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 Amendment
This office action is responsive to the amendment filed on 12/08/2025. As directed by the amendment: claims 1, 12, 13, and 17 have been amended and claim 10 remain withdrawn. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 11, filed 12/08/2025, with respect to the drawing objection have been fully considered and are persuasive. The applicant’s amendments to the figures to clearly indicate the outer perimeter of the main body overcomes the drawing objection. The drawing objection has been withdrawn.
Applicant’s arguments, see page 11, filed 12/08/2025, with respect to the claim objections have been fully considered and are persuasive. The applicant’s amendment to the claims overcome the minor informalities within the claims. The claim objections have been withdrawn.
Applicant’s arguments, see pages 11-12, filed 12/08/2025, with respect to the rejection(s) of claim(s) 13-15 under 35 U.S.C. 102(a)(1) as being anticipated by VanTassel et al (US 6652555 B1), herein referenced to as “VanTassel” have been fully considered and are persuasive.
The applicant has amended claim 13 to further recite “wherein the expandable framework includes a plurality of elongate anchoring appendages fixedly attached to and extending distally and radially outwardly from an outer perimeter of the main body”.
The examiner agrees that the embodiment shown in Figs. 37-40 of VanTassel does not explicitly disclose the plurality of plurality of elongate anchoring appendages fixedly attached to and extending distally and radially outwardly from an outer perimeter of the main body. They extend only distally from the outer perimeter of the main body but not radially outwardly form the outer perimeter.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of VanTassel and Li et al (US 20160100844 A1).
Applicant’s arguments, see pages 12-14, filed 12/08/2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 as being unpatentable over Ayres et al (US 20150005809 A1), herein referenced to as “Ayres” have been fully considered and are persuasive.
The applicant amended claim 1 to further recite: “wherein the occlusive element spans the proximal hub; wherein the expandable framework includes a plurality of elongate anchoring appendages extending distally from an outer perimeter of the main body in an axial direction away from the occlusive element, the plurality of elongate anchoring appendages each including a plurality of anchoring barbs extending therefrom, wherein the plurality of elongate anchoring appendages extend radially outwardly beyond the main body and beyond the occlusive element”. The examiner agrees that Ayres does not explicitly teach the occlusive element spanning the proximal hub and the plurality of elongate anchoring appendages extend radially outwardly beyond the main body and beyond the occlusive element.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ayres in view of O’Halloran et al (US 20240032935 A1) and Li et al (US 20160100844 A1).
Applicant’s arguments, see pages 14-15, filed 12/08/2025, with respect to the rejection(s) of claim(s) 13 and 17 under 35 U.S.C. 103 as being unpatentable over Ayres et al (US 20150005809 A1), herein referenced to as “Ayres” have been fully considered and are persuasive.
The applicant amended claim 1 to further recite: “wherein the expandable framework includes a plurality of elongate anchoring appendages extending distally and radially outwardly from the main body, the plurality of elongate anchoring appendages each including a plurality of anchoring barbs extending therefrom”.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ayres in view of Li et al (US 20160100844 A1).
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) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over VanTassel et al (US 6652555 B1), herein referenced to as “VanTassel” in view of Li et al (US 20160100844 A1), herein referenced to as “Li”.
Claim 13
VanTassel discloses: A medical implant 500 (see Figs. 37-40 and 43, col. 15, lines 36-40, col. 1, lines 65-67) for occluding a left atrial appendage (see col. 1, lines 65-67), comprising: an expandable framework 504a/b +506a/b (see Figs. 37-40 and 43 and 47-48, col. 15, lines 40-44) configured to shift between a collapsed configuration (see Fig. 40, col. 15, lines 9-21) and an expanded configuration (see Figs. 37 and 43, col. 15, lines 9-21); and an occlusive element 40 (see Figs. 37-40 and 43, col. 15, lines 1-15) secured to the expandable framework 504a/b +506a/b; wherein the expandable framework 658 includes a proximal hub 504a/b (see Figs. 37-40 and 43, col. 15, lines 40-44) and a plurality of interconnected struts 506a/b extending from the proximal hub 504a/b to a distal hub the hub formed by the meeting of 506a/b before the transition to 508 (see Fig. 37) to define a main body 506a/b in the expanded configuration; wherein the expandable framework 504a/b +506a/b includes a plurality of elongate anchoring appendages 508 (see Figs. 37 and 43, col. 14, lines 58-67) fixedly attached to and extending from an outer perimeter the outer perimeter of 506a/b, defined by the distal hub (see Figs. 37 and 43, they extend distally from the outer perimeter and are fixedly attached at the distal hub) of the main body 506a/b, the plurality of elongate anchoring appendages 508 each including a plurality of anchoring barbs 512 (see Fig. 43, col. 15, lines 34-35) extending therefrom.
