CTNF 18/885,880 CTNF 98040 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 12/11/2025 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 § 102 07-06 AIA 15-10-15 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. 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1, 2, 3, 4, 6, 9, 10, 11, and 12 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Wise et al. US 2023/0277757 A1 (hereinafter Wise), as cited in the IDS . Regarding claim 1 , Wise discloses an infusion adapter 200 (Fig. 2A – drug product delivery apparatus 200) for connection with an infusion fluid container 292 (Fig. 2D – saline source 292) , the infusion adapter 200 (Fig. 2A) comprising: a connection spike 230 (Fig. 2A – saline port 230) positioned at a first end of the infusion adapter 200 (Fig. 2A – saline port 230 is on the left-hand side of apparatus 200) , the connection spike 230 (Fig. 2A) having a main spike portion 232 (Fig. 2B – second end 232) and a puncturing point 231 (Fig. 2B – first end 231) configured to engage an injection port (see annotated Fig. 2D below) of an infusion fluid container 292 (Fig. 2D) ; a connection stick 280 (Fig. 2A – vial adapter 280) positioned at a second end of the infusion adapter 200 (Fig. 2A – vial adapter is on the right-hand side of apparatus 200) and arranged orthogonal to the connection spike 230 (Fig. 2A-2B), the connection stick 280 (Fig. 2A-2C) comprising a locking mechanism 280 (Fig. 2B-2C) including a biasing member B (see annotated Fig. 2A below) and an engagement member E (see annotated Fig. 2A below) , with the locking mechanism 280 (Fig. 2A) configured to connect to an external component 294 (Fig. 2D – vial 294) via a push-type engagement (Fig. 2D-2F – friction fit) ; and a joining member 210+240 (Fig. 2A – central interface member 210 and drug product port 240) connecting the connection spike 230 (Fig. 2A-2B, and Par. 60 – “ The second end 232 of the saline port 230 is coupled to the second access point 216b of the central interface member 210 ”) to the connection stick 280 (Fig. 2A-2B, and Par. 63 – “ The second end 242 of the drug product port 240 is coupled to the third access point 216c of the central interface member 210 ”) in the orthogonal arrangement (Fig. 2A-2B) , the joining member 210+240 integrally formed with the connection spike 230 (Fig. 2B) and the connection stick 280 (Fig. 2B) ; wherein a fluid path 250+260+270 (Fig. 2B-2C – first passageway 250, second passageway 260, and movable conduit 270) is formed through the joining member 210+240 (Fig. 2A) , the connection spike 230 (Fig. 2B) , and the connection stick 280 (Fig. 2B) , extending from the first end to the second end (Fig. 2B-2C – fluid path 250+260+270 is formed depending on the arrangement of control member 290) , to provide for a transfer of fluid injected from the second end to the first end (Fig. 2E – product is capable of transferring form the right side to the left side) . PNG media_image1.png 736 804 media_image1.png Greyscale Annotated Fig. 2A of Wise PNG media_image2.png 907 772 media_image2.png Greyscale Annotated Fig. 2D of Wise Regarding claim 2 , Wise discloses the invention of claim 1 . Wise further discloses wherein the biasing member B (see annotated Fig. 2A above) comprises a pair of cantilever arms (see annotated Fig. 2A above – each engagement member B is a cantilever arm) and the engagement member E (see annotated Fig. 2A above) comprises a projection extending radially outwards from each of the cantilever arms (see annotated Fig. 2A above – each cantilever arm of engagement member B extends radially outward to form a projection) , the pair of cantilever arms (see annotated Fig. 2A above) configured to deflect radially inward during engagement of the connection stick 280 (Fig. 2A) to the external component (Fig. 2F – the cantilever arms are capable of deflect inwardly because they have to flex/deflect to an extent to receive the cap and shoulder of the vial) . Regarding claim 3 , Wise discloses the invention of claim 2 . Wise further discloses wherein the joining member 210+240 (Fig. 2A) is structured as an L-shaped member (Fig. 2A-2F) and comprises a first segment 216b (Fig. 2B – second access point 216b) aligned with and joined to the connection spike 230 (Fig. 2B) ; and a second segment 