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 03/30/2026. As directed by the amendment: claims 1-3, 6, 10, and 16-18 have been amended and claims 7 and 20 remain withdrawn. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 6, filed 03/30/2026, with respect to the USC 112(f) interpretation of “anchoring feature” have been fully considered and are persuasive. The applicant has amended claim 6 to instead recite “one or more anchors”, which no longer invokes 112(f). The 112(f) is no longer invoked within the claims.
Applicant’s arguments, see pages 6-7, filed 03/30/2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(1) as being anticipated by Rudakov et al (US 20140371777 A1), herein referenced to as “Rudakov” have been fully considered and are persuasive.
The applicant has amended claim 1 to further recite “wherein the expandable member includes a coiled portion that is configured to change diameter of the expandable member by coiling further over itself to decrease the diameter of the coiled portion and uncoiling from itself to increase the diameter of the coiled portion”.
The examiner agrees that Rudakov does not explicitly disclose: a coiled portion that is configured to change diameter of the expandable member by coiling further over itself to decrease the diameter of the coiled portion and uncoiling from itself to increase the diameter of the coiled portion.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rudakov in view of Hansen (US 20130053872 A1).
Applicant’s arguments, see pages 7-9, filed 03/30/2026, with respect to the rejection(s) of claim(s) 10 and 16 under 35 U.S.C. 103 as being unpatentable over Rudakov in view of Anderson et al (US 20190374229 A1), herein referenced to as “Anderson” have been fully considered and are persuasive.
The applicant amended claim 10 to further recite “wherein the coiled strip is adapted to change diameter by coiling further over itself to decrease the diameter of the coiled strip and uncoiling from itself to increase the diameter of the coiled strip”.
The applicant amend claim 16 to further recite “wherein the expandable member includes at least one coiled portion that is configured to change diameter by coiling further over itself or uncoiling from itself”.
The examiner agrees that Rudakov and Anderson does not explicitly teach the coiled strip is configured/adapted to change diameter by coiling further over itself or uncoiling from itself.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rudakov in view of Anderson and Hansen.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claim limitation “by coiling further over itself or uncoiling from itself” renders the claim indefinite because it is not clear if “itself” refers to a first of the two or more annular rings, a second of the two or more annular rings, or both of the two or more annular rings. For the purpose of prior art examination this limitation will be interpreted as “by coiling further over themselves or uncoiling from themselves”. Appropriate correction is required.
Claim Objections
Claim 2 is objected to because of the following informalities:
Claim #
Line #
Current
Suggested change
2
2
ring is adapted
ring that is adapted
Appropriate correction is required.
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) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rudakov et al (US 20140371777 A1), herein referenced to as “Rudakov” in view of Hansen (US 20130053872 A1), herein referenced to as “Hansen”.
Claim 1
Rudakov discloses: An occlusive device 800 (see Figs. 11-18D, [0487]), comprising: an expandable member 810 (see Figs. 11-18D, [0487]) defining a profile (see Figs. 11-18D, [0487], the support frame defines the profile of the device) of the LAAC device 800, the expandable member 810 moveable between a first diameter (see Figs. 11 and 16A, [0488] and [0518], delivery configuration) for delivery and any of a plurality of second diameters (see Figs. 16B-16D, [0518], the expanding diameters as the device reaches its deployed configuration where the diameter is constrained by the lumen of the vessel that the device is placed into in order for the device to anchor into the vessel) greater than the first diameter for deployment (see Figs. 16A-16D); and a covering 812 (see Figs. 11-18D, [0517]) extending over at least a portion 812 extends over 810 (see Figs. 11-18D) of the expandable member 810, the covering 812 adapted to accommodate changes (see Figs. 16A-16D, [0520]) in the expandable member 810 between the first diameter (see Fig. 11 and 16A) and the plurality of second diameters (see Figs. 16B-16D).
The preamble, " left atrial appendage closure (LAAC)," merely recites intended uses of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Rudakov meets the structural limitations of the claim, and is capable of being used for left atrial appendage closure as an occluding device to stop the flow of blood that can expand to fit lumens of bodily vessels.
