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 .
Claims 1-20 are examined in this office action.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4 and 11-14 is/are rejected under 35 U.S.C. 102(1) as being anticipated by Zhong et al. (US Pub No. 20220105269 A1).
Regarding claim 1, Zhong discloses a method (Fig. 8) for determining patterns in an insulin delivery system (system 10A, Fig. 1) to improve a user’s glucose levels over time ("… improve projections of glucose levels …" - Para [0005]), the method comprising:
determining user data corresponding to operational information of an insulin pump of the insulin delivery system and/or user behavior information (Obtain projected levels of glucose in patient over time frame 800, Fig. 8);
determining first glucose data corresponding to a set of blood glucose values of a user of the insulin pump over a first period of time (Obtain projected levels of glucose in patient over time frame 800, Fig. 8) ;
determining an abnormality in the first glucose data based on the glucose data exceeding a threshold value for a second period of time within the first period of time (Determine whether projected levels of glucose leave prescribed range 802, Fig. 8);
determining an action associated with the abnormality and the user data (Detect maintenance event that alters projected levels of glucose such that projected levels of glucose do not leave prescribed range 806, Fig. 8) ;
causing a display to present a message indicative of the action ("Processing circuitry 30 may interfere with user interface 34 to output the graphical alert, examples of which may be shown by way of user interfaces 400A and 400B in FIGS. 4A and 4B." - Para [0145]);
determining second glucose data over a third period of time after the first period of time and after causing the display to present the message ("Processing circuity 30 may … once again obtain a current glucose level." - Para [0145]); and
determining the second glucose data satisfies the threshold value for a fourth time period during the third period of time, the second glucose data indicative of improved glucose levels for the user ("Based on current glucose level, processing circuitry 30 may determine updated projected levels of glucose. Processing circuitry 30 may determine that the projected levels of glucose do not leave the prescribed range." - Para [0145]).
Examiner interprets the first period of time and the second period of time to be the time frame disclosed in step 800 of Fig. 8 and the third period of time and the fourth period of time to be the time period over which the processing circuitry obtains a glucose level as disclosed in Paragraph 0145.
Regarding claim 2, Zhong discloses the method (Fig. 8) as disclosed above, further comprising:
determining the user data corresponds to the second period of time (Determine whether projected levels of glucose leave prescribed range 802, Fig. 8), wherein the user data is indicative of exercise data, infusion site data, insulin delivery data, and/or food data.
Examiner interprets projected levels of glucose to be insulin delivery data.
Regarding claim 3, Zhong discloses the method (Fig. 8) as disclosed above, wherein:
first glucose data ("Processing circuitry of patient device 24 may interface with telemetry circuitry 36 to communicate with sensor 20, whereby processing circuitry may obtain a current glucose level in patient 12. Processing circuitry may determine, based on the current glucose level, the projected levels of glucose in patient 12 over a time frame (800)." - Para [0144], Fig. 8) and the second glucose data ("Processing circuitry may detect the maintenance event and interface with telemetry circuit 36 to communicate with sensor 20 to once again obtain a current glucose level." - Para [0145]) are generated by a blood glucose monitor (sensor 20 (e.g., glucose sensor), Fig. 1).
Regarding claim 4, Zhong discloses the method (Fig. 8) as disclosed above, wherein:
the action corresponds to eating food ("You may need to eat carbs." - Fig. 4B).
Regarding claim 11, Zhong discloses a system (system 10A, Fig. 1) for detecting patterns relating to an insulin delivery system to improve a user’s glucose levels over time ("… improve projections of glucose levels …" - Para [0005]), the system comprising:
memory (memory 32, Fig. 7) configured to store computer-executable instructions("Memory 32 may store program instructions that, when executed by processing circuitry 30, cause processing circuitry 30 to provide the functionality ascribed to patient device 24 throughout this disclosure." - Para [0128]); and
at least one computer processor (processing circuitry 30, Fig. 7) configured to access memory and execute the computer-executable instructions to:
determine user data corresponding to operational information of an insulin pump of the insulin delivery system and/or user behavior information (Obtain projected levels of glucose in patient over time frame 800, Fig. 8);
determine first glucose data corresponding to a set of blood glucose values of a user of the insulin pump over a first period of time (Obtain projected levels of glucose in patient over time frame 800, Fig. 8);
determine an abnormality in the first glucose data based on the glucose data exceeding a threshold value for a second period of time within the first period of time (Determine whether projected levels of glucose leave prescribed range 802, Fig. 8);
determine an action associated with the abnormality and the user data (Detect maintenance event that alters projected levels of glucose such that projected levels of glucose do not leave prescribed range 806, Fig. 8);
cause a display to present a message indicative of the action ("Processing circuitry 30 may interfere with user interface 34 to output the graphical alert, examples of which may be shown by way of user interfaces 400A and 400B in FIGS. 4A and 4B." - Para [0145]);
determine second glucose data over a third period of time after the first period of time and after causing the display to present the message ("Processing circuity 30 may … once again obtain a current glucose level." - Para [0145]); and
determine the second glucose data satisfies the threshold value for a fourth time period during the third period of time, the second glucose data indicative of improved glucose levels for the user ("Based on current glucose level, processing circuitry 30 may determine updated projected levels of glucose. Processing circuitry 30 may determine that the projected levels of glucose do not leave the prescribed range." - Para [0145]).
Examiner interprets the first period of time and the second period of time to be the time frame disclosed in step 800 of Fig. 8 and the third period of time and the fourth period of time to be the time period over which the processing circuitry obtains a glucose level as disclosed in Paragraph 0145.
Regarding claim 12, Zhong discloses the system (system 10A, Fig. 1) as recited above, wherein
the at least one computer processor (processing circuitry 30, Fig. 7) is further configured to access memory and execute the computer-executable instructions to determine the user data corresponds to the second period of time ("Memory 32 may store program instructions that, when executed by processing circuitry 30, cause processing circuitry 30 to provide the functionality ascribed to patient device 24 throughout this disclosure." - Para [0128]), and wherein the user data is indicative of exercise data, infusion site data, insulin delivery data (Determine whether projected levels of glucose leave prescribed range 802, Fig. 8), and/or food data.
Examiner interprets projected levels of glucose to be insulin delivery data.
Regarding claim 13, Zhong discloses the system (system 10A, Fig. 1) as recited above, wherein
first glucose data ("Processing circuitry of patient device 24 may interface with telemetry circuitry 36 to communicate with sensor 20, whereby processing circuitry may obtain a current glucose level in patient 12. Processing circuitry may determine, based on the current glucose level, the projected levels of glucose in patient 12 over a time frame (800)." - Para [0144], Fig. 8) and the second glucose data ("Processing circuitry may detect the maintenance event and interface with telemetry circuit 36 to communicate with sensor 20 to once again obtain a current glucose level." - Para [0145]) are generated by a blood glucose monitor (sensor 20 (e.g., glucose sensor), Fig. 1).
Regarding claim 14, Zhong discloses the system (system 10A, Fig. 1) as recited above, wherein
the action corresponds to eating food ("You may need to eat carbs." - Fig. 4B).
Claim(s) 5 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (US Pub No. 20220105269 A1) in view of Lee et al. (US Pub No. 20240009392 A1).
Regarding claim 5, Zhong in view of Lee discloses the method (Zhong, Fig. 8) as disclosed above, wherein
Zhong does not expressly disclose that the action corresponds to, adjusting operational settings of the insulin pump, and/or removing the insulin pump from the user.
Lee teaches that the action corresponds to, adjusting operational settings of the insulin pump ("... the anticipated basal insulin delivery action may be that insulin delivery from the medicament delivery device may be suspended for at least a portion of the time window." - Para [0046]), and/or removing the insulin pump from the user.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Zhong to include that the action corresponds to, adjusting operational settings of the insulin pump, and/or removing the insulin pump from the user as taught by Lee to output a recommendation on the display for action by the user to adjust their glucose level (Lee, Para [0006]).
Regarding claim 15, Zhong in view of Lee discloses the system (Zhong, system 10A, Fig. 1) as disclosed above, wherein
Zhong does not expressly disclose that the action corresponds to, adjusting operational settings of the insulin pump, and/or removing the insulin pump from the user.
