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 .
Notice of Amendment
In response to the amendment filed on 5/20/2026, amended claims 1, 5, 8, 11, 15, and 18 are acknowledged. Claims 1-20 remain pending. The following new and reiterated grounds of rejection are set forth:
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-6, 8-11, 13, and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamath et al. (US Publication No. 2017/0340253 A1) (previously cited), further in view of Lee et al. (US Publication No. 2020/0205705 A1).
Regarding claim 1, Kamath et al. discloses an analyte sensor system, comprising:
a first electrode (16) configured to generate a first analyte signal stream (see [0070] – “In some embodiments, the sensing region 14 includes a glucose-measuring working electrode 16, an optional auxiliary working electrode 18, a reference electrode 20, and a counter electrode 22. Generally, the sensing region 14 includes means to measure two different signals, 1) a first signal associated with glucose and non-glucose related electroactive compounds having a first oxidation potential, wherein the first signal is measured at the glucose-measuring working electrode disposed beneath an active enzymatic portion of a membrane system, and 2) a second signal associated with the baseline and/or sensitivity of the glucose sensor”);
a second electrode (18) configured to generate a non-enzyme signal stream indicating a level of a non-enzyme over time (see [0070] – “In some embodiments, the sensing region 14 includes a glucose-measuring working electrode 16, an optional auxiliary working electrode 18, a reference electrode 20, and a counter electrode 22. Generally, the sensing region 14 includes means to measure two different signals, 1) a first signal associated with glucose and non-glucose related electroactive compounds having a first oxidation potential, wherein the first signal is measured at the glucose-measuring working electrode disposed beneath an active enzymatic portion of a membrane system, and 2) a second signal associated with the baseline and/or sensitivity of the glucose sensor”; see also [0131] and [0138]-[0139]);
a sensor electronics module (see Figure 6) configured to:
determine a level of a first analyte based on the first analyte signal stream (see [0131] – “The auxiliary working electrode 18 provides a signal substantially comprising the baseline signal, b, which can be (for example, electronically or digitally) subtracted from the glucose signal obtained from the glucose-measuring working electrode to obtain the signal contribution due to glucose only according to the following equation: Signalglucose only=Signalglucose-measuring working electrode−Signalbaseline-measuring working electrode”); and
adjust the level of the first analyte based on the non-enzyme signal stream (see [0131] – “The auxiliary working electrode 18 provides a signal substantially comprising the baseline signal, b, which can be (for example, electronically or digitally) subtracted from the glucose signal obtained from the glucose-measuring working electrode to obtain the signal contribution due to glucose only according to the following equation: Signalglucose only=Signalglucose-measuring working electrode−Signalbaseline-measuring working electrode” and [0139] – “For example, if an interferant such as acetaminophen is ingested by a host implanted with a conventional implantable electrochemical glucose sensor (namely, one without means for eliminating acetaminophen), a transient non-glucose related increase in signal output would occur. However, by utilizing the electrode system of the preferred embodiments, both working electrodes respond with substantially equivalent increased current generation due to oxidation of the acetaminophen, which would be eliminated by subtraction of the auxiliary electrode signal from the glucose-measuring electrode signal”).
It is noted Kamath et al. does not specifically teach adjusting parameters of a model using the non-enzyme signal stream to adjust the level of the first analyte based on the non-enzyme signal stream. However, Lee et al. teaches adjust the level of the first analyte based on the non-enzyme signal stream by adjusting parameters of a model using the non-enzyme signal stream (see Figure 32 and [0295] – “In some examples, a break-in model is determined using a non-enzyme sensor. A non-enzyme sensor is a sensor that is generated without an enzyme to react with analyte. As a result, a non-enzyme sensor will not generate raw sensor signal indicative of analyte, but will behave similarly to an analyte sensor during break-in. For example, because it lacks enzyme, a non-enzyme sensor will not exhibit electrochemical break-in, but will exhibit membrane break-in as its membrane becomes hydrates. In some examples, one or more non-enzyme sensors are used to generate break-in models”; see also [0300]-[0301] and [0309]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kamath et al. to include adjusting parameters of a model using the non-enzyme signal stream to adjust the level of the first analyte based on the non-enzyme signal stream, as disclosed in Lee et al., so as to account contributions caused by membrane break-in as the membrane becomes hydrated (see Lee et al.: [0295]).
Regarding claim 2, Kamath et al. discloses the sensor electronics module being configured to adjust the level of the first analyte comprises the sensor electronics module being configured to subtract, from the level of the first analyte, a value based on the non-enzyme signal stream (see [0131] – “The auxiliary working electrode 18 provides a signal substantially comprising the baseline signal, b, which can be (for example, electronically or digitally) subtracted from the glucose signal obtained from the glucose-measuring working electrode to obtain the signal contribution due to glucose only according to the following equation: Signalglucose only=Signalglucose-measuring working electrode−Signalbaseline-measuring working electrode”).
Regarding claim 3, Kamath et al. discloses the first electrode and the second electrode are separate from each other (see Figure 1A).
Regarding claim 4, Kamath et al. discloses the first electrode comprises a first electrode at least partially covered by a membrane and the second electrode comprises a second electrode at least partially covered by the membrane (see [0096] – “In the illustrated embodiments of FIGS. 3A and 3B, the membrane system 22 is positioned at least over the glucose-measuring working electrode 16 and the optional auxiliary working electrode 18, however the membrane system may be positioned over the reference and/or counter electrodes 20,22 in some embodiments”).
Regarding claim 5, Lee et al. teaches adjusting parameters of the model using the non-enzyme signal stream comprises adjusting calibration parameters of a sensor break-in model using the non-enzyme signal stream (see Figure 32 and [0295] – “In some examples, a break-in model is determined using a non-enzyme sensor. A non-enzyme sensor is a sensor that is generated without an enzyme to react with analyte. As a result, a non-enzyme sensor will not generate raw sensor signal indicative of analyte, but will behave similarly to an analyte sensor during break-in. For example, because it lacks enzyme, a non-enzyme sensor will not exhibit electrochemical break-in, but will exhibit membrane break-in as its membrane becomes hydrates. In some examples, one or more non-enzyme sensors are used to generate break-in models”; see also [0300]-[0301] and [0309]).
Regarding claim 6, Kamath et al. discloses a third electrode (20) configured to generate a second analyte signal stream, wherein adjusting the level of the first analyte is further based on the second analyte signal stream (see [0118] – “The transport-measuring electrode can be configured to measure any of a number of substantially constant analytes or factors, such that a change measured by the transport-measuring electrode can be used to indicate a change in solute (for example, glucose) transport to the membrane system 22. Some examples of substantially constant analytes or factors that can be measured include, but are not limited to, oxygen, carboxylic acids (such as urea), amino acids, hydrogen, pH, chloride, baseline, or the like. Thus, the transport-measuring electrode provides an independent measure of changes in solute transport to the membrane, and thus sensitivity changes over time”).
Regarding claim 8, Kamath et al. discloses an analyte sensor system, comprising:
a first electrode (16) covered by a membrane, the first electrode configured to generate a first analyte signal stream (see [0070] – “In some embodiments, the sensing region 14 includes a glucose-measuring working electrode 16, an optional auxiliary working electrode 18, a reference electrode 20, and a counter electrode 22. Generally, the sensing region 14 includes means to measure two different signals, 1) a first signal associated with glucose and non-glucose related electroactive compounds having a first oxidation potential, wherein the first signal is measured at the glucose-measuring working electrode disposed beneath an active enzymatic portion of a membrane system, and 2) a second signal associated with the baseline and/or sensitivity of the glucose sensor” and [0096] – “In the illustrated embodiments of FIGS. 3A and 3B, the membrane system 22 is positioned at least over the glucose-measuring working electrode 16 and the optional auxiliary working electrode 18, however the membrane system may be positioned over the reference and/or counter electrodes 20,22 in some embodiments”);
a second electrode (18) configured to generate a non-enzyme signal stream indicating a level of non-enzymes over time (see [0070] – “In some embodiments, the sensing region 14 includes a glucose-measuring working electrode 16, an optional auxiliary working electrode 18, a reference electrode 20, and a counter electrode 22. Generally, the sensing region 14 includes means to measure two different signals, 1) a first signal associated with glucose and non-glucose related electroactive compounds having a first oxidation potential, wherein the first signal is measured at the glucose-measuring working electrode disposed beneath an active enzymatic portion of a membrane system, and 2) a second signal associated with the baseline and/or sensitivity of the glucose sensor”; see also [0131] and [0138]-[0139]);
a sensor electronics module (see Figure 6), configured to:
determine a level of a first analyte based on the first analyte signal stream (see [0131] – “The auxiliary working electrode 18 provides a signal substantially comprising the baseline signal, b, which can be (for example, electronically or digitally) subtracted from the glucose signal obtained from the glucose-measuring working electrode to obtain the signal contribution due to glucose only according to the following equation: Signalglucose only=Signalglucose-measuring working electrode−Signalbaseline-measuring working electrode”); and
adjust the level of the first analyte based on the non-enzyme signal stream (see [0131] – “The auxiliary working electrode 18 provides a signal substantially comprising the baseline signal, b, which can be (for example, electronically or digitally) subtracted from the glucose signal obtained from the glucose-measuring working electrode to obtain the signal contribution due to glucose only according to the following equation: Signalglucose only=Signalglucose-measuring working electrode−Signalbaseline-measuring working electrode” and [0139] – “For example, if an interferant such as acetaminophen is ingested by a host implanted with a conventional implantable electrochemical glucose sensor (namely, one without means for eliminating acetaminophen), a transient non-glucose related increase in signal output would occur. However, by utilizing the electrode system of the preferred embodiments, both working electrodes respond with substantially equivalent increased current generation due to oxidation of the acetaminophen, which would be eliminated by subtraction of the auxiliary electrode signal from the glucose-measuring electrode signal”).
It is noted Kamath et al. does not specifically teach adjusting parameters of a model using the non-enzyme signal stream to adjust the level of the first analyte based on the non-enzyme signal stream. However, Lee et al. teaches adjust the level of the first analyte based on the non-enzyme signal stream by adjusting parameters of a model using the non-enzyme signal stream (see Figure 32 and [0295] – “In some examples, a break-in model is determined using a non-enzyme sensor. A non-enzyme sensor is a sensor that is generated without an enzyme to react with analyte. As a result, a non-enzyme sensor will not generate raw sensor signal indicative of analyte, but will behave similarly to an analyte sensor during break-in. For example, because it lacks enzyme, a non-enzyme sensor will not exhibit electrochemical break-in, but will exhibit membrane break-in as its membrane becomes hydrates. In some examples, one or more non-enzyme sensors are used to generate break-in models”; see also [0300]-[0301] and [0309]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kamath et al. to include adjusting parameters of a model using the non-enzyme signal stream to adjust the level of the first analyte based on the non-enzyme signal stream, as disclosed in Lee et al., so as to account contributions caused by membrane break-in as the membrane becomes hydrated (see Lee et al.: [0295]).
Regarding claim 9, Kamath et al. discloses the second electrode is covered by a second membrane (see [0096] – “In the illustrated embodiments of FIGS. 3A and 3B, the membrane system 22 is positioned at least over the glucose-measuring working electrode 16 and the optional auxiliary working electrode 18, however the membrane system may be positioned over the reference and/or counter electrodes 20,22 in some embodiments”).
Regarding claim 10, Kamath et al. discloses the sensor electronics module being configured to adjust the level of the first analyte comprises the sensor electronics module being configured to subtract, from the level of the first analyte, a value based on the non-enzyme signal stream (see [0131] – “The auxiliary working electrode 18 provides a signal substantially comprising the baseline signal, b, which can be (for example, electronically or digitally) subtracted from the glucose signal obtained from the glucose-measuring working electrode to obtain the signal contribution due to glucose only according to the following equation: Signalglucose only=Signalglucose-measuring working electrode−Signalbaseline-measuring working electrode”).
Regarding claim 11, Lee et al. teaches adjusting parameters of the model using the non-enzyme signal stream comprises adjusting calibration parameters of a sensor break-in model using the non-enzyme signal stream (see Figure 32 and [0295] – “In some examples, a break-in model is determined using a non-enzyme sensor. A non-enzyme sensor is a sensor that is generated without an enzyme to react with analyte. As a result, a non-enzyme sensor will not generate raw sensor signal indicative of analyte, but will behave similarly to an analyte sensor during break-in. For example, because it lacks enzyme, a non-enzyme sensor will not exhibit electrochemical break-in, but will exhibit membrane break-in as its membrane becomes hydrates. In some examples, one or more non-enzyme sensors are used to generate break-in models”; see also [0300]-[0301] and [0309]).
Regarding claim 13, Kamath et al. discloses a third electrode (20) covered by a second membrane configured to generate a second analyte signal stream indicating a level of a second analyte over time, wherein adjusting the level of the first analyte is further based on the second analyte signal stream (see [0096] – “In the illustrated embodiments of FIGS. 3A and 3B, the membrane system 22 is positioned at least over the glucose-measuring working electrode 16 and the optional auxiliary working electrode 18, however the membrane system may be positioned over the reference and/or counter electrodes 20,22 in some embodiments” and [0118] – “The transport-measuring electrode can be configured to measure any of a number of substantially constant analytes or factors, such that a change measured by the transport-measuring electrode can be used to indicate a change in solute (for example, glucose) transport to the membrane system 22. Some examples of substantially constant analytes or factors that can be measured include, but are not limited to, oxygen, carboxylic acids (such as urea), amino acids, hydrogen, pH, chloride, baseline, or the like. Thus, the transport-measuring electrode provides an independent measure of changes in solute transport to the membrane, and thus sensitivity changes over time”).
Regarding claim 15, Kamath et al. discloses a method comprising:
generating a first analyte signal stream using a first electrode (16) (see [0070] – “In some embodiments, the sensing region 14 includes a glucose-measuring working electrode 16, an optional auxiliary working electrode 18, a reference electrode 20, and a counter electrode 22. Generally, the sensing region 14 includes means to measure two different signals, 1) a first signal associated with glucose and non-glucose related electroactive compounds having a first oxidation potential, wherein the first signal is measured at the glucose-measuring working electrode disposed beneath an active enzymatic portion of a membrane system, and 2) a second signal associated with the baseline and/or sensitivity of the glucose sensor”);
generating a non-enzyme signal stream using a second electrode, wherein the non-enzyme signal stream indicates a level of non-enzymes over time (18) (see [0070] – “In some embodiments, the sensing region 14 includes a glucose-measuring working electrode 16, an optional auxiliary working electrode 18, a reference electrode 20, and a counter electrode 22. Generally, the sensing region 14 includes means to measure two different signals, 1) a first signal associated with glucose and non-glucose related electroactive compounds having a first oxidation potential, wherein the first signal is measured at the glucose-measuring working electrode disposed beneath an active enzymatic portion of a membrane system, and 2) a second signal associated with the baseline and/or sensitivity of the glucose sensor”; see also [0131] and [0138]-[0139]);
determining, using a sensor electronics module (see Figure 6), a level of a first analyte based on the first analyte signal stream (see [0131] – “The auxiliary working electrode 18 provides a signal substantially comprising the baseline signal, b, which can be (for example, electronically or digitally) subtracted from the glucose signal obtained from the glucose-measuring working electrode to obtain the signal contribution due to glucose only according to the following equation: Signalglucose only=Signalglucose-measuring working electrode−Signalbaseline-measuring working electrode”); and
adjusting, using the sensor electronics module, the level of the first analyte based on the non-enzyme signal stream (see [0131] – “The auxiliary working electrode 18 provides a signal substantially comprising the baseline signal, b, which can be (for example, electronically or digitally) subtracted from the glucose signal obtained from the glucose-measuring working electrode to obtain the signal contribution due to glucose only according to the following equation: Signalglucose only=Signalglucose-measuring working electrode−Signalbaseline-measuring working electrode” and [0139] – “For example, if an interferant such as acetaminophen is ingested by a host implanted with a conventional implantable electrochemical glucose sensor (namely, one without means for eliminating acetaminophen), a transient non-glucose related increase in signal output would occur. However, by utilizing the electrode system of the preferred embodiments, both working electrodes respond with substantially equivalent increased current generation due to oxidation of the acetaminophen, which would be eliminated by subtraction of the auxiliary electrode signal from the glucose-measuring electrode signal”).
It is noted Kamath et al. does not specifically teach adjusting the level of the first analyte comprises adjusting parameters of a model using the non-enzyme signal stream. However, Lee et al. teaches adjusting the level of the first analyte comprises adjusting parameters of a model using the non-enzyme signal stream (see Figure 32 and [0295] – “In some examples, a break-in model is determined using a non-enzyme sensor. A non-enzyme sensor is a sensor that is generated without an enzyme to react with analyte. As a result, a non-enzyme sensor will not generate raw sensor signal indicative of analyte, but will behave similarly to an analyte sensor during break-in. For example, because it lacks enzyme, a non-enzyme sensor will not exhibit electrochemical break-in, but will exhibit membrane break-in as its membrane becomes hydrates. In some examples, one or more non-enzyme sensors are used to generate break-in models”; see also [0300]-[0301] and [0309]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Kamath et al. to include adjusting parameters of a model using the non-enzyme signal stream to adjust the level of the first analyte based on the non-enzyme signal stream, as disclosed in Lee et al., so as to account contributions caused by membrane break-in as the membrane becomes hydrated (see Lee et al.: [0295]).
Regarding claim 16, Kamath et al. discloses adjusting the level of the first analyte comprises subtracting a value based on the non-enzyme signal stream from the level of the first analyte (see [0131] – “The auxiliary working electrode 18 provides a signal substantially comprising the baseline signal, b, which can be (for example, electronically or digitally) subtracted from the glucose signal obtained from the glucose-measuring working electrode to obtain the signal contribution due to glucose only according to the following equation: Signalglucose only=Signalglucose-measuring working electrode−Signalbaseline-measuring working electrode”).
Regarding claim 17, Kamath et al. discloses generating a second analyte signal stream using a third electrode (20), wherein the second analyte signal stream indicates a level of a second analyte over time, and wherein adjusting the level of the first analyte comprises subtracting a value based on the non-enzyme signal stream and a value based on the second analyte signal stream from the level of the first analyte (see [0118] – “The transport-measuring electrode can be configured to measure any of a number of substantially constant analytes or factors, such that a change measured by the transport-measuring electrode can be used to indicate a change in solute (for example, glucose) transport to the membrane system 22. Some examples of substantially constant analytes or factors that can be measured include, but are not limited to, oxygen, carboxylic acids (such as urea), amino acids, hydrogen, pH, chloride, baseline, or the like. Thus, the transport-measuring electrode provides an independent measure of changes in solute transport to the membrane, and thus sensitivity changes over time”).
Regarding claim 18, Lee et al. teaches adjusting the parameters of the model using the non-enzyme signal stream comprises adjusting calibration parameters of a sensor break-in model using the non-enzyme signal stream (see Figure 32 and [0295] – “In some examples, a break-in model is determined using a non-enzyme sensor. A non-enzyme sensor is a sensor that is generated without an enzyme to react with analyte. As a result, a non-enzyme sensor will not generate raw sensor signal indicative of analyte, but will behave similarly to an analyte sensor during break-in. For example, because it lacks enzyme, a non-enzyme sensor will not exhibit electrochemical break-in, but will exhibit membrane break-in as its membrane becomes hydrates. In some examples, one or more non-enzyme sensors are used to generate break-in models”; see also [0300]-[0301] and [0309]).
Claim(s) 7, 14, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamath et al. and Lee et al., further in view of Gottlieb et al. (US Publication No. 2011/0319734 A1) (previously cited).
Regarding claims 7, 14, and 20, it is noted Kamath et al. does not specifically teach the sensor electronics module being configured to adjust the level of the first analyte comprises the sensor electronics module being configured to determine a weighted sum of the first analyte signal stream, the non-enzyme signal stream, and the second analyte signal stream. However, Gottlieb et al. teaches the sensor electronics module being configured to adjust the level of the first analyte comprises the sensor electronics module being configured to determine a weighted sum of the first analyte signal stream, the non-enzyme signal stream, and the second analyte signal stream (see [0051] – “Similarly, in some embodiments of the invention, at least one electrode array is constructed from materials designed to predominantly sense signals resulting from the presence of glucose; and at least one electrode array is constructed from materials designed to predominantly sense signals resulting from background noise and/or signals resulting from interfering compounds. Similarly, in some embodiments of the invention, multiple analytes are sensed. In some embodiments at least one electrode array is constructed from materials designed to predominantly sense signals resulting from the presence of a first analyte, for example glucose; and at least one electrode array is constructed from materials designed to predominantly sense signals resulting from a second analyte, for example lactate” and [0054] – “In certain embodiments the methods comprise assigning a weighted value to signal data obtained from each of the first, second, third and fourth electrode arrays; and using the weighted signal values to compute an analyte concentration by fusing the various weighted signal values”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and method of Kamath et al. and Lee et al., to include the sensor electronics module being configured to adjust the level of the first analyte comprises the sensor electronics module being configured to determine a weighted sum of the first analyte signal stream, the non-enzyme signal stream, and the second analyte signal stream, as disclosed in Gottlieb et al., so as to examine sensor interference and sensor drift as well as sensor initialization and/or start-up in vivo (e.g. the run-in time that it takes for a sensor to settle into its aqueous environment and start transmitting meaningful information after being implanted in vivo) (see Gottlieb et al.: [0105]).
Claim(s) 12 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamath et al. and Lee et al., further in view of Petisce (US Publication No. 2013/0197333 A1) (previously cited).
Regarding claims 12 and 19, it is noted Kamath et al. does not specifically teach the sensor electronics module being configured to adjust the level of the first analyte comprises the sensor electronics module being configured to apply a correction factor based on the non-enzyme signal stream to the level of the first analyte. However, Petisce teaches the sensor electronics module being configured to adjust the level of the first analyte comprises the sensor electronics module being configured to apply a correction factor based on the non-enzyme signal stream to the level of the first analyte (see [0004] – “Disclosed and described herein are analyte sensors and sensor assemblies comprising either at least one pH sensor or a hematocrit sensor positioned in proximity to electrodes and methods for providing a correction factor for adjusting a glucose concentration value based on a measured pH value and/or a measured hematocrit level”; see also [0089] and [0091]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and method of Kamath et al. and Lee et al., to include the sensor electronics module being configured to adjust the level of the first analyte comprises the sensor electronics module being configured to apply a correction factor based on the non-enzyme signal stream to the level of the first analyte, as disclosed in Petisce, so as to compensate for the effect that pH and hematocrit have on the measurement of analyte when converting the raw signal to an analyte concentration value (see Petisce: [0089] and [0091]).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Instead, Applicant’s arguments are directed to the newly added subject matter of the amended claims, which is addressed in the new grounds of rejection as outlined above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791
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