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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/16/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 06/19/2026. As directed by the amendment: claims 1-4 and 16-19 have been amended and claims 7 and 20 remain withdrawn.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 7, filed 06/19/2026, with respect to the USC 112(b) rejections have been fully considered and are persuasive. The applicant’s amendments to the claims overcome the issues of clarity within the claims. The USC 112(b) rejections have been withdrawn.
Applicant's arguments, see pages 7-9, filed 06/19/2026, with respect to the rejections of claim 1 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” have been fully considered but they are not persuasive.
The applicant amended claim 1 to further recite “two or more annular rings that are each adapted to move between the first diameter and any of the plurality of the second diameters, wherein a first annular ring of the two or more annular rings is adapted to coil further over itself to decrease in diameter and to uncoil from itself to increase in diameter; wherein a second annular ring of the two or more annular rings is adapted to coil further over itself to decrease in diameter and to uncoil from itself to increase in diameter; a joining member that joins each of the two or more annular rings yet allows each of the two or more annular rings to expand independently”.
The applicant argues that the combination of references does not teach the amended claim limitations, particularly “the joining member that joins each of the two or more annular rings yet allows each of the two or more annular rings to expand independently”. They assert that the connectors 842a and 842b may provide for some relative movement between adjacent rings but would not allow for each of the rings to expand independently of each other. The examiner respectfully disagrees.
Rudakov, in figures 16A-16D, shows each of the rings expanding in sequence, hence independently as they exit the catheter. If they could not expand independently the device would only expand all at once after all of it leaves the catheter, rather than expanding from a distal to a proximal end as it leaves the catheter.
As such the rejection will be maintained.
Applicant's arguments, see pages 9-11, filed 06/19/2026, with respect to the rejections of claim 10 under 35 U.S.C. 103 as being unpatentable over Rudakov in view of Anderson and Hansen have been fully considered but they are not persuasive.
The applicant argues that the combination of Rudakov, Anderson, and Hansen does not explicitly teach "an outer anchor cable releasably secured to the outer end of the coiled strip" and "an inner anchor cable releasably secured to the inner end of the coiled strip". The applicant argues that distal and proximal ends of 510 do not define inner and outer ends of a coil. The examiner respectfully disagrees.
Inner and outer are relative terms that are defined as such by the Merriam-Webster online dictionary as "situated farther in" and "situated farther out" respectively. In this case, the distal end would be considered "inner" as when deployed the distal end would be situated further into a lumen, while the proximal end would considered "outer" as it would be situated farther out from the lumen, i.e. the case of a left atrial appendage or aneurysm.
As such the rejection will be maintained.
Applicant's arguments, see pages 11-12, filed 06/19/2026, with respect to the rejections of claim 16 under 35 U.S.C. 103 as being unpatentable over Rudakov in view of Anderson and Hansen have been fully considered but they are not persuasive.
The applicant amended claim 1 to further recite “two or more annular rings that are each adapted to move between the first diameter and any of the plurality of the second diameters, wherein a first annular ring of the two or more annular rings is adapted to coil further over itself to decrease in diameter and to uncoil from itself to increase in diameter; wherein a second annular ring of the two or more annular rings is adapted to coil further over itself to decrease in diameter and to uncoil from itself to increase in diameter; a joining member that joins each of the two or more annular rings yet allows each of the two or more annular rings to expand independently”.
The applicant argues that the combination of references does not teach the amended claim limitations, particularly “the joining member that joins each of the two or more annular rings yet allows each of the two or more annular rings to expand independently”. They assert that the connectors 842a and 842b may provide for some relative movement between adjacent rings but would not allow for each of the rings to expand independently of each other. The examiner respectfully disagrees.
Rudakov, in figures 16A-16D, shows each of the rings expanding in sequence, hence independently as they exit the catheter. If they could not expand independently the device would only expand all at once after all of it leaves the catheter, rather than expanding from a distal to a proximal end as it leaves the catheter.
As such the rejection will be maintained.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “wherein the backbone is adapted to allow the first annular ring of the two or more annular rings to increase or decrease in diameter while the second annular ring of the two or more annular rings does not change in diameter” and “wherein the backbone is adapted to allow the second annular ring of the two or more annular rings to increase or decrease in diameter while the first annular ring of the two or more annular rings does not change in diameter” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
Claims 18 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 18 and 19 recite “while the second/first annular ring of the two or more annular rings does not change in diameter”. The applicant does not have support for this limitation in the specification or in the Figures. While the specification notes that annular rings can expand independently, it does not specifically state that this occurs while another ring does not expand or otherwise change in diameter.
It is noted that any negative limitation or exclusionary provisions must have basis in the original disclosure. The mere absence of a positive recitation is not basis for an exclusion. See MPEP 2173.05(i).
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 4 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.
