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 .
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.
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.
Claims 10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0065824 A1 (Dagan) (cited by Applicant) in view of US 2001/0047198 A1 (Drasler) (previously cited), US 5,387,235 A (Chuter) (previously cited), and US 2013/0289703 A1 (Kinkade) (previously cited).
With regards to claim 10, Dagan discloses a vascular implant (Figs 6A-B and ¶¶ [0151], [0153] depict a stent 20 attached to an antenna 28), comprising a resilient zig-zag loop structure around an open center having multiple straight strut sections joined to one another by rounded crown sections (Figs. 6A-B depict a stent body 90 comprising a first strut portion 32; Figs. 2A-B, 6A-6B, 7A depict the strut portions formed as a single closed loop comprising multiple straight strut sections joined to one another by rounded junctions (i.e., rounded crown sections), wherein an attachment arm extends from each rounded crown section on at least one end of said two ends of said zig-zag loop structure (Figs. 6A-B and ¶¶ [0151]-[0152] depict a distal end of first strut portion 32 of the stent body having posts 92 extending from each rounded crown section).
Dagan teaches the apparatus and methods may be applied to a stent graft, mutatis mutandis (¶ [0179]), wherein a stent graft having strut portions and junctions may be used and/or an antenna may be coupled to the body of the stent graft via posts that longitudinally separate the antenna from a distal end of the body of the stent graft (¶ [0179]).
Dagan is silent with regards to a zig-zag loop structure around an open center, the zig-zag loop structure having multiple straight strut sections joined to one another by rounded crown sections, wherein: said zig-zag loop structure has two ends, with said rounded crown sections each disposed at one of the two ends with the straight strut sections in between; said straight strut sections and said crown sections position each entire straight strut section and each crown section in contact with the vascular lumen wall when deployed in vascular lumens of different sizes, whereby a plurality of vascular lumen diameters may be accommodated with a single size vascular implant.
In the same field of endeavor of vascular implants and vascular anchors, Drasler teaches a intravascular stent graft comprising a zig-zag loop structure around an open center, the zig-zag loop structure having multiple straight strut sections joined to one another by rounded crown sections (Figs. 9A-9C and ¶¶ [0141]-[0143] depict an attachment anchor 245 comprising nodes 365 and struts 370 arranged in a ring structure, wherein Figs. 9A-9B depict the struts 370 being straight in nondeployed and deployed states; ¶ [0145] depicts the anchor being a part of an intravascular stent-graft), wherein: said zig-zag loop structure has two ends, with said rounded crown sections each disposed at one of the two ends with the straight strut sections in between (Figs. 9A-9C depict the attachment anchor 245 having proximal and distal ends, wherein the nodes 365 are disposed on both ends with the struts 370 in between); said straight strut sections and said crown sections position each entire straight strut section and each crown section in contact with the vascular lumen wall when deployed in vascular lumens of different sizes, whereby a plurality of vascular lumen diameters may be accommodated with a single size vascular implant (Figs. 9A-9B depict the struts 370 being straight in nondeployed and deployed states, thereby indicating that the struts are configured to be straight in different circumferential ranges between the nondeployed and deployed states. ¶ [0032] discloses deployment of the attachment anchor such that it comes into contact with the vessel wall. ¶¶ [0033], [0144] discloses that the hinges allow for the anchor to be applied to a wider range of vessel diameters for the same attachment anchor. The Examiner notes that the recitation of “said straight strut sections and said crown sections position each entire straight strut section and each crown section in contact with the vascular lumen wall when deployed in vascular lumens of different sizes, whereby a plurality of vascular lumen diameters may be accommodated with a single size vascular implant” amounts to functional language. The specification indicates that the “straight strut sections provide an advantage of the strut section always being in contact with the vessel wall over its entire length, irrespective of the size of vessel into which it is deployed”. Therefore, one of ordinary skill would reasonably conclude that the function is a result of the strut sections being straight. The above disclosures of Figs. 9A-9B and ¶¶ [0032], [0033], [0144] of Drasler teaches straight strut sections which are capable of performing the functional language. Additionally, the similarity in size and shape of the structure of Drasler to that of the anchor frame of the Applicant’s invention suggests that the structure of Drasler is capable of performing the function.). 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 the implant of Dagan such that the stent of Dagan is substituted with the stent graft comprising the anchor of Drasler. Because both stents and stent grafts are capable of being used in conjunction with the invention of Dagan (¶ [0179] of Dagan), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
The above combination is silent with regards to an individual self-supporting resilient elongate strand with opposite ends brought into apposition to form the zig-zag loop structure.
