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 .
Response to Amendment
The rejections pursuant to 112(b) are withdrawn in light of amendments.
Response to Arguments
Applicant’s arguments, see Page 9 of Remarks, filed on January 22, 2026, with respect to the 35 U.S.C. § 112 (a) have been fully considered and are persuasive. The 35 U.S.C. § 112 (a) rejections of claims 1-15 and 21-25 has been withdrawn.
Applicant’s arguments, see Pages 15-23, of Remarks, titled “Claim Rejections - 35 U.S.C. § 103”, filed January 22, 2026, with respect to the rejection(s) of claim(s) 1-15 and 21-25 under Claim Rejections - 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art references in combination with previous prior art.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 7, and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the data connection" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the examiner interprets the limitation as “a data connection”.
Claim 7 recites the limitation "and the power contacts" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the examiner interprets the limitation as “and power contacts”.
Claim 7 recites the limitation “electrical contacts” in line 7. This limitation renders the claim indefinite because it is unclear whether the electrical contacts in claim 7 are the same electrical contacts disclosed in claim 1 or different electrical contacts from claim 1. For purposes of examination, the examiner interprets this limitation as being different than the electrical contacts as disclosed in claim 1.
Claim 27 recites the limitation "the detected aerobic exercise" in line 3. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the examiner interprets the limitation as “detected aerobic exercise”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3-5, 7, 9, 12, 15, 21, 25 are rejected under 35 U.S.C. 103 as being unpatentable over Amirouche et al. (US Pub No. 20130274576 A1) in view of O’Connor et al. (US Pub. No. 2017/0173261 A1, herein, O’Connor).
Regarding claim 1, Amirouche discloses a drug delivery system comprising:
a drug delivery device (100 – Fig.1) including:
a processor (1110 – Fig.11),
a memory storing programming code executable by the processor (1114 – Fig.11, “the microcontroller may begin executing code” – [0095], “allows the microcontroller to store and receive data at its discretion” – Para [0096]),
a drug container configured to contain a liquid drug (600, 610 – Fig.6B),
a pump drive mechanism configured to expel the liquid drug from the drug delivery device (“the contents of reservoirs may be delivered to a patient by a suitable pump mechanism” – Para [0075]),
a power source (1105 – Fig.11); and
an auxiliary device interface (Shown at 430 – Fig. 5A) including electrical contacts (431a,431b,431c – Fig.5A) and a data connector (“house electrical wires (not shown) linking the continuous glucose monitoring cannula and the control electronics on a circuit board within system” – Para [0071]) disposed at an external surface of a housing of the drug delivery device (200, 210 – Fig.1C) and that are coupled to the processor (1110 – Fig.11, the microcontroller and the interface are on the same device so therefore coupled); and
a removable sensor module (130 – Fig.1C, Para [0072]) configured to mechanically couple with the auxiliary device interface of the drug delivery device (Fig.1C, Fig.1D, “Sensor body may be received and housed in continuous glucose monitoring support socket attached to, e.g., lower housing” – Para [0064]) and establish an electrical connection to the processor via the data connector of the auxiliary device interface (Para [102])(“house electrical wires (not shown) linking the continuous glucose monitoring cannula and the control electronics on a circuit board within system” – Para [0071], Fig.11, Para [0094]), and when mechanically coupled with the auxiliary device interface of the drug delivery device, the removable sensor module is aligned with a bottom surface of the drug delivery device when placed on skin of the user (Fig.1B, Fig.1E), wherein the removable sensor module includes:
a sensor (400 - Fig.1C) operable to receive electrical power from the power source via the electrical contacts (“Sensor body has a recess that ensures the electrical contacting area of continuous glucose monitoring cannula is accessible and can make contact with a plurality of flexible electrical contacts” – Para [0071]), wherein the sensor is respectively configured to measure
parameters related to an orientation and a physical attribute of a user (“monitor the blood glucose of a patient” – Para [0063]); and
output a signal related to the measured parameters to the data connector of the auxiliary device interface for transmission to the processor (“house electrical wires (not shown) linking the continuous glucose monitoring cannula and the control electronics on a circuit board within system” – Para [0071], Fig.13).
However, Amirouche fails to explicitly disclose a plurality of different sensors wherein individual sensors of the plurality of different sensors are respectively configured to measure parameters (“acceleration sensor”- Para [0045]) related to an orientation and a movement of the sensor module.
O’Connor teaches plurality of different sensors (108 – Fig.1A, “one or more sensors” – Para [0026]), wherein individual sensors of the plurality of different sensors are respectively configured to measure parameters (“acceleration sensor”- Para [0045]) related to an orientation and a movement of the sensor module (“sensing motion” - Para [0045]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the sensor module of Amirouche to comprise a plurality of sensors configured to measure parameters related to an orientation and movement of the sensor module as taught by O’Connor since O’Connor teaches that one or more sensors are well known in drug delivery devices and an acceleration sensor is for sensing motion of the medical device like shaking or tapping which allows for advanced user communication with a medical device (O’Connor, Para [0045]-[0046]).
Regarding claim 3, Amirouche discloses the drug delivery system as recited above, wherein each of the plurality of sensors is configured to output a respective signal for receipt by the data connector of the auxiliary device interface (“house electrical wires (not shown) linking the continuous glucose monitoring cannula and the control electronics on a circuit board within system” – Para [0071], Fig.13). The sensors are capable of outputting a signal since each sensor necessarily generates an electrical output corresponding to its detected parameter, and because the sensors are electrically coupled to the control board through wiring, those signals are inherently received through the electrical connection associated with the auxiliary device interface.
Regarding claim 4, Amirouche discloses the drug delivery system as recited above, wherein the sensor module further comprises: a data connector coupled to the data connection of the auxiliary device interface (“house electrical wires (not shown) linking the continuous glucose monitoring cannula and the control electronics on a circuit board within system” – Para [0071]). It would have been inherent because the disclosed electrical connection must include a connection interface, from being wired together, which makes it capable of coupling the sensor module to the auxiliary device interface in order to transmit the sensor output signals.
Regarding claim 5, Amirouche discloses the drug delivery system as recited above, wherein the housing further comprises: a top surface (shown at 200 – Fig.1D) and a bottom surface (210 – Fig.1D), wherein the bottom surface has the module opening configured to hold the sensor module (430 – 5B) and an adhesive layer (“adhesive patch platform” – Para [0105]) configured to maintain the housing in contact with a surface when adhered to the surface (“affix system 100 to a suitable skin location” – Para [0105]) wherein the sensor module when held in the module opening contacts the surface, wherein the surface is skin (“If system includes an integrated continuous glucose monitoring module, a cannula (420 – Fig.1D) may be also inserted into the patient's skin”) – Para [0105]).
Regarding claim 7, Amirouche discloses the drug delivery system as recited above, wherein the power source of the drug delivery device (1105 – Fig.11) comprises:
a rechargeable power supply (“rechargeable battery” – Para [0094]); and
power supply connectors (1115, 1116 – Fig.11) coupled to the rechargeable power supply and power contacts of the auxiliary device interface (Fig.11); and
the sensor module (130 – Fig.1C) further comprises:
electrical contacts (421 – Fig.4), wherein the electrical contacts are coupled to the plurality of sensors (Fig.4) and configured to contact the power contacts of the auxiliary device interface (“make contact with a plurality of flexible electrical contacts”- Para [0071]).
Regarding claim 9, Amirouche discloses the drug delivery system as recited above, wherein the drug delivery device and the sensor module are operable to be worn simultaneously on the body of the user (“a continuous glucose metering and sensor device fully or partially imbedded in the user's body “ – Para [0041]).
However, Amirouche fails to explicitly disclose wherein the processor is operable when executing the programming code to: interpret signals received from the one or more sensors via the auxiliary device interface; and based on an interpretation of the signals received from the one or more sensors indicating that the user is participating in activity, adjust settings for delivery of an amount of the liquid drug from the drug container.
O’Connor teaches a processor (“computing hardware (e.g., a processor)” - Para [0011]) that is operable when executing the programming code to: interpret signals received from the one or more sensors via an auxiliary device interface (116 - Fig. 1A)(Para [0041]); and based on an interpretation of the signals received from the one or more sensors indicating that the user is participating in activity (Para.0023), adjust settings for delivery of an amount of the liquid drug from a drug container (“a reservoir” - Para [0014], Para [0038]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the processor of Amirouche to execute code to interpret signals from the sensors, indicating that the user is participating in activity, and adjusting the settings for delivery as taught by O’Connor since O’Connor teaches that interpreting signals and indicating that the user is participating in activity and adjusting the settings for delivery, is a well-known technique in insulin pump devices, which improves the accuracy of the drug delivery to the user, allowing for improved patient safety and treatment effectiveness.
Regarding claim 12, Amirouche discloses the drug delivery system as recited above, wherein the drug delivery device further comprises: a communication device (1102 – Fig.11) coupled to the processor (Fig.11), wherein the processor is configured when executing the programming code to: establish a wireless communication link (Wireless communication – Fig.11) via the communication device with an external device (1101 – Fig.11, “Bluetooth module which may facilitate communication with a handheld module” – Para [0094]); and output a generated alert via the communication device for delivery to the external device via the wireless communication link (“facilitate communication with a handheld module” – Para [0094], Fig.11).
Regarding claim 15, Amirouche discloses the drug delivery system as recited above, further comprising: a management device (1200 – Fig.12) including a management device processor (1214 – Fig.12), a management device memory (1208 – Fig.12), a communication device (1212 – Fig.12), and a user interface (1216 – Fig.12), wherein the user interface is configured to present information (1210 – Fig.12) and receive inputs (1202 – Fig.12) and the management device processor is operable to: receive alerts from the drug delivery device, the alerts based on measurements received from the one or more sensors (“The data collected by the device can be downloaded to the handheld controller” – Para [0099]).
Regarding claim 21, Amirouche discloses the drug delivery system as recited above, but Amirouche fails to explicitly disclose wherein the processor is operable, when executing the programming code, to: interpret signals received from the one or more sensors via the auxiliary device interface; and based on the interpretation of the signals, determine that the user of the drug delivery device and the sensor module is participating in aerobic exercise, and in response to the determination, temporarily reduce basal delivery of the liquid drug.
O’Connor teaches a processor (“computing hardware (e.g., a processor)” - Para [0011]) operable, when executing a programming code, to: interpret signals received from a one or more sensors (“one or more sensors” – Para [0026]) via an auxiliary device interface (116 – Fig.1A, Para [0038]); and based on the interpretation of the signals, determine that the user of the drug delivery device (100 – Fig.1) and a sensor module (108 - Fig. 1A) is participating in aerobic exercise (Para [0023]), and in response to the determination, temporarily reduce basal delivery of the liquid drug (Para [0038]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the processor of Amirouche to execute code to interpret signals, indicating that the user is participating in aerobic exercise, and temporarily reducing the basal delivery of the liquid drug as taught by O’Connor since O’Connor teaches that interpreting signals and indicating that the user is participating in aerobic exercise and temporarily reducing the basal delivery of the liquid drug, is a well-known technique in insulin pump devices, which improves the accuracy of the drug delivery to the user, allowing for improved patient safety and treatment effectiveness.
Regarding claim 25, Amirouche discloses the drug delivery system as recited above, wherein the processor, the memory, the drug container, and the pump drive mechanism are within the housing of the drug delivery device (Fig.6B, Fig.11).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Amirouche in view of O’Connor, and further in view of Newberry et al. (US Pub. No. 20190286233 A1, herein, Newberry).
Regarding claim 6, Amirouche, as modified, discloses the drug delivery system as recited above wherein the plurality of sensors of the sensor module are configured to output signals to the auxiliary device interface (O’Connor, Para [0026], Para [0030]).
However, Amirouche does not expressly disclose wherein the plurality of sensors of the sensor module further comprises: a photoplethysmography sensor configured to make a heart rate measurement; a three-axis accelerometer; and a three-axis gyroscope.
Newberry teaches wherein a plurality of sensors of the sensor module further comprises: a photoplethysmography sensor (110 - Fig. 1, Para [0007]) configured to make a heart rate measurement; a three-axis accelerometer (124 - Fig. 1, Para [0068]); and a three-axis gyroscope (122 - Fig. 1, Para [0068]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the sensor module disclosed by Amirouche, as modified, to further comprise a photoplethysmography sensor configured to make a heart rate measurement; a three-axis accelerometer; and a three-axis gyroscope as taught by Newberry to identify a motion artifact and correlate the motion artifact in the photoplethysmography signal to a predetermined photoplethysmography signal pattern (Newberry, Para [0007]) and to track acceleration, rotation, position, or orientation information of the biosensor in six degrees of freedom through three-dimensional space (Newberry, Para [0068]).
Claims 10-11, 13-14, 22-24, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Amirouche in view of O’Connor, and further in view of O’Connell et al. (US Pub. No. 20190209777 A1, herein, O’Connell).
Regarding claim 10, Amirouche, as modified, discloses the drug delivery system as recited above but Amirouche does not expressly disclose wherein: the memory is configured to store exercise indication information indicating an activity of a user, wherein the exercise indication information is a signal pattern or other parameters indicating exercise; and the processor is configured to: interpret signals received from the plurality of sensors via the auxiliary device interface; access the exercise indication information; compare a pattern obtained from the signal received from the plurality of sensors with the signal pattern or other parameters of the exercise indication information; and determine, based on a result of the comparing, that the pattern indicates aerobic exercise as a category of activity of the user.
O’Connell teaches that a memory is configured to store exercise indication information indicating an activity of a user, wherein the exercise indication information is a signal pattern or other parameters indicating exercise (“The heart rate monitor can detect the subject's heart rate prior to, during, and after exercise” – [Para 0167]); and the processor is configured to: interpret signals received from the plurality of sensors (1606 – Fig.16) via an auxiliary device interface (1610 – Fig.16); access the exercise indication information; compare a pattern obtained from the signal received from the plurality of sensors with the signal pattern or other parameters of the exercise indication information; and determine, based on a result of the comparing, that the pattern indicates aerobic exercise as a category of activity of the user (Para [0166-0168]).
The examiner has interpreted the exercise indication information as the heart rate of the user and the comparison of patterns from the sensor’s data is the differences in heart rate, determining if the user is participating in aerobic exercise.
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the drug delivery system disclosed by Amirouche, as modified, so that the memory is configured to store exercise indication information indicating an activity of a user, wherein the exercise indication information is a signal pattern or other parameters indicating exercise; and the processor is configured to: interpret signals received from the plurality of sensors via the auxiliary device interface; access the exercise indication information; compare a pattern obtained from the signal received from the plurality of sensors with the signal pattern or other parameters of the exercise indication information; and determine, based on a result of the comparing, that the pattern indicates aerobic exercise as a category of activity of the user as taught by O’Connell to influence the determination of other important factors, including the type of exercise instruction given to the subject, the dose of insulin to administer, the dose of glucagon to administer, whether to warn the subject of an unsafe circumstance, whether to advise the subject to consume a source of carbohydrates, or whether to terminate exercise (O’Connell, Para [0167]).
Regarding claim 11, Amirouche, as modified, discloses the drug delivery system as recited above wherein the processor is configured when executing the programming code to: interpret signals received from the plurality of sensors via the auxiliary device interface (O’Connor, Para [0020]).
Amirouche does not expressly disclose that wherein the processor is operable to: access the exercise indication information; compare a pattern obtained from the signal received from the plurality of sensors with a signal pattern or other parameters of the exercise indication information; and determine, based on a result of the comparing, that the pattern indicates anaerobic exercise as a category of activity of the user; based on an interpretation of the signals, determine that a wearer of the drug delivery device and the sensor module is participating in anaerobic exercise; and based on the determination, increase basal delivery of the liquid drug.
O’Connell teaches that wherein the processor is operable to: access the exercise indication information (“The heart rate monitor (406) can detect the subject's heart rate prior to, during, and after exercise” – [Para 0167]); compare a pattern obtained from the signal received from the plurality of sensors with a signal pattern or other parameters of the exercise indication information; and determine, based on a result of the comparing, that the pattern indicates anaerobic exercise as a category of activity of the user; based on an interpretation of the signals, determine that a wearer of the drug delivery device and the sensor module is participating in anaerobic exercise (Para [0166-0168]); and based on the determination, increase basal delivery of the liquid drug (“The heart rate that is communicated to telecommunications device can influence the determination of other important factors, including… the dose of insulin to administer” – Para [0167]);
The examiner interprets the exercise indication information as the heart rate of the user and the comparison of patterns from the sensor’s data is the differences in heart rate, determining if the user is participating in aerobic exercise.
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the drug delivery system as recited above wherein the processor is configured when executing the programming code to: interpret signals received from the plurality of sensors via the auxiliary device interface as disclosed by Amirouche so wherein the processor is operable to: access the exercise indication information; compare a pattern obtained from the signal received from the plurality of sensors with a signal pattern or other parameters of the exercise indication information; and determine, based on a result of the comparing, that the pattern indicates anaerobic exercise as a category of activity of the user; based on an interpretation of the signals, determine that a wearer of the drug delivery device and the sensor module is participating in anaerobic exercise; and based on the determination, increase basal delivery of the liquid drug as taught by O’Connell (Para [0167]).
Regarding claim 13, Amirouche, as modified, discloses the drug delivery system as disclosed above but does not expressly disclose wherein the generated alert is related to aerobic exercise and includes a recommendation, and the recommendation is for the user to: consume carbohydrates, sprint after completing the aerobic exercise, or after completing the aerobic exercise, to consume carbohydrates and administer a modified bolus dosage of the liquid drug based on a reduced liquid drug to carbohydrate ratio.
O’Connell teaches that wherein the generated alert is related to aerobic exercise (“ During exercise, user biometrics can be assessed in real-time to provide actionable advice to a user” – Para [0093]) and includes a recommendation, and the recommendation is for the user to: consume carbohydrates, sprint after completing the aerobic exercise, or after completing the aerobic exercise, to consume carbohydrates and administer a modified bolus dosage of the liquid drug based on a reduced liquid drug to carbohydrate ratio (“be advised to intake sugar immediately” – Para [0094]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the drug delivery system disclosed by Amirouche so wherein the generated alert is related to aerobic exercise and includes a recommendation, and the recommendation is for the user to: consume carbohydrates, sprint after completing the aerobic exercise, or after completing the aerobic exercise, to consume carbohydrates and administer a modified bolus dosage of the liquid drug based on a reduced liquid drug to carbohydrate ratio taught by O’Connell to normalize blood glucose levels (O’Connell, Para – 0094).
Regarding claim 14, Amirouche, as modified, discloses the drug delivery system as disclosed above, wherein the processor is configured when executing the programming code to: interpret signals received from the plurality of sensors via the auxiliary device interface (O’Connor, Para – [0020]).
Amirouche does not expressly disclose based on an interpretation of the signals, determine that the user of the drug delivery device and the sensor module is participating in anaerobic exercise; and based on the determination, generate an alert related to both the anaerobic exercise and a diabetes treatment plan of the user of the drug delivery device and the sensor module.
O’Connell teaches that based on an interpretation of the signals, determine that the user of the drug delivery device and the sensor module is participating in anaerobic exercise (“The heart rate monitor (406) can detect the subject's heart rate prior to, during, and after exercise” – Para [0167]); and based on the determination, generate an alert related to both the anaerobic exercise and a diabetes treatment plan of the user of the drug delivery device and the sensor module (“recommendation to adjust insulin dosage, and a recommendation to consume food or beverage.” – Para [0097]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the drug delivery system as disclosed by Amirouche so that based on an interpretation of the signals, determine that the user of the drug delivery device and the sensor module is participating in anaerobic exercise; and based on the determination, generate an alert related to both the anaerobic exercise and a diabetes treatment plan of the user of the drug delivery device and the sensor module as taught by O’Connell to modify or correct that biometric of the user (Para – [0097]).
Regarding claim 22, Amirouche, as modified, discloses the delivery device system as recited above but does not expressly disclose that wherein the processor when executing the programming code is further operable, when generating the alert, to: output a recommendation for the user to finish the anaerobic exercise with prolonged aerobic exercise for a cool down period.
O’Connell teaches that wherein the processor when executing the programming code is further operable, when generating the alert (Para [0097]), to: output a recommendation for the user to finish the anaerobic exercise with prolonged aerobic exercise for a cool down period (“recommendation to slow performance of an exercise, a recommendation to stop performance of an exercise” – Para [0097]) .
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the delivery device system as disclosed by Amirouche wherein the processor when executing the programming code is further operable, when generating the alert, to: output a recommendation for the user to finish the anaerobic exercise with prolonged aerobic exercise for a cool down period as taught by O’Connell to modify or correct that biometric of the user (Para – [0097]).
Regarding claim 23, Amirouche, as modified, discloses the delivery device system as recited above but does not expressly disclose that wherein the processor when executing the programming code is further operable, when generating the alert, to: output a recommendation for the user after completing the anaerobic exercise to consume carbohydrates and administer a modified bolus dosage of the liquid drug based on a reduced liquid drug to carbohydrate ratio.
O’Connell teaches that wherein the processor when executing the programming code is further operable, when generating the alert (Para [0097]), to: output a recommendation for the user after completing the anaerobic exercise to consume carbohydrates and administer a modified bolus dosage of the liquid drug based on a reduced liquid drug to carbohydrate ratio (“a recommendation to adjust insulin dosage, and a recommendation to consume food or beverage” – Para [0097]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the delivery device system as disclosed by Amirouche wherein the processor when executing the programming code is further operable, when generating the alert, to: output a recommendation for the user after completing the anaerobic exercise to consume carbohydrates and administer a modified bolus dosage of the liquid drug based on a reduced liquid drug to carbohydrate ratio as taught by O’Connell to modify or correct that biometric of the user (Para – [0097]).
Regarding claim 24, Amirouche, as modified, discloses the delivery device system as recited above but does not expressly disclose wherein the measured parameters related to the orientation and the movement of the sensor module stored as exercise indication information, which includes one or more of signal parameters indicating exercise, signal patterns related to physical activity, predetermined maximum signals indicating exercise, or a position of drug delivery system.
O’Connell teaches that wherein the measured parameters related to the orientation and the movement of the sensor module stored as exercise indication information, which includes one or more of signal parameters indicating exercise, signal patterns related to physical activity, predetermined maximum signals indicating exercise, or a position of drug delivery system (“The heart rate monitor (406) can detect the subject's heart rate prior to, during, and after exercise” – [Para 0167]);
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the delivery device system as disclosed by Amirouche wherein the measured parameters related to the orientation and the movement of the sensor module stored as exercise indication information, which includes one or more of signal parameters indicating exercise, signal patterns related to physical activity, predetermined maximum signals indicating exercise, or a position of drug delivery system as taught by O’Connell so it can influence the determination of other important factors, including the type of exercise instruction given to the subject, the dose of insulin to administer, the dose of glucagon to administer, whether to warn the subject of an unsafe circumstance, whether to advise the subject to consume a source of carbohydrates, or whether to terminate exercise (Para [0167]).
Regarding claim 26, Amirouche, as modified, discloses the delivery device system as recited above but does not expressly disclose wherein the processor, when determining that the pattern indicates aerobic exercise, is further configured to:
receive signals from the heart rate sensor, the accelerometer, and the gyroscope;
compare the received signals with stored exercise indication information comprising signal patterns generated using machine learning classifiers; and
classify the exercise as aerobic when a duration of the received signals exceeds a predetermined threshold and heart rate exceeds a preset threshold of maximum heart rate.
O’Connell teaches a processor (403 – Fig.4) when determining that the pattern indicates aerobic exercise, is further configured to:
receive signals from the heart rate sensor, the accelerometer, and the gyroscope (“The system receives a biometric measurement of a subject from biometric sensors” – Para [0122]);
compare the received signals with stored exercise indication information comprising signal patterns generated using machine learning classifiers (Para [0209], the machine learning would inherently be capable of comparing signals since machine learning analysis relies on comparing data against pattern to classify or identify conditions); and
classify the exercise as aerobic when a duration of the received signals exceeds a predetermined threshold and heart rate exceeds a preset threshold of maximum heart rate (Para [0234], [0235]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the processor as disclosed by Amirouche to be configured to use machine learning to compare signals as disclosed by O’Connell since O’Connell teaches that machine learning is a well-known tool to include in insulin pumps to analyze data which improves accuracy and efficiency of analyzing data.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Amirouche in view of O’Connor and O’Connell, and further in view of Yodfat et al. (US Pub No. 20130030358 A1, herein, Yodfat).
Regarding claim 27, Amirouche, as modified, discloses the delivery device system as recited above but does not expressly disclose wherein the processor is configured to: modify delivery of the liquid drug by applying a nocturnal basal reduction when the outputted signal indicates the detected aerobic exercise that occurred in an afternoon or in an evening.
Yodfat teaches a processor (10 – Fig.2a) is configured to: modify delivery of the liquid drug by applying a nocturnal basal reduction when the outputted signal indicates the detected aerobic exercise that occurred in an afternoon or in an evening (“pump users may set a greater IS value in the evening hours after daily exercise since the sensitivity to insulin increases when physically active.” – Para [0018]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the processor as disclosed by Amirouche to be configured to adjust the basal dosage when it indicates an exercise occurred in the afternoon since Yodfat teaches that adjusting basal dosages depending on if it is in the evening is a well-known technique in insulin pumps, allowing for improved safety and effectiveness of therapy.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm EST.
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/MARISSA TAYLOR/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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