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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 3, 2026 has been entered.
Status of Claims
This office action is in response to arguments and amendments entered on March 3, 2026 for the patent application 17/610,814 originally filed on November 12, 2021. Claims 16 and 31 are amended. Claims 1-15 are canceled. Claims 16-35 remain pending. The first office action of August 20, 2024, the second office action of February 10, 2025, the third office action of June 4, 2025, and the fourth office action of December 29, 2025 are fully incorporated by reference into this office action.
Response to Amendment
Applicant’s amendments to the claims have been noted by the Examiner.
The Applicant’s amendments to the claims are not sufficient to overcome the outstanding rejections under 35 USC 103, for reasons set forth below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 16-35 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (hereinafter “Chang,” US 2019/0096286) in view of Ma (US 2019/0366004).
Regarding claim 16, Chang discloses a drive mechanism for a resettable medicament delivery training device (see Chang Fig. 1, automatic injection training device 10), the drive mechanism comprising:
a plunger rod having a proximal end and a distal end, wherein the plunger rod comprises a stopper at the proximal end, wherein the stopper includes an outer diameter (see Chang Fig. 9, plunger rod 106; also Chang [0037], “The proximal end of the plunger rod 106 is arranged with a cylindrical hub 118, FIG. 9, which hub 118 is arranged with a circumferential ledge 120. On the hub 118, a friction element 122 is arranged having a number of circumferential ridges 124 on its outer surface,” wherein the friction element 122 with circumferential ridges 124 on the proximal end of the plunger rod 106 acts as a stopper. The stopper is round and the equivalent to “friction element 122” is also round, therefore both the “stopper" of the instant invention and the "friction element 122" of Chang inherently include "an outer diameter."),
a container having an inner chamber, an open proximal container end, an open distal container end leading into the inner chamber, and a stopper contact surface positioned in the inner chamber (see Chang Figs. 10 and 11, showing tubular demo container 128 having inner chamber; also Chang [0042], "the friction element 122 interacts with the distal section 142 of the tubular wall of the demo container 128," wherein the "friction element 122" is the stopper and the "distal section 142" is positioned in the inner chamber of the demo container 128.),
…
and a resetting structure (see Chang Fig. 12, showing reload cap unit 146),
wherein in an initial state of the drive mechanism the plunger rod extends through the open distal container end into the inner chamber and is axially fixedly arranged in a first position distal to the stopper contact surface in the container and biased towards the open proximal container end, and wherein the plunger rod is configured to be released from the first position, causing the plunger rod to move towards the open proximal container end to obtain a second position in the container proximal to the stopper contact surface (see Chang Fig. 3; also Chang [0040], “The injection training device is intended to be used as follows. When provided to the user, the plunger rod 106 is in the distal position with the drive spring 110 tensioned as seen in FIG. 3. The plunger rod 106 is held in this tensioned position by the flexible arms 78 of the actuator 62 fitting into the circumferential groove 108 of the plunger rod 106. The flexible arms 78 are prevented from releasing the plunger rod 106 by the actuator sleeve 82 being in contact with outer surfaces of the flexible arms 78 with the proximally directed end surfaces of its longitudinal ribs 90 abutting the tapering section 72 of the flexible arms 78, thereby preventing movement of the actuator sleeve 82 in the proximal direction by the force of the actuator sleeve spring 94. The ledges 102 of the arms 100 of the first signal generating element 96 are also positioned in the circumferential groove 208 of the plunger rod and held in place by the flexible arms 78 of the actuator as seen in FIG. 3. The proximal end is arranged with the cap 148 of the reload cap unit 146 attached and the plunger 154 placed inside the demo container as seen in FIG. 3.”; see also Chang Figs. 13-16, showing the stopper 122 starting distal to the stopper contact surface in Figs. 13 and 14, then moving past it to a position proximal to the stopper contact surface in Figs. 15 and 16),
