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 .
DETAILED ACTION
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “attachment of a disposable insulin dispensing unit to the insulin delivery device” (cl 1, 16, 28, 34) or “attachment of a disposable portion of the insulin delivery device to the durable portion” (cl 26) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. The drawings and specification show and describe the disposable dispensing unit as 233 and the delivery device/durable portion as 230. However, at least para 87 teaches: “Controller 232 is attached to dispensing unit 233 to form delivery device 230”. Figs 13A-13F show elements 233 and 230 appearing to be the same element. Therefore, the specification and drawings appear to teach that the dispensing unit is a part of, or the same as, the delivery device/durable portion. This is in contrast to the above claim limitations, which require the “dispensing unit” and the “delivery device”/”durable portion” to be separate elements that are joined in attachment.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4, 6-7, 10-11, 13, 16-19, 21-22, 24-26, 28-30, 34-36, 38-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0098105 (Lee) in view of US 2017/0351842 (Booth), US 2019/0009019 (Shor), and US 2024/0269376 (Tschirren).
Regarding claim 1, Lee teaches an insulin management method implemented by an insulin delivery device (Fig 1, para 50), comprising: detecting a starting activity comprising the insulin delivery device configured to be attachable to a user's body for a duration of a fasting period within an overall time period (“starting activity” implicitly comprises one or more of the steps prior to delivery of insulin from the delivery device 702; insulin delivery device is the “wearable drug delivery device”; lifecycle of a pod is several days, which would include a fasting period – i.e. sleep; see para 16-20, Fig 2, para 50-51); and initiating automated delivery of insulin in the form insulin doses based on periodically received blood glucose measurements during the fasting period (Fig 7, para 99-107, 116; delivery device operates over several 24 hr periods, including the fasting period).
Lee does not explicitly teach delivering correction bolus doses based on periodically received blood glucose measurements during the fasting period. However, Booth teaches that correction bolus doses may be delivered during a fasting period and based on a blood glucose measurement (para 33, 44-45). It would have been obvious to one of ordinary skill in the art at the time of the invention to initiate automated delivery of correction bolus doses based on periodically received blood glucose measurements during the fasting period in order to bring the user’s glucose level within acceptable limits, as taught by Booth.
Lee in view of Booth fails to teach detecting attachment of a disposable insulin dispensing unit to the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the insulin delivery device, automatically initiating automated delivery. However, Shor teaches detecting attachment of a disposable insulin dispensing unit to the insulin delivery device (para 192; connection sensor determining connection between 102 and 104; 104 is the delivery device; indicator unit detects when disposable component 102 and reusable component 104 are attached or detached; operation of the pump is stopped/ended when the two are detached and started when the two are attached; disposable component is the reservoir, reusable component is the delivery device; detachment is construed as an “ending activity”; attachment is construed as the “starting activity”, which has a primary function of connecting the reservoir and the delivery device) and initiating delivery when the dispensing unit and the delivery device are attached (para 215). Tschirren further teaches it was well known in the art to automatically initiate delivery of a medicament once attachment is detected (para 186: “starts automatically the injection procedure, for example after a delay time after the sensor patch unit determines that the device is attached …”). Both Shor and Tschirren teach that automatically initiating delivery upon detecting attachment of an element was a known alternative to manual initiation (Shor para 50 and Tschirren para 186). It would have been obvious to one of ordinary skill in the art at the time of the invention to detect attachment of a disposable insulin dispensing unit to the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the insulin delivery device, automatically initiate automated delivery, as taught by Shor and Tschirren. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, detecting attachment of a disposable insulin dispensing unit to the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the insulin delivery device, automatically initiating automated delivery yields predictable results (manual vs automatic initiation being well known alternatives).
Regarding claim 16, Lee teaches an insulin management system of an insulin delivery device configured to be attachable to a user's body for a duration of a fasting period within an overall time period (Fig 1, para 50; insulin delivery device is the “wearable drug delivery device” 702 or 724; lifecycle of a pod is several days, which would include a fasting period – i.e. sleep; see para 16-20, Fig 2, para 50-51), the system comprising: an activation component configured to detect a starting activity (activation component may be device 706, which communicates with and therefore is “configured to detect” a starting activity associated with preparation of use of the delivery device 702 – e.g. that device 702 is activated and ready for use); and a delivery component configured to initiate automated delivery of insulin based on periodically received blood glucose measurements during the fasting period (Fig 7, para 99-107, 116; delivery device operates over several 24 hr periods, including the fasting period; delivery component may be the pump 702).
Lee does not explicitly teach delivering correction bolus doses based on periodically received blood glucose measurements during the fasting period. However, Booth teaches that correction bolus doses may be delivered during a fasting period and based on a blood glucose measurement (para 33, 44-45). It would have been obvious to one of ordinary skill in the art at the time of the invention to initiate automated delivery of correction bolus doses based on periodically received blood glucose measurements during the fasting period in order to bring the user’s glucose level within acceptable limits, as taught by Booth.
Lee in view of Booth fails to teach detecting attachment of a disposable insulin dispensing unit to the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the insulin delivery device, automatically initiating automated delivery. However, Shor teaches detecting attachment of a disposable insulin dispensing unit to the insulin delivery device (para 192; connection sensor determining connection between 102 and 104; 104 is the delivery device; indicator unit detects when disposable component 102 and reusable component 104 are attached or detached; operation of the pump is stopped/ended when the two are detached and started when the two are attached; disposable component is the reservoir, reusable component is the delivery device; detachment is construed as an “ending activity”; attachment is construed as the “starting activity”, which has a primary function of connecting the reservoir and the delivery device) and initiating delivery when the dispensing unit and the delivery device are attached (para 215). Tschirren further teaches it was well known in the art to automatically initiate delivery once attachment is detected (para 186: “starts automatically the injection procedure, for example after a delay time after the sensor patch unit determines that the device is attached …”). Both Shor and Tschirren teach that automatically initiating delivery upon detecting attachment of an element was a known alternative to manual initiation (Shor para 50 and Tschirren para 186). It would have been obvious to one of ordinary skill in the art at the time of the invention to detect attachment of a disposable insulin dispensing unit to the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the insulin delivery device, automatically initiate automated delivery, as taught by Shor and Tschirren. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, detecting attachment of a disposable insulin dispensing unit to the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the insulin delivery device, automatically initiating automated delivery yields predictable results (manual vs automatic initiation being well known alternatives).
