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 .
Claim Status
Claims 1-20 are pending and examined herein.
Claims 1-20 are rejected.
Priority
Claims 1-20 are granted the claim to the benefit of priority to U.S. application 16/848,695 (in which the instant application is a continuation of) filed 14 April 2020 and U.S. Provisional application 62/945800 filed 09 December 2019. Thus, the effective filling date of claims 1-20 is 09 December 2019.
Information Disclosure Statement
The information disclosure statements (IDS) received on 30 August 2024 and 17 February 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Drawings
The drawings received 21 August 2024 are accepted.
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 1-20 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.
(Step 1)
Claims 1-10 and 20 fall under the statutory category of a process and claims 11-19 falls under the statutory category of a machine.
(Step 2A Prong 1)
Under the BRI, the instant claims recite judicial exceptions that are an abstract idea of the type that is in the grouping of a “mental process”, such as procedures for evaluating, analyzing or organizing information, and forming judgement or an opinion. The instant claims further recite judicial exceptions that are an abstract idea of the type that is in the grouping of a “mathematical concept”, such as mathematical relationships and mathematical equations.
Independent claims 1 and 11 recite mathematical concepts of “generating a simulated measurement using an actual measurement from a first sensor as input to a translation model, wherein: the actual measurement comprises… the simulated measurement comprises… the first sensor has a different design or configuration than the second sensor” and “estimating the value of the physiological condition using the simulated measurement, wherein estimating the value of the physiological condition comprises inputting the simulated measurement to an estimation model, and wherein the estimation model is configured to map the one or more measurement parameters that the second sensor would output to an estimated value for the physiological condition”.
Independent claim 20 recites mathematical concepts of “generating a simulated measurement through inputting an actual measurement from a first sensor to a translation model, wherein: the actual measurement comprises a first set of measurement parameters… the simulated measurement comprises a second set of measurement parameters… the translation model is configured to map the first set of measurement parameters… the first sensor has a different design or configuration than the second sensor” and “estimating the value of the physiological condition using the simulated measurement, wherein estimating the value of the physiological condition comprises inputting the simulated measurement to an estimation model”.
Dependent claims 7 and 16 recites a mental process of “determining an operating command for an insulin infusion device based on a difference between the estimated value for the physiological condition and a target value”.
The claims recite mathematical concepts of mathematical calculations as generating a simulated measurement through inputting an actual measurement from a first sensor to a translation model (which encompasses calculating simulated measurements by a shifting translation technique using model equations of polynomial functions, logistic functions, and sigmoidal functions which intake numerical values of measurement parameters of a first sensor and produces numerical outputs of measurement parameters of a second sensor see instant disclosure [0054]) and estimating the value of the physiological condition using the simulated measurement using an estimation model (which encompasses using a mathematical function to calculate estimated sensor glucose values, which is a value of a physiological condition, as a function of measurement parameters see instant disclosure [0059]). The MPEP states “There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word "calculating" in order to be considered a mathematical calculation. For example, a step of "determining" a variable or number using mathematical methods or "performing" a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation” 2106.04(a)(2)(I)(C). Thus, the claims recite mathematical concepts because the BRI of these limitations encompass mathematical calculations.
The claims recite mental processes of determining an operating command for an insulin infusion device based on a difference between the estimated value for the physiological condition and a target value (which encompass analyzing the estimated value and a target value and making a judgment of determining an operating command for an insulin infusion device). The human mind is capable of analyzing differences between numerical values and making a judgment of an operating command based on this difference. Thus, the claims recite a mental process.
Dependent claims 2-4, 6, 8-10, 12, 13, 15, and 17-19 further limit the mental process/ mathematical concept recited in the independent claim but do not change their nature as a mental process/mathematical concept. Thus, claims 1-20 recite abstract ideas.
(Step 2A Prong 2)
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). Integration into a practical application is evaluated by identifying whether there are any additional elements recited in the claim and evaluating those additional elements to determine whether they integrate the exception into a practical application.
The additional element in claims 1 and 20 of using a generic computer to perform judicial exceptions (i.e., one or more processors of an electronic device) and the additional elements in claim 11 of an electronic device comprising one or more processors and memory storing instructions that when executed cause the electronic device (which is interpreted as being a generic computer) to perform judicial exceptions do not integrate the judicial exceptions into a practical application because this is applying the judicial exceptions to a generic computer without an improvement to computer technology (see MPEP 2106.04(d)(1)). These additional elements only interact with the judicial exceptions in a manner by invoking a generic computer to perform the judicial exceptions.
The additional elements in claim 5 and 14 of wherein the first sensor is part of the electronic device, downloading the estimation model from a remote electronic device over a communications network and storing the estimation model in a memory of the electronic device for use with the first sensor does not integrate the judicial exceptions into a practical application because does not integrate the judicial exceptions into a practical application because this step constitutes as insignificant extra solution activity of transmitting data and storing data. This additional element only interacts with the judicial exceptions in a manner by transmitting and storing information on an electronic device. It is noted that the content of the data (i.e., the estimation model) falls under the abstract idea itself and does not change the active step of transmitting this information to an electronic device and storing this information on an electronic device.
The additional element in claims 7 and 16 of communicating, using a communication interface of electronic device, the estimated value for the physiological condition to a control device configured to determine the operating command for the insulin infusion device does not integrate the judicial exceptions into a practical application because this step constitutes as insignificant extra solution activity of outputting/transmitting data. This additional element only interacts with the judicial exceptions in a manner by outputting/transmitting the data to an electronic device. It is noted that the content of the data falls under the abstract idea and does not change the active step of transmitting data to an electronic device. Further, this additional element does not integrate the judicial exceptions into a practical application because it is not required by the claims due to being recited in the alternative form.
Thus, the additional elements do not integrate the judicial exceptions into a practical application and claims 1-20 are directed to the abstract idea.
(Step 2B)
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because:
The additional element in claims 1 and 20 of using a generic computer to perform judicial exceptions (i.e., one or more processors of an electronic device) and the additional elements in claim 11 of an electronic device comprising one or more processors and memory storing instructions that when executed cause the electronic device (which is interpreted as being a generic computer) to perform judicial exception is conventional as shown by MPEP 2106.05(b) and MPEP 2106.05(d)(II).
The additional elements in claim 5 and 14 of wherein the first sensor is part of the electronic device, downloading the estimation model from a remote electronic device over a communications network and storing the estimation model in a memory of the electronic device for use with the first sensor is conventional as shown MPEP 2106.05(b) and MPEP 2106.05(d)(II) which shows transmitting data over a network and storing and retrieving information in memory as well-understood, routine, and conventional functions of computers. It is noted that the content of the data (i.e., the estimation model) falls under the abstract idea itself and does not change the active step of transmitting this information to an electronic device and storing this information on an electronic device. Further, [0090] and claim 1 of Varsavsky et al. (US 20170209082 A1; cited in IDS received 30 August 2024), [0018] of Feldman (US 20160000360 A1), and [0041] of Mastrototaro et al. (US 20110218489 A1) all show a first glucose sensor part of an electronic device which store and transmit data.
The additional element in claims 7 and 16 of communicating, using a communication interface of electronic device, the estimated value for the physiological condition to a control device configured to determine the operating command for the insulin infusion device is conventional as shown by MPEP 2106.05(b) and MPEP 2106.05(d)(II). Further, this additional element does not amount to significantly more than the judicial exception because it is not required by the claims due to being recited in the alternative form.
Thus, the additional elements are not sufficient to amount to significantly more than the judicial exception because they are conventional.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6, 7, 9-13, 15, 16, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Varsavsky et al. (US 20170209082 A1; cited in IDS received 30 August 2024).
Independent claim 1 is directed to a method comprising: generating, by one or more processors of an electronic device, a simulated measurement using an actual measurement from a first sensor as input to a translation model,
Varsavsky et al. shows performing in-line sensor mapping by regressing an optical sensor signal with the electro chemical sensor signal which provides a model/equation which allows for generating a mapped (i.e., corrected) optical signals by inputting the electrochemical signals (or vice versa to generate mapped electrochemical signals using optical signals) which is interpreted as generating a simulated measurement using an actual measurement from a first sensor as input to a translation model (i.e., mapping between echem signal and optical signal using a regression model) (Varsavsky et al. [0184]-[0186]).
wherein: the actual measurement comprises one or more measurement parameters output by the first sensor as an indication of a value of a physiological condition, the simulated measurement comprises one or more measurement parameters that a second sensor would output given the same value of the physiological condition,
Varsavsky et al. shows generating a simulated measurement using an actual measurement from a first sensor as input to a translation model as mapping between sensor signals where signals obtained from a sensor is used to generate mapped/corrected signals for a different sensor (i.e., mapping between echem signal and optical signal using a regression model) which both are producing sensor signals by detecting glucose levels of a subject (physiological condition) (Varsavsky et al. [0184]-[0186]).
and the first sensor has a different design or configuration than the second sensor
Varsavsky et al. shows that the sensors have different designs with one being an electrochemical sensor and the other being an optical sensor (Varsavsky et al. [0186]).
and estimating, by the one or more processors, the value of the physiological condition using the simulated measurement, wherein estimating the value of the physiological condition comprises inputting the simulated measurement to an estimation model, and wherein the estimation model is configured to map the one or more measurement parameters that the second sensor would output to an estimated value for the physiological condition.
Varsavsky et al. shows using mapped optical sensor or electrochemical sensor signals, which is interpreted as being simulated measurement values, to produce an optical sensor glucose value or electrochemical sensor glucose value (i.e., the physiological condition) by calibrating the mapped signals to generate sensor glucose values (Varsavsky et al. [0187]). Varsavsky et al. shows generating an optical sensor glucose value using a model which intakes the mapped optical signal (i.e., the simulated measurement) which is then fused with the sensor glucose value of the different sensor to generate a single sensor glucose value (Varsavsky et al. [0269]-[0270] and [0278]).
Independent claim 11 is directed to an electronic device comprising: one or more processors; and memory storing programming instructions that, when executed by the one or more processors, cause the electronic device to perform the steps recited in claim 1.
Varsavsky et al. shows a data processing apparatus with instructions which when executed cause the apparatus to perform the data analysis process (Varsavsky et al. [0091]). As described above the process is shown by Varsavsky et al. in [0184]-[0187], [0269]-[0270], and [0278].
Independent claim 20 is directed to generating, by one or more processors of an electronic device, a simulated measurement through inputting an actual measurement from a first sensor to a translation model,
Varsavsky et al. shows performing in-line sensor mapping by regressing an optical sensor signal with the electrochemical sensor signal which provides a model/equation which allows for generating a mapped (i.e., corrected) optical signals by inputting the electrochemical signals (or vice versa to generate mapped electrochemical signals using optical signals) which is interpreted as generating a simulated measurement using an actual measurement from a first sensor as input to a translation model (i.e., mapping between echem signal and optical signal using a regression model) (Varsavsky et al. [0184]-[0186]).
wherein: the actual measurement comprises a first set of measurement parameters indicative of a value of a physiological condition, the simulated measurement comprises a second set of measurement parameters that a second sensor would output given the same value of the physiological condition, and the translation model is configured to map the first set of measurement parameters to the second set of measurement parameters,
Varsavsky et al. shows generating a simulated measurement using an actual measurement from a first sensor as input to a translation model as mapping between sensor signals where signals obtained from a sensor is used to generate mapped/corrected signals for a different sensor (i.e., mapping between echem signal and optical signal using a regression model) which both are producing sensor signals by detecting glucose levels of a subject (physiological condition) (Varsavsky et al. [0184]-[0186]). Varsavsky et al. shows generating mapped corrected signals, which is interpreted as being multiple signals, using the signals from a different sensor which is interpreted as being a set of measurement parameters for one sensor to produce a set of measurement parameters for a different sensor (Varsavsky et al. [0184]-[0186]).
and the first sensor has a different design or configuration than the second sensor;
Varsavsky et al. shows that the sensors have different designs with one being an electrochemical sensor and the other being an optical sensor (Varsavsky et al. [0186]).
and estimating, by the one or more processors, the value of the physiological condition using the simulated measurement, wherein estimating the value of the physiological condition comprises inputting the simulated measurement to an estimation model.
Varsavsky et al. shows using mapped optical sensor or electrochemical sensor signals, which is interpreted as being simulated measurement values, to produce an optical sensor glucose value or electrochemical sensor glucose value (i.e., the physiological condition) by calibrating the mapped signals to generate sensor glucose values (Varsavsky et al. [0187]). Varsavsky et al. shows generating an optical sensor glucose value using a model which intakes the mapped optical signal (i.e., the simulated measurement) which is then fused with the sensor glucose value of the different sensor to generate a single sensor glucose value (Varsavsky et al. [0269]-[0270] and [0278]).
Claims 2 and 12 are directed to wherein: the translation model is configured to map the one or more measurement parameters output by the first sensor to the one or more measurement parameters that the second sensor would output
Varsavsky et al. shows performing in-line sensor mapping by regressing an optical sensor signal with the electrochemical sensor signal which provides a model/equation which allows for generating a mapped (i.e., corrected) optical signals by inputting the electrochemical signals (or vice versa to generate mapped electrochemical signals using optical signals) which is interpreted as generating a simulated measurement of using an actual measurement from a first sensor as input to a translation model (i.e., mapping between echem signal and optical signal using a regression model) (Varsavsky et al. [0184]-[0186]).
the one or more measurement parameters output by the first sensor comprise a first parameter associated with an electrical signal produced by the first sensor in response to the physiological condition
Varsavsky et al. shows the electrochemical sensor signal is associated with an electrical signal produced by the sensor, such as a current Isig (Varsavsky et al. [0184] and [0248]).
and the one or more measurement parameters that the second sensor would output comprise a second parameter associated with an electrical signal that second sensor would produce in response to the physiological condition.
Varsavsky et al. shows that the optical sensor generates electrical signals such as a current from an assay channel and a current from a reference channel to generate a current ratio (Varsavsky et al. [0193]-[0195] and Fig. 20). Varsavsky et al. further shows that the optical sensor signal is an electrical signal represented as millivolts (i.e., mV) (Varsavsky et al. Fig. 17, 18, 21A, 21B, and 23A).
Claim 3 is directed to wherein the first parameter represents one of the following electrical characteristics: an electrical current, a voltage, or an impedance. Claim 4 is directed to wherein the second parameter represents the same electrical characteristic as the first parameter.
Claim 13 is directed to wherein: the first parameter represents one of the following electrical characteristics: an electrical current, a voltage, or an impedance; and the second parameter represents the same electrical characteristic as the first parameter.
Varsavsky et al. shows the electrochemical sensor signal is associated with an electrical signal produced by the sensor, such as a current Isig (Varsavsky et al. [0184] and [0248]). Varsavsky et al. shows that the optical sensor generates electrical signals such as a current from an assay channel and a current from a reference channel to generate a current ratio (Varsavsky et al. [0193]-[0195] and Fig. 20).
Dependent claims 6 and 15 is directed to wherein the first sensor and the second sensor are glucose sensors.
Varsavsky et al. shows that the electrochemical sensor and the optical sensor are glucose sensors (Varsavsky et al. [0023], [0024], and [0184]-[0187]).
Dependent claims 7 and 16 are directed to further comprising: determining an operating command for an insulin infusion device based on a difference between the estimated value for the physiological condition and a target value, or communicating, using a communications interface of electronic device, the estimated value for the physiological condition to a control device configured to determine the operating command for the insulin infusion device.
The BRI of the claim only requires one of determining an operating command or communicating the estimated value for the physiological condition to a control deceive. Varsavsky et al. shows communicating the estimated value for the physiologic condition to a control device configured to determine the operating command for the insulin infusion device as transmitting a fused sensor glucose value to an insulin pump of a closed-loop system (Varsavsky et al. claims 9-11). Varsavsky et al. shows a closed-loop system for diabetes includes a glucose sensor and an insulin infusion pump attached to the patient, wherein the delivery of insulin is automatically administered by the controller of the infusion pump (Varsavsky et al. [0011]).
Dependent claims 9 and 18 are directed to wherein the translation model is based on historical measurements from different instances of the first sensor and corresponding historical measurements from different instances of the second sensor.
Varsavsky et al. shows the in-line sensor mapping regression model is generated by regressing the optical sensor signal with the electrochemical sensor signal from sensor signals in a buffer which is interpreted as historical data from different instances of the first sensor with corresponding different instances of the second sensor which is interpreted as using historical measurements within previous measurement time period (i.e., the buffer period) (Varsavsky et al. [0186]).
Dependent claims 10 and 19 are directed to wherein the estimation model is based on historical measurements from different instances of the second sensor and corresponding reference measurements.
Varsavsky et al. shows performing dynamic regression based on meter glucose values (which are interpreted as being reference measurements) and the paired optical signal ratio inside a buffer (which is interpreted as being historical data which was collected during a particular previous time period) (Varsavsky et al. [0265]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 5, 8, 14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Varsavsky et al. (US 20170209082 A1; cited in IDS received 30 August 2024) as applied to claims 1 and 11 under 35 U.S.C. 102 above, and further in view of Feldman (US 20160000360 A1).
Claim 5 and 14 are directed to wherein the first sensor is part of the electronic device, and wherein the programming instructions further cause the electronic device to:
Varsavsky et al. shows a first sensor being part of the electronic device (Varsavsky et al. claim 1).
Varsavsky et al. does not show the process of download the estimation model from a remote electronic device over a communications network, and store the estimation model in a memory of the electronic device for use with the first sensor.
Like Varsavsky et al., Feldman shows processing glucose sensor signals from multiple sensors and correlating signals from multiple sensors. Feldman shows correlating the signals from two sensors and if the sensors are correlated transferring the calibration from one sensor to the other sensor to be used with the sensor which receives the calibration parameters (Feldman [0024], [0027] and [0028]). The calibration parameters are used to generate glucose values from the sensor signals and is interpreted as being an estimation model which generates an estimated value of a physiological condition (i.e., glucose value).
Claims 8 and 17 are directed to wherein the second sensor has an older design or configuration than the first sensor.
Varsavsky et al. does not show wherein the second sensor has an older design or configuration than the first sensor.
Like Varsavsky et al., Feldman shows processing glucose sensor signals from multiple sensors and correlating signals from multiple sensors. Feldman shows a sensor which is calibrated with reference values derived from a glucose meter to derive a calibration of the sensor to produce estimated glucose values when the sensor has reached a stability point which is interpreted as being an older sensor configuration because the sensor is configured with calibration data from a reference glucose meter prior to configuring the next sensor (Feldman [0027] and [0028]). Feldman et al. shows the next sensor is configured by transferring the calibration from the configuration of the older sensor to the next sensor (Feldman [0027] and [0028]).
An invention would have been obvious to one or ordinary skill in the art if some motivation in the prior art would have led that person to modify reference teachings to arrive at the claimed invention. It would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to have modified the calibration procedure which generates an estimation model for glucose levels of Varsavsky et al. with the process of transferring calibration parameters of an older configured sensor that calibrated the sensor signal using glucose meter measurements to a correlated next sensor which is configured with the calibration parameters from the previous sensor of Feldman because this would allow for the reduction of fingerstick (or arm stick) calibrations of the analyte sensor using glucose meters by transferring calibration parameters between prior and subsequent continuous glucose monitors (Feldman [0007], [0027], and [0028]). One would have a reasonable expectation of success because Varsavsky et al. shows the use of correlated sensors for measuring glucose values which are calibrated using glucose meter reference values while Feldman shows a process of initially calibrating a sensor with glucose meter reference values and then transferring calibration parameters of an initially/older calibrated sensor to a next sensor to calibrate the next sensor without the need for glucose meter reference values.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 8-15, and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9-12, and 21 of U.S. Patent No. 12,119,119 (referred to as ‘119 hereinafter). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated over reference application ‘119:
Regarding instant claims 1 and 11, ‘119 shows generating simulated measurements by applying a sensor translation model to the one or more measurements from the first sensor wherein the simulated measurement data represents one or more measurements that the second sensor would output in response to a value of the physiological condition that resulted in the one or more measurements from the first sensor (‘119 claim 1 lines 13-19). ‘119 further shows determining an estimated value of the physiological condition by applying an estimation model associated with the second sensing arrangement to the simulated measurement data (‘119 claim 1 lines 20-23). ‘119 shows the sensing arrangements are different sensing arrangements (‘119 claim 1 line 2). ‘119 shows the measurement from the first sensing arrangement is an actual measurement because it is obtained by the first sensing arrangement (‘119 claim 1 lines 11-12). Regarding instant claim 11, It is noted that the steps of claim 1 are implemented by a processing system which is interpreted as being an electronic device (such as a generic computer) (‘119 claim 1 lines 3, 11, 13, and 20) and it would have been obvious to one of ordinary skill in the art before the effective filling date to have a processing system programmed to perform the recited steps of generating simulated measurements and estimating the value of the physiological condition in accordance with claim one of ‘119.
Regarding instant claim 20, ‘119 shows generating simulated measurements by applying a sensor translation model to the one or more measurements from the first sensor wherein the simulated measurement data represents one or more measurements that the second sensor would output in response to a value of the physiological condition that resulted in the one or more measurements from the first sensor (‘119 claim 1 lines 13-19). ‘119 further shows determining an estimated value of the physiological condition by applying an estimation model associated with the second sensing arrangement to the simulated measurement data (‘119 claim 1 lines 20-23). ‘119 shows the sensing arrangements are different sensing arrangements (‘119 claim 1 line 2). ‘119 shows the measurement from the first sensing arrangement is an actual measurement because it is obtained by the first sensing arrangement (‘119 claim 1 lines 11-12). It is interpreted that the translation model is a mapping between measurement parameters of a first sensing element and a simulated measurement which represents measurement parameters that the second sensing element would output.
Regarding instant claims 2-4 and 12-13, ‘119 shows the simulated measurement for the second sensing arrangement is generated using a translation model by inputting the measurement from the first sensing arrangement and the simulated measurement data represents measurements that the second sensing element would output in response to a value of the physiological condition that resulted in the measurement from the first sensing element in the first sensing arrangement (‘119 claim 1 lines 13-19). It is interpreted that the translation model is a mapping between a measurement parameter of a first sensing element and a simulated measurement which represents measurement parameters that the second sensing element would output. ‘119 shows the measurements for the first sensing element and the simulated measurement for the second sensing element are at least one current values, voltage values, or impedance values (‘119 claim 21 lines 1-5).
Regarding instant claims 5 and 14, ‘119 shows the processing system obtains one or more measurements from the first sensing element which is interpreted that the processing system includes the first sensor (‘119 claim 1 lines 11-12). ‘119 shows downloading, by the processing system, the estimation model from a remote server via a network and it is interpreted that the processing system downloading the estimation model includes storing the downloaded estimation model (‘119 claim 6). Further, the limitation of for use with the first sensor is interpreted as being an intended use of the downloading process.
Regarding instant claims 6 and 15, ‘119 shows the first sensor and the second sensor are glucose sensors (Claim 10 lines 3-4).
Regarding instant claims 8 and 17, ‘119 shows the second sensing arrangement is a legacy glucose sensor which is an older design or configuration of the new sensing arrangement (i.e. the first sensing arrangement) (‘119 claim 9 lines 2-3).
Regarding instant claims 9 and 18, ‘119 shows the translation model is based on measurements from different instances of the first sensing arrangement and the second sensing arrangement (‘119 claim 11 lines 1-11).
Regarding instant claims 10 and 19, ‘119 shows that the estimation model is based on reference values and third measurement data which is historical measurements from additional instances of the second sensing arrangement (‘119 claim 12 lines 1-5).
Claims 7 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 12,119,119 (referred to as ‘119 hereinafter) in view of Varsavsky et al. (US 20170209082 A1; cited in IDS received 30 August 2024).
Regarding instant claims 7 and 16, ‘119 shows all the limitations of instant claims 1 and 11 as described above (‘119 claim 1). ‘119 further shows that the physiological condition is a glucose level (‘119 claim 17 and it is noted claim 17 includes all the limitations of ‘119 claim 1 due to its dependency).
‘119 does not explicitly show determining an operating command for an insulin infusion device based on a difference between the estimated value for the physiological condition and a target value or communicating, using a communications interface of electronic device, the estimated value for the physiological condition to a control device configured to determine the operating command for the insulin infusion device.
The BRI of the claim only requires one of determining an operating command or communicating the estimated value for the physiological condition to a control deceive. Varsavsky et al. shows communicating the estimated value for the physiologic condition to a control device configured to determine the operating command for the insulin infusion device as transmitting a glucose value to an insulin pump of a closed-loop system (Varsavsky et al. claims 9-11). Varsavsky et al. shows a closed-loop system for diabetes includes a glucose sensor and an insulin infusion pump attached to the patient, wherein the delivery of insulin is automatically administered by the controller of the infusion pump (Varsavsky et al. [0011]).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to have combined the generation of an estimated glucose level of ‘119 with the transmission of this estimated glucose value to an insulin pump of a closed loop system in which a controller of the infusion pump automatically administers insulin because this would allow for a process and system which automatically controls blood glucose of a subject by using estimated glucose levels generated by an estimation model (Varsavsky et al. claims 9-11 and [0011]). One would have a reasonable expectation of success because ‘119 shows generating estimated glucose levels while Varsavsky et al. shows transmitting estimated glucose levels to an insulin pump in a closed loop system to automatically administer insulin.
Conclusion
No claims are allowed.
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/JONATHAN EDWARD HAYES/Examiner, Art Unit 1685
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