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 .
Response to Amendments
The Amendment filed [date] has been entered.
Claims 1-36, 43, and 45 are cancelled.
Claims 37-42, 44, and 46-69 remain pending in the application.
Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 03/11/2025.
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.
Claim(s) 37-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reich et al (US20190269858; Hereafter Reich).
Regarding Claim 37, Reich discloses a medicament delivery device(100) comprising: a reservoir for medicament (111); a dispensing mechanism operable to dispense medicament from the reservoir (P0021), the dispensing mechanism comprising a sleeve (251B, 400) configured to rotate during the dispensing of medicament and having a plurality of formations at an end of the sleeve (ridges 420 and valleys 425); and a dosage measurement system (¶0034 dosage measurement system includes stacked components including multichannel rotary encoder 251) comprising (i) at least one mechanically actuated sensor (320) configured such that rotation of the sleeve (251B, 400) causes successive formations to engage the sensor such that the sensor detects rotation of the sleeve and (ii) a processor configured to determine a dosage dispensed from the medicament reservoir based on the detected rotation of the sleeve (¶0050 Ridges 420 are positioned relative to flexible contact leads 320 to pass over switches 310 and with incremental changes in the relative angular position of substrate 300 to mechanical wave generator 400, flexible contact leads 320 are reciprocally pushed against contact pads 315 to form closed and open circuits, which activate and deactivate switches 310. Controller 305 is electrically coupled to switches 310 to track each activation/deactivation of switches 310 and digitally encode a rotational position of substrate 300 relative to mechanical wave generator 400), the medicament delivery device comprising a dose dial (209) and a housing (207), wherein the dose dial is configured to be rotated relative to the housing to set a dose of medicament to be delivered by the dispensing mechanism (Fig 2e Fig 3 ¶0035 dose dial 209 spins relative to housing 207), and wherein the sensor is mounted to the dose dial (Fig 2e Fig 3 ¶0035 sensor substrate 300 is mounted to dose dialer and contained in same housing).
However, this embodiment of Reich does not expressly state wherein the medicament delivery device comprises a one- way mechanism, wherein the sensor is mounted to the dose dial via the one-way mechanism such that the sensor is resisted from rotating relative to the dose dial in the direction that the sleeve rotates during the dispensing of medicament and is permitted to rotate relative to the dose dial in the opposite direction that the sleeve rotates during the dispensing of medicament.
In another embodiment of Reich, the sensor is mounted to the dose dial via the one-way mechanism such that the sensor is resisted from rotating relative to the dose dial in the direction that the sleeve rotates during the dispensing of medicament and is permitted to rotate relative to the dose dial in the opposite direction that the sleeve rotates during the dispensing of medicament (Fig 5C ¶0043 peaks and valleys are in triangular shape composing ramps and steep cliffs that would prevent it from turning in one direction). This would prevent the dose dial from turning backwards.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify medicament delivery device of Reich to include the triangular peaks and valleys as taught by embodiment 5C of Reich for the purpose of preventing the dose dial from turning backwards.
Regarding Claim 38, Reich discloses the medicament delivery device according to claim 37, wherein the plurality of formations comprises a plurality of teeth (Fig 4, the surface formations 425 and 420 of wave generator/sleeve 400 are teeth).
Regarding Claim 39, Reich discloses the medicament delivery device according to claim 37, wherein the plurality of formations is formed on a proximal end of the sleeve (Fig 2E, formations of 251B are located in the opposite direction from the distal needle).
Regarding Claim 40, Reich discloses the medicament delivery device according to claim 37, wherein the sleeve is a dial sleeve or a drive sleeve (¶0048 mechanical wave generator 400 is affixed to dose dialer 209 and rotates with it as dose is dialed in).
Regarding Claim 41, Reich discloses the medicament delivery device according to claim 37, wherein the sensor (310) comprises a sensing member (320)that is configured to move from an unactuated state to an actuated state when the sensing member is engaged by one of the plurality of formations during rotation of the sleeve (¶0400 As substrate 300 and mechanical wave generator 400 rotate relative to each other), wherein the sensor detects movement of the sensing member between the unactuated and actuated states (¶0400 the profile shape activates and deactivates electro-mechanical switches 310 according to the waveform generated by the profile shape).
