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 .
Status of Claims
Claims 1-14 filed July 10, 2024 are pending and are hereby examined.
Claim Rejections - 35 USC § 103
3. 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.
4. 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.
5. 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.
6. 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.
7. Claims 1-14 are rejected under 35 U.S.C 103 as being unpatentable over Mueller et al (US 2009/0112478) in view of Lee et al (US 2022/0257151).
8. Re Claims 1, 10: Mueller discloses comprising:
determining whether a reference biometric value used to calculate a calibrated
biometric value from a biometric signal measured by a sensor is input (see [0065] glucose calibration reference value);
extracting a calibration parameter at a time point when the reference biometric
value is input, and determining whether a correction condition is satisfied based on the
extracted calibration parameter (see [0027-0028] calibration reference value); and
calculating a calibration factor depending on whether the correction condition is
satisfied and calculating the calibrated biometric value from the biometric signal
measured by the sensor using the calibration factor (see [0027-0028] calibration reference value).
However, Mueller fails to disclose the following explicitly. Meanwhile, Lee teaches:
a biometric signal (see [0096]).
From the teaching of Lee, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mueller’s modified sensor calibration algorithm with Lee‘s teaching of a biometric signal in order for “… stabilizing a continuous glucose monitoring system (see Lee Abstract).”
9. Re Claim 2: Mueller discloses wherein, if the correction condition is not satisfied, a current calibration factor is calculated from the input reference biometric value, and the calibrated biometric value is calculated from the biometric signal using the current calibration factor until a next reference biometric value is input (see [0027-0028] calibration reference value).
10. Re Claim 3: Mueller discloses comprising:
if the correction condition is satisfied, calculating a current calibration factor from
the input reference biometric value;
determining a calibration section to which the time point when the reference
biometric value is input belongs;
calculating a final calibration factor from the current calibration factor differently depending on the calibration section to which the time point when the reference biometric
value is input belongs, based on the determined calibration section; and
calculating a calibrated biometric value using the biometric signal measured by
the sensor and the final calibration factor until the next reference biometric value is input (see [0065] glucose calibration reference value).
11. Re Claim 4: Mueller discloses wherein the calibration section divides an entire usage period of the sensor into a first section, a second section, and a third section over time based on time of inserting the sensor into a body (see Fig. 1-2).
12. Re Claim 5: Mueller discloses wherein the current calibration factor is calculated as the final calibration factor when the time point when the reference biometric value is input is within the first section (see [0027-0028] calibration reference value).
13. Re Claim 6: Mueller discloses wherein, when the calibration section to which the time point when the reference biometric value is input is within the second section, a first compensation value is calculated from a difference between the current calibration factor and a previous calibration factor, and the final calibration factor is calculated by applying the first
compensation value to the current calibration factor (see Fig. 1-2).
14. Re Claim 7: Mueller discloses wherein, when the calibration section to which the time point when the reference biometric value is input is within the third section, a second compensation value is calculated from a difference between the current calibration factor and the previous calibration factor, and the final calibration factor is calculated by applying the second compensation value to the current calibration factor (see Fig. 1-2).
15. Re Claim 8: Mueller discloses comprising:
calculating an average value of previous final calibration factors calculated in the third section based on the time point when the reference biometric value is input;
and re-correcting the final calibration factor based on the average value (see [0064] average characteristic levels).
16. Re Claim 9: Mueller discloses wherein the re-correcting of the final calibration factor comprises:
calculating a correction threshold range based on the average value;
determining whether the final calibration factor is out of the correction threshold
range; and
re-correcting the final calibration factor, depending on whether the final calibration factor is out of the correction threshold range, and wherein the calibrated biometric value is calculated using the re-corrected final calibration factor (see [0094, 0100] threshold value).
17. Re Claim 10: Mueller discloses wherein, if the final calibration factor is out of the correction threshold range, the final calibration factor is re-corrected to the correction threshold range (see [0094, 0100] threshold value).
18. Re Claim 11: Mueller discloses wherein, if the final calibration factor is within the correction threshold range, the final correction factor is used as is (see [0094, 0100] threshold value).
19. Re Claim 12: Mueller discloses wherein the re-correcting of the final calibration factor comprises calculating a difference between the final calibration factor and the average value;
calculating a third compensation value from the difference between the final
calibration factor and the average value;
and re-correcting the final calibration factor with the third compensation value, and
wherein the calibrated biometric value is calculated using the re-corrected final
calibration factor (see [0027-0028] calibration reference value).
20. Re Claim 13: Mueller discloses wherein the sensor is configured to be inserted into the body of a user and continuously measure the biometric signal from body fluid for a certain period of time (see [0055] sensor values).
21. Re Claim 14: Mueller discloses wherein the sensor is configured to measure a blood glucose value of a user, and the reference biometric value is a reference blood glucose value measured by a separate blood glucose meter for calibrating the measured blood glucose value measured by the sensor (see [0063] real-time blood glucose value).
Examiner Notes
22. The Examiner suggests incorporating claims 9 (dependent on 8, 7, 4, and 3) and 12-14 together into the independent claims. Finally, the Examiner suggests incorporating more hardware from the Specification and any unique arrangements of hardware, unique hardware, or unique ways the hardware is communicating. The aforementioned claim suggestions, in combination together, are suggested to help advance prosecution forward, although further search, examination, and consideration is required.
Conclusion
23. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FAWAAD HAIDER whose telephone number is (571)272-7178. The examiner can normally be reached Mon-Fri 8 AM to 5 PM.
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25. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Florian Zeender can be reached on 571-272-6790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FAWAAD HAIDER/Primary Examiner, Art Unit 3627
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