DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 13, 2026 has been entered.
Status of Claims
This office action is in response to arguments and amendments entered on April 13, 2026 for the patent application 17/610,815 originally filed on November 12, 2021. Claims 16 and 31 are amended. Claims 1-15, 27, and 28 are canceled. Claims 16-26 and 29-35 remain pending. The first office action of September 11, 2024, the second office action of February 10, 2025, the third office action of June 20, 2025, and the fourth office action of January 23, 2026 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 Double Patenting rejections, for reasons set forth below.
The Applicant’s amendments to the claims are not sufficient to overcome the outstanding rejections under 35 USC 103, for reasons set forth below.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 16-26 and 29-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16, 19-22, and 24-29 of copending Application No. 17/610,814 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other as shown in the following table:
Instant application 17/610,815
Co-pending application 17/610,814
16. A drive mechanism for a medicament delivery training device, the delivery mechanism comprising:
a plunger rod having a proximal end and a distal end,
a stopper provided on the proximal end of the plunger rod, and (specification page 11 states, “The housing 3 has an inner stop structure 3a. The stop structure 3a comprises a plurality of radially inwards extending protrusions 3b. The radially inwards extending protrusions 3b form a central proximal opening 3c between them… The central proximal opening 3c is dimensioned such that the stopper 15 is not able to move through the central proximal opening 3c when the plunger rod 13 is moved in the proximal direction,” the stopper must work with an inner stop structure to function. Application ‘814 has the same disclosure in specification page 12.)
a container having an inner chamber, a proximal container end, and an open distal container end leading into the inner chamber, wherein the inner chamber has a distal portion, a proximal portion, and a stopper contact surface, wherein the stopper contact surface provides a gradual decrease of a diameter of the inner chamber in the proximal direction,
wherein the stopper contact surface is between the distal portion and the proximal portion of the inner chamber,
wherein the proximal portion inner diameter is dimensioned to cause friction between the stopper and the inner surface of the proximal portion to control a driving speed of the plunger after the stopper passes the stopper contact surface of the inner chamber.
wherein in an initial state of the delivery mechanism the plunger rod is axially fixedly arranged in a first position in which the stopper is arranged distally relative to the proximal portion and the stopper contact surface, and the plunger rod is biased towards the 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 proximal container end and the stopper to result in an initial signal by impacting with the stopper contact surface (The “stopper contact surface” is the same as the “inner stop structure” of application ‘814), and to subsequently move into the proximal portion proximal to the stopper contact surface.
16. A drive mechanism for a resettable medicament delivery training device, 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,
25. The drive mechanism as claimed in claim 16, comprising a housing configured to receive the container, wherein the housing has an open proximal housing end configured to receive the resetting structure.
26. The drive mechanism as claimed in claim 25, 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.
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, 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,
and a resetting structure,
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,
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,
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, 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.
17. The drive mechanism as claimed in claim 16, wherein the stopper has an outer stopper diameter, the distal portion has a distal portion inner diameter and the proximal portion has a proximal portion inner diameter which is smaller than the distal portion inner diameter and the outer stopper diameter, the distal portion transitioning to the proximal portion via the stopper contact surface.
26. The drive mechanism as claimed in claim 25, 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.
18. The drive mechanism as claimed in claim 16, comprising 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 distal portion.
19. The drive mechanism as claimed in claim 16, comprising 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.
19. The drive mechanism as claimed in claim 18, comprising 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.
20. The drive mechanism as claimed in claim 19, comprising 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.
20. The drive mechanism as claimed in claim 19, 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.
21. The drive mechanism as claimed in claim 20, 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.
21. The drive mechanism as claimed in claim 19, wherein the actuator sleeve is biased towards the proximal position.
22. The drive mechanism as claimed in claim 20, wherein the actuator sleeve is biased towards the proximal position.
22. The drive mechanism as claimed in claim 19, comprising a delivery member cover configured to move linearly relative to the container, between an initial position and an activating 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.
24. The drive mechanism as claimed in claim 20, comprising 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.
23. The drive mechanism as claimed in claim 16, comprising a housing configured to receive the container, wherein the housing has an inner stop structure configured to stop proximal movement of the plunger rod in the inner chamber, causing the stopper to impact with the stop structure, resulting in a subsequent signal.
26. The drive mechanism as claimed in claim 25, 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.
24. The drive mechanism as claimed in claim 23, wherein the stop structure comprises a plurality of radially inwards extending protrusions.
27. The drive mechanism as claimed in claim 26, wherein the inner stop structure comprises a plurality of radially inwards extending protrusions configured to enable the resetting structure to be received between them.
25. The drive mechanism as claimed in claim 24, wherein the container is provided with a proximal engagement structure configured to engage with the housing.
28. The drive mechanism as claimed in claim 25, wherein the container is provided with a proximal engagement structure configured to engage with the housing.
26. The drive mechanism as claimed in claim 24, wherein the radially inwards extending protrusions are arranged to form a central proximal opening into the container.
29. The drive mechanism as claimed in claim 27, wherein the radially inwards extending protrusions form a central proximal opening into the container, configured to receive the resetting structure.
29. A medicament delivery training device comprising a delivery mechanism as claimed in claim 16.
16. A drive mechanism for a resettable medicament delivery training device…
30. The medicament delivery training device as claimed in claim 29, wherein the drive mechanism is configured to be actuated mechanically or electrically.
16. A drive mechanism for a resettable medicament delivery training device… (mechanical actuation is implied)
31. A medicament delivery training device comprising:
a housing;
a drive mechanism positioned within the housing, where the drive mechanism comprises:
a plunger rod having a proximal end and a distal end,
a stopper provided on the proximal end of the plunger rod, and (specification page 11 states, “The housing 3 has an inner stop structure 3a. The stop structure 3a comprises a plurality of radially inwards extending protrusions 3b. The radially inwards extending protrusions 3b form a central proximal opening 3c between them… The central proximal opening 3c is dimensioned such that the stopper 15 is not able to move through the central proximal opening 3c when the plunger rod 13 is moved in the proximal direction,” the stopper must work with an inner stop structure to function. Application ‘814 has the same disclosure in specification page 12.)
a container having an inner chamber, a proximal end, and an open distal end, where the inner chamber has a distal portion having a first inner diameter and a proximal portion having a second diameter different than the first diameter, and wherein the stopper contact surface (The “stopper contact surface” is the same as the “inner stop structure” of application ‘814) separates the distal portion from the proximal portion, and
wherein the proximal portion inner diameter is dimensioned to cause friction between the stopper and the inner surface of the proximal portion to control a driving speed of the plunger rod after the stopper passes the stopper contact surface of the inner chamber,
wherein in an initial state of the delivery mechanism the plunger rod is axially fixedly arranged in a first position in which the stopper is arranged distally relative to the proximal portion and the stopper contact surface, and the plunger rod is biased towards the proximal end, and
wherein the plunger rod is configured to be released from the first position, causing the plunger rod to move towards the proximal end of the container such that the stopper results in an initial signal by impacting with the stopper contact surface, where thereafter the plunger rod moves into the proximal portion proximal to the stopper contact surface.
16. A drive mechanism for a resettable medicament delivery training device, the drive mechanism comprising:
25. The drive mechanism as claimed in claim 16, comprising a housing configured to receive the container, wherein the housing has an open proximal housing end configured to receive the resetting structure.
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,
26. The drive mechanism as claimed in claim 25, 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.
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, 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,
and a resetting structure,
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,
wherein 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,
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, 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.
32. The medicament delivery training device as claimed in claim 31, wherein the housing comprises an inner stop structure that stops proximal movement of the plunger rod within the inner chamber such that the stopper impacts the inner stop structure and generating a second signal.
26. The drive mechanism as claimed in claim 25, 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.
33. The medicament delivery training device as claimed in claim 31 further comprising a holding structure having a radially flexible arm releasably engaged with a radial recess on the plunger rod to maintain the plunger rod in a biased and axially fixed position within the distal portion.
19. The drive mechanism as claimed in claim 16, comprising 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.
34. The medicament delivery training device as claimed in claim 33 further comprising an actuator sleeve operatively engaged with the holding structure, where the actuator sleeve moves between a proximal position and a distal position such that when in the proximal position the actuator sleeve prevents the radially flexible arm from disengaging from the radial recess.
20. The drive mechanism as claimed in claim 19, comprising 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.
The instant application is broader than co-pending application 17/610,814, which additionally features limitations for resetting device.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 16-26 and 29-35 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 medicament delivery training device (see Chang Fig. 1, automatic injection training device 10), the delivery mechanism comprising:
a plunger rod having a proximal end and a distal end (see Chang Fig. 9, plunger rod 106),
a stopper provided on the proximal end of the plunger rod (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” as apparent in instant specification page 11, for the stopper to function properly, it must impact with an inner stop structure that has a narrower opening than the width of the stopper), and
a container having an inner chamber, a proximal container end, and an open distal container end leading into the inner chamber, wherein the inner chamber has a distal portion, a proximal portion (see Chang Figs. 10 and 11, showing tubular demo container 128 having inner chamber) …
wherein the stopper contact surface is between the distal portion and the proximal portion of the inner chamber (see Chang Figs. 15-17, showing the friction element 122 with circumferential ridges 124 on the proximal end of the plunger rod 106 acts as a stopper. Also a signal generating element 96 at the proximal end of the plunger impacting a contact surface to generate a first audible feedback signal indicating the start of an injection phase, then continuing to the proximal portion where it causes a second audible feedback signal)
wherein the proximal portion inner diameter is dimensioned to cause friction between the stopper and the inner surface of the proximal portion to control a driving speed of the plunger rod after the stopper passes the stopper contact surface of the inner chamber (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),
wherein in an initial state of the delivery mechanism the plunger rod is axially fixedly arranged in a first position in which the stopper is arranged distally relative to the proximal portion and the stopper contact surface, and the plunger rod is biased towards the 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 proximal container end and the stopper to result in an initial signal by impacting with the stopper contact surface, and to subsequently move into the proximal portion 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).
Chang does not explicitly teach a stopper contact surface, wherein the stopper contact surface provides a gradual decrease of a diameter of the inner chamber in the proximal direction.
However, Ma discloses a stopper contact surface, wherein the stopper contact surface provides a gradual decrease of a diameter of the inner chamber in the proximal direction (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 a stopper contact surface, wherein the stopper contact surface provides a gradual decrease of a diameter of the inner chamber in the proximal direction, 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 stopper has an outer stopper diameter, the distal portion has a distal portion inner diameter and the proximal portion has a proximal portion inner diameter which is smaller than the distal portion inner diameter and the outer stopper diameter, the distal portion transitioning to the proximal portion via the stopper contact surface (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 18, 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 distal portion (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 19, 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 20, 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 21, 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 22, 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, 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 23, Chang in view of Ma discloses a housing configured to receive the container, wherein the housing has an inner stop structure configured to stop proximal movement of the plunger rod in the inner chamber, causing the stopper to impact with the stop structure, resulting in a subsequent signal (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 24, Chang in view of Ma discloses wherein the stop structure comprises a plurality of radially inwards extending protrusions (see Chang Fig. 4, such as tongues 30).
Regarding claim 25, 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 26, Chang in view of Ma discloses wherein the radially inwards extending protrusions are arranged to form a central proximal opening into the container (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 29, Chang in view of Ma discloses a medicament delivery training device comprising a delivery mechanism as claimed in claim 16 (see Chang Fig. 1, automatic injection training device 10).
Regarding claim 30, Chang in view of Ma discloses wherein the drive mechanism is configured to be actuated mechanically or electrically (see Chang Fig. 1, automatic injection training device 10, a mechanical actuation is implied unless otherwise disclosed).
Regarding claim 31, Chang discloses a medicament delivery training device (see Chang Fig. 1, automatic injection training device 10) comprising:
a housing (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.”);
a drive mechanism positioned within the housing, where the drive mechanism comprises:
a plunger rod having a proximal end and a distal end (see Chang Fig. 9, plunger rod 106),
a stopper provided on the proximal end of the plunger rod (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” as apparent in instant specification page 11, for the stopper to function properly, it must impact with an inner stop structure that has a narrower opening than the width of the stopper), and
a container having an inner chamber, a proximal end, an open distal end, and … where the inner chamber has a distal portion having a first inner diameter and a proximal portion having a second diameter different than the first diameter, and wherein the stopper contact surface separates the distal portion from the proximal portion (see Chang Figs. 10 and 11, showing tubular demo container 128 having inner chamber), and
wherein the proximal portion inner diameter is dimensioned to cause friction between the stopper and the inner surface of the proximal portion to control a driving speed of the plunger rod after the stopper passes the stopper contact surface of the inner chamber (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.”),
wherein in an initial state of the delivery mechanism the plunger rod is axially fixedly arranged in a first position in which the stopper is arranged distally relative to the proximal portion and the stopper contact surface, and the plunger rod is biased towards the 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), and
wherein the plunger rod is configured to be released from the first position, causing the plunger rod to move towards the proximal end of the container such that the stopper results in an initial signal by impacting with the stopper contact surface, where thereafter the plunger rod moves into the proximal portion proximal to the stopper contact surface (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).
Chang does not teach a stopper contact surface, wherein the stopper contact surface provides a gradual decrease of a diameter of the inner chamber in the proximal direction.
However, Ma discloses a stopper contact surface, wherein the stopper contact surface provides a gradual decrease of a diameter of the inner chamber in the proximal direction (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 a stopper contact surface, wherein the stopper contact surface provides a gradual decrease of a diameter of the inner chamber in the proximal direction, 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 housing comprises an inner stop structure that stops proximal movement of the plunger rod within the inner chamber such that the stopper impacts the inner stop structure and generating a second signal (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 33, Chang in view of Ma discloses a holding structure having a radially flexible arm releasably engaged with a radial recess on the plunger rod to maintain the plunger rod in a biased and axially fixed position within the distal portion (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 34, Chang in view of Ma discloses an actuator sleeve operatively engaged with the holding structure, where the actuator sleeve moves between a proximal position and a distal position such that when in the proximal position the actuator sleeve prevents the radially flexible arm from 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 a delivery member cover that slides axially relative to the housing and the container from an initial position to an activating position such that an actuator sleeve is moved distally to release the plunger rod to move proximally relative to the container (Chang [0019], “the needle cover is connected to a third energy accumulating element which urges the needle cover towards the proximal end such that the proximal portion of the needle cover protrudes from the proximal end of the elongated housing. The plunger may be also axially moveable in relation to the elongated housing towards the distal end from the second position to the first position against the axial force from the first energy accumulating element”).
Response to Arguments
The Applicant’s arguments filed on April 13, 2026 have been fully considered, but are not persuasive.
As an initial matter, the Applicant points out that "Chang does not call attention to the gradual decrease of the inner diameter." However, the Examiner notes that an examination of the drawings depicting the disputed claim limitations reveals that the structure of the relevant portions of the instant invention and Chang are exactly the same. For instance, instant Fig. 5 shows the stopper contact surface providing a gradual decrease of a diameter of the inner chamber in the proximal direction (diameter d2 decreases to diameter d1 after the stopper contact surface 11j). However, Chang Figs. 13-16 show the exact same structure, showing stopper 122 initially positioned distally to the stopper contact surface in Figs. 13 and 14. The stopper contact surface is not named in Chang, but Fig. 11 clearly shows the same type of stopper contact surface as described in the instant claims, along with the same gradual decrease of the diameter of the inner chamber proximal to the stopper contact surface. Chang Figs. 15 and 16 show the continued progression of the plunger rod and stopper past the stopper contact surface toward the proximal end of the injection device.
Regarding the Ma reference, the Applicant respectfully argues that "Ma teaches away from 'a stopper contact surface, wherein the stopper contact surface provides a gradual decrease of a diameter of the inner chamber in the proximal direction' as Applicant submits. In Ma, a gradual increase of an inner diameter in a proximal direction is highlighted to allow venting of trapped air. See Ma paragraph [0058]. To perform this venting feature, an ordinary person in the art cannot think of the contrary: a gradual decrease of an inner diameter in the proximal direction of the device. As such, Ma teaches away from Applicant's Claim."
The Examiner respectfully disagrees. The Examiner notes 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. We can confirm this simply by looking at Ma Fig. 1, which shows a decrease in diameter of the inner chamber in the direction of the patient as the stopper 140 is pushed.
The Applicant further respectfully argues that "none of the references even discusses a stopper that results in an initial signal. Chang uses 'signal generating elements' to generate 'audible feedback signals.' See Chang Claim 14. And Ma does not even discuss generating signals. So, Applicant's Claim 'causing...the stopper to result in an initial signal by impacting with the stopper contact surface' cannot be obvious over Chang in view of Ma."
The Examiner respectfully disagrees. The Examiner first notes that the claim recites, "causing...the stopper to result in an initial signal by impacting with the stopper contact surface" (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.
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 will be maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Shluzas et al. (US 2016/0206834), Figs. 6-7 show embodiments where the inner chamber containing the stopper gradually becomes narrower towards the patient end of the syringe.
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/STEPHEN ALVESTEFFER/ Examiner, Art Unit 3715
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