Regarding Claim 42, Reich discloses the medicament delivery device according to claim 41, wherein each formation (420 peaks and 425 valleys) comprises a leading edge (420) and wherein engagement of the sensor (contact point 320) with the leading edge (420) of a first formation of the plurality of formations (Fig 4, peaks 420 and valleys 425) until engagement of the sensor with the leading edge of an adjacent second formation of the plurality of formations during rotation of the sleeve represents one encoding period (¶0050 sensor contact point 320 flexes as it nears peak 420 during rotation to encode the rotation), and wherein the sensor is actuated for between 40% to 60% of the encoding period (Fig 4, half of the formations are peaks and ¶0051 in this embodiment the activations from the peaks are encoding periods).
Claim(s) 54-58, 63-65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Byerly et al (WO2019040313; hereafter Byerly).
Regarding Claim 54, Byerly discloses a dosage measurement system (80) for a medicament delivery device (¶0001), wherein the medicament delivery device (¶0001) comprises a reservoir for medicament (20) and a dispensing mechanism operable to dispense medicament from the reservoir (¶0002), the dispensing mechanism comprising a component configured to rotate during the dispensing of medicament (¶0079 sleeve 99 has ramp elements 102 that are designed to turn the sleeve when actuated), the component (99) comprising a plurality of first (ramp feature 102) and second encoder regions (recess 110), the dosage measurement system comprising: first and second sensors that are offset such that rotation of the component by angular displacement (see [0055]) causes one of the first encoder regions to align with the first sensor whilst one of the second encoder regions aligns with the second sensor and then one of the second encoder regions, to align with the first sensor whilst one of the first encoder regions aligns with the second sensor (Fig 7, as the sleeve 99 rotates, the sensor regions move in a rotation; P0081 Fig 8 one of the sensor assemblies 84 is located closer to a recess region in height and one is located closer to a peak region in height so that one would be active and one would be inactive during encoding as it would not fall to the recess at the same time as the other sensor), the first and second sensors configured to differentiate between the first (102) and second (110) encoder regions to detect rotation of the component (¶0080 the difference between the first and second encoder regions are translated into counts which then detect rotation and rotation amount); and a processor (¶0056 electronics assembly 76 includes microcontroller, processing core and memory) configured to determine a dosage dispensed from the medicament reservoir based on the detected rotation of the component (¶0080 Rotational sensor 86 generates signals indicating this angular movement and those signals are used by the controller to determine the total rotation of the dose setting member during dose delivery that can be used to determine the amount of the dose delivery).
However, Byverly does not expressly state further rotation of the component by the same amount of angular displacement.
Byverly teaches in [0055] that the controller may be configured to receive data indicative of the angular movement of the dose setting member that can be used to determine from the outputs the amount of dose delivered by operation of the medication delivery device.
Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to rotate the component by the same amount of angular displacement, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding Claim 55, Byerly discloses the dosage measurement system according to claim 54, wherein the component (99) comprises a plurality of formations (surface features 101), wherein each first encoding region (ramp peak 102)comprises at least a portion of a respective formation (Fig 7 102 is portion of 101) that is detectable by the first and second sensors as the component rotates (¶0080 Rotational sensor 86 generates signals indicating this angular movement and those signals are used by the controller to determine the total rotation of the dose setting member during dose delivery that can be used to determine the amount of the dose delivery), wherein the second encoder regions are provided between adjacent first encoder regions (Fig 7 second encoder region 110 is between the peaks of 102).
Regarding Claim 56, Byerly discloses the dosage measurement system according to claim 54, wherein each formation comprises a tooth, wherein each first encoding region comprises at least a portion of a respective tooth that is detectable by the first and second sensors as the component rotates, wherein each second encoder region comprises at least a gap between adjacent teeth (Fig 7 110 is a gap between ramp/teeth 102).