VanTassel does not explicitly disclose: the plurality of elongate anchoring appendages extending distally and radially outwardly from the outer perimeter of the main body.
However, Li in a similar field of invention teaches a medical implant 400 (see Figs. 4-5 and 16) for occluding a left atrial appendage (see Figs. 4-5) with an expandable framework 20 + 114 (see Figs. 4-5 and 16, [0070]) with a main body 20 with an outer perimeter (see annotated Fig. 5 below) and a plurality of elongate anchoring appendages 114 + 124 (see annotated Fig. 5 below and Fig. 16) extending therefrom. Li further teaches: the plurality of elongate anchoring appendages 114 + 124 (see annotated Fig. 5 below and Fig. 16) extending distally and radially outwardly (see annotated Fig. 5 below) from the outer perimeter (see annotated Fig. 5 below) of the main body 20.
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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 VanTassel to incorporate the teachings of Li and teach a medical implant for occluding a left atrial appendage with the plurality of elongate anchoring appendages extending distally and radially outwardly from the outer perimeter of the main body. Motivation for such can be found in Li as this configuration allows the anchor of the struts/plurality of elongate anchoring appendages to stably pin at different depths in the left atrial appendage (see Figs. 4-5, and [0070]).
Claim 14
The combination of VanTassel and Li teaches: The medical implant of claim 13, see 103 rejection above. VanTassel further discloses: wherein the plurality of elongate anchoring appendages 508 is configured to extend radially outward of the occlusive element 40 in the expanded configuration (see Figs. 37 and 43, 508 extends radially outward from 40, and into the LAA walls).
Claim 15
The combination of VanTassel and Li teaches: The medical implant of claim 13, see 103 rejection above. VanTassel further discloses: wherein each of the plurality of elongate anchoring appendages 508 is fixedly attached to the outer perimeter the outer perimeter of 506a/b, defined by the distal hub of the main body 506a/b at a single location each of 508 extends from one point at the outer perimeter of 506a/b, defined by the distal hub (see Fig. 37).
Claim(s) 13-15 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ayres et al (US 20150005809 A1), herein referenced to as “Ayres” in view of Li.
Claim 13
Ayres discloses: A medical implant 690 (see Fig. 30B, [0152]) for occluding a left atrial appendage (see [0076], to occlude a left atrial appendage), comprising: an expandable framework 691 (see Fig. 30B, [0152]) configured to shift between a collapsed configuration (see [0078], collapsed/delivery configuration, see also [0075], loaded into a delivery sheath) and an expanded configuration (see Fig. 30B, [0075], the expanded configuration of the device); and an occlusive element 692 + covering component (see Fig. 30B, [0152] and [0077]) secured to the expandable framework 691 (see Fig. 30B, [0152]); wherein the expandable framework 691 includes a proximal hub 695 (see Fig. 30B, [0152]) and a plurality of interconnected struts 694 (see Fig. 30B, [0152]) extending from the proximal hub 695 (see Fig. 30B, 694 is extending from 695) to a distal hub 698 (see Fig. 30B, [0153], 698, is connected to a strut 699 to 695 which is connected to the other struts 694) to define a main body 693 + 699 + 698 (see Fig. 30B, [0152]) in the expanded configuration (see Fig. 30B); wherein the expandable framework 691 includes a plurality of elongate anchoring appendages 696a + 696b + 696c (see Fig. 30B, [0153]) fixedly attached to (see Fig. 30, [0153], 696a + 696b + 696c is fixedly attached to the outer perimeter via 698 which is connected to 699, and the struts that define the outer perimeter, 694) and extending from an outer perimeter the outer perimeter of 693 + 699 + 698 (see Fig. 30B, 696a/696b/696c, extends out of the outer perimeter of the main body) of the main body 698 (see Fig. 30B, 696a + 696b + 696c extend from 698 which is connected to 699 which in turn is connected to 695 and 694 which make up 693, furthermore 696a/696b/696c extend distally from within 693, hence 696a/696b/696c are fixedly attached, via a permanent fixture, which is welding, see [0154], to the outer perimeter of the main body and extending from the outer perimeter).
Ayres (Fig. 30B) does not explicitly disclose: the plurality of elongate anchoring appendages each including a plurality of anchoring barbs extending therefrom and the plurality of elongate anchoring appendages extending distally and radially outwardly from the outer perimeter of the main body.
However, a variant embodiment of Ayres in the same field of invention teaches a medical implant 1050 (see Fig. 57) with a plurality of elongate anchoring appendages 1052 (see Fig. 57) extending from a main body 1054 (see Fig. 57). Ayres (Fig. 57) further teaches: the plurality of elongate anchoring appendages 1052 each including a plurality of anchoring barbs 1058 (see Fig. 57, [0225], anchor features such as barbs, at any locations of the elongate members) extending therefrom.
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 Ayres to incorporate the teachings of a variant (Fig. 57) embodiment of Ayres and teach a medical implant with the plurality of elongate anchoring appendages each including a plurality of anchoring barbs extending therefrom. Motivation for such can be found in Ayres to assist in resisting migration of the occlusion device by coming into contact at the implant site, even at multiple regions of the device (see [0225], see furthermore [0074], elements disclosed in Ayres are to be combined).
Ayres does not explicitly teach: the plurality of elongate anchoring appendages extending distally and radially outwardly from the outer perimeter of the main body.
However, Li in a similar field of invention teaches a medical implant 400 (see Figs. 4-5 and 16) for occluding a left atrial appendage (see Figs. 4-5) with an expandable framework 20 + 114 (see Figs. 4-5 and 16, [0070]) with a main body 20 with an outer perimeter (see annotated Fig. 5 below) and a plurality of elongate anchoring appendages 114 + 124 (see annotated Fig. 5 below and Fig. 16) extending therefrom. Li further teaches: the plurality of elongate anchoring appendages 114 + 124 (see annotated Fig. 5 below and Fig. 16) extending distally and radially outwardly (see annotated Fig. 5 below) from the outer perimeter (see annotated Fig. 5 below) of the main body 20.
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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 Ayres to incorporate the teachings of Li and teach a medical implant for occluding a left atrial appendage with the plurality of elongate anchoring appendages extending distally and radially outwardly from the outer perimeter of the main body. Motivation for such can be found in Li as this configuration allows the anchor of the struts/plurality of elongate anchoring appendages to stably pin at different depths in the left atrial appendage (see Figs. 4-5, and [0070]).
Claim 14
The combination of Ayres and Li teaches: The medical implant of claim 13, see 103 rejection above. Ayres further teaches: wherein the plurality of elongate anchoring appendages 696a + 696b + 696c is configured to extend radially outward of the occlusive element 692 + covering component in the expanded configuration (see Fig. 30B, the 696a/696b/696c extend radially outward from the covering component as they are outside of the covering component).
Claim 15
The combination of Ayres and Li teaches: The medical implant of claim 13, see 103 rejection above. Ayres further teaches: wherein each of the plurality of elongate anchoring appendages 696a + 696b + 696c is fixedly attached to the outer perimeter the outer perimeter of 693 + 699 + 698 of the main body 693 + 699 + 698 at a single location 698 (see Fig. 30B, 696a + 696b + 696c each originate from 698 at a single point).
Claim 17
Ayres discloses: A medical device system 690 + delivery sheath (see Fig. 30B, [0152], [0075]), comprising: a catheter delivery sheath (see [0075]); a core wire delivery catheter (see [0075], loaded into a delivery sheath, the implant medical device releasably attached to a delivery catheter) movably disposed (see [0075], pushing the device out the distal end of the delivery sheath using the delivery catheter) within a lumen the lumen of the delivery sheath (see [0075]) of the catheter delivery sheath; and a medical implant 690 (see Fig. 30B, [0152]) for occluding a left atrial appendage (see [0076], to occlude a left atrial appendage) releasably connected to a distal portion distal portion of the delivery catheter of the core wire (see [0075], the implant medical device releasably attached to a delivery catheter); wherein the medical implant 690 includes an expandable framework 691 (see Fig. 30B, [0152]) configured to shift between a collapsed configuration (see [0078], collapsed/delivery configuration, see also [0075], loaded into a delivery sheath) and an expanded configuration (see Fig. 30B, [0075], the expanded configuration of the device), and an occlusive element 692 + covering component (see Fig. 30B, [0152] and [0077]) secured to the expandable framework 691 (see Fig. 30B, [0152]); wherein the expandable framework 691 includes a proximal hub 695 (see Fig. 30B, [0152]) and a plurality of interconnected struts 694 (see Fig. 30B, [0152]) extending from the proximal hub 695 (see Fig. 30B, 694 is extending from 695), the plurality of interconnected struts 694 defining a main body 693 + 699 + 698 (see Fig. 30B, [0152]) in the expanded configuration (see Fig. 30B); wherein the expandable framework 691 includes a plurality of elongate anchoring appendages 696a + 696b + 696c (see Fig. 30B, [0153]) extending from the main body 698 (see Fig. 30B, 696a + 696b + 696c extend from 698 which is connected to 699 which in turn is connected to 695 and 694 which make up 693, furthermore 696a/696b/696c extend distally from within 693).
Ayres (Fig. 30B) does not explicitly disclose: the plurality of elongate anchoring appendages each including a plurality of anchoring barbs extending therefrom and the plurality of elongate anchoring appendages extending distally and radially outwardly from the outer perimeter of the main body.
However, a variant embodiment of Ayres in the same field of invention teaches a medical implant 1050 (see Fig. 57) with a plurality of elongate anchoring appendages 1052 (see Fig. 57) extending from a main body 1054 (see Fig. 57). Ayres (Fig. 57) further teaches: the plurality of elongate anchoring appendages 1052 each including a plurality of anchoring barbs 1058 (see Fig. 57, [0225], anchor features such as barbs, at any locations of the elongate members) extending therefrom.
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 Ayres to incorporate the teachings of a variant (Fig. 57) embodiment of Ayres and teach a medical implant with the plurality of elongate anchoring appendages each including a plurality of anchoring barbs extending therefrom. Motivation for such can be found in Ayres to assist in resisting migration of the occlusion device by coming into contact at the implant site, even at multiple regions of the device (see [0225], see furthermore [0074], elements disclosed in Ayres are to be combined).
Ayres does not explicitly teach: the plurality of elongate anchoring appendages extending distally and radially outwardly from the outer perimeter of the main body.
However, Li in a similar field of invention teaches a medical implant 400 (see Figs. 4-5 and 16) for occluding a left atrial appendage (see Figs. 4-5) with an expandable framework 20 + 114 (see Figs. 4-5 and 16, [0070]) with a main body 20 with an outer perimeter (see annotated Fig. 5 below) and a plurality of elongate anchoring appendages 114 + 124 (see annotated Fig. 5 below and Fig. 16) extending therefrom. Li further teaches: the plurality of elongate anchoring appendages 114 + 124 (see annotated Fig. 5 below and Fig. 16) extending distally and radially outwardly (see annotated Fig. 5 below) from the outer perimeter (see annotated Fig. 5 below) of the main body 20.
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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 Ayres to incorporate the teachings of Li and teach a medical implant for occluding a left atrial appendage with the plurality of elongate anchoring appendages extending distally and radially outwardly from the outer perimeter of the main body. Motivation for such can be found in Li as this configuration allows the anchor of the struts/plurality of elongate anchoring appendages to stably pin at different depths in the left atrial appendage (see Figs. 4-5, and [0070]).
Claim 18
The combination of Ayres and Li teaches: The medical device system of claim 17, see 103 rejection above. Ayres further teaches: wherein the expandable framework 691 is disposed in the collapsed configuration (see [0078], collapsed/delivery configuration, see also [0075], loaded into a delivery sheath) when the medical implant 690 is disposed within the lumen the lumen of the delivery sheath of the catheter delivery sheath and the expandable framework 691 is configured to shift toward the expanded configuration (see Fig. 30B, [0075], the expanded configuration of the device) when the medical implant is disposed outside (see [0075]) of the lumen the lumen of the delivery sheath of the catheter delivery sheath.
Claim 19
The combination of Ayres and Li teaches: The medical device system of claim 17, see 103 rejection above. Ayres further teaches: wherein the plurality of elongate anchoring appendages 696a + 696b + 696c is configured to selectively shift (see [0154], the axial movement) between a first configuration (see [0154], 696 can axially move in relation to 691 while expanded, hence when proximally moved it would be in a first configuration, this would cause 696a + 696b + 696c to draw radially inwards as well, as it would abut/slide against the rest of the frame of 693) and a second configuration (see [0154], 696 can axially move in relation to 691 while expanded, hence when distally moved it would be in a second configuration, which is shown in Fig. 30B) when the medical implant 690 is in the expanded configuration (see Fig. 30B).
Claim 20
The combination of Ayres and Li teaches: The medical device system of claim 19, see 103 rejection above. Ayres further teaches: wherein the plurality of elongate anchoring appendages 696a + 696b + 696c is configured to engage a wall of the left atrial appendage (see [0153], provide anchoring) in the second configuration (see Fig. 30B) to retain the medical implant (see [0153], anchor) within the left atrial appendage.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ayres and Li as applied to claim 13 above, and further in view of Zhou et al (US 20220031333 A1), herein referenced to as “Zhou”.
Claim 16
The combination of Ayres and Li teaches: The medical implant of claim 13, see 103 rejection above. The combination of Ayres and Li does not explicitly teach: wherein the plurality of elongate anchoring appendages is disposed proximal of the distal hub in the collapsed configuration.
However, Zhou in a similar field of invention teaches a medical implant 100 (see Figs. 2-4a) with a plurality of elongate anchoring appendages 112 + 130 (see Figs. 2-4a), a proximal hub 120 (see Figs. 2-4a), a distal hub 150 (see Figs. 2-4a), a collapsed configuration (see Fig. 4a) and an expanded configuration (see Fig. 3). Zhou further teaches: wherein the plurality of elongate anchoring appendages 112 + 130 is disposed proximal (see Fig. 4a, 130 is disposed proximal of the distal hub’s distal opening, hence proximal of the distal hub, and in the expanded configuration in Fig. 3, it is disposed distal of the distal hub) of the distal hub 150 in the collapsed configuration (see Fig. 4a).
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 Ayres to incorporate the teachings of Zhou and teach a medical implant with the plurality of elongate anchoring appendages is disposed proximal of the distal hub in the collapsed configuration. Motivation for such can be found in Zhou as this allows a controlled retraction of the medical implant device during its retrieval by having the expandable framework have mechanical self-limiting capabilities, which prevents entanglement of the medical implant (see [0069]).
Claim(s) 1-9 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ayres in view of O’Halloran et al (US 20240032935 A1), herein referenced to as “O’Halloran” and Li.
Claim 1
Ayres discloses: A medical implant 690 (see Fig. 30B, [0152]) for occluding a left atrial appendage (see [0076], to occlude a left atrial appendage), comprising: an expandable framework 691 (see Fig. 30B, [0152]) configured to shift between a collapsed configuration (see [0078], collapsed/delivery configuration, see also [0075], loaded into a delivery sheath) and an expanded configuration (see Fig. 30B, [0075], the expanded configuration of the device); and an occlusive element 692 + covering component (see Fig. 30B, [0152] and [0077]) secured to the expandable framework 691 (see Fig. 30B, [0152]); wherein the expandable framework 691 includes a proximal hub 695 (see Fig. 30B, [0152]) and a plurality of interconnected struts 694 (see Fig. 30B, [0152]) extending from the proximal hub 695 (see Fig. 30B, 694 is extending from 695), the plurality of interconnected struts 694 defining a main body 693 + 699 + 698 (see Fig. 30B, [0152]) in the expanded configuration (see Fig. 30B); wherein the expandable framework 691 includes a plurality of elongate anchoring appendages 696a + 696b + 696c (see Fig. 30B, [0153]) extending distally (see annotated Fig. 30B below) from an outer perimeter (see annotated Fig. 30B below) of the main body 698 (see Fig. 30B, 696a + 696b + 696c extend from 698 which is connected to 699 which in turn is connected to 695 and 694 which make up 693, furthermore 696a/696b/696c extend distally from within 693) in an axial direction (see annotated Fig. 30B below) away from the occlusive element 692 + covering component.
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Ayres (Fig. 30B) does not explicitly disclose: the plurality of elongate anchoring appendages each including a plurality of anchoring barbs extending therefrom; wherein the occlusive element spans the proximal hub; wherein the plurality of elongate anchoring appendages extend radially outwardly beyond the main body and beyond the occlusive element.
However, a variant embodiment of Ayres in the same field of invention teaches a medical implant 1050 (see Fig. 57) with a plurality of elongate anchoring appendages 1052 (see Fig. 57) extending from a main body 1054 (see Fig. 57). Ayres (Fig. 57) further teaches: the plurality of elongate anchoring appendages 1052 each including a plurality of anchoring barbs 1058 (see Fig. 57, [0225], anchor features such as barbs, at any locations of the elongate members) extending therefrom.
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 Ayres to incorporate the teachings of a variant (Fig. 57) embodiment of Ayres and teach a medical implant with the plurality of elongate anchoring appendages each including a plurality of anchoring barbs extending therefrom. Motivation for such can be found in Ayres to assist in resisting migration of the occlusion device by coming into contact at the implant site, even at multiple regions of the device (see [0225], see furthermore [0074], elements disclosed in Ayres are to be combined).
Ayres does not explicitly teach: wherein the occlusive element spans the proximal hub; wherein the plurality of elongate anchoring appendages extend radially outwardly beyond the main body and beyond the occlusive element.
However, O’Halloran in a similar field of invention teaches a medical implant 60 (see Fig. 9) for occluding a left atrial appendage (see Figs. 3A-3C, LAA) with a main body 4 (see Fig. 9) with a proximal hub 2 (see Fig. 9) and an occlusive element 6 + 62 (see Fig. 9). O’Halloran further teaches: wherein the occlusive element 6 + 62 (see Fig. 9, [0145]) spans the proximal hub 2 (see Fig. 9, [0145]).
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 Ayres to incorporate the teachings of O’Halloran and teach a medical implant with the occlusive element spans the proximal hub. Motivation for such can be found in O’Halloran as this prevents an embolus from passing through the proximal hub/connecting hub (see [0145]).
The combination of Ayres and O’Halloran does not explicitly teach: wherein the plurality of elongate anchoring appendages extend radially outwardly beyond the main body and beyond the occlusive element.
However, Li in a similar field of invention teaches a medical implant 400 (see Figs. 4-5 and 16) for occluding a left atrial appendage (see Figs. 4-5) with an occlusive element 11 (see Figs. 4-5 and 16), an expandable framework 20 + 114 (see Figs. 4-5 and 16, [0070]) with a main body 20 with an outer perimeter (see annotated Fig. 5 below) and a plurality of elongate anchoring appendages 114 + 124 (see annotated Fig. 5 below and Fig. 16) extending therefrom. Li further teaches: the plurality of elongate anchoring appendages 114 + 124 (see annotated Fig. 5 below and Fig. 16) extend radially outwardly (see annotated Fig. 5 below) beyond the main body 20 and beyond the occlusive element 11.
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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 Ayres and O’Halloran to incorporate the teachings of Li and teach a medical implant for occluding a left atrial appendage with the plurality of elongate anchoring appendages extend radially outwardly beyond the main body and beyond the occlusive element. Motivation for such can be found in Li as this configuration allows the anchor of the struts/plurality of elongate anchoring appendages to stably pin at different depths in the left atrial appendage (see Figs. 4-5, and [0070]).
Claim 2
The combination of Ayres, O’Halloran, and Li teaches: The medical implant of claim 1, see 103 rejection above. Ayres further teaches: wherein each elongate anchoring appendage 696a + 696b + 696c of the plurality of elongate anchoring appendages 696a + 696b + 696c is fixedly attached to the expandable framework 691 (see Fig. 30B, each are attached at 698, [0153]) at a first end the first end of 696a/696b/696c attached at 698 (see Fig. 30B) and extends to a free end 697 (see Fig. 30B, [0153]) opposite the first end the first end of 696a/696b/696c attached at 698.
