Prosecution Insights
Last updated: August 17, 2026
Application No. 17/053,139

APPARATUS AND METHODS FOR PUNCTURING TISSUE

Final Rejection §103
Filed
Nov 05, 2020
Priority
May 08, 2018 — provisional 62/668,396 +1 more
Examiner
PREMRAJ, CATHERINE C
Art Unit
3794
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Boston Scientific Corporation
OA Round
7 (Final)
56%
Grant Probability
Moderate
8-9
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 56% of resolved cases
56%
Career Allowance Rate
115 granted / 204 resolved
-13.6% vs TC avg
Strong +48% interview lift
Without
With
+48.4%
Interview Lift
resolved cases with interview
Typical timeline
4y 2m
Avg Prosecution
51 currently pending
Career history
264
Total Applications
across all art units

Statute-Specific Performance

§101
1.0%
-39.0% vs TC avg
§103
59.2%
+19.2% vs TC avg
§102
19.1%
-20.9% vs TC avg
§112
16.1%
-23.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 204 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 . 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. 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. 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. Claim(s) 65-66, 70, and 78 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urbanski et al., (US 20140206987; hereinafter Urbanski) in view of Newton et al., (US 5688269; hereinafter Newton), Visram et al., (US 20050159738; hereinafter Visram), and Godara et al., (US 20160235471; hereinafter Godara). Regarding claim 65, Urbanski (Figures 3C, 7A, and 8) discloses a kit comprising an introducer (800) and an elongate puncture device (100), the elongate puncture device (100) including a distal tip electrode (106) which enables recording epicardial EGM and a shaft (102) of the elongate puncture device (100) is electrically insulated (by the introducer 800) to reduce noise in any collected local EGM; wherein the introducer (800) comprises an introducer shaft (shat of introducer 800) having a lumen configured to movably receive the elongate puncture device (100), the introducer shaft (shaft of introducer 800) connected to a hub (108), ([0047]-[0048], [0055], [0067]-0072], [0096], [0131]), and the kit further comprises: a distal tip marker (812) which is visible under a fluoroscopy imaging system for positioning the elongate puncture device (100) relative to the introducer (800) and a distal end marker (819) of the introducer (800) which is visible under the fluoroscopy imaging system ([0069], [0078], [0084], [0130]). Urbanski fails to disclose the introducer shaft comprising an internal metal tube which is interposed between two layers of electrical insulation with both ends of the two layers being joined together to bond the layers to reduce noise in any EGM collected by the elongate puncture device. However, Newton (Figure 8) teaches a kit comprising an introducer (68) and an elongate internal device (14), the introducer shaft comprising an internal metal tube (20) which is electrically isolated and interposed between two layers of electrical insulation (22, 70) with both ends of the two layers (22, 70) being joined together to bond the layers (22, 70), such that electrical insulation is on an inside of the lumen and an outside surface of the introducer shaft (Col. 8, lines 28-50). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Urbanski to include the introducer shaft comprising an internal metal tube which is interposed between two layers of electrical insulation with both ends of the two layers being joined together to bond the layers such that electrical insulation is on an inside of the lumen and an outside surface of the introducer shaft, as taught by Newton, because the modification would provide a safety shield assembly for the kit (Newton; Col. 8, lines 28-50). Furthermore, since the modified kit would include this safety shield assembly, it would reduce noise in any EGM collected by the elongate puncture device in the modified kit. Urbanski/Newton fails to teach that the electrical insulation creates a space that decreases towards a distal end of the introducer shaft. However, Visram (Figures 1-4) teaches an electrosurgical device in which the insulation of an introducer (104) creates a space (200) which decreases towards a distal end of an introducer shaft (204), ([0035]-[0036], [0043]). It would have been an obvious matter of design choice to substitute the straight space taught by Urbanski/Newton with the space that decreases towards a distal end of the introducer shaft, as taught by Visram, since applicant has not disclosed that having a space that decreases towards a distal end of the introducer shaft solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of a space that decreases towards a distal end of the introducer shaft, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. Furthermore, since the space would decrease toward a distal end of the introducer shaft in the modified device, there would be a tighter fit between the elongate puncture device and the introducer shaft at the distal end of the introducer shaft. Urbanski/Newton/Visram fails to teach that the elongate puncture device includes a proximal marker for positioning the elongate puncture device relative to the introducer, the proximal marker including a distal end and a proximal end; the proximal marker is positioned on the elongate body such that when the distal end of the proximal marker of the elongate puncture device is observable as being positioned at a proximal end of a hub of the introducer, a tip of the elongate puncture device