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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/27/24, 10/08/24, 08/06/24, 06/03/24, 03/29/24, 01/31/24, 12/15/23, 09/15/23, 05/17/23, 05/04/23, 02/23/23 and 01/18/23 have been considered.
Amendment Entered
In response to the amendment filed on February 3, 2026, amended claims 1-3, 10 and 13-15 have been entered.
Response to Arguments
Applicant's remarks and amendments with respect to the rejections under U.S.C. 101 have been fully considered. While Examiner agrees that the claimed invention does not explicitly recite mathematical calculations, after considering the amendments, Examiner argues that nothing from the claims, accompanying specification, and/or drawings suggest that the method steps cannot be practically performed mentally, or using pen/paper. Applicant argues the invention is not an abstract idea. Examiner notes that although the claims include an analyte sensor, temperature sensor, processor, etc., no physical aspect of the monitoring device mentioned in the claims is novel. The claims merely recite data gathering/outputting steps. Applicant further argues the claims integrate into a practical application. Examiner notes that according to MPEP 2106.04(d)(2), the practical application consists of administering a specific medication in response to the collected data. Alternately, a practical application would consist of incorporating additional structure to the detection system. Accordingly, Examiner maintains that the identified judicial exception recites a mental process that is not integrated into a practical application. As such, the 35 USC 101 rejections are maintained. Examiner suggests incorporating more structure to the claim or a medication administration step. Please see corresponding rejection heading below for more detailed analysis.
Applicant’s remaining arguments filed with respect to the 102 rejections raised in the previous office action were fully considered, but are moot in view of the current combination of references that were necessitated by amendment. Please see prior art section below for more detail, updated citations (Harley-Trochimczyk reference), and updated obviousness rationale.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 21 follows.
Regarding claim 1, the claim recites an analyte monitoring device for generating temperature data indicative of an external temperature of the analyte sensor. Thus, the claim is directed to a machine, which is one of the statutory categories of invention
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“ calculate a sensitivity adjustment of the analyte sensor based on the temperature data corresponding to the first time; add the sensitivity adjustment corresponding to the first time to a total sensitivity adjustment; and determine whether the first time is below a predetermined time threshold, and if the first time is below the predetermined time threshold, generate temperature data indicative of an external temperature of the analyte sensor measured by the temperature sensor corresponding to a second time and calculate an interval between the second time and the first time”
These limitations describe a mathematical and/or mental process as the skilled artisan is capable of performing the judicial exception mentally, or using pen and paper. Furthermore, nothing from the claims or applicant’s accompanying specification shows that the skilled artisan would not be able to perform the judicial exception mentally, or using pen and paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“analyte monitoring device, analyte sensor, temperature sensor for measuring an external temperature of the analyte sensor, one or more processors configured to wake up periodically to generate temperature data indicative of the external temperature of the analyte sensor measured by the temperature sensor, wherein the one or more processors are configured to wake up periodically during storage of the analyte monitoring device prior to activation of the analyte monitoring device, communication module, one or more memories communicatively coupled to the one or more processors, the analyte sensor, the temperature sensor, and the communication module, wherein the one or more processors are configured to: generate temperature data indicative of an external temperature of the analyte sensor measured by the temperature sensor corresponding to a first time”
The following additional limitations from claim 13 is considered
“computer-readable medium”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant pre-solution and post-solution activity e.g., mere generic sensors, receiving data, outputting data.
Furthermore, the additional limitations recite well-known structural limitations (generically recited sensors, a processor, etc.) pertaining insignificant extra-solution activity and as such, do not amount to significantly more than the identified judicial exception.
Independent claim 13 is also not patent eligible for substantially similar reasons.
Dependent claims 2-12 and 14-20 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea.
Therefore, claims 1-20 are not patent eligible under 35 USC 101.
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 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.
Claims 1-11, 13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US Patent Application Document 2022/0095968) and in further view of Harley-Trochimczyk (US Patent Application Document 2019/0227022).
Wang was applied in the previous office action
Regarding claim 1, Wang teaches an analyte monitoring device [par. 533] comprising: one or more processors [fig. 2A, element 251; par. 445], an analyte sensor [fig. 2A, element 252; par. 445], a temperature sensor for measuring an external temperature of the analyte sensor [fig. 2A, element 254; par. 445, 507], a communication module [par. 447, 451 “telemetry module 232”], and one or more memories [fig. 2A, element 256; par. 445] communicatively coupled to the one or more processors, the analyte sensor, the temperature sensor, and the communication module [par. 445, 446], wherein the one or more processors are configured to: generate temperature data indicative of an external temperature of the analyte sensor measured by the temperature sensor corresponding to a first time [par. 507]; calculate a sensitivity adjustment of the analyte sensor based on the temperature data corresponding to the first time [par. 446, par. 506]; add the sensitivity adjustment corresponding to the first time to a total sensitivity adjustment [par. 488, equation (4)]; and determine whether the first time is below a predetermined time threshold, and if the first time is below the predetermined time threshold, generate temperature data indicative of an external temperature of the analyte sensor measured by the temperature sensor corresponding to a second time, the second time being after the first time, and calculate a time interval between the second time and the first time [par. 500, 502, 503; Examiner notes the time delay is the interval between the second time and the first time].
However, Wang does not teach one or more processors configured to wake up periodically to generate temperature data indicative of the external temperature of the analyte sensor measured by the temperature sensor, wherein the one or more processors are configured to wake up periodically during storage of the analyte monitoring device prior to activation of the analyte monitoring device
Harley-Trochimczyk teaches one or more processors configured to wake up periodically to generate temperature data indicative of the external temperature of the analyte sensor measured by the temperature sensor, wherein the one or more processors are configured to wake up periodically during storage of the analyte monitoring device prior to activation of the analyte monitoring device [par. 561-563]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Wang, to incorporate one or more processors configured to wake up periodically to generate temperature data indicative of the external temperature of the analyte sensor measured by the temperature sensor, wherein the one or more processors are configured to wake up periodically during storage of the analyte monitoring device prior to activation of the analyte monitoring device, as the peak temperature to which an analyte sensor is exposed prior to a sensor session may affect an initial sensitivity and/or baseline for the analyte sensor upon insertion into the skin of a host, as evidence by Harley-Trochimczyk [par. 561]
Regarding claims 3 and 15, Wang further teaches the one or more processors are configured to calculate the sensitivity adjustment of the analyte sensor based on the temperature data corresponding to the first time, by multiplying the external temperature corresponding to the first time by a time interval by a sensor sensitivity change rate [par. 505, 506].
Regarding claims 4 and 16, Wang further teaches the time interval is a time interval between the second time and the first time [par. 500, 502, 503; Examiner notes the time delay is the interval between the second time and the first time]
Regarding claims 5 and 17, Wang further teaches the sensor sensitivity change rate is M=MTmax /Tmax, wherein Tmax is a predetermined maximum temperature for which a sensitivity Tmax adjustment is calculated, and wherein MTmax is a sensor sensitivity change rate at the predetermined maximum temperature [par. 486, 487, 599].
Regarding claims 6 and 18, Wang teaches an analyte monitoring device, as disclosed above and the temperature value is a known selected temperature [par. 599], a factory calibrated temperature compensated sensitivity [par. 486] and the time interval between the second time and the first time is 1 hour [par. 501]
Although Wang does not explicitly teach Tmax is 30 °C and wherein MTmax is 0.003 % /hour, this would be obvious to a person having ordinary skill in the art when the invention was filed since Wang also suggests selecting a known temperature for calibration [par. 599], and a factory calibrated temperature compensated sensitivity [par. 486]. Therefore, selecting a maximum temperature of 30 °C and MTmax is 0.003 % /hour would involve only routine skill in the art.
Regarding claims 7 and 19, Wang teaches the one or more processors are further configured to generate temperature data indicative of the temperature of the analyte sensor measured by the temperature sensor corresponding to a time when the temperature is a known temperature, and to calculate a sensitivity adjustment of the analyte sensor based on the temperature data corresponding to the time as 0 [par. 599; Examiner notes the calibration temperature is a known temperature, the temperature is determined at a time being 0]
Although Wang does not explicitly teach the temperature is equal to or below 0 °C, this would be obvious to a person having ordinary skill in the art when the invention was filed since Wang also suggests selecting a known temperature for calibration [par. 599]. Therefore, selecting a temperature of 0 °C would involve only routine skill in the art.
Regarding claims 8 and 20, Wang further teaches the total sensitivity adjustment is a sum of a plurality of sensitivity adjustments corresponding a plurality of times, and wherein the plurality of times includes the first time and the second time [par. 518, 519; Equation (8)].
Regarding claim 9, Wang further teaches the one or more processors are further configured to determine whether the first time is below the predetermined time threshold, and if the first time exceeds the predetermined time threshold, to calculate a fixed sensitivity adjustment, and to add the fixed sensitivity adjustment to the stored total sensitivity adjustment as a final sensitivity adjustment [par. 488, equation (4), par. 501]
Regarding claim 10, Wang further teaches the fixed sensitivity adjustment is calculated by multiplying a predetermined maximum temperature for which a sensitivity adjustment is calculated, by a time interval, by a fixed sensor sensitivity change rate [par. 505, 506, 599; Examiner notes the temperature value may be a known temperature].
Regarding claim 11, Wang teaches a selected known temperature [par. 599]
Although Wang does not explicitly teach the fixed sensor sensitivity change rate is a sensor sensitivity change rate at a temperature of half of the predetermined maximum temperature, this would be obvious to a person having ordinary skill in the art when the invention was filed since Wang also suggests selecting a known temperature for calibration [par. 599]. Therefore, selecting a temperature half of the predetermined maximum temperature would involve only routine skill in the art.
Regarding claim 13, Wang teaches a computer program product stored on a computer-readable medium [par. 466] comprising instructions to: generate temperature data indicative of an external temperature of an analyte sensor [fig. 2A, element 252; par. 445] operably connected to the computer-readable medium measured by a temperature sensor [fig. 2A, element 254; par. 445] operably connected to the computer-readable medium corresponding to a first time [par. 445, 446, 507]; calculate a sensitivity adjustment of the analyte sensor based on the temperature data corresponding to the first time [par. 446, 506]; add the sensitivity adjustment corresponding to the first time to a total sensitivity adjustment [par. 488, equation (4)]; and determine whether the first time is below a predetermined time threshold, and if the first time is below the predetermined time threshold, generate temperature data indicative of an external temperature of the analyte sensor measured by the temperature sensor corresponding to a second time and calculate an interval between the second time and the first time [par. 500, 502, 503; Examiner notes the time delay is the interval between the second time and the first time].
Claims 2 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Wang and Harley-Trochimczyk in view of Parasnis (US Patent Application Document 2010/0309947)
Parasnis was applied in the previous office action
Regarding claims 2 and 14, Wang and Harley-Trochimczyk teach an analyte monitoring device, as disclosed above
Wang further teaches the one or more processors are further configured to: determine whether the first time is below a predetermined time threshold, and if the first time is equal to the predetermined time threshold, store the total sensitivity adjustment in the one or more memories [par. 507]
However, Wang and Harley-Trochimczyk do not teach the one or more memories comprising at least one One Time Programmable (OTP) memory.
Parasnis teaches the one or more memories comprising at least one One Time Programmable (OTP) memory [par. 57].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Wang and Harley-Trochimczyk, to incorporate the one or more memories comprising at least one One Time Programmable (OTP) memory, for implementing a functioning temperature-measuring system, as evidence by Parasnis [par. 57]
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Wang and Harley-Trochimczyk in view of Willis (US Patent Application Document 2007/0299617)
Willis was applied in Applicant’s IDS and the previous office action
Regarding claim 12, Wang and Harley-Trochimczyk teach an analyte monitoring device, as disclosed above
However, Wang and Harley-Trochimczyk do not teach the one or more processors further are configured to perform a sensitivity adjustment to the analyte sensor, by dividing a sensor sensitivity of the analyte sensor by 100, and by multiplying by a difference between 100 and the final sensitivity adjustment.
Willis teaches the one or more processors further are configured to perform a sensitivity adjustment to the analyte sensor, by normalizing the data [par. 260]
Although Willis does not explicitly teach the one or more processors further are configured to perform a sensitivity adjustment to the analyte sensor, by dividing a sensor sensitivity of the analyte sensor by 100, and by multiplying by a difference between 100 and the final sensitivity adjustment, this would be obvious to a person having ordinary skill in the art when the invention was filed since Willis also suggests he one or more processors further are configured to perform a sensitivity adjustment to the analyte sensor, by normalizing the data [par. 260]. Therefore, dividing a sensor sensitivity of the analyte sensor by 100, and by multiplying by a difference between 100 and the final sensitivity adjustment would involve only routine skill in the art.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8 AM - 5 PM.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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