DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 2-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 2, the claim(s) recites “comparing a number of received counts associated with the signals received from the sensor device for the one or more periods of time with one or more benchmarked count thresholds associated with the one or more periods of time;
determining whether a wakeup event of the sensor electronics module or an anomalous event has occurred based on the comparison;” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“monitoring, by a controller of a sensor electronics module, counts associated with signals received from a sensor device for one or more periods of time;”
“controlling a power mode of the sensor electronics module based on the determination.”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, sensor devices are general field of use and controllers are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of determining whether received counts seem consistent with wakeup conditions or an anomalous event and controlling a power mode of the system – a process that may lead to no change in the power mode of the system based on the gathered data and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claims 3-12 also do not add significantly more to the exception as they merely add details to the mental steps, add details to the extrasolution data gathering steps, add general field of use components to facilitate the extrasolution data gathering, and add mental steps.
Regarding Claim 13, the claim(s) recites “compare a number of received counts associated with the signals received from the analyte sensor for the one or more periods of time with one or more benchmarked count thresholds associated with the one or more periods of time;
determine whether a wakeup event of the sensor electronics circuitry or an anomalous event has occurred based on the comparison;” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“monitor counts associated with signals received from the analyte sensor for one or more periods of time;”
“control a power mode of the sensor electronics circuitry based on the determination.”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, analyte sensors are general field of use and electronic circuitries, transceivers, and processors are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of determining whether received counts seem consistent with wakeup conditions or an anomalous event and controlling a power mode of the system – a process that may lead to no change in the power mode of the system based on the gathered data and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claims 14-20 also do not add significantly more to the exception as they merely add details to the mental steps, add details to the extrasolution data gathering steps, add general field of use components to facilitate the extrasolution data gathering, and add mental steps.
Regarding Claim 2, the claim(s) recites “comparing a number of received counts associated with the signals received from the sensor device for the one or more periods of time with one or more benchmarked count thresholds associated with the one or more periods of time;
determining whether a wakeup event of the sensor electronics module or an anomalous event has occurred based on the comparison;” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“monitoring, by a controller of a sensor electronics module, counts associated with signals received from a sensor device for one or more periods of time;”
“controlling a power mode of the sensor electronics module based on the determination.”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, sensor devices are general field of use and controllers and non-transitory computer-readable mediums are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of determining whether received counts seem consistent with wakeup conditions or an anomalous event and controlling a power mode of the system – a process that may lead to no change in the power mode of the system based on the gathered data and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 and claims dependent thereon rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding Claim 8, the term “wherein determining whether the wakeup event or the anomalous event has occurred further comprises determining that the anomalous event has occurred when the second benchmarked count threshold divided by the second period of time is non-proportional to the first benchmarked count threshold divided by the first period of time." renders the claim indefinite because the thresholds are set by practitioners and do not reflect the current state of the patient. Appropriate changes would include -- wherein determining whether the wakeup event or the anomalous event has occurred further comprises determining that the anomalous event has occurred when the number of received counts for a second period of time divided by the second period of time is non-proportional to the number of received counts for a second period of time first benchmarked count threshold divided by the first period of time. -- and Examiner will be interpreting the claim as such.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 2-, 7, 10-14, 18, and 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bohm et al (US 2012/0078071) (“Bohm”) as noted in Applicant IDS dated 12/16/2024.
Regarding Claim 2, Bohm teaches a computer-implemented method for managing power modes of an electronic device (Abstract, Fig. 1, [0116] continuous analyte sensor system 8 including a sensor electronics module 12, [0215]-[0216] power mode management steps applied to sensor electronics module 12), comprising:
monitoring, by a controller of a sensor electronics module, counts associated with signals received from a sensor device for one or more periods of time (Fig. 2A, [0125]-[0126] sensor electronics module 12 is used to find counts associated with signals received from a sensor device / potentiostat 210 for one or more periods of time, [0128] potentiostat data measured continuously with integration of counts measured at predetermined intervals, [0117] “For example, the sensor electronics module 12 can include a potentiostat, a power source for providing power to the sensor, other components useful for signal processing and data storage, and preferably a telemetry module for transmitting data from the sensor electronics module to one or more display devices. Electronics can be affixed to a printed circuit board (PCB), or the like, and can take a variety of forms. For example, the electronics can take the form of an integrated circuit (IC), such as an Application-Specific Integrated Circuit (ASIC), a microcontroller, and/or a processor.” Monitored by a controller);
comparing a number of received counts associated with the signals received from the sensor device for the one or more periods of time with one or more benchmarked count thresholds associated with the one or more periods of time ([0216] “Accordingly, the sensor electronics module 12 can be configured to be in a low power mode, wherein the sensor electronics module periodically performs measurements… In one embodiment, if the sensor electronics module 12 measures below a predetermined threshold, then sensor electronics module remains in a low power mode. Should the threshold be exceeded, then the sensor electronics module 12 can enter an operational mode. The threshold can be selected based on values that would indicate the sensor electronics module 12 is not operatively connected to sensor 10 or, even if connected to the sensor, the sensor is not implanted in a host. The threshold can be zero measured counts, zero measured current or zero measured response. The threshold can also be set to be slightly above zero so that noise, leakage current or the like does not falsely indicate that the sensor electronics module 12 is operatively connected to sensor 10.” Where the data is measured continuously at predetermined time intervals, thus reflecting one or more periods of time that are each compared to the above described thresholds);
determining whether a wakeup event of the sensor electronics module or an anomalous event has occurred based on the comparison ([0216] “Should the threshold be exceeded, then the sensor electronics module 12 can enter an operational mode.” Threshold can be based on wakeup event such as a connection to patient or if the device is measuring an anomalous event from noise / artifact); and
controlling a power mode of the sensor electronics module based on the determination ([0216]).
Regarding Claim 3, Bohm teaches the computer-implemented method of claim 2, wherein determining whether the wakeup event or the anomalous event has occurred comprises determining that the anomalous event has occurred when the number of received counts for a first period of time of the one or more periods of time is lower than a first benchmarked count threshold of the one or more benchmarked count thresholds associated with the first period of time ([0216] “The threshold can also be set to be slightly above zero so that noise, leakage current or the like does not falsely indicate that the sensor electronics module 12 is operatively connected to sensor 10.” Counts are associated with a predetermined time interval / period of time and are compared against a noise benchmark count threshold, thus indicating that a number of received counts that correlate to noise would be below the threshold, recognized as such, and the system would remain in the low power mode).
Regarding Claim 7, Bohm teaches the computer-implemented method of claim 2, wherein determining whether the wakeup event or the anomalous event has occurred comprises determining that the anomalous event has occurred when at least one of (i) the number of received counts for a first period of time of the one or more periods of time is lower than a first benchmarked count threshold of the one or more benchmarked count thresholds associated with the first period of time or (ii) the number of received counts for a second period of time of the one or more periods of time is lower than a second benchmarked count threshold of the one or more benchmarked count thresholds associated with the second period of time ([0216] “The threshold can also be set to be slightly above zero so that noise, leakage current or the like does not falsely indicate that the sensor electronics module 12 is operatively connected to sensor 10.” Counts are associated with a predetermined time interval / period of time and are compared against a noise benchmark count threshold, thus indicating that a number of received counts that correlate to noise would be below the threshold, recognized as such, and the system would remain in the low power mode)..
Regarding Claim 10, Bohm teaches the computer-implemented method of claim 2, wherein the sensor device comprises a transcutaneous analyte sensor ([0121]).
Regarding Claim 11, Bohm teaches the computer-implemented method of claim 2, further comprising transmitting an indication of the determination ([0175], [0206], [0215]-[0220] components outside of measuring are turned off in low-power mode and energized when in operational mode, thus the activation of a user interface from the mode switching will transmit an indication of the determination to a user).
Regarding Claim 12, Bohm teaches the computer-implemented method of claim 2, wherein controlling the power mode comprises refraining from initiating an operational mode of the sensor electronics module when the determination is that the anomalous event has occurred (See Claim 2 Rejection, [0216] threshold can be set so that noise, leakage current, or the like do not falsely indicate that the sensor electronic module 12 is connected to sensor 10, thus refraining from initiating an operational mode).
