3DETAILED 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 3, 20 has been entered.
Status of Objections and Rejections
All rejections for the first claim set (apparatus claims 8-13 and 17) from the previous office action are maintained.
All rejections for the second claim set (method claims 1-7 and 14-16) from the previous office action are withdrawn in view of Applicant’s amendment.
New grounds of rejection are necessitated by the amendments.
For the first claim set: claims 8-13 and 17
Claim Rejections - 35 USC § 102
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) 8-10 and 12-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Feldman (US 2010/0213057).
Regarding claim 8, Feldman teaches an analyte sensor (Fig. 1; ¶4: electrochemical analyte monitoring system) for measuring an analyte concentration (¶4: a current directly proportional to analyte concentration), the analyte sensor comprising a first electrode (Fig. 1: working electrode) and a second electrode (Fig. 1: counter electrode), the first electrode being configured to electrochemically react with an analyte for generating an electrical signal (¶30: the redox polymer 102 disposed on the working electrode passes electrons, or a current, between the primary reactant and the working electrode).
Further, the limitation “the analyte sensor being configured for measuring the analyte concentration according to claim 1” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Feldman teaches all structural limitations of the presently claimed analyte sensor, and thus it is capable of measuring the analyte concentration by the method of claim 1.
Regarding claim 9, Feldman teaches wherein the first electrode is a working electrode (Fig. 1: working electrode).
Regarding claim 10, Feldman teaches wherein the first electrode comprises at least one of enzyme, glucose oxidase (¶75: a glucose electrode having a sensing layer containing a catalyst, e.g., glucose oxidase).
Regarding claim 12, the designation “wherein the second electrode is configured to measure an oxygen saturation in the environment of the second electrode” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Feldman teaches all structural limitations of the presently claimed analyte sensor, and oxygen is electroreduced to H2O on the counter electrode (Fig. 1; ¶31, Equation 2). Thus, the counter electrode of Feldman is capable of measuring an oxygen saturation in the environment of the second electrode.
Regarding claim 13, Feldman teaches wherein the first electrode and second electrode are arranged on opposing sides of a/the substrate of the analyte sensor (Fig. 8A; ¶67: the electrodes 801 and 803 on the substrate; here, electrodes 801 and 803 are arranged on the opposing sides of the substrate).
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) 11 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman in view of Liu (US 2012/0132525).
Regarding claim 11, Feldman discloses all limitations of claim 10 and wherein the first electrode comprising at least one transition metal complex (Fig. 1; ¶30: the working electrode electrocatalyst layer 102 and 103; redox polymer 102) comprising a modified poly(vinylpyridine) backbone (¶87: a mass transport limiting layer is a membrane composed of crosslinked polymers such as polymers of polyvinylpyridine) loaded with Os complexes covalently coupled through a bidentate linkage (¶85: the sensing element is a redox active component including Osmium-based mediator molecules that include (bidente) ligands).
Feldman does not disclose the Os complexes is poly(bi-imidizyl) Os complexes.
However, Liu teaches polymers for use as redox mediators in electrochemical biosensors including polymeric backbones attached with transition metal complexes ([Abstract]). The redox polymer has a modified poly(vinylpyridine) backbone loaded with poly(bi-imidizyl) Ox complexes via bidentate linkage (¶171).
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 Feldman by substituting the Os complexes loaded into the polyvinylpyridine with one formed of poly(bi-imidizyl) Os complexes as taught by Liu. The suggestion for doing so would have been that poly(bi-imidizyl) Os complexes loaded polyvinylpyridine is a suitable material for the redox mediators in electrochemical sensors and the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Regarding claim 17, Feldman discloses all limitations of claim 8, but fail to teach wherein the first and second electrodes are the sole electrodes of the analyte sensor.
However, Liu teaches enzyme-based electrochemical sensors employ two or three electrodes including the working electrode and the reference electrode (¶6). In the three electrode system, the third electrode is a counter electrode; while in the two electrode system, the reference electrode also serves as the counter-electrode (¶6). Thus, Liu teaches the two electrode system, wherein the first and second electrode are the sole electrodes of the analyte sensor, i.e., one working electrode and the other electrode is a combined reference/counter electrode.
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 Feldman by substituting its three electrode system with a two electrode system as suggested by Liu because it is known in the prior art that the electrochemical sensor may employ two or three electrodes. Here, the substitution of one known element for another would yield nothing more than predictable results. MPEP 2141(III)(B).
For the second claim set: claims 1-7 and 14-16
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) 1-2, 5, 7, and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yao (US 4,805,624) in view of Iyengar (US 2005/0069892).
Regarding claim 1, Yao teaches a method for measuring a concentration of an analyte using an electrochemical analyte sensor ([Abstract]: electrochemical sensors and methods for measurement of the concentration of carbohydrates) having a first electrode (Fig. 1; col. 7, l. 48: working electrode 2) and a second electrode (Fig. 1; col. 7, l. 21: counter electrode 8), the first electrode being configured to react with the analyte for generating an electrical signal (col. 4, l. 62: a working (detecting) electrode; col. 5, ll. 16-18: the current generated at the W surface), the method comprising:
applying a modulated voltage signal between the first electrode and the second electrode (col. 5, ll. 15-16: applying variable and pulsating potentials (voltage)), the modulate voltage signal being a predefined modulated voltage signal (here, the applied variable and pulsating voltage is deemed to be the predefined modulated voltage signal);
determining a current signal in response to the applied modulated voltage signal (col. 5, ll. 16-18: the current generated by redox processes at the W surface are recorded);
determining an electric potential working point of the analyte sensor based on the determined current signal (col. 4, ll. 23-24: the reduction peak 1: -0.80 V for glucose; here, this voltage is deemed to be the potential working point);
operating the analyte sensor at the determined electric potential working point (Fig. 7: plots of the peak current with respect to the square roots of the scan rates; here, the sensor was operated to investigate the redox under diffusion control based on the peak, i.e., the potential working point); and
measuring the concentration of the analyte based on the electrical signal generated at the first electrode (col. 5, ll. 20-22: the amplitude of the current signals are linearly dependent upon the carbohydrate concentration).
Yao further discloses the output 31 is fed to a micro-processor controller for processing (col. 10, ll. 33-34), but fails to teach using the controller to apply the modulated voltage.
However, Iyengar teaches an electrochemical system ([Abstract]) including a controller (Fig. 18; ¶185) and a DAC 606 coverts digital signals from controller 610 to analog signals to be applied to the test strip (Fig. 18: 600) after signal conditioning (Fig. 18: 602).
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 Yao by incorporating a controller for applying a voltage signal as taught by Iyengar because it is known in the prior art that a controller is not only able to apply a modulated voltage signal to the electrochemical system and also process the sensed current signals (Iyengar ¶185). 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, Yao teaches wherein the modulated voltage signal is applied in time-discrete steps (col. 5, ll. 15-16: variable and pulsating potentials (voltage)).
Regarding claim 5, Yao teaches wherein the first electrode is a working electrode and/or wherein the second electrode is selected from the group consisting of a counter electrode (col. 4, ll. 62-63: working (detecting) electrode W and counter electrode C).
Regarding claim 7, Yao teaches wherein the analyte is glucose and the concentration of the glucose is measured (col. 3, ll. 45-46: the peaks are specific to the carbohydrate, e.g., glucose; a current proportional to an analyte concentration, such as glucose; col. 8, ll. 43-44: the peak height is directly proportional to the concentration of the species in solution) and outputted on a display (col. 8, ll. 44-47: the current and voltage values as sensed by the electrode may be displayed on combined or separate ammeter and coulometer unit 27 of Fig. 2).
Regarding claim 14, Yao teaches a digital controller is used to apply the modulated voltage signal (Fig. 2; col. 7, ll. 62-64: digital function generator 23 provides a variable voltage driving mechanism for potentiostat 24).
Regarding claim 15, Yao and Iyengar disclose all limitation of claim 1. Yao does not disclose wherein the modulated voltage signal is sinusoidal.
However, Iyengar discloses an AC sinusoidal voltage 510 is superimposed onto a DC potential (¶92), which result in the generation of a DC and AC current (¶93). The DC component of the measured signal may be comprised mostly of Faradaic signal components, which are affected by the analyte concentration and environmental factors; while the AC component of the measured signal may be comprised mostly of capacitive signal components, which are less likely to be affected by the analyte but are responsive to the environmental factors (¶133). Thus, the AC component may be used to independently gain information about the environmental factors without being influenced by the analyte concentration (¶133).
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 Yao by incorporating a sinusoidal AC voltage signal as taught by Iyengar because it would independently gain information about the environmental factors without being influenced by the analyte concentration (¶133) or electrode fouling to make correction for a more accurate concentration estimate (¶171). 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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yao in view of Iyengar, and further in view of Roy (US 2012/0108932).
Regarding claim 3, Yao and Iyengar disclose all limitations of claim 1 but fails to teach wherein the step of determining a current signal in response to the applied modulated voltage signal comprises: determining the amplitude of the current signal and the average current signal at the first electrode in response to the applied modulated voltage signal and in response to the electrical signal generated at the first electrode from the reaction with the analyte.
However, Roy teaches an electro-chemical glucose sensor may generate current at a nanoAmp level, and an amplitude of such current may change based on a glucose level in the body fluid (¶138). Further, Roy teaches when determining at least one metric, it would ascertain the at least one sensor signal based on at least in part on the series of samples of the at least one sensor signal, i.e., the characteristic comprising one or more values descriptive of how data are distributed with respect to an average of the data (¶14).
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 Yao and Iyengar by employing the current amplitude as the current signal as taught by Roy because the current amplitude changes based on a glucose level detected by an electro-chemical sensor (¶138). Here, the substitution of one known element for another would yield nothing more than predictable results is prima facie obvious. MPEP 2141(III)(B). Further, 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 Yao and Iyengar by using average current signal in response to the applied modulated signal and generated at the first electrode from the reaction with the analyte (Yao, col. 5, ll. 16-18) because the averaged value is a descriptive of how data are distributed to ascertain the value (Roy, ¶14). Here, use of averaged current signal would yield nothing more than predictable results.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yao in view of Iyengar, and further in view of Feldman (US 2010/0213057).
Regarding claim 6, Yao and Iyengar disclose all limitations of claim 1 but fails to teach the method further comprising harvesting energy released by the electrochemical reaction of the analyte with the first electrode and using the energy to power the operation of the analyte sensor.
However, Feldman teaches a self-powered analyte sensor (title), which spontaneously passes a current directly proportional to analyte concentration in the absence of an external power source (¶4). The self-powered analyte sensor facilitates the oxidation reaction of glucose, between the primary reactant and the working electrode, and uses the resulting flow of electrons to produce an electrical current that provides a low-level of power (¶30). The self-powering feature provides the advantage of providing a low level of continuous power in the absence of an external power supply while also detecting an analyte level thereby requiring little to no equilibration time between analyte measurement intervals (¶29).
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 Yao and Iyengar by using the generated current to provide a low-level power, i.e., harvesting energy from the electrochemical reaction at the working electrode, to power the sensor as taught by Feldman because the self-powering feature provides the advantage of providing a low level of continuous power in the absence of an external power supply while also detecting an analyte level thereby requiring little to no equilibration time between analyte measurement intervals (¶29).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yao in view of Iyengar, and further in view of Liu.
Regarding claim 16, Yao and Iyengar disclose all limitations of claim 1, but fail to teach wherein the first and second electrodes are the sole electrodes of the analyte sensor.
However, Liu teaches enzyme-based electrochemical sensors employ two or three electrodes including the working electrode and the reference electrode (¶6). In the three electrode system, the third electrode is a counter electrode; while in the two electrode system, the reference electrode also serves as the counter-electrode (¶6). Thus, Liu teaches the two electrode system, wherein the first and second electrode are the sole electrodes of the analyte sensor, i.e., one working electrode and the other electrode is a combined reference/counter electrode.
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 Yao and Iyengar by substituting its three electrode system with a two electrode system as suggested by Liu because it is known in the prior art that the electrochemical sensor may employ two or three electrodes. Here, the substitution of one known element for another would yield nothing more than predictable results. MPEP 2141(III)(B).
Allowable Subject Matter
Claim(s) 4 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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 claim 4 with particular attention to the limitations:
regulating the applied modulated voltage signal such that the ratio of the determined amplitude of the current signal at the first electrode to the determined average current signal falls within a predetermined range to determine an electric potential working point of the first electrode (claim 4)
Here, Yao teaches a method for measuring a concentration of an analyte using an electrochemical analyte sensor ([Abstract]) having a first electrode (Fig. 1: working electrode 2) and a second electrode (Fig. 1: counter electrode 8), the first electrode being configured to react with the analyte for generating an electrical signal (col. 4, l. 62; col. 5, ll. 16-18), the method comprising: applying a modulated voltage signal between the first electrode and the second electrode, the modulate voltage signal being a predefined modulated voltage signal (col. 5, ll. 15-16); determining a current signal in response to the applied modulated voltage signal (col. 5, ll. 16-18); determining an electric potential working point of the analyte sensor based on the determined current signal (col. 4, ll. 23-24); operating the analyte sensor at the determined electric potential working point (Fig. 7); and measuring the concentration of the analyte based on the electrical signal generated at the first electrode (col. 5, ll. 20-22). However, Yao does not teach regulating the applied modulated voltage signal such that the ratio of the determined amplitude of the current signal at the first electrode to the determined average current signal falls within a predetermined range to determine an electric potential working point of the first electrode for determining the electric potential working point of the analyte sensor.
Response to Arguments
Applicant’s arguments has/have been considered but are moot because the arguments do not apply to any of the references being used in the current rejection.
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 on M-F: 8:30am - 5:30pm.
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/C. SUN/Primary Examiner, Art Unit 1795
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