Claim 3
The combination of Ayres, O’Halloran, and Li teaches: The medical implant of claim 2, see 103 rejection above. Ayres further teaches: wherein the plurality of elongate anchoring appendages 696a + 696b + 696c is integrally formed (see [0154], 691 which includes 693 + 699 + 698, is welded to 696 via 699, the plain definition of which as defined by the Online Cambridge dictionary is “to join two pieces of metal together permanently by melting the parts that touch”, joining the two parts into one, hence a single monolithic structure) with the main body 693 + 699 + 698 as a single monolithic structure.
Claim 4
The combination of Ayres, O’Halloran, and Li teaches: The medical implant of claim 1, see 103 rejection above. Ayres further teaches: wherein each elongate anchoring appendage 696a + 696b + 696c of the plurality of elongate anchoring appendages 696a + 696b + 696c is devoid of a direct connection (see Fig. 30B, 696a/696b/696c do not directly contact one another, they are indirectly joined by 698, see [0153]) to any other elongate anchoring appendage 696a + 696b + 696c of the plurality of elongate anchoring appendages 696a + 696b + 696c.
Claim 5
The combination of Ayres, O’Halloran, and Li teaches: The medical implant of claim 1, see 103 rejection above. Ayres further teaches: wherein the plurality of elongate anchoring appendages 696a + 696b + 696c is configured to shift between a first configuration (see [0154], 696 can axially move in relation to 691 while expanded, hence when proximally moved it would be in a first configuration, this would cause 696a + 696b + 696c to draw radially inwards as well, as it would abut/slide against the rest of the frame of 693) and a second configuration (see [0154], 696 can axially move in relation to 691 while expanded, hence when distally moved it would be in a second configuration, which is shown in Fig. 30B) relative to the main body 693 + 699 + 698 when the expandable framework is in the expanded configuration (see Fig. 30B).
Claim 6
The combination of Ayres, O’Halloran, and Li teaches: The medical implant of claim 5, see 103 rejection above. Ayres further teaches: wherein in the first configuration (see [0154] and Fig. 30B, when 698 is proximally pulled into 693 + 699 + 698), the plurality of elongate anchoring appendages 696a + 696b + 696c is disposed within (see Fig. 30B, a portion of the length of 696a/696b/696c is within 691/693) an interior the interior of 693 (see Fig. 30B) of the main body 693 + 699 + 698.
Claim 7
The combination of Ayres, O’Halloran, and Li teaches: The medical implant of claim 5, see 103 rejection above. Ayres further teaches: wherein in the second configuration (see Fig. 30B, [0154], the second configuration as shown, 696a/696b/696c extend away from the 699, which is a portion of the main body), the plurality of elongate anchoring appendages 696a + 696b + 696c extends away from the main body 693 + 699 + 698.
Claim 8
The combination of Ayres, O’Halloran, and Li teaches: The medical implant of claim 5, see 103 rejection above. Ayres further teaches: wherein in the second configuration (see Fig. 30B, [0154], the second configuration as shown), the plurality of elongate anchoring appendages 696a + 696b + 696c extends an axial distance (see annotated Fig. 30B below) distally from the main body 693 + 699 + 698 and a radial distance (see annotated Fig. 30B below) outward from the main body 693 + 699 + 698.
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Claim 9
The combination of Ayres, O’Halloran, and Li teaches: The medical implant of claim 8, see 103 rejection above. Ayres further teaches: wherein the axial distance (see annotated Fig. 30B below claim 8) is greater than the radial distance (see annotated Fig. 30B below claim 8).
Claim 11
The combination of Ayres, O’Halloran, and Li teaches: The medical implant of claim 5, see 103 rejection above. Ayres further teaches: wherein the plurality of elongate anchoring appendages 696a + 696b + 696c is self-biased (see [0149], the material disclosed in Fig. 30A, is the same as Fig. 30B, which is Nitinol, which is a self-expanding material, on the second configuration in which the device self-expands to is shown in Fig. 30B) toward the second configuration.
Claim 12
The combination of Ayres, O’Halloran, and Li teaches: The medical implant of claim 11, see 103 rejection above. Ayres further teaches: wherein the plurality of elongate anchoring appendages 696a + 696b + 696c is configured to be pulled to the first configuration by at least one tether 699 (see Fig. 30B, [0154], 699 allows axial pulling of 698 and 696, which would move 696a + 696b + 696c into the first configuration, when moved proximally).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771