DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed January 15, 2026 has been entered. Claims 16-23 and 25-36 remain pending in the application. Claim 24 has been cancelled, and claims 1-15 were previously cancelled. Applicant’s amendments to the claims have overcome the objections previously set forth in the Non-Final Office Action mailed October 21, 2025.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 16-23, 25, 27-31, and 33-36 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Bom et al. (WO 2011003979).
Regarding claim 16, Bom discloses an autoinjector (injection device 100), comprising:
a case (housing 102 and cartridge holding part 103) adapted to receive a medicament container (cartridge 104; Figure 1);
a one-piece plunger (piston rod 107) adapted to be displaced in a proximal direction relative to the case for a dispensing operation from an initial position (Figure 1) to an end position (“A piston rod 107 is…operatively coupled to the injection button 105 such that when the cap 115 is off and the injection button 105 is pressed against the housing 102 the piston rod 107 will advance axially through the housing 102 a certain distance, thereby displacing the piston 108 in the cartridge 104 an equivalent distance to inject a desired amount of drug through the outlet 141.” [Page 18,, lines 6-11]);
a drive spring (spring 111) configured to provide energy for moving the plunger into the end position relative to the case (“The movement of the piston rod 107 is realised through a coupling ring 130 being in engagement with a helical track (not visible) in the injection button 105, and a driver 110 which is in engagement with the coupling ring 130 and which is adapted to engage with, and transmit a driving force to, the piston rod 107. The driver 110 is powered by a spring 111” [Page 18, lines 12-16]); and
a feedback mechanism (radially deflectable click fingers 126 having tips 127) operable to provide a perceivable audible feedback by a feedback feature of the feedback mechanism impacting the plunger, wherein the feedback feature comprises a projection (tip 127) configured to impact the plunger (“A couple of radially deflectable click fingers 126 are provided on the guide member 120 (only one is visible), each click finger 126 having a tip 127 for engagement with the piston rod 107.” [Page 20, lines 9-11]; “Fig. 10b is a perspective view showing the other two sides of the piston rod 107. On the third side, opposite to the first side, a number of teeth 119 are distributed in a way similar to the distribution on the first side. On the fourth side a number of teeth 196 are distributed, the teeth 196 being smaller than the teeth 119 but larger than the teeth 195…At the end of an injection the tip 127 of the other click finger 126 rides over a tooth 196 to provide an audible confirmation of the dose completion.” [Page 21, lines 12-20]).
Regarding claim 17, Bom discloses the autoinjector of claim 16, wherein the perceivable audible feedback is indicative for an end of the dispensing operation with the plunger, at the end of the dispensing operation, being in the end position relative to the case (“Fig. 10b is a perspective view showing the other two sides of the piston rod 107. On the third side, opposite to the first side, a number of teeth 119 are distributed in a way similar to the distribution on the first side. On the fourth side a number of teeth 196 are distributed, the teeth 196 being smaller than the teeth 119 but larger than the teeth 195…At the end of an injection the tip 127 of the other click finger 126 rides over a tooth 196 to provide an audible confirmation of the dose completion.” [Page 21, lines 12-20]).
Regarding claim 18, Bom discloses the autoinjector of claim 16, wherein the feedback feature is a displaceable feature (click fingers 126) that is displaced before impacting the plunger (“During an injection the tip 127 of one of the click fingers 126 rides over the teeth 195 thereby providing an audible confirmation of the progression of the injection…At the end of an injection the tip 127 of the other click finger 126 rides over a tooth 196 to provide an audible confirmation of the dose completion.” [Page 21, lines 9-20], wherein the click fingers 126 radially displace as they override the teeth 195, 196).
Regarding claim 19, Bom discloses (Previously Presented) The autoinjector of claim 18, wherein the displaceable feature is elastically displaced before impacting the plunger (“During an injection the tip 127 of one of the click fingers 126 rides over the teeth 195 thereby providing an audible confirmation of the progression of the injection…At the end of an injection the tip 127 of the other click finger 126 rides over a tooth 196 to provide an audible confirmation of the dose completion.” [Page 21, lines 9-20], wherein the click fingers 126 are elastically displaced as they override the teeth 195, 196).
