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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/16/2026 has been entered.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 10/24/2025 has/have been considered by the Examiner.
Status of the Claims
Claim 4 is newly cancelled. Claims 1 and 5 are currently amended. Claims 1-3, 5-7, and 9-15 are currently pending. Claims 1-3, 5-7, and 9-15 are currently rejected.
Response to Arguments
Applicant's arguments filed 01/16/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “an integrated extension set” being integrated with ‘the device’ and having only one coupler) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Examiner notes that “an integrated extension set” is only functionally recited in claim 1. Examiner further notes that the specification does not provide any special definition for “an integrated extension set” requiring particular components to be ‘integrated’ in the manner argued by Applicant, nor does the claim as written require any further functional and/or structural limitations regarding the integrated extension set.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, combining the integrated extension set of Carter with the catheter system of Huang modified by Burkholz allows more flexibility of movement for the patient during treatment, and also provides attachment with a pump unit which delivers fluid. See rejection of claim 5 below.
Additionally, Applicant seems to disagree with Examiner’s characterization of Huang and Burkholz regarding the “near patient access port”, but fails to specifically point out any errors regarding the characterization of Huang and Burkholz’s “near patient access port”.
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.
Claim(s) 1-3, 9-11, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al (US 20200001051 A1; hereafter Huang) in view of Burkholz et al (US 20170120008 A1; hereafter Burkholz).
Regarding claim 1, Huang discloses an integrated midline catheter system (Abstract) comprising:
a catheter adapter (catheter advancement assembly 20, fig. 2 and fig. 3b, [0045]) comprising a catheter (catheter 22, fig. 3b, [0045]), a body receiving the catheter (catheter hub 24, fig. 3b, [0045]), and a side port (branch pipe 24a, fig. 3b, [0045]);
a catheter insertion device (insertion tool 10, fig. 2 and fig. 3a, [0044]) comprising a housing (housing 12 which in turn includes a first portion 12A and a second portion 12B, fig. 3a, [0040]), an introducer needle (hollow needle 18, fig. 3a, [0044]) extending distally from the housing (12) (see fig. 3a which shows the hollow needle 18 extending distally from second housing portion 12b), and a guidewire advancement tab (pusher 34, fig. 3a, [0111]) moveable relative to the housing (12) to advance ([0114] pusher 34 is moved distally form a position close to the proximal end of the housing shown in fig. 12a to a position close to the needle base as shown in fig. 12b; this movement advances the guidewire 32) a guidewire (guidewire 32, fig. 3a, [0111]) through the introducer needle (18, fig. 3a, [0112] guidewire extends through hollow needle 18), wherein the catheter adapter (20, fig. 2) is disposed at least partially within the housing (12) (see fig. 1 and fig. 2 which show a portion of catheter adapter 20 disposed within housing 12; [0045] at least a portion of the catheter 22, and the catheter hub 24, are pre-disposed within the housing 12) and configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to be advanced distally along the housing (12) ([0125] catheter hub 24 and catheter 22, which are part of the catheter adapter 20 as shown in fig. 3b, move distally and further distal movement of the catheter hub and the catheter is prevented by the distal portion of the housing),
Huang is silent to the side port (24a) in fluid communication with the catheter (22) and a near patient access port.
Burkholz, in the art of catheter adapters, teaches a catheter adapter (catheter adapter 20 and catheter 12, fig. 1 and fig. 7, respectively noted in [0057] and [0071]) comprising a catheter (catheter 12, fig. 7, [0071]), a body receiving the catheter (catheter adapter 20, figs. 1 and 7, [0057]), and a side port (later access port 56, fig. 7, [0070]) in fluid communication with the catheter (12) ([0070] the lateral access port 56 may be connected to a section of extension tube 60 for establishing fluid communication between an intravenous fluid source and the internal cavity 26 of the catheter adapter or lumen 44 of the catheter; [0053] fluid from the intravenous fluid source may flow through the lumen 44 and into the catheter 12 without interruption);
a near patient access port (first luer access 72, second luer access 73, and septum 74, fig. 7, [0076]) in fluid communication ([0076] a first luer access 72 is in fluid communication with the extension tube 60) with the side port (56, fig. 7) of the catheter adapter (20/12, fig. 7) ([0070] lateral access port 56 may be connected to a section of extension tube 60 for establishing fluid communication between an intravenous fluid source and the internal cavity 26 of the catheter adapter or lumen 44 of the catheter), the near patient access port (72/73/74) comprising a connector portion (blood control split septum 74, fig. 7, [0076] blood control split septum 74 associated with the first luer access 72) configured to be coupled to a peripheral probe device (Examiner notes that claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.), the connector portion (74) comprising a split septum needle-free connector ([0076] a blood control split septum 74 associated with the first luer access 72), and
wherein the near patient access port (first luer access 72, second luer access 73, and septum 74, fig. 7, [0076]) further comprises a secondary port (second luer access 73, fig. 7, [0076]), and wherein the secondary port is coupleable (Examiner notes that the claim language “coupleable” implies functional language and the prior art must only be capable of performing the recited function.) to an integrated extension set (Since the secondary port 73 explicitly is a luer access, thus having a luer connection, the secondary port/second luer access 73 meets the limitation of being “coupleable” to an integrated extension set.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the have the side port 24a and catheter 22 of Huang in fluid communication as taught by Burkholz and to include a near patient access port as taught by Burkholz since both Huang and Burkholz deal with catheters. One would have been motivated to make the modification of fluid communication because having the side port and catheter in fluid communication and having the near patient access port with a connector portion allows for fluid reservoirs to be connected to the catheter and delivered through the side port and catheter to the patient as noted by Burkholz [0070]. Also, the septum 74 allows for a reduction in catheter-related bloodstream infection as noted by Burkholz [0076].
Regarding claim 2, Huang modified by Burkholz discloses the system of claim 1, as described above. Huang further discloses wherein the guidewire advancement tab (pusher 34, fig. 3a) is positioned closer to a proximal end of the housing (12) ([0114] pusher 34 is located in a position close to the proximal end of the housing as shown in fig. 12a) of the catheter insertion device (10, fig. 2 and fig. 3a) than a distal end of the housing (12) of the catheter insertion device (10) (see fig. 1 and fig. 3a which show that the guidewire advancement tab / pusher 34 is located closer to the proximal end of the housing 12 than the distal end of the housing 12).
Regarding claim 3, Huang modified by Burkholz discloses the system of claim 1, as described above. Huang further discloses wherein the catheter insertion device (insertion tool 10, fig. 1) comprises a handle (handle 16, fig. 1) ([0043] insertion tool 10 includes a handle 16 for a clinician to stably hold the insertion tool 10 during operation).
Regarding claim 9, Huang modified by Burkholz discloses the system of claim 1, as described above.
Huang is silent to the catheter adapter comprising a stabilization platform.
Burkholz further teaches wherein the catheter adapter (20/12, figs. 1 and 7) comprises a stabilization platform (wing element 62, fig. 1 and 7, [0057] catheter adapter 20 may include wing element 62 made up of first wing member 68 and second wing member 70 which provide increased catheter stability and therefore increase dwell time).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify the catheter adapter of Huang to have a stabilization platform as taught by Burkholz, because as previously noted both references deal with catheters. One would have been motivated to make the modification because, as noted by Burkholz [0062], the stabilization platform 62 provides catheter stability and increases dwell time.
Regarding claim 10, Huang modified by Burkholz discloses the system of claim 9, as described above, including wherein the stabilization platform comprises a pair of stabilizing wings (first wing member 68 and second wing member 70, fig. 1 and 7, [0057] catheter adapter 20 may include wing element 62 made up of first wing member 68 and second wing member 70 which provide increased catheter stability and therefore increase dwell time).
Regarding claim 11, Huang modified by Burkholz discloses the system of claim 1, as described above. Huang further discloses wherein the catheter insertion device (10, fig. 2 and 3a) is detachable from the catheter adapter (20, fig. 2 and 3b) after insertion of the catheter within a patient's vasculature ([0125]-[0126] after the catheter 22 has been advanced into the patient’s vasculature the housing can be released from the catheter hub 24).
Regarding claim 14, Huang modified by Burkholz as applied to claim 3 above discloses the system of claim 3, including wherein the handle (Huang 16) is positioned closer to a distal end of the housing the catheter insertion device than a proximal end of the housing of the catheter insertion device (Huang fig. 1 shows handle 16 positioned on the distal end of the catheter insertion device).
Regarding claim 15, Huang modified by Burkholz applied to claim 3 and claim 14 above, discloses the system of claim 3 and claim 14, and also discloses wherein the handle is configured (Examiner notes that claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to be grasped between a thumb and index finger of a clinician (Examiner notes that the handle shown in fig. 1 of Huang could be grasped between a thumb and index finger and thus satisfies the claim.).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang modified by Burkholz as applied to claim 1 above, and further view of Carter et al (US-20160296742-A1; hereafter Carter).
Regarding claim 5, Huang modified by Burkholz discloses the system of claim 1, as described above.
Huang modified by Burkholz is silent to a proximal access port coupled to a proximal end of the integrated extension set.
Carter, in the field of luer connectors, teaches wherein a port (first coupler 30, fig. 4, [0030] coiled extension set 26 includes a first coupler 30 for connecting the coiled extension set 26 to a downstream device) is coupleable to an integrated extension set (coiled extension set 26, fig. 4, [0030] coiled extension set 26 also includes a second coupler 32 for connecting the coiled extension set 26 to the injector pump 24), and
a proximal access port (second coupler 32, fig. 4, [0030]) is coupled to a proximal end portion of the integrated extension set (coiled extension set 26, fig. 4, [0030] coiled extension set 26 also includes a second coupler 32 for connecting the coiled extension set 26 to the injector pump 24).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to couple an integrated extension set to the secondary port of Huang and Burkholz and to a proximal access port as taught by Carter all references deal with tubing connections and vascular access devices. One would have been motivated to make the modification because including the extension set improves the flexibility of fluid source and patient arrangements during treatment, allowing the patient to move more comfortably without risking dislodging the catheter. Also, one would have been motivated to make the modification because the extension set, having the second coupler, facilitates the attachment of the infusion system to an injector pump or other fluid source.
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang modified by Burkholz and Carter, as applied to claim 5 above, and further in view of Aslam et al (US-20180161546-A1; hereafter Aslam).
Regarding claim 6, Huang modified by Burkholz and Carter discloses the system of claim 5 including the proximal access port.
Huang modified by Burkholz and Carter is silent to proximal access port being color-coded to provide a flow rate indication.
Aslam, directed to an intravenous catheter stopper, teaches wherein a portion of a catheter (stopper 110) is color-coded to provide a flow rate indication ([0035] stopper may be color coded according to a flow rate).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the proximal access port to include the color-code taught by Aslam, since all the references deal with intravenous catheters. One would have been motivated to color code the proximal access port so that the user would see the color code when attaching the catheter to the fluid source, which would improve user awareness of the delivery dosages for which the setup is appropriate.
Regarding claim 7, Huang modified by Burkholz and Carter discloses the system of claim 5 including the proximal access port.
Huang modified by Burkholz and Carter is silent to the proximal access port including indicia.
Aslam teaches wherein a portion of the catheter comprises indicia indicative of at least one of catheter length and catheter gauge ([0035] stopper may be color coded according to the size of the catheter lumen).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the proximal access port to include the indica indicating catheter gauge as taught by Aslam since all the references deal with intravenous catheters. One would have been motivated to color code the proximal access port so that the user would see the color code when attaching the catheter to the fluid source, which would improve user awareness of the delivery dosages for which the setup is appropriate.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang modified by Burkholz as applied to claim 1 above and further in view of Velez et al (US-20030191453-A1; hereafter Velez).
Regarding claim 12, Huang modified by Burkholz discloses the system of claim 1, as described above.
Huang modified by Burkholz is silent to wherein the catheter comprises a reinforced tip.
Velez, directed to a catheter assembly, teaches wherein the catheter ([0032] elongated tube 22 comprises infusion section 42, section 42 noted in fig. 8) comprises a reinforced tip (support tip 56, fig. 9, [0051] support 48 includes support tip 56).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to add the reinforced tip of Velez to the catheter of Huang modified by Burkholz because all references deal with catheters. One would have been motivated to make the modification because the reinforced tip being integrally formed with the support 48 as taught by Velez [0051] aids in directing the guidewire through the tip of the catheter in a predictable manner. Furthermore, with reinforcement the tip is less likely to be damaged or accidentally deformed during storage, transport, and usage.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang modified by Burkholz as applied to claim 1 above and further in view of Keimel et al (US-20050208090-A1; hereafter Keimel).
Regarding claim 13, Huang modified by Burkholz discloses the system of claim 1, as described above.
Huang modified by Burkholz is silent to wherein the catheter adapter comprises a strain relief.
Keimel, in the field of catheters, teaches wherein the catheter adapter (access port 901, fig. 9) comprises a strain relief (strain relief sleeve 903, fig. 9, [0063]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify Huang modified by Burkholz with the strain relief sleeve as taught be Keimel since all references deal with catheters. One would have been motivated to add a strain relief to the catheter adapter of Huang modified by Burkholz because this would help protect and stabilize the tubing connections and would relieve strain on the tubing, thus reducing wear on the equipment over time.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Burkholz et al (US-20190321599-A1) - see [0040] and figs. 1a/b; connector 30 includes a luer adapter on the proximal end of a second extension tube 44
Burkholz et al (US-20190021640-A1) - see [0049] and figs. 1a-c and fig. 4; see coupler element 32
Blanchard et al (US-20200078564-A1) - see [0041] and fig. 2a/b, see fig. 6b and [0063], various catheter assembly connector configurations
Burkholz et al (US-20200316346-A1) - see figs. 1a-e and [0078-0080], various configurations of ports and extension tubes, catheter assembly connectors
Burkholz et al (US-20210212618-A1) - see fig. 2 and [0040-0041], extension set used with a PIVC having a branching connector
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
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.
/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 06/12/2026
Prosecution Insights