Regarding claim 28-30, Lee teaches a computer-implemented method for managing delivery of insulin during a fasting period from an insulin delivery device worn for the fasting period (Fig 1, para 50; insulin delivery device is the “wearable drug delivery device” 702 or 724; lifecycle of a pod is several days, which would include a fasting period – i.e. sleep; see para 16-20, Fig 2, para 50-51), wherein the method is carried out by a computing application provided at a mobile user computing device (Fig 7, para 99-107; application 779 at mobile user computing device 773, 707), the method comprising: requesting from a user a value of a total daily basal insulin dose information used in a defined period prior to the fasting period (para 20-24, 34-37, 48-50, 99, 104-114; basal quantity is determined for different time segments, which would include non-fasting periods prior to the fasting period; total daily basal dose information is received by the controller and used for determining insulin delivery); pairing the mobile user computing device to a controller of the insulin delivery device (paired via connection 791 to controller 723, 721, 726 of the delivery device), the controller detecting a starting activity of the insulin delivery device, thereby, initiating automated delivery of insulin in response to periodically received blood glucose measurements during the fasting period (Fig 7, para 99-107, 116; delivery device operates over several 24 hr periods, including the fasting period; delivery component may be the pump 702); and transmitting and receiving information to and from the controller of the delivery device during the fasting period (delivery device operates over several days, and communicates with 707, 704, and 706 including during fasting periods), wherein the value from the user of the total daily basal insulin dose information includes a usual number of units of basal insulin received from a non-fasting form of insulin therapy (para 20-23; basal profile construed as a “usual” quantity or number of units; para 48-50, 65), and pairing the mobile user computing device to a blood glucose monitor, thereby, allowing transfer of blood glucose measurements to the insulin delivery device via the mobile user computing device (monitor 704 paired via connection 792; para 99-107).
Lee does not explicitly teach delivering correction bolus doses based on periodically received blood glucose measurements during the fasting period. However, Booth teaches that correction bolus doses may be delivered during a fasting period and based on a blood glucose measurement (para 33, 44-45). It would have been obvious to one of ordinary skill in the art at the time of the invention to initiate automated delivery of correction bolus doses based on periodically received blood glucose measurements during the fasting period in order to bring the user’s glucose level within acceptable limits, as taught by Booth.
Lee in view of Booth fails to teach detecting attachment of a disposable insulin dispensing unit to the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the insulin delivery device, automatically initiating automated delivery. However, Shor teaches detecting attachment of a disposable insulin dispensing unit to the insulin delivery device (para 192; connection sensor determining connection between 102 and 104; 104 is the delivery device; indicator unit detects when disposable component 102 and reusable component 104 are attached or detached; operation of the pump is stopped/ended when the two are detached and started when the two are attached; disposable component is the reservoir, reusable component is the delivery device; detachment is construed as an “ending activity”; attachment is construed as the “starting activity”, which has a primary function of connecting the reservoir and the delivery device) and initiating delivery when the dispensing unit and the delivery device are attached (para 215). Tschirren further teaches it was well known in the art to automatically initiate delivery once attachment is detected (para 186: “starts automatically the injection procedure, for example after a delay time after the sensor patch unit determines that the device is attached …”). Both Shor and Tschirren teach that automatically initiating delivery upon detecting attachment of an element was a known alternative to manual initiation (Shor para 50 and Tschirren para 186). It would have been obvious to one of ordinary skill in the art at the time of the invention to detect attachment of a disposable insulin dispensing unit to the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the insulin delivery device, automatically initiate automated delivery, as taught by Shor and Tschirren. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, detecting attachment of a disposable insulin dispensing unit to the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the insulin delivery device, automatically initiating automated delivery yields predictable results (manual vs automatic initiation being well known alternatives).
Regarding claim 34, Lee teaches an insulin management method of use of an insulin delivery device (Fig 1, para 50) configured to be attachable to a user's body for a duration of a fasting period within an overall time period (Fig 1, para 50; insulin delivery device is the “wearable drug delivery device” 702 or 724; lifecycle of a pod is several days, which would include a fasting period – i.e. sleep; see para 16-20, Fig 2, para 50-51), the method comprising: carrying out a starting activity of the insulin delivery device (a starting activity associated with preparation of use of the delivery device 702 – e.g. that device 702 is activated and ready for use); and receiving automated delivery of insulin based on periodically received blood glucose measurements during the fasting period (Fig 7, para 99-107, 116; delivery device operates over several 24 hr periods, including the fasting period; delivery component may be the pump 702; pump and/or user receives delivery from a reservoir).
Lee does not explicitly teach delivering correction bolus doses based on periodically received blood glucose measurements during the fasting period. However, Booth teaches that correction bolus doses may be delivered during a fasting period and based on a blood glucose measurement (para 33, 44-45). It would have been obvious to one of ordinary skill in the art at the time of the invention to initiate automated delivery of correction bolus doses based on periodically received blood glucose measurements during the fasting period in order to bring the user’s glucose level within acceptable limits, as taught by Booth.
Lee in view of Booth fails to teach detecting attachment of a disposable insulin dispensing unit to the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the insulin delivery device, automatically initiating automated delivery. However, Shor teaches detecting attachment of a disposable insulin dispensing unit to the insulin delivery device (para 192; connection sensor determining connection between 102 and 104; 104 is the delivery device; indicator unit detects when disposable component 102 and reusable component 104 are attached or detached; operation of the pump is stopped/ended when the two are detached and started when the two are attached; disposable component is the reservoir, reusable component is the delivery device; detachment is construed as an “ending activity”; attachment is construed as the “starting activity”, which has a primary function of connecting the reservoir and the delivery device) and initiating delivery when the dispensing unit and the delivery device are attached (para 215). Tschirren further teaches it was well known in the art to automatically initiate delivery once attachment is detected (para 186: “starts automatically the injection procedure, for example after a delay time after the sensor patch unit determines that the device is attached …”). Both Shor and Tschirren teach that automatically initiating delivery upon detecting attachment of an element was a known alternative to manual initiation (Shor para 50 and Tschirren para 186). It would have been obvious to one of ordinary skill in the art at the time of the invention to detect attachment of a disposable insulin dispensing unit to the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the insulin delivery device, automatically initiate automated delivery, as taught by Shor and Tschirren. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, detecting attachment of a disposable insulin dispensing unit to the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the insulin delivery device, automatically initiating automated delivery yields predictable results (manual vs automatic initiation being well known alternatives).
Regarding claims 2, 17, 35, Lee in view of Booth, Shor, and Tschirren further teaches detecting or carrying out an ending activity associated with ending the use of the insulin delivery device; and terminating automated delivery of the correction bolus doses of insulin and an end detecting component configured to detect an ending activity associated with ending the use of the insulin delivery device (Lee para 50-51; an “ending activity” construed as an end of the pod’s lifecycle; automated delivery of insulin is terminated at the end of the lifecycle; “end detecting component” is the management device 706 or communication device 764 or processor 761 which communicates with the delivery device 702, which detects the end of the lifecycle).
Regarding claims 2-4, 17-19, 36, Lee in view of Booth, Shor, and Tschirren teaches detecting an ending activity associated with ending the use of the insulin delivery device; and terminating automated delivery of the insulin correction bolus doses and an end detecting component configured to detect an ending activity associated with ending the use of the insulin delivery device as discussed above, but fails to teach the starting activity has a primary function other than initiating automated delivery of insulin from the insulin delivery device, thereby, being simultaneously reused as an indication to initiate automated delivery of insulin from the insulin delivery device or the starting activity comprises one or more of: arrival of a pre-set time of the day; removal of the insulin delivery device from a power charger, or the activation component is configured to detect, as the starting activity, one or more of: arrival of a pre-set time of the day as the starting activity; removal of the insulin delivery device from a power charger. However, Shor teaches detecting an ending activity associated with ending the use of the insulin delivery device; and terminating automated delivery of the insulin correction bolus doses and an end detecting component configured to detect an ending activity associated with ending the use of the insulin delivery device as discussed above, and the starting activity has a primary function other than initiating automated delivery of insulin from the insulin delivery device, thereby, being simultaneously reused as an indication to initiate automated delivery of insulin from the insulin delivery device, and the starting activity comprises arrival of a pre-set time of the day (para 47, 163, 201, 209-211; delivery of insulin may be based on a pre-set time of day), or carrying out the starting activity further comprises removal of the insulin delivery device from a power charger (para 160-161, Fig 15A; delivery device may be charged by a charging station, a wall outlet, a computing device, etc.; a “starting activity” would include charging the device and then removing the device from the charger in order to carry, wear, and operate the device as desired). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide steps of detecting an ending activity associated with ending the use of the insulin delivery device; and terminating automated delivery of the insulin correction bolus doses and an end detecting component configured to detect an ending activity associated with ending the use of the insulin delivery device as discussed above, and the starting activity has a primary function other than initiating automated delivery of insulin from the insulin delivery device, thereby, being simultaneously reused as an indication to initiate automated delivery of insulin from the insulin delivery device, and the starting activity comprises arrival of a pre-set time of the day, and to make the activation component is configured to detect, as the starting activity, one or more of: arrival of a pre-set time of the day as the starting activity; removal of the insulin delivery device from a power charger; and carrying out the starting activity further comprises removal of the insulin delivery device from a power charger in order to properly start and end the delivery of insulin, as taught by Shor. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, detecting an ending activity associated with ending the use of the insulin delivery device; and terminating automated delivery of the insulin correction bolus doses and an end detecting component configured to detect an ending activity associated with ending the use of the insulin delivery device as discussed above, and the starting activity has a primary function other than initiating automated delivery of insulin from the insulin delivery device, thereby, being simultaneously reused as an indication to initiate automated delivery of insulin from the insulin delivery device, and the starting activity comprises arrival of a pre-set time of the day, and to make the activation component is configured to detect, as the starting activity, one or more of: arrival of a pre-set time of the day as the starting activity; removal of the insulin delivery device from a power charger; and carrying out the starting activity further comprises removal of the insulin delivery device from a power charger yields predictable results (a desired blood glucose at the necessary or desired time, or proper charging and operation of the delivery device).
Regarding claims 6-7, 21-22, 38-39 Lee in view of Booth, Shor, and Tschirren further teaches the activation component is configured to detect, as the starting activity, one or more of: a proximity to or pairing of a controller of the insulin delivery device to a user computing device on which a user application associated with the insulin delivery device is installed (Lee para 99, 104-114; controller 761, 768, 764, 769, or 706 of the insulin delivery device may be wirelessly paired to a user computing device 707 on which a user application 779, 771, 778 is installed; the controller and the user computing device are paired – communication between and “detection” of the pairing is required to operate the delivery device); a proximity to or pairing of the controller of the insulin delivery device to a smart insulin pen; a fill level of an insulin reservoir of a disposable insulin dispensing unit indicative of a sufficiently filled insulin reservoir for initiating the automated delivery of insulin; a movement of a plunger of an insulin reservoir of a disposable insulin dispensing unit indicative of a filing of the insulin reservoir, wherein the activation component detects receiving, from the paired user computing device, a total daily basal insulin dose information as received from a non-fasting insulin management modality in a defined period prior to the fasting period for use in determining the correction bolus doses of insulin (Lee para 20-24, 34-37, 48-50, 99, 104-114; a paired user computing device 707; basal quantity is determined for different time segments, which would include non-fasting periods prior to the fasting period; total daily basal dose information is received by the controller and used for determining insulin delivery). Furthermore, one of ordinary skill in the art would recognize that a total daily basal insulin dose information (including in a defined period prior to a fasting period) should be used in determining the correction bolus doses, because both basal and bolus insulin affects blood glucose level, and insulin must be managed so as not to deliver too little or too much (see Booth para 32-33). Accounting for a total daily insulin basal dose information as received from a non-fasting insulin management modality in a defined period prior to the fasting period in determining the correction bolus doses would have been within the level of ordinary skill in the art and obvious. It would have been obvious to one of ordinary skill in the art at the time of the invention to receive from the paired user computing device, a total daily basal insulin dose information as received from a non-fasting insulin management modality in a defined period prior to the fasting period for use in determining the correction bolus doses of insulin in order to deliver an appropriate amount of insulin, as taught by Lee and Booth.
Regarding claims 10-11, 13, Lee in view of Booth, Shor, and Tschirren further teaches the correction bolus doses of insulin are compensated for by a determined insulin on board (Fig 7, para 68-69, 99-107, 116 of Lee; insulin is administered based on insulin on board), delivering at least a first correction bolus dose of insulin that is compensated for by the determined insulin on board set equal to an assumed insulin on board that is determined based on an assumed external dose calculated to correct an initial blood glucose value of the user to a target blood glucose (para 69; insulin on board correction factor applied based on an assumed external dose, e.g. manually administered dose, implicitly calculated to correct an “initial blood glucose value” of the use – e.g. the value before the manual dose is administered – to a target blood glucose – e.g. the desired resulting glucose), the determined insulin on board includes the assumed insulin on board and a known delivered insulin from the insulin delivery device (para 39-43, 48-50; if pod history is insufficient, an “assumed” starting insulin on board may be used; the insulin on board would also account for delivered insulin in order to determine a total/determined insulin on board). Furthermore, one of ordinary skill in the art would have recognized that blood glucose is affected by the insulin on board, which would include both an “assumed” insulin on board (in the case that there is insufficient history) and a “delivered” insulin from the delivery device, in addition to the correction bolus doses. Determining the appropriate amount for the correction bolus doses compensated by determine insulin on board, wherein the determined insulin on board includes the assumed insulin on board and a known delivered insulin from the delivery device, and delivering at least a first correction bolus dose that is compensated for by the determined insulin on board set equal to an assumed insulin on board that is determined based on an assumed external dose calculated to correct an initial blood glucose value of the user to a target blood glucose would have been obvious to one of ordinary skill in the art at the time of the invention in order to achieve the desired blood glucose levels. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, the correction bolus doses compensated by determine insulin on board, and delivering at least a first correction bolus dose that is compensated for by the determined insulin on board, wherein the determined insulin on board includes the assumed insulin on board and a known delivered insulin from the delivery device set equal to an assumed insulin on board that is determined based on an assumed external dose calculated to correct an initial blood glucose value of the user to a target blood glucose, wherein the determined insulin on board includes the assumed insulin on board and a known delivered insulin from the delivery device, yields predictable results (a desired blood glucose).
Regarding claim 24-25, Lee in view of Booth, Shor, and Tschirren teaches the delivery component comprises a processor and a memory configured to provide non-transitory, computer-readable program instructions to the processor to execute functions of the components (Lee para 123; Fig 7; delivery component 702 comprises processor and memory 721, 723), a mobile user computing device comprising: a processor and a memory configured to provide non-transitory, computer- readable program instructions to the processor to execute functions of components; a basal insulin input component configured to request a value from a user of a total daily basal insulin dose information used in a defined period prior to the fasting period; and a controller pairing component configured to pair the mobile user computing device to a controller of the insulin delivery device (Lee para 123; mobile user computing device 707 with processor and memory 771, 773; basal insulin input component 778 configured to request total daily basal dose information in a defined period prior to the fasting period, para 48-50, 88, 106; pairing component 774 pairs the mobile user computing device 707 to controller 726, 721, 723, of the delivery device).
Regarding claim 26, Lee teaches an automatic insulin delivery device attachable to a user's body for a duration of a fasting period, the device comprising: a durable portion including a delivery component configured to control a delivery correction bolus doses of insulin based on received blood glucose measurements (Fig 1, 7, para 50, 99-107, 116; delivery device/durable portion 702 is attached and operates over several 24 hr periods, including the fasting period), the delivery component comprising: an activation component configured to detect a starting activity (activation component may be device 706, which communicates with and therefore is “configured to detect” a starting activity associated with preparation of use of the delivery device 702 – e.g. that device 702 is activated and ready for use); and a delivery component configured to initiate automated delivery of insulin based on periodically received blood glucose measurements during the fasting period (Fig 7, para 99-107, 116; delivery device operates over several 24 hr periods, including the fasting period; delivery component may be the pump 702); and reservoir configured to automatically deliver the correction bolus doses to the user (Fig 7, para 99-107, 116; reservoir 725).
Lee does not explicitly teach delivering correction bolus doses based on periodically received blood glucose measurements during the fasting period. However, Booth teaches that correction bolus doses may be delivered during a fasting period and based on a blood glucose measurement (para 33, 44-45). It would have been obvious to one of ordinary skill in the art at the time of the invention to initiate automated delivery of correction bolus doses based on periodically received blood glucose measurements during the fasting period in order to bring the user’s glucose level within acceptable limits, as taught by Booth.
Lee fails to teach a disposable portion comprising the reservoir configured to contain insulin. However, Shor teaches a disposable portion comprising the reservoir configured to contain insulin and configured to automatically deliver the correction bolus doses to the user (see page 5, 23). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide a disposable portion comprising the reservoir configured to contain insulin and configured to automatically deliver the correction bolus doses to the user in order to provide insulin, as taught by Shor. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, providing a disposable portion comprising the reservoir configured to contain insulin and configured to automatically deliver the correction bolus doses to the user yields predictable results (providing insulin).
Lee in view of Booth fails to teach detecting attachment of a disposable insulin dispensing unit to the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the insulin delivery device/durable portion, automatically initiating automated delivery. However, Shor teaches detecting attachment of a disposable insulin dispensing unit to the insulin delivery device/durable portion (para 192; connection sensor determining connection between 102 and 104; 104 is the delivery device; indicator unit detects when disposable component 102 and reusable component 104 are attached or detached; operation of the pump is stopped/ended when the two are detached and started when the two are attached; disposable component is the reservoir, reusable component is the delivery device; detachment is construed as an “ending activity”; attachment is construed as the “starting activity”, which has a primary function of connecting the reservoir and the delivery device) and initiating delivery when the dispensing unit and the delivery device/durable portion are attached (para 215). Tschirren further teaches it was well known in the art to automatically initiate delivery once attachment is detected (para 186: “starts automatically the injection procedure, for example after a delay time after the sensor patch unit determines that the device is attached …”). Both Shor and Tschirren teach that automatically initiating delivery upon detecting attachment of an element was a known alternative to manual initiation (Shor para 50 and Tschirren para 186). It would have been obvious to one of ordinary skill in the art at the time of the invention to detect attachment of a disposable insulin dispensing unit to the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the insulin delivery device/durable portion, automatically initiate automated delivery, as taught by Shor and Tschirren. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, detecting attachment of a disposable insulin dispensing unit to the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the insulin delivery device, automatically initiating automated delivery yields predictable results (manual vs automatic initiation being well known alternatives).
Claim(s) 5, 20, 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0098105 (Lee) in view of US 2017/0351842 (Booth), US 2019/0009019 (Shor), and US 2024/0269376 (Tschirren) and further in view of US 2019/0321553 (Grosman).
Regarding claims 5, 20, 37, Lee in view of Booth, Shor, and Tschirren fails to teach the activation component is configured to detect, as the starting activity, one or more of: attachment of the insulin delivery device to the user; detachment of an applicator of the insulin delivery device from the insulin delivery device; and a verbal command or selection by the user indicating a desire to initiate automated delivery of insulin. However, Grosman teaches that the automated delivery of insulin may be initiated by a command or selection by a user indicating a desire to initiate automated delivery of insulin (para 58, 124; operation of the closed loop can be initiated by the patient, construed as a “selection by a user”). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the activation component configured to detect, as the starting activity, one or more of: attachment of the insulin delivery device to the user; detachment of an applicator of the insulin delivery device from the insulin delivery device; and a verbal command or selection by the user indicating a desire to initiate automated delivery of insulin in order to activate the delivery device as desired, as taught by Grosman. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, making the activation component configured to detect, as the starting activity, one or more of: attachment of the insulin delivery device to the user; detachment of an applicator of the insulin delivery device from the insulin delivery device; and a verbal command or selection by the user indicating a desire to initiate automated delivery of insulin yields predictable results (initiation of the delivery process).
Claim(s) 6, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0098105 (Lee) in view of US 2017/0351842 (Booth), US 2019/0009019 (Shor), and US 2024/0269376 (Tschirren) and further in view of US 2015/0151041 (Yodfat).
Regarding claims 6, 21, Lee in view of Booth, Shor, and Tschirren teaches the activation component is configured to detect, as the starting activity, one or more of: a proximity to or pairing of a controller of the insulin delivery device to a user computing device on which a user application associated with the insulin delivery device is installed a proximity to or pairing of the controller of the insulin delivery device to a smart insulin pen; a fill level of an insulin reservoir of a disposable insulin dispensing unit indicative of a sufficiently filled insulin reservoir for initiating the automated delivery of insulin; a movement of a plunger of an insulin reservoir of a disposable insulin dispensing unit indicative of a filing of the insulin reservoir, as discussed above. However, Yodfat is further cited for teaching detecting a fill level of an insulin reservoir of a disposable insulin dispensing unit indicative of a sufficiently filled insulin reservoir for initiating the automated delivery of insulin (Fig 2, para 68-69; fill level of reservoir is indicated/detected prior to operation of the pump). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the activation component configured to detect, as the starting activity, one or more of: a proximity to or pairing of a controller of the insulin delivery device to a user computing device on which a user application associated with the insulin delivery device is installed a proximity to or pairing of the controller of the insulin delivery device to a smart insulin pen; a fill level of an insulin reservoir of a disposable insulin dispensing unit indicative of a sufficiently filled insulin reservoir for initiating the automated delivery of insulin; a movement of a plunger of an insulin reservoir of a disposable insulin dispensing unit indicative of a filing of the insulin reservoir in order to determine that a proper amount of insulin has been loaded, as taught by Yodfat. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, making the activation component configured to detect, as the starting activity, one or more of: a proximity to or pairing of a controller of the insulin delivery device to a user computing device on which a user application associated with the insulin delivery device is installed a proximity to or pairing of the controller of the insulin delivery device to a smart insulin pen; a fill level of an insulin reservoir of a disposable insulin dispensing unit indicative of a sufficiently filled insulin reservoir for initiating the automated delivery of insulin; a movement of a plunger of an insulin reservoir of a disposable insulin dispensing unit indicative of a filing of the insulin reservoir yields predictable results (initiation of the delivery process).
Claim(s) 8, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0098105 (Lee) in view of US 2017/0351842 (Booth), US 2019/0009019 (Shor), and US 2024/0269376 (Tschirren) and further in view of US 2014/0094771 (Li).
Regarding claims 8, 23, Lee in view of Booth, Shor, and Tschirren fails to teach initiating automated delivery of insulin includes priming the delivery device to be ready to deliver the insulin or the delivery component is configured to prime the delivery device to be ready to deliver the insulin or the correction bolus doses of insulin. However, Li teaches that a pump/delivery device may be primed in order to make the needle ready for injection (para 35, 38). It would have been obvious to one of ordinary skill in the art at the time of the invention to make initiating automated delivery of insulin include priming the delivery device to be ready to deliver the insulin or the delivery component is configured to prime the delivery device to be ready to deliver the insulin or the correction bolus doses of insulin, as taught by Li. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, initiating automated delivery of insulin include priming the delivery device to be ready to deliver the insulin/correction bolus doses of insulin or the delivery component is configured to prime the delivery device yields predictable results (preparing the delivery device for injection).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0098105 (Lee) in view of US 2017/0351842 (Booth), US 2019/0009019 (Shor), and US 2024/0269376 (Tschirren) and further in view of US 2014/0180203 (Budiman).
Regarding claim 9, Lee in view of Booth, Shor, and Tschirren fails to teach the insulin delivery device refrains from administering basal insulin at a preset or default rate or in a preset or default pattern. However, Budiman teaches that it was well known in the art to suspend/refrain from administering basal insulin at a preset or default rate or in a preset or default pattern in order to achieve a desired blood glucose level (para 21, 126; basal delivery may be suspended). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the insulin delivery device refrains from administering basal insulin at a preset or default rate or in a preset or default pattern in order to achieve a desired blood glucose level, as taught by Budiman. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, the insulin delivery device refraining from administering basal insulin at a preset or default rate or in a preset or default pattern yields predictable results (a desired blood glucose level).
Claim(s) 12, 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0098105 (Lee) in view of US 2017/0351842 (Booth), US 2019/0009019 (Shor), and US 2024/0269376 (Tschirren) and further in view of US 2022/0211944 (Mensinger).
Regarding claim 12, 39, Lee in view of Booth, Shor, and Tschirren fails to teach calculating correction bolus doses by comparing an evaluated blood glucose measurement to a target blood glucose to obtain a difference, the difference adjusted by a user insulin sensitivity factor to obtain a resultant dose amount, the resultant dose amount compensated by the determined insulin on board. However, Mensinger teaches delivering insulin doses by comparing an evaluated blood glucose measurement to a target blood glucose to obtain a difference, the difference adjusted by a user insulin sensitivity factor to obtain a resultant dose amount, the resultant dose amount compensated by the determined insulin on board (para 8-11). Lee teaches a dose amount compensated by the determined insulin on board (Fig 7, para 68-69, 99-107, 116 of Lee; insulin is administered based on insulin on board). It would have been obvious to one of ordinary skill in the art at the time of the invention to calculate correction bolus doses by comparing an evaluated blood glucose measurement to a target blood glucose to obtain a difference, the difference adjusted by a user insulin sensitivity factor to obtain a resultant dose amount, in order to tailor the insulin treatment to the specific patient/user, as taught by Mensinger (para 26), and to make the resultant dose amount compensated by the determined insulin on board because it was known that blood glucose is affected by the insulin on board in addition to the correction bolus doses. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, calculating correction bolus doses by comparing an evaluated blood glucose measurement to a target blood glucose to obtain a difference, the difference adjusted by a user insulin sensitivity factor to obtain a resultant dose amount, the resultant dose amount compensated by the determined insulin on board yields predictable results (a desired blood glucose level for a specific user).
Claim(s) 7, 14-15, 28-30, 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0098105 (Lee) in view of US 2017/0351842 (Booth), US 2019/0009019 (Shor), and US 2024/0269376 (Tschirren) and further in view of US 2020/0197608 (Mazlish).
Regarding claim 7, 14-15, 39, Lee in view of Booth, Shor, and Tschirren teaches receiving, from the paired user computing device, a total daily insulin basal dose information as received from a non-fasting insulin management modality in a defined period prior to the fasting period for use in determining the correction bolus doses of insulin as discussed above, but fails to teach the correction bolus doses of insulin are based on a user's insulin sensitivity factor derived from a total daily basal dose information used in a defined period prior to the fasting period, wherein the total daily basal dose information is an average total number of basal dose units given in an overall time period. However, Mazlish teaches insulin dose being determined by total daily basal dose information as received from a non-fasting insulin management modality in a defined period prior to the fasting period for use in determining the correction bolus doses as discussed above, and the doses are based on a user's insulin sensitivity factor derived from a total daily basal insulin dose information used in a defined period prior to the fasting period, wherein the total daily basal insulin dose information is an average total number of basal dose units given in an overall time period (para 60-71, 103-105; ISF, insulin sensitivity is a function of total daily basal dose information in a defined period, including prior to fasting; total daily basal dose information may include average total basal dose per day). Furthermore, one of ordinary skill in the art would recognize that the correction bolus doses of insulin may be based on a user’s sensitivity factor in order to provide a user-specific dose of insulin. It would have been obvious to one of ordinary skill in the art at the time of the invention to make the correction bolus doses determined by total daily basal dose information as received from a non-fasting insulin management modality in a defined period prior to the fasting period for use in determining the correction bolus doses, and the doses are based on a user's insulin sensitivity factor derived from a total daily basal dose information used in a defined period prior to the fasting period, wherein the total daily basal insulin dose information is an average total number of basal dose units given in an overall time period, in order to provide an appropriate amount of insulin for the specific user, as taught by Mazlish. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, making the correction bolus doses determined by total daily basal insulin dose information as received from a non-fasting insulin management modality in a defined period prior to the fasting period for use in determining the correction bolus doses of insulin, and the doses are based on a user's insulin sensitivity factor derived from a total daily basal insulin dose information used in a defined period prior to the fasting period, wherein the total daily basal dose information is an average total number of basal dose units given in an overall time period yields predictable results (a desired blood glucose level for a specific user).
Regarding claim 28-30, Lee teaches a computer-implemented method for managing delivery of insulin during a fasting period from an insulin delivery device worn for the fasting period (Fig 1, para 50; insulin delivery device is the “wearable drug delivery device” 702 or 724; lifecycle of a pod is several days, which would include a fasting period – i.e. sleep; see para 16-20, Fig 2, para 50-51), wherein the method is carried out by a computing application provided at a mobile user computing device (Fig 7, para 99-107; application 779 at mobile user computing device 773, 707), the method comprising: requesting from a user a value of a total daily basal insulin dose information used in a defined period prior to the fasting period (para 20-24, 34-37, 48-50, 99, 104-114; basal quantity is determined for different time segments, which would include non-fasting periods prior to the fasting period; total daily basal dose information is received by the controller and used for determining insulin delivery); pairing the mobile user computing device to a controller of the insulin delivery device (paired via connection 791 to controller 723, 721, 726 of the delivery device), the controller detecting a starting activity of the insulin delivery device, thereby, initiating automated delivery of insulin in response to periodically received blood glucose measurements during the fasting period (Fig 7, para 99-107, 116; delivery device operates over several 24 hr periods, including the fasting period; delivery component may be the pump 702); and transmitting and receiving information to and from the controller of the delivery device during the fasting period (delivery device operates over several days, and communicates with 707, 704, and 706 including during fasting periods), wherein the value from the user of the total daily basal insulin dose information includes a usual number of units of basal insulin received from a non-fasting form of insulin therapy (para 20-23; basal profile construed as a “usual” quantity or number of units; para 48-50, 65), and pairing the mobile user computing device to a blood glucose monitor, thereby, allowing transfer of blood glucose measurements to the insulin delivery device via the mobile user computing device (monitor 704 paired via connection 792; para 99-107).
Lee does not explicitly teach delivering correction bolus doses based on periodically received blood glucose measurements during the fasting period. However, Booth teaches that correction bolus doses may be delivered during a fasting period and based on a blood glucose measurement (para 33, 44-45). It would have been obvious to one of ordinary skill in the art at the time of the invention to initiate automated delivery of correction bolus doses based on periodically received blood glucose measurements during the fasting period in order to bring the user’s glucose level within acceptable limits, as taught by Booth.
Lee in view of Booth fails to teach detecting attachment of a disposable insulin dispensing unit to the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the insulin delivery device, automatically initiating automated delivery. However, Shor teaches detecting attachment of a disposable insulin dispensing unit to the insulin delivery device (para 192; connection sensor determining connection between 102 and 104; 104 is the delivery device; indicator unit detects when disposable component 102 and reusable component 104 are attached or detached; operation of the pump is stopped/ended when the two are detached and started when the two are attached; disposable component is the reservoir, reusable component is the delivery device; detachment is construed as an “ending activity”; attachment is construed as the “starting activity”, which has a primary function of connecting the reservoir and the delivery device) and initiating delivery when the dispensing unit and the delivery device are attached (para 215). Tschirren further teaches it was well known in the art to automatically initiate delivery once attachment is detected (para 186: “starts automatically the injection procedure, for example after a delay time after the sensor patch unit determines that the device is attached …”). Both Shor and Tschirren teach that automatically initiating delivery upon detecting attachment of an element was a known alternative to manual initiation (Shor para 50 and Tschirren para 186). It would have been obvious to one of ordinary skill in the art at the time of the invention to detect attachment of a disposable insulin dispensing unit to the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the insulin delivery device, automatically initiate automated delivery, as taught by Shor and Tschirren. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, detecting attachment of a disposable insulin dispensing unit to the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the insulin delivery device, automatically initiating automated delivery yields predictable results (manual vs automatic initiation being well known alternatives).
Mazlish further teaches requesting from a user a value of a total daily basal dose information used in a defined period prior to the fasting period (para 60-71, 103-105; ISF, insulin sensitivity is a function of total daily basal dose information in a defined period, including prior to fasting; user may input basal rate). It would have been obvious to one of ordinary skill in the art at the time of the invention to request from a user a value of a total daily basal dose information used in a defined period prior to the fasting period in order to determine insulin sensitivity, as taught by Mazlish.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0098105 (Lee) in view of US 2017/0351842 (Booth), US 2019/0009019 (Shor), and US 2024/0269376 (Tschirren) and further in view of US 2021/0015996 (Winheim)
Regarding claim 27, Lee in view of Booth, Shor, and Tschirren fails to teach the reservoir is configured to be fillable from a non-fasting insulin injection device used during a non-fasting period preceding the fasting period. However, Winheim teaches that an insulin reservoir may be filled from a non-fasting insulin injection device (para 100; injection device is a syringe). Further, it has been held that “a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim" (see MPEP 2114 [R-1]). In this case, “used during a non-fasting period …” recites how the reservoir and injection device are intended to be employed, and does not differentiate the claimed apparatus from Winheim. It would have been obvious to one of ordinary skill in the art at the time of the invention to make the reservoir configured to be fillable from a non-fasting insulin injection device used during a non-fasting period preceding the fasting period, as taught by Winheim. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, making the reservoir configured to be fillable from a non-fasting insulin injection device used during a non-fasting period preceding the fasting period yields predictable results (filling the reservoir).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0098105 (Lee) in view of US 2017/0351842 (Booth), US 2019/0009019 (Shor), and US 2024/0269376 (Tschirren), US 2020/0197608 (Mazlish) and further in view of US 2015/0011970 (Kamen).
Regarding claim 31, Lee in view of Booth, Shor, and Tschirren and Mazlish fails to teach providing a display of a session history of information relating to a fasting period to the user. However, Kamen teaches displaying a session history of information to the user (para 441, 442). One of ordinary skill in the art would recognize the importance of information relating to the fasting period, including the basal profile (also taught by Lee, para 20-23), glucose level, insulin doses, etc. so that the user could understand what conditions occurred during the fasting period and what therapies were applied. It would have been obvious to one of ordinary skill in the art at the time of the invention to provide a display of a session history of information relating to a fasting period to the user in order to show the user what conditions occurred during the fasting period and what therapies were applied, as taught by Kamen. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, providing a display of a session history of information relating to a fasting period to the user yields predictable results (providing information to the user).
