DETAILED ACTION
Response to Amendment
This is a final office action in response to a communication filed on September 4, 2026. Claims 1-24 and 27-28 are pending in the application.
Status of Objections and Rejections
Claime interpretation under 35 U.S.C. §112(f) are maintained.
Some rejections under 35 U.S.C. §112 from the previous office action are withdrawn in view of Applicant’s amendment, and some are maintained as described below.
All rejections under 35 U.S.C. §103 are maintained.
New grounds of rejection are necessitated by the amendments.
Claim Interpretation
Applicant amended claim 1 that the measurement circuitry measures a potentiometric signal at the ion-selective electrode and a potentiostatic signal at the first potentiostatic electrode. The embodiment of the recited circuitry is exemplified in Fig. 6 that a wearable sensor 600 includes an ion-selective electrode (ISE) 602 and a potentiostatic electrode 604 (Fig. 6; PGpub ¶57). The potentiostatic electrode 604 may be a working electrode WE (¶57). The specification further discloses the ISE 602 and the potentiostatic electrode 604 may have their separate reference electrode and/or counter electrode or share one single additional electrode to operate in conjunction (¶58). Thus, the signal at the ion-selective electrode is a potentiometric signal due to the ion-selective membrane and the signal at the potentiostatic electrode (i.e., another working electrode) is potentiostatic signal based on the disclosure of the instant application.
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 Objections
Claim(s) 1 and 23 is/are objected to because of the following informalities:
Claim 1, line 8: “application” should be “application or insertion”
Claim 23, lines 2-3: delete “on application of the electrochemical sensor to the subject”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-24 and 27 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation "application or insertion of an electrochemical sensor onto or into skin of a subject" in lines 1-2. It is no disclosure in the specification for “application… of an electrochemical sensor onto… skin of a subject” and thus it is deemed as new matter. The specification only discloses when electrochemical sensors integrated into wearable devices, they have been attached or inserted onto or into a user (PGpub ¶5) in the background section. The embodiments of the instant application include application that comprises insertion of one or more electrodes under the skin of a subject (¶42). Thus, it is suggested to delete “application… onto” and to be “for detecting insertion of an electrochemical sensor into skin of a subject” in claim 1. Subsequent similar limitations in claim 1, 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 24 recites the limitation "a wearable device comprising the circuitry of claim 1; and a host device," which is not disclosed in the specification and deemed as new matter because the specification discloses the opposite (PGpub, ¶27; original claim 24).
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) 1-24 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 void 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.
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 24 recites the limitation "a wearable device comprising the circuitry of claim 1; and a host device." It is unclear the structural relationship of the wearable device and the host device, and which device comprises the circuitry of claim 1.
Claim 28 recites the limitation "application of an electrochemical sensor to a subject" in lines 1-2. 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 into skin of a subject” as specified in PGpub ¶42.
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) 1-3, 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 or insertion of an electrochemical sensor onto or into skin of 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 a potentiometric 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, e.g., an ISE);
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 another working 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 onto or into skin of the subject based on the potentiometric 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) is in a “dry” condition or in a “wet” condition, i.e., whether the sensor is being under the skin and in the body fluid. 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 potentiometric 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 potentiostatic 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; here the measurement is between the first potentiostatic electrode, i.e., a working electrode, and the second potentiostatic electrode, i.e., a counter electrode).
Regarding claim 16, Lin teaches wherein the first potentiostatic electrode comprises a working electrode (Fig. 3; ¶100: working electrode) and the second potentiostatic electrode comprises a counter electrode (Fig. 3; ¶100: counter electrode).
Regarding claim 17, the designation “wherein the processing circuitry is configured to transition the electrochemical sensor from a low-power state to an active state upon detection of application of the electrochemical 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 potentiometric 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 material or article worked upon. "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Young, 75 F.2d. 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)). MPEP 2115.
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:
a 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) comprising the circuitry of claim 1 (as described in claim 1); and
a host device (Fig. 4; e.g., ¶18: a data receiving device).
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 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), the method comprising:
measuring a potentiometric 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 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) is in a “dry” condition or in a “wet” condition, i.e., whether the sensor is being under the skin and in the body fluid. 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 13, 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 skin of the subject comprises: calculating a first score based on the potentiometric signal, the first score indicative of a proximity of the potentiometric signal to an expected potentiometric signal when the electrochemical sensor is applied to the skin of the subject; 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 skin of the subject; and determining whether the electrochemical sensor is applied to the skin of the subject based on the first and second scores (claim 4).
Here, Lin teaches circuitry (Fig. 3; ¶100: an electrical circuit) for detecting application or insertion of an electrochemical sensor onto or into skin of 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 a potentiometric 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); 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 potentiometric signal and calculating a second score based on the potentiostatic signal to determine whether the electrochemical sensor is applied to the skin of the subject based on the first and second scores that are indicative of a proximity to an expected signal.
Response to Arguments
Applicant’s arguments have been considered but are unpersuasive.
Applicant argues the recited components may include any structure for carrying out the functionality thereof (Response, p. 7, para. 2). This argument is unpersuasive because when an element is recited as performing a specified function without the recital of structure, material, or acts in support thereof, such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. 35 U.S.C. 112(f). Applicant argues the construction as means-plus-function claims is entirely logically inconsistent with the cited references, and the Office Action does not have the same structure as the components explicitly depicted in the present application as described in the Specification and Figures (p. 7, last para.). This argument is unpersuasive. Examiner notes that claim 1 is rejected as these elements perform the recited functions, and, for example, claims 11-12 are rejected as their specified structures.
Applicant argues what a potentiometric signal and a potentiostatic signal are (pp. 8-10), and asserts that Lin has no discussion of use of ISEs or potentiometric sensor setups (p. 10, para. 4). This argument is unpersuasive because the operation modes of obtaining a potentiometric signal and/or a potentiostatic signal are not required in the prior art. Examiner notes that claim interpretation is relied on the claim language in light of the specification as it would be understood by one of ordinary skill in the art, but not external evidence such as Wikipedia. Based on the disclosure of specification, Examiner provides claim interpretation regarding the potentiometric signal and potentiostatic signal and makes rejection based on such interpretation.
Applicant argues Lin has no discussion in determining application of a sensor onto the skin or insertion of a sensor into the skin of a patient (p. 10, para. 3). This argument is unpersuasive because Lin teaches 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 inserted under the skin and in the body fluid or not.
Last, Examiner notes that “detecting insertion of an electrochemical sensor into skin of a subject” is directly based on the comparison between the calculated potentiometric signal and the expected potentiometric signal and the comparison between the calculated potentiostatic signal and the expected potentiostatic signal (e.g., claim 4). Claim 1 recites a much broader scope that the detection is based on the measured potentiometric and potentiostatic signals, and does not specify steps as recited in claim 4.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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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/C. SUN/Primary Examiner, Art Unit 1795
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