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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/29/2025 has been entered.
Response to Amendment
The amendment filed 12/29/2025 has been entered. Claims 21-31, 33, 38-40 are pending in the application. Applicant’s amendments to the claims have overcome every objection and 112(b) rejection previously set forth in the Final Office Action mailed 10/03/2025 .
Claim Rejections - 35 USC § 103
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 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.
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.
Claims 21, 23-25, 27, 29-31, 33, 38 are rejected under 35 U.S.C. 103 as being unpatentable over Schedler (US 2019/0009072) in view of Sweeney (US 5,496,288) and further in view of Schultz (US 2014/0276651).
Regarding claim 21, Schedler discloses a one-piece fluid line connector (300 and 330, Fig 3B) comprising: a main body (300, Fig 3B) having a male luer lock fitting (310 and 320, Fig 3B); and a cap (330, Fig 3B) coupled to the main body (See Fig 3A); the cap is moveable to an aligned position in which the cap is aligned with a central axis of the male luer lock fitting of the main body (Para 0062; See Fig 3A), wherein the cap includes a through-hole (336, Fig 3B) configured such that, in the aligned position, the shape of the through-hole permits a correspondingly-shaped female luer lock fitting to pass therethrough and engage the male luer lock fitting (Para 0063); wherein the male luer lock fitting includes a thread (322, Fig 3B) and a luer taper (See taper of tubular body 310, Fig 3B), the luer taper is configured to be received by the correspondingly-shaped female luer lock fitting and the thread is configured to receive one or more lugs of the correspondingly-shaped female luer lock fitting (Para 0052 and 0063); and wherein the through-hole of the cap is configured such that, when the cap is in the aligned position, as each of the one or more lugs of the correspondingly-shaped female luer lock fitting passes therethrough, the respective lug is aligned with an entrance of the thread of the male luer lock fitting (Para 0063, See Fig 4C; Once the lugs 130 pass through the corresponding through-hole, they are aligned with the entrance of the thread i.e., opening of the body portion 320).
Schedler is silent regarding the cap coupled to the main body by a living hinge; wherein the living hinge is configured such that the cap is moveable to an aligned position in which the cap is aligned with a central axis of the male luer lock fitting of the main body; and wherein, when the cap is in the aligned position, the through-hole is adjacent to the entrance of the thread such that there is no void between the through-hole and the thread.
Sweeney teaches a main body (134, Fig 6) having a male luer lock fitting, a cap (136, Fig 6) coupled to the main body by a living hinge (138, Fig 6); wherein the living hinge is configured such that the cap is moveable to an aligned position in which the cap is aligned with a central axis of the male luer lock fitting of the main body (Col 4, line 66-Col 5, line 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cap to be coupled to the main body via a living hinge as taught by Sweeney in order to provide easier manipulation of the cover with one hand (Col 2, lines 52-54).
Schultz teaches fluid line connector (144, Fig 68) comprising: a main body having a male luer lock fitting (Para 0107); and a cap (148, Fig 68) coupled to the main body (See Fig 68); wherein, when the cap is in the aligned position, the through-hole is adjacent to the entrance of the thread such that there is no void between the through-hole and the thread (Para 0111, See Fig 48 and 68; The funnel-like guide 136 is directly adjacent to the thread of the male luer lock fitting to assist in guiding the female luer fitting into the male fitting).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cap to include a funnel-like guide in the through-hole and have the through-hole adjacent to the thread as taught by Schultz in order to assist guiding a female Luer-type connector toward male distal tip (Para 0111).
Regarding claim 23, the modified invention of Schedler, Sweeney, and Schultz discloses the through-hole (336, Fig 3B -Schedler) is configured to rotationally restrain at least one lug of a correspondingly-shaped female luer lock fitting in at least one axial position of the female luer lock fitting within the cap (Para 0063, See Fig 3A -Schedler; at the axial position when the lugs are aligned and first enter the through-hole, it cannot be rotated until it passes through the inner surface 334).
