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 .
Claims 1-7 and 9-21 are examined in this office action.
Claims 1, 12, 17, and 20 are currently amended.
Claim 8 is cancelled.
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) 1-7, 9-12, 14-17, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Henderson et al. (US Pub No. 2015/0297833 A1) in view of Liscio et al. (US Pub No. US 2020/0289754 A1) and Watts et al. (US Pub No. 2020/0030540 A1).
Regarding claim 1, Henderson in view of Liscio and Watts discloses an auto-injector (Henderson, autoinjector 1, Fig. 1) comprising:
a housing (Henderson, case 2, Fig. 1) for receiving a syringe (Henderson, syringe 6, Fig. 1) (Henderson, “… a syringe carrier in the case 2 that is adapted to hold a syringe 6 …” – Para [0109]) having a barrel (Henderson, body 20, Fig. 5) containing a medicament (Henderson, “… the syringe 6 includes a body 20 containing a medicament …” – Para [0127]), a plunger (Henderson, plunger 10, Fig. 1) and a needle (Henderson, needle 22, Fig. 6);
a plunger driver (Henderson, trigger button beams 16, Fig. 3) configured to act on the syringe plunger to move the syringe plunger through the housing (Henderson, “… the trigger button beams 16 move distally relative to the case 2, and deflect the tongues 15. When the tongues 15 are deflected, the hook 15.1 disengages the ratchet faces 10.5 of the legs 10.2, and the plunger 1, under the force of the drive springs 9, moves distally relative to the case 2.” – Para [0138]) during a needle insertion phase (Henderson, Fig. 12) and injection phase (Henderson, Fig. 13);
a safety shroud (Henderson, interlock sleeve 17, Fig. 1); and
a plunger driver latch (Henderson, interlock beams 17.1, Fig. 1) coupled to said safety shroud (Henderson, “… two interlock beams 17.1 extend in the proximal direction from the distal end of the interlock sleeve 17.” – Para [0121]) and moveable between first (Henderson, “… the interlock sleeve 17 is in the extended position …” – Para [0121]) and second positions (Henderson, “… the interlock sleeve 17 is in the retracted position …” – Para [0121]) and configured to:
while in the first position before the needle insertion phase, latch the plunger driver at a pre-insertion position in the housing (Henderson, “… when the interlock sleeve 17 is in the extended position, the trigger button may be locked and prevented from actuation.” – Para [0121]),
move to the second position (Henderson, “When the interlock sleeve 17 moves from the extended position to the retracted position, the proximal ends of the interlock beams 17.1 cause the button locking beams 18 to deflect.” – Para [0121]) as a result of pressure applied to the safety shroud (Henderson, “When the autoinjector 1 is placed on the injection site, interlock sleeve 17 may be pushed int the proximal direction into a retracted position …” – Para [0119]), to unlatch the plunger driver from the pre-insertion position (Henderson, “When the button locking beams 18 are deflected, the trigger buttons 16 may move in the distal direction.” – Para [0122]) and allow forward movement of the plunger driver to a post-insertion and injection position in the housing (Henderson, “… the trigger button beams 16 move distally relative to the case 2 …” – Para [0138]), and
return to the first position upon removal or reduction of pressure on the safety shroud (Henderson, “… the interlock sleeve 17 returns to the extended state under the force of the spring …” – Para [0141]), wherein the auto-injector comprises a biasing member configured to bias the plunger driver latch towards the first position (Henderson, “The interlock sleeve 17 may be biased by a spring in an extended position …” – Para [0119]).
Henderson does not expressly a plunger driver latch rotatably coupled to said safety shroud and pivotably moveable and that the plunger driver latch is configured to latch the plunger driver at the post-insertion and injection position and to unlatch the plunger driver from the post-insertion and injection position and allow forward movement of the plunger driver to deploy the safety shroud.
Liscio teaches a plunger driver latch (locking arms 39, Fig. 3) rotatably coupled to said safety shroud (needle sleeve 23, Fig. 5) and pivotably moveable between first (Figs 3 and 4) and second positions (Fig. 5) and that the plunger driver latch ("A locking mechanism …" - Para [0082]) is configured to latch the plunger driver at the post-insertion and injection position ("A locking mechanism (not shown) may be provided to lock the needle 23 in the extended position after use of the device." - Para [0082]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the auto-injector of Henderson to include a plunger driver latch rotatably coupled to said safety shroud and pivotably moveable between first and second positions and that the plunger driver latch is configured to latch the plunger driver at the post-insertion and injection position as taught by Liscio to prevent the user accidentally injuring themselves on the needle 432 (Liscio, Para [0125]).
