DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on July 10, 2026 were received and fully considered. Claims 11, 22, 27, and 30 were amended1. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
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 11-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim 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 11 follows.
Regarding claim 1, the claim recites a method for real-time self-calibration of a glucose sensor. Thus, the claim is directed to a process/method, 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:
“A method for real-time self-calibration of a glucose sensor… generating a plurality of Nyquist plots based on respective outputs of the plurality of EIS procedures; monitoring a Nyquist plot length and a higher-frequency Nyquist slope across the plurality of Nyquist plots to detect changes in the Nyquist plot length and the higher-frequency Nyquist slope; calibrating the glucose sensor based on the detected changes in the Nyquist plot length and in the higher-frequency Nyquist slope by adjusting a calibration factor for the glucose sensor based on the detected changes in the Nyquist plot length and in the higher-frequency Nyquist slope”
These limitations describe a mathematical calculation. Furthermore, the limitations also describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper.
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:
“…performing a plurality of electrochemical impedance spectroscopy (EIS) procedures for at least one working electrode of the glucose sensor…providing a level of glucose using the calibrated glucose sensor”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant extra-solution activity, i.e., mere data gathering steps necessary to perform the identified judicial exception and providing a level of glucose (akin to outputting/displaying) do not integrate an abstract idea into a practical application. See MPEP 2106.05(g).
The additional limitations also do not add significantly more to the identified judicial exception because they relate to widely-understood, routine, and conventional techniques in continuous analyte monitoring techniques. See references applied in the current office action for example teachings. See also published instant specification, which further acknowledges the well-known nature of EIS diagnostics (par.0334).
Dependent claims 12-21 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.
Therefore, claims 11-21 are not patent eligible under 35 USC 101.
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 (i.e., changing from AIA to pre-AIA ) 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Telson et al. (US PG Pub. No. 2011/0040163 A1) (hereinafter “Telson”) in view of Wang et al. (US PG Pub. No. 2007/0170073 A1) (hereinafter “Wang”).
Telson and Wang were applied in the previous office action.
With respect to claim 11, Telson teaches a method for real-time self-calibration of a glucose sensor (abstract “use of electrical impedance spectroscopy to adjust calibration settings in… an in vivo continuous glucose monitoring sensor”), comprising: performing a plurality of electrochemical impedance spectroscopy (EIS) procedures for at least one working electrode of the glucose sensor (par.0036-37 “measuring impedance of a system over a range of frequencies”; par.0041-42 “Other frequencies… may also be utilized… EIS tests may be performed”); generating a plurality of Nyquist plots based on respective outputs of the plurality of EIS procedures (par.0036 “results, including all of the parameters utilized, can be plotted in both Bode and Nyquist plots”; par.0046 “R and C can be obtained from… Nyquist plots”; see also Fig. 3); calibrating the glucose sensor based on the detected changes in the Nyquist plot
However, Telson does not explicitly teach monitoring a Nyquist plot length and a higher-frequency Nyquist slope across the plurality of Nyquist plots to detect changes in the Nyquist plot length and the higher-frequency Nyquist slope by adjusting a calibration factor for the glucose sensor based on the detected changes in the Nyquist plot length and in the higher-frequency Nyquist slope.
Wang suggests monitoring a Nyquist plot length and a higher-frequency Nyquist slope across the plurality of Nyquist plots to detect changes in the Nyquist plot length and the higher-frequency Nyquist slope by adjusting a calibration factor for the glucose sensor based on the detected changes in the Nyquist plot length and in the higher-frequency Nyquist slope (monitoring changes in Nyquist plot, including arc length, higher frequency slope, etc. as depicted in Fig. 16; see also par.0127-131 “diagnostic EIS procedures with sensor remedial action… performing the EIS procedure is mapped on a Nyquist plot… an additional remedial action could be performed… to calibrate the sensor… to further confirm whether the sensor is truly failing… can both detect and possibly repair/correct an inaccurate sensor”).
Therefore, it would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Telson to incorporate monitoring a Nyquist plot length, in the manner recited, for the purpose of confirming whether additional remedial action is needed including sensor calibration, as evidence by Wang (par.0127-0131). As Wang teaches calibrating an analyte sensor based on analysis of Nyquist plot, further assessing changes in plot length, higher-frequency slope, etc. would merely involve routine skill in the art. Lastly, PHOSITA would have had predictable success combining Telson and Wang since both teachings relate to the same narrow field of endeavor, i.e. utilizing EIS and analysis of Nyquist plots to assess analyte sensor performance.
With respect to claim 12, Telson teaches further including monitoring a value of a voltage at a counter electrode of the glucose sensor (par.0070).
With respect to claim 13, Wang suggests setting a baseline Nyquist plot length; and setting a baseline higher-frequency Nyquist slope (Fig. 16; par.0114). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Telson to incorporate setting a baseline with respect to the Nyquist plot, in the manner recited, for the purpose of giving valuable information on the aging of the sensor, as evidence by Wang (par.0114).