Regarding claim 24, the modified invention of Schedler, Sweeney, and Schultz discloses in the aligned position, the cap is fastenable to the main body (Para 0062 -Schedler, flastenable via friction fit).
Regarding claim 25, the modified invention of Schedler, Sweeney, and Schultz discloses the cap is fastenable to the male luer lock fitting of the main body (Para 0062 -Schedler, flastenable via friction fit).
Regarding claim 27, the modified invention of Schedler, Sweeney, and Schultz discloses cap is rotationally fixable relative to the main body (Col 5, lines 2-12 -Sweeney; as the cap and hinge are integrally formed with the main body, it is rotationally locked to it).
Regarding claim 29, the modified invention of Schedler, Sweeney, and Schultz discloses a portion of the cap is configured to receive a portion of the main body when the cap is in the aligned position, such that the portion of the cap is radially external to the main body (Para 0062, See Fig 4C -Schedler).
Regarding claim 30, the modified invention of Schedler, Sweeney, and Schultz discloses the through-hole (336, Fig 3B -Schedler) of the cap has a variable radius (Para 0061, See Fig 4D -Schedler).
Regarding claim 31, the modified invention of Schedler, Sweeney, and Schultz discloses the through-hole (336, Fig 3B -Schedler) of the cap comprises one or more adjacent sectors (See annotated Fig 4D) with different radii (Para 0061 -Schedler).
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Regarding claim 33, the modified invention of Schedler, Sweeney, and Schultz discloses the main body (300, Fig 3B -Schedler) further comprises a conduit (350, Fig 3B -Schedler) configured to be attached to a fluid feed container to provide a fluid connection between the fluid feed container and the male luer lock fitting of the main body (Para 0071 -Schedler).
Regarding claim 38, Schedler discloses a fluid line assembly (assembly seen in Fig 3B) comprising: a one-piece fluid line connector (300 and 330, Fig 3B) comprising: a main body (300, Fig 3B) having a male luer lock fitting (310 and 320, Fig 3B); and a cap (330, Fig 3B) coupled to the main body (See Fig 3A); the cap is moveable to an aligned position in which the cap is aligned with a central axis of the male luer lock fitting of the main body (Para 0062; See Fig 3A), wherein the cap includes a through-hole (336, Fig 3B) configured such that, in the aligned position, the shape of the through-hole permits a correspondingly-shaped female luer lock fitting to pass therethrough and engage the male luer lock fitting (Para 0063); wherein the male luer lock fitting includes a thread (322, Fig 3B) and a luer taper (See taper of tubular body 310, Fig 3B), the luer taper is configured to be received by a correspondingly-shaped female luer lock fitting and the thread is configured to receive one or more lugs of the correspondingly-shaped female luer lock fitting (Para 0052 and 0063); and wherein the through-hole of the cap is configured such that, when the cap is in the aligned position, as a lug of the correspondingly-shaped female luer lock fitting passes therethrough, the lug is aligned with an entrance of the thread of the male luer lock fitting (Para 0063, See Fig 4C; Once the lugs 130 pass through the corresponding through-hole, they are aligned with the entrance of the thread i.e., opening of the body portion 320); and a correspondingly-shaped female luer lock fitting (100, Fig 3B) connectable to the one-piece fluid line connector, the correspondingly-shaped female luer lock fitting comprising one or more lugs (130, Fig 3B) configured to be received by the thread of the male luer lock fitting of the one-piece fluid line connector; wherein the female luer lock fitting is configured to connect with the one-piece fluid line connector such that a fluid may flow between the main body of the one-piece fluid line connector and the female luer lock fitting (Para 0059, 0063, 0071).
Schedler is silent regarding the cap coupled to the main body by a living hinge; wherein the living hinge is configured such that the cap is moveable to an aligned position in which the cap is aligned with a central axis of the male luer lock fitting of the main body; and wherein, when the cap is in the aligned position, the through-hole is adjacent to the entrance of the thread such that there is no void between the through-hole and the thread.
