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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 30 October 2025 has been entered.
Response to Amendment
The amendments filed 30 October 2025 have been entered. Claims 35-36, 45-47, 49-51, 53-55, and 59-62 are pending; claims 24-25, 44, 48, 52, and 56-58 are cancelled.
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.
Claim(s) 35-36, 45-46, 49-51, 53-55, and 59-62 is/are rejected under 35 U.S.C. 103 as being obvious over Wedekind (US 20170281000 A1) in view of Saint 2019 (US 20190015596 A1), further in view of Mairs (US 20190066831 A1).
Regarding claim 35, Wedekind (US 20170281000 A1) teaches a diabetes management system, comprising:
a continuous glucose monitor (Paragraph 0056-0057, 0077-0084—continuous monitoring of blood glucose values…; Paragraph 0085—continuous analyte sensor 8 can be…an implantable continuous glucose sensor; Continuous analyte sensor 8 including sensor electronics unit 6) configured to
wirelessly transmit glucose data of a user via a first wireless communication method and a second wireless communication method (Paragraph 0008-0022—a plurality of communication protocols can be used for communication between a sensor electronics unit and one or more display devices…a first communication protocol can utilize radio transmission, such as Bluetooth…a second communication protocol can utilize a radio frequency field, such as near field communication; Paragraph 0100—one or more of communication channels 106A-N can utilize different communication protocols from each other….communication channels can use a first communication protocol, such as a radio transmission like Bluetooth, and communication channels 108A-N can use a second, different communication protocol, such as an RF field like NFC or RFID; Communication channels 106 and 108 between display devices 20 and sensor electronics unit 6, Fig. 1C-2A),
the first wireless communication method having a first communication range, and the second wireless communication method having a second communication range (Paragraph 0089—the sensor electronics unit can pair with one or more display devices…can first advertise to pair…using a communication protocol, such as, without limitation, Bluetooth…NFC…and/or any other communication protocol; paragraph 0139—communication protocols can have different ranges…for example, and without limitation, range 506 can be indicative at least in part of the range of RF fields, such as, without limitation, NFC…range 506 can be in the order of centimeters…; Paragraph 0140—range 508 can be indicative at least in part of a second communication protocol…the second communication protocol can utilize radio transmission, such as Bluetooth…range 508 can be over approximately thirty feet…),
wherein the first wireless communication method requires user action (Paragraph 0148—in some cases, the command to send data can be a command that requests the data to be sent over NFC. Such may be desirable when security is important (e.g., the user wants data to only be sent to close devices); Paragraph 0172—where NFC or RFID is used, transmission 604 can be sent using a tap-to-start initiation…) and
the second wireless communication method is intermittent at predetermined intervals (Paragraph 0066, 0076, 0087, 0091, 0094—the sensor electronics unit can be configured for periodic, systematic, regular, irregular, or aperiodic transmission of sensor information to one or more display devices (e.g., every 1, 2, 5, or 10 minutes or more…the periodic check can occur at a predetermined time intervals and/or after a predetermined number of counts, such as every 5, 10, 15, or any desirable number of minutes…),
wherein the second communication range is greater than the first communication range (paragraph 0139—communication protocols can have different ranges…for example, and without limitation, range 506 can be indicative at least in part of the range of RF fields, such as, without limitation, NFC…range 506 can be in the order of centimeters…; Paragraph 0140—range 508 can be indicative at least in part of a second communication protocol…the second communication protocol can utilize radio transmission, such as Bluetooth…range 508 can be over approximately thirty feet…; Paragraph 0148—in some cases, the command to send data can be a command that requests the data to be sent over NFC. Such may be desirable when security is important (e.g., the user wants data to only be sent to close devices); Paragraph 0172—where NFC or RFID is used, transmission 604 can be sent using a tap-to-start initiation…);
a device in wireless communication with the continuous glucose monitor and coupleable to or including a manual insulin pen (Paragraph 0060-0061-- The sensor electronics unit can connect to display devices (e.g., mobile devices, specialized medical receivers), or any of the other display devices described in this disclosure; Paragraph 0068-- a plurality of display devices (e.g., a custom analyte monitoring device, a mobile phone, a tablet, a smart watch, a reference analyte monitor, a medicament delivery device, a medical device and a personal computer) may be configured to wirelessly communicate with the sensor electronics unit; paragraph 0078, 0081— Display Device 20A can be a specialized medical receiver…display device 20E may be a medicament delivery device such as an insulin delivery pen , or other devices for delivery medication…other display devices can include… a medicament delivery device (e.g., Display Device 20E)), the device being configured to perform operations comprising:
wirelessly receiving the glucose data from the continuous glucose monitor via the first wireless communication method upon being moved into the first communication range (Paragraph 0023—a display device can use NFC to power and/or initiate the communication from a sensor electronics unit to the display device; Paragraph 0096-0098—sensor electronics unit 6 and display device 20 can communicate over a plurality of communication protocols over communication channels 106, 108…to transmit information between two or more electronics…using…Bluetooth…NFC… and/or any wired and/or wireless connection; Paragraph 0148—in some cases, the command to send data can be a command that requests the data to be sent over NFC. Such may be desirable when security is important (e.g., the user wants data to only be sent to close devices); Paragraph 0172—where NFC or RFID is used, transmission 604 can be sent using a tap-to-start initiation…), and
wirelessly transmitting the glucose data and other data via the second communication method (Paragraph 0068-- sensor information wirelessly communicated by the sensor electronics unit…may include, for example and without limitation, sensor data, such as raw data and/or transformed sensor data, such as analyte concentration values, rate of change information, trend information, alert information, sensor diagnostic information, calibration information, temperature readings or non-visual information such as sound, etc; Paragraph 0078--As will be discussed in greater detail below, Display Devices 20A-E may also communicate amongst each other and/or through each other to Analyte Sensor System 4; Paragraph 0100-0101—communication between each of the display devices 20A-N can use any of the communication protocols described in this disclosure, including radio transmission (e.g., Bluetooth) or RF fields (e.g., NFC or RFID)…can transmit data (e.g. estimated blood glucose levels, pairing information, information about a sensor electronics unit 6, calibration information, timing information…raw sensor data, system status information, detected faults, alerts…commands/requests…to one another; Paragraph 0100-0101—communication between each of the display devices 20A-N can use any of the communication protocols described in this disclosure, including radio transmission (e.g., Bluetooth) or RF fields (e.g., NFC or RFID)…can transmit data (e.g. estimated blood glucose levels, pairing information, information about a sensor electronics unit 6, calibration information, timing information…raw sensor data, system status information, detected faults, alerts…commands/requests…to one another));
and a mobile application on a remote computing device (Paragraph 0077—display devices 20A-E can run a software application, such as a mobile application…) configured to perform operations comprising:
receiving the glucose data and other data automatically via the second wireless communication method from the device (Paragraph 0100—one or more of communication channels 106A-N can utilize different communication protocols from each other….communication channels can use a first communication protocol, such as a radio transmission like Bluetooth, and communication channels 108A-N can use a second, different communication protocol, such as an RF field like NFC or RFID; Communication channels 106 and 108 between display devices 20 and sensor electronics unit 6, Fig. 1C-2B),
wherein the device is configured to wirelessly receive the glucose data via direct communication from the continuous glucose monitor only via the first wireless communication method (Paragraph 0100—one or more of communication channels 106A-N can utilize different communication protocols from each other….one or more of Communication Channels 108A-N can utilize different communication protocols from each other…in some cases, any of Communication Channels 106A-N can utilize the same communication protocols as any of Communication Channels 108A-N…in some cases, any of Communication Channels 106A-N can utilize different communication protocols as any of Communication Channels 108A-N. That is, it is appreciated that any kind of permutation of different communication protocols can be used as the Communication Channels 106A-N, 108A-N between Sensor Electronics Unit 6 and Display Devices 20A-N…communication channels can use a first communication protocol, such as a radio transmission like Bluetooth, and communication channels 108A-N can use a second, different communication protocol, such as an RF field like NFC or RFID; Communication channels 106 and 108 between display devices 20 including a medicament delivery device or specialized receiver and sensor electronics unit 6, Fig. 1C-2B), and
wherein the device is configured to wirelessly transmit the other data and the glucose data via direct communication to the mobile application only via the second wireless communication method (Paragraph 0100—one or more of communication channels 106A-N can utilize different communication protocols from each other…one or more of Communication Channels 108A-N can utilize different communication protocols from each other... in some cases, any of Communication Channels 106A-N can utilize the same communication protocols as any of Communication Channels 108A-N…in some cases, any of Communication Channels 106A-N can utilize different communication protocols as any of Communication Channels 108A-N. That is, it is appreciated that any kind of permutation of different communication protocols can be used as the Communication Channels 106A-N, 108A-N between Sensor Electronics Unit 6 and Display Devices 20A-N…communication channels can use a first communication protocol, such as a radio transmission like Bluetooth, and communication channels 108A-N can use a second, different communication protocol, such as an RF field like NFC or RFID; Paragraph 0101--Display Device 20A and Display Device 20C are configured to communication with each other…any other display device, including any of Display Devices 20A-N, can instead be used. Display Devices 20A,C can communicate with each other through Communication Channel 259. Over Communication Channel 259, Display Devices 20A,C can utilize any communication protocol described in this disclosure. By way of illustrative example, and without limitation, Display Devices 20A,C can communicate with each other using an RF field such as NFC or RFID; Communication channels 106 and 108 between display devices 20 including a mobile phone and sensor electronics unit 6 and communication channel 259 between two display devices 20, Fig. 1C-2B).
In particular, Wedekind demonstrates that direct communication may be present between the mobile application and the continuous glucose monitor as well as between the device and the continuous glucose monitor as shown in Figs. 1C-2B. Furthermore, as Wedekind discloses that “any kind of permutation of different communication protocols can be used as the communication channels 106A-N, 108A-N between Sensor Electronics Unit 6 and Display Devices 20A-N” which, in combination with the various described scenarios of any communication channels 106A-N sharing the same communication protocols as any of communication channels 108A-N and using different communication protocols from each other, it is clear that Wedekind supports the use of a same, first communication protocol for transmitting data back and forth between the continuous glucose monitor and a first device (e.g. a medicament delivery device or accessory thereof) and a different communication protocol for transmitting data back and forth between the first device and a second device (e.g. a mobile phone or application thereof).
Wedekind discloses that the system may include an insulin delivery pen or “other devices for delivery medication” (Paragraph 0078-- Display device 20E alternatively or in addition to being a display device, may be a medicament delivery device that can act cooperatively with Analyte Sensor System 4 to deliver medicaments to Host 2. By way of illustration, and without limitation, Display Device 20E can be an insulin delivery pump, an insulin delivery pen, or other devices for delivery medication) and display devices such as “specialized medical receivers” (Paragraph 0060).
However, Wedekind fails to specifically disclose the device is a pen cap releasably coupleable to a manual insulin pen and configured to perform operations comprising: detecting one or more dosing events of the manual insulin pen, wherein a dosing event is inferred from a decapping event of the pen cap from the manual insulin pen and a capping event of the pen cap to the manual insulin pen, and determining timing data corresponding to the one or more dosing events; and a mobile application on a remote computing device configured to perform operations comprising: analyzing the glucose data in combination with the timing data, wherein the analyzing comprises identifying one or more patterns in the glucose data and the timing data, and outputting, on a display, a coaching message based on the analysis of the glucose data and the timing data.
Saint 2019, in the same field of endeavor of a medication management system to be used in diabetes (Paragraph 0004-0007), teaches a system including
a pen cap releasably coupleable to a manual insulin pen (Paragraph 0022-0024--The smart cap according to the disclosed technology can be designed to be placed on or integrated with a conventional medication pen, such as an insulin pen or other type of medication pen) and configured to perform operations comprising:
detecting one or more dosing events of the manual insulin pen, wherein a dosing event is inferred from a decapping event of the pen cap from the manual insulin pen and a capping event of the pen cap to the manual insulin pen (Paragraph 0024-0025--smart cap 100 can be designed to transmit the tracked data when the smart cap 100 is removed from the pen; Paragraph 0039-0040--In some implementations, the smart cap is designed to simply transmit that a dose delivery of the constant dose has occurred (e.g., whenever the smart cap is removed or replaced from the medication pen)…).
It would have been obvious to one having ordinary skill in the device to modify the system of Wedekind to utilize a smart pen cap as described by Saint 2019 as a mobile device as the smart pen cap may be seen as a simple substitution for the example embodiments of the mobile devices of a specialized medical receiver or medicament delivery device (e.g. an insulin delivery pen) as each of these devices is known in the art and directly interfaces with a medicament delivery component, while the dosing data provided by the smart cap of Saint 2019 may be substituted for the “other data” (described above) or additionally transmitted in the Wedekind system to would predictably improve the ability of the system to manage a user’s diabetes by monitoring the occurrence of dosing actions which would affect a user’s blood glucose levels.
Saint 2019 additionally discloses the pen cap is configured to perform operations comprising determining timing data corresponding to one or more dosing events of the at least one drug injection device (Paragraph 0022—tracking the time of delivery; paragraph 0039-0040-- each time the smart cap is removed from the medication pen (or replaced), the smart cap can transmit the dialed-in constant dose to the companion device, such as a smartphone…In some implementations, the smart cap is designed to simply transmit that a dose delivery of the constant dose has occurred (e.g., whenever the smart cap is removed or replaced from the medication pen)… ; Paragraph 0046-0048, 0055-0061-- reports can provide average daily amounts of correction and carb covering insulin…reports can provide percentages of fast-acting insulin used for glucose level correction and for covering carbs, and possibly also long-acting insulin… The process to optimize treatment recommendations and/or conditions can include receiving or determining a minimum time between doses that is based on a last dose size…NOTE: these determinations make clear that Saint determines timing data such as time of delivery, dosage amount, and type of insulin delivered). In one example, the user sets a particular dose size and the application assumes that the user set dose was delivered each time a transmission is received from the smart cap);
And a mobile application on a remote computing device (Paragraph 0040--companion device, such as on a smartphone using a smartphone application (also referred to as an “app”)) is configured to perform operations comprising:
analyzing the glucose data in combination with the timing data (Paragraph 0046-0048, 0055-0061-- reports can provide average daily amounts of correction and carb covering insulin…reports can provide percentages of fast-acting insulin used for glucose level correction and for covering carbs, and possibly also long-acting insulin…When additional insulin delivery is needed based on the tracking of the blood sugar level and the insulin delivery tracking… applying an artificial pancreas algorithm to implement a minimum correction dose delivery using an insulin pen system includes tracking a blood sugar level (e.g., glucose level) of a user and tracking at least one dose amount of insulin delivered to the user... The process to optimize treatment recommendations and/or conditions can include receiving or determining a minimum time between doses that is based on IOB, e.g., where the prompting of the user to administer the additional dose is delayed to wait longer when more insulin is active (on board) in the user's body),
and
outputting, on a display, a coaching message based on the analysis of the glucose data and the timing data (Paragraph 0050-- When active (e.g., by user touch selection), the active delivery setting can provide an alarm, such as a sound, a light, a text message, etc., through the companion device, the smart cap, a smart pen, or a combination of the devices. The alarm can remind the user to administer the medication delivery as indicated on the active delivery settings; paragraph 0055-- When additional insulin delivery is needed based on the tracking of the blood sugar level and the insulin delivery tracking, an alarm can be sent through the pen system to alert the user that the user should administer another dose of insulin, including the dose amount).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Wedekind with the additional timing data determination and related analysis of the timing data and glucose data together of Saint 2019 in order to predictably improve the ability of the system to accurately track and estimate insulin and glucose levels and provide recommendations for maintaining a safe blood glucose levels by monitoring both glucose and insulin delivery history while also improving user experience and compliance by reducing a number of injections needed (by monitoring an amount of time between injections and thus allowing for a next dose and a correction dose to potentially be combined).
While the combined system of Wedekind and Saint 2019 discloses the analysis of the glucose data in combination with the timing data and the outputting of a coaching message based on the analysis, the combination does not explicitly disclose wherein the analysis comprises identifying one or more patterns in the glucose data and the timing data.
Mairs, in the same field of endeavor of medical devices and patient management systems for monitoring the condition of a diabetic patient (Paragraph 0004-0021), discloses a system which analyzes data by identifying one or more patterns in the data (see Fig. 1, 14, and 17-18—Observed Patterns & Some Possible Causes; paragraph 0047, 0063-0067-- event pattern(s) detected or otherwise identified based on measurement data for the user's physiological condition… After obtaining the measurement data for the evaluation period, the snapshot presentation process 300 continues by identifying a plurality of different monitoring periods within the evaluation period, identifying event detection thresholds or other parameters or criteria used for detecting event patterns based on the measurement data, and then analyzing the measurement data associated with each of the different monitoring periods with respect to the event detection thresholds to identify event patterns occurring within the respective monitoring periods (tasks 304, 306, 308).) and outputting, on a display, a coaching message based on the analysis of the data (See display of Fig. 1, 14, and 17-18; paragraph 0047, 0156-- information pertaining to a displayed event pattern may be analyzed in connection with other therapeutic or physiological information associated with the patient to identify a remedial action that could potentially resolve, mitigate, correct or otherwise address the event pattern (e.g., adding a new medication, adjusting dosages or delivery rates, and the like) and provide corresponding graphical indicia of the remedial action in connection with the displayed event pattern). While Mairs does not disclose the data being analyzed includes both glucose data and timing data, Mairs does clearly disclose that analyzed patterns in the glucose data may correspond to various patterns of timing data, where the timing data would include a time or amount of a dose and where the patient may be recommended actions relating to the timing data to modify the pattern in the glucose data (See Fig. 1, 14, and 17-18, “Some Possible Causes” include medications or insulin being omitted, too slow, incorrectly timed, too low, too high, etc. while remedial action recommendations may include reducing or increasing an insulin dose; paragraph 0154, 0164, 0180-0181, 0184-- based on the type of event pattern detected, the patient's current therapy regimen, and the patient's physiological condition, recommended modifications or adjustments to the patient's current therapy regimen may be determined and indicated on the snapshot GUI display…the displayed therapy regimen information 1710 includes a listing of the medications or other medicaments the patient is currently taking. In the illustrated embodiment, the current patient therapy information 1710 indicates the patient administers basal insulin injections in the evening and also administers meal-time insulin… The list of potential causes may be personalized or otherwise tailored for the medications or classes of medications corresponding to the patient's current therapy regimen (e.g., a possible cause related to insulin will not be displayed if the patient is not taking insulin).).
As the combination of Wedekind with Saint 2019 discloses the monitoring and analysis of both glucose data and timing data and Mairs discloses the analyzing of patient data for patterns where the patterns include patterns in glucose data which may correspond to patterns in timing data, it would have been obvious to one having ordinary skill in the art at the time of filing to modify the combination of Wedekind and Saint 2019 to include the pattern analysis of Mairs in order to determine patterns in the measured glucose data and timing data to predictably improve patient outcomes by monitoring blood glucose and timing together to determine if shifts in blood glucose are caused by particular dosing habits which are indicated by timing data (such as chronically over-dosing around a particular mealtime, see Mairs Fig. 1, column 2), in order to provide suggestions for avoiding or altering behaviors which are consistently leading to periods of poor control or high-risk blood glucose levels.
Regarding claim 36, the combination of Wedekind, Saint 2019, and Mairs teaches the diabetes management system of claim 35, wherein the first wireless communication method is a near-field communication method, and the second wireless communication method is a wireless method with a larger radio frequency (paragraph 0139—communication protocols can have different ranges…for example, and without limitation, range 506 can be indicative at least in part of the range of RF fields, such as, without limitation, NFC…range 506 can be in the order of centimeters…; Paragraph 0140—range 508 can be indicative at least in part of a second communication protocol…the second communication protocol can utilize radio transmission, such as Bluetooth…range 508 can be over approximately thirty feet…)
Regarding claim 45, the combination of Wedekind, Saint 2019, and Mairs teaches the system of claim 35. Saint 2019 further discloses wherein the coaching message comprises a recommendation for a behavioral intervention of the user based on the analysis (Paragraph 0055-0058-- the method can be applied for minimizing correction doses using the insulin pen system, in which the method includes determining when to prompt the user to intake (e.g., eat) an amount of carbohydrates (e.g., to raise blood sugar levels to a predetermined blood sugar level)…The process to optimize treatment recommendations and/or conditions can include receiving or determining a minimum time between doses that is based on a last dose size, e.g., where the prompting of the user to administer an additional dose is applied with respect to the minimum time and is thereby delayed longer after larger doses. The process to optimize treatment recommendations and/or conditions can include receiving or determining a minimum time between doses that is based on IOB, e.g., where the prompting of the user to administer the additional dose is delayed to wait longer when more insulin is active (on board) in the user's body).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Wedekind with the coaching message based on additional timing data determination and related analysis of Saint 2019 in order to predictably improve the ability of the system to enable a user to maintain a safe blood glucose levels by providing a recommendation based on both glucose and insulin delivery history.
Mairs additionally discloses wherein the coaching message comprises a recommendation for a behavioral intervention of the user based on the analysis (see Fig. 1, element 126/136/146—“Some Possible Causes” include “exercised before dinner?” etc. and Fig. 14, element 1426—“Consider: reducing evening basal insulin dose by 10%-20%, adding bedtime snack; paragraph 0047-- information pertaining to a displayed event pattern may be analyzed in connection with other therapeutic or physiological information associated with the patient to identify a remedial action that could potentially resolve, mitigate, correct or otherwise address the event pattern (e.g., adding a new medication, adjusting dosages or delivery rates, and the like) and provide corresponding graphical indicia of the remedial action in connection with the displayed event pattern).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of the combined Wedekind and Saint 2019 with the coaching message details of Mairs, which provide suggestions relating to patterns in user behavior which may be creating patterns in blood glucose in order to predictably improve the ability of the system to enable a user to maintain a safe blood glucose levels by providing a recommendation based on both glucose and insulin delivery history.
Regarding claim 46, the combination of Wedekind, Saint 2019, and Mairs teaches the system of claim 45. Saint 2019 further discloses wherein the coaching message comprises a recommendation for a time to administer a dose (Paragraph 0050, 0055-0058-- The process to optimize treatment recommendations and/or conditions can include receiving or determining a minimum time between doses that is based on a last dose size, e.g., where the prompting of the user to administer an additional dose is applied with respect to the minimum time and is thereby delayed longer after larger doses. The process to optimize treatment recommendations and/or conditions can include receiving or determining a minimum time between doses that is based on IOB, e.g., where the prompting of the user to administer the additional dose is delayed to wait longer when more insulin is active (on board) in the user's body).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Wedekind with the coaching message based on additional timing data determination and related analysis of Saint 2019 in order to predictably improve the ability of the system to enable a user to maintain a safe blood glucose levels by providing a recommendation based on both glucose and insulin delivery history.
Regarding claim 49, the combination of Wedekind, Saint 2019, and Mairs teaches the system of claim 35. Mairs additionally discloses wherein the coaching message is based at least in part on the one or more patterns identified by the analysis (see Fig. 1—“Observed Patterns & Some Possible Causes” include “Variable SG-Lunch time”, “Low SG-Pre-Dinner” and “High SG-Fasting time” with messages based on these patterns including “exercised before dinner?” and “Basal insulin injections too high?” etc. and Fig. 14—similarly includes observed patterns of glucose along with related recommendations such as “Consider: reducing evening basal insulin dose by 10%-20%, adding bedtime snack”; paragraph 0047-- information pertaining to a displayed event pattern may be analyzed in connection with other therapeutic or physiological information associated with the patient to identify a remedial action that could potentially resolve, mitigate, correct or otherwise address the event pattern (e.g., adding a new medication, adjusting dosages or delivery rates, and the like) and provide corresponding graphical indicia of the remedial action in connection with the displayed event pattern).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of the combined Wedekind and Saint 2019 with the coaching message details of Mairs, which provide suggestions relating to patterns in user behavior which may be creating patterns in blood glucose in order to predictably improve the ability of the system to enable a user to maintain a safe blood glucose levels by providing a recommendation based on both glucose and insulin delivery history.
Regarding claim 50, the combination of Wedekind, Saint 2019, and Mairs teaches the system of claim 35. Mairs additionally discloses wherein the one or more patterns comprises a recurring glucose pattern for a time of day (See Figs. 1, 14, 17-18—Observed patterns include “Variable SG-Lunch time”, “Low SG-Pre-Dinner” and “High SG-Fasting time” among others which demonstrate a recurring glucose pattern for a time of day).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of the combined Wedekind and Saint 2019 with the glucose pattern determination of Mairs to predictably improve the ability of the system to enable a user to maintain a safe blood glucose levels by monitoring and notifying a user of patterns of poor blood glucose control or risky levels of blood glucose to enable a user to make remedial or intervening actions.
Regarding claim 51, the combination of Wedekind, Saint 2019, and Mairs teaches the system of claim 35. Mairs additionally discloses wherein the coaching message comprises a tip or education regarding health of the user based at least in part on the one or more patterns in the glucose data and the timing data (Figs. 1, 14, 17-18—includes potential causes for blood glucose patterns, which may educate the patient as to the effects of different behaviors, such as exercising around a meal time or eating snacks of inconsistent size or timing; Paragraph 0047, 0094-- information pertaining to a displayed event pattern may be analyzed in connection with other therapeutic or physiological information associated with the patient to identify a remedial action that could potentially resolve, mitigate, correct or otherwise address the event pattern (e.g., adding a new medication, adjusting dosages or delivery rates, and the like) and provide corresponding graphical indicia of the remedial action in connection with the displayed event pattern…Depending upon the embodiment and context of use, the type of information that may be communicated between the system 516 and device 512 may include, but is not limited to, data, programs, updated software, education materials, warning messages, notifications, device settings, therapy parameters, or the like.).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of the combined Wedekind and Saint 2019 with the coaching message details of Mairs, which provide messages relating to patterns in user behavior which may be creating patterns in blood glucose in order to predictably improve the ability of the system to enable a user to maintain a safe blood glucose levels by informing the patient of a connection between their behaviors and blood glucose levels as well as possible remedial actions.
Regarding claim 53, the combination of Wedekind, Saint 2019, and Mairs teaches the system of claim 35. Mairs additionally discloses wherein the coaching message is based at least in part on glucose data received in a time period after a dosing event (See Figs. 1, 14, 17-18—observed patterns of blood glucose may take place around set times, which can include a time period after a dosing event. See also the suggestion of possible causes relating to the timing or dosing of insulin (e.g., an observed pattern of blood glucose around lunch time and a suggestion of improper pre-meal insulin in relation); Paragraph 0064-- the different monitoring periods within the evaluation period include an overnight time period, a fasting time period, a breakfast time period, a lunch time period, and a dinner time period. Additionally, in some embodiments, additional monitoring periods may be identified relative to other events, such as, for example, meal indications corresponding to a meal bolus…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Wedekind with the coaching message of Mairs in order to predictably improve the ability of the system to enable a user to maintain a safe blood glucose levels by providing a recommendation based on both glucose and insulin delivery history, where a message based on glucose data in a time period after a dosing event would predictably enable a user to determine if their dosing behaviors were successful in maintaining an ideal blood glucose level or if they should be modified.
Regarding claim 54, the combination of Wedekind, Saint 2019, and Mairs teaches the system of claim 35. Saint 2019 additionally discloses wherein the coaching message indicates whether the user is underdosing or overdosing for a meal based at least in part on glucose data received in a time period after a dosing event for the meal (Paragraph 0055-0060--The method includes, based on the tracked blood sugar level and dose amount of insulin delivered, determining when to prompt the user to administer an additional dose of insulin, which is based on a determination that a predetermined amount of insulin is needed to lower the blood sugar level to a predetermined blood sugar level).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Wedekind with the coaching message based on additional timing data determination and related analysis of Saint 2019 in order to predictably improve the ability of the system to enable a user to maintain a safe blood glucose levels by providing a recommendation based on both glucose and insulin delivery history.
Mairs additionally discloses wherein the coaching message indicates whether the user is underdosing or overdosing for a meal based at least in part on glucose data received in a time period after a dosing event for the meal (See Figs. 1, 14, 17-18—observed patterns of blood glucose may take place around set times, which can include a time period after a dosing event. See also the suggestion of possible causes relating to the dosing of insulin which indicate under or over-dosing (e.g., an observed pattern of blood glucose around lunch time and a suggestion of improper insulin to carbohydrate ratio, or a low pre-dinner glucose pattern and a suggestion of basal insulin injections being too high); Paragraph 0064-- the different monitoring periods within the evaluation period include an overnight time period, a fasting time period, a breakfast time period, a lunch time period, and a dinner time period. Additionally, in some embodiments, additional monitoring periods may be identified relative to other events, such as, for example, meal indications corresponding to a meal bolus…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Wedekind with the coaching message of Mairs in order to predictably improve the ability of the system to enable a user to maintain a safe blood glucose levels by providing a recommendation based on both glucose and insulin delivery history, where a message based on glucose data in a time period after a dosing event would predictably enable a user to determine if their dosing behaviors were successful in maintaining an ideal blood glucose level or if they should be modified.
Regarding claim 55, the combination of Wedekind, Saint 2019, and Mairs teaches the system of claim 35.Saint 2019 additionally discloses wherein the coaching message is based at least in part on whether the user is adhering to a recommended dose, wherein user adherence to the recommended dose is based on a likelihood of user adherence determined from the analysis (Paragraph 0048—a coaching message may additionally include “a new animated flower blooms every time the dose calculator is used, so that over time many flowers are displayed, indicating that the dose calculator is being utilized frequently. This informs a physician or caregiver at a glance, and helps reinforce good behavior to the user.” To indicate adherence to the calculated dose).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Wedekind with the coaching message based on additional timing data determination and related analysis of Saint 2019 in order to predictably improve the ability of the system to enable a user to maintain a safe blood glucose levels by providing a recommendation based on both glucose and insulin delivery history, where a message based on user adherence would encourage a user to remain compliant and thus maintain a safe blood glucose level.
Mairs additionally discloses wherein the coaching message is based at least in part on whether the user is adhering to a recommended dose, wherein user adherence to the recommended dose is based on a likelihood of user adherence determined from the analysis (See Figs. 1, 14, 17-18—see blood glucose observed patterns and the suggestion of possible causes relating to user adherence (e.g., variable SG may be caused by pre-meal insulin being incorrectly timed, too slow, or omitted); Paragraph 0107-- Where information on the report relates to an individual subject, the diagnostic and therapeutic parameters may be used to assess the health status and relative well-being of that subject, assess the subject's compliance to a therapy, as well as to develop or modify treatment for the subject and assess the subject's behaviors that affect his/her therapy).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Wedekind with the coaching message of Mairs in order to predictably improve the ability of the system to enable a user to maintain a safe blood glucose levels by providing a recommendation based on both glucose and insulin delivery history, where a message based on user adherence would enable a user to understand the consequences of adhering or not adhering to a recommended dosage and to take remedial actions in response.
Regarding claim 59, the combination of Wedekind, Saint 2019, and Mairs teaches the system of claim 35. Saint 2019 additionally discloses wherein the timing data does not include a dose amount (Paragraph 0022—tracking the time of delivery; paragraph 0039-0040--In some implementations, the smart cap is designed to simply transmit that a dose delivery of the constant dose has occurred (e.g., whenever the smart cap is removed or replaced from the medication pen)… ; Paragraph 0046-0048, 0055-0061--reports can provide percentages of fast-acting insulin used for glucose level correction and for covering carbs, and possibly also long-acting insulin… The process to optimize treatment recommendations and/or conditions can include receiving or determining a minimum time between doses that is based on a last dose size…NOTE: these determinations make clear that Saint determines timing data such as time of delivery, dosage amount, and type of insulin delivered). In one example, the user sets a particular dose size and the application assumes that the user set dose was delivered each time a transmission is received from the smart cap).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Wedekind to utilize the particular timing data of Saint 2019 in order to improve the ability of the system to inform a user of whether their dose actions are timed properly or not in order to encourage the user to maintain a safe blood sugar or otherwise suggest remedial actions.
Mairs, similarly discloses that the timing data which may contribute to patterns does not include a dose amount (see Fig. 1, 14, and 17-18—Observed Patterns & Some Possible Causes may include the timing of a dose; paragraph 0047, 0063-0067-- event pattern(s) detected or otherwise identified based on measurement data for the user's physiological condition… After obtaining the measurement data for the evaluation period, the snapshot presentation process 300 continues by identifying a plurality of different monitoring periods within the evaluation period, identifying event detection thresholds or other parameters or criteria used for detecting event patterns based on the measurement data, and then analyzing the measurement data associated with each of the different monitoring periods with respect to the event detection thresholds to identify event patterns occurring within the respective monitoring periods (tasks 304, 306, 308).).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Wedekind to utilize the particular timing data of Mairs in order to improve the ability of the system to inform a user of whether their dose actions are timed properly or not according to the resulting effect on the user’s blood sugar in order to encourage the user to maintain a safe blood sugar or otherwise suggest remedial actions.
Regarding claim 60, the combination of Wedekind, Saint 2019, and Mairs teaches the system of claim 35. Mairs additionally discloses wherein the operations further comprise determining an adjustment to one or more therapy settings based on the one or more patterns (Figs. 1, 14, 17-18; paragraph 0094, 0107, 0154, 0158-0164, 0168-0169, 0226-- the type of information that may be communicated between the system 516 and device 512 may include, but is not limited to, data, programs, updated software, education materials, warning messages, notifications, device settings, therapy parameters, or the like… Where information on the report relates to an individual subject, the diagnostic and therapeutic parameters may be used to assess the health status and relative well-being of that subject, assess the subject's compliance to a therapy, as well as to develop or modify treatment for the subject and assess the subject's behaviors that affect his/her therapy… the server 206 may identify a modification to the dosage or delivery rate of insulin to be delivered by the infusion device 202 during future instances of the monitoring period associated with the highest prioritized detected event pattern; paragraph 0153-- based on the type of event pattern detected, the patient's current therapy regimen, and the patient's physiological condition, recommended modifications or adjustments to the patient's current therapy regimen may be determined and indicated on the snapshot GUI display. In one or more embodiments, logic rules or formula are maintained and utilized to determine how the patient's current therapy regimen should be modified given the patient's current therapy configuration, the patient's physiological condition, the event pattern type, and potentially other patient-specific variables or factors…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Wedekind to utilize the therapy adjustment based on patterns of Mairs in order to improve the ability of the system to aid a user in maintaining a safe blood sugar by performing a remedial action (e.g., a therapy adjustment) when a pattern indicates that a user’s blood sugar has not been adequately managed by current therapy parameters.
Regarding claim 61, the combination of Wedekind, Saint 2019, and Mairs teaches the system of claim 35. Wedekind additionally discloses determining a likelihood of a future hypoglycemic event based on sensor data (Paragraph 0012-0016, 0057, 0188-- The sensor electronics unit may communicate data indicative of analyte levels, such as analyte measurement data or estimated analyte values, to the display device…the sensor electronics unit can include electronics configured to process data, and/or a data stream, associated at least in part with an analyte concentration measured by the continuous analyte sensor in order to generate sensor information that includes raw sensor data, transformed sensor data, and/or any other sensor data or data derived therefrom, e.g., predictive or trend data; paragraph 0136-0137, 0187--whether the host is determined to be in or near hypoglycemia based on currently measured, previously measured and/or predicted glucose concentrations).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Wedekind, which discloses determining a likelihood of a future hypoglycemic event, with the teachings of Mairs relating to a coaching message based on the one or more patterns, in order to provide a coaching message which comprises a likelihood of a future hypoglycemic event based on the one or more patterns as such a message would predictably improve the ability of the system to promote user behavior which maintains a safe blood sugar by notifying a user when a pattern indicates that a user’s blood sugar