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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/09/2026 has been entered.
Response to Amendment
In the amendment filed 05/20/2026, the following has occurred: Claims 30, 38, 41-45, 47, 50, 52-53, 55, and 58 have been amended. Now, claims 30-56 and 58-59 are pending.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 30-56 and 58-59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12,033,749. Although the claims at issue are not identical, they are not patentably distinct from each other because each of the limitations recited in claims 30-56 and 58-59 are also recited in claims 1-29 of the ‘749 patent, which also recites additional limitations.
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.
Claim(s) 30-36, 39, 42-46, 48, and 58-59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masciotti, US Patent Application Publication No. 2018/0103879 in view of Sloan, US Patent Application Publication No. 2010/0275108 and further in view of Hayter, US Patent No. 10,002,233.
As per claim 30, Masciotti teaches a continuous analyte monitoring system, comprising: an analyte sensor configured to sense analyte levels of a patient to generate one or more sensed signals (see paragraph 0020; analyte sensor measures analyte concentration); a transmitter configured to: transmit data representative of the one or more sensed signals to a processor (see paragraph 0040; the sensed signal is converted to an analyte concentration and transmitted to the display device (processor)); generate a plurality of event indications based on the one or more sensed signals, the plurality of generated event indications indicating one or more errors associated with the analyte sensor (see paragraphs 0040-0043; raw signals assessed to determine the performance of the sensor, resulting in MSP metric indicating a sensor event error from sensor performance deficiency); and take one or more actions to resolve the one or more errors (see paragraph 0096; display device displays an indication that the sensor needs to be replaced, which would resolve the sensor error).
Masciotti describes the transmitter sending events indicative of sensor error to a processor as described above. However, Masciotti does not explicitly teach the processor carrying out the function of generating the event indications and the processor being configured to determine one or more root causes of the one or more errors associated with the analyte sensor based on a pattern associated with the plurality of generated event indications; and take one or more actions to resolve the one or more root causes.
Sloan teaches a transmitter configured to transmit one or more sensed signals to a processor, the processor configured to generate a plurality of event indications based on the one or more sensed signals (see paragraph 0037; transmitter unit communicates sensor data to a transmitter processor, such as a CPU), generating the event indications (see paragraph 0049; processor performs error detection based upon data signals received from the transmitter unit). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to substitute the transmitter and processor structure for carrying out the functions in Masciotti with the motivation of enhancing the type and size of data accessible (see paragraph 0004 of Sloan).
Hayter teaches determine one or more root causes of the one or more errors associated with the analyte sensor based on a pattern associated with the plurality of generated event indications (see column 23, line 62 – column 24, line 2; determines root causes of detected error conditions, including whether electrode voltage signal is within a predetermined range, transmitter unit temperature out of range, and the like. Patterns associated with the event indications make include, for example, temperature measurements from measurements taking during a sampling cycle of the sensor signal – column 10, lines 43 - 47); and take one or more actions to resolve the one or more root causes (see column 29, lines 12-23; user may be notified with alarms or alerts to resolve the root causes (e.g. verify sensor position, sensor contact with transmitter, replace sensor with a new sensor). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to identify a root cause of a sensor error to take an action to resolve the root cause for errors identified the system of Masciotti and Sloan with the motivation of improving the accuracy of glucose measurements (see column 10, line 64 – column 11, line 8 of Hayter).
As per claim 31, Masciotti, Sloan, and Hayter teaches the system of claim 30 as described above. Masciotti further teaches each of the plurality of event indications indicates whether the sensed signals are above a maximum configured error threshold or below a minimum configured error threshold (see paragraph 0059; MSP deficiency determined if MSP is below a threshold).
As per claim 32, Masciotti, Sloan, and Hayter teaches the system of claim 1 as described above. Masciotti does not explicitly teach the pattern associated with the event indications indicates multiple consecutive event indications indicative of the sensed signals being above a maximum configured error threshold. Hayter further teaches the pattern associated with the event indications indicates multiple consecutive event indications indicative of the sensed signals being above a maximum configured error threshold (see column 24, lines 29-37; error flags determined and stored based in part on rate of variance exceeding a predetermined threshold). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to identify a root cause of a sensor error to take an action to resolve the root cause for errors identified the system of Masciotti and Sloan for the reasons given above with respect to claim 30.
