Office Action Predictor
Last updated: April 15, 2026
Application No. 18/225,810

MEDICAL INTRODUCER AND SHEATH

Non-Final OA §103
Filed
Jul 25, 2023
Examiner
GILBERT, ANDREW M
Art Unit
3700
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Cook Medical Technologies LLC
OA Round
1 (Non-Final)
64%
Grant Probability
Moderate
1-2
OA Rounds
4y 0m
To Grant
94%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allow Rate
447 granted / 693 resolved
-5.5% vs TC avg
Strong +30% interview lift
Without
With
+29.8%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
5 currently pending
Career history
698
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
38.4%
-1.6% vs TC avg
§102
29.7%
-10.3% vs TC avg
§112
19.8%
-20.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 693 resolved cases

Office Action

§103
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 . Acknowledgments Claims 1-20 are pending for examination. Information Disclosure Statement The information disclosure statement filed 2/12/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. Here, a copy of the EPO European Search Report from 2/8/2024 has not been provided. Specification The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claim 16 recites: “wherein the tip has a rest inner diameter that is smaller than an inner diameter of the inner polymer tube” (emphasis added). Paragraph [0021] of the Specification discloses that the crosslinked polymer sleeve (50) has a rest diameter (17) that is smaller than the outer diameter (16) of the dilator (15) to provide a tight interface therebetween. However, the Specification does not provide antecedent basis for the scope of claim 16, which recites the tip (25) has a rest inner diameter that is smaller than an inner diameter of the inner polymer tube. It is noted, that the inner polymer tube and dilator do not need to be the same diameter and the claimed tip includes more than just the crosslinked polymer sleeve. Thus, the specification is object to for failing to provide proper antecedent basis for the claimed subject matter. Applicant is advised to consider whether claim 16 should be amended to match scope disclosed in paragraph [0021]. Claim Objections Claims 2 and 8 objected to because of the following informalities: In regards to claim 2, the term “wherein radiopaque marker” in line 1 should be changed to “wherein the radiopaque marker”. In regards to claim 8, the term “the polymer tube” in line 2 should be changed to “the inner polymer tube”. Appropriate correction is required. 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 9-10, 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katsurada et al (2020/0276413) (“Katsurada”) in view of Yee Roth (2008/0108974). Regarding claim 9, Katsurada discloses an introducer sheath (Fig 1; catheter 1 is fully capable of acting as the claimed introducer sheath because it is capable of introducing a guidewire through lumen 4b – see P12, P27) comprising: a composite tube (5) extending between a hub (8) and a tip (3), and the composite tube includes a braid (6b) with a hollow cylindrical shape sandwiched between (Fig 2; P28), and in contact with, an inner polymer tube (6a) and an outer thermoplastic tube (6c); the tip including a radiopaque marker (2 in 7; see P31-37), which is a loaded thermoplastic (e.g. polyurethane elastomer loaded with tungsten – P32-35, including P37 which sets forth the radiopaque material can be only in distal region 7), and a cosslinked polymer sleeve (proximal region 9; Fig 2) that receives a distal segment of the composite tube (proximal region 9 receives a distal segment the composite tube via 9 being bonded to 6a and 6c at their distal ends as shown in Fig 2. In others the proximal end of 9 receives the distal end of 6a/6c to allow bonding. Applicant is strongly advised to further define the scope of receives and the structural connection/orientation between the polymer sleeve and the composite tube to distinguish over the applied art); and at least partially receives the radiopaque marker (proximal region 9 at least partially receives the radiopaque marker 2 in 7 by the distal end of region 9 being connected to and thus receiving the proximal end of 7 as shown in Fig 2. Applicant is strongly advised to further define the scope of receives and the structural connection/orientation between the polymer sleeve and the composite tube to distinguish over the applied art); an outer surface of the crosslinked polymer sleeve