DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 30-58 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/25/2026.
Claim Objections
Claims 16 and 22 are objected to because of the following informalities:
Claim 16: The phrase “displayed on pump replacement control element” appears to omit an article. It should read “displayed on the pump replacement control element.”
Claim 22: The phrase “comprises wireless data interface” appears to omit an article. It should read “comprises a wireless data interface.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 7, 13, 14, 18, 19, 20, 21, and 26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites “maintain the delivery of therapy by the ambulatory medical device”; “the ambulatory medical device” lacks antecedent basis and differs from the “ambulatory medicament pump” recited in claim 1. The claim should consistently recite “the ambulatory medicament pump.”
Claim 7 recites “an alert type of the malfunction alert”; “the malfunction alert” lacks antecedent basis.
Claim 13 recites “generate, via the pump replacement control element, a success alert”; “the pump replacement control element” has no antecedent basis in claim 13, which depends directly from claim 1. The claim should introduce “a pump replacement control element” or depend from a claim that introduces it.
Claim 14 recites “further comprising the pump replacement control element”; “the pump replacement control element” has no antecedent basis. The claim should recite “a pump replacement control element.”
Claim 18 recites “the electronic processor” and “the pump replacement control element”. Claim 1 recites “a hardware processor,” not “the electronic processor,” and claim 18 does not introduce a pump replacement control element. The claim should use consistent antecedent terminology and introduce the control element.
Claim 19 recites “the electronic processor,” and “the pump replacement control element,”. The two terms lack antecedent basis for the reasons stated for claim 18.
Claim 20 recites “the electronic processor”; “the electronic processor” lacks antecedent basis because claim 1 recites “a hardware processor.” The claim should use a consistent introduced processor term.
Claim 21 recites “the electronic processor”; “the electronic processor” lacks antecedent basis because claim 1 recites “a hardware processor.” The claim should use a consistent introduced processor term.
Claim 26 recites “the electronic processor”; “the electronic processor” lacks antecedent basis.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 9, 14, 15, 16, 17, 20, 23, 24, 28, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Remde (US 2011/0218495A1) in view of Brewer et al. (US 20170203030A1; hereinafter “Brewer”), Sehgal et al. (US 2014/0266713A1; hereinafter “Sehgal”), Smith et al. (US 20120078222A1; hereinafter “Smith”), Moberg et al. (US 20040085215A1; hereinafter “Moberg II”), Moberg et al. (US 2007/0255125A1; hereinafter “Moberg”), and Estes (US 2020/0219174A1).
In relation to independent claim 1, this claim recites: “an ambulatory medicament pump configured to determine that the ambulatory medicament pump fails to meet a manufacturer specification and to transmit a request for a replacement ambulatory medicament pump, the ambulatory medicament pump comprising:
a data interface configured to connect to a remote electronic device;
a pump monitoring system configured to determine a functional state of at least one of a plurality of pump components of the ambulatory medicament pump;
a non-transitory memory configured to store specific computer-executable instructions;
and a hardware processor in communication with the non-transitory memory and configured to execute the specific computer-executable instructions to at least:
direct delivery of therapy to a subject;
access a manufacturer specification configured to establish a minimum operating parameter of the ambulatory medicament pump;
determine the functional state of the at least one of the plurality of pump components of the ambulatory medicament pump,
wherein the functional state of the at least one of the plurality of pump components comprises at least one of the following:
a battery failing to meet a manufacturer's specification;
an input/output communication error;
an electrical failure;
a mechanical failure;
a fluid pressure outside a pressure threshold;
a pump controller malfunction;
an error associated with the non-transitory memory;
the pump has exceeded a manufacturer's warranty;
a software malfunction;
the pump has an indication of being tampered with;
the pump has exceeded a usage threshold criterion; or
the pump is subject to a manufacturer recall;
determine, in response to determining the functional state of the at least one of the plurality of pump components, that the ambulatory medicament pump fails to meet the manufacturer specification; in response to determining that the medicament pump fails to meet the manufacturer specification,
automatically generate a replacement alert configured to indicate that the ambulatory medicament pump may need to be replaced; and transmit, via the data interface, the request to the remote electronic device for the replacement ambulatory medicament pump.” Claim 1 is rejected in the following manner:
an ambulatory medicament pump configured to determine a component state and a replacement condition.
Remde discloses the replacement-capable pump core. Remde discloses: “FIG. 1b depicts a later situation where a status of the first insulin pump 505 is such that it may be replaced due to the filling state of its insulin reservoir, the status of the battery and/or the occurrence of an error condition.” (Remde ¶ [0059].) Remde further discloses component-state monitoring. Remde discloses: “In the same way, the occurrence of an error condition, such as a device error or an occluded cannula, may be monitored in the test mode 201.” (Remde ¶ [0063].)
a non-transitory memory, a hardware processor, and direct delivery of therapy.
Remde discloses a stored infusion program used with a replacement pump. Remde discloses: “the infusion program stored in the memory 42 of the insulin pump 1 may be transferred to the replacement pump via the radiofrequency interface 60.” (Remde ¶ [0066].) Remde does not expressly state the claimed non-transitory-memory/ instruction formulation. Brewer fills that gap. Brewer discloses: “The control circuitry 240 of the controller device 200 can include one or more microprocessors 241 configured to execute computer-readable instructions stored on one or more memory devices 242 so as to achieve any of the control operations described herein.” (Brewer ¶ [0093].)
• access a manufacturer specification establishing a minimum operating parameter; compare the functional state and determine failure.
Remde discloses a minimum-value comparison. Remde discloses: “the determined filling state of the insulin reservoir may be compared to a minimum value stored in the memory unit 42.” (Remde ¶ [0063].) Remde does not expressly identify that minimum value as manufacturer-derived or describe the broader measured-component comparison. Sehgal fills that gap. Sehgal discloses: “Maintenance threshold data can, for example, be determined by a manufacturer of the medical device using historical test data.” (Sehgal ¶ [0043].) Sehgal discloses: “Processor 220 in medical device 140 can be configured to determine whether maintenance is required by comparing a measured parameter value 320 for a component with a corresponding maintenance threshold value.” (Sehgal ¶ [0042].)
• the enumerated component states including battery, communication, electrical/mechanical, pressure, controller/memory, software, and usage conditions.
