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 .
Election/Restrictions
Applicant’s election of Invention I, Species A1, Claims 1-6 and 8-14, in the reply filed on 05/26/2026 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 7 and 15-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/26/2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 1-6 and 8-14 are hereby under examination.
Claim Rejections - 35 USC § 112
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 2 and 13 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.
Claim 2 recites the limitation “determining an equivalent series resistance of the analyte sensor”, which fails to effectively define the metes and bounds of the claim as it is unclear as to the meaning behind the phrase “equivalent series resistance”. The applicant does make indications regarding the “equivalent series resistance of the electrochemical system (Par. 68 and 143 of applicant’s spec., filed 08/24/2023), however, the claim recites “equivalent series resistance of the analyte sensor”. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as any type of resistance measurement.
Claim 13 recites the limitation "the step” in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this will be interpreted as -a step-.
Claim Rejections - 35 USC § 103
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 claims are generally directed towards a method for determining a membrane property of an analyte sensor. The method includes generating a fast-transient voltage signal and applying the voltage signal to measurement electrodes, measuring the response signals, and determination at least one membrane property by evaluating the response signal.
Claim(s) 1, 5-6, 9-10, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Willis (US Pub. No. US 20070299617) hereinafter Willis, and further in view of Benni (US Pub. No. 20200033258) hereinafter Benni.
Regarding claim 1, Willis discloses A method for determining at least one membrane property of an analyte sensor (Par. 49 (biofouling of membrane)) (Par. 26 (barrier membrane)) (Par. 167, 175 (biofouling measurement)), wherein the analyte sensor comprises at least two measurement electrodes (Par. 167-168, “FIG. 4C is a schematic representation of a third illustrative biosensor configuration 90, wherein working electrode 14 and counter electrode 12 are implanted within a subject, and reference electrode 13 contacts the skin surface 10 of a subject….”), wherein at least one of the measurement electrodes comprises at least one membrane element having at least one membrane property (Par. 167-168, (membrane 40 present with the electrodes))(Par. 26 (barrier membrane)) (Par. 49, 175 (biofouling of membrane)), the method comprising the following steps:
a) generating at least one fast-transient voltage signal and applying the fast-transient voltage signal to the measurement electrodes at an application time t0 (Par. 176, “shows a graph of the behavior of the poise potential [E.sub.wr].sub.1, established between a working electrode and reference electrode, when a square wave voltage pulse is applied to the working electrode.”) (Fig. 5 (response measured for [Ewr]obs over the rise time between [Ewr]0 and[Ewr]1))(Par. 178, “where [E.sub.wr].sub.obs represents the observed potential on the exponentially rising part of the curve in FIG. 5.”)).
Willis fails to explicitly disclose b) measuring a first response signal U1 at a first time t1 and a second response signal U2 at a second time t2 with t0≠t1≠t2, wherein the application time t0 precedes the first time t1 and the second time t2;
c) determining a response signal U0 at the application time t0 by evaluating the first response signal U1 and the second response signal U2; and
d) determining the at least one membrane property by evaluating the response signal U0 at the application time t0.
Willis does disclose b) measuring a first response signal U1 at a first time t1 and a second response signal U2 at a second time t2 with t0≠t1≠t2, wherein the application time t0 precedes the first time t1 and the second time t2 (Fig. 5 (response measured for [Ewr]obs over the rise time between [Ewr]0 and[Ewr]1))(Par. 178, “where [E.sub.wr].sub.obs represents the observed potential on the exponentially rising part of the curve in FIG. 5.”));
c) determining a response signal U0 at the application time t0 (Par. 175, “the R.sub.biofouling term is the variable component and therefore the total uncompensated resistance R.sub.u, and its effect on the poise potential, may be used to track the extent of biofouling.”) (Par. 176, “shows a graph of the behavior of the poise potential [E.sub.wr].sub.1, established between a working electrode and reference electrode, when a square wave voltage pulse is applied to the working electrode.”) (Fig. 5 (response measured for [Ewr]obs over the rise time between [Ewr]0 and[Ewr]1))(Par. 178, “where [E.sub.wr].sub.obs represents the observed potential on the exponentially rising part of the curve in FIG. 5.”)); and
d) determining the at least one membrane property by evaluating the response signal U0 at the application time t0 (Par. 49, 167 (effect of biofouling of membrane)) (Par. 175, “the R.sub.biofouling term is the variable component and therefore the total uncompensated resistance R.sub.u, and its effect on the poise potential, may be used to track the extent of biofouling.”) (Par. 176, “shows a graph of the behavior of the poise potential [E.sub.wr].sub.1, established between a working electrode and reference electrode, when a square wave voltage pulse is applied to the working electrode.”) (Fig. 5 (response measured for [Ewr]obs over the rise time between [Ewr]0 and[Ewr]1))(Par. 178, “where [E.sub.wr].sub.obs represents the observed potential on the exponentially rising part of the curve in FIG. 5.”)).
