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 .
Response to Amendment
In the amendment filed 12/17/2025, the following has occurred: Claim 57 has been canceled. Now, claims 30-56 and 58-59 are pending.
The previous rejection under 35 U.S.C. 112(d) is withdrawn based on the canceling of claim 57.
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 § 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 58-59 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 2A Prong One
Claim 58 recites generating a plurality of event indications based on one or more sensed signals; determining one or more root causes associated with the plurality of event indications based on a pattern associated with the plurality of event indications; and taking one or more actions to resolve the one or more root causes.
These limitations, as drafted, given the broadest reasonable interpretation, encompass managing personal behavior, which is a subgrouping of Certain Methods of Organizing Human Activity. For example, the claim encompasses a person generating event indicators, determining a root cause for the event indicators and then taking manual action to resolve the root cause. For example, the user could look at some result from a sensor, determine that a patient has some condition, and taking some action with the patient. The claim does not limit the scope of event indications, root causes, or actions to resolve the root causes. Therefore, such manual steps encompass Certain Methods of Organizing Human Activity.
Claim 59 incorporates the abstract idea of claim 58 and further identifies the event indications in relation to thresholds. As explained above, these manual steps encompass Certain Methods of Organizing Human Activity.
Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas along with insignificant, extra-solution data gathering and transmitting activity.
Claims 58-59, directly or indirectly, recite the following additional elements at a high level of generality and merely utilized as tools to implement the abstract idea:
Claims 58-59:
Performing steps “by the processor.”
The written description discloses that the recited computer components encompass generic components including “an Internet server, a router, a desktop or laptop computer, a smartphone, a tablet, a processor, a module, or the like, and may be implemented in various forms, including, for example, an integrated circuit or collection thereof, a printed circuit board or collection thereof” (see paragraph 00111). As set forth in the MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application.
Claims 58-59, directly or indirectly, recite the following additional elements at a high level of generality, involving no more that extra-solution data gathering and transmitting activity:
Claim 58-59:
sensing, by an analyte sensor, analyte levels of a patient to generate one or more sensed signals.
transmitting, by a transmitter, the one or more sensed signals to a processor.
These additional elements are recited at a high degree of generality and are merely involved in insignificant extra solution data gathering and transmitting of data over a generic computer network. As set forth in MPEP 2106.05(g) insignificant, extra-solution activity, such as insignificant acquisition and data transmission, is an example of when an abstract idea has not been integrated into a practical application.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above with respect to integration into a practical application, the additional elements are recited at a high level of generality, and the written description indicates that these elements are generic computer components. Using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.”).
Insignificant, extra solution, data gathering and transmitting activity (e.g. sensing and transmitting data) has been found to not amount to significantly more than an abstract idea (see MPEP 2106.05(g) and Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016)).
Additionally, the aforementioned additional elements, considered in combination, do not provide an improvement to a technical field or provide a technical improvement to a technical problem. Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Claims 30-56
Claims 30-56 include the recitations of determining by a processor “one or more root causes” associated with event indications “indicating one or more errors associated with the analyte sensor” and the processor taking “one or more actions to resolve the one or more root causes.” As explained at paragraphs 00140-00142 of the specification, this process provides a technical improvement to the operation of analyte sensor devices by providing resolutions to performance problems and to prevent similar problems from arising in the future. To the extent that an abstract idea is recited in the claims, this technical improvement integrates the abstract idea into a practical application. Therefore, claims 30-56 are not directed to an abstract idea
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 Mizuoka, US Patent Application Publication No. 2013/0337571.
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 or more root causes associated with the plurality of generated event indications 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).
Mizuoka teaches determine one or more root causes associated with a plurality of generated event indications based on a pattern associated with the plurality of generated event indications (see paragraph 0043; a series of determination values are calculated to determine the abnormal determination values; paragraph 0132 describes that the type of error is determined for the abnormal waveform value); and take one or more actions to resolve the one or more root causes (see paragraph 0177; the user can be notified of the type of error and given advice about countermeasures so that the appropriate action can be taken). 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 further assisting the user in correcting sensor errors (see paragraph 0011 of Mizuoka).
As per claim 31, Masciotti, Sloan, and Mizuoka 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 Mizuoka 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. Mizuoka 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 paragraph 0117-0118; abnormal error is calculated according to a series of conditions, which may be outside of the upper 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 with the motivation of further assisting the user in correcting sensor errors (see paragraph 0011 of Mizuoka).
As per claim 33, Masciotti, Sloan, and Mizuoka 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. Mizuoka 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 paragraphs 0033-0034; provides different examples of types of errors (i.e. causes) such as sensor moisture). 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 further assisting the user in correcting sensor errors (see paragraph 0011 of Mizuoka).
As per claim 34, Masciotti, Sloan, and Mizuoka 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).
As per claim 35, Masciotti, Sloan, and Mizuoka 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. Mizuoka 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 paragraph 0117-0118; abnormal error is calculated according to a series of conditions, which may be outside of the lower 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 with the motivation of further assisting the user in correcting sensor errors (see paragraph 0011 of Mizuoka).
As per claim 36, Masciotti, Sloan, and Mizuoka 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. Mizuoka 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 paragraphs 0033-0034; provides different examples of types of errors (i.e. causes) such as an error resulting from an impact which would be a type of compression on the sensor 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 with the motivation of further assisting the user in correcting sensor errors (see paragraph 0011 of Mizuoka).
As per claim 39, Masciotti, Sloan, and Mizuoka 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 Mizuoka teaches the system of claim 30 as described above. Masciotti does not explicitly teach determining the one or more root causes. Mizuoka further teaches determining the one or more root causes associated with the plurality of event indications is performed automatically after the plurality of event indications are generated (see paragraph 0043; a series of determination values are calculated to determine the abnormal determination values; paragraph 0132 describes that the type of error is determined for the abnormal waveform value). 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).
As per claim 43, Masciotti, Sloan, and Mizuoka teaches the system of claim 30 as described above. Masciotti does not explicitly teach taking the one or more actions to resolve the one or more root causes is performed automatically after determining the one or more root causes. Mizuoka further teaches taking the one or more actions to resolve the one or more root causes is performed automatically after determining the one or more root causes (see paragraph 0177; the user can be notified of the type of error and given advice about countermeasures so that the appropriate action can be taken). 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 further assisting the user in correcting sensor errors (see paragraph 0011 of Mizuoka).
As per claim 44, Masciotti, Sloan, and Mizuoka teaches the system of claim 30 as described above. Masciotti does not explicitly teach the one or more actions. Mizuoka 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 paragraph 0136; at least provides user with need to order 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 further assisting the user in correcting sensor errors (see paragraph 0011 of Mizuoka).
As per claim 45, Masciotti, Sloan, and Mizuoka 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, wherein determining the one or more root causes is further based on the secondary sensor data. Mizuoka 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 paragraph 0175; at least temperature detection used to determine type of 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 with the motivation of further assisting the user in correcting sensor errors (see paragraph 0011 of Mizuoka).
As per claim 46, Masciotti, Sloan, and Mizuoka 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. Mizuoka 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 paragraph 0175; at least temperature detection used to determine type of 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 with the motivation of further assisting the user in correcting sensor errors (see paragraph 0011 of Mizuoka).
As per claim 48, Masciotti, Sloan, and Mizuoka teaches the system of claim 30 as described above. Masciotti does not explicitly teach the processor is further configured to generate an event indication. Mizuoka 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 paragraph 0034; reagent movement error refers to an error caused by an impact outside of the sensor, which is encompassed by an error associated with the transmitter and one or more other connected devices). 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 further assisting the user in correcting sensor errors (see paragraph 0011 of Mizuoka).
As per claim 58, Masciotti teaches a method comprising: sensing, by an analyte sensor, analyte levels of a patient to generate one or more sensed signals (see paragraph 0020; analyte sensor measures analyte concentration); transmitting, by a transmitter, 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)); generating a plurality of event indications based on the one or more sensed signals (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); determining, by the processor, one or more root causes associated with the plurality of event indications based on a pattern associated with the plurality of event indications; and taking, by the processor, one or more actions to resolve the one or more root causes (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 or more root causes associated with the plurality of generated event indications 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).
Mizuoka teaches determine one or more root causes associated with a plurality of generated event indications based on a pattern associated with the plurality of generated event indications (see paragraph 0043; a series of determination values are calculated to determine the abnormal determination values; paragraph 0132 describes that the type of error is determined for the abnormal waveform value); and take one or more actions to resolve the one or more root causes (see paragraph 0177; the user can be notified of the type of error and given advice about countermeasures so that the appropriate action can be taken). 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 further assisting the user in correcting sensor errors (see paragraph 0011 of Mizuoka).
As per claim 59, Masciotti, Sloan, and Mizuoka 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) 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 Mizuoka, US Patent Application Publication No. 2013/0337571 and further in view of Brister, US Patent Application Publication No. 2013/0267809.
As per claim 37, Masciotti, Sloan, and Mizuoka 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, Mizuoka, 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 wherein 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 Mizuoka 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 Mizuoka with the motivation of improving levels of accuracy in ranges of analyte data (see paragraph 0374 of Brister).
As per claim 41, Masciotti, Mizuoka, Sloan, and Brister teaches the system of claim 40 as described above. As noted above, Masciotti does not explicitly teach the one or more root causes. Mizuoka further teaches the one or more root causes comprises at least one of: compression on the analyte sensor; or damage to a membrane of the patient coupled to the analyte sensor (see paragraphs 0033-0034; provides different examples of types of errors (i.e. causes) such as an error resulting from an impact which would be a type of compression on the sensor error). Masciotti and Mizuoka does not explicitly teach determining the one or more root causes comprises determining multiple consecutive event indications indicate the differential between the one more sensed signals and the one or more filtered signals is above a configured threshold. Brister further teaches determining one or more root causes comprises determining multiple consecutive event indications indicate 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 and Mizuoka 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 Mizuoka 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 Mizuoka 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 Mizuoka 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 Mizuoka, US Patent Application Publication No. 2013/0337571 and further in view of Kaib, US Patent Application Publication No. 2017/0007129.
As per claim 49, Masciotti, Sloan, and Mizuoka 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, Mizuoka, US Patent Application Publication No. 2013/0337571 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, Mizuoka, 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 Mizuoka, US Patent Application Publication No. 2013/0337571 and further in view of Mensinger, US Patent Application Publication No. 2014/0012511.
As per claim 51, Masciotti, Sloan, and Mizuoka 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 Mizuoka 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, Mizuoka, 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 Mizuoka 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 Mizuoka, US Patent Application Publication No. 2013/0337571 and further in view of Harper, US Patent Application Publication No. 2010/0265073.
As per claim 52, Masciotti, Sloan, and Mizuoka 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).
Response to Arguments
In the remarks filed 12/17/2025, Applicant argues (1) a terminal disclaimer will be filed upon an indication of allowability; (2) the claims do not recite an abstract idea, integrate any abstract idea into a practical application, and recite significantly more than any abstract idea; (3) Mizuoka discloses identifying a type of error but not a root cause of the error; (4) Mizuoka does not teach actively determining a root cause of an error.
Applicant’s argument (1) regarding the filing of a terminal disclaimer is acknowledged.
In response to argument (2), the examiner respectfully maintains the rejections as set forth above. Because these arguments do not identify specific claim language, they are not found to be persuasive.
In response to argument (3), representative independent claim 30 does not define the term “root cause.” As recited in claim 30, “root cause” is only recited as something that is “associated with the plurality of event indications based on a pattern associated with the plurality of event indications.” In the context of some sort of causal effect being associated event indications, the examiner respectfully maintains that identifying a type of error (cause) associated with a series of waveform anomalies (event indications) is encompassed by the recited limitation. For example, Mizuoka describes identifying the abnormal waveform error as “reagent movement error” identifies an impact from the outside of the biological sample measurement sensor that “causes a reagent…to shift away from the position where it is supposed to be” (see paragraph 0034). Therefore, the examiner respectfully maintains that the broadest reasonable interpretation of the recited limitation encompasses the teachings of Mizuoka.
In response to argument (4), an example of actively determining a root cause of an error is detecting and displaying a particular type of error (see paragraphs 0058-0059). In this example, a cause of the anomalies is an “exposure error.” If repeated detection is caused by exposure, this is actively determined by displaying assistance in purchasing new sensors. Displaying this message addresses the root cause (repeated exposure) of the anomalies. Therefore, the examiner respectfully maintains that the broadest reasonable interpretation of the recited limitation encompasses the teachings of Mizuoka.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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C. Luke Gilligan
Primary Examiner
Art Unit 3683
/CHRISTOPHER L GILLIGAN/ Primary Examiner, Art Unit 3683