Remde discloses battery state and device error/occlusion monitoring. Remde discloses: “Optionally, the state of the battery 80 may also be determined and compared to a minimum value in an analogue way to the insulin reservoir.” (Remde ¶ [0063].) Remde does not expressly list the full set of component conditions. Smith fills the battery, telemetry, motor, firmware-checksum, reservoir, and preset-limit conditions. Smith discloses: “a battery with a low charge level (AC-2), an error associated with an acoustic transducer or other alarm (AC-3), a fully depleted battery (AC-4), a battery fault (AC-5), an occlusion (AC-6), a telemetry fault (AC-7), a motor error, such motor current too low (AC-8), a baseplate/pump assembly disconnection (AC-9), a firmware checksum error (AC-10), a variables checksum error (AC-11), a low reservoir (AC-12), an empty reservoir (AC-13), a battery fault (AC-14), a zeroing procedure error (AC-15), and a temperature (e.g. within the housing 202) above a preset limit (AC-16).” (Smith ¶ [0511].) Moberg II fills the pressure-threshold and sensor-failure portions. Moberg II discloses: “As before, if the detector 210 is a pressure limit switch, then an axial force that exceeds the set point of the pressure limit switch 210 will cause the switch to close thus providing an electrical signal through electrical leads 211 and to the system's electronics.” (Moberg II ¶ [0013].) Moberg II discloses: “If either the Encoder Count Threshold in block 3070 or the Time Difference Threshold in block 3080 is exceeded, a failure with the force sensor is detected and reported at block 3090.” (Moberg II ¶ [0178].)
automatically generate a replacement alert.
Remde discloses an alert in the error state. Remde discloses: “the insulin delivery may be terminated, and the insulin pump may emit an alert signal via the sound generator 71 and/or the light-emitting diode 70 throughout the modes 200 - 206.” (Remde ¶ [0067].) Remde does not expressly make the alert a maintenance/replacement alert generated from a manufacturer-derived threshold. Sehgal fills that gap. Sehgal discloses: “Based on this comparison, processor 220 can generate an alert to be displayed on display 230 of medical device 140 when the measured parameter value 320 meets or exceeds the corresponding maintenance threshold value.” (Sehgal ¶ [0045].)
• a data interface to a remote electronic device and transmission of a replacement-pump request.
Remde discloses replacement-pump searching and acknowledgement. Remde discloses: “The control unit 40 may then change to the search mode 203, in which the insulin pump 1 searches for an infrared signal from a second and unused replacement pump.” (Remde ¶ [0064].) Remde does not expressly disclose a request to a remote electronic device for a replacement pump. Moberg fills the external-interface portion. Moberg discloses: “Network interface 1316 is suitably configured to support data communication with a device external to the infusion system, e.g., any of the network devices 104 mentioned in the above description of infusion system 100 (see FIG. 1).” (Moberg ¶ [0140].) Estes fills the request-for-pump portion. Estes discloses: “The method may further include providing the single package to a requestor in response to a request for at least the pump device.” (Estes ¶ [0009].)
• Motivation to combine.
Remde is expressly directed to an insulin pump whose status may require replacement and that exchanges information with a replacement pump. Sehgal supplies a manufacturer-derived component threshold and alert workflow, Moberg supplies external medical-system communication, and Estes supplies a request-responsive infusion-pump distribution workflow. A person of ordinary skill in the art would have combined these compatible pump-maintenance, network-communication, and distribution teachings to cause a threshold-detected replacement need to initiate a remote replacement request, thereby reducing delay in obtaining a replacement pump and preserving therapy continuity.
In relation to claim 9, this claim recites: “The ambulatory medicament pump of claim 1, wherein generating the replacement alert comprises contacting a manufacturer or a healthcare provider.” Claim 9 is rejected in the following manner:
• Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
• generating the replacement alert by contacting a manufacturer or healthcare provider.
Remde discloses: “FIG. 1 b depicts a later situation where a status of the first insulin pump 505 is such that it may be replaced due to the filling state of its insulin reservoir, the status of the battery and/or the occurrence of an error condition.” (Remde ¶ [0059].) Remde does not expressly disclose generating the replacement alert by contacting a manufacturer or healthcare provider. Moberg fills that gap. Moberg discloses: “Such network communications may include notifications to third parties (parents, caregivers, medical equipment manufacturers) transmitted via email, pager messages, telephone calls, or any suitable data communication format.” (Moberg ¶ [0005].)
Sehgal supplies the threshold-generated alert: “Based on this comparison, processor 220 can generate an alert to be displayed on display 230 of medical device 140 when the measured parameter value 320 meets or exceeds the corresponding maintenance threshold value.” (Sehgal ¶ [0045].)
Motivation to combine.
It would have been obvious to send Sehgal’s threshold-derived replacement alert to the manufacturer or provider using Moberg’s expressly disclosed third-party notification channel, so that a qualified entity can coordinate replacement service.
In relation to claim 14, this claim recites: “The ambulatory medicament pump of claim 1, further comprising the pump replacement control element.” Claim 14 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
• a pump replacement control element.
Remde discloses: “FIG. 1 b depicts a later situation where a status of the first insulin pump 505 is such that it may be replaced due to the filling state of its insulin reservoir, the status of the battery and/or the occurrence of an error condition.” (Remde ¶ [0059].) Remde does not expressly disclose a pump replacement control element. Estes fills that gap. Estes discloses: “The controller device 200 may be configured as a reusable component that provides electronics and a user interface to control the operation of the pump device 100.” (Estes ¶ [0035].)
Brewer supplies a pump-maintenance user interface: “FIGS. 6A-6D depict an example pump maintenance user interface 600, which can be presented to the user when conducting pump maintenance.” (Brewer ¶ [0066].)
• Motivation to combine.
It would have been obvious to use the known controller/user-interface structures as the replacement control element for Remde’s replacement-capable pump.
In relation to claim 15, this claim recites: “The ambulatory medicament pump of claim 14, wherein generating the replacement alert is via the pump replacement control element.” Claim 15 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 14 is incorporated herein.
generating the replacement alert via the pump replacement control element
Remde discloses: “the insulin delivery may be terminated and the insulin pump may emit an alert signal via the sound generator 71 and/or the light-emitting diode 70 throughout the modes 200 - 206.” (Remde ¶ [0067].) Remde does not expressly disclose generating the replacement alert via the pump replacement control element. Sehgal fills that gap. Sehgal discloses: “Based on this comparison, processor 220 can generate an alert to be displayed on display 230 of medical device 140 when the measured parameter value 320 meets or exceeds the corresponding maintenance threshold value.” (Sehgal ¶ [0045].)