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0098105 (Lee) in view of US 2017/0351842 (Booth), US 2019/0009019 (Shor), and US 2024/0269376 (Tschirren), US 2020/0197608 (Mazlish) and further in view of US 2022/0273873 (Williams).
Regarding claim 32, Lee in view of Booth, Shor, Tschirren and Mazlish fails to teach providing user training in use of the insulin delivery device to the user. However, Williams teaches providing training in use of a device to a user (para 60, 96). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide user training in use of the insulin delivery device to the user in order for the user to properly use the device, as taught by Williams. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, providing user training in use of the insulin delivery device to the user yields predictable results (using the device).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0098105 (Lee) in view of US 2017/0351842 (Booth), US 2019/0009019 (Shor), and US 2024/0269376 (Tschirren), US 2020/0197608 (Mazlish) and further in view of US 2021/0260289 (Kamath).
Regarding claim 33, Lee in view of Booth, Shor, Tschirren and Mazlish fails to teach coordinating a fast-ending procedure for the user including dividing a fast-ending meal bolus into a first portion equal to a remaining insulin in the insulin delivery device at the end of the fasting period and a second portion to be delivered to the user utilizing a delivery method other than the delivery device in a non-fasting period immediately following the fasting period. However, Kamath teaches a split bolus, wherein a fast-ending meal bolus is divided into a first portion at the end of a fasting period – e.g. just before a first meal – and a second portion in a non-fasting period immediately following the fasting period – e.g. after the meal (para 182). Furthermore, Lee teaches that the pods (delivery device) may run out of insulin and are replaced, and that the user may manually administer a dose, construed as “a delivery method other than the delivery device”, prior to replacement (para 54, 69). It would have been obvious to one of ordinary skill in the art at the time of the invention to coordinate a fast-ending procedure for the user including dividing a fast-ending meal bolus into a first portion equal to a remaining insulin in the delivery device at the end of the fasting period and a second portion to be delivered to the user utilizing a delivery method other than the delivery device in a non-fasting period immediately following the fasting period in order to achieve a desired glucose response specific to the meal, and to provide insulin in case of the delivery device running out of insulin, as taught by Kamath and Lee. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, coordinating a fast-ending procedure for the user including dividing a fast-ending meal bolus into a first portion equal to a remaining insulin in the delivery device at the end of the fasting period and a second portion to be delivered to the user utilizing a delivery method other than the delivery device in a non-fasting period immediately following the fasting period yields predictable results (a desired blood glucose response).
Response to Arguments
Applicant's arguments filed 1/13/26 have been fully considered but they are not persuasive.
With regards to Applicant’s argument that “Lee is directed towards addressing a lack of sufficient history when onboarding a new long-term device” and “[t]herefore, it would not be obvious to modify the device of Lee to automatically activate, as recited by the amended independent claims, as input is required by the user to onboard the long-term device of Lee”, Examiner respectfully disagrees. Lee’s teaching of a long-term device does not preclude automatic activation. Furthermore, the prior art teaches that it was well known in the art to either manually or automatically activate a delivery device. Therefore, automatic activation was within the level of ordinary skill in the art and obvious.
With regards to Applicant’s argument that “the above-cited portions of Shor are specifically directed to an indicator unit of a delivery device that ‘provide[s] information to a patient before, during, and / or after delivery.’”, Examiner respectfully asserts that the cited portions dealing with the indicator unit are not relevant to the claim rejection. However, Shor’s teaching that “[w]hen the disposable component 102 and the reusable component 104 are attached (or reattached), operation may be initiated” is relevant.
With regards to Applicant’s argument that “Shor does not teach or even suggest ‘activation of the automated delivery of correction bolus doses of insulin by the insulin delivery device, in specific response to detecting attachment of a disposable insulin dispensing unit to the insulin delivery device.’” and “[s]pecifically, while Shor teaches that ‘operation of the pump cannot occur unless the disposable component 102 and reusable component 104 are properly attached’ this is merely showing the pre-requisites for the ability of the insulin delivery device to operate, which is not the same as, or equivalent to, ‘activation of the automated delivery of correction bolus doses of insulin by the insulin delivery device, in specific response to detecting attachment of a disposable insulin dispensing unit to the insulin delivery device.’", Examiner respectfully disagrees. The initiation, according to Shor, is in response to the attachment of the components 102 and 104; attachment occurs, and thereafter initiation occurs, in that necessary order. “Response” is defined as “something done as a reaction” (Merriam-Webster). Shor’s initiation is therefore a response to the attachment.
With regards to Applicant’s argument that “[n]owhere does Shor teach that this specific initiation or activation is automatic, and ‘in specific response to detecting attachment of a disposable insulin dispensing unit to the insulin delivery device,’ as required by amended claim 1.” Examiner respectfully asserts that it was well known in the art to either manually or automatically activate a delivery device, as presented in the rejection above. Therefore, automatic activation was within the level of ordinary skill in the art and obvious.
With regards to Applicant’s argument that “Shor clearly teaches sufficiently intense warnings that the user will be notified so as to be able to manually provide a proper response and does not teach or suggest ‘activation of the automated delivery of correction bolus doses of insulin by the insulin delivery device, in specific response to detecting attachment of a disposable insulin dispensing unit to the insulin delivery device,’ as recited by amended Claim 1” Examiner respectfully disagrees. Shor teaches that “the device 100 can provide information and/or alerts to the patient before, during, and/or after delivery”. Therefore, the warnings are not specifically provided so as to provide a manual response. They may, for example, be provided to show an abnormal or critical condition aside from normal delivery of insulin (e.g. low reservoir, malfunction, etc.; “if the alert is noncritical, the alert may be less intense if the patient is sleeping, so as to not disturb the patient”). Therefore, it is clear from Shor’s disclosure that automatic delivery may occur and does occur independent of the indications.
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.
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/ANDREW H NGUYEN/Primary Examiner, Art Unit 3741