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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 14, 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 48-50 and 54 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 36 from which claims 48-50 depend recites that the drug container is not movable relative to the housing. However, 48-50 refer to features which are found on the embodiment which includes a syringe carrier. The relationship between the housing and carrier is not detailed. Generally, a syringe carrier implies the syringe is held within the carrier and the carrier moves with the syringe. Thus, it would appear the specification at the time of filing does not encompass subject matter which includes both a syringe carrier and a drug container which is not movable relative to the housing. Claim 54 recites “a locking tab of the needle shroud.” However, claim 36 recites a locking tab protruding from the shroud beam. It is not clear if this is the same or a different locking tab. It is considered as a different locking tab as rejected below.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 36, 46-47, and 51-55 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Saussaye et al. (US 2019/0298934 A1).
With regard to claims 36, 44, 46, 47, 53, and 55, Saussaye et al. teach a drug delivery device comprising: a housing (Fig. 1 member 1) configured to contain a drug container with a needle, wherein the drug container is not movable relative to the housing (Figs. 1-8 member S, position of S within 1 is unchanged); a needle shroud that is telescopically arranged with the housing (Fig. 2 member 10, showing pre-use state); and a cap that is configured to be releasably connected to the drug delivery device before use of the drug delivery device (Fig. 1 member C), 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 drug delivery device after use of the drug delivery device, the cap does not release a post-use shroud lock (Fig. 9, [0071], [0076], the shroud is locked in place after use and would not be released by contact from the cap, the claim does not recite what constitutes an attempt to re-apply the cap), wherein the needle shroud comprises a shroud beam, wherein the shroud beam comprises a locking tab protruding radially outwards from the shroud beam, and wherein the locking tab is configured to abut the housing when the post-use shroud lock is engaged (Fig. 37, [0076] not numbered in 36 but cutouts shown in 37 provide a beam which can include tab 112 which has a proximally-facing surface which abuts a distally facing ramp surface of the housing in zone 106 in Fig. 36, due to the shape of the groove/ramp the beam flexes as claimed [0064], [0071]).
With regard to claim 45, the cap may be spaced as recited after an attempt to re-apply the cap.
With regard to claims 51 and 52, see Fig. 36 connection with initial zone 102 ([0068]).
With regard to claim 54, a user may take the cap and touch the proximally facing surface of the cap to the distally facing surface of tab 11 of member 10 (Fig. 2).
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) 37-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saussaye et al. (US 2019/0298934 A1) as applied to claim 36 above, and further in view of Bernhard et al. (US 2019/0151561 A1).
With regard to claims 37-42, Saussaye et al. teach a cap but does not disclose how such a cap may prevent re-capping. However, 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 Saussaye et al. as in Bernhard et al. to prevent remounting of the cap to ensure the device does not get mistakenly reused. As combined the cap would include arms which could abut the shroud in an attempt to re-apply the cap.
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saussaye et al. (US 2019/0298934 A1) as applied to claim 36 above, and further in view of Glover et al. (WO 2017/046556 A1).
With regard to claim 43, Saussaye et al. teach a device substantially as claimed but do not disclose an inner wall reinforcement. However, Glover et al. teach a shroud with an inner wall reinforcement at 28b around opening 29 which retain the spring (Fig. 2, Pg. 9 lines 10-11). 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 reinforcement in Sauaasye et al. as in Glover et al. for providing a retention surface for the needle.
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.
Conclusion
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
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