As per claim 33, Masciotti, Sloan, and Hayter teaches the system of claim 32 as described above. Masciotti does not explicitly teach the multiple consecutive event indications indicate that the sensed signals are above the maximum configured error threshold, the one or more root causes comprise at least one of: a malfunction associated with the analyte sensor; high sensitivity of the analyte sensor; damage to a membrane of the patient coupled to the analyte sensor; or high moisture condition associated with the analyte sensor. Hayter further teaches the multiple consecutive event indications indicate that the sensed signals are above the maximum configured error threshold, the one or more root causes comprise at least one of: a malfunction associated with the analyte sensor; high sensitivity of the analyte sensor; damage to a membrane of the patient coupled to the analyte sensor; or high moisture condition associated with the analyte sensor (see column 23, line 62 – column 24, line 2; signal or temperature out of range being a malfunction). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to identify a root cause of a sensor error to take an action to resolve the root cause for errors identified the system of Masciotti and Sloan for the reasons given above with respect to claim 30.
As per claim 35, Masciotti, Sloan, and Hayter teaches the system of claim 30 as described above. Masciotti does not explicitly teach the pattern associated with the event indications indicates multiple consecutive event indications indicative of the sensed signals being below a minimum configured error threshold. Hayter further teaches the pattern associated with the event indications indicates multiple consecutive event indications indicative of the sensed signals being below a minimum configured error threshold (see column 32, lines 38-42; determines whether sensor sensitivity is below an acceptable threshold level). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to identify a root cause of a sensor error to take an action to resolve the root cause for errors identified the system of Masciotti and Sloan for the reasons given above with respect to claim 30.
As per claim 36, Masciotti, Sloan, and Hayter teaches the system of claim 35 as described above. Masciotti does not explicitly teach the multiple consecutive event indications indicate that the sensed signals are below the minimum configured error threshold, the one or more root causes comprise at least one of: compression on the analyte sensor; wound trauma at an interface between the analyte sensor and the patient; low sensor sensitivity associated with the analyte sensor; or deteriorated quality of a signal sensed by the analyte sensor. Hayter further teaches the multiple consecutive event indications indicate that the sensed signals are below the minimum configured error threshold, the one or more root causes comprise at least one of: compression on the analyte sensor; wound trauma at an interface between the analyte sensor and the patient; low sensor sensitivity associated with the analyte sensor; or deteriorated quality of a signal sensed by the analyte sensor (see column 32, lines 38-42; determines whether sensor sensitivity is below an acceptable threshold level). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to identify a root cause of a sensor error to take an action to resolve the root cause for errors identified the system of Masciotti and Sloan for the reasons given above with respect to claim 30.
As per claim 39, Masciotti, Sloan, and Hayter teaches the system of claim 30 as described above. Masciotti further teaches one or more of the plurality of event indications indicate a rate of change associated with the one or more sensed signals being higher than a threshold (see paragraphs 0062; determines sensor rate of change to determine sensor delamination).
As per claim 42, Masciotti, Sloan, and Hayter teaches the system of claim 30 as described above. Masciotti does not explicitly teach determining the one or more root causes. Hayter further teaches determining the one or more root causes associated with the plurality of event indications automatically after the plurality of event indications are generated (see column 23, line 62 – column 24, line 2; determines root causes of detected error conditions, including whether electrode voltage signal is within a predetermined range, transmitter unit temperature out of range, and the like). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to identify a root cause of a sensor error to take an action to resolve the root cause for errors identified the system of Masciotti and Sloan for the reasons given above with respect to claim 30.
