referring to “an analyte sensor” as a whole, “an enzyme-based electrochemical sensor”, or both. For the purposes of examination, “the sensor” is being interpreted as referring to either “an analyte sensor” or “an enzyme-based electrochemical sensor”. It is recommended to the Applicant to amend the claims to clearly define what “the sensor” encompasses.
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claim 3, the claim recites “the sensor” in line 2 (two instances). However, claim 1 has been amended to recite “an analyte sensor” and “an enzyme-based electrochemical sensor”, in line 3. In light of the specification, it is currently unclear if “the sensor”, recited in claim 4 is referring to “an analyte sensor” as a whole, “an enzyme-based electrochemical sensor”, or both. For the purposes of examination, “the sensor” is being interpreted as referring to either “an analyte sensor” or “an enzyme-based electrochemical sensor”. It is recommended to the Applicant to amend the claims to clearly define what “the sensor” encompasses.
Regarding claim 23, line 2 recites “one or more membrane layers”. However, claim 1 has been amended to recite “the sensor employs a membrane”, in line 4. In light of the specification, it is currently unclear if “one or more membrane layers” is the same as, related to, or different from “a membrane” recited in claim 1. For the purposes of examination, “one or more membrane layers” is related to “a membrane” recited in claim 1.
Regarding claim 55, the claim recites “the sensor” in line 6. However, claim 55 has been amended to recite “a continuous analyte sensor” and “an enzyme-based electrochemical sensor”, in lines 3-5. In light of the specification, it is currently unclear if “the sensor”, recited in line 6 is referring to “a continuous analyte sensor” as a whole, “an enzyme-based electrochemical sensor”, or both. For the purposes of examination, “the sensor” is being interpreted as referring to either “a continuous analyte sensor” or “an enzyme-based electrochemical sensor”. It is recommended to the Applicant to amend the claims to clearly define what “the sensor” encompasses.
Regarding claim 55, the claim recites “the sensor” in line 13. However, claim 55 has been amended to recite “a continuous analyte sensor” and “an enzyme-based electrochemical sensor”, in lines 3-5. In light of the specification, it is currently unclear if “the sensor”, recited in line 13 is referring to “a continuous analyte sensor” as a whole, “an enzyme-based electrochemical sensor”, or both. For the purposes of examination, “the sensor” is being interpreted as referring to either “a continuous analyte sensor” or “an enzyme-based electrochemical sensor”. It is recommended to the Applicant to amend the claims to clearly define what “the sensor” encompasses.
Regarding claim 55, the claim recites “the sensor” in line 21. However, claim 55 has been amended to recite “a continuous analyte sensor” and “an enzyme-based electrochemical sensor”, in lines 3-5. In light of the specification, it is currently unclear if “the sensor”, recited in line 21 is referring to “a continuous analyte sensor” as a whole, “an enzyme-based electrochemical sensor”, or both. For the purposes of examination, “the sensor” is being interpreted as referring to either “a continuous analyte sensor” or “an enzyme-based electrochemical sensor”. It is recommended to the Applicant to amend the claims to clearly define what “the sensor” encompasses.
Claim Rejections - 35 USC § 101 - Modified Necessitated by Applicant’s Amendments
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 1-3, 5-6, 10-15, 17-29, 49, 51-52, and 55 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.
Analysis of independent claims 1 and 55:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a method, which describes one of the four statutory categories of patentable subject matter, i.e., a process. Claim 55 is directed to a system, which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1 and 55 recite an abstract idea. In particular, the claims recite the following:
Independently modeling at least one factor that influences the signal, the at least one factor arising from an individualized characteristic of the sensor and/or an individualized physiological characteristic of the patient, wherein the independent modeling includes modeling an electrochemical break-in by determining at least one parameter associated with an interference layer of the analyte sensor controlling diffusion of an interfering species and independently determining a second at least one parameter associated with a catalyst surface of the analyte sensor facilitating analyte-specific reactions;
Modifying one or more models of the at least one factor that is independently modeled; and
Outputting data representative of the concentration of the analyte in the patient based at least in part on the modified one or more models.
These elements recited in claims 1 and 55 are drawn to an abstract idea since (1) they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations; and/or (2) they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Independently modeling at least one factor that influences the signal is drawn to an abstract idea since it involves mathematical concepts such as mathematical calculations. For example, independently modeling factors that influences a signal involves determining different values for modeling an electrochemical break-in, such as values or variables relating to the interference layer and the catalyst surface. The claims currently do not further define what “modeling” entails. Alternatively and/or additionally, independently modeling at least one factor that influences the signal is drawn to an additional abstract idea since it can be interpreted as involving a mental process that can be practically performed in the human mind with the aid of pen and paper. For example, a person with ordinary skill in the art could reasonably model different factors that cause changes in the electrochemical break-in, such as if an interference layer and a catalyst surface will increase or decrease electrochemical break-in. There is nothing to suggest an undue level of complexity in the modeling step.