Sweeney teaches a main body (134, Fig 6) having a male luer lock fitting, a cap (136, Fig 6) coupled to the main body by a living hinge (138, Fig 6); wherein the living hinge is configured such that the cap is moveable to an aligned position in which the cap is aligned with a central axis of the male luer lock fitting of the main body (Col 4, line 66-Col 5, line 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cap to be coupled to the main body via a living hinge as taught by Sweeney in order to provide easier manipulation of the cover with one hand (Col 2, lines 52-54).
Schultz teaches fluid line connector (144, Fig 68) comprising: a main body having a male luer lock fitting (Para 0107); and a cap (148, Fig 68) coupled to the main body (See Fig 68); wherein, when the cap is in the aligned position, the through-hole is adjacent to the entrance of the thread such that there is no void between the through-hole and the thread (Para 0111, See Fig 48 and 68; The funnel-like guide 136 is directly adjacent to the thread of the male luer lock fitting to assist in guiding the female luer fitting into the male fitting).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cap to include a funnel-like guide in the through-hole and have the through-hole adjacent to the thread as taught by Schultz in order to assist guiding a female Luer-type connector toward male distal tip (Para 0111).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Schedler (US 2019/0009072) in view of Sweeney (US 5,496,288) and further in view of Schultz (US 2014/0276651) and further in view of Young (US 2009/0299339).
Regarding claim 22, the modified invention of Schedler, Sweeney, and Schultz discloses all of the elements of the invention as discussed above, however, is silent regarding the cap has a guide portion, the guide portion being configured to determine a helical movement of at least one of the one or more lugs between the cap and the thread when the female luer lock fitting is rotated in the cap, the at least one of the one or more lugs is adjacent the guide portion of the cap, and the cap is in the aligned position.
Young teaches an analogous one-piece fluid line connector (connector of Fig 13) comprising a cap (6, Fig 6) that has a guide portion (10, Fig 13), the guide portion being configured to determine a helical movement of at least one of the one or more lugs between the cap and the thread when the female luer lock fitting is rotated in the cap, the at least one of the one or more lugs is adjacent the guide portion of the cap, and the cap is in the aligned position (Para 0065).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cap to include guide portions 10 as disclose by Young in order to help guide the lugs into the male luer lock (Para 0065).
Claims 26 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Schedler (US 2019/0009072) in view of Sweeney (US 5,496,288) and further in view of Schultz (US 2014/0276651) and further in view of Ferlic (US 2013/0171030).
Regarding claim 26, the modified invention of Schedler, Sweeney, and Schultz discloses all of the elements of the invention as discussed above, however, is silent regarding the cap is fastenable using a snap-fit connection.
Ferlic teaches a main body (1002, Fig 25) and a cap (1006, Fig 25) coupled to the main body by a living hinge (1008, Fig 25); wherein the cap is fastenable using a snap-fit connection (Para 0143, lines 1-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cap to be fastenable using a snap-fit connection as taught by Ferlic in order to provide a friction or interference fit between the main body and cap, provide a hermetic seal, and prevent an inadvertent release of the cap (Para 0143, lines 1-13).
Regarding claim 28, the modified invention of Schedler, Sweeney, and Schultz discloses all of the elements of the invention as discussed above, however, is silent regarding a portion of the main body is configured to receive the cap when the cap is in the aligned position, such that the portion of the main body is radially external to the cap.
Ferlic teaches a main body (1002, Fig 25) and a cap (1006, Fig 25) coupled to the main body by a living hinge (1008, Fig 25); wherein a portion of the main body is configured to receive the cap when the cap is in the aligned position, such that the portion of the main body is radially external to the cap (See Fig 30; Para 0143, lines 1-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cap to be arranged such that the main body is radially external to the cap as taught by Ferlic in order to provide a friction or interference fit between the main body and cap, provide a hermetic seal, and prevent an inadvertent release of the cap (Para 0143, lines 1-13).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Schedler (US 2019/0009072) in view of Sweeney (US 5,496,288) and further in view of Schultz (US 2014/0276651) and further in view of Smolenski (US 2005/0040648).
