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 .
Acknowledgments
This office action is in response to the reply filed on 6/23/23 (preliminary amendment). Claims 16-35 are pending.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7/10/25;7/3/24;4/1/24;7/7/23;6/15/23 are in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDSs are being considered by the Examiner.
Allowable Subject Matter
Claim 22 is 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 elements of the second locking mechanism in claim 22 in concatenation with the other elements of the independent claim are not known or taught in the prior art. Claim 23 is further objected to based on dependency.
Claim 30 is 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.
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 16-21, 24-29, 31-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kemp et al. (US 2013/0131602) (“Kemp”). Kemp discloses:
(claim 16) An arrangement for a drug delivery device, the arrangement comprising: a housing element 2; a plunger rod 8 being arranged axially movable with respect to the housing element and rotationally fixed with respect to the housing element [0130]; a transfer member 14 being arranged rotatably with respect to the housing element; and an energy member 11 configured to provide energy to provide a torque onto the transfer member, wherein the transfer member and the plunger rod are operatively coupled such that a rotation of the transfer member is converted into an axial movement of the plunger rod, and wherein the arrangement comprises a released state in which (i) the energy member provides the torque onto the transfer member and (ii) the transfer member rotates in a first rotational direction due to the torque and forces the plunger rod to move axially in a distal direction [0130].
(Claim 31): as above and additionally: a medicament container 5 with a needle 6; and a needle shroud 3 telescopically coupled to the housing and axially movable with respect to the housing between an extended position in which the needle is covered by the needle shroud and a retracted position in which the needle is exposed [0023] Figs. 8A,B,9,10
(Claim 35): as above and additionally: (from claim 24) wherein the arrangement is configured such that, in the released state, the transfer member 13 is configured to move axially with respect to the housing element in a proximal direction until the transfer member contacts an end-stop of the arrangement. [0148-0149]
Claim 17: the plunger rod 8 is rotationally fixed to the housing element via a splined interface. (splined engagement in the grounding member 12) [0141]
Claim 18: in the released state, the transfer member 14 rotates by at least n-times 360 degrees wherein n is an integer greater than or equal to 1. [0141-0142]
Claim 19: the plunger rod 8 and the transfer member 14 are operatively coupled via a threaded interface 16. [0130]
Claim 20: the arrangement has a first locked state, in which a releasable first locking mechanism 3 prevents a rotational movement of the transfer member 14, the first locking mechanism 3.8 comprises a first rotation-lock element rotationally and axially fixed with respect to the transfer member and a second rotation-lock element 14.1 rotationally and axially fixed with respect to the housing element, the first and second rotation-lock elements of the first locking mechanism being configured to engage each other, and the engagement of the first and second rotation-lock elements of the first locking mechanism prevents the rotational movement of the transfer member. Figs. 7B,C [0146]
Claim 21: the second rotation-lock element 14.1 is a displaceable element, the displaceable rotation-lock element is displaceable in a radial direction, and the displaceable rotation-lock element is orientated circumferentially. Figs. 7B,C
Claim 24: in the released state, the transfer member 13 is configured to move axially with respect to the housing element until the transfer member contacts an end-stop of the arrangement. [0148-0149]
Claim 25: in the released state and after contacting the end-stop, the transfer member 14 is configured to continue to rotate. [0130]
Claim 26: the transfer member 13 is configured to move in a proximal direction.
Claim 27: the end-stop comprises a first friction-reduction element, a proximal end of the transfer member comprises a second friction-reduction element, a low-friction interface is formed between the first and second friction reduction elements, at least one of the first or second friction reduction elements is a tapering protrusion 13.1, and the other one of the first or second friction reduction elements is an indentation 12.1. [0134]
Claim 28: the indentation and/or the tapering protrusion are rotationally symmetric with respect to a rotational axis of the transfer member. Fig. 2
Claim 29: the energy member is a drive spring 11 connected to the transfer member at a first connection point and connected to the housing element at a second connection point, and during axial movement of the transfer member, the first connection point and the second connection point are axially moved with respect to each other. [0130,0141]
Claim 32: the medicament container comprises a drug. M, Fig. 1
Claim 33: the drug delivery device is an auto-injector. See abstract
Claim 34: A method of dispensing the drug with the drug delivery device according to claim 32. See above
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783