DETAILED ACTION
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 1-6 and 8-11 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) calibrating sensitivity for glucose measurement. The recited claims covers performance of the limitation in the mind, and accordingly falls within the “Mental Processes” grouping of abstract ideas.
This judicial exception is not integrated into a practical application because the claims fail to recite any further use of the determined sensitivity, nor does it recite any other elements.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims wholly recite an abstract idea of going through steps to determine a sensitivity, which can be performed mentally.
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 5, 6, and 11 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 5 recites determining reliability of the first sensitivity is high when “the first sensitivity is higher or lower than the previous sensitivity at each of the two consecutive calibration points”. Claim 1, from which claim 5 depends, recites determining a single “first sensitivity” from the sensor data and a reference value, and defines “a previous sensitivity” as a single “final sensitivity determined at a preceding calibration point”. It is therefore unclear how the single first sensitivity of claim 1 could be compared against the single previous sensitivity “at each of at least two consecutive calibration points”. It is unclear whether a respective first sensitivity and a respective previous sensitivity are determined at each of the at least two consecutive calibration points where this relationship holds, or some other comparison. For purposes of examination, that is how it will be interpreted, consistent with what is stated in [0070] – “when the first sensitivity is higher or lower than the previous sensitivity continuously—at least two consecutive times or more”.
As to claim 11, the claim recites adjusting the sensitivity “according to at least one of” the three methods recited. Under the broadest reasonable interpretation, the claim is satisfied when just one of the three methods is performed. However, the second method recites the liability of “the sensitivity”, and third method recites “the previous glucose value”, “the previous sensitivity”, and “the preceding calibration point”, all of which are introduced in a previous method. Where the first and/or second method is not performed, these terms lack antecedent basis.
In addition, claim 11 recites “adjusting the sensitivity to obtain an adjusted sensitivity” and then “determining the adjusted sensitivity as the calibrated sensitivity”. Where more than one of the three methods is performed, it is unclear which adjusted sensitivity is determined as the calibrated sensitivity, or whether the methods operate on the output of one another (e.g. when both the first and third method is used, the output of the first method is used as input of the third method).
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)(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.
(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) 11 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Shin et al. (US 2005/0004439).
As to claim 11, Shin teaches a method for calibrating sensitivity for glucose measurement in a terminal receiving data from a sensor transmitter attached to a body of a user ([0056] – glucose monitor 100 worn by the user; [0060] – calibrate the data), the method comprising: obtaining an offset value ([0093] – an offset value of 3 is used); determining, based on the offset value, a sensitivity from the sensor data generated by a sensor of the sensor transmitter, and a reference glucose value obtained from a blood glucose monitoring system (BGMS) ([0093] - MSPSR (modified single point sensitivity ratio) calculation), the sensor being at least partially inserted into skin of the user ([0057] – sensor terminating in subcutaneous tissue); and adjusting the sensitivity to obtain an adjusted sensitivity according to at least one of: a first method in which the sensitivity is adjusted based on a predetermined sensor sensitivity assigned when the sensor is manufactured; a second method in which the sensor is adjusted based on reliability of the sensitivity (Fig. 16 – block 1210 – difference between the PES (previous estimated slope) and CFc (current calibration check)), the reliability being determined based on a difference between the sensitivity and a previous sensitivity representing a final sensitivity determined at a preceding calibration point (blocks 1410/1420 – Criteria 3a/3b determines whether the difference reflects a change in sensitivity of the sensor – [0127], and where it indicates a change in sensitivity, the slope calculation is updated – [0128]; [0142] – subsequent calibrations employ a weighted average using a sensitivity ratio calculated from data collected since the last calibration and a previous sensitivity ratios calculated for previous calibrations); and a third method in which the sensitivity is adjusted based on whether a glucose value from the sensor data, the offset value, and the sensitivity is within a specific range, wherein the specific range is specified by a previous glucose value and the reference glucose value, and wherein the previous glucose value is obtained from the sensor data, a previous offset value used at the preceding calibration point, and the previous sensitivity; and determining the adjusted sensitivity as the calibrated sensitivity ([0145] – the new sensitivity ratio calculated is used to convert new data to blood glucose readings).
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 4-6, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shin et al. (US 2005/0004439) in view of Budiman et al. (US 2014/0121480) and further in view of Lee et al. (WO 2021/182871) (US counterpart US 2023/0039204 being used as the translation, with all citations referring to this document).
As to claim 1, Shin teaches a method for calibrating sensitivity for glucose measurement in a terminal receiving sensor data from a sensor transmitter attached to a body of a user (([0056] – glucose monitor 100 worn by the user; [0060] – calibrate the data), the method comprising: obtaining an offset value for determining sensitivity value ([0093] – an offset value of 3 is used); determining, based on the offset value, a first sensitivity from the sensor data generated by a sensor of the sensor transmitter and a reference glucose value obtained from a blood glucose monitoring system (BGMS) ([0093] - MSPSR (modified single point sensitivity ratio) calculation), the sensor being at least partially inserted into skin of the user ([0057] – sensor terminating in subcutaneous tissue); determining a third sensitivity by adjusting the second sensitivity based on reliability of the first sensitivity that is based on a difference between the first sensitivity and a previous sensitivity representing a final sensitivity determined at a preceding calibration point (Fig. 16 – block 1210 – difference between the PES (previous estimated slope) and CFc (current calibration check); blocks 1410/1420 – Criteria 3a/3b determines whether the difference reflects a change in sensitivity of the sensor – [0127], and where it indicates a change in sensitivity, the slope calculation is updated – [0128]; [0142] – subsequent calibrations employ a weighted average using a sensitivity ratio calculated from data collected since the last calibration and a previous sensitivity ratios calculated for previous calibrations);
Shin does not expressly teach determining a second sensitivity from the first sensitivity and a predetermined sensor sensitivity assigned when the sensor is manufactured; and determining a fourth sensitivity from the third sensitivity based on whether a glucose value obtained from the offset value and the third sensitivity is within a specific range, wherein the specific range is specified by a previous glucose value and the reference glucose value, and wherein the previous glucose value is obtained from the sensor data, a previous offset value used at the preceding calibration point, and the previous sensitivity; and determining the fourth sensitivity as the calibrated sensitivity.
Budiman teaches deriving a corrected sensitivity from both the computed sensitivity and a manufacture-assigned nominal sensitivity. Budiman teaches a comparison against sensor-code nominal sensitivity in the calibration validations check ([0026]) and that prior information regarding the sensor based on past calibrations is used to obtain the nominal estimate of the sensor sensitivity ([0055]). Budiman further teaches that the sensor sensitivity obtained from the manufacturing lot can be combined with real-time observations of past calibrations to improve the robustness of each calibration instance ([0054]). Finally, Budiman states that the resulting method comprises providing a nominal estimate of sensitivity based on at least one of past calibrations and sample lot statistics, computing a current sensitivity based on the reference analyte concentration value and the sensor data, and applying a correction factor to determine a corrected sensitivity ([0090]). It would have been obvious to modify Shin with Bohm to utilize a manufacture-derived a priori sensitivity information to improve accuracy of the starting measurements.
The above combination still fails to expressly teach determining a fourth sensitivity from the third sensitivity based on whether a glucose value obtained from the offset value and the third sensitivity is within a specific range, wherein the specific range is specified by a previous glucose value and the reference glucose value, and wherein the previous glucose value is obtained from the sensor data, a previous offset value used at the preceding calibration point, and the previous sensitivity; and determining the fourth sensitivity as the calibrated sensitivity.
While Shin does teach converting valid measurements to blood glucose readings “based on a particular version of the sensitivity ratio” ([0150]) and to compare resulting blood glucose readings to “an out-of-range limit” ([0150]), this range is a fixed limit rather than a range specified by a previous glucose value and the reference glucose value. Lee teaches a continuous glucose monitoring system in which calibration is done by calculating a difference between a measured biometric value measured at the first time point by the sensor transmitter using the calibration sensitivity used up to the first time point and a reference biometric value at the first time point ([0068]) and determining whether this difference is within a threshold range ([0068]). Thus, Lee teaches specifying a validity window for a newly determined calibration by reference to a glucose value obtained from the current sensor data using the sensitivity in effect from the previous calibration (i.e. the previous glucose value) and the reference glucose value. It would have been obvious to one of ordinary skill in the art to modify the above combination with Lee to allow the use of previous measurements to factor in to account for changes in the sensor sensitivity during the lifespan of the glucose sensor to increase the accuracy of the device.
