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 .
Election/Restrictions
Applicant’s election without traverse of Species A in the reply filed on 7/20/26 is acknowledged.
Claims 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/20/26.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Plambech (US 2016/0228651 A1).
With regard to claim 1, Plambech discloses A drug delivery device (Fig. 3-5) for delivering a fixed dose, wherein the drug delivery device comprises: -a housing assembly (201, 220, 320, Fig. 4) defining an axial direction, wherein the housing assembly comprises a guide structure comprising an activation-guide-portion extending in the axial direction, a drive- guide-portion extending in the circumferential direction, and a stop-guide-portion extending in the axial direction (221, 321-324, 329, Fig. 5); -a drive mechanism adapted for delivering the fixed dose, wherein the drive mechanism (200, Fig. 3, [0054]) comprises: --a drive tube adapted to be guided along the activation-guide-portion for activation, along the drive-guide-portion during dosing, and wherein the drive tube is adapted to be stopped by the stop-guide-portion at the completion of the fixed dose (210, 310, fig. 6, [0061]), --a drive spring (235 fig. 4)) adapted for rotating the drive tube to expel a dose ([0059]), --a piston rod (280) operationally connected to the housing assembly and the drive tube ([0022], [0057]); -an activation mechanism (290, Fig. 4, [0056]) comprising an axially displaceable connector adapted for moving the drive tube along the activation-guide-portion, in response to the application of a force in a first axial direction on the connector, wherein the connector and the drive tube can be moved from a first axial position to a second axial position, whereby the drive mechanism is activated, wherein the direction from the first axial position towards the second axial position defines the first axial direction ([0056], [0065], [0107]); -a return spring (139, Fig. 4) for axially biasing the connector in a second axial direction opposite the first axial direction ([0053], [0105]-[0106]); wherein the drive spring is adapted for rotating the drive tube along the drive- guide-portion , in response to activation of the drive mechanism, and wherein the drive mechanism, the drive-guide-portion and the stop-guide-portion, are adapted to drive the drive tube from an activated position to an intermediate position to a stop position, whereby the fixed dose is delivered ([0059]); wherein the drug delivery device further comprises a split-dose-prevention mechanism adapted for limiting the axial movement of the connector during dosing, wherein the split dose prevention mechanism ([0056], [0065]) comprises: - a split-dose-prevention structure (204, Fig. 4, [0065]) provided on the drive tube and extending in a circumferential direction, and - a retention portion provided on the connector, wherein: --for the drive tube being arranged in the intermediate position, the split-dose-prevention structure and the retention portion are arranged with a transverse overlap, whereby movement of the connector in the second axial direction is limited by the split-dose prevention structure ([0056], [0065]), --for the drive tube being arranged in the stop position, the split-dose-prevention structure and the retention portion are arranged with a transverse clearance and/or an axial gap, whereby the return spring can move the connector in the second axial direction, wherein the axial movement is not limited by the split-dose prevention structure, in response to releasing the applied force in the first direction on the connector 310
([0056], [0065]).
With regard to claim 2 and 3, Plambech discloses wherein the activation- guide-portion (221, 321) is an axial portion, and wherein the drive-guide-portion (323, 324) is a step-wise helical portion comprises sequences of helical and axial portions.
With regard to claim 4, Plambech discloses Plambech discloses wherein the drug delivery device comprises a reservoir (380, fig. 3) with a piston ([0014], piston loaded in the cartridge), and wherein the piston rod (280) is adapted for contacting and advancing the piston during dosing ([0014]).
With regard to claim 5, Plambech discloses wherein the housing further comprises an inner thread (245, [0054]), wherein the piston rod (280) further comprises an outer thread for threadably engaging the internal thread of the housing assembly ([0054]), wherein the drive tube (310, [0060], [0062], [0069]) is axially splined to the piston rod, whereby the drive tube is axially movable and rotationally locked relative to the piston rod ([0060], [0062], [0069]), whereby the piston rod is operationally connected to the housing assembly and the drive tube (Fig. 7a, 7b).
With regard to claim 6, Plambech discloses wherein the drive spring (235) is arranged between the drive tube and the housing (Fig. 4).
With regard to claim 7, Plambech discloses wherein the drive spring (235) for rotating the drive tube further is compressible for moving the drive tube in the second axial direction during rotation ([0059], [0081]).
With regard to claim 8, Plambech discloses wherein the drive spring (235) is a torsional spring adapted for rotating the drive tube and thereby advancing the piston rod to expel a dose ([0059], [0081]).
With regard to claim 9, Plambech discloses wherein the torsional drive spring (235) is pre-strained, whereby it is adapted to drive the drive tube, in response to activation of the drive mechanism and thereby deliver the fixed dose ([0054], [0059], [0086], [0106]).
With regard to claim 10, Plambech discloses wherein the torsional drive spring (235) comprises a compressible section ([0054], [0059], [0086], [0106]).
With regard to claim 11, Plambech discloses wherein the connector (170, 270) comprises an activation tab (181, [0050], [0107]) comprising a transverse surface portion (fig. 3), and wherein an engageable surface portion of the drive tube is transverse (210, 310), whereby initiation of dosing is provided by a rotational movement induced by the torsional drive spring ([0107]).
With regard to claim 12, Plambech discloses wherein the drug delivery device is adapted for delivering a predefined plurality of fixed doses ([0061], [0064]), wherein the stop-guide-portion is the activation-guide-portion, and wherein the drive mechanism, the drive guide portion and the stop guide portion are adapted to drive the drive tube from an activated position to an intermediate position to a stop position, whereby the fixed dose is delivered ([0061], [0064]).
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) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Plambech (US 2016/0228651 A1) in view of Karlsson et al. (US 2014/0228769 A1).
With regard to claim 15, Plambech discloses wherein the drug delivery device further comprises a hollow needle for delivery ([0024]).
However, Plambech does not disclose a shield.
Karlsson teaches a similar drug delivery device as Plambech (Fig. 2, [0024]-[0030], [0095]-[0108]) and further teaches a shield (70/99) and a needle cannula (94), wherein the shield is arranged to uncover and cover the needle cannula ([0024]-[0030]), [0095]-[0108]), in response to moving the shield in the first axial and the second axial direction, wherein the shield is adapted for moving the connector in the first axial direction, in response to the application of a force in the first axial direction on the shield ([0024]-[0030]), [0095]-[0108]), whereby the drive mechanism can be activated, and wherein the connector is adapted for moving the shield in the second axial direction, in response to releasing the applied force in the first axial direction on the shield, whereby the drug delivery device is adapted for moving the shield in the second axial direction, in response to releasing the applied force and to the drive tube reaching the stop guide portion ([0024]-[0030]), [0095]-[0108]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Plambech with the needle shield as taught by Karlsson for the purpose of covering the needle prior to use ([0024]-[0030]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/ Primary Examiner, Art Unit 3783
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