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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-8) in the reply filed on 02/07/2025 is acknowledged. The traversal is on the ground(s) that amended claim 1 contains a special technical feature over Vitello and Manke wherein all the groups contain one or more of the same technical features recited in claim 1, since all groups read on claim 1. There is unity of invention, since claim 1 avoids the prior art and satisfies the requirement of unity of invention. This is not found persuasive because the amended claim 1 does not overcome Vitello, since examiner interprets the distal end portion of the tip connector is where the frangible members 34 are located (see annotated figure below).
PNG
media_image1.png
443
562
media_image1.png
Greyscale
The requirement is still deemed proper and is therefore made FINAL.
Response to Amendment
This office action is responsive to the amendment filed on 11/19/2025. As directed by the amendment: Claims 1 and 7 have been amended, no claims have been cancelled, and claim 11 has been added. Thus, claims 1-11 are presently pending in the application wherein claims 9-10 are withdrawn.
Applicant’s amendments to the drawing and claim 1 have overcome the previous objection and 112 rejections previously set forth in the Non-Final Office Action mailed 09/15/2025.
Response to Arguments
Applicant states, lines 10-19 on page 7, filed 11/19/2025, that the examiner indicated that none of the cited art discloses “a closure cap having a distal end, the closure cap configured to sealingly close a distal opening of the tip, the closure cap being releasably connected to the tip connector, the distal end of the closure cap external to the tip connector;” or “a tip connector configured to engage a tip of the medical injection device, the tip connector having a distal end portion; a closure cap configured to sealingly close a distal opening of the tip, the closure cap being releasably connected to the distal end portion of the tip connector;” as discussed during the examiner interview. Examiner agreed during the interview that the proposed amendment would overcome the previous rejection; however, examiner now interprets the distal end portion of the tip connector to be where the frangible members 34 are connected (see annotated figure below). Therefore, Vitello discloses a tip connector 22 configured to engage a tip of the medical injection device (column 9, lines 11-16) wherein the tip connector 22 having a distal end portion (see annotated figure below), a closure cap 30 configured to sealingly close a distal opening of the tip (column 9, lines 57-63).
PNG
media_image1.png
443
562
media_image1.png
Greyscale
Applicant’s arguments, see lines 10-22 on page 10, with respect to the rejection of the claims have been fully considered and are persuasive. Applicant argues that none of the cited references disclose or teach the amendments to claim 1 as agreed during the examiner interview and that the distal end portion of the end cap member of Vitello is not releasably connected to the syringe cap. Examiner agrees that the amendments “the closure cap being releasably connected to the distal end portion of the tip connector” to claim 1 overcomes the previous rejection; therefore, the rejection in view of Manke has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Imbert (US 6190364).
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 1-4, 6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Vitello (US 9311592); in view of Imbert (US 6190364).
Regarding Claim 1, Vitello discloses a tip cap (closure (20); Fig.3) for a medical injection device (Fig.2), comprising: - a tip connector (cap member (22)) configured to engage a tip of the medical injection device (column 9, lines 11-16), the tip connector (22) having a distal end portion (see annotated figure below); - a closure cap (syringe cap (30)) configured to sealingly close a distal opening of the tip (the syringe cap (30) engages with a nozzle of the medical device to prevent fluid flow) (column 9, lines 57-63); - an RFID tag (code segment (202’) in the form of an RFID structure) (column 14 (lines 63-67)- column 15 (lines 1-6)) comprising a chip (indicator member (32)) (portion of the RFID tag is embedded the indicator member (32)) (column 14 (lines 63-67)- column 15 (lines 1-6)) and an antenna (antenna (204)), wherein