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 .
Status of Claims
This office action is responsive to the amendment filed 13 April 2026.
Claims 1-15, 19, and 34 are canceled.
Claims 16, 20, 21, 31, and 33 are amended.
Claims 16-18, 20-33, and 35 are presently pending in this application.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 13 April 2026 has been entered.
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.
Claims 16, 17, 19-25, and 30-34 are rejected under 35 U.S.C. 103 as being unpatentable over Alexandersson (US Patent Publication No. 20190192776 A1), in view of Jacobson (US Patent Publication No. 20200139046 A1), in further view of Giambattista et al. (US Patent Publication No. 20150335829 A1), hereinafter Giambattista.
Regarding claim 16, Alexandersson discloses a medicament delivery device (Alexandersson: Fig. 1, medicament delivery device 1) comprising: a housing (Fig. 2, comprised of deliver member cover 7 and actuator sleeve 11), a medicament container housing (Fig. 3, medicament container holder 17) arranged in the housing (Fig. 2 and 3, holder 17 is arranged within delivery member cover 7), a forward-biased rotator structure (Fig. 6, rotator 25 is proximally biased towards needle direction of the device 1 via resilient member 27; para. 0054) configured to move the medicament container housing (Fig. 3, holder 17) in a forward direction in the housing (holder 17 is displaced proximally by the rotator 25 and plunger holder 21, which are moved proximally by resilient member 27; para. 0058 and 0048), a resilient member (Fig. 9A, resilient member 29) configured to bias the plunger rod (Fig. 9A, plunger rod 23) in a forward direction (Fig. 9A, plunger rod 23 is proximally biased via resilient member 29; para. 0056), and a forward-biased plunger rod (Fig. 9A, plunger rod 23 is proximally biased via resilient member 29; para. 0056) extending axially inside the rotator structure (Fig. 9A, plunger rod 23 extends axially within rotator 25) and, the rotator structure (Fig. 6, rotator 25) having a first rotator guide track structure (Fig. 6, guide structure 25a) configured to cooperate with an inner surface structure of the housing (Fig. 5 and 6, guide structures 25a receive inwards extending portion 13b; para. 0055), enabling: rotation of the rotator structure (rotator 25 rotates; para. 0055) when the rotator structure (Fig. 6, rotator 25) is rotated from the first rotator position (Fig. 6, first rotator position defined by portion 13b located at contiguous proximal portion 25b, in which the rotator 25 will rotate when portion 13b is moved towards portion 25c; para. 0055) to the second rotator position (Fig. 6, second rotator position defined by 13b reaching distal portion 25c, causing rotation of rotator 25; para. 0055 and 0063), causing the forward-biased rotator structure (Fig. 6, rotator 25 is proximally biased via resilient member 27; para. 0054), the plunger rod (Fig. 9A, plunger rod 23) and the medicament container housing (Fig. 3, medicament container holder 17) to move a first forward distance in the housing (rotator 25, holder 17, and plunger holder 21, which houses the plunger rod 23, moves forward upon portion 13b reaching distal portion 25c; para. 0063) to perform an auto-penetration operation (auto-penetration procedure is permitted upon portion 13b reaching distal portion 25c; para. 0063-0067).
Alexandersson does not expressly disclose a delivery member cover slidably arranged in the housing wherein the delivery member cover is configured to be moved axially from an extended position relative to the housing to a retracted position, thereby causing the rotator structure to rotate from a first rotator position to a second rotator position; and the plunger rod having a first axial engagement position with the rotator structure when the rotator structure is in the first rotator position and the second rotator position; wherein the rotator structure has an inner surface with an inwardly extending stepped structure, wherein the inwardly extending stepped structure comprises a first step and an axially extending groove adjacent to the first step, wherein the plunger rod comprises a protrusion extending outwardly from the plunger rod and configured to interact with the s inwardly extending stepped structure, wherein after the rotator structure rotates a radial distance, the protrusion clears the first step and moves into the groove and wherein the plunger rod is released from axial engagement once it is moved into the axially extending groove.
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Jacobsen teaches a delivery member cover (Fig. 7A-7C, skin sensor 700 shields needle 902; para. 0141) slidably arranged in a housing (skin sensor 700 retracts within housing 500; para. 0141; Figs. 3A-3C) wherein the delivery member cover (Fig. 7A-7C, skin sensor 700) is configured to be moved axially from an extended position (Fig. 7A, initial position of sensor 700 is in forward position; para. 0166) relative to the housing (Fig. 1, housing 500) to a retracted position (Fig. 7C, sensor 700 is fully retracted; para. 0166), thereby causing a rotator structure (Fig. 7, syringe lock 600) to rotate from a first rotator position (Fig. 7A, lock 500 is in initial position; para. 0166) to a second rotator position (Fig. 7B, lock 500 rotates to second position; para. 0166); and a plunger rod (Fig. 1, plunger tube 1100) extending axially inside the rotator structure (Fig. 10A-10F, plunger tube 1100 is inside syringe lock 600) and having a first axial engagement position (Fig. 10A-10F, plunger tube 1100 engages with syringe lock 600 at tab 1112) with the rotator structure (Fig. 1, syringe lock 600) when the rotator structure (Fig. 1, syringe lock 600) is in the first rotator position (Fig. 10A) and the second rotator position (Fig. 10B); wherein rotator structure (Fig. 10A-10F, syringe lock 600) that has an inner surface with an inwardly extending stepped structure (Fig. 10A-10F, guiding trail 604 extends inwardly from the exterior of lock 600 to the interior of lock 600), wherein the inwardly extending stepped structure (Fig. 10A-10F, guiding trail 604) comprises a first step (Fig. 10A-F above, first step A, which extends from resting ledge 606 to right before syringe lock end stop 610) and an axially extending groove (Fig. 10A-10F, end stop 610 extends axially from the interior surface of the lock 600) adjacent to the first step (Fig. 10A-F above, first step A) and the plunger rod (Fig. 10A-10F, plunger rod tube 1100) is comprises a protrusion extending outwardly (Fig. 10A-10F, syringe assembly tab 1112) from the plunger rod (Fig. 10A-10F, plunger rod tube 1100) configured to interact with the inwardly extending stepped structure (Fig. 10A-10F, syringe assembly tab 1112 cooperates with guiding trail 604), wherein after the rotator structure (Fig. 7, syringe lock 600) rotates a radial distance (Fig. 10B to 10D, lock 600 rotates a distance), the protrusion (Fig. 10A-10F, syringe assembly tab 1112) clears the first step (Fig. 10A-F above, first step A) and moves into the axially extending groove (Fig. 10A-10F, end stop 610) and wherein the plunger rod (Fig. 10A-10F, plunger rod tube 1100) is released from axial engagement once it is moved into the axially extending groove (Fig. 10B-E, once the tab 1112 clears first step A going in to Fig. 10C, plunger rod 1100 is released from axial engagement as seen in Fig. 10E).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Alexandersson such that a delivery member cover slidably arranged in the housing wherein the delivery member cover is configured to be moved axially from an extended position relative to the housing to a retracted position, thereby causing the rotator structure to rotate from a first rotator position to a second rotator position; and the plunger rod having a first axial engagement position with the rotator structure when the rotator structure is in the first rotator position and the second rotator position; wherein the rotator structure has an inner surface with an inwardly extending stepped structure, wherein the inwardly extending stepped structure comprises a first step and an axially extending groove adjacent to the first step, wherein the plunger rod comprises a protrusion extending outwardly from the plunger rod and configured to interact with the s inwardly extending stepped structure, wherein after the rotator structure rotates a radial distance, the protrusion clears the first step and moves into the groove and wherein the plunger rod is released from axial engagement once it is moved into the axially extending groove as taught by Jacobsen in order to shield the needle in an initial position and engage with the rotator structure to begin the auto-penetration process (Jacobsen: para. 0141 and para. 0166), reduce the risk of accidental activation of the auto injector (para. 0170), and allow the plunger rod to interact with the syringe lock 600 and create various rotator positions (Jacobsen: para. 0169 and 0176).
Alexandersson in view of Jacobsen does not expressly disclose the rotator structure preventing axial forward movement of the rotator structure inside the housing when the rotator structure is in the first rotator position and releasing of the rotator structure from axial engagement with the inner surface structure of the housing when the rotator structure is rotated from the first rotator position towards the second rotator position.
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Giambattista teaches a rotator structure (Giambattista: Fig. 7, rotator 82) preventing axial forward movement of the rotator structure (Fig. 7, rotator 82) inside a housing (Fig. 2 and 7 shown above, rotator 82 movement within contractor 12 is prevented when third contact members 30 is in pos. A, blocked by circumferential section 90II; para. 0068) when the rotator structure (Fig. 7, rotator 82) is in a first rotator position (Fig. 7 shown above, pos. A) and releasing of the rotator structure (Fig. 7, rotator 82) from axial engagement with an inner surface structure (Fig. 4, third contact members 30) of a housing (Fig. 2, contractor 12) when the rotator structure (Fig. 7, rotator 82) is rotated from the first rotator position (Fig. 7 shown above, pos. A) towards a second rotator position (Fig. 2 and 7, rotator 82 movement within contractor 12 is released when third contact members 30 is in pos. II; para. 0074).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rotator structure of Alexandersson in view of Jacobsen such that the rotator structure prevents axial forward movement of the rotator structure inside the housing when the rotator structure is in the first rotator position and releasing of the rotator structure from axial engagement with the inner surface structure of the housing when the rotator structure is rotated from the first rotator position towards the second rotator position as taught by Giambattista in order to lock the rotator from axial movement during the initial position (Giambattista: para. 0068) and to allow for the release of axial movement of the plunger upon reaching another position (Giambattista: para. 0074). Furthermore, it would be obvious to combine the inwardly extending stepped structure of Giambattista with the stepped structure of Jacobson, as any change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 17, Alexandersson in view of Jacobsen and Giambattista discloses the device above.
Alexandersson in view of Jacobsen does not expressly disclose that the rotator structure is configured to cooperate with the inner surface structure of the housing to provide a final rotation of the rotator structure towards a third rotator position in an end stage of the auto-penetration operation, causing the plunger rod to be released from its engagement with the rotator structure in the first axial engagement position and move in the forward direction relative to the rotator structure.
Giambattista teaches a rotator structure (Giambattista: Fig. 7, rotator 82) is configured to cooperate with an inner surface structure (Fig. 4, third contact members 30) of a housing (Fig. 2, contractor 12) to provide a final rotation (Fig. 7, pos. IV is the final rotation position of the rotator 82; para. 0076) of a rotator structure (Fig. 7, rotator 82) towards a third rotator position (Fig. 7, pos. IV) in an end stage of an auto-penetration operation (the final stage of the auto-penetration operation occurs between pos. IV and pos. V; para. 0076), causing a plunger rod (Fig. 2, plunger rod 102) to be released from its engagement with the rotator structure (Fig. 7, when rotator 82 is in pos. IV, plunger rod 102 is released from engagement with rotator 82; para. 0076) in a first axial engagement position (Fig. 7 and 8, pos. III is in the intermediate position and engaged with section 100V; para. 0072) and move in the forward direction (Fig. 7, plunger rod moves from pos. IV to pos. V, moving forward relative to rotator 82; para. 0076) relative to the rotator structure (Fig. 7, rotator 82).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rotator structure of Alexandersson in view of Jacobsen such that the rotator structure is configured to cooperate with the inner surface structure of the housing to provide a final rotation of the rotator structure towards a third rotator position in an end stage of the auto-penetration operation, causing the plunger rod to be released from its engagement with the rotator structure in the first axial engagement position and move in the forward direction relative to the rotator structure as taught by Giambattista in order allow medicament to be expelled via the auto-penetration operation (Giambattista: para. 0076).
Regarding claim 20, Alexandersson in view of Jacobsen and Giambattista discloses the device above.
Alexandersson in view of Giambattista does not expressly disclose the radially outwards extending protrusion rests when the rotator structure is in the first rotator position.
Jacobsen teaches a radially outwards extending protrusion (Fig. 10A-10F, syringe assembly tab 1112) rests on the first step (Fig. 10A-10F above, syringe assembly tab 1112 rests on first step A while lock 600 is in first position; para. 0177) when the rotator structure (Fig. 10A-10F, syringe lock 600) is in the first rotator position (Fig. 10A).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rotator structure of Alexandersson in view of Jacobsen such that stepped structure has a first step on which the radially outwards extending protrusion rests when the rotator structure is in the first rotator position as taught by Jacobsen in order to restrict forward movement of the syringe assembly and allow the rotator structure to be in an unlocked position (para. 0177).
Regarding claim 21, Alexandersson in view of Jacobsen and Giambattista discloses the device above.
Alexandersson in view of Giambattista does not expressly disclose the radially outwards extending protrusion clears the first step when the rotator structure is rotated from the second rotator position towards the third rotator position.
Jacobsen teaches a radially outwards extending protrusion (Fig. 10A-10F, syringe assembly tab 1112) clears the first step (Fig. 10A-F above, first step A) when a rotator structure (Fig. 10A-10F, syringe lock 600) is rotated from a second rotator position (Fig. 10B) towards a third rotator position (Fig. 10B-E, tab 1112 moves into end stop 610 upon rotation, thus clearing first step A; para. 0179).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rotator structure of Alexandersson in view of Jacobsen such that the stepped structure includes an axially extending groove opening from the first step, the radially outwards extending protrusion being configured to move into the groove from the first step when the rotator structure is rotated from the second rotator position towards the third rotator position as taught by Jacobsen in order to allow injection of the medicament (Jacobsen: para. 0179).
Regarding claim 22, Alexandersson in view of Jacobsen and Giambattista discloses the device above.
Alexandersson in view of Jacobsen does not expressly disclose that the inner surface structure of the housing includes a radially inwards extending pin and the first rotator guide track structure comprises a circumferential radially outwards extending rib portion bearing against the pin when the rotator structure is rotated from the first rotator position towards the second rotator position, enabling the rotator structure to rotate relative to the housing but preventing it to move forward.
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Giambattista teaches an inner surface structure (Giambattista: Fig. 4, third contact members 30) of a housing (Fig. 2, contractor 12) that includes a radially inwards extending pin (Fig. 4, third contact members 30 are pins) and a first rotator guide track structure (Fig. 7, outer guiding members 90) comprising a circumferential radially outwards extending rib portion (Fig. 7, circumferential section 90II) bearing against the pin (Fig. 7, section 90II blocks contact members 30) when a rotator structure (Fig. 7, rotator 82) is rotated from a first rotator position (Fig. 7 above, pos. A) towards a second rotator position (Fig. 7 shown above, when rotator 82 is rotated from pos. A to pos. II, section 90II blocks members 30), enabling the rotator structure (Fig. 7, rotator 82) to rotate relative to the housing (Fig. 2, contractor 12) but preventing it to move forward (Fig. 2 and 7 shown above, rotator 82 movement within contractor 12 is prevented when third contact members 30 is in pos. A, blocked by circumferential section 90’; para. 0068).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rotator structure of Alexandersson in view of Jacobsen such that the inner surface structure of the housing includes a radially inwards extending pin and the first rotator guide track structure comprises a circumferential radially outwards extending rib portion bearing against the pin when the rotator structure is rotated from the first rotator position towards the second rotator position, enabling the rotator structure to rotate relative to the housing but preventing it to move forward as taught by Giambattista in order to lock the rotator from axial movement during the initial position (Giambattista: para. 0068).
Regarding claim 23, Alexandersson in view of Jacobsen and Giambattista discloses the device above, wherein the rotator structure is forward-biased (Fig. 6, rotator 25 is proximally biased towards needle direction of the device 1 via resilient member 27; para. 0054).
Alexandersson in view of Jacobsen does not expressly disclose that the first rotator guide track structure comprises an axial radially outwards extending rib portion, the circumferential radially outwards extending rib portion transitioning to the axial radially outwards extending rib portion, enabling the forward-biased rotator structure to move forward relative to the housing when the rotator structure is moved from the first rotator position and the pin moves past the circumferential radially outwards extending rib portion.
Giambattista teaches a first rotator guide track structure (Giambattista: Fig. 7, outer guiding members 90) comprising an axial radially outwards extending rib portion (Fig. 7, longitudinal section 90III), a circumferential radially outwards extending rib portion (Fig. 7, circumferential section 90II) transitioning to the axial radially outwards extending rib portion (Fig. 7, section 90II transitions to longitudinal section 90III), enabling a rotator structure (Fig. 7, rotator 82) to move forward relative to the housing (Fig. 2, contractor 12) when the rotator structure (Fig. 7, rotator 82) is moved from the first rotator position (Fig. 7 shown above, pos. A) and a pin (Fig. 4, third contact members 30 are pins) moves past the circumferential radially outwards extending rib portion (Fig. 7 shown above, members 30 move from pos. A to pos. II, moving past section 90II).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rotator structure such that the first rotator guide track structure comprises an axial radially outwards extending rib portion, the circumferential radially outwards extending rib portion transitioning to the axial radially outwards extending rib portion, enabling the forward-biased rotator structure to move forward relative to the housing when the rotator structure is moved from the first rotator position and the pin moves past the circumferential radially outwards extending rib portion as taught by Giambattista in order to allow for the release of axial movement upon reaching the second position (Giambattista: para. 0074).
Regarding claim 24, Alexandersson in view of Jacobsen and Giambattista discloses the device above.
Alexandersson in view of Jacobsen does not expressly disclose that the first rotator guide track structure has a helical radially outwards extending rib portion, the axial radially outwards extending rib portion transitioning to the helical radially outwards extending rib portion, the helical radially outwards extending rib portion providing a final rotation of the rotator structure from the second rotator position towards the third rotator position.
Giambattista teaches the first rotator guide track structure (Fig. 7, outer guiding members 90) has a helical radially outwards extending rib portion (Fig. 7, inclined section 90IV), the axial radially outwards extending rib portion (Fig. 7, longitudinal section 90III) transitioning to the helical radially outwards extending rib portion (Fig. 7, section 90III transitions to section 90IV), the helical radially outwards extending rib portion (Fig. 7, inclined section 90IV) providing a final rotation (Fig. 7, pos. IV) of the rotator structure (Fig. 7, rotator 82) from the second rotator position (Fig. 7, pos. III) towards the third rotator position (Fig. 7, pos. IV is reached when member 30 slides along section 90IV).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rotator structure of Alexandersson in view of Jacobsen such that the first rotator guide track structure has a helical radially outwards extending rib portion, the axial radially outwards extending rib portion transitioning to the helical radially outwards extending rib portion, the helical radially outwards extending rib portion providing a final rotation of the rotator structure from the second rotator position towards the third rotator position as taught by Giambattista in order to allow for a final rotation of the rotator and enable an end state of the auto-penetration operation (Giambattista: para. 0076).
Regarding claim 25, Alexandersson in view of Jacobsen and Giambattista discloses the device above.
Alexandersson in view of Jacobsen does not expressly disclose that the helical radially outwards extending rib portion is provided on an outer surface of the rotator structure and has an axially extending component and a circumferentially extending component.
Giambattista teaches a helical radially outwards extending rib portion (Giambattista: Fig. 7, inclined section 90IV) is provided on an outer surface of a rotator structure (Fig. 7, section 90IV is disposed on the exterior of rotator 82) and has an axially extending component (Fig. 7, section 90IV is inclined, therefore it extends axially) and a circumferentially extending component (Fig. 7, section 90IV is inclined, therefore it extends circumferentially).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rotator structure of Alexandersson in view of Jacobsen such that the helical radially outwards extending rib portion is provided on an outer surface of the rotator structure and has an axially extending component and a circumferentially extending component as taught by Giambattista in order to allow for a final rotation of the rotator and enable an end state of the auto-penetration operation (Giambattista: para. 0076).
Regarding claim 30, Alexandersson in view of Jacobsen and Giambattista discloses the device above, wherein the rotator structure (Fig. 6, rotator 25) is a rotator sleeve (Fig. 7, rotator 25 is a sleeve) provided with the first rotator guide track (Fig. 6, guide structure 25a).
Alexandersson does not expressly disclose the rotator structure comprises a rotator and a rotator sleeve configured to be rotationally and axially locked to the rotator.
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Jacobsen teaches a rotator structure (Jacobsen: Fig. 10A-10F, syringe lock 600) comprising a rotator (Fig. 10B shown above, syringe lock 600) and a rotator sleeve (Fig. 10B shown above, rotator sleeve C) configured to be rotationally and axially locked to the rotator (Fig. 10A-10F shown above, rotator sleeve A is shown to be rotationally locked, in Fig. 10A-10C, and axially locked with the rotator B, as the rotator sleeve A moves in unison with rotator B).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rotator structure of Alexandersson such that the rotator structure comprises a rotator and a rotator sleeve configured to be rotationally and axially locked to the rotator as taught by Jacobsen in order to allow the rotator to interact with the delivery member cover (Fig. 10A-10F, skin sensor 700) and the rotator sleeve to interact with the plunger rod (Jacobsen: Fig. 10A-10F, plunger tube 1100).
Regarding claim 31, Alexandersson discloses a medicament delivery device (Alexandersson: Fig. 1, medicament delivery device 1) comprising: a housing (Fig. 2, comprised of deliver member cover 7 and actuator sleeve 11), a medicament container housing (Fig. 3, medicament container holder 17) arranged in the housing (Fig. 2 and 3, holder 17 is arranged within delivery member cover 7), a rotator structure (Fig. 6, rotator 25) comprising a rotator sleeve (Fig. 7, rotator 25 is a sleeve), a resilient member (Fig. 6, resilient member 27) operatively associated with the rotator structure (Fig. 6, member 27 moves rotator 25; para. 0055) that biases the rotator in a proximal direction (member 27 biases rotator 25 distally towards needle; para. 0055), a plunger rod (Fig. 9A, plunger rod 23) extending axially inside the rotator structure (Fig. 9A, plunger rod 23 extends axially within rotator 25), wherein the rotator sleeve (Fig. 6, rotator 25) comprises a first rotator guide track structure (Fig. 6, guide structure 25a) that engages with an inner surface structure (Fig. 5 and 6, guide structures 25a receive inwards extending portion 13b; para. 0055) of the housing (Fig. 2, comprised of deliver member cover 7 and actuator sleeve 11) when the rotator structure (Fig. 6, rotator 25) is rotated from the first rotator position (Fig. 6, first rotator position defined by portion 13b located at contiguous proximal portion 25b, in which the rotator 25 will rotate when portion 13b is moved towards portion 25c; para. 0055) to the second rotator position (Fig. 6, second rotator position defined by 13b reaching distal portion 25c, causing rotation of rotator 25; para. 0055 and 0063), wherein disengagement of the rotator structure (Fig. 6, rotator 25) from the inner surface structure (Fig. 5 inwards extending portion 13b) after rotation of the rotator structure (Fig. 6, rotator 25) from the first rotator position (Fig. 6, first rotator position defined by portion 13b located at contiguous proximal portion 25b, in which the rotator 25 will rotate when portion 13b is moved towards portion 25c; para. 0055) towards the second rotator position (Fig. 6, second rotator position defined by 13b reaching distal portion 25c, causing rotation of rotator 25; para. 0055 and 0063), causes the resilient member (Fig. 6, resilient member 27) to move the rotator structure (Fig. 6, rotator 25), the plunger rod (Fig. 9A, plunger rod 23), and the medicament container housing (Fig. 3, medicament container holder 17) a first forward distance relative to the housing (rotator 25, holder 17, and plunger holder 21, which houses the plunger rod 23, moves forward upon portion 13b reaching distal portion 25c; para. 0063) to perform an auto-penetration operation (auto-penetration procedure is permitted upon portion 13b reaching distal portion 25c; para. 0063-0067).
Alexandersson does not expressly disclose a delivery member cover slidably arranged in the housing; a rotator operatively associated with the delivery member cover; a rotator sleeve operatively connected to and rotatably locked to the rotator such that rotation of the rotator sleeve causes an equal amount of rotation of the rotator, wherein the delivery member cover moves axially from an extended position relative to the housing to a retracted position causing the rotator to rotate, and wherein the plunger rod has a first axial engagement position with the rotator when the rotator sleeve is in a first rotator position and in a second rotator position; wherein the rotator comprises an inwardly extending stepped structure within the inner diameter of the rotator and the plunger rod comprises a protrusion extending outward from the plunger rod, wherein the inwardly extending stepped structure comprises a first step and an axially extending groove adjacent to the first step, the protrusion is configured to interact with the inwardly extending stepped structure, wherein the protrusion clears the first step and moves into the groove after the rotator moves a radial distance, and wherein the plunger rod is released from axial engagement once it is moved into the axially extending groove.
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Jacobsen teaches a delivery member cover a delivery member cover (Fig. 7A-7C, skin sensor 700 shields needle 902; para. 0141) slidably arranged in a housing (skin sensor 700 retracts within housing 500; para. 0141); a rotator (Fig. 10B shown above, rotator sleeve C) operatively associated with the delivery member cover (Fig. 7A-7C, syringe lock 600 is operatively associated with skin sensor 700); a rotator (Fig. 10A-10F, syringe lock 600) operatively connected to and rotatably locked to the rotator (Fig. 10B shown above, rotator sleeve C is connected to and rotationally locked to lock 600) such that rotation of the rotator sleeve causes an equal amount of rotation of the rotator (Fig. 10A and 10B, rotation of lock 600 causes equal rotation in rotator sleeve C), wherein the delivery member cover (Fig. 7A-7C, skin sensor 700) is configured to be moved axially from an extended position (Fig. 7A, initial position of sensor 700 is in forward position; para. 0166) relative to the housing (Fig. 1, housing 500) to a retracted position (Fig. 7C, sensor 700 is fully retracted; para. 0166), thereby causing a rotator structure (Fig. 7, syringe lock 600) to rotate (Fig. 7B, lock 500 rotates to second position upon skin sensor 700 retraction; para. 0166), and wherein a plunger rod (Fig. 10A-10F, plunger rod tube 1100) has a first axial engagement position (Fig. 10A-10F, plunger tube 1100 engages with syringe lock 600 at tab 1112) with the rotator (Fig. 10B shown above, rotator sleeve C) when the rotator (Fig. 10A-10F, syringe lock 600) is in a first rotator position (Fig. 10A) and in a second rotator position (Fig. 10B), wherein the rotator (Fig. 10A-10F, syringe lock 600) comprises an inwardly extending stepped structure (Fig. 10A-10F, guiding trail 604 extends inwardly from the exterior of lock 600 to the interior of lock 600) within the inner diameter of the rotator (Fig. 10A-10F, syringe lock 600) and the plunger rod (Fig. 10A-10F, plunger rod tube 1100) comprises a protrusion extending outward (Fig. 10A-10F, syringe assembly tab 1112) from the plunger rod (Fig. 10A-10F, plunger rod tube 1100), wherein the inwardly extending stepped structure (Fig. 10A-10F, guiding trail 604) comprises a first step (Fig. 10A-F above, first step A, which extends from resting ledge 606 to right before syringe lock end stop 610) and an axially extending groove (Fig. 10A-10F, end stop 610 extends axially from the interior surface of the lock 600) adjacent to the first step (Fig. 10A-F above, first step A), wherein the protrusion is configured to interact with the stepped structure (Fig. 10A-10F, syringe assembly tab 1112 cooperates with guiding trail 604), wherein the protrusion (Fig. 10A-10F, syringe assembly tab 1112) clears the first step (Fig. 10A-F above, first step A) and moves into the axially extending groove (Fig. 10A-10F, end stop 610) after the rotator structure (Fig. 7, syringe lock 600) rotates a radial distance (Fig. 10B to 10D, lock 600 rotates a distance), wherein the plunger rod (Fig. 10A-10F, plunger rod tube 1100) is released from axial engagement once it is moved into the axially extending groove (Fig. 10B-E, once the tab 1112 clears first step A going in to Fig. 10C, plunger rod 1100 is released from axial engagement as seen in Fig. 10E).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Alexandersson to include a delivery member cover slidably arranged in the housing; a rotator operatively associated with the delivery member cover; a rotator sleeve operatively connected to and rotatably locked to the rotator such that rotation of the rotator sleeve causes an equal amount of rotation of the rotator, wherein the delivery member cover moves axially from an extended position relative to the housing to a retracted position causing the rotator to rotate, and wherein the plunger rod has a first axial engagement position with the rotator when the rotator sleeve is in a first rotator position and in a second rotator position; wherein the rotator comprises an inwardly extending stepped structure within the inner diameter of the rotator and the plunger rod comprises a protrusion extending outward from the plunger rod, wherein the inwardly extending stepped structure comprises a first step and an axially extending groove adjacent to the first step, the protrusion is configured to interact with the inwardly extending stepped structure, wherein the protrusion clears the first step and moves into the groove after the rotator moves a radial distance, and wherein the plunger rod is released from axial engagement once it is moved into the axially extending groove as taught by Jacobsen in order to shield the needle in an initial position and engage with the rotator structure to begin the auto-penetration process (Jacobsen: para. 0141 and para. 0166), reduce the risk of accidental activation of the auto injector (para. 0170), and allow the plunger rod to interact with the syringe lock 600 and create various rotator positions (Jacobsen: para. 0169 and 0176).
Alexandersson in view of Jacobsen does not expressly disclose that the engagement of the first rotator guide track structure with the inner surface structure of the housing prevents axial proximal movement of the rotator when the rotator sleeve is in the first rotator position.
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Giambattista teaches a rotator sleeve (Giambattista: Fig. 7, rotator 82) comprising a rotator guide track structure (Fig. 7, guide members 90) preventing axial forward movement of the rotator structure (Fig. 7, rotator 82) inside a housing (Fig. 2 and 7 shown above, rotator 82 movement within contractor 12 is prevented when third contact members 30 is in pos. A, blocked by circumferential section 90II; para. 0068) when the rotator sleeve (Fig. 7, rotator 82) is in the first rotator position (Fig. 7 shown above, pos. A); wherein a stepped structure (Fig. 8, inner guiding members 100) is an inwardly extending stepped structure (Fig. 8, inner guiding members 100 extending inwardly from the rotator 82).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rotator sleeve of Alexandersson in view of Jacobsen such that the engagement of the first rotator guide track structure with the inner surface structure of the housing prevents axial proximal movement of the rotator when the rotator sleeve is in the first rotator position as taught by Giambattista in order to lock the rotator from axial movement during the initial position (Giambattista: para. 0068) and to allow for the release of axial movement of the plunger upon reaching another position (Giambattista: para. 0074). Furthermore, it would be obvious to combine the inwardly extending stepped structure of Giambattista with the stepped structure of Jacobson, as any change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 32, Alexandersson in view of Jacobsen and Giambattista disclose the device above.
Alexandersson in view of Giambattista does not expressly disclose that the rotator and the rotator sleeve are axially locked relative to each other causes the same amount of axial movement of the rotator sleeve.
Jacobsen teaches a rotator (Jacobsen: Fig. 10A-10F, syringe lock 600) and a rotator (Fig. 10A-10F, syringe lock 600) that are axially locked relative to each other (Fig. 10A-10F, lock 600 and sleeve C are axially locked, moving with each other throughout the operation) causes the same amount of axial movement of the rotator sleeve (Fig. 10A-10F, lock 600 and sleeve C are axially locked, moving with each other throughout the operation).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rotator structure of Alexandersson in view of Giambattista such that it comprises a rotator and the rotator sleeve that are axially locked relative to each other causes the same amount of axial movement of the rotator sleeve as taught by Jacobsen in order to allow for the delivery member cover to interact with the rotator structure, which, in turn, interacts with the plunger tube (Jacobsen: para. 0177-0179).
Regarding claim 33, Alexandersson in view of Jacobsen and Giambattista disclose the device above.
Alexandersson in view of Giambattista does not expressly disclose that the rotator and the rotator sleeve are integral forming a single component.
Jacobsen teaches a rotator (Fig. 10B shown above, rotator sleeve C) and a rotator (Fig. 10A-10F, syringe lock 600) that are integral forming a single component (Fig. 10B shown above, lock 600 and sleeve C are an integral, single component).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rotator structure of Alexandersson in view of Giambattista such that it comprises a rotator and a rotator sleeve that are integral forming a single component as taught by Jacobsen in order to allow for the delivery member cover to interact with the rotator structure, which, in turn, interacts with the plunger tube (Jacobsen: para. 0177-0179).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Alexandersson in view of Jacobsen in further view of Giambattista and Atterbury et al. (US Patent Publication No. 20200030537 A1), hereinafter Atterbury.
Regarding claim 18, Alexandersson in view of Jacobsen and Giambattista discloses the device above.
Alexandersson in view of Jacobsen does not expressly disclose that the rotator structure is configured to axially engage with the inner surface structure of the housing, thereby preventing further axial forward movement of the rotator structure and the medicament container housing in the housing.
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Giambattista teaches a rotator structure (Giambattista: Fig. 7, rotator 82) configured to axially engage with the inner surface structure (Fig. 7 shown above, rotator 82 axially engages third contact members 30 at pos. A, blocked by circumferential section 90II; para. 0068) of a housing (Fig. 2, contractor 12), thereby preventing further axial forward movement of the rotator structure (Fig. 2 and 7 shown above, rotator 82 movement within contractor 12 is prevented when third contact members 30 is in pos. A, blocked by circumferential section 90II; para. 0068) and the medicament container housing (Fig. 2, medicament container holder 56 is also prevented from axial forward movement while in the initial position; para. 0057) in the housing (Fig. 2, contractor 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rotator structure of Alexandersson in view of Jacobsen such that the rotator structure is configured to axially engage with the inner surface structure of the housing, thereby preventing further axial forward movement of the rotator structure and the medicament container housing in the housing as taught by Giambattista in order to lock the rotator from axial movement during the initial position (Giambattista: para. 0068) and to ensure distance between the needle tip and the neck portion of the medicament container (para. 0057).
Alexandersson in view of Jacobsen and Giambattista does not expressly disclose that the rotator structure moves a first forward distance to axially engage with the inner surface structure of the housing.
Atterbury teaches a rotator structure (Atterbury: Fig. 11, shuttle 190) that moves a first forward distance (shuttle 190 moves downward as guide key 162 travels through lower vertical portion 192A) to axially engage with an inner surface structure (Fig. 21, guide key 162 axially engages with shuttle 190 at the end of the portion 192A when it abuts surface 193; para. 0067) of a housing (Fig. 21, mixing chamber 160).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rotator structure of Alexandersson in view of Jacobsen and Giambattista such that the rotator structure moves a first forward distance to axially engage with the inner surface structure of the housing as taught by Atterbury in order to prevent further downward movement of the rotator structure (para. 0067).
Claims 26-29 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Alexandersson in view of Jacobsen in further view of Giambattista and Lawlis et al. (US Patent Publication No. 20120265136 A1), hereinafter Lawlis.
Regarding claim 26, Alexandersson in view of Jacobsen and Giambattista discloses the device above.
Alexandersson in view of Jacobsen and Giambattista does not expressly disclose that the delivery member cover is configured to initially be arranged in an initial position in which it is arranged further in the housing than in the extended position, wherein the delivery member cover is configured to be moved from the initial position to the extended position, causing the rotator structure to rotate from an initial rotator position to the first rotator position.
Lawlis teaches a delivery member cover (Lawlis: Fig. 1B, needle shield 120) is configured to initially be arranged in an initial position (needle shield 120 starts retracted before extension into the first position; para. 0089-0091) in which it is arranged further in the housing (Fig. 1B, housing 110) than in the extended position (needle shield 120, when retracted, is further in housing 110 than when extended; para. 0089-0091), wherein the delivery member cover (Fig. 1B, needle shield 120) is configured to be moved from the initial position (needle shield 120 in the retracted initial position; para. 0089) to the extended position (needle shield 120 extends upon reaching first position; para. 0089-0091), causing a rotator structure (Fig. 1B, rotator 118) to rotate from an initial rotator position to the first rotator position (rotator 118 rotates as a result of needle shield 120 extending, rotating to the first rotation position; para. 0089-0091).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Alexandersson in view of Giambattista to include a delivery member cover that is configured to initially be arranged in an initial position in which it is arranged further in the housing than in the extended position, wherein the delivery member cover is configured to be moved from the initial position to the extended position, causing the rotator structure to rotate from an initial rotator position to the first rotator position as taught by Lawlis in order to shield the needle before pressing the auto-injector into the delivery sight (Lawlis: para. 0089-0091).
Regarding claim 27, Alexandersson in view of Jacobsen, Giambattista, and Lawlis discloses the device above.
Alexandersson in view of Giambattista and Lawlis does not expressly disclose the plunger rod has an initial axial engagement position with the rotator structure when the rotator structure is in the initial rotator position, and wherein the plunger rod is configured to disengage from the initial axial engagement position and move forward axially a priming distance relative to the rotator structure and engage with the rotator structure in the first axial engagement position.
Jacobson teaches a plunger rod (Jacobson: Fig. 10A-10F, plunger rod tube 1100) has an initial axial engagement position (Fig. 10E, tube 1100 is in an initial position; para. 0179) with a rotator structure (Fig. 10E, tube 1100 is in initial position engaging with guiding trail 604 of the syringe lock 600; para. 0179) when the rotator structure (Fig. 10A-10F, syringe lock 600) is in an initial rotator position (Fig. 10E, syringe lock is in initial position 600), and wherein the plunger rod (Fig. 10A-10F, plunger rod tube 1100) is configured to disengage from the initial axial engagement position (Fig. 10E, tube 1100 is in an initial position; para. 0179) and move forward axially a priming distance (Fig. 10F, tube 1100 moves forward a distance into the first position; para. 0177 and 0179) relative to the rotator structure (Fig. 10A-10F, syringe lock 600) and engage with the rotator structure (Fig. 10A-10F, syringe lock 600) in the first axial engagement position (Fig. 10F and 10A, tube 1100 is in first position on guide trail 604).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plunger rod and rotator structure of Alexandersson in view of Giambattista and Lawlis such that the plunger rod has an initial axial engagement position with the rotator structure when the rotator structure is in the initial rotator position, and wherein the plunger rod is configured to disengage from the initial axial engagement position and move forward axially a priming distance relative to the rotator structure and engage with the rotator structure in the first axial engagement position as taught by Jacobsen in order to allow the auto-injector to deliver two doses, reloading in between injection operations (Jacobsen: para. 0176 and 0179).
Regarding claim 28, Alexandersson in view of Jacobsen, Giambattista, and Lawlis discloses the device above.
Alexandersson in view of Giambattista and Lawlis does not expressly disclose the stepped structure has a second step on which the radially outwards extending protrusion rests when the rotator structure is in an initial rotator position.
Jacobsen teaches the stepped structure (Fig. 10A-10F, guiding trail 604) has a second step (Fig. 10A-10F shown above, step A) on which the radially outwards extending protrusion (Fig. 10A-10F, syringe assembly tab 1112) rests when the rotator structure (Fig. 10A-10F, syringe lock 600) is in an initial rotator position (Fig. 10A-F above, syringe lock is in initial position 600, wherein tab 1112 rests on step A).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rotator structure of Alexandersson in view of Giambattista and Lawlis such that the stepped structure has a second step on which the radially outwards extending protrusion rests when the rotator structure is in an initial rotator position as taught by Jacobsen in order to allow the auto-injector to deliver two doses, reloading in between injection operations (Jacobsen: para. 0176 and 0179).
Regarding claim 29, Alexandersson in view of Jacobsen, Giambattista, and Lawlis discloses the device above.
Alexandersson in view of Giambattista and Lawlis does not expressly disclose the first step (Jacobsen: Fig. 10A-10F, ledge 606) is arranged closer to the front end of the housing than the second step.
Jacobsen teaches a stepped structure comprising a first step that is arranged closer to a front end of a housing than a second step.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rotator structure of Alexandersson in view of Giambattista and Lawlis such that the first step is arranged closer to the front end of the housing than the second step as taught by Jacobsen in order to allow the auto-injector to deliver two doses, reloading in between injection operations (Jacobsen: para. 0176 and 0179).
Regarding claim 35, Alexandersson in view of Jacobsen and Giambattista disclose the device above.
Alexandersson in view of Jacobsen and Giambattista does not expressly disclose that the delivery member cover that has an initial position, a retracted position an extended position, where when in an initial position the delivery member cover is arranged further into a housing than when in the extended position and when the delivery member cover moves from the initial position to the extended position a rotator rotates from an initial rotator position to a first rotator position.
Lawlis teaches a delivery member cover (Lawlis: Fig. 1B, needle shield 120) that has an initial position (needle shield 120 starts retracted before extension into the first position; para. 0089-0091), a retracted position (needle shield 120 in the retracted initial position; para. 0089) an extended position (needle shield 120 extends upon reaching first position; para. 0089-0091), where when in an initial position (needle shield 120 in the retracted initial position; para. 0089) the delivery member cover (Fig. 1B, needle shield 120) is arranged further into a housing (Fig. 1B, housing 110) than when in the extended position (needle shield 120, when retracted, is further in housing 110 than when extended; para. 0089-0091) and when the delivery member (Fig. 1B, needle shield 120) cover moves from the initial position (needle shield 120 in the retracted initial position; para. 0089) to the extended position (needle shield 120 extends upon reaching first position; para. 0089-0091) a rotator rotates from an initial rotator (Fig. 1B, rotator 118) position to a first rotator position (rotator 118 rotates as a result of needle shield 120 extending, rotating to the first rotation position; para. 0089-0091).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Alexandersson in view of Giambattista to include a delivery member cover has an initial position, a retracted position an extended position, where when in an initial position the delivery member cover is arranged further into the housing than when in the extended position and when the delivery member cover moves from the initial position to the extended position the rotator rotates from an initial rotator position to the first rotator position as taught by Lawlis in order to shield the needle before pressing the auto-injector into the delivery sight (Lawlis: para. 0089-0091).
Response to Arguments
Applicant’s arguments, see page 9, filed 13 April 2026, with respect to the objections to claim 31 and the rejection of claims 31-33 and 35 under 35 USC 112(b) have been fully considered and are persuasive. The objections to claim 31 and the rejection of claims 31-33 and 35 has been withdrawn.
Applicant’s arguments, see pages 9-13, filed 13 April 2026, with respect to the rejections of claims 16-18, 20-33, and 35 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of an alternative interpretation of Alexandersson in view of Jacobsen and Giambattista discussed above.
Conclusion
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
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