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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Palmisano et al., “Electrochemical immobilization of enzymes on conducting organic salt electrodes: preparation of an oxygen independent and interference-free glucose biosensor,” Journal of Electroanalytical Chemistry 381 (1995) 235-237 (hereafter “Palmisano”) as evidenced by Malitesta, “Glucose Fast-Response Amperometric Sensor Based on Glucose Oxidase Immobilized in an Electropolymerized
Poly(o-phenyienediamine) Film,” Anal. Cham. 1990, 62, 2735-2740 (hereafter “Malitesta”).
Addressing claim 1 , Palmisano discloses an oxygen-independent analyte sensor (see the title) comprising: at least one electrode (see 2.3. Electrode preparation, which is on page 236. Also, note ” 2.2. Apparatus - The basic electrochemical apparatus has been described elsewhere [1].” Endnote [1] is Malitesta.); and an oxygen-independent analyte sensing molecule (“GOD (type VII from Aspergillus Niger, 137000U/g), . . . .” See 2.1. Chemicals. While GOD by itself is typically oxygen dependent, when incorporated into the working electrode as described in Palmisano it is oxygen independent:
“Electrochemical immobilization of enzymes on conducting organic salt
electrodes: preparation of an oxygen independent and interference-free
glucose biosensor [italicizing by the Examiner]” – title;
“The resulting biosensor which can be operated in absence of oxygen is capable of
excluding efficiently the majority of the electroactive interferents…[italicizing by the Examiner]” (see
1. Introduction);
and “The given results demonstrate the feasibility of electrochemical
immobilization of enzymes on COS electrodes. This can open new possibilities in designing oxygen independent interference-free biosensors . . . .” (see 4. Conclusion)
) disposed on the at least one electrode (see the second paragraph of 2.3. Electrode preparation. ) wherein the at least one electrode is electropolymerized with the oxygen-independent analyte sensing molecule (see again the second paragraph of 2.3. Electrode preparation. Also, note the following in the last paragraph of 1. Introduction, “ In this work, preliminary results are given demonstrating the possibility of extending the approach of electrochemical immobilization of enzymes to COS. Glucose oxidase (GOD) has been entrapped in a poly o-phenylenediamine (PPD) film electropolymerized on a N-methylphenaziniumtetracyanoquinodimethanide (NMP.TCNQ) electrode.[italicizing by the Examiner]”) .
Addressing claim 3 ,for the additional limitation of this claim see Palmisano Figures 1 and 4(C).
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Habermüller et al., “An Oxygen-Insensitive Reagentless Glucose Biosensor Based on Osmium-Complex Modified Polypyrrole,” Electroanalysis 2000, 12, No. 17 (hereafter “Habermüller”).
Addressing clam 1, Habermülle discloses an oxygen-independent analyte sensor (see the title) comprising: at least one electrode; and an oxygen-independent analyte sensing molecule (“PQQ-dependent glucose dehydrogenase from Erwinia species 34-1 as biological recognition element, . . . .” See Sensor architecture: on page 1385.) disposed on the at least one electrode (Figure 1), wherein the at least one electrode is electropolymerized with the oxygen-independent analyte sensing molecule (see
Figure 1 and the first two paragraphs of 2.5. Preparation and Characterization of Biosensors, which is on page 1385.).
Addressing claim 3, for the additional limitation of this claim see Habermüller Figure 4.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
Claims 1-3, 6, 8-13, 15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mallas et al. US 2020/0245910 A1 (hereafter “Mallas”) in view of Palmisano as evidenced by Malitesta and in view of Habermüller.
Addressing claim 1, Mallas discloses an analyte sensor (see the title, Abstract, and Figure 1) comprising: at least one electrode (see Figure 1 noting sensor electrodes 20 therein; see also paragraph [0177]); and an analyte sensing molecule disposed on the at least one electrode (this feature is implied by the following, “For example, the sensor electrodes 20 may be used in physiological parameter sensing applications in which some type of biomolecule is used as a catalytic agent. For example, the sensor electrodes 20 may be used in a glucose and oxygen sensor having a glucose oxidase (GOx) enzyme catalyzing a reaction with the sensor electrodes 20. The sensor electrodes 20, along with a biomolecule or some other catalytic agent, may be placed in a human body in a vascular or non-vascular environment.[italicizing by the Examiner]” See paragraph [0181].).
Mallas, though, does not disclose that the analyte sensing molecule is oxygen-independent nor “. . . ., wherein the at least one electrode is electropolymerized with the oxygen-independent analyte sensing molecule.”
Palmisano, and Habermüller each discloses an oxygen-independent analyte sensor as set forth in Applicant’s claim 1. See the rejection of claim 1 under
35 U.S.C. 102(a)(1) as being anticipated by Palmisano as evidenced by Malitesta above and see also the rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Habermüller. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to substitute the electropolymerized oxygen-independent analyte sensing molecule of ether Palmisano as evidenced by Malitesta or of Habermüller for that in analyte sensor of Mallas because
(a) as indicated above Mallas allows for a wide choice of analyte sensing molecule (“some type of biomolecule is used as a catalytic agent”);
(b) as a specific example of an analyte sensing molecule Mallas mentions the glucose sensitive enzyme glucose oxidase, and Palmisano as evidenced by Malitesta and Habermüller both also disclose using a glucose sensitive enzyme.
So, to substitute the electropolymerized oxygen-independent analyte sensing molecule of ether Palmisano as evidenced by Malitesta or of Habermüller for that in analyte sensor of Mallas is prima facie obvious as simple substitution of one known element (analyte sensing molecule) for another to obtain predictable results. See MPEP 2143(I)(B). Moreover, Palmisano discloses, “The resulting biosensor [with electrochemically immobilized glucose oxidase] which can be operated in absence of oxygen is capable of excluding efficiently the majority of the electroactive interferents.” See the last paragraph of 1. Introduction. Habermüller discloses, “Optimization of the glucose sensors aiming on a high mediator loading in the film and effective ET [electron transfer] reactions lead to oxygen-independent glucose sensors with high sensitivity, although the limitation of substrate diffusion through the polymer is still quite high. Ongoing work is mainly dealing with increased hydrophilicity of this new, promising biosensor material.” See 4. Conclusions.
Addressing claim 2, for the additional limitations of this claim see the following, Mallas Figure 3 noting therein measurement processor 395; paragraph [0190] noting therein “The measurement processor 395 generates sensor measurements. The sensor measurements may be stored in a measurement memory (not shown)…”, Mallas paragraph [0176] noting therien “It will be understood that each block of the flowchart illustrations, and combinations of blocks in the flowchart illustrations, can be implemented by programing instructions, including computer program instructions (as can any menu screens described in the figures). These computer program instructions may be loaded onto a computer or other programmable data processing apparatus (such as a controller, microcontroller, or processor in a sensor electronics device) to produce a machine, such that the instructions which execute on the computer or other programmable data processing apparatus create instructions for implementing the functions specified in the flowchart block or blocks. These computer program instructions may also be stored in a computer-readable memory . . . .[italicizing by the Examiner]”; and see Mallas paragraph [0012] noting therein “. . . . an Electrochemical Impedance Spectroscopy (EIS) procedure to generate EIS-related data for the working electrode; periodically measuring, by the physical sensor electronics, a potential difference between the counter electrode and the working electrode (Vcntr); periodically obtaining a blood glucose (BG) value for the user; determining whether the BG is valid, and pairing said BG value with said Isig, Vcntr, and EIS-related data if the BG is a valid BG; determining, by said microcontroller, whether a calibration error exists; and, when there is no calibration error, calculating, by said microcontroller, a sensor glucose (SG) value based on said paired BG, Isig, Vcntr, and EIS-related data. [italicizing by the Examiner]”
Addressing claim 3, for the additional limitation of this claim see Mallas
Figure 25A noting in the top graph “Sensor current (glucose dependent)”. This current would be expected to be different when either the oxygen-indent analyte molecule of Palmisano as evidenced by Malitesta or of Habermüller is adopted into the sensor of Mallas as discussed in the rejection of underlying claim 1. See also Mallas Figure 15A, Palmisano Figures 1 and 4(C), and Habermüller Figure 4.
Addressing claim 6, the additional limitation of this claim may be inferred from Mallas Figure 99, which is “an illustration of double layer capacitance over time…” (see Mallas paragraph [0138]), and paragraph [0645], which states, “. . . . the EIS technique measures the double layer capacitance (which is directly related to surface area) over the whole electrode surface area and, as such, is more representative of the properties of the electrode, including the actual surface area.”
Addressing claim 8, for the additional limitation of this claim see Mallas paragraph [0652] noting therein Rp, which is “the polarization resistance (i.e., resistance to voltage bias and charge transfer between the electrode and electrolyte), . . . .”
Addressing claim 9, for the additional limitation of this claim see Mallas paragraph [0255] noting therein “In addition, glucose-independent impedance data provides information on loss of sensor sensitivity during extended wear—potentially due to local oxygen deficit at the insertion site—using, e.g., values for phase angle and/or imaginary impedance at 1 kHz and higher frequencies.[italicizing by the Examiner]” See also the first sentence of Mallas paragraph [0239], Figure 22, the second sentence of Mallas paragraph [0293], and paragraph [0879] noting especially, “In preferred embodiments, a baseline EIS will be established early in wear.”
Addressing claim 10, for the additional limitation of this claim recall from the rejection of underlying claim 9, immediately preceding this claim rejection, that Mallas discloses in paragraph [0255] “In addition, glucose-independent impedance data provides information on loss of sensor sensitivity during extended wear—potentially due to local oxygen deficit at the insertion site—using, e.g., values for phase angle and/or imaginary impedance at 1 kHz and higher frequencies….[italicizing by the Examiner]”, and in paragraph [0879] “In preferred embodiments, a baseline EIS will be established early in wear.” It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application from these disclosures to adjust the analyte measurement based on a reference EIS parameter value, during the early wear period, either compute an analyte concentration correction factor from the determined loss of sensor sensitivity and/or subtract the baseline EIS from the EIS measurements or determinations in order to increase the accuracy of the analyte concentration calculated from the original electrochemical measurement data.
Addressing claim 11, Mallas discloses an analyte sensor (see the title, Abstract, and Figure 1) comprising: at least one electrode (see Figure 1 noting sensor electrodes 20 therein; see also paragraph [0177]); and an analyte sensing molecule disposed on the at least one electrode (this feature is implied by the following, “For example, the sensor electrodes 20 may be used in physiological parameter sensing applications in which some type of biomolecule is used as a catalytic agent. For example, the sensor electrodes 20 may be used in a glucose and oxygen sensor having a glucose oxidase (GOx) enzyme catalyzing a reaction with the sensor electrodes 20. The sensor electrodes 20, along with a biomolecule or some other catalytic agent, may be placed in a human body in a vascular or non-vascular environment.[italicizing by the Examiner]” See paragraph [0181].).
Mallas, though, does not disclose that the analyte sensing molecule is oxygen-independent nor “. . . ., wherein the at least one electrode is electropolymerized with the oxygen-independent analyte sensing molecule.”
Palmisano, and Habermüller each discloses an oxygen-independent analyte sensor as set forth in Applicant’s claim 1. See the rejection of claim 1 under
35 U.S.C. 102(a)(1) as being anticipated by Palmisano as evidenced by Malitesta above and see also the rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Habermüller. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to substitute the electropolymerized oxygen-independent analyte sensing molecule of ether Palmisano as evidenced by Malitesta or of Habermüller for that in analyte sensor of Mallas because
(a) as indicated above Mallas allows for a wide choice of analyte sensing molecule (“some type of biomolecule is used as a catalytic agent”);
(b) as a specific example of an analyte sensing molecule Mallas mentions the glucose sensitive enzyme glucose oxidase, and Palmisano as evidenced by Malitesta and Habermüller both also disclose using a glucose sensitive enzyme.
So, to substitute the electropolymerized oxygen-independent analyte sensing molecule of ether Palmisano as evidenced by Malitesta or of Habermüller for that in analyte sensor of Mallas is prima facie obvious as simple substitution of one known element (analyte sensing molecule) for another to obtain predictable results. See MPEP 2143(I)(B). Moreover, Palmisano discloses, “The resulting biosensor [with electrochemically immobilized glucose oxidase] which can be operated in absence of oxygen is capable of excluding efficiently the majority of the electroactive interferents.” See the last paragraph of 1. Introduction. Habermüller discloses, “Optimization of the glucose sensors aiming on a high mediator loading in the film and effective ET [electron transfer] reactions lead to oxygen-independent glucose sensors with high sensitivity, although the limitation of substrate diffusion through the polymer is still quite high. Ongoing work is mainly dealing with increased hydrophilicity of this new, promising biosensor material.” See 4. Conclusions.
Mallas further discloses that the analyte sensor includes one or more processors; and one or more processor-readable media storing instructions which, when executed by the one or more processors, causes performance of:processing an electrochemical impedance spectroscopy (EIS) parameter value in response to exposure to the analyte. See the following, Mallas Figure 3 noting therein measurement processor 395, paragraph [0190] noting therein “The measurement processor 395 generates sensor measurements. The sensor measurements may be stored in a measurement memory (not shown)…”, and see paragraph [0012] noting therein “. . . . an Electrochemical Impedance Spectroscopy (EIS) procedure to generate EIS-related data for the working electrode; periodically measuring, by the physical sensor electronics, a potential difference between the counter electrode and the working electrode (Vcntr); periodically obtaining a blood glucose (BG) value for the user; determining whether the BG is valid, and pairing said BG value with said Isig, Vcntr, and EIS-related data if the BG is a valid BG; determining, by said microcontroller, whether a calibration error exists; and, when there is no calibration error, calculating, by said microcontroller, a sensor glucose (SG) value based on said paired BG, Isig, Vcntr, and EIS-related data. [italicizing by the Examiner]”
Thus, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to perform the “sensing” and “determining” steps of claim 11 because the oxygen- independent analyte sensor of Mallas as modified by Palmisano as evidenced by Malitesta or Habermüller as just discussed is especially configured to perform to these steps. In other words, performing the steps of claim 11 is just using the oxygen- independent analyte sensor of Mallas as modified by Palmisano as evidenced by Malitesta or Habermüller as intended.
Addressing claim 12, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to determine a sensor glucose value based on the EIS parameter because (1) as indicated in the rejection of underlying claim 11 all of Palmisano, Malitesta, and Habermüller disclose sensing glucose, and (2) Mallas discloses in paragraph [0333],” As was noted previously, in embodiments, various of the above-described impedance-related parameters may be used, either individually or in combination, as inputs into one or more fusion algorithms for generating more reliable sensor glucose values. Specifically, it is known that, unlike a single-sensor (i.e., a single-working-electrode) system, multiple sensing electrodes provide higher-reliability glucose readouts, as a plurality of signals, obtained from two or more working electrodes, may be fused to provide a single sensor glucose value. Such signal fusion utilizes quantitative inputs provided by EIS to calculate the most reliable output sensor glucose value from the redundant working electrodes. [italicizing by the Examiner]”
Addressing claim 13, for the additional limitation of this claim see Mallas
Figure 25A noting in the top graph “Sensor current (glucose dependent)”. This current would be expected to be different when either the oxygen-indent analyte molecule of Palmisano as evidenced by Malitesta or of Habermüller is adopted into the sensor of Mallas as discussed in the rejection of underlying claim 1. See also Mallas Figure 15A, Palmisano Figures 1 and 4(C), and Habermüller Figure 4.
Addressing claim 15, the additional limitation of this claim may be inferred from Mallas Figure 99, which is “an illustration of double layer capacitance over time…” (see Mallas paragraph [0138]), and paragraph [0645], which states, “. . . . the EIS technique measures the double layer capacitance (which is directly related to surface area) over the whole electrode surface area and, as such, is more representative of the properties of the electrode, including the actual surface area.”
Addressing claim 17, for the additional limitation of this claim see Mallas paragraph [0652] noting therein Rp, which is “the polarization resistance (i.e., resistance to voltage bias and charge transfer between the electrode and electrolyte), . . . .”
Addressing claim 18, for the additional limitation of this claim recall from from the rejection of underlying claim 11,that Mallas discloses in paragraph [0255] “In addition, glucose-independent impedance data provides information on loss of sensor sensitivity during extended wear—potentially due to local oxygen deficit at the insertion site—using, e.g., values for phase angle and/or imaginary impedance at 1 kHz and higher frequencies….[italicizing by the Examiner]”, and in paragraph [0879] “In preferred embodiments, a baseline EIS will be established early in wear.” It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application from these disclosures to adjust the analyte measurement based on a reference EIS parameter value, during the early wear period, either compute an analyte concentration correction factor from the determined loss of sensor sensitivity and/or subtract the baseline EIS from the EIS measurements or determinations in order to increase the accuracy of the analyte concentration calculated from the original electrochemical measurement data.
Addressing claim1 9, for the additional limitation of this claim see Mallas paragraph [0255] noting therein “In addition, glucose-independent impedance data provides information on loss of sensor sensitivity during extended wear—potentially due to local oxygen deficit at the insertion site—using, e.g., values for phase angle and/or imaginary impedance at 1 kHz and higher frequencies.[italicizing by the Examiner]” See also the first sentence of Mallas paragraph [0239], Figure 22, the second sentence of Mallas paragraph [0293], and paragraph [0879] noting especially, “In preferred embodiments, a baseline EIS will be established early in wear.”
Addressing claim 20, Mallas discloses an analyte sensor (see the title, Abstract, and Figure 1) comprising: at least one electrode (see Figure 1 noting sensor electrodes 20 therein; see also paragraph [0177]); and an analyte sensing molecule disposed on the at least one electrode (this feature is implied by the following, “For example, the sensor electrodes 20 may be used in physiological parameter sensing applications in which some type of biomolecule is used as a catalytic agent. For example, the sensor electrodes 20 may be used in a glucose and oxygen sensor having a glucose oxidase (GOx) enzyme catalyzing a reaction with the sensor electrodes 20. The sensor electrodes 20, along with a biomolecule or some other catalytic agent, may be placed in a human body in a vascular or non-vascular environment.[italicizing by the Examiner]” See paragraph [0181].).
Mallas, though, does not disclose that the analyte sensing molecule is oxygen-independent nor “. . . ., wherein the at least one electrode is electropolymerized with the oxygen-independent analyte sensing molecule.”
Palmisano, and Habermüller each discloses an oxygen-independent analyte sensor as set forth in Applicant’s claim 1. See the rejection of claim 1 under
35 U.S.C. 102(a)(1) as being anticipated by Palmisano as evidenced by Malitesta above and see also the rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Habermüller. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to substitute the electropolymerized oxygen-independent analyte sensing molecule of ether Palmisano as evidenced by Malitesta or of Habermüller for that in analyte sensor of Mallas because
(a) as indicated above Mallas allows for a wide choice of analyte sensing molecule (“some type of biomolecule is used as a catalytic agent”);
(b) as a specific example of an analyte sensing molecule Mallas mentions the glucose sensitive enzyme glucose oxidase, and Palmisano as evidenced by Malitesta and Habermüller both also disclose using a glucose sensitive enzyme.
So, to substitute the electropolymerized oxygen-independent analyte sensing molecule of ether Palmisano as evidenced by Malitesta or of Habermüller for that in analyte sensor of Mallas is prima facie obvious as simple substitution of one known element (analyte sensing molecule) for another to obtain predictable results. See MPEP 2143(I)(B). Moreover, Palmisano discloses, “The resulting biosensor [with electrochemically immobilized glucose oxidase] which can be operated in absence of oxygen is capable of excluding efficiently the majority of the electroactive interferents.” See the last paragraph of 1. Introduction. Habermüller discloses, “Optimization of the glucose sensors aiming on a high mediator loading in the film and effective ET [electron transfer] reactions lead to oxygen-independent glucose sensors with high sensitivity, although the limitation of substrate diffusion through the polymer is still quite high. Ongoing work is mainly dealing with increased hydrophilicity of this new, promising biosensor material.” See 4. Conclusions.
Mallas further discloses that the analyte sensor includes one or more processors; and one or more processor-readable media storing instructions which, when executed by the one or more processors, causes performance of:processing an electrochemical impedance spectroscopy (EIS) parameter value in response to exposure to the analyte. See the following, Mallas Figure 3 noting therein measurement processor 395, paragraph [0190] noting therein “The measurement processor 395 generates sensor measurements. The sensor measurements may be stored in a measurement memory (not shown)…”, and see paragraph [0012] noting therein “. . . . an Electrochemical Impedance Spectroscopy (EIS) procedure to generate EIS-related data for the working electrode; periodically measuring, by the physical sensor electronics, a potential difference between the counter electrode and the working electrode (Vcntr); periodically obtaining a blood glucose (BG) value for the user; determining whether the BG is valid, and pairing said BG value with said Isig, Vcntr, and EIS-related data if the BG is a valid BG; determining, by said microcontroller, whether a calibration error exists; and, when there is no calibration error, calculating, by said microcontroller, a sensor glucose (SG) value based on said paired BG, Isig, Vcntr, and EIS-related data. [italicizing by the Examiner]”
Thus, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to perform the “sensing” and “determining” steps of claim 11 because the oxygen- independent analyte sensor of Mallas as modified by Palmisano as evidenced by Malitesta or Habermüller as just discussed is especially configured to perform to these steps. In other words, performing the steps of claim 11 is just using the oxygen- independent analyte sensor of Mallas as modified by Palmisano as evidenced by Malitesta or Habermüller as intended.
As for having one or more non-transitory processor-readable media storing instructions which, when executed by one or more processors, cause performance of this sensing, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to do so because Mallas discloses
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Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Mallas in view of Palmisano as evidenced by Malitesta or Habermüller as applied to claims 1-3, 6, 8-13, 15, and 17-20above, and further in view of Lin et al.
US 20230053254 A1 (hereafter “Lin”).
Addressing claim 7, although Mallas as modified by Palmisano as evidenced by Malitesta or Habermüller does disclose at least one electrode includes a plurality of electrodes (see Mallas Figure 2A and paragraphs [0016] and [0185]) these electrodes are not configured in an interdigital arrangement (see again Mallas Figure 2A).
Lin discloses “methods and materials designed to test the operation of devices such as electrochemical analyte sensors using non-Faradaic Electrochemical Impedance Spectroscopy (EIS).” See paragraph [0005]. The sensor used to exemplify these methods appears very similar in overall cross section to that Mallas (compare Lin Figure 4 with Mallas Figure 1). Lin discloses that the electrodes of the analyte sensor are in an interdigitated electrode configuration, which in one embodiment may include three electrodes. See Figures 5A and 5B, and paragraphs [0019] and [0020]. Barring evidence to the contrary, such as unexpected results, to have the electrodes of the analyte sensor of Mallas as modified by Palmisano as evidenced by Malitesta or Habermüller be in an interdigitated electrode configuration is prima facie obvious as simple substitution of one known element (measurement electrodes) for another to obtain predictable results. See MPEP 2143(I)(B).
Addressing claim 16, although Mallas as modified by Palmisano as evidenced by Malitesta or Habermüller does disclose at least one electrode includes a plurality of electrodes (see Mallas Figure 2A and paragraphs [0016] and [0185]) these electrodes are not configured in an interdigital arrangement (see again Mallas Figure 2A).
Lin discloses “methods and materials designed to test the operation of devices such as electrochemical analyte sensors using non-Faradaic Electrochemical Impedance Spectroscopy (EIS).” See paragraph [0005]. The sensor used to exemplify these methods appears very similar in overall cross section to that Mallas (compare Lin Figure 4 with Mallas Figure 1). Lin discloses that the electrodes of the analyte sensor are in an interdigitated electrode configuration, which in one embodiment may include three electrodes. See Figures 5A and 5B, and paragraphs [0019] and [0020]. Barring evidence to the contrary, such as unexpected results, to have the electrodes of the analyte sensor of Mallas as modified by Palmisano as evidenced by Malitesta or Habermüller be in an interdigitated electrode configuration is prima facie obvious as simple substitution of one known element (measurement electrodes) for another to obtain predictable results. See MPEP 2143(I)(B).
Allowable Subject Matter
Claims 4, 5, and 14 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:
a) the combination of limitations in claim 4 has the following underlined feature
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Applicant’s pre-grant application publication (US 20250143609 A1) paragraph [0077] states,
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In contrast, there is no suggestion in any of Mallas, Palmisano, Malitesta, or Habermüller, which all disclose sensing glucose, of having the analyte sensor comprise a competitive binding molecule. Markle et al. US 20080188722 A1 (hereafter “Markle”) discloses a glucose sensor comprising the competitive binding molecule HPTS-triCysMA (see Applicant’s claim 5, which depends from claim 4); however, it does not also comprise glucose oxidase and is, moreover, an optical sensor. See in Markle the title, Abstract, and paragraphs [0033] and [0142].
b) claim 5 depends from allowable claim 4.
c) the combination of limitations in claim 14 has the following underlined features
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See the discussion above regarding the allowability of claim 4.
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/ALEXANDER S NOGUEROLA/ Primary Examiner, Art Unit 1795
Prosecution Insights