Estes supplies the controller user interface: “The controller device 200 may be configured as a reusable component that provides electronics and a user interface to control the operation of the pump device 100.” (Estes ¶ [0035].)
Motivation to combine.
It would have been obvious to present Sehgal’s threshold-derived alert through the controller/user interface already used to control the replacement-capable pump.
In relation to claim 16, this claim recites: “The ambulatory medicament pump of claim 14, wherein the functional state of the at least one of the plurality of pump components is displayed on pump replacement control element.” Claim 16 is rejected in the following manner:
• Base rejection incorporated.
The proposed rejection of claim 14 is incorporated herein.
• displaying the functional state on the pump replacement control element.
Remde discloses: “In the same way, the occurrence of an error condition, such as a device error or an occluded cannula, may be monitored in the test mode 201.” (Remde ¶ [0063].) Remde does not expressly disclose displaying the functional state on the pump replacement control element. Moberg fills that gap. Moberg discloses: “Network communications from local devices within the medical device system may convey device status information, physiologic patient data, alerts, and/or alarms to the external devices.” (Moberg ¶ [0005].)
Brewer supplies the pump-maintenance user interface: “FIGS. 6A-6D depict an example pump maintenance user interface 600, which can be presented to the user when conducting pump maintenance.” (Brewer ¶ [0066].)
• Motivation to combine.
It would have been obvious to display the component state communicated by Moberg on the existing pump-maintenance/replacement control interface so the user can see the basis for the replacement decision.
In relation to claim 17, this claim recites: “The ambulatory medicament pump of claim 14, wherein the pump replacement control element comprises a graphical user interface.” Claim 17 is rejected in the following manner:
• Base rejection incorporated.
The proposed rejection of claim 14 is incorporated herein.
• a graphical user interface for the pump replacement control element.
Remde discloses: “FIG. 1b depicts a later situation where a status of the first insulin pump 505 is such that it may be replaced due to the filling state of its insulin reservoir, the status of the battery and/or the occurrence of an error condition.” (Remde ¶ [0059].) Remde does not expressly disclose a graphical user interface for the pump replacement control element. Brewer fills that gap. Brewer discloses: “FIGS. 6A-6D depict an example pump maintenance user interface 600, which can be presented to the user when conducting pump maintenance.” (Brewer ¶ [0066].)
Estes supplies a controller device that provides a user interface: “The controller device 200 may be configured as a reusable component that provides electronics and a user interface to control the operation of the pump device 100.” (Estes ¶ [0035].)
• Motivation to combine.
It would have been obvious to implement the controller interface as the known graphical pump-maintenance interface to display and accept replacement controls.
In relation to claim 20, this claim recites: “The ambulatory medicament pump of claim 1, wherein the electronic processor is further configured to execute the specific computer-executable instructions to at least: transmit, via the data interface, the functional state of the at least one of the plurality of pump components of the ambulatory medicament pump to the remote electronic device.” Claim 20 is rejected in the following manner:
• Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
• transmitting the functional state to the remote electronic device.
Remde discloses: “In the same way, the occurrence of an error condition, such as a device error or an occluded cannula, may be monitored in the test mode 201.” (Remde ¶ [0063].) Remde does not expressly disclose transmitting the functional state to the remote electronic device. Moberg fills that gap. Moberg discloses: “Network communications from local devices within the medical device system may convey device status information, physiologic patient data, alerts, and/or alarms to the external devices.” (Moberg ¶ [0005].)
Moberg further supplies the external interface: “Network interface 1316 is suitably configured to support data communication with a device external to the infusion system, e.g., any of the network devices 104 mentioned in the above description of infusion system 100 (see FIG. 1).” (Moberg ¶ [0140].)
• Motivation to combine.
It would have been obvious to transmit the monitored replacement-triggering state from Remde to Moberg’s external device so that the remote system can support maintenance and replacement decisions.
In relation to claim 23, this claim recites: “The ambulatory medicament pump of claim 1, wherein determining the functional state of the at least one of the plurality of pump components of the ambulatory medicament pump comprises receiving the functional state via the pump monitoring system.” Claim 23 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
receiving the functional state via a pump monitoring system
Remde discloses: “In the same way, the occurrence of an error condition, such as a device error or an occluded cannula, may be monitored in the test mode 201.” (Remde ¶ [0063].) Remde does not expressly disclose receiving the functional state via a pump monitoring system. Sehgal fills that gap. Sehgal discloses: “Processor 220 in medical device 140 can be configured to determine whether maintenance is required by comparing a measured parameter value 320 for a component with a corresponding maintenance threshold value.” (Sehgal ¶ [0042].)
Moberg II independently confirms a monitored sensor failure: “If either the Encoder Count Threshold in block 3070 or the Time Difference Threshold in block 3080 is exceeded, a failure with the force sensor is detected and reported at block 3090.” (Moberg II ¶ [0178].)
Motivation to combine.
It would have been obvious to implement the stated test-mode monitoring as a sensor-based pump monitoring system that supplies the functional state to the replacement logic.
In relation to claim 24, this claim recites: “The ambulatory medicament pump of claim 1, wherein determining the functional state of the at least one of the plurality of pump components of the ambulatory medicament pump comprises receiving the functional state from the remote electronic device via the data interface.” Claim 24 is rejected in the following manner:
• Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
• receiving the functional state from a remote electronic device via the data interface.
Remde discloses: “The control unit 40 may then change to the search mode 203, in which the insulin pump 1 searches for an infrared signal from a second and unused replacement pump.” (Remde ¶ [0064].) Remde does not expressly disclose receiving the functional state from a remote electronic device via the data interface. Moberg fills that gap. Moberg discloses: “network interface 1316 may be configured to support unidirectional communication from translation device 1300, or bidirectional communication between translation device 1300 and network devices.” (Moberg ¶ [0140].)
Moberg discloses the content of such communication: “Network communications from local devices within the medical device system may convey device status information, physiologic patient data, alerts, and/or alarms to the external devices.” (Moberg ¶ [0005].)
• Motivation to combine.
It would have been obvious to obtain the relevant state from Moberg’s remote network device over the bidirectional interface before invoking Remde’s replacement process, enabling centralized monitoring.
In relation to claim 28, this claim recites: “The ambulatory medicament pump of claim 26, wherein the period of time is based at least in part on a level of seriousness associated with the replacement alert.” Claim 28 is rejected in the following manner:
• Base rejection incorporated.
