DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/21/2026 has been entered.
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 16-19, 21, 25, 27-30, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Istoc (US 20160051749 A1) in view of Schuster et al. (US 20160129182 A1).
Regarding claim 16, Istoc discloses an injection device (infusion pump 112, Fig 1) comprising: a first acoustic signal generator ([0027]: piezoelectric sound generator producing audio output 214, Fig 2A) operable to generate an acoustic signal (audio output 214, Fig 2A); a wireless unit (radio; [0029]); and a controller (processor 200, Fig 2A) configured to transmit status information to a mobile device (controller 122, Fig 2B) ([0028]) using the wireless unit (radios [0029]: “The radios within the infusion pump 112 and controller 122 enable communication between the infusion pump 112, the controller 122 and the electronics package 108 associated with the sensor set”), wherein the first acoustic signal generator ([0027]: piezoelectric sound generator producing audio output 214, Fig 2A) is configured to receive a control signal from the mobile device (122) ([0022]: “the controller 122 is a commercially available mobile phone configured to run proprietary or customized software capable of controlling the infusion pump 112”; therefore the controller 122 is structurally capable to control the functions of infusion pump 112, including the alarms and audio output 214 ; Fig 2A-2B shows communication path between them) to cause the first acoustic signal generator to generate an alert (alert generated by audio output 214; Fig 2A; [0027]; both 200 and 200’ are in communication and structurally capable to generate alert; [0022]) having one or more acoustic properties ([0030]: level of the alert which depend on intensity and related properties) that are selected by the mobile device (122) based on both the status information transmitted by the injection device to the mobile device (status information; [0028]: either display 212 or 212’ can show various status information regarding both the infusion pump 112 and the controller; therefore status information is being transmitted from pump 112 to controller 122 via communications and environmental sensor suite 210/210′; [0030]) and the environmental acoustic signals ([0030]; alerts change intensity/volume based on environmental acoustic signals and displayed clock time status) detected by the mobile device ([0029]);
Istoc discloses the alert generated by the first acoustic signal generator (alert generated by audio output 214; Fig 2A; [0027]; both 200 and 200’ are in communication and structurally capable to generate alert; [0022]) but is silent wherein the injection device further comprises a second acoustic signal generator, and wherein the second acoustic signal generator is configured to receive a control signal from the mobile device to cause the second acoustic signal generator to generate a reference noise arranged to eliminate ambient noise, in addition to the alert generated by the first acoustic signal generator.
Schuster teaches an injection device ([0034]) comprising a second acoustic signal generator, and wherein the second acoustic signal generator (one or more noise cancellation microphone transducers; [0075]) to cause the second acoustic signal generator (noise cancellation microphone transducers; [0075]) to generate a reference noise (reference noise accounted for in the correction acoustic signal,[0057]) arranged to eliminate ambient noise ([0057])
Istoc/Schuster as modified teaches the second signal generator (noise cancellation microphone transducers; from Schuster) is configured to receive a control signal from the mobile device ([0022]: “the controller 122 is a commercially available mobile phone configured to run proprietary or customized software capable of controlling the infusion pump 112”; therefore the controller 122 is structurally capable of controlling the functions of infusion pump 112. As modified, the incorporated microphone transducer is being controlled by the pump which in turn is being controlled by the controller 122)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Istoc by to include a second acoustic signal generator as taught by Schuster for the purpose of eliminating ambient noise present to eliminate the possibility of interference ([0057]; [0108]).
Regarding claim 17, Istoc/Schuster discloses the injection device of claim 16. Istoc discloses further comprising a vibration element (alarm component 205, Fig 2A) configured to generate a haptic feedback (vibration; [0027]), wherein the alert further comprises the haptic feedback ([0027]:“vibration alarm that enables vibration of the entire infusion pump 112”).
Regarding claim 18, Istoc/Schuster discloses the injection device of claim 16. Istoc discloses wherein the acoustic properties ([0030]: level of the alert which depend on intensity and related properties) of the alert are additionally selected based on predetermined settings, wherein the predetermined settings comprise one or more of: feedback preferences, acoustic preferences, hearing limitations, visual limitations, or haptic limitations (Feedback preferences; [0027]: “Accessible via the user interface 208/208′ and display 212/212′, the alarms component 205/205′ allows users to program various alarms conditions such as, but not limited to low or high level thresholds for sensor measurements, periodic alarms and the like.”; [0030]).