Modifying one or more models of the at least one factor that is independently modeled is drawn to an abstract idea since it involves mathematical concepts such as mathematical calculations. For example, modifying the model involves adjusting different values, such as constants within a calibration equation. The claims currently do not further define the process of “modifying one or more models”. Alternatively and/or additionally, modifying one or more models is drawn to an additional abstract idea since it can be interpreted as involving a mental process that can be practically performed in the human mind with the aid of pen and paper. For example, a person with ordinary skill in the art could reasonably adjust or modify a constant of a calibration equation. There is nothing to suggest an undue level of complexity in the modeling step.
Outputting data representative of the concentration of the analyte in the patient based at least in part on the modified one or more models is drawn to an abstract idea since it involves mathematical concepts such as mathematical calculations. For example, outputting data representative of the concentration of the analyte based at least in part on the modified one or more models involves applying a model, such as a calibration equation, to a value. The claims currently do not further define the process of outputting data. Alternatively and/or additionally, outputting data representative of the concentration of the analyte based at least in part on the modified one or more models is drawn to an additional abstract idea since it can be interpreted as involving a mental process that can be practically performed in the human mind with the aid of pen and paper. For example, a person with ordinary skill in the art could reasonably apply a calibration equation to a value and output the data. There is nothing to suggest an undue level of complexity in the modeling step.
Prong Two: Claims 1 and 55 do not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “a computing device … comprising a continuous analyte monitoring application … configured to” (claim 55)), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “providing an analyte sensor comprising an enzyme-based electrochemical sensor, wherein the sensor employs a membrane disposed over at least a portion of an electroactive surface of the sensor” (claim 1), “receiving a signal from the analyte sensor located within a body of the patient” (claim 1), “receiving individualized characteristic data associated with the individualized characteristic of the sensor and/or the individualized physiological characteristic of the patient” (claim 1), “continuous analyte sensor electronics coupled to a continuous analyte sensor that generates data indicative of the analyte concentration of the patient, wherein the continuous analyte sensor comprises an enzyme-based electrochemical sensor employing a membrane disposed over at least a portion of an electroactive surface of the sensor” (claim 55), “receive a signal from the continuous analyte sensor” (claim 55), “receive individualized characteristic data associated with the individualized characteristic of the sensor and/or the individualized physiological characteristic of the patient” (claim 55)); using generic data-putting components (e.g., “displaying the data representative of the concentration of the analyte in the patient on a display” (claim 1), “display upon a display device” (claim 55))).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional.
For example, an analyte sensor comprising an enzyme-based electrochemical sensor, wherein the sensor employs a membrane disposed over at least a portion of an electroactive surface of the sensor is well-understood, routine, and conventional, as disclosed by Vanslyke et al. (WO 2019038661 A1) - (para. [0051-0053], para. [0068]) and Bohm et al. (US 20140114156 A1) - (para. [0265]).
For example, receiving a signal from a continuous analyte sensor is well-understood, routine, and conventional, as disclosed by the instant application - (para. [0107], “systems and methods of measuring glucose in a host are known …”).
For example, receiving individualized characteristic data associated with the individualized characteristic of the sensor and/or the individualized physiological characteristic of the patient is well-understood, routine, and conventional, as disclosed by Vanslyke et al. (WO 2019038661 A1) - (Fig. 3, element 302, Fig. 16, element 1608, element 1612, Fig. 17, element 1706, para. [0078], para. [0079], para. [0145], para. [0159-0160], para. [0162]).
For example, a display for displaying data is well-understood, routine, and conventional, as disclosed by Vanslyke et al. (WO 2019038661 A1) - para. [0046], [0066].