The proposed rejection of claim 26 is incorporated herein.
• making the suspension period depend at least in part on alert seriousness.
Remde discloses: “the insulin delivery may be terminated and the insulin pump may emit an alert signal via the sound generator 71 and/or the light-emitting diode 70 throughout the modes 200 - 206.” (Remde ¶ [0067].) Remde does not expressly disclose making the suspension period depend at least in part on alert seriousness. Sehgal fills that gap. Sehgal discloses: “The notification system can be configured to push the alert to a pre-determined subset of clients 120 and MCD 130 or all of these devices depending on the criticality of the alert.” (Sehgal ¶ [0048].)
Brewer supplies severity indication in a maintenance reminder: “The maintenance reminder includes a banner message 502 briefly identifying the maintenance activity and indicating the severity of the deadline (e.g., via color, symbols, font size, font effects), a detailed message 504 describing what the user has to do to comply with the maintenance activity, and a confirmatory interface element 506 through which the user has to provide explicit input indicating that the user has viewed the notification in order for it to be dismissed.” (Brewer ¶ [0065].)
• Motivation to combine.
It would have been obvious to vary the duration of the safety suspension in response to the known criticality/severity of the maintenance alert so that more serious conditions receive a more protective response.
In relation to claim 29, this claim recites: “The ambulatory medicament pump of claim 1, wherein determining the functional state of the at least one of the plurality of pump components of the ambulatory medicament pump is via the pump monitoring system.” Claim 29 is rejected in the following manner:
• Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
• determining the functional state via the pump monitoring system.
Remde discloses: “In the same way, the occurrence of an error condition, such as a device error or an occluded cannula, may be monitored in the test mode 201.” (Remde ¶ [0063].) Remde does not expressly disclose determining the functional state via the pump monitoring system. Sehgal fills that gap. Sehgal discloses: “Processor 220 in medical device 140 can be configured to determine whether maintenance is required by comparing a measured parameter value 320 for a component with a corresponding maintenance threshold value.” (Sehgal ¶ [0042].)
Moberg II supplies a concrete monitored failure: “If either the Encoder Count Threshold in block 3070 or the Time Difference Threshold in block 3080 is exceeded, a failure with the force sensor is detected and reported at block 3090.” (Moberg II ¶ [0178].)
• Motivation to combine.
It would have been obvious to label and implement Remde’s test-mode state determination as the known pump monitoring system with component measurements and thresholds.
Claims 2, 10, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Remde (US 2011/0218495A1) in view of Brewer et al. (US 20170203030A1; hereinafter “Brewer”), Sehgal et al. (US 2014/0266713A1; hereinafter “Sehgal”), Smith et al. (US 20120078222A1; hereinafter “Smith”), Moberg et al. (US 20040085215A1; hereinafter “Moberg II”), Moberg et al. (US 2007/0255125A1; hereinafter “Moberg”), and Estes (US 2020/0219174A1), as discussed above with respect to claim 1, and in further view of Blomquist (US 2014/0171772A1).
In relation to claim 2, this claim recites: “The ambulatory medicament pump of claim 1, wherein the ambulatory medicament pump comprises the at least one of a plurality of pump components, the plurality of pump components comprising: a user interface; a battery; a charging element; a power management controller; a medicament reservoir; a wireless interface; a pump controller; and a pump motor.” Claim 2 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
the claimed user interface, rechargeable / charging arrangement, wireless interface, controller, reservoir, and motor as an expressly recited component set.
Remde discloses: “FIG. 1 b depicts a later situation where a status of the first insulin pump 505 is such that it may be replaced due to the filling state of its insulin reservoir, the status of the battery and/or the occurrence of an error condition.” (Remde ¶ [0059].) Remde does not expressly disclose the claimed user interface, rechargeable / charging arrangement, wireless interface, controller, reservoir, and motor as an expressly recited component set. Smith fills that gap. Smith discloses: “An infusion pump assembly in accordance with at least one of the present inventions includes a housing with a cartridge receiving area, a plunger pusher, a stepper motor, having a shaft and coils, operatively connected to the plunger pusher, an encoder, operably connected to the motor shaft, that generates encoder output representative of shaft position, a battery operatively connected to the motor, an analog-to-digital (A/D) converter that generates A/D converter output that is a digital representation of battery voltage, and a controller.” (Smith ¶ [0040].)
Smith further provides the rechargeable-battery/controller arrangement: “A system in accordance with at least one of the present inventions includes a housing, a fluid displacement device and drive mechanism in the housing, a rechargeable battery in the housing and adapted to power the drive mechanism, a pair of contacts operatively connected to the rechargeable battery and supported by the housing, and a controller.” (Smith ¶ [0051].) Estes supplies a pump user interface: “The controller device 200 may be configured as a reusable component that provides electronics and a user interface to control the operation of the pump device 100.” (Estes ¶ [0035].) Blomquist supplies the wireless interface: “The communication port 235 shown is a wireless port that communicates wirelessly with the computing device 550, such as a radio frequency (RF) port or infrared (IR) port for example.” (Blomquist ¶ [0039].)
Motivation to combine.
A person of ordinary skill would have incorporated these known pump-control, battery, reservoir, motor, user-interface, and wireless-port structures into Remde’s replacement-capable pump to implement the known replacement workflow with ordinary pump hardware.
In relation to claim 10, this claim recites: “The ambulatory medicament pump of claim 1, wherein generating the replacement alert comprises generating a display of instructions for resolving the detected device condition.” Claim 10 is rejected in the following manner:
• Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
• a display of instructions for resolving the detected device condition.
Remde discloses: “In the same way, the occurrence of an error condition, such as a device error or an occluded cannula, may be monitored in the test mode 201.” (Remde ¶ [0063].) Remde does not expressly disclose a display of instructions for resolving the detected device condition. Blomquist fills that gap. Blomquist discloses: “In some examples, the controller 220 may display a device error code and a recommendation to see the diabetes professional rather than present instructions to the user or patient that the pump program should be changed.” (Blomquist ¶ [0059].)
Sehgal further teaches that the alert can display the affected component and suggested maintenance: “Based on this comparison, processor 220 can generate an alert to be displayed on display 230 of medical device 140 when the measured parameter value 320 meets or exceeds the corresponding maintenance threshold value.” (Sehgal ¶ [0045].)
• Motivation to combine.
