DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1 and 19-37 are currently pending. Claims 1 and 19-37 are currently rejected.
Response to Arguments
Applicant's arguments filed 01/20/2026 have been fully considered but they are not persuasive.
The amendments to claims 1, 29, 30, and 37 obviate the previous objections and 112b rejections, which as such are withdrawn and not applied to the claims as currently amended.
Applicant amended the claim language to add the phrase “so as to be stationary”, and points to figures 4 and 6 of Besson showing the syringe assembly in different positions relative to the shells 28 and 46. As previously noted in the rejection of claim 1 under Besson, “Besson [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”. Fig. 4 shows the actuation position, and fig. 6 shows the injection position. See the rejection of claim 1 below which refers to Besson [0070], [0065], [0025] and [0066] to describe the position of the syringe relative to the housing in each state.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., syringe not moving/being stationary relative to housing) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As written currently, the claim language “the pre-filled syringe being fixed so as to be stationary relative to the housing in the storage state, the dispensing state and lock-out state” does not indicate that the syringe does not move relative to the housing at all, only that in the three positions mentioned the syringe is stationary relative to the housing. Therefore, even if the syringe has a different location in all three states, as long as there is a moment in which the syringe is fixed relative to the housing in each of the three states then the limitation as written is met by the prior art. See the rejections below.
If Applicant wishes to further pursue this difference between Besson and the instant application, Examiner suggests altering the claim language so as to clarify that, for example, the pre-filled syringe has the same position/fixed by the same structure relative to the housing in all three states, the pre-filled syringe is stationary relative to the housing during all three states and during the transitions between states, or the pre-filled syringe and housing do not move longitudinally relative to one another during transitions between the different states, or similar more specific arrangements which will effectively include the limitation which Applicant argues in the Remarks of 01/20/2026. Examiner further suggests that the Applicant consider the prior art noted in the conclusion of this and previous communications, and in particular Hirshel et al (US 20210154407 A1), if considering further amendments along this line of reasoning.
Claim Rejections - 35 USC § 102
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.
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). 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 (upper housing shell 46, lower housing shell 28, and spring guide member 90, fig. 2B; [0058] 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) in the storage state ([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 dispensing state ([0065] syringe holder 24 within the device 10 and relative to the cassette body 26 until the syringe holder 24 abuts a stop 102 defined by the cassette body 26, see fig. 6) and lock-out state ([0025] fig. 12 shows a post use position of the device, [0066] further use of the device is prevented after patient removes needle guard 22 from a skin surface; see fig. 12 which shows that syringe holder 24 is still engaged with stop 102 in the post-use/lock-out state),
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).
Regarding claim 19, Besson 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 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 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 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 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 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 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 discloses the autoinjector according to claim 19, as described above, 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 discloses the autoinjector according to one of claim 1, and 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 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 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 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 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 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 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 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 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 Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 27 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Besson as applied to claims 1 or 19 above, and further in view of Mehawej (US 20200171248 A1; hereafter Mehawej).
Regarding claim 27, Besson discloses the autoinjector according to claim 19, including the one or more lock-out arms (lock protrusion 108, fig. 11B, [0066]).
Besson 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 discloses the autoinjector according to claim 31, as described above.
Besson 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hirshel et al (US 20210154407 A1) - syringe fixed relative to housing, needle guard moves suddenly once a pressure threshold is reaches so that needle is suddenly inserted, injector has pre-, mid-, and post-injection positions (see figs. 2a-2c, figs. 3a-6c, and figs. 7a-7c, along with the Brief Description of the Drawings)
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.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 02/20/2026