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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/09/2026 has been entered.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5-7, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schleicher et al. (US 20170312430 A1).
Regarding Claim 1, Schleicher discloses a drug delivery device (Pen system 290, Fig 2B) comprising: a reservoir (body 247, Fig 2B) adapted to contain a drug (medication inside the body 247; [0035]); an injection mechanism (body 257, Fig 2B) coupled with the reservoir (247) to deliver the drug (medication); a power source (power source 103, Fig 1A); one or more sensors (force sensor 107, temperature sensor 109, transducer 111; Fig 1A); a memory (non-volatile memory; [0018]); a controller (microcontroller 113, Fig 1A) powered by the power source (103) and having an active mode (high-power mode (HPM); [0035]) and a low-power mode (low-power mode (LPM); [0035]), the controller (113) being configured to: while operating in the active mode (HPM), use the one or more sensors (force sensor 107 or transducer 111) to detect that the injection mechanism has performed an injection ([0024];[0035]), generate in the memory (non-volatile memory) a data entry indicative of a state of the drug delivery device and/or the injection ([0019]: “date and time of each injection may be accurately recorded and stored in memory” ), and switch into the low-power mode subsequent to or contemporaneous with detecting that the injection mechanism has performed the injection ([0025]; when no compressive force is being applied the device enter in LPM) and a wireless communication module (transceiver 101, Fig 1A; [0016]) powered by the power source (103)([0016]) and configured to: establish a wireless connection (BLUETOOTH low energy (BLE) communication; [0016]) with a user device (271, Fig 2B) by transmitting one or more wireless signals to the user device ([0037]: “Processing device 271 may be coupled to receive data from drug cartridge 261 to store/analyze this data (either when plunger head 200 is in power conservation mode or high-power mode”; coupling requires transmission of wireless signals to the user device 271) while the controller (113) is operating in the low-power mode (LPM), and transmit a message (data; [0037]) indicative of the state of the drug delivery device and/or the injection to the user device ([0037]).
Regarding Claim 2, Schleicher discloses the drug delivery device of claim 1, the wireless communication module (101) being configured to: detect a first wireless communication module (WCM) trigger (signal originated from microcontroller 113; [0016]), and wherein establishing the wireless connection comprises initiating a sequence of one or more communication attempts in response to detecting the first WCM trigger ([0016]; BLUETOOTH low energy (BLE) communication protocol comprises the claimed advertising steps).
Regarding Claim 3, Schleicher discloses the drug delivery device of claim 2, wherein: the controller (113) and the wireless communication module (101) are communicatively connected by a processor interface ([0016]; structure and function imply the presence of a interface between 101 and 113, which is needed for communication to take place), the controller (113) is configured to send a signal indicative of the first WCM trigger (signal originated from microcontroller 113; [0016]) via the processor interface (interface between 101 and 113), and detecting the first WCM trigger by the wireless communication module comprises receiving the signal (signal originated from microcontroller 113; [0016]) indicative of the first WCM trigger via the processor interface (interface between 101 and 113).
Regarding Claim 5, Schleicher discloses the drug delivery device of claim 3, wherein sending the signal indicative of the first WCM trigger by the controller (signal originated from microcontroller 113; [0016]) is at least in part in response to detecting ([0021]) that the injection mechanism has performed the injection ([0037]; data of injection is sent to 271 for processing).
Regarding Claim 6, Schleicher discloses the drug delivery device of claim 2, wherein detecting the first WCM trigger (signal originated from microcontroller 113; [0016]) by the wireless communication module (101) comprises detecting, using the one or more sensors (force sensor 107, transducer 111; Fig 1A), while the controller is in the low-power mode, a user action ([0033]: “when the user presses down on plunger, plunger head 200 may register this compressive force and switch from a power conservation (low-power) mode to a high-power mode or vice versa depending on the type of pressure applied (e.g., if the pressure single is uniquely identifiable as an “on” signal)”)
Regarding Claim 7, Schleicher discloses the drug delivery device of claim 6, comprising: a compartment (chamber 255, Fig 2B + body 257, Fig 2B) configured to contain a cartridge (cartridge 261, Fig 2B) and/or a button (distal end of plunger that is pushed; [0036],[0021]); and wherein the user action comprises at least one of i) opening a compartment of the drug delivery device, ii) closing the compartment of the drug delivery device, or iii) pressing the button of the drug delivery device ([0021]: “transducer 111 may have a piezoelectric element that may detect the dynamic changes in pressure when a user depresses a plunger in the syringe (e.g., FIG. 2A) or injection pen system (e.g., FIG. 2B).”).
Regarding Claim 17, Schleicher discloses the drug delivery device of claim 1, wherein the controller (113) is configured to: detect a controller activation trigger (compression force; [0024]), while operating in the low-power mode (power conservation mode) of the controller (113), and switch into the active mode (high-power mode) of the controller (113) in response to detecting the controller (113) activation trigger (compression force; [0024]: “microcontroller 113 enters a high-power mode in response to the compressive force applied to plunger head 100”).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fischell (US 4731051 A).
In regard to claim 1, Fischell discloses a drug delivery device (implantable programmable infusion pump (IPIP) 10, Fig 1)comprising: a reservoir (medication reservoir 15, Fig 2) adapted to contain a drug (Col 5, line 66- Col 6, line 2); an injection mechanism (catheter 11, Fig 2) coupled with the reservoir (15) to deliver the drug (Fig 2); a power source (battery 43, Fig 4); one or more sensors (Col 6, lines 23-29); a memory (RAM 47, Fig 6); a controller (controller 35, Fig 4) powered by the power source (43) and having an active mode (delivery state) and a low-power mode (idle and standby state, Fig 9-10), the controller (35) being configured to: while operating in the active mode (delivery state), use the one or more sensors (23) to detect that the injection mechanism has performed an injection (Col 6, lines 25-26 : “a pump monitor 23 monitors actual pump actuation and hence fluid flow”), generate in the memory a data entry indicative of a state of the drug delivery device and/or the injection (Fig 6 shows data stored in memory RAM 47; Col18, lines 40-45, Fig 11), and switch into the low-power mode subsequent to or contemporaneous with detecting that the injection mechanism has performed the injection (Col 12, lines 57-59 :“The controller can be placed in the idle state at any time during its operation by receiving a "run-to-idle" command.”); and a wireless communication module (transmitter/receiver 36, Fig 4) powered by the power source (43) and configured to: establish a wireless connection with a user device (patient programming unit (PPU) 12, Fig 1) by transmitting one or more wireless signals to the user device (Col 8, lines 20-31) while the controller is operating in the low-power mode (Col 15, lines 19-21: “in operation, the physician first establishes a communication interface between the IPIP and the MPU. The physician will order the IPIP to enter the standby state.”), and transmit a message indicative of the state of the drug delivery device and/or the injection to the user device (Col 15, lines 20-40).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 8, 10, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Schleicher et al. (US 20170312430 A1) in view of Jorgensen et al. (US 20110270214 A1).
Regarding Claim 8, Schleicher discloses the drug delivery device of claim 1. Schleicher is silent regarding the wireless communication module being configured to: receive, while operating in an active mode of the wireless communication module, a confirmation from the user device, wherein the confirmation comprises at least one of i) an acknowledgement of the established wireless connection or ii) an indication that the user device received the message, and in response to receiving the confirmation, switch into a low-power mode of the wireless communication module.
Jorgensen teaches a drug delivery device (Fig 10) comprising a wireless communication module (communication means; [0053]) being configured to: receive, while operating in an active mode (energized state; [0053]) of the wireless communication module (communication means; [0053]), a confirmation from the user device ([0053]: “the communication means have successfully transmitted an amount of data to a corresponding device”), wherein the confirmation comprises at least one of i) an acknowledgement of the established wireless connection or ii) an indication that the user device received the message ([0053, indication is received that the data is transmitted and communications means change from energized state to sleep state]), and in response to receiving the confirmation, switch into a low-power mode (sleep state; [0053]) of the wireless communication module (communication means; [0053]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Schleicher with a similar communication module having a sleep state and an energized state as taught by Jorgensen for the purpose of wirelessly transmitting and/or receiving data with optimal efficiency ([0053]).
Regarding Claim 10, Schleicher/Jorgensen discloses the drug delivery device of claim 8. Schleicher is silent regarding the wireless communication module being configured to: determine that a communication time window expired; in response to determining that the communication time window expired, switch into the low-power mode of the wireless communication module.
Jorgensen teaches a drug delivery device (Fig 10) comprising a wireless communication module (communication means; [0053]) being configured to: determine that a communication time window expired ([0053]); in response to determining that the communication time window expired, switch into the low-power mode of the wireless communication module ([0053]: “The state for the communication means may be changed from the energized to the sleep state when a first pre-set condition is met, e.g. when (i) the communication means have unsuccessfully tried to establish wireless communication with a corresponding device for a predefined amount of time” ).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Schleicher/Jorgensen with a similar communication module having a sleep state and an energized state as taught by Jorgensen for the purpose of wirelessly transmitting and/or receiving data with optimal efficiency and minimize energy consumption if communication time reach to a predetermined value ([0053]).
