DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed May 27, 2025 has been entered. Claims 1-2, 4-6, and 10-23 remain pending in the application. Claims 3 and 7-9 have been cancelled. Applicant’s amendments to the claims have overcome the objections previously set forth in the Non-Final Office Action mailed February 27, 2025.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 5-6, and 8-23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Thukral (US Pub. No. 2009/0006061 A1) in view of Mastrototaro (US Pat. No. 6,424,847 B1).
Regarding Claim 1, Thukral discloses a system comprising:
a glucose monitoring device (glucose sensor 604; [0160]) comprising an in vivo glucose sensor (“a sensor that measures glucose concentration such as, for example, a Subcutaneous Continuous Glucose Monitor (SCGM)” [0150]);
one or more processors (processors 16, 34) in communication with the glucose monitoring device ([0064]-[0068], particularly [0067]); and
a memory (memory device 44, computer memory 38, and other memories accessible by server computer 12 and client computer 14, see [0072], [0079]) operably coupled to the one or more processors and storing instructions that, when executed by the one or more processors, causes the one or more processors to:
receive signal levels from the in vivo glucose sensor of the glucose monitoring device, the signal levels representative of glucose levels (see all of [0178]; i.e., receiving latest glucose value from glucose update module);
determine a medication delivery profile to be administered by a medication delivery device (insulin pump 606) based on the signal levels representative of the glucose levels (see all of [0151], [0160], [0178], [0180]; i.e., via ALGO 510);
determine whether one or more of the signal levels are associated with a fault condition or potential fault condition ([0178]; i.e., sensor delay or failure or [0180]; i.e., outdated);
generate a notification on a user interface of a control unit (“modules for monitoring and informing status ” [0143]) in data communication with the glucose monitoring device based on the fault condition or the potential fault condition (see all of [0143], [0181]; i.e., informing user of status), wherein the notification comprises an alarm ([0143]; i.e., alarms); and
modify the medication delivery profile to be administered by the medication delivery device based on a preprogrammed medication delivery profile when the fault condition or potential fault condition is determined ([0178]; i.e., delivery profile based on predicted glucose from last control cycle or [0180]; i.e., preprogrammed basal control), wherein the preprogrammed medication delivery profile comprises a predetermined basal profile ([0164]; i.e., basal insulin of the control cycle; [0180]; i.e., preprogrammed basal control).
While Thukral further discloses that the glucose sensor may be a subcutaneous continuous glucose monitor ([0150]), Thukral does not further disclose that the glucose monitoring device being an in vivo glucose sensor having a first portion configured to be transcutaneously positioned under a skin layer of a user and a second portion configured to be arranged above the skin layer; and Thurkrai does not explicitly disclose the fault condition or potential fault condition comprises one or more of a communication failure between the one or more processors and the glucose monitoring device or dislodgement of the in vivo glucose sensor.
Mastrototaro discloses a system comprising: a glucose monitoring device (glucose monitor 100) comprising an in vivo glucose sensor (subcutaneous glucose sensor set 10; [Col. 5, lines 17-18] i.e., glucose sensor) having a first portion (electrodes 20) configured to be transcutaneously positioned under a skin layer of a user (col. 5, lines 46-58) and a second portion (i.e., portion of glucose sensor 12) configured to be arranged above the skin (Fig. 2; col. 5, lines 51-58); one or more processors (processor 200) in communication with the glucose monitoring device; and a memory (col. 6, lines 14-16; i.e., memory of data processor 200 containing the instructions) operably coupled to the one or more processors and storing instructions that, when executed by the one or more processors, causes the one or more processors to: receive signal levels from the in vivo analyte sensor of the glucose monitoring device, the signal levels representative of glucose levels (col. 8, lines 51-58); determine a medication delivery profile to be administered by a medication delivery device based on the signals representative of glucose levels (col. 7, lines 26-35; i.e., using feedback from the glucose sensor measurements to control the delivery rate of closed loop system); determine whether one or more of the signal levels are associated with a fault condition or potential fault condition (“Each memory storage value is considered valid (Valid ISIG value) unless one of the following calibration cancellation events occurs: an unstable signal alarm (as discussed above), a sensor initialization event (as discussed above), a sensor disconnect alarm, a power on/off event, an out-of-range alarm (as discussed above), or a calibration error alarm.” [Col 10, lines 50-56]), wherein the fault condition or potential fault condition comprises one or more of a communication failure between the one or more processors and the glucose monitoring device or dislodgement of the in vivo glucose sensor (“The sensor disconnect alarm is activated when the glucose monitor 100 does not detect a signal. In preferred embodiments, when 2 or more out of 5 interval values collected within a given memory storage rate are less than 1.0 Nano-Amp, the disconnect alarm is triggered. In alternative embodiments, more or less values need be below a particular amperage to trigger the disconnect alarm depending of the acceptable range or sensor readings and the stability of the sensor signal.” [Col 11, lines 10-18]); and generate a notification (i.e., alarm) on a user interface of a control unit (i.e., computer) in data communication with the glucose monitoring device based on the fault condition or the potential fault condition, wherein the notification comprises an alarm (Fig. 10; col. 10, line 26 until col. 11, line 21; i.e., different alarms). Mastrototaro discloses that in addition to the in vivo glucose sensor having a portion configured to be transcutaneously positioned under the skin layer and another portion configured to be arranged above the skin layer, different types of subcutaneous glucose sensors and/or other glucose sensors (col. 5, lines 27-45) including glucose sensors that are only on the external surface of the skin or are placed below the skin layer surface are known suitable alternative sensor configuration for an insulin delivery system with a glucose monitoring device (col. 5, lines 46-64).
Therefore, since both Thukral and Mastrototaro are drawn to systems for controlling medication delivery based on signal levels from a glucose monitoring device, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Thukral with the feature of the glucose monitoring device being an in vivo glucose sensor having a first portion configured to be transcutaneously positioned under a skin layer of a user and a second portion configured to be arranged above the skin layer as disclosed by Mastrototaro for monitoring glucose levels in the patient and since Mastrototaro discloses that such configuration of the glucose sensor are one of the known suitable configuration for an insulin delivery system. Moreover, one of ordinary skill in the art would have recognized this as a simple substitution of one known element (i.e., subcutaneous glucose sensor of Thukral) for another (i.e., glucose sensor with a first portion configured to be transcutaneously positioned under a skin layer and a second portion configured to be arranged above the skin layer of Mastrototaro) to obtain predictable results (i.e., alternative glucose sensors suitable for monitoring glucose in an insulin delivery system), see MPEP 2143(I)(B) for additional details. Additionally, it would have been obvious to one of ordinary skill in the art at the time of the invention to further modify the system of Thukral to include the fault condition or potential fault condition comprises one or more of a communication failure between the one or more processors and the glucose monitoring device or dislodgement of the in vivo glucose sensor based on the teachings of Mastrototaro so as to account for potential communication failures and disconnection of the in vivo glucose sensor leading to the delayed sensor signal or sensor failure of Thukral ([0178]).
Regarding Claim 2, Thukral in view of Mastrototaro discloses the system of claim 1, wherein the one or more processors is electrically coupled to the control unit or to the in vivo glucose sensor ([0148]; [0067] of Thukral; col. 10, line 26 until col. 11, line 21 of Mastrototaro);
Regarding Claim 5, Thukral in view of Mastrototaro discloses the system of claim 1, wherein both further discloses prior to generation of the notification, the control unit is configured to generate an instruction to confirm the fault condition or the potential fault condition, and wherein the notification is generated if the fault condition or the potential fault condition is confirmed ([0097]; i.e., quality check of Thukral; col. 11, line 1-7; i.e., in the event of power on/off, the potential fault condition of being power off is confirmed by the length of time power is off to confirm actual power off before generating requirement to recalibrate upon turning on of Mastrototaro).
Regarding Claim 6, Thukral in view of Mastrototaro discloses the system of claim 1, wherein both discloses the fault condition or the potential fault condition further comprises a glucose sensor malfunction ([0178]; i.e., sensor failure of Thukral and col. 10, line 50 until col. 11, line 21; i.e., sensor disconnect or calibration error of Mastrototaro).
Regarding Claim 10, Thukral in view of Mastrototaro discloses the system of claim 1, wherein both further discloses the fault condition or the potential fault condition further comprises a sensor signal loss, such that the control unit is not receiving the signal levels from the glucose monitoring device ([0178]; i.e., sensor signal not received of Thukral and col. 11, lines 10-21 and Col 10, line 50 – Col 11, line 11; i.e., sensor disconnect of Mastrototaro).
Regarding Claim 11, Thukral in view of Mastrototaro discloses the system of claim 10, wherein Thukral does not explicitly disclose that the notification on the user interface based on the fault condition or the potential fault condition is provided after 20 minutes have elapsed since the sensor signal loss. However, Mastrototaro further discloses the notification on the user interface based on the fault condition or the potential fault condition is provided after 20 minutes have elapsed since the sensor signal loss (col. 11, lines 1-5; i.e., powered off longer than 30 min). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to further modify the system of Thukral in view of Mastrototaro with the feature of the notification on the user interface based on the fault condition or the potential fault condition is provided after 20 minutes have elapsed since the sensor signal loss as disclosed by Mastrototaro so as to provide the current status to the user ([0143] of Thukral).
Regarding Claim 12, Thukral in view of Mastrototaro discloses the system of claim 1, wherein both further discloses the alarm is visual; audible; vibratory; or a combination of any of visual, audible, or vibratory ([0143] informing user wherein information may be presented graphical and audio formats, see [0136] of Thukral; and Fig. 10 of Mastrototaro).
Regarding Claim 13, Thukral in view of Mastrototaro discloses the system of claim 1, wherein both further discloses the notification further comprises an instruction to perform a corrective action ([0181] of Thukral and col. 17, lines 41-42; i.e., notifying user that re-calibration is required of Mastrototaro).
Regarding Claim 14, Thukral in view of Mastrototaro discloses the system of claim 13, but Thukral does not explicitly disclose that the instruction to perform the corrective action comprises an instruction to replace the glucose monitoring device. However, Mastrototaro further discloses the instruction to perform the corrective action comprises an instruction to replace the glucose monitoring device (“Re-calibration or replacement of the glucose sensor 12 is required once an unstable signal alarm is activated” [Col 10, lines 45-49]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to further modify the system of Thukral in view of Mastrototaro with the feature of the instruction to perform the corrective action comprises an instruction to replace the glucose monitoring device as disclosed by Mastrototaro so as to prevent unstable signal (col. 10, lines 45-49).
Regarding Claim 15, Thukral in view of Mastrototaro discloses the system of claim 13, wherein both further discloses the instruction to perform the corrective action comprises a recommendation to verify the glucose levels ([0097] of Thukral and col. 7, lines 55-59 of Mastrototaro).
Regarding Claim 16, Thukral in view of Mastrototaro discloses the system of claim 13, wherein both further discloses the instruction to perform the corrective action comprises a recommendation to modify a medication delivery rate ([0181]; i.e., rate of Controlled-Obs mode of Thukral; and col. 7, lines 26-35; i.e., modifying medication delivery rate in a closed-loop system with an infusion pump of Mastrototaro).
Regarding Claim 17, Thukral in view of Mastrototaro discloses the system of claim 13, wherein both further discloses the instruction to perform the corrective action comprises a recommendation to modify a medication delivery amount ([0181]; i.e., amount of Controlled-Obs mode of Thukral; col. 7, lines 26-35; i.e., modifying medication delivery amount in a closed-loop system with an infusion pump since the amount delivered is based on the drug delivery rate of Mastrototaro).
Regarding Claim 18, Thukral in view of Mastrototaro discloses the system of claim 1, both further discloses comprising a medication delivery device (i.e., infusion pump) configured to deliver medication based on the received signal levels, wherein the medication delivery device is in data communication with the control unit ([0160], Fig. 6 of Thukral and col. 7, lines 26-34; i.e., modifying medication delivery rate in a closed-loop system with an infusion pump of Mastrototaro).
Regarding Claim 21, Thukral in view of Mastrototaro discloses the system of claim 1.
Thukral fails to explicitly wherein the one or more processors are further caused to resume determining the medication delivery profile to be administered by the medication delivery device based on the signals representative of glucose levels when the fault condition or the potential fault condition is corrected.
Mastrototaro discloses the one or more processors are further caused to resume determining the medication delivery profile to be administered by the medication delivery device based on the signals representative of glucose levels when the fault condition or the potential fault condition is corrected (Corrected by re-calibrating or replacing the sensor: “Re-calibration or replacement of the glucose sensor 12 is required once an unstable signal alarm is activated.” [Col 10, lines 45-47]; restart medication delivery profile after calibration: “The glucose monitor 100…may process data from both the glucose sensor 12 and an infusion pump to establish a closed loop system to control the infusion pump based on glucose sensor measurements.” [Col 7, lines 24-30], “blood glucose reference readings are entered into the glucose monitor 100 periodically through out each day of use. Preferably calibration is conducted immediately after the initialization/stabilization of a glucose sensor 12 and once a day thereafter. However, calibration may be conducted more or less often depending on whether a glucose sensor 12 has been replaced, whether a calibration cancellation event has occurred, the stability of the glucose sensor 12 sensitivity over time, or the like.” [Col 12, lines 14-23]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the system of Thukral to include the one or more processors are further caused to resume determining the medication delivery profile to be administered by the medication delivery device based on the signals representative of glucose levels when the fault condition or the potential fault condition is corrected based on the teachings of Mastrototaro to ensure that the system is able to provide closed loop diabetes control in an efficient manner (Mastrototaro [Col 7, lines 24-30]).
Regarding Claim 22, Thukral in view of Mastrototaro discloses the system of claim 1, wherein Thukral further discloses that the predetermined basal profile comprises a maximum basal delivery rate ([0164], [0178]; i.e., the maximum appropriate basal delivery rate based on the glucose measurement of the control cycle).
Regarding Claim 19, Thukrai discloses a system comprising:
a glucose monitoring device (glucose sensor 604; [0160]) comprising an in vivo glucose sensor (“a sensor that measures glucose concentration such as, for example, a Subcutaneous Continuous Glucose Monitor (SCGM)” [0150]);
one or more processors (processors 16, 34) in communication with the glucose monitoring device ([0064]-[0068], particularly [0067]); and
a memory (memory device 44, computer memory 38, and other memories accessible by server computer 12 and client computer 14, see [0072], [0079]) operably coupled to the one or more processors and storing instructions that, when executed by the one or more processors, causes the one or more processors to:
receive signal levels from the in vivo glucose sensor of the glucose monitoring device, the signal levels representative of glucose levels ([0178]; i.e., receiving latest glucose value from glucose update module);
determine a medication delivery profile to be administered by a medication delivery (insulin pump 606) device based on the signal levels representative of the glucose levels (see all of [0151], [0160], [0178], [0180]; i.e., via ALGO 510);
determine whether one or more of the signal levels are associated with a fault condition or potential fault condition ([0178]; i.e., sensor delay or failure or [0180]; i.e., outdated);
generate a notification on a user interface of a control unit (“modules for monitoring and informing status ” [0143]) in data communication with the glucose monitoring device based on the fault condition or the potential fault condition ([0143], [0181]; i.e., informing user of status), wherein the notification comprises an instruction to perform a corrective action (see all of [0181]); and
modify the medication delivery profile to be administered by the medication delivery device based on a preprogrammed medication delivery profile when the fault condition or potential fault condition is determined ([0178]; i.e., delivery profile based on predicted glucose from last control cycle or [0180]; i.e., preprogrammed basal control), wherein the preprogrammed medication delivery profile comprises a predetermined basal profile ([0164]; i.e., basal insulin of the control cycle; [0180]; i.e., preprogrammed basal control).
While Thukrai further discloses that the glucose sensor may be a subcutaneous continuous glucose monitor ([0150]), Thukrai does not further disclose that the glucose monitoring device being an in vivo glucose sensor having a first portion configured to be transcutaneously positioned under a skin layer of a user and a second portion configured to be arranged above the skin layer; and Thurkrai does not explicitly disclose the fault condition or potential fault condition comprises one or more of a communication failure between the one or more processors and the glucose monitoring device or dislodgement of the in vivo glucose sensor.
However, as explained above, Mastrototaro discloses a system comprising: a glucose monitoring device (100) comprising an in vivo glucose sensor (10) (col. 5, lines 17-18; i.e., glucose sensor) having a first portion (20) configured to be transcutaneously positioned under a skin layer of a user (col. 5, lines 46-51) and a second portion (i.e., portion of glucose sensor 12) configured to be arranged above the skin (Fig. 2; col. 5, lines 51-58); and that such glucose sensor are known suitable alternative sensor configuration along with different types of subcutaneous glucose sensors and/or other glucose sensors (col. 5, lines 27-45) including glucose sensors that are only on the external surface of the skin or are placed below the skin layer surface for an insulin delivery system with a glucose monitoring device (col. 5, lines 46-64); and a memory (col. 6, lines 14-16; i.e., memory of data processor 200 containing the instructions) operably coupled to one or more processors (200) and storing instructions that, when executed by the one or more processors, causes the one or more processors to: determine whether one or more signal levels are associated with a fault condition or potential fault condition (“Each memory storage value is considered valid (Valid ISIG value) unless one of the following calibration cancellation events occurs: an unstable signal alarm (as discussed above), a sensor initialization event (as discussed above), a sensor disconnect alarm, a power on/off event, an out-of-range alarm (as discussed above), or a calibration error alarm.” [Col 10, lines 50-56]), wherein the fault condition or potential fault condition comprises one or more of a communication failure between the one or more processors and the glucose monitoring device or dislodgement of the in vivo glucose sensor (“The sensor disconnect alarm is activated when the glucose monitor 100 does not detect a signal. In preferred embodiments, when 2 or more out of 5 interval values collected within a given memory storage rate are less than 1.0 Nano-Amp, the disconnect alarm is triggered. In alternative embodiments, more or less values need be below a particular amperage to trigger the disconnect alarm depending of the acceptable range or sensor readings and the stability of the sensor signal.” [Col 11, lines 10-18]).
Therefore, since both Thukrai and Mastrototaro are drawn to systems for controlling medication delivery based on signal levels from a glucose monitoring device, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Thukrai with the feature of the glucose monitoring device being an in vivo glucose sensor having a first portion configured to be transcutaneously positioned under a skin layer of a user and a second portion configured to be arranged above the skin layer as disclosed by Mastrototaro for monitoring glucose levels in the patient and since Mastrototaro discloses that such configuration of the glucose sensor are one of the known suitable configuration for an insulin delivery system. Moreover, one of ordinary skill in the art would have recognized this as a simple substitution of one known element (i.e., subcutaneous glucose sensor of Thukrai) for another (i.e., glucose sensor with a first portion configured to be transcutaneously positioned under a skin layer and a second portion configured to be arranged above the skin layer of Mastrototaro) to obtain predictable results (i.e., alternative glucose sensors suitable for monitoring glucose in an insulin delivery system), see MPEP 2143(I)(B) for additional details.
Additionally, it would have been obvious to one of ordinary skill in the art at the time of the invention to further modify the system of Thukral to include the fault condition or potential fault condition comprises one or more of a communication failure between the one or more processors and the glucose monitoring device or dislodgement of the in vivo glucose sensor based on the teachings of Mastrototaro so as to account for potential communication failures and dislodgement of the in vivo glucose sensor leading to the delayed sensor signal or sensor failure of Thukral ([0178]).
Regarding Claim 23, Thukral in view of Mastrototaro discloses the system of claim 19, but Thukral does not explicitly disclose that the corrective action comprises replacing the glucose monitoring device. However, Mastrototaro further discloses the instruction to perform the corrective action comprises replacing the glucose monitoring device (“Re-calibration or replacement of the glucose sensor 12 is required once an unstable signal alarm is activated” [Col 10, lines 45-49]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to further modify the system of Thukral in view of Mastrototaro with the feature of the instruction to perform the corrective action comprises replacing the glucose monitoring device as disclosed by Mastrototaro so as to prevent unstable signal (col. 10, lines 45-49).
Regarding Claim 20, Thukrai discloses a method comprising:
receiving, using one or more processors (16, 34), signal levels from an in vivo glucose sensor ([0150]) of a glucose monitoring device (604) ([0160]) ([0064]-[0068], particularly [0067]));
determining, using the one or more processors, a medication delivery profile to be administered by a medication delivery device (606) based on the signal levels representative of the glucose levels ([0151], [0160], [0178], [0180]; i.e., via ALGO 510);
determining, using the one or more processors, whether one or more of the signal levels are associated with a fault condition or potential fault condition ([0178]; i.e., sensor delay or failure or [0180]; i.e., outdated);
generating, using the one or more processors, a notification on a user interface of a control unit (i.e., module for monitoring and informing status) in data communication with the glucose monitoring device based on the fault condition or the potential fault condition ([0143], [0181]; i.e., informing user of status), wherein the notification comprises an alarm ([0143]; i.e., alarms); and
modifying the medication delivery profile to be administered by the medication delivery device based on a preprogrammed medication delivery profile when the fault condition or potential fault condition is determined ([0178]; i.e., delivery profile based on predicted glucose from last control cycle or [0180]; i.e., preprogrammed basal control), wherein the preprogrammed medication delivery profile comprises a predetermined basal profile ([0164]; i.e., basal insulin of the control cycle; [0180]; i.e., preprogrammed basal control).
While Thukrai further discloses that the glucose sensor may be a subcutaneous continuous glucose monitor ([0150]), Thukrai does not further disclose that the glucose monitoring device being an in vivo glucose sensor having a first portion configured to be transcutaneously positioned under a skin layer of a user and a second portion configured to be arranged above the skin layer; and Thurkrai does not explicitly disclose the fault condition or potential fault condition comprises one or more of a communication failure between the one or more processors and the glucose monitoring device or dislodgement of the in vivo glucose sensor.
However, as explained above, Mastrototaro discloses a method comprising: receiving signal levels from a glucose monitoring device (100) comprising an in vivo glucose sensor (10) (col. 5, lines 17-18; i.e., glucose sensor) having a first portion (20) configured to be transcutaneously positioned under a skin layer of a user (col. 5, lines 46-51) and a second portion (i.e., portion of glucose sensor 12) configured to be arranged above the skin (Fig. 2; col. 5, lines 51-58) and that such glucose sensor are known suitable alternative sensor configuration along with different types of subcutaneous glucose sensors and/or other glucose sensors (col. 5, lines 27-45) including glucose sensors that are only on the external surface of the skin or are placed below the skin layer surface for an insulin delivery system with a glucose monitoring device (col. 5, lines 46-64); and
determining whether one or more of the signal levels are associated with a fault condition or potential fault condition (“Each memory storage value is considered valid (Valid ISIG value) unless one of the following calibration cancellation events occurs: an unstable signal alarm (as discussed above), a sensor initialization event (as discussed above), a sensor disconnect alarm, a power on/off event, an out-of-range alarm (as discussed above), or a calibration error alarm.” [Col 10, lines 50-56]), wherein the fault condition or potential fault condition comprises one or more of a communication failure between the one or more processors and the glucose monitoring device or dislodgement of the in vivo glucose sensor (“The sensor disconnect alarm is activated when the glucose monitor 100 does not detect a signal. In preferred embodiments, when 2 or more out of 5 interval values collected within a given memory storage rate are less than 1.0 Nano-Amp, the disconnect alarm is triggered. In alternative embodiments, more or less values need be below a particular amperage to trigger the disconnect alarm depending of the acceptable range or sensor readings and the stability of the sensor signal.” [Col 11, lines 10-18]).
Therefore, since both Thukrai and Mastrototaro are drawn to methods for controlling medication delivery based on signal levels from a glucose monitoring device, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Thukrai with the feature of the glucose monitoring device being an in vivo glucose sensor having a first portion configured to be transcutaneously positioned under a skin layer of a user and a second portion configured to be arranged above the skin layer as disclosed by Mastrototaro for monitoring glucose levels in the patient and since Mastrototaro discloses that such configuration of the glucose sensor are one of the known suitable configuration for an insulin delivery system. Moreover, one of ordinary skill in the art would have recognized this as a simple substitution of one known element (i.e., subcutaneous glucose sensor of Thukrai) for another (i.e., glucose sensor with a first portion configured to be transcutaneously positioned under a skin layer and a second portion configured to be arranged above the skin layer of Mastrototaro) to obtain predictable results (i.e., alternative glucose sensors suitable for monitoring glucose in an insulin delivery system), see MPEP 2143(I)(B) for additional details.
Additionally, it would have been obvious to one of ordinary skill in the art at the time of the invention to further modify the method of Thukral to include the fault condition or potential fault condition comprises one or more of a communication failure between the one or more processors and the glucose monitoring device or dislodgement of the in vivo glucose sensor based on the teachings of Mastrototaro so as to account for potential communication failures and dislodgement of the in vivo glucose sensor leading to the delayed sensor signal or sensor failure of Thukral ([0178]).
Claim 4 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Thukral (US Pub. No. 2009/0006061 A1) in view of Mastrototaro (US Pat. No. 6,424,847 B1) as applied in claim 1 above, and further in view of Ford (US Pub. No. 2002/0045808 A1).
Regarding Claim 4, Thukrai in view of Mastrototaro discloses the system of claim 1, wherein Thukrai further discloses that data communication via conventional wired or wirelessly connected ([0065]-[0066], [0068]) but does not explicitly disclose that the data communication comprises a Bluetooth® wireless communication protocol. However, Ford also discloses a system with a glucose monitoring device in communication with another computer system via standard computer interface such as USB or wirelessly including via Bluetooth ([0150]). Therefore, since both Thukrai in view of Mastrototaro and Ford are drawn to systems with analyte monitoring in data communication with a control unit, it would have been obvious to one of ordinary skill at the time of the invention to modify the wireless data communication of the system of Thukrai in view of Mastrototaro with a Bluetooth enabled communication protocol as disclosed by Ford since such means is known to be suitable form of wireless communication between a glucose monitoring device and a computer.
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 4-6, and 10-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the argument that the prior art of record, namely Thukral (US 20090006061) and Mastrototaro (USPN 6424847) fail to disclose or suggest “wherein the fault condition or potential fault condition comprises one or more of a communication failure between the one or more processors and the glucose monitoring device or dislodgement of the in vivo glucose sensor” as required by the amended independent claims, the examiner respectfully disagrees. As detailed in the rejections above, Thukral discloses a system comprising determining whether one or more of the signal levels are associated with a fault condition or potential fault condition ([0178]; i.e., sensor delay or failure or [0180]; i.e., outdated). Mastrototaro discloses determining whether one or more of the signal levels are associated with a fault condition or potential fault condition (“Each memory storage value is considered valid (Valid ISIG value) unless one of the following calibration cancellation events occurs: an unstable signal alarm (as discussed above), a sensor initialization event (as discussed above), a sensor disconnect alarm, a power on/off event, an out-of-range alarm (as discussed above), or a calibration error alarm.” [Col 10, lines 50-56]), wherein the fault condition or potential fault condition comprises one or more of a communication failure between the one or more processors and the glucose monitoring device or dislodgement of the in vivo glucose sensor (“The sensor disconnect alarm is activated when the glucose monitor 100 does not detect a signal. In preferred embodiments, when 2 or more out of 5 interval values collected within a given memory storage rate are less than 1.0 Nano-Amp, the disconnect alarm is triggered. In alternative embodiments, more or less values need be below a particular amperage to trigger the disconnect alarm depending of the acceptable range or sensor readings and the stability of the sensor signal.” [Col 11, lines 10-18]). Mastrototaro, in at least [Col 10, line 50 – Col 11, line 21] discloses numerous fault conditions, which include a sensor disconnection/dislodgment and numerous communication failures between the sensor and the glucose monitor. Additionally, the limitation “dislodgement of the in vivo glucose sensor” under the broadest reasonable interpretation is not limited to the sensor becoming dislodged from the skin layer. The limitation can also reasonably be interpreted as the sensor becoming physically disconnected from the other components of the system.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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