As to claim 4, Budiman teaches that predetermined sensor sensitivity includes a predetermined ideal sensitivity for the sensor or for a group of sensors including the sensor ([0056]).
As to claim 5, Shin teaches determining the reliability of the first sensitivity is high when the first sensitivity is higher or lower than the previous sensitivity at each of at least two consecutive calibration points ([0129] – fine tuning is performed when two MBG entry in succession indicate a change in slope) as well as determining whether there has been a directional change between the CFp and CFc ([0121]), and obtaining a combined sensitivity from the first two sensitivities ([0131] – calibration factor).
As to claim 6, Shin teaches wherein the obtaining of the combined sensitivity includes averaging the first sensitivity and the second sensitivity ([0131]).
As to claim 8, Lee teaches when the obtained glucose value is within the specific range, determining the third sensitivity as the fourth sensitivity ([0026] – when the difference is within the threshold range, the first calibration mode is selected, and in the first calibration mode, one reference biometric value is measured. Accordingly, no corrective substitution is made and the sensitivity is simply determined from the current pairing).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shin et al. (US 2005/0004439), Budiman et al. (US 2014/0121480) and Lee et al. (WO 2021/182871; US 2023/0039204), and further in view of Goode, JR. et al. (US 2005/0043598).
As to claim 2, the above combination does not expressly teach when the first sensitivity is higher than the predetermined sensor sensitivity, determining the predetermined sensor sensitivity as the second sensitivity. Budiman discloses that data can be stratified based on the ratio between the sensitivity during calibration and the best estimate of true sensor sensitivity ([0051], Fig. 7), thus allowing for an application of a different correction depending on the computed sensitivity is higher or lower than the nominal sensitivity. Shin teaches that the MSPSR is compared to a valid sensitivity range to see if it’s reasonable, the range determined based on measurements made in-vitro (e.g. at manufacture), and to call out a calibration error alarm if the MSPSR is higher.
Goode teaches a system for minimizing or eliminating signal noise within glucose sensors (Abstract) and teaches that when a signal change exceeds a cone of possibility, to replace the value with the top value that the cone allows for ([0387]). While this is not directly applied to sensitivities, it shows that it would be within reason to utilize a certain upper bound number to reduce the likelihood of error. Accordingly, it would have been obvious to modify the above combination with Goode and utilize a lower bound number than the calculated one to increase the accuracy of the device.
Allowable Subject Matter
Claims 3, 9, and 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, as well as overcoming the 101 rejection.
As to claim 3, the prior art of record fails to teach and/or fairly suggest, when the first sensitivity is lower than the predetermined sensors sensitivity: processing the predetermined sensor sensitivity to obtain a processed sensitivity corresponding to one-third of the predetermined sensor sensitivity depending on the sensor; and determining the processed sensitivity as the second sensitivity.
As to claim 9, the prior art of record fails to teach and/or fairly suggest, when the glucose value is out of the specific range, obtaining an adjusted sensitivity from the sensor data, the offset value, the previous glucose value, and the reference glucose value; and determining the adjusted sensitivity as the fourth sensitivity.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant has argued that the “resulting calibrated sensitivity is then applied to sensor data to generate the measured glucose value”. However, the examiner notes that the claims recite no such limitation, where the sensor data is processed with the calibrated sensitivity. Had there been such a recitation, it would constitute a practical application to the abstract idea.
In addition, the applicant has argued that the claims cannot be performed solely as a mental process, because they require receipt of sensor data from a body-worn transmitter. The examiner first notes that the test for whether the claim, as a whole, is directed to an abstract idea isn’t whether it is wholly and solely directed to an abstract idea, but whether it recites/contains an abstract idea. Second, the examiner notes that the recitation of a well understood, routine, and conventional devices is not considered to be significantly more than the abstract idea.
While applicant’s assertion that the claimed method addresses a technological problem specifically in continuous glucose measurement is acknowledged, the asserted improvement is in the accuracy of a calculated value, achieved entirely by the recited abstract idea itself. Where the asserted improvement is in the abstract idea itself, it is not an improvement in the technology. See MPEP 2106.05(a).
The 101 rejection is thereby maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 8/14/26
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