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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 11-21, in the reply filed on March 30, 2026 is acknowledged. Therefore, claims 22-30 are withdrawn from consideration.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under U.S.C. 120, 121, or 365 is acknowledged. The prior-filed applications (16/391666 filed on 4/23/2019; 14/466138 filed on 8/22/2014; and 61/916637 filed on 12/16/2013) are acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 31, 2024 has been considered by the examiner.
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; and providing a level of glucose using the calibrated glucose sensor.”
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…”
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 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 was cited in applicant’s IDS submitted on January 31, 2024.
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.
Wang teaches 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 (monitoring changes in Nyquist plot, including arc length, higher frequency slope, etc. as depicted in Fig. 16; see also par.0114).
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 and a higher-frequency Nyquist slope, in the manner recited, for the purpose of giving valuable information on the aging of the sensor, as evidence by Wang (par.0114). Furthermore, 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”).
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).
Conclusion
No claim is allowed.
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
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