Liscio does not expressly disclose that the plunger driver latch is configured to unlatch the plunger driver from the post-insertion and injection position and allow forward movement of the plunger driver to deploy the safety shroud.
Watts teaches that the plunger driver latch (syringe plunger 206) is configured to unlatch the plunger driver (safety plunger 222) from the post-insertion and injection position ("The safety plunger 206 decouples from the syringe plunger 222 at a point on the inward stroke, which may be when the syringe plunger 222 has expelled all of a medicament …" - Para [0053]) and allow forward movement of the plunger driver (safety plunger 206) to deploy the safety shroud (sheath 214) ("After decoupling, the safety plunger may move longitudinally relative to the syringe plunger 222 and continued movement of the safety plunger 206 moves the sheath 214 into a position covering the needle." - Para [0053]). Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the auto-injector of Henderson to include that the plunger driver latch is configured to unlatch the plunger driver from the post-insertion and injection position and allow forward movement of the plunger driver to deploy the safety shroud as taught by Watts so that the syringe plunger 222 has expelled all of a medicament or drug from the barrel 214 (Watts, Para [0053]).
Examiner interprets the interlocks beams 17.1 as being connected to interlock sleeve 17. Thus, as interlock sleeve 17 moves from an extended to a retracted position or is biased by a spring, so is the interlock beams 17.1.
Regarding claim 2, Henderson in view of Liscio and Watts discloses the auto-injector (Henderson, autoinjector 1, Fig. 1) as recited above, wherein
before deployment of the safety shroud (Henderson, Fig. 13), the safety shroud is moveable between an extended position and a retracted position in the housing (Henderson, “an interlock sleeve slidably disposed in the case and having an extended position and a retracted position relative to the case.” – Para [0009]) as a result of said applying, or removal or reduction of pressure (Henderson, “When the autoinjector 1 is placed on the injection site, interlock sleeve may be pushed in the proximal direction into a retracted position …” – Para [0119]).
Regarding claim 3, Henderson in view of Liscio and Watts discloses the auto-injector (Henderson, autoinjector 1, Fig. 1) as recited above, wherein
before deployment of the safety shroud (Henderson, Fig. 13), movement of the safety shroud (Henderson, interlock sleeve 17) from the extended position to the retracted position moves the plunger driver latch (Henderson, interlock beams 17.1) from the first position to the second position (Henderson, “When the interlock sleeve 17 moves from the extended position to the retracted position, the proximal ends of the interlock beams 17.1 cause the button locking beams 18 to deflect.” – Para [1021]) to unlatch the plunger driver from the pre-insertion position (Henderson, “When the button locking beams 18 are deflected, the trigger buttons beams 16 may move in the distal direction.” – Para [0122]).
Regarding claim 4, Henderson in view of Liscio and Watts discloses the auto-injector (Henderson, autoinjector 1, Fig. 1) as recited above, wherein
movement of the safety shroud from the retracted position to the extended position (Henderson, “… the interlock sleeve 17 returns to the extended state under the force of the spring …” – Para [0141]) returns the plunger driver latch to the first position (Henderson, “the interlock sleeve 17 returns to the extended state under the force of the spring …” – Para [0141])
Henderson does not expressly disclose to unlatch the plunger driver from the post-insertion and injection position
Watts teaches to unlatch the plunger driver from the post-insertion and injection position (“The safety plunger 206 decouples from the syringe plunger 222 at a point on the inward stroke, which may be when the syringe plunger has expelled all of a medicament or drug from the barrel 214.” – Para [0053]). B
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the auto-injector of Henderson to include to unlatch the plunger driver from the post-insertion and injection position as taught by Watts so the safety plunger 206 moves the sheath 214 into a position covering the needle (Watts, Para [0053]).
Examiner interprets the interlocks beams 17.1 as being connected to interlock sleeve 17. Thus, as interlock sleeve 17 moves from a retracted to an extended position, so do the interlock beams 17.1.
Regarding claim 5, Henderson in view of Watts discloses the auto-injector ((Henderson, autoinjector 1, Fig. 1) as recited above, wherein
the safety shroud ((Henderson, interlock sleeve 17, Fig. 3) comprises a first angled cam surface configured to engage a second angled cam surface of the plunger driver ((Henderson, resilient button locking beams 18, Fig. 3) ((Henderson, “Proximal ends of the interlock beams 17.1 include ramped surfaces which engage with corresponding ramped surfaces of resilient button locking beams 18 disposed in the case 2.” – Para [0121]) to move the plunger driver latch to the second position when the safety shroud is moved to the retracted position ((Henderson, “When the interlock sleeve moves from the extended position to the retracted position, the proximal ends of the interlock beams 17.1 cause the button locking beams 18 to deflect.” – Para [0121]).
Examiner interprets the interlock beams 17.1 to be connected to the interlock sleeve 17, and thus the ramped surfaces of 17.1 to be part of interlock sleeve 17.
Regarding claim 6, Henderson in view of Liscio and Watts discloses the auto-injector (Henderson, autoinjector 1, Fig. 1) as recited above, wherein
Henderson does not expressly disclose that the plunger driver latch comprises a pivot and wherein the plunger driver latch is rotatable about the pivot to move between the first position and the second position.
Liscio teaches that the plunger driver latch (locking arms 39, Fig. 3) comprises a pivot (pivot point 342, Fig. 11) and wherein the plunger driver latch is rotatable about the pivot to move between the first position (“… a locking position (shown in FIGS. 11 and 13) …” – Para [0108]) and the second position (“… a release position …” – Para [0108]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the auto-injector of Henderson to include that the plunger driver latch comprises a pivot and wherein the plunger driver latch is rotatable about the pivot to move between the first position and the second position as taught by Liscio to prevent the user accidentally injuring themselves on the needle 432 (Liscio, Para [0125]).
Regarding claim 7, Henderson in view of Liscio and Watts discloses the auto-injector (Henderson, autoinjector 1, Fig. 1) as recited above, wherein
Henderson does not expressly disclose the plunger driver latch is configured to: rotate about the pivot from the first position to the second position responsive to said engagement between the first angled cam surface and the second angled cam surface; and rotate about the pivot from the second position to the first position responsive to disengagement of the first angled cam surface from the second angled cam surface
Liscio teaches that the plunger driver latch (locking arms 339, Fig. 11) is configured to:
rotate about the pivot (pivot point 342, Fig. 11) from the first position (“… a locking position (shown in FIGS. 11 and 13) …” – Para [0108]) to the second position (“… a release position …” – Para [0108]) responsive to said disengagement between the first angled cam surface (the contact portion 346 of needle sleeve 23) and the second angled cam surface (first ends 339a) (“… the contact portions 346 (of the needle sleeve 23) engage the respective first ends 339a of the locking arms and urge the locking arms 339 to pivot about the pivot point 342.” – Para [0112]), and
rotate about the pivot from the second position to the first position (“… the locking arms are generally moveable between the locked and release positions in a number of ways … for example by pivoting … and rotating …” – Para [0143) responsive to disengagement of the first angled cam surface from the second angled cam surface (“A locking mechanism (now shown) may be provided to lock the needle sleeve 23 in the extended position after use of the device.” – Para [0125], Fig. 11)
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the auto-injector of Henderson to include that the plunger driver latch is configured to: rotate about the pivot from the first position to the second position responsive to said engagement between the first angled cam surface and the second angled cam surface; and rotate about the pivot from the second position to the first position responsive to disengagement of the first angled cam surface from the second angled cam surface as taught by Liscio to prevent the user accidentally injuring themselves on the needle 432 (Liscio, Para [0125]).
Examiner interprets the return of the needle sleeve 23 in the extended position to be depicted by FIG. 11 which also depicts the return of the locking arms 339 in the first position from the second position.
Regarding claim 9, Henderson in view of Liscio and Watts discloses the auto-injector (Henderson, autoinjector 1, Fig. 1) as recited above, wherein
the biasing member comprises a spring (Henderson, “The interlock sleeve 17 may be biased by a spring in an extended position …” – Para [0119]).