216c (Fig. 2B – third access point 216c) aligned with and joined to the connection stick 280 (Fig. 2B) ; wherein the first segment 216b (Fig. 2B) and second segment 216c (Fig. 2B) are connected at a junction 214 (Fig. 2B – outer wall 214 of central interface member 210) . Regarding claim 4 , Wise discloses the invention of claim 3 . Wise further discloses wherein the connection spike 230 (Fig. 2A) comprises an end flange (see annotated Fig. 2E above) on an end thereof opposite the connection spike 230 (Fig. 2A) , and wherein the first segment 216b (Fig. 2B) comprises a central column (see annotated Fig. 2E above – the portion of saline port 230 below the flange) joined to the end flange (see annotated Fig. 2E above) , with the central column (see annotated Fig. 2E above) including a plurality of reinforcement ribs (see annotated Fig. 2E above) formed thereon that extend radially outward from the central column (see annotated Fig. 2E above – ribs surround the left and right sides of the central column) , the reinforcement ribs (see annotated Fig. 2E above) increasing a mechanical strength a connection between the joining member 210+240 (Fig. 2A) and the connection spike 230 (see annotated Fig. 2E above – the annotated ribs provide longitudinal reinforcement between port 230 and central interface member 210) . Regarding claim 6 , Wise discloses the invention of claim 4 . Wise further discloses wherein the first segment 216b (Fig. 2B) comprises a rest plate located along a length of the first segment 216b (Fig. 2A, and see annotated Fig. 2E above – the rest plate is the upper surface of the central interface member 210) between the plurality of reinforcement ribs (see annotated Fig. 2E above) and the junction 214 (Fig. 2B) , the rest plate (see annotated Fig. 2E above) oriented in parallel with the end flange (see annotated Fig. 2E above – rest plate is horizontally parallel with the flange) and spaced apart therefrom by a gap (see annotated Fig. 2E above – the spaced apart gap is the fluid line) provided by the central column (see annotated Fig. 2E above) and the plurality of reinforcement ribs (see annotated Fig. 2E above) . Regarding claim 9 , Wise discloses the invention of claim 3 . Wise further discloses wherein the second segment 216c (Fig. 2B) comprises an elongated portion 240 (Fig. 2B – drug product port 240) and a flanged divider (see annotated Fig. 2B below) , the elongated portion 240 (Fig. 2B) generally extending a full length of the second segment 216c (Fig. 2B) , with one end thereof joined with the first segment 216b (Fig. 2B) and another end thereof joined with the flanged divider (see annotated Fig. 2B below) . PNG media_image3.png 598 458 media_image3.png Greyscale Annotated Fig. 2B of Wise Regarding claim 10 , Wise discloses the invention of claim 9 . Wise further discloses wherein the flanged divider (see annotated Fig. 2B above) is affixed to the elongated portion 240 (Fig. 2B) on one face thereof and to the connection stick 280 (Fig. 2B) on an opposing face thereof (see annotated Fig. 2B above – the flange divider connects with the port 240 on the lower surface and with the adapter 280 on the upper surface ). Regarding claim 11 , Wise discloses the invention of claim 9 . Wise further discloses wherein the elongated portion 240 (Fig. 2B) comprises a tapered member that flares outward along a length thereof as the elongated portion 240 (Fig. 2B) extends from the end thereof joined with the first segment 216b (Fig. 2b) to the end thereof joined with the divider flange (see annotated Fig. 2B above – drug port 240 flares outwardly towards the annotated flanged divider) . Regarding claim 12 , Wise discloses the invention of claim 11 . Wise further discloses wherein a thickness of an outer wall of the elongated portion 240 (Fig. 2B) increases along the length thereof as the elongated portion 240 (Fig. 2B) extends from the end thereof joined with the first segment 216b (Fig. 2B) to the end thereof joined with the divider flange (see annotated Fig. 2B above – the cross-section shows an increasing width of port 240 towards the annotated flanged divider) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-20-02-aia AIA 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. 