Regarding claim 20, Bom discloses the autoinjector of claim 19, wherein the plunger has a radially protruding feature (teeth 195 and 196; Figures 10a-10b), which is configured to interact with the feedback feature to displace the feedback feature from a first radial position relative to the plunger to a second radial position relative to the plunger (“During an injection the tip 127 of one of the click fingers 126 rides over the teeth 195 thereby providing an audible confirmation of the progression of the injection…At the end of an injection the tip 127 of the other click finger 126 rides over a tooth 196 to provide an audible confirmation of the dose completion.” [Page 21, lines 9-20], wherein the click fingers 126 are radially displaced as they override the teeth 195, 196).
Regarding claim 21, Bom discloses the autoinjector of claim 20, wherein the radially protruding feature is ramped proximally (teeth 195 and 196; Figures 10a-10b)
Regarding claim 22, Bom discloses the autoinjector of claim 20, wherein the displaceable feature (click fingers 126 having tip 127) is ramped distally (Figure 7).
Regarding claim 23, Bom discloses the autoinjector of claim 16, wherein the feedback mechanism comprises a plurality of feedback features (“A couple of radially deflectable click fingers 126 are provided on the guide member 120 (only one is visible), each click finger 126 having a tip 127 for engagement with the piston rod 107.” [Page 20, lines 9-11]), wherein at least a portion of the plunger is arranged between the feedback features (Figure 17, Figures 18a-c, for example).
Regarding claim 25, Bom discloses the autoinjector of claim 16, further comprising: a plunger holder (spring base 160), the plunger being releasably engaged to the plunger holder (via the connection of the driver 110 and coupling ring 130; Figures 14-15), wherein the plunger, when released from the plunger holder, is arranged to be driven in a proximal direction relative to the plunger holder for the dispensing operation, wherein the drive spring biases the plunger in the proximal direction relative to the plunger holder to drive the dispensing operation (see all of [0127-0129]; “During the distal movement of the driver 110 the piston rod 107, being slaved by the pawls 176, and thereby the piston 108, is displaced a distance H (see FIG. 16), corresponding to the desired volume of drug to be delivered to the user.” [0129]).
Regarding claim 27, Bom discloses the autoinjector of claim 25, further comprising a movable member (injection button 105) that is movable relative to the plunger holder and the plunger between a first position (Figures 1-2) and a second position (Figure 3), wherein, when the movable member is in the first position, proximal movement of the plunger is prevented (see all of [0127-0129] wherein movement of piston rod 107 requires pressing of the injection button 105 from the first position to the second position).
Regarding claim 28, Bom discloses the autoinjector of claim 27, wherein, before engagement between the plunger and the plunger holder is released, a relative movement between the movable member and the plunger is required (see all of [0127-0129] wherein movement of piston rod 107 relative to the spring base 160 requires pressing of the injection button 105 from the first position to the second position).
Regarding claim 29, Bom discloses the autoinjector of claim 27, wherein the movable member has a user contact surface (push face 152) that is arranged to contact a user of the autoinjector (“The user inserts the injection needle 106 through the skin and applies a force to the push face 152 to press the injection button 105 down towards the housing 102” [0127]), and wherein, in the first position of the movable member, the user contact surface is further away from the plunger holder than in the second position of the movable member (position of push face 152 in Figures 1 and 2 as compared to Figure 3).
Regarding claim 30, Bom discloses the autoinjector of claim 27, wherein the movable member comprises a tubular portion (distal portion of injection button 105 having push face 152) that protrudes from the case in the first position of the movable member (Figures 1-2).
Regarding claim 31, Bom discloses the autoinjector of claim 30, wherein, in the first position, the movable member protrudes further from the case than in the second position (position of distal end of injection button 105 in Figures 1 and 2 as compared to Figure 3).
Regarding claim 33, Bom discloses the autoinjector of claim 25, wherein at least a portion of the plunger holder (spring base 160) is arranged within the case (Figure 1).
Regarding claim 34, Bom discloses the autoinjector of claim 16, wherein the autoinjector comprises the medicament container (cartridge 104) with a medicament (“a cartridge 104 which contains the liquid drug” [Page 17, lines 24-25]).
Regarding claim 35, Bom discloses the autoinjector of claim 16, wherein the medicament container comprises a syringe (cartridge 104) with a needle (injection needle 106).
Regarding claim 36, Bom discloses the autoinjector of claim 16, wherein the feedback feature impacts the plunger to generate the perceivable audible feedback by the feedback feature impacting the plunger (“A couple of radially deflectable click fingers 126 are provided on the guide member 120 (only one is visible), each click finger 126 having a tip 127 for engagement with the piston rod 107.” [Page 20, lines 9-11]; “Fig. 10b is a perspective view showing the other two sides of the piston rod 107. On the third side, opposite to the first side, a number of teeth 119 are distributed in a way similar to the distribution on the first side. On the fourth side a number of teeth 196 are distributed, the teeth 196 being smaller than the teeth 119 but larger than the teeth 195…At the end of an injection the tip 127 of the other click finger 126 rides over a tooth 196 to provide an audible confirmation of the dose completion.” [Page 21, lines 12-20]).
Claims 16-19 and 25-36 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Grunhut et al. (US 20090312705).
Regarding claim 16, Grunhut discloses an autoinjector (device for automatic injection 1), comprising:
a case (upper housing assembly 100 and lower housing assembly 200) adapted to receive a medicament container (container 50; “A container 50…is received in at least one of the upper and lower housing assemblies 100, 200.” [0086]);
a one-piece plunger (plunger rod 28) adapted to be displaced in a proximal direction relative to the case for a dispensing operation from an initial position (Figure 2) to an end position (Figure 14);
a drive spring (first spring 30) configured to provide energy for moving the plunger into the end position relative to the case (“Spring 30…causes movement of the piston 7 within the container 50 to cause the product 3 to be expelled therefrom through the injection needle 6.” [0090]; “The first spring 30 therefore pushes distally the plunger rod 28, the container 50 and the ring 26 as the container is caused to move to its injection position.” [0119]); and
a feedback mechanism operable to provide a perceivable audible feedback by a feedback feature of the feedback mechanism impacting the plunger, wherein the feedback feature comprises a projection (“first spring presents a variable diameter” [0135]) configured to impact the plunger (“it is possible to produce an audible indicator at the end of the injection: in such a case, for instance, the first spring presents a variable diameter that engages a projection 32 only at or near the end of the injection.” [0135]).
Regarding claim 17, Grunhut discloses the autoinjector of claim 16, wherein the perceivable audible feedback is indicative for an end of the dispensing operation with the plunger, at the end of the dispensing operation, being in the end position relative to the case (“it is possible to produce an audible indicator at the end of the injection: in such a case, for instance, the first spring presents a variable diameter that engages a projection 32 only at or near the end of the injection.” [0135]).
Regarding claim 18, Grunhut discloses the autoinjector of claim 16, wherein the feedback feature is a displaceable feature that is displaced before impacting the plunger (“it is possible to produce an audible indicator at the end of the injection: in such a case, for instance, the first spring presents a variable diameter that engages a projection 32 only at or near the end of the injection.” [0135], wherein the spring 30, and therefore the “variable diameter” is displaced prior to the end of the injection/impacting the projection 32 of plunger rod 28; Figures 6-14).
Regarding claim 19, Grunhut discloses the autoinjector of claim 18, wherein the displaceable feature is elastically displaced before impacting the plunger (“it is possible to produce an audible indicator at the end of the injection: in such a case, for instance, the first spring presents a variable diameter that engages a projection 32 only at or near the end of the injection.” [0135], wherein the spring 30, and therefore the “variable diameter” is elastically displaced prior to the end of the injection/impacting the projection 32 of plunger rod 28; Figures 6-14).
Regarding claim 25, Grunhut discloses the autoinjector of claim 16, further comprising: a plunger holder (inner cylinder 19a), the plunger (plunger rod 28) being releasably engaged to the plunger holder (“A plunger rod 28 for causing said piston 7 to move with respect to said container 50, as will be explained later, is received within the inner cylinder 19a of said outer sleeve 19 of the upper housing assembly 100.” [0089]; “flexible teeth 21 of the inner cylinder 19a being engaged in the radial stop 29 of the plunger rod 28” [0106]), wherein the plunger, when released from the plunger holder, is arranged to be driven in a proximal direction relative to the plunger holder for the dispensing operation, wherein the drive spring (first spring 30) biases the plunger in the proximal direction relative to the plunger holder to drive the dispensing operation (“During this movement, the teeth 25 come in contact with the flexible teeth 21 of the inner cylinder 19a and cause said flexible teeth 21 to deflect radially and outwardly… The flexible teeth 21 are now disengaged from the radial stop 29 of the plunger rod 28 and the first spring 30 is now free to move from its compressed condition to an extended condition. The first spring 30 expands and causes the plunger rod 28, which is coupled to said container 50, to move in the distal direction…The first spring 30 therefore pushes distally the plunger rod 28, the container 50 and the ring 26 as the container is caused to move to its injection position.” [0118-0119]).
Regarding claim 26, Grunhut discloses the autoinjector of claim 25, wherein the drive spring is configured to rotate the plunger relative to the plunger holder (“The radial projections 32 provided on the plunger rod 28 are in contact with said first spring 30 but they do not prevent the first spring 30 from extending in the distal direction. In consequence, each time the radial projections 32 touch a part of the first spring 30, for instance each time they touch a spire of the spring, they produce a sound…The first spring 30 and the radial projections 32 therefore constitute injection controlling means that produce an audible indicator as the product 3 is being expelled from the container 50” [0127-0128], wherein the radial projections 32 would pivot/rotate as they are contacted by the spires of the spring 30 relative to the inner cylinder 19a based on the movement of the first spring 30).
Regarding claim 27, Grunhut discloses the autoinjector of claim 25, further comprising a movable member (safety shield 10) that is movable relative to the plunger holder (inner cylinder 19a) and the plunger between a first position (Figure 4) and a second position (Figure 6; “The safety shield 10 is coupled to the housing 8 and is able to move between a first position and a second position in which the tip of the needle does not extend beyond a distal end of the safety shield 10.” [0094]), wherein, when the movable member is in the first position, proximal movement of the plunger is prevented (“Due to safety features of the inventive device 1, a user cannot activate the device 1 (i.e., cause the container 50 to move from its initial position to its injection position) until the safety shield 10 is caused to move a predetermined distance in the proximal direction. Indeed, the container 50 is in its passive state as long as the safety shield 10 has not moved out of its first position.” [0105]).
Regarding claim 28, Grunhut discloses the autoinjector of claim 27, wherein, before engagement between the plunger and the plunger holder is released, a relative movement between the movable member and the plunger is required (“As the device 1 is pressed against the user's skin, the safety shield 10 is caused to move in the proximal direction and into the housing 8. Due to safety features of the inventive device 1, a user cannot activate the device 1 (i.e., cause the container 50 to move from its initial position to its injection position) until the safety shield 10 is caused to move a predetermined distance in the proximal direction…With the device 10 pressed against his/her skin (and the safety shield 10 moved out of its first position in the proximal direction), the container 50 adopts its active state, and the user can activate the device 1 and begin an injection by pressing the push button 23.” [0105]).
Regarding claim 29, Grunhut discloses the autoinjector of claim 27, wherein the movable member (safety shield 10) has a user contact surface (bearing surface 11) that is arranged to contact a user of the autoinjector (“the user applies the device 1 on the injection site 4 by means of the bearing surface 11 of the safety shield 10” [0115]), and wherein, in the first position of the movable member (Figure 4), the user contact surface is further away from the plunger holder (inner cylinder 19a) than in the second position of the movable member (Figure 6).
Regarding claim 30, Grunhut discloses the autoinjector of claim 27, wherein the movable member comprises a tubular portion (proximal portion of safety shield 10) that protrudes from the case in the first position of the movable member (Figure 4-5).
Regarding claim 31, Grunhut discloses the autoinjector of claim 30, wherein, in the first position, the movable member protrudes further from the case than in the second position (Figures 4-5 as compared to Figures 6-8).
Regarding claim 32, Grunhut discloses the autoinjector of claim 27, wherein the movable member (safety shield 10) has a proximal aperture that forms a passage for an injection needle (injection needle 6, see Figures 12-14 with needle 6 protruding proximally out of safety shield 10), the injection needle protruding proximally through the proximal aperture from the movable member during the dispensing operation (Figures 12-14).
Regarding claim 33, Grunhut discloses the autoinjector of claim 25, wherein at least a portion of the plunger holder (inner cylinder 19a) is arranged within the case (upper housing assembly 100; Figure 2).
Regarding claim 34, Grunhut discloses the autoinjector of claim 16, wherein the autoinjector comprises the medicament container (container 50) with a medicament (“product 3 for injection” [0086]).
Regarding claim 35, Grunhut discloses the autoinjector of claim 16, wherein the medicament container comprises a syringe (“container 50 such as, for example, a syringe” [0086]) with a needle (needle 6; Figure 2).
Regarding claim 36, Grunhut discloses the autoinjector of claim 16, wherein the feedback feature impacts the plunger to generate the perceivable audible feedback by the feedback feature impacting the plunger (“it is possible to produce an audible indicator at the end of the injection: in such a case, for instance, the first spring presents a variable diameter that engages a projection 32 only at or near the end of the injection.” [0135]).
Response to Arguments
Applicant’s arguments with respect to claims 16-23 and 25-36 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
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