DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/25/2026 has been entered.
Claims 1-11 are examined in this office action.
Claim 11 is new.
Allowable Subject Matter
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments, see pages 7-16, filed 8/25/2026, with respect to the rejection(s) of claim(s) 1-10 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Holmqvist in view of Shi and Chuvashova.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist (EP 3548116 B1) in view of Shi et al. (US Pub No. 20210138161 A1) and in further view of Chuvashova (US Pub No. 2016112921 A1).
Regarding claim 1, Holmqvist disclose a medical injection system (Holmqvist, 100, Fig. 1) extending from a distal end to a proximal end along an axial direction comprising:
a cartridge module (Holmqvist, plunger rod 13 and plunger recess) comprising:
a plunger comprising (Holmqvist, plunger rod 13, Fig. 2) a plunger recess (Holmqvist, “The plunger rod 13, which has radial recesses …” – Para [0067]) and configured to move in the axial direction (Holmqvist, “The plunger rod 13, configured to move axially inside the housing …” – Para [0026]); and
an injection module (Holmqvist, tubular extension member 15, moveable sleeve 17, delivery cover member 5, Fig. 2) configured to accommodate the cartridge module and comprising:
an actuator (Holmqvist, tubular extension member 15, Fig. 2) configured to accommodate the plunger (Holmqvist, as shown in Fig. 2) and one or more upper elastic pieces (Holmqvist, radially flexible arms, Para [0067]) corresponding, to the plunger recess, the one or more upper elastic pieces are compressed inward against the plunger recess, and the actuator limits movement of the plunger in the axial direction (Holmqvist, “The plunger rod 13, which has radial recesses configured to receive a respective one of the radially flexible arms, is thereby maintained in an initial axial position.” – Para [0067]),
a starter (Holmqvist, moveable sleeve 17) comprising one or more rotational ramps (Holmqvist, radially extending portion 17a, Fig. 3) and forming a penetrable structure for accommodating the actuator (Holmqvist, “The moveable sleeve 17 is configured to receive the tubular extension member 15 …” – Para [0067]), and
a needle cover (Holmqvist, delivery member cover 5), forming a penetrable structure for accommodating the cartridge module (Holmqvist, Figs. 2 and 8A) and comprising one or more motion steering protrusions (Holmqvist, legs 5a, 5b) which contact the one or more rotational ramps (Holmqvist, “The moveable sleeve 17 may have two such radially extending portions 17a, each configured to cooperate with a respective distal end surface 5c of a leg 5a, 5b.” – Para [0043]),
wherein the penetrable structure of the starter further comprises:
an inner annular surface configured to compress the one or more upper elastic pieces inward (Holmqvist, “… the radially flexible arms are configured to be pressed radially inwards by the inner surface of the moveable sleeve.” – Para [0067]), and
one or more accommodating spaces located on the inner annular surface (Holmqvist, “The moveable sleeve 17 may furthermore have an inner surface provided with recesses.” – Para [0067])
wherein, when the needle cover moves toward the proximal end:
the one or more motion steering protrusions push the one or more rotational ramps to cause a rotation of the starter around an axis aligned with the axial direction (Holmqvist, “… as the distal end surface 5c slides along the radially extending portion 17a, the cam surface, of the movable sleeve 17 and the delivery member cover 5 is moved proximally. The moveable sleeve 17 is then rotated …” – Para [0067]):
the rotation of the starter moves the one or more accommodating spaces into alignment with the one or more upper elastic pieces, such that the one or more upper elastic pieces are no longer compressed inward by the inner annular surface (Holmqvist, “When the moveable sleeve 17 is being rotated, the radially flexible arms, which initially are pressed radially inwards by the inner surface of the moveable sleeve, will be able to flex radially outwards into the recesses of the moveable sleeve 17.” – Para [0067])
Holmqvist does not expressly disclose an actuator … comprising one or more rotating chutes, wherein the one or more rotating chutes extend from the distal end toward the proximal end while extending circumferentially in a first circumferential direction, wherein the one or more rotational ramps extend from the distal end toward the proximal end while extending circumferentially in a second circumferential direction opposite to the first circumferential direction, and one or more rotational protrusions located on the inner annular surface and engaging the one or more rotating chutes, wherein the rotation of the starter causes the one or more rotational protrusions to move along the one or more rotating chutes, such that the starter moves toward the proximal end while rotating.
Shi teaches an actuator (rotating tube 5, Fig. 9) … comprising one or more rotating chutes (inclined track 51 and straight track 52, Fig. 9), wherein the one or more rotating chutes extend from the distal end toward the proximal end while extending circumferentially in a first circumferential direction (arrow as shown in Fig. 20), wherein the starter (front sleeve 4, Fig. 5) comprises one or more rotational protrusions (inclined surface acting portion 45, Fig. 8) located on the inner annular surface (the inner edge of the front sleeve 4) and engaging the one or more rotating chutes ("… the bevel acting portion 45 on the inner edge of the front sleeve 4 and the beveled track 51 on the outer edge of the rotating tube 5 cooperate …" Para [0092]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include an actuator … comprising one or more rotating chutes, wherein the one or more rotating chutes extend from the distal end toward the proximal end while extending circumferentially in a first circumferential direction and one or more rotational protrusions located on the inner annular surface and engaging the one or more rotating chutes as taught by Shi for providing the reliable locking protection of the front shield (Shi, Abstract).
Shi does not expressly disclose that the one or more rotational ramps extend from the distal end toward the proximal. end while extending circumferentially in a second circumferential direction opposite to the first circumferential direction, wherein the rotation of the starter causes the one or more rotational protrusions to move along the one or more rotating chutes, such that the starter moves toward the proximal end while rotating.
Chuvashova relates to a pen injector drug delivery device and is therefore from an art which is the same as or closely analogous to those of Applicant’s claims. Chuvashova teaches a drug delivery device that is configured to deliver a predetermined amount of medicament by the interaction a guide element and an actuator member which lock the actuator guide member after delivery of the medicament, thus improving the reliability and safety of the pen injector (Para [0047] – [0050]). More specifically, Chuvashova describes that the device pen injector includes:
Chuvashova teaches that the one or more rotational ramps (protruding structures 62, Fig. 7) extend from the distal end toward the proximal end while extending circumferentially in a second circumferential direction opposite to the first circumferential direction (See annotated Fig. 7), wherein the rotation of the starter (plunger rod 24, Figs. 2-4) causes the one or more rotational protrusions (ribs 38, Fig. 4) to move along the one or more rotating chutes (grooves 36, Fig. 4), such that the starter moves toward the proximal end while rotating (“When the threaded plunger rod 24 now rotates, it will be moved in the proximal direction …” – Para [0064]).
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Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include that the one or more rotational ramps extend from the distal end toward the proximal end while extending circumferentially in a second circumferential direction opposite to the first circumferential direction, wherein the rotation of the starter causes the one or more rotational protrusions to move along the one or more rotating chutes, such that the starter moves toward the proximal end while rotating as taught by Chuvashova for minimizing delivery of wrong quantities of medicament (Chuvashova, Para [0067]).
Regarding claim 2, Holmqvist in view of Shi and Chuvashova disclose the medical injection system (Holmqvist, 100, Fig. 1) as recited above, wherein
Holmqvist does not expressly disclose that the one or more rotating chutes are connected to one or more longitudinal chutes extending along the axial direction and wherein, when the one or more rotational protrusions move along the one or more rotating chutes to positions near respective ends of the one or more rotating chutes, the one or more rotational protrusions are moved toward the one or more longitudinal chutes.
Shi teaches that the one or more rotating chutes (inclined track 51, Fig. 9) are connected to one or more longitudinal chutes (straight track 52, Fig. 9) extend along the axial direction and wherein, when the one or more rotational protrusions move along the one or more rotating chutes to positions near respective ends of the one or more rotating chutes, the one or more rotational protrusions are moved toward the one or more longitudinal chutes (“… continue to push the insulin injection needle, and the inclined surface acting portion 45 on the front cannula 4 is in contact with the straight track 52 on the rotating tube 5.” – Para [0094]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection apparatus of Holmqvist to include that the one or more rotating chutes are connected to one or more longitudinal chutes extending along the axial direction and wherein, when the one or more rotational protrusions move along the one or more rotating chutes to positions near respective ends of the one or more rotating chutes, the one or more rotational protrusions are moved toward the one or more longitudinal chutes as taught by Shi for providing the reliable locking protection of the front shield (Shi, Abstract).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist (EP 3548116 B1) in view of Shi et al. (US Pub No. 20210138161 A1) and Chuvashova (US Pub No. 2016112921 A1) and in further view of Yin (US Pub No. 20220215779 A1).
Regarding claim 3, Holmqvist in view of Shi and Chuvashova disclose the medical injection system (Holmqvist, 100, Fig. 1) as recited above, further comprising
a housing (Holmqvist, housing 3) for accommodating the cartridge module (Holmqvist, plunger rod 13, Fig. 2) and the injection module (Holmqvist, tubular extension member 15, moveable sleeve 17, delivery cover member 5, Fig. 2), wherein the actuator is fixed to the housing, and when the cartridge module is pressed down against skin of a subject, the needle cover is moved toward the proximal end (Holmqvist, “… as the distal end surface 5c slides along the radially extending portion 17a, the cam surface, of the movable sleeve 17 and the delivery member cover 5 is moved proximally).
Holmqvist does not expressly disclose that the actuator is fixed to the housing.
Yin relates to a delivery mechanism for a medicament delivery training device, and is therefore from an art which is the same as, or very closely analogous to, those of the Applicant’s claims. Yin teaches an autoinjector with a holding structure that is configured to house the plunger with arms that are configured to engage with recesses in the plunger. As the actuator is moved in the proximal direction its arms move out of the recesses in the plunger and allow the plunger to move further along, thus allowing for an injection to be completed (Para [0075]). More specifically, Yin describes that the actuator includes:
Yin teaches that the actuator (holding structure 21) is fixed to the housing (“The holding structure 21 is configured to be fixedly arranged in the housing 3.” – Para [0060])
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include that the actuator is fixed to the housing as taught by Yin in order to receive a distal end portion 13b of the plunger rod 13. (Yin, Para [0060]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist (EP 3548116 B1) in view of Shi et al. (US Pub No. 20210138161 A1) and Chuvashova (US Pub No. 2016112921 A1) and in further view of Chang et al. (US Pub No. 2021/0023309 A1).
Regarding claim 4, Holmqvist in view of Shi and Chuvashova disclose the medical injection system (Holmqvist, 100, Fig. 1) as recited above, wherein
Holmqvist does not expressly disclose an injection completion feedback module, wherein the injection completion feedback module comprises: a click ring which forms a penetrable structure for accommodating the actuator; and a compression collar which forms a penetrable structure for accommodating the plunger, the compression collar comprising an impact surface formed in the penetrable structure of the compression collar corresponding to the click ring, wherein when the click ring contacts the impact surface of the compression collar, an injection completion feedback prompt is generated.
Chuvashova teaches that when the click ring (ledge 80) contacts the impact surface of the compression collar (inner surface of the actuator guide member 90), an injection completion feedback prompt is generated (“… whereby the at least one ledge 80 will hit the inner surface of the actuator guide member 90, producing audible sounds, which sounds indicate that the delivery operation is completed.” – Para [0066]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include that when the click ring contacts the impact surface of the compression collar, an injection completion feedback prompt is generated as taught by Chuvashova for minimizing delivery of wrong quantities of medicament (Chuvashova, Para [0067]). Modifying Holmqvist in this way would allow the user of the device of Holmqvist to receive audible feedback for confirmation that the injection has been completed. Holmqvist discloses that an audible click may be used but does not disclose the mechanism that produces the clicking sound. Including a click ring around the actuator and a compression around the plunger of Holmqvist that contact each other to produce an audible sound would be one way of producing the feedback sound.
Chuvashova does not expressly disclose that its click ring forms a penetrable structure for accommodating the actuator and that its compression collar forms a penetrable structure for accommodating the plunger.
Chang teaches an injection completion feedback module (10, Fig. 3), wherein the injection completion feedback module comprises: a click ring (dose plate 163) which forms a penetrable structure for accommodating the actuator (driver sleeve 143) (“The dose plate 163 is a ring-shaped structure comprising a central opening as a passage for the driver sleeve 143…” – Para [0066]); and a compression collar (dose knob 146) which forms a penetrable structure for accommodating the plunger (Fig. 6), the compression collar comprising an impact surface (See annotated Fig. 22) formed in the penetrable structure of the compression collar corresponding to the click ring.
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Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include an injection completion feedback module, wherein the injection completion feedback module comprises: a click ring which forms a penetrable structure for accommodating the actuator; and a compression collar which forms a penetrable structure for accommodating the plunger, the compression collar comprising an impact surface formed in the penetrable structure of the compression collar corresponding to the click ring as taught by Chang in order to generate nonvisual responses (Chang, Para [0098]).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist (EP 3548116 B1) in view of Shi et al. (US Pub No. 20210138161 A1) and Chuvashova (US Pub No. 2016112921 A1) and in further view of Chang et al. (US Pub No. 2021/0023309 A1) and Smith et al. (US Pub No. 2019/0374721 A1).
Regarding claim 5, Holmqvist in view of Shi, Chuvashova and Chang disclose the medical injection system (Holmqvist, 100, Fig. 1) as recited above, wherein
Holmqvist does not expressly disclose that the actuator further comprises one or more lower elastic pieces, and when the one or more lower elastic pieces are pushed outward by the plunger, the one or more lower elastic pieces compress against the click ring to prevent the click ring from contacting the impact surface of the compression collar.
Smith relates to a medication delivery device with a dose setting operation which is the same as, or very closely analogous to, those of Applicant’s claims. Smith teaches a device with a mechanism that locks the dose setting sleeve and thereby prevents the user from operating the injector. The dose setting sleeve is locked by an actuator with projections that engage and disengage with the dose setting sleeve. More specifically, Smith describes that the device includes:
Smith teaches that the actuator (the drive sleeve 2) further comprises one or more lower elastic pieces (“The drive sleeve 2 further comprises a deflectable feature 39.”; “The deflectable feature 39 may be elastic.” – Para [0174], [0176]), and when the one or more lower elastic pieces are pushed outward by the plunger (“… the piston rod 4 abuts or almost abuts the inner surface of the deflectable feature 39. Thus, the piston rod 4 prevents an inward deflection of the deflectable feature 39 in the primed state.” – Para [0177]) the one or more lower elastic pieces compress against the click ring (dose setting sleeve 5b) (“… the deflectable feature 39 returns elastically to into its outward position. The projection 40 arranged on the deflectable feature 39 now abuts the second stop face 44 of the dose setting sleeve 5b.” – Para [0229]) to prevent the click ring from rotating (“Thereby a rotation of the dose setting sleeve 5…is prevented.” – Para [0213])
Smith does not teach that the one or more lower elastic pieces compress against the click ring to prevent the click ring from contacting the impact surface of the compression collar.
Examiner interprets the prevention of the rotation of the dose setting sleeve to be the equivalent of the claimed prevention of the click ring from contacting the impact surface of the compression collar because they both achieve the same function of preventing the feedback mechanism from delivering a feedback output to the user (“During the first step of the dose setting operation, the dose setting sleeve 5 is rotated. Thereby, the deflectable detent 6 is subsequently disengaged from and engaged with the grooves 3d of the body 3. Each time the deflectable detent 6 is engaged with or disengaged from a groove 3d, an audible and/or tactile feedback is provided to a user.” – Para [0201]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include that the actuator further comprises one or more lower elastic pieces, and when the one or more lower elastic pieces are pushed outward by the plunger, the one or more lower elastic pieces compress against the click ring to prevent the click ring from contacting the impact surface of the compression collar as taught by Smith in order to “…creates an audible and tactile feedback…” (Smith, Para [0153]).
Regarding claim 6, Holmqvist in view of Shi, Chuvashova, Chang, and Smith discloses the medical injection system (Holmqvist, 100, Fig. 1) as recited above.
Holmqvist does not expressly disclose that after the plunger moves in the axial direction of the medical injection system, the plunger no longer pushes the one or more lower elastic pieces of the actuator outward.
Smith teaches that after the plunger (piston rod 4) moves in the axial direction of the medical injection system, the plunger no longer pushes the one or more pieces (deflectable feature 39) of the actuator outward ("The piston rod 4 is designed to transfer an axial movement through the medication delivery device 1 …”, “Thus, the section 4c having the maximum radial extension no longer prevents a deflection of the deflectable feature 39." - Para [0136], Para [0228])
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include that after the plunger moves in the axial direction of the medical injection system, the plunger no longer pushes the one or more lower elastic pieces of the actuator outward as taught by Smith in order to create “an audible and tactile feedback…” (Smith, Para [0153]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist (EP 3548116 B1) in view of Shi et al. (US Pub No. 20210138161 A1) and Chuvashova (US Pub No. 2016112921 A1) and in further view of Dasbach et al. (WO 2022029097 A1).
Regarding claim 7, Holmqvist in view of Shi and Chuvashova discloses the medical injection system (Holmqvist, 100, Fig. 1) as recited above, further comprising
Holmqvist does not expressly disclose a cap structure, wherein the cap structure comprises: a cap cover which forms a structure accommodating at least a portion of the cartridge module, and a shield remover, which is arranged to be coupled to the cap cover, comprising a needle guard remover, wherein, when the shield remover is removed from the medical injection system, the needle guard remover removes a needle guard to expose a needle body.
Dasbach relates to a drug delivery device auto-injector and is therefore from an art which is the same as, or very closely analogous to those of Applicant’s claims. Dasbach teaches a drive mechanism meant to move device from an initial position to a final position in order to deliver a medication. More specifically Dasbach describes that the auto-injector includes:
Dasbach teaches a cap structure (cap 101, grabber 103, needle shield 125), wherein the cap structure comprises: a cap cover (cap 100) which forms a structure accommodating at least a portion of the cartridge module, and a shield remover (grabber 103), which is arranged to be coupled to the cap cover (“The cap 101 may include grabber 103…” – Para [0074]), comprising a needle guard remover (needle shield 125), wherein, when the shield remover is removed from the medical injection system, the needle guard remover removes a needle guard to expose a needle body (“The needle shield may be interlocked with the cap, e.g., via the grabber, and removed together with the cap to prepare the device for operation." - Para [0074]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include a cap structure, wherein the cap structure comprises: a cap cover which forms a structure accommodating at least a portion of the cartridge module; and a shield remover, which is arranged to be coupled to the cap cover and comprises a needle guard remover, wherein when the shield remover is removed from the medical injection system, the needle guard remover removes a needle guard to expose a needle body as taught by Dasbach so the needle shield may be interlocked with the cap and removed together with the cap to prepare the device for operation (Dasbach, Para [0074]).
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist (EP 3548116 B1) in view of Shi et al. (US Pub No. 20210138161 A1) and Chuvashova (US Pub No. 2016112921 A1) and in further of Smith et al. (US Pub No. 2019/0374721 A1) and Fiard et al. (US Pub No. 2022/0370720 A1).
Regarding claim 8, Holmqvist in view of Shi, Chuvashova and Smith discloses the medical injection system (Holmqvist, 100, Fig. 1) as recited above, further comprising
Holmqvist does not expressly disclose a backstop module, wherein the backstop module comprises: a front housing which forms a structure accommodating at least a portion of the cartridge module and the injection module, comprising one or more fixing holes; and a syringe holder which is accommodated in the front housing comprising: one or more fixing protrusions corresponding to the one or more fixing holes of the front housing to fix the syringe holder to the front housing, one or more elastic pieces coupled to the needle cover to limit movement of the needle cover in the axial direction of the medical injection system, and one or more fixing pieces corresponding to the one or more elastic pieces, and when the needle cover moves in another axial direction of the medical injection system, the one or more elastic pieces are compressed to be accommodated in the one or more fixing pieces, and the movement of the needle cover is no longer limited.
Smith teaches a backstop module (1, Fig. 1), wherein the backstop module comprises: a front housing (body 3) which forms a structure comprising at least a portion of the cartridge module and the injection module (Fig. 2), comprising or more fixing holes (“the body 3 comprises an opening 3c…” – Para [0129]); and a syringe holder (non-return ratchet 15) which is accommodated in the front housing (Fig. 2) comprising on or more fixing protrusions (“a lug 15a of a non-return ratchet 15…” – Para [0129]) corresponding to the one or more fixing holes of the front housing (“The lug 15a is configured to be received in the opening 3c of the body 3.” – Para [0167]) to fix the syringe holder to the front housing (“The engagement of the non-return ratchet 15 with the body 3 by the lug 15a being received in the opening 3c fixes the non-return ratchet 15 with respect to the body 3.” – Para [0167]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include a backstop module, wherein the backstop module comprises: a front housing which forms a structure accommodating at least a portion of the cartridge module and the injection module, comprising one or more fixing holes; and a syringe holder which is accommodated in the front housing comprising: one or more fixing protrusions corresponding to the one or more fixing holes of the front housing to fix the syringe holder to the front housing as taught by Smith in order to increase the security of the device (Smith, Para [0007]).
Smith does not expressly disclose one or more elastic pieces coupled to the needle cover to limit movement of the needle cover in the axial direction of the medical injection system, and one or more fixing pieces corresponding to the one or more elastic pieces, and when the needle cover moves in another axial direction of the medical injection system, the one or more elastic pieces are compressed to be accommodated in the one or more fixing pieces, and the movement of the needle cover is no longer limited.
Fiard teaches one or more elastic pieces (protrusion 303) (“The locking unit 30A also comprises a protrusion 303…” – Para [0115]) coupled to the needle cover (needle shield 20A, Fig. 7) to limit the movement of the needle cover in the axial direction of the medical injection system (“… the needle shield 20A can be locked in the safety position.” – Para [0119]) and one or more fixing pieces (first track portion 301) corresponding to the one or more elastic pieces (Fig. 7) and when the needle cover moves in the another axial direction of the medical injection system (See annotated Fig. 7) , the one or more elastic pieces are compressed to be accommodated in the one or more fixing pieces (“… the protrusion 303 can freely slide in the first track portion 301…” – and the movement of the needle is no longer limited (“This allows the needle shield 20A to move freely from the initial shielding position to the retracted position and vice versa…” – Para [0117]).
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Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include one or more elastic pieces coupled to the needle cover to limit movement of the needle cover in the axial direction of the medical injection system, and one or more fixing pieces corresponding to the one or more elastic pieces, and when the needle cover moves in another axial direction of the medical injection system, the one or more elastic pieces are compressed to be accommodated in the one or more fixing pieces, and the movement of the needle cover is no longer limited as taught by Fiard in order to prevent a further movement from the initial position to the retracted position (Fiard, Para[ 0004]).
Regarding claim 9, Holmqvist in view of Shi, Chuvashova, Smith, and Fiard discloses the medical injection system (Holmqvist, 100, Fig. 1) as recited above, wherein
Holmqvist does not expressly disclose that the needle cover further comprises one or more buckles, and the front housing further comprises one or more annular protrusions, and when the one or more elastic pieces no longer limit the movement of the needle cover, the needle cover moves in the axial direction of the medical injection system, such that the one or more annular protrusions contact the one or more buckles to limit the movement of the needle cover in the other axial direction of the medical injection system.
Fiard teaches that the needle cover (needle shield 20A) comprises one or more buckles (second track portion 302), and the front housing (locking actuator 40A) further comprises one or more annular protrusions (“a protrusion 303 provided on the locking actuator 40A.” – Para [0115]) and when the one or more elastic pieces no longer limit the movement of the needle cover, the needle cover moves in the axial direction of the medical injection system ("… the locking unit 30A is in an open mode: the protrusion 303 can freely slide in the first track portion 301… This allows the needle shield to move freely from the initial shielding position to the retracted position…" - Para [0117], Figs. 7 and 8), such that the one or more annular protrusions contact the one or more buckles to limit the movement of the needle cover in the other axial direction of the medical injection system ("… the protrusion 303 has completely moved to the second track portion 302…the needle shield 20A can be locked in the safety position." - Para [0119]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include that the needle cover further comprises one or more buckles, and the front housing further comprises one or more annular protrusions, and when the one or more elastic pieces no longer limit the movement of the needle cover, the needle cover moves in the axial direction of the medical injection system , such that the one or more annular protrusions contact the one or more buckles to limit the movement of the needle cover in the other axial direction of the medical injection system as taught by Fiard in order to prevent a further movement from the initial position to the retracted position (Fiard, Para [0004]).
Regarding claim 10, Holmqvist in view of Shi, Chuvashova, Smith, and Fiard discloses the medical injection system (Holmqvist, 100, Fig. 1) as recited above, wherein
Holmqvist does not expressly disclose that when the one or more elastic pieces no longer limit the movement of the needle cover, the needle cover moves in the axial direction of the medical injection system, and the one or more fixing protrusions limit a movement range of the needle cover.
Fiard teaches that when the one or more elastic pieces (protrusion 303) no longer limit the movement of the needle cover (needle shield 20A, “the locking unit 30A is in an open mode: the protrusion 303 can freely slide in the first track position 301…” – Para [0117]), the needle cover moves in the axial direction of the medical injection system, and the one or more fixing protrusions limit a movement range of the needle cover (“This allows the needle shield 20A to move freely from the initial shielding position to the retracted position…" - Para [0117], Figs. 7 and 8).
Examiner interprets the movement range of the needle cover to be between the initial shielding position and the retracted position.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical injection system of Holmqvist to include that when the one or more elastic pieces no longer limit the movement of the needle cover, the needle cover moves in the axial direction of the medical injection system, and the one or more fixing protrusions limit a movement range of the needle cover as taught by Fiard in order to prevent a further movement from the initial position to the retracted position (Fiard, Para [0004]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