In the same field of endeavor of vascular implants and vascular anchors, Chuter teaches an anchor comprising an individual self-supporting resilient elongate strand with opposite ends brought into apposition to form the zig-zag loop structure (Figs. 2-4 and Col. 9, lines 53-66 depict a spring assembly 6 formed form a continuous piece of fine gauge stainless steel spring wire, wherein two ends of the piece of bent wire are permanently attached end-to-end as to form a circular structure). 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 the zig-zag loop structure of the anchor of the above combination to incorporate that it is formed of an individual self-supporting resilient elongate strand with opposite ends brought into apposition as taught by Chuter. The motivation would have been to provide a method that is capable of forming the anchor, thereby improving the ease of manufacturing the device. Additionally or alternatively, it would have been the simple substitution of one method for forming the anchor for another to obtain predictable results.
The above combination teaches the anchor frame and vascular implant being formed of Nitinol (see at least ¶ [0127] of Dagan. Additionally or alternatively, see at least ¶ [0141] of Drasler). However, the above combination is silent with regards to whether the straight strut sections are shape set to maintain the straight configuration upon deployment.
In a system relevant to the problem forming vessel attachment elements, Kinkade teaches a ring comprising a plurality of crowns and a plurality of struts or straight segments (Fig. 18 and ¶ [0053] depict a ring 1807 formed of a self-expanding or spring material such as Nitinol comprising crowns 1852 and straight segments 1854), wherein the straight strut sections are shape set to maintain the straight configuration upon deployment (¶ [0053] discloses a shape-set sinusoidal pattern, wherein the ring is provided with a mechanical memory to return or recoil from a delivery configuration to an expanded deployed configuration). 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 the method of forming the struts of the above combination, based on the teachings of Kinkade, to incorporate that it is shape-set. The motivation would have been to provide a more resilient structure that is more capable of maintaining its shape. Additionally or alternatively, it would have been the simple substitution of one known method for forming the anchor for another to obtain predictable results.
With regards to claim 18, the above combination teaches or suggests the vascular implant of claim 10. The above combination teaches that the individual self-supporting resilient elongate strand is formed from a single wire (Figs. 2-4 and Col. 9, lines 53-66 of Chuter depict a spring assembly 6 formed form a continuous piece of fine gauge stainless steel spring wire, wherein two ends of the piece of bent wire are permanently attached end-to-end as to form a circular structure)
The above combination is silent regarding whether the wire is nitinol.
In the same field of endeavor of vascular implants and vascular anchors, Drasler teaches an anchor formed of nitinol wire (¶ [0037]). 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 the wire of the above combination to incorporate that it is nitinol as taught by Drasler. The motivation would have been to improve deformation characteristics.
Claims 11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Dagan in view of Drasler, Chuter, and Kinkade, as applied to claim 10 above, and in view of US 2005/0154321 A1 (Wolinsky) (previously cited).
With regards to claim 11, the above combination teaches or suggests the vascular implant of claim 10 (see the above §103 rejection of claim 10), wherein said zig-zag structure is configured as an anchor frame attachable to a vascular device (Figs. 6A-B and ¶¶ [0151]-[0152] of Dagan depict the stent being attachable to an antenna 28), and said anchor frame further comprises: an anchor isolation section disposed in each attachment arm (Figs. 6A-B and ¶¶ [0151]-[0152] of Dagan depict posts 92 connected to each crown section, wherein the posts comprise a first section adjacent to and connected to the crown, a second section comprising the through holes 94, and a third section between the first and second sections, wherein the third section amounts to an isolation section; ¶ [0152] of Dagan disclose the posts are formed of electrical insulator, which is for electrically isolating the antenna 28 from the stent body 90).
The above combination is silent with regards to the anchor isolation section being configured to allow independent motion between the zig-zag loop structure and another vascular implant component attached by said attachment arms.
In the same field of endeavor of fixing a sensor in a lumen, Wolinsky discloses an anchor isolation section being configured to allow independent motion between an anchor section another vascular implant component (Fig. 1A, 1D, and ¶¶ [0023]-[0025] disclose a connecting element 12 between a crown of struts 10 and an attachment point at sensor 20, which can be flexible to enable movement of the sensor within the movement or rigid to maintain sensor 20 at a constant position, wherein the connecting element 12 comprises a first section adjacent to and connected to the crown of struts 10, a second section adjacent to and connected to the sensor 20, and a central portion between the first and second sections, wherein the central portion amounts to an anchor isolation section. The specification and the claims do not provide any structural or functional limitations that preclude such an interpretation). 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 at least the anchor isolation section of Dagan to incorporate that it is flexible as taught by Wolinsky. Because both rigid and flexible materials are capable of connecting a sensor to an anchor, it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, the motivation would have been to prevent extraneous movement of the anchor from interfering with the sensing capabilities of the antenna of Dagan (as described in ¶¶ [0174]-[0178] of Dagan).
With regards to claim 19, the above combination teaches or suggests the vascular implant of claim 10 (see the above §103 rejection of claim 10).
The above combination is silent with regards to whether the individual self-supporting resilient elongate strand is laser cut from a nitinol tube.
