DETAILED ACTION
Response to Amendment
The amendment filed June 3, 2026 has been entered. Claim 1 has been amended. Claims 1-5 and 9-13 are currently pending in the application.
Response to Arguments
Applicant's arguments filed June 3, 2026 have been fully considered but they are not persuasive. Regarding Applicant’s arguments that the amendment has overcome the current rejection, the Examiner agrees that, if the amendment were supported by the disclosure, that it would overcome the current rejection, however, the amendment fails to find support in the disclosure as originally filed, and the language renders the scope indefinite as it does not appear to match the disclosed embodiment as set forth below. For this reason, the claim must be examined as if any portion of the surface may be continuous from edge to edge, and not the entire proximal surface as claimed. The rejection is maintained for these reasons as set forth below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 and 9-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 sets forth that the disk has a proximal surface defining a single plane from edge to edge that is smooth and continuous across an entirety of the proximal surface. The disclosure makes no mention of a single plane, edge-to-edge surface on the disk as claimed. In addition, the figures depict the disk as having an annular opening 61 therethrough. This opening would be considered as a discontinuity, absent further definition of the proximal surface portion which is intended to be in a single plane from edge to edge (e.g., the present surface lies in a single plane across a flat proximal portion, however, the opening provides for a discontinuity in the surface thereby breaking up the top surface structure. Because the disclosure fails to define what the top surface is, or how the single plane is constructed, it fails to support the amendment as currently set forth.
Claims 1-5 and 9-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. As above, the disclosure fails to set forth limits to the edge-to-edge single plane feature for the disk element. Based upon the disclosure, it is impossible to define the structural limits imparted by such a limitation on the disk element. It is unclear if only the present surface lies on a single plane and that the center aperture is separate, or if the entire proximal surface must be a complete body without any openings or discontinuities. For the purposes of examination, the claim will be examined as if only a portion of the disk need lie in a single plane which is consistent with the disclosed embodiment wherein the opening forms a discontinuous portion of the disk surface.
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 defining a single plane from edge to edge (the surface is substantially smooth as depicted in Figure 3, around at least a portion of the disk which is considered the edge to edge proximal surface; 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; as above, if the claim is amended to require the proximal surface to define a single plane from edge to edge, which is supported by the disclosure, 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
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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