CTNF 18/431,836 CTNF 98282 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-21-aia AIA Claim (s) 1-22 are rejected under 35 U.S.C. 103 as being unpatentable over Dugas (U.S Patent Pub. No. 20230398290 A1) in view of Shin et al. (U.S Patent Pub. No. 20130041353 A1, “Shin”) in view of Shor et al. (U.S Patent Pub. No. 20230123806 A1, “Shor”) . Regarding claim 1 , Dugas discloses the limitations of (Claim 1) a sensor module (100 in Fig. 1) comprising: PNG media_image1.png 501 1044 media_image1.png Greyscale a housing (140 in Fig. 1) comprising a channel extending through a longitudinal axis of the housing (140, see annotated Dugas drawing 1 below and para. 0036 – cylindrical wall 140 defines an interior channel), wherein the channel is configured to receive a fluid substance (see para. 0035 – right-hand side of channel defining chamber 110 holds a drug; an outlet in fluid communication with the channel (see annotated Dugas drawing 1 above and para. 0035 – chamber 110 of the annotated channel has an outlet); a capacitive sensor (150 in Fig. 1) positioned inside the channel (see annotated Dugas drawing 1 above and para. 0036 – capacitive sensor 150 comprises electrodes 150a and 150b that may extend along an inner side of housing 140 and thus are positioned inside the channel); an actuator (130 in Fig. 1) at least partially surrounded by the capacitive sensor (150, see Fig. 1 and para. 0035 – stopper 130 is actuated to dispense the drug). While Dugas discloses that the left-hand side of actuator (130) forming chamber (120 in Fig. 1) may comprise air that is pressurized by some mechanism or that the stopper (130) is actuated by another mechanism (see para. 0035), Dugas fails to disclose an outlet valve and a pump comprising a fluid reservoir configured to contain a solution, wherein during operation of the sensor module, activation of the pump pushes at least some of the solution from the fluid reservoir into the channel to advance the actuator into the channel. Shin discloses a drug delivery device (600 in Fig. 6A-6B) having an electro-osmotic pump (610), wherein Shin teaches (Claim 1) the drug delivery device (600) comprising: a housing defining a channel (680 in Fig. 6A) therethrough (see Fig. 6A and annotated Shin drawing 1 below, see para. 0158 – right-hand side of device 600 is interpreted as the housing defining chamber 680 as the channel), PNG media_image2.png 398 921 media_image2.png Greyscale an actuator (657b in Fig. 6A, see para. 0158 – separator 657b is actuated to dispense the delivery fluid 658), and a pump (610, 660 in Fig. 6A) in the form of an electro-osmotic pump (610) that comprises a fluid reservoir (660 in Fig. 6A) configured to contain a solution (656a in Fig. 6A, see para. 0158-0159), wherein during operation of the drug delivery device (600), activation of the pump (610) pushes at least some of the solution (656a) from the fluid reservoir (660) into the channel (680) to advance the actuator (657b) in the channel (680, see annotated Shin drawing 1 above and para. 0158 – during operation pump 610 pushes the solution 656a into channel 680 as seen at chamber 656b to advance actuator 657b in the channel 680). Since Dugas discloses a drug delivery device having a housing defining a channel therein with a drug chamber (110) and a chamber (120) to be pressurized by any suitable mechanism to advance an actuator (130) therebetween, and Shin discloses a drug delivery device having a housing defining a channel (680) therein with a drug chamber (658) and a chamber (656b) to be pressurized by an electro-osmotic pump (610) to advance an actuator (657b) between the two chambers, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the module taught by Dugas to incorporate electro-osmotic pump and its reservoir as taught by Shin such that the chamber (110) of Dugas would be equivalent to the chamber (656b) of Shin yielding an electro-osmotic pump (610) and its reservoir (660) as taught by Shin in fluid communication with the chamber (120) of the channel of Dugas. Shin provides that electro-osmotic pumps are advantageous in drug delivery devices as they are elegant in their simplicity comprises merely an ion-exchange membrane sandwiched between two electrodes, has no moving parts, and provides a current controlled flow-rate (see para. 0003). Shor discloses a drug delivery device (100 in at least Fig. 1-2) comprising a drug chamber (106 in Fig. 23A-23B) in fluid communication with an outlet valve (221 in Fig. 25E). Since modified Dugas disclose a drug chamber (110 in Fig. 1) in fluid communication with an outlet and subsequently a needle (see para. 0035), and Shor discloses a drug chamber (106) in fluid communication with an outlet and subsequently a needle (216 in Fig. 23B), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outlet taught by modified Dugas to incorporate an outlet valve as taught by Shor. Shor provides that the outlet of the drug chamber can comprise an outlet valve that is opened and closed using any technique, e.g., electronically, with pressure and/or hydrodynamic forces, operated as one-way flapper valves, etc, and said outlet valve enables the drug to be delivered or sealed off from delivery at any given time (see para. 0189). Regarding claim 2 , modified Dugas discloses the sensor module of claim 1, as discussed above. In modified Dugas, Dugas discloses (Claim 2) wherein, during operation of the sensor module (100), advancement of the actuator (130) into the channel ejects at least a portion of the fluid substance in the channel via the outlet (see Fig. 1, annotated Dugas drawing 1 above for channel, and para. 0035). In modified Dugas, Shor discloses the outlet valve (221). Regarding claim 3 , modified Dugas discloses the sensor module of claim 1, as discussed above. In modified Dugas, Dugas discloses (Claim 3) wherein the capacitive sensor (150) is configured to measure a capacitance across the channel (see annotated Dugas drawing 1 above for channel, see para. 0037). Regarding claim 4 , modified Dugas discloses the sensor module of claim 3, as discussed above. In modified Dugas, Dugas discloses (Claim 4) wherein the capacitance across the channel provides an indication of an amount of the fluid substance ejected via the outlet (see annotated Dugas drawing 1 above for channel, see para. 0037 – the capacitance across the channel defined by housing 140 provides an indication in the changing volume of chambers 110 and 120 and thus an indication of an amount of the drug ejected from chamber 120 via the outlet). In modified Dugas, Shor discloses the outlet valve (221). Regarding claim 5 , modified Dugas discloses the sensor module of claim 1, as discussed above. However, modified Dugas fails to disclose (Claim 5) further comprising an inlet valve in fluid communication with the channel and a pod, the pod is configured to store the fluid substance. Shin discloses another embodiment of a similar drug delivery device (700 in Fig. 7A-7B) having an electro-osmotic pump (710 in Fig. 7A-7B), wherein Shin teaches (Claim 5) comprising an inlet valve (798, 798a in Fig. 7A-7C) in fluid communication the channel (780 in Fig. 7A-7C) and a pod (see Fig. 7A-7C and Fig. 9C, see para. 0124, 0166 and 0172 – channel 780 is in fluid communication with a fluid delivery inlet 798 comprising a pierceable septum 798a and thus together constitute an inlet valve, the inlet valve 798 may be in fluid communication with a pod which is shown in Fig. 9C as a syringe that engages with the fluid delivery inlet 983). Since modified Dugas discloses a drug chamber (110) for a drug delivery device, and Shin disclose a similar drug chamber for a drug delivery device, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug chamber of modified Dugas to have an inlet valve in fluid communication with a pod as taught by Shin. Shin provides that the drug chamber having a port/septum allows for filling and refilling of the drug chamber for reuse of the drug delivery device (see para. 0124). Regarding claim 6 , modified Dugas discloses the sensor module of claim 1, as discussed above. In modified Dugas, Dugas discloses (Claim 6) wherein the capacitive sensor (150) comprises a first capacitor plate (150a in Fig. 1) and a second capacitor plate (150b in Fig. 1, see para. 0022 and 0036). Regarding claim 7 , modified Dugas discloses the sensor module of claim 1, as discussed above. In modified Dugas, Dugas discloses (Claim 7) wherein the outlet is fluidly connected to a needle assembly to deliver the fluid substance ejected via the outlet to a patient (see para. 0035). In modified Dugas, Shor discloses the outlet valve (221) fluidly connected to a needle assembly (216, see Fig. 25E and para. 0189). Regarding claim 8 , modified Dugas discloses the sensor module of claim 1, as discussed above. In modified Dugas, Shin discloses (Claim 8) wherein the pump (610, 660 in Fig. 6A) comprises an electroosmotic pump (610, see para. 0159). Regarding claim 9 , modified Dugas discloses the sensor module of claim 1, as discussed above. In modified Dugas, Dugas discloses (Claim 9) wherein the channel defines a first chamber portion (120 in Fig. 1) and a second chamber portion (110 in Fig. 1, see annotated Dugas drawing 1 above for channel), the capacitive sensor (150 in Fig. 1) positioned inside the first chamber portion (120, see Fig. 1 and para. 0036 – the electrodes 150a and 150b of capacitive sensor 150 may extend along an inner side of housing 140 and thus are positioned inside the first chamber portion 120), and wherein the second chamber portion (110) is configured to receive the fluid substance (see para. 0035 – first chamber portion 110 receives the drug). Regarding claim 10 , modified Dugas discloses the sensor module of claim 9, as discussed above. In modified Dugas, Dugas discloses (Claim 10) wherein at least a portion of the first chamber portion (120) and at least a portion of the second chamber portion (110) are separated by the actuator (130, see Fig. 1). Regarding claim 11 , modified Dugas discloses the sensor module of claim 1, as discussed above. In modified Dugas, Dugas discloses wherein the electrodes (150a) and (150b) of the capacitive sensor (150) may extend along an inner side of housing (140) and thus are exposed to any fluid in the channel (see annotated Dugas drawing 1 above for channel). Dugas in view of Shin in combination disclose the chamber (110) of Dugas would be equivalent to the chamber (656b) of Shin yielding an electro-osmotic pump (610) and its reservoir (660) containing the solution (656a) as taught by Shin would be in fluid communication with the chamber (120) of the channel of Dugas. Thus, in combination the capacitive sensor (150) of Dugas would extend along an inner side of housing (140) and thus be exposed to the solution (656a) taught by Shin when the solution is in the channel. Regarding claim 12 , Dugas discloses the limitations of (Claim 12) a sensor module (100 in Fig. 1) comprising: PNG media_image1.png 501 1044 media_image1.png Greyscale a housing (140 in Fig. 1) comprising a channel configured to receive a fluid substance (see annotated Dugas drawing 1 below and para. 0036 – cylindrical wall 140 defines an interior channel which in chamber 110 is configured to receive a drug), a capacitive sensor (150 in Fig. 1) positioned inside the channel (see annotated Dugas drawing 1 above and para. 0036 – capacitive sensor 150 comprises electrodes 150a and 150b that may extend along an inner side of housing 140 and thus are positioned inside the channel); an actuator (130 in Fig. 1), wherein during operation of the sensor module (100), reciprocation of the actuator (130) along the channel ejects at least a portion of the fluid substance in the channel via an outlet ( see Fig. 1, annotated Dugas drawing 1 above for channel, and para. 0035 – stopper 130 is reciprocated within the channel to dispense the drug via an outlet). However, Dugas fails to disclose an inlet valve in fluid communication with the channel and removably connected to a pod containing the fluid substance and an outlet valve. Shin discloses a drug delivery device (700 in Fig. 7A-7B) having an electro-osmotic pump (710 in Fig. 7A-7B), wherein Shin teaches (Claim 12) comprising an inlet valve (798, 798a in Fig. 7A-7C) in fluid communication the channel (780 in Fig. 7A-7C) and removably connected to a pod containing the fluid substance (see Fig. 7A-7C and Fig. 9C, see para. 0124, 0166 and 0172 – channel 780 is in fluid communication with a fluid delivery inlet 798 comprising a pierceable septum 798a and thus together constitute an inlet valve, the inlet valve 798 may be in fluid communication with a pod which is shown in Fig. 9C as a syringe that removably connects to the fluid delivery inlet 983). Since modified Dugas discloses a drug chamber (110) for a drug delivery device, and Shin disclose a similar drug chamber for a drug delivery device, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug chamber of modified Dugas to have an inlet valve in fluid communication with and removably connected to a pod as taught by Shin. Shin provides that the drug chamber having a port/septum allows for filling and refilling of the drug chamber for reuse of the drug delivery device (see para. 0124). Shor discloses a drug delivery device (100 in at least Fig. 1-2) comprising a drug chamber (106 in Fig. 23A-23B) in fluid communication with an outlet valve (221 in Fig. 25E). Since modified Dugas disclose a drug chamber (110 in Fig. 1) in fluid communication with an outlet and subsequently a needle (see para. 0035), and Shor discloses a drug chamber (106) in fluid communication with an outlet and subsequently a needle (216 in Fig. 23B), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outlet taught by modified Dugas to incorporate an outlet valve as taught by Shor. Shor provides that the outlet of the drug chamber can comprise an outlet valve that is opened and closed using any technique, e.g., electronically, with pressure and/or hydrodynamic forces, operated as one-way flapper valves, etc, and said outlet valve enables the drug to be delivered or sealed off from delivery at any given time (see para. 0189). Regarding claim 13 , modified Dugas discloses the sensor module of claim 12, as discussed above. In modified Dugas, Dugas discloses (Claim 12) wherein the capacitive sensor (150) comprises a first capacitor plate (150a in Fig. 1) and a second capacitor plate (150b in Fig. 1, see para. 0022 and 0036). Regarding claim 14 , modified Dugas discloses the sensor module of claim 13, as discussed above. In modified Dugas, Dugas discloses (Claim 14) measuring the capacitance across the first (150a) and second capacitor plates (150b) and, based on the measured capacitance, determine an amount of the fluid substance ejected via the outlet (see para. 0037 – the capacitance across the channel defined by housing 140 provides an indication in the changing volume of chambers 110 and 120 and thus an indication of an amount of the drug ejected from chamber 120 via the outlet). However, modified Dugas fails to disclose (Claim 14) further comprising a controller in communication with the capacitive sensor, the controller configured to measure a capacitance across the first and second capacitor plates and, based on the measured capacitance, determine an amount of the fluid substance ejected via the outlet valve. Dugas discloses another embodiment of a sensor module (see Fig. 5) comprising a similar housing (520 in Fig. 5) with the capacitive sensor and pair of electrodes as described in the embodiment of Fig. 1 (see para. 0059), wherein the embodiment of Fig. 5 of Dugas teaches (Claim 14) further comprising a controller (545 in Fig. 5) in communication with the capacitive sensor (see para. 0060 – processor 545 receives the capacitance measurement from the capacitive sensor via measurement circuit 540 in Fig. 5), the controller (545) configured to measure a capacitance across the first and second capacitor plates and, based on the measured capacitance, determine an amount of the fluid substance ejected via the outlet (see para. 0060 and 0063). Since the sensor module (100) of Fig. 1 of Dugas discloses a capacitive sensor for measuring the capacitance across a first and second capacitor plate to determine the amount of fluid substance ejected via the outlet, and the sensor module (500) of Fig. 5 of Dugas discloses a similar capacitive sensor in communication with a controller for performing the same functions, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor module of Fig. 1 of Dugas to have the controller of the sensor module of Fig. 5 of Dugas as Dugas teaches that a processor in communication with the capacitive sensor can determined the amount of drug remaining in the housing, control the actuation of the actuator based on the capacitance, and determine the amount of drug delivered to the patient (see para. 0060 and 0063). Regarding claim 15 , modified Dugas discloses the sensor module of claim 12, as discussed above. While Dugas discloses that the left-hand side of actuator (130) forming chamber (120 in Fig. 1) may comprise air that is pressurized by some mechanism or that the stopper (130) is actuated by another mechanism (see para. 0035), Dugas fails to disclose (Claim 15) further comprising a pump, wherein activation of the pump is configured to reciprocate the actuator along the channel. Shin discloses another embodiment of a drug delivery device (600 in Fig. 6A-6B) having an electro-osmotic pump (610), wherein Shin teaches (Claim 15) further comprising a pump (610, 660 in Fig. 6A) in the form of an electro-osmotic pump (see para. 0158-0159), wherein activation of the pump (610, 660) is configured to reciprocate the actuator (657b in Fig. 6A) along the channel (680 in Fig. 6A, see para. 0158 – the right-hand side of device 600 is interpreted as the housing defining chamber 680 as the channel during operation pump 610 pushes the solution 656a into channel 680 to advance actuator 657b in the channel 680). Since Dugas discloses a drug delivery device having a housing defining a channel therein with a drug chamber (110) and a chamber (120) to be pressurized by any suitable mechanism to advance an actuator (130) therebetween, and the embodiment of Fig. 6 of Shin discloses a drug delivery device having a housing defining a channel (680) therein with a drug chamber (658) and a chamber (656b) to be pressurized by an electro-osmotic pump (610) to advance an actuator (657b) between the two chambers, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the module taught by Dugas to incorporate electro-osmotic pump and its reservoir as taught by Shin such that the chamber (110) of Dugas would be equivalent to the chamber (656b) of Shin yielding an electro-osmotic pump (610) and its reservoir (660) as taught by Shin in fluid communication with the chamber (120) of the channel of Dugas. Shin provides that electro-osmotic pumps are advantageous in drug delivery devices as they are elegant in their simplicity comprises merely an ion-exchange membrane sandwiched between two electrodes, has no moving parts, and provides a current controlled flow-rate (see para. 0003). Regarding claim 16 , modified Dugas discloses the sensor module of claim 15, as discussed above. In modified Dugas, the embodiment of Fig. 6 of Shin discloses (Claim 16) wherein the pump (610, 660 in Fig. 6A) comprises an electroosmotic pump (610, see para. 0158-0159), the electroosmotic pump (610) in communication with a fluid reservoir (660 in Fig. 6A) containing a solution (656a in Fig. 6A, see para. 0158), wherein, during operation of the device (600), activation of the electroosmotic pump (610) pushes at least some of the solution (656a) from the fluid reservoir (660) into the channel (680, see para. 0158 – pump 610 pushes the solution 656a from reservoir 660 into the channel 680 as indicated at 656b), thereby pushing the actuator (657b) away from the electroosmotic pump (610, see para. 0158). Regarding claim 17 , modified Dugas discloses the sensor module of claim 12, as discussed above. In modified Dugas, Dugas discloses (Claim 17) wherein the outlet is fluidly connected to a needle assembly configured to deliver the fluid substance ejected via the outlet to a patient (see para. 0035). In modified Dugas, Shor discloses the outlet valve (221) fluidly connected to a needle assembly (216, see Fig. 25E and para. 0189). Regarding claim 18 , Dugas discloses the limitations of (Claim 18) a sensor module (100 in Fig. 1) comprising: a housing (140 in Fig. 1) comprising: a channel extending through a longitudinal axis of the housing (140, see annotated Dugas drawing 1 below and para. 0036 – cylindrical wall 140 defines an interior channel), the channel defining a first chamber (120 in Fig. 1) and a second chamber (110 in Fig. 1, see para. 0035); PNG media_image1.png 501 1044 media_image1.png Greyscale an outlet in fluid communication with the channel (see annotated Dugas drawing 1 above and para. 0035 – chamber 110 of the annotated channel has an outlet); wherein the second chamber (110 in Fig. 1) is configured to receive a fluid substance (see para. 0035); a capacitive sensor (150 in Fig. 1) comprising a first capacitor plate (150a in Fig.1) and a second capacitor plate (150b in Fig. 1 and para. 0036), wherein the first (150a) and second (150b) capacitor plates are positioned inside the first chamber (120, see Fig. 1 and para. 0036 – capacitive sensor 150 comprises electrode plates 150a and 150b that may extend along an inner side of housing 140 and thus are positioned inside the first chamber 120 within housing 140); an actuator (130 in Fig. 1) at least partially surrounded by the first (150a) and second (150b) capacitor plates (see Fig. 1 and para. 0035); wherein during operation of the sensor module (100), reciprocation of the actuator (130) along the channel ejects at least a portion of the fluid substance in the second chamber (110) via the outlet (see Fig. 1, annotated Dugas drawing 1 above for channel, and para. 0035 – stopper 130 is reciprocated within the channel to dispense the drug from second chamber 110 via outlet). While Dugas discloses that the left-hand side of actuator (130) forming chamber (120 in Fig. 1) may comprise air that is pressurized by some mechanism or that the stopper (130) is actuated by another mechanism (see para. 0035), Dugas fails to disclose (Claim 18) an outlet valve; and inlet valve in fluid communication with channel; wherein the second chamber is configured to receive a fluid substance via the inlet valve; a controller in communication with the capacitive sensor; and a pump, wherein activation of the pump is configured to reciprocate the actuator along the channel; wherein the controller is configured to measure a capacitance across the first and second capacitor plates and, based on the measured capacitance, determine an amount of the fluid substance ejected via the outlet valve. Shor discloses a drug delivery device (100 in at least Fig. 1-2) comprising a drug chamber (106 in Fig. 23A-23B) in fluid communication with an outlet valve (221 in Fig. 25E). Since Dugas disclose a drug chamber (110 in Fig. 1) in fluid communication with an outlet and subsequently a needle (see para. 0035), and Shor discloses a drug chamber (106) in fluid communication with an outlet and subsequently a needle (216 in Fig. 23B), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outlet taught by Dugas to incorporate an outlet valve as taught by Shor. Shor provides that the outlet of the drug chamber can comprise an outlet valve that is opened and closed using any technique, e.g., electronically, with pressure and/or hydrodynamic forces, operated as one-way flapper valves, etc, and said outlet valve enables the drug to be delivered or sealed off from delivery at any given time (see para. 0189). Shin discloses a drug delivery device (700 in Fig. 7A-7B) having an electro-osmotic pump (710 in Fig. 7A-7B), wherein Shin teaches (Claim 18) comprising an inlet valve (798, 798a in Fig. 7A-7C) in fluid communication the channel (780 in Fig. 7A-7C, see para. 0124 and 0166 - channel 780 is in fluid communication with a fluid delivery inlet 798 comprising a pierceable septum 798a and thus together constitute an inlet valve); wherein the second chamber (790 in Fig. 7A-7C) is configured to receive a fluid substance via the inlet valve (798, 798a, see para. 0124, 0166 and 0172 – second chamber 790 is in fluid communication with a fluid delivery inlet 798 comprising a pierceable septum 798a which is configured to receive the drug from a syringe as seen for example in Fig. 9C). Since modified Dugas discloses a drug chamber (110) for a drug delivery device, and Shin disclose a similar drug chamber for a drug delivery device, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug chamber of modified Dugas to have an inlet valve in fluid communication with the channel as taught by Shin. Shin provides that the drug chamber having a port/septum allows for filling and refilling of the drug chamber for reuse of the drug delivery device (see para. 0124). Dugas discloses another embodiment of a sensor module (see Fig. 5) comprising a similar housing (520 in Fig. 5) with the capacitive sensor and pair of electrodes as described in the embodiment of Fig. 1 (see para. 0059), wherein the embodiment of Fig. 5 of Dugas teaches (Claim 18) a controller (545 in Fig. 5) in communication with the capacitive sensor (see para. 0060 – processor 545 receives the capacitance measurement from the capacitive sensor via measurement circuit 540 in Fig. 5), the controller (545) is configured to measure a capacitance across the first and second capacitor plates and, based on the measured capacitance, determine an amount of the fluid substance ejected via the outlet (see para. 0060 and 0063). Since the sensor module (100) of Fig. 1 of Dugas discloses a capacitive sensor for measuring the capacitance across a first and second capacitor plate to determine the amount of fluid substance ejected via the outlet, and the sensor module (500) of Fig. 5 of Dugas discloses a similar capacitive sensor in communication with a controller for performing the same functions, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor module of Fig. 1 of modified Dugas to have the control circuit (530) including the controller (545) of the sensor module of Fig. 5 of Dugas as Dugas teaches that a processor in communication with the capacitive sensor can determine the amount of drug remaining in the housing, control the actuation of the actuator based on the capacitance, and determine the amount of drug delivered to the patient (see para. 0060 and 0063). Shin discloses another embodiment of a drug delivery device (600 in Fig. 6A-6B) having an electro-osmotic pump (610), wherein Shin teaches (Claim 18) further comprising a pump (610, 660 in Fig. 6A) in the form of an electro-osmotic pump (see para. 0158-0159), wherein activation of the pump (610, 660) is configured to reciprocate the actuator (657b in Fig. 6A) along the channel (680 in Fig. 6A, see para. 0158 – the right-hand side of device 600 is interpreted as the housing defining chamber 680 as the channel during operation pump 610 pushes the solution 656a into channel 680 to advance actuator 657b in the channel 680). Since Dugas discloses a drug delivery device having a housing defining a channel therein with a drug chamber (110) and a chamber (120) to be pressurized by any suitable mechanism to advance an actuator (130) therebetween, and Shin discloses a drug delivery device having a housing defining a channel (680) therein with a drug chamber (658) and a chamber (656b) to be pressurized by an electro-osmotic pump (610) to advance an actuator (657b) between the two chambers, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the module taught by modified Dugas to incorporate electro-osmotic pump and its reservoir as taught by Shin such that the chamber (110) of Dugas would be equivalent to the chamber (656b) of Shin yielding an electro-osmotic pump (610) and its reservoir (660) as taught by Shin in fluid communication with the chamber (120) of the channel of Dugas. Shin provides that electro-osmotic pumps are advantageous in drug delivery devices as they are elegant in their simplicity comprises merely an ion-exchange membrane sandwiched between two electrodes, has no moving parts, and provides a current controlled flow-rate (see para. 0003). Regarding claim 19 , modified Dugas discloses the sensor module of claim 18, as discussed above. In modified Dugas, the embodiment of Fig. 7 of Shin discloses (Claim 19) wherein the inlet valve (798, 798a in Fig. 7A-7C) is removably connected to a pod configured to store the fluid substance (see Fig. 7A-7C and Fig. 9C, see para. 0124, 0166 and 0172 – the inlet valve 798, 798a may be in fluid communication with a pod which is shown in Fig. 9C as a syringe that removably connects to the fluid delivery inlet). Regarding claim 20 , modified Dugas discloses the sensor module of claim 18, as discussed above. In modified Dugas, Dugas discloses (Claim 20) wherein the outlet is fluidly connected to a needle assembly to deliver the fluid substance ejected via the outlet to a patient (see para. 0035). In modified Dugas, Shor discloses the outlet valve (221) fluidly connected to a needle assembly (216, see Fig. 25E and para. 0189). Regarding claim 21 , modified Dugas discloses the sensor module of claim 18, as discussed above. In modified Dugas, the embodiment of Fig. 6 of Shin discloses (Claim 21) wherein the pump (610, 660 in Fig. 6A) comprises an electroosmotic pump (610, see para. 0158-0159), the electroosmotic pump (610) in communication with a fluid reservoir (660 in Fig. 6A) containing a solution (656a in Fig. 6A, see para. 0158), wherein, during operation of the device (600), activation of the electroosmotic pump (610) pushes at least some of the solution (656a) from the fluid reservoir (660) into the first chamber (656b, see para. 0158 – pump 610 pushes the solution 656a from reservoir 660 into the first channel as indicated at 656b), thereby pushing at least a portion of the actuator (657b) into the second chamber (658 in Fig. 6A, see para. 0158). Regarding claim 22 , modified Dugas discloses the sensor module of claim 21, as discussed above. In modified Dugas, Dugas discloses wherein the first capacitor plate (150a) and second capacitor plate (150b) of the capacitive sensor (150) may extend along an inner side of housing (140) and thus are exposed to any fluid in the channel (see annotated Dugas drawing 1 above for channel). Dugas in view of the embodiment of Fig. 6 of Shin in combination disclose the chamber (110) of Dugas would be equivalent to the chamber (656b) of Shin yielding an electro-osmotic pump (610) and its reservoir (660) containing the solution (656a) as taught by Shin would be in fluid communication with the chamber (120) of the channel of Dugas. Thus, in combination the first (150a) and second (150b) capacitor plates of Dugas would extend along an inner side of housing (140) and thus be exposed to the solution (656a) taught by Shin when the electroosmotic pump (610) is activated . 07-22-aia AIA Claim (s) 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Dugas in view of Shin in view of Short as applied to claim 18 above, and further in view of Phillips et al. (U.S Patent Pub. No. 20190365990 A1, “Phillips”) . Regarding claim 23 , modified Dugas discloses the sensor module of claim 18, as discussed above. In modified Dugas, the embodiment of Fig. 5 of Dugas discloses (Claim 23) an electronic assembly (530 in Fig. 5), and the first capacitive plate and second capacitive plate (see Fig. 1 and see para. 0059). However, modified Dugas fails to disclose (Claim 23) an electronics assembly, the electronics assembly comprising a first plurality of pins connecting the electronics assembly to the first capacitive plate, and a second plurality of pins connecting the electronics assembly to the second capacitive plate. Phillips discloses a capacitive sensing arrangement for a drug delivery device, wherein the drug delivery device comprises a reservoir system (800 in Fig. 11) having a reservoir (802) with selectively arranged electrical contacts (804 in Fig. 11) that use capacitance to determine the fill volume of the reservoir (802, see para. 0006, 0068 and 0070). Phillips teaches (Claim 23) an electronics assembly (808 in Fig. 11, see para. 0074), the electronics assembly (808) comprising a plurality of pins (806 in Fig. 11) connecting the electronics assembly (808) to the plurality of electrical contacts (804, see para. 0074). Since Dugas discloses an electronics assembly (530 in Fig. 5) electronically coupled to the first and second capacitor plates (see Fig. 5), and Phillips discloses an electronics assembly (808) electronically coupled to a plurality of capacitance measuring electrical contacts (804) via a plurality of pins (806), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coupling between the first and second capacitor plate and electronics assembly of modified Dugas to incorporate a plurality of pins as taught by Phillips such that a first plurality of pins connects the electronics assembly to the first capacitive plate, and a second plurality of pins connects the electronics assembly to the second capacitive plate according to known methods to yield predictable results. Phillips provides that contact pins contact the respective electrical contact to complete an electrical circuit to be detected by the controller of the electronics assembly (see para. 0074). Thus, one of ordinary skill in the art would have recognized the electrical connection of Dugas modified to be a physical connection in the form of contact pins would yield results that are predictable. Regarding claim 24 , modified Dugas discloses the sensor module of claim 23, as discussed above. In modified Dugas, the embodiment of Fig. 5 of Dugas discloses (Claim 24) wherein the controller (545 in Fig. 5) is integrated into the electronics assembly (530 in Fig. 5, see para. 0058). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 4 :00 PM EST . 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /K.M.T./Examiner, Art Unit 3783 /COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783 Application/Control Number: 18/431,836 Page 2 Art Unit: 3783 Application/Control Number: 18/431,836 Page 3 Art Unit: 3783 Application/Control Number: 18/431,836 Page 4 Art Unit: 3783 Application/Control Number: 18/431,836 Page 5 Art Unit: 3783 Application/Control Number: 18/431,836 Page 6 Art Unit: 3783 Application/Control Number: 18/431,836 Page 7 Art Unit: 3783 Application/Control Number: 18/431,836 Page 8 Art Unit: 3783 Application/Control Number: 18/431,836 Page 9 Art Unit: 3783 Application/Control Number: 18/431,836 Page 10 Art Unit: 3783 Application/Control Number: 18/431,836 Page 11 Art Unit: 3783 Application/Control Number: 18/431,836 Page 12 Art Unit: 3783 Application/Control Number: 18/431,836 Page 13 Art Unit: 3783 Application/Control Number: 18/431,836 Page 14 Art Unit: 3783 Application/Control Number: 18/431,836 Page 15 Art Unit: 3783 Application/Control Number: 18/431,836 Page 16 Art Unit: 3783 Application/Control Number: 18/431,836 Page 17 Art Unit: 3783 Application/Control Number: 18/431,836 Page 18 Art Unit: 3783 Application/Control Number: 18/431,836 Page 19 Art Unit: 3783 Application/Control Number: 18/431,836 Page 20 Art Unit: 3783 Application/Control Number: 18/431,836 Page 21 Art Unit: 3783 Application/Control Number: 18/431,836 Page 22 Art Unit: 3783 Application/Control Number: 18/431,836 Page 23 Art Unit: 3783 Application/Control Number: 18/431,836 Page 24 Art Unit: 3783
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