With respect to claim 14, Wang suggests further comprising adjusting or resetting the baseline Nyquist plot length in response to a railing of the voltage value at the counter electrode (par.0114). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Telson to incorporate adjusting or resetting the baseline Nyquist plot length, in the manner recited, for the purpose of giving valuable information on the aging of the sensor, as evidence by Wang (par.0114).
With respect to claim 15, Wang suggests discarding one or more glucose values sensed by the glucose sensor in response to the monitored higher-frequency Nyquist slope becoming negative (abstract; par.0114). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Telson to incorporate discarding/rejecting one or more glucose values sensed by the glucose sensor, in the manner recited, for the purpose of giving valuable information on the aging of the sensor, as evidence by Wang (abstract; par.0114).
With respect to claim 16, Wang suggests discarding one or more glucose values sensed by the glucose sensor in response to the monitored Nyquist plot length increasing above a calculated threshold (abstract; par.0114). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Telson to incorporate discarding/rejecting one or more glucose values sensed by the glucose sensor, in the manner recited, for the purpose of giving valuable information on the aging of the sensor, as evidence by Wang (abstract; par.0114).
With respect to claim 17, Wang suggests wherein a baseline Nyquist plot length and a baseline higher-frequency Nyquist slope are set at respective values that are reflective of an EIS state at the beginning of the glucose sensor's life (par.0114). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Telson to incorporate setting baseline values that are reflective of an EIS state at the beginning of the glucose sensor’s life, in the manner recited, for the purpose of giving valuable information on the aging of the sensor, as evidence by Wang (abstract; par.0114).
Claims 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Telson and Wang, as applied to claim 11, in further view of Yodfat et al. (US PG Pub. No. 2007/0191702 A1) (hereinafter “Yodfat”).
Yodfat was applied in the previous office action.
With respect to claims 18-21, Telson and Wang teach a method for real-time self-calibration of a glucose sensor, as established above.
However, Telson and Wang do not explicitly teach the limitations further recited in claims 18-21.
Regarding claim 18, Yodfat teaches calculating an amount of insulin to be delivered to a user of the glucose sensor based on a calculated level of glucose in the user's body (par.0020; Fig. 1).
Regarding claim 19, Yodfat teaches transmitting the provided level of glucose to an insulin delivery device (par.0020; Fig. 1).
Regarding claim 20, Yodfat teaches wherein the insulin delivery device is an insulin pump (par.0020).
Regarding claim 21, Yodfat teaches wherein the glucose sensor and the insulin pump cooperate in a closed-loop system (par.0020).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Telson and Wang to incorporate calculating an amount of insulin to be delivered to a user based on a calculated level of glucose and utilizing a closed-loop insulin delivery system (pump) for the purpose of delivering the appropriate dosage of insulin to the patient, as evidence by Yodfat (par.0020).
Response to Arguments
Applicant’s arguments filed with respect to the 35 USC 101 rejections raised in the previous office action have been fully considered, but they were not persuasive. Applicant appears to argue that the claims do not recite a mental process and/or mathematical calculations. Examiner respectfully disagrees. Nothing from the claims, as currently recited, suggest that the skilled artisan would not be capable of monitoring a Nyquist plot and performing the calibration step, the latter of which could involve adjusting/changing signal values via mathematical calculation using simple pen/paper. Applicant goes on to argue that the claims should be patent eligible as they are analogous to Diamond v. Diehr. Examiner does not find this persuasive. Examiner argues the Diehr decision is not relevant since the Diehr claims utilized the result of a mathematical calculation in order to subsequently apply rubber curing. In other words, the Diehr claims did not just merely recite a mathematical formula; the Diehr claims recited an additional step of performing rubber curing which the courts ruled to be significantly more than an abstract idea. Here, there is no significantly more step as the additional limitation (“providing a level of glucose using the calibrated glucose sensor”) is akin to insignificant extra-solution activity, displaying, etc. For at least these reasons, the 35 USC 101 rejections are maintained. Please see corresponding rejection heading above for more detail.
Applicant's arguments filed with respect to the 35 USC 103 rejections raised in the previous office action have been fully considered, but they are not persuasive. Applicant argues that the prior art references do not teach and/or suggest monitoring a Nyquist plot length and a higher-frequency Nyquist slope across the plurality of Nyquist plots to detect changes in the Nyquist plot length and the higher-frequency Nyquist slope by adjusting a calibration factor for the glucose sensor based on the detected changes in the Nyquist plot length and in the higher-frequency Nyquist slope, as set forth in the current amendment. Examiner respectfully disagrees and has provided updated citations from a different embodiment from Wang, the maintained secondary reference, which are believed to render obvious to PHOSITA these limitations. Specifically, Wang discloses diagnostic EIS procedures including mapping a Nyquist plot in order to assess whether remedial action (e.g. sensor calibration) is needed. See par.0127-131. As such, the applied prior art sets forth calibration of an analyte sensor based on analysis of Nyquist plot, of which assessing changes in plot length, higher-frequency slope, etc. would merely involve routine skill in the art. For at least these reasons, the 35 USC 103 rejections are maintained. Please see prior art section above for more detail, updated citations, and updated obviousness rationale.
Conclusion
No claim is allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
1 Claims 22-30 remain withdrawn from consideration per restriction requirement, with mailing date 2/5/2026.
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