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 .
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) 19-37 and 39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brereton et al. (US 2013/0289492 A1).
With regard to claim 19, Brereton et al. teach a drug delivery device comprising: a housing element (Fig. 1 housing 2); a protection member arranged axially movable with respect to the housing element and configured to cover a drug delivery element (Fig. 1 member 3); and a movable member arranged axially and rotationally movable with respect to the housing element and arranged rotationally movable with respect to the protection member (Fig. 1 member 12, [0067]), wherein the drug delivery device has an initial state in which (i) the protection member is in an extended position to cover the drug delivery element (Fig. 1) (ii) the protection member is movable in a proximal direction from the extended position into a retracted position to expose the drug delivery element (see at least Fig. 8, [0065]) and (iii) the protection member is coupled to the movable member in a distal direction and the proximal direction ([0064] 12 and 3 are rigidly connected) such that (a) a distal movement of the protection member in the distal direction results in a distal movement of the movable member (see at least [0064], Figs. 13 and 16) and (b) a proximal movement of the protection member results in a proximal movement of the movable member (see at least [0065], Fig. 4), wherein the drug delivery device is configured such that, starting from the initial state, a movement of the protection member in the proximal direction initiates a rotation of the movable member relative to the protection member by a predetermined angle (see at least [0067], [0075]), whereby the coupling of the protection member and the movable member in the distal direction is released such that the protection member is movable towards the extended position relative to the movable member (see at least [0079]), wherein the movable member is configured to be rotated during movement of the protection member in the proximal direction (the device as whole may be rotated and moved proximally, alternatively while the protection member is moved proximally to a retracted position the device may be rotated which would rotate the movable member).
With regard to claim 20, see Fig. 1 plunger rod 9, energy member 7, and lock interface between 10.2 and 9.4. See at least [0061], [0070], [0074] regarding states and movement.
With regard to claim 21, see Fig. 1 transfer member 10 which rotates to allow release of the plunger ([0070]).
With regard to claims 22 and 23, see at least the movement of member 10 in the L shaped aperture shown in Fig. 9.
With regard to claim 24, 7 is connected to 2 at 2.5 and is connected to 10 via the connection to 8 at 8.1; 10 and 8 are connected.
With regard to claims 25-28, member 4 is also considered as part of the housing element which is keyed to 3, 12.3 (protrusion) provides a first rotation lock feature and 3.3/3.35/4.2 (slit) provides a lock feature of the housing element to lock 12 and 4 via 3 ([0058], [0063], [0064], [0067]). 10 is connected to 12 via 4, second rotation lock feature 12.4 engages a rotation-lock surface of 4 providing a rotation-lock feature of 10 ([0064], [0067]). A slide is formed by the thread 4.1 (thread would have a beveled surface), as 12 rotates relative to 4 12.3 slides along the thread ([0067], [0068]).
With regard to claim 29, 12 moves axially relative to 2, see transition in the Figs.
With regard to claims 30-32, see protection coupling feature 3.3 and moveable member coupling feature 12.3 which can be considered to have sections (Fig. 5, [0063], [0067]).
With regard to claim 33, a coupling surface of 12 abuts coupling 2.3 of the housing element (exemplary Fig. 7, [0068]).
With regard to claim 34, see housing 4, container 5, needle 6 (Fig. 1, Fig. 6, see 3 move with respect to 4 in transition between Fig. 12-Fig. 13).
With regard to claims 35 and 37, see housing 4, container 5 (Fig. 1, abstract).
With regard to claim 36, see needle 6 (Fig. 6).
With regard to claim 39, Brereton et al. teach a drug delivery device comprising: a housing element (Fig. 1 member 2); a housing with the housing element fixed to or integrated in the housing (Fig. 1 member 10); a medicament container holder configured to hold a medicament container, wherein the medicament container holder is axially fixed with respect to the housing (Fig. 1 member 4, [0063]); a protection member arranged axially movable with respect to the housing element and configured to cover a drug delivery element (Fig. 1 member 3); and a movable member arranged axially and rotationally movable with respect to the housing element and arranged rotationally movable with respect to the protection member (Fig. 1 member 12, [0067]), wherein the drug delivery device has an initial state in which (i) the protection member is in an extended position to cover the drug delivery element (Fig. 1) (ii) the protection member is movable in a proximal direction from the extended position into a retracted position to expose the drug delivery element (see at least Fig. 8, [0065]) and (iii) the protection member is coupled to the movable member in a distal direction and the proximal direction ([0064] 12 and 3 are rigidly connected) such that (a) a distal movement of the protection member in the distal direction results in a distal movement of the movable member (see at least [0064], Figs. 13 and 16) and (b) a proximal movement of the protection member results in a proximal movement of the movable member (see at least [0065], Fig. 4), wherein the drug delivery device is configured such that, starting from the initial state, a movement of the protection member in the proximal direction initiates a rotation of the movable member relative to the protection member by a predetermined angle (see at least [0067], [0075]), whereby the coupling of the protection member and the movable member in the distal direction is released such that the protection member is movable towards the extended position relative to the movable member (see at least [0079]).
Response to Arguments
Applicant's arguments filed March 6, 2026 have been fully considered but they are not persuasive. Applicant argues that in Brereton et al. the moveable member only rotates after movement of the protection member in the proximal direction has stopped. As noted in the rejection above the wherein clause does not tie the movements relative to other portions of the device or times of use. The amendments are sufficient to overcome the previous rejections under 35 U.S.C. 112.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bendek et al. (US 2016/0361503 A1) cited by the Applicant on the IDS discloses at least members 14 which rotate while member 13 moves proximally. The Examiner would also note that limitations to the distal and proximal movements of the protection member resulting in distal and proximal movements of the moveable member are also not tied relative to any other portion of the device.
THIS ACTION IS MADE FINAL. 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 EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783