Lee teaches that the action corresponds to, adjusting operational settings of the insulin pump ("... the anticipated basal insulin delivery action may be that insulin delivery from the medicament delivery device may be suspended for at least a portion of the time window." - Para [0046]), and/or removing the insulin pump from the user.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Zhong to include that the action corresponds to, adjusting operational settings of the insulin pump, and/or removing the insulin pump from the user as taught by Lee to output a recommendation on the display for action by the user to adjust their glucose level (Lee, Para [0006]).
Claim(s) 6 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (US Pub No. 20220105269 A1) in view of Bazargan et al. (US Pub No. 20210409943 A1).
Regarding claim 6, Zhong in view of Lee discloses the method (Zhong, Fig. 8) as disclosed above, wherein
Zhong does not expressly disclose that the second period of time is the same amount as the fourth period of time.
Bazargan teaches that the second period of time (“… the first biometric data may include … all glucose measurement data for a predetermined time period …” – Para [0103]) is the same amount as the fourth period of time (“… the second biometric data may include … all glucose measurement data for predetermined time period (e.g., the same time period to which the glucose measurement data of the first biometric data corresponds …” – Para [0104]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Zhong to include that the second period of time is the same amount as the fourth period of time as taught by Bazargan for obtaining biometric data (Bazargan, Para [0007]).
Regarding claim 16, Zhong in view of Bazargan discloses the system (Zhong, system 10A, Fig. 1) as disclosed above, wherein
Zhong does not expressly disclose that the second period of time is the same amount as the fourth period of time.
Bazargan teaches that the second period of time (“… the first biometric data may include … all glucose measurement data for a predetermined time period …” – Para [0103]) is the same amount as the fourth period of time (“… the second biometric data may include … all glucose measurement data for predetermined time period (e.g., the same time period to which the glucose measurement data of the first biometric data corresponds …” – Para [0104]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Zhong to include that the second period of time is the same amount as the fourth period of time as taught by Bazargan for obtaining biometric data (Bazargan, Para [0007]).
Claim(s) 7-10 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (US Pub No. 20220105269 A1) in view of Bedell et al. (WO 2022026596 A1).
Regarding claim 7, Zhong in view of Bedell discloses the method (Zhong, Fig. 8) as disclosed above, further comprising
Zhong does not expressly disclose determining to request additional user data based on the user data and/or the abnormality; and determining prompt information to elicit the additional user data based on the user data and/or the abnormality.
determining to request additional user data (Generate and display one or more text-based options based on parsed user input 3505, Fig. 13) based on the user data (Receive user voice input 3501, Fig. 13) and/or the abnormality; and determining prompt information to elicit the additional user data based on the user data and/or the abnormality ("… at block 3505, the method 3500 generates and displays one or more text-based options to the user. The text-based options can be based on the parsed user voice input." - Para [0132]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Zhong to include determining to request additional user data based on the user data and/or the abnormality; and determining prompt information to elicit the additional user data based on the user data and/or the abnormality as taught by Bedell to administer insulin in a manner that maintains glucose levels (Bedell, Para [0004]).
Regarding claim 8, Zhong in view of Bedell discloses the method (Zhong, Fig. 8) as disclosed above, further comprising
Zhong does not expressly disclose causing the display to present the prompt information; and determining the additional user data after the causing the display to present the prompt information.
Bedell teaches causing the display to present the prompt information (Generate and display one or more text based options based on parsed user input 3505, Fig. 13); and determining the additional user data after the causing the display to present the prompt information ("From block 3505, the method 3500 moves to decision state 3506 at which is determined whether and which type of additional user input is received." - Para [0136]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Zhong to include causing the display to present the prompt information; and determining the additional user data after the causing the display to present the prompt information as taught by Bedell to administer insulin in a manner that maintains glucose levels (Bedell, Para [0004]).
Regarding claim 9, Zhong in view of Bedell discloses the method (Zhong, Fig. 8) as disclosed above, wherein
Zhong does not expressly disclose that the additional user data corresponds to additional exercise data, additional infusion site data, additional insulin delivery data, and/or additional food data.
Bedell teaches that the additional user data ("The user has spoken … "I took 12 units of Humalog." - Para [0209]) corresponds to additional exercise data, additional infusion site data, additional insulin delivery data, and/or additional food data.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Zhong to include that the additional user data corresponds to additional exercise data, additional infusion site data, additional insulin delivery data, and/or additional food data as taught by Bedell to administer insulin in a manner that maintains glucose levels (Bedell, Para [0004]).
Regarding claim 10, Zhong in view of Bedell discloses the method (Zhong, Fig. 8) as disclosed above, wherein
determining the action is based on the additional user data (Zhong, "Based on current glucose level, processing circuitry 30 may determine updated projected levels of glucose." - Para [0145]).
Regarding claim 17, Zhong in view of Bedell discloses the system (Zhong, system 10A, Fig. 1) as disclosed above, wherein the at least one computer processor is further configured to access memory and execute the computer-executable instructions (Zhong, "Processing circuitry of patient device 24 may interface with telemetry circuitry 36 to communicate with sensor 20, whereby processing circuitry may obtain a current glucose level in patient 12. Processing circuitry may determine, based on the current glucose level, the projected levels of glucose in patient 12 over a time frame (800)." - Para [0144], Fig. 8)
Zhong does not expressly disclose that the system is configured to determine to request additional user data based on the user data and/or the abnormality; and determine prompt information to elicit the additional user data based on the user data and/or the abnormality.
Bedell teaches that the system is configured to determine to request additional user data (Generate and display one or more text-based options based on parsed user input 3505, Fig. 13) based on the user data (Receive user voice input 3501, Fig. 13) and/or the abnormality; and determine prompt information to elicit the additional user data based on the user data and/or the abnormality ("… at block 3505, the method 3500 generates and displays one or more text-based options to the user. The text-based options can be based on the parsed user voice input." - Para [0132]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Zhong to include that the system is configured to determine to request additional user data based on the user data and/or the abnormality; and determining prompt information to elicit the additional user data based on the user data and/or the abnormality as taught by Bedell to administer insulin in a manner that maintains glucose levels (Bedell, Para [0004]).
Regarding claim 18, Zhong in view of Bedell discloses the system (Zhong, system 10A, Fig. 1) as disclosed above, wherein the at least one computer processor is further configured to access memory and execute the computer-executable instructions (Zhong, "Processing circuitry of patient device 24 may interface with telemetry circuitry 36 to communicate with sensor 20, whereby processing circuitry may obtain a current glucose level in patient 12. Processing circuitry may determine, based on the current glucose level, the projected levels of glucose in patient 12 over a time frame (800)." - Para [0144], Fig. 8)
Zhong does not expressly disclose that the system is configured to cause the display to present the prompt information; and determine the additional user data after the causing the display to present the prompt information.
Bedell teaches that the system is configured to cause the display to present the prompt information (Generate and display one or more text based options based on parsed user input 3505, Fig. 13); and determine the additional user data after the causing the display to present the prompt information ("From block 3505, the method 3500 moves to decision state 3506 at which is determined whether and which type of additional user input is received." - Para [0136]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Zhong to include that the system is configured to cause the display to present the prompt information; and determine the additional user data after the causing the display to present the prompt information as taught by Bedell to administer insulin in a manner that maintains glucose levels (Bedell, Para [0004]).
Regarding claim 19, Zhong in view of Bedell discloses the system (Zhong, system 10A, Fig. 1) as disclosed above, wherein
Zhong does not expressly disclose that the additional user data corresponds to additional exercise data, additional infusion site data, additional insulin delivery data, and/or additional food data.
Bedell teaches that the additional user data ("The user has spoken … "I took 12 units of Humalog." - Para [0209]) corresponds to additional exercise data, additional infusion site data, additional insulin delivery data, and/or additional food data.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Zhong to include that the additional user data corresponds to additional exercise data, additional infusion site data, additional insulin delivery data, and/or additional food data as taught by Bedell to administer insulin in a manner that maintains glucose levels (Bedell, Para [0004]).
Regarding claim 20, Zhong in view of Bedell discloses the system (Zhong, system 10A, Fig. 1) as disclosed above, wherein
determining the action is based on the additional user data (Zhong, "Based on current glucose level, processing circuitry 30 may determine updated projected levels of glucose." - Para [0145]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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