CTNF 18/039,045 CTNF 81760 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. This office action is in response to applicant’s communication of 6/23/2023. Currently claims 22-43 are pending. Claims 22-32 are allowable. Claims 33-42 are rejected below. Claim 43 is objected to below. Information Disclosure Statement The information disclosure statement (IDS) submitted on 6/15/2023, 7/7/2023, 4/01/2024, 7/03/2024, 7/8/2025, 10/06/2025, 1/27/2026, 2/04/2026, 1/02/2026 is being considered by the examiner. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-12-aia AIA (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. 07-15-03-aia AIA Claim(s) 33-42 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2015/090320 A2 (CPU INNOVATION) . CPU discloses and teaches a container-holder subassembly for a drug delivery device, comprising a needle shroud (13 fig.2) configured to cover a needle of a medicament container, a container holder (12 fig.2) configured to hold a medicament container, wherein the needle shroud and the container holder are coupled to each other so that the needle shroud is moveable with respect to the container holder in axial direction (p. 18 l.21-30), the container-holder subassembly is configured to be inserted into a housing (11/1/5) for a drug delivery device (1 fig.2, p. l.25-26). While the container and needle of claim 34 are not shown in the figures of CPU, they are nonetheless disclosed therein (see p. 1.4-5). The container being freely accessible from the proximal end is a standard construction to facilitate assembly of injection devices well-known to the skilled person in the art and known that a device of this type would contain these structures (it is examiner’s position that these elements are inherent in the art of CPU also see fig.2, p. l.25-26 and identified structures above). Concerning claim 35 and the container holder (12) and the needle shroud (13) are rotationally fixed with respect to each other (as in figure 2), the container holder comprises a first rotation-lock feature and the needle shroud comprises a second rotation-lock feature (left and right sides of 55 or 56 and complementary structure on the holder), and the first and second rotation-lock features are engaged with each other to prevent a rotation of the container holder and the needle shroud with respect to each other (see figure 2). Concerning claim 36 and a shroud spring (17) coupled to the needle shroud and the container holder, the shroud spring configured to provide a restoring force acting in distal direction on the needle shroud when the needle shroud is moved in a proximal direction with respect to the container holder (again as in figure 2). Concering claim 37 and the needle shroud (13)comprises two arms (each one extends from main body of 13 near 55) extending from a first portion of the needle shroud in a proximal direction, the container holder comprises two arms (see both sides of 12 near 53 left and right sides) extending from a first portion of the container holder in the proximal direction, the two arms of the needle shroud are arranged between the two arms of the container holder in an angular direction, the container holder comprises at least one window (see near 53 as in figure 2) through which the medicament container held in the container holder can be observed, the container holder comprises a snap feature (see near 12 or 47 as in figures 2 and 9 for examples) arranged next to the at least one window for axially and/or rotationally fixing the container holder to the housing, the container-holder subassembly comprises a cap arranged at a distal end of the container-holder subassembly, and the cap (37 for example) is configured to be releasably coupled to the needle shroud. Concerning claim 38 and the needle shroud comprises two arms extending from a first portion of the needle shroud in a proximal direction (left and right sides of 55 or 56), the container holder comprises two arms (see both sides of 12 near 53 left and right sides) extending from a first portion of the container holder in the proximal direction, and the two arms of the needle shroud are arranged between the two arms of the container holder in an angular direction (as in figure 2). Concerning claim 39 and the container holder comprises at least one window (see near 53 as in figure 2) through which the medicament container held in the container holder can be observed, and the container holder comprises a snap feature (see near 12 or 47 as in figures 2 and 9 for examples) arranged next to the at least one window for axially and/or rotationally fixing the container holder to the housing. Concerning claim 40 and the container- holder subassembly comprises a cap (37 for example) arranged at a distal end of the container-holder subassembly, the cap being configured to be releasably coupled to the needle shroud. Concerning claim 41 and the housing has a length of at least 75 % of a length of the drug delivery device (see figures 2 and 9 and note length of 11/1/5 structure housing). Concerning claim 42 and a medicament container with a medicament; and the container-holder subassembly according to claim 33 see previously identified sturctures of claim 33 above and medicament container (medicament cartridge that resides in space near 49) . Claim Objections Claim 43 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim as it is depending on two separate independent claims. See MPEP § 608.01(n). It is recommended that applicant amend the claims to only depend from one independent claim and include the elements of the other dependent claim in the body of the claim itself. Appropriate correction is required. Allowable Subject Matter 12-151-07 AIA 07-97 12-51-07 Claim s 22-32 allowed. The prior art of US 2016/287812 A1 (Nielsen), and US 2018/126088 A1 (Radmer) are considered relevant but fail to disclose the “…an axial-locking mechanism prevents an axial movement of the drive member, wherein the drive subassembly is configured to be switched from the second locked state into the first locked state by releasing the axial-locking mechanism and moving the drive member in an axial direction..”. 12-151-08 AIA 07-43 12-51-08 Claim 43 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. PHILLIP A. GRAY Primary Examiner Art Unit 3783 /PHILLIP A GRAY/Primary Examiner, Art Unit 3783 Application/Control Number: 18/039,045 Page 2 Art Unit: 3783 Application/Control Number: 18/039,045 Page 3 Art Unit: 3783 Application/Control Number: 18/039,045 Page 4 Art Unit: 3783 Application/Control Number: 18/039,045 Page 5 Art Unit: 3783 Application/Control Number: 18/039,045 Page 6 Art Unit: 3783