Rudakov does not explicitly disclose: wherein the expandable member includes a coiled portion that is configured to change diameter of the expandable member by coiling further over itself to decrease the diameter of the coiled portion and uncoiling from itself to increase the diameter of the coiled portion.
However, Hansen in a similar field of invention teaches an occlusive device 10 (see Figs. 1-9) with an expandable member 20 + 50 (see Figs. 1-9, [0074], nitinol, unroll and expand) with a first diameter (see Fig. 4A) and a plurality of second diameters (see Fig. 4B, any points in which 20 expands from Fig. 4A to Fig. 4B). Hansen further teaches: wherein the expandable member 20 + 50 includes a coiled portion 20 (see Figs. 3-4B, 20 is coiled in on itself) that is configured to change diameter R1 (see Fig. 4A, [0022], twice the radius is the diameter) of the expandable member 20 by coiling further over itself (see Fig. 4A, when 20 is further coiled the diameter of the device is reduced, [0022]) to decrease the diameter R1 of the coiled portion 20 and uncoiling from itself (see Fig. 4B, when 20 is uncoiled/less coiled the diameter of the device is increased) to increase the diameter R2 (see Fig. 4B, [0022]) of the coiled portion 20.
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 Rudakov to incorporate the teachings of Hansen and teach an occlusive device with the expandable member includes a coiled portion that is configured to change diameter of the expandable member by coiling further over itself to decrease the diameter of the coiled portion and uncoiling from itself to increase the diameter of the coiled portion. Motivation for such can be found in Hansen as this functions to stably close the neck/ostium of an appendage such as an aneurysm while remodeling the surrounding tissue to avoid migration of the device (see [0037]).
Claim 2
The combination of Rudakov and Hansen teaches: The LAAC device of claim 1, see 103 rejection above. Hansen further teaches: wherein the coiled portion 20 comprises an annular ring 20 (see Figs. 1-6, 20 is an annular ring) is adapted to move between the first diameter (see Fig. 4A) and any of the plurality of second diameters (see Fig. 4B, and the intervening diameters with Fig. 4A).
Claim 3
The combination of Rudakov and Hansen teaches: The LAAC device of claim 1, see 103 rejection above. The combination of Rudakov and Hansen further teaches: wherein the coiled portion 810 comprises two or more annular rings 862 + 864 + 868 (see Figs. 11-18D, [0497], Rudakov discloses multiple rings, and when modified with Hansen, each of the rings are coiled portions 20, that each are adapted to be between the first and plurality of second diameters) that are each adapted to move between the first diameter (see Fig. 16A) and any of the plurality of second diameters (see Figs. 16B-16D) by coiling further over itself or uncoiling from itself (see 112b rejection above, interpreted as “themselves”, Rudakov discloses multiple, and when modified with Hansen, each of the rings are coiled portions that uncoil or further coil).
Claim 4
The combination of Rudakov and Hansen teaches: The LAAC device of claim 3, see 103 rejection above. Rudakov further discloses: further comprising a joining member 842a + 842b (see Figs. 11-18D, [0490]) that joins each of the two or more annular rings 862 + 864 + 868 yet allows each of the two or more annular rings 862 + 864 + 868 to expand independently (see Figs. 16A-16D, each of the rings expanding independently as the device is released from its sheath/catheter).
Claim 5
The combination of Rudakov and Hansen teaches: The LAAC device of claim 1, see 103 rejection above. Rudakov further discloses: wherein the expandable member 810 is biased to a greatest diameter (see [0498]-[0499], the device is configured to expand to provide anti-migration benefits, hence as large as possible to fit different vessel lumens and to provide some anchoring) of the plurality of second diameters.
Claim(s) 6 and 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rudakov in view of Hansen as applied to claim 1 above, and further in view of Anderson et al (US 20190374229 A1), herein referenced to as “Anderson”.
Claim 6
The combination of Rudakov and Hansen teaches: The LAAC device of claim 1, see 103 rejection above. The combination of Rudakov and Hansen does not explicitly teach: wherein the expandable member further comprises one or more anchoring features.