Willis does teach generating a slope (Par. 43, 47 (slope measurement)) and generating linear expressions for prediction (Par. 257, 262)).
Benni teaches generating a trendline between two points, where the trendline has a specified slope and intercept (Par. 41, “the data used to produce a given data point 36A, 36B (e.g., blood sample, NIRS sensing) is collected at or about the same time, and each data point 36A, 36B reflects data collected at a different point in time; e.g., data for data point 36A collected at T1, and data collected for data point 36B collected at T2, where T1 is different than T2. These data points may be connected via a trend line 32F, and a slope and intercept value determined. The slope value and intercept value may respectively be referred to as an “Individual Subject Calibration Slope” and a “Multi-point Subject Calibration Intercept”).
Willis and Benni are considered to be analogous art to the claimed invention as they are involved with mathematical analysis of biological data.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Willis with that of Willis and Benni to include b) measuring a first response signal U1 at a first time t1 and a second response signal U2 at a second time t2 with t0≠t1≠t2 of Willis, wherein the application time t0 precedes the first time t1 and the second time t2; c) determining a response signal U0 at the application time t0 by evaluating the first response signal U1 and the second response signal U2 of Willis; and d) determining the at least one membrane property by evaluating the response signal U0 at the application time t0 through the combination of references and implementing the trendline generation of Benni with the measured data of Willis as it would have yielded the predictable result of allowing for the generation of an equation to predict data values (Willis (Par. 262)).
Regarding claim 5, modified Willis further discloses wherein the analyte sensor is an in vivo sensor (Willis (abstract) (Par. 167 (in vivo)).
Regarding claim 6, modified Willis further discloses wherein the method is performed during in vivo measurement (Willis (abstract) (Par. 167-174 (in vivo)).
Regarding claim 9, modified Willis further discloses wherein the membrane property is permeability of the membrane element (Willis (Par. 49, 167 (effect of biofouling of membrane)) (Par. 175, “the R.sub.biofouling term is the variable component and therefore the total uncompensated resistance R.sub.u, and its effect on the poise potential, may be used to track the extent of biofouling.”) (Par. 176, “shows a graph of the behavior of the poise potential [E.sub.wr].sub.1, established between a working electrode and reference electrode, when a square wave voltage pulse is applied to the working electrode.”) (Fig. 5 (response measured for [Ewr]obs over the rise time between [Ewr]0 and[Ewr]1))(Par. 178, “where [E.sub.wr].sub.obs represents the observed potential on the exponentially rising part of the curve in FIG. 5.”))).
Regarding claim 10, modified Willis further discloses wherein the fast-transient voltage signal has a square wave form or a sine wave signal form (Willis (Par. 176, “shows a graph of the behavior of the poise potential [E.sub.wr].sub.1, established between a working electrode and reference electrode, when a square wave voltage pulse is applied to the working electrode.”) (Fig. 5 (response measured for [Ewr]obs over the rise time between [Ewr]0 and[Ewr]1))(Par. 178, “where [E.sub.wr].sub.obs represents the observed potential on the exponentially rising part of the curve in FIG. 5.”))).
Regarding claim 13, modified Willis further discloses further comprising the step of determining a concentration of at least one analyte in bodily fluid using the at least one analyte sensor (Willis (Par. 176, “shows a graph of the behavior of the poise potential [E.sub.wr].sub.1, established between a working electrode and reference electrode, when a square wave voltage pulse is applied to the working electrode.”) (Fig. 5 (response measured for [Ewr]obs over the rise time between [Ewr]0 and[Ewr]1))(Par. 178, “where [E.sub.wr].sub.obs represents the observed potential on the exponentially rising part of the curve in FIG. 5.”))(Par. 7, 133( concentration measurements with biosensor))).
Regarding claim 14, modified Willis fails to explicitly disclose the limitations of the claim.