Regarding Claim 57, Byerly discloses the dosage measurement system according to claim 54, wherein the first and second sensors are arranged such that for all rotational positions of the component in which the first sensor aligns with one of the first encoding regions, the second sensor aligns with one of the second encoding regions (P0081 Fig 8 one of the sensor assemblies 84 is located closer to a recess region in height and one is located closer to a peak region in height so that one would be active and one would be inactive during encoding as it would not fall to the recess at the same time as the other sensor).
Regarding Claim 58, Byerly discloses the dosage measurement system according to claim 54, wherein the component (99) comprises a plurality of encoding periods (formations on 101), wherein each encoding period comprises one of the first encoding regions (102 peak) and an adjacent second encoding region (110 recess), wherein for a given rotational position of the component the first sensor is aligned with a portion of one of the encoding periods and the second sensor is aligned with a different portion of one of the encoding periods (In figure 8 it can be seen that one sensor is aligned with the recess of one region while another sensor is aligned with the peak of a different encoding period).
Regarding Claim 63, Byerly discloses The dosage measurement system according to claim 54, wherein each of the first and second encoding regions extends about the rotational axis of the component by the same predetermined angle (Fig 7 and 8, peaks 102 and valleys 110 are the same length and occur the same amount of times around the circumference of 101 so it is broken down into equal lengths and degrees around that circumference).
Regarding Claim 64, Byerly discloses the dosage measurement system according to claim 63, wherein the second sensor is offset from the first sensor about the rotational axis in a first direction by an odd number integer multiple of the angle that each first encoding region subtends about the rotational axis. In figure 7 and 8, there are 20 separate encoding region pairs, each of them being a peak and a valley measuring up to 18 degrees, 9 degrees apart between each adjacent encoding region which is an odd number integer.
Regarding Claim 65, Byerly discloses the dosage measurement system according to claim 54, wherein the processor (¶0056 electronics assembly 76 includes microcontroller, processing core and memory)is configured to determine a dosage dispensed from the medicament reservoir by a process including counting the number of transitions between the first and second encoding regions detected by the first and second sensors (¶0080 Rotational sensor 86 generates signals indicating this angular movement and those signals are used by the controller to determine the total rotation of the dose setting member during dose delivery that can be used to determine the amount of the dose delivery; ¶0055 A controller is operably connected to the sensor system to receive outputs from the rotational sensor. The controller begins receiving generated signals from the rotational sensor indicative of counts from first to last one for a total number of counts that is used for determining total angular displacement.).
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reich as applied to claim 43 above, and further in view of Byerly et al (WO 2019040313; hereafter Byerly).
Regarding Claim 44, Reich discloses the medicament delivery device according to claim 43.
Reich is silent on comprising a torque limiter, wherein the sensor is mounted to the dose dial via the torque limiter such that rotation of the dose dials relative to the housing with a torque greater than a predetermined limit causes the torque limiter to move to an open state such that the dose dial can rotate relative to the sensor.
Byerly however teaches a medication delivery device with a sensing system that comprises a torque limiter, wherein the sensor (Fig 5 114) is mounted to the dose dial (30) via the torque limiter (108) such that rotation of the dose dial relative to the housing with a torque greater than a predetermined limit causes the torque limiter to move to an open state such that the dose dial can rotate relative to the sensor (P0078 "As flange 38 rotates during dose delivery, the pin(s) and dose button maintain their relative position, and contact surface 111 of pin 104 rides up over each surface feature shown as projection 102 against the biasing force of coil spring 108. Pin 104 then drops down into each recess 110 between adjacent projections. Pin 104 thereby operates as a following member which follows the contours of the projections and recesses." This is for the purpose of preventing overturning the dose by providing a little resistance.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify medicament delivery device of Reich to include the torque limiter as taught by Byerly for the purpose of preventing overturning the dose by providing a little resistance.
Claim(s) 46-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reich, in view of Pederson et al (US20190192782; hereafter Pederson) and further in view of Byerly et al (WO 2019040313; hereafter Byerly).
