Prosecution Insights
Last updated: April 19, 2026
Application No. 18/108,099

IMPLANTABLE MEDICAL DEVICE WITH OPPOSING BARBS FOR BI-DIRECTIONAL STABILITY

Final Rejection §103
Filed
Feb 10, 2023
Examiner
KHANDKER, RAIHAN R
Art Unit
3771
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
BOSTON SCIENTIFIC CORPORATION
OA Round
4 (Final)
64%
Grant Probability
Moderate
5-6
OA Rounds
2y 11m
To Grant
99%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allow Rate
100 granted / 157 resolved
-6.3% vs TC avg
Strong +60% interview lift
Without
With
+60.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
61 currently pending
Career history
218
Total Applications
across all art units

Statute-Specific Performance

§101
1.4%
-38.6% vs TC avg
§103
48.6%
+8.6% vs TC avg
§102
21.4%
-18.6% vs TC avg
§112
23.3%
-16.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 157 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 . Response to Arguments Applicant's arguments, see pages 6-7, filed 12/19/2025, with regards to the rejection of claim 1 under 35 U.S.C. 103 as being unpatentable over Wu et al (US 20150342612 A1), herein referenced to as “Wu” in view of Inouye et al (US 20180310925 A1), herein referenced to as “Inouye” have been fully considered but they are not persuasive. The applicant argues that there is no motivation to modify Wu with Inouye and that “as an occlusive element can promote endothelization after implantation” would not motivate a person of ordinary skill in the art, herein referenced to as “PHOSITA”. The applicant argues that since Wu teaches the occluder 19 completely covers the entrance of the left atrial appendage (LAA) “thereby realizing the effect of completely occluding the left atrial appendage” that a PHOSITA would recognize that adding the membrane of Inouye to stent 1 of Wu for the same person would be redundant to the function of Wu. The examiner respectfully disagrees. Endothelization would be introduced within the LAA where the stent 1 of Wu is inserted into. Thus, in this modification, this would better anchor the device of Wu within the LAA, and not just around the ostium where the device is anchored against. Hence, the added functionality is not redundant. The applicant additionally asserts that the Office wishes to assert that the alleged benefit of endothelization is “new” to Wu within the addition of the membrane of Inouye. The applicant further asserts that Wu teaches a membrane made of PET or PTFE, hence Wu would already provide the same endothelization benefit. The examiner respectfully disagrees, as this would be in a different location than with the combination with Inouye, as the benefit would only extend to the portion of the device of Wu that is in the left atrium, not the left atrial appendage which the combination with Inouye would provide. The applicant poses the same arguments for independent claims 10 and 19. For the same reasons, the examiner respectfully disagrees. Applicant's arguments, see pages 8-9, filed 12/19/2025, with regards to the rejection of claim 19 under 35 U.S.C. 103 as being unpatentable over Wu et al (US 20150342612 A1), herein referenced to as “Wu” in view of Inouye et al (US 20180310925 A1), herein referenced to as “Inouye” have been fully considered but they are not wholly persuasive. The applicant argues that in claim 19, the combination of Wu and Inouye does not explicitly teach that expandable frame is braided or a “expandable braided frame”. The applicant cites that the stent of Wu is formed by laser cutting a nickel-titanium memory alloy tube ([0055]). However, Wu teaches that the expandable frame comprises a nitinol/nickel-titanium material (see [0055]), but does not teach that it is formed via braiding. The claimed phrase “an expandable braided frame” is being treated as a product by process limitation; that is, that the expandable frame is made by braiding. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113. Thus, even though Wu is silent as to the process being braiding to create the expandable frame, it appears that the stent in Wu would be the same or similar as that claimed; especially since both applicant’s product and the prior art product is made of a nickel-titanium material (see applicant’s patent application publication [0071], nickel-titanium alloy/nitinol). This does not constitute a new ground of rejection as both the statutory basis for the rejection and the evidence the expandable frame 1 and 19 from Wu relied upon in support of the rejection remains the same. There is a change of rationale from simple substitution see MPEP 2141 (III-B) to some teaching, suggestion, or motivation in the prior art see MPEP 2141 (III-G) which does not necessarily constitute a new ground of rejection see MPEP 1207.03(a) (II) as this change in rationale is citing a different portion of a reference to elaborate upon that which has been cited previously see MPEP 1207.03(a) (II-1.). As such the rejection of the claims will be maintained. 