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 .
Compact Prosecution
With respect to Claim Interpretation, the Examiner has provided some notes regarding “[BRI on the record]” throughout the Office Action, so that the record is clear about the scope of the claimed invention, and the record is also clear about the basis for the Examiner’s analyses. A clear record of the claim interpretation could expedite the examination by creating the condition to allow the examination to focus on Applicant’s inventive concept and its comparison with related prior art.
If there are disagreements, Applicant may present an alternative interpretation based on MPEP 2111. The Examiner will adopt Applicant’s interpretation on the record, if Applicant’s interpretation is reasonable and/or arguments are persuasive.
Applicant may amend claims relying on the Examiner’s claim interpretation provided on the record.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 17-19, 21-23, 45-46, 48-50 and 52-56 are rejected under 35 U.S.C. 103 as being unpatentable over Nabutovsky et al. (US 20210366609 A1) in view of Fuchs et al. (US 20030139179 A1).
Regarding Claim 17, Nabutovsky teaches A method, comprising:
transmitting, by a sensor control device (sensor control device 102), data indicative of an analyte level to a reader device (reader device 120) via a first wireless communication protocol (
“FIG. 1 is a conceptual diagram depicting an example embodiment of an analyte monitoring system 100 that includes a sensor applicator 150, a sensor control device 102, and a reader device 120. Here, sensor applicator 150 can be used to deliver sensor control device 102 to a monitoring location on a user's skin where a sensor 104 is maintained in position for a period of time by an adhesive patch 105. Sensor control device 102 is further described in FIGS. 2B and 2C, and can communicate with reader device 120 via a communication path 140 using a wired or wireless technique. Example wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC) and others. Users can view and use applications installed in memory on reader device 120 using screen 122 (which, in many embodiments, can comprise a touchscreen), and input 121. A device battery of reader device 120 can be recharged using power port 123.” Nabutovsky ¶ 72.);
ing the missing historical data indicative of the analyte level (
“Example embodiments of methods for data backfilling in an analyte monitoring system will now be described. In accordance with the disclosed subject matter, gaps in analyte data and other information can result from interruptions to communication links between various devices in an analyte monitoring system 100.” Nabutovsky ¶ 118.
The missing historical data are mapped to “gaps in analyte data” and data to be backfilled.
Nabutovsky teaches requesting missing historical data due to connection interruption, stating “At Step 606, the communication link is re-established between the first device and the second device (e.g., the first device comes back into the wireless communication range of the second device). Upon reconnection, the second device requests historical analyte data according to a last lifecount metric for which data was received. In accordance with the disclosed subject matter, the lifecount metric can be a numeric value that is incremented and tracked on the second device in units of time (e.g., minutes), and is indicative of an amount of time elapsed since the sensor control device was activated.” Nabutovsky ¶ 121.);
in response to a
[BRI on the record] The Examiner is reading “a second wireless communication protocol” as being required to be different from “a first wireless communication protocol.”
[Mapping Analysis]
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Nabutovsky teaches requesting missing historical data due to connection interruption, stating “At Step 606, the communication link is re-established between the first device and the second device (e.g., the first device comes back into the wireless communication range of the second device).” Nabutovsky ¶ 121.); and
displaying the missing historical data indicative of the analyte level on an analyte trend graph of the analyte monitoring software application (
“As embodied herein, the second device can also output the requested historical analyte data to a display of the second device, such as, for example to a glucose trend graph of a sensor results GUI, such as those described with respect to FIGS. 2D to 2I. For example, As embodied herein, the requested historical analyte data can be used to fill in gaps in a glucose trend graph by displaying the requested historical analyte data along with previously received analyte data.” Nabutovsky ¶ 123.).
Nabutovsky’s first embodiment does not explicitly disclose:
determining, by an analyte monitoring software application, whether there is missing historical data indicative of the analyte level which exceeds a predetermined threshold amount of data;
in response to determining that the predetermined threshold is exceeded, prompting a user within the analyte monitoring software application to request of the missing historical data;
the request is user-initiated; and
transmitting data via a second wireless communication protocol.