Regarding Claim 46, Reich discloses a dosage measurement system for a medicament delivery device (100), wherein the medicament delivery device comprises: a housing (107) containing a reservoir for medicament (111); a dispensing mechanism operable to dispense medicament from the reservoir (¶0021 dispensing mechanism) and comprising a component (251B/400) configured to rotate during the dispensing of medicament, the component comprising a plurality of formations (ridges 420 and valleys 425); and an actuator (209) configured to be movable relative to the housing (207) upon actuation to operate the dispensing mechanism to dispense medicament from the reservoir (¶0021), and a dosage measurement system (¶0034 dosage measurement system includes stacked components including multichannel rotary encoder 251) comprising (i) at least one mechanically actuated sensor (320) configured such that rotation of the sleeve (251B, 400) causes successive formations to engage the sensor such that the sensor detects rotation of the sleeve and (ii) a processor configured to determine a dosage dispensed from the medicament reservoir based on the detected rotation of the sleeve (¶0050 Ridges 420 are positioned relative to flexible contact leads 320 to pass over switches 310 and with incremental changes in the relative angular position of substrate 300 to mechanical wave generator 400, flexible contact leads 320 are reciprocally pushed against contact pads 315 to form closed and open circuits, which activate and deactivate switches 310. Controller 305 is electrically coupled to switches 310 to track each activation/deactivation of switches 310 and digitally encode a rotational position of substrate 300 relative to mechanical wave generator 400).
Reich is silent on the dosage measurement system comprising: a sensor moveable from an idle position to a detecting position wherein rotation of the component causes successive formations to be detected by the sensor such that the sensor detects rotation of the component.
Pederson however teaches an accessory to the dose setting mechanism that also tracks dosages wherein rotation of the component causes successive formations to be detected by the sensor such that the sensor detects rotation of the component (¶0086 goes from idle mode to wake up mode when dose is dialed). This is for the purpose of saving battery when left not in use and for quick activation when about to be used.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify medicament delivery device of Reich to include the rotation-based activation from idle state as taught by Pederson for the purpose of saving battery when left not in use and for quick activation when about to be used.
Reich is silent on a processor configured to determine a dosage dispensed from the medicament reservoir based on the detected rotation of the component;
Byerly however teaches a processor (P0056 electronics assembly 76 includes microcontroller, processing core and memory) configured to determine a dosage dispensed from the medicament reservoir based on the detected rotation of the component (P0080 Rotational sensor 86 generates signals indicating this angular movement and those signals are used by the controller to determine the total rotation of the dose setting member during dose delivery that can be used to determine the amount of the dose delivery). This is for the purpose of calculating the dose delivered (¶0080).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify medicament delivery device of Reich to include the processor as taught by Byerly for the purpose of calculating the dose delivered.
Regarding Claim 47, the modified Reich discloses the dosage measurement system according to claim 46, wherein the actuator is slidable relative to the housing ( dose dial 209 spins with actuator 400 relative to housing 207).
Regarding Claim 48, the modified Reich discloses the dosage measurement system according to claim 46, wherein the activation switch comprises a pivotal member that pivots from the off state to the on state to activate the dosage measurement system (¶0050 Ridges 420 are positioned relative to flexible contact leads 320 to pass over switches 310 and with incremental changes in the relative angular position of substrate 300 to mechanical wave generator 400, flexible contact leads 320 are reciprocally pushed against contact pads 315 to form closed and open circuits, which activate and deactivate switches 310).
Regarding Claim 49, the modified Reich discloses the dosage measurement system according to claim 46, wherein the medicament delivery device comprises a stop and wherein the activation switch is configured to rest against the stop when the activation switch is in the off state (Fig 5C, the recess of 515 is a stop for the biased member 320 to rest on when not actively moving).