Claim 4 recites the limitation "the two or more slots" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claims 1 (which claim 3 is dependent on), 3 (which claim 4 is dependent on), and 4 do not positively recite “the two or more slots” and furthermore it is not clear what the structural relationship of the slots are to the rest of the device in claim 4. For the purpose of prior art examination this limitation will be interpreted as “wherein the joining member comprises two or more slots”. 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), wherein the expandable member includes comprises two or more annular rings 862 + 864 + 868 (see Figs. 11-18D, [0497]) 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), 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); 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 a first annular ring of the two or more annular rings is adapted to coil further over itself to decrease in diameter and to uncoil from itself to increase in diameter; wherein a second annular ring of the two or more annular rings is adapted to coil further over itself to decease in diameter and to uncoil from itself to increase in diameter.
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 annular ring 20 (see Figs. 3-4B, 20 is coiled in on itself) that is adapted to coil further over itself (see Fig. 4A, when 20 is further coiled the diameter of the device is reduced, [0022]) to decrease in diameter R1 (see Fig. 4A, [0022], twice the radius is the diameter) and to uncoil 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]).
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 annular ring is adapted to coil further over itself to decrease in diameter and to uncoil from itself to increase in diameter. 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]).
The combination of Rudakov and Hansen further teaches: a first annular ring 862 of the two annular rings and a second annular ring 864 of the two or more annular rings are adapted to coil further over themselves to decrease in diameter and to uncoil from themselves to increase in diameter (Rudakov discloses multiple annular rings 862 + 864, and when modified with Hansen, each of the rings are coiled portions that uncoil or further coil).
Claim 2
The combination of Rudakov and Hansen teaches: The LAAC device of claim 1, see 103 rejection above. Rudakov (Figs. 11-18D) does not explicitly disclose: wherein the joining member comprises two or more slots, and each of the two or more annular rings extend through one of the two or more slots.
However, a variant embodiment of Rudakov (Fig. 62) teaches in the same field of invention an expandable member 2615 (see Fig. 62, [0694], torqued state/coiled state in Fig. 62 and a relaxed state, similar to Fig. 2, which is an expanded diameter shape) with two or more annular rings two of 2616 (see Fig. 62) with a joining member 2610 (see Fig. 62). Rudakov (Fig. 62) further teaches: wherein the joining member comprises 2610 two or more slots 2620 + 2622 (see Fig. 62, [0069], apertures), and each of the two or more annular rings a proximal ring terminating at 2640 extends through 2620 (see Fig. 62, [0690]) and a distal ring terminated at 2642 extends through 2622 (see Fig. 62, [0690]) extend through one of the two or more slots 2620 + 2622 (see Fig. 62).
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 (Figs. 11-18D) to incorporate the teachings of a variant embodiment of Rudakov (Fig. 62) and teach an occlusive device with the joining member comprises two or more slots, and each of the two or more annular rings extend through one of the two or more slots. Motivation for such can be found in Rudakov as these gaps allow for a segmented design for greater flexibility at the tip of the catheter without being adversely impacted by a coiled implant secured to the tip in a compressed state (see [0689]).
Claim 3
The combination of Rudakov and Hansen teaches: The LAAC device of claim 1, see 103 rejection above. Rudakov further discloses: wherein the two or more annular rings 862 + 864 + 868 further comprise a third annular ring 868 (see Figs. 11-18D, [0497]).
Claim 4
The combination of Rudakov and Hansen teaches: The LAAC device of claim 3, see 103 rejection above. Rudakov (Figs. 11-18D) does not explicitly disclose: wherein the joining member comprises two or more slots (see 112b rejection above) further comprise a third slot, and the third annular ring extends through the third slot.
However, a variant embodiment of Rudakov (Figs. 65-67) teaches in the same field of invention an expandable member 2850 (see Fig. 65-67, [0707], torqued state/coiled state in Fig. 62 and a relaxed state, similar to Fig. 2, which is an expanded diameter shape) with three or more annular rings three of 2850 (see Fig. 62) with a joining member 2810 (see Fig. 62). Rudakov (Fig. 62) further teaches: wherein the joining member comprises 2810 two or more slots 2820 + 2822 (see Fig. 62, [0069], apertures) further comprise a third slot 2824 (see Figs. 65-67, [0703]), and third annular ring a third ring of 2850 that extends through 2824 (see Figs. 66-67, [0703]) extends through the third slot 2824 (see Figs. 66-67, [0703])
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 (Figs. 11-18D) to incorporate the teachings of a variant embodiment of Rudakov (Figs. 65-67) and teach an occlusive device with the joining member comprises two or more slots (see 112b rejection above) further comprise a third slot, and the third annular ring extends through the third slot. Motivation for such can be found in Rudakov as these gaps allow for a segmented design for greater flexibility at the tip of the catheter without being adversely impacted by a coiled implant secured to the tip in a compressed state (see [0689]).