Nabutovsky’s second embodiment teaches:
determining, by an analyte monitoring software application, whether there is missing historical data indicative of the analyte level which exceeds a predetermined threshold amount of data (
[BRI on the record] With respect to “threshold amount of data,” the Examiner is reading the “threshold” to mean: a threshold based a metric that is indicative of amount data, an example of which is a time duration threshold. This interpretation is consistent with the specification, which states, “According to some embodiments, analyte monitoring software application can be configured to monitor for gaps in historical analyte data that exceed a predetermined threshold (e.g., more than two (2) hours of missing historical analyte data, more than three (3) hours of missing historical analyte data, or more than four (4) hours of missing historical analyte data). Those of skill in the art will understand that the example predetermined thresholds are illustrative only, and other thresholds can be implemented.” Spec. ¶ 83.
[Mapping Analysis]
“Any glucose trace gaps less than 45 minutes had missing values imputed with the nearest observation or average of nearest observations if both were available (the observations immediately before or after the gap). For a longer gap, each missing value was imputed with the average of the observations at the same time in previous and next days.” Nabutovsky ¶ 314.
“Example embodiments of methods for data backfilling in an analyte monitoring system will now be described. In accordance with the disclosed subject matter, gaps in analyte data and other information can result from interruptions to communication links between various devices in an analyte monitoring system 100.” Nabutovsky ¶ 118.
The missing historical data is mapped to missing data that responsible for the data gaps.
The predetermined threshold amount of data is mapped to the data collected within 45 minutes.
The 45 minutes’ worth of data is only an example. The Examiner also conducts KSR obviousness-to-try analysis: – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. For example, there are predictable solutions of 1-45 minutes as integer threshold solutions or (1 minute, 1 hour, 1 day, or 1 month) as other threshold solutions. Using these threshold values to replace 45 minutes would produce predictable results.
The analyte monitoring software application is mapped to Nabutovsky’s software that implements the algorithms disclosed.
After the combination of Nabutovsky’s first and second embodiments, after the system determines that the gap is significant enough, the system would make request to backfill the data from the sensor device.);
in response to determining that the predetermined threshold is exceeded, request of the missing historical data(
After the combination of Nabutovsky’s first and second embodiments, after the system determines that the gap is significant enough, the system would make request to backfill the data from the sensor device. See fig. 6A 608, 610.);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Nabutovsky’s determination of missing data with Nabutovsky’s other teachings. One of ordinary skill in the art would be motivated to more efficiently backfill data. The missing data are backfilled when a relatively large amount of data are needed. For a small amount missing data, they could be interpolated. Fewer connections are made and only for more significant amount of data.
Nabutovsky’s earlier embodiments do not explicitly disclose prompting a user within the analyte monitoring software application to confirm the request; the request is user-initiated; and transmitting data via a second wireless communication protocol.
Nabutovsky’s third embodiment teaches
prompting a user within the analyte monitoring software application to confirm the request (“(e.g., dismissing the check sensor system alarm, pressing a confirmation ‘OK’ button 1142, etc.).” Nabutovsky ¶ 169. “. . . reader device 120 can visually display an alert or prompt for a confirmation by the user.” Nabutovsky ¶ 139. After this teaching is combined with Nabutovsky’s first and second embodiments, the request of the missing historical data requires confirmation from the user. The analyte monitoring software application is mapped to Nabutovsky’s software that implements the algorithms disclosed.);
the request is user-initiated (when the request is user confirmed, the request is user-initiated).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Nabutovsky’ user confirmation with Nabutovsky’s other teachings. One of ordinary skill in the art would be motivated to provide user with more control of a software system. A user could intervene by granting or denying a request.
Nabutovsky does not explicitly disclose:
transmitting data via a second wireless communication protocol.
Fuchs teaches transmitting data via a second wireless communication protocol (
“For example, if a user 109 of remote device 104 is going to move to a distance from telematics device 106 such that second wireless network protocol 112 can no longer be established or maintained between telematics device 106 and remote device 104, then user 109 can request to switch communication session to first wireless network protocol 110. ” Fuchs ¶ 58.
