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
The amendment filed 6/30/2026 has been entered. Claims 1-4, 7-10, 12-13, 15-18, 22-24, and 26-27 are pending in the application. Applicant’s amendments to the Specification and Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 4/1/2026.
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 and 22 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 (protrusions 142 configured to selectively couple SMF 130 to autoinjector 100, [0115] & Fig. 2B); and
a needle shield indicator configured to indicate to a user whether an injector needle shield is in a retracted position or in an extended 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 or an extended position, as SMF 130 is fully stretched when shield 712 is retracted and the color would not be visible and SMF 130 is not stretched when shield 712 is extended and the color would 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]; “the needle shield 112 may extend slightly past the front end wall 122 of the AI housing 110 and be adapted to operate as a trigger to arm the activation and drive control unit 108 when the needle shield 112 is depressed by contact with the skin.”, [0111]), 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 relative to the accessory body (surface 136 is configured to move between a compressed/flattened position and an uncompressed position relative to protrusions 142, see Fig. 1A-1B), 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; “the needle shield 112 may extend slightly past the front end wall 122 of the AI housing 110 and be adapted to operate as a trigger to arm the activation and drive control unit 108 when the needle shield 112 is depressed by contact with the skin”, [0111]; the needle shield is configured to retract) and the extended position of the contact surface corresponds with the extended position of the injector needle shield (the uncompressed position of surface 136 corresponds to the extended position of shield 712, see Fig.1A-1B and 12A-12C; the needle shield is configured to extend and is initially in an extended position, [0111] and [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 22, Fenster discloses all the limitations of claim 16. Fenster further discloses the needle shield indicator accessory 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, [0110]-[0114] and [0139] & Fig. 1A-1B).
Claim(s) 15-18 and 22-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dasbach (US 20230146367 A1).
Regarding claim 15, Dasbach discloses a needle shield indicator accessory for a drug delivery device (patch 20, abstract and [0086] & Fig. 7-9), comprising: an accessory body configured to be selectively coupled with an injector housing (housing 22 configured to couple to injector 10, [0086] & Fig. 7-9; also see [0073] and [0079] & Fig. 3); and a needle shield indicator configured to indicate to a user whether an injector needle shield is in a retracted position or in an extended position (rupturing element 27, support member 30, and fluid reservoir 23 are being interpreted as a needle shield indicator, [0086]-[0088] & Fig. 7-9; element 27, member 30, and reservoir 23 are configured to release fluid from reservoir 23 when needle sleeve 19 of injector 10 is in a retracted position, which is being interpreted as indicating to a user that sleeve 19 is retracted, [0067-[0068], [0071], [0084], [0093]-[0095] & Fig. 1B and 7-9; fluid is not released until sleeve 19 is retracted, the absence of fluid release may be interpreted as an indication to a user that sleeve 19 is extended),
wherein the needle shield indicator includes a contact surface configured to contact the user (rupturing element 27 including an adhesive 35 configured to adhere to the skin of a patient, [0090] & Fig. 7-9), wherein the contact surface is movable between an extended position and a retracted position relative to the accessory body (rupturing element 27 configured to move between an initial position (Fig. 7) to an activated position (Fig. 8) relative to housing 22, [0089]), wherein the retracted position of the contact surface corresponds with the retracted position of the injector needle shield and the extended position of the contact surface corresponds with the extended position of the injector needle shield (activated position shown in Fig. 8 corresponds with a retracted position of sleeve 19 as injector 10 has been positioned in aperture 24 and depressed against the skin, [0093]; initial position shown in Fig. 7 corresponds with a extended position of sleeve 19 as injector 10 has not been positioned in aperture 24 and depressed against the skin yet, [0091]-[0094]).
Regarding claims 16 and 18, Dasbach discloses all the limitations of claim 15. Dasbach 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) a visual indicator or (c) a haptic indicator, when the injector needle shield is in the retracted position (the fluid in fluid reservoir 23 is being interpreted as a feedback component, [0084], [0086], and [0093]-[0094] & Fig. 7-9; when sleeve 19 retracts after injector 10 is pressed down on patch 20 (activated position Fig. 8), cool/hot fluid is released, which is may be interpreted as providing a visual or haptic indication to the user, [0093] and [0084]).
Regarding claim 17, Dasbach discloses all the limitations of claim 16. Dasbach discloses the needle shield indicator accessory wherein the feedback component is movable between a first position and a second position (the fluid in reservoir 23 is movable from reservoir 23 to outside of reservoir 23, [0084] and [0093]-[0094] & Fig. 7-9).
Regarding claim 22, Dasbach discloses all the limitations of claim 16. Dasbach discloses the needle shield indicator accessory wherein the contact surface is configured to trigger the feedback component when the contact surface is in the retracted position (rupturing element 27 triggers the fluid from reservoir 23 when rupturing element is in the activated position of Fig. 8, [0093]-[0094]).
Regarding claim 23, Dasbach discloses all the limitations of claim 15. Dasbach 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 (housing 22 having a distal edge having a diameter significantly larger than a diameter of sleeve 19, see Fig. 3).
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) 24 and 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dasbach (US 20230146367 A1) as applied to claim 15 above, and further in view of Tsals (US 20030229308 A1).
Regarding claims 24 and 26-27, Dasbach discloses all the limitations of claim 15. However, Dasbach fails to explicitly disclose the needle shield indicator accessory wherein the needle shield indicator includes an accessory reference feature, wherein the injector housing includes an injector reference feature, and wherein the accessory reference feature and the injector reference feature are aligned when the injector needle shield is in the retracted position, 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, and wherein the accessory reference feature is a cutout portion having a similar shape as the portion of the drug viewing window.
However, Tsals teaches a needle shield indicator accessory (injector adapter 20 for use with an automatic injector 10, [0032] and [0034]& Fig. 1-4) 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]; when injector 10 is coupled to adapter 20, the needle shield 11 is in a retracted position, [0036]-[0039] & Fig. 1-4), and 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).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Dasbach with Tsals to include an accessory reference feature, wherein the injector housing includes an injector reference feature, and wherein the accessory reference feature and the injector reference feature are aligned when the injector needle shield is in the retracted position, 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, and wherein the accessory reference feature is a cutout portion having a similar shape as the portion of the drug viewing window, since such a modification would provide a window to provide visual access to the user during the injection process to permit the user to know the level of drug still within the injector, provide structure to help couple the injector to the patch, and permit visual access to other portions of the injector when it is engaged with the patch (see [0039] of Tsals).
As modified, patch 20 of Dasbach would include receiving portion 24, including cutout 34A and 34B, of Tsals and injector 10 of Dasbach would include a drug viewing window 19 of Tsals.
Response to Arguments
Applicant's arguments filed 6/30/2026 have been fully considered but they are not persuasive. In response to Applicant’s arguments that after injection is complete, the retracted position of the second surface 136 (compressed) corresponds to an extended position of the needle shield 712 (deployed), the Examiner finds that once autoinjector 100 is removed, needle shield 712 returns to an extended position and the compressive force is no longer present on SMF 130. SMF 130 would return to an uncompressed position (see [0111] and [0139] of Fenster).
In response to Applicant’s arguments that that prior to injection, the injector needle shield 112 is in a retracted position while the second surface 136 of the SMF 130 is in an extended position, the Examiner finds that “the needle shield 112 may extend slightly past the front end wall 122 of the AI housing 110 and be adapted to operate as a trigger to arm the activation and drive control unit 108 when the needle shield 112 is depressed by contact with the skin.” ([0111]). Needle shield 112 is initially in an extended position prior to injection, as is SMF 130.
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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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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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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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