However, Willis does teach in an exemplary embodiment A non-transitory computer readable medium having stored thereon computer executable instructions for performing the method of claim 1 (Method as taught by Willis and Benni in claim 1 above) when executed on a computer or on a computer network (Willis (Par. 59, “The present invention also provides a method of adjusting the output of an in vivo biosensor for drift due to biofouling and a computer program product, comprising a computer usable medium having a computer readable program code embodied therein, wherein the computer readable program code comprises an algorithm adapted to execute the method of adjusting the output signal of an in vivo biosensor for drift due to biofouling”) (Par. 110 (computer implementation))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Willis with that of Willis and Benni to include A non-transitory computer readable medium having stored thereon computer executable instructions for performing the method of claim 1 when executed on a computer or on a computer network through the combination of embodiments as differing computation structures are known (Willis (Par. 110)) and it would have yielded the predictable result of providing the exact computational structures needed to execute the method on a computer.
Claim(s) 2 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Willis in view of Benni as applied to claim 1 above, and further in view of Lambertson (WO 2019115687 A1) hereinafter Lambertson.
Willis and Benni teach the method of claim 1 above.
Regarding claim 2, modified Willis fails to explicitly disclose the limitations of the claim.
Willis does teach wherein the evaluating the response signal U0 in step d) comprises determining a resistance of the analyte sensor and determining the at least one membrane property from the resistance of the analyte sensor (Willis (Par. 49, 167 (effect of biofouling of membrane)) (Par. 175, “the R.sub.biofouling term is the variable component and therefore the total uncompensated resistance R.sub.u, and its effect on the poise potential, may be used to track the extent of biofouling.”) (Par. 176, “shows a graph of the behavior of the poise potential [E.sub.wr].sub.1, established between a working electrode and reference electrode, when a square wave voltage pulse is applied to the working electrode.”) (Fig. 5 (response measured for [Ewr]obs over the rise time between [Ewr]0 and[Ewr]1))(Par. 178, “where [E.sub.wr].sub.obs represents the observed potential on the exponentially rising part of the curve in FIG. 5.”))).
However, Lambertson teaches determining an equivalent series resistance of the analyte sensor (Page 66, Claim 7, (determination of equivalent series resistance)) and determining the at least one membrane property from the equivalent series resistance of the analyte sensor (Page 66, Claim 7, (adjustment based on equivalent series resistance)) (Page 20, lines 14-19 (equivalent series resistance to improve accuracy)).
Willis, Benni, and Lambertson are considered to be analogous art to the claimed invention as they are involved with mathematical analysis of biological data.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Willis and Benni with that of Lambertson to include wherein the evaluating the response signal U0 in step d) of Willis comprises determining an equivalent series resistance of the analyte sensor of Willis and determining the at least one membrane property from the equivalent series resistance of the analyte sensor of Willis through the combination of references as it would have yielded the predictable result of evaluating biofouling (Willis (Par. 175)) and improve measurement accuracy (Lambertson (Page 20, lines 14-19)).
Regarding claim 8, modified Willis fails to explicitly disclose the limitations of the claim.
Willis does teach resistance levels indicative of biofouling (Willis (Par. 49, 167 (effect of biofouling of membrane)) (Par. 175, “the R.sub.biofouling term is the variable component and therefore the total uncompensated resistance R.sub.u, and its effect on the poise potential, may be used to track the extent of biofouling.”) (Par. 176, “shows a graph of the behavior of the poise potential [E.sub.wr].sub.1, established between a working electrode and reference electrode, when a square wave voltage pulse is applied to the working electrode.”) (Fig. 5 (response measured for [Ewr]obs over the rise time between [Ewr]0 and[Ewr]1))(Par. 178, “where [E.sub.wr].sub.obs represents the observed potential on the exponentially rising part of the curve in FIG. 5.”))).
However, Lambertson teaches wherein the method comprises at least one failsafe step, wherein the failsafe step is triggered depending on the determined property (Page 38, lines 18-31).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Willis and Benni with that of Lambertson to include wherein the method comprises at least one failsafe step, wherein the failsafe step is triggered depending on the determined membrane property of Willis through the combination of references as it would have yielded the predictable result of preventing false measurements (Lambertson (Page 38, lines 18-31)).
Claim(s) 3-4 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Willis in view of Benni as applied to claim 1 above, and further in view of Kalghatgi (US Pub. No. 20170135678) hereinafter Kalghatgi.
Willis and Benni teach the method of claim 1 above.
Regarding claim 3, modified Willis fails to explicitly disclose the limitations of the claim.
