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
Claims filed on May 26th, 2026 have been entered. Claims 1-7, 9- 24, 34, 37, and 39- 49 are pending in the application. Claims 6-7, 9- 10, 15- 16, and 34 remain withdrawn for being drawn to an unelected species.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1-5, 11- 14, 17- 21 and 48 under 35 U.S.C. 103 over Devellian et al. (WO 2018/081466) in view of O’Halloran et al. (EP 3636172) has been withdrawn in light of applicant’s amendments; specifically Devellian does not teach wherein the detachable proximal portion carries a frame when detached from a main body of the scaffold, wherein the frame of the detachable proximal portions is configured to couple with a portion of the self- expandable support.
Claim(s) 22-24, 37, 39- 41, 45- 47, and 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devellian et al. (WO 2018/081466) in view of Oral et al. (US 9,011,551), Heipl (WO 2015/189307), Van Tassel et al. (US 6,551,303), and Bush et al. (EP 0479435).
Regarding claims 22 and 41, Devellian (Devellian et al.) teaches a left atrial appendage occlusion device (Fig. 16)(abstract), comprising: a scaffold (foam body 1600) having a sidewall, a proximal end and a distal end (see annotated Fig. 16 below), and a self- expanding support (stent 1602)(Paragraph 0131) carried within the scaffold (Paragraph 0130), wherein the support defines a cavity therein (see annotated Fig. 16 below), wherein the proximal end of the scaffold has a proximal opening (1606)(Paragraph 0131).
Regarding the scaffold being expandable, as Devellian teaches that the foam body and the stent “may have the same or similar features” to the “foam body 3002 and tubular body 3080” (Paragraph 0130) and then teaches that foam body 3002 is expandable (Paragraph 0262 teaches that the device, including the foam body, has an expanded configuration, therefore the body is expandable.), it would be obvious to one of ordinary skill in the art that the foam body 1600 would also be expandable.
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Devellian does not teach the self-expandable support comprising a proximal hub and a plurality of struts extending distally from the proximal hub, an electronic system comprising a plurality of contacts configured to contact tissue of the left atrial appendage and stabilize the electronic system after implantation of the electronic system in the left atrial appendage, wherein the plurality of contacts are positioned at a distal end of the electronics system, the plurality of contacts each comprising an atraumatic distal configuration, the plurality of contacts each comprising a loop configured to contact the tissue of the left atrial appendage; and a coiled wire coupling the self-expandable support and the electronic system, the coiled wire being directly coupled to the proximal hub at a first end and directly coupled to the electronic system at a second end, wherein the electronic system is configured to be positioned at least partially distal to the left atrial appendage occlusion device.
Devellian teaches in a separate embodiment, a similar left atrial appendage device (1020)(Figs. 45A- 45D)(Paragraphs 0198- 0201) with a support (internal support structure 1032) comprising a proximal hub (central hub 1046) and a plurality of struts (1038) extending distally from the proximal hub (see annotated Fig. 45A below).
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It would have been obvious to one of ordinary skill in the art to modify the support as taught by the combination to have a proximal hub and a plurality of struts as taught by the second embodiment of Devellian for the purpose of providing an internal support. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one support for another because both supports are disclosed as equivalent structures for providing internal support within the implant and aiding in the expansion of the implant (Devellian, Paragraphs 0131 and 0200) and substitution of one for the other would have resulted in the predictable result of an implant that is supported while inserted within a body and which is aided in expansion. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Oral (Oral et al.) teaches a similar left atrial appendage occlusion device (194)(Fig. 3C)(abstract) with a support (304) and an electronic system (transponder unit 106) comprising a plurality of contacts (conductive struts 302) configured to contact tissue of the left atrial appendage and stabilize the electronic system after implantation of the electronic system in the left atrial appendage (Column 5, Lines 57- 64), a mainstay strut (306) coupling the support and the electronic system (Column 8, Lines 11- 14), wherein the electronic system is configured to be positioned at least partially distal to the left atrial appendage occlusion device (see annotated Fig. 3C below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as taught by Devellian to have the electronic system as taught by Oral, in order to monitor the left atrial appendage and to administer treatment to the LAA (Column 1, Lines 15- 17).
The combination of Devellian and Oral does not teach a coiled wire coupling the self-expandable support and the electronic system, the coiled wire being directly coupled to the proximal hub at a first end and directly coupled to the electronic system at a second end or wherein the plurality of contacts are positioned at a distal end of the electronics system, the plurality of contacts each comprising an atraumatic distal configuration, the plurality of contacts each comprising a loop configured to contact the tissue of the left atrial appendage.
Heipl teaches a similar left atrial appendage occlusion device (100)(Fig. 4b) with a support and an anchor (118)(On Page 4, Lines 1-4, Heipl teaches that Fig. 4b shows the device with only the distal anchoring portion shown, however, it would have been obvious that the device shown in Fig. 4b would have a support as shown in Fig. 1), with a coiled wire that is a coiled spring (spring 109) coupling the support and the anchor (Page 7, Lines 31- 35 and Page 9, Lines 36- 37).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as taught by the combination to have a coiled wire coupling the self-expandable support and the electronic system as taught by Heipl, since Heipl teaches that the coiled wire provides a force to draw the proximal portion further into the left atrial appendage (Page 9, Lines 27- 35).
Regarding the coiled wire being directly coupled to the proximal hub at a first end and directly coupled to the electronic system at a second end, as the combination teaches that the coiled wire is coupled to the center of the support device (Oral, see annotated Fig. 3D below), and the proximal hub of Devellian is the center of the support device, with the struts surrounding a cavity (Devellian, see annotated Fig. 45A below), the coiled wire would be directly coupled to the proximal hub at a first end. Furthermore, the combination teaches that the coiled wire is directly coupled to the electronic system at a second end (Oral, see annotated Fig. 3D below).
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The combination does not teach wherein the plurality of contacts are positioned at a distal end of the electronics system, the plurality of contacts each comprising an atraumatic distal configuration, the plurality of contacts each comprising a loop configured to contact the tissue of the left atrial appendage.
Van Tassel (Van Tassel et al.) teaches a left atrial appendage occlusion device (40)(Fig. 5) and a plurality of prongs (50) that have atraumatic bulbs (55) on their tips (Column 6, Lines 28- 44).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plurality of contacts of the combination to have an atraumatic distal configuration such as an atraumatic bulb as taught by Van Tassel, since Van Tassel teaches that the atraumatic bulbs “will not perforate the left atrial appendage” (Column 6, Lines 33- 35) and therefore prevent damage to the left atrial appendage.
The combination does not teach wherein the plurality of contacts comprise one or more loops configured to contact the tissue of the left atrial appendage.
Bush (Bush et al.) teaches an implantable device (10)(Fig. 1) in the heart (Column 1, Lines 15- 22; Column 2, Lines 21- 24; Column 5, Lines 10- 17) comprising an electronic system (electronic connector 16), a plurality of contacts (curvilinear electrodes 18) wherein the plurality of contacts comprise one or more loops (Column 7, Lines 6- 9) configured to contact tissue (Column 5, Lines 10- 17).
It would have been obvious to one of ordinary skill in the art to modify the shape of the plurality of contacts as taught by the combination to be loops as taught by Bush, since Bush teaches that this shape provides adequate surface area for defibrillation (Column 2, Lines 13- 17).
Regarding claims 23 and 24, Devellian, Oral, Heipl and Van Tassel make obvious the device with the electronic system with a plurality of contacts and a coiled wire as discussed above.
The combination further teaches wherein the electronic system comprises a pacing system (As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as taught by Devellian to have the electronic system as taught by Oral, in order to monitor the left atrial appendage and to administer treatment to the LAA. Oral further teaches in Column 5, Lines 8- 26 that the transponder unit can be multi-mode and include a treatment stage that applies an electrical pulse to the heart, and therefore paces it.), wherein the plurality of contacts are configured to electrically connect the pacing system to the tissue of the left atrial appendage (As Oral teaches that the plurality of contacts are conductive (Column 5, Lines 57- 61), it would be obvious that the contacts would electrical connect the pacing system to the tissue.).
Regarding claim 37, Devellian, Oral, Heipl and Van Tassel make obvious the device with the electronic system with a plurality of contacts and a coiled wire as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as taught by Devellian to have the electronic system as taught by Oral, in order to monitor the left atrial appendage and to administer treatment to the LAA (Column 1, Lines 15- 17) and it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plurality of contacts of the combination to have an atraumatic distal configuration such as an atraumatic bulb as taught by Van Tassel, since Van Tassel teaches that the atraumatic bulbs “will not perforate the left atrial appendage” (Column 6, Lines 33- 35) and therefore prevent damage to the left atrial appendage.
Regarding wherein the plurality of contacts comprise one or more rounded edges configured to contact the tissue of the left atrial appendage, for the combination, the device would have the contacts as taught by Oral with the atraumatic ends that are rounded as taught by Van Tassel, therefore the plurality of contacts would have rounded edges that contact the tissue of the left atrial appendage (see annotated Fig. 7 of Oral below)(Column 6, Lines 45- 57 of Van Tassel).
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Regarding claim 39, Devellian, Oral, Heipl and Van Tassel make obvious the device with the electronic system with a plurality of contacts and a coiled wire as discussed above.
The combination further teaches wherein the plurality of contacts are collapsible, the plurality of contacts configured to be delivered in a collapsed configuration in a delivery catheter (Oral, Column 8, Lines 11- 14)(As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as taught by Devellian to have the electronic system as taught by Oral, in order to monitor the left atrial appendage and to administer treatment to the LAA. It would have been further obvious to use the disclosed delivery method, including the collapsed configuration, in order to successfully deliver the device of Oral).
Regarding claim 40, Devellian, Oral, Heipl and Van Tassel make obvious the device with the electronic system with a plurality of contacts and a coiled wire as discussed above.
The combination further teaches wherein the electronic system comprises a pressure sensor (transducer 106)(Oral, Column 3, Lines 34- 40 and Column 5, Lines 8- 26) connected to the coiled wire (Oral, Column 8, Lines 11- 14)(As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as taught by Devellian to have the electronic system as taught by Oral, in order to monitor the left atrial appendage and to administer treatment to the LAA.).
Regarding claim 45, Devellian, Oral, Heipl and Van Tassel make obvious the device with the electronic system with a plurality of contacts and a coiled wire as discussed above.
Devellian further teaches wherein the support comprises a plurality of struts forming a plurality of apexes (Paragraph 0131).
Regarding claim 46, Devellian, Oral, Heipl and Van Tassel make obvious the device with the electronic system with a plurality of contacts and a coiled wire as discussed above.
The combination does not teach wherein the support comprises a plurality of anchors configured to engage tissue of the left atrial appendage.
Devellian teaches in a separate embodiment, a similar left atrial appendage device (10)(Figs. 28A- Fig. 28D)(Paragraph 0164-0169) with a support (101) that comprises a plurality of anchors (120) configured to engage tissue of the left atrial appendage (Paragraph 0165).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the support as taught by the combination to have a plurality of anchors as taught by the second embodiment of Devellian, since the anchors secure the device within the left atrial appendage.
Regarding claim 47, Devellian, Oral, Heipl and Van Tassel make obvious the device with the electronic system with a plurality of contacts and a coiled wire as discussed above.
Devellian further teaches wherein the sidewall provides a cushion between the support and a wall of the left atrial appendage (Paragraph 0130 teaches that the foam body, which the sidewall is a part of, acts as a cushion between the support and the left atrial appendage.).
Regarding wherein the scaffold has a tubular body and the sidewall comprises a compressible open cell foam, as Devellian teaches that the foam body and the stent “may have the same or similar features” to the “foam body 3002 and tubular body 3080” (Paragraph 0130) and then teaches that foam body 3002 and therefore the sidewall is tubular (Paragraph 0271), a compressible foam (Paragraph 0263), and is an open cell foam due to the presence of pores (Paragraph 0264).
Regarding claim 49, Devellian, Oral, Heipl and Van Tassel make obvious the device with the electronic system with a plurality of contacts and a coiled wire as discussed above.
Regarding wherein the plurality of contacts are position at a distal end of the electronics system, the plurality of contacts each comprising an atraumatic distal configuration configured to contact the tissue of the left atrial appendage, the combination teaches that the plurality of contacts are positioned at a proximal end of the electronics system (see annotated Fig. 3D below), however it would have been obvious to modify the location of the plurality of contacts as taught by the combination to be at a distal end of the electronics system, since it has been held that a mere reversal of parts is an obvious modification of the prior art (see MPEP 2144.04(VI)(A)).
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Claim(s) 42-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devellian et al. (WO 2018/081466) in view of Oral et al. (US 9,011,551), Heipl (WO 2015/189307), Van Tassel et al. (US 6,551,303), and Bush et al. (EP 0479435), as applied to claim 22 above, in further view of Bahmanyar et al. (WO 2019/186101).
Regarding claims 42, 43, and 44, Devellian, Oral, Heipl, Van Tassel, and Bush make obvious the device with the electronic system with a plurality of contacts and a coiled wire as discussed above.
The combination further teaches that the conductive struts (302) is able to sense from the walls of the left atrial appendage (Column , Lines 57- 60) and that the conductive struts are connects to the transponder through the wire (see Fig. 3C).
The combination does not teach the device further comprising (claim 42) a pressure transducer positioned to measure left atrial pressure, (claim 43) wherein the pressure transducer is electronically connected to the electronic system via the coiled wire, and (claim 44) wherein the pressure transducer comprises an antenna extending proximally from a proximal end of the left atrial appendage occlusion device.
Bahmanyar (Bahmanyar et al.) teaches a similar device (10)(Fig. 1) for implantation in the heart (abstract) with a support (6, 8)(Page 9, Lines 16- 17), a casing (2), a pressure transducer (4, Page 8, Lines 25- 30) (Bahmanyar teaches on Page 16, Lines 11- 27 that the pressure sensor can be a pressure transducer) positioned to measure left atrial pressure (Page 1, Line 10) which comprises an antenna (16) extending proximally from a proximal end of the device (Page 10, Lines 14- 18).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the pressure sensor of the combination to be the pressure transducer and antenna as taught by Bahmanyar for the purpose of measuring pressure within the heart. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute the pressure sensor for the pressure transducer and antenna because both are disclosed as equivalent structures for measuring pressure within the heart (Oral, Column 3, Lines 34- 40; Bahmanyar, Page 1, Line 10) and substitution of one for the other would have resulted in the predictable result of measuring and conveying the pressure that is within the heart. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Allowable Subject Matter
Claims 1-5, 11- 14, and 17- 21 are allowed.
The following is an examiner’s statement of reasons for allowance:
The closest prior art of record is Devellian et al. (WO 2018/081466), O’Halloran et al. (EP 3636172), and Oral (US 9,011,551).
Devellian (Devellian et al.) teaches a left atrial appendage occlusion device (Fig. 16)(abstract), comprising: a scaffold (foam body 1600) having a sidewall, a proximal end and a distal end (see annotated Fig. 16 below), and a self- expanding support (stent 1602)(Paragraph 0131) carried within the scaffold (Paragraph 0130), wherein the support defines a cavity therein (see annotated Fig. 16 below), wherein the proximal end of the scaffold has a proximal opening (1606)(Paragraph 0131).
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O’Halloran (O’Halloran et al.) teaches a left atrial appendage occlusion device (4)(Fig. 5)(abstract), comprising: a frame (cover 6) carried by a flap (9)(see Fig. 5 below) coupled to an implantable occlusion apparatus (4)(Paragraph 0052)(Paragraph 0059 teaches that the device in Fig. 5 is similar to the device 4 which is shown in Fig. 1 and Fig. 7. Therefore, it would have the cover, the proximal opening, and the closure as shown in Fig. 1 and Fig. 7) having a proximal end with an opening (see annotated Fig. 5 below), wherein the proximal end of the cover has an open configuration, wherein in the open configuration the proximal end has a proximal opening configured to receive therethrough an electronic system for delivery (Paragraph 0059)(see Fig. 5) and a closed configuration, wherein in the closed configuration the proximal end forms an occlusive proximal end (see annotated Fig. 7 below)(Paragraphs 0015 and 0050).
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Oral (Oral et al.) teaches a similar left atrial appendage occlusion device (194)(Fig. 3C)(abstract) with a support (304) and an electronic system (transponder unit 106) comprising a plurality of contacts (conductive struts 302) configured to contact tissue of the left atrial appendage and stabilize the electronic system after implantation of the electronic system in the left atrial appendage (Column 5, Lines 57- 64), a mainstay strut (306) coupling the support and the electronic system (Column 8, Lines 11- 14), wherein the electronic system is configured to be positioned at least partially distal to the left atrial appendage occlusion device (see annotated Fig. 3C below).
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However, the prior art does not teach or suggest (claim 1) wherein the detachable proximal portion carries a frame when detached from a main body of the scaffold, wherein the frame of the detachable proximal portion is configured to couple with a portion of the self-expandable support. Furthermore, there is no motivation to modify Devellian, O’Halloran, or Oral to have the detachable proximal portion carry a frame.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments, see Pages 9- 11, filed May 26th, 2026, with respect to the rejections have been fully considered and are persuasive. The rejections of the claims have been withdrawn.
Applicant’s argument, see Page 11, regarding that it would not have been obvious to one of ordinary skill in the art to modify the device to have the curvilinear electrodes of Bush as atraumatic contacts at a distal end of an electronics system has been fully considered but is not persuasive. Within the combination, the contacts (Oral, conductive struts 302) contact the tissue to allow for sensing or treatment (Oral, Column 5, Lines 57- 64) and engage the inner wall (Oral, 202) therefore, providing a greater surface area for the contacts to apply to tissue through loops (Bush, Column 2, Lines 13- 17) as taught by Bush would have been obvious.
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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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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