Nabutovsky already teaches losing connection due to distance between devices, stating “A disconnection event can also result from the first device being moved outside a wireless communication range of the second device, from the presence of a physical barrier that obstructs the first device and/or the second device, or from anything that otherwise prevents wireless communications from occurring between the first and second devices.” Nabutovsky ¶ 120.
After Nabutovsky is combined with Fuchs, when the disconnection based on the first protocol occurs, reconnection may occur according to Fuchs based on the second protocol. Therefore, the transmission of Nabutovsky Fig. 6A 610 could be based on the second protocol after the reconnection.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Fuchs’ reconnection based on a second communication protocol with primary reference Nabutovsky. One of ordinary skill in the art would be motivated to enhance reliability of network connection between devices. “For example, if a user 109 of remote device 104 is going to move to a distance from telematics device 106 such that second wireless network protocol 112 can no longer be established or maintained between telematics device 106 and remote device 104, then user 109 can request to switch communication session to first wireless network protocol 110. ” Fuchs ¶ 58.
Regarding Claim 18, Nabutovsky in view of Fuchs teaches The method of claim 17, wherein displaying the missing historical data indicative of the analyte level on the analyte trend graph comprises displaying the missing historical data adjacent to the data indicative of the analyte level transmitted via the first wireless communication protocol (
“As embodied herein, the second device can also output the requested historical analyte data to a display of the second device, such as, for example to a glucose trend graph of a sensor results GUI, such as those described with respect to FIGS. 2D to 2I. For example, As embodied herein, the requested historical analyte data can be used to fill in gaps in a glucose trend graph by displaying the requested historical analyte data along with previously received analyte data.” Nabutovsky ¶ 123.
Nabutovsky in view of Fuchs teaches that acquired missing historical data could be based on the second wireless communication protocol and the previously acquired data based on the first wireless communication protocol.
“For example, if a user 109 of remote device 104 is going to move to a distance from telematics device 106 such that second wireless network protocol 112 can no longer be established or maintained between telematics device 106 and remote device 104, then user 109 can request to switch communication session to first wireless network protocol 110. ” Fuchs ¶ 58.
Nabutovsky already teaches losing connection due to distance between devices, stating “A disconnection event can also result from the first device being moved outside a wireless communication range of the second device, from the presence of a physical barrier that obstructs the first device and/or the second device, or from anything that otherwise prevents wireless communications from occurring between the first and second devices.” Nabutovsky ¶ 120.
After Nabutovsky is combined with Fuchs, when the disconnection based on the first protocol occurs, reconnection may occur according to Fuchs based on the second protocol. Therefore, the transmission of Nabutovsky Fig. 6A 610 is based on the second protocol after the reconnection.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Fuchs’ reconnection based on a second communication protocol with primary reference Nabutovsky. One of ordinary skill in the art would be motivated to enhance reliability of network connection between devices.
Regarding Claim 19, Nabutovsky in view of Fuchs teaches The method of claim 18, further comprising:
calculating projected missing historical data indicative of an analyte level (
“Any glucose trace gaps less than 45 minutes had missing values imputed with the nearest observation or average of nearest observations if both were available (the observations immediately before or after the gap).” Nabutovsky ¶ 314.); and
displaying the projected missing historical data indicative of the analyte level on the analyte trend graph of the analyte monitoring software application (
“As embodied herein, the second device can also output the requested historical analyte data to a display of the second device, such as, for example to a glucose trend graph of a sensor results GUI, such as those described with respect to FIGS. 2D to 2I. For example, As embodied herein, the requested historical analyte data can be used to fill in gaps in a glucose trend graph by displaying the requested historical analyte data along with previously received analyte data.” Nabutovsky ¶ 123.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Nabutovsky’s displaying missing data with Nabutovsky’s other teachings. One of ordinary skill in the art would be motivated to provide visual representation of the data for a user’s easy reviewing. After the combination of these embodiments, projected missing historical data along with backfilled missing history data could be displayed in the analyte trend graph.).
Regarding Claim 21, Nabutovsky in view of Fuchs teaches The method of claim 17, wherein the first wireless communication protocol is a Bluetooth or Bluetooth Low Energy wireless communication protocol (“Example wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC) and others. Users can view and use applications installed in memory on reader device 120 using screen 122 (which, in many embodiments, can comprise a touchscreen), and input 121. A device battery of reader device 120 can be recharged using power port 123.” Nabutovsky ¶ 72.).
Regarding Claim 22, Nabutovsky in view of Fuchs teaches The method of claim 17, wherein the second wireless communication protocol is a Near Field Communication protocol (“Example wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC) and others. Users can view and use applications installed in memory on reader device 120 using screen 122 (which, in many embodiments, can comprise a touchscreen), and input 121. A device battery of reader device 120 can be recharged using power port 123.” Nabutovsky ¶ 72.).
Regarding Claim 23, Nabutovsky in view of Fuchs teaches The method of claim 17, wherein the second wireless communication protocol is different from the first wireless communication protocol (
“For example, if a user 109 of remote device 104 is going to move to a distance from telematics device 106 such that second wireless network protocol 112 can no longer be established or maintained between telematics device 106 and remote device 104, then user 109 can request to switch communication session to first wireless network protocol 110. ” Fuchs ¶ 58.
Nabutovsky already teaches losing connection due to distance between devices, stating “A disconnection event can also result from the first device being moved outside a wireless communication range of the second device, from the presence of a physical barrier that obstructs the first device and/or the second device, or from anything that otherwise prevents wireless communications from occurring between the first and second devices.” Nabutovsky ¶ 120.
After Nabutovsky is combined with Fuchs, when the disconnection based on the first protocol occurs, reconnection may occur according to Fuchs based on the second protocol. Therefore, the transmission of Nabutovsky Fig. 6A 610 is based on the second protocol after the reconnection.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Fuchs’ reconnection based on a second communication protocol with primary reference Nabutovsky. One of ordinary skill in the art would be motivated to enhance reliability of network connection between devices. “For example, if a user 109 of remote device 104 is going to move to a distance from telematics device 106 such that second wireless network protocol 112 can no longer be established or maintained between telematics device 106 and remote device 104, then user 109 can request to switch communication session to first wireless network protocol 110. ” Fuchs ¶ 58.
Regarding Claim 45, Nabutovsky in view of Fuchs teaches The method of claim 17, wherein the missing historical data indicative of the analyte level is associated with a gap on the analyte trend graph of the analyte monitoring software application (
“Any glucose trace gaps less than 45 minutes had missing values imputed with the nearest observation or average of nearest observations if both were available (the observations immediately before or after the gap). For a longer gap, each missing value was imputed with the average of the observations at the same time in previous and next days.” Nabutovsky ¶ 314.
“Example embodiments of methods for data backfilling in an analyte monitoring system will now be described. In accordance with the disclosed subject matter, gaps in analyte data and other information can result from interruptions to communication links between various devices in an analyte monitoring system 100.” Nabutovsky ¶ 118.).
Regarding Claim 46, Nabutovsky in view of Fuchs teaches The method of claim 17, wherein the predetermined threshold comprises a predetermined number of hours of missing historical data indicative of the analyte level (
“Any glucose trace gaps less than 45 minutes had missing values imputed with the nearest observation or average of nearest observations if both were available (the observations immediately before or after the gap). For a longer gap, each missing value was imputed with the average of the observations at the same time in previous and next days.” Nabutovsky ¶ 314.
“Example embodiments of methods for data backfilling in an analyte monitoring system will now be described. In accordance with the disclosed subject matter, gaps in analyte data and other information can result from interruptions to communication links between various devices in an analyte monitoring system 100.” Nabutovsky ¶ 118.
The missing historical data is mapped to missing data that responsible for the data gaps.
The predetermined threshold amount of data is mapped to the data collected within 45 minutes.
The 45 minutes’ worth of data is only an example. The Examiner also conducts KSR obviousness-to-try analysis: – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. For example, there are predictable solutions of 1-45 minutes as integer threshold solutions or (1 minute, 1 hour, 1 day (24 hours), or 1 month) as other threshold solutions. Using these threshold values to replace 45 minutes would produce predictable results.).
Regarding Claim 48, Nabutovsky teaches An analyte monitoring system, comprising:
a sensor control device (sensor control device 102 including in-vivo sensor) configured to be worn on skin of a subject (person), the sensor control device comprising an analyte sensor, wherein a portion of the analyte sensor is configured to be positioned through the skin and in fluid contact with a bodily fluid of the subject, and wherein the portion of the analyte sensor is further configured to sense an analyte level in the bodily fluid (
“FIG. 1 is a conceptual diagram depicting an example embodiment of an analyte monitoring system 100 that includes a sensor applicator 150, a sensor control device 102, and a reader device 120. Here, sensor applicator 150 can be used to deliver sensor control device 102 to a monitoring location on a user's skin where a sensor 104 is maintained in position for a period of time by an adhesive patch 105. Sensor control device 102 is further described in FIGS. 2B and 2C, and can communicate with reader device 120 via a communication path 140 using a wired or wireless technique. ” Nabutovsky ¶ 72.
“In vivo monitoring systems can include a sensor that, while positioned in vivo, makes contact with the bodily fluid of the user and senses the analyte levels contained therein. The sensor can be part of the sensor control device that resides on the body of the user and contains the electronics and power supply that enable and control the analyte sensing. The sensor control device, and variations thereof, can also be referred to as a ‘sensor control unit,’ an ‘on-body electronics’ device or unit, an ‘on-body’ device or unit, or a ‘sensor data communication’ device or unit, to name a few. ” Nabutovsky ¶ 70.
“To increase patient adherence to a plan of frequent glucose monitoring, in vivo analyte monitoring systems can be utilized, in which a sensor control device may be worn on the body of an individual who requires analyte monitoring. To increase comfort and convenience for the individual, the sensor control device may have a small form-factor and can be applied by the individual with a sensor applicator. The application process includes inserting at least a portion of a sensor that senses a user's analyte level in a bodily fluid located in a layer of the human body, using an applicator or insertion mechanism, such that the sensor comes into contact with a bodily fluid.” Nabutovsky ¶ 5.),
wherein the sensor control device (sensor control device 102) further comprises wireless communication circuitry of the sensor control device configured to communicate with a reader device (reader device 120) via a first wireless communication protocol and a second wireless communication protocol (“FIG. 1 is a conceptual diagram depicting an example embodiment of an analyte monitoring system 100 that includes a sensor applicator 150, a sensor control device 102, and a reader device 120. Here, sensor applicator 150 can be used to deliver sensor control device 102 to a monitoring location on a user's skin where a sensor 104 is maintained in position for a period of time by an adhesive patch 105. Sensor control device 102 is further described in FIGS. 2B and 2C, and can communicate with reader device 120 via a communication path 140 using a wired or wireless technique. Example wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC) and others. Users can view and use applications installed in memory on reader device 120 using screen 122 (which, in many embodiments, can comprise a touchscreen), and input 121. A device battery of reader device 120 can be recharged using power port 123.” Nabutovsky ¶ 72.); and
the reader device (reader device 120), comprising:
wireless communication circuitry of the reader device configured to receive the data indicative of the analyte level from the sensor control device via the first wireless communication protocol (“FIG. 1 is a conceptual diagram depicting an example embodiment of an analyte monitoring system 100 that includes a sensor applicator 150, a sensor control device 102, and a reader device 120. Here, sensor applicator 150 can be used to deliver sensor control device 102 to a monitoring location on a user's skin where a sensor 104 is maintained in position for a period of time by an adhesive patch 105. Sensor control device 102 is further described in FIGS. 2B and 2C, and can communicate with reader device 120 via a communication path 140 using a wired or wireless technique. Example wireless protocols include Bluetooth, Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), Near Field Communication (NFC) and others. Users can view and use applications installed in memory on reader device 120 using screen 122 (which, in many embodiments, can comprise a touchscreen), and input 121. A device battery of reader device 120 can be recharged using power port 123.” Nabutovsky ¶ 72.); and
one or more processors coupled with a memory, the memory storing an analyte monitoring software application, wherein the analyte monitoring software application, when executed by the one or more processors, causes the one or more processors to (
“Users can view and use applications installed in memory on reader device 120 using screen 122 (which, in many embodiments, can comprise a touchscreen), and input 121. A device battery of reader device 120 can be recharged using power port 123.” Nabutovsky ¶ 72.
“In accordance with the disclosed subject matter, to some embodiments, a system to establish an analyte monitor regimen is also provided. The system includes a sensor control device comprising an analyte sensor coupled with sensor electronics, the sensor control device configured to transmit data indicative of an analyte level, and, a reader device comprising a display, wireless communication circuitry configured to receive the data indicative of the analyte level, and one or more processors coupled with a memory, the memory configured to store instructions that, when executed by the one or more processors, cause the one or more processors to output to the display an analyte level measurement, wherein after six months of initiating an analyte monitor regimen using the system for a type 2 diabetic patient having a predetermined comorbidity, a rate of hospitalization for a predetermined diagnostic category of the selected patient having the predetermined comorbidity can be reduced by at least 12% relative to an average rate of hospitalization for a predetermined diagnostic category of selected patients having the predetermined comorbidity without the continuous glucose monitor regimen..” Nabutovsky ¶ 18.):
ing the missing historical data indicative of the analyte level (
“Example embodiments of methods for data backfilling in an analyte monitoring system will now be described. In accordance with the disclosed subject matter, gaps in analyte data and other information can result from interruptions to communication links between various devices in an analyte monitoring system 100.” Nabutovsky ¶ 118.
The missing historical data are mapped to “gaps in analyte data” and data to be backfilled.
Nabutovsky teaches requesting missing historical data due to connection interruption, stating “At Step 606, the communication link is re-established between the first device and the second device (e.g., the first device comes back into the wireless communication range of the second device). Upon reconnection, the second device requests historical analyte data according to a last lifecount metric for which data was received. In accordance with the disclosed subject matter, the lifecount metric can be a numeric value that is incremented and tracked on the second device in units of time (e.g., minutes), and is indicative of an amount of time elapsed since the sensor control device was activated.” Nabutovsky ¶ 121.), and
receive from the sensor control device
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Nabutovsky teaches requesting missing historical data due to connection interruption, stating “At Step 606, the communication link is re-established between the first device and the second device (e.g., the first device comes back into the wireless communication range of the second device).” Nabutovsky ¶ 121.
“As embodied herein, the second device can also output the requested historical analyte data to a display of the second device, such as, for example to a glucose trend graph of a sensor results GUI, such as those described with respect to FIGS. 2D to 2I. For example, As embodied herein, the requested historical analyte data can be used to fill in gaps in a glucose trend graph by displaying the requested historical analyte data along with previously received analyte data.” Nabutovsky ¶ 123.), and
wherein the sensor control device is configured to transmit (Fig. 6A 608, 610), in response to a Fig. 6A 610)
“Example embodiments of methods for data backfilling in an analyte monitoring system will now be described. In accordance with the disclosed subject matter, gaps in analyte data and other information can result from interruptions to communication links between various devices in an analyte monitoring system 100.” Nabutovsky ¶ 118.
The missing historical data are mapped to “gaps in analyte data” and data to be backfilled.
Nabutovsky teaches requesting missing historical data due to connection interruption, stating “At Step 606, the communication link is re-established between the first device and the second device (e.g., the first device comes back into the wireless communication range of the second device). Upon reconnection, the second device requests historical analyte data according to a last lifecount metric for which data was received. In accordance with the disclosed subject matter, the lifecount metric can be a numeric value that is incremented and tracked on the second device in units of time (e.g., minutes), and is indicative of an amount of time elapsed since the sensor control device was activated.” Nabutovsky ¶ 121.).
Nabutovsky’s first embodiment does not explicitly disclose:
determine whether there is missing historical data indicative of the analyte level which exceeds a predetermined threshold amount of data,
in response to a determination that the predetermined threshold is exceeded, prompt a user to request of the missing historical data;
the request is user-initiated; and
transmitting the missing historical data via a second wireless communication protocol.
Nabutovsky’s second embodiment teaches:
determine whether there is missing historical data indicative of the analyte level which exceeds a predetermined threshold amount of data (
“Any glucose trace gaps less than 45 minutes had missing values imputed with the nearest observation or average of nearest observations if both were available (the observations immediately before or after the gap). For a longer gap, each missing value was imputed with the average of the observations at the same time in previous and next days.” Nabutovsky ¶ 314.
“Example embodiments of methods for data backfilling in an analyte monitoring system will now be described. In accordance with the disclosed subject matter, gaps in analyte data and other information can result from interruptions to communication links between various devices in an analyte monitoring system 100.” Nabutovsky ¶ 118.
The missing historical data is mapped to missing data that responsible for the data gaps.
The predetermined threshold amount of data is mapped to the data collected within 45 minutes.
The 45 minutes’ worth of data is only an example. The Examiner also conducts KSR obviousness-to-try analysis: – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. For example, there are predictable solutions of 1-45 minutes as integer threshold solutions or (1 minute, 1 hour, 1 day, or 1 month) as other threshold solutions. Using these threshold values to replace 45 minutes would produce predictable results.
This mapping is also consistent with the specification, which states, “According to some embodiments, analyte monitoring software application can be configured to monitor for gaps in historical analyte data that exceed a predetermined threshold (e.g., more than two (2) hours of missing historical analyte data, more than three (3) hours of missing historical analyte data, or more than four (4) hours of missing historical analyte data). Those of skill in the art will understand that the example predetermined thresholds are illustrative only, and other thresholds can be implemented.” Spec. ¶ 83.
After the combination of Nabutovsky’s first and second embodiments, after the system determines that the gap is significant enough, the system would make request to backfill the data from the sensor device.);
in response to a determination that the predetermined threshold is exceeded, request of the missing historical data (
After the combination of Nabutovsky’s first and second embodiments, after the system determines that the gap is significant enough, the system would make request to backfill the data from the sensor device.);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Nabutovsky’s determination of missing data with Nabutovsky’s other teachings. One of ordinary skill in the art would be motivated to more efficiently backfill data. The missing data are backfilled when a relatively large amount of data are needed. For a small amount missing data, they could be interpolated. Fewer connections are made and only for more significant amount of data.
Nabutovsky’s earlier embodiments do not explicitly disclose prompting a user to confirm the request; the request is user-initiated; and transmitting data via a second wireless communication protocol.
Nabutovsky’s third embodiment teaches
prompting a user to confirm the request (“(e.g., dismissing the check sensor system alarm, pressing a confirmation ‘OK’ button 1142, etc.).” Nabutovsky ¶ 169. “. . . reader device 120 can visually display an alert or prompt for a confirmation by the user.” Nabutovsky ¶ 139. After this teaching is combined with Nabutovsky’s first and second embodiments, the request of the missing historical data requires confirmation from the user.);
the request is user-initiated (when the request is user confirmed, the request is user-initiated).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Nabutovsky’ user confirmation with Nabutovsky’s other teachings. One of ordinary skill in the art would be motivated to provide user with more control of a software system. A user could intervene by granting or denying a request.
Nabutovsky does not explicitly disclose:
transmitting data via a second wireless communication protocol.
Fuchs teaches transmitting data via a second wireless communication protocol (
“For example, if a user 109 of remote device 104 is going to move to a distance from telematics device 106 such that second wireless network protocol 112 can no longer be established or maintained between telematics device 106 and remote device 104, then user 109 can request to switch communication session to first wireless network protocol 110. ” Fuchs ¶ 58.
Nabutovsky already teaches losing connection due to distance between devices, stating “A disconnection event can also result from the first device being moved outside a wireless communication range of the second device, from the presence of a physical barrier that obstructs the first device and/or the second device, or from anything that otherwise prevents wireless communications from occurring between the first and second devices.” Nabutovsky ¶ 120.
After Nabutovsky is combined with Fuchs, when the disconnection based on the first protocol occurs, reconnection may occur according to Fuchs based on the second protocol. Therefore, the transmission of Nabutovsky Fig. 6A 610 is based on the second protocol after the reconnection.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Fuchs’ reconnection based on a second communication protocol with primary reference Nabutovsky. One of ordinary skill in the art would be motivated to enhance reliability of network connection between devices. “For example, if a user 109 of remote device 104 is going to move to a distance from telematics device 106 such that second wireless network protocol 112 can no longer be established or maintained between telematics device 106 and remote device 104, then user 109 can request to switch communication session to first wireless network protocol 110. ” Fuchs ¶ 58.
Claims 49-50 and 52-56 are substantially similar to Claims 18-19, 21-23, and 45-46. The rejection analyses based on Nabutovsky in view of Fuchs for Claims 18-19, 21-23, and 45-46 are also applied to Claims 49-50 and 52-56.
Claims 20 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Nabutovsky in view of Fuchs as applied to Claim 19 or 50, in further view of Rucker et al. (US 20170061360 A1).
Regarding Claim 20, Nabutovsky in view of Fuchs teaches The method of claim 19, wherein the projected missing historical data is displayed
“As embodied herein, the second device can also output the requested historical analyte data to a display of the second device, such as, for example to a glucose trend graph of a sensor results GUI, such as those described with respect to FIGS. 2D to 2I. For example, As embodied herein, the requested historical analyte data can be used to fill in gaps in a glucose trend graph by displaying the requested historical analyte data along with previously received analyte data.” Nabutovsky ¶ 123.
The Examiner has explained that After Nabutovsky is combined with Fuchs, when the disconnection based on the first protocol occurs, reconnection may occur according to Fuchs based on the second protocol. Therefore, the transmission of Nabutovsky Fig. 6A 610 is based on the second protocol after the reconnection. The previously received analyte data are based on the first wireless communication protocol.
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).
Nabutovsky in view of Fuchs does not explicitly disclose displaying in a color or line pattern different for segments of the trend line.
Rucker teaches displaying in a color or line pattern different for segments of the trend line (“For example, a task bar or trend-line can be segmented in different colors or shading to indicate who was assigned to a task during a particular period of time, to indicate a future task that has not been assigned to a worker yet, etc.” Rucker ¶ 54.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Rucker’s different-color representation with Nabutovsky in view of Fuchs. One of ordinary skill in the art would be motivated to distinguish different parts of a trendline based on attributes of the data. More contextual information is provided to the user as a result.
Claim 51 is substantially similar to Claim 20. The rejection analyses based on Nabutovsky in view of Fuchs and Rucker for Claim 20 are also applied to Claim 51.
Claims 47 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Nabutovsky in view of Fuchs as applied to Claim 17 or 48, in further view of Nonn et al. (US 20210225020 A1).
Regarding Claim 47, Nabutovsky in view of Fuchs teaches The method of claim 17.
Nabutovsky in view of Fuchs does not explicitly teach wherein the predetermined threshold comprises a predetermined cumulative number of consecutive or non-consecutive data points.
Nonn teaches wherein the predetermined threshold comprises a predetermined cumulative number of consecutive or non-consecutive data points (“3. The method of example 2 wherein identifying the missing region of the point cloud includes determining that the missing region of the point cloud has fewer than a predetermined threshold number of data points.” Nonn ¶ 70. “4. The method of example 2 or example 3 wherein identifying the missing region of the point cloud includes identifying a hole in the point cloud that is larger than a user-defined threshold.” Nonn ¶ 70.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Nonn’s “predetermined threshold number of data points” with Nabutovsky in view of Fuchs. One of ordinary skill in the art would be motivated to conveniently and quickly identify significant missing region or gap of data. “3. The method of example 2 wherein identifying the missing region of the point cloud includes determining that the missing region of the point cloud has fewer than a predetermined threshold number of data points.” Nonn ¶ 70. It would also have been a Simple substitution of one known element for another to obtain predictable results (KSR). The disclosed different thresholds are known elements and they could be switched to produce predictable results.
Claim 57 is substantially similar to Claim 47. The rejection analyses based on Nabutovsky in view of Fuchs and Nonn for Claim 47 are also applied to Claim 57.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
SHARIFI et al. (US-20200213828-A1): “CONTEXTUALLY PROMPTING USERS TO SWITCH COMMUNICATION MODES.”
Miller et al. (US-11540751-B1):
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Kumar et al. (US-20210378601-A1): “ANALYTE MONITORING SYSTEMS AND METHODS.”
Wedekind et al. (US 20170281060 A1)
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/ZHENGXI LIU/Primary Examiner, Art Unit 2611