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 .
Response to Amendment
The amendment filed June 9, 2026 has been entered. Claims 1-8, 18-26, and 61-63 remain pending in the application, and claims 9-17 and 27-20 have been cancelled. Applicant’s amendments to the claims necessitate new grounds of rejection, as described in the Response to Arguments, 101 Rejections, 102 Rejections, and 103 Rejection below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8, 18-26, and 61-63 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. Claims 1-8, 18-26, and 61-63 are directed to a sensor, method, and non-transitory computer-readable medium using a computational algorithm, which is an abstract idea. Claims 1-8, 18-26, and 61-63 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a machine.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] – “calculate a change in the at least one EIS parameter after an injection of insulin”;
[B1] – “detect the presence of the excipient of insulin based on the change”; and
[C1] – “in a case where the presence of the excipient of insulin is detected, compensate the IsigWE1 based on a predetermined relationship between the IsigWE1 and the IsigWE2, wherein compensating the IsigWE1 reduces a false increase in the IsigWE1 caused by the excipient of insulin”; and
[D1] – “output the compensated IsigWE1 (IsigCOMP) for determining a compensated glucose level”.
These elements [A1]-[D1] of claim 1 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 (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.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] – “A glucose sensor”;
[B2] – “a working electrode configured to provide a current signal (IsigWE1) based on a level of glucose;
[C2] – “a background electrode configured to provide a current signal (IsigWE2) based on a presence of an excipient of insulin; and
[D2] – “a controller configured to: monitor the IsigWE1 at the working electrode; monitor the IsigWE2 at the background electrode; monitor at least one electrochemical impedance spectroscopy (EIS) parameter at the working electrode”;
These elements [A2]-[D2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the elements [A2-C2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the element [D2] is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. Also, limitations [A2-C2] are merely insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well-known elements. In particular, the glucose sensor is nothing more than a generic sensor detecting glucose, and the background electrode and working electrodes are generic electrodes. Such sensors are conventional as evidenced by:
U.S. Patent Application Publication No. US 20120097554 A1 (Shah et al.) discloses that glucose sensors [0006] and electrodes [0061] are typical for controlling glucose level [0005].
Further, the element [D2] 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)).
Claims 2-8 and 61-63 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exception:
Claim 7: “a memory”.
Each of these claim limitations does not integrate the exception into a practical application. In particular, the element of claim 7 is an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Also, this limitation from claim 7 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 is, one of display) 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); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
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 of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, 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.
The analysis of claim 18 is as follows:
Step 1: Claim 18 is drawn to a method.
Step 2A – Prong One: Claim 18 recites an abstract idea. In particular, claim 18 recites the following limitations:
[A1] – “calculating a change in the at least one EIS parameter after an injection of insulin”;
[B1] – “detecting the presence of the excipient of insulin based on the change”; and
[C1] – “in a case where the presence of the excipient of insulin is detected, compensating the IsigWE1 based on a predetermined relationship between the IsigWE1 and the IsigWE2, wherein compensating the IsigWE1 reduces a false increase in the IsigWE1 caused by the excipient of insulin”; and
[D1] – “outputting the compensated IsigWE1 (IsigCOMP) for determining a compensated glucose level”.
These elements [A1]-[D1] of claim 18 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 (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.
Step 2A – Prong Two: Claim 18 recites the following limitations that are beyond the judicial exception:
[A2] – “compensating a level of glucose from a glucose sensor based on a presence of an excipient of insulin”;
[B2] – “monitoring the IsigWE1 at the working electrode”;
[C2] – “monitor the IsigWE2 at the background electrode”; and
[D2] – “monitor at least one electrochemical impedance spectroscopy (EIS) parameter at the working electrode”.
These elements [A2]-[D2] of claim 18 do not integrate the exception into a practical application of the exception. In particular, the elements [A2-D2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: Claim 18 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the limitation [A2] does not qualify as significantly more because this limitation merely describes the nature of the data and does not incorporate the glucose sensor as part of the claimed invention. Also, limitations [A2-C2] are merely insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well-known elements. In particular, the glucose sensor is nothing more than a generic sensor detecting glucose, and the background electrode and working electrodes are generic electrodes. Such sensors are conventional as evidenced by Shah et al. (described above in the rejection of claim 1).
Claims 19-25 depend from claim 18, and recite the same abstract idea as claim 18. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exception:
Claim 24: “a memory”.
Each of these claim limitations does not integrate the exception into a practical application. In particular, the element of claim 24 is an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Also, this limitation from claim 18 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 is, one of display) 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); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
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 of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, 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.
The analysis of claim 26 is as follows:
Step 1: Claim 26 is drawn to a machine.
Step 2A – Prong One: Claim 26 recites an abstract idea. In particular, claim 26 recites the following limitations:
[A1] – “calculating a change in the at least one EIS parameter after an injection of insulin”;
[B1] – “detecting the presence of the excipient of insulin based on the change”; and
[C1] – “in a case where the presence of the excipient of insulin is detected, compensating the IsigWE1 based on a predetermined relationship between the IsigWE1 and the IsigWE2, wherein compensating the IsigWE1 reduces a false increase in the IsigWE1 caused by the excipient of insulin”; and
[D1] – “outputting the compensated IsigWE1 (IsigCOMP) for determining a compensated glucose level”.
These elements [A1]-[D1] of claim 26 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 (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.
Step 2A – Prong Two: Claim 26 recites the following limitations that are beyond the judicial exception:
[A2] – “A nontransitory computer-readable medium storing instructions that, when executed by a computing device, cause the computing device to perform a method for compensating a level of glucose from a glucose sensor based on a presence of an excipient of insulin”;
[B2] – “monitoring the IsigWE1 at the working electrode”;
[C2] – “monitor the IsigWE2 at the background electrode”; and
[D2] – “monitor at least one electrochemical impedance spectroscopy (EIS) parameter at the working electrode”.
These elements [A2]-[D2] of claim 26 do not integrate the exception into a practical application of the exception. The element [A2] is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). Additionally, the elements [B2-D2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: Claim 26 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the limitation [A2] does not qualify as significantly more because this limitation merely describes the nature of the data and does not incorporate the glucose sensor as part of the claimed invention. Also, limitations [A2-C2] are merely insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well-known elements. In particular, the glucose sensor is nothing more than a generic sensor detecting glucose, and the background electrode and working electrodes are generic electrodes. Such sensors are conventional as evidenced by Shah et al. (described above in the rejection of claim 1).
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 of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, 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.
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 1-8, 18-26, 61, and 63 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200245910 A1 (Mallas et al.)
Regarding claim 1, Mallas teaches a glucose sensor ([0012]) comprising:
a working electrode configured to provide a current signal (IsigWE1) based on a level of glucose ([0294] “Isig 2230 for a first working electrode WE1”; [0012] “periodically measuring, by the physical sensor electronics, a potential difference between the counter electrode and the working electrode (Vcntr); periodically obtaining a blood glucose (BG) value for the user”);
a background electrode configured to provide a current signal (IsigWE2) based on a presence of an excipient of insulin ([0294] “Isig 2240 for a second working electrode WE2”; [0362] “the m-cresol tends to “poison” the electrode(s), such that the latter can no longer detect glucose, until the insulin (and m-cresol) have been absorbed into the patient's tissue”); and
a controller ([0176] “data processing apparatus (such as a controller, microcontroller, or processor in a sensor electronics device)”) configured to:
monitor the IsigWE1 at the working electrode ([0190] “The signal processor 390 receives the sensor signal (e.g., a measured current or voltage) after the sensor signal is measured at the sensor 355 (e.g., the working electrode)”);
monitor the IsigWE2 at the background electrode ([0200]; [0222] “after the sensor stabilization timeframe has elapsed, the sensor transmits a sensor signal 350 to the signal processor 390.”);
monitor at least one electrochemical impedance spectroscopy (EIS) parameter at the working electrode ([0012] “Electrochemical Impedance Spectroscopy (EIS) procedure to generate EIS-related data for the working electrode”; [0254]);
