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 .
Response to Amendment
The amendment filed January 22, 2026 has been entered. Claims 16-17 and 19-35 remain pending in the application. Claim 18 has been cancelled. Applicant’s amendments to the abstract and claims have overcome the objections previously set forth in the Non-Final Office Action mailed October 29, 2025.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “drive unit” in claims 16 and 34.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 16-17, 19-22, and 27-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brereton et al. (US 20130289492).
Regarding claim 16, Brereton discloses a drive arrangement for a drug delivery device (auto-injector 1), the drive arrangement comprising:
a housing (housing 2 2) having a proximal end (distal portion 2.1) and a distal end (proximal portion 2.2; Figure 1, noted that Brereton describes “proximal” as close the injection site and “distal” as away from the injection site), a longitudinal axis extending between the proximal end and the distal end (Figure 1);
a plunger rod (plunger 9), which is arranged in the housing and movable relative to the housing (Figure 10);
a drive unit (compression spring 7) which is arranged to bias the plunger rod to move in the distal direction (“A plunger 9 for transmitting load from the compression spring 7 to the syringe 5 and to a stopper (illustrated in FIG. 10) in the syringe 5” [0060]); and
a plunger rod release member (lock 10), which comprises at least one plunger rod release feature (two resilient arms 10.2) which is arranged to engage a retention feature (circumferential notch 9.4) of the plunger rod (“In the initial state the resilient arms 10.2 are engaged in a circumferential notch 9.4 in the piston rod 9.1 in a manner to couple the piston rod 9.1 and the lock 10 for joint translation. (see FIG. 10)” [0061]);
wherein the plunger rod release member is movable relative to the housing from a first position into a second position, wherein, in the first position, the at least one plunger rod release feature engages the retention feature, wherein, when the at least one plunger rod release feature engages the retention feature, the plunger rod is prevented from moving relative to the plunger rod release member (“In the initial state the resilient arms 10.2 are engaged in a circumferential notch 9.4 in the piston rod 9.1 in a manner to couple the piston rod 9.1 and the lock 10 for joint translation. (see FIG. 10)” [0061]);
wherein, in the second position, the at least one plunger rod release feature is disengaged from the retention feature, thereby allowing the plunger rod to move in the distal direction under a force of the drive unit (“The resilient arms 10.2 are arranged to disengage from the circumferential notch 9.4 due to ramped engagement under axial load.” [0061]; “The resilient arms 10.2 are no longer outwardly supported by the skin trigger sleeve 3 but deflected outwards due to their ramped engagement to the piston rod 9.1 under load of the compression spring 7 decoupling the piston rod 9.1 from the lock 10 and the syringe carrier 4 and allowing it to push directly on the stopper 13 instead (see FIG. 10) for injecting the medicament.” [0070]),
wherein the plunger rod is rotationally secured relative to the plunger rod release member by the at least one plunger rod release feature interacting with the retention feature in the first position (“In the initial state the resilient arms 10.2 are engaged in a circumferential notch 9.4 in the piston rod 9.1 in a manner to couple the piston rod 9.1 and the lock 10 for joint translation. (see FIG. 10)” [0061]) and wherein movement from the first position to the second position involves rotational movement of the plunger rod release member and the plunger rod relative to the housing (“The resilient arms 10.2 are no longer outwardly supported by the skin trigger sleeve 3 but deflected outwards due to their ramped engagement to the piston rod 9.1… due to the interruption of the longitudinal ridge 3.5 the lock 10 is rotationally released from the piston rod 9.1. The clockwise torque on the plunger 9 rotates the lock 10…The short rotation of the lock 10 unscrews the plunger 9 further from the thrust tube 8 (see FIG. 11).” [0070-0071]); and
wherein the plunger rod is axially secured relative to the plunger rod release member by the at least one plunger rod release feature interacting with the retention feature in the first position (“In the initial state the resilient arms 10.2 are engaged in a circumferential notch 9.4 in the piston rod 9.1 in a manner to couple the piston rod 9.1 and the lock 10 for joint translation. (see FIG. 10)” [0061]) and wherein the movement from the first position to the second position involves axial movement of the plunger rod release member and the plunger rod relative to the housing (“Immediately prior to the needle 6 reaching an injection depth, the lock 10 advancing relative to the skin trigger sleeve 3 reaches a second circumferential portion 3.6.1 of an L-shaped aperture 3.6 in the skin trigger sleeve 3 interrupting the longitudinal ridge 3.5. The resilient arms 10.2 are no longer outwardly supported by the skin trigger sleeve 3 but deflected outwards due to their ramped engagement to the piston rod 9.1 under load of the compression spring 7 decoupling the piston rod 9.1 from the lock 10 and the syringe carrier 4 and allowing it to push directly on the stopper 13 instead (see FIG. 10) for injecting the medicament” [0070]).
Regarding claim 17, Brereton discloses the drive arrangement according to claim 16, wherein, in the first position, the at least one plunger rod release feature (resilient arms 10.2) is radially supported by a radial support (skin trigger sleeve 3; “the arcuate outer surface 10.3 is at least partially covered by the skin trigger sleeve 3 preventing outward deflection of the resilient arms 10.2 and thus axial disengagement of the lock 10 from the piston rod 9.1.” [0061]) and, in the second position, the radial support is removed to allow a radial movement of the at least one plunger rod release feature relative to the retention feature such that the at least one plunger rod release feature disengages the retention feature (“the lock 10 advancing relative to the skin trigger sleeve 3 reaches a second circumferential portion 3.6.1 of an L-shaped aperture 3.6 in the skin trigger sleeve 3 interrupting the longitudinal ridge 3.5. The resilient arms 10.2 are no longer outwardly supported by the skin trigger sleeve 3 but deflected outwards due to their ramped engagement to the piston rod 9.1 under load of the compression spring 7 decoupling the piston rod 9.1 from the lock 10 and the syringe carrier 4” [0070]).
Regarding claim 19, Brereton discloses the drive arrangement according to claim 16, wherein the movement of the plunger rod and the plunger rod release member from the first position to the second position is a helical movement relative to the housing (“A second longitudinal portion 3.6.2 of the L-shaped aperture is arranged to allow translation of the lock 10 in distal direction D relative to the skin trigger sleeve 3 in this state with the outwardly deflected resilient arms 10.2…The short rotation of the lock 10 unscrews the plunger 9 further from the thrust tube 8 (see FIG. 11).” [0070-0071]).
Regarding claim 20, Brereton discloses the drive arrangement according to claim 16, wherein a recess (second circumferential portion 3.6.1) is arranged in the housing, wherein, in the first position, the at least one plunger rod release feature (resilient arm 10.2) is angularly and/or axially offset from the recess (“In the initial state a longitudinal ridge 3.5 on the inner surface of the skin trigger sleeve 3 is engaged in a longitudinal notch 10.4 in the arcuate outer surface 10.3 so as to obstruct clockwise rotation (seen from the distal end D) of the lock 10 relative to the skin trigger sleeve 3. In this relative angular position the arcuate outer surface 10.3 is at least partially covered by the skin trigger sleeve 3 preventing outward deflection of the resilient arms 10.2 and thus axial disengagement of the lock 10 from the piston rod 9.1.” [0061]), and wherein, in the second position, the at least one plunger rod release feature is received within the recess (“Immediately prior to the needle 6 reaching an injection depth, the lock 10 advancing relative to the skin trigger sleeve 3 reaches a second circumferential portion 3.6.1 of an L-shaped aperture 3.6 in the skin trigger sleeve 3 interrupting the longitudinal ridge 3.5. The resilient arms 10.2 are no longer outwardly supported by the skin trigger sleeve 3 but deflected outwards” [0070]).
Regarding claim 21, Brereton discloses the drive arrangement according to claim 16, wherein, in the first position, engagement between the at least one plunger rod release feature (resilient arms 10.2) and the retention feature (circumferential notch 9.4) reacts against the force of the drive unit, which is pre-stressed (Figure 1).
Regarding claim 22, Brereton discloses the drive arrangement according to claim 16, wherein in the first position, a rotational movement of the plunger rod release member is blocked by a blocking interface established between the plunger rod release member and a moveable trigger member (skin trigger member 3; “the arcuate outer surface 10.3 is at least partially covered by the skin trigger sleeve 3 preventing outward deflection of the resilient arms 10.2 and thus axial disengagement of the lock 10 from the piston rod 9.1.” [0061]; “The plunger 9 and lock 10 are rotationally constrained at this point by a spline to the skin trigger sleeve 3 so the plunger 9 is prevented from rotating with the thrust tube 8.” [0066]), wherein the trigger member is movable to release the blocking (“To fire the auto-injector 1, it must be pushed with the proximal end P against the injection site, translating the skin trigger sleeve 3 in distal direction relative the housing 2” [0065]; “the lock 10 advancing relative to the skin trigger sleeve 3 reaches a second circumferential portion 3.6.1 of an L-shaped aperture 3.6 in the skin trigger sleeve 3 interrupting the longitudinal ridge 3.5. The resilient arms 10.2 are no longer outwardly supported by the skin trigger sleeve 3 but deflected outwards due to their ramped engagement to the piston rod 9.1 under load of the compression spring 7 decoupling the piston rod 9.1 from the lock 10 and the syringe carrier 4” [0070]).
Regarding claim 27, Brereton discloses the drive arrangement according to claim 16, wherein an interface between the at least one plunger rod release feature (resilient arms 10.2) and the retention feature (circumferential notch 9.4) which is established in the first position comprises at least one surface which is inclined relative to the longitudinal axis (Figure 10; “The resilient arms 10.2 are arranged to disengage from the circumferential notch 9.4 due to ramped engagement under axial load.” [0061]).
Regarding claim 28, Brereton discloses the drive arrangement according to claim 16, wherein the plunger rod release member (lock 10) comprises a main body (key hole part 10.1; Figures 9 and 10), and the at least one plunger rod release feature (resilient arms 10.2) is movably connected to the main body (Figure 10; “The lock 10 comprises a keyhole part 10.1 for keying with the piston rod 9.1 and two resilient arms 10.2 extending in proximal direction P from the keyhole part 10.1” [0061]; “The resilient arms 10.2 are no longer outwardly supported by the skin trigger sleeve 3 but deflected outwards due to their ramped engagement to the piston rod 9.1” [0070]).
Regarding claim 29, Brereton disclose the drive arrangement according to claim 16, wherein the plunger rod release member (lock 10) comprises a rigid main body or main body portion (keyhole part 10.1).
Regarding claim 30, Brereton discloses the drive arrangement according to claim 16, wherein the plunger rod release member (lock 10) is a collar (Figures 9-10; “The lock 10 comprises a keyhole part 10.1 for keying with the piston rod 9.1” [0061]).
Regarding claim 31, Brereton discloses the drive arrangement according to claim 16, wherein the at least one plunger rod release feature comprises a collar beam (resilient arms 10.2; “The lock 10 comprises a keyhole part 10.1 for keying with the piston rod 9.1 and two resilient arms 10.2 extending in proximal direction P from the keyhole part 10.1. In the initial state the resilient arms 10.2 are engaged in a circumferential notch 9.4 in the piston rod 9.1 in a manner to couple the piston rod 9.1 and the lock 10 for joint translation. (see FIG. 10)” [0061]).
Regarding claim 32, Brereton discloses the drive arrangement according to claim 31, wherein the collar beam is movably and/or resiliently connected to a sleeve-like main body portion (keyhole part 10.1) of the plunger rod release member (“The lock 10 comprises a keyhole part 10.1 for keying with the piston rod 9.1 and two resilient arms 10.2 extending in proximal direction P from the keyhole part 10.1.” [0061]; The resilient arms 10.2 are no longer outwardly supported by the skin trigger sleeve 3 but deflected outwards due to their ramped engagement to the piston rod 9.1” [0070]).
Regarding claim 33, Brereton discloses the drive arrangement according to claim 16, wherein the second position is a position in which the axial and/or rotational movement of the plunger rod release member is stopped (“The clockwise torque on the plunger 9 rotates the lock 10 until a lock boss 10.5 on the lock 10 abuts against a stop 3.4 in the skin trigger sleeve 3 in clockwise direction.” [0070]).
Regarding claim 34, Brereton discloses a drug delivery device (auto-injector 1) comprising: a reservoir (syringe 5); a medicament (medication M) for injection contained within the reservoir (“. The syringe 5 contains a dose of medication M intended to be delivered to a patient through the needle 6.” [0058]); and a drive arrangement comprising:
a housing (housing 2 2) having a proximal end (distal portion 2.1) and a distal end (proximal portion 2.2; Figure 1, noted that Brereton describes “proximal” as close the injection site and “distal” as away from the injection site), a longitudinal axis extending between the proximal end and the distal end (Figure 1);
a plunger rod (plunger 9), which is arranged in the housing and movable relative to the housing (Figure 10);
a drive unit (compression spring 7) which is arranged to bias the plunger rod to move in the distal direction (“A plunger 9 for transmitting load from the compression spring 7 to the syringe 5 and to a stopper (illustrated in FIG. 10) in the syringe 5” [0060]); and
a plunger rod release member (lock 10), which comprises at least one plunger rod release feature (two resilient arms 10.2) which is arranged to engage a retention feature (circumferential notch 9.4) of the plunger rod (“In the initial state the resilient arms 10.2 are engaged in a circumferential notch 9.4 in the piston rod 9.1 in a manner to couple the piston rod 9.1 and the lock 10 for joint translation. (see FIG. 10)” [0061]);
wherein the plunger rod release member is movable relative to the housing from a first position into a second position, wherein, in the first position, the at least one plunger rod release feature engages the retention feature, wherein, when the at least one plunger rod release feature engages the retention feature, the plunger rod is prevented from moving relative to the plunger rod release member (“In the initial state the resilient arms 10.2 are engaged in a circumferential notch 9.4 in the piston rod 9.1 in a manner to couple the piston rod 9.1 and the lock 10 for joint translation. (see FIG. 10)” [0061]);
wherein, in the second position, the at least one plunger rod release feature is disengaged from the retention feature, thereby allowing the plunger rod to move in the distal direction under a force of the drive unit (“The resilient arms 10.2 are arranged to disengage from the circumferential notch 9.4 due to ramped engagement under axial load.” [0061]; “The resilient arms 10.2 are no longer outwardly supported by the skin trigger sleeve 3 but deflected outwards due to their ramped engagement to the piston rod 9.1 under load of the compression spring 7 decoupling the piston rod 9.1 from the lock 10 and the syringe carrier 4 and allowing it to push directly on the stopper 13 instead (see FIG. 10) for injecting the medicament.” [0070]),
wherein the plunger rod is rotationally secured relative to the plunger rod release member by the at least one plunger rod release feature interacting with the retention feature in the first position (“In the initial state the resilient arms 10.2 are engaged in a circumferential notch 9.4 in the piston rod 9.1 in a manner to couple the piston rod 9.1 and the lock 10 for joint translation. (see FIG. 10)” [0061]) and wherein movement from the first position to the second position involves rotational movement of the plunger rod release member and the plunger rod relative to the housing (“The resilient arms 10.2 are no longer outwardly supported by the skin trigger sleeve 3 but deflected outwards due to their ramped engagement to the piston rod 9.1… due to the interruption of the longitudinal ridge 3.5 the lock 10 is rotationally released from the piston rod 9.1. The clockwise torque on the plunger 9 rotates the lock 10…The short rotation of the lock 10 unscrews the plunger 9 further from the thrust tube 8 (see FIG. 11).” [0070-0071]); and
wherein the plunger rod is axially secured relative to the plunger rod release member by the at least one plunger rod release feature interacting with the retention feature in the first position (“In the initial state the resilient arms 10.2 are engaged in a circumferential notch 9.4 in the piston rod 9.1 in a manner to couple the piston rod 9.1 and the lock 10 for joint translation. (see FIG. 10)” [0061]) and wherein the movement from the first position to the second position involves axial movement of the plunger rod release member and the plunger rod relative to the housing (“Immediately prior to the needle 6 reaching an injection depth, the lock 10 advancing relative to the skin trigger sleeve 3 reaches a second circumferential portion 3.6.1 of an L-shaped aperture 3.6 in the skin trigger sleeve 3 interrupting the longitudinal ridge 3.5. The resilient arms 10.2 are no longer outwardly supported by the skin trigger sleeve 3 but deflected outwards due to their ramped engagement to the piston rod 9.1 under load of the compression spring 7 decoupling the piston rod 9.1 from the lock 10 and the syringe carrier 4 and allowing it to push directly on the stopper 13 instead (see FIG. 10) for injecting the medicament” [0070]).
Regarding claim 35, Brereton discloses the drug delivery device according to claim 34, the drug delivery device being a needle-based injection device (needle 6) with an integrated non-replaceable container (syringe 5; “The syringe carrier 4 is arranged to hold a syringe 5 and support it at a proximal end in such a manner that the syringe 5 never moves relative to the syringe carrier 4.” [0058]), where the container holds a single dose (“a dose of Medication M” [0058]), whereby an entire deliverable volume is expelled when the drug delivery device is operated for delivering the single dose (“the user keeps the auto-injector 1 pressed against the injection site until the full dose contained in the syringe 5 has been delivered” [0078]).
Allowable Subject Matter
Claims 23-26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record fails to anticipate or render obvious “wherein one of the plunger rod release member and the interface member comprises a helical interface feature which is configured to convert an axial movement of the plunger rod release member relative to the interface member into an axial and rotational movement of the plunger rod release member relative to the interface member” as required by claim 23 in combination with the limitations of claim 16, from which claim 23 depends. The closest prior art of record is Brereton et al. (US 20130289492), which discloses the limitations of claim 16 (as detailed above), wherein the plunger rod release member (lock 10) is mechanically coupled to an interface member comprising a helical interface feature (retract collar 12 with third thread 12.1 and fourth thread 12.2 or syringe carrier 4 with fifth thread 4.1). However, Brereton does not disclose that this helical interface feature converts an axial movement of the plunger rod release member relative to the interface member into an axial and rotational movement of the plunger rod release member relative to the interface member as required by claim 23.
Response to Arguments
Applicant’s arguments with respect to claims 16-17 and 19-35 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
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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