Regarding Claim 13, Schleicher/Jorgensen discloses the drug delivery device of claim 8. Schleicher is silent regarding the wireless communication module being configured to: detect a second WCM trigger, while operating in the low-power mode of the wireless communication module, and switch into the active mode of the wireless communication module in response to detecting the second WCM trigger.
Jorgensen teaches a drug delivery device (Fig 10) comprising a wireless communication module (communication means; [0053]) being configured to: detect a second WCM trigger ([0051]: “first user-operatable means for setting a dose of drug to be expelled and second user-operatable means for expelling a set dose”), while operating in the low-power mode (sleep/hibernating state) of the wireless communication module, and switch into the active mode (energized/first operating state) of the wireless communication module (communication means; [0053]) in response to detecting the second WCM trigger ([0051]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Schleicher/Jorgensen with a similar communication module having a sleep state and an energized state with first and second triggers (user-operatable means) as taught by Jorgensen for the purpose of wirelessly transmitting and/or receiving data with optimal efficiency upon trigger recognition ([0051]).
Regarding Claim 15, Schleicher/Jorgensen discloses the drug delivery device of claim 13. Schleicher discloses comprising: at least one of i) a compartment (chamber 255, Fig 2B + body 257, Fig 2B) configured to contain injection fluid (medication), or ii) a button (distal end of plunger that is pushed; [0036],[0021]); Schleicher is silent wherein detecting the second WCM trigger by the wireless communication module comprises detecting a user action using the one or more sensors; and wherein the user action comprises at least one of i) opening the compartment ii) closing the compartment, or iii) pressing the button.
Jorgensen teaches a drug delivery device (Fig 10) comprising a wireless communication module (communication means; [0053]) being configured to: detect a second WCM trigger ([0051]: “first user-operatable means for setting a dose of drug to be expelled and second user-operatable means for expelling a set dose”) wherein detecting the second WCM trigger ([0051]) by the wireless communication module (communication means; [0053]) comprises detecting a user action ([0051]: “second user-operatable means for expelling a set dose”) using the one or more sensors (Gray code type detector for sensing dosage data; [abstract]); and wherein the user action comprises at least one of i) opening the compartment ii) closing the compartment, or iii) pressing the button ([0024]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Schleicher/Jorgensen wherein the second trigger comprises the user action of expelling the dose as taught by Jorgensen for the purpose of wirelessly transmitting and/or receiving dose dispensing data with optimal efficiency upon trigger recognition ([0051]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Schleicher et al. (US 20170312430 A1) in view of Celentano et al. (US 20100160860 A1).
Regarding Claim 19, Schleicher discloses the drug delivery device of claim 1. Schleicher is silent wherein the controller and the wireless communication module are configured to operate asynchronously.
Celentano teaches a device (Fig 2) wherein the controller (processors 50 and 54, Fig 2) and the wireless communication module (wireless communication circuit 52, Fig 2) are configured to operate asynchronously ([0064]; [0059])
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Schleicher with a similar UART interface as taught by Jorgensen for the purpose of wirelessly transmitting and receiving dose dispensing data asynchronously, which makes communication less susceptible to timing issues ([0059]).
Response to Arguments
Applicant's arguments filed 03/09/2026 have been fully considered but they are not persuasive. Applicant submits that Schleicher does not disclose or suggest amended claim 1. Applicant submits that the term "be coupled" does not imply the establishment of the connection.
Examiner respectfully disagrees.
Schleicher discloses in [0037]: “Processing device 271 (e.g., a smartphone, tablet, general purpose computer, distributed system, servers connect to the internet, or the like) may be coupled to receive data from drug cartridge 261 to store/analyze this data (either when plunger head 200 is in power conservation mode or high-power mode).”; [0016]: “Transceiver 101 may include BLUETOOTH low energy (BLE) communication and may also include an antenna (e.g., for near field communication (NFC). Transceiver 101 may be configured to wirelessly communicate with a remote device (e.g., a smart phone, a glucose monitor, an insulin pump, or a computer) using one or more wireless communication methods. The one or more wireless communication methods may include, for example, radio data transmission, Bluetooth, BLE, NFC, infrared data transmission, electromagnetic induction transmission, and/or other suitable electromagnetic, acoustic, or optical transmission methods”.
If processing devices 271 might be coupled to receive data [0037]; the coupling encompasses stablishing a connection. The connection can be stablished via any of the methods disclosed in [0016] when plunger head 200 is in power conservation mode.
Additionally, in efforts to advance prosecution, claim 1 is being rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fischell (US 4731051 A).
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
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
Prosecution Insights