Regarding claim 19, Istoc/Schuster discloses the injection device of claim 16. Istoc discloses further comprising a photoelectric element (ambient light sensors; [0029]) configured to detect ambient light levels ([0030]), wherein the acoustic properties ([0030]: level of the alert which depend on intensity and related properties) of the alert are additionally selected based on the detected ambient light levels ([0030]: “For example, if a clock indicates it is 3 AM, the ambient sensors determine it is dark, microphones detect very little ambient noise, and accelerometers indicate sporadic movement it may be determined the user is asleep and audible alarms may be automatically programmed to start off somewhat quietly and gradually increase in intensity over time.”).
Regarding claim 21, Istoc/Schuster discloses the injection device of claim 16. Istoc discloses wherein the controller (200) is configured to control the first acoustic signal generator (piezoelectric sound generator; [0027]) to generate the alert (alert generated by audio output 214; Fig 2A; [0027] with an amplitude within each of multiple frequency bands selected based on the environmental acoustic signals, and/or to generate the alert at a volume that is selected based on the environmental acoustic signals ([0030]; alerts change intensity/volume based on environmental acoustic signals).
Regarding claim 25, Istoc discloses a feedback system (infusion system 100, Fig 1) comprising: an injection device (infusion pump 112, Fig 1) and a mobile device (controller 122, Fig 2B), wherein the injection device (112) comprises: a first acoustic signal generator ([0027]: piezoelectric sound generator) operable to generate an acoustic signal (signal generated by audio output 214); a wireless unit (radio; [0029]); and a first controller (processor 200, Fig 2A) configured to transmit status information to the mobile device (122; [0028]) using the wireless unit (radios; [0029]); wherein the mobile device (122) comprises: a first acoustic sensor (communications and environmental sensor suite 210’; [0029]: microphone) configured to detect environmental acoustic signals ([0030]), and a second controller (processor 200’, Fig 2B) configured to transmit a control signal to the first acoustic signal generator ([0027]: piezoelectric sound generator) of the injection device (112) ) ([0022]: “the controller 122 is a commercially available mobile phone configured to run proprietary or customized software capable of controlling the infusion pump 112”; therefore the controller display 126 is structurally capable to control the functions of infusion pump 112, including the alarms and audio output 214 ; Fig 2A-2B shows communication path between them) to cause the first acoustic signal generator ([0027]: piezoelectric sound generator) to generate an alert (alert generated by audio output 214; Fig 2A; [0027]; both 200 and 200’ are in communication and structurally capable to generate alert) having acoustic properties ([0030]: level of the alert which depend on intensity and related properties) that are selected by the mobile device (122) based on both the status information transmitted to the mobile device (status information [0028]; [0030]) by the injection device (112) and the environmental acoustic signals ([0030]; alerts change intensity/volume based on environmental acoustic signals and displayed clock time status) detected by the mobile device ([0029]).
Istoc discloses the alert generated by the first acoustic signal generator (alert generated by audio output 214; Fig 2A; [0027]; both 200 and 200’ are in communication and structurally capable to generate alert; [0022]) but is silent wherein the injection device further comprises a second acoustic signal generator; and wherein the second controller is configured to transmit a control signal to the second acoustic signal generator to cause the second acoustic signal generator to generate a reference noise arranged to eliminate ambient noise.
Schuster teaches an injection device ([0034]), wherein the injection device further comprises a second acoustic signal generator (one or more noise cancellation microphone transducers; [0075]); to generate a reference noise (reference noise accounted for in the correction acoustic signal,[0057]) arranged to eliminate ambient noise ([0057]).
Istoc/Schuster teaches wherein the second controller (processor 200’, Fig 2B from Istoc) is configured to transmit a control signal to the second acoustic signal generator (noise cancellation microphone transducers; from Schuster) to cause the second acoustic signal generator to generate a reference noise arranged to eliminate ambient noise ([0022]: the controller 122 is structurally capable of controlling the functions of infusion pump 112. As modified, the incorporated microphone transducer is being controlled by the pump which in turn is being controlled by the controller 122; Second controller 200’ is structurally capable to emit a control signal emitted to the first controller to indicate generation of the reference noise by the noise cancellation microphone transducer; claim language does not exclude control of the noise cancellation microphone transducer by indirect transmission via intermediate element such as the first controller.
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Istoc by to include a second acoustic signal generator as taught by Schuster for the purpose of eliminating ambient noise present to eliminate the possibility of interference ([0057]; [0108]).
