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 .
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 configured to guide movement of a probe through 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).
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 features comprising lead-ins configured to guide movement of a probe through 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 configured to guide movement of a probe through 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).
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 features comprising lead-ins configured to guide movement of a probe through 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 “a flow diverting feature, where the flow diverting feature comprises a lead-in configured to guide movement of a probe through the first port and/or the second port”. Applicant argues the inserts are not placed nor configured to guide a probe into the first port or the second port. More specifically:
Applicant argues that a probe would hit one of the sides of the inserts and get stuck. The examiner is not persuaded as that would just suggest to a user to withdraw the probe and try to center said probe better. Further, Bihlmaier discloses sloped surfaces to assist in guiding/leading said probe towards the center of the lumen and the inserts.
Applicant argues that the inserts are not placed at an entrance or exit to the first port or the second port and thus cannot be lead-ins. The examiner believes such a view is narrower than broadest reasonable interpretation. The argument also lacks nexus with the claim language. Applicant requires “guide movement of a probe through the first and/or second port”, not “guide movement of a probe into the opening of the first and/or second port”. A lead-in can be located in any position to help guide the probe into another part of the device. For example, the inserts 211/213 are located before the junction (and thus lead-in to the junction) and insert 212 is located before the narrower section that leads to the catheter (and is thus a lead-in to said narrower section).
The examiner does want to clarify that he does not consider a lead-in as having to be directly at the beginning of the structure it is considered to lead into. So long as it guides a device as that device is being inserted (even if it has already been partially inserted such as in the case of Bihlmaier) it is considering as leading that device as it is being inserted (stressing the “in” at the start of inserted)
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 BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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, Michael Tsai can be reached at (571)270-5246. 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.
/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
Prosecution Insights