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
The amendment filed 08/03/2026 has been entered. Claims 1-9 and 11-20 remain pending in the application, claim 10 is cancelled, and claims 3 and 13 are withdrawn. Applicant’s amendments to the claims have overcome each 112(b) rejection previously set forth in the Non-Final Office Action mailed 05/04/2026, however has not overcome the prior art rejection.
Response to Arguments
Applicant's arguments filed 08/03/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 6-7 that Tsugita describes a temporary embolic filter that is temporarily deployed within a blood vessel during an interventional procedure, and is intentionally porous so that blood can flow through the filter while embolic material is captured, after which the filter is collapsed and removed. Thus, even if the filter was placed in a left atrial appendage, the LAA would not be occluded. The Office respectfully disagrees. Since this is a functional limitation, the device needs to be capable of being implanted in the LAA to occlude the LAA. The implantable medical device is shown in figure 2 when the device is expanded and occludes the vessel 70/74 with stent 20. This occlusion therefore can similarly occur in the LAA. Additionally, a full occlusion is not claimed, and thus even a partial occlusion with the filter of Tsugita would read on the claimed limitation. Therefore, the rejection is maintained.
Tsugita also discloses a covering that extends over the plurality of articulating members 54 as seen in figures 5A-5C where the covering 60 extends over the distal portion of the plurality of articulating members. Therefore, the rejection is maintained.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2, 4-5, 7-9, 11-12, and 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tsugita et al. (US Patent 5,910,154), hereinafter known as “Tsugita.”
With regards to claim 1, Tsugita discloses (Figures 2 and 5A-5C; Col 10 lines 53-57 – “the same filter assemblies may be incorporated directly into the stent catheter” an implantable medical device (figure 2), comprising:
an expandable frame 50 comprising:
a peripheral element 32;
a central element 40 rotatably disposed relative to the peripheral element 32 (Col 11 line 55 – Col 12 line 9);
a plurality of articulating members 54, each of the plurality of articulating members 54 having a first end 58 secured to the central element 40, a second end 56 secured to the peripheral element 32 (Col 11 lines 47-54) and a loop portion extending therebetween (see figure 5B for loop portion); and
a covering 60 extending over the plurality of articulating members 54 (figures 5A-5C - covering 60 extends over the distal portion of the plurality of articulating members);
wherein relative rotation between the central element 40 and the peripheral element 32 in a first relative rotational direction causes the loop portion of each of the plurality of articulating members 54 to extend radially outwardly beyond where the second end 56 of each of the plurality of articulating members 54 is secured to the peripheral element 32 (figure 5C; Col 11 line 55 – Col 12 line 9);
wherein the implantable medical device is adapted to be implanted within a left atrial appendage to occlude the left atrial appendage (functional limitation – the implantable medical device is capable of being implanted within a LAA to occlude the LAA as the configuration shown in figure 2 when the device is expanded and occludes the vessel 70/74 with stent 20; thus can also be implanted to the wall of the LAA to occlude the LAA).
With regards to claim 2, Tsugita discloses wherein the central element 40 comprises a first disk having a first diameter (figures 5A-5C – cross-section of the distal end of the central element 40 is shaped as a disk having a diameter).
With regards to claim 4, Tsugita discloses wherein the peripheral element 32 comprises an expandable stent structure 20 (Col 10 lines 7-11 and Col 10 lines 40-52 – sheath (peripheral element 32) is introduced over the catheter and stent; therefore the peripheral element comprises a stent catheter 10 and an expandable stent structure 20).
With regards to claim 5, Tsugita discloses wherein the second end 56 of each of the plurality of articulating members 54 is pivotably secured to the peripheral element 32 (see pivotable transition from figure 5B to figure 5C).
With regards to claim 7, Tsugita discloses wherein relative rotation of the central element 40 between the peripheral element 32 in a second relative rotational direction, opposing the first relative rotational direction, causes the loop portion of each of the plurality of articulating members 54 to retract radially inwardly inside of where the second end 56 of each of the plurality of articulating members 54 is secured to the peripheral element 32 (figure 5A; Col 11 line 55 – Col 12 line 9).
With regards to claim 8, Tsugita discloses wherein the covering 60 extends over the loop portion of each of the plurality of articulating members 54 (figures 5A - covering 60 extends over the distal loop portion of the plurality of articulating members 54).
With regards to claim 9, Tsugita discloses wherein the plurality of articulating members 54 are formed of a shape memory material (Col 8 lines 48-50 – Nitinol).
With regards to claim 11, Tsugita discloses (Figures 2 and 5A-5C; Col 10 lines 53-57 – “the same filter assemblies may be incorporated directly into the stent catheter” a left atrial appendage closure (LAAC) device (figure 2), comprising:
a peripheral element 32;
a central element 40, where the central element 40 and the peripheral element 32 are adapted to rotate relative to each other (Col 11 line 55 – Col 12 line 9);
a plurality of articulating members 54, each of the plurality of articulating members 54 having a first end 58 secured to the central element 40, a second end 56 pivotably secured (see pivotable transition from figure 5B to figure 5C) to the peripheral element 32 (Col 11 lines 47-54) and a loop portion extending therebetween (see figure 5B for loop portion); and
a covering 60 extending over the plurality of articulating members 54 (figures 5A-5C - covering 60 extends over the distal portion of the plurality of articulating members);
wherein relative rotation between the central element 40 and the peripheral element 32 in a first relative rotational direction causes the loop portion of each of the plurality of articulating members 54 to extend radially outwardly beyond a periphery of the peripheral element 32 (figure 5C; Col 11 line 55 – Col 12 line 9);
wherein the LAAC device is adapted to be implanted within a left atrial appendage to occlude the left atrial appendage (functional limitation – the LAAC device is capable of being implanted within a LAA to occlude the LAA as the configuration shown in figure 2 when the device is expanded and occludes the vessel 70/74 with stent 20; thus can also be implanted to the wall of the LAA to occlude the LAA).
With regards to claim 12, Tsugita discloses wherein the covering 60 extends over the plurality of articulating members 54 (figures 5A-5C).
With regards to claim 14, Tsugita discloses wherein the peripheral element 32 comprises an expandable stent structure 20 (Col 10 lines 7-11 and Col 10 lines 40-52 – sheath (peripheral element 32) is introduced over the catheter and stent; therefore the peripheral element comprises a stent catheter 10 and an expandable stent structure 20).
With regards to claim 15, Tsugita discloses wherein the plurality of articulating members 54 are formed of a shape memory material (Col 8 lines 48-50 – Nitinol).
With regards to claim 16, Tsugita discloses wherein the plurality of articulating members 54 are adapted to have a remembered shape corresponding to a maximum value for the overall diameter of the LAAC device (figure 5C is the expansion of the struts/frame in its enlarged/maximum diameter condition; Col 8 lines 48-50 disclose the struts 54 being made of Nitinol therefore exhibiting remembered shape qualities).
With regards to claim 17, Tsugita discloses (Figures 2 and 5A-5C; Col 10 lines 53-57 – “the same filter assemblies may be incorporated directly into the stent catheter” a left atrial appendage closure (LAAC) device (figure 2), comprising:
an expandable frame 50 moveable between a collapsed configuration (figure 5A) and an expanded configuration (figure 5C), the expandable frame 50 comprising:
a peripheral element 32;
a central element 40 rotatably disposed relative to the peripheral element 32 (Col 11 line 55 – Col 12 line 9);
a plurality of articulating members 54, each of the plurality of articulating members 54 having a first end 58 secured to the central element 40, a second end 56 secured to the peripheral element 32 (Col 11 lines 47-54) and a loop portion extending therebetween (see figure 5B for loop portion); and
a covering 60 disposed relative to the plurality of articulating members 54;
wherein rotation of the central element 40 relative to the peripheral element 32 causes the loop portion of each of the plurality of articulating members 54 to extend radially outwardly beyond a periphery of the peripheral element 32 (figure 5C; Col 11 line 55 – Col 12 line 9);
wherein, in the expanded configuration (figure 5C), the LAAC device is adapted to be implanted within a left atrial appendage to occlude the left atrial appendage (functional limitation – the LAAC device is capable of being implanted within a LAA to occlude the LAA as the configuration shown in figure 2 when the device is expanded and occludes the vessel 70/74 with stent 20; thus can also be implanted to the wall of the LAA to occlude the LAA).
With regards to claim 18, Tsugita discloses wherein the plurality of articulating members 54 are formed of a shape memory material (Col 8 lines 48-50 – Nitinol).
With regards to claim 19, Tsugita discloses wherein the plurality of articulating members 54 are adapted to have a remembered shape corresponding to the expanded configuration (figure 5C) of the expandable frame 50 (figure 5C is the expansion of the struts/frame in its expanded configuration; Col 8 lines 48-50 disclose the struts 54 being made of Nitinol therefore exhibiting remembered shape qualities).
With regards to claim 20, Tsugita discloses wherein rotating the central member 40 in a first direction causes the expandable frame 50 to move towards the expanded configuration (figure 5C) and rotating the central member 40 in a second direction opposing the first direction causes the expandable frame 50 to move towards the collapsed configuration (figure 5A; Col 11 line 55 – Col 12 line 9).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tsugita in view of Bodewadt et al. (US PGPub 2017/0367711), hereinafter known as “Bodewadt.”
With regards to claim 6, Tsugita discloses the implantable medical device as claimed in claim 1. Tsugita is silent to further comprising a plurality of pins pinning the second end of each of the plurality of articulating members to the peripheral element.
However, in a similar field of endeavor of occlusion devices, Bodewadt teaches (Figures 3 and 7) a plurality of pins 66/266 (paragraph 45 - restraining wires interpreted as pins as they firmly secure the device to the catheter) pinning the second end 216 of each of the plurality of articulating members to the peripheral element 264 (paragraphs 45 and 57).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the coupling of the plurality of articulating members to the peripheral element of Tsugita for the coupling of the plurality of articulating members to the peripheral element of Bodewadt. The difference between the prior art and the claimed invention is that Tsugita does not teach a plurality of pins. Bodewadt teaches (see Figs. 3 and 7) a similar device comprising a plurality of pins. Accordingly, the prior art references teach that it is known that the coupling of the plurality of articulating members to the peripheral element of Tsugita and the coupling of the plurality of articulating members to the peripheral element of Bodewadt are elements that are functional equivalents for providing coupling of the plurality of articulating members to the peripheral element. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the plurality of pins taught by Bodewadt for the plurality of articulating members to the peripheral element of Tsugita because both elements were known equivalents for providing and would have resulted in the predictable results of providing coupling to the device.
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 MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 08/13/2026
/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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