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
This office action is responsive to the amendment filed on September 30, 2025. As directed by the amendment: claims 5, 12, and 13 have been amended, no claims have been added, no claims have been canceled. Thus claims 1-15 are presently pending in this application. Applicant’s amendments to the Claims have overcome each and every objection and 35 U.S.C. 112(b) rejection previously set forth in the Non-Final Office Action mailed July 14, 2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 30, 2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant’s arguments, see Remarks, filed September 30, 2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. The examiner agrees with the applicant’s arguments that Kiilerich does not teach the spring comprising an initial amount of conserved energy sufficient to deliver the plurality of predefined doses and wherein each activation of the drive mechanism, and completion of a drive tube dose sequence reduces the amount of conserved energy in the drive spring. Therefore, the rejection has been withdrawn; and due to their dependency on claim 1, the rejections of claims 6-7 and 14-15 are also withdrawn for similar reasons. However, upon further consideration, a new ground(s) of rejection is made in view of IDS reference Cowe (US 10806865), in view of Smith (US 20130096513), 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.
Claims 1, 6-7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Cowe (US 10806865), in view of Smith (US 20130096513).
Regarding claim 1, Cowe discloses --- drug delivery device (injector of Fig. 1) for sequentially delivering a predefined plurality of fixed doses (C. 5: 39-56, injector configured to deliver a succession of doses of preset magnitude), wherein the drug delivery device comprises: - a housing assembly (Fig. 1, housings 10), - a drive mechanism (Fig. 2-3, spring 22 and drive shaft 24) comprising a drive tube (Fig. 2, tubular drive shaft 24), wherein the drive mechanism is adapted to sequentially deliver the predefined plurality of doses (C. 1:59-C. 2:8; C.6:7-16, drive mechanism (spring and drive shaft) is configured for driving the plunger to deliver the successive doses), and, - an activation mechanism for activating the drive mechanism (Fig. 4 and C. 5:54-56; C.7:23-29, dose setting knob 16, which, in its "pushed in" state activates the drive mechanism to release), wherein the drive mechanism comprises a pre-strained torsional drive spring (Fig. 2-3 and C.5:49-52, spring 22 is a preloaded torsion spring) conserving an initial amount of energy, and adapted for rotating the drive tube (Fig. 2-3 and C.5:49-52; C.6:1-3, torsion spring 22 is fully energized prior to first use and acts on drive shaft 24 to rotate it), wherein each activation of the drive mechanism, and completion of a drive tube dose sequence reduces the amount of conserved energy in the drive spring (C.2:19-22; C.5:49-52; and C.6:1-3, spring 22 is preloaded with sufficient energy to deliver the entire contents of the syringe over the succession of doses, thus the completion of each dose delivery would reduce the amount of energy stored in spring 22), and wherein the initial amount of conserved energy, which is the conserved energy before the first activation, is sufficient to deliver the predefined plurality of fixed doses (C.2:19-22; C.5:49-52; and C.6:1-3, spring 22 is preloaded with sufficient energy to deliver the entire contents of the syringe over the succession of doses).
Cowe fails to disclose wherein the plurality of predetermined doses are a fixed dose. However, Smith discloses wherein the plurality of predetermined doses are a fixed dose (Fig. 1 and [0011-0012], injector 1 only delivers a predetermined fixed dose, via the dose dial 5 only having markings for the single predetermined fixed dose).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cowe to incorporate the disclosures of Smith and modify the dose setting dial to only have markings for a single predetermined dose, such that the device delivers a predetermined plurality of fixed doses. Doing so would provide an improved injection device and user experience for delivery of an injected medication that requires multiple repeated doses over time (Smith, [0003-0004; 0009; 0011]).
Regarding claim 6 and Cowe, in view of Smith, Cowe further discloses ---the drug delivery device according to claim 1, wherein the torsional drive spring is arranged between the drive tube and the housing assembly (Figs. 2-3, spring 22 is arranged between drive shaft 24 and housings 10).
Regarding claim 7 and Cowe, in view of Smith, Cowe further discloses ---the drug delivery device according to claim 1, wherein the housing assembly comprises a fixed spring base (Fig. 2, inner part 23 of body 10), wherein an end of the torsional drive spring is attached to the fixed spring base (Fig. 2 and C. 5:59-61, an end of spring 22 is anchored to inner part 23).
Regarding claim 15 and Cowe, in view of Smith, Cowe further discloses ---the drug delivery device according to claim 1, wherein the drug delivery device comprises a needle mount for an injection needle (Fig. 2, distal end of syringe 12 comprises an attachment mount which may be configured to receive a needle hub assembly), and wherein the activation mechanism comprises an axially movable release button, adapted to activate the drive mechanism, in response to an axial movement (Fig. 4 and C. 5:54-56; C.7:23-29, dose setting knob 16, which is adapted to activate the drive mechanism to release, in response to dose setting knob 16 moving axially to its "pushed in" state).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Cowe (US 10806865), in view of Smith (US 20130096513), as applied to claim 1 above, and further in view of Lawlis et al. (US 20120265136), hereinafter Lawlis.
Regarding claim 14, Cowe, in view of Smith, discloses the drug delivery device according to claim 1.
Cowe, in view of Smith, fails to disclose wherein the drug delivery device comprises an integrated needle, and wherein the activation mechanism comprises an axially movable needle shield for covering and uncovering the needle, wherein the shield is adapted to activate the drive mechanism, in response to a movement in a proximal direction, whereby the needle is uncovered. However, Lawlis discloses wherein the drug delivery device comprises an integrated needle (Figs. 4A and 9A, device 100 comprises an integrated needle 424 mounted in the needle assembly 140 of the device), and wherein the activation mechanism comprises an axially movable needle shield for covering and uncovering the needle (Figs. 1 and 8, injection device comprises needle shield 120 for covering and uncovering needle 424), wherein the shield is adapted to activate the drive mechanism, in response to a movement in a proximal direction, whereby the needle is uncovered (Figs. 8 and [0091], needle shield proximal movement/retraction to uncover needle also releases the drive mechanism clutch to drive the dose ejection).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cowe, in view of Smith, to incorporate the disclosures of Lawlis and modify the drug delivery device to comprise an integrated needle, and modify the activation mechanism to comprise an axially movable needle shield for covering and uncovering the needle, wherein the shield is adapted to activate the drive mechanism, in response to a movement in a proximal direction, whereby the needle is uncovered. Doing so would provide the device with a permanently encased needle assembly and allow for the device to have an easy-to-use activation step wherein insertion of the needle and activation of the dose injection are combined in one action by the injector and ensures needle is not visible to patient during injection, which together aid in lessening patient's injection anxiety and ensures the user steps needed to place the unpackaged device from the lock position to a ready-to-use position are four or fewer, promoting ease of use (Lawlis, [0013, 0056, 0060-0062]).
Allowable Subject Matter
Claims 2-5 and 8-13 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:
Regarding claim 2, Cowe, in view of Smith, discloses the drug delivery device according to claim 1.
Cowe, in view of Smith, is silent to wherein - the housing assembly comprises a guide structure comprising a stop-and-activation-guide-portion, and a drive-guide-portion; -the drive tube is adapted to be guided along the stop-and-activation-guide-portion for activation of the drive mechanism, and along the drive-guide-portion for delivering a fixed dose, and to the stop- and-activation-guide-portion, wherein dosing is stopped, whereby the drive tube is adapted to be guided, in response to the conduction of a drive tube dose sequence comprising activation, dosing and stop of dosing; -the drive mechanism further comprises a piston rod operationally connected to the housing assembly and the drive tube; -the activation mechanism is adapted for moving the drive tube along the stop-and-activation-guide- portion in a first axial direction from a first axial position to a second axial position, and thereby activate the drive mechanism. No reference was found that would have made it obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Cowe, in view of Smith, to satisfy these limitations in combination with the limitations of claim 1. Claims 3-4 and 8-13 depend from claim --2.
Regarding claim 5, and Cowe, in view of Smith, Cowe further discloses the drug delivery device according to claim 1, wherein the torsional drive spring is compressional (C. 7:59-67, torsion spring 22 may have a compression portion to it).
Cowe, in view of Smith, is silent to whereby the drive mechanism is adapted for biasing the drive tube in a second axial direction. No reference was found that would have made it obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Cowe, in view of Smith, to satisfy these limitations in combination with the limitations of claim 1.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on September 30, 2025 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm EST.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783