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) 1 and 3-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dobson et al. (US 2020/0121853 A1).
With regard to claim 1, Dobson et al. teach a cassette unit sub-assembly for a medicament delivery device, the sub-assembly comprising: a body (20) extending along a longitudinal axis (L) from a proximal end to a distal end (Figs. 1 member 52); a delivery member guard (21) coaxially attached to the body (20) and being axially movable relative to the body (20) along the longitudinal axis (L) (Fig. 1b member 18); a lock member (22) attached to the body (20) (Fig. 6a member 136, [0155], rotate outward); wherein the lock member (22) is rotatable relative to the delivery member guard (21) between a locked position and an unlocked position, wherein, when the lock member is in the locked position, the delivery member guard is in an initial position relative to the body (Figs. 1a and 9a locked position); wherein the lock member (22) comprises a distally directed surface adjacent to a proximally directed surface of the delivery member guard (21) in the locked position (distal face of the protrusion at the end of 136, Fig. 6a); and wherein the distally directed surface of the lock member (22) is spaced apart in a circumferential direction relative to the longitudinal axis (L) from the proximally directed surface of the delivery member guard (21) in the unlocked position (when 136 moves outward); wherein, when in the unlocked position, the lock member (22) is configured to enable movement of the delivery member guard (21) proximally relative to the body (20) from the initial position to an extended position prior to an injection performed using the sub-assembly, the extended position being proximally forward of the initial position ([0155]), wherein the delivery member guard (21) is configured to receive a distally directed force on the delivery member guard (21) to initiate the injection when the lock member (22) is in the unlocked position ([0162]-[0164]); and wherein the distally directed force (i) causes initiation of the injection by causing movement of the delivery member guard (21) distally relative to the body (20), and (ii) does not cause the unlocking of the delivery member guard (21) ([0162]-[0164]); and wherein the lock member (22) remains attached to the body (20) during and after the injection (136 is not removed from the device).
With regard to claim 3, see Fig. 3 and Figs. 18 member 64.
With regard to claim 4, see Reference Figure 1 below.
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With regard to claims 5 and 6, see Reference Figure 2 below.
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With regard to claim 7, the lock is considered to further include 12 (Fig. 6a).
With regard to claim 8, the distal surface of the protrusions at the end of 136 form a ledge.
Claim(s) 9-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karlsson et al. (US 2014/0343507 A1) in view of Dobson et al. (US 2020/0121853 A1).
With regard to claims 9-11, Karlsson et al. teach a cap assembly which connects to an injector with a movable guard comprising a tubular outer cap (Fig. 5 member 132); an inner cap (Fig. 5 member 146) at least partially surrounded by the tubular outer cap; a clutch member rotationally fixed to the inner cap and positioned longitudinally between the tubular outer cap and the delivery member guard (Fig. 5 member 166, [0045]); wherein the clutch member comprises a clutch biasing member (Fig. 5 member 180), the clutch member being axially movable relative to the outer cap between a relaxed position and a tensioned position (see Figs. 7 and 8); wherein the tubular outer cap is axially fixed with and rotatable relative to the inner cap ([0043]); wherein the tubular outer cap comprises a plurality of engaging members (Fig. 6 protrusion members 178) and the clutch member comprises a plurality of counter engaging members (Fig. 6 protrusion member 172); and wherein the plurality of engaging members is adjacent with the plurality of counter engaging members when the clutch biasing member is in the tensioned position ([0046]). The cassette unit of Karlsson et al. is used with a subassembly that includes a body (Fig. 1 member 10) and an axially movable delivery member guard (Fig. 1 member 70). Karlsson et al. do not disclose a lock member or that in the extended position the guard is proximally forward of the initial position prior to injection. Dobson et al. teach a cassette unit sub-assembly for a medicament delivery device, the sub-assembly comprising: a body (20) extending along a longitudinal axis (L) from a proximal end to a distal end (Figs. 1 member 52); a delivery member guard (21) coaxially attached to the body (20) and being axially movable relative to the body (20) along the longitudinal axis (L) (Fig. 1b member 18); a lock member (22) attached to the body (20) (Fig. 6a member 136, [0155], rotate outward); wherein the lock member (22) is rotatable relative to the delivery member guard (21) between a locked position and an unlocked position, wherein, when the lock member is in the locked position, the delivery member guard is in an initial position relative to the body (Figs. 1a and 9a locked position); wherein the lock member (22) comprises a distally directed surface adjacent to a proximally directed surface of the delivery member guard (21) in the locked position (distal face of the protrusion at the end of 136, Fig. 6a); and wherein the distally directed surface of the lock member (22) is spaced apart in a circumferential direction relative to the longitudinal axis (L) from the proximally directed surface of the delivery member guard (21) in the unlocked position (when 136 moves outward); wherein, when in the unlocked position, the lock member (22) is configured to enable movement of the delivery member guard (21) proximally relative to the body (20) from the initial position to an extended position prior to an injection performed using the sub-assembly, the extended position being proximally forward of the initial position ([0155]), wherein the delivery member guard (21) is configured to receive a distally directed force on the delivery member guard (21) to initiate the injection when the lock member (22) is in the unlocked position ([0162]-[0164]); and wherein the distally directed force (i) causes initiation of the injection by causing movement of the delivery member guard (21) distally relative to the body (20), and (ii) does not cause the unlocking of the delivery member guard (21) ([0162]-[0164]); and wherein the lock member (22) remains attached to the body (20) during and after the injection (136 is not removed from the device). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the shield of Karlsson et al. extend as in Dobson et al. as this provides an equivalent shield and prevent reuse ([0106]).
With regard to claims 12 and 13, see proximal connector 182 and distal connector 168 (Fig. 5). The distal connector is adjacent the guard 70 and proximal connector 168 is adjacent the inner distal face of the outer cap (Fig. 7 of Karlsson et al. shows the clutch and cap abutment).
With regard to claim 14, see flexible arms 176 (Fig. 6).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karlsson et al. (US 2014/0343507 A1) in view of Dobson et al. (US 2020/0121853 A1) and Gylleby et al. (US 2017/0087304 A1).
With regard to claim 15, Karlsson et al. teach a medicament delivery device comprising the cassette unit (2) according to claim 9 (see the rejection above) and a drive assembly (Fig. 2 of Karlsson et al. including at least components 50, 40, 101, 110, 80). Karlsson et al. show the drive to be within the same housing as the cassette components. Karlsson et al. do not disclose the drive is reusably attached via a bayonet connection. However, Gylleby et al. teach an injector in which the drive is housed separately and attached via a bayonet connection (housing 10 is reusably attached via a bayonet [0035], [0063]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a reusable drive connected with a bayonet in Karlsson et al. as in Gylleby et al. as this would yield the same predictable result of delivery and reduce waste by having reusable components.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In light of the amendments a different feature of Dobson et al. is relied upon to teach the lock.
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 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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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783