Regarding Claim 50, the modified Reich discloses the dosage measurement system according to claim 46, wherein the activation switch (320) is configured to engage a part of the medicament delivery device (100) when the actuator is moved to operate the dispensing mechanism such that the activation switch is urged to the on state (¶0050 Ridges 420 are positioned relative to flexible contact leads 320 to pass over switches 310 and with incremental changes in the relative angular position of substrate 300 to mechanical wave generator 400, flexible contact leads 320 are reciprocally pushed against contact pads 315 to form closed and open circuits, which activate and deactivate switches 310. Controller 305 is electrically coupled to switches 310 to track each activation/deactivation of switches 310 and digitally encode a rotational position of substrate 300 relative to mechanical wave generator 400).
Regarding Claim 52, the modified Reich discloses the dosage measurement system according to claim 46, comprising first and second radial bearings, wherein the actuator (400) is rotatably mounted to a part of the device via the first and second bearings, the first and second bearings being axially spaced (¶0036 When substrate 300, first portion 251 A, and mechanical wave generator 400, second portion 251B, are assembled into rotary encoder 251, ridges 420 are co-radially aligned about a central axis 325 with flexible contact leads 320; During operation, substrate 300 and mechanical wave generator 400 rotate relative to each other about central axis 325).
Regarding Claim 53, the modified Reich discloses the dosage measurement system according to claim 46, comprising a support member (400) and a coupling member, wherein the actuator is fixed relative to the support member and wherein the support member is coupled to the coupling member (¶0030 “In other words, a first portion of the button housing (e.g., the sides of the button housing 261) is coupled to rotate around a longitudinal axis of the drug injection pen when attached to the dosage injection mechanism, and a second portion of the button housing (e.g., spinner 286) is coupled to rotate independently from the first portion.”).
Claim(s) 59-62is/are rejected under 35 U.S.C. 103 as being unpatentable over Byerly as in claim 58 above.
Regarding Claim 59, the modified Byerly discloses the dosage measurement system according to claim 58.
The embodiment of Byerly is silent on further comprising a third sensor that is aligned with a different portion of one of the encoding periods to the first and second sensors when the component is in said given rotational position.
Another embodiment of Byerly however states that the sensing component can include “one or more sensing elements” for detecting dosages (¶0054). This would be in order to better sense the movement of the component by providing more sensed outputs of the movement (¶0054). It is not however specific to three sensors.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to optimize and arrive at a third sensor, recognizing that third sensor that is aligned with a different portion of one of the encoding periods to the first and second sensors when the component is in said given rotational position is directly correlated to the redundancy of having multiple sensors in the same phase of detection along the rotation, which is a desirable characteristic, since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP 2144.04 VI-B. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Regarding Claim 60, the modified Byerly discloses the dosage measurement system according to claim 59.
The modified Byerly is silent on further comprising a fourth sensor that aligns with a different portion of one of the encoding periods to the first, second and third sensors when the component is in said given rotational position.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to optimize and arrive at a fourth sensor, fourth sensor that aligns with a different portion of one of the encoding periods to the first, second and third sensors when the component is in said given rotational position, which is a desirable characteristic, since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP 2144.04 VI-B. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Regarding Claim 61 the modified Byerly discloses the dosage measurement system according to claim 54.
The modified Byerly is silent on further comprising a third sensor configured such that, in use, when the component is rotated the third sensor aligns with one of the first encoding regions at the same time that the first sensor aligns with one of the first encoding regions.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to optimize and arrive at a third sensor, recognizing third sensor configured such that, in use, when the component is rotated the third sensor aligns with one of the first encoding regions at the same time that the first sensor aligns with one of the first encoding regions, which is a desirable characteristic, since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP 2144.04 VI-B. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Regarding Claim 62 the modified Byerly discloses the dosage measurement system according to claim 61
The modified Byerly is silent on further comprising a fourth sensor configured such that when the component is rotated the fourth sensor aligns with one of the first encoding regions at the same time that the second sensor aligns with one of the first encoding regions.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to optimize and arrive at a fourth sensor configured such that when the component is rotated the fourth sensor aligns with one of the first encoding regions at the same time that the second sensor aligns with one of the first encoding regions, which is a desirable characteristic, since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP 2144.04 VI-B. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Claim(s) 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reich in view of Byerly, as in claim 46 above in view of Pederson.
Regarding Claim 51, the modified Reich discloses the dosage measurement system according to claim 46,
The modified Reich is silent on wherein the activation switch is configured such that the activation switch moves a first distance from the off state to the on state and the sensor is configured such that the sensor moves a second distance from the idle position to the detecting position, wherein the second distance is greater than the first distance.
Pederson however teaches an accessory to the dose setting mechanism that also tracks dosages wherein rotation of the component causes successive formations to be detected by the sensor such that the sensor detects rotation of the component (¶0086 goes from idle mode to wake up mode when dose is dialed). This is for the purpose of saving battery when left not in use and for quick activation when about to be used.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify medicament delivery device of the modified Byerly to include the rotation-based activation from idle state as taught by Pederson for the purpose of saving battery when left not in use and for quick activation when about to be used.
Claim(s) 66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Byerly, as in claim 54 above in view of Pederson.
Regarding Claim 66, the modified Byerly discloses the dosage measurement system according to claim 54.
The modified Byerly is silent on wherein the first and second sensors are configured to move from an idle position to a detecting position, wherein movement of the sensors to the detecting position causes one of the first and second sensors to align with one of the first encoding regions and wherein the processor is configured such that when determining the dosage dispensed the processor compensates for said alignment when the sensor moves to the detecting position.
Pederson however teaches an accessory to the dose setting mechanism that also tracks dosages wherein rotation of the component causes successive formations to be detected by the sensor such that the sensor detects rotation of the component (¶0086 goes from idle mode to wake up mode when dose is dialed). This is for the purpose of saving battery when left not in use and for quick activation when about to be used.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify medicament delivery device of the modified Byerly to include the rotation-based activation from idle state as taught by Pederson for the purpose of saving battery when left not in use and for quick activation when about to be used.
Claim(s) 67-69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Byerly as in claim 54 above in view of Reich.
Regarding Claim 67, the modified Byerly discloses the dosage measurement system according to claim 54, wherein the processor is configured to determine a dosage dispensed from the medicament reservoir based on a signal from one of the first and second sensors (¶0056 electronics assembly 76 includes a processor that detects angular movement and determines dose dispensed based on the total counts). Byerly also teaches that the first and second switch are not in the same phase as each other (Fig 7 and 8).
The modified Byerly is silent on an inverse signal from the other one of the first and second sensors.
Reich however teaches that the electronics assembly receives signals from both the encoding activations of the switches and the decoding activation of the switches (¶0052). This is for the purpose of having a signal for all scenarios during rotation.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify medicament delivery device of the modified Byerly to include the inverse signal as taught by Reich for the purpose of having a signal for all scenarios during rotation.
Regarding Claim 68 the modified Byerly discloses the dosage measurement system according to claim 67.
Byerly is silent on wherein the processor is configured to determine a dosage dispensed from the medicament reservoir based on a superposition of the signal from one of the first and second sensors and the inverse signal from the other one of the first and second sensors
Reich however teaches the processor is configured to determine a dosage dispensed from the medicament reservoir based on a superposition of the signal from one of the first and second sensors and the inverse signal from the other one of the first and second sensors (¶0050 in process block 615, the relative rotation between the substrate and the mechanical in which the switches are activated and deactivated. ¶0051 In one embodiment both of those activation and deactivation signals are encoded to be interpreted as distance rotated and then dosage dispensed). This is for the purpose of having a signal specific to all scenarios during rotation which could lead to more accurate understanding of rotation amount and therefore how much medication has been dispensed.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify medicament delivery device of the modified Byerly to include the inverse signal as taught by Reich for the purpose of having a signal for all scenarios during rotation.
Regarding Claim 69 the modified Byerly discloses the dosage measurement system according to claim 68
The modified Byerly is silent on wherein the processor is configured to determine a dosage dispensed from the medicament reservoir by comparing the superposition to a first threshold value and a second threshold value greater than the first threshold value.
Reich however teaches that the processor (process block 615) can determine the dosage dispensed by comparing the superposition of a first threshold value and a second threshold value greater than the first threshold value (¶0052 “Finally, in a process block 625, controller 305 generates a signal, based upon the encoding of the activations and/or deactivations of one or more switches 310, that is indicative of the dosage of a fluid disposed over a period of time. In one embodiment, the signal is a stateful value representative of the absolute rotational position between substrate 300 and mechanical wave generator 400 as measured from a zeroed position or reference position. This signal may be wirelessly transmitted from drug injection pen 101 to processing device 121 periodically or on-demand. It should be appreciated that process 600 represents one example use case scenario of rotary encoder 251 with a drug injection pen; however, rotary encoder 251 is well suited to encode rotary motions in a variety of other types of devices.”) This is for the purpose of finding the absolute displacement and using it to determine how much medication has been dispensed.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify medicament delivery device of the modified Byerly to include the processor is configured to determine a dosage dispensed from the medicament reservoir by comparing the superposition to a first threshold value and a second threshold value greater than the first threshold value as taught by Reich for the purpose of finding the absolute displacement and using it to determine how much medication has been dispensed.
Response to Arguments
In regards to claims 37, 43, and 45 and the Applicant’s argument that “Reich actually teaches that there is no rotational movement of the alleged sensor (320) relative to the alleged dose dial (209) during the dispensing of medicament… Reich is in fact silent on the arrangement of FIG. 5C acting as a one-way mechanism… Furthermore, the interpretation taken by the Office regarding the alleged one-way mechanism of Reich does not appear to make technical sense… Applicant respectfully submits that the Office's argument that Reich is a "one-way mechanism" therefore suggests a hindsight interpretation the disclosure in Reich informed by the solution disclosed in the present application.”
This is not persuasive for the following reasons
The rejection does not rely upon Reich’s rotational locking arrangement as expressly disclosing the claimed one-way mechanism. Rather, Reich is relied upon for teaching a medicament delivery device having a dose dial/control wheel, a dosage measurement system, and a rotary encoder in which a substrate carrying the mechanically actuated sensor is mechanically coupled to the dose dial and rotates in response to dispensing. Reich expressly teaches that the drug delivery control wheel 209 and substrate 300 are mechanically coupled to rotate when fluid is dispensed. Reich further teaches that the substrate 300 carries the flexible contact leads 320, and that relative rotation between the substrate and mechanical wave generator causes the ridges of the wave generator to engage the flexible contact leads and thereby generate the signals used to determine rotational position and dosage.
Reich expressly recognizes that different mechanical configurations may be employed. Reich describes the rotary encoder as being applicable to different drug injection pens and to arrangements in which different components rotate relative to one another (see [0022;0033-0034];. Reich further expressly provides multiple alternative profile configurations for the mechanical wave generator, including triangular and truncated triangular profiles. FIGS. 5A-5E are expressly disclosed as alternative profile shapes for the mechanical wave generator. Reich explains that the profile shape and relative spacing of the switches may be selected to obtain mechanically stable angular positions, and that the profile shape may be selected for functional purposes including reduction of friction and increased switch longevity (see [0045]). It would be obvious to one of ordinary skill in the art that the mechanical interface disclosed by Reich may be modified according to the desired mechanical operation. More importantly, the claimed “one-way mechanism” is a particular mechanical relationship between the dose dial and sensor. Applicant has not established that providing such a directional coupling would require anything more than the application of a known mechanical arrangement to Reich’s existing rotationally coupled components. The modification would retain Reich’s basic operating principle—rotation associated with dose selection/dispensing is mechanically sensed by the rotary encoder—while selectively permitting relative movement in one rotational direction and resisting relative movement in the other.
Therefore the rejection is not relying upon hindsight as the Applicant argued, but rather the proposed modification is based upon Reich teaching a device having embodiments which provides a rotary encoder having mechanically coupled rotating components, multiple alternative mechanical wave-generator profiles, and alternative arrangements in which different components may rotate relative to one another.
Applicant’s arguments with respect to the rejection(s) of claim 54 under 35 U.S.C. 102 to Byerly have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a different interpretation of the previously applied Byerly reference under 35 U.S.C. 103.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
09/09/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights