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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/28/2025 has been entered.
Claim Objections
Claim 22 objected to because of the following informalities: Claim 22 line 1 recites limitation: “The insulin delivery device of claim 1(…)”. Insulin device is introduced in independent claim 12. Claim 1 recites an on-body drug delivery device. Appropriate correction is required.
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 1-4, 6, 8-9, and 11-23 are rejected under 35 U.S.C. 103 as being unpatentable over Crouther et al. (US 20160089493 A1) in view of Tieck et al. (US 20160015957 A1) in further view of DeLaquil et al. (US 20110122026 A1).
Regarding claim 1, Crouther embodiment of Fig 2, hereinafter Crouther-2, discloses an on-body drug delivery device (medical device 210, Fig 2a), comprising: at least one housing (case of medical device 210, Fig 2a; [0041]); a wireless communications transceiver (communication component or module of the medical device 210; [0041]: communication module or component is a transmitter/receiver) positioned inside the at least one housing (case) for transmitting and receiving wireless communications ([0041]); an adhesive pad (adhesive patch 220, Fig 2a) secured to a surface of the at least one housing (case of 210) for securing the on-body drug delivery device (210) to a user ([0045]); multiple antennas ([0044] shows that antenna 260 could be any of the antennas of the disclosure; [0060]: “The medical device may include one, two, or more external antennas”; therefore antenna 260 could be multiple antennas) positioned outside of the at least one housing (case) for wireless communication ([0045]); wherein the antennas (multiple antennas; [0060]) are electrically connected with the wireless communications transceiver ([0041]); the antennas direct at least some of the transmitted wireless communications to other medical devices ([0044]: “(…)the portable electronic device 240 may communicate with a communication component or module of the medical device 210 that transmits information using the antenna 260”).
Crouther-2 is silent regarding a beamformer positioned inside the at least one housing; the multiples antennas are organized into an antenna array; wherein the antennas are electrically connected with the beamformer and the wireless communications transceiver; and wherein the beamformer is configured to perform beamforming with the antenna array to reduce transmitted wireless communications from the on-body drug delivery device from being absorbed by the user of the on-body drug delivery device and to direct at least some of the transmitted wireless communications to other medical devices.
Tieck teaches a beamformer (electronics 60; [0631]) positioned inside the at least one housing (housing 33, Fig 4E; [0416]); the multiples antennas are organized into an antenna array ([0625]; multiples antennas arranged in a special array); wherein the antennas (plurality of antennas in an array; [0631]) are electrically connected with the beamformer ([0601]; [0625]; [0627]; electronics circuit 60 is connected to the RF sensor device 34 further connected to the antenna array) and the wireless communications transceiver (68) ([0490]; transceiver 68 is included in the electronic circuit 60; therefore is electrically connected as well); and wherein the beamformer (60) is configured to perform beamforming with the antenna array (plurality of antennas in an array; [0631]) to reduce transmitted wireless communications from the on-body drug delivery device from being absorbed by the user of the on-body drug delivery device ([0607]; the beamforming of the array of antennas and the electronics 60 allow for a directional communication instead of an omnidirectional, this reduces the quantity of signals being absorbed in the body).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the communication between the portable electronic device and antenna of device of Crouther-2 with an antenna array connected to a beamformer as well as a transceiver positioned inside a housing as taught by Tieck for the purpose of having beamforming capabilities for improved sensitivity and accuracy ([0631]- [0632]).
Crouther-2/Tieck does not explicitly disclose the antenna array performing beamforming to direct at least some of the transmitted wireless communications to other medical devices.
DeLaquil teaches a beamformer (scalable and/or reconfigurable true-time-delay analog beamformer system; abstract) is configured to perform beamforming with the antenna array (antenna an antenna array; abstract) to direct at least some of the transmitted wireless communications to other medical devices ([0027]-[0028]: “it will be understood that the disclosed systems and methods may be implemented with any other type of phased array antenna system, with any other type of antenna system having multiple antenna elements (…) In this regard, the disclosed systems and methods may be implemented with any apparatus configured to receive and/or transmit signals of any frequency or frequency range suitable for propagation through a variety of media including, but not limited to, gaseous medium (e.g., air), solid medium (e.g., earth, tissue)”).
Crouther-2/Tieck/DeLaquil discloses wherein the beamformer (similar electronics as taught by Tieck; [0631]) is configured to perform beamforming with the antenna array (antenna 260 of Crouther-2 modified to be an antenna array as taught by Tieck and reconfigured as taught by DeLaquil to communicate with Crouther’s smartphone) to direct at least some of the transmitted wireless communications to other medical devices (smartphone; [0044] of Crouther).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Crouther-2/Tieck with similar scalable and reconfigurable beamforming system as taught by DeLaquil for the purpose of being capable of reconfiguration by changing its beam-position mapping, either dynamically or at install-time; the number of beams or beam positions that are desired advantageously do not need to be known prior to the design or selection of the beamformer system (abstract; ([0027]-[0028]).
Crouther-2/Tieck/DeLaquil are silent wherein the antennas of the antenna array are secured to the adhesive pad.
Crouther embodiment of Fig 8, hereinafter Crouther-8, teaches the on-body drug delivery device further comprising an adhesive pad (adhesive layer 820, Fig 8a) for securing the on-body drug delivery device (810) to the user and wherein the antennas (830; [0068]: “antenna or other antenna configurations”) are secured to the adhesive pad (820, Fig 8a)([0068])
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the array of antennas of device of Crouther-2/Tieck/DeLaquil to be secured to an adhesive path as taught by Crouther-8 for the purpose of having superior signal performance compared to wire tube attached antenna ([0068]).
Regarding claim 2, Crouther-2/Tieck/DeLaquil/Crouther-8 disclose the on-body drug delivery device of claim 1. Crouther-2 discloses wherein the multiples antennas (multiple antennas; [0060]) is used to communicate with an external medical device (portable handheld wireless electronic device 240, Fig 2a).
Crouther-2 is silent wherein the beamforming is used to communicate with an external medical device.
Tieck teaches the multiples antennas are organized into an antenna array ([0625]; multiples antennas arranged in a special array); wherein the beamformer (60) is configured to perform beamforming with the antenna array (plurality of antennas in an array; [0631])
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the communication of array of antennas and external medical device of Crouther-2/Tieck/DeLaquil/Crouther-8 to be able to communicate using beamforming as taught by Tieck for improved sensitivity and accuracy ([0631]-[0632]).
Regarding claim 3, Crouther-2/Tieck/DeLaquil/Crouther-8 disclose the on-body drug delivery device of claim 1. Crouther-2 is silent wherein the antenna array is configured to obtain better reception from target directions.
Tieck teaches the multiples antennas are organized into an antenna array ([0625]; multiples antennas arranged in a special array); wherein the antennas (plurality of antennas in an array; [0631]) are electrically connected with the beamformer ([0601]; [0625]; [0627]; electronics circuit 60 is connected to the RF sensor device 34 further connected to the antenna array) wherein the antenna array is configured to obtain better reception from target directions ([0607]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the communication between the portable electronic device and antenna array of device of Crouther-2/Tieck/DeLaquil/Crouther-8 with a similar configuration of antenna array and beamformer as taught by Tieck for the purpose of having beamforming capabilities for improved sensitivity and accuracy ([0631]- [0632]).
Regarding claim 4, Crouther-2/Tieck/DeLaquil/Crouther-8 discloses the on-body drug delivery device of claim 3. Crouther-2 discloses wherein the antenna array (multiples antennas; [0060]) is configured to obtain reception from a direction of a management device (portable handheld wireless electronic device 240, Fig 2a) that manages the on-body drug delivery device (210) ([0045]).
Regarding claim 6, Crouther-2/Tieck/DeLaquil/Crouther-8 discloses the on-body drug delivery device of claim 1. Crouther-2 discloses wherein the antennas (multiples antennas;[0060]) are electrically connected to the wireless communications transceiver (communication component or module of the medical device 210; [0041]: communication module or component is a transmitter/receiver) via one or more wired connections (abstract: “the pump including a processor and a communication module for wireless communications. An antenna is disposed in the delivery tubing of the pump outside the case with an antenna feed interconnecting the external antenna with the internal communication module.”; [0007]).
Crouther-2 is silent wherein the antennas are electrically connected to the beamformer.
Tieck teaches the antennas (antenna array; ([0625]) are electrically connected to the beamformer (60) and the wireless communications transceiver (68) via one or more wired connections ([0601]; [0625]; [0627], Fig 5; electronics circuit 60 is connected to the RF sensor device 34 further connected to the antenna array) and the wireless communications transceiver (68) ([0490]; transceiver 68 is included in the electronic circuit 60; therefore is electrically connected as well) via one or more wired connections (Fig 5; [0601];[0625]: RF sensor 34 and/or detectable features 42 are connected to the antenna array, RF sensor 34 is connected to electronics 60 and transceiver 68 as seen in Fig 5)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the antenna array of multiples antennas, beamformer and transceiver of Crouther-2/Tieck/DeLaquil/Crouther-8 with a wired connection between them as taught by Tieck for the purpose of having an increase reliability and consistency in the communication ([0650]: “Any of the embodiments described herein with respect to use involving RFID also may be implemented with physical wired connection”).
Regarding claim 8, Crouther-2/Tieck/DeLaquil/Crouther-8 discloses the on-body drug delivery device of claim 1. Crouther-2 discloses further comprising a medicament storage (insulin reservoir (not shown)) for storing a medicament for delivery to a user ([0045]: “The infusion set 240 comprises tubing 230 that interfaces between an insulin reservoir (not shown) contained in or attached to the infusion pump 210”.).
