DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/17/2025 has been entered.
Status of the Claims
The status of the claims as of the response filed 11/17/2025 is as follows: Claim 19 remains cancelled. Claims 1, 8, 11, and 20 are currently amended. Claim 9 and 18 are as previously presented. Claims 2-7, 10, and 12-17 are original. Claims 1-18 and 20 are currently pending in the application and have been considered below.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosures of the prior-filed applications, Application Nos. 62/893,717 and 62/893,727, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For example, the above provisional applications do not provide adequate support for determining, based on a connection to a short-range communication system of a vehicle, that the patient is in the vehicle as recited in independent claims 1 and 11, because they include no disclosure of connections to short-range communication systems of a vehicle. However, this subject matter is supported by at least paras. [0063], [0079], & [0107]-[0108] of the originally-filed specification of parent application 17/004,981. Further, though these provisional applications contemplate “adjust[ing] the glucose target for driving mode” once a user has been determined to be driving a vehicle based on gesture data (see Pg 16 of each provisional specification), they do not provide any further details on how the glucose target is adjusted (e.g. up or down) nor what the driving mode entails with respect to insulin delivery. Accordingly, these provisional applications also do not provide adequately support for automatically implement, without patient confirmation, the driving therapy protocol to deliver insulin to maintain a glucose level of the patient above a hypoglycemia threshold as in claims 1, 11, and 20. However, this subject matter is supported by at least paras. [0005], [0022], & [0040] of the originally-filed specification of parent application ‘981. Claims 1, 11, and 20 (and the claims depending therefrom) are therefore not entitled to the priority date of the previously filed provisional applications, and instead receive the effective filing date of parent application 17/004,891: 8/27/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/3/2025 is in accordance with the provisions of 37 CFR 1.97 and is considered by the Examiner.
Response to Amendment
Rejection Under 35 USC 112(b)
Claim 20 has been amended to sufficiently clarify the indefinite element such that the corresponding 35 USC 112(b) rejection is withdrawn.
Rejection Under 35 USC 103
The amendments made to the claims introduce limitations that are not fully addressed in the previous office action, and thus the corresponding 35 USC 103 rejections are withdrawn. However, Examiner will consider the amended claims in light of an updated prior art search and address their patentability with respect to prior art below.
Response to Arguments
Rejection Under 35 USC 103
On page 7 of the response filed 11/17/2025 Applicant argues that “Desborough describes receiving an explicit user input indicating an override to be implemented, e.g., indicating that the user is driving” and modifying an insulin profile “based on explicit user input indicating the temporary override” (emphasis original), such that Desborough “effectively teaches away from ‘automatically implement, without patient confirmation, the driving therapy protocol to delivery insulin to maintain a glucose level of the patient above a hypoglycemia threshold’” (emphasis original). Applicant’s arguments are fully considered, but are not persuasive. Though Examiner concedes that Desborough does not disclose modifying a therapy protocol based on a gesture-based determination that a user is operating a vehicle, it does still disclose modifying a therapy protocol based on a determination that the user is driving a vehicle (e.g. based on a user’s manual indication or selection of this type of activity as in [0098]). The determined temporary activity-based override profiles are then automatically implemented at the insulin pump, as indicated by [0210] showing that the baseline basal insulin rate is modified (e.g. via automatic implementation in a closed-loop manner as noted in [0180]) based on the temporary activity-based profile such as a driving delivery profile as in [0098]. Thus, when considered in combination with the teachings of Kadous (which include automatically determining whether a user is driving a vehicle based on user gesture and location data rather than based on explicit user inputs), the cited prior art does sufficiently suggest determining and automatically implementing, without patient confirmation, a driving therapy protocol based on a determination that the patient is operating the vehicle (see paras. 13-15 of the final rejection mailed 9/22/2025 as well as paras. 14-17 below for a full explanation of the combined teachings of these references). The result of such a combination would include a system that can automatically detect user gestures to determine when the user is driving (as in Kadous) and use of the driving determination to modify and automatically implement an insulin delivery profile based on knowledge of the user’s driving activity so that hypoglycemia events are avoided (as in Desborough). Because the gesture- and location-based driving determination of Kadous replaces the explicit user input of Desborough to make the determination of whether the user is driving, the automatically implemented insulin delivery profile override as in Desborough occurs “without patient confirmation” in the context of the combination.
On pages 7-8 of the response Applicant argues that “the combination of Desborough and Kadous do not disclose or suggest ‘inhibiting alerts not related to the glucose level of the patient with respect to [a] hypoglycemia threshold.’” Applicant’s arguments are fully considered, but are not persuasive. Examiner submits that Kadous does disclose automatically inhibiting output functions of a user device when a user is determined to be operating a vehicle (Kadous Col2 L35-59, Col7 L32-50), which is considered functionally equivalent to inhibiting alerts not related to the glucose level of a patient with respect to a hypoglycemia threshold because Kadous does not mention any alerts specifically related to glucose level of a patient, such that the disabled outputs would include those not related to blood glucose.
Accordingly, Examiner maintains that the presently cited prior art references do teach the amended claims, as explained in more detail in the updated 35 USC 103 rejections below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 8 recites “modify presentation of alerts while implementing the driving therapy protocol based on a relevance of the alerts to the glucose level of the patient or to the delivery of insulin.” Applicant’s original specification does not provide sufficient written support for modifying the presentation of alerts based on a relevance of the alerts to the glucose level of the patient or to the delivery of insulin. At most, paras. [0017]-[0018], [0034], & [0071] describe how the presentation of higher priority alerts vs. lower priority alerts may be implemented or adjusted while a patient is determined to be driving, and give examples of higher priority alerts as “low blood glucose alert” and lower priority alerts as “low battery, meal reminders, etc.” Para. [0034] provides additional examples of higher priority alerts as indicating “low or dropping blood glucose level,” “high or spiking blood glucose level,” “instruct[ing] patient 12 to take action regarding their therapy (e.g., instructions to manually inject insulin),” “sever[e] low blood glucose (e.g., less than 54 mg/dL),” and “alerts for insulin pump 14 that indicate that therapy has stopped, e.g., due to occlusion, dead battery (“replace battery now”), reservoir empty, or critical pumping errors.” Para. [0034] provides further examples of lower priority alerts as “other, non-safety critical alerts, such as reminders to take medication, reminders to eat, low-battery alerts, change/replace sensor 20, and the like.” While these disclosures do provide many examples of various types of alerts related to patient glucose levels or insulin delivery being presented differently, there is no disclosure of the basis for the differing presentation schemas being a relevance of the alerts to the glucose level of the patient or to the delivery of insulin. Rather, certain types of alerts appear to be categorized as either higher priority or lower priority to differentiate how the different alerts should be presented to a patient when driving, but there is no support for the deciding factor between alerts being classified as “higher” or “lower” priority specifically being a relevance to glucose level of the patient or the delivery of insulin. Because this subject matter was not present in the original disclosure as filed, this limitation constitutes new matter and is rejected under 35 U.S.C. 112(a). To remedy this rejection, Examiner suggests modifying the language of claim 8 to make reference to modifying presentation of alerts with higher and/or lower priority in accordance with a driving alerting protocol as disclosed in paras. [0017]-[0018], [0034], & [0071] rather than referencing a relevance of the alerts to the glucose level of the patient or to the delivery of insulin.
Claim 20 recites “automatically implementing, without patient confirmation, the driving therapy protocol to delivery, by the insulin pump, insulin to maintain a glucose level of the patient above a hypoglycemia threshold while concurrently inhibiting alerts not related to the glucose level of the patient with respect to the hypoglycemia threshold.” Applicant’s original specification does not provide sufficient written support for a driving therapy protocol that maintains a glucose level of the patient above a hypoglycemia threshold, while also inhibiting alerts not related to the glucose level of the patient with respect to the same hypoglycemia threshold. At least paras. [0037], [0043], [0067], & [0072] of the specification describe a driving therapy protocol as operating an insulin pump according to “a higher target blood glucose level,” which is considered equivalent to maintaining a glucose level of the patient above a hypoglycemia threshold. Para. [0071] further describes a driving alert protocol that may inhibit lower priority alerts such as low battery, meal reminders, etc. while still allowing higher priority alerts such as low blood glucose alert when a patient is determined to be driving. The low blood glucose alert is disclosed as being output “if the blood glucose level is below some threshold (e.g., less than 70 mg/dl)” and/or if “a blood glucose level [is] below a threshold for a specified period of time (e.g., 2 minutes).” However, there is no indication that the target blood glucose level (i.e. the hypoglycemia threshold for the driving therapy protocol) and the low blood glucose threshold (i.e. the hypoglycemia threshold for the driving alert protocol) are the same threshold. Because this subject matter was not present in the original disclosure as filed, this limitation constitutes new matter and is rejected under 35 U.S.C. 112(a). To remedy this rejection, Examiner suggests modifying the language of claim 20 specify inhibiting “low priority alerts” or equivalent in accordance with paras. [0017]-[0018], [0034], & [0071].
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 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.
Claims 1, 3-5, 7, 9-11, 13-15, 17-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Desborough et al. (US 20170203039 A1) in view of Kadous (US 9037125 B1).
Claims 1 and 11
Desborough teaches an insulin pump for delivery of diabetes therapy, the insulin pump comprising: one or more processors configured to (Desborough [0180], noting an insulin pump with one or more microprocessors to execute stored computer-readable instructions to achieve any of the control operations of the invention, such as determining and administering insulin dosage parameters):
receive (Desborough [0098], [0162], [0208], noting the system receives a user input such as an indication of an activity such as driving a car for an extended period of time);
determine, based at least in part on the (Desborough [0098], [0162]-[0163], [0208]-[0210], noting the system accepts the user input of an activity and makes subsequent determinations about appropriate insulin pump delivery profiles such that the system is considered to determine that the user is engaging in the input activity (e.g. driving a car for an extended period of time));
determine a driving therapy protocol based on the determination that the patient is operating the vehicle (Desborough [0098], [0162]-[0163], [0208]-[0210], noting the system determines appropriate insulin pump delivery profiles according to the input activity such as driving a car for an extended period of time); and
automatically implement, (Desborough [0055], [0091], [0180], noting the insulin pump operates in a fully closed-loop manner such that automatically determined insulin doses (e.g. temporary profiles associated with a driving activity as in [0098] & [0208]-[0210]) are delivered automatically; such temporary profiles may operate to reduce the likelihood that the patient experiences a hypoglycemia event by striving to meet a glucose level target such as not having glucose levels drop below a certain level (i.e. a hypoglycemia threshold) per abstract, [0098] & [0210]).
Though Desborough teaches a system for a processor-based insulin pump system determining and implementing a driving therapy protocol based on indications that a user is driving a vehicle (e.g. via a user input as in [0098], [0162], & [0208]), it does not describe the system utilizing gesture data and short-range communication system connections to determine that the patient is inside of and operating the vehicle, and thus this reference fails to explicitly disclose receiving gesture data indicative of a gesture of a patient using the insulin pump; determining, based on a connection to a short-range communication system of a vehicle, that the patient is in the vehicle; determining, based at least in part on the gesture data, that the patient is operating the vehicle; and automatically implementing the driving therapy protocol without patient confirmation.
However, Kadous teaches a system for determining when a user is operating a vehicle and making automatic adjustments to operation of user devices when a user is determined to be operating the vehicle (Kadous abstract) that specifically detects when the user is operating the vehicle by:
receiving gesture data indicative of a gesture of a user (Kadous Col2 L35-59, Col5 L41-55, noting a wearable device detects an indication of movement of a user such as turning a steering wheel, moving a gear shift, etc., i.e. gesture data indicative of a gesture, and sends such gesture data to another processor-based computing system);
determining, based on a connection to a short-range communication system of a vehicle, that the user is in the vehicle (Kadous Col2 L35-59, Col7 L65 – Col8 L10 noting location module 22 (e.g. as embodied in the processor-based computing system as in Col7 L26-29) makes an inference that a user is in a vehicle based on the wearable device being within range of a wireless communication signal of the vehicle, i.e. based on a connection to a short-range communication system of a vehicle);
determining, based at least in part on the gesture data, that the patient is operating the vehicle (Kadous Col2 L35-59, Col5 L41-55, noting the processor-based computing system further determines that a user is driving based on analyzing the gesture data from the wearable device); and
automatically implementing functions of a user device without patient confirmation based on the determination that the patient is operating the vehicle (Kadous Col2 L35-59, Col12 L4-16, noting functions or operations of a user device are automatically enabled/disabled based on the location-based and gesture-based determination that a user is operating a vehicle, i.e. an operation of the device is automatically implemented without user confirmation).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the insulin pump processor of Desborough to include the gesture- and short-range communication-based driving determination functionality of Kadous in order to utilize more accurate and real-time sensor data to determine when a user is actively driving a vehicle (as suggested by Kadous Col19 L51-65) rather than relying on potentially unreliable patient self-reporting inputs of activities so that a function of the user device appropriate to the driving activity (e.g. control of an insulin pump in accordance with a driving therapy protocol as in Desborough) can be automatically implemented without explicit user confirmation and the user’s blood glucose can be beneficially controlled in accordance with their actual activities.
Claim 11 recites substantially similar subject matter as claim 1, and is also rejected as above.
Claims 3 and 13
Desborough in view of Kadous teaches the insulin pump of claim 1, and the combination further teaches wherein the driving therapy protocol comprises reducing a dosage of insulin relative to a default dosage (Desborough [0098], noting a temporary insulin delivery profile for a driving activity may include setting a target blood glucose level higher than their normal target blood glucose level, which per [0210] results in reducing a dosage of insulin relative to a default dosage).
Claim 13 recites substantially similar subject matter as claim 3, and is also rejected as above.
Claims 4 and 14
Desborough in view of Kadous teaches the insulin pump of claim 1, and the combination further teaches wherein the driving therapy protocol comprises increasing a target glucose level relative to a default target glucose level (Desborough [0098], noting a temporary insulin delivery profile for a driving activity may include setting a target blood glucose level higher than their normal target blood glucose level).
Claim 14 recites substantially similar subject matter as claim 4, and is also rejected as above.
Claims 5 and 15
Desborough in view of Kadous teaches the insulin pump of claim 1, and the combination further teaches wherein the gesture data is obtained by a wearable device worn by the patient (Kadous Col2 L35-51, noting a wearable computing device worn by the user provides the movement/gesture data).
Claim 15 recites substantially similar subject matter as claim 5, and is also rejected as above.
Claims 7 and 17
Desborough in view of Kadous teaches the insulin pump of claim 1, and the combination further teaches wherein the driving therapy protocol is one that reduces a likelihood of hypoglycemia relative to a default therapy protocol (Desborough [0098], [0162]-[0163], noting a temporary insulin delivery profile for a driving activity may include setting a target blood glucose level higher than their normal target blood glucose level, e.g. in accordance with a user preference to reduce a likelihood of a hypoglycemic event per the abstract).
Claim 17 recites substantially similar subject matter as claim 7, and is also rejected as above.
Claims 9 and 18
Desborough in view of Kadous teaches the insulin pump of claim 1, and the combination further teaches wherein the insulin pump is coupled to the short-range communication system of the vehicle (Desborough [0180], noting an insulin pump with one or more microprocessors to execute stored computer-readable instructions to achieve any of the control operations of the invention; see also Kadous Col2 L35-59, Col7 L65 – Col8 L10 noting location module 22 (e.g. as embodied in the processor-based computing system as in Col7 L26-29) makes an inference that a user is in a vehicle based on the wearable device being within range of a wireless communication signal of the vehicle, i.e. based on a connection to a short-range communication system of a vehicle. When considered in the context of the combination explained above for claims 1 and 11, the processor of the insulin pump as in Desborough is equivalent to the processor-based computing system of Kadous such that the insulin pump is considered to be “coupled” to the short-range communication system of the vehicle via its connection to the wearable device, which is in turn communicating with the short-range communication system of the vehicle).
Claim 18 recites substantially similar subject matter as claim 9, and is also rejected as above.
Claim 10
Desborough in view of Kadous teaches the insulin pump of claim 1, and the combination further teaches wherein the driving therapy protocol causes the diabetes therapy to be managed differently when the patient is operating the vehicle relative to when the patient is a passenger in the vehicle (Desborough [0098], [0208]-[0210], noting the temporary insulin delivery profile associated with an activity (e.g. driving) is different than the normal/default insulin delivery profile, indicating that when a user is determined to be driving (e.g. via the gesture and short-range communication methods of Kadous such as in Col19 L51-65, when considered in the context of the combination) the diabetes therapy would be managed differently than when the patient is determined to merely be a passenger in the vehicle (e.g. via the gesture and short-range communication methods of Kadous such as in Col19 L51-65, when considered in the context of the combination)).
Claim 20
Desborough teaches a method for delivery of diabetes therapy (Desborough [0180], noting an insulin pump with one or more microprocessors to execute stored computer-readable instructions to achieve any of the control operations of the invention, such as determining and administering insulin dosage parameters), the method comprising:
determining, by one or more processors of an insulin pump based at least in part on received (Desborough [0098], [0162]-[0163], [0208]-[0210], noting the system accepts the user input of an activity and makes subsequent determinations about appropriate insulin pump delivery profiles such that the system is considered to determine that the user is engaging in the input activity (e.g. driving a car for an extended period of time));
determining, using the one or more processors of the insulin pump, a driving therapy protocol based on the determination that the patient is operating the vehicle (Desborough [0098], [0162]-[0163], [0208]-[0210], noting the system determines appropriate insulin pump delivery profiles according to the input activity such as driving a car for an extended period of time); and
automatically implementing, (Desborough [0091], [0180], noting the insulin pump operates in a fully closed-loop manner such that determined insulin doses (e.g. temporary profiles associated with a driving activity as in [0098] & [0208]-[0210]) are delivered automatically; such temporary profiles may operate to reduce the likelihood that the patient experiences a hypoglycemia event by striving to meet a glucose level target such as not having glucose levels drop below a certain level (i.e. a hypoglycemia threshold) per abstract, [0098] & [0210]).
Though Desborough teaches a system for a processor-based insulin pump system determining and implementing a driving therapy protocol based on indications that a user is driving a vehicle (e.g. via a user input as in [0098], [0162], & [0208]), it does not describe the system utilizing gesture data to determine that the patient operating the vehicle. Desborough fails to explicitly disclose determining, based at least in part on received gesture data, that the patient is operating the vehicle; and automatically implementing the driving therapy protocol without patient confirmation, while concurrently inhibiting alerts not related to the glucose level of the patient with respect to the hypoglycemia threshold.
However, Kadous teaches a system for determining when a user is operating a vehicle and making automatic adjustments to operation of user devices when a user is determined to be operating the vehicle (Kadous abstract) that specifically determines when the user is operating the vehicle based at least in part on gesture data (Kadous Col2 L35-59, Col5 L41-55, noting the processor-based computing system determines that a user is driving based on analyzing the gesture data from a wearable device) and automatically implements and/or inhibits functions of a user device without patient confirmation based on the determination that the patient is operating the vehicle (Kadous Col2 L35-59, Col7 L32-50, Col12 L4-16, noting functions or operations of a user device are automatically enabled/disabled based on the gesture-based determination that a user is operating a vehicle, i.e. an operation of the device is automatically implemented without user confirmation; such operations can include disabling outputs that would normally be provided on a user interface device so that a user is not distracted by outputs while driving, considered to encompass “inhibiting alerts not related to the glucose level of the patient with respect to the hypoglycemia threshold” because Kadous does not mention any alerts specifically related to glucose level of a patient, such that the disabled outputs would include those not related to blood glucose).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the user-indicated driving determination method of Desborough to include the gesture-based driving determination functionality of Kadous in order to utilize more accurate and real-time sensor data to determine when a user is actively driving a vehicle (as suggested by Kadous Col19 L51-65) rather than relying on potentially unreliable patient self-reporting inputs of activities so that a function of the user device appropriate to the driving activity (e.g. control of an insulin pump in accordance with a driving therapy protocol as in Desborough, as well as inhibition of outputs/alerts unrelated to blood glucose level as in Kadous Col7 L32-50) can be automatically implemented without explicit user confirmation such that the user’s blood glucose can be beneficially controlled in accordance with their actual activities and driving distractions can be concurrently minimized, thereby enhancing patient safety.
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Desborough and Kadous as applied to claims 1 or 11 above, and further in view of Stewart et al. (US 20190052748 A1).
Claims 2 and 12
Desborough in view of Kadous teaches the insulin pump of claim 1, and the combination further teaches wherein the one or more processors are further configured to: (Desborough [0098], noting that the activity-based insulin delivery profile is a temporary override of a baseline or normal basal insulin infusion rate, indicating that when the activity period is determined to be over (e.g. by determining that the designated length of time of an activity has expired as in [0098] & [0208]), a default therapy protocol is resumed).
In summary, though the present combination teaches gesture-based determinations of driving behavior as well as suggests that a default therapy protocol may be resumed when the patient is no longer performing the activity (e.g. driving), it fails to explicitly disclose that a determination that the patient is no longer operating the vehicle is based at least in part on detecting an updated gesture of the patient. However, Stewart teaches an analogous gesture-based driving determination system (Stewart [0074]) that detects updated gestures of a user after they have been determined to be operating the vehicle which are used to determine that the user is no longer operating the vehicle (Stewart [0067], [0081]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of resuming normal insulin delivery for a user of the combination to include determining that the driving activity has stopped based on updated gesture data of the user as in Stewart in order to utilize real-time sensor data to determine when a user is no longer actively driving a vehicle (as suggested by Stewart [0067]) rather than relying on potentially unreliable inputting of expected activity time periods so that the user’s blood glucose can be beneficially controlled in accordance with their actual activities (as in Desborough).
Claim 12 recites substantially similar subject matter as claim 2, and is also rejected as above.
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Desborough and Kadous as applied to claims 1 or 11 above, and further in view of Hayter et al. (US 20180199890 A1).
Claims 6 and 16
Desborough in view of Kadous teaches the insulin pump of claim 5. The combination further shows that an insulin pump may be communicatively coupled to a patient device such as a mobile phone (Desborough Fig. 1, [0108]), as well as that the gesture-detecting wearable device is communicatively coupled to a user device such as a mobile phone (Kadous Fig. 1, Col4 L18-55). However, the present combination does fails to explicitly disclose wherein the gesture data is received by the one or more processors of the insulin pump via an intermediary patient device communicatively coupling the wearable device and the insulin pump. However, Hayter teaches a system in which an intermediary patient device relays sensor data from one or more sensors (such as activity monitors embodied as wearable accelerometer devices) to a medication delivery device (such as an insulin pump) (Hayter [0032], noting a hub device which may collect data from one or more patient monitors (e.g. a wearable accelerometer as in [0031]) and relay the sensed information to medication delivery device 120 (e.g. an insulin pump as in [0006]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the sending of gesture data from a wearable device to a processor of an insulin pump as in the combination to include sending the gesture data via an intermediary patient device as in Hayter in order to facilitate either real-time or batch sending of patient sensor data aggregated from multiple sensors to the pump via a small and discreet relay hub device (as suggested by Hayter [0032]).
Claim 16 recites substantially similar subject matter as claim 6, and is also rejected as above.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Desborough and Kadous as applied to claim 1 above, and further in view of Mensinger et al. (US 20140012510 A1).
Claim 8
Desborough in view of Kadous teaches the insulin pump of claim 1, and the combination further teaches wherein the one or more processors are further configured to modify presentation of alerts while implementing the driving therapy protocol (Kadous Col2 L51-59, Col7 L32-50, noting presentation of displayable information or output (i.e. alerts) at a user device (e.g. an insulin pump when considered in the context of the combination) may be modified when a user is determined to be driving a vehicle (i.e. while implementing the driving therapy protocol when considered in the context of the combination) so that certain outputs that may be distracting to a driver are disabled).
Though the present combination teaches modifying presentation of potentially distracting user interface outputs when a user is determined to be driving a vehicle, it fails to explicitly disclose modifying presentation of alerts while implementing the driving therapy protocol specifically based on a relevance of the alerts to the glucose level of the patient or to delivery of the insulin. However, Mensinger teaches that alerts relating to a user’s blood glucose level may be prioritized for display even when an alert profile for the user’s current context dictates that other types of alerts are silenced or disabled (Mensinger [0009], [0075], [0083], [0090], [0172], noting customizable alert settings for different user contexts (e.g. exercising, sleeping, driving, flying, being in a meeting, etc.) that allow for prioritization of some types of alerts (such as those relevant to a user’s blood glucose level when driving as in [0083]) over others based on severity/relevance to blood glucose level (as in [0090]) when operating under the context-specific alert profile). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the enablement/disablement of certain outputs at a user device when the user is determined to be driving as in the combination such that the outputs/alerts are enabled/disabled based on their relevance to the glucose level of the patient as in Mensinger in order to permit the highest priority hypoglycemia alerts relevant to a user’s ability to safely drive the vehicle to still be communicated to a user even while other lower priority alerts that may be potentially distracting are minimized, thereby enhancing the safe operation of the vehicle by the user (as suggested by Mensinger [0009] & [0090] and Kadous Col1 L6-16 & Col7 L36-45).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Para. [0084] of Henrich et al. (US 20180104412 A1) describes methods for adjusting blood glucose thresholds for a user and providing user alerts related to blood glucose levels while the user is driving.
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/KAREN A HRANEK/ Primary Examiner, Art Unit 3684