As per claim 43, Masciotti, Sloan, and Hayter teaches the system of claim 30 as described above. Masciotti does not explicitly teach the processor is configured to take the one or more actions to resolve the one or more root causes automatically after the determination of the one or more root causes. Hayter further teaches t take the one or more actions to resolve the one or more root causes automatically after the determination of the one or more root causes (see column 29, lines 12-23; user may be notified with alarms or alerts to resolve the root causes (e.g. verify sensor position, sensor contact with transmitter, replace sensor with a new sensor). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to identify a root cause of a sensor error to take an action to resolve the root cause for errors identified the system of Masciotti and Sloan for the reasons given above with respect to claim 30.
As per claim 44, Masciotti, Sloan, and Hayter teaches the system of claim 30 as described above. Masciotti does not explicitly teach the one or more actions. Hayter further teaches the one or more actions comprise at least one of: indicating to a user to relocate or reorient the analyte sensor on a body of the patient; indicating to the user to change a position of the body of the patient; indicating to the user to change a diet of the patient; indicating to the user to apply a cream to an interface between the analyte sensor and the patient; indicating to the user to apply an agent to an interface between the analyte sensor and the patient; indicating to the user to have the patient digest one or more supplements to increase adhesion of the analyte sensor at the interface between the analyte sensor and the patient; indicating to the user that a specific activity has caused one or more event indications; indicating to the user to re-calibrate the analyte sensor; indicating to the user to order a new analyte sensor for the patient; or ordering a new analyte sensor for the patient (see column 29, lines 12-23; user may be notified with alarms or alerts to resolve the root causes (e.g. verify sensor position, sensor contact with transmitter, replace sensor with a new sensor). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to identify a root cause of a sensor error to take an action to resolve the root cause for errors identified the system of Masciotti and Sloan for the reasons given above with respect to claim 30.
As per claim 45, Masciotti, Sloan, and Hayter teaches the system of claim 30 as described above. Masciotti does not explicitly teach the processor is further configured to receive secondary sensor data associated with the patient; and the processor is configured to determine the one or more root causes is further based on the secondary sensor data. Hayter further teaches the processor is further configured to receive secondary sensor data associated with the patient, wherein determining the one or more root causes is further based on the secondary sensor data (see column 23, line 62 – column 24, line 2; determines root causes of detected error conditions, including whether electrode voltage signal is within a predetermined range, transmitter unit temperature out of range, and the like). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to identify a root cause of a sensor error to take an action to resolve the root cause for errors identified the system of Masciotti and Sloan for the reasons given above with respect to claim 30.
As per claim 46, Masciotti, Sloan, and Hayter teaches the system of claim 45 as described above. Masciotti does not explicitly teach the secondary sensor data comprises at least one: accelerometer data associated with movement of the analyte sensor; temperature data indicating a temperature associated with the analyte sensor; gyrometer data indicating an orientation of the analyte sensor; moisture detection data indicating a moisture level at an interface between the analyte sensor and the patient; or heart sensor data indicating a heart rate of the patient. Hayter further teaches the secondary sensor data comprises at least one: accelerometer data associated with movement of the analyte sensor; temperature data indicating a temperature associated with the analyte sensor; gyrometer data indicating an orientation of the analyte sensor; moisture detection data indicating a moisture level at an interface between the analyte sensor and the patient; or heart sensor data indicating a heart rate of the patient (see column 29, lines 39-42; at least temperature detection used to determine error). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to identify a root cause of a sensor error to take an action to resolve the root cause for errors identified the system of Masciotti and Sloan for the reasons given above with respect to claim 30.
As per claim 48, Masciotti, Sloan, and Hayter teaches the system of claim 30 as described above. Masciotti does not explicitly teach the processor is further configured to generate an event indication. Hayter further teaches at least one event indication included in the plurality of event indication indicative of one or more errors associated with the transmitter, an application executed by the processor, one or more other connected devices, or one or more applications executing on the one or more other connected devices (see column 29, lines 28-46; error may be based on contact between sensor and transmitter). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to identify a root cause of a sensor error to take an action to resolve the root cause for errors identified the system of Masciotti and Sloan for the reasons given above with respect to claim 30.
