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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/3/26 has been entered.
Response to Amendment
Receipt is acknowledged of applicant's amendment filed on 8/3/26. Claims 2, 4-7, 12 and 16 are cancelled. Claims 1, 9-11, 13-14 and 17-20 are currently pending and an action on the merits is as follows.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 9-11, 13-14 and 17-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Scott et al. US 2019/0274598.
Regarding claim 1, 14, 18 and 20, Scott discloses a method comprising:
providing a quantified effect of at least one electrical performance parameter on a calculation of a concentration of an analyte in a fluid sample, wherein the quantified effect is a transfer function that relates changes in electrical performance parameters with concentrations of the analyte and is determined prior to provision of a sensor to a user ([¶309] a model is used to equate a measured parameter to analyte concentration), and wherein at least one of the electrical performance parameters comprises an electrochemical impedance spectroscopy (EIS) output signal or a counter electrode voltage (Vcntr) ([¶276] the parameter measured is impedance, specifically EIS as taught by 2012/0265037 which is incorporated by reference);
providing a group of sensors, the group of sensors comprising a test sensor and a plurality of other sensors formed on a substrate ([¶372] several sensors in a lot maybe on the same substrate);
testing the test sensor with a known concentration of the analyte in a test sample to determine the at least one electrical performance parameter of the test sensor, wherein the test sensor has been separated from the plurality of other sensors from the substrate ([¶352-354] calibration of one sensor in the lot can be applied to the other sensors); and
associating the at least one electrical performance parameter and the transfer function of the test sensor with a selected sensor from the group of sensors using printed machine-readable data, the selected sensor being different from the test sensor ([¶281] the calibration information can be printed or coded on the sensor)
associating the quantified effect with the selected sensor ([¶309,317] the characteristic or calibration factor is associated with the sensor)
measuring an unknown concentration of the analyte in a user with the selected sensor to obtain a measured electrical performance parameter ([¶86,271,309] the sensor is used for in vivo sensing and the calibration parameter determined in vitro is used to determine the analyte concentration in the subject); and
predicting an estimated blood analyte level based on the measured electrical performance parameter and the quantified effect ([¶214,271,309]).
Regarding claim 9, Scott discloses the printed machine-readable data located on selected packaging and wherein the method further comprises confining the selected sensor in the selected packaging ([¶352-354] calibration of one sensor in the lot can be applied to the other sensors. [¶281] the calibration information can be printed or coded on the sensor).
Regarding claim 10, Scott discloses associating the at least one electrical performance parameter of the test sensor with the selected sensor comprises associating the at least one electrical performance parameter of the test sensor with each sensor from the group of sensors ([¶352-354] calibration of one sensor in the lot can be applied to the other sensors).
Regarding claim 11, Scott discloses wherein the printed machine-readable data is located on the substrate associated with the selected sensor ([¶281] the calibration information can be printed or coded on the sensor).
Regarding claim 13, Scott discloses measuring the unknown concentration of the analyte in the user comprising measuring the unknown concentration of the analyte in interstitial fluid in the user with the selected sensor to obtain a measured electrical performance parameter, and wherein the analyte is glucose ([¶83,84] glucose is sensed from interstitial fluid).
Regarding claim 17, Scott discloses enclosing remaining sensors of the group of sensors in respective packaging, wherein the printed machine-readable data onto the respective packaging ([¶255,281] the calibration information can be printed or coded on the sensor or the packaging of each sensor).
Response to Arguments
Applicant's arguments filed 8/3/26 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that Scott does not disclose “wherein the quantified effect is a transfer function that relates changes in electrical performance parameters with concentrations of the analyte”, Examiner respectfully disagrees. Applicant has miscategorized the transfer function of Scott. Scott discloses a transfer function from in vitro testing to in vivo testing. The in vitro testing is used to determine the sensitivity curve or transfer function, under a broadest reasonable interpretation a transfer function is just a correlation of one parameter to another, of the measured electrical characteristic of the sensor and the analyte concentration of the solution ([¶74,271,285]).
Regarding Applicant’s argument that Scott does not disclose “wherein at least one of the electrical performance parameters comprises an electrochemical impedance spectroscopy (EIS) output signal or a counter electrode voltage (Vcntr)”, Examiner respectfully disagrees. Applicant argues that Scott does not disclose using a sensed EIS input into an estimation algorithm or spectroscopy at certain frequencies. It is noted that the algorithm and frequencies are not recited in the claim language. Additionally, Scott discloses impedance can be the measured sensor characteristic that correlates to the analyte level ([¶270]) and Scott incorporates by reference 20120265037 which specifically uses EIS as its impedance measurement for analyte sensing ([¶276]).
Regarding Applicant’s argument that Scott does not disclose “measuring an unknown concentration of the analyte in a user with the selected sensor to obtain a measured electrical performance parameter”, Examiner respectfully disagrees. Scott specifically discloses in vivo testing and sensing where the sensor measures a blood analyte level by measuring the electrical response of the sensor electrodes and converting that to an analyte concentration ([¶83]) and the in vitro testing and calibration is used to inform the in vivo sensing ([¶236]) or the in vitro testing and calibration can be replaced with in vivo testing ([¶275]).
Regarding Applicant’s argument that Scott does not disclose “predicting an estimated blood analyte level based on the measured electrical performance parameter and the quantified effect”, Examiner respectfully disagrees. Scott discloses predicting future analyte levels based on current measured levels and those current analyte levels are determined by using the measured electrical performance parameter from the sensor and the quantified effect to determine the analyte level that correlates with that electrical parameter reading.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 5712723672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL A CATINA/Examiner, Art Unit 3791
/TSE CHEN/ Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights