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
This office action is responsive to the amendment filed on June 3, 2026. As directed by the amendment: claims 1, 5-7, and 10 have been amended, no claims have been added, no claims have been canceled. Thus claims 1-14 are presently pending in this application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed February 6, 2026.
Response to Arguments
Applicant’s arguments, see Remarks, filed June 3, 2026, with respect to the rejection(s) of claim(s) 1 and 10 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 103 have been fully considered and are persuasive. With regards to claim 1, Yeh does not disclose the amended limitation “the opening extending from the second end of the body to a position intermediate the first end of the body and the second end of the body”. Therefore, the rejection has been withdrawn. Due to their dependency on claim 1, the rejections of claims 2-9 are withdrawn for similar reasons. With regards to claim 10, neither Yeh nor Sanders discloses the amended limitation “the opening extending from the second end of the body to a position intermediate the first end of the body and the second end of the body”. Therefore, the rejection has been withdrawn. Due to their dependency on claim 10, the rejections of claims 11-14 are withdrawn for similar reasons. However, upon further consideration, in light of the amendments, a new ground(s) of rejection is made below.
On pg. 6 of the Remarks, applicant argues that Yeh does not disclose the limitations of claim 14, saying that Yeh does not disclose “wherein the body of the cap engages the male luer and radially expands as the cap is moved from the first position to the second position” since arms 462 of Yeh contact the edge of outlet port 912 to prevent insertion of the medical connector 900 . The examiner respectfully disagrees. As shown in Figs. 12A-B and described in [0089], arms 462 are deflected outwardly to permit the medical connector 900 to be inserted further. This deflection of arms 462 causes an increase in the width between radially opposing arms 462/member 464. Since arms 462 are disposed radially around the cap body 404 (see figs. 10-11), the arms 462 outwards deflections result in a radial expansion of at least a portion of the cap body 402/404, as the cap is moved from the first position to the second position. The radial expansion can also be seen in the difference between Fig. 12A wherein arms 462 have not been deflected yet and abut against the edge of outlet port 912, versus Fig. 12B wherein arms 462 have radially deflected/expanded and radially surround a portion of outlet port 912. Thus, Yeh reads on the claim limitation.
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Yeh et al. (US 20190167969), hereinafter Yeh, in view of Fangrow et al. (US 20200324102), hereinafter Fangrow.
Regarding claim 1, Yeh discloses a cap (Fig. 9-10, cap 400) for a closed male luer connector (Fig. 9, connector 900) having a housing (Fig. 2A and 12A, body 904; examiner notes: Connector 900 of embodiments in Fig. 2 and Fig. 12 are equivalent) and a male luer (Fig. 2A and 12A, male luer 906), the closed male luer connector having a closed position where a fluid path through the closed male luer connector is closed (Fig. 2A, 12A and [0087], connector 900 in a closed position wherein fluid pathway 908 is sealed) and an open position where the fluid path through the closed male luer connector is open (Fig. 2B, 12B and [0087], connector 900 is in an open position wherein fluid pathway 908 is open), the cap comprising: a body (Fig. 10-11, cap body 402/404) having a first end (Fig. 11, opening 412) and a second end positioned opposite the first end (Fig. 11, first end 426 and inlet port 410, opposite opening 412), the body defining an opening configured to receive a portion of the male luer of the closed male luer connector (Fig. 12B, inlet port 410 has opening configured to receive a portion of male luer 906), the body configured to actuate the closed male luer connector from the closed position to the open position when the cap is fully inserted into the closed male luer connector (Fig. 12B and [0089], cap body 402/404 is configured to actuate connector 900 from closed position of Fig. 12A to open position of Fig. 12B when the cap 400 is engaged fully within outlet port 912 of connector 900), wherein the body is configured to expand in a radial direction (Fig. 12A-B and [0089], the arms 462 of body 402/404 are able to deflect radially to expand the cross-sectional width between arms 462 to be greater than the outer surface of the body 904 at port 912).
Yeh fails to disclose the opening extending from the second end of the body to a position intermediate the first end of the body and the second end of the body. However, Fangrow discloses the opening extending from the second end of the body to a position intermediate the first end of the body and the second end of the body (Fig. 6F-G and [0098-0099], body of priming cap 200 comprises an internal opening which extends from a second end 242 and second end of conduit housing 212 (similar to first end 426 and inlet port 410 of Yeh) to the plug 236 which is at a position intermediate the second end 242 and the first end 240/exit bore 218 (similar to opening 412 of Yeh)).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Yeh to incorporate the disclosures of Fangrow and modify the body to have a plug disposed proximate to the first end to define a blocked end of the internal opening such that the opening extends from the second end of the body to a position intermediate the first end of the body and the second end of the body. Doing so would inhibit fluid from passing through the first end of the cap, while still allowing air to be vented from/filtered through the cap such that the connector and/or catheter or other medical device may be properly primed without the need to introduce additional fluids, such as saline, to remove air. Thus, providing a priming cap which is safer to use and can help limit infections (Fangrow [0098]).
Regarding claim 2 and Yeh, in view of Fangrow, Yeh further discloses the cap of claim 1, wherein the second end of the body is configured to engage a valve member of the closed male luer connector (Fig. 12A-B, inlet port 410 engages with the extension member 920 of valve post 910) to actuate the closed male luer connector from the closed position to the open position when the cap is fully inserted into the closed male luer connector (Figs. 12A-B and [0089], inlet port 410 engagement with valve post 910/extension member 920 actuates the connector from closed position of Fig. 12A to open position of Fig. 12B when the cap 400 is engaged within outlet port 912 of connector 900).
Regarding claim 3 and Yeh, in view of Fangrow, Yeh further discloses the cap of claim 1, further comprising an engagement member (Fig. 11, engagement members: inlet port 410 and arms 462) configured to engage the male luer and a portion of the housing of the closed male luer connector when the cap is partially and fully inserted into the closed male luer connector (Fig. 12B and [0089], engagement members engage with male luer 906 and outlet port 912 of body 904 when the cap 400 is engaged within connector 900).
Regarding claim 4 and Yeh, in view of Fangrow, Yeh further discloses the cap of claim 3, wherein engagement member comprises a tab extending from the second end of the body (Fig. 11-12, arms 462 comprise member 464 extends from the second end side of the arm on the body).
Regarding claim 5 and Yeh, in view of Fangrow, Yeh further discloses the cap of claim 3, wherein the engagement member comprises a first tab and a second tab extending from the body, the first tab spaced from the second tab (Fig. 11-12 and [0086], each arm 462 comprise member 464 extends from the second end side of the arm on the body, therefore a first tab and second tab are spaced from each other).
Regarding claim 6 and Yeh, in view of Fangrow, Yeh further discloses the cap of claim 1, wherein the body defines a slit extending in a direction parallel to a longitudinal axis of the cap (Figs. 10-11 and [0084], body 402/404 comprises windows/slits 460 on outer surface of body 402/404, which extend parallel to axis 430), and wherein the body is configured to expand in the radial direction due to the slit (Figs. 10-12 and [0089], slits 460 form the arms 462 which are configured to deflect radially outward, resulting a radial expansion of at least a portion of body 402/404).
Regarding claim 7 and Yeh, in view of Fangrow, Yeh further discloses the cap of claim 1, wherein the body defines a first slit and a second slit positioned opposite the first slit, the first slit and the second slit each extending in a direction parallel to a longitudinal axis of the cap (Figs. 10-11 and [0084], body 402/404 comprises windows/slits 460 on outer surface of body 402/404, which extend parallel to axis 430, and at least one first slit is positioned diametrically opposite to a second slit on the outer surface) and wherein the body is configured to expand in the radial direction due to the first slit and the second slit (Figs. 10-12 and [0089], each slit 460 forms a corresponding arm 462, wherein the arms 462 are configured to deflect radially outward, resulting a radial expansion of at least a portion of body 402/404).
Regarding claim 8 and Yeh, in view of Fangrow, Yeh further discloses the cap of claim 6, wherein the body defines a recessed portion on an inner surface of the body defining the opening (Fig. 11-12, body 402/404 comprises a recessed region between inner surface of body 404 and outer surface of port 410, which helps define the opening through which connector 900 engages with cap 400).
Regarding claim 9 and Yeh, in view of Fangrow, Yeh further discloses the cap of claim 1, wherein the body comprises a plurality of external ribs extending in a direction parallel to a longitudinal axis of the cap (Fig. 10 and [0092], body 402/404 comprises ribs 440 on outer surface of body portion 402, which extend parallel to axis 430).
Claims 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Yeh (US 20190167969), in view of Sanders et al. (US 20190314583), hereinafter Sanders, and Fangrow (US 20200324102).