As per claim 58, Masciotti teaches a method, performed by a continuous analyte monitoring system, for automatically self-diagnosing and resolving performance problems associated with the continuous analyte monitoring system, comprising: sensing, by an analyte sensor of the continuous analyte monitoring system,, analyte levels of a patient to generate one or more sensed signals (see paragraph 0020; analyte sensor measures analyte concentration); transmitting, by a transmitter of the continuous analyte monitoring system, data representative of the one or more sensed signals to a processor of the continuous analyte monitoring system (see paragraph 0040; the sensed signal is converted to an analyte concentration and transmitted to the display device (processor)); generating a plurality of event indications based on the one or more sensed signals, the plurality of event indications indicating one or more errors associated with the analyte sensor (see paragraphs 0040-0043; raw signals assessed to determine the performance of the sensor, resulting in MSP metric indicating a sensor event error from sensor performance deficiency); and take one or more actions to resolve the one or more errors (see paragraph 0096; display device displays an indication that the sensor needs to be replaced, which would resolve the sensor error).
Masciotti describes the transmitter sending events indicative of sensor error to a processor as described above. However, Masciotti does not explicitly teach the processor carrying out the function of generating the event indications and the processor being configured to determine one or more root causes of the one or more errors associated with analyte sensor based on a pattern associated with the plurality of generated event indications; and take one or more actions to resolve the one or more root causes.
Sloan teaches a transmitter configured to transmit one or more sensed signals to a processor, the processor configured to generate a plurality of event indications based on the one or more sensed signals (see paragraph 0037; transmitter unit communicates sensor data to a transmitter processor, such as a CPU), generating the event indications (see paragraph 0049; processor performs error detection based upon data signals received from the transmitter unit). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to substitute the transmitter and processor structure for carrying out the functions in Masciotti with the motivation of enhancing the type and size of data accessible (see paragraph 0004 of Sloan).
Hayter teaches determine one or more root causes of the one or more errors associated with the analyte sensor based on a pattern associated with the plurality of generated event indications (see column 23, line 62 – column 24, line 2; determines root causes of detected error conditions, including whether electrode voltage signal is within a predetermined range, transmitter unit temperature out of range, and the like. Patterns associated with the event indications make include, for example, temperature measurements from measurements taking during a sampling cycle of the sensor signal – column 10, lines 43 - 47); and take one or more actions to resolve the one or more root causes (see column 29, lines 12-23; user may be notified with alarms or alerts to resolve the root causes (e.g. verify sensor position, sensor contact with transmitter, replace sensor with a new sensor). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to identify a root cause of a sensor error to take an action to resolve the root cause for errors identified the system of Masciotti and Sloan with the motivation of improving the accuracy of glucose measurements (see column 10, line 64 – column 11, line 8 of Hayter).
As per claim 59, Masciotti, Sloan, and Hayter teaches the method of claim 58 as described above. Masciotti further teaches each of the plurality of event indications indicates whether the sensed signals are above a maximum configured error threshold or below a minimum configured error threshold (see paragraph 0059; MSP deficiency determined if MSP is below a threshold).
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masciotti, US Patent Application Publication No. 2018/0103879 in view of Sloan, US Patent Application Publication No. 2010/0275108 and Hayter, US Patent No. 10,002,233 and further in view of Mizuoka, US Patent Application Publication No. 2013/0337571.
As per claim 34, Masciotti, Sloan, and Hayter teaches the system of claim 33 as described above. Masciotti does not explicitly teach a moisture sensor configured to determine a moisture level at an interface between the analyte sensor and the patient to generate moisture detection data, and wherein the processor is further configured to receive the moisture detection data. Mizuoka further teaches a moisture sensor configured to determine a moisture level at an interface between the analyte sensor and the patient to generate moisture detection data, and wherein the processor is further configured to receive the moisture detection data (see paragraph 0033; the moisture data is detected by measurement sensor with the knowledge that the moisture reactions with the reagent disposed in the measurement section of the sensor). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to add a moisture sensor to the system of Masciotti and Sloan with the motivation of addressing sensor errors in commonly applied sensors in an analyte sensor environment (see paragraph 0005 of Mizuoka).
Claim(s) 37-38, 40-41, 47, 53, and 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masciotti, US Patent Application Publication No. 2018/0103879 in view of Sloan, US Patent Application Publication No. 2010/0275108 and Hayter, US Patent No. 10,002,233 and further in view of Brister, US Patent Application Publication No. 2013/0267809.
As per claim 37, Masciotti, Sloan, and Hayter teaches the system of claim 36 as described above. Masciotti further teaches the one or more sensed signals indicate one or more analyte measurements (see paragraph 0020; analyte sensor measures analyte concentration); the processor is further configured to: receive one or more reference analyte measurements from the patient (see paragraph 0029; transmitter may be on the patient). However, Masciotti does not explicitly teach transmit the one or more reference analyte measurements to the transmitter; and the transmitter is further configured to generate the plurality of event indications based on a comparison of the one or more analyte measurements and the one or more reference analyte measurements. Brister teaches receive one or more reference analyte measurements from a patient (see paragraph 0512; ; input of reference analyte values); and transmit the one or more reference analyte measurements to a transmitter (see paragraph 0525; reference analyte data is passed or downloaded); and the transmitter is further configured to generate a plurality of event indications based on a comparison of the one or more analyte measurements and the one or more reference analyte measurements (see paragraph 0531; reference data can be compared to sensor data). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to utilize the reference analyte data in the determinations of Masciotti with the motivation of accurately addressing calibration issues with an analyte monitoring device, which would be useful with the monitoring device of Masciotti (see paragraph 0531 of Brister).
As per claim 38, Masciotti, Hayter, Sloan, and Brister teaches the system of claim 37 as described above. As noted above, Masciotti does not explicitly teach the reference analyte measurement for comparison. Brister further teaches determining one or more root causes comprises determining that a difference between the one or more analyte measurements and the one or more reference analyte measurements is greater than a threshold (see paragraph 0531; sensor and reference analyte measurements compared to threshold); and the one or more root causes comprise deficient sensor calibration (see paragraph 0531; need for calibration and re-initialization indicates root cause deficiency of calibration). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to utilize the reference analyte data in the determinations of Masciotti for the reasons given above with respect to claim 8.
As per claim 40, Masciotti, Sloan, and Hayter teaches the system of claim 30 as described above. Masciotti further teaches the processor is further configured to apply one or more filters to the one or more sensed signals to produce one or more filtered signal (see paragraph 0047; filters the sensor data in calculating the MSP). Masciotti does not explicitly teach each of the plurality of event indications indicates whether a differential between the one more sensed signals and the one or more filtered signals is above a configured threshold. Brister teaches a transmitter is configured to apply one or more filters to one or more sensed signals to produce one or more filtered signals (see paragraph 0604; sensor data is filtered); and each of a plurality of event indications indicates whether a differential between the one more sensed signals and the one or more filtered signals is above a configured threshold (see paragraph 0604; aberrancy of sensor data can be determined comparing raw and filtered data above a set threshold). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to utilize filtered data with thresholds in the error determinations of Masciotti, Sloan, and Hayter with the motivation of improving levels of accuracy in ranges of analyte data (see paragraph 0374 of Brister).
As per claim 47, Masciotti, Sloan, and Hayter teaches the system of claim 30 as described above. Masciotti does not explicitly teach the processor is further configured to receive an indication from a server indicating a pattern associated with event indications for a population of patients, wherein determining the one or more root causes is further based on the pattern associated with the event indications for the population. Brister teaches a processor is configured to receive an indication from a server indicating a pattern associated with event indications for a population of patients, wherein determining one or more root causes is based on the pattern associated with the event indications for the population (see paragraph 0550; baseline data used to determine errors can be based on a sensor data from a set of patients). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to utilize population data in the error determinations of Masciotti with the motivation of improving levels of accuracy in ranges of analyte data (see paragraph 0374 of Brister).
As per claim 53, Masciotti, Sloan, and Hayter teaches the system of claim 48 as described above. Masciotti does not explicitly teach the one or more actions comprise at least one of: indicating to a user to uninstall and re-install the application executed by the processor; or indicating to the user to reopen the application executed by the processor. Brister further teaches one or more actions comprise at least one of: indicating to a user to uninstall and re-install the application executed by the processor; or indicating to the user to reopen the application executed by the processor (see paragraph 0493; error flag can be transmitted to user to perform reinsertion or other corrective action). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to utilize the user instruction of Brister for an error of Masciotti with the motivation of improving levels of accuracy in ranges of analyte data (see paragraph 0374 of Brister).
As per claim 56, Masciotti, Sloan, and Hayter teaches the system of claim 48 as described above. Masciotti does not explicitly teach the at least one event indication indicates receipt, by the processor, of incorrect data transmitted by the one or more applications executing on the one or more other connected devices. Brister teaches an event indication indicates receipt, by the processor, of incorrect data transmitted by one or more applications executing on one or more other connected devices (see paragraph 0493; error flag from sensor represents incorrect data transmitted by one connected device). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to utilize the event indication of Brister for an error of Masciotti with the motivation of improving levels of accuracy in ranges of analyte data (see paragraph 0374 of Brister).
Claim(s) 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masciotti, US Patent Application Publication No. 2018/0103879 in view of Sloan, US Patent Application Publication No. 2010/0275108 and Hayter, US Patent No. 10,002,233 and further in view of Kaib, US Patent Application Publication No. 2017/0007129.
As per claim 49, Masciotti, Sloan, and Hayter teaches the system of claim 48 as described above. Masciotti does not explicitly teach the at least one event indication indicates an issue with a battery of the transmitter. Kaib teaches an event indication indicates an issue with a battery of a transmitter (see paragraph 0142; provides coding of different types of errors including battery issues). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to including battery issues in the error detection of Masciotti with the motivation of assisting a user in correcting known errors with a medical device (see paragraph 0147 of Kaib).
Claim(s) 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masciotti, US Patent Application Publication No. 2018/0103879 in view of Sloan, US Patent Application Publication No. 2010/0275108, Hayter, US Patent No. 10,002,233 and Kaib, US Patent Application Publication No. 2017/0007129 and further in view of Mensinger, US Patent Application Publication No. 2014/0012511.
As per claim 50, Masciotti, Hayter, Sloan, and Kaib teaches the system of claim 49 as described above. Masciotti does not explicitly teach the processor is further configured to determine whether a warranty period associated with the transmitter has expired, wherein the one or more actions comprise: indicating to a user to order a new transmitter for the patient upon determining the warranty period has expired; or ordering a new transmitter for the patient upon determining the warranty period has not expired. Mensinger teaches a processor is configured to determine whether a warranty period associated with a transmitter has expired, wherein one or more actions comprise: indicating to a user to order a new transmitter for a patient upon determining the warranty period has expired; or ordering a new transmitter for the patient upon determining the warranty period has not expired (see paragraphs 0024; glucose monitors include a transmitter, paragraph 0222; warranty expiration used to initiate or recommend order). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to incorporate warranties for ordering parts in Masciotti and Kaib with the motivation of providing users with desired help to fit their needs (see paragraph 0222 of Mensinger).
Claim(s) 51 and 54-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masciotti, US Patent Application Publication No. 2018/0103879 in view of Sloan, US Patent Application Publication No. 2010/0275108 and Hayter, US Patent No. 10,002,233 and further in view of Mensinger, US Patent Application Publication No. 2014/0012511.
As per claim 51, Masciotti, Sloan, and Hayter teaches the system of claim 48 as described above. Masciotti does not explicitly teach the at least one event indication indicates an initial pairing between the transmitter and the processor has failed. Mensinger teaches an event indication indicates an initial pairing between a transmitter and a processor has failed (see paragraph 0208; paring between a sensor and smart phone failure indicated). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to identify paring as a failure in the system of Masciotti with the motivation of assisting a user with common electronics malfunctions (see paragraph 0208 of Mensinger).
As per claim 54, Masciotti, Sloan, and Hayter teaches the system of claim 48 as described above. Masciotti does not explicitly teach the at least one event indication indicates an initial pairing between the one or more other connected devices and the processor has failed. Mensinger teaches an event indication indicates an initial pairing between one or more other connected devices and a processor has failed (see paragraph 0208; paring between a sensor and smart phone failure indicated). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to identify paring as a failure in the system of Masciotti with the motivation of assisting a user with common electronics malfunctions (see paragraph 0208 of Mensinger).
As per claim 55, Masciotti, Hayter, Sloan and Mensinger teaches the system of claim 54 as described above. Masciotti does not explicitly teach the initial pairing fails due, at least in part, to the one or more other connected devices refusing authorization of the processor. Mensinger further teaches the initial pairing fails due, at least in part, to the one or more other connected devices refusing authorization of the processor (see paragraph 0208; paring between a sensor and smart phone failure indicated; paragraph 0107; describes pairing involving the communication of IDs between devices, therefore failure would represent a refusal for this process to take place). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to identify paring as a failure in the system of Masciotti with the motivation of assisting a user with common electronics malfunctions (see paragraph 0208 of Mensinger).
Claim(s) 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masciotti, US Patent Application Publication No. 2018/0103879 in view of Sloan, US Patent Application Publication No. 2010/0275108 and Hayter, US Patent No. 10,002,233 and further in view of Harper, US Patent Application Publication No. 2010/0265073.
As per claim 52, Masciotti, Sloan, and Hayter teaches the system of claim 48 as described above. Masciotti does not explicitly teach the at least one event indication indicates that a connection between the transmitter and the processor has been lost for a period greater than a threshold; and wherein the processor is further configured to indicate to a user to take one or more remedial actions comprising, at least one of: indicating to a user to disable and re-enable a Bluetooth function on a device where the processor is running; indicating to the user to power cycle the device where the processor is running; or indicating to the user to uninstall and re-install the application executed by the processor.. Harper teaches an event indication indicates that a connection between a transmitter and a processor has been lost for a period greater than a threshold (see paragraph 0024; connection has been down for a predetermined time period); and wherein the processor is further configured to indicate to a user to take one or more remedial actions comprising, at least one of: indicating to a user to disable and re-enable a Bluetooth function on a device where the processor is running; indicating to the user to power cycle the device where the processor is running; or indicating to the user to uninstall and re-install the application executed by the processor (see paragraph 0022; provides user ability to re-enable alarm, which is a Bluetooth function – paragraph 0032). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to add the additional features of determining connection loss and re-enablement to the system of Masciotti with the motivation of providing needed features of selectively disabling and enabling features in glucose monitoring systems (see paragraph 0007 of Harper).
Distinguishing Subject Matter
Claim 41 distinguishes over the prior art The following is a statement of reasons for the indication of distinguishing subject matter: The primary reason that claim 41, when combined with the limitations of the claims on which it depends, is the inclusion of the additional steps of determining the root cause of the error by determining multiple consecutive event indications indicate differential between sensed signals and filtered signals above a threshold and the root cause is compression of the analyte sensor or damage to a membrane of the patient coupled to the analyte sensor. The closest prior art (Masciotti, Sloan, and Hayter) teaches the determination of a root cause of a detected error associated with an analyte sensor. While Hayter teaches several different types of root causes, Hayter does not teach the root cause being a compression of the analyte sensor or damage to a membrane of the patient coupled to the analyte sensor. Additionally, it would not have been obvious to one of ordinary skill in the art to further modify the combination of teachings as Hayter and the other references do not explain how the cause of errors could be modified to detect these types of errors.
Response to Arguments
Applicant’s argument regarding the filing of a terminal disclaimer upon an indication of allowability is acknowledged.
Applicant’s arguments regarding the rejections under 35 U.S.C. 101 are moot in view of the withdrawal of these rejections.
Applicant’s arguments regarding the rejections under 35 U.S.C. 103 are moot in view of the new grounds of rejection detail ablve.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Reihman, US Patent Application Publication No. 2017/0124350, discloses determining reasons that cause detected errors of an analyte sensor system.
Breton, US Patent Application Publication No. 2008/0172205, discloses detecting low sensor sensitivity that causes sensor related errors.
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C. Luke Gilligan
Primary Examiner
Art Unit 3683
/CHRISTOPHER L GILLIGAN/ Primary Examiner, Art Unit 3683
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