DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 13, 2026 has been entered.
Response to Arguments
Applicant's arguments filed February 4, 2026 have been fully considered but they are not persuasive. Regarding Applicant’s arguments that the amendment requiring the disk that is “smooth and continuous across an entirety of a proximal disk surface…” overcomes the prior art, the Examiner respectfully disagrees. After consideration, the term “continuous” is being given its broadest reasonable interpretation which would include “an unbroken whole; without interruption” as per the Oxford dictionary. In this sense, the stepped proximal surface of the bearing element 32 of Jugl is considered to be continuous even if the surface is not defined in a single plane. If the claim were amended to require the proximal surface of the disk to be a continuous planar surface across the entire proximal surface, it would overcome this interpretation and the cited prior art. Until the language is amended, the rejection is considered proper and is maintained below.
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.
Claim(s) 1-5 and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wieselblad et al. (US 2012/0136315), and further in view of Jugl et al. (US 2013/0018328).
Regarding claim 1, Wieselblad et al. (henceforth Wieselblad) discloses (Figures 1-5) a medicament delivery device comprising: a first housing part (10) having a proximal end and comprising a multi- chamber container (14, Figure 1, the container comprises a liquid medicament and diluent which are mixed prior to delivery as per paragraph [0048]) having a distal stopper (15b, it is noted that Wieselblad refers to the end furthest from the patient as the distal end as per paragraph [0032]) and a proximal stopper (15a) separated by an axial distance (they are separated prior to attachment of housing 10 to housing 12 as per paragraph [0048] which discloses that the plungers are moved together during connection of housings 10 and 12); a second housing part (12) that is movably attached to first housing part and where relative movement between of the first and second housing parts reduces the axial distance (paragraph [0048] discloses that as housing 10 is screwed into housing 12, the plunger will abut piston 15b to cause the medicament to mix with the diluent via movement of the plungers); a plunger rod (26) rotationally fixed within the second housing part (paragraph [0048] sets forth that the plunger rod is locked from axial and rotational movement relative to housing 12 until housing 10 is fully inserted therein); wherein relative movement between the first and second housings causes the distal stopper to move proximally relative to the proximal stopper for mixing at least two substances present inside the multi-chamber container (paragraph [0048], via cooperation of threads on housings 10 and 12). Wieselblad does not explicitly disclose the rotating contact element between the plunger rod and stopper or the journaled connection.
Jugl et al. (henceforth Jugl) teaches (Figure 3) a medication delivery device comprising a stopper (36), a rotating contact element comprising a disk having a smooth and continuous (see annotated figure below) proximal surface (the surface is substantially smooth as depicted in Figure 3; the claim does not require the proximal surface to lie in a single plane from edge to edge and the disk of Jugl is considered to be substantially smooth and continuous along its proximal surface; each stepped portion comprises a smooth transition; there are no discontinuities or surface textures which might not read on the limitation as currently set forth; as above, if the claim is amended to require the proximal surface to define a single plane from edge to edge, it would overcome the current rejection and cited prior art) and a central passage configured so that the disk is journaled to the proximal end of the shaft (see distal portion of shaft extending between opening in the disk) such that when the rotating contact element engages the distal stopper during the relative movement of the displacement of the first housing part relative to the second housing part the rotating contact element will rotate with the stopper and relative to the plunger rod and the shaft (disk 32; see annotated figure below and paragraphs [0033] and [0064]; the disk is coupled to the distal end of the plunger rod shaft and provides a bearing surface between the plunger rod and piston 36 for centering the shaft on the piston and reducing friction), and a journaled connection comprising a shaft (distal extension of plunge rod 10); having a proximal end and a distal end, wherein the distal end is fixedly attached to a terminal proximal end face of the plunger rod (see annotated figure below), wherein the shaft engages the rotating contact element such that rotation of a housing part relative to another housing part causes rotation of the plunger rod, but not rotation of the contact element (paragraphs [0033] and [0064]); wherein the rotating contact element remains in contact with the stopper to move proximally along with the stopper during dose delivery proximal movement; see paragraph [0069] which discloses the bearing disc centering on the stopper during distal movement; the bearing disc is disclosed as being rotatably mounted to the piston rod as per paragraph [0064]; the bearing disc is rotatably mounted to the piston rod and is therefore fully capable of rotating with any engaged surface or element, e.g., the piston, which is not rotationally locked relative to the plunger rod).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the injector of Wieselblad to comprise the rotating contact element of Jugl so as to allow for a means providing a bearing surface which allows for proper centering of the plunger rod relative to the stopper via a rotatable connection as taught by Jugl (e.g., paragraph [0066]). In such a combination, the journal bearing of Jugl would be applied to the piston engagement portion of the plunger rod of Wieselblad so as to provide a means of ensuring the plunger rod is centered on the piston and provides for the desired application force between the piston end and plunger via relative rotation between the components. It’s noted that the plunger of Wieselblad rotates during dose delivery and would therefore benefit from the bearing assembly of Jugl as set forth above (see e.g., paragraph [0050] of Wieselblad which discloses the rotation of the plunger during delivery).
