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
Claim Objections
Claim 38 is objected to because of the following informalities: “filing” appears to be in error for “filling”. Appropriate correction is required.
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 a durable portion of 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 durable portion 702 of delivery device; 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 the durable portion of the insulin delivery device configured to be attachable for a duration of only a fasting period. However, the limitation, “configured to be attachable … for a duration of only a fasting period” does not provide a structural limitation nor a method step. A “fasting period” is a period wherein the user does not consume food – it’s not a step of operating the device, nor does it limit the structure of the device. Lee’s device would operate in the same manner with the same steps and comprise the same components whether the user consumes food or not. If, for example, the insulin delivery device is attached at the start of a fasting period, operates for a period of time, and the device is removed before the fast is broken (whether the fast is 12 hours or 3 days), then the claim is met. The actions of the user (fasting or eating) do not change or limit the operation or structure of the device because Lee’s purpose is automatic control of insulin by providing “a ‘closed loop’ processing algorithm or automated insulin delivery mechanisms, allowing a substantially immediate and safe initiation of automated delivery at first pod use, while also allowing the delivery mechanism to match any changes in the user's insulin needs over time” (para 17).
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.
Furthermore, both Lee and Booth teach that it was known in the art to operate and control insulin during a fasted state (in Lee, the 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; in Booth, para 41-45). It would have been obvious to one of ordinary skill in the art at the time of the invention to configure the insulin delivery device to be attachable to a user’s body for a duration of only a fasting period in order to properly control insulin/blood glucose level during the fasting period, as taught by Lee and Booth.
Lee in view of Booth fails to teach detecting attachment of a disposable insulin dispensing unit to the durable portion of 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 dispensing unit to the 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 a durable portion of the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the durable portion of 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 a durable portion of the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the durable portion of 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 (Fig 1, para 50; insulin delivery device is the “wearable drug delivery device” 702 or 724), 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), a durable portion of 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 (durable portion 702 or 724 of delivery device; 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 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 the durable portion of the insulin delivery device configured to be attachable for a duration of only a fasting period. However, the limitation, “configured to be attachable … for a duration of only a fasting period” does not provide a structural limitation nor a method step. A “fasting period” is a period wherein the user does not consume food – it’s not a step of operating the device, nor does it limit the structure of the device. Lee’s device would operate in the same manner with the same steps and comprise the same components whether the user consumes food or not. If, for example, the insulin delivery device is attached at the start of a fasting period, operates for a period of time, and the device is removed before the fast is broken (whether the fast is 12 hours or 3 days), then the claim is met. The actions of the user (fasting or eating) do not change or limit the operation or structure of the device because Lee’s purpose is automatic control of insulin by providing “a ‘closed loop’ processing algorithm or automated insulin delivery mechanisms, allowing a substantially immediate and safe initiation of automated delivery at first pod use, while also allowing the delivery mechanism to match any changes in the user's insulin needs over time” (para 17).
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.
Furthermore, both Lee and Booth teach that it was known in the art to operate and control insulin during a fasted state (in Lee, the 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; in Booth, para 41-45). It would have been obvious to one of ordinary skill in the art at the time of the invention to configure the insulin delivery device to be attachable to a user’s body for a duration of only a fasting period in order to properly control insulin/blood glucose level during the fasting period, as taught by Lee and Booth.
Lee in view of Booth fails to teach detecting attachment of a disposable insulin dispensing unit to a durable portion of the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the durable portion of the insulin delivery device, automatically initiating automated delivery. However, Shor teaches detecting attachment of a disposable dispensing unit to the 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 a durable portion of the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the durable portion of 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 a durable portion of the insulin delivery device and in response to detecting the attachment of the disposable insulin dispensing unit to the durable portion of 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 from an insulin delivery device (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 (para 20-24, 34-37, 48-50, 99, 104-114; basal quantity is determined for different time segments; 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), a durable portion of the insulin delivery device, wherein the insulin delivery device is configured to be attachable to a user's body for a duration of a fasting period within an overall time period (durable portion 702 or 724 of delivery device; 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 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 the insulin delivery device configured to be attachable for a duration of only a fasting period. However, the limitation, “configured to be attachable … for a duration of only a fasting period” does not provide a structural limitation nor a method step. A “fasting period” is a period wherein the user does not consume food – it’s not a step of operating the device, nor does it limit the structure of the device. Lee’s device would operate in the same manner with the same steps and comprise the same components whether the user consumes food or not. If, for example, the insulin delivery device is attached at the start of a fasting period, operates for a period of time, and the device is removed before the fast is broken (whether the fast is 12 hours or 3 days), then the claim is met. The actions of the user (fasting or eating) do not change or limit the operation or structure of the device because Lee’s purpose is automatic control of insulin by providing “a ‘closed loop’ processing algorithm or automated insulin delivery mechanisms, allowing a substantially immediate and safe initiation of automated delivery at first pod use, while also allowing the delivery mechanism to match any changes in the user's insulin needs over time” (para 17).