the chip is overmolded in one of the tip connector (22) and the closure cap (30) (Fig.16) (column 14 (lines 63-67)- column 15 (lines 1-6)) and the antenna (204) is overmolded in the other one of the tip connector (22) and the closure cap (30) (the antenna (204) is embedded in the cap member (22)) (Fig.16A) (column 14 (lines 63-67)- column 15 (lines 1-6)), the chip (32) and the antenna (204) being electrically connected by a bridge (frangible member (34)) (the antenna (204) connected to portion of RFID tag embedded in the indicator member (32) via frangible members (34); Fig.16A) configured to break under a relative movement (pulling force) applied to the closure cap (30) and the tip connector (22), the relative movement applied to the closure cap (30) and the tip connector (22) releases the closure cap from the tip connector (the pulling force applied to the end cap member (22) and the syringe cap (30) (since the end cap member (22) and the syringe cap (30) are connected to each other) releases the end cap member (22) from the syringe cap (30) when the frangible members (34) rupture (column 11, lines 7-21 and column 15, lines 7-19), and the antenna (204) is located at an interface (see annotated figure below) between the tip connector (22) and the closure cap (30) (the antenna (204) and the syringe cap (30) are located at an interface that is part of the cap member (22) and part of the syringe cap (30) as seen below), the tip connector (22) and the closure cap (30) being made as a single piece from chemically not bonding materials (the syringe cap (30) and the cap member (22) are made from a single piece from chemically not bonding material, since the RFID structure is embedded in both the cap member (22) and the syringe cap (30)/indicator member (32) (column 14 (lines 63-67)- column 15 (lines 1-16)) wherein the cap member (22) and the syringe cap (30) are released when the frangible
PNG
media_image2.png
297
448
media_image2.png
Greyscale
PNG
media_image1.png
443
562
media_image1.png
Greyscale
member (34) breaks (column 11, lines 7-13).
Vitello does not appear to disclose a closure cap being releasably connected to a distal end portion of a tip connector.
Imbert teaches it was known in the art a closure cap (44) being releasably connected to a distal end portion (end portion away from the patient) of a tip connector (58) via threads (82 and 52) as seen in Fig.4 (column 5, lines 31-35). The modified threads would be modified to the distal ends of the syringe cap/closure cap and the cap member/tip connector.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Vitello to incorporate the teachings of Imbert to have a closure cap being releasably connected to a distal end portion of a tip connector in order to easily access the tip of the syringe by merely rotating the outer cap/tip connector relative to the luer collar/closure cap (column 6, lines 28-29).
Regarding Claim 2, Vitello as modified discloses the tip cap according to claim 1, and Imbert further teaches wherein the tip connector (58) and the closure cap (44) comprise mutually engaging threaded portions (82 and 52) (column 5, lines 31-35).
Regarding Claim 3, Vitello as modified discloses all the limitations of claim 1 above.
Vitello does not appear to disclose a closure cap comprises a sealing septum configured to abut a tip of a medical injection device.
Imbert teaches it was known in the art to have a sealing septum (67) that abuts the tip (22) of the syringe as seen in Fig.4 (column 4, lines 42-44).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Vitello to incorporate the teachings of Imbert to have a closure cap comprises a sealing septum configured to abut a tip of a medical injection device in order to enhance sealing the tip of the medical device (column 4, lines 42-44).
Regarding Claim 4, Vitello as modified discloses the tip cap according to claim 1, and further discloses wherein the antenna (204) presents a ring shape extending about a longitudinal axis of the tip cap (20) (the antenna (204) is annular and embedded in the cap member (22) centered around the longitudinal axis as seen in Fig.16).
Regarding Claim 6, Vitello as modified discloses the tip cap according to claim 4, and further discloses wherein the bridge (34) is orthogonal to the longitudinal axis of the tip cap (the frangible member (34) is orthogonal to the longitudinal axis as seen in Figs.6 and 16).