Regarding claim 27, Istoc/Schuster discloses the feedback system of claim 25. Istoc discloses wherein either the injection device (112) or the mobile device (122) further comprises a vibration element (alarm component 205/205′, Fig 2A-B) configured to generate a haptic feedback (vibration; [0027]), wherein the alert further comprises the haptic feedback ([0027]: “vibration alarm that enables vibration of the entire infusion pump 112, controller 122 or both so a user can be discretely notified of an alarm condition”).
Regarding claim 28, Istoc/Schuster discloses the feedback system of claim 25. Istoc discloses wherein the acoustic properties ([0030]: level of the alert which depend on intensity and related properties) of the alert (204) are additionally selected based on predetermined settings ([0030]: “a microphone may detect ambient noise and automatically adjust audible alarms to appropriate levels”).
Regarding claim 29, Istoc/Schuster discloses the feedback system of claim 28. Istoc discloses wherein the predetermined settings comprise one or more of: feedback preferences, acoustic preferences, hearing limitations, visual limitations, or haptic limitations (Feedback preferences; [0027]: “Accessible via the user interface 208/208′ and display 212/212′, the alarms component 205/205′ allows users to program various alarms conditions such as, but not limited to low or high level thresholds for sensor measurements, periodic alarms and the like.”; [0030]).
Regarding claim 30, Istoc/Schuster discloses the feedback system of claim 25. Istoc discloses wherein either the injection device (112) or the mobile device (122) further comprises a photoelectric element (ambient light sensors; [0029]) configured to detect ambient light levels ([0030]), wherein the acoustic properties ([0030]: level of the alert which depend on intensity and related properties) of the alert are additionally selected based on the detected ambient light levels ([0030]: “For example, if a clock indicates it is 3 AM, the ambient sensors determine it is dark, microphones detect very little ambient noise, and accelerometers indicate sporadic movement it may be determined the user is asleep and audible alarms may be automatically programmed to start off somewhat quietly and gradually increase in intensity over time.”).
Regarding Claim 33, Istoc/Schuster discloses the feedback system of claim 25. Istoc wherein the first controller (200) is configured to control the first acoustic signal generator ([0027]: piezoelectric sound generator) to generate the alert (alert generated by audio output 214; Fig 2A; [0027]) with an amplitude within each of multiple frequency bands selected based on the environmental acoustic signals, and/or to generate the alert at a volume that is selected based on the environmental acoustic signals ([0030]; alerts change intensity/volume based on environmental acoustic signals).
Claims 20 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Istoc (US 20160051749 A1) in view of Schuster et al. (US 20160129182 A1) in further view of Istoc (US 8487758 B2), hereinafter Istoc-2.
Regarding claim 20, Istoc/Schuster discloses the injection device of claim 16. Istoc discloses wherein the controller (200) is configured to control the first acoustic signal generator (piezoelectric sound generator; [0027]) to generate the alert (alert generated by audio output 214; Fig 2A; [0027]; However, Istoc/Schuster are silent regarding having a frequency spectrum, pitch or tone that is selected based on the environmental acoustic signals and/or to generate the alert within a frequency band that is selected based on the environmental acoustic signals.
Istoc-2 teaches a feedback system (insulin infusion system; Fig 1-2) comprising a controller (controller 100, Fig 1), an acoustic signal generator (audio transducer or speaker 110, Fig 1) to generate an alert having a frequency spectrum, pitch or tone that is selected based on the environment acoustic signals and/or to generate the alert within a frequency band that is selected based on the environment acoustic signals (Col. 17 line 66- Col. 18, line 17)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Istoc/Schuster with the teaching of an alert having a frequency, pitch or tone that is selected based on the environment acoustic signals as taught by Istoc-2 for the purpose of increase alarm effectivity depending on the environmental conditions (Col. 17 line 66- Col. 18, line 17).
Regarding claim 32, Istoc/Schuster discloses the feedback system of claim 25. Istoc discloses wherein the first controller (200) is configured to control the first acoustic signal generator ([0027]: piezoelectric sound generator) to generate the alert (alert generated by audio output 214; Fig 2A; [0027]). Istoc does not explicitly disclose having a frequency spectrum, pitch or tone that is selected based on the environmental acoustic signals and/or to generate the alert within a frequency band that is selected based on the environmental acoustic signals.
Istoc-2 teaches a feedback system (insulin infusion system; Fig 1-2) comprising a controller (controller 100, Fig 1), a first acoustic signal generator (audio transducer or speaker 110, Fig 1) to generate an alert having a frequency spectrum, pitch or tone that is selected based on the environmental acoustic signals and/or to generate the alert within a frequency band that is selected based on the environment acoustic signals (Col. 17 line 66- Col. 18, line 17)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Istoc/Schuster with the teaching of an alert having a frequency, pitch or tone that is selected based on the environment acoustic signals as taught by Istoc-2 for the purpose of increase alert effectivity depending on the environmental conditions (Col. 17 line 66- Col. 18, line 17).
Claims 16, and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over by Mirov (US 20180165422 A1) in view of Istoc (US 20160051749 A1) in further view of Schuster et al. (US 20160129182 A1).
Regarding claim 16, Mirov discloses an injection device (syringe 10, Fig 1) comprising: a first acoustic signal generator (transducer 24, Fig 3) operable to generate an acoustic signal ([0025; [0037]); a wireless unit (transceiver 30, Fig 2); and a controller (microcontroller 26, Fig 2) configured to transmit status information to a mobile device (smart phone; [0031]) using the wireless unit (30) ([0031]: “Plunger head 22 may transmit data (e.g., the amount of medication 20 dispensed and time and date it was dispensed) to a remote device (e.g., a smart phone, a glucose monitor, an insulin pump, or a computer) via one or more of the wireless communication methods.”),
Mirov is silent wherein the first acoustic signal generator is configured to receive a control signal from the mobile device to cause the first acoustic signal generator to generate an alert having one or more acoustic properties that are selected by the mobile device based on both the status information transmitted by the injection device to the mobile device and environmental acoustic signals detected by the mobile device, wherein the injection device further comprises a second acoustic signal generator, and wherein the second acoustic signal generator is configured to receive a control signal from the mobile device to cause the second acoustic signal generator to generate a reference noise arranged to eliminate ambient noise, in addition to the alert generated by the first acoustic signal generator.
Istoc teaches an injection device (infusion pump 112, Fig 1) comprising: a first acoustic signal generator ([0027]: piezoelectric sound generator producing audio output 214, Fig 2A) operable to generate an acoustic signal (audio output 214, Fig 2A); a wireless unit (radio; [0029]); and a controller (processor 200, Fig 2A) configured to transmit status information to a mobile device (controller 122, Fig 2B) ([0028]) using the wireless unit (radios [0029]: “The radios within the infusion pump 112 and controller 122 enable communication between the infusion pump 112, the controller 122 and the electronics package 108 associated with the sensor set”), wherein the first acoustic signal generator ([0027]: piezoelectric sound generator producing audio output 214, Fig 2A) is configured to receive a control signal from the mobile device (122) ([0022]: “the controller 122 is a commercially available mobile phone configured to run proprietary or customized software capable of controlling the infusion pump 112”; therefore the controller display 126 is structurally capable to control the functions of infusion pump 112, including the alarms and audio output 214 ; Fig 2A-2B shows communication path between them) to cause the first acoustic signal generator to generate an alert (alert generated by audio output 214; Fig 2A; [0027]; both 200 and 200’ are in communication and structurally capable to generate alert; [0022]) having one or more acoustic properties ([0030]: level of the alert which depend on intensity and related properties) that are selected by the mobile device (122) based on both the status information transmitted by the injection device to the mobile device (status information; [0030]; [0028]: either display 212 or 212’ can show various status information regarding both the infusion pump 112 and the controller; therefore status information is being transmitted from pump 112 to controller 122 via communications and environmental sensor suite 210/210′) and the environmental acoustic signals ([0030]; alerts change intensity/volume based on environmental acoustic signals and displayed clock time status) detected by the mobile device ([0029]); Istoc discloses the alert generated by the first acoustic signal generator (alert generated by audio output 214; Fig 2A; [0027]; both 200 and 200’ are in communication and structurally capable to generate alert; [0022])
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Mirov by configuring the smart phone to control the injection device and modify the transducer to generate an alert as taught by Istoc to improve user experience and alert the user of device status taking in consideration ambient signals ([0030]).
Mirov/Istoc are silent wherein the injection device further comprises a second acoustic signal generator, and wherein the second acoustic signal generator is configured to receive a control signal from the mobile device to cause the second acoustic signal generator to generate a reference noise arranged to eliminate ambient noise, in addition to the alert generated by the first acoustic signal generator.
