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. Information Disclosure Statement The information disclosure statement (IDS) submitted on 10/19/2023 and 7/19/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Objections Claim(s) 1-14 is/are objected to because of the following informalities: In regards to claim 1, the term “a needle support” in line 2 should be changed to “a slidable needle support”. Claims 2-14 are objected to by virtue of depending on a n objected claim. Here, in claim 1, lines 3-4 recite an injection needle actuation mechanism configured to engage and slidably move the needle support. Later, in claim 1, ln 9 the claim recites “the slidable needle support” and similar recitations are made in dependent claim s 9 and 10. For purposes of clarity and consistency, the recitation in claim 1, line 2 is advised to be change to “a slidable needle support” to match that in claim 1, ln 9 and claim s 9 and 10. Appropriate correction is required. 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. Claims 3 , 7-9 , and 14 are 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 3 recites the limitation "a second arm" in ln 2. However, in contrast to claim 2, which claim 3 does not depend from, a first arm has not been recited for the spring. Thus, it is unclear how the spring can have a second arm without a first arm. For purposes of this examination, the phrase “a second arm” has been interpreted to mean “an arm”. Claim 7 recites the limitation "the radial cam" in ln 2. There is insufficient antecedent basis for this limitation in the claim. Claim 7 depends from claim 1, not claim 4 which recites a radial cam. Thus, it is unclear whether claim 7 is intended to depend from claim 1 or claim 4. For purposes of this examination, claim 7 has been interpreted to depend from claim 4. Claim s 8-9 are rejected by virtue of depending from a rejected base claim. Claim 14 recites the limitation "the needle orifice" in ln 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether the needle orifice is a portion of the needle (e.g. distal needle opening) and thus the stopper is connected to the needle or the needle orifice is an opening in the stopper wall that allows the needle to pass therethrough. For purposes of this examination, claim 14 has been interpreted to mean “wherein the skin contact wall portion comprises a needle orifice formed therethrough configured to allow the needle to pass therethrough between the extended and retracted positions.” 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. Claim(s) 1- 3 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Pananen et al (2022/0226567) . Regarding claim 1, Pananen et al discloses a drug delivery device (e.g. 100; Fig 1; P20) , including a delivery unit (e.g. 128; P42) comprising a subcutaneous delivery system including a needle support (184) , an injection needle (132) mounted on the needle support (e.g. Fig 5A-C) , and an injection needle actuation mechanism (124) configured to engage and slidably move the needle support from a retracted position (e.g. Fig 5a) where the injection needle is within a housing (102, 126) of the drug delivery device to an extended delivery position where the injection needle projects through a skin contact wall of the housing (e.g. Fig 5B; P23) , wherein the needle actuation mechanism comprises a slider-crank linkage mechanism comprising a crank rod (146) pivotally connected to the housing (via connection point 150; e.g. Figs 5A-C) , a connecting rod (188) pivotally connected to the crank rod (e.g. at pivot point 180; e.g. Figs 5A-C) and pivotally connected to the slidable needle support (e.g. at pivot point 192; e.g. Figs 5A-C) , and a spring (174) biasing the slider-crank linkage mechanism from a first retracted position prior to use where the needle is fully inserted within the housing towards an extended position for drug administration and further to a second retracted position after use (e.g. Figs 5A-C; P59-P61) . Regarding claim 2, Pananen et al discloses wherein the spring (174) is a torsion spring (P55) having a first arm (178) engaging a support structure of the housing (e.g. Figs 5A-C; where 178 engages arm 148 which is connected to the housing at end 182. Arm 148 is within the broadest reasonable interpretation of a support structure of the housing as art 148 is connected to the housing and supports an element, e.g. arm 206. Applicant is advised to further structurally define the scope of a support structure of the housing to distinguish Applicant’s claimed invention from Pananen et al) and a second arm (176) engaging the slider-crank linkage mechanism (e.g. Figs 5A-C; where 176 engages 146) . Regarding claim 3, Pananen et al discloses wherein the spring (174) is a tension or compression spring (P66; spring 177 can be a variety