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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2 June 2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 2 June 2025, has been considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on 2 June 2025. As directed by the amendment: claims 2, 8, and 10 have been amended. Thus claims 2-21 are presently pending in this application, and claims 16-21 remain withdrawn. Applicant’s amendments to the Claims have overcome the objection previously set forth in the Final Office Action mailed 14 March 2025.
Response to Arguments
Applicant's arguments filed 2 June 2025 have been fully considered.
The arguments directed to the amendments are persuasive, therefore, the rejection of claim 2 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Binier (US 10232123 B1) and Cannan et al. (WO 2018160073 A1) as outlined further below.
The arguments on pages 10 and 11 have been fully considered but they are not persuasive.
Applicant argues on pages 10 and 11 that although the claims do not explicitly state that the output signal is generated by a dispensing event, if the signal did not correspond to a dispensing event, it would not be possible to derive from the signal any information about the dose amount dispensed. Applicant argues Binier does not refer to a dispensed dose amount, but rather to a set does to be dispensed. The dose set by a dose-setting mechanism does not necessarily correspond to the dose actually administered because of possible mistakes and real-world factors that prevent full dose administration. Therefore, the mere act of setting a dose does not indicate the dose amount that is actually dispensed to the user.
The examiner agrees that there may be factors and mistakes that prevent full dose administration, resulting in the actual dose administered being different, however, while there is a possibility for mistakes and errors, Binier explicitly describes the signal as corresponding to the injected dose (Col 3 lines 31-35 “a processing unit configured to process the at least one vibration signal from the dose-setting action and the at least one dosage click from the dose-setting action for generating set dose information corresponding to the injected dose”). Under normal conditions, the dose setting click of Binier equates to the actual dose administered. A click generated from dose dispensation is also vulnerable to mistakes, for example, the device may not be fully filled and a click could represent the mechanism functioning without actually injecting any medicament. The act of setting a dose does not always, perfectly indicate the dose amount dispensed, but perfection is not required.
Applicant argues on page 11 that the dose dispensing event and/or the dose amount dispensed can be detected “based on the first output signal”. Applicant argues that in other words, no other signal is required to detect the dose dispensing event and/or the dose amount dispensed. Applicant argues the claim limitation is not taught by the art because Binier requires using acoustic signals in combination with vibration signals.
The examiner points to the Advisory action mailed 15 May 2025. “The position of the examiner is that based on the output signal" is not implying that no other signal is required and does not indicate that no other signal can be used in combination. A detection of an event can be based on multiple signals in combination. The exclusion of other signals can be specified in the claim but without such an exclusion a broadest reasonable interpretation would include the possibility of additional signals and elements being used.”
Claim Objections
Claims 9-11 are objected to because of the following informalities:
Claims 9-11 recite “a DC bias voltage”. “A DC voltage” was already introduced in claim 2, so this should instead recite “the DC voltage”
Claims 9-11 recite “a current”. “A maximum current” was already introduced in claim 2, so this should instead recite “the maximum current”.
Claims 9-11 recite “an amplitude of the first output signal”. “An amplitude of the first output signal” was already introduced in claim 8, so this should instead recite “the amplitude of the first output signal”.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 8-11, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Binier (US 10,232,123 B1) in view of Cannan et al. (WO 2018/160073 A1).
Regarding claim 2, Binier discloses an electronic add-on module (10 Fig 1) configured to be releasably attached to a drug delivery device (As shown in Fig 4, Col 5 lines 35-38 “injected dose detection device 10 which may be detachably attached to an injection device 200 for detecting an injected dose of the injection device 200”), the electronic add-on module comprising: a housing (100 Fig 5); an electric power source arranged inside the housing (124 Fig 2); a circuit board assembly (112 Fig 2) electrically connected to the electric power source (as shown in Fig 3, the components of the circuit board are all electrically connected to the battery through the switch and the processing unit, Col 7 lines 41-44); an acoustic sensor arrangement (125 Fig 6) electrically connected to the circuit board assembly (Col 6 lines 15-16 “The circuit board 112 may include the vibration sensor 102 and the acoustic sensor 125.”, as shown in Figs 5 and 6) and configured to generate a first output signal (Col 6 lines 40-41 “The acoustic sensor 125 may transmit the at least one dosage click to the processing unit 106.”); a processing circuit (106 Fig 3) configured to process the first output signal received from the sensor (Col 6 lines 40-41 “The acoustic sensor 125 may transmit the at least one dosage click to the processing unit 106.”, 704, 705 Fig 7), wherein the processing circuit is configured to detect a dose dispensing event, and/or a dose amount dispensed based on the first output signal received from the sensor (Col 3 lines 31-35 “a processing unit configured to process the at least one vibration signal from the dose-setting action and the at least one dosage click from the dose-setting action for generating set dose information corresponding to the injected dose” the information corresponding to the injected dose is a dose amount dispensed, Col 6 lines 40-41 “The acoustic sensor 125 may transmit the at least one dosage click to the processing unit 106.”).
However, Binier fails to disclose a conditioning circuit configured to condition the first output signal of the acoustic sensor arrangement, wherein conditioning the first output signal comprises at least one of the following conditioning operations: removing a DC voltage, limiting a maximum current running in the conditioning circuit, or modulating the first output signal by elongating a duration the first output signal, rectifying the first output signal and/or smoothing the first output signal.
Cannan et al. teaches a conditioning circuit ([0075] “Preferably, the acoustic sensor consists of a circuit that includes one or more microphones, an amplifier and a filter.”) configured to condition the first output signal of the acoustic sensor arrangement ([0076] “The acoustic sensors may be configured to generate output signals”), wherein conditioning the first output signal comprises at least one of the following conditioning operations: removing a DC voltage ([0077] “remove the DC offset”), limiting a maximum current running in the conditioning circuit, or modulating the first output signal by elongating a duration the first output signal, rectifying the first output signal and/or smoothing the first output signal ([0077] “the signal is rectified to remove the DC offset and smoothed”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the module of Binier to include the conditioning circuit with the limitations as taught by Cannan et al. to process the signal to better allow the “event to be identified as an increase in signal relative to the background level.” [0077]
Regarding claim 8, modified Binier discloses the electronic add-on module according to claim 2. Modified Binier further teaches wherein conditioning the first output signal comprises amplifying the first output signal by increasing an amplitude of the first output signal (Cannan et al. [0075] “a low power dual operational amplifier may be used to amplify the signal.”).
Regarding claim 9, modified Binier teaches the electronic add-on module according to claim 8. Modified Binier further teaches wherein the conditioning circuit comprises at least one of the following: a DC-filter unit configured to remove a DC bias voltage of the acoustic sensor arrangement; a filter electrical impedance unit configured to limit a current into an amplifier unit; the amplifier unit configured to increase an amplitude of the first output signal ([0075] “a low power dual operational amplifier may be used to amplify the signal.”); an amplifier-decoupling unit configured to decouple a power supply to the amplifier unit; or an envelope detection circuit configured to modulate the first output signal.
Regarding claim 10, modified Binier teaches the electronic add-on module according to claim 8. Modified Binier further teaches wherein the conditioning circuit comprises at least one of the following: a DC-filter unit configured to remove a DC bias voltage of the acoustic sensor arrangement, wherein the DC-filter unit is connected upstream of the amplifier unit; a filter electrical impedance unit configured to limit a current into an amplifier unit, wherein the filter electrical impedance unit is connected upstream of the amplifier unit; the amplifier unit configured to increase an amplitude of the first output signal ([0075] “a low power dual operational amplifier may be used to amplify the signal.”); an amplifier-decoupling unit configured to decouple a power supply to the amplifier unit; or an envelope detection circuit configured to modulate the first output signal, wherein the envelope detection circuit is connected downstream of the amplifier unit and electrically connected to the processing circuit.
Regarding claim 11, modified Binier teaches the electronic add-on module according to claim 8. Modified Binier further teaches wherein the conditioning circuit comprises at least one of the following: a DC-filter unit configured to remove a DC bias voltage of the acoustic sensor arrangement; a filter electrical impedance unit configured to limit a current into an amplifier unit; the amplifier unit configured to increase an amplitude of the first output signal ([0075] “a low power dual operational amplifier may be used to amplify the signal.”); an amplifier-decoupling unit configured to decouple a power supply to the amplifier unit; or an envelope detection circuit configured to modulate the first output signal, wherein the envelope detection circuit comprises an RC element with a resistor and a grounded capacitor, and wherein a diode is connected in parallel with the resistor.
Regarding claim 14, modified Binier discloses the electronic add-on module according to claim 2. Binier further discloses wherein the electronic add- on module comprises at least one non-acoustic sensor arrangement (Vibration sensor 102 Figs 5, 6), and wherein a second output signal of the at least one non-acoustic sensor arrangement (the vibration detected by the vibration sensor) is used to classify a detected dose event into a relevant or a non-relevant dose event (if the vibration sensor detects a dose being dialed the signal is sent to the processing unit. The processing unit can change the vibration threshold depending on feedback from the user about the accuracy of the detected dose. As such the classification of a non-relevant dose event is when the vibration sensor data is classified as an “invalid input”, and a relevant dose event is when the vibration sensor data is classified as a “valid input” Col 7 lines 5-15).
Regarding claim 15, modified Binier discloses the electronic add-on module according to claim 2. Binier further discloses wherein the acoustic sensor arrangement is a micro-electromechanical system (MEMS) acoustic sensor arrangement (Col 8 lines 35-36 “The vibration sensor 102 and the acoustic sensor 125 may be a microelectromechanical system (“MEMS”) sensor.”).
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Binier (US 10,232,123 B1) in view of Cannan et al. (WO 2018/160073 A1) and Huang et al. (US 8,958,592 B2).
Regarding claim 3, modified Binier discloses the electronic add-on module according to claim 2. Binier further discloses wherein the acoustic sensor arrangement is coupled to the circuit board assembly (See the sensor 125 on the circuit board in Fig 6).
However, modified Binier is silent to wherein the acoustic sensor arrangement comprises a port hole that allows sound waves to enter the acoustic sensor arrangement.
Huang et al. teaches an acoustic sensor arrangement (100 Fig 1C) comprises a port hole that allows sound waves to enter the acoustic sensor arrangement (sound inlets (25, 35) Fig 1C). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the acoustic sensor array of modified Binier to include the port hole as taught by Huang et al. to provide a path for sound waves to reach the membrane of the microphone (Col 1 lines 47-61).
Regarding claim 4, modified Binier teaches the electronic add-on module according to claim 3. Modified Binier further discloses wherein the electronic add- on module has a coupling portion (108 Fig 2) for releasable attachment to a drug delivery device (Col 6 lines 9-10 “The housing 100 may include a joint surface 108 which may surround and cradle the injection device 200”, Col 5 lines 35-38 “injected dose detection device 10 which may be detachably attached to an injection device 200”), and wherein the port hole is directed towards the coupling portion (the microphone 125 of Binier as shown in Fig 2, modified to include a port hole of Huang et al. would result in the port hole being directed towards the coupling portion, as shown in Huang et al. Fig 1C, the port holes 25 and 35 are arranged to receive a sound signal entering at the holes 11 and 12 in the case 10, in the device of Binier, the sound source is the dosage clicking of the injection device 200 so the port hole would be arranged to be directed toward the injection device which is through the coupling portion).
Regarding claim 5, modified Binier teaches the electronic add-on module according to claim 3. However, modified Binier is silent to wherein the circuit board assembly, when the electronic add-on module is releasably attached to the drug delivery device, is arranged between the drug delivery device and the acoustic sensor arrangement, and wherein the circuit board assembly comprises a through hole configured to guide sound waves to the port hole of the acoustic sensor arrangement.
Huang teaches wherein the circuit board assembly (60 Fig 1C) is arranged between the audio source (the sound source enters through holes 11 and 12 on case 10 Fig 1C) and the acoustic sensor arrangement (100 Fig 1C), and wherein the circuit board assembly comprises a through hole (61, 62 Fig 1C) configured to guide sound waves to the port hole (25, 35 Fig 1C) of the acoustic sensor arrangement. It would have been obvious to arrange the microphone on the opposite side of the circuit board of Binier because a bottom port microphone design “provides better airtight, better phase and sensitivity matching and a better signal-to-noise ratio (SNR) because it uses chambers of housings as its cavities.” (Col 3 lines 37-40).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Binier (US 10,232,123 B1) in view of Cannan et al. (WO 2018/160073 A1) and Larsen (US 2009/0069742 A1).
Regarding claim 6, modified Binier discloses the electronic add-on module according to claim 2. However, modified Binier fails to discloses wherein the processing circuit is configured to compare the first output signal from the acoustic sensor arrangement to a threshold value, and wherein detection by the processing circuit is triggered based on a comparison between the first output signal and the threshold value.
Larsen teaches a processing circuit (Fig 2, [0040] “a signal processor for full or partial processing of measured signals.“, [0044] “acoustical signals picked-up by the microphone are first low-pass filtered and then converted to a digital format before being provided to a microprocessor.”) is configured to compare the first output signal from the acoustic sensor arrangement to a threshold value ([0036] “if the detected "click-sound" falls within a certain frequency range, say a low frequency range, a dose of medicament is being set.” A frequency range would include a threshold value), and wherein detection by the processing circuit is triggered based on a comparison between the first output signal and the threshold value ([0036] “if the detected "click-sound" falls within a certain frequency range, say a low frequency range, a dose of medicament is being set.”, [0042] “process the recorded signals by for example counting the number of recorded "clicks" so that the amounts of a set dose of medicament and an expelled dose of medicament can be stored in the module.” the processing circuit would need to detect If the detected sound falls within the frequency range in order to store the amounts of a set dose). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of modified Binier to include the processing limitations as taught by Larsen to distinguish different sounds from each other such as the click from dose setting compared to a click from an expelling sequence. [0036]
Regarding claim 7, modified Binier discloses the electronic add-on module according to claim 2. However, modified Binier fails to teach wherein the processing circuit comprises an analog-to-digital converter configured to convert the first output signal to a numerical value, and wherein the processing circuit is configured to compare the numerical value to a numerical threshold value.
Larsen teaches a processing circuit (Fig 2) comprises an analog-to-digital converter (ADC Fig 2, [0044] “converted to a digital format”) configured to convert the first output signal to a numerical value ([0037] “the recording of low frequency click sounds in response to a dose being set and the recording of high frequency click sounds”, a frequency is numerical), and wherein the processing circuit is configured to compare the numerical value to a numerical threshold value ([0036] “if the detected "click-sound" falls within a certain frequency range, say a low frequency range, a dose of medicament is being set. Similarly, if the detected "click-sounds" falls within a high frequency range a dose of medicament is being expelled from the medication delivery device.” The processing circuit compares the numerical frequency to the certain frequency ranges to determine what type of event caused the click). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the device of modified Binier to include the processing limitations as taught by Larsen to distinguish different sounds from each other such as the click from dose setting compared to a click from an expelling sequence. [0036]
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Binier (US 10,232,123 B1) in view of Cannan et al. (WO 2018/160073 A1), Byerly et al. (US 2021/0330891 A1), and Meyer et al. (US 2023/0105463 A1).
Regarding claim 12, modified Binier discloses the electronic add-on module according to claim 2. Binier further discloses a switch (122 Fig 1) configured to be actuated to activate the acoustic sensor arrangement (as shown in Figs 2 and 3, the circuit 112 which includes microphone 125 is powered by the battery 124 when the switch 122 is actuated).
However, modified Binier fails to disclose wherein the electronic add- on module comprises: a first portion defining an auxiliary dose dial grip and configured to be releasably attached to a dose dial grip of the drug delivery device, wherein the first portion has a longitudinal axis; a second portion coupled to the first portion, the second portion allowing relative rotational movement about the longitudinal axis and relative axial movement parallel to the longitudinal axis with respect to the first portion, and wherein the second portion defines an auxiliary dose button configured to apply pressure onto the dose button of the drug delivery device when the electronic add-on module is releasably attached to the drug delivery device; and wherein, at least when the electronic add-on module is releasably attached to the drug delivery device, an axial relative movement of the second portion along the longitudinal axis with respect to the first portion actuates the switch.
Byerly et al. teaches an electronic add- on module (300 Fig 22) comprises: a first portion (302 Fig 22) defining an auxiliary dose dial grip and configured to be releasably attached to a dose dial grip (32 Fig 2) of the drug delivery device ([0004] “The device further includes a coupling component attached to rotate and translate with the dose setting member.” [0005] “The coupling member is configured to removably couple to a dose setting member of the medication delivery device.”, [0087]), wherein the first portion has a longitudinal axis; a second portion (120 Fig 22) coupled to the first portion (see the coupling of 120 and 302 in Fig 22, [0085] “The cooperation of flange 312 and shoulder 314 provides a firm, mechanical connection”), the second portion allowing relative rotational movement about the longitudinal axis and relative axial movement parallel to the longitudinal axis with respect to the first portion ([0087] “When the module is pushed to deliver a dose, the complementary teeth 320 and 324 separate, causing wall member 302 to uncouple from, and spin relative to, outer wall 120.”), and wherein the second portion defines an auxiliary dose button ([0087] “the module is pushed to deliver a dose”) configured to apply pressure onto the dose button (42 Fig 2, see the arrangement in Fig 22, [0039] “Proximal face 43 of button 42 serves as a push surface against which a force can be applied manually (i.e. directly by user contact or through dose detection module 20) to push actuator 34 in a distal direction”, [0093]) of the drug delivery device when the electronic add-on module is releasably attached to the drug delivery device (as shown in Fig 22). It would have been obvious to one of ordinary skill in the art at the time of effective filing to configure the module of modified Binier with the limitations as taught by Byerly et al. to provide a structure that “does not interfere with the normal operation of the device” and “provides a dosing component that is useful during dose setting to rotate the dose setting component” [0091].
Meyer et al. teaches a switch configured to be actuated to activate the dose measuring circuitry arrangement ([0156] “the battery is electrically coupled to the printed circuit board”, [0158] “the dose counter” ), wherein, an axial relative movement of the second portion (base 40 [0156] Fig 72A, B) along the longitudinal axis with respect to the first portion (cap 220, [0156] Fig 72A, B) actuates the switch ([0156] “the switch 1302 is moveable between the first position where the battery is not electrically coupled of the printed circuit board, and the second position, wherein the battery is electrically coupled to the printed circuit board, in response to the movement of the cap member 220 relative to the base member 40 between the first and second positions”). It would have been obvious to one of ordinary skill in the art at the time of effective filing to include the switch limitations as taught by Meyer et al. in the device of modified Binier to automatically activate the device upon use to minimize power consumption when not in use [0154] and to prevent an instance where a user forgets to turn on the device before use.
Regarding claim 13, modified Binier teaches the electronic add-on module according to claim 12. Modified Binier further teaches wherein the electronic add-on module comprises a clutch mechanism (Byerly- Figs 23-25), wherein, when the clutch mechanism is engaged (Byerly- the clutch is shown engaged in Fig 25), relative rotational movement about the longitudinal axis between the first portion and the second portion is prevented (Byerly- [0087] “During dose setting, outer wall 120 is spring-biased in the direction causing teeth 320 to engage with teeth 324. This rotationally couples together outer wall 120 and wall member 302, thereby coupling the dose setting member and the module.”), wherein, when the clutch mechanism is disengaged, relative rotational movement about the longitudinal axis between the first portion and the second portion is allowed (Byerly- [0087] “When the module is pushed to deliver a dose, the complementary teeth 320 and 324 separate, causing wall member 302 to uncouple from, and spin relative to, outer wall 120.”), and wherein, when the electronic add-on module is releasably attached to the drug delivery device, the switch is configured to be actuated prior to disengagement of the clutch mechanism (the switch of Myer must be actuated to identify a dose setting, the disengagement of the clutch of Byerly is performed after the dose is set to deliver the dose, the modified module of Binier would include the switch being actuated first, then the dose being set, then the clutch being disengaged when the button is pushed to deliver the dose).
Conclusion
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783