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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/6/2026 has been entered.
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.
Claim(s) 1, 2, 5-8, 10-13, 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al (US 2019/0321599) in view of Bihlmaier et al (US 10,792,399).
Regarding claim 1, 2 and 5, Burkholz disclose an integrated catheter system comprising: a catheter adapter comprising a catheter 20 and an inlet 12, the catheter configured to be inserted into a patient's vasculature (¶38); a needle-free connector 30 comprising a first port (connected to 24), a second port positioned opposite the first port (fig 1A), and a side port (connected to 44) positioned between the first port and the second port (fig 1A), the second port comprising a valve member 38 (¶42); intermediate tubing 24 extending between the inlet of the catheter adapter and the first port of the needle-free connector (fig 1A); and extension tubing 44 extending from the side port of the needle-free connector (fig 1A),
While Burkholz substantially discloses the invention as claimed, it does not disclose the needle-free connector comprises chlorhexidine, wherein the needle-free connector comprises a flow diverting feature, and wherein the flow diverting feature comprises a lead-in positioned at an entrance or exit to the first port and/or second port and configured to guide movement of a probe through the first port and/or second port as the probe is first inserted into the first port and/or second port.
Bihlmaier discloses a catheter system which includes antimicrobial inserts 211/212/213 (fig 2D, abstract) which elutes antimicrobial agents to provide antimicrobial protection to the device (Col.5 ll 46-51). Chlorhexidine diacetate and chlorhexidine gluconate as antimicrobial agents are specifically disclosed (Col.7 ll 48-50). Inserts 211/212/213, especially 211/213, comprise lead-ins configured to guide movement of a probe through the first port and/or the second port (fig 2D). Bihlmaier also discloses an insert 104 (fig 1D) which has an expanded opening at one end, said opening facilitating insertion of another device. “For example, insert 104 could be placed within the lumen of a port or a female luer so that, when another device (e.g. a male luer) is inserted into the port or female luer, the other device may insert into the expanded opening.” (Col.9 ll 61-67). In fig 2D of Bihlmaier insert 211 is positioned at an exit of the first port and insert 212 is positioned at an entrance of the second port, and both assist in guiding movement of a probe through the first and second port (note that as currently claimed either of 211 or 212 would suffice as the flow diverting features due to and/or).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Burkholz such that it includes a flow diverting feature comprising chlorhexidine gluconate (or diacetate) in each of the first, second, and side ports, said flow diverting feature comprises a lead-in positioned at an entrance or exit to the first port and/or second port and configured to guide movement of a probe through the first port and/or second port as the probe is first inserted into the first port and/or second port as taught by Bihlmaier to provide antimicrobial protection to the device and to help center inserted structures inserted into the ports.
Regarding claim 6, wherein the flow diverting feature comprises an insert or coating comprising the chlorhexidine (see combination in claim 1 and inserts 211/212/213).
Regarding claim 7, wherein the needle-free connector comprises a body defining a longitudinal axis extending between the first port and the second port, and wherein the side port extends from the body at an angle of 30-150 degrees relative to the longitudinal axis of the body (fig 1B; approximately 45/135 degrees).
Regarding claim 8, wherein the side port is in fluid communication with the body of the needle-free connector via an inlet, and wherein the inlet is offset from the longitudinal axis of the body of the needle-free connector (longitudinal axis is through center of lumen 41 in fig 1B, inlet to side port is slightly off said axis).
Regarding claim 10, wherein the lead-in comprises a frusto-conical surface (see combination in claim 1 and right side of 211 of Bihlmaier).
Regarding claim 11, wherein the chlorhexidine is configured to elute over a predetermined time period (Col.1 ll 59).
Regarding claims 12, 13 and 16, Burkholz discloses a catheter system comprising: a catheter adapter comprising a catheter 20 and an inlet 12, the catheter configured to be inserted into a patient's vasculature (¶38); and a needle-free connector 30 comprising a first port (connected to 24), a second port positioned opposite the first port (fig 1A), and a side port (connected to 44) positioned between the first port and the second port (fig 1A), the second port comprising a valve member 38
While Burkholz substantially discloses the invention as claimed, it does not disclose the needle-free connector comprises chlorhexidine, wherein the needle-free connector comprises a flow diverting feature, and wherein the flow diverting feature comprises a lead-in positioned at an entrance or exit to the first port and/or second port and configured to guide movement of a probe through the first port and/or second port as the probe is first inserted into the first port and/or second port.