of spring types including tension or compression) engaging a support structure of the housing (e.g. Figs 5A-C; where 178 engages arm 148 which is connected to the housing at end 182. Arm 148 is within the broadest reasonable interpretation of a support structure of the housing as art 148 is connected to the housing and supports an element, e.g. arm 206. Applicant is advised to further structurally define the scope of a support structure of the housing to distinguish Applicant’s claimed invention from Pananen et al) and a n arm (176 ; see 112(b) discussion above ) engaging the crank rod (146) or connecting rod of the slider-crank linkage mechanism (e.g. Figs 5A-C). Claim(s) 1- 2, 4-6 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Dalanni et al (10569011) . Regarding claim 1, Dalanni et al discloses a drug delivery device (100; Fig 1-10) , including a delivery unit (e.g. 100) comprising a subcutaneous delivery system including a needle support (184 , 284 ) , an injection needle (174) mounted on the needle support (e.g. Fig 1; col 4, ln 36-43) , and an injection needle actuation mechanism (180, 280) configured to engage and slidably move the needle support from a retracted position where the injection needle is within a housing of the drug delivery device (e.g. col 4, lns 42-49; Fig 1-2) to an extended delivery position where the injection needle projects through a skin contact wall of the housing (e.g. e.g. col 4, lns 42-49; Fig 3-4) , wherein the needle actuation mechanism comprises a slider-crank linkage mechanism comprising a crank rod (183a, 283a) pivotally connected to the housing (via the torsion spring 181, 281; e.g. col 4, lns 51-53) , a connecting rod (183b, 283b) pivotally connected to the crank rod (e.g. col 4, lns 51-53; e.g. Figs 1, 3, 5 , 7-9 ) and pivotally connected to the slidable needle support (e.g. e.g. col 4, lns 51-53; e.g. 183b, 283b connected to 184 , 284; Figs 1, 3, 5, 7-9) , and a spring (1 81, 281 ) biasing the slider-crank linkage mechanism from a first retracted position prior to use where the needle is fully inserted within the housing towards an extended position for drug administration and further to a second retracted position after use (e.g. Figs 1-10; col 4, ln 40-col 5, lns 16; col 5, lns 34-col 6, ln 8 ) . Regarding claim 2, Dalanni et al discloses wherein the spring is a torsion spring (181, 281) having a first arm engaging a support structure of the housing (spring is connected to device housing, e.g. 102; see e.g. Fig 1 and 7) and a second arm engaging the slider-crank linkage mechanism (second arm engages 183a, 283a; e.g. col 4, lns 50-53; Fig 1, 3, 7) . Regarding claim 4, Dalanni et al discloses wherein the needle actuation mechanism further comprises a rotatable actuation disc (256, 257; Figs 7-9) having a radial cam (col 5, lns 54-63; Figs 7-9; where disk 256 has a rotating surface 257) including a blocking portion configured to hold the slider-crank linkage mechanism in the first retracted position (col 5, lns 54-63; where disk 256 has a rotating surface 257 and the block portion is the cylindrical surface that holds level 297 in the engage position for part of the rotation) , and a release portion configured to allow the slider-crank linkage mechanism to move (col 5, lns 54-63; where disk 256 has a rotating surface 257 and the release portion is the flat surface of 257 that allows lever 297 to rotate) . Regarding claim 5, Dalanni et al discloses wherein the actuation disc (256) is coupled to a pumping system of the drug delivery device (col 5, lns 54-63; where 256 is a drive wheel of the fluid drive mechanism 150) . Regarding claim 6, Dalanni et al discloses wherein the actuation disc is coupled to a rotor of a pump engine of the pumping system (col 5, lns 54-63; where 256 is a drive wheel of the fluid drive mechanism 150 and thus is a rotor a pump engine of a pumping system; see also col 3, lns 58-63 and Fig 1) . 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim s 10- 13 is/are FILLIN "Enter appropriate claim identification information" \* MERGEFORMAT rejected under 35 U.S.C. 103 as being unpatentable over Pananen et al, as applied to claim 1 above, in view of Lavi et al (2002/0055711). Pananen et al discloses the invention substantially as claimed except for expressly disclosing a stopper configured to stop the slideable needle support or slider-crank linkage mechanism in the extended position for drug administration, the stopper configured to be displaced to release the slider-crank linkage mechanism after use and removal of the drug delivery device. Lavi et al teaches that it is known to have a stopper (51; Figs 1, 7-9) configured to stop the slideable needle support (40 with pin 44) or slider-crank linkage mechanism in the extended position for drug administration ( P90; Fig 8 ) , the stopper configured to be displaced to release slideable needle support after use and removal of the drug delivery device ( P91; Fig 9 ) for the purpose of providing a locking feature to allow drug delivery to occur while preventing tampering with the device once delivery is complete (P93) . It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery insertion device as taught by Pananen et al with the stopper and pin as taught by Lavi et al for the purpose of a locking feature to allow drug delivery to occur while preventing tampering with the device once delivery is complete (P93) . In the modified device of Pananen et al the pin could be placed, e.g., on the slidable needle support 184 such that the stopper ’s pin engaging portion 54 would block proximal movement and maintain the needle in the extended position during delivery while connected to a patient as taught by Lavi et al . Regarding claims 11-12, in the modified device of Pananen et al in view of Lavi et al, Lavi further discloses that the stopper is pivotally connected to the housing via pivot coupling (53 connecting 51 to 20 via 27; Figs 7-9). Regarding claim 1 3, in the modified device of Pananen et al in view of Lavi et al, Lavi further discloses wherein the stopper (51) forms a skin contact wall portion configured to be in abutment against the skin of the patient during drug administration (Fig 8; where 56 contact tissue of body B) . Claim s 10-13 is/are FILLIN "Enter appropriate claim identification information" \* MERGEFORMAT rejected under 35 U.S.C. 103 as being unpatentable over Dilanni et al, as applied to claim 1 above, in view of Lavi et al (2002/0055711). Dilanni et al discloses the invention substantially as claimed except for expressly disclosing a stopper configured to stop the slideable needle support or slider-crank linkage mechanism in the extended position for drug administration, the stopper configured to be displaced to release the slider-crank linkage mechanism after use and removal of the drug delivery device. Lavi et al teaches that it is known to have a stopper (51; Figs 1, 7-9) configured to stop the slideable needle support (40 with pin 44) or slider-crank linkage mechanism in the extended position for drug administration (P90; Fig 8) , the stopper configured to be displaced to release slideable needle support after use and removal of the drug delivery device (P91; Fig 9) for the purpose of providing a locking feature to allow drug delivery to occur while preventing tampering with the device once delivery is complete (P93). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery insertion device as taught by Dilanni et al with the stopper and pin as taught by Lavi et al for the purpose of a locking feature to allow drug delivery to occur while preventing tampering with the device once delivery is complete (P93). In the modified device of Dilanni et al the pin could be placed, e.g., on the slidable needle support 184 such that the stopper’s pin engaging portion 54 would block proximal movement and maintain the needle in the extended position during delivery while connected to a patient as taught by Lavi et al. Regarding claims 11-12, in the modified device of Dilanni et al in view of Lavi et al, Lavi further discloses that the stopper is pivotally connected to the housing via pivot coupling (53 connecting 51 to 20 via 27; Figs 7-9). Regarding claim 13, in the modified device of Dilanni et al in view of Lavi et al, Lavi further discloses wherein the stopper (51) forms a skin contact wall portion configured to be in abutment against the skin of the patient during drug administration (Fig 8; where 56 contact tissue of body B) . Allowable Subject Matter Claims 7-9 and 14 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. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 894 Form. Careful review is advised. Specifically: Insertion d evices utilizing linkages: 2016/ 0 339179 (e.g. Figs 15-19); WO2008/065646 ; 2008/0208139; 2019/0160225. Disc shaped actuation mechanisms: 2016/0184512 (e.g. disc 302 with cam 305c engaging 10b of actuator; Figs 17a-19); 2016/0199590; 2016/0213837; 9610402; 2019/0117880; 2021/0369957, 20200023122. To expedite prosecution in the event the applicant has any questions or proposed claim amendments to discuss the applicant is invited to contact the examiner at the telephone number listed below. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Andrew M. Gilbert whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-7216 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 9:00 am - 5:30 pm (EST), Monday - Friday . 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 , Thomas Barrett can be reached at 571-272-4726 . 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. /ANDREW M GILBERT/ Primary Examiner, Art Unit 3700