DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 19, 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1, 5, 7, and 10 are objected to because of the following informalities:
Claim 1, line 3 recites “an open position where a fluid path”, should read “an open position where the fluid path” for clarity of the antecedent basis established earlier in the claim.
Claim 5 recites “first and second tabs”, should read “a first tab and a second tab”, for clarity.
Claim 7 recites “the first and second slits”, should read “the first slit and second slit”, for clarity.
Claim 10, line 5 recites “an open position where a fluid path”, should read “an open position where the fluid path” for clarity of the antecedent basis established earlier in the claim.
Claim 10, line 14 recites “the closed luer connection”, should read “the closed luer connector” for clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yeh et al. (US 20190167969), hereinafter Yeh.
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 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), 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).
Regarding claim 2, Yeh 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, Yeh 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, Yeh 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, Yeh discloses the cap of claim 3, wherein the engagement member comprises first and second tabs 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, Yeh 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).
Regarding claim 7, Yeh discloses the cap of claim 1, wherein the body defines a first slit and a second slit positioned opposite the first slit, the first and second slits 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).
Regarding claim 8, Yeh 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, Yeh 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).
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 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.
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 closed 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 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 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 closed 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 connection 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]).
Regarding claim 11 and Yeh, in view of Sanders, 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, 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, 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, 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
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.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783