Bihlmaier discloses a catheter system which includes antimicrobial inserts 211/212/213 (fig 2D, abstract) which elutes antimicrobial agents to provide antimicrobial protection to the device (Col.5 ll 46-51). Chlorhexidine diacetate and chlorhexidine gluconate as antimicrobial agents are specifically disclosed (Col.7 ll 48-50). Inserts 211/212/213, especially 211/213, comprise lead-ins configured to guide movement of a probe through the first port and/or the second port (fig 2D). Bihlmaier also discloses an insert 104 (fig 1D) which has an expanded opening at one end, said opening facilitating insertion of another device. “For example, insert 104 could be placed within the lumen of a port or a female luer so that, when another device (e.g. a male luer) is inserted into the port or female luer, the other device may insert into the expanded opening.” (Col.9 ll 61-67). In fig 2D of Bihlmaier insert 211 is positioned at an exit of the first port and insert 212 is positioned at an entrance of the second port, and both assist in guiding movement of a probe through the first and second port (note that as currently claimed either of 211 or 212 would suffice as the flow diverting features due to and/or). Alternatively, flow diverting feature/insert 211 could be considered to be at the entrance to the second port (and would be sufficient to meet the claim).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Burkholz such that it includes a flow diverting feature comprising chlorhexidine gluconate (or diacetate) in each of the first, second, and side ports, said flow diverting feature comprises a lead-in positioned at an entrance or exit to the first port and/or second port and configured to guide movement of a probe through the first port and/or second port as the probe is first inserted into the first port and/or second port as taught by Bihlmaier to provide antimicrobial protection to the device and to help center inserted structures inserted into the ports.
Regarding claim 17, wherein the flow diverting feature comprising an insert or coating comprising the chlorhexidine (see combination in claim 1 and inserts 211/212/213).
Claim(s) 3, 4, 14 and 15is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al (US 2019/0321599) in view of Bihlmaier et al (US 10,792,399) and Burkholz et al (US 2017/0120028, hereafter Burkholz ‘028)
Regarding claims 3, 4, 14 and 15, while Burkholz substantially discloses the invention as claimed, it does not disclose the needle-free connector comprises a lube comprising the chlorhexidine nor a coating comprising the chlorhexidine.
Burkholz ‘028 discloses using chlorhexidine-eluting coating or lubricants within needle-free connector 102 (¶44).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Burkholz such that the needle-free connector comprises a chlorhexidine coating or lubricant as taught by Burkholz ‘028 to provide an (additional, once modified by Bihlmaier) antimicrobial feature to the device, and which assists in decreasing the insertion force of an inserted device.
Response to Arguments
Applicant’s arguments are not persuasive. Applicant argues Bihlmaier fails to teach “the flow diverting feature comprises a lead-in positioned at an entrance or exit to the first port and/or second port and configured to guide movement of a probe through the first port and/or second port as the probe is first inserted into the first port and/or second port”.
Applicant argues on page 6 that there is no teaching in Bihlmaier that the inserts 211/212 are also lead-ins positioned at an entrance or exit to the first port and/or the second port as the probe is first inserted into the first port and/or second port as they are located in the middle of ported intravenous catheter 210 instead of the entrance or exit. The examiner is not persuaded. Applicant requires a needle-free connector comprising a first port and second port (and other structures), thus other un-claimed structures can be present (such as a main central body from which all three ports project). Bihlmaier fig 2D can be said to show a needle-free connector having a body with an insert 211 at the exit of the first port and an insert 212 at the entrance to the second port, either which alone will be sufficient to meet the claim.
On page 7, Applicant argues limitations drawn to “as the probe is first inserted into the first port and/or second port”. Yet such a limitation would also read upon when the probe is inserted into the ports for the first time. Even without such an interpretation by the examiner, Applicant’s language seems to bely such a strict interpretation as being argued as it would be unclear how a lead-in positioned at the exit to either port could guide a device that has not yet been inserted far enough to reach the exit.
Finally, the examiner wants to clarify, since Applicant’s amendments this time quote the examiner’s responses from the previous action, that amending the claims to unequivocally place a lead-in at the entrance to the first port would still be considered an obvious modification in view of Bihlmaier. For example, Bihlmaier discloses an insert 104 (fig 1D) which has an expanded opening at one end, said opening facilitating insertion of another device. “For example, insert 104 could be placed within the lumen of a port or a female luer so that, when another device (e.g. a male luer) is inserted into the port or female luer, the other device may insert into the expanded opening.” (Col.9 ll 61-67). One of ordinary skill in the art would appreciate that the specific placement of Bihlmaier would be depend on its desired application. Specifically, when there is a desire to disinfect the fluid, it will be placed farther into the device; while a desire to disinfect an inserted connector lends more naturally to placing the insert at the opening/entrance of the device to minimize chance of transferring microorganisms to the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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