Regarding claim 10, Henderson in view of Liscio and Watts discloses the auto-injector (Henderson, autoinjector 1, Fig. 1) as recited above, wherein
Henderson does not expressly disclose that the plunger driver comprises an engagement member; wherein the plunger driver latch comprises a first blocking surface and a second blocking surface; wherein when the plunger driver latch is in the first position, the first blocking surface of is configured to engage the engagement member of the plunger driver to latch the plunger driver at the pre-insertion position ; and wherein when the plunger driver latch is in the second position, the second blocking surface is configured to engage the engagement member of the plunger driver to latch the plunger driver at the post-insertion and injection position
Liscio teaches that the plunger driver (sleeve 23, locking arms 39, Fig. 3) comprises an engagement member (first end of locking arms 39a, contact portions 46, Fig. 3);
wherein the plunger driver latch (deflectable arms 43, Fig. 3) comprises a first blocking surface (end of deflectable arms 43, Fig. 3) and a second blocking surface (lugs 44, Fig. 4);
wherein when the plunger driver latch is in the first position (“… a relaxed state (shown in FIGS. 3 and 4) …” – Para [0073]), the first blocking surface is configured to engage the engagement member of the plunger driver (“In the relaxed state, ends of the deflectable arms 43 abut a respective first end 39a …” – Para [0073], Fig. 3) to latch the plunger driver at the pre-insertion position ("The deflectable arms 43 in the relaxed state thereby act as securing members and prevent the locking arms 39 from rotating into the release position." - Para [0073]); and
wherein when the plunger driver latch is in the second position ("The deflectable arms 43 are moveable … to a deflected state (shown in FIG. 5)." - Para [0073]), the second blocking surface (lugs 44, Fig. 4) is configured to engage the engagement member of the plunger driver ("… contact portions 46 of the needle sleeve 23 engage the lugs of the deflectable arms 43." - Para [0078]) to latch the plunger driver at the post-insertion and injection position ("The deflectable arms 43 are thereby moved out of contact with the respective first ends 39a of the locking arms 39, and so the locking arms are no longer prevented from rotating into the release position." - Para [0078]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the auto-injector of Henderson to include that the plunger driver comprises an engagement member; wherein the plunger driver latch comprises a first blocking surface and a second blocking surface; wherein when the plunger driver latch is in the first position, the first blocking surface of is configured to engage the engagement member of the plunger driver to latch the plunger driver at the pre-insertion position ; and wherein when the plunger driver latch is in the second position, the second blocking surface is configured to engage the engagement member of the plunger driver to latch the plunger driver at the post-insertion and injection position as taught by Liscio to surround and conceal the needle 432 to prevent the user accidentally injuring themselves on the needle 432 (Liscio, Para [0125]).
Regarding claim 11, Henderson in view of Liscio and Watts discloses the auto-injector (Henderson, autoinjector 1, Fig. 1) as recited above, wherein
Henderson does not expressly disclose that the plunger driver is configured to decouple from the plunger of the syringe at the post-insertion and injection position
Watts teaches that the plunger driver is configured to decouple from the plunger of the syringe at the post-insertion and injection position (“The safety plunger 206 decouples from the syringe plunger 222 at a point on the inward stroke, which may be when the syringe plunger 222 has expelled all of a medicament or drug from the barrel 214.” – Para [0053]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the auto-injector of Henderson to include that the plunger driver is configured to decouple from the plunger of the syringe at the post-insertion and injection position as taught by Watts to move the sheath into a position covering the needle (Watts, Para [0053]).
Regarding claim 12, Henderson in view Liscio and Watts discloses the auto-injector (Henderson, autoinjector 1, Fig. 1) as recited above, wherein
Henderson does not expressly disclose that after said unlatching of the plunger driver from the post-insertion and injection position, the plunger driver is configured apply a continuous force to the safety shroud to deploy the safety shroud.
Watts teaches that after said unlatching of the plunger driver from the post-insertion and injection position (“The safety plunger 206 decouples from the syringe plunger 222 at a point on the inward stroke …” – Para [0053]), the plunger driver (safety plunger 206, Fig. 2) is configured apply a continuous forward force to the safety shroud to deploy the safety shroud (‘After decoupling, the safety plunger may move longitudinally relative to the syringe plunger 222 and continued movement of the safety plunger moves the sheath 214 into a position covering the needle.” – Para [0053]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the auto-injector of Henderson to include that after said unlatching of the plunger driver from the post-insertion and injection position, the plunger driver is configured apply a continuous force to the safety shroud to deploy the safety shroud as taught by Watts to move the sheath into a position covering the needle (Watts, Para [0053]).
Regarding claim 14, Henderson in view of Liscio and Watts discloses the auto-injector (Henderson, autoinjector 1, Fig. 1) as recited above, wherein
the auto-injector comprises an openable lid (Henderson, door 3, Fig. 1) to allow insertion and removal of the syringe (Henderson, “In the open position, the door 3 provides access to a syringe carrier in the case 2 that is adapted to hold a syringe 6 …” – Para [0109]), wherein the lid is configured to hinge between an open position and a closed position (Henderson, “… the door 3 may be formed on a side of the case 2 and rotate about a transverse hinge between the open and closed positions.” – Para [0109]).
Regarding claim 15, Henderson in view of Liscio and Watts discloses the auto-injector (Henderson, autoinjector 1, Fig. 1) as recited above, wherein
the lid (Henderson, door 3, Fig. 3) is configured on a closing movement thereof to prime a drive spring (Henderson, drive spring 9, Fig. 1) of the plunger driver (Henderson, trigger button beams 16, Fig. 3)( Henderson, “… the drive springs have been compressed … and the door 3 is being closed.” – Para [0116]).
Regarding claim 16, Henderson in view of Liscio and Watts discloses the auto-injector (Henderson, autoinjector 1, Fig. 1) as recited above, wherein
in combination with a syringe (Henderson, syringe 6, Fig. 1) comprising a syringe safety shroud (Henderson, needle shield 23, Fig. 19) configured to cover a needle of the syringe when in a closed position (Henderson, “… the syringe 6 with the needle shield 23 in an extended position, covering a distal tip of the needle 22.” – Para [0125]).
Regarding claim 17, Henderson in view of Liscio and Watts discloses the auto-injector (Henderson, autoinjector 1, Fig. 1) as recited above, wherein
Henderson does not expressly disclose after said unlatching of the plunger driver from the post-insertion and injection position, the plunger driver is configured apply a continuous forward force to the syringe safety shroud to deploy the syringe safety shroud.
Watts teaches that after said unlatching of the plunger driver from the post-insertion and injection position (“The safety plunger 206 decouples from the syringe plunger 222 at a point on the inward stroke, which may be when the syringe plunger 222 has expelled all of a medicament or drug from the barrel 214.” – Para [0053]), the plunger driver (safety plunger 206, Fig. 2) is configured apply a continuous forward force to the syringe safety shroud to deploy the syringe safety shroud (“After decoupling, the safety plunger 206 may move longitudinally relative to the syringe plunger 222 and continued movement of the safety plunger 206 moves the sheath 214 into a position covering the needle.” – Para [0053]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the auto-injector of Henderson to include that after said unlatching of the plunger driver from the post-insertion and injection position, the plunger driver is configured apply a continuous forward force to the syringe safety shroud to deploy the syringe safety shroud as taught by Watts to move the sheath into a position covering the needle (Watts, Para [0053]).
Regarding claim 19, Henderson in view of Liscio and Watts discloses a kit of parts (Henderson, auto-injector 1, syringe 6, needle shield 23, Figs. 1 and 19) comprising:
the auto-injector (Henderson, auto-injector 1, Fig. 1) claim 1; and
a syringe (Henderson, syringe 6, Fig. 1) comprising a syringe safety shroud (Henderson, needle shield 23, Fig. 19) configured to cover a needle of the syringe when in a deployed position (Henderson, “… the syringe 6 with the needle shield 23 in an extended position, covering a distal tip of the needle 22.” – Para [0125]).
Regarding claim 20, Henderson in view of Liscio and Watts discloses the kit of parts (Henderson, auto-injector 1, syringe 6, needle shield 23, Figs. 1 and 19) as recited above, wherein
Henderson does not expressly disclose that after said unlatching of the plunger driver from the post-insertion and injection position, the plunger driver is configured apply a continuous forward force to the syringe safety shroud to deploy the syringe safety shroud.
Watts teaches that after said unlatching of the plunger driver from the post-insertion and injection position (“The safety plunger 206 decouples from the syringe plunger 222 at a point on the inward stroke, which may be when the syringe plunger 222 has expelled all of a medicament or drug from the barrel 214.” – Para [0053]), the plunger driver (safety plunger 206, Fig. 2) is configured apply a continuous forward force to the syringe safety shroud to deploy the syringe safety shroud (“After decoupling, the safety plunger 206 may move longitudinally relative to the syringe plunger 222 and continued movement of the safety plunger 206 moves the sheath 214 into a position covering the needle.” – Para [0053]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the kit of parts of Henderson to include that after said unlatching of the plunger driver from the post-insertion and injection position, the plunger driver is configured apply a continuous forward force to the syringe safety shroud to deploy the syringe safety shroud as taught by Watts to move the sheath into a position covering the needle (Watts, Para [0053]).
Claim(s) 13, 18, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Henderson et al. (US Pub No. 2015/0297833 A1) in view of Liscio et al. (US Pub No. US 2020/0289754 A1) and Watts et al. (US Pub No. 2020/0030540 A1) and in further view of Franke et al. (US Pub No. 2020/039.
Regarding claim 13, Henderson in view of Liscio, Watts, and Franke discloses the auto-injector (Henderson, autoinjector 1, Fig. 1) as recited above, wherein
Henderson does not expressly disclose that the plunger driver is configured to lock out the safety shroud on deployment thereof.
Franke teaches that the plunger driver (locking mechanism 47, Fig. 2A) is configured to lock out the safety shroud on deployment thereof (“A locking mechanism 47 is provided to prevent displacement of the sleeve 28 when the device is in the safe state.” – Para [0053])
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the auto-injector of Henderson to include that the plunger driver is configured to lock out the safety shroud on deployment thereof as taught by Franke so the sleeve 28 conceals the needle 24 (Franke, Para [0052]).
Regarding claim 18, Henderson in view of Liscio, Watts, and Franke discloses the auto-injector (Henderson, autoinjector 1, Fig. 1) as recited above, wherein
Henderson does not expressly disclose that the plunger driver is configured to lock out the syringe safety shroud on deployment thereof.
Franke teaches that the plunger driver (locking mechanism 47, Fig. 2A) is configured to lock out the syringe safety shroud on deployment thereof (“A locking mechanism 47 is provided to prevent displacement of the sleeve 28 when the device is in the safe state.” – Para [0053])
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the auto-injector of Henderson to include that the plunger driver is configured to lock out the syringe safety shroud on deployment thereof as taught by Franke so the sleeve 28 conceals the needle 24 (Franke, Para [0052]).
Regarding claim 21, Henderson in view of Liscio, Watts, and Franke discloses the auto-injector (Henderson, autoinjector 1, Fig. 1) as recited above, wherein
Henderson does not expressly disclose that the plunger driver is configured to lock out the syringe safety shroud on deployment thereof.
Franke teaches that the plunger driver (locking mechanism 47, Fig. 2A) is configured to lock out the syringe safety shroud on deployment thereof (“A locking mechanism 47 is provided to prevent displacement of the sleeve 28 when the device is in the safe state.” – Para [0053])
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the auto-injector of Henderson to include that the plunger driver is configured to lock out the syringe safety shroud on deployment thereof as taught by Franke so the sleeve 28 conceals the needle 24 (Franke, Para [0052]).
Response to Arguments
Applicant’s arguments, see pages 1-2, filed 6/25/2026, with respect to the rejection(s) of claim(s) 1-7 and 9-21 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 Henderson.
Applicant argues that the interlock beams 17.1 work together as part of the interlock sleeve 17 in a different manner than the claimed plunger driver latch, translating axially and not rotating. Therefore, without conceding the rejections and solely to advance prosecution, Applicant has amended claim 1 to further distinguish from the references by indicating that the plunger driver latch is "rotatably" coupled to the safety shroud and "pivotably" moveable between the first and second positions. Pending claim 6 recites that the plunger driver latch comprises a pivot and is rotatable about the pivot. In rejecting claim 6, the Examiner cited a completely different component of Henderson, the pivoted clip 21.1, as being equivalent to the plunger driver latch without providing any rationale for this change or explanation of why the two parts could be considered equivalent to one another or interchangeable. In fact, pivoted clip 21.1 is part of the syringe/needle shield assembly.
Examiner interprets that Henderson does not teach a plunger driver latch that is rotatably coupled to the safety shroud and pivotably moveable between the first and second positions. However, Liscio teaches a plunger driver latch that is rotatably coupled to the safety shroud and pivotably moveable between the first and second positions as recited in the rejection above.
With respect to applicant's argument the rejection above teaches the claimed limitations. The rejection above is maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights