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 .
Preliminary Amendments
Applicant’s preliminary amendment filed on August 23, 2024 is acknowledged. Claims 25-26 are canceled. Claims 1-24 and 27-28 are currently pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
"circuitry" in claims 1-24 and 27-28;
“measurement circuitry” in claims 1 and 11-12;
“processing circuitry” in claims 1, 6, 15, 17-18, and 20;
“drive circuitry” in claims 12-14.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The specification discloses the circuitry comprises measurement circuitry and processing circuitry (e.g., claim 1), and the measurement circuit 304 is typically implemented as a transimpedance amplifier or a current conveyor (PGpub, ¶51). The specification further discloses the drive circuitry may comprise a digital to analog converter, DAC (¶20). There is no disclosure on the corresponding structure of the processing circuitry in the specification.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1-24 and 27-28 is/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 pre-AIA the applicant regards as the invention.
Claim limitation “processing circuitry” in claims 1, 6, 15, 17-18, and 20 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification merely discloses that the processing circuitry 700 comprises ISE measurement circuitry 702, ISE scoring circuitry 704, potentiostatic measurement circuitry 706, potentiostatic scoring circuitry 708, and fusion circuitry 710 (PGpub ¶66), and how these components function (e.g., ¶¶67-68, 70-71), but of any structures that perform these functions by these components.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 1 recites the limitation "application of an electrochemical sensor to a subject" in line 1. It is unclear what “application” means. Since the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It is suggested to be “insertion of an electrochemical sensor under the skin of a subject” as specified in PGpub ¶42. As a result, the similar limitations in claim 1, line 8, and claims 4, 9, 17, 22-23, and 28 are requested to amend according to this amendment.
Dependent claim(s) 2-22 is/are rejected based on rejected claim 1. Claims 23-24 and 27 is/are rejected due to the incorporation of claim 1. Claim 28 is rejected due to the similar limitation “detecting application of an electrochemical sensor to a subject.”
Claim 14 recites the limitation "the drive circuitry" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is suggested to dependent claim 14 on claim 13.
Claim 24 recites the limitation "the wearable device" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is suggested to be “a wearable device.”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 13, 15-24, and 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin (US 2023/0053254).
Regarding claim 1, Lin teaches circuitry (Fig. 3; ¶100: an electrical circuit) for detecting application of an electrochemical sensor to a subject (this preamble is deemed to be a statement with regard to the intended use and are not further limiting in so far as the structure of the product is concerned. MPEP § 2111.02(II)), the electrochemical sensor comprising an ion-selective electrode (Fig. 3; ¶100: working electrode; ¶57: the working electrode is used as a glucose sensor using analyte sensing layer; thus, the working electrode is an ion-selective electrode) and a first potentiostatic electrode (¶57: the sensor comprising 1, 2, 3, 4 or more working electrodes; here, one working electrode is deemed to be the ion-selective electrode, and another working electrode is deemed to be the first potentiostatic electrode), the circuitry comprising:
measurement circuitry (Fig. 3: electric circuit) configured to:
measure an ion-selective signal at the ion-selective electrode (Fig. 3; ¶100: measured value of the voltage, Vmeausred, between a reference electrode and a working electrode; here, Vmeasured is from the one working electrode);
measure a potentiostatic signal at the first potentiostatic electrode (Fig. 3; ¶100: a current measurement (isig) that is output from the potentiostat; here, isig is from the another electrode);
processing circuitry (¶73: the processor is capable of characterizing one or more signals received from the electrochemical sensor).
Lin does not explicitly disclose the processing circuitry configured to: detect application of the electrochemical sensor to the subject based on the ion-selective signal and the potentiostatic signal.
