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 .
ART REJECTION:
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) 1,4-7,10-12, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seo et al(USPGPUB 2022/0369929 A1).
-- In considering claim 1, the claimed subject matter that is met by Seo et al(Seo) includes:
1) a) measuring a first temperature dependent signal is met by the implant device(110) calculating bio information, wherein the device autonomously calculates first bio information(see: Seo, sec[0048]);
2) b) measuring a second temperature dependent signal which is different from the first temperature dependent signal and which is related to a current flow in the in vivo analyte sensor is met by the cloud server calculating second bio information, which is different than the first bio information(see: sec[0048])
3) c) correlating the first temperature dependent signal and the second temperature dependent signal for determining the reliability of the in vivo analyte sensor is met by the first bio information and the second bio information being compared, so as to determine a margin of error of the measured and calculated data(see: sec[0048]).
-- With regards to claim 4,
1) the first temperature dependent signal is a temperature value which is measured by a temperature sensor and/or which is determined from a signal measured by the temperature sensor is met by the implanted devices including a temperature sensor configured to measure a temperature within the body and calculate bio information based on an output value of the temperature sensor(see: Seo, sec[0021]).
-- With regards to claim 5,
1) the first temperature dependent signal is measured by a temperature sensor comprising an on body part of the analyte sensor is met by the implant device including a temperature sensor(see: Seo, sec[0021]).
-- With regards to claim 6,
1) the first temperature dependent signal and the second temperature dependent signal are independent from at least one measurement signal of an analyte concentration determined by the analyte sensor is met by the smart devices(130) at step 1016), determining a concentration level of a target material based on bio information(see: Seo, sec[0113]), that concentration level of a target material being different than temperature values
-- With regards to claim 7,
1) the determining of the reliability of the analyte sensor comprises comparing the correlation of the first temperature dependent signal and the second temperature dependent signal according to step c0 to at least one predetermined correlation of the first temperature dependent signal and the second temperature dependent signal, determining a deviation of the correlation from the predetermined correlation, and comparing the deviation to at least one threshold value, and wherein the analyte sensor is considered reliable when the deviation is below or equal to the threshold value and otherwise the analyte sensor is considered to be failed is met by the first and second calculated bio information are compared to determine if the comparison is within a margin or error(see: Seo, sec[0048]), such that when the comparison data is not within the margin of error, the bio information is measured and calculated again, which inherently implies that the sensor would not have been reliable, if the error is calculated again, and wherein the margin of error would have constituted the claimed threshold value. The requirement to measure and calculate the bio information again, would have been indicative of failed sensor.
-- With regards to claim 10,
1) the predetermined correlation is determined in vivo and/or during manufacturing of the analyte sensor is met by the device(110) being a sensor that is implanted in the body of a user, to determine bio information(see: Seo, sec[0011]).
-- With regards to claim 11,
1) at least one failsafe step, wherein the failsafe step is triggered when the analyte sensor is considered to be failed is met by the comparison data not included in the margin of error, and the external device restarting the process in order to calculate the first and second bio information again(see: Seo, sec[0070]).
-- In considering claim 12, the claimed subject matter that is met by Seo et al(Seo) includes:
1) the in vivo analyte sensor for determining concentration of analyte in bodily fluid is met by the smart device(130) determining a concentration level of a target material based on bio information from the implant device(110)(see: Seo, sec[0113]);
2) the in vivo analyte sensor is configured for measuring a first temperature dependent signal and for measuring a second temperature dependent signal which is different from the first temperature dependent signal, and which is related to a current flow in the analyte sensor is met by the implanted devices including a temperature sensor configured to measure a temperature within the body and calculate bio information based on an output value of the temperature sensor(see: Seo, sec[0021]).
3) wherein the in vivo analyte sensor comprises at least one sensor electronics configured for correlating the first temperature dependent signal and the second temperature dependent signal for determining a reliability of the analyte sensor is met by the first and second bio information being compared to determine a margin of error between the two(see: Seo, sec[0048]).
-- Claim 15 recites subject matter that is met as discussed in the rejection of claims 1 and 12 above.
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.
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.
Claim(s) 8-9, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seo et al(Seo) in view of Wu et al(2011/0231105 A1).
-- With regards to claim 8, Seo does not teach:
1) the threshold value for the deviation of the correlation of the first temperature dependent signal and the second temperature dependent signal to the at least one predetermined correlation is at least one percentage error.
However, as discussed in claim 1 above, Seo does desire to correlate temperature values so as to determine error between the readings of the sensors. Use of biometric sensor systems which determine error as percentage errors is well known. In related art, Wu et al(Wu) teaches a compensation of discrepancy for a biosensor, wherein errors in output signals of tested samples are monitored for accuracy and reliability for particular sensors used(see: Wu, Abstract).
In particular, Wu teaches biosensor systems, which utilize measuring devices, which measure and analytes and compare the output signals with the presence and/or concentration of one or more analytes in the sampled output(see: sec[0008]), and wherein a percent bias limit is analyzed so as to determine the percentage of analyses falling within a selected percent bias limit, so as to determine the performance of the biosensor system(see: Wu, sec[0020]).
Since the use of percent bias limits is well known, as taught by Wu, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the measurement devices of Wu, into the system of Seo, since this would have helped ensure the accuracy of readings of the sensors in Wu, so as to determine the amount of error in the readings of the devices, in relation to the concentration of analytes in the samples that are measured.
-- With regards to claim 9, upon incorporation of the Measurement devices of Wu, into the system of Seo, as discussed in claim 8 above, the claimed threshold value is dependent on a determined analyte concentration would have been met, since the measurement devices determine the percentage based on determined analyte concentrations(see: Wu, sec[0020]).
-- With regards to claim 13, upon incorporation of Wu into Seo for the reasons as discussed in claim 9 above, the in vivo analyte sensor is a two-electrode-sensor having two measurement electrodes or a three-electrode-sensor having three measurement electrodes or a multi-electrode-sensor having more than three measurement electrodes would have been met by the one or more electrodes in the test sensor for sampling the concentration of substances in the analytes determined by the measuring device(see: Wu, sec[0017]), which would have been readily incorporated into the system of Seo, since this would have provided a reliable means of testing the analyte samples in an efficient an accurate manner.
-- With regards to claim 14,
1) the two of the measurement electrodes are arranged on opposing sides of the in vivo analyte sensor would have been met by the working and counter electrodes(see: Wu, sec[0136]).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seo et al(Seo) as applied to claim 1 above, and further in view of Uenluebayir et al(USPGPUB 2009/066347 A1).
-- With regards to claim 2, Seo does not teach:
1) the in vivo analyte sensor comprising at least two measurement electrodes, wherein measuring the second temperature dependent signal in step B) comprises applying a fast transient voltage signal to the measurement electrodes and measuring the second temperature dependent signal in response to the applied fast transient voltage signal.
Use of analyte sensors comprising electrodes which have fast transient voltage signals applied is well known. In related art, Uenluebayir et al(Uenluebayir) teaches a biosensor, which utilizes electrodes that receive a transient voltage so as to determine measurements of the analyte being monitored(see: Uenluebayir, sec[0041]). Since the use of sensors which comprise electrodes that utilize transient voltage to determine measurements for the sensor is well known, as taught by Uenluebayir, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the sensor electrodes(152,132) and voltage source of Uenluebayir, into the system of Seo, since this would have provided a means of determining accurate and reliable measurements from the sensors in the system, which monitoring the analytes.
-- Claim 3 recites subject matter that was met by Seo in claim 1 above, except for:
1) the in vivo analyte sensor comprises a membrane, wherein the second temperature dependent signal is related to an electrical resistance of the membrane.
Although not specifically taught by Seo, use of biosensors which include membranes wherein output is related to electrical resistance of the membrane is well known. In related art, Uenluebayir discloses a biosensor with method for measuring concentration of an analyte that is being monitored, wherein the sensor has electrodes, and a selective membrane arranged between, such that electrical resistance changes are measured upon contact with the analyte(see: Uenluebayir, sec[0013]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the biosensor, which selective membrane, as discussed in Uenluebayir, into the system of Seo, since this would have provided an more accurate determination of analyte concentration in the system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
In related art, Miller et al(USPat 9,681,807 B2) teaches a system for determining analyte measurements, wherein measuring a first temperature dependent signal is met by the analyte sensor system(8), including implantable sensor(312) that is attached to sensor electronics module including sensor measurement circuit(310)(see: Miller, column 22, lines 18-25); and wherein the sensor electronics module executes prospective algorithms used to generate transformed sensor data, including evaluating estimated analyte values with time corresponding measured analyte values, and evaluating a stability of the sensor and/or sensor data therefrom(see: Miller, column 19, lines 21-36).
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/DARYL C POPE/Primary Examiner, Art Unit 2686