calculate a change in the at least one EIS parameter after an injection of insulin ([0290] “analysis of EIS data relating to one or more of at least three primary factors, i.e., potential sensor failure modes: (1) signal start-up; (2) signal dip; and (3) sensitivity loss”; [0295]; [0360-0367]; [0367] “the impedance magnitude will exhibit the same behavior as described above regardless of whether the insulin being infused is fast-acting or slow.”; [0763]);
detect the presence of the excipient of insulin based on the change ([0360] “the potential impact on (i.e., interference with) sensor signal that may be caused by the medication being infused and/or an inactive component thereof.”; [0367] “EIS can be used to detect the presence of an interfering agent--in this case, m-cresol.”); and
in a case where the presence of the excipient of insulin is detected, compensate the IsigWE1 based on a predetermined relationship between the IsigWE1 and the IsigWE2 ([0350] “directed to the use of EIS in optimizing sensor calibration. By way of background, in current methodologies, the slope of a BG vs. Isig plot, which may be used to calibrate subsequent Isig values”; “BG and Isig follow a fairly linear relationship, and offset can be taken as a constant.”; [0360-0361] “m-cresol has been found to negatively impact a glucose sensor if insulin (and, therefore, m-cresol) is being infused in close proximity to the sensor. Therefore, a system in which a sensor and an infusion catheter are to be combined in a single needle must be able to detect, and adjust for, the effect of m-cresol on the sensor signal”), wherein compensating the IsigWE1 reduces a false increase in the IsigWE1 caused by the excipient of insulin ([0336] “This mapping is critical, as it helps avoid false positives in instances where a dip is not real. Where the Isig divergence is real, the algorithm will select the sensor with the higher Isig.”; [0354] “an EIS-based dynamic slope approach, where EIS is used to adjust slope, may be used for calibration purposes. FIG. 38A shows an example of how this method can be used to improve sensor accuracy.”; [0763] “the direction of error can also be used to inform users and/or the insulin delivery system in connection with SG being a “false low” or a “false high” value”); and
output the compensated IsigWE1 for determining a compensated glucose level (IsigCOMP) ([0344] “the fused Isig value 3589 is calculated using the filtered Isigs (3522, 3524, and so on) for the plurality of electrodes”).
Regarding claim 2, Mallas teaches the glucose sensor of claim 1, wherein the at least one EIS parameter is a real impedance at 0.1 Hz ([0266] “EIS may be performed at frequencies in the μHz to MHz range, in embodiments, a narrower range of frequencies (e.g., between about 0.1 Hz and about 8 kHz) may be sufficient”; [0289] “0.1 Hz real impedance between two or more working electrodes”).
Regarding claim 3, Mallas teaches the glucose sensor of claim 1, wherein the at least one EIS parameter is an imaginary impedance at 0.1 Hz ([0266]; [0304] “0.1 Hz data”, indicates that, whereas imaginary impedance at 0.1 Hz appears to be fairly steady”).
Regarding claim 4, Mallas teaches the glucose sensor of claim 1, wherein the predetermined relationship between IsigWE1 and the IsigWE2 is a linear relationship ([0197] “the amount of current flowing from the counter electrode 536 to a working electrode 534 has a fairly linear relationship with unity slope to the amount of oxygen present in the area surrounding the enzyme and the electrodes.”; [0352] “by using this dynamic offset approach, it is possible to maintain a linear relationship between Isig and BG.”).
Regarding claim 5, Mallas teaches the glucose sensor of claim 4, wherein the IsigCOMP is equal to:
IsigWE1 - α * IsigWE2,
where α is a slope of the linear relationship ([0676] “Fig. 79 shows the combined effect on the calibration curve, where both the offset and the slope of the linear fit for the period of sensitivity loss (6235) change relative to the calibration curve 6231 for the normally-functioning time windows”; [0197] “the amount of current flowing from the counter electrode 536 to a working electrode 534 has a fairly linear relationship with unity slope to the amount of oxygen present in the area surrounding the enzyme and the electrodes.”; [0352] “by using this dynamic offset approach, it is possible to maintain a linear relationship between Isig and BG.”; The standard equation for linear relationships is y=mx+b, where m=slope, therefore the linear relationship between the electrodes follows this equation, where α can be any slope value).
Regarding claim 6, Mallas teaches the glucose sensor of claim 5, wherein the slope has a profile based on a number of injections of insulin ([0178] “The sensor 12 monitors glucose levels in the body and may be used in conjunction with automated or semi-automated medication infusion pumps”; [0191] “combination infusion pump/glucose sensor”; [0194]; [0218]; [0365] “the patient just administered an unneeded dose of insulin which, depending on the patient's glucose level prior to administration of the bolus, may put the patient at risk of experiencing a hypoglycemic event. This scenario reinforces the desirability of a means of detecting interferents that is as glucose-independent as possible”; [0639]; [0985]; The amount of insulin infused impacts the Isig values, thus impacting the slope.).