Regarding Claim 11, Vitello discloses a tip cap (20; Fig.3) for a medical injection device (Fig.2), comprising: - a tip connector (22) configured to engage a tip of the medical injection device (column 9, lines 11-16); - a closure cap (30) having a distal end (end away from the patient), the closure cap configured to sealingly close a distal opening of the tip (the syringe cap (30) engages with a nozzle of the medical device to prevent fluid flow) (column 9, lines 57-63); - an RFID tag (code segment (202’) in the form of an RFID structure) (column 14 (lines 63-67)- column 15 (lines 1-6)) comprising a chip (indicator member (32)) (portion of the RFID tag is embedded the indicator member (32)) (column 14 (lines 63-67)- column 15 (lines 1-6)) and an antenna (antenna (204)), wherein the chip is overmolded in one of the tip connector (22) and the closure cap (30) (Fig.16) (column 14 (lines 63-67)- column 15 (lines 1-6)) and the antenna (204) is overmolded in the other one of the tip connector (22) and the closure cap (30) (the antenna (204) is embedded in the cap member (22)) (Fig.16A) (column 14 (lines 63-67)- column 15 (lines 1-6)), the chip (32) and the antenna (204) being electrically connected by a bridge (frangible member (34)) (the antenna (204) connected to portion of RFID tag embedded in the indicator member (32) via frangible members (34); Fig.16A) configured to break under a relative movement (pulling force) applied to the closure cap (30) and the tip connector (22), the relative movement applied to the closure cap (30) and the tip connector (22) releases the closure cap from the tip connector (the pulling force applied to the end cap
PNG
media_image2.png
297
448
media_image2.png
Greyscale
member (22) and the syringe cap (30) (since the end cap member (22) and the syringe cap (30) are connected to each other) releases the end cap member (22) from the syringe cap (30) when the frangible members (34) rupture (column 11, lines 7-21 and column 15, lines 7-19), and the antenna (204) is located at an interface (see annotated figure below) between the tip connector (22) and the closure cap (30) (the antenna (204) and the syringe cap (30) are located at an interface that is part of the cap member (22) and part of the syringe cap (30) as seen below), the tip connector (22) and the closure cap (30) being made as a single piece from chemically not bonding materials (the syringe cap (30) and the cap member (22) are made from a single piece from chemically not bonding material, since the RFID structure is embedded in both the cap member (22) and the syringe cap (30)/indicator member (32) (column 14 (lines 63-67)- column 15 (lines 1-16)) wherein the cap member (22) and the syringe cap (30) are released when the frangible member (34) breaks (column 11, lines 7-13).
Vitello does not appear to disclose a closure cap being releasably connected to a tip connector wherein the distal end of the closure cap external to the tip connector.
Imbert teaches it was known in the art a closure cap (44) being releasably connected to a tip connector (58) via threads (82 and 52) as seen in Fig.4 (column 5, lines 31-35). The distal end (end away from the patient) of the closure cap (44) is external to the tip connector (58) when removing the closure cap from the tip connector. The modified threads would be modified to the distal ends of the syringe cap/closure cap and the cap member/tip connector.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Vitello to incorporate the teachings of Imbert to have a closure cap being releasably connected to a tip connector wherein the distal end of the closure cap external to the tip connector in order to easily access the tip of the syringe by merely rotating the outer cap/tip connector relative to the luer collar/closure cap (column 6, lines 28-29).
Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Vitello (US 9311592) and Imbert (US 6190364) as applied to claim 1 above, and further in view of Kucuk (WO 2014/086437).
Regarding Claim 5, Vitello as modified discloses all the limitations of claim 4 above.
Vitello does not appear to disclose a bridge is parallel to a longitudinal axis of a tip cap.
Kucuk teaches it was known in the art to have a welding column (40.1; Fig.1c) that is parallel to the longitudinal axis of the closure cap (20) wherein the welding column connect fastener (3) and the closure cap (20) (Fig.1b).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Vitello to incorporate the teachings of Kucuk to have a bridge is parallel to a longitudinal axis of a tip cap in order to unintentionally break the material of the locking connection between the fastener and the closure cap during and after assembly (page 15, last paragraph).
Regarding Claim 8, Vitello as modified discloses all the limitations of claim 1 above.
Vitello does not appear to disclose a chemically not bonding materials of a tip connector and a closure cap are polycarbonate and thermoplastic elastomer.