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.
Furthermore, both Lee and Booth teach that it was known in the art to operate and control insulin during a fasted state (in Lee, the 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; in Booth, para 41-45). It would have been obvious to one of ordinary skill in the art at the time of the invention to configure the insulin delivery device to be attachable to a user’s body for a duration of only a fasting period in order to properly control insulin/blood glucose level during the fasting period, as taught by Lee and 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 dispensing unit to the 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; insulin delivery device is the “wearable drug delivery device” 702 or 724), 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), a durable portion of the insulin delivery device, wherein the insulin delivery device is configured to be attachable to a user's body for a duration of a fasting period within an overall time period (durable portion 702 or 724 of delivery device; 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 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 the insulin delivery device configured to be attachable for a duration of only a fasting period. However, the limitation, “configured to be attachable … for a duration of only a fasting period” does not provide a structural limitation nor a method step. A “fasting period” is a period wherein the user does not consume food – it’s not a step of operating the device, nor does it limit the structure of the device. Lee’s device would operate in the same manner with the same steps and comprise the same components whether the user consumes food or not. If, for example, the insulin delivery device is attached at the start of a fasting period, operates for a period of time, and the device is removed before the fast is broken (whether the fast is 12 hours or 3 days), then the claim is met. The actions of the user (fasting or eating) do not change or limit the operation or structure of the device because Lee’s purpose is automatic control of insulin by providing “a ‘closed loop’ processing algorithm or automated insulin delivery mechanisms, allowing a substantially immediate and safe initiation of automated delivery at first pod use, while also allowing the delivery mechanism to match any changes in the user's insulin needs over time” (para 17).
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.
Furthermore, both Lee and Booth teach that it was known in the art to operate and control insulin during a fasted state (in Lee, the 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; in Booth, para 41-45). It would have been obvious to one of ordinary skill in the art at the time of the invention to configure the insulin delivery device to be attachable to a user’s body for a duration of only a fasting period in order to properly control insulin/blood glucose level during the fasting period, as taught by Lee and 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 durable portion of the insulin delivery device, automatically receiving automated delivery of correction bolus doses of insulin based on periodically received blood glucose measurements during the fasting period. However, Shor teaches detecting attachment of a disposable dispensing unit to the 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 durable portion of the insulin delivery device, automatically receiving automated delivery of correction bolus doses of insulin based on periodically received blood glucose measurements during the fasting period, 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 durable portion of the insulin delivery device, automatically receiving automated delivery of correction bolus doses of insulin based on periodically received blood glucose measurements during the fasting period 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 the disposable insulin dispensing unit indicative of a sufficiently filled insulin reservoir for initiating the automated delivery of insulin; a movement of a plunger of the insulin reservoir of the 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, the device comprising: a durable portion of 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, the 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 the insulin delivery device configured to be attachable for a duration of only a fasting period. However, the limitation, “configured to be attachable … for a duration of only a fasting period” does not provide a structural limitation nor a method step. A “fasting period” is a period wherein the user does not consume food – it’s not a step of operating the device, nor does it limit the structure of the device. Lee’s device would operate in the same manner with the same steps and comprise the same components whether the user consumes food or not. If, for example, the insulin delivery device is attached at the start of a fasting period, operates for a period of time, and the device is removed before the fast is broken (whether the fast is 12 hours or 3 days), then the claim is met. The actions of the user (fasting or eating) do not change or limit the operation or structure of the device because Lee’s purpose is automatic control of insulin by providing “a ‘closed loop’ processing algorithm or automated insulin delivery mechanisms, allowing a substantially immediate and safe initiation of automated delivery at first pod use, while also allowing the delivery mechanism to match any changes in the user's insulin needs over time” (para 17).
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.
Furthermore, both Lee and Booth teach that it was known in the art to operate and control insulin during a fasted state (in Lee, the 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; in Booth, para 41-45). It would have been obvious to one of ordinary skill in the art at the time of the invention to configure the insulin delivery device to be attachable to a user’s body for a duration of only a fasting period in order to properly control insulin/blood glucose level during the fasting period, as taught by Lee and Booth.
Lee fails to teach a disposable portion comprising the reservoir configured to contain insulin. However, Shor teaches a disposable portion comprising the reservoir and configured to automatically deliver the correction bolus doses to the user (see para 5, 22-24). 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 4/13/26 have been fully considered but they are not persuasive.
Applicant’s arguments regarding the drawing objection are persuasive. The drawing objection is withdrawn.
With regards to Applicant’s argument that “[s]ince any modification of the wearable insulin delivery device taught by Lee so as to be ‘configured to be attachable to a user's body for a duration of only a fasting period within an overall time period’ would render the device of Lee unsatisfactory for its specifically-stated intended purpose, as a matter of law, there can be no suggestion or motivation to combine any reference with Lee”, Examiner respectfully asserts that there does not need to be any modification made to Lee to configure the device to be attachable to a user's body for a duration of only a fasting period because fasting or not fasting is something done by the user – it does not change the structure or operation of the device. The device of Lee is attached, the device, controller, processor, etc runs through its processes to administer insulin or not, and the device is detached. Whether the user fasts or not does not change the operation or structure of the device. Furthermore, the device of Lee is capable of operating under fasting conditions (lifecycle of a pod is several days, which would include a fasting period – i.e. sleep). Therefore, the device, which operates comprises sensors and operates automatically, would account for and operate properly during “only a fasting period”.
With regards to Applicant’s argument that “Booth also discloses that the wearable insulin delivery device is contemplated and configured to be worn not just during periodic fasting periods, but also during meal times”, Examiner respectfully asserts that while both Lee and Booth account for meal times, they also account for fasting periods, as discussed above. Therefore, attaching and operating the insulin delivery device only during a fasting period in order to control insulin and blood glucose during the fasting period was within the level of ordinary skill in the art and obvious.
Examiner respectfully asserts that the modification does not “render the device of Lee unsatisfactory for its specifically-stated intended purpose” or “render the device of Booth unsatisfactory for its specifically-stated intended purpose” because the purpose of Lee and Booth is to control insulin and blood glucose. The purpose is achieved whether the user fasts or not. Here again, whether the user fasts or not does not change the operation or the structure of the device.
With regards to Applicant’s argument that “in para. [0009] and repeatedly throughout the specification, Shor specifically states that the medicant for treating Parkinsons is ‘levodopa/carbidopa,’ as does Claim 2 of Shor”, “Shor does not disclose how such Parkinsons drugs could be dosed only during a fasting period”, “Shor cannot teach an insulin delivery device configured to be attachable to a user's body for a duration of only a fasting period within an overall time period, nor any method of using the same”, and “if the device of Shor were modified so as to be ‘configured to be attachable to a user's body for a duration of only a fasting period within an overall time period,’ this would render the device of Shor unsatisfactory for its specifically-stated intended purpose - delivering liquid medicaments to patients with Parkinson's Disease or other CNS disorders”, Examiner respectfully asserts that the combination does not modify Shor. Shor was cited for teaching detecting attachment of a disposable dispensing unit to the delivery device. 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 dispensing unit to the delivery device in order to provide automated operation of the device, as taught by Shor. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The modification of Lee in view of Booth and Shor does not render Lee unsuitable for its intended purpose because both Lee and Shor deal with automatic delivery of medicament (see para 16). Furthermore, Shor teaches: “the devices can be used for the delivery of any fluid medicament for the treatment of any medical condition, as well as for the delivery of non-drug fluids, e.g., nutrients, vitamins, imaging agents, etc” (para 9), and therefore is not limited to medicaments for Parkinson’s disease or other CNS disorders.
With regards to Applicant’s argument that Tschirren “teaches detection of attachment of the device to the skin of the user, not detection of attachment of a disposable portion of the device to a durable portion of the device”, Examiner respectfully asserts that Shor was cited for teaching detection of attachment of a disposable portion of the device to a durable portion of the device as cited above. Tschirren was cited for teaching automatically initiating delivery once attachment is detected. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
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/ANDREW H NGUYEN/Primary Examiner, Art Unit 3741
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