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 Objections
Claim 36 is objected to because of the following informalities: claim 36 has a portion of the claim underlined even though it is a new claim which is inconsistent with standard formatting. Appropriate correction is required.
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) 16-18 and 24-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glover et al. (WO 2017/046556 A1)
With regard to claims 16, 25, 26, Glover et al. teach a drug delivery device comprising: a housing (Fig. 1 member 24) configured to contain a drug container with a needle; a needle shroud that is telescopically arranged with the housing (Fig. 2 member 28); and a cap that is configured to be releasably connected to the housing before use of the drug delivery device (Fig. 1 member 32), wherein at least one of the cap and the needle shroud is configured such that when an attempt is made to re-apply the cap onto the housing after use of the drug delivery device, the cap does not release a post-use shroud lock (Fig. 6 the shroud is locked in place via tabs 42a/b and ramps 48 a/b, Pg. 19 lines 5-24, as such the cap would not release the lock), wherein when the attempt is made to re-apply the cap onto the housing after use of the drug delivery device, a proximally-facing surface of the cap is configured to abut a surface of the needle shroud without releasing the post-use shroud lock (the proximal surface of the cap is able to abut a surface of 30 without releasing the lock, a use may bring it into contact).
With regard to claims 17 and 18, in the locked position in Fig. 6 the shroud 28 extends further distally than in the initial capped position in Fig. 1, as such the cap would not be able to be reattached, the cap would not be able to unlock the device.
With regard to claim 24, see the interior portion around 29 in the areas of 28b (Fig. 2).
With regard to claim 27 a proximal end of the cap may be spaced as recited after an attempt.
With regard to claim 28 see the transition from Fig. 2-Fig. 6.
With regard to claim 29, see Fig. 1.
With regard to claim 30-32 see projections 44 abutting pin 42 (Fig. 1).
With regard to claims 33 and 34, see the lock between 4aqa/b and 48 a/b (Fig. 1).
With regard to claim 35, see barrel 14 with medicament in volume 21 (Fig. 1).
Claim(s) 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mosebach et al. (US 2016/0144129 A1).
With regard to claim 36, Mosebach et al. teach drug delivery device comprising: a housing (Fig. 1A member 2) configured to contain a drug container with a needle, wherein the drug container is not movable relative to the housing ([0074]); a needle shroud that is telescopically arranged with the housing (Fig. 3 member 7); and a cap (Fig. 3 member 11) that is configured to be releasably connected to the housing before use of the drug delivery device, wherein at least one of the cap and the needle shroud is configured such that when an attempt is made to re-apply the cap onto the housing after use of the drug delivery device, the cap does not release a post-use shroud lock (Figs. 21-22, [0085], 7 is locked after use in a position which extends further than the initial position, as such the cap would not release the lock), wherein the needle shroud comprises a locking tab protruding radially outward (Fig. 21B 7.1), and wherein the locking tab is configured to abut the housing when the post-use shroud lock is engaged (Fig. 22 7.1 engages 2.12).
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) 17, 18, and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glover et al. (WO 2017/046556 A1) as applied to claim 16 above, and further in view of Bernhard et al. (US 2019/0151561 A1).
With regard to claims 17, 18, 20-22, alternatively, if the device of Glover et al. is not found to be configured to prevent the cap from attaching as recited, Bernhard et al. teach a cap with projecting arms 32 that prevent a cap from being remounted which is beneficial in ensuring the device does not mistakenly get reused (Fig. 2a, [0005], [0072]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include a safety feature in Glover et al. as in Bernhard et al. to prevent remounting of the cap to ensure the device does not get mistakenly reused. Further, regarding claims 20-22, as combined the cap would include arms which could abut the shroud in an attempt to re-apply the cap.
Response to Arguments
Applicant's arguments filed December 4, 2025 have been fully considered but they are not persuasive. Regarding claim 16, Applicant argues in Fig. 1 the cap does not abut the shroud. However, a proximally-facing surface of the cap is capable of being placed in abutment with a surface of the shroud without releasing the lock, such a configuration would be different than what is shown in Fig. 1. Regarding new claim 36, a new reference is relied on.
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