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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/24/2026 has been entered.
Status of the Claims
Claims 2-18 are cancelled. Claim 38 is newly added. Claims 1 and 33 are currently amended. Claims 1 and 19-38 are currently pending. Claims 1 and 19-38 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 04/24/2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. 102 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 Therefore, the rejection has been withdrawn.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 an updated interpretation of Besson, alternatively in view of Hirschel et al (US-20210154407-A1) and/or Ekman et al (US 20130296795 A1).
Applicant argues that Besson does not disclose “a trigger arm engaging the opening in the housing in the storage state of the autoinjector”. Examiner notes that “opening” could be interpreted to be the space formed within the housing, an indentation of other like feature formed as part of the housing, or a cutout in the housing. Examiner invites Applicant to consider the relevant art cited in the conclusion.
Claim Rejections - 35 USC § 102 and 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 19-26, 28-31, and 33-37 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Besson (WO 2020173993 A1; hereafter Besson), or alternatively under 35 U.S.C. 103 as obvious over in view of Besson in view of Hirschel et al (US 20210154407 A1; hereafter Hirschel) (in a first alternative), Besson in view of Ekman et al (US 20130296795 A1; hereafter Ekman) (in a second alternative), or Besson in view of both Hirschel and Ekman (in a third alternative). Note that a pdf of Besson was previously provided in the Non-Final Office Action with mailing date 11/29/2024.
Regarding claim 1, Besson discloses an autoinjector (drug delivery device 10, fig. 2B; [0058] drug delivery device 10 is an auto-injector) comprising:
a housing (motor body 42, upper housing shell 46, lower housing shell 28, and spring guide member 90, fig. 2B; [0058] motor body 42, upper housing shell 46, lower housing shell 28; [0061] spring guide member 90 secured to the upper housing shell 46);
a pre-filled syringe (barrel 52, [0059], fig. 2a/b) mounted in the housing (46/28) (see fig. 2a/b which shows the syringe mounted within the housing);
a needle guard (needle cover 22, fig. 2A, [0059]) mounted axially moveable in the housing and configured to move between a storage state, a dispensing state and a lock-out state ([0059] the needle cover 22 is moveable between a pre-use position, an actuation position, and a post-use position), the needle guard configured to adopt different axial positions relative to the housing in each of the storage state (figs. 1a/b and figs. 2a/b show needle guard 22 in the position associated with the storage state), the dispensing state (figs. 5/6 show needle guard 22 in the injection position/dispensing state) and the lock-out state (figs. 7/8 show needle guard 22 in the post-use position/lock-out state) (note that figs. 1b, 5, and 7, clearly show that that the needle guard 22 has a different axial position relative to housing 46/28 in each state),
the pre-filled syringe (barrel 52) being fixed so as to be stationary relative to the housing (46/28/90) ([0070] audio indicator member 94 is configured to restrict movement of the syringe holder 24 when the plunger body 80 is in the pre-use position),
the needle guard (22) configured to be axially moved in a distal direction between the storage state and the dispensing state (see fig. 1a vs fig. 5), and configured to be axially moved in a proximal direction between the dispensing state and the lock-out state (see fig. 5 vs fig. 7); and
a drive chassis (plunger body 80 and lever actuation member 44, fig. 2b; [0060] plunger body 80 is part of drive assembly 40) mounted in the housing (46/28/90) and biased with respect to the housing ([0060] drive member 84 engages the plunger body 80 and biases the plunger body 80 in a direction extending from the second subassembly 14 toward the first subassembly 12, see fig. 1a; [0061] drive member 84 is received by the spring guide member 90 such that the drive member 84 is positioned between the plunger body 80 and the spring guide member 90, [0060] drive member 84 is a compression spring), the drive chassis (80/44) further being fixed, in the storage state of the autoinjector, with respect to the housing ([0059] When the lever actuation member 44 is in the locked position, the lever actuation member 44 is engaged with the motor body 42 and the drive assembly 40 to prevent movement of the drive assembly 40, see fig. 1a which shows storage position; note [0060] plunger body 80 is part of drive assembly 40), the drive chassis (80/44) being linearly guided within the housing ([0059] progressive figures show linear movement of drive chassis 80 with respect to housing 46/28/90; fig. 2A, storage position; fig. 4, actuation position; fig. 6, injection position; fig. 8, post-use position) and being generally U-shaped (fig. 2A, fig. 16, show a generally U-shaped arrangement defined by the limbs of plunger body 80),
the housing (motor body 42, upper housing shell 46, lower housing shell 28, and spring guide member 90, fig. 2B) comprising an opening (cavity formed between housing components shown in fig. 2B) and the drive chassis (80/44, fig. 2b) comprising a trigger arm (lever actuation member 44, fig. 2A; [0060]) engaging the opening in the housing in the storage state of the autoinjector (figs. 1a/b and figs. 2a/b show the storage state; [0059] When the lever actuation member 44 is in the locked position, the lever actuation member 44 is engaged with the motor body 42).
