DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 03/18/2024. Claims 1-13 are pending and examined below.
Claim Rejections - 35 USC § 102
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 11=13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipate by EP 2256494 B1 (cited by IDS 10/21/2025; hereinafter referred to as “Saidara”).
Regarding claim 1, Saidara, a system for monitoring physiological characteristics, teaches a calibration alarm method (paragraphs [0099], [0102]) comprising:
determining an input time of a reference biometric value for calibrating a measurement biometric value measured by a sensor (paragraph [0102]);
determining a calibration period in which the input time of the reference biometric value is included (“A reminder timer can also be triggered by a user providing a reference value to the monitor”; paragraph [0102]);
calculating a next calibration time based on the determined calibration period (paragraph [0102]); and
providing a calibration alarm to a user based on the calculated next calibration time (“the reminders can be alarm signals”; paragraph [0099]),
wherein the sensor is configured to be insertable into body of the user and measure biometric information of the user for a certain period of time (abstract; paragraph [0033]).
Regarding claim 2, Saidara teaches wherein:
the sensor is a sensor configured to measure a blood glucose level of the user (paragraph [0021]), and
the reference biometric value is a reference blood glucose value measured using a separate blood glucose meter to calibrate a measurement blood glucose value measured by the sensor (“…processing a previously entered blood glucose reference value, for example from a meter, to calibrate the sensor set…”; paragraph [0034]; “While a calibration is pending or valid as a result of entry of a calibration reference value (e.g., a blood glucose value measured by a blood glucose meter)…”; paragraph [0036]).
Regarding claim 11, Saidara teaches wherein the providing of the calibration alarm comprises:
determining whether the next calibration time has arrived (paragraphs [0099]-[0102]);
determining whether a calibration condition parameter measured at a time point when the next calibration time arrives satisfies a calibration condition (paragraphs [0099]-[0102]); and
if the calibration condition parameter satisfies the calibration condition, generating the calibration alarm and providing the generated calibration alarm to the user (paragraphs [0099]-[0102]).
Regarding claim 12, Saidara teaches wherein if the calibration condition parameter measured at the time point when the next calibration time arrives does not satisfy the calibration condition, the calibration condition parameter is monitored for a set time, and if the calibration condition parameter monitored for the set time satisfies the calibration condition, the calibration alarm is generated (paragraphs [0099]-[0103]).
Regarding claim 13, Saidara teaches continuous biometric information measurement system (abstract), comprising:
a sensor configured to be insertable into body of a user and configured to continuously measure a biometric value of the user for a certain period of time (102; paragraph [0021]; Figure 1A); and
a user terminal configured to receive the measured biometric value and calibrate the measured biometric value using a reference biometric value (108’ paragraphs [0021]-[0023]; Figure 1A),
wherein the user terminal is configured to determine an input time of the reference biometric value for calibrating the measured biometric value measured by the sensor (paragraphs [0099]-[0103]), determine a calibration period in which the input time of the reference biometric value is included (paragraphs [0099]-[0103]), calculate a next calibration time based on the determined calibration period and provide a calibration alarm to the user based on the calculated next calibration time (paragraphs [0099]-[0103]).
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.
Claim(s) 3-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saidara as applied to claim 1 above, and further in view of US 20100274515 A1 (hereinafter referred to as “Hoss”).
Regarding claim 3, Saidara does not explicitly teach wherein when a next reference biometric value is input regardless of the next calibration time, a calibration time is recalculated based on a calibration period in which an input time of the next reference biometric value is included.
However, Hoss, a method of dynamic analyte sensor calibration based on sensor stability profile, teaches wherein when a next reference biometric value is input regardless of the next calibration time, a calibration time is recalculated based on a calibration period in which an input time of the next reference biometric value is included (abstract; paragraphs [0090], [0099]-[0102]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Saidara, to implement a dynamic calibration timing period, as taught by Hoss, because when the calibration schedule is fixed and is determined from when the sensor is first positioned in contact with the user's analyte, and the calibration time period falls when it is not convenient or practical to the user, the convenience of the analyte monitoring system may be diminished (paragraph [0013]; as taught by Hoss).
Regarding claim 3, Saidara, in view of Hoss, teaches wherein when a next reference biometric value is input regardless of the next calibration time, a calibration time is recalculated based on a calibration period in which an input time of the next reference biometric value is included (paragraphs [0090], [0099]-[0102]; as taught by Hoss).
Regarding claim 4, Saidara, in view of Hoss, teaches wherein the calibration alarm method calculates a calibration factor using the reference biometric value or the next reference biometric value, and, until a new reference biometric value is input, calibrates the measurement biometric value using the calibration factor (paragraphs [0090], [0099]-[0102]; as taught by Hoss).
Regarding claim 5, Saidara, in view of Hoss, teaches wherein, in the calibration alarm method, the calibration period is divided into an additional stabilization period, a buffer period, and a final stabilization period (paragraphs [0090], [0099]-[0102]; as taught by Hoss).
Regarding claim 6, Saidara, in view of Hoss, teaches wherein when the input time of the reference biometric value is within the additional stabilization period, the next calibration time is calculated based on which one calibration period among the additional stabilization period, the buffer period, and final stabilization period includes a first calibration cycle preset after the input time of the reference biometric value (paragraphs [0090], [0099]-[0102]; as taught by Hoss).
Regarding claim 7, Saidara, in view of Hoss, teaches wherein if the first calibration cycle preset after the input time of the reference biometric value is within the additional stabilization period, the next calibration time is calculated using the first calibration cycle preset after the input time of the reference biometric value (paragraphs [0090], [0099]-[0102]; as taught by Hoss).
Regarding claim 8, Saidara, in view of Hoss, teaches wherein if the first calibration cycle preset after the input time of the reference biometric value is within the buffer period, the next calibration time is calculated using the first calibration cycle preset after the input time of the reference biometric value (paragraphs [0090], [0099]-[0102]; as taught by Hoss).
Regarding claim 9, Saidara, in view of Hoss, teaches wherein if the first calibration cycle preset after the input time of the reference biometric value is within the final stabilization period, the next calibration time is calculated using an end time point of the buffer period (paragraphs [0090], [0099]-[0102]; as taught by Hoss).
Regarding claim 10, Saidara, in view of Hoss, teaches wherein if the input time of the reference biometric value is within the buffer period or the final stabilization period, the next calibration time is calculated using a second calibration cycle preset after the input time of the reference biometric value (paragraphs [0090], [0099]-[0102]; as taught by Hoss).
Conclusion
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/ABID A MUSTANSIR/ Examiner, Art Unit 3791