wherein when the plunger rod moves from the first position towards the second position, the stopper of the plunger rod impacts the stopper contact surface and results in an initial signal indicating that medicament administration has commenced (see Chang Fig. 14 and [0041], “The first signal generating element 96 also moves axially together with the plunger rod 106 a predetermined distance D1 until the first signal generating element 96 is released from the plunger rod 106 when the proximal end surface of the first signal generating element 96 impacts with the distal end surface of the flange 137 of the demo container 128, FIG. 14, causing a first audible feedback signal which simulates the start of an injection phase. The impact results in a distinct click which indicates to the user that the first phase of the injection has been simulated,” a signal generating element 96 at the proximal end of the plunger impacts a contact surface and generates a first audible feedback signal indicating the start of an injection phase),
wherein, after producing the initial signal, the plunger rod and the stopper move past the stopper contact surface to the second position in the container (Chang [0042], “The plunger rod 106 continues in the proximal direction wherein the friction element 122 interacts with the distal section 142 of the tubular wall of the demo container 128, FIG. 15, such that a frictional resistive force between the friction element 122 and the tubular wall 140 of the demo container 128 causes the plunger rod 106 to be moved with a uniform speed and resistance simulating an injection phase of a medicament delivery. When the friction element 122 reaches the proximal section 144, FIG. 16, the resistive force is greatly reduced or even removed, whereby the plunger rod 106 is accelerated until the second signal generating element 126 impacts the distal surfaces of the tongues 30 of the housing, FIG. 17, causing a second audible feedback signal which simulates the end of an injection phase,” after the plunger rod [and stopper] generates the initial signal, the plunger rod [and stopper] continues past the initial stopper contact surface), and
wherein the resetting structure is configured to be manually inserted into the container via the open proximal container end when the plunger rod is in the second position, the resetting structure being configured to be moved manually towards the distal open end of the container to reset the plunger rod in the first position (Chang [0043], “The reload cap unit 146 is now attached to the proximal end of the training device by entering the plunger 154 into the central passage 48 of the medicament delivery element guard. The end surface of the plunger 154 is brought in contact with the second signal generating element 126 of the plunger rod 106. The plunger rod 106 and the plunger 154 will be moved in the distal direction against the axial force of the drive spring 110. During the movement, the inwardly directed ledges 102 of the arms 100 of the first signaling element 96 will enter the circumferential groove 108 of the plunger rod 106. At the end of the movement of the plunger rod 106 in the distal direction, the inwardly directed ledges 74 of the flexible arms 78 of the actuator 62 will also enter the circumferential groove 108 of the plunger rod 106. The actuator sleeve 82 is now free to move in the proximal direction due to the force of the actuator sleeve spring 94 to its initial position wherein the proximally end surfaces of the longitudinal ribs 90 come in contact with the tapering segment 72 of the flexible arms 78, thereby again blocking the flexible arms 78 of the actuator 62 as seen in FIG. 3. The injection training device reload process is finished and the device is ready for training injection again.”).
Chang does not explicitly teach every limitation of wherein the stopper contact surface provides a gradual decrease of a diameter of the inner chamber in the proximal direction until the diameter of the inner chamber is smaller than the outer diameter of the stopper.
While Chang does not explicitly call attention to the changing diameter of the inner chamber, Chang [0042] does disclose that the friction element 122 (stopper) interacts with the distal section 142 (inner chamber). In order for the friction element to "interact" with the distal section, its diameter must be larger than the diameter of the distal section. This is apparent in Chang Fig. 14, showing the friction element 122 (stopper) just prior to entry into the distal section 142 (inner chamber), where the friction element is visibly bigger in diameter than the distal section. Then Chang Fig. 15, shows the friction element 122 compressed against the narrower walls of the distal section 142 ("interacting" with it). Thus, Chang provides support for providing a gradual decrease of a diameter of the inner chamber in the proximal direction until the diameter of the inner chamber is smaller than the outer diameter of the stopper, but does not state it explicitly.
However, Ma provides a similar invention which more explicitly discloses wherein the stopper contact surface provides a gradual decrease of a diameter of the inner chamber in the proximal direction until the diameter of the inner chamber is smaller than the outer diameter of the stopper (Ma [0058], “In one or more embodiments, the inner diameter of the second sidewall portion 118B increases gradually in the proximal direction. The inner diameter of the barrel 110 increases gradually in the proximal direction such that the gap 150 exists between the barrel 110 and stopper 140 when the stopper 140 is pulled into this location.”; Note that Ma [0050] states, “In this disclosure, a convention is followed wherein the distal end of the device is the end closest to a patient and the proximal end of the device is the end away from the patient and closest to a practitioner.” This is opposite to the convention used in the instant disclosure. Therefore, the gradual increase of diameter in the proximal direction described by Ma is the same as the gradual decrease of diameter in the proximal direction as described in the instant claims, since the proximal/distal directions are reversed between Ma and in the instant invention; see also Ma Fig. 1, showing a decrease in diameter of the inner chamber in the proximal direction as the stopper 140 is pushed. Alternatively, Ma Fig. 1 also shows “distal wall 116,” where the inner chamber narrows towards the patient end of the syringe).
Ma is analogous to Chang, as both are drawn to the art of medicament delivery devices. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Chang, to include wherein the stopper contact surface provides a gradual decrease of a diameter of the inner chamber in the proximal direction until the diameter of the inner chamber is smaller than the outer diameter of the stopper, as taught by Ma, since it would be a simple substitution of a variable diameter inner chamber for a constant diameter inner chamber to obtain predictable results. Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 17, Chang in view of Ma discloses wherein the resetting structure is an elongated structure (see Chang Fig. 12, reload cap unit 146 is elongated).
Regarding claim 18, Chang in view of Ma discloses a cap, wherein the resetting structure is fixedly arranged in the cap (see Chang Fig. 12, reload cap unit 146 with resetting structure).
Regarding claim 19, Chang in view of Ma discloses a holding structure provided with a radially flexible arm, wherein the plunger rod is provided with a radial recess configured to engage with the radially flexible arm to maintain the plunger rod axially fixed in the first position (Chang [0040], “The plunger rod 106 is held in this tensioned position by the flexible arms 78 of the actuator 62 fitting into the circumferential groove 108 of the plunger rod 106. The flexible arms 78 are prevented from releasing the plunger rod 106 by the actuator sleeve 82 being in contact with outer surfaces of the flexible arms 78 with the proximally directed end surfaces of its longitudinal ribs 90 abutting the tapering section 72 of the flexible arms 78, thereby preventing movement of the actuator sleeve 82 in the proximal direction by the force of the actuator sleeve spring 94. The ledges 102 of the arms 100 of the first signal generating element 96 are also positioned in the circumferential groove 208 of the plunger rod and held in place by the flexible arms 78 of the actuator”).
Regarding claim 20, Chang in view of Ma discloses an actuator sleeve configured to receive the holding structure, the actuator sleeve being configured to move between a proximal position and a distal position, wherein in the proximal position the actuator sleeve is configured to urge the radially flexible arm radially inwards to engage with the radial recess (Chang [0043], “The reload cap unit 146 is now attached to the proximal end of the training device by entering the plunger 154 into the central passage 48 of the medicament delivery element guard. The end surface of the plunger 154 is brought in contact with the second signal generating element 126 of the plunger rod 106. The plunger rod 106 and the plunger 154 will be moved in the distal direction against the axial force of the drive spring 110. During the movement, the inwardly directed ledges 102 of the arms 100 of the first signaling element 96 will enter the circumferential groove 108 of the plunger rod 106. At the end of the movement of the plunger rod 106 in the distal direction, the inwardly directed ledges 74 of the flexible arms 78 of the actuator 62 will also enter the circumferential groove 108 of the plunger rod 106. The actuator sleeve 82 is now free to move in the proximal direction”).
Regarding claim 21, Chang in view of Ma discloses wherein when the actuator sleeve is in the distal position the actuator sleeve is configured to enable the radially flexible arm to move radially outwards to disengage from the radial recess, thereby releasing the plunger rod from the first position (see Chang Fig. 13 and [0041], “The actuator sleeve 82 is then moved in the distal direction in relation to the device, tensioning the actuator sleeve spring 94, until the actuator sleeve 82 is moved out of contact with the flexible arms 78 of the actuator 62”).
Regarding claim 22, Chang in view of Ma discloses wherein the actuator sleeve is biased towards the proximal position (see Chang Fig. 13 and [0041], “The actuator sleeve 82 is then moved in the distal direction in relation to the device, tensioning the actuator sleeve spring 94, until the actuator sleeve 82 is moved out of contact with the flexible arms 78 of the actuator 62,” the actuator sleeve spring 94 biases the actuator sleeve towards the proximal position).
Regarding claim 23, Chang in view of Ma discloses wherein the radially flexible arm is configured to engage with the radial recess when the plunger rod is moved from the second position towards the first position by the resetting structure, thereby axially locking the plunger rod in the first position (see Chang Fig. 3 and [0043], “At the end of the movement of the plunger rod 106 in the distal direction, the inwardly directed ledges 74 of the flexible arms 78 of the actuator 62 will also enter the circumferential groove 108 of the plunger rod 106. The actuator sleeve 82 is now free to move in the proximal direction due to the force of the actuator sleeve spring 94 to its initial position wherein the proximally end surfaces of the longitudinal ribs 90 come in contact with the tapering segment 72 of the flexible arms 78, thereby again blocking the flexible arms 78 of the actuator 62 as seen in FIG. 3.”).
Regarding claim 24, Chang in view of Ma discloses a delivery member cover configured to move linearly relative to the container, between an initial position and an activating position, the delivery member cover being biased towards the initial position, wherein the delivery member cover is configured to move the actuator sleeve from the proximal position to the distal position when moved from the initial position to the activating position (Chang Fig. 13 and [0041], “This causes the medicament delivery element guard 44 to be moved in the distal direction in relation to the rest of the device, FIG. 13, tensioning the medicament delivery element guard spring 56. After a certain distance, distally directed end surfaces of the arms 52 of the medicament delivery element guard 44 come in contact with proximally directed surfaces of the circumferential collar 88 of the actuator sleeve 82. The actuator sleeve 82 is then moved in the distal direction in relation to the device, tensioning the actuator sleeve spring 94, until the actuator sleeve 82 is moved out of contact with the flexible arms 78 of the actuator 62,” the delivery element guard 44 is a delivery member cover).
Regarding claim 25, Chang in view of Ma discloses a housing configured to receive the container, wherein the housing has an open proximal housing end configured to receive the resetting structure (Chang [0031], “The automatic injection training device 10 according to the present invention may comprise an elongated housing 12 having a distal end 14 and a proximal end 16. The training device further comprises a cap 20 at the distal end of the housing. The housing extends along a longitudinal axis L and is provided with a central passage 21 in the proximal end; FIG. 4. The elongated housing 12 may also comprise two oppositely positioned inspection windows 22 for assessing visually the current state of the injection training device.”).
Regarding claim 26, Chang in view of Ma discloses wherein the housing has an inner stop structure configured to stop proximal movement of the plunger rod in the inner chamber, causing the plunger rod to obtain the second position (see Chang Figs. 16-17 and [0032], “the resistive force is greatly reduced or even removed, whereby the plunger rod 106 is accelerated until the second signal generating element 126 impacts the distal surfaces of the tongues 30 of the housing”).
Regarding claim 27, Chang in view of Ma discloses wherein the inner stop structure comprises a plurality of radially inwards extending protrusions configured to enable the resetting structure to be received between them (see Chang Fig. 4, such as tongues 30).
Regarding claim 28, Chang in view of Ma discloses wherein the container is provided with a proximal engagement structure configured to engage with the housing (Chang [0038], “The demo container 128 is arranged to be connected to the housing such that the arms 132 at the proximal end fit between the inwardly directed ledges 30 with the protrusions 134 gripping around the circumferential ledge 28”).
Regarding claim 29, Chang in view of Ma discloses wherein the radially inwards extending protrusions form a central proximal opening into the container, configured to receive the resetting structure (Chang [0043], “The reload cap unit 146 is now attached to the proximal end of the training device by entering the plunger 154 into the central passage 48 of the medicament delivery element guard.”).
Regarding claim 30, Chang in view of Ma discloses resettable medicament delivery training device comprising a drive mechanism as claimed in claim 16 (see Chang Fig. 1, automatic injection training device 10).
Regarding claim 31, Chang discloses an assembly for a resettable medicament delivery training device (see Chang Fig. 1, automatic injection training device 10), the assembly comprising:
a drive mechanism comprising (see Chang Fig. 1, automatic injection training device 10);
a hollow plunger rod having a proximal end and a distal end, wherein the plunger rod comprises a stopper at the proximal end, wherein the stopper includes an outer diameter (see Chang Fig. 9, plunger rod 106; also Chang [0037], “the plunger rod 106 is hollow”; also Chang [0037], “The proximal end of the plunger rod 106 is arranged with a cylindrical hub 118, FIG. 9, which hub 118 is arranged with a circumferential ledge 120. On the hub 118, a friction element 122 is arranged having a number of circumferential ridges 124 on its outer surface,” wherein the friction element 122 with circumferential ridges 124 on the proximal end of the plunger rod 106 acts as a stopper. The stopper is round and the equivalent to “friction element 122” is also round, therefore both the “stopper" of the instant invention and the "friction element 122" of Chang inherently include "an outer diameter.");
a spring partially positioned within the plunger rod (Chang [0037], “the plunger rod 106 is hollow and a compression drive spring 110 is placed inside the plunger rod 106”); and
a holding structure releasably engaged with an outside surface of the plunger rod, a container having an inner chamber, an open proximal end, an open distal end, and a stopper contact surface positioned in the inner chamber (Chang [0008], “an actuation assembly configured to hold the plunger in the first position and to release the plunger from the first position. A first signal generating element is releasably connected to the plunger and a second signal generating element is fixedly connected to the plunger”; also Chang [0042], "the friction element 122 interacts with the distal section 142 of the tubular wall of the demo container 128," wherein the "friction element 122" is the stopper and the "distal section 142" is positioned in the inner chamber of the demo container 128.),
…
a resetting structure (see Chang Fig. 12, showing reload cap unit 146),
wherein in an initial state of the holding structure the plunger rod extends through the open distal end and is axially fixedly arranged in a first position distal to the stopper contact surface relative to the container such that the spring biases the plunger rod towards the open proximal end (see Chang Fig. 3; also Chang [0040], “The injection training device is intended to be used as follows. When provided to the user, the plunger rod 106 is in the distal position with the drive spring 110 tensioned as seen in FIG. 3. The plunger rod 106 is held in this tensioned position by the flexible arms 78 of the actuator 62 fitting into the circumferential groove 108 of the plunger rod 106. The flexible arms 78 are prevented from releasing the plunger rod 106 by the actuator sleeve 82 being in contact with outer surfaces of the flexible arms 78 with the proximally directed end surfaces of its longitudinal ribs 90 abutting the tapering section 72 of the flexible arms 78, thereby preventing movement of the actuator sleeve 82 in the proximal direction by the force of the actuator sleeve spring 94. The ledges 102 of the arms 100 of the first signal generating element 96 are also positioned in the circumferential groove 208 of the plunger rod and held in place by the flexible arms 78 of the actuator as seen in FIG. 3. The proximal end is arranged with the cap 148 of the reload cap unit 146 attached and the plunger 154 placed inside the demo container as seen in FIG. 3.”; see also Chang Figs. 13-16, showing the stopper 122 starting distal to the stopper contact surface in Figs. 13 and 14),
wherein movement of the holding structure from the initial state disengages the plunger rod from the first position such that the plunger rod moves axially towards the open proximal end to reach a second position proximal to the stopper contact surface relative to the container (Chang [0008], “an actuation assembly configured to hold the plunger in the first position and to release the plunger from the first position. A first signal generating element is releasably connected to the plunger and a second signal generating element is fixedly connected to the plunger”; see also Chang Figs. 13-16, showing the stopper 122 starting distal to the stopper contact surface in Figs. 13 and 14, then moving past it to a position proximal to the stopper contact surface in Figs. 15 and 16),
wherein when the plunger rod moves from the first position towards the second position, the stopper of the plunger rod impacts the stopper contact surface and results in an initial signal indicating that medicament administration has commenced (see Chang Fig. 14 and [0041], “The first signal generating element 96 also moves axially together with the plunger rod 106 a predetermined distance D1 until the first signal generating element 96 is released from the plunger rod 106 when the proximal end surface of the first signal generating element 96 impacts with the distal end surface of the flange 137 of the demo container 128, FIG. 14, causing a first audible feedback signal which simulates the start of an injection phase. The impact results in a distinct click which indicates to the user that the first phase of the injection has been simulated,” a signal generating element 96 at the proximal end of the plunger impacts a contact surface and generates a first audible feedback signal indicating the start of an injection phase),
wherein, after producing the initial signal, the plunger rod and the stopper move past the stopper contact surface to the second position in the container (Chang [0042], “The plunger rod 106 continues in the proximal direction wherein the friction element 122 interacts with the distal section 142 of the tubular wall of the demo container 128, FIG. 15, such that a frictional resistive force between the friction element 122 and the tubular wall 140 of the demo container 128 causes the plunger rod 106 to be moved with a uniform speed and resistance simulating an injection phase of a medicament delivery. When the friction element 122 reaches the proximal section 144, FIG. 16, the resistive force is greatly reduced or even removed, whereby the plunger rod 106 is accelerated until the second signal generating element 126 impacts the distal surfaces of the tongues 30 of the housing, FIG. 17, causing a second audible feedback signal which simulates the end of an injection phase,” after the plunger rod [and stopper] generates the initial signal, the plunger rod [and stopper] continues past the initial stopper contact surface), and
wherein the resetting structure is manually inserted into the open proximal end when the plunger rod is in the second position such that the resetting structure is moved manually towards the distal open end so as to push and reset the plunger rod back to the first position (Chang [0043], “The reload cap unit 146 is now attached to the proximal end of the training device by entering the plunger 154 into the central passage 48 of the medicament delivery element guard. The end surface of the plunger 154 is brought in contact with the second signal generating element 126 of the plunger rod 106. The plunger rod 106 and the plunger 154 will be moved in the distal direction against the axial force of the drive spring 110. During the movement, the inwardly directed ledges 102 of the arms 100 of the first signaling element 96 will enter the circumferential groove 108 of the plunger rod 106. At the end of the movement of the plunger rod 106 in the distal direction, the inwardly directed ledges 74 of the flexible arms 78 of the actuator 62 will also enter the circumferential groove 108 of the plunger rod 106. The actuator sleeve 82 is now free to move in the proximal direction due to the force of the actuator sleeve spring 94 to its initial position wherein the proximally end surfaces of the longitudinal ribs 90 come in contact with the tapering segment 72 of the flexible arms 78, thereby again blocking the flexible arms 78 of the actuator 62 as seen in FIG. 3. The injection training device reload process is finished and the device is ready for training injection again.”).
Chang does not explicitly teach every limitation of wherein the stopper contact surface provides a gradual decrease of a diameter of the inner chamber in the proximal direction until the diameter of the inner chamber is smaller than the outer diameter of the stopper.
While Chang does not explicitly call attention to the changing diameter of the inner chamber, Chang [0042] does disclose that the friction element 122 (stopper) interacts with the distal section 142 (inner chamber). In order for the friction element to "interact" with the distal section, its diameter must be larger than the diameter of the distal section. This is apparent in Chang Fig. 14, showing the friction element 122 (stopper) just prior to entry into the distal section 142 (inner chamber), where the friction element is visibly bigger in diameter than the distal section. Then Chang Fig. 15, shows the friction element 122 compressed against the narrower walls of the distal section 142 ("interacting" with it). Thus, Chang provides support for providing a gradual decrease of a diameter of the inner chamber in the proximal direction until the diameter of the inner chamber is smaller than the outer diameter of the stopper, but does not state it explicitly.
However, Ma discloses wherein the stopper contact surface provides a gradual decrease of a diameter of the inner chamber in the proximal direction until the diameter of the inner chamber is smaller than the outer diameter of the stopper (Ma [0058], “In one or more embodiments, the inner diameter of the second sidewall portion 118B increases gradually in the proximal direction. The inner diameter of the barrel 110 increases gradually in the proximal direction such that the gap 150 exists between the barrel 110 and stopper 140 when the stopper 140 is pulled into this location.”; Note that Ma [0050] states, “In this disclosure, a convention is followed wherein the distal end of the device is the end closest to a patient and the proximal end of the device is the end away from the patient and closest to a practitioner.” This is opposite to the convention used in the instant disclosure. Therefore, the gradual increase of diameter in the proximal direction described by Ma is the same as the gradual decrease of diameter in the proximal direction as described in the instant claims, since the proximal/distal directions are reversed between Ma and in the instant invention; see also Ma Fig. 1, showing a decrease in diameter of the inner chamber in the proximal direction as the stopper 140 is pushed. Alternatively, Ma Fig. 1 also shows “distal wall 116,” where the inner chamber narrows towards the patient end of the syringe).
Ma is analogous to Chang, as both are drawn to the art of medicament delivery devices. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Chang, to include wherein the stopper contact surface provides a gradual decrease of a diameter of the inner chamber in the proximal direction until the diameter of the inner chamber is smaller than the outer diameter of the stopper, as taught by Ma, since it would be a simple substitution of a variable diameter inner chamber for a constant diameter inner chamber to obtain predictable results. Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 32, Chang in view of Ma discloses wherein the resetting structure is fixedly arranged in a cap releasably connectable to a housing that holds the drive mechanism (see Chang Fig. 12, reload cap unit 146 with resetting structure; also Chang [0020], “The reload cap unit comprises a removable proximal cap having a shaft element that is configured for being introduced into the elongated housing assembly through a proximal opening of the needle cover.”).
Regarding claim 33, Chang in view of Ma discloses wherein the holding structure comprises a radially flexible arm releasably engaged with a radial recess on the plunger rod to maintain the plunger rod axially fixed in the first position (Chang [0008], “a tubular demo container axially and rotationally fixed relative to the elongated housing and having a tubular wall extending along the longitudinally axis (L); a reloadable plunger assembly comprising a plunger which is movable in the demo container between a first and a second position, and a first energy accumulating element configured to move the plunger from the first to the second position; an actuation assembly configured to hold the plunger in the first position and to release the plunger from the first position. A first signal generating element is releasably connected to the plunger and a second signal generating element is fixedly connected to the plunger”).
Regarding claim 34, Chang in view of Ma discloses an actuator sleeve operationally engaged with the holding structure having a radially flexible arm, where the actuator sleeve moves between a proximal position and a distal position, wherein when in the proximal position the actuator sleeve prevents the radially flexible arm from flexing radially outward and disengaging from the radial recess (Chang [0043], “The reload cap unit 146 is now attached to the proximal end of the training device by entering the plunger 154 into the central passage 48 of the medicament delivery element guard. The end surface of the plunger 154 is brought in contact with the second signal generating element 126 of the plunger rod 106. The plunger rod 106 and the plunger 154 will be moved in the distal direction against the axial force of the drive spring 110. During the movement, the inwardly directed ledges 102 of the arms 100 of the first signaling element 96 will enter the circumferential groove 108 of the plunger rod 106. At the end of the movement of the plunger rod 106 in the distal direction, the inwardly directed ledges 74 of the flexible arms 78 of the actuator 62 will also enter the circumferential groove 108 of the plunger rod 106. The actuator sleeve 82 is now free to move in the proximal direction”).
Regarding claim 35, Chang in view of Ma discloses wherein the housing has an inner stop structure with a through hole and configured to stop proximal movement of the plunger rod relative to the container as the plunger rod moves from the first position to the second position (see Chang Figs. 16-17 and [0032], “the resistive force is greatly reduced or even removed, whereby the plunger rod 106 is accelerated until the second signal generating element 126 impacts the distal surfaces of the tongues 30 of the housing”).
Response to Arguments
The Applicant’s arguments filed on March 3, 2026 have been fully considered, but are not persuasive.
The Applicant respectfully argues, "In Chang, '[t]he first signal generating element 96 also moves axially together with the plunger rod 106 a predetermined distance D1 until the first signal generating element 96 is released from the plunger rod 106 when the proximal end surface of the first signal generating element 96 impacts with the distal end surface of the flange 137 of the demo container 128, FIG. 14, causing a first audible feedback signal which simulates the start of an injection phase' and 'the distal end of the demo container 128 is arranged with an annular flange 137 having a distal end surface' ... See Chang, [0038] and [0041]. As such, 'the first audible feedback signal' is caused by 'the first signal generating element' impacting the surface of the annular flange, not by the stopper impacting the stopper contact surface in the inner chamber when the diameter of the inner chamber is smaller than the outer diameter of the stopper. Additionally, the 'annular flange' in Chang is 'arranged' at 'the distal end of the demo container,' not a stopper contact surface 'positioned in the inner chamber.' Furthermore, in Chang, 'the first signal generating element' 'is released from the plunger rod' and hence does not move past the flange with the plunger rod after impacting with the flange; therefore Chang does not disclose 'after producing the initial signal, the plunger rod and the stopper move past the stopper contact surface to the second position in the container' in Claim 16."
The Examiner respectfully disagrees. The Examiner first notes that the claim recites, "the stopper of the plunger rod impacts the stopper contact surface and results in an initial signal" (wherein the stopper equates to the "friction element 122" and the stopper contact surface equates to the "distal section 142"). The claim does not state that the stopper impacting the stopper contact surface actually produces the signal, it only "results in" the signal being produced. In Chang, the movement of the friction element (stopper) into the distal section (inner chamber) causes the first signal generating element 96 to impact the flange 137, causing a first audible feedback signal (initial signal). Therefore, Chang still discloses these limitations when read under the broadest reasonable interpretation in light of the specification.
The Examiner further notes that the claim recites, "after producing the initial signal, the plunger rod and the stopper move past the stopper contact surface." As noted above, under the broadest reasonable interpretation, it is not clear if the plunger rod and the stopper are actually producing the signal, or if they are causing the signal to be produced, as disclosed by Chang. The Applicant notes that Chang discloses the "first signal generating element" does not move past the flange (and therefore also does not move past the stopper contact surface) after the initial signal is generated. However, this detail is not claimed. The claims only require that the plunger rod and the stopper move past the stopper contact surface, which is disclosed in Chang (see Chang Fig. 16, showing the friction element 122 attached to the plunger rod and moved entirely past the narrower distal section 142).
For the above reasons, the cited references Chang and Ma still disclose or render obvious all of the claim limitations, and the 35 USC 103 rejections are maintained.
Conclusion
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/STEPHEN ALVESTEFFER/ Examiner, Art Unit 3715