is located inside of the lumen of the introducer shaft, and when the proximal end of the proximal marker of the elongate puncture device is observable as being positioned at the proximal end of the hub of the introducer, the tip of the elongate puncture device extends distal of or lines up with a distal end of a shaft of the introducer shaft. However, Godara (Figures 1 and 3a-3d) teaches an elongate puncture device (130) including a proximal marker (138) for positioning the elongate puncture device (130) relative to an introducer (100); and wherein the proximal marker (138) is positioned on the elongate body of the puncture device (130) such that when the proximal marker (138) of the elongate puncture device (130) is observable as being positioned at a proximal end of a hub (106) of the introducer (100), a tip of the elongate puncture device (130) extends distal of or lines up with a distal end of a shaft of the introducer shaft (100), ([0028-[0029]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Urbanski/Newton/Visram to include a proximal marker for positioning the elongate puncture device relative to the introducer; and wherein the proximal marker is positioned on the elongate body such that when the proximal marker of the elongate puncture device is visible to a naked eye as being positioned at a proximal end of a hub of the introducer, a tip of the elongate puncture device extends distal of or lines up with a distal end of a shaft of the introducer shaft, as taught by Godara, because the modification would indicate the location of the puncture device in the target area relative to the introducer (Godara; [0028]), aiding in the traversal and proper location of the device and its associated elements in the target area. Furthermore, the proximal marker of the modified device would be at the proximal end of the hub when the elongate puncture device (100) is fully inserted into the introducer (800) such that the distal tip marker (812) is at the distal end marker (819), as shown in Figure 7A of Urbanski. Therefore, in the modified device, when the proximal end of the proximal marker is at the proximal end of the hub, the distal tip marker is at the distal end marker and the tip of the elongate puncture device would be located inside of the lumen of the introducer shaft, and when the proximal end of the proximal marker of the elongate puncture device is observable as being positioned at the proximal end of the hub of the introducer, the tip of the elongate puncture device would extend distal of the distal end of the introducer shaft. Regarding claim 66, Urbanski (Figures 3C, 7A, and 8) further discloses that the introducer (800) and the elongate puncture device (100) are configured such that the introducer (800) has the ability to deliver and withdraw fluid while the elongate puncture device (100) is inserted therethrough ([0047]-[0048], [0055], [0067]-0072], [0096], [0131]). Regarding claim 70, Urbanski (Figures 3C, 7A, and 8) further discloses a stylet (104) wherein a cross section of the stylet (104) varies along a length of the stylet (104), tapering down towards a distal tip of the stylet (104) to allow a flow of a fluid through a tip of the introducer (800) when the stylet (104) is installed ([0047]-[0048], [0055], [0067]-0072], [0096], [0131]); and the stylet (104) is electrically insulated and operable to be connected to a recording system to facilitate collecting EGM information to help in positioning a tip of the introducer when approaching a heart ([0041]-[0042], [0055], [0098], [0123]). Regarding claim 78, Urbanski (Figures 3C, 7A, and 8) further discloses that the elongate puncture device (100) comprises a radiofrequency guidewire ([0130]). Claim(s) 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urbanski in view of Newton, Visram, and Godara. Regarding claim 67, Urbanski/Newton/Visram/Godara fails to teach that there is a radial gap between an inner diameter of a tip of the introducer and outer diameter of the elongate puncture device, and wherein an inner diameter of a tip of the introducer is 0.978 mm (.0385 inches) +/- 0.013 mm (.0005 inches), and an maximum outer diameter of the elongate puncture device (100) is 0.889 mm (.0350 inches) +/- 0.013 mm (.0005 inches), whereby a minimum radial gap with this geometry is 0.032 mm (.00125"). However, Urbanski discloses a tubular member defining a lumen about 0.0325 inches (0.82 mm) to about 0.0335 inches (0.85 mm), ([0072]). The claimed range and the range disclosed by Urbanski are so mathematically close that the difference between the two ranges is virtually negligible absent any showing of unexpected results or criticality, and it has been found that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. MPEP 2144.05.I. Claim(s) 79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urbanski in view of Newton, Godara, and Kurth et al., (US 20090105654; hereinafter Kurth). Regarding claim 79, Urbanski (Figures 3C, 7A, and 8) discloses a kit for puncturing tissue comprising: an elongate puncture device (100) including a distal tip electrode (106) which enables recording epicardial EGM and a shaft (102) of the elongate puncture device (100) is electrically insulated (by the introducer 800) to reduce noise in any collected local EGM; wherein: an introducer (800) comprises an introducer shaft which is connected to a hub (108), ([0047]-[0048], [0055], [0067]-[0072], [0096], [0131]), and the kit further comprises: a distal tip marker (812) which is visible under a fluoroscopy imaging system for positioning the elongate puncture device (100) relative to the introducer (800) and a distal end marker (819) of the introducer (800) which is visible under the fluoroscopy imaging system ([0069], [0078], [0084], [0130]). Urbanski fails to disclose that there is a radial gap between an inner diameter of a tip of the introducer and outer diameter of the elongate puncture device, and wherein an inner diameter of a tip of the introducer is 0.978 mm (.0385 inches) +/- 0.013 mm (.0005 inches), and an maximum outer diameter of the elongate puncture device (100) is 0.889 mm (.0350 inches) +/- 0.013 mm (.0005 inches), whereby a minimum radial gap with this geometry is 0.032 mm (.00125"). However, Urbanski discloses a tubular member defining a lumen about 0.0325 inches (0.82 mm) to about 0.0335 inches (0.85 mm), ([0072]). The claimed range and the range disclosed by Urbanski are so mathematically close that the difference between the two ranges is virtually negligible absent any showing of unexpected results or criticality, and it has been found that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. MPEP 2144.05. Urbanski fails to teach the introducer shaft comprising an internal metal tube which is interposed between two layers of electrical insulation with both ends of the two layers being joined together to bond the two layers to reduce noise in any EGM collected by the elongate puncture device. However, Newton (Figure 8) teaches a kit comprising an introducer (68) and an elongate internal device (14), the introducer shaft comprising an internal metal tube (20) which is interposed between two layers of electrical insulation (22, 70) with both ends of the two layers (22, 70) being joined together to bond the layers (22, 70), (Col. 8, lines 28-50). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Urbanski to include the introducer shaft comprising an internal metal tube which is interposed between two layers of electrical insulation with both ends of the two layers being joined together to bond the layers, as taught by Newton, because the modification would provide a safety shield assembly for the kit (Newton; Col. 8, lines 28-50). Furthermore, since the modified kit would include this safety shield assembly, it would reduce noise in any EGM collected by the elongate puncture device in the modified kit. Urbanski/Newton/Visram fails to teach that the elongate puncture device includes a proximal marker for positioning the elongate puncture device relative to the introducer, the proximal marker including a distal end and a proximal end; the proximal marker is positioned on the elongate body such that when the distal end of the proximal marker of the elongate puncture device is observable as being positioned at a proximal end of a hub of the introducer, a tip of the elongate puncture device is located inside of the lumen of the introducer shaft, and when the proximal end of the proximal marker of the elongate puncture device is observable as being positioned at the proximal end of the hub of the introducer, the tip of the elongate puncture device extends distal of or lines up with a distal end of a shaft of the introducer shaft. However, Godara (Figures 1 and 3a-3d) teaches an elongate puncture device (130) including a proximal marker (138) for positioning the elongate puncture device (130) relative to an introducer (100); and wherein the proximal marker (138) is positioned on the elongate body of the puncture device (130) such that when the proximal marker (138) of the elongate puncture device (130) is observable as being positioned at a proximal end of a hub (106) of the introducer (100), a tip of the elongate puncture device (130) extends distal of or lines up with a distal end of a shaft of the introducer shaft (100), ([0028-[0029]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Urbanski/Newton/Visram to include a proximal marker for positioning the elongate puncture device relative to the introducer; and wherein the proximal marker is positioned on the elongate body such that when the proximal marker of the elongate puncture device is visible to a naked eye as being positioned at a proximal end of a hub of the introducer, a tip of the elongate puncture device extends distal of or lines up with a distal end of a shaft of the introducer shaft, as taught by Godara, because the modification would indicate the location of the puncture device in the target area relative to the introducer (Godara; [0028]), aiding in the traversal and proper location of the device and its associated elements in the target area. Furthermore, the proximal marker of the modified device would be at the proximal end of the hub when the elongate puncture device (100) is fully inserted into the introducer (800) such that the distal tip marker (812) is at the distal end marker (819), as shown in Figure 7A of Urbanski. Therefore, in the modified device, when the proximal end of the proximal marker is at the proximal end of the hub, the distal tip marker is at the distal end marker and the tip of the elongate puncture device would be located inside of the lumen of the introducer shaft, and when the proximal end of the proximal marker of the elongate puncture device is observable as being positioned at the proximal end of the hub of the introducer, the tip of the elongate puncture device would extend distal of the distal end of the introducer shaft. Urbanski (Figures 3C, 7A, and 8) further discloses that the electrode (106) includes a radiopaque marker (810) and a dome of the electrode (106) is distal to the radiopaque marker (810), ([0047]-[0048], [0055], [0067]-0072], [0096], [0131]), but Urbanski/Newton/Godara fails to teach that the elongate puncture device includes a radiopaque coil covered by insulation extending around a curve of a distal end portion, wherein the radiopaque marker is distal to the radiopaque coil. However, Kurth (Figures 10-11) teaches an elongate device including a radiopaque coil (225) extending around a distal end portion (224) which is positioned proximal to the distal tip of the device ([0102]-[0104]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Urbanski/Newton/Godara to include a radiopaque coil extending around a distal end portion, as taught by Kurth, because the modification would provide imaging/locating of not only the distal electrode, but the entire distal end portion as well (Kurth; [0102]-[0104]) to provide tracking of the entire distal portion of the device. Furthermore, the modified device would include a radiopaque coil extending around a distal end portion (Urbanski; Figure 8; 212), which has a curved configuration as shown in Figure 8. Therefore, the radiopaque coil would extend around the curve of the distal end portion 212 in the modified device. Additionally, the radiopaque marker (810) of the electrode (106) in Figure 7A of Urbanski would be distal to the distal end portion (212; Figure 8) including the radiopaque coil as taught by Kurth. Therefore, the radiopaque marker (810) would be distal to the radiopaque coil of the distal end portion (212) in the modified device. Finally, since the modified device would include the insulation taught by Newton, the radiopaque coil would be covered by insulation. Claim(s) 89 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urbanski/Newton/Visram/Godara, as applied to claim 65, and further in view of Bagaoisan et al., (US 20140018732; hereinafter Bagaoisan). Regarding claim 89, Urbanski/Newton/Visram/Godara teaches the kit of claim 65, but fails to teach wherein the proximal marker is a tactile marker. However, Bagaoisan (Figure 7A-7B) teaches an elongate puncture system ([0008]-[0009]) comprising tactile markers (703), ([0129]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the markers taught by Urbanski/Newton/Visram/Godara with the tactile markers taught by Bagaoisan since both markers perform the same function of indicating the configuration of the distal end of the elongate member within an introducer, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B). Claim(s) 90 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urbanski/Newton/Godara/Kurth, as applied to claim 79, and further in view of Bagaoisan. Regarding claim 90, Urbanski/Newton/Godara/Kurth teaches the kit of claim 79, but fails to teach wherein the proximal marker is a tactile marker. However, Bagaoisan (Figure 7A-7B) teaches an elongate puncture system ([0008]-[0009]) comprising tactile markers (703), ([0129]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the markers taught by Urbanski/Newton/Godara/Kurth with the tactile markers taught by Bagaoisan since both markers perform the same function of indicating the configuration of the distal end of the elongate member within an introducer, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B). Claim(s) 93 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urbanski/Newton/Visram/Godara/Bagaoisan, as applied to claim 65, and further in view of Kume et al., (US 20170296798; hereinafter Kume). Regarding claim 93, Urbanski/Newton/Visram/Godara/Bagaoisan teaches the kit of claim 89, but fails to teach wherein the proximal marker is formed by laser etching. However, Kume (Figures 19A-19B) teaches an elongate puncture device comprising a depth indicator marker (124) formed by laser etching ([0018], [0086]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Urbanski/Newton/Visram/Godara/Bagaoisan to include the markers, including the proximal markers, formed by laser etching, as taught by Kume, since the known methods/devices of Urbanski/Newton/Visram/Godara/Bagaoisan and Kume achieve the same result of providing a tracking marker (Godara, [0028]-[0029]; Kume, [0018]). Therefore, the combined method/device including the teachings of Urbanski/Newton/Visram/Godara/Bagaoisan and Kume, as mentioned above, would yield the same predictable result of providing a tracking marker, and it has been held that combining known methods/devices which yield the same predictable result is obvious to one of ordinary skill in the art. MPEP2143.I.A. Claim(s) 94 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urbanski/Newton/Godara/Kurth/Bagaoisan, as applied to claim 79, and further in view of Kume. Regarding claim 94, Urbanski/Newton/Godara/Kurth/Bagaoisan teaches the kit of claim 89, but fails to teach wherein the proximal marker is formed by laser etching. However, Kume (Figures 19A-19B) teaches an elongate puncture device comprising a depth indicator marker (124) formed by laser etching ([0018], [0086]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Urbanski/Newton/Godara/Kurth/Bagaoisan to include the markers, including the proximal markers, formed by laser etching, as taught by Kume, since the known methods/devices of Urbanski/Newton/Godara/Kurth/Bagaoisan and Kume achieve the same result of providing a tracking marker (Godara, [0028]-[0029]; Kume, [0018]). Therefore, the combined method/device including the teachings of Urbanski/Newton/Godara/Kurth/Bagaoisan and Kume, as mentioned above, would yield the same predictable result of providing a tracking marker, and it has been held that combining known methods/devices which yield the same predictable result is obvious to one of ordinary skill in the art. MPEP2143.I.A. Response to Arguments Applicant's arguments filed 01/02/2026 have been fully considered but they are not persuasive. With regard to Applicant’s argument that the cited references fail to disclose/teach the newly amended limitations “the introducer comprises an introducer shaft having a lumen configured to movably receive the elongate puncture device, the introducer shaft is connected to a hub, the introducer shaft comprising an internal metal tube which is electrically isolated and interposed between two layers of electrical insulation with both ends of the two layers being joined together to bond the two layers such that electrical insulation is on an inside of the lumen and an outside surface of the introducer shaft, the introducer shaft is configured to reduce noise in any EGM collected by the elongate puncture device, wherein the electrical insulation creates a space that decreases towards a distal end of the introducer shaft such that there is a tighter fit between the elongate puncture device and the introducer shaft at the distal end of the introducer shaft; the elongate puncture device includes a proximal marker for positioning the elongate puncture device relative to the introducer, the proximal marker including a distal end and a proximal end; the proximal marker is positioned on the elongate body such that when the distal end of the proximal marker of the elongate puncture device is observable as being positioned at a proximal end of a hub of the introducer, a tip of the elongate puncture device is located inside of the lumen of the introducer shaft, and when the proximal end of the proximal marker of the elongate puncture device is observable as being positioned at the proximal end of the hub of the introducer, the tip of the elongate puncture device extends distal of the distal end of the introducer shaft…and wherein when the proximal end of the proximal marker is at the proximal end of the hub, the distal tip marker is at the distal end marker” in independent claim 65, as well as similar new amendments in independent claim 79, Examiner respectfully disagrees. Urbanski (Figure 7A) discloses the introducer shaft (shaft of introducer 800) having a lumen configured to movably receive the elongate puncture device (100), ([0069], [0078], [0084], [0130]). Furthermore, Newton teaches the introducer comprising an internal metal tube electrically isolated and interposed between two layers of insulation, wherein the electrical insulation creates a space that decreases towards a distal end of the introducer shaft such that there is a tighter fit between the elongate puncture device and the introducer shaft at the distal end of the introducer shaft (Col. 8, lines 28-50). Finally, Godara teaches a proximal marker for depth indication at the proximal end of the elongate puncture device. Therefore, the proximal marker of the modified device would be at the proximal end of the hub when the elongate puncture device (100) is fully inserted into the introducer (800) such that the distal tip marker (812) is at the distal end marker (819), as shown in Figure 7A of Urbanski. In the modified device of the combination, when the distal end of the proximal marker of the elongate puncture device is observable as being positioned at a proximal end of a hub of the introducer, a tip of the elongate puncture device would be located inside of the lumen of the introducer shaft, and when the proximal end of the proximal marker of the elongate puncture device is observable as being positioned at the proximal end of the hub of the introducer, the tip of the elongate puncture device would extend distal of or line up with a the distal end of a shaft of the introducer shaft; and wherein when the proximal end of the proximal marker is at the proximal end of the hub, the distal tip marker is at the distal end marker. Accordingly, Examiner maintains that the Urbanski/Newton/Visram/Godara combination teaches the invention as claimed at least in amended independent claim 65 and the Urbanski/Newton/Godara/Kurth combination teaches the invention as claimed at least in amended independent claim 79. Conclusion THIS ACTION IS MADE FINAL. 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 CATHERINE PREMRAJ whose telephone number is (571)272-8013. The examiner can normally be reached Monday - Friday: 8:00 AM - 5:00 PM. 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, Joseph Stoklosa can be reached at 571-272-1213. 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. /C.C.P./Examiner, Art Unit 3794 /EUN HWA KIM/Primary Examiner, Art Unit 3794
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Prosecution Timeline

Show 14 earlier events
Mar 18, 2025
Response after Non-Final Action
Apr 29, 2025
Final Rejection mailed — §103
Jul 01, 2025
Response after Non-Final Action
Jul 28, 2025
Request for Continued Examination
Aug 01, 2025
Response after Non-Final Action
Oct 01, 2025
Non-Final Rejection mailed — §103
Jan 01, 2026
Response Filed
May 05, 2026
Final Rejection mailed — §103 (current)

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Prosecution Projections

8-9
Expected OA Rounds
56%
Grant Probability
99%
With Interview (+48.4%)
4y 2m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 204 resolved cases by this examiner. Grant probability derived from career allowance rate.

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