Regarding claim 9, Crouther-2/Tieck/DeLaquil/Crouther-8 discloses the on-body drug delivery device of claim 8. Crouther-2 discloses the delivery of insulin ([0045]) but it is silent wherein the medicament includes at least one of therapeutics, painkillers, chemotherapy agents, glucagon, hormonal agents, blood thinners, antibiotics, antidepressants, anti-anxiety agents, antipsychotics, birth control agents, statins, or blood pressure control agents .
Crouther embodiment of Fig 7a, hereinafter Crouther-7, teaches wherein the medicament includes at least one of therapeutics, painkillers, chemotherapy agents, glucagon, hormonal agents, blood thinners, antibiotics, antidepressants, anti-anxiety agents, antipsychotics, birth control agents, statins, or blood pressure control agents ([0061]: “antenna system 700 for use with medical devices such as an insulin, pramlintide and glucagon pumps”).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the medicine delivered by device of Crouther-2/Tieck/DeLaquil/Crouther-8 with glucagon as taught by Crouther-7 for the purpose of regulating blood sugar and treating hypoglycemia, which is well known in the art.
Regarding claim 11, Crouther-2/Tieck/Crouther-8/Crouther-7 disclose the on-body drug delivery device of claim 9. Crouther-2 discloses wherein the on-body drug delivery device (210) processor (abstract) and antenna array (multiples antennas; [0060] modified in claim 1 to be in array) are configured to communicate with a glucose sensor ([0039]: “a sensor of a user physiological parameter such as glucose”; multiples antennas transmit glucose data from glucose sensor to handheld device 240).
Crouther-2 is silent wherein the processor is a beamformer.
Tieck teaches the multiples antennas are organized into an antenna array ([0625]; multiples antennas arranged in a special array); wherein the antennas (plurality of antennas in an array; [0631]) are electrically connected with the beamformer ([0601]; [0625]; [0627]; electronics circuit 60 is connected to the RF sensor device 34 further connected to the antenna array); wherein the beamformer (60) is configured to perform beamforming with the antenna array (plurality of antennas in an array; [0631]) wherein the processor is a beamformer ([0456]; circuit 60 has processing electronincs).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the processor of medical device of Crouther-2/Tieck/Crouther-8/Crouther-7 with a similar beamformer to be able to communicate using beamforming for improved sensitivity and accuracy ([0631]- [0632]).
Regarding claim 21, Crouther-2/Tieck/DeLaquil/Crouther-8 discloses the on-body drug delivery device of claim 1. Crouther-2 discloses the antennas direct at least some of the transmitted wireless communications to other medical devices ([0044]: “(…)the portable electronic device 240 may communicate with a communication component or module of the medical device 210 that transmits information using the antenna 260”); the other medical device include at least one of a personal diabetes manager device, a sensor, or a management device that is a tablet, smartwatch, or a smartphone. ([0044]; smartphone).
Crouther-2 is silent wherein at least some of the transmitted wireless communications to the other medical device are directed by the beamformer.
Tieck teaches a beamformer (electronics 60; [0631]) positioned inside the at least one housing (housing 33, Fig 4E; [0416]); the multiples antennas are organized into an antenna array ([0625]; multiples antennas arranged in a special array); wherein the antennas (plurality of antennas in an array; [0631]) are electrically connected with the beamformer ([0601]; [0625]; [0627]; electronics circuit 60 is connected to the RF sensor device 34 further connected to the antenna array) and the wireless communications transceiver (68) ([0490]; transceiver 68 is included in the electronic circuit 60; therefore is electrically connected as well); and wherein the beamformer (60) is configured to perform beamforming with the antenna array (plurality of antennas in an array; [0631]) to reduce transmitted wireless communications from the on-body drug delivery device from being absorbed by the user of the on-body drug delivery device ([0607]; the beamforming of the array of antennas and the electronics 60 allow for a directional communication instead of an omnidirectional, this reduces the quantity of signals being absorbed in the body).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the communication between the portable electronic device and antenna of method of Crouther-2 with an antenna array connected to a beamformer as well as a transceiver positioned inside a housing as taught by Tieck for the purpose of having beamforming capabilities for improved sensitivity and accuracy ([0631]- [0632]).
Crouther-2/Tieck does not explicitly disclose the antenna array performing beamforming to direct at least some of the transmitted wireless communications to other medical devices.