07-21-aia AIA Claim s 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Wise . Regarding claim 5 , Wise discloses the invention of claim 4 . Wise further discloses wherein the plurality of reinforcement ribs (see annotated Fig. 2E above) comprises a first rib and a second rib positioned on opposing sides of the central column (see annotated Fig. 2E above – the ribs are positioned left and right to the central column). However, Wise does not currently disclose with each of the first rib and the second rib having a wedge-shaped construction. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of Wise’s rib to be a wedge, as it is a matter of engineering design to configure the ribs in different ways, where the change in form or shape, without any new or unexpected result, is an obvious engineering design. See In re Dailey , 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04). Regarding claim 14 , Wise discloses the invention of claim 1 . However, Wise does not disclose wherein the infusion adapter comprises an integrally formed, molded adapter. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Wise to be integrally formed, since such modification would have involved making elements integral. Making elements integral is generally recognized as being within the level of ordinary skill in the art. In re Larson , 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) . 07-21-aia AIA Claim s 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Wise in view of Ou et al. US 2022/0395643 A1 (hereinafter Ou), as cited in the IDS . Regarding claim 7 , Wise discloses the invention of claim 6 . Wise further discloses wherein the infusion adapter comprises a spike cap positioned over the connection spike, to protect the puncturing point, and wherein the rest plate provides a datum for the spike cap, to ensure proper connection of the spike cap onto the connection spike. Ou, in the same field of endeavor of syringes (Par. 2), teaches wherein the infusion adapter comprises a spike cap 116 (Fig. 1 – end cap 116) positioned over the connection spike 112 (Fig. 1 – dispensing tip 112) , to protect the puncturing point (Par. 264, and Fig. 1 – the points where end cap 116 connects to the outer surface of dispensing tip 112) , and wherein the rest plate provides a datum for the spike cap 116 (Fig. 1 – the points where end cap 116 connects to the outer surface of dispensing tip 112) , to ensure proper connection of the spike cap 116 (Fig. 1) onto the connection spike 112 (Par. 264, and Fig. 1, when the components are connected as shown they ensure the proper connection as shown) . It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the adapter of Wise to further include a spike cap as taught by Ou, in order to cover and protect the dispensing tip. It is well-known in the art that such a medical device should remain sterilized during shipment and storage until usage. Regarding claim 8 , Wise in view of Ou discloses the invention of claim 7 . The combination further discloses wherein the gap (see annotated Fig. 2E of Wise above – the spaced apart gap is the fluid line) is sized to allow for entry of a sterilizing gas into an interior of the spike cap 116 (Fig. 1 of Ou, and Par. 278 – “ As a result, a sterilization gas (e.g., ethylene oxide) is able to pass through the micro-apertures 326, 328 and the membrane 335 for sterilizing inside the fluid chamber 305 ”) with the spike cap 116 (Fig. 1) positioned over the connection spike 230 (Fig. 2A of Wise) , so as to provide for sterilizing of the connection spike 230 (Fig. 2A of Wise) . Examiner notes that once the modification is made as discussed in claim 7 , the spike cap 116 of Ou is incorporated onto the connection spike 230 of Wise, including the apertures of the spike cap 116 . Thus, the combined device is capable of allowing an entry for sterilization gas as taught by Ou . 07-21-aia AIA Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wise in view of Lev et al. US 2017/0312175 A1 (hereinafter Lev), as cited in the IDS . Regarding claim 13 , Wise discloses the invention of claim 1 . However, Wise does not disclose wherein the connection stick comprises a membrane seat that retains a membrane therein, the membrane providing for a closed transfer of fluid when the connection stick is connected to the external component. Lev, in the same field of endeavor of drug transfer devices (Title), teaches wherein the connection stick 110 (Fig. 12 – drug transfer device 110) comprises a membrane seat 114 (Fig. 12 – sheath 114) that retains a membrane therein (Par. 83 – “ a sheath 114 which maintains sterile conditions during storage and for use as a sealing member ”) , the membrane providing for a closed transfer of fluid when the connection stick 110 (Fig. 12, and Par. 83) is connected to the external component 111 (Fig. 12 – liquid transfer member 111) . It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connection stick of Wise to further include a membrane seat as taught by Lev, in order to maintain sterile conditions during storage and for use as a sealing member for use with an external component (Par. 83 of Lev) . 07-21-aia AIA Claim s 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Wise in view of Hanner et al. US 2017/0087297 A1 (hereinafter Hanner), as cited in the IDS . Regarding claim 15 , Wise discloses the invention of claim 1 . Wise further discloses a fluid transfer system (Fig. 2D-2E shows a transfer system) comprising: an infusion fluid container 292 (Fig. 2D – saline source 292) containing an infusion fluid 296 (Fig. 2D-2E – IV administration set 296) therein, the infusion fluid container 292 (Fig. 2D) comprising a first port (see annotated Fig. 2E above – injection port) and a second port (see annotated Fig. 2E above – the other port next to the injection port of saline source 292) ; the infusion adapter 200 (Fig. 2A) of claim 1 (see rejection of claim 1 above) , with the connection spike 230 (Fig. 2A) engaged with the first port (see annotated Fig. 2E above) such that the infusion adapter 200 (Fig. 2A) is in fluid communication with the infusion fluid container 292 (Fig. 2A and Fig. 2D) ; and a vial assembly 294 (Fig. 2E – vial 294) coupled to the connection stick 280 (Fig. 2E) , the vial assembly 294 (Fig. 2E) comprising a pre-filled vial 294 (Fig. 2E) containing medication fluid and a vial adapter (Fig. 2D-2F – the neck end of vial 294) , with the connection stick 280 (Fig. 2E) engaged with the vial adapter (Fig. 2E – adapter 280 engaged with the neck of vial 294) . However, Wise does not disclose the ports each having a fluid barrier member therein; an intravenous tubing connected to the second port such that the intravenous tubing is in fluid communication with the infusion fluid container; and the syringe assembly coupled to the connection stick. Hanner, in the same field of infusion adapter (Title), teaches the ports 104, 108 (Fig. 13 – port 140, 108) each having a fluid barrier member 106, 110 (Fig. 13 – fluid barrier member 106, 110) therein; an intravenous tubing 120 (Fig. 13 – intravenous tubing 120) connected to the second port 104 (Fig. 13) such that the intravenous tubing 120 (Fig. 13) is in fluid communication with the infusion fluid container 102 (Fig. 13 – container 102) ; and the syringe assembly 130 (Fig. 13 – injector adapter member 130) coupled to the connection stick 16 (Fig. 13 – port 16 of infusion adapter 10) . It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Wise to have fluid barrier members, intravenous tubing, and the syringe assembly as taught by Hanner, in order to securely connecting an adapter to a drug bag for drug transfer procedure (Par. 3 of Hanner). Regarding claim 17 , Wise in view of Hanner discloses the invention of claim 15 . The combination further discloses wherein the syringe adapter 130 (Fig. 13 of Hanner) comprises a housing defining a cavity (Fig. 13 of Hanner – the cavity of adapter 130) within which the locking mechanism 280 (Fig. 2F of Wise) is received (Fig. 2F of Wise modified by Hanner – the cavity extending below the shoulders of the vial where the defined engagement portions and cantilevers are received) upon connection of the connection stick 280 (Fig. 2E of Wise) with the syringe adapter 130 (Fig. 13 of Hanner) . 