Regarding Claim 13, Bohm teaches an analyte sensor system (Abstract, Fig. 1, [0116] continuous analyte sensor system 8 including a sensor electronics module 12, [0215]-[0216] power mode management steps applied to sensor electronics module 12), comprising:
an analyte sensor (Fig. 2A, [0128] potentiostat data measured continuously with integration of counts measured at predetermined intervals); and
sensor electronics circuitry electrically coupled to the analyte sensor (Fig. 2A, [0125]-[0126] sensor electronics module 12 is used to find counts associated with signals received from a sensor device / potentiostat 210 for one or more periods of time), the sensor electronics circuitry comprising:
a transceiver ([0125], [0138] telemetry module / transceiver); and
at least one processor coupled to the transceiver and to a memory ([0117] “For example, the sensor electronics module 12 can include a potentiostat, a power source for providing power to the sensor, other components useful for signal processing and data storage, and preferably a telemetry module for transmitting data from the sensor electronics module to one or more display devices. Electronics can be affixed to a printed circuit board (PCB), or the like, and can take a variety of forms. For example, the electronics can take the form of an integrated circuit (IC), such as an Application-Specific Integrated Circuit (ASIC), a microcontroller, and/or a processor.” [0127] sensor electronics module 12 uses processor and processor module 214, the processor coupled to the transceiver / telemetry module 232 and memories / RAM 218 and program memory 216), the at least one processor being configured to:
monitor counts associated with signals received from the analyte sensor for one or more periods of time (Fig. 2A, [0125]-[0126] sensor electronics module 12 is used to find counts associated with signals received from a sensor device / potentiostat 210 for one or more periods of time, [0128] potentiostat data measured continuously with integration of counts measured at predetermined intervals);
compare a number of received counts associated with the signals received from the analyte sensor for the one or more periods of time with one or more benchmarked count thresholds associated with the one or more periods of time ([0216] “Accordingly, the sensor electronics module 12 can be configured to be in a low power mode, wherein the sensor electronics module periodically performs measurements… In one embodiment, if the sensor electronics module 12 measures below a predetermined threshold, then sensor electronics module remains in a low power mode. Should the threshold be exceeded, then the sensor electronics module 12 can enter an operational mode. The threshold can be selected based on values that would indicate the sensor electronics module 12 is not operatively connected to sensor 10 or, even if connected to the sensor, the sensor is not implanted in a host. The threshold can be zero measured counts, zero measured current or zero measured response. The threshold can also be set to be slightly above zero so that noise, leakage current or the like does not falsely indicate that the sensor electronics module 12 is operatively connected to sensor 10.” Where the data is measured continuously at predetermined time intervals, thus reflecting one or more periods of time that are each compared to the above described thresholds);
determine whether a wakeup event of the sensor electronics circuitry or an anomalous event has occurred based on the comparison ([0216] “Should the threshold be exceeded, then the sensor electronics module 12 can enter an operational mode.” Threshold can be based on wakeup event such as a connection to patient or if the device is measuring an anomalous event from noise / artifact); and
control a power mode of the sensor electronics circuitry based on the determination ([0216]).
Regarding Claim 14, Bohm teaches the analyte sensor system of claim 13, wherein, to determine whether the wakeup event or the anomalous event has occurred, the at least one processor is further configured to determine that the anomalous event has occurred when the number of received counts for a first period of time of the one or more periods of time is lower than a first benchmarked count threshold of the one or more benchmarked count thresholds associated with the first period of time ([0216] “The threshold can also be set to be slightly above zero so that noise, leakage current or the like does not falsely indicate that the sensor electronics module 12 is operatively connected to sensor 10.” Counts are associated with a predetermined time interval / period of time and are compared against a noise benchmark count threshold, thus indicating that a number of received counts that correlate to noise would be below the threshold, recognized as such, and the system would remain in the low power mode).
Regarding Claim 18, Bohm teaches the analyte sensor system of claim 13, wherein to determine whether the wakeup event or the anomalous event has occurred, the at least one processor is configured to determine that the anomalous event has occurred when at least one of (i) the number of received counts for a first period of time of the one or more periods of time is lower than a first benchmarked count threshold of the one or more benchmarked count thresholds associated with the first period of time or (ii) the number of received counts for a second period of time of the one or more periods of time is lower than a second benchmarked count threshold of the one or more benchmarked count thresholds associated with the second period of time ([0216] “The threshold can also be set to be slightly above zero so that noise, leakage current or the like does not falsely indicate that the sensor electronics module 12 is operatively connected to sensor 10.” Counts are associated with a predetermined time interval / period of time and are compared against a noise benchmark count threshold, thus indicating that a number of received counts that correlate to noise would be below the threshold, recognized as such, and the system would remain in the low power mode).
Regarding Claim 20, Bohm teaches the analyte sensor system of claim 13, wherein the analyte sensor comprises a transcutaneous analyte sensor ([0121]).
Regarding Claim 21, Bohm teaches a non-transitory computer-readable medium storing computer-executable instructions, which, when executed by one or more processors of an analyte sensor system (Abstract, Fig. 1, [0116] continuous analyte sensor system 8 including a sensor electronics module 12, [0215]-[0216] power mode management steps applied to sensor electronics module 12, [0117], [0127] sensor electronics module 12 may evaluate data by a processor module 214 with program memory 216 to process data streams), perform an operation comprising:
monitoring, by a controller of a sensor electronics module, counts associated with signals received from a sensor device for one or more periods of time (Fig. 2A, [0125]-[0126] sensor electronics module 12 is used to find counts associated with signals received from a sensor device / potentiostat 210 for one or more periods of time, [0128] potentiostat data measured continuously with integration of counts measured at predetermined intervals, [0117] “For example, the sensor electronics module 12 can include a potentiostat, a power source for providing power to the sensor, other components useful for signal processing and data storage, and preferably a telemetry module for transmitting data from the sensor electronics module to one or more display devices. Electronics can be affixed to a printed circuit board (PCB), or the like, and can take a variety of forms. For example, the electronics can take the form of an integrated circuit (IC), such as an Application-Specific Integrated Circuit (ASIC), a microcontroller, and/or a processor.” Monitored by a controller);
comparing a number of received counts associated with the signals received from the sensor device for the one or more periods of time with one or more benchmarked count thresholds associated with the one or more periods of time ([0216] “Accordingly, the sensor electronics module 12 can be configured to be in a low power mode, wherein the sensor electronics module periodically performs measurements… In one embodiment, if the sensor electronics module 12 measures below a predetermined threshold, then sensor electronics module remains in a low power mode. Should the threshold be exceeded, then the sensor electronics module 12 can enter an operational mode. The threshold can be selected based on values that would indicate the sensor electronics module 12 is not operatively connected to sensor 10 or, even if connected to the sensor, the sensor is not implanted in a host. The threshold can be zero measured counts, zero measured current or zero measured response. The threshold can also be set to be slightly above zero so that noise, leakage current or the like does not falsely indicate that the sensor electronics module 12 is operatively connected to sensor 10.” Where the data is measured continuously at predetermined time intervals, thus reflecting one or more periods of time that are each compared to the above described thresholds);
determining whether a wakeup event of the sensor electronics module or an anomalous event has occurred based on the comparison ([0216] “Should the threshold be exceeded, then the sensor electronics module 12 can enter an operational mode.” Threshold can be based on wakeup event such as a connection to patient or if the device is measuring an anomalous event from noise / artifact); and
controlling a power mode of the sensor electronics module based on the determination ([0216]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bohm in view of Salas-Boni et al (US 2016/0029966) (“Salas-Boni”).
