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 .
Response to Amendment
Receipt is acknowledged of applicant's amendment filed on 1/28/2026. Claim 3 is cancelled. Claims 1, 2, 4-7, 9-14 and 16-20 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, 2, 4-7, 9-14 and 16-20 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);
providing a group of sensors, the group of sensors including 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 a test sensor from the group of sensors 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)
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).
Regarding claim 2, Scott discloses associating the quantified effect with the selected sensor ([¶309]).
Regarding claims 4 and 19, Scott discloses associating the quantified effect with the selected sensor;
measuring an unknown concentration of the analyte in a user with the selected sensor to obtain a measured electrical performance parameter ([¶309]); and
predicting an estimated blood analyte level based on the measured electrical performance parameter and the quantified effect ([¶214] future analyte levels can be predicted).
Regarding claim 5, Scott discloses measuring an unknown concentration of the analyte in a user with the selected sensor to obtain a measured electrical performance parameter; and
predicting an estimated blood analyte level based on the measured electrical performance parameter and the quantified effect ([¶214] future analyte levels can be predicted).
Regarding claim 6, Scott discloses the at least one electrical performance parameter comprises an electrical current signal (Isig), an electrochemical impedance spectroscopy (EIS) output signal, and/or a counter electrode voltage (Vcntr) ([¶274-276] current, voltage or impedance can be measured to determine the analyte concentration).
Regarding claim 7, Scott discloses providing the quantified effect of the at least one electrical performance parameter on the calculation of the concentration of the analyte in the fluid sample comprises providing a transfer function equation ([¶309] a model is used to equate a measured parameter to analyte concentration).
Regarding claim 9, Scott discloses associating the at least one electrical performance parameter of the test sensor with the selected sensor from the group of sensors comprises printing machine readable data onto selected packaging and 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 disclose associating the at least one electrical performance parameter of the test sensor with the selected sensor from the group of sensors 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 associating the at least one electrical performance parameter of the test sensor with the selected sensor from the group of sensors and associating the quantified effect with the selected sensor comprises printing machine readable data onto a substrate associated with the selected sensor ([¶281] the calibration information can be printed or coded on the sensor).
Regarding claim 12, Scott discloses measuring an unknown concentration of the analyte in a user with the selected sensor to obtain a measured electrical performance parameter ([¶214,309] a model is used to equate a measured parameter to analyte concentration).
Regarding claim 13, Scott discloses measuring an unknown concentration of the analyte in interstitial fluid in a 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 16, Scott discloses providing a quantified effect of the at least one electrical performance parameter on a calculation of a concentration of an analyte in a fluid sample, wherein the quantified effect is the transfer function that relates changes in electrical performance parameters with concentrations of the analyte ([¶309] a model or equation is used to convert the measured parameter to an analyte concentration); and associating the quantified effect with the remaining sensors from the group of sensors ([¶352-354] calibration of one sensor in the lot can be applied to the other sensors).
Regarding claim 17, Scott discloses providing a quantified effect of the 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 ([¶309] a model or equation is used to convert the measured parameter to an analyte concentration); and
associating the quantified effect with the remaining sensors from the group of sensors ([¶352-354] calibration of one sensor in the lot can be applied to the other sensors).
enclosing each of the remaining sensors in respective packaging, wherein associating the at least one electrical performance parameter of the test sensor with the remaining sensors from the group of sensors and associating the quantified effect with the remaining sensors from the group of sensors comprises printing 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 1/28/26 have been fully considered but they are not persuasive.
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. Applicant states that Scott only describes the use of a model/equation to determine both the in vivo sensing characteristic and the calibration but this is not the case. At ¶308, Scott discloses using a model on the in vitro sensing characteristic and the manufacturing parameter, representation and characteristic referring to values or signals. ¶309 then discloses the in vivo characteristic is determined from the in vitro characteristic produced by the model. The sensor device is used to determine readings of the analyte in a patient as also shown in the overall document and ¶86,271 specifically.
Conclusion
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 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.
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/MICHAEL A CATINA/Examiner, Art Unit 3791
/TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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