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Regarding claim 2, Wieselblad further discloses wherein the first housing (10) is rotatable relative to the second housing (12) which causes the multi-chamber container to move distally relative to the plunger rod (paragraph [0048]).
Regarding claims 3 and 5, Wieselblad further discloses wherein the second housing (12) has a distal end separated by a distance from the proximal end of the first housing part (10) and where the second housing part is threadedly attached (via threads 20 on first housing 10 which engage with corresponding threads 24 on an inner surface of the second housing 12) to the first housing part and where relative rotation reduces the distance between the distal end of the second housing and the proximal end of the first housing (paragraph [0048]).
Regarding claim 4, Wieselblad further discloses an activation member (driver 34) located in the second housing part (12) that is operatively connected to the plunger rod (26, Figure 1; paragraph [0040]).
Regarding claim 9, Jugl further teaches wherein the rotating contact element abuts the distal stopper to prevent the rotating contacting element from rotating when the second housing part is rotated relative to the first housing part (any application of force between the distal stopper and the plunger rod which overcomes the frictional force of the contact element on the plunger rod will serve to lock the rotation of the contact element relative to the piston rod as claimed; such movement is disclosed by Elmén with respect to the movement of the two housing components and the combined device is considered fully capable of functioning in the claimed manner).
Regarding claim 10, Wieselblad further discloses wherein the activation member (34) comprises an activator sleeve (body of 34) having a flexible tongue (protrusions 36; Figure 5, paragraph [0040]) that engages the plunger rod prior to the mixing of the two substances (paragraph [0040]; as in Figure 3, the plunger rod and activation member are installed in the second housing 12 before attachment of housing 10 which provides for the mixing).
Regarding claim 11, Wieselblad further discloses wherein the flexible tongue (36) fits into a groove (38) in the plunger rod to prevent axial movement of the plunger rod in the proximal direction (at a minimum, the plunger rod cannot move distally due to interaction between the plunger head and driver due to a limit of travel of the protrusions within the groove).
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wieselblad in view of Jugl, and further in view of Elmén et al. (US 2011/0087163).
Regarding claim 12, Wieselblad/Jugl disclose the claimed invention substantially as set forth above for claim 10, but fail to teach wherein depression of the cover causes proximal movement of the activator sleeve so that the flexible tongue disengages from the plunger rod to allow for axial movement.
Regarding claim 12, Elmén et al. (henceforth Elmén) teaches a cover (40) positioned at the distal end of a second housing part (21), wherein depression of the cover causes proximal movement of the activator sleeve causing the flexible tongue to disengage from the plunger rod so the plunger rod can move axially toward the proximal end of the first housing part (paragraphs [0031] and [0040]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Wieselblad/Jugl to comprise the plunger engaged activation sleeve of Elmén so as to allow for a means of locking axial movement of the plunger assembly during attachment of the first housing while allowing for axial movement during dose delivery. Wieselblad discloses a drive assembly with the same features and it would be obvious to modify it as it maintains the original function of the device of Wieselblad for preventing axial movement of the plunger until dose delivery. In such a combination, the rotation prevention means of Wieselblad (the protrusions within the groove of the plunger) could be maintained with the additional utility of moving the driving member out of engagement with the plunger after actuation to allow for the same rotation during delivery as taught by Wieselblad.
Regarding claim 13, Wieselblad/Jugl teach the claimed invention substantially as set forth above for claim 1, and Wieselblad further teaches that the first housing part 10 abuts a proximal end of second housing 12 after complete installation (paragraph [0048]), but fails to explicitly disclose the protrusions and recesses.
Elmén further teaches one or more annular protrusions coupled to the first housing part (12); and one or more annular recesses on an inner surface of the second housing part (21), wherein the one or more annular recesses corresponds to the one or more annular protrusions, and wherein the one or more annular protrusions are configured to lock into the one or more annular recesses when the relative movement of the first and second housing parts is complete (paragraph [0037] discloses the connection of the protrusions and recesses though they are not depicted in the figures).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the housing connections of Wieselblad/Jugl to comprise the protrusions and recesses of Elmén so as to result in a positive locking of the two bodies together after connection as taught by Elmén (paragraph [0037]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783