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. Response to Amendment This office action is responsive to the preliminary amendment filed on May 17, 2023 . As directed by the amendment: no claims have been amended, no claims have been added, no claims have been canceled. Thus claims 1-13 are presently pending in this application. Applicant’s amendment to the Specification has been entered in the original disclosure, as no substantial information has been added to the specification . Information Disclosure Statement The information disclosure statement (IDS) submitted on May 17, 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The information disclosure statement (IDS) submitted on June 11, 2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The information disclosure statement (IDS) submitted on March 5, 2026 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 9 recites the limitation "the adhesive pad". There is insufficient antecedent basis for this limitation in the claim. There is no prior recitation of the adhesive pad; however, claim 8, which claim 9 depends from, instead defines an adhesive layer. For examining purposes, “the adhesive pad” is interpreted to depend from the “adhesive layer”. 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. (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 1 and 4-6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cabiri et al. (US 20190381239) , hereinafter Cabiri . Regarding claim 1, Cabiri discloses a drug delivery device (device of Fig. 6) comprising: a housing (Fig. 6, housing of device) having a top surface (Annotated Fig. 6, top housing surface) and a bottom surface (Annotated Fig. 6, bottom housing surface); a container received within the housing (Fig. 3 and [0103, 0148], medicine reservoir, received within housing, visible through window 316b of housing) , the container configured to receive a medicament ([0148], reservoir is preloaded with medicine), the container comprising a stopper configured to move within the container ([0103, 0148-0149], plunger slidably located within proximal opening of reservoir syringe); a drive assembly configured to move the stopper ([0144-0147], internally powered driver moves plunger) ; a needle having a retracted position where the needle is positioned within the housing ([0139], needle wherein the needle driver has retracted state wherein needle is retracted into the housing) and an extended position where a portion of the needle protrudes from the housing ([0138]), needle has an active state wherein its tip extends out of the housing ; a needle shield (Fig. 6, needle cover 609a) secured to the housing and receiving a portion of the needle (Fig. 6 and 10, and [0117], needle cover 609a attaches to housing at opening 619 and covers the needle); and an adhesive assembly comprising an adhesive layer (Fig. 6, adhesive surface 612) secured to the bottom surface of the housing (Annotated Fig. 6, adhesive surface 612 secured to bottom housing surface) and a liner (Fig. 6, liner 609b) secured to the adhesive layer (Fig. 6, 10, and [0116], liner 609b attaches to adhesive surface 612) , the liner configured to be removed from the adhesive layer ([0116], liner 609b configured to be removed from adhesive surface 612), the liner comprises one of a protrusion and a liner opening (Annotated Fig. 6, liner opening) and the needle shield comprises the other of the protrusion and the liner opening (Fig. 6, needle cover 609a comprises protrusion with handle 610), the protrusion is received by the liner opening to secure the liner to the needle shield (Annotated Fig. 6, protrusion/handle 610 extends through liner opening to secure liner 609b to needle cover 609a), wherein the liner is configured to be separated from the adhesive layer upon removal of the needle shield from the housing (Fig. 6 and [0116, 0141], needle cover 609a and liner 609b are a unit configured to be removed from the delivery device together). Annotated Fig. 6 of Cabiri Regarding claim 4, Cabiri discloses the device of claim 1, wherein the liner comprises a main body (Annotated Fig. 6, liner 609b main body) covering at least a portion of the adhesive layer (Annotated Fig. 6 and [0011], main body aligns with and covers adhesive surface 612) and an extension portion extending from the main body (Annotated Fig. 6, Liner 609b extension portion), the extension portion of the liner comprises one of the protrusion and the liner opening (Annotated Fig. 6, extension portion contains liner opening). Regarding claim 5, Cabiri discloses the device of claim 4, wherein the needle shield is positioned between the main body of the liner and the extension portion of the liner (Annotated Fig. 6B, a portion of needle shield 609a extends between main body and extension portion). Regarding claim 6, Cabiri discloses the device of claim 4, wherein the main body of the liner entirely covers the adhesive layer (Annotated Fig. 6 and [0011], main body aligns with and covers the entirety of adhesive surface 612) . Claim s 1-2, 4, 6, 8, 10, and 12 are rejected under 35 U.S.C. 102(a)( 1 ) as being anticipated by Shermer et al. (US 7250037) , hereinafter Shermer. Regarding claim 1, Shermer discloses a drug delivery device (Fig. 1, device 1000) comprising: a housing (Fig. 1, housings 110/210) having a top surface (Fig. 1, top housing 110 surface) and a bottom surface (Fig. 1-2, bottom housing 210 surface) ; a container received within the housing (Fig. 6, 10A, and 12, reservoir 100), the container configured to receive a medicament (Fig. 12 and Col.9:19-38, reservoir 100 receives a fluid drug), the container comprising a stopper (Fig. 10A, reservoir 100 contains disk-shaped Belleville spring 130) configured to move within the container (Fig. 6 and Col. 12:49-59, fingers of spring 130 are configured to move within reservoir to drive fluid expulsion); a drive assembly configured to move the stopper (Fig. 10A and Col 11:65-Col.12:3; Col.12:49-52, pin 140 which controls the activation/movement of spring 130) ; a needle (Fig. 6, needle 222) having a retracted position where the needle is positioned within the housing (Fig. 6, needle 222 retracted in housing 210) and an extended position where a portion of the needle protrudes from the housing (Fig. 11C, needle 222 extended through housing 210); a needle shield (Fig. 10B, needle cap 240) secured to the housing and receiving a portion of the needle (Fig. 11A, needle cap 240 secured to housing 210 and receiving needle 222); and an adhesive assembly (Fig. 2, adhesive assembly 250/260) comprising an adhesive layer secured to the bottom surface of the housing (Fig. 2, adhesive layer 250 secured to bottom housing 210) and a liner secured to the adhesive layer (Fig. 2 and Col. 6:16-19, liner comprising removable film and removable member 262 of pull handle 260), the liner configured to be removed from the adhesive layer (Fig. 11B and Col. 6:16-19, liner configured to be removed from adhesive layer 250) , the liner comprises one of a protrusion and a liner opening (Fig. 2 and 11B, liner comprises a protrusion which extends from member 262) and the needle shield comprises the other of the protrusion and the liner opening (Fig. 2, 10C, and 11B, needle shield 240 comprises an opening on its flexible member 242), the protrusion is received by the liner opening to secure the liner to the needle shield (Fig. 2 and 10B and Cl. 24:9-13, protrusion of member 262 is received by opening of flexible member 242 to secure liner to needle shield 240) , wherein the liner is configured to be separated from the adhesive layer upon removal of the needle shield from the housing (Fig. 11B and [46-54], liner is removed from adhesive layer 250 at same time needle cap 240 is removed from needle 222/housing 210). Regarding claim 2, Shermer discloses the device of claim 1. wherein the liner comprises the protrusion (Fig. 2 and 11B, liner comprises a protrusion which extends from member 262) and the needle shield comprises the liner opening (Fig. 2, 10C, and 11B, needle shield 240 comprises an opening on its flexible member 242) . Regarding claim 4, Shermer discloses the device of claim 1, wherein the liner comprises a main body covering at least a portion of the adhesive layer (Fig. 2 and Col. 6:16-19, removable film portion of liner, which covers the entirety of adhesive layer 250) and an extension portion extending from the main body (Fig. 2 and Col. 6:16-19, removable member 262 of liner, which covers and extends from outer surface of removable liner) , the extension portion of the liner comprises one of the protrusion and the liner opening (Fig. 2 and 11B, protrusion extends from member 262). Regarding claim 6, Shermer discloses the device of claim 4, wherein the main body of the liner entirely covers the adhesive layer (Fig. 2 and Col. 6:16-19, removable film covers the entirety of adhesive layer 250) . Regarding claim 8, Shermer discloses an adhesive assembly for a drug delivery device (Fig. 2, adhesive assembly 250/206 of device 1000) comprising a housing (Fig. 1, housings 110/210) , a needle (Fig. 6, needle 222) having a retracted position where the needle is positioned within the housing (Fig. 6, needle 222 retracted in housing 210) and an extended position where a portion of the needle protrudes from the housing (Fig. 11C, needle 222 extended through housing 210) , and a needle shield (Fig. 10B, needle cap 240) secured to the housing and receiving a portion of the needle (Fig. 11A, needle cap 240 secured to housing 210 and receiving needle 222) , the adhesive assembly comprising: an adhesive layer configured to be secured to a bottom surface of the housing (Fig. 2, adhesive layer 250 secured to bottom housing 210) ; and a liner secured to the adhesive layer (Fig. 2 and Col. 6:16-19, liner comprising removable film and removable member 262 of pull handle 260) , the liner is configured to be removed from the adhesive layer (Fig. 11B and Col. 6:16-19, liner configured to be removed from adhesive layer 250) , the liner comprises a protrusion (Fig. 2 and 11B, liner comprises a protrusion which extends from member 262) configured to be received by a liner opening defined by the needle shield (Fig. 2 and 10B and Cl. 24:9-13, protrusion of member 262 is received by opening of flexible member 242 on needle shield 240 to secure liner to needle shield 240) , wherein the liner is configured to be separated from the adhesive layer upon removal of the needle shield from the housing (Fig. 11B and [46-54], liner is removed from adhesive layer 250 at same time needle cap 240 is removed from needle 222/housing 210) . Regarding claim 10, Shermer discloses the assembly of claim 8, wherein the liner comprises a main body covering at least a portion of the adhesive layer (Fig. 2 and Col. 6:16-19, removable film portion of liner, which covers the entirety of adhesive layer 250) and an extension portion extending from the main body (Fig. 2 and Col. 6:16-19, removable member 262 of liner, which covers and extends from outer surface of removable liner) , the protrusion positioned on the extension portion of the liner (Fig. 2 and 11B, protrusion extends from member 262) . Regarding claim 12, Shermer discloses the assembly of claim 10, wherein the main body of the liner entirely covers the adhesive layer (Fig. 2 and Col. 6:16-19, removable film covers the entirety of adhesive layer 250) . 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. Claims 7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Shermer (US 7250037), in view of Halac et al. (US 20190117133), hereinafter Halac. Regarding claim 7, Shermer discloses device of claim 1, as explained above. Shermer further discloses that protrusion of member 262 and the opening on flexible member 242 causes the pull handle 260 and needle cap 240 to be interlocked (Fig. 2 and Col. 6:63-66). Shermer does not expressly disclose wherein the protrusion and the liner opening form a snap-fit. However, Halac discloses wherein the protrusion and the liner opening form a snap-fit (Fig. 14C and [0282], anchoring features between components may be snap-fit features). It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Shermer to incorporate the disclosures of Halac and modify the interlock between the protrusion and the liner opening to form a snap-fit. Doing so would provide an anchoring/interlocking feature which secures and aligns the components during manufacturing (Halac, [0217, 0282]). Regarding claim 13, Shermer discloses device of claim 8, as explained above. Shermer further discloses that protrusion of member 262 and the opening on flexible member 242 causes the pull handle 260 and needle cap 240 to be interlocked (Fig. 2 and Col. 6:63-66). Shermer does not expressly disclose wherein the protrusion and the liner opening form a snap-fit. However, Halac discloses wherein the protrusion and the liner opening form a snap-fit (Fig. 14C and [0282], anchoring features between components may be snap-fit features). It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Shermer to incorporate the disclosures of Halac and modify the interlock between the protrusion and the liner opening to form a snap-fit. Doing so would provide an anchoring/interlocking feature which secures and aligns the components during manufacturing (Halac, [0217, 0282]). Allowable Subject Matter Claims 3 and 11 are 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. Claim 9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 3 , Shermer discloses the device of claim 2 . Shermer is silent to wherein the liner and the adhesive layer define a clearance opening that receives a portion of the protrusion . No reference was found that would have made it obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Shermer to satisfy these limitations in combination with the previously stated limitations of claim 2, which claim 3 depends from . Regarding claim 9 , Shermer discloses the device of claim 8 . Shermer is silent to wherein the liner and the adhesive pad define a clearance opening that receives a portion of the protrusion . No reference was found that would have made it obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Shermer to satisfy these limitations in combination with the previously stated limitations of claim 8, which claim 9 depends from . Regarding claim 11 , Shermer discloses the device of claim 10 . Shermer is silent to wherein the liner comprises a folding line separating the main body of the liner from the extension portion of the liner, the extension portion of the liner configured to be folded relative to the main body of the liner about the folding line. No reference was found that would have made it obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Shermer to satisfy these limitations in combination with the previously stated limitations of claim 10, which claim 11 depends from . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SARAH D GRASMEDER whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0258 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8 am-5 pm EST . 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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. /SARAH DYMPNA GRASMEDER/ Examiner, Art Unit 3783 /BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783