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. Election/Restrictions Applicant’s election without traverse of Group 2 in the reply filed on February 5 th 2026 is acknowledged. Claims 1-4, 7-10, and 12-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 5 th 2026. Specification The disclosure is objected to because of the following informalities: in paragraph [0059], “accessory 150” should be corrected to “accessory 50”, and in paragraph [0064], “second position 273”, in the last line, should be corrected to “second position 275” . Appropriate correction is required. 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 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. (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) 15-18, 2 1 -24, and 26-27 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Tsals ( US 20030229308 A1 ). Regarding claim 15, Tsals discloses a needle shield indicator accessory for a drug delivery device (injector adapter 20 for use with an automatic injector 10, [0032] and [0034]& Fig. 1-4) , comprising: an accessory body configured to be selectively coupled with an injector housing ( base portion 22 of adapter 20 configured to be releasable coupled to injector 10, [0034] & Fig. 1-2 and 4 ) ; and a needle shield indicator configured to indicate to a user whether an injector needle shield is in a retracted position ( receiving portion 24 includes catch es 36 which are configured to engage cavity 17 of injector 10 when body element 11 of injector 10 retracts, [0039] & Fig. 3-4; “ during engagement of the working end 14 of the injector 10 within the injector adapter 20, the base portion 22 provides the body sensing element 11 with a firm surface to push against; i n addition, this retraction action of the body element 11 operates to cause a snap cooperation of the slit/cavity 17 and the catches 36 to support the engagement/disengagement of the working end 14 within the injector receiving portion 24. Furthermore, this snap cooperation also aligns the retracted injection needle 12 with the hole 28 … in preparation for injection. ”; receiving portion 24 including catch es 36 can be interpreted as a needle shield indicator considering portion 24 with catch es 36 is capable of creating a snap connection to cavity 17 of injector 10 which is directly related to body element 11, which is a retractable needle shield (see Fig. 3), entering a retracted position ; the snap of the snap connection provides an audible and/or haptic indication to the user ) . Regarding claim s 16 and 18 , Tsals discloses all the limitations of claim 15. Tsals further discloses t he needle shield indicator accessory wherein the needle shield indicator includes a feedback component configured to provide the user feedback when the injector needle shield is in the retracted position , wherein the feedback component provides the user with (b) an audible indicator or (c) a haptic indicator, when the injector needle shield is in the retracted position (the two catches 36 are being interpreted as a feedback component, [0039] & Fig. 3-4; catches 36 are configured to cause a snap connection with cavity 17 of injector 10, the snap connection can be interpreted as an audible or haptic indication that element 11 of injector 10 is in a retracted position, see [0039] & Fig. 3-4) . Regarding claim 17, Tsals discloses all the limitations of claim 16. Tsals further discloses the needle shield indicator accessory wherein the feedback component is movable between a first position and a second position (catches 36 are movable between a first and second position with respect to injector 10, see Fig. 3-4; as injector 10 is coupled and uncoupled to adapter 20, catches 36 move in and out of a first and second position with respect to injector 10) . Regarding claims 21-22, Tsals discloses all the limitations of claim 16. Tsals further discloses the needle shield indicator accessory wherein the needle shield indicator includes a contact surface configured to contact the user (adhesive system 27 configured to attach to the skin of a patient, [0036]-[0037] & Fig. 4) , wherein the contact surface is movable between an extended position and a retracted position (adhesive system 27 is capable of moving between a position in which injector 10 is connected and disconnected as a user can move adapter 20, including system 27, relative to injector 10 , [ 0037 ] and [0039] & Fig. 3-4) , wherein the retracted position of the contact surface corresponds with the retracted position of the injector needle shield (a position in which adapter 20, including adhesive system 27, is pressed/moved against injector 10 can be interpreted as a retracted position; in this position, element 11 would also be retracted as injector 10 and adapter 20 are connected, [0039] & Fig. 4) , and wherein the contact surface is configured to trigger the feedback component when the contact surface is in the retracted position ( adhesive system 27 can be interpreted as configured to trigger the coupling of catches 36 to cavity 17 when adhesive system 27 is in the retracted position as adhesive system 27 is being interpreted as displaced by the user to facilitate the connection, [0036]-[0037] and [0039] & Fig. 1- 4 ) . Regarding claim 23, Tsals discloses all the limitations of claim 15. Tsals further discloses the needle shield indicator accessory wherein the accessory body includes a distal portion having a diameter significantly larger than a diameter of the injector needle shield ( the bottom of base portion 22 has a diameter seen to be significantly larger than a diameter of body element 11, see Fig. 1-4) . Regarding claim s 24 and 26 , Tsals discloses all the limitations of claim 15. Tsals further discloses the needle shield indicator accessory wherein the needle shield indicator includes an accessory reference feature (cutout 34A on receiving portion 24 is being interpreted as an accessory reference feature, [0039] & Fig. 1-4) , wherein the injector housing includes an injector reference feature, wherein the injector housing includes a drug viewing window and wherein the injector reference feature is defined by at least a portion of the drug viewing window (any portion or all of drug window 19 on injector 10 is being interpreted as an injector reference feature, [0039] & Fig. 3-4), and wherein the accessory reference feature and the injector reference feature are aligned when the injector needle shield is in the retracted position (when injector 10 is couped to adapter 20, window 19 and cutout 34A are aligned to provide visual access, [0039] & Fig. 4; “ where a drug window 19 (FIGS. 4-5) is included within the working end 14 of the injector 10, a corresponding cutout 34A (FIG. 1, or other cutout, opening, aperture, gap, etc.) in the injector receiving portion 24 provides visual access to the user during the injection process to permit the user to know the level of drug still within the injector 10 ”, [0039]) . Regarding claim 27, Tsals discloses all the limitations of claim 26. Tsals further discloses the needle shield indicator accessory wherein the accessory reference feature is a cutout portion having a similar shape as the portion of the drug viewing window (cutout 34A seen having a similar shape as drug window 19 to permit visual access, see Fig. 1-4) . Claim(s) 15-18 and 2 1 -2 3 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Fenster ( US 20150258284 A1 ). Regarding claim 15, Fenster discloses a needle shield indicator accessory for a drug delivery device (skin manipulating flange (SMF) 130 and colored needle shield 712 for autoinjector 100, [0110] and [0138]-[0139] & Fig. 1A-2B and 12A-12C), comprising: an accessory body configured to be selectively coupled with an injector housing (protrusion s 142 configured to selectively couple SMF 130 to autoinjector 100, [0115] & Fig. 2B ; alternatively, the outermost surface of SMF 130 and protrusions 142 can be interpreted as an accessory body, [0115] & Fig. 1A-2B) ; and a needle shield indicator configured to indicate to a user whether an injector needle shield is in a retracted position ( the translucent nature of SMF 130 and the color of shield 712 allows for visual indication to a user that shield 712 is in a retracted position , as SMF 130 is fully stretched when shield 712 is retracted and the color would not be visible, [0110]-[0111], [ 0114 ], [ 0118 ], and [0138]-[0139] & Fig. 1A- 2B and 12A-12C; “ The SMF 130 also facilitates device placement and simplifies the injection procedure by eliminating the skin stretch or pinch step for injection site preparation, thereby allowing the user to … view the injection needle through the SMF material, thereby ensuring visual feedback that the injection needle is in place and/or upon injection completion, the injection needle is retracted ”, [0110]; “ the SMF 130, 230 may be made from a flexible material, such as transparent polyurethane or silicone-polyurethane co-polymer, which allows the user to view the injection needle 116 through the SMF 130, 230 during an injection. In other embodiments, the SMF 130, 230 may be made from a translucent or an opaque polyurethane material, a nitrile rubber copolymer material, or any other suitable material capable of flexing. ”, [0113]; “ the needle shield 700 may be colored to indicate to the user that the injection is completed. More specifically, when the injection cycle has been completed and the colored needle shield 712 is subsequently deployed to cover the exposed injection needle, the deployed, colored needle shield 700 indicates to the user that the injection is completed. ”, [0139]). Regarding claims 16 and 18, Fenster discloses all the limitations of claim 15. Fenster further discloses the needle shield indicator accessory wherein the needle shield indicator includes a feedback component configured to provide the user feedback when the injector needle shield is in the retracted position, wherein the feedback component provides the user with a visual indicator, when the injector needle shield is in the retracted position (the color of shield 712 is being interpreted as a feedback component capable of providing the user with a visual indicator when shield 712 is retracted, see Fig. 1A-1B and [0139]; “ when the injection cycle has been completed and the colored needle shield 712 is subsequently deployed to cover the exposed injection needle, the deployed, colored needle shield 700 indicates to the user that the injection is completed. ”; the lack of color present can be interpreted as a visual indication that the needle shield 712 is retracted, or not deployed). Regarding claim 17, Fenster discloses all the limitations of claim 16. Fenster further discloses the needle shield indicator accessory wherein the feedback component is movable between a first position and a second position (the color on shield 712 is capable of moving being a deployed and not deployed position, [0111] and [0138]-[0139] & Fig. 1A-1B). Regarding claim s 21 -22 , Fenster discloses all the limitations of claim 15. Fenster further discloses the needle shield indicator accessory wherein the needle shield indicator includes a contact surface configured to contact the user ( second end surface 136 surface of SMF 130 is configured to contact skin, [0112]-[0113] & Fig. 1A-2B) , wherein the contact surface is movable between an extended position and a retracted position (surface 136 is configured to move between a compressed/flattened position and an uncompressed position, see Fig. 1A-1B) , and wherein the retracted position of the contact surface corresponds with the retracted position of the injector needle shield (the compressed position of surface 136 corresponds to the retracted position of shield 712, see Fig.1A-1B and 12A-12C), and wherein the contact surface is configured to trigger the feedback component when the contact surface is in the retracted position (surface 136 can be interpreted as triggering the color of shield 712 to no longer be visible as the compression of surface 136 allows for shield 712 to retract, [011 0 ]-[0114] and [0139] & Fig. 1A-1B). Regarding claims 23, Fenster discloses all the limitations of claim 15. Fenster further discloses the needle shield indicator accessory wherein the accessory body includes a distal portion having a diameter significantly larger than a diameter of the injector needle shield (side surface 138 of the outer body of SMF 130 is flared outwardly, [0113] & Fig. 2B; the diameter of the distal portion of surface 138 is seen having a larger diameter than a diameter of shield 712/112, see Fig. 1A-1B) . Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Plambech ( US-20220288318-A1 ), Gonzales ( US-20050222539-A1 ), Bitar ( US-20160129198-A1 ), Bitar ‘930 ( US-20160106930-A1 ), Cabiri ( US-20180311437-A1 ), Liversidge ( WO-2009095701-A1 ), and Basbach ( WO-2021198364-A1 ). Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT MARTIN ADAM RADOMSKI whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-2703 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday: 7:30-4:30 CT . 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, FILLIN "SPE Name?" \* MERGEFORMAT Kevin Sirmons can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-4965 . 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. /MARTIN A RADOMSKI/ Examiner, Art Unit 3783 /EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783