However, Lin teaches a “dry” EIS used as a dry electrical test to evaluate material properties (¶6). The measured output current is used to observe the electrical characteristic (e.g., capacitance) of the sensor, which is correlated with a parameter associated with an electrochemical response of the analyte sensor (¶7). The electrical characteristic, e.g., capacitance, can be used as a measure of the parameter associated with the electrochemical response and further comparing the parameter to one or more predetermined values so as to determine whether the electrochemical response enables a measurement of a concentration level of the analyte in the vivo environment (¶8). In other words, the measured electrical characteristic can distinguish the “dry” condition (i.e., outside the fluid for measurements) from the “wet” condition (i.e., measuring the analyte in the fluid), which can be used to detect whether the electrochemical sensor is applied to the subject (e.g., being inserted under the skin and in the body fluid).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lin by utilizing its electric circuit to determine whether the electrochemical response (determined from the capacitance) enables a measurement of a concentration level of the analyte in the in-vivo environment because it is useful for determining an administration of insulin to the body of a diabetic patient (¶8) or characterizing properties of material layers of the sensor in a non-destructive, sensitive and rapid manner (¶5). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Regarding claim 2, Lin teaches wherein the ion-selective signal comprises a voltage (Fig. 3; ¶100: Vmeasured between the reference electrode and the working electrode).
Regarding claim 3, Lin teaches wherein the potentiostatic signal comprises a current (Fig. 3; ¶100: isig that is output from the potentiostat).
Regarding claim 13, Lin discloses all limitations of claim 1, and further discloses a computer system 2600 connected to the working electrode via a potentiostat so as to apply the voltage potentials and sense the output current (Fig. 26; ¶141). Thus, Lin teaches drive circuitry configured to apply a stimulus to a second potentiostatic electrode of the electrochemical sensor, the measured potentiostatic signal being a response to the stimulus.
Further, the designation “configured to apply a stimulus to a second potentiostatic electrode of the electrochemical sensor, the measured potentiostatic signal being a response to the stimulus” is functional limitation in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Lin teaches a drive circuitry that applies the voltage potentials and sense the output current to the working electrode (Fig. 26; ¶141), and thus the drive circuitry is capable of applying a stimulus to a second potentiostatic electrode of the electrochemical sensor, and measuring potentiostatic signal in response to the stimulus.
Regarding claim 15, Lin teaches wherein the electrochemical sensor comprises a second potentiometric electrode (Fig. 3; ¶100: counter electrode), wherein the processing circuitry is configured to determine an impedance between the first and second potentiostatic electrodes (¶147: example electrical characteristics include impedance).
Regarding claim 16, Lin teaches wherein the first potentiometric electrode comprises a working electrode (Fig. 3; ¶100: working electrode) and the second potentiometric electrode comprises a counter electrode (Fig. 3; ¶100: counter electrode).
Regarding claim 17, the designation “wherein the processing circuitry is configured to transition the wearable sensor from a low-power state to an active state upon detection of application of the wearable sensor to the subject” is functional limitation in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding claims 18 and 20, Lin teaches wherein the processing circuitry is configured to: determine a concentration of an analyte in the electrochemical sensor based on the ion-selective electrode signal and wherein the processing circuitry is configured to determine a concentration of an analyte in the electrochemical sensor based on the potentiostatic signal (Fig. 2; ¶73: processors designed to convert a sensor current input signal (e.g., ISIG) to a blood glucose concentration; here, each of the multiple working electrode as disclosed in ¶57 can be used to determine the analyte concentration).
Regarding claims 19 and 21, the claimed analytes are product-by-process limitations. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113(I). Here, there is no apparent difference between the claimed analyte sensor and the one of the prior art as taught by Yang.
Regarding claim 22, Lin teaches wherein application of the electrochemical sensor to the subject comprises insertion of the ion- selective electrode and the first potentiostatic electrode through the skin of the subject (Fig. 4; ¶102: a subcutaneous sensor insertion system for the in-vivo measurement).
Regarding claim 23, Lin teaches an electrochemical sensor (Fig. 4; ¶102: a subcutaneous sensor insertion system) comprising:
a needle for insertion into a subject on application of the electrochemical sensor to the subject (Fig. 4; ¶102: insertion needle 14);
an ion-selective electrode; a first potentiostatic electrode (¶57: the sensor comprising 1, 2, 3, 4 or more working electrodes; the working electrode is used as a glucose sensor using analyte sensing layer; thus, a first working electrode is deemed to be an ion-selective electrode and a second working electrode is deemed to be the first potentiostatic electrode); and
circuitry of claim 1 (as described in claim 1),
wherein the ion-selective electrode and the potentiostatic electrode are disposed on the needle (¶57: the sensor comprising 1, 2, 3, 4 or more working electrodes).
Regarding claim 24, Lin teaches a system (Fig. 4; ¶102: a subcutaneous sensor insertion system) comprising:
the wearable device (Fig. 4; ¶102: a flexible sensor 12; ¶103: the proximal part of the sensor 12 is mounted in a mounting base 30 adapted for placement onto the skin of a user); and
a host device comprising the circuitry of claim 1 (as described in claim 1).
Regarding claim 27, Lin teaches an electronic device (Fig. 4; ¶102: a subcutaneous sensor insertion system) comprising the circuitry of claim 1 (as described in claim 1), wherein the electronic device comprises an analyte monitoring device (Fig. 4; ¶102: a monitor 201 for monitoring a user’s condition in response to signals derived from the sensor electrode).
Regarding claim 28, Lin teaches a method, wherein an electrochemical sensor (Fig. 4; ¶102: a subcutaneous sensor insertion system) comprising an ion-selective electrode and a first potentiostat electrode (¶57: the sensor comprising 1, 2, 3, 4 or more working electrodes; the working electrode is used as a glucose sensor using analyte sensing layer; thus, a first working electrode is deemed to be an ion-selective electrode and a second working electrode is deemed to be the first potentiostatic electrode), the method comprising:
measuring an ion-selective signal at the ion-selective electrode (Fig. 3; ¶100: measured value of the voltage, Vmeausred, between a reference electrode and a working electrode; here, Vmeasured is from the first working electrode);
measuring a potentiostatic signal at the first potentiostatic electrode (Fig. 3; ¶100: a current measurement (isig) that is output from the potentiostat; here, isig is from the second working electrode).
Lin does not explicitly disclose the method is of detecting application of an electrochemical sensor to a subject or detecting application of the electrochemical sensor to the subject based on the ion-selective signal and the potentiostatic signal.
However, Lin teaches a “dry” EIS used as a dry electrical test to evaluate material properties (¶6). The measured output current is used to observe the electrical characteristic (e.g., capacitance) of the sensor, which is correlated with a parameter associated with an electrochemical response of the analyte sensor (¶7). The electrical characteristic, e.g., capacitance, can be used as a measure of the parameter associated with the electrochemical response and further comparing the parameter to one or more predetermined values so as to determine whether the electrochemical response enables a measurement of a concentration level of the analyte in the vivo environment (¶8). In other words, the measured electrical characteristic can distinguish the “dry” condition (i.e., outside the fluid for measurements) from the “wet” condition (i.e., measuring the analyte in the fluid), which can be used to detect whether the electrochemical sensor is applied to the subject (e.g., being inserted under the skin and in the body fluid).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lin by utilizing its electric circuit to determine whether the electrochemical response (determined from the capacitance) enables a measurement of a concentration level of the analyte in the in-vivo environment because it is useful for determining an administration of insulin to the body of a diabetic patient (¶8) or characterizing properties of material layers of the sensor in a non-destructive, sensitive and rapid manner (¶5). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Claim(s) 11-12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin (US 2023/0053254) in view of Lee (US 2019/0346434).
Regarding claim 11, Lin discloses all limitations of claim 1, but fails to teach wherein the measurement circuitry comprises a transimpedance amplifier or a current conveyor for measuring the potentiostatic signal.
However, Lee teaches each potentiostat including of two operational amplifiers: one amplifier maintains the potential difference between a working electrode and a reference electrode, and the other one works as a transimpedance amplifier to convert a current to a voltage signal (¶227).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lin by incorporating a transimpedance amplifier for measuring the potentiostatic signal, i.e., a voltage signal converted from a current signal, as taught by Lee because transimpedance amplifier is known in the art for potentiostatic measurement and applying a known technique to a known device ready for improvement to yield predictable results is prima facie obvious. MPEP 2141(III)(D). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Regarding claim 12, Lin discloses all limitations of claim 1, but fails to teach wherein the measurement circuitry comprises an analog-to-digital converter, ADC, configured to sample the potentiostatic signal.
However, Lee teaches the target analyte detection device includes an analog-to-digital converter (ADC) circuit, and the input of the ADC circuit is coupled to an output of the potentiostat (¶25). The target analyte detection device also includes a microcontroller electrically coupled to the ADC circuit and receives a measurement signal from an output of the ADC circuit (¶25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lin by incorporating an ADC for receiving the measurement signal from an output of the potentiostat, i.e., sampling the potentiostatic signal, as taught by Lee because ADC is known in the art for potentiostatic measurement and applying a known technique to a known device ready for improvement to yield predictable results is prima facie obvious. MPEP 2141(III)(D). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Regarding claim 14, Lin discloses all limitations of claim 1, but fails to teach wherein the drive circuitry comprises a digital to analog converter, DAC.
However, Lee teaches a potentiostat connected to a digital-to-analog converter (DAC) for potential control (¶213).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lin by incorporating a DAC for potential control on the potentiostat as taught by Lee because DAC is known in the art for potentiostatic measurement and applying a known technique to a known device ready for improvement to yield predictable results is prima facie obvious. MPEP 2141(III)(D). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Allowable Subject Matter
Claim(s) 4-10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not disclose nor render obvious all of the cumulative limitations of claims 4-10 with particular attention to the limitations:
wherein detecting application of the electrochemical sensor to the body comprises: calculating a first score based on the ion-selective signal, the first score indicative of a proximity of the ion-selective signal to an expected ion-selective signal when the electrochemical sensor is applied to the body; calculating a second score based on the potentiostatic signal, the second score indicative of a proximity of the potentiostatic signal to an expected potentiostatic signal when the electrochemical sensor is applied to the body; and determining whether the electrochemical sensor is applied to the body based on the first and second scores (claim 4).
Here, Lin teaches circuitry (Fig. 3; ¶100: an electrical circuit) for detecting application of an electrochemical sensor to a subject (this preamble is deemed to be a statement with regard to the intended use), the electrochemical sensor comprising an ion-selective electrode (¶57: the working electrode is used as a glucose sensor using analyte sensing layer; thus, the working electrode is an ion-selective electrode) and a first potentiostatic electrode (Fig. 3; ¶100: working electrode; ¶57: the working electrode is used as a glucose sensor using analyte sensing layer; the sensor comprising 1, 2, 3, 4 or more working electrodes; here one working electrode is deemed to be an ion-selective electrode and another working electrode is deemed to be the first potentiostatic electrode), the circuitry comprising: measurement circuitry (Fig. 3: electric circuit) configured to: measure an ion-selective signal at the ion-selective electrode (Fig. 3; ¶100: measured value of the voltage, Vmeausred); measure a potentiostatic signal at the first potentiostatic electrode (Fig. 3; ¶100: a current measurement (isig) that is output from the potentiostat); and processing circuitry (¶73: the processor is capable of characterizing one or more signals received from the electrochemical sensor). Further, Lin teaches a “dry” EIS used as a dry electrical test to evaluate material properties (¶6). The measured output current is used to observe the electrical characteristic (e.g., capacitance) of the sensor, which is correlated with a parameter associated with an electrochemical response of the analyte sensor (¶7). The electrical characteristic, e.g., capacitance, can be used as a measure of the parameter associated with the electrochemical response and further comparing the parameter to one or more predetermined values so as to determine whether the electrochemical response enables a measurement of a concentration level of the analyte in the vivo environment (¶8). In other words, the measured electrical characteristic can distinguish the “dry” condition (i.e., outside the fluid for measurements) from the “wet” condition (i.e., measuring the analyte in the fluid), which can be used to detect whether the electrochemical sensor is applied to the subject (e.g., being inserted under the skin and in the body fluid). However, Lin does not teach calculating a first score based on the ion-selective signal and calculating a second score based on the potentiostatic signal when the electrochemical sensor is applied to the body to determine whether the electrochemical sensor is applied to the body based on the first and second scores that are indicative of a proximity to an expected signal.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLYN M SUN whose telephone number is (571)272-6788. The examiner can normally be reached M-F: 8:30am - 5:30pm.
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/C. SUN/Primary Examiner, Art Unit 1795
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