Schuster teaches an injection device ([0034]) comprising a second acoustic signal generator, and wherein the second acoustic signal generator (one or more noise cancellation microphone transducers; [0075]) to cause the second acoustic signal generator (noise cancellation microphone transducers; [0075]) to generate a reference noise (reference noise accounted for in the correction acoustic signal,[0057]) arranged to eliminate ambient noise ([0057])
Mirov/Istoc/Schuster as modified teaches the second signal generator (noise cancellation microphone transducers; from Schuster) is configured to receive a control signal from the mobile device (Istoc teaching of [0022]: “the controller 122 is a commercially available mobile phone configured to run proprietary or customized software capable of controlling the infusion pump 112”; therefore the controller 122 is structurally capable of controlling the functions of infusion pump 112. As modified, the incorporated microphone transducer is being controlled by the pump which in turn is being controlled by the controller 122)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Istoc to include a second acoustic signal generator as taught by Schuster for the purpose of eliminating ambient noise present to eliminate the possibility of interference ([0057]; [0108]).
Regarding claim 24, Mirov/Istoc/Schuster discloses the injection device of claim 16. Mirov discloses wherein the injection device (10) is an injection pen or a supplemental device provided with a part for coupling the supplemental device to an injection pen ([0071]).
Regarding claim 25, Mirov discloses a feedback system (syringe 10, Fig 1 + smart phone; [0026]) comprising an injection device (syringe 10, Fig 1) and a mobile device (smart phone; [0026]), wherein the injection device (10) comprises: a first acoustic signal generator (transducer 24, Fig 3) operable to generate an acoustic signal ([0025; [0037]); a wireless unit (transceiver 30, Fig 2); and a first controller (microcontroller 26, Fig 2) configured to transmit status information to the mobile device using the wireless unit (30) ([0031]: “Plunger head 22 may transmit data (e.g., the amount of medication 20 dispensed and time and date it was dispensed) to a remote device (e.g., a smart phone, a glucose monitor, an insulin pump, or a computer) via one or more of the wireless communication methods.”); wherein the mobile device (smart phone; [0026]) comprises: a first acoustic sensor (smartphone includes microphones) configured to detect environmental acoustic signals (microphones of smartphones are capable of detecting environmental acoustic signals), and a second controller (smartphone processor).
Mirov is silent wherein the second controller is configured to transmit a control signal to the first acoustic signal generator of the injection device to cause the first acoustic signal generator to generate an alert having acoustic properties that are selected by the mobile device based on both the status information transmitted to the mobile device by the injection device and the environmental acoustic signals detected by the mobile device; wherein the injection device further comprises a second acoustic signal generator; and wherein the second controller is configured to transmit a control signal to the second acoustic signal generator to cause the second acoustic signal generator to generate a reference noise arranged to eliminate ambient noise, in addition to the alert generated by the first acoustic signal generator.
Istoc teaches a feedback system (infusion system 100, Fig 1) comprising: an injection device (infusion pump 112, Fig 1) and a mobile device (controller 122, Fig 2B), wherein the injection device (112) comprises: a first acoustic signal generator ([0027]: piezoelectric sound generator) operable to generate an acoustic signal (signal generated by audio output 214); a wireless unit (radio; [0029]); and a first controller (processor 200, Fig 2A) configured to transmit status information to the mobile device (122; [0028]) using the wireless unit (radios; [0029]); wherein the mobile device (122) comprises: a first acoustic sensor (communications and environmental sensor suite 210’; [0029]: microphone) configured to detect environmental acoustic signals ([0030]), and a second controller (processor 200’, Fig 2B) configured to transmit a control signal to the first acoustic signal generator ([0027]: piezoelectric sound generator) of the injection device (112) ) ([0022]: “the controller 122 is a commercially available mobile phone configured to run proprietary or customized software capable of controlling the infusion pump 112”; therefore the controller display 126 is structurally capable to control the functions of infusion pump 112, including the alarms and audio output 214 ; Fig 2A-2B shows communication path between them) to cause the first acoustic signal generator to generate an alert (alert generated by audio output 214; Fig 2A; [0027]; both 200 and 200’ are in communication and structurally capable to generate alert) having acoustic properties ([0030]: level of the alert which depend on intensity and related properties) that are selected by the mobile device (122) based on both the status information transmitted to the mobile device (status information; [0028]; [0030]) by the injection device (112) and the environmental acoustic signals ([0030]; alerts change intensity/volume based on environmental acoustic signals and displayed clock time status) detected by the mobile device ([0029]). Istoc further discloses the alert generated by the first acoustic signal generator (alert generated by audio output 214; Fig 2A; [0027]; both 200 and 200’ are in communication and structurally capable to generate alert; [0022]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Mirov by configuring the smart phone to control the injection device and modify the transducer to generate an alert as taught by Istoc to improve user experience and alert the user of device status taking in consideration ambient signals ([0030]).
