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 .
Election/Restrictions
Applicant’s election without traverse of Species 1 (Figs. 2-5, 8, 9) in the reply filed on 9/2/2026 is acknowledged. Applicant indicates Species 1 encompasses claims 1-4, 6-9, 16-20. However, claim 16 is directed to species 3 (Figs. 7, 10). Paragraph [0077] of the published application, along with Figs. 10A-10B, discusses the expandable coating which swells or expands to fill much of the space between the first coil winding (290a) and second coil winding (280b). Therefore, claim 16 is withdrawn as directed to a non-elected species. Claims 1-4, 6-9, 17-20 are presently pending for examination.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al (CN 115886918; wherein the English machine translation is cited below; hereinafter as “Li ‘918”).
Li ‘918 discloses the following limitations:
Claim 1. A left atrial appendage closure (LAAC) device (Figs. 4-5), comprising:
an expandable occlusive element (6+7) movable from a collapsed configuration for delivery to an expanded configuration for deployment (Fig. 4b, 5b; page 6; “the supporting frame can be made of metal pipe material or wire with shape memory function material by laser cutting or weaving and so on, and by using the heat treatment device by shaping, expanding into a space net-shaped structure”); and
an atraumatic anchor (8) engaged with the expandable occlusive element, the atraumatic anchor capable of engaging pectinate within the left atrial appendage (LAA) in order to secure the expandable occlusive element within the LAA (Figs. 4b, 5b; pages 11-12).
Claim 8. The LAAC device of claim 1, wherein the atraumatic anchor comprises a helical coil (8) having an atraumatic tip (Figs. 4b, 5b; the term ‘atraumatic’ is not claimed in a structural manner, the tip of Li ‘918 is curved inwards away from pectinate and therefore considered atraumatic due to its curve).
Claim(s) 1 and 4 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Li et al (US 2024/0245406; hereinafter as “Li ‘406”).
Li ‘406 discloses the following limitations:
Claim 1. A left atrial appendage closure (LAAC) device (Fig. 1), comprising:
an expandable occlusive element (20) movable from a collapsed configuration for delivery to an expanded configuration for deployment ([0069], [0070]); and
an atraumatic anchor (10) engaged with the expandable occlusive element, the atraumatic anchor capable of engaging pectinate within the left atrial appendage (LAA) in order to secure the expandable occlusive element within the LAA. ([0069], [0071]).
Claim 4. The LAAC device of claim 1, wherein the atraumatic anchor comprises a proximal base portion (11) that wraps around the expandable occlusive element in order to secure the atraumatic anchor to the expandable occlusive element ([0071], [0072]; Fig. 1).
Claim(s) 1, 17 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ruiz (US 2011/0082495).
Ruiz discloses the following limitations:
Claim 1. A left atrial appendage closure (LAAC) device (Figs. 3-5), comprising:
an expandable occlusive element (60) ([0036], [0038]) movable from a collapsed configuration (Fig. 5A) for delivery to an expanded configuration (Fig. 5C) for deployment; and
an atraumatic anchor (50) engaged with the expandable occlusive element (disk 50 itself has no sharp or piercing ends, instead the distal end of base 51 is rounded and therefore the disk 50 is considered atraumatic), the atraumatic anchor capable of engaging pectinate within the left atrial appendage (LAA) (16) in order to secure the expandable occlusive element within the LAA (the disk is capable of being placed inside the LAA to engage pectinate).
Claim 17. The LAAC device of claim 1, wherein the expandable occlusive element is keyed to a delivery device (80) component (82) ([0042]).
Claim 19. The LAAC device of claim 17, wherein the atraumatic anchor comprises one or more helical coils (58) ([0042]; the threads form a helical coiling on the inner wall of base 51 of atraumatic anchor 50).
Claim(s) 1, 6 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Subramaniam et al (US 2019/0209179).
Subramaniam et al discloses the following limitations:
Claim 1. A left atrial appendage closure (LAAC) device (Fig. 11), comprising:
an expandable occlusive element (1103) movable from a collapsed configuration for delivery to an expanded configuration for deployment ([0069]); and
an atraumatic anchor (1107) engaged with the expandable occlusive element, the atraumatic anchor capable of engaging pectinate within the left atrial appendage (LAA) in order to secure the expandable occlusive element within the LAA (sealing element is capable of being placed within the LAA to engage pectinate).
Claim 6. The LAAC device of claim 1, wherein the atraumatic anchor (1107) comprises a proximal base (narrowed proximal neck portion) having an inner surface (1104) adapted to engage the expandable occlusive element (Fig. 11; [0069]; the wire/filament is disposed therethrough) and an outer surface (1112) that is threaded in order to threadedly engage a threaded sleeve forming part of a delivery device (1122) ([0069]; it is noted the delivery device is not positively claimed as an element of the device).
Claim 7. The LAAC device of claim 1, wherein the atraumatic anchor (1107) comprises a proximal base (narrowed proximal neck portion) having an inner surface (1104) adapted to engage the expandable occlusive element (Fig. 11; [0069]; the wire/filament is disposed therethrough) and an outer surface (111) including two or more slots (each valley between the raised threads is considered a slot) adapted to engage with a torquer element (1102) forming part of a delivery device (1122) ([0069]; it is noted the delivery device is not positively claimed as an element of the device).
Claim(s) 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaplan et al (US 2014/0277074).
Kaplan et al discloses the following limitations:
Claim 18. A left atrial appendage closure (LAAC) device (Figs. 4-5), comprising:
an expandable foam element (400) movable from a collapsed configuration for delivery to an expanded configuration for deployment ([0047]); and
an atraumatic anchor (408/502) engaged with the expandable foam element, the atraumatic anchor adapted to engage pectinate within the left atrial appendage (LAA) in order to secure the expandable occlusive element within the LAA ([0055]; screw wire is considered atraumatic as it does not puncture epicardial surface 506 as seen in Fig. 5).
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) 2, 3 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li ‘918 in view of Kaplan et al.
Claims 2 and 3. Li ‘918 discloses the invention substantially as claimed above, but fails to disclose the expandable occlusive element comprises a foam element (as per claim 2), wherein the collapsed configuration corresponds to the foam element being constrained within a delivery device and the expanded configuration corresponds to the foam element expanding to a biased configuration when no longer constrained by the delivery device (as per claim 3).
However, in the same field of endeavor, Kaplan et al teaches a LAAC device, where the expandable occlusive element is a foam element (204, 400) ([0047]), wherein the collapsed configuration corresponds to the foam element being constrained within a delivery device and the expanded configuration corresponds to the foam element expanding to a biased configuration when no longer constrained by the delivery device (Figs. 8-15; [0062]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the occlusive element of Li ‘918 to be a foam element, wherein the collapsed configuration corresponds to the foam element being constrained within a delivery device and the expanded configuration corresponds to the foam element expanding to a biased configuration when no longer constrained by the delivery device, as taught by Kaplan et al, to allow the occlusive element to conform to the irregular surfaces of the LAA as it expands, providing a complementary surface structure to the native LAA wall to further enhance anchoring and promote sealing ([0047]).
Claim 18. Li ‘918 discloses a left atrial appendage closure (LAAC) device (Figs. 4-5), comprising:
an expandable occlusive element (6+7) movable from a collapsed configuration for delivery to an expanded configuration for deployment (Fig. 4b, 5b; page 6; “the supporting frame can be made of metal pipe material or wire with shape memory function material by laser cutting or weaving and so on, and by using the heat treatment device by shaping, expanding into a space net-shaped structure”); and
an atraumatic anchor (8) engaged with the expandable occlusive element, the atraumatic anchor capable of engaging pectinate within the left atrial appendage (LAA) in order to secure the expandable occlusive element within the LAA (Figs. 4b, 5b; pages 11-12).
Li ‘918 fails to disclose the expandable occlusive element is a foam element.
However, in the same field of endeavor, Kaplan et al teaches a LAAC device, where the expandable occlusive element is a foam element (204, 400) ([0047]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the occlusive element of Li ‘918 to be a foam element, as taught by Kaplan et al, to allow the occlusive element to conform to the irregular surfaces of the LAA as it expands, providing a complementary surface structure to the native LAA wall to further enhance anchoring and promote sealing ([0047]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li ‘918 in view of Li ‘406.
Claim 9. Li ‘918 discloses the invention substantially as claimed above, but fails to disclose the helical coil comprises one or more retention bumps.
However, in the same field of endeavor, Li ‘406 teaches a LAAC device, wherein the anchoring rods (12) (akin to the anchoring helical coils 8 of Li ‘918) comprises one or more retention bumps (131) ([0073]-[0075]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the helical coils of Li ‘918 with one or more retention bumps based upon the teachings of Li ‘406 as the retentions bumps will extend into the gap of the pectinate, allowing the bumps to be clamped and therefore promoting anchoring of the device ([0073]-[0075])
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li ‘918 in view of Kaplan et al and Center et al (US 2022/0125567)
Claim 20. Li ‘918 discloses a left atrial appendage closure (LAAC) device (Figs. 4-5), comprising:
an expandable occlusive element (6+7) movable from a collapsed configuration for delivery to an expanded configuration for deployment (Fig. 4b, 5b; page 6; “the supporting frame can be made of metal pipe material or wire with shape memory function material by laser cutting or weaving and so on, and by using the heat treatment device by shaping, expanding into a space net-shaped structure”); and
an atraumatic anchor (8) engaged with the expandable occlusive element, the atraumatic anchor comprising:
a base portion (4) adapted to be secured to the expandable element;
a coil (8) adapted to extend distally from the base portion and capable of engaging with pectinate within the left atrial appendage (LAA) (Figs. 4b, 5b; pages 11-12).
Li ‘918 fails to disclose the expandable occlusive element is a foam element.
However, in the same field of endeavor, Kaplan et al teaches a LAAC device, where the expandable occlusive element is a foam element (204, 400) ([0047]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the occlusive element of Li ‘918 to be a foam element, as taught by Kaplan et al, to allow the occlusive element to conform to the irregular surfaces of the LAA as it expands, providing a complementary surface structure to the native LAA wall to further enhance anchoring and promote sealing ([0047]).
Li ‘918 further fails to disclose the atraumatic anchor comprising an atraumatic tip secured to a distal end of the coil. However, in the same field of endeavor, Larsen et al teaches a LAAC device comprising an expandable occlusive element (102) and an atraumatic anchor (190) comprising an atraumatic tip (200) secured to the distal end of the wire (akin to the helical coil of Li ‘918) (Fig. 12; [0151]-[053]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the atraumatic anchor of Li ‘918 with an atraumatic tip secured to the distal end of the helical based upon the teachings of Center et al to reduce the potential for perforation or pericardial effusion ([0151]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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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.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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