In a first alternative, Besson is silent to the pre-filled syringe (barrel 52) being fixed so as to be stationary relative to the housing (46/28/90).
Hirschel, in the art of autoinjectors, teaches wherein the pre-filled syringe (product container 13, fig. 2b, [0073]) is fixed so as to be stationary relative to the housing (housing 2, fig. 2b, [0073] A product container 13 in the form of a syringe is non-slidably accommodated in the housing 2; see [0074-0075] which further describe the locking arrangement which prevents relative motion between the syringe and the housing).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the pre-filled syringe of Besson to be fixed so as to be stationary relative to the housing, as taught by Hirschel, since both references deal with drug delivery automatically triggered by movement of a needle protective element (Hirschel: [0079] describes movement of needle protective element 3 resulting in insertion of needle 13a in patient’s skin once a certain threshold of force is met), and the needle shield having a storage state (Hirschel: figs. 2a-c, [0058] and [0076]), a dispensing state (Hirschel: figs. 3a-6c, [0059-0062]), and a lock-out state (Hirschel: figs. 7a-7c, [0063] and [0078]). One would have been motivated to make the modification because the arrangement of Hirschel requires less moving parts, serving to simplify the injection mechanism of Besson since the syringe itself need not move relative to the housing.
In a second alternative, Besson is silent to the housing comprising an opening and the trigger arm engaging the opening in the housing in the storage state of the autoinjector.
Ekman, in the art of autoinjectors, teaches wherein the housing (housing 2, fig. 1, [0055] housing 2 has castellations 2.3) comprising an opening (space formed by the castellations and the housing inner wall in which the trigger arm/dog 2.3 engages, see fig. 5) and the drive chassis (plunger 7, fig. 3, [0051] “The plunger 7 has a thrust plate 7.1 arranged at its distal end with two or more plunger arms 7.2 extending from the edges of the thrust plate 7.1 in proximal direction P, the plunger arms 7.2 having a respective outwardly protruding dog 7.3.”) comprising a trigger arm (outwardly protruding dog 7.3, fig. 5, [0051]) engaging the opening in the housing in the storage state of the autoinjector (see fig. 3, [0061] “When the ramped protrusion has pushed the dog 7.3 inwards (see FIG. 3) the dog 7.3 is no longer engaged with the most distal castellation of the set 2.3 so the plunger 7 may be translated in proximal direction P.”; Examiner notes that in storage state, prior to beginning of delivery, dog 7.3 is engaged with the most distal castellation).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the engagement of the trigger arm of Besson such that the trigger arm engaged an opening formed in the housing while in the storage state, as taught by Ekman, since Ekman also deals with a deflectable trigger arm moved due to the compression of a needle shield. One would have been motivated to make the modification because having the trigger arm engage directly with the housing better ensures no relative movement of the trigger arm (and thus the drive chassis) and the housing prior to the desired time of dose delivery.
In a third alternative, Besson is silent to the pre-filled syringe being fixed so as to be stationary relative to the housing and to the housing comprising an opening and the trigger arm engaging the opening in the housing in the storage state of the autoinjector, and Besson is modified in view of both Hirschel and Ekman, in the manners described above, in this third alternative.
Regarding claim 19, Besson or any alternative discloses the autoinjector according to claim 1, as described above. Besson further discloses wherein the needle guard (22, fig. 2a, fig. 11b) further comprises one or more lock-out arms (lock protrusion 108, fig. 11B, [0066]).
Regarding claim 20, Besson or any alternative discloses the autoinjector according to claim 1, as described above. Besson further discloses wherein the needle guard (22, fig. 2a) further comprises a plunger arm (lock protrusion 108, fig. 11B, [0066]).
Or alternatively, Besson further discloses a needle guard (needle cover 22, fig. 2A, [0059]) comprising a plunger arm ([0064] a portion of the needle cover 22 engages the lever actuation member 44).
Examiner notes that the plunger arm as claimed does not include any particular structural/functional limitations past being an arm connected to the needle guard. Also, note that plunger arm 142 of the Applicant’s specification, introduced at the bottom of page 24, notes that the plunger arm 142 is part of the release mechanism, which informs the second possible rejection listed above.
Regarding claim 21, Besson or any alternative discloses the autoinjector according to claim 1, as described above. Besson further discloses wherein the needle guard (needle cover 22, fig. 2a) surrounds a needle (cannula 56, fig. 2b, [0059]) of the pre-filled syringe (52, fig. 2a) in the storage state (see figs. 1a-2b) and in the lock-out state (see fig. 8) ([0059] needle cover 22 is configured to shield the cannula 56 of the syringe assembly 16 from the patient when the device 10 is in the pre-use and the post-use positions).
Regarding claim 22, Besson or any alternative discloses the autoinjector according to claim 1, as described above. Besson further discloses wherein the needle guard (needle cover 22, fig. 2a) does not surround a needle (cannula 56, fig. 2b, [0059]) of the pre-filled syringe (52, fig. 2a) in the dispensing state ([0065] cannula 56 of the syringe assembly 16 extends beyond the needle cover 22, see fig. 5).
Regarding claim 23, Besson or any alternative discloses the autoinjector according to claim 1, as described above. Besson also discloses further comprising a lock-out spring (spring 68, fig. 2b, [0059]) arranged between the needle guard (22) and the housing (46/28/90) (note that in fig. 2b the spring 68 is shown arranged between needle cover 22 and housing portion 46).
Regarding claim 24, Besson or any alternative discloses the autoinjector according to claim 23, as described above. Besson further discloses wherein the needle guard (22, fig. 2b) is configured to compress the lock-out spring (68, fig. 2) upon moving between the storage state (see fig. 2b) and the dispensing state (see fig. 6 which shows that spring 68 is compressed).
Regarding claim 25, Besson or any alternative discloses the autoinjector according to claim 23, as described above. Besson further discloses wherein the needle guard (22, fig. 2b) is configured to be moved by a relaxation of the lock-out spring (68, fig. 2b) between the dispensing state (see fig. 6, spring 68 is compressed) and the lock-out state (see fig. 8, spring 68 is relaxed) ([0059] spring 68 biases the needle cover 22 towards the pre-use position/storage state and the post-use position/lock-out state).
Regarding claim 26, Besson or any alternative discloses the autoinjector according to claim 19, as described above. Besson further discloses including one lock-out arm (lock protrusion 108, fig. 11B, [0066]) comprises an engagement portion (face of lock protrusion 108 shown to make contact with the edge of the housing cut-out in fig. 11a/b) that is configured to engage a corresponding cut-out (hole in the housing through which the needle guard 22 extends as shown in fig. 11a/b, compare to fig. 6 to see that housing portion 28 comprises the hole through which the needle guard extends) in the housing of the autoinjector in the lock-out state ([0066] fig. 11a/b shows the post-use position/lock-out state of the autoinjector).
Regarding claim 28, Besson or any alternative discloses the autoinjector according to one of claim 1. Besson further discloses wherein the needle guard (22, fig. 11a/b) comprises an anti-pull off feature (lock protrusion 108, fig. 11b, [0066]) cooperating with the housing (46/28/90, see fig. 11a/b, note [0068] lower housing shell 28 includes an indicator platform 202, see fig. 6 which shows position of platform 202, note position of lock protrusion 108 in fig. 11a/b).
Regarding claim 29, Besson or any alternative discloses the autoinjector according to claim 28, as described above. Besson further discloses wherein the needle guard further (needle cover 22, fig. 2b) comprises a plunger arm ([0064] portion of the needle cover 22 engages the lever actuation member 44, see fig. 2b and fig. 12b; note that the portion of the needle cover 22 located near the actuation member 44 is the lower arm as shown in fig. 2b and Examiner interprets the lower side of the needle cover 22 as shown in the figures to be the “plunger arm”), and the anti-pull off feature (lock protrusion 108, fig. 11b, [0066]) is arranged at the plunger arm (note that in fig. 11b the portion of needle guard 22 including lock protrusion 108 is on the lower arm as shown in fig. 11a/b, and thus the anti-pull off feature is arranged at the plunger arm).
Regarding claim 30, Besson or any alternative discloses the autoinjector according to claim 29, as described above. Besson further discloses wherein the anti-pull off feature (lock protrusion 108, fig. 11b, [0066]) comprises a protrusion (lock protrusion 108, fig. 11b, note that the anti-pull off feature is not described as comprising anything else) configured to engage a hole in the housing (see fig. 11b, anti-pull off feature engages the hole in the housing portion 28 through which the needle guard 22 extends).
Regarding claim 31, Besson or any alternative discloses the autoinjector according to claim 1, as described above. Besson further discloses the needle guard (22, fig. 11b) further comprises one or more clip arms (lock protrusion 108, fig. 11B, [0066]).
Regarding claim 33, Besson or any alternative discloses the autoinjector according to claim 20, as described above. Besson further discloses wherein the plunger arm ([0064] portion of the needle cover 22 engages the lever actuation member 44) is configured to cooperate with a trigger arm (lever actuation member 44, fig. 2A; [0060]) of the drive chassis (80/44, fig. 2b) to activate a release mechanism of the autoinjector ([0065] the lever actuation member 44 being in the released position allows the plunger body 80 to move).
Regarding claim 34, Besson or any alternative discloses the autoinjector according to claim 33, as described above. Besson further discloses wherein axial movement of the needle guard (22, fig. 2b to fig. 4 shows axial movement of needle guard 22) towards the drive chassis (80/44, fig. 2b) is configured to release the drive chassis (80/44) with respect to the housing (46/28/90) upon activation of the autoinjector ([0064] a portion of the needle cover 22 engages and moves the lever actuation member 44 from the locked position to the released position; [0065] the lever actuation member 44 being in the released position allows the plunger body 80 to move).
Regarding claim 35, Besson or any alternative discloses the autoinjector according to claim 34, as described above. Besson further discloses wherein the axial movement of the needle guard (22, fig. 2b) is configured to deflect the trigger arm ([0064-0065] movement of needle guard/needle cover 22 deflects trigger arm/lever actuation member 44 from the locked position, shown in fig. 2b, to the released position, shown in fig. 4 and fig. 6) in a direction transverse to the axial movement (see fig. 2b vs figs. 4 and 6 which show that the trigger arm 44 has been deflected in a direction transverse to the axial movement of the needle guard).
Regarding claim 36, Besson or any alternative discloses the autoinjector according to claim 35, as described above. Besson further discloses wherein the plunger arm ([0064] portion of the needle cover 22 engages the lever actuation member 44) is configured to deflect the trigger arm (44, fig. 2b) ([0064-0065] movement of needle guard/needle cover 22 causes a portion of the needle cover 22 to engage and deflect trigger arm/lever actuation member 44 from the locked position, shown in fig. 2b, to the released position, shown in fig. 4 and fig. 6) in a direction transverse to the axial movement of the needle guard (see fig. 2b vs figs. 4 and 6 which show that the trigger arm 44 has been deflected in a direction transverse to the axial movement of the needle guard 22).
Regarding claim 37, Besson or any alternative discloses the autoinjector according to claim 1, as described. Besson further discloses wherein the drive chassis (80/44, fig. 2a) comprises a dispensing limb (plunger rod portion 82, fig. 2A; [0060]) as well as a trigger limb ([0060] plunger body 80 defines drive opening 86 which serves as the housing to drive member 84, shown in fig. 2A; Examiner interprets the trigger limb of Besson to be the portion of 80 that defines drive opening 86), the trigger limb and the dispensing limb being arranged in parallel to one another ([0060] dispensing limb/plunger rod portion 82 and drive member 84 parallel, 84 received into the trigger limb/the portion of 80 that defines drive opening 86, fig. 2A) and connected to one another at a respective distal end side of the dispensing limb and the trigger limb via a web (see fig. 2a, Examiner interprets the web of plunger body 80 to be the portion of plunger body 80 extending between the plunger rod portion 82 and the portion of 80 that defines drive opening 86).
Claim(s) 27 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Besson or any alternative as applied to claims 1 or 19 above, and further in view of Mehawej (US 20200171248 A1; hereafter Mehawej).
Regarding claim 27, Besson or any alternative discloses the autoinjector according to claim 19, including the one or more lock-out arms (Besson: lock protrusion 108, fig. 11B, [0066]).
Besson or any alternative is silent to the one or more lock-out arms comprising two or more lock-out arms.
Mehawej, in the art of injection devices, teaches an autoinjector (injection device 10, fig. 1, [0037]) with a needle guard (needle guard 14, fig. 2, [0037]) wherein one or more lock-out arms includes two or more lock-out arms (two arms of needle guard 14 shown in fig. 2, note [0045] retaining arm 12b of housing 12 engages with the window 14b of needle guard 14 to limit movement of needle guard 14 relative to the housing 12; see fig. 2 which shows the window 14b on the lock-out arm of the needle guard 14) with a lock-out spring (return spring 24, fig. 2 and fig. 5a/d, [0043] return spring 24 abuts against the distal end of needle guard 14) being arranged between the two or more lock-out arms (see fig. 5a/d which shows the return spring 24 located centrally in the needle guard 14 and thus between the two arms of the needle guard 14 which are shown in fig. 2).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the needle guard of Besson to include a second lock-out arm as taught by Mehawej since both references deal with needle guards for injection devices. One would have been motivated to make the modification because having one lock-out arm instead of two would help to ensure that the needle guard properly engages the housing without bending, since two engagement points would allow the needle guard to engage with the housing in a more balanced and secure fashion, decreasing the likely hood of the return spring pushing the needle guard off center.
Regarding claim 32, Besson or any alternative discloses the autoinjector according to claim 31, as described above.
Besson or any alternative is silent to wherein the drive chassis is configured to engage the one or more clip arms to deflect the one or more clip arms radially inwardly away from the housing in the dispensing state.
Mehawej, in the art of injection devices, teaches an autoinjector (injection device 10, fig. 1, [0037]) with a needle guard (needle guard 14, fig. 2, [0037]) and a housing, wherein the housing further comprises one or more clip arms (retaining arm 12b, fig. 5a, [0049] needle guard 14 may be inserted into the housing such that the retaining arms 12b extend through the respective window 14b of the needle guard 14) wherein the drive chassis (ram 16, fig. 2, [0039]) is configured to engage the one or more clip arms (12b, fig. 5a) to deflect the one or more clip arms radially outwardly toward the housing (12, fig. 5a) in the dispensing state ([0055] sloped surface 16d of the ram 16 presses against the retaining arm 12b, the retaining arm 12b flexes into the window 14b, [0056] flexure of the retaining arm 12b allows medication expulsion).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Besson to include two clip arms engaging between the housing and the needle guard as taught by Mehawej, since both references deal with needle guards for injection devices. One would have been motivated to make the modification because having two clip arms between the housing and the needle guard would be more secure than just having one lock protrusion as Besson shows in fig. 11b to retain the needle guard in association with the housing.