However, Willis does disclose time frames with microseconds (Willis (Par. 176, “… FIG. 5 shows an ordinate labeled "E, volts" and an abscissa labeled in microseconds "t, .mu.sec". In FIG. 5, the graph of the exponential rise to the poise potential [E.sub.wr].sub.1 is represented by the solid black line and is further labeled "[E.sub.wr].sub.obs".)).
Kalghatgi teaches wherein the first time t1 is in the range from 1 μs to 5 μs after the application time t0 (Par. 29, “The high voltage power source that can be used for carrying out the reverse plasmaporation step of this invention can…” “… applied as discrete pulses (1-100 in number) having pulse durations ranging from 1 ns to 10 μs and magnitude of voltage ranging from 3-30 kV.”).
Willis, Benni, and Kalghatgi are considered to be analogous art to the claimed invention as they are involved with mathematical analysis of biological data.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Willis and Benni with that of Kalghatgi to include wherein the first time t1 is in the range from 1 μs to 5 μs after the application time t0 through the combination of references as Willis discloses signals in the microsecond range, differing pulse lengths and times are known (Kalghatgi (Par. 29)) and it would have yielded the same or similar result of evaluating the response.
Regarding claim 4, modified Willis fails to explicitly disclose the limitations of the claim.
However, Willis does disclose time frames with microseconds (Willis (Par. 176, “… FIG. 5 shows an ordinate labeled "E, volts" and an abscissa labeled in microseconds "t, .mu.sec". In FIG. 5, the graph of the exponential rise to the poise potential [E.sub.wr].sub.1 is represented by the solid black line and is further labeled "[E.sub.wr].sub.obs".)).
Kalghatgi further teaches wherein the second time t2 is in the range from 1 μs to 5 μs after the first time t1 (Kalghatgi (Par. 29, “The high voltage power source that can be used for carrying out the reverse plasmaporation step of this invention can…” “… applied as discrete pulses (1-100 in number) having pulse durations ranging from 1 ns to 10 μs and magnitude of voltage ranging from 3-30 kV.”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Willis, Benni, and Kalghatgi with that of Kalghatgi to include wherein the second time t2 is in the range from 1 μs to 5 μs after the first time t1 for the reasoning as indicated in claim 3 above.
Regarding claim 11, modified Willis fails to explicitly disclose the limitations of the claim.
However, Willis does disclose pulses in microseconds (Willis (Par. 176, “… FIG. 5 shows an ordinate labeled "E, volts" and an abscissa labeled in microseconds "t, .mu.sec". In FIG. 5, the graph of the exponential rise to the poise potential [E.sub.wr].sub.1 is represented by the solid black line and is further labeled "[E.sub.wr].sub.obs")).
Kalghatgi teaches wherein the fast-transient voltage signal comprises a non-continuous signal having a pulse duration that is ≤20 μs (Par. 29, “The high voltage power source that can be used for carrying out the reverse plasmaporation step of this invention can…” “… applied as discrete pulses (1-100 in number) having pulse durations ranging from 1 ns to 10 μs and magnitude of voltage ranging from 3-30 kV.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Willis and Benni with that of Kalghatgi to include wherein the fast-transient voltage signal comprises a non-continuous signal having a pulse duration that is ≤20 μs for the reasoning as indicated in claim 3 above.
Regarding claim 12, modified Willis fails to explicitly disclose the limitations of the claim.
However, Willis does disclose pulses in microseconds (Willis (Par. 176, “… FIG. 5 shows an ordinate labeled "E, volts" and an abscissa labeled in microseconds "t, .mu.sec". In FIG. 5, the graph of the exponential rise to the poise potential [E.sub.wr].sub.1 is represented by the solid black line and is further labeled "[E.sub.wr].sub.obs".)).
Kalghatgi teaches wherein the fast-transient voltage signal comprises a non-continuous signal having a pulse duration that is ≤10 μs (Par. 29, “The high voltage power source that can be used for carrying out the reverse plasmaporation step of this invention can…” “… applied as discrete pulses (1-100 in number) having pulse durations ranging from 1 ns to 10 μs and magnitude of voltage ranging from 3-30 kV.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Willis and Benni with that of Kalghatgi to include wherein the fast-transient voltage signal comprises a non-continuous signal having a pulse duration that is ≤10 μs for the reasoning as indicated in claim 3 above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARI SINGH KANE PADDA whose telephone number is (571)272-7228. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ARI S PADDA/Examiner, Art Unit 3791
/RENE T TOWA/Primary Examiner, Art Unit 3791
