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. REQUIREMENT FOR UNITY OF INVENTION As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art. The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e). When Claims Are Directed to Multiple Categories of Inventions: As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories: (1) A product and a process specially adapted for the manufacture of said product; or (2) A product and a process of use of said product; or (3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or (4) A process and an apparatus or means specifically designed for carrying out the said process; or (5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process. Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c). Restriction is required under 35 U.S.C. 121 and 372. This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1. In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted. Group I , claim(s) 1-11 , drawn to a fluid delivery device . Group II , claim(s) 12-15 , drawn to a system . Group III, claim(s) 16-17, drawn to a vial adapter. Group IV, claim(s) 18-19, drawn to a vial adapter. The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a fluid delivery device comprising: a reservoir configured to carry medicament; an insertion mechanism that delivers medicament to a patient , this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Yodfat (US 2010/0145276 A1) . Yodfat teaches a fluid delivery device (figure 11b) comprising: a reservoir 220 configured to carry medicament; an insertion mechanism 404 that delivers medicament to a patient. Groups I and III lack unity of invention because the groups do not share the same or corresponding technical feature. Groups I and IV lack unity of invention because the groups do not share the same or corresponding technical feature. Groups II and III lack unity of invention because the groups do not share the same or corresponding technical feature. Groups II and IV lack unity of invention because the groups do not share the same or corresponding technical feature. Groups III and IV lack unity of invention because the groups do not share the same or corresponding technical feature. During a telephone conversation with Jomy Methipara on 3/10/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-11. Affirmation of this election must be made by applicant in replying to this Office action. Claims 12-19 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Applicant is advised that the reply to this requirement to be complete must include ( i ) an election of a species or invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention. The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species. Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention. Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17( i ). The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined. In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01. Information Disclosure Statement The information disclosure statement filed 11/30/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. 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. Regarding claim 9, the recitation of “at least two check valves in the fluid path” renders the claim indefinite because the original disclosure discloses element 170 being a part of vial connector system in paragraph 0042, lines 4-5 (“The check valve 170 of the vial connector system”). However, claim 9 requires two check valves in the fluid path which is a path between the reservoir and the insertion mechanism as claimed in claim 1. Therefore, the claim is unclear regarding how the valve 170 could be in the vial connector system and the fluid path at the same time. For examination purposes, examiner construes that if the valve is controlling a flow in the fluid path then the valve is construed as being present in the fluid path. 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. Claims 1 , 2 and 7-9 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Weston (US 5,480,381). Regarding claim 1, Weston teaches a fluid delivery device (figure 1) comprising: a reservoir 31 configured to carry medicament; an insertion mechanism 20 that delivers medicament to a patient (column 5, lines 56-59), a vial connector system (see “VS” in figure 1 below) configured to engage and disengage a vial 16 for filling of the medicament into the reservoir 31; and a fluid path (path being construed as hollow portion from an end of element 7 that is closest to element 20 in figure 2 to element 20) establishing fluid communication between the reservoir 31 and the insertion mechanism (integrated structure formed by elements 19 and 20 ) ; wherein the vial connector system (see portion of the device marked by element “VS” in figure 1 below) is disposed in the fluid path between the reservoir and the insertion mechanism. Regarding claim 2, Weston teaches wherein the vial connector system (see “VS” in figure 1 above) includes retaining features (see “R” in figure 1 above) for mating with the vial 16 . Regarding claim 7, Weston teaches wherein the vial connector system includes a check valve 18 to prevent the vial connector system from dispensing the medicament. Regarding claim 8, Weston teaches wherein the insertion mechanism 20 includes a check valve 19 to prevent the insertion mechanism from filling the reservoir. Regarding claim 9, Weston teaches further comprising at least two check valves 18, 19 in the fluid path to control the medicament flow during the filling and during operation. 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 3 , 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Weston (US 5,480,381) in view of Mijers et al. ( US 2020/0146939 A1 ) . Regarding claim 3, Weston discloses the claimed invention substantially as claimed, as set forth above in claim 1. Weston further discloses the vial connector system includes a needle (see “N” in figure 1 above) for filling the reservoir but is silent regarding a needle being a retractable needle . However , Mijers teaches a design of a transfer apparatus (figure 2 ) comprising a needle 8 being a retractable needle (due to extension of element 11, element 8 is construed as a retractable needle) for the purpose of covering the needle when the vial is not connected to the device thereby protecting the needle from accidents (paragraph 0046, lines 11-24). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the needle of Weston to incorporate a retractable needle as taught by Mijers for the purpose of covering the needle when the vial is not connected to the device thereby protecting the needle from accidents (paragraph 0046, lines 11-24). Regarding claim 4, Weston discloses the claimed invention substantially as claimed, as set forth above in claim 1. Weston is silent regarding wherein the vial connector system includes a safety cap for shielding the retractable needle. However, Mijers teaches wherein the vial connector system (figure 4) includes a safety cap 37 for shielding the retractable needle for the purpose of protecting the connector from impurities (paragraph 0050, lines 13-17). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the vial connector system of Weston to incorporate wherein the vial connector system includes a safety cap for shielding the retractable needle as taught by Mijers for the purpose of protecting the connector from impurities (paragraph 0050, lines 13-17). Regarding claim 6, Weston discloses the claimed invention substantially as claimed, as set forth above in claim 1. Weston is silent regarding wherein the retractable needle retracts automatically. However, Mijers teaches wherein the retractable needle 8 retracts automatically (paragraph 0046, lines 17-24) for the purpose of covering the needle when the vial is not connected to the device thereby protecting the needle from accidents (paragraph 0046, lines 11-24). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the needle of Weston to incorporate wherein the retractable needle retracts automatically as taught by Mijers for the purpose of covering the needle when the vial is not connected to the device thereby protecting the needle from accidents (paragraph 0046, lines 11-24). Claim s 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Weston (US 5,480,381) in view of Carilli (US 5,709,667) . Regarding claim 3, Weston discloses the claimed invention substantially as claimed, as set forth above in claim 1. Weston further discloses the vial connector system includes a needle (see “N” in figure 1 above) for filling the reservoir but is silent regarding a needle being a retractable needle. However, Carilli teaches a design of a needle protection system (figure 1) comprising a retractable needle 30 for the purpose of protecting the personnel from accidental stab (column 1, lines 16-20). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention before the effective filing of the claimed invention to modify the needle of Weston to incorporate a retractable needle as taught by Carilli for the purpose of protecting the personnel from accidental stab (column 1, lines 16-20). Regarding claim 5, Weston discloses the claimed invention substantially as claimed, as set forth above in claim 1. Weston is silent regarding wherein the retractable needle retracts manually. However, Carilli teaches wherein the retractable needle retracts manually (column 5, lines 14-17) for the purpose of protecting the personnel from accidental stab (column 1, lines 16-20). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the needle of Weston to incorporate wherein the retractable needle retracts manually as taught by Carilli for the purpose of protecting the personnel from accidental stab (column 1, lines 16-20). Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Weston (US 5,480,381) in view of Searle et al. (US 2016/0074587 A1) . Regarding claim 10, Weston discloses the claimed invention substantially as claimed, as set forth above in claim 1. Weston is silent regarding comprising a gyroscopic chip to provide orientation feedback of the fluid delivery device during filling operation. However, Searle teaches a design of a syringe with a vial connector (figure 13) comprising a gyroscopic chip to provide orientation feedback of the fluid delivery device during filling operation (paragraph 0057, lines 17-19) for the purpose of providing orientation information to perform an appropriate action such as air purge or filling operation (paragraph 0057, lines 17-19). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, to modify the fluid delivery device of Weston to incorporate a gyroscopic chip to provide orientation feedback of the fluid delivery device during filling operation as taught by Weston for the purpose of providing orientation information to perform an appropriate action such as air purge or filling operation (paragraph 0057, lines 17-19). Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Weston (US 5,480,381) in view of Dominiak et al. (US 5,478,211) . Regarding claim 11, Weston discloses the claimed invention substantially as claimed, as set forth above in claim 1. Weston further discloses a motor 4. Weston is silent regarding a motor including an H-bridge chip that allows the motor to change direction and generate a vacuum pressure for the filling operation. However, Dominiak teaches a design of an ambulatory infusion pump comprising motor including an H-bridge chip (column 24, lines 49-59) that allows the motor to change direction and generate a vacuum pressure for the filling operation (column 22, lines 62-67, change in direction and refilling is being taught and therefore, H-bridge chip is capable to generate vacuum) for the purpose of the purpose of using a well-known approach to drive the motor in an appropriate direction (column 24, line 49-59). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the motor of Weston to incorporate a motor including an H-bridge chip that allows the motor to change direction and generate a vacuum pressure for the filling operation as taught by Dominiak for the purpose of the purpose of using a well-known approach to drive the motor in an appropriate direction (column 24, line 49-59). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT NILAY J SHAH whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9689 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Thursday 8:00 AM-4:30 PM EST . 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 CHELSEA STINSON can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-1744 . 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. /NILAY J SHAH/ Primary Examiner, Art Unit 3783