DETAILED ACTION
Non-Final Rejection
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 .
Claims Status
Claims 1-20 are pending.
Claim Objections
Claim 1 is objected to because of the following informalities:
Insert “at” before “least” in line 10. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-20 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. Claim 11 recites, “[o]ne or more non-transitory processor-readable media storing instructions which, when executed by one more processors, cause the performance of: …” The present participle form (storing) would indicates an action taking place while the claim is directed to a structure. It is unclear if the memory therefore includes the instructions as part of the structure. For purposes of examination, the Office interpreted the instructions as being included in the memory. However, the Office recommends amending the claim to state, “One or more non-transitory processor-readable media with instructions stored therein which, when executed …” or the like to overcome the rejection. The same issue applies to claims 1 and 20.
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, are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) estimating, determining, and comparing functions in the body of the claim. These limitations were interpreted as mental concepts as the limitations amount to evaluations capable of being performed in the mind (i.e. there are no limitations that indicate these functions would be impossible to perform mentally). The limitations can alternatively be interpreted as mathematical concepts. Independent claims 11 and 20 rejected on the same basis as claim 1. This judicial exception is not integrated into a practical application because the final function of adjusting a calibration factor when the determined difference is below the predetermined threshold value fails to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception. More specifically, it is left unsaid what calibration factor is being adjusted (i.e. is the factor related to the system?). Also as claimed, the calibration factor adjustment only relies on the timing of a value falling below a threshold which arguably is not a meaningful limit. A practical application that uses something calculated from the previous limitations in adjusting the calibration factor of the glucose sensor would appear to be a more persuasive practical application. The other limitations of claim 1 are arguably related extra-solution data gathering or mere instructions to implement an abstract idea on a computer. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception under step 2B analysis because the recitation of hardware amount to using a computer as a tool to perform an abstract idea. The acquisition of sensor data and EIS data amount to insignificant extra-solution data gathering under the step 2B analysis. Claim 2 was interpreted as additional mental concepts but could be a practical application if the claim used a different phrase than “based on.” Claim 3, 7, 9, 10, 14, 15, 16, and 19 were interpreted as additional abstract mental concepts. Claims 4-6, 17 were interpreted as additional extra-solution data gathering. Claims 8 and 18 were interpreted as limitations related to organizing human activity.
Note
The following reference is provided for Applicant’s benefit:
Sharma et al., "Prediction of Glucose Sensor Sensitivity in the Presence of Biofouling Using Machine Learning and Electrochemical Impedance Spectroscopy," IEEE Sensors Journal, vol. 23, no. 16, pp. 18785-18797, 15 Aug.15, 2023. This article was published after the effective filing date of this application but does touch on many of the features discussed in the specification and recited in the claims.
Worden et al. (US 2010/0314248) – “[0060] Cyclic voltammetric experiments were conducted by sweeping the potential of the working electrode between 200 mV and -600 mV at a scan rate of 100 mV s.sup.-1, causing fructose in the vicinity of the electrode to be reduced to mannitol in the positive direction and mannitol to be oxidized to fructose in the reverse direction. All electrochemical measurements were made in 100 mM PBS (pH 6.0) at 60.degree. C. using an electrode with a controlled surface area of 0.07 cm.sup.2. The slope of the calibration plot, which depicts peak current vs. concentration, is a measure of the biosensor's sensitivity. The maximum turnover rate (TR.sub.max), which corresponds to the number of fructose molecules reduced per TmMtDH molecule per second, was calculated using Eq. 6 (Eisenwiener and Schulz, 1969)”
Li et al. (US 2015/0246814) – [0042] -“With reference to FIG. 15, as-grown CNT patterns may trap air bubbles rendering the surfaces of individual CNTs inaccessible to an electrolytic aqueous solution. As a result, it may be difficult to control the effective electrode surface area for electrochemical detection. Further, a low current response may result in difficult calibration of an associated sensor or device and difficult quantification of analyte concentration in a respective aqueous solution.”
Chapman et al. (US 2023/0255527) - [0102] The sensitivity of a biosensor may be partially dependent on the active surface area of the electrodes in the biosensor. Accordingly, the calibration process can use the calculated surface area from the automated image analysis to adjust a projected sensitivity for the biosensor. Returning to the specific example above, the active surface area of the electrodes can be dependent on the number of microneedles that are formed. Accordingly, the calibration process can use the number of detected microneedles to adjust a projected sensitivity for the biosensor… [0164] In some embodiments, calibration adjustments can be generally proportional to divergence from an expected value in the performance data. For example, increases or decreases in surface area of the electrode (e.g., microneedle tips), due to variation in the electrode formation (e.g., tip geometry and/or missing microneedle tip(s)) can be used to update the calibration adjustments. Returning to the specific example above, the production data can indicate that the active area of the sensor is 80 percent of an expected value (e.g., of a mean after production). In this example, the calibration adjustments can include a signal filter that boosts the signal by 25 percent, thereby returning to about 100 percent of the expected signal strength. In another example, variation in electrode resistance and/or other electrical characteristics can be used to update the calibration adjustments (e.g., to update and/or adjust a poise potential applied to a microsensor during operation of the biosensor to account for the different electrical characteristics).
Chapman provides the closest prior art as this reference teaches looking at changes in active surface area based on sensor electrical characteristics changing. However, the electrical characteristics do not include Isig, Vcntr, or EIS parameters.
Choy et al. (US 2022/0031205) – see [0163] which essentially appears to include the same teachings recited above in Chapman. This reference however is associated with the assignee (Medtronic) of this application.
Conclusion
Claims 1-20 are rejected. Note, no prior art rejections were included in this Office Action. It is anticipated that resolution of the 112 and 101 issues will likely place the application in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tho Q. Tran whose telephone number is (571)270-1892. The examiner can normally be reached 7-5.
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/THO Q TRAN/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791