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, wherein the expandable member 810 comprising two or more annular rings 862 + 864 + 868 (see Figs. 11-18D, [0497]) that are each adapted to move between the minimal diameter (see Figs. 11 and 16A) and the deployment diameter (see Figs. 16B-16D); wherein each of the two or more annular rings 862 + 864 + 868 are adapted to increase in diameter and decrease diameter independently (see Figs. 16A-16D, each of the rings expanding independently as the device is released from its sheath/catheter); 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; wherein a first annular ring of the two or more annular rings is adapted to coil further over itself to decrease in diameter and to uncoil from itself to increase in diameter; wherein a second annular ring of the two or more annular rings is adapted to coil further over itself to decease in diameter and to uncoil from itself to increase in diameter; 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; wherein a first annular ring of the two or more annular rings is adapted to coil further over itself to decrease in diameter and to uncoil from itself to increase in diameter; wherein a second annular ring of the two or more annular rings is adapted to coil further over itself to decease in diameter and to uncoil from itself to increase in diameter.
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 adapted to coil further over itself (see Fig. 4A, when 20 is further coiled the diameter of the device is reduced, [0022]) to decrease in diameter R1 (see Fig. 4A, [0022], twice the radius is the diameter) and to uncoil 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]).
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 annular ring is adapted to coil further over itself to decrease in diameter and to uncoil from itself to increase in diameter. 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]).
The combination of Rudakov and Hansen further teaches: a first annular ring 862 of the two annular rings and a second annular ring 864 of the two or more annular rings are adapted to coil further over themselves to decrease in diameter and to uncoil from themselves to increase in diameter (Rudakov discloses multiple annular rings 862 + 864, and when modified with Hansen, each of the rings are coiled portions that uncoil or further coil).
Claim 17
The combination of Rudakov, Anderson, and Hansen teaches: The LAAC device of claim 16, see 103 rejection above. Rudakov (Figs. 11-18D) does not explicitly disclose: further comprising a backbone including two or more slots, and each of the two or more annular rings extend through one of the two or more slots.
However, a variant embodiment of Rudakov (Fig. 62) teaches in the same field of invention an expandable member 2615 (see Fig. 62, [0694], torqued state/coiled state in Fig. 62 and a relaxed state, similar to Fig. 2, which is an expanded diameter shape) with two or more annular rings two of 2616 (see Fig. 62). Rudakov (Fig. 62) further teaches: further comprising a backbone 2610 (see Fig. 62, [0069]) including two or more slots 2620 + 2622 (see Fig. 62, [0069], apertures), and each of the two or more annular rings a proximal ring terminating at 2640 extends through 2620 (see Fig. 62, [0690]) and a distal ring terminated at 2642 extends through 2622 (see Fig. 62, [0690]) extend through one of the two or more slots 2620 + 2622 (see Fig. 62).
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 (Figs. 11-18D) to incorporate the teachings of a variant embodiment of Rudakov (Fig. 62) and teach an occlusive device with a backbone including two or more slots, and each of the two or more annular rings extend through one of the two or more slots. Motivation for such can be found in Rudakov as these gaps allow for a segmented design for greater flexibility at the tip of the catheter without being adversely impacted by a coiled implant secured to the tip in a compressed state (see [0689]).
Claim 18
The combination of Rudakov, Anderson, and Hansen teaches: The LAAC device of claim 17, see 103 rejection above. The combination of Rudakov (Figs. 11-18D and Fig. 62) further teaches: wherein the backbone is adapted to allow the first annular ring of the two or more annular rings to increase or decrease in diameter while the second annular ring of the two or more annular rings does not change in diameter.
The language, "wherein the backbone is adapted to allow the first annular ring of the two or more annular rings to increase or decrease in diameter while the second annular ring of the two or more annular rings does not change in 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 the annular rings expand independently such that only one ring deploys at a time, as shown in Figures 16A-16D as the device is deployed to be released.
Furthermore, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 I.
Claim 19
The combination of Rudakov, Anderson, and Hansen teaches: The LAAC device of claim 17, see 103 rejection above. The combination of Rudakov (Figs. 11-18D and Fig. 62) further teaches: wherein the backbone is adapted to allow the second annular ring of the two or more annular rings to increase or decrease in diameter while the first annular ring of the two or more annular rings does not change in diameter.
The language, "wherein the backbone is adapted to allow the second annular ring of the two or more annular rings to increase or decrease in diameter while the first annular ring of the two or more annular rings does not change in 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 the annular rings expand independently such that only one ring deploys at a time, as shown in Figures 16A-16D as the device is deployed to be released.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zarbatany et al (US 20220117555 A1) teaches an LAAC device with three annular rings that are capable of expanding and coiling (see Figs. 9 and 10D)
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
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