Further, “continuous analyte sensor electronics”, “a computing device” and “a continuous analyte monitoring application”, does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1 and 55 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to pre-solution data gathering steps or generic post-solution steps of displaying data, which merely facilitate the abstract idea.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of the dependent claims:
Claims 2-3, 5-6, 10-15, 17-29, 49, 51, and 55 depend from the independent claim 1 or claim 52. The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“wherein the factors being independently modeled include diffusion time-lag, diffusion enzyme activity and/or IG to BG dynamics” (claim 2), “wherein the factors being independently modeled include a sensitivity of the sensor and/or a baseline response of the sensor” (claim 3), “wherein modeling of the IG to BG dynamics includes modeling compartmental bias” (claim 10), “wherein modeling compartmental bias includes modeling a steady-state compartmental bias component separately from a time lag compartmental bias component” (claim 11), “wherein the factors being independently modeled include progressive sensor decline, wherein the progressive sensor decline causes the signal to decline as the analyte sensor approaches end of life” (claim 12), “wherein the individualized characteristic data includes s a measure of in vivo impedance” (claim 17), “wherein the factors being modeled include enzyme activity and the modeling of the enzyme activity is performed using the Michaelis Menten equation” (claim 18), “wherein the individualized characteristic data associated with the individualized sensor characteristics includes a level of glucose or oxygen exposure over a lifetime of the analyte sensor” (claim 19), “wherein the modeling of at least one factor that influences the signal comprises modeling of one or more factors influencing a non-analyte component of the signal” (claim 20), “wherein one of the factors being modeled is an enzyme reaction with the analyte” (claim 21), “wherein the enzyme is glucose oxidase and the analyte is glucose” (claim 22), “wherein one of the factors being modeled is diffusion of the analyte through one or more membrane layers of the analyte sensor” (claim 23), “wherein the diffusion time-lag factor is modeled by physical and thermodynamic sensor characteristics” (claim 24), “wherein the diffusion time-lag factor is modeled based on a time-shift model, a transfer function of diffusional processes, or deconvolution” (claim 25), “wherein the factors being modeled include electrochemical break-in, the electrochemical break-in being modeled as a function of hydration” (claim 26), “wherein receiving individualized characteristic data includes receiving physiological characteristics of the patient during a previous sensor session” (claim 27), “wherein one of the factors being independently modeled is a non-constant noise component of the signal” (claim 28), “one or more of the factors being modeled is diffusion through the membrane of an electroactive compound that interferes with the signal” (claim 29), “wherein a model and model parameters based on averages across population data are modified based on the individualized physiological patient characteristics” (claim 51), “wherein the individualized physiological patient characteristics include patient age and body mass index (BMI)” (claim 52)),
Further describe the pre-solution activity (or the structure used for such activity) (“the enzyme-based electrochemical sensor employs a glucose oxidase enzyme” (claim 5), “the enzyme-based electrochemical sensor measures H202 produced by an enzyme catalyzed reaction of glucose” (claim 6), “wherein the individualized characteristic data includes data received prior to sensor insertion” (claim 13), “wherein at least some of the individualized characteristic data is received after an in vivo sensor session has begun” (claim 14), “wherein the individualized characteristic data associated with the individualized sensor characteristics includes factory-derived information” (claim 15)).
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subjection matter. Claims 1-3, 5-6, 10-15, 17-29, 49, 51-52, and 55 are rejected.
Response to Arguments
Applicant's arguments filed 01/16/2026 have been fully considered but they are not persuasive.
Applicants have argued on pages 10-11 of Remarks, filed 01/16/2026, that the amended claims are “not directed to an abstract idea because the claimed modeling is integrated into a practical application tied to a particular machine and specific sensor physics”.
The Examiner respectfully disagrees. The Examiner does agree that independent claims 1 and 55 recite an enzyme-based electrochemical sensor with a membrane, receiving a signal from the sensor, and modeling a factor that influences the signal. However, as recited above, receiving a signal from an analyte sensor is a pre-solution step of data gathering by well-known, routine, and conventional methods. Further, the abstract ideas are not tied to/integrated with the analyte sensor, as argued. While the claims recite “independently modeling at least one factor that influences the signal …”, the abstract idea as a whole is not integrated into a particular machine because beyond “modeling at least one factor that influences the signal”, the result of the abstract idea does not rely on “a signal” from the sensor. For example, the received signal is not manipulated in any way based on the modifying of the one or more models.
Applicants have argued on page 11 of Remarks, filed 01/16/2026, that “the layer-resolved parameter determination … depends on device-specific membrane architecture and electrochemical behavior during hydration and early settling … modeling break-in and modifying the output is expressly taught as a device-specific improvement to sensor start-up accuracy. These features improve the functioning of the electrochemical sensor system itself … not merely the processing of data”.
The Examiner respectfully disagrees. As recited above, utilizing an analyte sensor comprising an enzyme-based electrochemical sensor, employing a membrane, to receiving a signal, is directed towards pre-solution steps, and the modeling and modifying the models are directed towards abstract ideas. While the claims recite receiving a signal from a sensor, the abstract idea is not tied to or integrated into a particular machine, as argued by Applicants. The abstract idea recited above does not use the received signal in any way. The received signal is not manipulated or used to output data.
Claim Rejections - 35 USC § 103 - Newly Applied Necessitated by Applicant’s Amendments
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-3, 5-6, 10-15, 17, 20-29, 49, 51-52, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Vanslyke et al. (WO 2019/038661 A1) (previously cited), hereinafter referred to as Vanslyke, in view of Bohm et al. (US 20140114156 A1) (previously cited), hereinafter referred to as Bohm, in view of Chapman et al. (US 20220225901 A1) (previously cited), hereinafter referred to as Chapman.