Regarding claim 39, the modified invention of Schedler, Sweeney, and Schultz discloses all of the elements of the invention as discussed above, however, is silent regarding at least one of the one or more lugs of the female luer lock fitting is in a plane that is axially offset from a plane of a different one of the one or more lugs.
Smolenski teaches at least one of the one or more lugs (92, Fig 8) of the lock fitting (76, Fig 8) is in a plane that is axially offset from a plane of a different one of the one or more lugs (90, Fig 8) (Para 0065; See Fig 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the one or more lugs to include lugs axially offset from one another as taught by Smolenski in order to have a connector that operates more effectively for the useful life of the equipment, is produced at a reasonable cost, and helps with ensuring consistent centered alignment of the connector (Para 0010 and Para 0073, lines 6-11).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Schedler (US 2019/0009072) in view of Sweeney (US 5,496,288) and further in view of Schultz (US 2014/0276651) and further in view of Moldestad (US 4,211, 439).
Regarding claim 40, the modified invention of Schedler, Sweeney, and Schultz discloses all of the elements of the invention as discussed above, however, is silent regarding at least one of the one or more lugs of the female luer lock fitting has a greater angular extent around the circumference of the female luer lock fitting than another of the one or more lugs.
Moldestad teaches at least one of the one or more lugs (one of lugs 22, Fig 1) of the lock fitting (16, Fig 1) has a greater angular extent around the circumference of lock fitting than another of the one or more lugs (another one of lugs 22, Fig 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the one or more lugs to have varied angular extent around the circumference as taught by Moldestad in order to have a connector that can prescreen out all but one out of thousands of fluid lines (Col 2, lines 3-12).
Response to Arguments
Applicant’s argument filed 12/29/2025, on pages 4-5, regarding Shultz does not address the technical problem solved by the present invention and thus would not be consulted by the skilled person seeking to modify the device of Schedler have been fully considered but are not persuasive. As detailed in MPEP 2141.01(a)(I), “A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor. Shultz and the instant application are both classified in CPCs indented under A61M 39/00 directed to tubes, tube connectors, tube couplings, valves, etc. Further, they are both directed to medical connectors. Therefore, they are within the same field of endeavor and considered analogous art. One of ordinary skill in the art would consult analogous art to gain the advantages of the art, and thus would look Shultz to have the added benefit of having a feature to guide a female Luer-type connector toward a male distal tip (Para 0111).
Applicant’s argument filed 12/29/2025, on pages 5-7, regarding Schultz teaches that a void is present between the shield portion and the thread have been fully considered but is not persuasive. Applicant asserts that para 0064 indicates that the embodiment of Fig 48 is of the same type as shown in Fig 5B and that Fig. 48 does not show how that shield portion is provided on the male luer connector. Firstly, para 0064 does not mention Fig 5B, so it is unclear how Applicant is drawing that conclusion. Further, Examiner pointed to both Figs 48 and 68. Fig 48 provided the numeral for the guide feature 136 and Fig 68 illustrates how it is coupled to the male luer connector. Applicant also points to paragraph 0115 as to why Fig 68 shows a retractable shield portion. Paragraph 0115 clearly states that it is discussing the embodiments of Figs. 105-110. It appears that Applicant has misconstrued Examiners reliance on Schultz in the rejection. Schultz is relied on to teach that it would be obvious to include a guide member 136 on a cap that attaches to a male luer connector (specifically the cap of Schedler). This guide member 136 eliminates the void as seen in Fig 68 of Schultz and provides the benefit of guiding the female Luer-type connector toward a male distal tip (Para 0111). Therefore, the combined invention of Schedler, Sweeney, and Shultz does, in fact, teach all of the elements of the claimed invention.
Conclusion
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783