Regarding claim 10, Yeh discloses ---a closed male luer connector (Fig. 9, connector 900) comprising: a housing (Fig. 2A and 12A, body 904; examiner notes: Connector 900 of embodiments in Fig. 2 and Fig. 12 are equivalent); a male luer (Fig. 2A and 12A, male luer 906, which is closed by post 910 in closed position); a female connector (Fig. 2 and 9, inlet port 902), the closed male luer connector having a closed position where the fluid path through the closed male luer connector is closed (Fig. 2A, 12A and [0087], connector 900 in a closed position wherein fluid pathway 908 is sealed) and an open position where a fluid path through the closed male luer connector is open (Fig. 2B, 12B and [0087], connector 900 is in an open position wherein fluid pathway 908 is open); and a cap (Fig. 9-10, cap 400) having a body (Fig. 10-11, cap body 402/404) having a first end (Fig. 11, opening 412) and a second end positioned opposite the first end (Fig. 11, first end 426 and inlet port 410, opposite opening 412), the body defining an opening configured to receive a portion of the male luer (Fig. 12B, inlet port 410 has opening configured to receive a portion of male luer 906), the body configured to actuate the closed male luer connector from the closed position to the open position when the cap is fully inserted into the closed male luer connector (Fig. 12B and [0089], cap body 402/404 is configured to actuate connector 900 from closed position of Fig. 12A to open position of Fig. 12B when the cap 400 is engaged fully within outlet port 912 of connector 900), wherein the body is configured to expand in a radial direction (Fig. 12A-B and [0089], the arms 462 of body 402/404 are able to deflect radially to expand the cross-sectional width between arms 462 to be greater than the outer surface of the body 904 at port 912); the cap having a first position where the cap is engaged with the male luer, a portion of the male luer is received within the opening of the cap, and the closed male luer connector is in the closed position (Fig. 12A and [0087], cap 400 first position wherein cap is engaged with luer 906 such that a portion of luer 906 is within port 410 and connector 900 is in closed position), and a second position where the closed male luer connector is in the open position (Fig. 12B and [0089], cap 400 in second position wherein the connector 900 is in open position), wherein the second position is spaced from the first position in a direction extending parallel to a longitudinal axis of the cap (Fig. 12A vs 12B, first position (Fig. 12A) and second position (Fig. 12B) of cap 400 are spaced in a direction parallel to longitudinal axis 430).
Yeh fails to disclose wherein the female connector is a female luer. However, Sanders discloses wherein the female connector is a female luer (Fig. 1 and 0084], attachment 24 (equivalent to inlet port 902 of Yeh) may be configured as a female luer connector).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yeh to incorporate the disclosures of Sanders and modify the female connector to be a female luer. Doing so would allow for easy/simple connection to any component with a corresponding male luer connector, such as a syringe, container, or other medical device (Sanders, [0084]).
Yeh, in view of Sanders, fails to disclose the opening extending from the second end of the body to a position intermediate the first end of the body and the second end of the body. However, Fangrow discloses the opening extending from the second end of the body to a position intermediate the first end of the body and the second end of the body (Fig. 6F-G and [0098-0099], body of priming cap 200 comprises an internal opening which extends from a second end 242 and second end of conduit housing 212 (similar to first end 426 and inlet port 410 of Yeh) to the plug 236 which is at a position intermediate the second end 242 and the first end 240/exit bore 218 (similar to opening 412 of Yeh)).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified Yeh, in view of Sanders, to incorporate the disclosures of Fangrow and modify the body to have a plug disposed proximate to the first end to define a blocked end of the internal opening such that the opening extends from the second end of the body to a position intermediate the first end of the body and the second end of the body. Doing so would inhibit fluid from passing through the first end of the cap, while still allowing air to be vented from/filtered through the cap such that the connector and/or catheter or other medical device may be properly primed without the need to introduce additional fluids, such as saline, to remove air. Thus, providing a priming cap which is safer to use and can help limit infections (Fangrow [0098]).
Regarding claim 11 and Yeh, in view of Sanders and Fangrow, Yeh further discloses ---the closed male luer connector of claim 10, further comprising a valve member (Fig. 2 and 12, valve post 910) having an extension positioned radially outward from the male luer (Fig, 2 and 12, valve post 910 has extension member 920, which is positioned radially outward from male luer 906), the second end of the cap engaged with the extension when the cap is in the first and second positions (Fig. 12A-B, inlet port 410 engaged with extension member 920 in the first and second positions).
Regarding claim 12 and Yeh, in view of Sanders and Fangrow, Yeh further discloses the--- closed male luer connector of claim 11, wherein a portion of the valve member is configured to extend through a seal when the closed male luer connector is moved from the closed position to the open position (Fig. 2B and 12B, the tip portion of the valve post 910 is configured to extend through a seal portion at the end of bellow member 919 and into the inlet port 902 (See annotated Fig. 2B below) when the connector 900 is moved to the open position seen in Fig. 12B (and Fig. 2B)).
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Annotated Fig. 2B of Yeh
Regarding claim 13 and Yeh, in view of Sanders and Fangrow, Yeh further discloses ---the closed male luer connector of claim 12, wherein movement of the cap from the first position to the second position causes the second end of the cap to move the valve member and to extend a portion of the valve member through the seal (Fig. 2B and 12B, movement of cap 400 from first position (Fig. 12A) to second position (Fig. 12B/2B) causes the tip portion of the valve post 910 to extend through the seal (See annotated Fig. 2B).
Regarding claim 14 and Yeh, in view of Sanders and Fangrow, Yeh further discloses ---the closed male luer connector of claim 10, wherein the body of the cap engages the male luer and radially expands as the cap is moved from the first position to the second position (Fig. 12A-B and [0088-0089], cap 400 engages the male luer 906 via inlet port 410 and has arms 462 which radially expand as it moves from first position (Fig. 12A) to second position (Fig. 12B)).
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 SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 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, 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.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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