However, Anderson in a similar field of invention teaches an LAAC device 10 (see Fig. 2) with an expandable member 12 (see Fig. 2) and a covering 14 (see Fig. 2). Anderson further teaches: wherein the expandable member 12 further comprises one or more anchors 16 (see Fig. 2, [0070], barbed anchoring members that piece into the LAA tissue).
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 Rudakov to incorporate the teachings of Anderson and teach a LAAC device with one or more anchors. Motivation for such can found in Anderson as they assist in holding the implant fixed adjacent to the left atrial appendage (see [0070]).
Claim 8
The combination of Rudakov and Hansen teaches: The LAAC device of claim 1, see 103 rejection above. Rudakov further discloses: wherein the covering 812 having a periphery the periphery of 812 (see Fig. 12), and the periphery the periphery of 812 of the covering 812 is secured to a periphery the periphery of 810 (see Fig. 12, the outermost portions of the 810 attached to 812) of the expandable member 810.
The combination of Rudakov and Hansen does not explicitly teach: wherein the covering comprises a fabric.
However, Anderson in a similar field of invention teaches an LAAC device 110 (see Fig. 3) with an expandable member 112 (see Fig. 3) and a covering 114 (see Fig. 3). Anderson further teaches: wherein the covering 114 comprises a fabric (see [0072], a fabric).
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 Rudakov to incorporate the teachings of Anderson and have a LAAC device with a fabric covering. This is due to using fabric for coverings/occlusive members (see [0072] of Anderson) is common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Claim 9
The combination of Rudakov, Hansen, and Anderson teaches: The LAAC device of claim 8, see 103 rejection above. The combination of Rudakov and Anderson further teaches: wherein the fabric (Rudakov and modified by Anderson has the covering 812 to be made of fabric) includes a mounting region portion of 812 through which 872 is inserted (see Fig. 12) disposed within a central portion the central portion of 812 (see Fig. 12) of the fabric (Rudakov and modified by Anderson has the covering 812 to be made of fabric) that is adapted to releasably accommodate a delivery sheath 802 (see Fig. 12 [0506]).
Claim(s) 10-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rudakov in view of Anderson and Hansen.
Claim 10
Rudakov discloses: An occlusive device 300 (see Figs. 2-4D, [0449]), comprising: an expandable member 302 (see Figs. 2-4D, [0449]) defining a profile (see Figs. 2-4D, 302 defines the profile of the device) of the LAAC device 300, the expandable member 302 including a coiled strip (see Figs. 2-4D, [0450] and [0453], helical/coiled body) having an inner end 312 (see Fig. 3, [0450]) and an outer end 310 (see Fig. 3, [0450]), the coiled strip 312 adapted to coil over on itself (see Fig. 4D, 312 coiled over itself at 312); and a covering 304 (see Figs. 2-4D, [0449]) extending over at least a portion a portion of 302 of the expandable member 302, the covering 304 adapted to accommodate changes in a diameter of the expandable member (see [0449], 304 expands as 302 expands).
The preamble, " left atrial appendage closure (LAAC)," merely recites intended uses of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Rudakov meets the structural limitations of the claim, and is capable of being used for left atrial appendage closure as an occluding device to stop the flow of blood that can expand to fit lumens of bodily vessels.
Rudakov does not explicitly disclose: wherein the coiled strip is adapted to change diameter by coiling further over itself to decrease the diameter of the coiled strip and uncoiling from itself to increase the diameter of the coiled strip; an outer anchor cable releasably securable to the outer end of the coiled strip; an inner anchor cable releasably securable to the inner end of the coiled strip; wherein the expandable member is adapted to be changed in diameter by moving one of the outer anchor cable and the inner anchor cable while holding the other of the outer anchor cable and the inner anchor cable stationary, thereby causing the expandable member to coil or uncoil; the covering is a fabric.