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. Claim(s) 1-2, 4-7, and 9-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al (US 20150342612 A1), herein referenced to as “Wu” in view of Inouye et al (US 20180310925 A1), herein referenced to as “Inouye”. Claim 1 Wu discloses: An implantable medical device 1 (see Figs. 1-12, [0052]), comprising: an expandable frame the frame of 1 (see Figs. 1-12) defining a body the body of 1 (see Figs. 1-12) of the implantable medical device 1 and including a proximal region the proximal region of 1 near the distally-facing fixation burrs (see annotated Fig. 3 below) and a distal region the distal region of 1 near the proximally-facing fixation burrs (see annotated Fig. 3 below), the expandable frame the frame 1 moveable between a collapsed configuration stretched state (see [0054] and [0058], stretched and compressed along an axial direction) for delivery (see [0058]) and an expanded configuration plum blossom shaped state (see Figs. 1-4 and 12, [0047]) for deployment; one or more proximally-facing fixation burrs (see annotated Fig. 3 below) secured relative to the distal region (see annotated Fig. 3 below) of the expandable frame the frame 1; and one or more distally-facing fixation burrs (see annotated Fig. 3 below) secured relative to the proximal region (see annotated Fig. 3 below) of the expandable frame the frame 1; wherein the one or more proximally-facing fixation burrs (see annotated Fig. 3 below) and the one or more distally- facing fixation burrs (see annotated Fig. 3 below) together are adapted to provide the implantable medical device with bi- directional stability (see [0013], two-way anchoring thorns, see [0033], will not move or tilt in two directions). PNG media_image1.png 606 784 media_image1.png Greyscale Wu does not explicitly disclose: a membrane extending over the expandable frame; the one or more proximally-facing burrs securing the membrane relative to the expandable frame; the one or more distally-facing fixation burrs extending through the membrane, the one or more distally-facing fixation burrs securing the membrane relative to the expandable frame. However, Inouye in a similar field of invention teaches an implantable medical device 100 (see Fig. 3) comprising an expandable frame 110 (see Fig. 3), burrs 140 (see Fig. 3) in a proximal region (see annotated Fig. 3 below) of the expandable frame 110 and burrs (see annotated Fig. 3 below) in a distal region (see annotated Fig. 3 below) of the expandable frame 110. Inouye further teaches: a membrane 120 (see Fig. 3, [0052]-[0054]) extending over the expandable frame 110 (see Fig. 3, the element extends over the expandable frame); the burrs 140 in the proximal region securing the membrane 120 relative to the expandable frame 110 (see Fig. 3, [0059], 140 pass through 120, and [0060], retain occlusive element on the expandable framework); the burrs (see annotated Fig. 3 below) in the distal region (see annotated Fig. 3 below) extending through the membrane 120 (see Fig.3 , [0059], 140 passes through 120), the burrs securing the membrane 120 relative to the expandable frame 110 (see Fig. 3, [0060]). PNG media_image2.png 649 766 media_image2.png Greyscale It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wu to incorporate the teachings of Inouye and teach an implantable medical device with a membrane extending over the expandable frame; the burrs in a proximal region securing the membrane relative to the expandable frame; the burrs in the distal region extending through the membrane, the burrs in the distal region securing the membrane relative to the expandable frame. Motivation for such can be found in Inouye as an occlusive element can promote endothelization after implantation, which by providing it over a larger surface of the implant would assist the device in close the left atrial appendage from the patient’s circulatory system (see [0062]) furthermore having the barbs extending through the occlusive element/membrane prevents the occlusive element from coming off/falling off on its own (see [0065]). The combination of Wu and Inouye further teaches: the one or more proximally-facing burrs securing the membrane relative to the expandable frame; the one or more distally-facing fixation burrs extending through the membrane, the one or more distally-facing fixation burrs securing the membrane relative to the expandable frame (as modified, an occlusive element is added over the proximal and distal regions of the expandable frame, hence they would extend over the proximally-facing burrs and the distally-facing burrs of Wu, which would secure the membrane relative to the expandable frame). Claim 2 The combination of Wu and Inouye teaches: The implantable medical device of claim 1, see 103 rejection above. Wu further discloses: wherein the one or more proximally- facing fixation burrs (see annotated Fig. 3 below claim 1) are disposed within a distal region distal region of the frame away from hub 6 of the expandable frame the frame of 1. Claim 4 The combination of Wu and Inouye teaches: The implantable medical device of claim 1, see 103 rejection above. Wu further discloses: wherein the expandable frame the frame of 1 comprises a plurality of struts 4 (see Figs. 1-4, [0052], the frame of 1 is made of a plurality of struts). Claim 5 The combination of Wu and Inouye teaches: The implantable medical device of claim 4, see 103 rejection above. Wu further discloses: wherein the one or more distally- facing fixation burrs (see annotated Fig. 3 below claim 1) are secured to at least some of the plurality of struts 4 (see Fig. 3). Claim 6 The combination of Wu and Inouye teaches: The implantable medical device of claim 4, see 103 rejection above. Wu further discloses: wherein the one or more proximally- facing fixation burrs (see annotated Fig. 3 below claim 1) are secured to at least some of the plurality of struts 4 (see Fig. 3). Claim 7 The combination of Wu and Inouye teaches: The implantable medical device of claim 1, see 103 rejection above. Wu further discloses: wherein the implantable medical device 1 comprises an LAAC (left atrial appendage closure) device left atrial appendage occlusion device (see Figs. 10-12, [0053]). Claim 9 The combination of Wu and Inouye teaches: The implantable medical device of claim 1, see 103 rejection above. Wu further discloses: wherein the expandable frame the frame of 1 is biased to the expanded configuration (see [0053], self-expandable). Claim 10 Wu discloses: A left atrial appendage closure device 1 (see Figs. 1-12, [0052]), comprising: an expandable frame the frame of 1 (see Figs. 1-12) including a proximal region the proximal region of 1 near the distally-facing fixation burrs (see annotated Fig. 3 below) and a distal region the distal region of 1 near the proximally-facing fixation burrs (see annotated Fig. 3 below), the expandable frame the frame of 1 moveable between a collapsed configuration stretched state (see [0054] and [0058], stretched and compressed along an axial direction) for delivery (see [0058]) and an expanded configuration plum blossom shaped state (see Figs. 1-4 and 12, [0047]) for deployment; one or more proximally-facing fixation burrs (see annotated Fig. 3 below) secured relative to the expandable frame the frame 1; and one or more distally-facing fixation burrs (see annotated Fig. 3 below) secured relative to the expandable frame the frame 1; wherein the one or more proximally-facing fixation burrs (see annotated Fig. 3 below) and the one or more distally- facing fixation burrs (see annotated Fig. 3 below) together are adapted to provide the left atrial appendage closure device with bi-directional stability (see [0013], two-way anchoring thorns, see [0033], will not move or tilt in two directions). PNG media_image1.png 606 784 media_image1.png Greyscale Wu does not explicitly disclose: a membrane extending over at least the proximal region and the distal region of the expandable frame; the one or more proximally-facing fixation burrs extending through the membrane and securing the membrane relative to the proximal region of the expandable frame; and the one or more distally-facing fixation burrs securing the membrane relative to the distal region of the expandable frame. However, Inouye in a similar field of invention teaches an implantable medical device 100 (see Fig. 3) comprising an expandable frame 110 (see Fig. 3), burrs 140 (see Fig. 3) in a proximal region (see annotated Fig. 3 below) of the expandable frame 110 and burrs (see annotated Fig. 3 below) in a distal region (see annotated Fig. 3 below) of the expandable frame 110. Inouye further teaches: a membrane 120 (see Fig. 3, [0052]-[0054]) extending over at least the proximal region (see annotated Fig. 3 below) and the distal region (see annotated Fig. 3 below) of the expandable frame 110 (see Fig. 3, the element extends over the expandable frame); the burrs 140 in the distal region (see annotated Fig. 3 below) extending through the membrane 120 (see Fig. 3, [0059], 140 pass through 120) and securing the membrane 120 relative to the proximal region (see annotated Fig. 3 below, the burrs in the distal region secure the entirety of the continuous membrane, including relative to the proximal region of the expandable frame) of expandable frame 110 (see Fig. 3, [0060], retain occlusive element on the expandable framework); the burrs (see annotated Fig. 3 below) in the proximal region (see annotated Fig. 3 below) extending through the membrane 120 (see Fig.3 , [0059], 140 passes through 120), the burrs securing the membrane 120 relative to the distal region (see annotated Fig. 3 below, the burrs in the proximal region secure the entirety of the continuous membrane, including relative to the distal region of the expandable frame) of the expandable frame 110 (see Fig. 3, [0060]). PNG media_image2.png 649 766 media_image2.png Greyscale It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wu to incorporate the teachings of Inouye and teach an implantable medical device with a membrane extending over at least the proximal region and the distal region of the expandable frame; the burrs in the distal region extending through the membrane and securing the membrane relative to the proximal region of the expandable frame; and burrs in the proximal region securing the membrane relative to the distal region of the expandable frame. Motivation for such can be found in Inouye as an occlusive element can promote endothelization after implantation, which by providing it over a larger surface of the implant would assist the device in close the left atrial appendage from the patient’s circulatory system (see [0062]) furthermore having the barbs extending through the occlusive element/membrane prevents the occlusive element from coming off/falling off on its own (see [0065]). The combination of Wu and Inouye further teaches: the one or more proximally-facing fixation burrs extending through the membrane and securing the membrane relative to the proximal region of the expandable frame; and the one or more distally-facing fixation burrs securing the membrane relative to the distal region of the expandable frame (as modified, an occlusive element is added over the proximal and distal regions of the expandable frame, hence they would extend over the proximally-facing burrs and the distally-facing burrs of Wu, which would secure the membrane relative to the their respective regions of expandable frame, for example a proximally facing burr would help retain membrane relative to the proximal region as it would not be able to move distally past the proximally facing burr, hence staying proximal). Claim 11 The combination of Wu and Inouye teaches: The left atrial appendage closure device of claim 10, see 103 rejection above. Wu further discloses: wherein the one or more proximally-facing fixation burrs (see annotated Fig. 3 below claim 10) are disposed within a distal region distal region of the frame away from hub 6 of the expandable frame the frame of 1. Claim 12 The combination of Wu and Inouye teaches: The left atrial appendage closure device of claim 10, see 103 rejection above. Wu further discloses: wherein the one or more distally-facing fixation burrs (see annotated Fig. 3 below claim 1) are disposed within a proximal region proximal region of the frame close to hub 6 of the expandable frame the frame of 1. Claim 13 The combination of Wu and Inouye teaches: The left atrial appendage closure device of claim 10, see 103 rejection above. Wu further discloses: wherein the expandable frame the frame of 1 is adapted to enable the expandable frame the frame 1 to be partially recaptured (see [0034], withdrawn) within a delivery device 13/14 catheter (see Figs. 6-8, [0052]) for repositioning (see [0034]) the expandable frame the frame of 1, wherein the one or more distally-facing fixation burrs (see annotated Fig. 3 below claim 1) are disposed within the delivery device (see [0034], withdrawn) when the expandable frame is partially recaptured (see [0034], to adjust the releasing position, or event to withdraw the whole stent). Claim 14 The combination of Wu and Inouye teaches: The left atrial appendage closure device of claim 10, see 103 rejection above. Wu further discloses: wherein the expandable frame the frame of 1 is biased to the expanded configuration (see [0053], self-expandable). Claim 15 The combination of Wu and Inouye teaches: The left atrial appendage closure device of claim 10, see 103 rejection above. Wu further discloses: wherein the expandable frame the frame of 1 comprises a shape memory material (see [0055], nickel-titanium memory alloy tube). Claim 16 The combination of Wu and Inouye teaches: The left atrial appendage closure device of claim 10, see 103 rejection above. Wu further discloses: wherein the expandable frame the frame of 1 comprises a plurality of laser-cut struts (see [0055], laser-cutting), and the proximally-facing fixation struts the proximal struts of the frame 1 (see Figs. 1-3) are laser cut as part of the laser-cut struts (see [0055], laser-cutting is how the frame of 1, which includes proximal struts is made). Claim 17 The combination of Wu and Inouye teaches: The left atrial appendage closure device of claim 16, see 102 rejection above. Wu does not explicitly disclose: wherein the distally-facing fixation struts are welded to the laser-cut struts. Wu teaches that the distally-facing fixation struts comprises a nickel-titanium alloy material (see [0012]), but is silent as using welding as a method of attachment. The claimed phrase “wherein the distally-facing fixation struts are welded to the laser-cut struts” means that the distally-facing fixation struts were made by a welding technique, as explained in the instant application. Wu teaches that welding of nitinol elements is a known alternative to laser cutting or heat shaping, or other methods, see (see [0021]) Therefore, even if “welding” results in different structural characteristics of the end product than other molding methods, it still would have been prima facie obvious at the time the invention was made to use a “welded” material such as nickel-titanium in Wu as claimed since Wu teaches that welding is recognized as a useful technique for forming an left atrial appendage closure device. Claim 18 The combination of Wu and Inouye teaches: The left atrial appendage closure device of claim 10, see 103 rejection above. Wu further discloses: further comprising a membrane 19 (see Figs. 8-9a, [0052]) covering at least a proximal portion proximal portion of 1 (see Figs. 8-9a) of the expandable frame the frame of 1. Claim 19 Wu discloses: A left atrial appendage closure device 1 (see Figs. 1-12, [0052]), comprising: an expandable braided frame the frame of 1 and 19 (see Figs. 1-12, [0052]) moveable between a collapsed configuration stretched state (see [0054] and [0058], stretched and compressed along an axial direction) for delivery (see [0058]) and an expanded configuration plum blossom shaped state (see Figs. 1-4 and 12, [0047]) for deployment; one or more proximally-facing fixation burrs (see annotated Fig. 3 below) secured to a distal region the distal region of 1 near the proximally-facing fixation burrs (see annotated Fig. 3 below) of the expandable braided frame the frame of 1 and 19; and one or more distally-facing fixation burrs (see annotated Fig. 3 below) secured to a proximal region the proximal region of 1 near the distally-facing fixation burrs (see annotated Fig. 3 below) the expandable braided frame the frame of 1 and 19; wherein the one or more proximally-facing fixation burrs (see annotated Fig. 3 below) and the one or more distally- facing fixation burrs (see annotated Fig. 3 below) together are adapted to provide the left atrial appendage closure device with bi-directional stability (see [0013], two-way anchoring thorns, see [0033], will not move or tilt in two directions). PNG media_image1.png 606 784 media_image1.png Greyscale Wu does not explicitly disclose: the expandable frame is braided; a membrane extending over at least part of the expandable frame; the one or more proximally-facing fixation burrs securing the membrane relative to the expandable braided frame; and the one or more distally-facing fixation burrs securing the membrane relative to the expandable frame. However, Wu teaches that the expandable frame comprises a nitinol/nickel-titanium material (see [0055]), but does not teach that it is formed via braiding. The claimed phrase “an expandable braided frame” is being treated as a product by process limitation; that is, that the expandable frame is made by braiding. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113. Thus, even though Wu is silent as to the process being braiding to create the expandable frame, it appears that the stent in Wu would be the same or similar as that claimed; especially since both applicant’s product and the prior art product is made of a nickel-titanium material (see applicant’s patent application publication [0071], nickel-titanium alloy/nitinol). However, Inouye in a similar field of invention teaches an implantable medical device 100 (see Fig. 3) comprising an expandable frame 110 (see Fig. 3), burrs 140 (see Fig. 3) in a proximal region (see annotated Fig. 3 below) of the expandable frame 110 and burrs (see annotated Fig. 3 below) in a distal region (see annotated Fig. 3 below) of the expandable frame 110. Inouye further teaches: a membrane 120 (see Fig. 3, [0052]-[0054]) extending over at least a part of the expandable frame 110 (see Fig. 3, the element extends over the expandable frame); the burrs 140 in the proximal region securing the membrane 120 relative to the expandable frame 110 (see Fig. 3, [0059], 140 pass through 120, and [0060], retain occlusive element on the expandable framework); the burrs (see annotated Fig. 3 below) in the distal region (see annotated Fig. 3 below) securing the membrane 120 relative to the expandable frame 110 (see Fig. 3, [0060]). PNG media_image2.png 649 766 media_image2.png Greyscale It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wu to incorporate the teachings of Inouye and teach an implantable medical device with a membrane extending over at least a part of the expandable frame; the burrs in a proximal region securing the membrane relative to the expandable frame; the burrs in the distal region extending through the membrane, the burrs in the distal region securing the membrane relative to the expandable frame. Motivation for such can be found in Inouye as an occlusive element can promote endothelization after implantation, which by providing it over a larger surface of the implant would assist the device in close the left atrial appendage from the patient’s circulatory system (see [0062]) furthermore having the barbs extending through the occlusive element/membrane prevents the occlusive element from coming off/falling off on its own (see [0065]). The combination of Wu and Inouye further teaches: the one or more proximally-facing burrs securing the membrane relative to the expandable frame; the one or more distally-facing fixation burrs securing the membrane relative to the expandable frame (as modified, an occlusive element is added over the proximal and distal regions of the expandable frame, hence they would extend over the proximally-facing burrs and the distally-facing burrs of Wu, which would secure the membrane relative to the expandable frame). Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Tischler as applied to claim 1 above, and further in view of Arcaro et al (US 20190091014 A1), herein referenced to as “Arcaro”. Claim 8 The combination of Wu and Inouye teaches: The implantable medical device of claim 1, see 102 rejection above. The combination of Wu and Inouye teaches does not explicitly teach: wherein the implantable medical device comprises a heart valve implant. However, Arcaro in a similar field of invention teaches a medical device 100 + 1102 (see Fig. 37, [0090]) with an expandable frame 1102 (see Fig. 37) and proximally facing fixation burrs 5700 (see Fig. 37). Arcaro further teaches: wherein the implantable medical device 100 + 1102 comprises a heart valve implant (see [0090], prosthetic valve). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wu to incorporate the teachings of Arcaro and have the implantable medical device be a heart valve implant. Motivation for such can be found in Arcaro as this type of device is used for cardiac valve replacement to treat a failing or otherwise defective aortic or mitral valve (see [0086]). Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Inouye as applied to claim 19 above, and further in view of Tischler et al (US 20170224354 A1), herein referenced to as “Tischler”. The combination of Wu and Inouye teaches: The left atrial appendage closure device of claim 19, see 103 rejection above. Wu and Inouye does not explicitly teach: wherein the one or more proximally-facing fixation burrs and/or the one or more distally-facing fixation burrs comprise wire elements that are separately formed and subsequently attached to the expandable braided frame. However, Tischler in a similar field of invention teaches a left atrial appendage closure device 200 (see Figs. 5-9) with an expandable braided frame 210 (see Figs. 5-9) and a plurality of burrs 250 (see Figs. 5-9). Tischler further teaches: wherein the plurality of burrs 250 comprise wire elements the anchors are wire elements (see Figs. 5-9, [0047]) that are separately formed and subsequently attached (see [0050], 250 may be manufactured separately and added at a later time…) to the expandable braided frame 210. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wu to incorporate the teachings of Tischler and have wherein the one or more proximally-facing fixation burrs and/or the one or more distally-facing fixation burrs comprise wire elements that are separately formed and subsequently attached to the expandable braided frame. Motivation for such can be found in Tischler as this allows for greater control over the shape of the anchors before attachment to achieve a desired profile/shape (see [0054]). 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 RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 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, Darwin Erezo can be reached at 571-272-4695. 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. RAIHAN R. KHANDKER Examiner Art Unit 3771 /RAIHAN R KHANDKER/Examiner, Art Unit 3771 /DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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Prosecution Timeline

Feb 10, 2023
Application Filed
Nov 21, 2024
Non-Final Rejection — §103
Feb 25, 2025
Response Filed
Apr 30, 2025
Final Rejection — §103
Jun 26, 2025
Response after Non-Final Action
Sep 04, 2025
Request for Continued Examination
Sep 09, 2025
Response after Non-Final Action
Sep 19, 2025
Non-Final Rejection — §103
Dec 19, 2025
Response Filed
Jan 27, 2026
Final Rejection — §103 (current)

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Patent 12514589
DEVICE FOR VASCULAR OCCLUSION AND METHODS OF USE THEREOF
2y 5m to grant Granted Jan 06, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

5-6
Expected OA Rounds
64%
Grant Probability
99%
With Interview (+60.0%)
2y 11m
Median Time to Grant
High
PTA Risk
Based on 157 resolved cases by this examiner. Grant probability derived from career allow rate.

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