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 .
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.
Response to Amendment
This office action is in response to the reply filed on 05/26/2026. In the reply, Applicant amended claims 1, 6, 9-13, 16, 18 and 20, as well as the specification, and added new claim 21. Claims 1-16 and 18-21 are pending for examination. The amendments made to the specification are acknowledged and overcome the previous specification objections.
Response to Arguments
Applicant’s arguments, see Remarks, filed 05/26/2026, with respect to the rejection(s) of claims 1 and 10 under 35 USC 102(a)(1) as being anticipated by Dutta et al. (US 6458099), and claim 16 under 35 USC 102(a)(1) as being anticipated by Mewissen et al. (US 11883616) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn and new grounds of rejection have been set forth below.
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.
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 1-7, 10, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Mewissen (US 2022/0040447) in view of Moehle et al. (US 2009/0118661).
Regarding claim 1, Mewissen discloses a multi-lumen tapered tip (35) (see Fig. 1) comprising: a primary guidewire lumen having a primary guidewire lumen longitudinal axis (see Fig. 8B illustrating the primary guidewire lumen (52E) having a longitudinal axis), a secondary guidewire lumen having a secondary guidewire lumen longitudinal axis (see Fig. 8B illustrating a secondary guidewire lumen (50E) having a longitudinal axis), a shared guidewire lumen (67B) having a shared guidewire longitudinal axis colinear with the primary guidewire lumen longitudinal axis (see Fig. 8B illustrating the first guidewire lumen (52E) is colinear with 67B), and a first second guidewire junction at an intersection of the primary guidewire lumen (see Fig. 8B illustrating the lumen convergence region (66B), effectively functioning as a first second guidewire junction), the secondary guidewire lumen (50E) (see Fig. 8B) and the shared guidewire lumen (s67B; see Fig. 8B).
Mewissen fails to disclose the secondary guidewire lumen comprises an open trench.
Moehle et al. also discloses a multi-lumen catheter with a distal tip (see Fig. 4). Moehle et al. teaches the guidewire lumens comprise open trenches (60, 62). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Mewissen’s secondary guidewire lumen comprising an open trench, as taught by Moehle et al. Doing so would enable blood or other fluid to flow to/from the lumen whether the catheter is positioned within the patient’s vasculature (see paragraph [0046]).
Regarding claim 2, Mewissen as modified discloses a distal guidewire lumen port (see [0107] disclosing the tubular distal region (34) terminates in a penetrating tip (35), with a diameter that accommodates the guidewires, to which the distal end of the guidewire lumen serves as the port), the shared guidewire lumen extending between the distal guidewire lumen port and the first second guidewire junction (see Fig. 8B illustrating a common distal passageway (67B) extending through to the end portions of the catheter from the lumen convergence region (66B)).
Regarding claim 3, Mewissen as modified further discloses a proximal primary guidewire port (see [0108] disclosing the proximal region comprising lumen tubes (40, 42) connected to suitable fittings, such as Luer fittings (46, 48), that serve as guidewire input ports), the primary guidewire lumen extending between the proximal primary guidewire lumen port and the first second guidewire junction (see Fig. 8B illustrating the internal junctions of the first (52E) and second (50E) guidewire lumen at the convergence region (66B) where the lumen merge, thereby extending from the proximal input port down to the convergence region).
Regarding claim 4, Mewissen as modified further discloses a proximal secondary guidewire lumen port (see [0108] disclosing the proximal region comprising lumen tubes (40, 42) connected to suitable fittings, such as Luer fittings (46, 48), that serve as guidewire input ports), the secondary guidewire lumen extending between the proximal secondary guidewire lumen port and the second guidewire junction (see Fig. 8B illustrating the internal junctions of the first (52E) and second (50E) guidewire lumen at the convergence region (66B) where the lumen merge, thereby extending from the proximal input port down to the convergence region).
Regarding claim 5, Mewissen as modified further discloses the secondary guidewire lumen (50E) curves inward to the first second guidewire junction (52E; see Fig. 8B).
Regarding claim 6, Moehle et al. further teaches wherein a shared guidewire lumen is offset from a central longitudinal axis of the multi-lumen tapered tip (see Fig. 8D illustrating the third lumen, effectively functioning as the shared guidewire lumen, has an offset from the central longitudinal axis at the tip of the catheter). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Mewissen’s modified multi-lumen tapered tip, wherein the shared guidewire lumen is offset from a central longitudinal axis of the multi-lumen tapered tip, as further taught by Moehle. Doing so would provide a means to position the distal end opening and its underlying channel off-center, in order to offset the shared guidewire lumen from the central longitudinal axis of the multi-lumen tapered tip (see Fig. 8D).
Regarding claim 7, Moehle further teaches wherein a primary guidewire lumen is offset from a central longitudinal axis of the multi-lumen tapered tip (see Fig. 7B illustrating a first/primary guidewire lumen (12) as being offset from the third lumen (15) at the distal tip of the catheter). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Mewissen’s modified multi-lumen tapered tip, wherein the primary guidewire lumen is offset from a central longitudinal axis of the multi-lumen tapered tip, as further taught by Moehle. Doing so would provide a means to position the distal end opening off-center, in order to offset the primary guidewire lumen from the central longitudinal axis of the multi-lumen tapered tip (see Fig. 7B).
Regarding claim 10, Mewissen discloses a multi-lumen tapered tip comprising: a primary guidewire lumen configured to receive a first guidewire (see Fig. 20 illustrating a first/primary guidewire lumen receiving a first guidewire (88)); a secondary guidewire lumen configured to receive a second guidewire (see Fig. 21 illustrating a secondary guidewire lumen receiving a second guidewire (90)); and a shared guidewire lumen configured to receive the second guidewire (see Fig. 8B illustrating the lumen convergence region (66B) effectively functioning as a shared guidewire lumen).
Mewissen fails to disclose the secondary guidewire lumen comprises a trench comprising an opening having a width greater than a width of the second guidewire.
Moehle et al. also discloses Moehle et al. also discloses a multi-lumen catheter with a distal tip (see Fig. 4). Moehle et al. teaches the guidewire lumens comprise open trenches (60, 62) comprising an opening having a width greater than a width of a guidewire (see Fig. 4 in which the widths are greater than the width of the lumens, thereby greater than the widths of the guidewires inserted therein). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Mewissen’s secondary guidewire lumen with a trench comprising an opening having a width greater than a width of the second guidewire, as further taught by Moehle et al. Doing so would enable blood or other fluid to flow to/from the lumen whether the catheter is positioned within the patient’s vasculature (see paragraph [0046]).
Regarding claim 14, Mewissen as modified further discloses a secondary guidewire lumen (50E; see Figs. 8B and 21), the second guidewire (90) being within the secondary guidewire lumen (see Fig. 21 illustrating the second guidewire (90) inserted into the secondary guidewire lumen).
Regarding claim 15, Mewissen as modified further discloses a first second guidewire junction at an intersection of the primary guidewire lumen (see Fig. 8B illustrating the lumen convergence region (66B) and the wall (73B) effectively functioning as the junction at the intersection of the primary guidewire lumen (52E), the secondary guidewire lumen (50E) (see Fig. 8B), and the shared guidewire lumen (see Fig. 8B).
Claims 8, 9, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Mewissen (US 2022/0040447) in view of Moehle et al. (US 2009/0118661) as applied to claim 1 above, and further in view of Hennessy et al. (US 2007/0142821).
Regarding claim 8, Mewissen in view of Moehle et al., fails to disclose wherein the shared guidewire lumen comprises an open trench. Hennessy et al. also discloses a multi-lumen catheter comprising a shared guidewire lumen (80). Hennessy et al. teaches wherein the shared guidewire lumen comprises an open trench (see [0030] disclosing the guidewire port (82) forms a deepening trench in the exchange joint outer surface). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Mewissen’s shared guidewire lumen with an open trench, as taught by Hennessy et al. Doing so would facilitate multi-guidewire sequential probing and control alongside effective fluid management and reduced recirculation during intravascular procedures (see [0030]).
Regarding claim 9, Hennessy et al. also discloses a multi-lumen catheter. Hennessy et al. teaches wherein the open trench of a secondary guidewire lumen comprises an open trench has a variable width (see [0030] disclosing the dimensional and structural changes of the open trench forms by the guidewire port (82), begins near the proximal end and forms a deepening trench in the exchange joint (80), to which at the distal end, the port entirely encloses a guidewire, giving it a C-shaped, nearly circular cross-section, thereby establishing the open trench as having a variable width). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Mewissen’s modified multi-lumen tapered tip, wherein the open trench of the secondary guidewire lumen comprises an open trench has a variable width, as further taught by Hennessy et al. Doing so would facilitate sequential multi-guidewire probing and rapid exchange while maintaining a low profile, uniform outer diameter that prevents catching on guide catheters during vascular procedures (see [0030]).
Regarding claim 11, Hennessy et al. also discloses a multi-lumen catheter. Hennessy et al. teaches a guide tube within the shared guidewire lumen (see [0031] disclosing inserting the proximal end of the guidewire lumen (54) into the guidewire port (82) with a wire mandrel (96) to prevent the hypotube from collapsing, to which the hypotube effectively functions as the guide tube within a shared lumen to accommodate the guidewire). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Mewissen’s modified multi-lumen tapered tip, further comprising a guide tube within the shared guidewire lumen, as further taught by Hennessy et al. Doing so would prevent a primary guidewire from entering the shared lumen during multi-guidewire intravascular delivery (see [0031]).
Regarding claim 12, Hennessy further teaches wherein the second guidewire is within the guide tube (see [0030] disclosing the guidewire is directed into the guidewire lumen by inserting it into the guidewire port (82) and feeding it through the exchange joint (80), to which the hypotube effectively functions as the guide tube). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Mewissen’s modified multi-lumen tapered tip, wherein the second guidewire is within the guide tube, as further taught by Hennessy et al. Doing so would enable safe multi-guidewire tracking and sequential exchange while supporting optimal fluid management and a low-profile catheter design during intravascular procedures (see [0030]).
Regarding claim 13, Hennessy further teaches wherein the width of the opening is less than a width of the guide tube (see [0030] disclosing the exchange joint distal end (86), the guidewire port (82) almost entirely encloses a guidewire, and the wall defining the guidewire port has a C-shaped, nearly circular cross-section, thereby restricting the opening width relative to the inner body diameter). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Mewissen’s modified multi-lumen tapered tip, wherein the width of the opening is less than a width of the guide tube, as further taught by Hennessy et al. Doing so would securely retain the guide tube and secondary guidewire within a shared lumen while enabling selective wire release and maintaining a low-profile, uniform catheter structure (see [0030]).
Claims 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Mewissen (US 2022/0040447) in view of Moehle et al. (US 2009/0118661) and Hurley et al. (US 6605062).
Regarding claim 16, Mewissen discloses a method comprising: positioning a first guidewire within a primary guidewire lumen of a multi-lumen tapered tip (see Fig. 20 illustrating a first guidewire (88) positioned within a primary guidewire lumen); and positioning a second guidewire within a secondary guidewire lumen and a shared guidewire lumen of the multi-lumen tapered tip (see Fig. 21 illustrating a second guidewire (90) positioned within a secondary guidewire lumen and a shared guidewire lumen), the second guidewire preventing the first guidewire from entering the shared guidewire lumen (see Fig. 15 illustrating the second guidewire (90) positioned in a way to prevent the first guidewire (88) from entering the shared guidewire lumen); advancing a delivery system comprising the multi-lumen tapered tip over the second guidewire to an exchange location (see [0118] disclosing advancing the tapered catheter tip (35) into a targeted location (e.g. vascular blockage) following the path of the preloaded guidewire; Fig. 15 illustrating this configuration).
Mewissen fails to disclose the secondary guidewire lumen comprising an open trench; and releasing the second guidewire from the shared guidewire and through the open trench of the secondary guidewire lumen at the exchange location.
Moehle et al. also discloses a multi-lumen catheter with a distal tip (see Fig. 4). Moehle et al. teaches the guidewire lumens comprise open trenches (60, 62). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Mewissen’s secondary guidewire lumen comprising an open trench, as taught by Moehle et al. Doing so would advance a delivery system over the second guidewire to an exchange location while preventing guidewire entanglement and facilitating subsequent wire exchanges (see Figs. 8B, 8C).
Mewissen as modified by Moehle et al., fails to disclose releasing the second guidewire from the shared guidewire and through the open trench of the secondary guidewire lumen at the exchange location. Hurley et al. also discloses a catheter having lateral slits for guidewires (see Col. 2, lines 43-45). Hurley et al. teaches releasing the second guidewire from a shared guidewire and through an open trench of the secondary guidewire lumen at the exchange location (see Col. 3, lines 2-10 disclosing pulling the proximal end of the shaft laterally with respect to the second guidewire such that the guidewire emerges laterally from the longitudinal slit, followed by peeling the catheter off the second guidewire while the catheter is being retracted).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have performed the step of releasing the second guidewire from the shared guidewire and through the open trench of the secondary guidewire lumen at the exchange location, as taught by Hurley et al. Doing so would advance a delivery system over the second guidewire to an exchange location and subsequently release the second guidewire laterally through the open trench and longitudinal slit of the secondary lumen during catheter retraction and exchange (see Col. 3, lines 2-10).
Regarding claim 18, Mewissen as modified further discloses advancing the first guidewire through and out of the shared guidewire lumen (see [0076] disclosing the operational workflow at the exchange location where the first guidewire is advanced through and out of a shared location following the release of the secondary guidewire by the surgeon); and advancing the delivery system over the first guidewire to a deployment location (see [0106] disclosing over-the-wire mode of the multi-lumen catheter (30), thereby establishing the catheter’s use over a guidewire to a target location).
Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Mewissen (US 2022/0040447) in view of Moehle et al. (US 2009/0118661), in view of Hurley et al. (US 6605062) as applied to claim 18 above, and further in view of Roeder et al. (US 2016/0256304).
Regarding claim 19, Mewissen in view of Moehle et al. and Hurley et al. fails to disclose further comprising deploying a main vessel stent graft from the delivery system, the second guidewire extends through a coupling or a fenestration of the main vessel stent graft.
Roeder et al. also discloses a catheter system (see Fig. 4). Roeder et al. teaches deploying a main vessel stent graft from the delivery system (see [0043] disclosing the deployment of the stent graft (78) from an introducer (18) within a vessel), the second guidewire extends through a coupling or a fenestration of the main vessel stent graft (see [0043] disclosing a fenestrated stent graft (78) having at least one fenestration or opening (80) formed in the sidewall of the graft body (44), where the guidewire (26) is threaded through the lumen (52) of the graft and extended out through the fenestration or opening (80); Fig. 4 illustrating this configuration).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Mewissen’s modified multi-lumen tapered tip, further comprising deploying a main vessel stent graft from the delivery system, the second guidewire extends through a coupling or a fenestration of the main vessel stent graft, as further taught by Roeder et al. Doing so would provide a means to route a pre-loaded secondary catheter and guide wire through the lumen of the main prosthesis body and into an internal branch or aperture, in order to deploy a main vessel stent graft from the delivery system while ensuring that the second guidewire extends through a coupling or a fenestration of the main vessel stent graft (see [0043]).
Regarding claims 20, and 21, Roeder et al. further teaches further comprising: advancing a delivery system comprising a branch stent graft over the second guidewire and into the coupling or fenestration (see [0047] disclosing that a secondary stent graft, such as an extension stent graft loaded onto a secondary introducer, may be tracked over the guidewire and into the cannulated branch vessel (or branch/fenestration) to deliver and deploy the extension branch); and deploying the branch stent graft within the coupling or fenestration (see [0043] disclosing delivering and deploying a fenestrated stent graft (78) having at least one fenestration or opening (80) formed in the sidewall of the graft body (44), where the guidewire (26) is threaded through the lumen (52) of the graft and extended out through the fenestration or opening (80); Fig. 4 illustrating this configuration).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Mewissen’s modified multi-lumen tapered tip, further comprising: advancing a delivery system comprising a branch stent graft over the second guide wire and into the coupling or fenestration, and deploying the branch stent graft within the coupling or fenestration, as further taught by Roeder et al. Doing so would provide a means to route a pre-loaded secondary catheter and guidewire through converging internal lumens to a pre-cannulated branch or aperture, in order to advance a delivery system comprising a branch stent graft over the seconds guidewire and into the coupling or fenestration (see [0047]).
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 STEFAN BRADLEY CAMPBELL whose telephone number is (571)272-3498. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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, Melanie Tyson can be reached at (571) 272-9062. 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.
/STEFAN BRADLEY CAMPBELL/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
Prosecution Insights