The claims are generally directed towards a method for providing data representative of a concentration of an analyte in a patient, comprising: providing an analyte sensor comprising an enzyme-based electrochemical sensor, wherein the sensor employs a membrane disposed over at least a portion of an electroactive surface of the sensor; receiving a signal from the analyte sensor located within a body of the patient; independently modeling at least one factor that influences the signal, the at least one factor arising from an individualized characteristic of the sensor and/or an individualized physiological characteristic of the patient, wherein the independent modeling includes modeling an electrochemical break-in by determining a first at least one parameter associated with an interference layer of the analyte sensor controlling diffusion of interfering species and independently determining a second at least one parameter associated with a catalyst surface of the analyte sensor facilitating analyte-specific reactions; receiving individualized characteristic data associated with the individualized characteristic of the sensor and/or the individualized physiological characteristic of the patient; modifying one or more models of the at least one factor that is independently modeled based on the receiving the individualized characteristic data; outputting data representative of the concentration of the analyte in the patient based at least in part on the modified one or more models; and displaying the data representative of the concentration of the analyte in the patient on a display.
Regarding claim 1, Vanslyke discloses a method for providing data representative of a concentration of an analyte in a patient (Abstract, “method for monitoring blood glucose levels …”), comprising:
providing an analyte sensor comprising an enzyme-based electrochemical sensor (Fig. 1, elements 102, 104, 110, Fig. 2, elements 202, 210, 220, para. [0045-0046], “continuous analyte sensor system …”, para. [0051-0053], para. [0064], “sense a level of one or more analytes on or within the user, to generate a signal indicative of the level of one or more analytes …”, para. [0068], “glucose-oxidase reaction”);
receiving a signal from the analyte sensor located within a body of the patient (Fig. 1, element 102, Fig. 2, element 202, Fig. 16, element y.sub.t, para. [0046], “transcutaneous analyte sensor”, para. [0064], “sensor 202 may be configured to sense a level of one or more analytes on or within the user, to generate a signal …”, para. [0078], “sensor signal y.sub.t (e.g., an electrical current or voltage) provided by a sensor (e.g., sensor 102, 202) …”);
independently modeling at least one factor that influences the signal, the at least one factor arising from an individualized characteristic of the sensor and/or an individualized physiological characteristic of the patient (Fig. 16, element 1602, element 1604, Fig. 17 element 1704, para. [0075], “account for sensor properties including: sensitivity, baseline, and noise as they change through the lifetime of the sensors”, para. [0076], “model parameters for the selected calibration model may be determined … derived from an independent training set, and non-parametric deconvolution that compensates for the BG-to-IG kinetics”, para. [0079], “para. [0105], “each calibration model parameter is analyzed, individually …”, para. [0141-0143], “model M is selected … a parameters vector is initialized or set to an initial value …”, para. [0154], “parameter vectors may be updated …”, para. [0161], “calibration model comprises one or more calibration model parameters …”);
receiving individualized characteristic data associated with the individualized characteristic of the sensor and/or the individualized physiological characteristic of the patient (Fig. 3, element 302, Fig. 16, element 1608, element 1612, Fig. 17, element 1706, para. [0078], para. [0079], “considers the relationship between a blood glucose profile and an interstitial glucose profile …”, para. [0145], para. [0159-0160], “receive the sensor signal from sensor 202 … reference input may include any of a blood glucose reference, a noise metric of the time-varying electrical signal, an impedance of the analyte sensor, an input from a sensor 205 … acceleration, a galvanic response, an impedance of the sensor and/or tissue, a second electrochemical sensor, a temperature and an atmospheric pressure …”, para. [0162], “estimating at least one of the one or more calibration model parameters … based on at least the time-varying electrical signal …”);
modifying one or more models of the at least one factor that is independently modeled based on the receiving the individualized characteristic data (Fig. 16, element 1604, element 1612, para. [0143], “parameters vector is initialized …”, para. [0154], “parameters vector may be updated for the following iteration …”, Fig. 17, element 1706, para. [0162], “estimating at least one of the one or more calibration model parameters of the selected calibration model based on at least the time-varying electrical signal …”);
outputting data representative of the concentration of the analyte in the patient based at least in part on the modified one or more models (Fig. 2, element 220, Fig. 17, element 1708, para. [0066], para. [0163], “estimating the blood glucose level of the user based on the selected calibration model and using the at least one estimated parameter …”); and
displaying the data representative of the concentration of the analyte in the patient on a display (Fig. 2, element 232, para. [0066], “display configured to present information to the user, for example, estimated blood glucose levels of the user”).
However, Vanslyke does not explicitly disclose wherein the sensor employs a membrane disposed over at least a portion of an electroactive surface of the sensor.
Bohm teaches of an analogous method for processing sensor data and calibration (Abstract). Bohm teaches obtaining information prior to a sensor session and during a sensor session to generate, adjust, or updated a function to calibrate the sensor (para. [0294]). Bohm further teaches the sensor employs a membrane disposed over at least a portion of an electroactive surface of the sensor (para. [0265]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Vanslyke to additionally employ a membrane disposed over at least a portion of electroactive surfaces of the analyte sensor, as taught by Bohm. This is because Bohm teaches a membrane disposed over at least a portion of an electroactive surface of the sensor provides protection and diffusion resistance, thereby improving the sensor response towards an analyte (para. [00265]).
However, modified Vanslyke does not explicitly disclose wherein the independent modeling includes modeling an electrochemical break-in by determining a first at least one parameter associated with an interference layer of the analyte sensor controlling diffusion of interfering species and independently determining a second at least one parameter associated with a catalyst surface of the analyte sensor facilitating analyte-specific reactions.
Chapman teaches an analogous method and system for calibration of biosensors (Abstract, para. [0024]). Chapman teaches independently modeling at least one factor that influences a signal, the at least one factor arising from an individualized characteristic of the sensor and/or an individualized physiological characteristic of the patient (Fig. 8, para. [0158-0161]). Chapman further teaches the independent modeling includes modeling an electrochemical break-in by determining a first at least one parameter associated with an interference layer of the analyte sensor controlling diffusion of interfering species and independently determining a second at least one parameter associated with a catalyst surface of the analyte sensor facilitating analyte-specific reactions (para. [0158-0165], “predicting one or more performance metrics of the component using the production data … metrics related to an electrochemical response of an electrode … increases or decreases in surface area of the electrode, due to variation in the electrode formation can be used to update the calibration adjustments … membranes used for selectivity … adjusted based on the probability of an interfering species that is affected by variation in the membranes … variation in the thickness of membranes can be used to alter and/or adjust models that predict diffusion behavior … update calibration adjustments …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the independent modeling taught by modified Vanslyke to additionally include modeling an electrochemical break-in by determining a first at least one parameter associated with an interference layer of the analyte sensor controlling diffusion of interfering species and independently determining a second at least one parameter associated with a catalyst surface of the analyte sensor facilitating analyte-specific reactions, as taught by Chapman. This is because Chapman teaches production data, such as variations of different membranes and electrode formation, can be used as variables for a calibration adjustment to increase the electrodes predicted response to an analyte of interest (para. [0161]).
Regarding claim 2, modified Vanslyke discloses the method of claim 1, wherein the factors being independently modeled include diffusion time-lag, diffusion enzyme activity and/or IG to BG dynamics (Fig. 16, element 1608, element 1612, para. [0155], para. [0184]).
Regarding claim 3, modified Vanslyke discloses the method of claim 1, wherein the factors being independently modeled include a sensitivity of the sensor and/or a baseline response of the sensor (para. [0075], para. [0082], para. [0088], para. [0118], para. [0184]).
Regarding claim 5, modified Vanslyke discloses the method of claim 1, wherein the enzyme-based electrochemical sensor employs a glucose oxidase enzyme (para. [0051-0053], para. [0068], “glucose-oxidase reaction”).
Regarding claim 6, modified Vanslyke discloses the method of claim 5, wherein the enzyme-based electrochemical sensor measures H2O2 produced by an enzyme catalyzed reaction of glucose (para. [0051-0053], para. [0068], “glucose-oxidase reaction”).
Regarding claim 10, modified Vanslyke discloses the method of claim 2, wherein modeling of the IG to BG dynamics includes modeling compartmental bias (Fig. 3, element 302, para. [0079-0081], para. [0090]).
Regarding claim 11, modified Vanslyke discloses the method of claim 10, wherein modeling compartmental bias includes modeling a steady-state compartmental bias component separately from a time lag compartmental bias component (Fig. 3, element 302, para. [0079-0081], para. [0090]).
Regarding claim 12, modified Vanslyke discloses the method of claim 1, wherein the factors being independently modeled include progressive sensor decline, wherein the progressive sensor decline causes the signal to decline as the analyte sensor approaches end of life (para. [0075], para. [0177], para. [0184], “device-physiology interface state …”).
Regarding claim 13, modified Vanslyke discloses the method of claim 1, wherein the individualized characteristic data includes data received prior to sensor insertion (para. [0010], “initial value of the one or more calibration model parameters is a prior average value …”, para. [0078]).
Regarding claim 14, modified Vanslyke discloses the method of claim 1, wherein at least some of the individualized characteristic data is received after an in vivo sensor session has begun (Fig. 16, element 1612, Fig. 17, element 1706, para. [0161-0162]).
Regarding claim 15, modified Vanslyke discloses the method of claim 1, wherein the individualized characteristic data associated with the individualized sensor characteristics includes factory-derived information (para. [0100], “sensor specific and be determined accordingly to the manufacturer …”, para. [0184]).
Regarding claim 17, modified Vanslyke discloses the method of claim 1, wherein the individualized characteristic data includes a measure of in vivo impedance (para. [0065], “an impedance of the sensor and/or tissue”, para. [0160], para. [0184]).
Regarding claim 20, modified Vanslyke discloses the method of claim 1, wherein the modeling of at least one factor that influences the signal comprises modeling of one or more factors influencing a non-analyte component of the signal (para. [0184], “auxiliary electrode can be configured to generate a second signal associated with the non-analyte related electroactive compounds …”).
Regarding claim 21, modified Vanslyke discloses the method of claim 1, wherein one of the factors being modeled is an enzyme reaction with the analyte (para. [0093-0094], “sensor sensitivity leads to a decrease in amplitude in sensor signal … different formulation of the sensitivity profile …”).
Regarding claim 22, modified Vanslyke discloses the method of claim 21, wherein the enzyme is glucose oxidase and the analyte is glucose (para. [0068], “a current or voltage signal generated by the glucose oxidase reaction and thus related to the glucose concentration in the interstitial fluid …”).
Regarding claim 23, modified Vanslyke discloses the method of claim 1, wherein one of the factors being modeled is diffusion of the analyte through one or more membrane layers of the analyte sensor (para. [0075], “sensor calibration can be changed due to fouling of the membrane …”).
Regarding claim 24, modified Vanslyke discloses the method of claim 2, wherein the diffusion time-lag factor is modeled by physical and thermodynamic sensor characteristics (para. [0065], “temperature … an impedance of the sensor and/or tissue … physical property …”).
Regarding claim 25, modified Vanslyke discloses the method of claim 2, wherein the diffusion time-lag factor is modeled based on a time-shift model, a transfer function of diffusional processes, or deconvolution (para. [0145-0146, “means of deconvolution”).
Regarding claim 26, modified Vanslyke discloses the method of claim 1.
However, modified Vanslyke does not explicitly disclose wherein the factors being modeled include electrochemical break-in, the electrochemical break-in being modeled as a function of hydration.
Bohm further teaches the factors being modeled include electrochemical break-in, the electrochemical break-in being modeled as a function of hydration (para. [0017], para. [0298]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by modified Vanslyke to additionally include modeling electrochemical break-in, the electrochemical break-in being modeled as a function of hydration, as taught by Bohm. This is because Bohm teaches the level of sensor hydration affect sensor sensitivity, and can be accounted for to adjust the sensor sensitivity profile to obtain more accurate glucose levels (para. [0298]).
Regarding claim 27, modified Vanslyke discloses the method of claim 1, wherein receiving individualized characteristic data includes receiving physiological characteristics of the patient during a previous sensor session (para. [0131], “previously recorded from monitoring sessions of the same or different users”, para. [0138], “all previously acquired BG samples …”).
Regarding claim 28, modified Vanslyke discloses the method of claim 1, wherein one of the factors being independently modeled is a non-constant noise component of the signal (para. [0075], “noise as they change through the lifetime of the sensor(s)”, para. [0077], “noise magnitude”, para. [0177]).
Regarding claim 29, modified Vanslyke discloses the method of claim 1.
However, modified Vanslyke does not explicitly disclose wherein one or more of the factors being modeled is diffusion through the membrane of an electroactive compound that interferes with the signal.
Bohm further teaches one or more of the factors being modeled is diffusion through the membrane of an electroactive compound that interferes with the signal (para. [0272], [0306], [0316-0317]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by modified Vanslyke to additionally model diffusion through the membrane system of an electroactive compound that interferes with the signal, as taught by Bohm. This is because Bohm teaches factors of the membrane system can cause interfering compounds to be measured at the electrode, and modeling and correcting for the interfering compounds provides a more accurate glucose reading (para. [0317]).
Regarding claim 49, modified Vanslyke discloses the method of claim 1, wherein modifying the one or more models includes modifying a model of sensor end of life based on the individualized physiological patient characteristics (para. [0075], para. [0177], para. [0184], “device-physiology interface state …”).
Regarding claim 51, modified Vanslyke discloses the method of claim 1, wherein a model and model parameters based on averages across population data are modified based on the individualized physiological patient characteristics (para. [0131], “monitoring sensors of the same or different users”, para. [0174]).
Regarding claim 52, modified Vanslyke discloses the method of claim 51.
However, modified Vanslyke does not explicitly disclose wherein the individualized physiological patient characteristics include patient age and body mass index (BMI).
Bohm further teaches the individualized physiological patient characteristics include patient age and body mass index (BMI) (para. [0296], para. [0322]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and the individualized physiological patient characteristics disclosed by modified Vanslyke to additionally include patient age and body mass index (BMI), as taught by Bohm. This is because Bohm teaches information obtained prior to a sensor session or during a sensor session, such as BMI and a patients age allows for the sensor sensitivity profile to be generated, adjusted, or updated to obtain more accurate glucose measurements (para. [0294]).
Regarding claim 55, Vanslyke discloses a system for providing data representative of a concentration of an analyte in a patient (Abstract, “method for monitoring blood glucose levels … apparatus … can carry out similar functions”), comprising:
continuous analyte sensor electronics coupled to a continuous analyte sensor that generates data indicative of the analyte concentration of the patient (Fig. 1, elements 102, 104, 110, Fig. 2, elements 202, 210, 220, para. [0045-0046], “continuous analyte sensor system …”, para. [0064], “sense a level of one or more analytes on or within the user, to generate a signal indicative of the level of one or more analytes …”), wherein the continuous analyte sensor comprises an enzyme-based electrochemical sensor (para. [0051-0053], para. [0068], “glucose-oxidase reaction”); and
a computing device in communication with the continuous analyte sensor, the computing device comprising a continuous analyte monitoring application installed on the computing device (Fig. 1, Fig. 2, element 220, para. [0015], para. [0046-0047], para. [0063-0067]), wherein the continuous analyte monitoring application is configured to:
receive a signal from the continuous analyte sensor located within interstitial fluid of the patient (Fig. 1, element 102, Fig. 2, element 202, Fig. 16, element y.sub.t, para. [0046], “transcutaneous analyte sensor”, para. [0064], “sensor 202 may be configured to sense a level of one or more analytes on or within the user, to generate a signal …”, para. [0078], “sensor signal y.sub.t (e.g., an electrical current or voltage) provided by a sensor (e.g., sensor 102, 202) …”);
independently model at least one factor that influences the signal, the at least one factor arising from an individualized characteristic of the sensor and/or an individualized physiological characteristic of the patient (Fig. 16, element 1602, element 1604, Fig. 17 element 1704, para. [0075], “account for sensor properties including: sensitivity, baseline, and noise as they change through the lifetime of the sensors”, para. [0076], “model parameters for the selected calibration model may be determined … derived from an independent training set, and non-parametric deconvolution that compensates for the BG-to-IG kinetics”, para. [0079], “para. [0105], “each calibration model parameter is analyzed, individually …”, para. [0141-0143], “model M is selected … a parameters vector is initialized or set to an initial value …”, para. [0154], “parameter vectors may be updated …”, para. [0161], “calibration model comprises one or more calibration model parameters …”);
receive individualized characteristic data associated with the individualized characteristic of the sensor and/or the individualized physiological characteristic of the patient (Fig. 3, element 302, Fig. 16, element 1608, element 1612, Fig. 17, element 1706, para. [0078], para. [0079], “considers the relationship between a blood glucose profile and an interstitial glucose profile …”, para. [0145], para. [0159-0160], “receive the sensor signal from sensor 202 … reference input may include any of a blood glucose reference, a noise metric of the time-varying electrical signal, an impedance of the analyte sensor, an input from a sensor 205 … acceleration, a galvanic response, an impedance of the sensor and/or tissue, a second electrochemical sensor, a temperature and an atmospheric pressure …”, para. [0162], “estimating at least one of the one or more calibration model parameters … based on at least the time-varying electrical signal …”);
modify one or more models of the at least one of factor that is independently modeled based on the receiving the individualized characteristic data (Fig. 16, element 1604, element 1612, para. [0143], “parameters vector is initialized …”, para. [0154], “parameters vector may be updated for the following iteration …”, Fig. 17, element 1706, para. [0162], “estimating at least one of the one or more calibration model parameters of the selected calibration model based on at least the time-varying electrical signal …”); and
output data representative of the concentration of the analyte in the patient based at least in part on the modified one or more models for display upon a display device (Fig. 2, element 220, element 232, Fig. 17, element 1708, para. [0066], “display configured to present information to the user, for example, estimated blood glucose levels of the user”, para. [0163], “estimating the blood glucose level of the user based on the selected calibration model and using the at least one estimated parameter …”).
However, Vanslyke does not explicitly disclose the continuous analyte sensors employs a membrane disposed over at least a portion of an electroactive surface of the sensor.
Bohm teaches of an analogous method and system for processing sensor data and calibration (Abstract). Bohm teaches obtaining information prior to a sensor session and during a sensor session to generate, adjust, or updated a function to calibrate the sensor (para. [0294]). Bohm further teaches the continuous analyte sensors employs a membrane disposed over at least a portion of an electroactive surface of the sensor (para. [0265]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by Vanslyke to additionally employ a membrane disposed over at least a portion of electroactive surfaces of the analyte sensor, as taught by Bohm. This is because Bohm teaches a membrane disposed over at least a portion of an electroactive surface of the sensor provides protection and diffusion resistance, thereby improving the sensor response towards an analyte (para. [00265]).
However, modified Vanslyke does not explicitly disclose wherein the independent modeling includes modeling an electrochemical break-in by determining a first at least one parameter associated with an interference layer of the analyte sensor controlling diffusion of interfering species and independently determining a second at least one parameter associated with a catalyst surface of the analyte sensor facilitating analyte-specific reactions.
Chapman teaches an analogous method and system for calibration of biosensors (Abstract, para. [0024]). Chapman teaches independently modeling at least one factor that influences a signal, the at least one factor arising from an individualized characteristic of the sensor and/or an individualized physiological characteristic of the patient (Fig. 8, para. [0158-0161]). Chapman further teaches the independent modeling includes modeling an electrochemical break-in by determining a first at least one parameter associated with an interference layer of the analyte sensor controlling diffusion of interfering species and independently determining a second at least one parameter associated with a catalyst surface of the analyte sensor facilitating analyte-specific reactions (para. [0158-0165], “predicting one or more performance metrics of the component using the production data … metrics related to an electrochemical response of an electrode … increases or decreases in surface area of the electrode, due to variation in the electrode formation can be used to update the calibration adjustments … membranes used for selectivity … adjusted based on the probability of an interfering species that is affected by variation in the membranes … variation in the thickness of membranes can be used to alter and/or adjust models that predict diffusion behavior … update calibration adjustments …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the independent modeling taught by modified Vanslyke to additionally include modeling an electrochemical break-in by determining a first at least one parameter associated with an interference layer of the analyte sensor controlling diffusion of interfering species and independently determining a second at least one parameter associated with a catalyst surface of the analyte sensor facilitating analyte-specific reactions, as taught by Chapman. This is because Chapman teaches production data, such as variations of different membranes and electrode formation, can be used as variables for a calibration adjustment to increase the electrodes predicted response to an analyte of interest (para. [0161]).
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Vanslyke et al. (WO 2019/038661 A1) (previously cited), hereinafter referred to as Vanslyke, in view of Bohm et al. (US 20140114156 A1) (previously cited), hereinafter referred to as Bohm, in view of Chapman et al. (US 20220225901 A1) (previously cited), hereinafter referred to as Chapman as applied to claim 1 above, and further in view of Kovatchev et al. (US 20080314395 A1) (previously cited), hereinafter referred to as Kovatchev.
Regarding claim 18, modified Vanslyke discloses the method of claim 1.
However, modified Vanslyke does not explicitly disclose wherein the factors being modeled include enzyme activity and the modeling of the enzyme activity is performed using the Michaelis Menten equation.
Kovatchev teaches of an analogous method for improving the accuracy of a continuous glucose sensor by calibrating or remedying errors due to physiological time lag (Abstract, para. [0006]). Kovatchev further teaches the factors being modeled include enzyme activity and the modeling of the enzyme activity is performed using the Michaelis Menten equation (para. [0050-0052], para. [0061]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by modified Vanslyke to additionally have the factors being modeled include enzyme activity and the modeling of the enzyme activity is performed using the Michaelis Menten equation, as taught by Kovatchev. This is because Kovatchev teaches by modeling the enzyme activity using the Michaelis Menten equation, the accuracy of the CGS output can be improved (para. [0061]).
Regarding claim 19, modified Vanslyke discloses the method of claim 18, wherein the individualized characteristic data associated with the individualized sensor characteristics includes a level of glucose or oxygen exposure over a lifetime of the analyte sensor (para. [0096]).
Response to Arguments
Applicant's arguments filed 01/16/2026 have been fully considered but they are not persuasive.
Applicants have argued on pages 11-12 of Remarks, filed 01/16/2026, “the claims require … two different layers of the sensor stack (interference layer and catalyst/electrode surface) are each parameterized separately for early electrochemical settling” and that Chapman does not teach “in-vivo electrochemical break-in modeling … determining two in vivo break-in parameters … during early hydration/settling”.
Applicants arguments are not commensurate in scope with the claimed invention. The claimed invention currently does not require “in-vivo modeling” or modeling “during early hydration/settling” as argued by Applicants.
While the claims recite receiving a signal from an analyte sensor, the signal is not utilized by the independent modeling, modification of the models, outputting data, or displaying data. As reiterated above, Chapman teaches modeling factors that influence a signal of a sensor, including modeling an electrochemical break-in utilizing parameters associated with an interference layer and a parameter associated with a catalyst surface (Fig. 8, para. [0158-0165]).
Conclusion
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791