Kucuk teaches it was known in the art to have a hard portion (30; Fig.) made of polycarbonate (page 8, lines 13-16) and an elastomer part (10) made of thermoplastic elastomer (page 13, last paragraph).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Vitello to incorporate the teachings of Kucuk to have a chemically not bonding materials of a tip connector and a closure cap are polycarbonate and thermoplastic elastomer in order to withstand/survive a standard sterilization.
Claims 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Vitello (US 9311592); in view of Imbert (US 6190364) (alternate interpretation).
Regarding Claim 1, Vitello discloses a tip cap (closure (20); Fig.3) for a medical injection device (Fig.2), comprising: - a tip connector (cap member (22)) configured to engage a tip of the medical injection device (column 9, lines 11-16), the tip connector (22) having a distal end portion (see annotated figure below); - a closure cap (indicator member (32)) configured to sealingly close a distal opening of the tip (the indicator member (32) receives syringe cap (30) (column 10, lines 11-14) wherein the nozzle (2’) of the syringe is received within the syringe cap (30) (column 9, lines 60-67)); - an RFID tag (code segment (202’) in the form of an RFID structure) (column 14 (lines 63-67)- column 15 (lines 1-6)) comprising a chip (portion of the RFID tag embedded the cap member (22)) (column 14 (lines 63-67)- column 15 (lines 1-6)) and an antenna (antenna (204)), wherein the chip is overmolded in one of the tip connector (22) and the closure cap (Figs. 3B and 16) (column 14 (lines 63-67)- column 15 (lines 1-6)) and the antenna (204) is overmolded in the other one of the tip connector and the closure cap (32) (the antenna (204) is embedded in the indicator member (32)) (Figs.16A-B) (column 14 (lines 63-67)- column 15 (lines 1-6)), the chip and the antenna (204) being electrically connected by a bridge (frangible member (34)) (the antenna (204) connected to portion of RFID tag embedded in the cap member (22) via frangible members (34); Fig.16A) configured to break under a relative movement (pulling force) applied to the closure cap (30) and the tip connector (22), the relative movement applied to the closure cap (32) and the tip connector (22) releases the closure cap from the tip connector (the pulling force applied to the end cap member (22) releases the indicator member (32) from the cap member (22) when the frangible members (34) rupture (column 11, lines 7-21 and column 15, lines 7-19), and the antenna (204) is located at an interface (see annotated figure below) between the tip connector (22) and the closure cap (32) (see annotated figure below and Figs.16-16A), the tip connector (22) and the closure cap (32) being made as a single piece from chemically not bonding materials (the indicator member (32) and the cap member (22) are made from a single piece from chemically not bonding material, since the cap member (22) and the indicator member (32) are released when the frangible member (34) breaks (column 11, lines 7-13 and column 15, lines 7-19).
PNG
media_image1.png
443
562
media_image1.png
Greyscale
PNG
media_image2.png
297
448
media_image2.png
Greyscale
Vitello does not appear to disclose a closure cap being releasably connected to a distal end portion of a tip connector.
Imbert teaches it was known in the art a closure cap (44) being releasably connected to a distal end portion (end portion away from the patient) of a tip connector (58) via threads (82 and 52) as seen in Fig.4 (column 5, lines 31-35). The modified threads would be modified to the distal ends of the syringe cap/closure cap and the cap member/tip connector.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Vitello to incorporate the teachings of Imbert to have a closure cap being releasably connected to a distal end portion of a tip connector in order to easily access the tip of the syringe by merely rotating the outer cap/tip connector relative to the luer collar/closure cap (column 6, lines 28-29).
Regarding Claim 7, Vitello as modified discloses the tip cap according to claim 1, the antenna (204) comprising at least one protrusion extending radially into the material of the closure cap (32) (the antenna 204 is in the form of protrusions that extend radially in the material of the indicator member (32) as seen in Fig.16).
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 TANIA M ISMAIL whose telephone number is (313)446-6625. The examiner can normally be reached Monday-Thursday 8:00-3:30 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, Bhisma Mehta can be reached at 571-272-3383. 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.
/T.I./ Examiner, Art Unit 3783
/BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783