However, a variant embodiment (Fig. 4B) of Rudakov teaches in the same field of invention an occlusive device 502 (see Fig. 4B) with an expandable member 510 (see Fig. 4B) that is a coiled strip 510 (see Fig. 4B) with an inner end 542 (see Fig. 4B) and an outer end 540 (see Fig. 4B). Rudakov (Fig. 4B) further teaches: an outer anchor cable 520 (see Fig. 4B, [0454]) releasably securable (see [0453], the device is released and expanded to be implanted) to the outer end 540 of the coiled strip 510; an inner anchor cable 522 (see Fig. 4B, [0454]) releasably securable to the inner end 542 of the coiled strip 510; wherein the expandable member is adapted to be changed in diameter by moving one of the outer anchor cable and the inner anchor cable while holding the other of the outer anchor cable and the inner anchor cable stationary, thereby causing the expandable member to coil or uncoil.
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 Rudakov to incorporate the teachings of a variant embodiment of Rudakov (Fig. 4B) and teach an occlusive device with an outer anchor cable releasably securable to the outer end of the coiled strip; an inner anchor cable releasably securable to the inner end of the coiled strip. Motivation for such can be found in Rudakov as this allows for sequential deployment of the proximal and distal ends of an implant (see [0445]).
The language, "wherein the expandable member is adapted to be changed in diameter by moving one of the outer anchor cable and the inner anchor cable while holding the other of the outer anchor cable and the inner anchor cable stationary, thereby causing the expandable member to coil or uncoil," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Rudakov meets the structural limitations of the claim, and is capable of changing the diameter of the expandable member by moving one of the cables while holding the other stationary in order to cause the device to coil or uncoil via sequential deployment and retraction/coiling (see [0445] and [0455]-[0456]).
Rudakov does not explicitly teach: wherein the coiled strip is adapted to change diameter by coiling further over itself to decrease the diameter of the coiled strip and uncoiling from itself to increase the diameter of the coiled strip; the covering is a fabric.
However, Anderson in a similar field of invention teaches an LAAC device 110 (see Fig. 3) with an expandable member 112 (see Fig. 3) and a covering 114 (see Fig. 3). Anderson further teaches: wherein the covering 114 comprises a fabric (see [0072], a fabric).
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 Rudakov to incorporate the teachings of Anderson and have a LAAC device with a fabric covering. This is due to using fabric for coverings/occlusive members (see [0072] of Anderson) is common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
The combination of Rudakov and Anderson does not explicitly teach: wherein the coiled strip is adapted to change diameter by coiling further over itself to decrease the diameter of the coiled strip and uncoiling from itself to increase the diameter of the coiled strip.
However, Hansen in a similar field of invention teaches an occlusive device 10 (see Figs. 1-9) with an expandable member 20 + 50 (see Figs. 1-9, [0074], nitinol, unroll and expand) with a coiled strip 20 (see Figs. 1-9) with a first diameter (see Fig. 4A) and a plurality of second diameters (see Fig. 4B, any points in which 20 expands from Fig. 4A to Fig. 4B). Hansen further teaches: wherein the coiled strip 20 (see Figs. 3-4B, 20 is coiled in on itself) is adapted to change diameter by coiling further over itself (see Fig. 4A, when 20 is further coiled the diameter of the device is reduced, [0022]) to decrease the diameter R1 (see Fig. 4A, [0022], twice the radius is the diameter) of the coiled strip 20 and uncoiling from itself (see Fig. 4B, when 20 is uncoiled/less coiled the diameter of the device is increased) to increase the diameter R2 (see Fig. 4B, [0022]) of the coiled strip 20.
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 Rudakov to incorporate the teachings of Hansen and teach an occlusive device with the coiled strip is adapted to change diameter by coiling further over itself to decrease the diameter of the coiled strip and uncoiling from itself to increase the diameter of the coiled strip. Motivation for such can be found in Hansen as this functions to stably close the neck/ostium of an appendage such as an aneurysm while remodeling the surrounding tissue to avoid migration of the device (see [0037]).
Claim 11
The combination of Rudakov, Anderson, and Hansen teaches: The LAAC device of claim 10, see 103 rejection above. Rudakov further discloses: wherein the expandable member 510 is adapted to have a free state in which the coiled strip is coiled, and is actuated to a greater diameter (see [0445]-[0456], the device is initial coiled and then can be actuated to a greater diameter by being released, via expanding).
Claim 12
The combination of Rudakov, Anderson, and Hansen teaches: The LAAC device of claim 10, see 103 rejection above.
The language, " wherein the expandable member is adapted to have a free state in which the coiled strip is uncoiled, and is actuated to a reduced diameter," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Rudakov meets the structural limitations of the claim, and is capable of having a free state in which the coiled strip is uncoiled, as the device can have one end actuated to be uncoiled, and then can be actuated to be coiled by shortening the length between the distal and proximal ends via that two elongate members 520/522.
Claim 13
The combination of Rudakov, Anderson, and Hansen teaches: The LAAC device of claim 10, see 103 rejection above. Rudakov (Fig. 4B) further teaches: wherein the inner anchor cable 522 and the outer anchor cable 520 are each adapted to be removed from the expandable member 510 after deployment (see [0445] and [0454]-[0456], the cables can be removed to allow for deployment of the expandable member).
Claim 14 and Claim 15
The combination of Rudakov, Anderson, and Hansen teaches: The LAAC device of claim 10, see 103 rejection above. Rudakov does not explicitly teach: further comprising a fabric actuation cable that is releasably securable to the fabric, wherein the fabric actuation cable is adapted to be actuated in order to pull the fabric taut relative to the expandable member.
However, Anderson in a similar field of invention teaches an LAAC device 710 (see Figs. 10-12) with an expandable member 712 (see Figs. 10-12) and a fabric 714 (see Figs. 10-12). Anderson further teaches: further comprising a fabric actuation cable 17 (see Figs. 10-12, [0097]) that is releasably securable (see Figs. 10-12, [0099], is releasably coupled to 714) to the fabric 714, wherein the fabric actuation cable 17 is adapted to be actuated (see Figs. 10-12, [0098]-[099], 714 is cinched via actuation of 17 to pull it taut over 712) in order to pull the fabric 714 taut relative to the expandable member 712.
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 Rudakov to incorporate the teachings of Anderson and teach a LAAC device with a fabric actuation cable that is releasably securable to the fabric, wherein the fabric actuation cable is adapted to be actuated in order to pull the fabric taut relative to the expandable member. Motivation for such can be found in Anderson as this maintains the occlusive member under tension over the outer surface of the framework which prevents wrinkles from forming in the occlusive member and reduce the likelihood of thrombus being trapped in the wrinkles (see [0077] and [0099]).
Claim 16
Rudakov discloses: An occlusive device 800 (see Figs. 11-18D, [0487]), comprising: an expandable member 810 (see Figs. 11-18D, [0487]) defining a profile (see Figs. 11-18D, [0487], the support frame defines the profile of the device) of the LAAC device 800, the expandable member 810 moveable between a minimal diameter (see Figs. 11 and 16A, [0488] and [0518], delivery configuration) and a maximum diameter (see [0498]-[0499], the device is configured to expand to provide anti-migration benefits, hence as large as possible to fit different vessel lumens and to provide some anchoring, the greatest being the maximum diameter), the expandable member adapted to move to a deployment diameter (see Figs. 16B-16D, [0518], the expanding diameters as the device reaches its deployed configuration where the diameter is constrained by the lumen of the vessel that the device is placed into in order for the device to anchor into the vessel) that is intermediate the minimal diameter (see Figs. 11 and 16A, [0488] and [0518], delivery configuration) and the maximum diameter (see [0498]-[0499], the device is configured to expand to provide anti-migration benefits, hence as large as possible to fit different vessel lumens and to provide some anchoring, the greatest being the maximum diameter); and a covering 812 (see Figs. 11-18D, [0517]) extending over at least a portion 812 extends over 810 (see Figs. 11-18D) of the expandable member 810, the covering 812 adapted to accommodate changes (see Figs. 16A-16D, [0520]) in the expandable member 810 between the minimal diameter and the increased diameter (see Figs. 11 and 16A-16D).
The preamble, " left atrial appendage closure (LAAC)," merely recites intended uses of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Rudakov meets the structural limitations of the claim, and is capable of being used for left atrial appendage closure as an occluding device to stop the flow of blood that can expand to fit lumens of bodily vessels.
The language, " that is limited by dimensions of a left atrial appendage (LAA) in which the LAAC device is deployed," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Rudakov meets the structural limitations of the claim, and is capable of flexibly expanding to fit within the lumen of a LAA, and being limited in expansion by the dimensions of the LAA, using the force of the expansion to anchor the device within the LAA, similar to other lumens the device may be implanted within.
Rudakov does not explicitly disclose: wherein the expandable member includes at least one coiled portion that is configured to change diameter by coiling further over itself or uncoiling from itself; the covering is a fabric.
However, Anderson in a similar field of invention teaches an LAAC device 110 (see Fig. 3) with an expandable member 112 (see Fig. 3) and a covering 114 (see Fig. 3). Anderson further teaches: wherein the covering 114 comprises a fabric (see [0072], a fabric).
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 Rudakov to incorporate the teachings of Anderson and have a LAAC device with a fabric covering. This is due to using fabric for coverings/occlusive members (see [0072] of Anderson) is common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
The combination of Rudakov and Anderson does not explicitly teach: wherein the expandable member includes at least one coiled portion that is configured to change diameter by coiling further over itself or uncoiling from itself.
However, Hansen in a similar field of invention teaches an occlusive device 10 (see Figs. 1-9) with an expandable member 20 + 50 (see Figs. 1-9, [0074], nitinol, unroll and expand) with a minimal diameter (see Fig. 4A) and a deployment diameter (see Fig. 4B, any points in which 20 expands from Fig. 4A to Fig. 4B). Hansen further teaches: wherein the expandable member 20 + 50 includes at least one coiled portion 20 (see Figs. 3-4B, 20 is coiled in on itself) that is configured to change diameter R1/R2 (see Figs. 4A-4B, [0022]) of by coiling further over itself (see Fig. 4A, when 20 is further coiled the diameter of the device is reduced, [0022]) or uncoiling from itself (see Fig. 4B, when 20 is uncoiled/less coiled the diameter of the device is increased)
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 Rudakov to incorporate the teachings of Hansen and teach an occlusive device with the expandable member includes at least one coiled portion that is configured to change diameter by coiling further over itself or uncoiling from itself. Motivation for such can be found in Hansen as this functions to stably close the neck/ostium of an appendage such as an aneurysm while remodeling the surrounding tissue to avoid migration of the device (see [0037]).
Claim 17
The combination of Rudakov, Anderson, and Hansen teaches: The LAAC device of claim 16, see 103 rejection above. Hansen further teaches: wherein the coiled portion 20 comprises an annular ring 20 (see Figs. 1-6, 20 is an annular ring) adapted to move between the minimal diameter (see Fig. 4A) and the deployment diameter (see Fig. 4B).
Claim 18
The combination of Rudakov, Anderson, and Hansen teaches: The LAAC device of claim 16, see 103 rejection above. The combination of Rudakov and Hansen further teaches: wherein the expandable member 810 comprises two or more annular rings 862 + 864 + 868 (see Figs. 11-18D, [0497], Rudakov discloses multiple rings, and when modified with Hansen, each of the rings are coiled portions 20, that each are adapted to be between the minimal diameter and the deployment diameter) that are each adapted to move between the minimal diameter (see Fig. 16A) and the deployment diameter (see Figs. 16B-16D).
Claim 19
The combination of Rudakov, Anderson, and Hansen teaches: The LAAC device of claim 18, see 103 rejection above. Rudakov further discloses: wherein each of the two or more annular rings 862 + 864 + 868 are adapted to expand independently (see Figs. 16A-16D, each of the rings expanding independently as the device is released from its sheath/catheter).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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