Besson modified by Mehawej discloses the claimed invention except for the clip arms associated with the needle guard instead of the housing. It would have been an obvious matter of rearrangement of parts to one of ordinary skill in the art before the effective filing date to reverse the engagement of the needle guard and the housing so that the housing included the windows 14b and the needle guard included retaining arms 12b which engaged outwardly through the windows 14b of the housing and were deflected inwards by the ram 16 instead of outwardly to relieve engagement of the arms 12b with the windows 14b, thereby yielding predictable results without change to inventive function. Furthermore, the reversed arrangement would be obvious to try by beneficially including a resilient, flexible portion with the needle guard instead of the housing, thus simplifying the housing, the larger piece of the device, and including the flexible resilient portion, instead of on the interior of the housing, on the exterior of the needle guard which would be easier to see during manufacturing. Thus, it would be easier to tell if there was a flaw with the resilient portion prior to full assembly, thus decreasing the frequency of devices malfunctioning. MPEP 2144.04(VI)(C). Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation, and the autoinjector of Besson modified by Mehawej would still be able to perform the injection.
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Besson modified by Ekman or Besson modified by both Hirschel and Ekman as applied to claim 1 above, and further in view of Ekman.
Regarding claim 38, Besson modified by Ekman, or alternatively Besson modified by Hirschel and Ekman, discloses the autoinjector of claim 1, as described above.
Besson as modified in either case is silent to wherein the opening in the housing is one of two openings and the trigger arm of the drive chassis is one of two trigger arms, each trigger arm of the two trigger arms engaging a respective opening of the two openings in the housing in the storage state of the autoinjector.
Ekman further teaches wherein the opening (space formed by the castellations and the housing inner wall in which the trigger arm/dog 2.3 engages, see fig. 5) in the housing (housing 2, fig. 1, [0055] housing 2 has castellations 2.3) is one of two openings (see fig. 3, note that a second set of castellations is located on the opposite side of the housing) and the trigger arm (outwardly protruding dog 7.3, fig. 5, [0051]) of the drive chassis (plunger 7, fig. 3, [0051] “The plunger 7 has a thrust plate 7.1 arranged at its distal end with two or more plunger arms 7.2 extending from the edges of the thrust plate 7.1 in proximal direction P, the plunger arms 7.2 having a respective outwardly protruding dog 7.3.”) is one of two trigger arms (see fig. 3 which shows two outwardly protruding dogs/trigger arms 7.3), each trigger arm of the two trigger arms engaging a respective opening of the two openings in the housing in the storage state of the autoinjector (see fig. 3, note two trigger arms 7.3, [0061] “When the ramped protrusion has pushed the dog 7.3 inwards (see FIG. 3) the dog 7.3 is no longer engaged with the most distal castellation of the set 2.3 so the plunger 7 may be translated in proximal direction P.”; Examiner notes that in storage state, prior to beginning of delivery, each dog 7.3 is engaged with the most distal castellation).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify Besson as modified by Ekman, or to further modify Besson as modified by Hirschel and Ekman, to include a second trigger arm engaging a second opening, as taught by Ekman, since all three references deal with autoinjectors. One would have been motivated to make the modification because having an additional trigger arm/opening cooperation better ensures that the device is not prematurely triggered. Additionally, Examiner notes this modification amounts to a duplication of parts. It would thus further have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Besson modified by Ekman, or Besson modified by Hirschel and Ekman, to include an additional trigger arm cooperating with an additional opening since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art (see MPEP 2144.04 (VI-B)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, and in particular to the engagement of stop features extending through apertures formed in the walls of housing elements in injection devices.
Kemp et al (US-20180214637-A1) – [0081] and fig. 12a describe a longitudinal slot 2.3 through the surface of a housing/rear case 2.2; figs. 12a-j show a variety of other slot/protrusion interactions; [0127] describes alignment of apertures in a cap 11, case 2, and/or needle shroud 7 to aid in assembly
Martin (US-5417660-A) – “needle guard 14 is prevented from retracting inwardly into the casing 12 by the tabs 50 and 52 which are forced out through the apertures 80 and 82 by a resilient force of their respective supports 76 and 78”; see figs. 1-3
Scott et al (US-10632259-B2) – “First, as shown in FIG. 6, the support 52 is inserted into the housing 51 such that the prong 521 of the support 52 is engaged with and fixed to the first finger 511 of the housing 51.”; see fig. 6
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 09/21/2026
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