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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/19/21 and 07/25/23 have been considered by the examiner.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 21, 2025 has been entered.
Amendment Entered
In response to the amendment filed on November 21, 2025, amended claims 1, 8 and 19 have been entered. Claims 2-6, 11-15 and 20 have been cancelled.
Response to Arguments
Applicant's remarks and amendments with respect to the rejections under U.S.C. 101 have been fully considered. While Examiner agrees that the claimed invention does not explicitly recite mathematical calculations, Examiner maintains that nothing from the claims, accompanying specification, and/or drawings suggest that the method steps cannot be practically performed mentally, or using pen/paper. Applicant argues the invention is not an abstract idea. Examiner notes that although the claims include an electrochemical cell, no physical aspect of the electrochemical cell mentioned in the claims is novel. The claims merely recite data gathering/outputting steps. Applicant further argues the claims integrate into a practical application. Examiner notes that according to MPEP 2106.04(d)(2), the practical application consists of administering a specific medication in response to the collected data. Alternately, a practical application would consist of incorporating additional structure to the device. Lastly, Applicant argues the claims provide an inventive concept and are not well-understood, routine, and conventional activity in the field. Examiner notes the cited references teach all the components of the present application. Therefore, as currently claimed, the invention is not an improvement in technology. Accordingly, Examiner maintains that the identified judicial exception recites a mental process that is not integrated into a practical application. For at least these reasons, the 35 USC 101 rejections are maintained. Please see corresponding rejection heading below for more detailed analysis.
Applicant's remarks and amendments with respect to the rejections under U.S.C. 112 have been fully considered and were not persuasive. Examiner notes the limitation “approximately negative 40 degrees to approximately negative 90 degrees” is still indefinite. Please see corresponding rejection heading below for more detailed analysis.
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were fully considered are moot in view of the current combination of references that were necessitated by amendment. Please see prior art section below for more detail, updated citations (Muthukumar and Claussen reference), and updated obviousness rationale.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 7-9, 19 and 21-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a method. Thus, claim 1 is directed towards a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“responsive to determining that the electrical current satisfies a threshold; determining a charge transfer conductance based on a first impedance of the plurality of impedances corresponding to a frequency of at least 0.1 hertz (Hz) and less than or equal to 100 Hz ; determining a solution resistance based on a second impedance of the plurality of impedances corresponding to a frequency greater than 500 Hz and less than or equal to 8 kilohertz (kHz); determining a non-constant phase double layer capacitance based on the solution resistance, the charge transfer conductance, and a third impedance of the plurality of impedances corresponding to a first frequency at which an impedance phase is approximately negative 40 degrees to approximately negative 90 degrees; determining a presence of electrochemical interference on the representation of the electrochemical cell of the blood glucose level of the patient based on the solution resistance, the charge transfer conductance, and the non-constant phase double layer capacitance;”
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“an electrochemical cell... measuring an electrical current that is proportional to an impedance of the electrochemical cell, the electrical current representing a blood glucose level of a patient; measuring a plurality of impedances of the electrochemical cell corresponding to a plurality of frequencies; and outputting a signal based on the determination of the presence of electrochemical interference
Electrochemical cells are generic devices, and are conventional means for generating electrical energy. These appear to be nothing more than generic devices and, as such, do not integrate the judicial exception into a practical application. Furthermore, outputting a signal based on the determination of the presence of electrochemical interference pertains to mere extra-solution activity, which does not integrate the judicial exception into a practical application and/or recite significantly more. See MPEP 2106.05(g).
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Rather, Examiner takes official notice that they are widely known structural components that have been set forth in prior analyte monitoring systems. See Hasty [p. 119, col. 1, par. 3; col. 2 par. 8- p. 120, col. 1 par. 1], which shows the importance of using non-constant EIS to account for interference in electrochemical cells.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101.
Independent claim 19 is also not patent eligible for substantially similar reasons.
Dependent claims 7-9 and 21-25 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Thus, claims 1, 7-9, 19 and 21-25 are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112B
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 7-9, 19 and 21-25 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “approximately negative 40 degrees to approximately negative 90 degrees” in claim 1 is a relative term which renders the claim indefinite. The term “approximately negative 40 degrees to approximately negative 90 degrees” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear if the impedance phase should be exactly negative 90 degrees or negative 40 degrees or in a range to meet this limitation. Additionally, claims 8 and 19 recites the limitation “approximately negative 40 degrees to approximately negative 90 degrees”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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, 7-9, 19, 21, 23, 25 are rejected under 35 U.S.C. 103 as being unpatentable over Varsavsky (U.S. Patent Application Publication 2015/0164371A1), Muthukumar (U.S. Patent Application Publication 2021/0325380A1), Hasty (U.S. Patent Application Publication 2023/0294097A1) and Claussen (U.S. Patent Application Publication 2020/0025753A1).
Varsavsky was applied in the previous office action
Regarding claim 1, Varsavsky teaches a method comprising: monitoring, via a device including an electrochemical cell, an electrical current that is proportional to an impedance of the electrochemical cell [fig. 15A; par. 233]; responsive to determining that the electrical current satisfies a threshold [par. 191], measuring, via the device, a plurality of impedances of the electrochemical cell corresponding to a plurality of frequencies [fig. 16A; par. 239]; determining a charge transfer conductance and a solution resistance [par. 234, 634], determining the presence of electrochemical interference [par. 344]; and outputting a signal based on the determination of the presence of electrochemical interference [par. 344].
Although Varsavsky does not explicitly teach determining the presence of electrochemical interference based on the solution resistance and the charge transfer conductance, this would be obvious to a person having ordinary skill in the art when the invention was filed since Varsavsky also suggests calculating Warburg impedance which requires solution resistance and polarization resistance (resistance to voltage bias and charge transfer between the electrode and electrolyte) [par. 237, 634]. Additionally, Varsavsky teaches the use of impedance to detect interference [par. 344]. Therefore, incorporating determining the presence of electrochemical interference based on the solution resistance and the charge transfer conductance would only involve routine skill in the art.
However, Varsavsky does not teach determining a charge transfer conductance based on a first impedance of the plurality of impedances corresponding to a frequency of at least 0.1 hertz (Hz) and less than or equal to 100 Hz; determining a solution resistance based on a second impedance of the plurality of impedances corresponding to a frequency greater than 500 Hz and less than or equal to 8 kilohertz (kHz); determining a non-constant phase double layer capacitance based on the solution resistance, the charge transfer conductance, and a third impedance of the plurality of impedances corresponding to a first frequency at which an impedance phase is approximately negative 40 degrees to approximately negative 90 degrees; determining a presence of electrochemical interference on the representation of the electrochemical cell of the blood glucose level of the patient based on the solution resistance, the charge transfer conductance, and the non-constant phase double layer capacitance
Muthukumar teaches determining a charge transfer conductance based on a first impedance of the plurality of impedances corresponding to a frequency of at least 0.1 hertz (Hz) and less than or equal to 100 Hz [par. 224, 239]; determining a solution resistance based on a second impedance of the plurality of impedances corresponding to a frequency [par. 239]; determining a double layer capacitance based on the solution resistance, the charge transfer conductance, and a third impedance of the plurality of impedances corresponding to a first frequency [par. 239, 240, 243]; determining a presence of electrochemical interference on the representation of the electrochemical cell of the blood glucose level of the patient based on the solution resistance, the charge transfer conductance, and the double layer capacitance [par. 224, 225, 239, 243]
Hasty teaches non-constant phase double layer capacitance based on a third impedance of the plurality of impedances corresponding to a first frequency at which an impedance phase is approximately negative 40 degrees to approximately negative 90 degrees [fig. 4A-D; par. 168, 175, 176; Examiner notes a non-faradaic system is inherently non-constant]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Varsavsky, to incorporate non-constant phase double layer capacitance based on a third impedance of the plurality of impedances corresponding to a first frequency at which an impedance phase is approximately negative 40 degrees to approximately negative 90 degrees, for determining the important contribution to the total impedance, as evidence by Hasty [par. 176]
Claussen teaches determining a solution resistance based on a second impedance of the plurality of impedances corresponding to a frequency greater than 500 Hz and less than or equal to 8 kilohertz (kHz) [par. 63]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Varsavsky, to incorporate determining a solution resistance based on a second impedance of the plurality of impedances corresponding to a frequency greater than 500 Hz and less than or equal to 8 kilohertz (kHz), for determining solution resistance at an intermediate frequency, as evidence by Claussen [par. 63]
Regarding claim 7, Varsavsky further teaches determining an amount of electrochemical interference [par. 256, 344] and determining the double layer capacitance [par. 234].
Although Varsavsky does not explicitly teach determining an amount of electrochemical interference based on the double layer capacitance, this would be obvious to a person having ordinary skill in the art when the invention was filed since Varsavsky also suggests Pollutants reduces surface area [par. 256]. Additionally, Varsavsky teaches double layer capacitance is directly related to surface area [par. 627] Therefore, incorporating determining an amount of electrochemical interference based on the double layer capacitance value would only involve routine skill in the art.
However, Varsavsky does not teach non-constant phase double layer capacitance
Hasty teaches non-constant phase double layer capacitance [fig. 4A-D; par. 168, 175, 176; Examiner notes a non-faradaic system is inherently non-constant]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Varsavsky, to incorporate non-constant phase double layer capacitance, for determining the important contribution to the total impedance, as evidence by Hasty [par. 176]
Regarding claim 8, Varsavsky further teaches wherein the plurality of impedances corresponding to a plurality of frequencies is a first plurality of impedances measured at a first time [fig. 15A; par. 16, 233], wherein the charge transfer conductance is a first charge transfer conductance, wherein the solution resistance is a first solution resistance [par. 234, 634], where the double layer capacitance is a first double layer capacitance [par. 634, 679], wherein determining the amount of electrochemical interference comprises: measuring, via the device, a second plurality of impedances of the electrochemical cell corresponding to the plurality of frequencies at a second time [par. 16 “after a calculated time interval, performing a second EIS procedure to generate a second set of data for the values associated with the one or more EIS-based parameters”]; and determining a second charge transfer conductance and a second solution resistance of the electrochemical cell based on the second plurality of impedances at fewer than four of the corresponding plurality of frequencies [par. 234]; determining a second double layer capacitance based on the second solution resistance, the second charge transfer conductance, and on the impedance value of the second plurality of impedance values corresponding to a frequency [par. 243, 634, 679]; and determining the amount of electrochemical interference [par. 256, 344] and determining the second double layer capacitance [par. 16, 234]..
Although Varsavsky does not explicitly teach determining the amount of electrochemical interference based on the first double layer capacitance and the second double layer capacitance, this would be obvious to a person having ordinary skill in the art when the invention was filed since Varsavsky also suggests Pollutants reduces surface area [par. 256]. Additionally, Varsavsky teaches double layer capacitance is directly related to surface area [par. 627] Therefore, incorporating determining an amount of electrochemical interference based on the first and second double layer capacitance value would only involve routine skill in the art.
However, Varsavsky does not teach non-constant phase double layer capacitance at which the impedance phase is approximately negative 40 degrees to approximately negative 90 degrees
Hasty teaches non-constant phase double layer capacitance at which the impedance phase is approximately negative 40 degrees to approximately negative 90 degrees [fig. 4A-D; par. 168, 175, 176; Examiner notes a non-faradaic system is inherently non-constant]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Varsavsky, to incorporate non-constant phase double layer capacitance at which the impedance phase is approximately negative 40 degrees to approximately negative 90 degrees, for determining the important contribution to the total impedance, as evidence by Hasty [par. 176]
Regarding claim 9, Varsavsky further teaches determining a Nyquist slope [par. 15]; and determining whether the electrochemical interference is caused by at least one insulin excipient or acetaminophen based on the Nyquist slope [par. 337, 341, 342].
Regarding claim 19, Varsavsky further teaches a non-transitory computer-readable storage medium having stored thereon instructions that, when executed, configure a processor [par. 151] to: monitor, via a device including an electrochemical cell, an electrical current that is proportional to an impedance of the electrochemical cell [fig. 15A; par. 233]; responsive to determining that the electrical current satisfies a threshold [par. 191], receive one or more measurements from the device of a plurality of impedances of the electrochemical cell corresponding to a plurality of frequencies [fig. 16A; par. 239]; determine a charge transfer conductance and a solution resistance of the electrochemical cell based on the plurality of impedances at a subset of the corresponding plurality of frequencies [par. 234, 634]; wherein the subset of the corresponding plurality of frequencies is fewer than four of the corresponding plurality of frequencies [par. 234-237; Examiner notes that Varsavsky teaches determining impedances by applying alternating high and low frequency, which Examiner interprets to applying 2 frequencies (high and low)]; determine the presence of electrochemical interference [par. 344]; and output a signal based on the determination of the presence of electrochemical interference [par. 344].
Although Varsavsky does not explicitly teach determining the presence of electrochemical interference based on the solution resistance and the charge transfer conductance, this would be obvious to a person having ordinary skill in the art when the invention was filed since Varsavsky also suggests calculating Warburg impedance which requires solution resistance and polarization resistance (resistance to voltage bias and charge transfer between the electrode and electrolyte [par. 237, 634]. Additionally, Varsavsky teaches the use of impedance to detect interference [par. 344]. Therefore, incorporating determining the presence of electrochemical interference based on the solution resistance and the charge transfer conductance would only involve routine skill in the art.
However, Varsavsky does not teach determining a charge transfer conductance based on a first impedance of the plurality of impedances corresponding to a frequency of at least 0.1 hertz (Hz) and less than or equal to 100 Hz; determining a solution resistance based on a second impedance of the plurality of impedances corresponding to a frequency greater than 500 Hz and less than or equal to 8 kilohertz (kHz); determining a non-constant phase double layer capacitance based on the solution resistance, the charge transfer conductance, and a third impedance of the plurality of impedances corresponding to a first frequency at which an impedance phase is approximately negative 40 degrees to approximately negative 90 degrees; determining a presence of electrochemical interference on the representation of the electrochemical cell of the blood glucose level of the patient based on the solution resistance, the charge transfer conductance, and the non-constant phase double layer capacitance
Muthukumar teaches determining a charge transfer conductance based on a first impedance of the plurality of impedances corresponding to a frequency of at least 0.1 hertz (Hz) and less than or equal to 100 Hz [par. 224, 239]; determining a solution resistance based on a second impedance of the plurality of impedances corresponding to a frequency [par. 239]; determining a double layer capacitance based on the solution resistance, the charge transfer conductance, and a third impedance of the plurality of impedances corresponding to a first frequency [par. 239, 240, 243]; determining a presence of electrochemical interference on the representation of the electrochemical cell of the blood glucose level of the patient based on the solution resistance, the charge transfer conductance, and the double layer capacitance [par. 224, 225, 239, 243]
Hasty teaches non-constant phase double layer capacitance based on a third impedance of the plurality of impedances corresponding to a first frequency at which an impedance phase is approximately negative 40 degrees to approximately negative 90 degrees [fig. 4A-D; par. 168, 175, 176; Examiner notes a non-faradaic system is inherently non-constant]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Varsavsky, to incorporate non-constant phase double layer capacitance based on a third impedance of the plurality of impedances corresponding to a first frequency at which an impedance phase is approximately negative 40 degrees to approximately negative 90 degrees, for determining the important contribution to the total impedance, as evidence by Hasty [par. 176]
Claussen teaches determining a solution resistance based on a second impedance of the plurality of impedances corresponding to a frequency greater than 500 Hz and less than or equal to 8 kilohertz (kHz) [par. 63]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Varsavsky, to incorporate determining a solution resistance based on a second impedance of the plurality of impedances corresponding to a frequency greater than 500 Hz and less than or equal to 8 kilohertz (kHz), for determining solution resistance at an intermediate frequency, as evidence by Claussen [par. 63]
Regarding claims 21 and 25, Varsavsky further teaches the signal comprises information indicative of an amount of electrochemical interference [par. 256, 344].
Regarding claim 23, Varsavsky further teaches the device includes a delivery lumen configured to output insulin [par. 153].
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Varsavsky, Muthukumar, Hasty and Claussen and in further view of Masciotti (U.S. Patent Application Publication 2021/0137420 A1).
Masciotti was applied in the previous office action
Regarding claim 22, Varsavsky, Muthukumar, Hasty and Claussen teach a method comprising: monitoring, via a device including an electrochemical cell, an electrical current, as disclosed above.
However, Varsavsky, Muthukumar, Hasty and Claussen do not teach determining whether to cause an alert to be output based on the signal, wherein the alert comprises at least one of an audible alert sound, a visual alert indicator, or information configured to by displayed by a user interface.
Masciotti teaches determining whether to cause an alert to be output based on the signal, wherein the alert comprises at least one of an audible alert sound, a visual alert indicator, or information configured to by displayed by a user interface [par. 69, 89]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Varsavsky, Muthukumar, Hasty and Claussen, to incorporate determining whether to cause an alert to be output based on the signal, wherein the alert comprises at least one of an audible alert sound, a visual alert indicator, or information configured to by displayed by a user interface, for notifying the user once a condition for the alarm has been met, as evidence by Masciotti [par. 79]
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Varsavsky, Muthukumar, Hasty and Claussen and in further view of Yuds (U.S. Patent Application Publication 2021/0187189 A1).
Yuds was applied in the previous office action
Regarding claim 24, Varsavsky, Muthukumar, Hasty and Claussen teach a method comprising: monitoring, via a device including an electrochemical cell, an electrical current, as disclosed above.
However, Varsavsky, Muthukumar, Hasty and Claussen do not teach the delivery lumen is separated from the electrochemical cell by less than 100 millimeters.
Yuds teaches the delivery lumen is within the same housing as the sensor [par. 86].
Although Yuds does not explicitly teach the delivery lumen is separated from the electrochemical cell by less than 100 millimeters, this would be obvious to a person having ordinary skill in the art when the invention was filed since Yuds also suggests the analyte sensor and the pump for delivering a bolus dose are within the same housing [par. 86], allowing for the two to be in close proximity to each other. Therefore, separating the sensor and delivery lumen by less than 100mm would only involve routine skill in the art
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791