It would have been obvious to display an error code and corrective instruction in connection with a replacement alert to guide the user through resolution of the diagnosed pump condition.
In relation to claim 22, this claim recites: “The ambulatory medicament pump of claim 1, wherein the data interface comprises wireless data interface.” Claim 22 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
a wireless data interface
Remde discloses: “An acknowledgement signal may be sent to the replacement pump via the infrared interface 50, and the radiofrequency interface 60 may then switched on.” (Remde ¶ [0065].) Remde does not expressly disclose a wireless data interface. Blomquist fills that gap. Blomquist discloses: “The communication port 235 shown is a wireless port that communicates wirelessly with the computing device 550, such as a radio frequency (RF) port or infrared (IR) port for example.” (Blomquist ¶ [0039].)
Remde’s acknowledgement is exchanged over an infrared interface: “An acknowledgement signal may be sent to the replacement pump via the infrared interface 50, and the radiofrequency interface 60 may then switched on.” (Remde ¶ [0065].)
Motivation to combine.
It would have been obvious to use Blomquist’s expressly wireless port as the data interface for the known replacement-request / acknowledgement communications, improving convenience for a portable infusion pump.
Claims 3, 4, 5, 6, 7, 13, 18, 19, 25, 26, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Remde (US 2011/0218495A1) in view of Brewer et al. (US 20170203030A1; hereinafter “Brewer”), Sehgal et al. (US 2014/0266713A1; hereinafter “Sehgal”), Smith et al. (US 20120078222A1; hereinafter “Smith”), Moberg et al. (US 20040085215A1; hereinafter “Moberg II”), Moberg et al. (US 2007/0255125A1; hereinafter “Moberg”), and Estes (US 2020/0219174A1), as discussed above with respect to claim 1, and in further view of Michaud et al. (US 2020/0306445A1; hereinafter “Michaud”).
In relation to claim 3, this claim recites: “The ambulatory medicament pump of claim 1, wherein the hardware processor is further configured to execute the specific computer-executable instructions to at least: receive, via user interaction with a pump replacement control element, a manual instruction configured to request the replacement ambulatory medicament pump; and transmit, based on the manual instruction, via the data interface, the request to the remote electronic device for the replacement ambulatory medicament pump.” Claim 3 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
a manual user interaction that requests the replacement pump and is then transmitted to a remote ordering endpoint.
Remde discloses: “The control unit 40 may then change to the search mode 203, in which the insulin pump 1 searches for an infrared signal from a second and unused replacement pump.” (Remde ¶ [0064].) Remde does not expressly disclose a manual user interaction that requests the replacement pump and is then transmitted to a remote ordering endpoint. Estes fills that gap. Estes discloses: “The method may also include, in response to an individual user request to a pharmacy for repeated deliveries of infusion pump devices, distributing a plurality of infusion pump devices from the pharmacy inventory to the individual user while contemporaneously distributing insulin from the pharmacy inventory.” (Estes ¶ [0007].)
Michaud supplies a user-facing remote control: “If the user selects to turn the auto-off feature on, the user can enter a time period of the auto-off feature into a numeric keypad.” (Michaud ¶ [0100].) Moberg supplies the external interface: “Network interface 1316 is suitably configured to support data communication with a device external to the infusion system, e.g., any of the network devices 104 mentioned in the above description of infusion system 100 (see FIG. 1).” (Moberg ¶ [0140].)
Motivation to combine.
It would have been obvious to permit a user of the replacement-capable pump to trigger the known Estes pump request from a known remote-control input and transmit it on Moberg’s interface, giving the user a manual alternative to automatic threshold detection.
In relation to claim 4, this claim recites: “The ambulatory medicament pump of claim 1, wherein the hardware processor is further configured to execute the specific computer-executable instructions to at least: in response to determining that the ambulatory medicament pump fails to meet the manufacturer specification: maintain the delivery of therapy by the ambulatory medical device to the subject; and repeat generation of the replacement alert on a schedule until an alert modification condition occurs.” Claim 4 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
repeatedly generating the replacement alert on a schedule until a modification condition occurs.
Remde discloses: “the insulin pump 1 may thus supply the patient with insulin throughout all the method steps or modes 200 - 206 illustrated in FIG. 2, except in the switch-off mode 207.” (Remde ¶ [0067].) Remde does not expressly disclose repeatedly generating the replacement alert on a schedule until a modification condition occurs. Michaud fills that gap. Michaud discloses: “Otherwise, the alert can re-annunciate periodically until the alert is closed.” (Michaud ¶ [0097].)
Sehgal supplies the threshold-based maintenance alert: “Based on this comparison, processor 220 can generate an alert to be displayed on display 230 of medical device 140 when the measured parameter value 320 meets or exceeds the corresponding maintenance threshold value.” (Sehgal ¶ [0045].)
Motivation to combine.
It would have been obvious to apply Michaud’s periodic re-annunciation to Sehgal’s threshold-based replacement alert in Remde’s pump so that the patient receives recurring notice while therapy is maintained, thereby reducing the risk that a replacement need is overlooked.
In relation to claim 5, this claim recites: “The ambulatory medicament pump of claim 4, wherein the alert modification condition comprises a change in the functional state of the at least one of the plurality of pump components.” Claim 5 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 4 is incorporated herein.
making the scheduled alert modification condition a change in the monitored functional state.
Remde discloses: “In the same way, the occurrence of an error condition, such as a device error or an occluded cannula, may be monitored in the test mode 201.” (Remde ¶ [0063].) Remde does not expressly disclose making the scheduled alert modification condition a change in the monitored functional state. Michaud fills that gap. Michaud discloses: “The user can acknowledge and close the alert by selecting the OK item, which will clear the alert and update the home and lock screens as well as the battery status screen to indicate the low battery status.” (Michaud ¶ [0098].)
Sehgal supplies the continuing measured-parameter/threshold comparison: “Processor 220 in medical device 140 can be configured to determine whether maintenance is required by comparing a measured parameter value 320 for a component with a corresponding maintenance threshold value.” (Sehgal ¶ [0043].)
Motivation to combine.
It would have been obvious to condition a repeating alert on the current result of Sehgal’s recurring comparison and to cease or modify it when the monitored condition changes, as a predictable implementation of a threshold-based maintenance reminder that avoids presenting a stale alert.
In relation to claim 6, this claim recites: “The ambulatory medicament pump of claim 1, wherein the replacement alert is dismissible by the user.” Claim 6 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
a replacement alert dismissible by the user.