07-22-aia AIA Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Wise in view of Hanner as applied to claim 15 above, and further in view of Kato et al. US 2021/0128411 A1 (hereinafter Kato) . Regarding claim 16 , Wise in view of Hanner discloses the invention of claim 15 . However, the combination does not disclose wherein the fluid barrier member comprises a rubber bung. Kato, in the same field of endeavor of drug solution preparation apparatus (Title), teaches wherein the fluid barrier member comprises a rubber bung (Fig. 1, and Par. 56 – “ a stopper body (e.g., a rubber stopper, not shown) ”) . It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the fluid barrier member of the combination that allows the device to remain sterile until usage, for the rubber bung of Kato, since these mechanisms perform the same function of covering the ports and keep the interior of the apparatus sterile. Simply substituting one barrier means for another would yield the predicable result of allowing a fluid transfer system to remain sterile. See MPEP 2143 . 07-22-aia AIA Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Wise in view of Hanner as applied to claim 15 above, and further in view of Lev . Regarding claim 18 , Wise in view of Hanner discloses the invention of claim 17 . The combination wherein the syringe adapter 130 (Fig. 13 of Hanner) configured to engage the connection stick 280 (Fig. 2E of Wise) upon connection of the syringe assembly 130 (Fig. 2E of Wise upon modification by Hanner) to the infusion adapter 200 (Fig. 2E of Wise) , However, the combination does not disclose the vial adapter comprises another membrane, the another membrane seated in the cavity of the housing and configured to engage the membrane of the connection stick; with the engaging of the membrane and the another membrane providing a substantially leak-free connection of the infusion adapter with the syringe adapter during transfer of the medication fluid. Lev, in the same field of endeavor of drug transfer devices (Title), teaches the vial adapter comprises another membrane (Fig. 1 – drug vials 20 are sealed by drug vial stopper 31) , the another membrane seated in the cavity of the housing and configured to engage the membrane 114 (Fig. 12 – sheath 114, and Par. 83 – “ a sheath 114 which maintains sterile conditions during storage and for use as a sealing member ”) of the connection stick 110 (Fig. 12 – drug transfer device 110) ; with the engaging of the membrane and the another membrane (Fig. 13 shows how the stopper engages with sheath 114) providing a substantially leak-free connection (Par. 83 – “ The puncturing cannula 113 is covered by a sheath 114 which maintains sterile conditions during storage and for use as a sealing member for use with a drug vial 20 ”) of the infusion adapter with the syringe adapter during transfer of the medication fluid (Fig. 13 and Par. 83 – sheath 114 is used as a sealing member) . It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further include the membrane seat of the connection stick and the adapter with another membrane within the housing as taught by Lev, in order to maintain sterile conditions during storage and for use as a sealing member for use with an external component (Par. 83 of Lev) . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bar-El et al. US 11,786,442 B2 teaches a liquid transfer device with a flange. Navarra US 2024/0099939 A1 teaches a needle assembly with a housing. Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm. 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, Sarah Al-Hashimi can be reached at (571) 272-7159. 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. /QUYNH DAO LE/Examiner, Art Unit 3781 /CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781 Application/Control Number: 18/885,880 Page 2 Art Unit: 3781 Application/Control Number: 18/885,880 Page 3 Art Unit: 3781 Application/Control Number: 18/885,880 Page 4 Art Unit: 3781 Application/Control Number: 18/885,880 Page 5 Art Unit: 3781 Application/Control Number: 18/885,880 Page 6 Art Unit: 3781 Application/Control Number: 18/885,880 Page 7 Art Unit: 3781 Application/Control Number: 18/885,880 Page 8 Art Unit: 3781 Application/Control Number: 18/885,880 Page 9 Art Unit: 3781 Application/Control Number: 18/885,880 Page 10 Art Unit: 3781 Application/Control Number: 18/885,880 Page 11 Art Unit: 3781 Application/Control Number: 18/885,880 Page 12 Art Unit: 3781 Application/Control Number: 18/885,880 Page 13 Art Unit: 3781 Application/Control Number: 18/885,880 Page 14 Art Unit: 3781
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