DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed on 02/20/26 has been entered in the case. Claims 2-5, 7-20, 22-28 are pending for examination and claims 1, 6 & 21 are cancelled.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 2-10, 12-28 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Jennings (WO2009/019440).
Regarding claim 2, Jennings’440 discloses a drug delivery device 110, comprising:
an elongate member 112 having a proximal end 119/128 (in Fig. 1b) configured to contact a skin at an injection site;
a drug container 116 with a needle 118 arranged in the elongate member, see Fig. 1b, the needle 118 having a proximal needle tip configured to pierce the skin at the injection site;
a needle shield 123 configured to attach to the needle 118 and cover the proximal needle tip, see Figs. 3a-3b; and
a cap 111 that is detachable from the drug delivery device, see Figs. 1b-2a, the cap 111 comprising a cap member 111 (or an oval-shaped member, see Figs. 1a & 1c) providing an outer surface of the cap 111, wherein the outer surface is configured to be manipulated by a user to detach the cap from the drug delivery device; and
a barb member 125 one or more barbs 125a-125b configured to engage the needle shield 123, the one or more barbs 125a-125b being axially locked to the cap member 111, see Figs. 3a-3b, and the cap member 111 being rotatable (see curved arrow in Fig. 3b) relative to the barb member 125 in order to detach the cap from the drug delivery device (e.g., a needle shield 123 is removed by rotating the cap whilst the locking mechanism remains engaged, see abstract; the body of the cap is rotatable relative to the housing whilst the shield retainer does not rotate relative to the discharge nozzle, see lines 20-21 of page 3, also see lines 5-6 of page 3; during rotation, the shield retainer 125 does not rotate relative to the discharge nozzle 118 and the rotational movement of the cap 111 relative to the housing 112, see lines 15-16 of page 11);
wherein the barb member 125 and the cap member 111 are separate component
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Regarding claim 3, wherein a proximal end of the cap 111 covers a proximal end of the needle shield, see Fig. 1a.
Regarding claim 4, wherein the needle shield 123 is configured to be removed from the needle 118 when the cap 111 is detached from the drug delivery device (e.g. the cap 111 is pulled off the housing 112, the boot 123 (needle shield) is pulled away from the syringe 114 with the cap 111, lines 24-25 of page 10).
Regarding claim 5, wherein the one or more barbs 125a/125 are axially locked to the cap member 111 such that relative axial movement between the one or more barbs and the outer surface (of the cap) is prevented, see Figs. 3a-3b.
Regarding claim 6, wherein the elongate member 112 has a proximal end 119 configured to contact the skin adjacent to the injection site, see similar Fig. 1b.
Regarding claim 7, wherein the elongate member 112 is configured to extend axially beyond the proximal needle tip when the cap is detached (e.g., in a retracted position, the needle 118 is contained within the housing 112, lines 15-16 on page 6 & see Fig. 1b.
Regarding claim 8, wherein relative axial movement between the drug container 116 and the elongate member 112 is necessary to pierce skin at the injection site.
Regarding claim 9, wherein the cap 111 is threadedly (indirectly) coupled to the elongate member 112 (e.g., the body of the cap is rotatable relative to the housing 112…, wherein the cap comprises means for converting rotational movement of the cap relative to the housing, lines 20-24 of page 3; the converting means is provided by a first threads on the shield retainer and a second thread on the sleeve and the first and second threads engage each other so that rotational movement of the body of the cap results in linear movement of the shield retainer with respect to the exit aperture, lines 28-31 on page 3).
Regarding claim 10, wherein the cap 111 comprises a sheet comprising the one or more barbs 125a.
Regarding claim 12, wherein the one or more barbs comprise a plurality of barbs 125a, Fig. 2a.
Regarding claim 13, wherein the plurality of barbs 125/125a are configured to engage the needle shield 123.
Regarding claim 14, wherein the plurality of barbs 125/125a are configured to engage the needle shield 123 between a proximal end (adjacent to needle shield retainer in Fig. 3a) of the needle shield 123 and a distal end (adjacent to element 171a) of the needle shield.
Regarding claim 15, wherein the drug container 116 is a syringe.
Regarding claim 16, wherein the syringe is held in a syringe carrier 24/26 and wherein the syringe is supported at a proximal end of the syringe in the syringe carrier, see Fig. 3a.
Regarding claim 17, further comprising a drive spring 130 and a plunger 134.
Regarding claim 18, wherein the plunger 134 is configured to transfer a spring force of the drive spring 130 to a movable stopper 122 within the drug container 116 to dispense a drug from the drug container.
Regarding claim 19, wherein the drive spring 130 is arranged in a distal part of drug delivery device.
Regarding claim 20, wherein the drug delivery device is an auto-injector.
Regarding claim 22, Note: the claim 22 involves 112 issues, as discussed above. For examining purpose, based on the Fig. 6, Examiner assumes that the cap 25 is rotatable whilst removing or pulling the clip or barbs in longitudinal (or axial) direction away from the drug delivery device.
In this case, wherein the cap 111 is configured such that the one or more barbs 125/125a rotate independently of the cap with the one or more barbs engaging the needle shield 123 as the cap 111 is removed from the drug delivery device 110 (e.g., During rotation, the shield retainer 125 (the one or more barbs) does not rotate… This conversion of rotational motion to linear motion is achieved through engagement of screw threads 172, 173 on the central boss 121 and on the shield retainer 125, see lines 15-20 on page 11).
Regarding claim 23, wherein the drug delivery device is configured such that the one or more barbs 125/125a remove the needle shield 123 from the drug container as the cap 111 is removed from the drug delivery device without axially moving the drug container within the drug delivery device.
Regarding claims 24-25, wherein the one or more barbs are arranged within the elongate member 112 when the cap 110 is attached to the drug delivery device, see Fig. 1a.
Regarding claim 26, this claim is being rejected using the same analysis in combination of claims 1, 7 & 8 in the noted the above.
Regarding claim 27, wherein the cap 111 is threadedly (via threads 172 & 173, in Figs. 3a-3b) coupled to the elongated member.
Regarding claim 28, wherein the one or more barbs 125/125a are arranged within the elongate member 112 when the cap is attached to the drug delivery device, see Fig. 3a.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jennings (WO2009/019440) in view of Jennings et al. (US 2010/0016793).
Jennings’440 discloses all the claimed subject matter as required except for the limitation that the sheet is a metal sheet. It appears in the cross-section that the sheet 125 is formed of a metal sheet, see Fig. 3a.
Jennings’793 discloses a cap comprising: a sheet 190; wherein the sheet 190 is a metal sheet.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the sheet device of Jennings’440 with providing a sheet formed of metal material, as taught by Jennings’793, in order to create more flexibility and holding the needle shield firmly.
Response to Arguments
Applicant's arguments filed 02/20/25 have been fully considered but they are not persuasive.
Applicant’s arguments, see Remarks, filed 02/20/26, with respect to prior arts Jennings et al. (US 2010/0016793) and Rand (US 5,137,516) have been fully considered and are persuasive. The claims 2-7, 10-20, 22-23 & 26 are being rejected under 102(b) to Jennings; and the claims 2-9, 12-10, 23-28 are being rejected under 102(b) to Rand have been withdrawn.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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 QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached M-F 7:30 am-4:00 pm.
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/QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783