Remde discloses: “the insulin delivery may be terminated and the insulin pump may emit an alert signal via the sound generator 71 and/or the light-emitting diode 70 throughout the modes 200 - 206.” (Remde ¶ [0067].) Remde does not expressly disclose a replacement alert dismissible by the user. Michaud fills that gap. Michaud discloses: “The user can acknowledge and close the alert by selecting the OK item, which will clear the alert and update the home and lock screens as well as the battery status screen to indicate the low battery status.” (Michaud ¶ [0098].)
Brewer independently teaches a dismissible maintenance notification: “The maintenance reminder includes a banner message 502 briefly identifying the maintenance activity and indicating the severity of the deadline (e.g., via color, symbols, font size, font effects), a detailed message 504 describing what the user has to do to comply with the maintenance activity, and a confirmatory interface element 506 through which the user has to provide explicit input indicating that the user has viewed the notification in order for it to be dismissed.” (Brewer ¶ [0065].)
Motivation to combine.
It would have been obvious to make the non-emergency replacement alert dismissible using Michaud’s and Brewer’s known acknowledgement controls, while retaining the underlying monitored condition and any re-annunciation logic.
In relation to claim 7, this claim recites: “The ambulatory medicament pump of claim 1, wherein an alert type of the malfunction alert comprises a critical alert type or a non-critical alert type, wherein the critical alert type indicates that the functional state of the at least one of the plurality of pump components is sufficient to reduce or stop delivery of therapy, and wherein the non-critical alert type therapy indicates that the functional state of the at least one of the plurality of pump components is not sufficient to reduce or stop delivery of therapy.” Claim 7 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
a critical/non-critical alert classification that distinguishes a condition sufficient to reduce or stop therapy from one that is not.
Remde discloses: “the insulin delivery may be terminated and the insulin pump may emit an alert signal via the sound generator 71 and/or the light-emitting diode 70 throughout the modes 200 - 206.” (Remde ¶ [0067].) Remde does not expressly disclose a critical/non-critical alert classification that distinguishes a condition sufficient to reduce or stop therapy from one that is not. Sehgal fills that gap. Sehgal discloses: “The notification system can be configured to push the alert to a pre-determined subset of clients 120 and MCD 130 or all of these devices depending on the criticality of the alert.” (Sehgal ¶ [0048].)
Smith supplies the distinct pump alarm conditions: “a battery with a low charge level (AC-2), an error associated with an acoustic transducer or other alarm (AC-3), a fully depleted battery (AC-4), a battery fault (AC-5), an occlusion (AC-6), a telemetry fault (AC-7), a motor error, such motor current too low (AC-8), a baseplate/pump assembly disconnection (AC-9), a firmware checksum error (AC-10), a variables checksum error (AC-11), a low reservoir (AC-12), an empty reservoir (AC-13), a battery fault (AC-14), a zeroing procedure error (AC-15), and a temperature (e.g. within the housing 202) above a preset limit (AC-16).” (Smith ¶ [0511].) Michaud supplies the low-battery alert that warns “all deliveries will stop”: “This alert can inform the user that the pump battery must be charged or all deliveries will stop.” (Michaud ¶ [0098].)
Motivation to combine.
It would have been obvious to classify the multiple known pump conditions by criticality and associate urgent conditions with therapy reduction/cessation while presenting less urgent conditions without cessation, so that attention and treatment response correspond to the risk posed by the condition.
In relation to claim 13, this claim recites: “The ambulatory medicament pump of claim 1, wherein the hardware processor is further configured to execute the specific computer-executable instructions to at least: receive, via the data interface, a confirmation signal from the remote electronic device, the confirmation signal configured to indicate that the request for the replacement ambulatory medicament pump was received by the remote electronic device; and generate, via the pump replacement control element, a success alert configured to indicate that the request for the replacement ambulatory medicament pump was successfully received by the remote electronic device.” Claim 13 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
receipt from a remote electronic device of confirmation that a replacement request was received and a corresponding success alert.
Remde discloses: “An acknowledgement signal may be sent to the replacement pump via the infrared interface 50, and the radiofrequency interface 60 may then switched on.” (Remde ¶ [0065].) Remde does not expressly disclose receipt from a remote electronic device of confirmation that a replacement request was received and a corresponding success alert. Moberg fills that gap. Moberg discloses: “network interface 1316 may be configured to support unidirectional communication from translation device 1300, or bidirectional communication between translation device 1300 and network devices.” (Moberg ¶ [0140].)
Michaud supplies a confirmation presentation: “A confirmation screen can then be presented informing the user that the feature will stop all deliveries after the set period of time and requiring a user to confirm the setting.” (Michaud ¶ [0100].) Estes supplies the pump-request transaction: “The method may further include providing the single package to a requestor in response to a request for at least the pump device.” (Estes ¶ [0009].)
Motivation to combine.
It would have been obvious to use the known acknowledgement in Remde as a remote receipt confirmation for the known Estes request and present that result on Michaud’s controller, thereby informing the user that the replacement transaction was received.
In relation to claim 18, this claim recites: “The ambulatory medicament pump of claim 1, wherein the electronic processor is further configured to execute the specific computer-executable instructions to at least: in response to determining that the medicament pump fails to meet the manufacturer specification, prompt the subject to authorize a replacement of the ambulatory medicament pump; and receive, via the pump replacement control element, a command to authorize the replacement of the ambulatory medicament pump.” Claim 18 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
prompting the subject to authorize replacement and receiving an authorization command via the control element.
Remde discloses: “The control unit 40 may then change to the search mode 203, in which the insulin pump 1 searches for an infrared signal from a second and unused replacement pump.” (Remde ¶ [0064].) Remde does not expressly disclose prompting the subject to authorize replacement and receiving an authorization command via the control element. Michaud fills that gap. Michaud discloses: “A confirmation screen can then be presented informing the user that the feature will stop all deliveries after the set period of time and requiring a user to confirm the setting.” (Michaud ¶ [0100].)
Estes supplies the request for a pump device: “The method may further include providing the single package to a requestor in response to a request for at least the pump device.” (Estes ¶ [0009].)
Motivation to combine.
It would have been obvious to require the user to confirm/authorize the known pump request before committing the replacement transaction, using Michaud’s confirmation in Remde’s replacement workflow.
In relation to claim 19, this claim recites: “The ambulatory medicament pump of claim 1, wherein the electronic processor is further configured to execute the specific computer-executable instructions to at least: in response to determining that the medicament pump fails to meet the manufacturer specification, prompt the subject, via the pump replacement control element, to select a time period for which the replacement of the ambulatory medicament pump is desired; receive, via the pump replacement control element, a selected time period for which the replacement of the ambulatory medicament pump is desired; and in response to receiving the selected time period for which the additional supply of medicament is desired, transmit, via the data interface, the selected time period for which the replacement of the ambulatory medicament pump is desired to the remote electronic device.” Claim 19 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
prompting for, receiving, and remotely transmitting a selected replacement time period.
Remde discloses: “FIG. 1 b depicts a later situation where a status of the first insulin pump 505 is such that it may be replaced due to the filling state of its insulin reservoir, the status of the battery and/or the occurrence of an error condition.” (Remde ¶ [0059].) Remde does not expressly disclose prompting for, receiving, and remotely transmitting a selected replacement time period. Estes fills that gap. Estes discloses: “The method may also include submitting the prescription to a pharmacy for repeated deliveries of the infusion pump devices over a predetermined period of time.” (Estes ¶ [0006].)
Michaud teaches user entry of a time period: “If the user selects to turn the auto-off feature on, the user can enter a time period of the auto-off feature into a numeric keypad.” (Michaud ¶ [0100].) Moberg teaches bidirectional external communication: “network interface 1316 may be configured to support unidirectional communication from translation device 1300, or bidirectional communication between translation device 1300 and network devices.” (Moberg ¶ [0140].)
Motivation to combine.
It would have been obvious to let the user select a delivery period for the Estes replacement-pump request through Michaud’s numeric user interface and submit it using Moberg’s network, enabling scheduled replacement fulfillment.
In relation to claim 25, this claim recites: “The ambulatory medicament pump of claim 1, wherein meeting the manufacturer's specification comprises at least one of: maintaining or discharging a sufficient supply of power; or battery charging appropriately.” Claim 25 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
defining manufacturer-specification compliance by adequate power handling and appropriate battery charging.
Remde discloses: “Optionally, the state of the battery 80 may also be determined and compared to a minimum value in an analogue way to the insulin reservoir.” (Remde ¶ [0063].) Remde does not expressly disclose defining manufacturer-specification compliance by adequate power handling and appropriate battery charging. Smith fills that gap. Smith discloses: “A system in accordance with at least one of the present inventions includes a housing, a fluid displacement device and drive mechanism in the housing, a rechargeable battery in the housing and adapted to power the drive mechanism, a pair of contacts operatively connected to the rechargeable battery and supported by the housing, and a controller.” (Smith ¶ [0051].)
Michaud supplies the charging-condition alert: “This alert can inform the user that the pump battery must be charged or all deliveries will stop.” (Michaud ¶ [0098].)
Motivation to combine.
It would have been obvious to implement the manufacturer-derived battery threshold in a rechargeable battery/controller arrangement and to alert the user to charge the battery, thereby providing an objective power-maintenance implementation of the specification.
In relation to claim 26, this claim recites: “The ambulatory medicament pump of claim 1, wherein the electronic processor is further configured to execute the specific computer-executable instructions to at least: in response to generating the replacement alert, suspending function of one or more elements of the ambulatory medicament pump for a period of time.” Claim 26 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
suspending one or more pump elements for a period after generating the replacement alert.
Remde discloses: “the insulin delivery may be terminated and the insulin pump may emit an alert signal via the sound generator 71 and/or the light-emitting diode 70 throughout the modes 200 - 206.” (Remde ¶ [0067].) Remde does not expressly disclose suspending one or more pump elements for a period after generating the replacement alert. Sehgal fills that gap. Sehgal discloses: “When these conditions are met, the medical device 140 or the affected component can be automatically turned off or otherwise rendered inoperable until the suggested maintenance is performed.” (Sehgal ¶ [0045].)
Michaud supplies a set-period stop-delivery feature: “The auto-off feature can automatically turn off and stop delivering medicament with the pump when there has been no interaction with the remote controller or pump for a set period of time.” (Michaud ¶ [0100].)
Motivation to combine.
It would have been obvious to apply Sehgal’s automatic suspension to selected pump elements after the replacement alert and use Michaud’s set-period feature to provide a controlled safety interval.
In relation to claim 27, this claim recites: “The ambulatory medicament pump of claim 26, wherein the period of time comprises a preset period of time.” Claim 27 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 26 is incorporated herein.
a preset period for the suspension
Remde discloses: “the insulin delivery may be terminated and the insulin pump may emit an alert signal via the sound generator 71 and/or the light-emitting diode 70 throughout the modes 200 - 206.” (Remde ¶ [0067].) Remde does not expressly disclose a preset period for the suspension. Michaud fills that gap. Michaud discloses: “The auto-off feature can automatically turn off and stop delivering medicament with the pump when there has been no interaction with the remote controller or pump for a set period of time.” (Michaud ¶ [0100].)
Michaud further teaches user entry of the time period: “If the user selects to turn the auto-off feature on, the user can enter a time period of the auto-off feature into a numeric keypad.” (Michaud ¶ [0100].)
Motivation to combine.
It would have been obvious to set the suspension interval in advance using Michaud’s known auto-off timer so that the alert response is consistent and predictable.
Claim 8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Remde (US 2011/0218495A1) in view of Brewer et al. (US 20170203030A1; hereinafter “Brewer”), Sehgal et al. (US 2014/0266713A1; hereinafter “Sehgal”), Smith et al. (US 20120078222A1; hereinafter “Smith”), Moberg et al. (US 20040085215A1; hereinafter “Moberg II”), Moberg et al. (US 2007/0255125A1; hereinafter “Moberg”), and Estes (US 2020/0219174A1), as discussed above with respect to claim 1, and in further view of Mazlish et al. (US 2018/0200437A1).
In relation to claim 8, this claim recites: “The ambulatory medicament pump of claim 1, wherein the hardware processor is configured to execute the specific computer-executable instructions to: reduce the delivery of therapy based at least partially on the determination that the ambulatory medicament pump fails to meet the manufacturer specification.” Claim 8 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
reducing, rather than only terminating, delivery based on the failure determination.
Remde discloses: “the insulin delivery may be terminated and the insulin pump may emit an alert signal via the sound generator 71 and/or the light-emitting diode 70 throughout the modes 200 - 206.” (Remde ¶ [0067].) Remde does not expressly disclose reducing, rather than only terminating, delivery based on the failure determination. Mazlish fills that gap. Mazlish discloses: “the block 1810 may be applied to available insulin delivery segments that may be back-filled to reduce the insulin delivered.” (Mazlish ¶ [0182].)
Mazlish further ties decreasing delivery to a baseline basal rate: “As an additional example, with respect to decreasing insulin delivery (such as when personalizing for a negative correction bolus), the control device may calculate the reduction in IOB if each delivery action delivered the minimum allowed ratio or multiple of the baseline basal insulin rate, such as 0×.” (Mazlish ¶ [0183].)
Motivation to combine.
It would have been obvious to provide Mazlish’s known reduced-delivery option in addition to Remde’s termination option when Sehgal’s threshold workflow identifies a pump condition, enabling a graded safety response rather than an all-or-nothing response.
In relation to claim 12, this claim recites: “The ambulatory medicament pump of claim 1, wherein the hardware processor is configured to execute the specific computer-executable instructions to at least: maintain, in response to determining that the ambulatory medicament pump fails to meet the manufacturer specification, the delivery of therapy to the subject at a reduced rate.” Claim 12 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
maintaining therapy at a reduced rate after the failure determination.
Remde discloses: “the insulin pump 1 may thus supply the patient with insulin throughout all the method steps or modes 200 - 206 illustrated in FIG. 2, except in the switch-off mode 207.” (Remde ¶ [0067].) Remde does not expressly disclose maintaining therapy at a reduced rate after the failure determination. Mazlish fills that gap. Mazlish discloses: “the block 1810 may be applied to available insulin delivery segments that may be back-filled to reduce the insulin delivered.” (Mazlish ¶ [0182].)
Mazlish further states: “As an additional example, with respect to decreasing insulin delivery (such as when personalizing for a negative correction bolus), the control device may calculate the reduction in IOB if each delivery action delivered the minimum allowed ratio or multiple of the baseline basal insulin rate, such as 0×.” (Mazlish ¶ [0183].)
Motivation to combine.
It would have been obvious to combine Remde’s continued-delivery modes with Mazlish’s known reduced-basal-delivery control when Sehgal identifies a condition requiring precaution but not complete cessation, providing a predictable intermediate safety response.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Remde (US 2011/0218495A1) in view of Brewer et al. (US 20170203030A1; hereinafter “Brewer”), Sehgal et al. (US 2014/0266713A1; hereinafter “Sehgal”), Smith et al. (US 20120078222A1; hereinafter “Smith”), Moberg et al. (US 20040085215A1; hereinafter “Moberg II”), Moberg et al. (US 2007/0255125A1; hereinafter “Moberg”), and Estes (US 2020/0219174A1), as discussed above with respect to claim 1, and in further view of Blomquist (US 2014/0171772A1) and Raskin et al. (US 2021/0213200A1).
In relation to claim 11, this claim recites: “The ambulatory medicament pump of claim 1, wherein the hardware processor is configured to execute the specific computer-executable instructions to at least: maintain, in response to determining that the ambulatory medicament pump fails to meet the manufacturer specification, the delivery of therapy to the subject at a normal rate.” Claim 11 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
maintaining therapy at a normal rate after the failure determination
Remde discloses: “the insulin pump 1 may thus supply the patient with insulin throughout all the method steps or modes 200 - 206 illustrated in FIG. 2, except in the switch-off mode 207.” (Remde ¶ [0067].) Remde does not expressly disclose maintaining therapy at a normal rate after the failure determination. Blomquist fills that gap. Blomquist discloses: “Basal rate refers to a type of twenty-four hour background infusion of insulin by an insulin pump that mimics the continuous background release of insulin from a normal pancreas. It is the rate of insulin delivery the patient normally needs independent of the consumption of meals.” (Blomquist ¶ [0033].)
Raskin supplies continuity of therapy care: “By using the backup therapy data, the subject can maintain a level of therapy care that matches or more closely matches what was being provided by the ambulatory medicament device than clinical data, which may be outdated if available at all.” (Raskin ¶ [0121].)
Motivation to combine.
It would have been obvious to maintain the known background basal therapy where the detected condition does not require an immediate stop, while initiating the replacement workflow, to preserve continuity of care until a replacement is available.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Remde (US 2011/0218495A1) in view of Brewer et al. (US 20170203030A1; hereinafter “Brewer”), Sehgal et al. (US 2014/0266713A1; hereinafter “Sehgal”), Smith et al. (US 20120078222A1; hereinafter “Smith”), Moberg et al. (US 20040085215A1; hereinafter “Moberg II”), Moberg et al. (US 2007/0255125A1; hereinafter “Moberg”), and Estes (US 2020/0219174A1), as discussed above with respect to claim 1, and in further view of Ray (US 2008/0133261A1).
In relation to claim 21, this claim recites: “The ambulatory medicament pump of claim 1, wherein the electronic processor is configured to execute the specific computer-executable instructions to at least: receive, via the data interface from the remote electronic device, an indication of the status of a delivery of the replacement of the ambulatory medicament pump.” Claim 21 is rejected in the following manner:
• Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
• receiving from the remote device an indication of the delivery status of the replacement pump.
Remde discloses: “FIG. 1 b depicts a later situation where a status of the first insulin pump 505 is such that it may be replaced due to the filling state of its insulin reservoir, the status of the battery and/or the occurrence of an error condition.” (Remde ¶ [0059].) Remde does not expressly disclose receiving from the remote device an indication of the delivery status of the replacement pump. Ray fills that gap. Ray discloses: “the second notification is sent to sender 105 at the sender notification address indicating that item 110 has been delivered.” (Ray ¶ [0029].)
Estes teaches direct shipping of the requested infusion-pump components: “In this case, as with the pharmacy visit, a lower paperwork burden is imposed on the individual requesting the infusion pumps, but also has the additional advantage of having the components shipped directly to the individual's address.” (Estes ¶ [0028].) Ray further provides an internet e-mail to a computer: “In order to send the second notification, the delivery system operator can send an e-mail through the Internet to the sender notification address which delivers the second notification to sender computer 175.” (Ray ¶ [0029].)
• Motivation to combine.
It would have been obvious to apply Ray’s electronic delivery-status notification to the Estes shipped replacement-pump order and receive it at the remote component of Remde’s networked system, so the user knows whether the replacement has arrived.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