DeLaquil teaches a beamformer (scalable and/or reconfigurable true-time-delay analog beamformer system ; abstract) is configured to perform beamforming with the antenna array (antenna an antenna array; abstract) to direct at least some of the transmitted wireless communications to other medical devices ([0027]-[0028]: “it will be understood that the disclosed systems and methods may be implemented with any other type of phased array antenna system, with any other type of antenna system having multiple antenna elements (…) In this regard, the disclosed systems and methods may be implemented with any apparatus configured to receive and/or transmit signals of any frequency or frequency range suitable for propagation through a variety of media including, but not limited to, gaseous medium (e.g., air), solid medium (e.g., earth, tissue)”).
Crouther-2/Tieck/DeLaquil discloses wherein the beamformer (similar electronics as taught by Tieck; [0631]) is configured to perform beamforming with the antenna array (antenna 260 of Crouther-2 modified to be an antenna array as taught by Tieck and reconfigured as taught by DeLaquil to communicate with Crouther’s smartphone) to direct at least some of the transmitted wireless communications to other medical devices (smartphone; [0044] of Crouther).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Crouther-2/Tieck with similar scalable and reconfigurable beamforming as taught by DeLaquil for the purpose of being capable of reconfiguration by changing its beam-position mapping, either dynamically or at install-time to perform beamforming with the smartphone; the number of beams or beam positions that are desired advantageously do not need to be known prior to the design or selection of the beamformer system (abstract).
Regarding claim 22, Crouther-2/Tieck/DeLaquil/Crouther-8 discloses the insulin delivery device of claim 1. Crouther-2 discloses the antennas direct at least some of the transmitted wireless communications to other medical devices ([0044]: “(…)the portable electronic device 240 may communicate with a communication component or module of the medical device 210 that transmits information using the antenna 260”); wherein the other medical devices include include at least one of a personal diabetes manager device, a continuous glucose monitor, or a management device that is a tablet, smartwatch, or a smartphone ([0044]; smartphone).
Crouther-2 is silent wherein at least some of the transmitted wireless communications to the other medical device are configured to be directed by the beamformer.
Tieck teaches a beamformer (electronics 60; [0631]) positioned inside the at least one housing (housing 33, Fig 4E; [0416]); the multiples antennas are organized into an antenna array ([0625]; multiples antennas arranged in a special array); wherein the antennas (plurality of antennas in an array; [0631]) are electrically connected with the beamformer ([0601]; [0625]; [0627]; electronics circuit 60 is connected to the RF sensor device 34 further connected to the antenna array) and the wireless communications transceiver (68) ([0490]; transceiver 68 is included in the electronic circuit 60; therefore is electrically connected as well); and wherein the beamformer (60) is configured to perform beamforming with the antenna array (plurality of antennas in an array; [0631]) to reduce transmitted wireless communications from the on-body drug delivery device from being absorbed by the user of the on-body drug delivery device ([0607]; the beamforming of the array of antennas and the electronics 60 allow for a directional communication instead of an omnidirectional, this reduces the quantity of signals being absorbed in the body).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the communication between the portable electronic device and antenna of method of Crouther-2 with an antenna array connected to a beamformer as well as a transceiver positioned inside a housing as taught by Tieck for the purpose of having beamforming capabilities for improved sensitivity and accuracy ([0631]- [0632]).
Crouther-2/Tieck does not explicitly disclose the antenna array performing beamforming to direct at least some of the transmitted wireless communications to other medical devices.
DeLaquil teaches a beamformer (scalable and/or reconfigurable true-time-delay analog beamformer system ; abstract) is configured to perform beamforming with the antenna array (antenna an antenna array; abstract) to direct at least some of the transmitted wireless communications to other medical devices ([0027]-[0028]: “it will be understood that the disclosed systems and methods may be implemented with any other type of phased array antenna system, with any other type of antenna system having multiple antenna elements (…) In this regard, the disclosed systems and methods may be implemented with any apparatus configured to receive and/or transmit signals of any frequency or frequency range suitable for propagation through a variety of media including, but not limited to, gaseous medium (e.g., air), solid medium (e.g., earth, tissue)”).
Crouther-2/Tieck/DeLaquil discloses wherein the beamformer (similar electronics as taught by Tieck; [0631]) is configured to perform beamforming with the antenna array (antenna 260 of Crouther-2 modified to be an antenna array as taught by Tieck and reconfigured as taught by DeLaquil to communicate with Crouther’s smartphone) to direct at least some of the transmitted wireless communications to other medical devices (smartphone; [0044] of Crouther).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Crouther-2/Tieck with similar scalable and reconfigurable beamforming as taught by DeLaquil for the purpose of being capable of reconfiguration by changing its beam-position mapping, either dynamically or at install-time to perform beamforming with the smartphone; the number of beams or beam positions that are desired advantageously do not need to be known prior to the design or selection of the beamformer system (abstract).
Regarding claim 12, Crouther embodiment of Fig 2, hereinafter Crouther-2, discloses an insulin delivery device (medical device 210, Fig 2a), comprising: at least one housing (case of medical device 210, Fig 2a; [0041]) for housing an insulin storage (insulin reservoir (not shown); [0045]) and an insulin pump (the infusion pump 210, Fig 2a); an adhesive pad (adhesive patch 220, Fig 2a) secured to a bottom surface (surface seen in Fig 2a) of the at least one housing (case of medical device 210) for securing the insulin delivery device (210) to skin of the user (Fig 2a) ([0045]); a wireless communications transceiver (communication component or module of the medical device 210; [0041]: communication module or component is a transmitter/receiver) positioned inside the at least one housing (case of medical device210) for transmitting and receiving wireless communications ([0041]); a processor (processor, [0007]) positioned inside the at least one housing (case of medical device210); multiple antennas ([0044] shows that antenna 260 could be any of the antennas of the disclosure; [0060]: “The medical device may include one, two, or more external antennas”; therefore antenna 260 could be multiple antennas) having a communication connection with the wireless communications transceiver ([0041]: “Thus substantial space can be saved by locating them externally to the transmitter/receiver component with which they are connected.”); the antennas direct at least some of the transmitted wireless communications to other medical devices ([0044]: “(…)the portable electronic device 240 may communicate with a communication component or module of the medical device 210 that transmits information using the antenna 260”).
Crouther-2 is silent regarding a beamformer positioned inside the at least one housing; multiple antennas organized into an antenna array that are positioned on a surface of the at least one housing; and wherein the beamformer is configured to perform beamforming with the antenna array to reduce transmitted wireless communications from the insulin delivery device from being absorbed by a user of the insulin delivery device.
Tieck teaches a beamformer (electronics 60; [0631]) positioned inside the at least one housing (housing 33, Fig 4E; [0416]); the multiples antennas are organized into an antenna array ([0625]; multiples antennas arranged in a special array); wherein the antennas (plurality of antennas in an array; [0631]) are electrically connected with the beamformer ([0601]; [0625]; [0627]; transceiver 68 is included in the electronic circuit 60 which is connected to the RF sensor device 34 further connected to the antenna array); and wherein the beamformer (60) is configured to perform beamforming with the antenna array (plurality of antennas in an array; [0631]) to reduce transmitted wireless communications from the insulin delivery device from being absorbed by the user of the insulin delivery device ([0607]; the beamforming of the array of antennas and the electronics 60 allow for a directional communication instead of a omnidirectional, this reduces the quantity of signals being absorbed in the body).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the communication between the portable electronic device and antenna of device of Crouther-2 with an antenna array connected to a beamformer as well as a transceiver positioned inside a housing as taught by Tieck for the purpose of having beamforming capabilities for improved sensitivity and accuracy ([0631]- [0632]).
Crouther-2/Tieck does not explicitly disclose the antenna array performing beamforming to direct at least some of the transmitted wireless communications to other medical devices.
DeLaquil teaches a beamformer (scalable and/or reconfigurable true-time-delay analog beamformer system ; abstract) is configured to perform beamforming with the antenna array (antenna an antenna array; abstract) to direct at least some of the transmitted wireless communications to other medical devices ([0027]-[0028]: “it will be understood that the disclosed systems and methods may be implemented with any other type of phased array antenna system, with any other type of antenna system having multiple antenna elements (…) In this regard, the disclosed systems and methods may be implemented with any apparatus configured to receive and/or transmit signals of any frequency or frequency range suitable for propagation through a variety of media including, but not limited to, gaseous medium (e.g., air), solid medium (e.g., earth, tissue)”).
Crouther-2/Tieck/DeLaquil discloses wherein the beamformer (similar electronics as taught by Tieck; [0631]) is configured to perform beamforming with the antenna array (antenna 260 of Crouther-2 modified to be an antenna array as taught by Tieck and reconfigured as taught by DeLaquil to communicate with Crouther’s smartphone) to direct at least some of the transmitted wireless communications to other medical devices (smartphone; [0044] of Crouther).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Crouther-2/Tieck with similar scalable and reconfigurable beamforming system as taught by DeLaquil for the purpose of being capable of reconfiguration by changing its beam-position mapping, either dynamically or at install-time; the number of beams or beam positions that are desired advantageously do not need to be known prior to the design or selection of the beamformer system (abstract).
Crouther-2/Tieck/DeLaquil are silent regarding the antenna array being positioned on a surface of the at least one housing.
Crouther embodiment of Fig 6, hereinafter Crouther-6 teaches an insulin delivery device (medical device 610, Fig 6) comprising an antenna (mounted external antenna 660, Fig 6) being positioned on a surface (top surface, Fig 6) of the at least one housing (housing of medical device 610, Fig 6).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the antenna array of device of Crouther-2/Tieck to be located on a surface of the housing as taught by Crouther-6 for the purpose of enhancing signal transmission as result of being located outside and not inside the housing ([0060]).
Regarding claim 13, Crouther-2/Tieck/DeLaquil/Crouther-6 discloses the insulin delivery device of claim 12. Crouther-2 discloses wherein the communication connection is a wireless connection (Claim 3 or Claim 4; both capacitive coupling and inductive coupling are form of wireless connection).
Regarding claim 14, Crouther-2/Tieck/DeLaquil/Crouther-6 discloses the insulin delivery device of claim 12. Crouther-2 discloses wherein the communication connection is a wired connection (abstract: “the pump including a processor and a communication module for wireless communications. An antenna is disposed in the delivery tubing of the pump outside the case with an antenna feed interconnecting the external antenna with the internal communication module.”; [0007])
Regarding to claim 15, Crouther-2/Tieck/DeLaquil/Crouther-6 discloses the insulin delivery device of claim 12. Crouther-2 is silent wherein the wireless communications transceiver communicates in accordance with a Bluetooth protocol, a Bluetooth Low Energy protocol, or a WiFi protocol.
Tieck discloses an infusion pump device 30 comprising a transceiver (transceiver 68, Fig 5; [0490]: “transceiver 68, configured to receive, transmit, or both receive and transmit information from or to a further electronic device (not shown), such as, but not limited to, a user's computer, a health care entity's computer, or the like.” ) wherein the wireless communications transceiver (68) communicates in accordance with a Bluetooth protocol, a Bluetooth Low Energy protocol, or a WiFi protocol. ([0489]: (transceiver 68 is capable of WiFi and Bluetooth communication through link 64 not shown)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the transceiver of Crouther-2/Tieck/DeLaquil/Crouther-6 with a similar transceiver as the one disclosed by Tieck having a communication link able to transmit information via Wifi or Bluetooth to external devices ([0489]: radio frequency RF, Bluetooth, WiFi, inductive coupling, or other wireless communication link”; [0490]: : “transmit information from or to a further electronic device (not shown), such as, but not limited to, a user's computer, a health care entity's computer, or the like”)
Regarding to claim 16, Crouther-2/Tieck/DeLaquil/Crouther-6 discloses the insulin delivery device of claim 12. Crouther-2 discloses wherein the at least one housing (case of medical device 210, Fig 2a) includes at least one opening (side opening from where connector 230 and multiples antenna extend, Fig 2a; [0045]) for the antennas to pass through to the interior of the at least one housing ([0045]; antenna is being part of the tubing 230 connected to the interior of the medical device 210), where the antennas (multiples antennas; [0060]) are electrically connected to the wireless communications transceiver (communication module;[0041]) (electrical connection is achieved through feed connection).
Crouther-2 is silent regarding the antennas electrically connected with the beamformer.
Tieck teaches a beamformer (electronics 60; [0631]) positioned inside the at least one housing (housing 33, Fig 4E; [0416]); the multiples antennas are organized into an antenna array ([0625]; multiples antennas arranged in a special array); wherein the antennas (plurality of antennas in an array; [0631]) are electrically connected with the beamformer ([0601]; [0625]; [0627]; electronics circuit 60 is connected to the RF sensor device 34 further connected to the antenna array)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Crouther-2/Tieck/DeLaquil/Crouther-6 with similar beamformer in electrical connection with the antennas as taught by Tieck for the purpose of having beamforming capabilities for improved sensitivity and accuracy ([0631]- [0632]).
Regarding to claim 17, Crouther embodiment of Fig 2, hereinafter Crouther-2, discloses a method, comprising: encapsulating inside a housing (case) of an on-body drug delivery device (medical device 210, Fig 2a) a wireless communications transceiver (communication component or module of the medical device 210; [0007]; [0041]: communication module or component is a transmitter/receiver) positioned for transmitting and receiving wireless communications ([0041]); encapsulating inside the housing (case) of the on-body drug delivery device (210) a processor (processor, [0007]); antenna (antenna 260, Fig 2a); securing the antenna (260) outside of the housing (case) for wireless communication on behalf of the on-body drug delivery device (210)(Fig 2a; antenna is secured to the infusion set;[0042]); creating a communication connection between the wireless communications transceiver (transmitter/receiver interpreted as communication module; [0041]]) and the antenna (260).
Crouther-2 further discloses wherein the antenna comprises multiple antennas ([0044] shows that antenna 260 could be any of the antennas of the disclosure; [0060]: “The medical device may include one, two, or more external antennas”; therefore antenna 260 could be multiple antennas); a processor for wireless communication with a medical device (claim 1: processor communicates wirelessly to medical device 240 using the antennas; [0044] hand held device is not limited to phone and could be other devices that control the medical pump); the antennas direct at least some of the transmitted wireless communications to other medical devices ([0044]: “(…)the portable electronic device 240 may communicate with a communication component or module of the medical device 210 that transmits information using the antenna 260”).
Crouther-2 is silent regarding the multiples antenna being an antenna array; the processor being a beamformer; encapsulating inside a housing of an on-body drug delivery device a beamformer for beamforming of wireless communications transmitted to external medical devices from an antenna array; and beamforming wireless communications that are transmitted to external medical devices from the antenna array to reduce transmitted wireless communications from the on-body drug delivery device from being absorbed by a user of the ion-body drug delivery device and to direct at least some of the transmitted wireless communications to other medical devices.
Tieck teaches the multiples antennas are organized into an antenna array ([0625]; multiples antennas arranged in a special array); encapsulating inside a housing (housing 33, Fig 4E; [0416]) of an on-body drug delivery device (infusion pump device 30, Fig 1) a beamformer (electronics 60; [0631]) for beamforming of wireless communications from an antenna array (plurality of antennas in an array; [0631]); and beamforming wireless communications from the antenna array (plurality of antennas in an array; [0630]-[0631]) to reduce transmitted wireless communications from the on-body drug delivery device from being absorbed by a user of the on-body drug delivery device ([0607]; the beamforming of the array of antennas and the electronics 60 allow for a directional communication instead of a omnidirectional, this reduces the quantity of signals being absorbed in the body).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the multiples antennas, and the processor of method of Crouther-2 with a similar antenna array and beamformer as taught by Tieck for the purpose of having beamforming capabilities for improved sensitivity and accuracy ([0631]- [0632]).
Crouther-2/Tieck does not explicitly disclose the antenna array performing beamforming to direct at least some of the transmitted wireless communications to other medical devices.
DeLaquil teaches a beamformer (scalable and/or reconfigurable true-time-delay analog beamformer system ; abstract) is configured to perform beamforming with the antenna array (antenna an antenna array; abstract) to direct at least some of the transmitted wireless communications to other medical devices ([0027]-[0028]: “it will be understood that the disclosed systems and methods may be implemented with any other type of phased array antenna system, with any other type of antenna system having multiple antenna elements (…) In this regard, the disclosed systems and methods may be implemented with any apparatus configured to receive and/or transmit signals of any frequency or frequency range suitable for propagation through a variety of media including, but not limited to, gaseous medium (e.g., air), solid medium (e.g., earth, tissue)”).
Crouther-2/Tieck/DeLaquil discloses wherein the beamformer (similar electronics as taught by Tieck; [0631]) is configured to perform beamforming with the antenna array (antenna 260 of Crouther-2 modified to be an antenna array as taught by Tieck and reconfigured as taught by DeLaquil to communicate with Crouther’s smartphone) to direct at least some of the transmitted wireless communications to other medical devices (smartphone; [0044] of Crouther).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Crouther-2/Tieck with similar scalable and reconfigurable beamforming system as taught by DeLaquil for the purpose of being capable of reconfiguration by changing its beam-position mapping, either dynamically or at install-time; the number of beams or beam positions that are desired advantageously do not need to be known prior to the design or selection of the beamformer system (abstract).
Regarding to claim 18, Crouther-2/Tieck/DeLaquil discloses the method of claim 17. Crouther-2 discloses further comprising securing an adhesive pad (adhesive patch 220, Fig 2a) to the on-body drug delivery device (210) for securing the on-body drug delivery device (210) to a user ([0045]).
Regarding to claim 19, Crouther-2/Tieck/DeLaquil discloses the method of claim 18. Crouther-2 is silent regarding the securing the antenna array comprises securing the antenna array to the adhesive pad.
Tieck teaches the multiples antennas are organized into an antenna array ([0625]; multiples antennas arranged in a special array).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the multiples antennas, and the processor of method of Crouther-2 with a similar antenna array as taught by Tieck for the purpose of having beamforming capabilities for improved sensitivity and accuracy ([0631]- [0632]).
Crouther-2/Tieck are silent regarding the antenna array comprises securing the antenna array to the adhesive pad.
Crouther embodiment of Fig 8, hereinafter Crouther-8, teaches a method comprising an adhesive pad (adhesive layer 820, Fig 8a) for securing the on-body drug delivery device (810) to the user and wherein the antennas (830; [0068]: “antenna or other antenna configurations”) are secured to the adhesive pad (820, Fig 8a)([0068]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the array of antennas of method of Crouther-2/Tieck to be secured to an adhesive path as taught by Crouther-8 for the purpose of having superior signal performance ([0068]).
Regarding to claim 20, Crouther-2/Tieck/DeLaquil/Crouther-8 discloses the method of claim 19. Crouther- 2 is silent wherein the securing the antenna array comprises securing the antenna array to the adhesive pad to form an antenna array secured to the adhesive pad.
Tieck teaches the multiples antennas are organized into an antenna array ([0625]; multiples antennas arranged in a special array) and beamforming wireless communications from the antenna array (plurality of antennas in an array; [0630]-[0631]) to reduce transmitted wireless communications from the on-body drug delivery device from being absorbed by a user of the on-body drug delivery device ([0607]; the beamforming of the array of antennas and the electronics 60 allow for a directional communication instead of a omnidirectional, this reduces the quantity of signals being absorbed in the body).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the multiples antennas, and the processor of method of Crouther-2 with a similar antenna array and beamformer as taught by Tieck for the purpose of having beamforming capabilities for improved sensitivity and accuracy ([0631]- [0632]).
Crouther-2/Tieck discloses the antenna array but are silent wherein the securing the antenna array comprises securing the antenna array to the adhesive pad to form an antenna array secured to the adhesive pad.
Crouther-8, teaches a method comprising an adhesive pad (adhesive layer 820, Fig 8a) for securing the on-body drug delivery device (810) to the user and wherein the antennas (830; [0068]: “antenna or other antenna configurations”) are secured to the adhesive pad (820, Fig 8a)([0068]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the array of antennas of method of Crouther-2/Tieck/DeLaquil/Crouther-8 to be secured to an adhesive path as taught by Crouther-8 for the purpose of having superior signal performance ([0068]).
Regarding to claim 23, Crouther-2/Tieck/DeLaquil discloses the method of claim 17. Crouther-2 discloses the antennas direct at least some of the transmitted wireless communications to other medical devices ([0044]: “(…)the portable electronic device 240 may communicate with a communication component or module of the medical device 210 that transmits information using the antenna 260”); the other medical device include at least one of a personal diabetes manager device, a sensor, or a management device that is a tablet, smartwatch, or a smartphone ([0044]; smartphone).
Crouther-2 is silent wherein at least some of the transmitted wireless communications to the other medical device are configured to be directed by the beamformer.
Tieck teaches a beamformer (electronics 60; [0631]) positioned inside the at least one housing (housing 33, Fig 4E; [0416]); the multiples antennas are organized into an antenna array ([0625]; multiples antennas arranged in a special array); wherein the antennas (plurality of antennas in an array; [0631]) are electrically connected with the beamformer ([0601]; [0625]; [0627]; electronics circuit 60 is connected to the RF sensor device 34 further connected to the antenna array) and the wireless communications transceiver (68) ([0490]; transceiver 68 is included in the electronic circuit 60; therefore is electrically connected as well); and wherein the beamformer (60) is configured to perform beamforming with the antenna array (plurality of antennas in an array; [0631]) to reduce transmitted wireless communications from the on-body drug delivery device from being absorbed by the user of the on-body drug delivery device ([0607]; the beamforming of the array of antennas and the electronics 60 allow for a directional communication instead of an omnidirectional, this reduces the quantity of signals being absorbed in the body).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the communication between the portable electronic device and antenna of method of Crouther-2 with an antenna array connected to a beamformer as well as a transceiver positioned inside a housing as taught by Tieck for the purpose of having beamforming capabilities for improved sensitivity and accuracy ([0631]- [0632]).
Crouther-2/Tieck does not explicitly disclose the antenna array performing beamforming to direct at least some of the transmitted wireless communications to other medical devices.
DeLaquil teaches a beamformer (scalable and/or reconfigurable true-time-delay analog beamformer system ; abstract) is configured to perform beamforming with the antenna array (antenna an antenna array; abstract) to direct at least some of the transmitted wireless communications to other medical devices ([0027]-[0028]: “it will be understood that the disclosed systems and methods may be implemented with any other type of phased array antenna system, with any other type of antenna system having multiple antenna elements (…) In this regard, the disclosed systems and methods may be implemented with any apparatus configured to receive and/or transmit signals of any frequency or frequency range suitable for propagation through a variety of media including, but not limited to, gaseous medium (e.g., air), solid medium (e.g., earth, tissue)”).
Crouther-2/Tieck/DeLaquil discloses wherein the beamformer (similar electronics as taught by Tieck; [0631]) is configured to perform beamforming with the antenna array (antenna 260 of Crouther-2 modified to be an antenna array as taught by Tieck and reconfigured as taught by DeLaquil to communicate with Crouther’s smartphone) to direct at least some of the transmitted wireless communications to other medical devices (smartphone; [0044] of Crouther).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the method of Crouther-2/Tieck with similar scalable and reconfigurable beamforming as taught by DeLaquil for the purpose of being capable of reconfiguration by changing its beam-position mapping, either dynamically or at install-time to perform beamforming with the smartphone; the number of beams or beam positions that are desired advantageously do not need to be known prior to the design or selection of the beamformer system (abstract).
Response to Arguments
Applicant’s arguments with respect to Claims 1-4, 6, 8-9, and 11-23 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.
Conclusion
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783