has a flush transition to an outer surface of the composite tube at a proximal end of the crosslinked polymer sleeve (outer surface of 9 at its proximal end has a flush transition with distal end of 6a/6c as shown in Fig 2. Here the transition is flush as they “hav[e] or form[ing] a continuous plane or unbroken surface” (see Webster’s Dictionary’s definition of “flush”), and a distal portion of the crosslinked polymer sleeve extends distally beyond a distal end of the inner polymer tube (Fig 2; 9 is distal to the distal ends of 6a/6c); and the radiopaque marker having a tapered segment distal to the flush transition (radiopaque tungsten powder 2 is mixed into distal region 7 which tapers to a tip distal to the flush transition where 6a/6c engage 9). However, Katsurada does not expressly disclose the composite tube extending between a valve and the tip. Yee Roth teaches that it is known to have a composite tube (Fig 2) that extends between a valve (16a) and a tip (34; Fig 2) for the purpose of providing a hemostasis valve to seal around a guidewire to prevent loss of fluid or entry of air embolism (P17). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the introducer sheath hub as taught by Katsurada to include the valve as taught by Yee Roth for the purpose of a hemostasis valve to seal around a guidewire to prevent loss of fluid or entry of air embolism (P17). Regarding claim 10, Katsurada as modified by Yee Roth, disclose wherein the radiopaque marker is entirely positioned distally of a distal end of the inner polymer tube (2 in 7 is entirely distal to the distal end of 6a in Fig 2). Regarding claim 16, Katsurada as modified by Yee Roth, disclose wherein the tip has a rest inner diameter that is smaller than an inner diameter of the inner polymer tube (Fig 2 where the inner diameter of 7 at the distal tip is smaller than the inner diameter of 6a). Regarding claim 17, Katsurada as modified by Yee Roth, disclose wherein the radiopaque marker is positioned distally of a distal end of the inner polymer tube (2 in 7 is positioned distal to the distal end of 6a in Fig 2). Regarding claim 18, Katsurada as modified by Yee Roth, discloses wherein the tapered segment of the radiopaque marker (2 in region 7) is in mold contact with an inner surface of a tapered segment of the crosslinked polymer sleeve (the examiner notes “mold contact” is a product-by-process limitation and has been interpreted to mean contact between the elements. Here, 2 in 7 is in “mold contact” with an inner surface of 9 at the inner surface mold point where proximal end of 7 contacts the distal end of 9; see arrows in annotated Fig 2 below). The applicant is strongly advised to further structurally define how the tapered segments of the radiopaque marker and polymer sleeve contact another. PNG media_image1.png 253 316 media_image1.png Greyscale Claim 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katsurada, in view of Stigall et al (9149600). Regarding claim 19, Katsurada discloses a work-in-progress introducer sheath (Fig 1; catheter 1 is fully capable of acting as the claimed introducer sheath because it is capable of introducing a guidewire through lumen 4b – see P12, P27 and fully capable of being a work-in-progress introducer sheath as the device is capable of performing work/treatment) comprising: a composite tube (1) extending between a proximal end (8; Fig 1) and a tip (3), and the composite tube includes a braid (6b) with a hollow cylindrical shape sandwiched between (Fig 2; P28), and in contact with, an inner polymer tube (6a) and an outer thermoplastic tube (6c), the tip (3) including a radiopaque marker, (2 in 7; see P31-37), which is a loaded thermoplastic (e.g. polyurethane elastomer loaded with tungsten – P32-35, including P37 which sets forth the radiopaque material can be only in distal region 7), and a crosslinked polymer sleeve (proximal region 9; Fig 2) that receives a distal segment of the composite tube (9 receives distal end of 6a/6c; see additional discussion above in claim 9) and at least partially receives the radiopaque marker (9 receives proximal end of 7; see additional discussion above in claim 9); an outer surface of the crosslinked polymer sleeve has a flush transition to an outer surface of the composite tube at a proximal end (where 9 is bonded to 6c in Fig 2 is a flush transition; see additional discussion above in claim 9), and the radiopaque marker having a tapered segment distal to the flush transition (2 in 7 tapers distal to the connection of 9 to 6c; Fig 2); and a distal portion of the crosslinked polymer sleeve extends distally beyond a distal end of the inner polymer tube (9 extends distally beyond the distal end of 6a in Fig 2). However, Katsurada does not expressly disclose a peel away tube covering, and in contact with, a distal segment of the composite tube, the flush transition, and the crosslinked polymer sleeve. Stigall et al teaches that it is known to have a distal catheter tip having a peel away tube (shrink tube 150; peel away – see col 4, lns 66-col 5, ln 1), and in contact with, a distal segment of the composite tube (148), the flush transition (142/144), and the crosslinked polymer sleeve (120; Fig 5) for the purpose of bonding the segments together while constraining the flow of materials so they fuse together to form a composite tip (col 5, lns 27-32). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the introducer sheath as taught by Katsurada with the peel away tube shrink tubing as taught by Stigall et al for the purpose of improving the bonding the segments together while constraining the flow of materials so they fuse together to form a composite tip (col 5, lns 27-32). Claims 1-4, 6, 8-13, 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cise et al (11191566) (“Cise”) in view of Katsurada et al (2020/0276413) (“Katsurada”). Regarding claim 1, Cise discloses an introducer (Fig 1) comprising: a sheath (102) and a dilator (col 4, lns 37-42; e.g. 50, Fig 11) having a first configuration in which the dilator is received in the sheath (col 4, lns 37-42), and a second configuration in which the dilator is out of contact with the sheath (col 4, lns 37-42; when dilator is removed after placement); the sheath (102) including a composite tube (102; Fig 1, 1A) extending between a valve (col 4, lns 40-42; and a tip (104), and the composite tube includes a braid (134) with a hollow cylindrical shape (134; Fig 1a) sandwiched between, and in contact with, an inner polymer tube (132) and an outer thermoplastic tube (136); the tip including a radiopaque marker (104; the tip may be radiopaque col 10, ln 37-39), and a crosslinked polymer sleeve (124; sleeve is polymeric and crosslinks to the polymeric tip and shaft at the butt joint; see col 4, lns 59-60; see also illustration of assembly in Fig 8 and 10, with bonding step 1025; col 6, lns 33-36, col 10, lns 19-23, and col 11, lns 1-2) that receives a distal segment of the composite tube and at least partially receives the radiopaque marker (Fig 1; 124 overlaps the tip-shaft joint to strengthen the joint – col 4, lns 59-60; see also illustration of assembly in Fig 8 and 10; col 6, lns 33-36, col 10, lns 19-23, and col 11, lns 1-2. The examiner notes that the term “receives” has been interpreted to taught by the radial overlapping of the composite tube and tip by the polymer sleeve); an outer surface of the crosslinked polymer sleeve has a flush transition to an outer surface of the composite tube at a proximal end of the crosslinked polymer sleeve (Fig 1; transition from 102 to 104 across 124 is flush along its outer surface), and a distal portion of the crosslinked polymer sleeve extends distally beyond a distal end of the inner polymer tube (Fig 1; 124 overlaps the tip-shaft joint to strengthen the joint – col 4, lns 59-60 and thus 124 has a distal portion that extends distally beyond a distal end of 132 which ends at the butt joint connection to 104). However, Cise does not expressly disclose the tip being a radiopaque loaded thermoplastic and the radiopaque marker having a tapered segment that is distal to the flush transition. Katsurada teaches that it is known to have a tip (7) of an introducer (catheter 1 is an introducer capable of delivery a guidewire; Fig 2; P27), where the tip is a radiopaque loaded thermoplastic (7 may be a polyurethane elastomer mixed with tungsten powder (P31-P35) and a the tip having a tapered segment distal a flush transition (Fig 2; tip 7 is tapered along its length) for the purpose of enhancing the visibility of the distal tip under x-ray fluoroscopy (P35) and improving insertability during treatment (P12-P13 and P39). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the radiopaque tip as taught by Cise to be a tungsten loaded thermoplastic tapered radiopaque tip as taught by Katsurada for the purpose of enhancing the visibility of the distal tip under x-ray fluoroscopy (P35) and improving insertability during treatment (P12-P13 and P39). The examiner notes that the modification would result in a tapered segment distal to the flush transition as modifying 104 of Cise to be a tapered towards it tip would have a taper distal to the flush transition at 124. Regarding claim 2-3, Cise as modified by Katsurada discloses wherein the radiopaque marker abuts the distal end of the braid and the inner polymer tube (Fig 1; 104 and 108 form a butt joint so the distal end of braid 134 and distal end of 132 abuts 104; see col 4, lns 58-60). Regarding claim 4, Cise as modified by Katsurada discloses wherein the tapered segment of the radiopaque marker is in contact with a tapered segment of the crosslinked polymer sleeve (as modified, tip 104 is a tapered tip in view of Katsurada so the overlapping portion of 124 over 104 would form a tapered segment of the crosslinked polymer sleeve that contacts the tapered segment of the radiopaque marker). Regarding claim 6, Cise as modified by Katsurada discloses wherein the crosslinked polymer sleeve is opaque (Fig 1; 124 is a polymeric sleeve – see citations above in claim 1 that disclosed as being transparent). Regarding claim 8, Cise as modified by Katsurada discloses wherein the radiopaque marker is positioned distally of a distal end of the inner polymer tube (104 is distal to 132; Fig 1; see col 4, lns 58-60); the radiopaque marker has a tapered segment in contact with the tapered segment of the crosslinked polymer sleeve (as modified, tip 104 is a tapered tip in view of Katsurada so the overlapping portion of 124 over 104 would form a tapered segment of the crosslinked polymer sleeve that contacts the tapered segment of the radiopaque marker; and the radiopaque marker is a tungsten loaded material (Katsurada discloses 7 may be a polyurethane elastomer mixed with tungsten powder (P31-P35) see discussion and modification above in claim 1). Regarding claim 9, Cise as modified by Katsurada discloses the invention substantially as claimed as set forth and discussed above in claim 1. Regarding claims 10-11, Cise as modified by Katsurada discloses wherein the radiopaque marker is entirely positioned distally of a distal end of the inner polymer tube and wherein the radiopaque marker abuts a distal end of the inner polymer tube (see discussion above in claims 2-3; here 104 is entirely positioned distally of the distal end of 132 and abuts it by the disclosure of the butt-joint between 104 and 108). Regarding claim 12, Cise as modified by Katsurada discloses wherein the radiopaque marker is a tungsten loaded material (Katsurada discloses 7 may be a polyurethane elastomer mixed with tungsten powder (P31-P35)). Regarding claim 13, Cise as modified by Katsurada discloses wherein the tapered segment of the radiopaque marker is in mold contact with an inner surface of a tapered segment of the crosslinked polymer sleeve (as modified 104 is tapered and the portion overlapped by the 124 would be tapered as well and in mold contact with each other. Applicant is strongly advised to further structurally define the respective structures and connections therebetween). Regarding claim 16, Cise as modified by Katsurada discloses wherein the tip has a rest inner diameter that is smaller than an inner diameter of the inner polymer tube (as modified, 104 is tapered such that its distal end would have a smaller inner diameter than the inner diameter of 132; see e.g., how see Fig 2 of Katsurada where inner diameter of 7 at 2 is smaller than the inner diameter of the shaft by 6a). Regarding claim 17, Cise as modified by Katsurada discloses wherein the radiopaque marker is positioned distally of a distal end of the inner polymer tube (Fig 1; 104 is distal to distal end of 132 via the butt-joint connection). Regarding claim 18, Cise as modified by Katsurada discloses wherein the tapered segment of the radiopaque marker is in mold contact with an inner surface of a tapered segment of the crosslinked polymer sleeve (as modified 104 is tapered and the portion overlapped by the 124 would be tapered as well and in mold contact with each other. Applicant is strongly advised to further structurally define the respective structures and connections therebetween). Regarding claim 19, Cise as modified by Katsurada discloses the invention substantially as claimed as set forth and discussed above in claim 1, including the introducer sheath being a work-in-progress introducer sheath (here this limitation is taught in a number of ways. For example, the introducer sheath 100; Fig 1 of Cise as modified by Katsurada as set forth above is fully capable of performing work/treatment. Additionally, and/or alternatively, Cise discloses manufacture steps to produce the final structure of the introducer sheath (e.g. Figs 7-8, 10). Additionally, Cise discloses a peel away tube covering, and in contact with, a distal segment of the composite tube, the flush transition, and the cross-linked polymer sleeve (FEP shell 349; Fig 8; shell 349 encompasses the tip, cuff, and sheath shaft and may be heated to cause the shell to shrink and apply pressure while the tip, cuff, and sheath shaft are melted and bonded together. See col 10, lns 17-32. The examiner notes that FEP shell is removable (col 10, ln 62) and is fully capable of being peeled away when removed. The examiner notes the scope of “peel away” would include the capability of the covering to be cut and then peeled away. Additionally, see alternative rejection below. Regarding claim 20, Cise as modified by Katsurada discloses wherein the tip includes a segment with five layers that includes a portion of the inner polymer tube, a portion of the braid, a portion of the thermoplastic tube, a portion of the crosslinked polymer sleeve and a portion of the peel away tube (See Fig 1 and Fig 9. Here, the tip 104 is joined to the inner polymer tube, braid, thermoplastic tube (e.g. shaft 108 with 132, 134, 136) as a butt-joint with polymer sleeve 124 overlapping the joint. The peel away tube 349 covers the butt-joint and thus the tip has a segment with five layers – 132, 134, 136, 124, and 349). Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cise et al (11191566) (“Cise”) in view of Katsurada et al (2020/0276413) (“Katsurada”) as applied to claim 1, in further view of Haarer (9757541). Regarding claim 5, Cise as modified by Katsurada does not expressly disclose wherein the tip has a rest inner diameter that is smaller than an outer diameter of the dilator where the tip contacts the dilator in the first configuration. Cise as modified by Katsurada does disclose wherein the tip has a rest inner diameter that is smaller than an inner diameter of the inner polymer tube (as modified, 104 is tapered such that its distal end would have a smaller inner diameter than the inner diameter of 132; see e.g., how see Fig 2 of Katsurada where inner diameter of 7 at 2 is smaller than the inner diameter of the shaft by 6a). Typically, an outer diameter of the dilator is going to be similar sized or smaller than the inner diameter of the inner polymer tube. So as modified the taper of 104 at the distal tip is likely smaller than an outer diameter of a dilator that is capable of being placed through the sheath such that the tip is fully capable of contacting the dilator in the first configuration. Additionally and/or alternatively, Haarer teaches that it is known to have a dilator system (Summary; 100), having an introducer sheath (107; Fig 4B) having a tip (302) with a rest inner diameter smaller than that of an outer diameter of a dilator (103) where the tip contacts the dilator (302 contacting 103 in Fig 4B; see col 10, lns 62-col 11, lns 13) for the purpose of providing a smooth transition between the sheath and the dilator and helping to prevent ovalization of the sheath distal tip (col 10, lns 62-col 11, lns 13). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distal tip as taught by Cise and Katsurada with the tapered distal tip of smaller diameter than the dilator introduced through the sheath as taught by Haarer for the purpose of providing a smooth transition between the sheath and the dilator and helping to prevent ovalization of the sheath distal tip (col 10, lns 62-col 11, lns 13). Claims 7 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cise et al (11191566) (“Cise”) in view of Katsurada et al (2020/0276413) (“Katsurada”) as applied to claim 1 and 13 above respectively, and in further view of Deckman et al (8702679) (“Deckman”). Cise and Katsurada disclose the invention substantially as claimed except for wherein a distal end segment of the tip includes exactly one layer, which is a portion of the crosslinked polymer sleeve. Deckman teaches that it is known to have an introducer system (Fig 1) having a sheath catheter 300 having a composite tube with an inner tube 303, braid 302, and outer tube 310 (Fig 3e) with a radiopaque marker 311 and an crosslinked polymer sleeve 313 that forms a distal end segment of a tip (Fig 3e) including exactly one layer (layer of 313 at distal end distal to 311), which is a portion of the crosslinked polymer sleeve (313) for the purpose of providing a distal tip of low durometer to provide an atraumatic tip (col 14, lns 51-56; col 17, lns 15-18). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the crosslinked polymer sleeve and tip as taught by Cise in view of Katsurada with the tip formed just of a single layer of the crosslinked polymer sleeve as taught by Deckman for the purpose of providing a distal tip of low durometer to provide an atraumatic tip (col 14, lns 51-56; col 17, lns 15-18). As modified, the crosslinked polymer sleeve 124 of Cises in view of Katsurada would extend distal of the radiopaque tip 104 such that 124 forms the distal end of the tip as taught by Deckman. Regarding claim 15, Cise as modified by Katsurada and Deckman, discloses wherein the crosslinked polymer sleeve is opaque (Fig 1; 124 is a polymeric sleeve – see citations above in claim 1 that disclosed as being transparent). Claims 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cise et al (11191566) (“Cise”) in view of Katsurada et al (2020/0276413) (“Katsurada”), in further view of Stigall et al (9149600). In the addition and/or alternative to the rejection of claims 19-20 above over Cise in view of Katsurada, in the event that the FEP shell 349 of Cise is found to not be a peel away heat shrink tube, Stigall et al teaches that it is known to have a distal catheter tip having a peel away tube (shrink tube 150; peel away – see col 4, lns 66-col 5, ln 1), and in contact with, a distal segment of the composite tube (148), the flush transition (142/144), and the crosslinked polymer sleeve (120; Fig 5) for the purpose of bonding the segments together while constraining the flow of materials so they fuse together to form a composite tip (col 5, lns 27-32). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the FEP shell as taught by Cise in view of Katsurada to be the peel away tube shrink tubing as taught by Stigall et al for the purpose of improving the bonding the segments together while constraining the flow of materials so they fuse together to form a composite tip (col 5, lns 27-32). Regarding claim 20, Cise as modified by Katsurada and Stigall et al discloses wherein the tip includes a segment with five layers that includes a portion of the inner polymer tube, a portion of the braid, a portion of the thermoplastic tube, a portion of the crosslinked polymer sleeve and a portion of the peel away tube (See Fig 1 and Fig 9. Here, the tip 104 is joined to the inner polymer tube, braid, thermoplastic tube (e.g. shaft 108 with 132, 134, 136) as a butt-joint with polymer sleeve 124 overlapping the joint. The peel away shrink tubing 150 taught by Stigall et al would cover the butt-joint and thus the tip has a segment with five layers – 132, 134, 136, 124, and 150 in view of Stigall et al). Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO 892 form. Specifically: Tapered radiopaque tips: 20120310212, 20060095050, 20230172658 Flush tip with crosslinked sleeve: 20020156459, 8235968, 20230240694, 11623067, 20190366036, 10046138, EP3056238 Introducer: 20190344051 Shrink tubing: 11000670 Relevant: 20250249205, EP1062965 (cited by EPO, no radiopaque taper or flush transition) To expedite prosecution in the event the applicant has any questions or proposed claim amendments to discuss the applicant is invited to contact the examiner at the telephone number listed below. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew M. Gilbert whose telephone number is (571)272-7216. The examiner can normally be reached 9:00 am - 5:30 pm (EST), Monday - Friday. 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, Thomas Barrett can be reached at 571-272-4726. 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. /ANDREW M GILBERT/Primary Examiner, Art Unit 3700
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Prosecution Timeline

Jul 25, 2023
Application Filed
Jan 10, 2026
Non-Final Rejection — §103
Mar 26, 2026
Applicant Interview (Telephonic)
Mar 31, 2026
Applicant Interview (Telephonic)
Apr 01, 2026
Examiner Interview Summary

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Prosecution Projections

1-2
Expected OA Rounds
64%
Grant Probability
94%
With Interview (+29.8%)
4y 0m
Median Time to Grant
Low
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