Regarding claim 7, Mallas teaches the glucose sensor of claim 6, further comprising: a memory storing the number of injections of insulin and the profile ([0190] “the signal processor 390 receives the sensor signal (e.g., a measured current or voltage) after the sensor signal is measured at the sensor 355 (e.g., the working electrode). The signal processor 390 processes the sensor signal and generates a processed sensor signal. The measurement processor 395 receives the processed sensor signal and calibrates the processed sensor signal utilizing reference values. In one embodiment, the reference values are stored in a reference memory and provided to the measurement processor 395.”; [0194]; [0218]; [0639]; [0845]; [0985]).
Regarding claim 8, Mallas teaches the glucose sensor of claim 1, wherein the excipient of insulin includes one or more of peroxide, phenol, M-cresol, glycerol, zinc, zinc oxide, disodium phosphate, sodium chloride, sodium hydroxide, hydrogen chloride, niacinamide, and arginine hydrochloride ([0361] “the diluent used with insulin contains m-cresol as a preservative”).
Regarding claim 18, Mallas teaches a method for compensating a level of glucose from a glucose sensor based on a presence of an excipient of insulin ([0012] “the present disclosure provides a method of optimizing sensor glucose calculation for a glucose sensor used for measuring the level of glucose in the body of a user”; [0360] “the use of EIS for interferent detection. Specifically, it may be desirable to provide a medication infusion set that includes a combination sensor and medication-infusion catheter, where the sensor is placed within the infusion catheter”), the method comprising:
monitoring a current signal (IsigWE1) at a working electrode of the glucose sensor ([0294] “Isig 2230 for a first working electrode WE1”; [0012] “periodically measuring, by the physical sensor electronics, a potential difference between the counter electrode and the working electrode (Vcntr); periodically obtaining a blood glucose (BG) value for the user”; [0190]);
monitoring a current signal (IsigWE2) at a background electrode of the glucose sensor ([0012]; [0294] “Isig 2240 for a second working electrode WE2”; [0362] “the m-cresol tends to “poison” the electrode(s), such that the latter can no longer detect glucose, until the insulin (and m-cresol) have been absorbed into the patient's tissue”; [0200]; [0222] “after the sensor stabilization timeframe has elapsed, the sensor transmits a sensor signal 350 to the signal processor 390.”); and
monitoring at least one electrochemical impedance spectroscopy (EIS) parameter at the working electrode ([0012] “Electrochemical Impedance Spectroscopy (EIS) procedure to generate EIS-related data for the working electrode”; [0254]);
calculating a change in the at least one EIS parameter after an injection of insulin ([0290] “analysis of EIS data relating to one or more of at least three primary factors, i.e., potential sensor failure modes: (1) signal start-up; (2) signal dip; and (3) sensitivity loss”; [0295]; [0360-0367]; [0367] “the impedance magnitude will exhibit the same behavior as described above regardless of whether the insulin being infused is fast-acting or slow.”; [0763]);
detecting the presence of the excipient of insulin based on the change ([0360] “the potential impact on (i.e., interference with) sensor signal that may be caused by the medication being infused and/or an inactive component thereof.”; [0367] “EIS can be used to detect the presence of an interfering agent--in this case, m-cresol.”); and
in a case where the presence of the excipient of insulin is detected, compensating the IsigWE1 based on a predetermined relationship between the IsigWE1 and the IsigWE2 ([0350] “directed to the use of EIS in optimizing sensor calibration. By way of background, in current methodologies, the slope of a BG vs. Isig plot, which may be used to calibrate subsequent Isig values”; “BG and Isig follow a fairly linear relationship, and offset can be taken as a constant.”; [0360-0361] “m-cresol has been found to negatively impact a glucose sensor if insulin (and, therefore, m-cresol) is being infused in close proximity to the sensor. Therefore, a system in which a sensor and an infusion catheter are to be combined in a single needle must be able to detect, and adjust for, the effect of m-cresol on the sensor signal”), wherein compensating the IsigWE1 reduces a false increase in the IsigWE1 caused by the excipient of insulin ([0336] “This mapping is critical, as it helps avoid false positives in instances where a dip is not real. Where the Isig divergence is real, the algorithm will select the sensor with the higher Isig.”; [0354] “an EIS-based dynamic slope approach, where EIS is used to adjust slope, may be used for calibration purposes. FIG. 38A shows an example of how this method can be used to improve sensor accuracy.”; [0763] “the direction of error can also be used to inform users and/or the insulin delivery system in connection with SG being a “false low” or a “false high” value”); and
outputting the compensated IsigWE1 (IsigCOMP) for determining a compensated glucose level ([0344] “the fused Isig value 3589 is calculated using the filtered Isigs (3522, 3524, and so on) for the plurality of electrodes”).
Regarding claim 19, Mallas teaches the method of claim 18, wherein the at least one EIS parameter is a real impedance at 0.1 Hz ([0266] “EIS may be performed at frequencies in the μHz to MHz range, in embodiments, a narrower range of frequencies (e.g., between about 0.1 Hz and about 8 kHz) may be sufficient”; [0289] “0.1 Hz real impedance between two or more working electrodes”).
Regarding claim 20, Mallas teaches the method of claim 18, wherein the at least one EIS parameter is an imaginary impedance at 0.1 Hz ([0266]; [0304] “0.1 Hz data”, indicates that, whereas imaginary impedance at 0.1 Hz appears to be fairly steady”).
Regarding claim 21, Mallas teaches the method of claim 18, wherein the predetermined relationship between IsigWE1 and the IsigWE2 is a linear relationship ([0197] “the amount of current flowing from the counter electrode 536 to a working electrode 534 has a fairly linear relationship with unity slope to the amount of oxygen present in the area surrounding the enzyme and the electrodes.”; [0352] “by using this dynamic offset approach, it is possible to maintain a linear relationship between Isig and BG.”).
Regarding claim 22, Mallas teaches the method of claim 21, wherein the IsigCOMP is equal to:
IsigWE1 - α * IsigWE2,
where α is a slope of the linear relationship ([0676] “Fig. 79 shows the combined effect on the calibration curve, where both the offset and the slope of the linear fit for the period of sensitivity loss (6235) change relative to the calibration curve 6231 for the normally-functioning time windows”; [0197] “the amount of current flowing from the counter electrode 536 to a working electrode 534 has a fairly linear relationship with unity slope to the amount of oxygen present in the area surrounding the enzyme and the electrodes.”; [0352] “by using this dynamic offset approach, it is possible to maintain a linear relationship between Isig and BG.”; The standard equation for linear relationships is y=mx+b, where m=slope, therefore the linear relationship between the electrodes follows this equation, where α can be any slope value).
Regarding claim 23, Mallas teaches the method of claim 22, wherein the slope has a profile based on a number of injections of insulin ([0178] “The sensor 12 monitors glucose levels in the body and may be used in conjunction with automated or semi-automated medication infusion pumps”; [0191] “combination infusion pump/glucose sensor”; [0194]; [0218]; [0365] “the patient just administered an unneeded dose of insulin which, depending on the patient's glucose level prior to administration of the bolus, may put the patient at risk of experiencing a hypoglycemic event. This scenario reinforces the desirability of a means of detecting interferents that is as glucose-independent as possible”; [0639]; [0985]; The amount of insulin infused impacts the glucose sensor values and Isig values, thus impacting the slope.).
Regarding claim 24, Mallas teaches the method of claim 23, further comprising: storing the number of injections of insulin and the profile in a memory of the glucose sensor ([0190] “the signal processor 390 receives the sensor signal (e.g., a measured current or voltage) after the sensor signal is measured at the sensor 355 (e.g., the working electrode). The signal processor 390 processes the sensor signal and generates a processed sensor signal. The measurement processor 395 receives the processed sensor signal and calibrates the processed sensor signal utilizing reference values. In one embodiment, the reference values are stored in a reference memory and provided to the measurement processor 395.”; [0194]; [0218]; [0639]; [0845]; [0985]).
Regarding claim 25, Mallas teaches the method of claim 18, wherein the excipient of insulin includes one or more of peroxide, phenol, M-cresol, glycerol, zinc, zinc oxide, disodium phosphate, sodium chloride, sodium hydroxide, hydrogen chloride, niacinamide, and arginine hydrochloride ([0361] “the diluent used with insulin contains m-cresol as a preservative”).
Regarding claim 26, Mallas a nontransitory computer-readable medium storing instructions that, when executed by a computing device ([0985] “Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer)”), cause the computing device to perform a method for compensating a level of glucose from a glucose sensor based on a presence of an excipient of insulin ([0012]; [0360]), the method comprising:
monitoring a current signal (IsigWE1) at a working electrode of the glucose sensor ([0294] “Isig 2230 for a first working electrode WE1”; [0012] “periodically measuring, by the physical sensor electronics, a potential difference between the counter electrode and the working electrode (Vcntr); periodically obtaining a blood glucose (BG) value for the user”; [0190]);
monitoring a current signal (IsigWE2) at a background electrode of the glucose sensor ([0012]; [0294] “Isig 2240 for a second working electrode WE2”; [0362] “the m-cresol tends to “poison” the electrode(s), such that the latter can no longer detect glucose, until the insulin (and m-cresol) have been absorbed into the patient's tissue”; [0200]; [0222] “after the sensor stabilization timeframe has elapsed, the sensor transmits a sensor signal 350 to the signal processor 390.”); and
monitoring at least one electrochemical impedance spectroscopy (EIS) parameter at the working electrode ([0012] “Electrochemical Impedance Spectroscopy (EIS) procedure to generate EIS-related data for the working electrode”; [0254]);
calculating a change in the at least one EIS parameter after an injection of insulin ([0290] “analysis of EIS data relating to one or more of at least three primary factors, i.e., potential sensor failure modes: (1) signal start-up; (2) signal dip; and (3) sensitivity loss”; [0295]; [0360-0367]; [0367] “the impedance magnitude will exhibit the same behavior as described above regardless of whether the insulin being infused is fast-acting or slow.”; [0763]);
detecting the presence of the excipient of insulin based on the change ([0360] “the potential impact on (i.e., interference with) sensor signal that may be caused by the medication being infused and/or an inactive component thereof.”; [0367] “EIS can be used to detect the presence of an interfering agent--in this case, m-cresol.”); and
in a case where the presence of the excipient of insulin is detected, compensating the IsigWE1 based on a predetermined relationship between the IsigWE1 and the IsigWE2 ([0350] “directed to the use of EIS in optimizing sensor calibration. By way of background, in current methodologies, the slope of a BG vs. Isig plot, which may be used to calibrate subsequent Isig values”; “BG and Isig follow a fairly linear relationship, and offset can be taken as a constant.”; [0360-0361] “m-cresol has been found to negatively impact a glucose sensor if insulin (and, therefore, m-cresol) is being infused in close proximity to the sensor. Therefore, a system in which a sensor and an infusion catheter are to be combined in a single needle must be able to detect, and adjust for, the effect of m-cresol on the sensor signal”), wherein compensating the IsigWE1 reduces a false increase in the IsigWE1 caused by the excipient of insulin ([0336] “This mapping is critical, as it helps avoid false positives in instances where a dip is not real. Where the Isig divergence is real, the algorithm will select the sensor with the higher Isig.”; [0354] “an EIS-based dynamic slope approach, where EIS is used to adjust slope, may be used for calibration purposes. FIG. 38A shows an example of how this method can be used to improve sensor accuracy.”; [0763] “the direction of error can also be used to inform users and/or the insulin delivery system in connection with SG being a “false low” or a “false high” value”); and
outputting the compensated IsigWE1 (IsigCOMP) for determining a compensated glucose level ([0344] “the fused Isig value 3589 is calculated using the filtered Isigs (3522, 3524, and so on) for the plurality of electrodes”).
Regarding claim 61, Mallas teaches the glucose sensor of claim 1, wherein the controller is configured to detect the presence of the excipient of insulin based on the change in the at least one EIS parameter during a predetermined period ([0096-0098] “FIGS. 59A-59C show changes in EIS parameters relating to circuit elements during start-up and calibration”).
Regarding claim 63, Mallas teaches the glucose sensor of claim 5, wherein the slope depends on a distance between a cannula, through which insulin is injected, and the working electrode ([0143] “Nyquist plots having different lengths for different sensor configurations.”; [0177] “Inside the cannula 16 is a sensing portion 18 of the sensor 12 to expose one or more sensor electrodes 20 to the user's bodily fluids through a window 22 formed in the cannula 16. In one embodiment, the one or more sensor electrodes 20 may include a counter electrode, a reference electrode, and one or more working electrodes. After insertion, the insertion needle 14 is withdrawn to leave the cannula 16 with the sensing portion 18 and the sensor electrodes 20 in place at the selected insertion site.”; [0255]; [0261]; The sensor configuration, which includes a cannula being placed at the insertion site with the sensing portion electrodes impacts the Nyquist slope).
Claim Rejections - 35 USC § 103
Claim 62 is rejected under 35 U.S.C. 103 as being unpatentable over US 20200245910 A1 (Mallas et al.) in view of US 20210386331 A1 (Hossein et al.).
Regarding claim 62, Mallas teaches the glucose sensor of claim 1
Mallas does not explicitly teach wherein a voltage applied to the background electrode is in a range from 500 mV to 600 mV.
However,
Hossein teaches wherein a voltage applied to the background electrode is in a range from 500 mV to 600 mV ([0007] “the background electrode is operated in the 500-600 mV range”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor taught by Mallas to include a background electrode voltage of 500-600 mV. One would have been motivated to make this modification because calculating a sensor glucose value based on the different voltage potentials provides a more accurate measure of sensor glucose values, as suggested by Hossein [0007].
Response to Arguments
Applicant's arguments filed June 9, 2026 have been fully considered but they are not persuasive. With respect to the 101 Rejections in the Non-Final Office Action (See Pages 6-7 of Applicant’s Response “Claim Rejections under 35 U.S.C. § 101”), Applicant argues that the claims as a whole are directed to a specific solution to a specific technological problem in continuous glucose monitoring and are not directed to an abstract idea. Applicant states that the amended claims integrate any exception into a practical application. Applicant states that the amended claims describe a particular way to solve the problem of a “false increase in glucose readings” caused by excipients in insulin, producing a corrected signal for determining a compensated glucose level, which is not an abstract idea.
With respect to the 102 Rejections in the Non-Final Office Action (See Pages 7-8 of Applicant’s Response “Claim Rejections under 35 U.S.C. § 102”), Applicant argues that Mallas does not describe compensating for a false increase in IsigWE1 caused by an excipient of insulin.
There are new grounds of claim rejections that were necessitated by the claim amendments.
MPEP § 2111 discusses proper claim interpretation, including giving claims their broadest reasonable interpretation in light of the specification during examination. Under broadest reasonable interpretation (BRI), the words of a claim must be given their plain meaning unless such meaning is inconsistent with the specification, and it is improper to import claim limitations from the specification into the claim.
Regarding the 101 rejections, the claims, as written describe a sensor, method, and non-transitory computer-readable medium for compensating a current signal and glucose level using generic sensors. The claims do not recite a practical application for using a compensated glucose value, but merely describe the monitoring of data, calculation of a change, and detection of the excipient “based on the change” in order to compensate the Isig and glucose level. The claims do not define the process by which the “change” detects the excipient of insulin, but rather describe a detection of the presence, which may be interpreted as a mental process, as there is nothing in the detection step that could not be performed by the human mind but for the recitation of generic computer components. Additionally, the compensation of the Isig and glucose level are merely adjusting values based on the presence of the excipient of insulin. The claims, as written, do not describe a practical application for the compensated values, and there is nothing in the compensation step that would preclude the step from being performed by the human mind.
Regarding the 102 rejections, under BRI, the claim amendment of claims 1, 18, and 26 recites “wherein compensating the IsigWE1 reduces a false increase in the IsigWE1 caused by the excipient of insulin”, which can be interpreted to mean that the compensation is capable of reducing false high values. Mallas teaches that the direction of error can be used to inform users of a “false high” value using EIS dip detection [0763]. Additionally, Mallas describes in [0366-0367] that the Isig increase due to m-cresol can be detected using EIS and the sensing can be changed, or compensated, to adjust for the impact of the interferent. Therefore, the amended claim limitations of claims 1, 18, and 26 as written are taught by Mallas under BRI. The newly added claim 62 has been rejected over Mallas in view of Hossein, as described above.
Claims 2-8, 19-25, and 61-63 are rejected because the rejections of claims 1, 18, and 26 are proper and the prior art teaches or suggests all the features of these claims for the reasons described in the 102 and 103 Rejections.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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