Regarding Claim 4, while Bohm teaches the computer-implemented method of claim 2, wherein:
monitoring the counts associated with signals received from a sensor device for one or more periods of time comprises determining the number of received counts associated with the signals received from the sensor device for a plurality of time intervals, each time interval comprising a first period of time of the one or more periods of time (See Claim 2 Rejection, [0128] data measured continuously represents a plurality of time intervals and the predetermined time intervals are each a singular period of time); and
determining whether the wakeup event or the anomalous event has occurred comprises determining that the anomalous event has occurred when the number of received counts is lower than a first benchmarked count threshold of the one or more benchmarked count thresholds associated with the first period of time ([0216] “The threshold can also be set to be slightly above zero so that noise, leakage current or the like does not falsely indicate that the sensor electronics module 12 is operatively connected to sensor 10.” Counts are associated with a predetermined time interval / period of time and are compared against a noise benchmark count threshold, thus indicating that a number of received counts that correlate to noise would be below the threshold, recognized as such, and the system would remain in the low power mode), Bohm fails to teach determining that the anomalous event has occurred when the number of received counts is lower than a first benchmarked count threshold for only a single time interval of the plurality of time intervals.
However Salas-Boni teaches a analyte monitoring system (Abstract, [0038]-[0040]) where a signal artifact can be identified as either short-term artifact or long-term artifact, where short-term artifact is associated with spurious noise ([0039]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the consideration that spurious noise will only be present in the data for a short term duration as taught by Salas-Boni and identify transient changes within Bohm as the form of recognizing noise to prevent an unnecessary change in operational mode, thus wasting power.
Regarding Claim 15, while Bohm teaches the analyte sensor system of claim 13, wherein:
to monitor the counts associated with signals received from the analyte sensor for one or more periods of time, the at least one processor is configured to determine the number of received counts associated with the signals received from the analyte sensor for each of a plurality of time intervals, each time interval comprising a first period of time of the one or more periods of time (See Claim 13 Rejection, [0128] data measured continuously represents a plurality of time intervals and the predetermined time intervals are each a singular period of time); and
to determine whether the wakeup event or the anomalous event has occurred, the at least one processor is configured to determine that the anomalous event has occurred when the number of received counts is lower than a first benchmarked count threshold of the one or more benchmarked count thresholds associated with the first period of time ([0216] “The threshold can also be set to be slightly above zero so that noise, leakage current or the like does not falsely indicate that the sensor electronics module 12 is operatively connected to sensor 10.” Counts are associated with a predetermined time interval / period of time and are compared against a noise benchmark count threshold, thus indicating that a number of received counts that correlate to noise would be below the threshold, recognized as such, and the system would remain in the low power mode), Bohm fails to teach determining that the anomalous event has occurred when the number of received counts is lower than a first benchmarked count threshold for only a single time interval of the plurality of time intervals.
However Salas-Boni teaches a analyte monitoring system (Abstract, [0038]-[0040]) where a signal artifact can be identified as either short-term artifact or long-term artifact, where short-term artifact is associated with spurious noise ([0039]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the consideration that spurious noise will only be present in the data for a short term duration as taught by Salas-Boni and identify transient changes within Bohm as the form of recognizing noise to prevent an unnecessary change in operational mode, thus wasting power. Thus, if only a single time interval exhibits a spurious noise characteristic, this would support the conclusion that this time period reflects an anomalous event and provides greater confidence that the system should not be changed to an operational mode.
Claim(s) 5-6 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bohm in view of Salas-Boni and further in view of Steil et al (US 2008/0188796) (“Steil”) as noted in Applicant IDS dated 12/16/2024.
Regarding Claim 5, while Bohm teaches the computer-implemented method of claim 2, wherein:
monitoring the counts associated with signals received from a sensor device for one or more periods of time comprises determining the number of received counts associated with the signals received from the sensor device for each of a plurality of time intervals, each time interval comprising a first period of time of the one or more periods of time (See Claim 2 Rejection, [0128] data measured continuously represents a plurality of time intervals and the predetermined time intervals are each a singular period of time); and
determining whether the wakeup event or the anomalous event has occurred comprises determining that the anomalous event has occurred when the number of received counts is lower than a first benchmarked count threshold of the one or more benchmarked count thresholds associated with the first period of time ([0216] “The threshold can also be set to be slightly above zero so that noise, leakage current or the like does not falsely indicate that the sensor electronics module 12 is operatively connected to sensor 10.” Counts are associated with a predetermined time interval / period of time and are compared against a noise benchmark count threshold, thus indicating that a number of received counts that correlate to noise would be below the threshold, recognized as such, and the system would remain in the low power mode),
Bohm fails to teach determining that the anomalous event has occurred when the number of received counts is lower than a first benchmarked count threshold for only a single time interval of the plurality of time intervals.
However Salas-Boni teaches a analyte monitoring system (Abstract, [0038]-[0040]) where a signal artifact can be identified as either short-term artifact or long-term artifact, where short-term artifact is associated with spurious noise ([0039]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the consideration that spurious noise will only be present in the data for a short term duration as taught by Salas-Boni and identify transient changes within Bohm as the form of recognizing noise to prevent an unnecessary change in operational mode, thus wasting power. Thus, if only a single time interval exhibits a spurious noise characteristic, this would support the conclusion that this time period reflects an anomalous event.
Yet their combined efforts fail to teach determining that the anomalous event has occurred when the number of received counts is higher than a first benchmarked count threshold.
However Steil teaches a closed-loop glucose monitoring system (Abstract) where a benchmark threshold of noise can be placed both below expected values and above expected values (Fig. 17, [0214]-[0216]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that a first benchmark threshold of considering noise of Bohm can also be set for values above expected data values as taught by Steil as a simple substitution of one form of noise monitoring in analyte values for another to obtain predictable results of reduced risk of erroneously entering the operational mode.
Regarding Claim 6, Bohm teaches the computer-implemented method of claim 5, wherein the plurality of time intervals comprise a plurality of consecutive time intervals (See Claims 1 and 5 Rejection, wherein the plurality of time intervals are continuously measured for predetermined intervals, and thus constitute consecutive time intervals).
Regarding Claim 16, while Bohm teaches the analyte sensor system of claim 13, wherein:
to monitor the counts associated with signals received from the analyte sensor for one or more periods of time, the at least one processor is configured to determine the number of received counts associated with the signals received from the analyte sensor for each of a plurality of time intervals, each time interval comprising a first period of time of the one or more periods of time (See Claim 13 Rejection, [0128] data measured continuously represents a plurality of time intervals and the predetermined time intervals are each a singular period of time); and
determining whether the wakeup event or the anomalous event has occurred comprises determining that the anomalous event has occurred when the number of received counts is lower than a first benchmarked count threshold of the one or more benchmarked count thresholds associated with the first period of time ([0216] “The threshold can also be set to be slightly above zero so that noise, leakage current or the like does not falsely indicate that the sensor electronics module 12 is operatively connected to sensor 10.” Counts are associated with a predetermined time interval / period of time and are compared against a noise benchmark count threshold, thus indicating that a number of received counts that correlate to noise would be below the threshold, recognized as such, and the system would remain in the low power mode),
Bohm fails to teach determining that the anomalous event has occurred when the number of received counts is lower than a first benchmarked count threshold for only a single time interval of the plurality of time intervals.
However Salas-Boni teaches a analyte monitoring system (Abstract, [0038]-[0040]) where a signal artifact can be identified as either short-term artifact or long-term artifact, where short-term artifact is associated with spurious noise ([0039]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the consideration that spurious noise will only be present in the data for a short term duration as taught by Salas-Boni and identify transient changes within Bohm as the form of recognizing noise to prevent an unnecessary change in operational mode, thus wasting power. Thus, if only a single time interval exhibits a spurious noise characteristic, this would support the conclusion that this time period reflects an anomalous event.
Yet their combined efforts fail to teach determining that the anomalous event has occurred when the number of received counts is higher than a first benchmarked count threshold.
However Steil teaches a closed-loop glucose monitoring system (Abstract) where a benchmark threshold of noise can be placed both below expected values and above expected values (Fig. 17, [0214]-[0216]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that a first benchmark threshold of considering noise of Bohm can also be set for values above expected data values as taught by Steil as a simple substitution of one form of noise monitoring in analyte values for another to obtain predictable results of reduced risk of erroneously entering the operational mode.
Regarding Claim 17, Bohm teaches the analyte sensor system of claim 16, wherein the plurality of time intervals comprise a plurality of consecutive time intervals (See Claims 13 and 16 Rejection, wherein the plurality of time intervals are continuously measured for predetermined intervals, and thus constitute consecutive time intervals).
Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bohm as evidenced by Maccallum (WO 2015/077886) and Mirov (US 2017/0049352) in view of Salas-Boni
Regarding Claim 9, while Bohm teaches the computer-implemented method of claim 2, wherein the anomalous event comprises a noise event (See Claim 2 Rejection, where a electrostatic discharge is recognized as potential noise in electrical physiological monitoring as noted in Maccallum [0014] and where electrostatic discharge is characterized as a transient spike as noted in Mirov [0128]), Bohm fails to teach wherein the anomalous event comprises an electrostatic discharge (ESD) based on the specific characteristics of electrostatic discharge noise.
However Salas-Boni teaches a analyte monitoring system (Abstract, [0038]-[0040]) where a signal artifact can be identified as either short-term artifact or long-term artifact, where short-term artifact is associated with spurious noise ([0039]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the consideration that spurious noise will only be present in the data for a short term duration as taught by Salas-Boni and identify transient changes within Bohm as the form of recognizing noise to prevent an unnecessary change in operational mode, thus wasting power. One of ordinary skill in the art would recognize that this addition would recognize electrostatic discharge’s transient nature.
Yet their combined efforts fail to teach determining that the anomalous event of electrostatic discharge has occurred as the transient spike may surpass the low benchmark threshold set by Bohm.
However Steil teaches a closed-loop glucose monitoring system (Abstract) where a benchmark threshold of noise can be placed both below expected values and above expected values (Fig. 17, [0214]-[0216]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that a second benchmark threshold of considering noise in Bohm can also be set for values above expected data values as taught by Steil as an addition that enables the identification of multiple instances of noise. Finally, it would be obvious that if Bohm’s recognition of noise is expanded to consider noise by a short-term nature (Salas-Boni) and still accounting for spikes with a high threshold (Steil), Bohm would be able to identify an anomalous even of electrostatic discharge.
Regarding Claim 19, while Bohm teaches the analyte sensor system of claim 13, wherein the anomalous event comprises a noise event (See Claim 2 Rejection, where a electrostatic discharge is recognized as potential noise in electrical physiological monitoring as noted in Maccallum [0014] and where electrostatic discharge is characterized as a transient spike as noted in Mirov [0128]), Bohm fails to teach wherein the anomalous event comprises an electrostatic discharge (ESD) based on the specific characteristics of electrostatic discharge noise.
However Salas-Boni teaches a analyte monitoring system (Abstract, [0038]-[0040]) where a signal artifact can be identified as either short-term artifact or long-term artifact, where short-term artifact is associated with spurious noise ([0039]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the consideration that spurious noise will only be present in the data for a short term duration as taught by Salas-Boni and identify transient changes within Bohm as the form of recognizing noise to prevent an unnecessary change in operational mode, thus wasting power. One of ordinary skill in the art would recognize that this addition would recognize electrostatic discharge’s transient nature.
Yet their combined efforts fail to teach determining that the anomalous event of electrostatic discharge has occurred as the transient spike may surpass the low benchmark threshold set by Bohm.
However Steil teaches a closed-loop glucose monitoring system (Abstract) where a benchmark threshold of noise can be placed both below expected values and above expected values (Fig. 17, [0214]-[0216]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that a second benchmark threshold of considering noise in Bohm can also be set for values above expected data values as taught by Steil as an addition that enables the identification of multiple instances of noise. Finally, it would be obvious that if Bohm’s recognition of noise is expanded to consider noise by a short-term nature (Salas-Boni) and still accounting for spikes with a high threshold (Steil), Bohm would be able to identify an anomalous even of electrostatic discharge.
Allowable Subject Matter
No prior art rejection is applied to claim 8 because the prior art fails to teach wherein determining whether the wakeup event or the anomalous event has occurred further comprises determining that the anomalous event has occurred when the second benchmarked count threshold divided by the second period of time is non-proportional to the first benchmarked count threshold divided by the first period of time. However, the claims are not allowed at this time due to the rejections under 35 USC 101, as set forth above
Conclusion
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
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