Mirov/Istoc are silent wherein the injection device further comprises a second acoustic signal generator; and wherein the second controller is configured to transmit a control signal to the second acoustic signal generator to cause the second acoustic signal generator to generate a reference noise arranged to eliminate ambient noise.
Schuster teaches an injection device ([0034]), wherein the injection device further comprises a second acoustic signal generator (one or more noise cancellation microphone transducers; [0075]); to generate a reference noise (reference noise accounted for in the correction acoustic signal,[0057]) arranged to eliminate ambient noise ([0057]).
Mirov/Istoc/Schuster teaches wherein the second controller (processor 200’, Fig 2B from Istoc) is configured to transmit a control signal to the second acoustic signal generator (noise cancellation microphone transducers; from Schuster) to cause the second acoustic signal generator to generate a reference noise arranged to eliminate ambient noise ([0022]: the controller 122 is structurally capable of controlling the functions of infusion pump 112. As modified, the incorporated microphone transducer is being controlled by the pump which in turn is being controlled by the controller 122; Second controller 200’ is structurally capable to emit a control signal emitted to the first controller to indicate generation of the reference noise by the noise cancellation microphone transducer; claim language does not exclude control of the noise cancellation microphone transducer by indirect transmission via intermediate element such as the first controller.
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Mirov/Istoc to include a second acoustic signal generator as taught by Schuster for the purpose of eliminating ambient noise present to eliminate the possibility of interference ([0057]; [0108]).
Regarding claim 26, Mirov/Istoc/Schuster discloses the feedback system of claim 25. Mirov discloses wherein the first device (10) is an injection pen or a supplemental device provided with a part for coupling the supplemental device to an injection pen ([0071]).
Response to Arguments
Applicant’s arguments with respect to claims 16-21, 24-30, and 32-33 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant submits that applied reference do not disclose amended claim limitations. Examiner respectfully disagrees.
Please see below relevant portion of claim 1:
Istoc discloses (…) wherein the first acoustic signal generator ([0027]: piezoelectric sound generator producing audio output 214, Fig 2A) is configured to receive a control signal from the mobile device (122) ([0022]: “the controller 122 is a commercially available mobile phone configured to run proprietary or customized software capable of controlling the infusion pump 112”; therefore the controller 122 is structurally capable to control the functions of infusion pump 112, including the alarms and audio output 214 ; Fig 2A-2B shows communication path between them) to cause the first acoustic signal generator to generate an alert (alert generated by audio output 214; Fig 2A; [0027]; both 200 and 200’ are in communication and structurally capable to generate alert; [0022]) having one or more acoustic properties ([0030]: level of the alert which depend on intensity and related properties) that are selected by the mobile device (122) based on both the status information transmitted by the injection device to the mobile device (status information;[0030]; [0028]: either display 212 or 212’ can show various status information regarding both the infusion pump 112 and the controller; therefore status information is being transmitted from pump 112 to controller 122 via communications and environmental sensor suite 210/210′) and the environmental acoustic signals ([0030]; alerts change intensity/volume based on environmental acoustic signals and displayed clock time status) detected by the mobile device ([0029]) (…)
Schuster teaches an injection device ([0034]) comprising a second acoustic signal generator, and wherein the second acoustic signal generator (one or more noise cancellation microphone transducers; [0075]) to cause the second acoustic signal generator (noise cancellation microphone transducers; [0075]) to generate a reference noise (reference noise accounted for in the correction acoustic signal,[0057]) arranged to eliminate ambient noise ([0057])
Istoc/Schusteras modified teaches the second signal generator (noise cancellation microphone transducers; from Schuster) is configured to receive a control signal from the mobile device ([0022]: “the controller 122 is a commercially available mobile phone configured to run proprietary or customized software capable of controlling the infusion pump 112”; therefore the controller 122 is structurally capable of controlling the functions of infusion pump 112. As modified, the incorporated microphone transducer is being controlled by the pump which in turn is being controlled by the controller 122)
Modified first controller 200 is capable to generate a control signal to the incorporated microphone transducer to generate a reference noise. Second controller 200’ is capable of sending controlling signals to operate first controller. Claim functional language does not require the second controller to directly emit a control signal to the second acoustic signal generator. Indirect transmission via intermediate element such as the first controller remain within the scope of the claim.
Examiner respectfully recommends to include structural details or additional elements of the device of instant application that accomplish the claimed function and/or specify the type of status information that is transmitted to the mobile device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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