In the same field of endeavor of fixing a sensor in a lumen, Wolinsky discloses that an anchor can be manufactured from a wire or a laser cut tube made of, for example, nickel-titanium alloy (¶ [0022]; also see Fig. 1A). 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 the individual self-supporting resilient elongate strand of the above combination to incorporate that it is laser cut from a nitinol tube as taught by Wolinsky. Because a laser cut tube (¶ [0022] of Wolinksy) and a wire (Col. 9, lines 53-66 of Chuter) are capable of being used to produce an anchor, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Dagan in view of Drasler, and Chuter, as applied to claim 10 above, and further in view of US 2005/0049689 A1 (Gray) (previously-cited).
With regards to claim 12, the above combination teaches or suggests the vascular implant of claim 10 (see the above §103 rejection of claim 10).
The above combination further teaches the opposite ends brought into apposition are permanently attached end-to-end (Col. 9, lines 53-66 of Chuter)
Dagan is silent as to whether said opposite ends are spaced apart to form a nonconducting gap whereby said zig-zag loop structure is electrically discontinuous.
In the same field of endeavor of vascular implants, Gray discloses an electrically discontinuous frame in which ends of strands are spaced apart to form a nonconducting gap (Fig. 10 depict a medical stent with conductive strands 221 and junctions 222; Fig. 11 and ¶ [0101] depict the conductive strands being spaced apart to form a gap, wherein the gap is non-conducting because electrically isolating non-conductive material 234 is between the strands) while also providing an permanent attachment (¶ [0101] discloses the strands being fastened together by fastening material 234). 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 the attachment of the opposite ends of the above combination to incorporate that they are spaced apart and form a nonconductive gap based on the structural components as taught by Gray. Because both the connection of Chuter and the connection of Gray are capable of connecting strut sections in a frame, it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, because Dagan teaches elements for electrically insulating the antenna from the rest of the stent body (¶ [0152] of Dagan), the motivation would have been to provide further electrical insulation between the antenna and elements of the anchor.
With regards to claim 13, the above combination teaches or suggests that said nonconducting gap comprises a split crown with two crown section pieces separated by a gap (See the above combination of Dagan in view of Drasler and Gray. See Fig. 11 and ¶ [0101] of Gray depicts the ends of the strands 228, 230 forming a split crown separated by a break, and a non-conductive material 234 securing the strands together).
The above combination is silent with regards to an attachment arm connected to each crown section piece, wherein each attachment arm comprises an elongate member extending away from the zig-zag structure.
In the same field of endeavor of vascular implants, Gray discloses an attachment arm connected to each crown section piece (Fig. 11 depicts a conductive strand 226 connected to strand 228 via non-conductive material 234 and another conductive strand 224 connected to strand 230 via non-conductive material 230), wherein each attachment arm comprises an elongate member extending away from the zig-zag structure (Fig. 11 depicts strands 224, 226 being elongated and extending away from the zig-zag structure formed by strands 228, 230). 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 the above combination to incorporate the attachment arms as taught by Gray. The motivation would have been to provide additional anchor material so as to allow for a better attachment of the anchor frame to the vessel.
The Examiner notes that Gray does not teach the strands are configured to attach to a sensor.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Dagan in view of Drasler, Chuter, and Kinkade, as applied to claim 10 above, and in view of US 2003/0125797 A1 (Chobotov) (previously cited)
With regards to claim 14, the above combination teaches or suggests the vascular implant of claim 10 (see the above §103 rejection of claim 10).
The above combination is silent with regards to at least one tissue-engaging barb on a plurality of said respective straight sections, wherein each said tissue-engaging barb extends outward from the strut section in a first direction and a second direction wherein the first direction is at an acute angle with respect to a length direction of the straight strut and the second direction extends outwardly from a plane in which lies the straight strut portion and a base portion of the barb attached to the straight strut section such that, when the zig-zag structure is deployed within a vascular lumen in contact with the lumen wall, said barbs are positioned to extend into the lumen wall while aligned with a direction of blood flow in the vascular lumen.
In a related embodiment, Dagan discloses at least one tissue-engaging barb on a plurality of said straight sections, wherein each said tissue-engaging barb extends outward from the strut section in a first direction at an acute angle with respect to a length direction of the straight strut such that, when the zig-zag structure is deployed within a vascular lumen in contact with the lumen wall, said barbs are positioned to extend into the lumen wall while aligned with a direction of blood flow in the vascular lumen (Figs. 7A and ¶ [01158] disclose anchoring barb 93 on the strut sections for facilitating anchoring into the blood vessel, wherein the barbs extend outward from a longitudinal axis of the strut). 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 the struts of the above combination to incorporate tissue-engaging barbs as taught by Fig. 7A of Dagan. The motivation would have been to provide a better anchoring of the stent to the blood vessel wall (see ¶ [0158] of Dagan).
The above combination is silent regarding the strut extending in two directions, the second direction being outwardly from a plane in which lies the straight strut portion and a base portion of the barb.
In a system relevant to the problem of anchoring elements in a vessel, Chobotov teaches a strut extending in two directions, the second direction being outwardly from a plane in which lies the straight strut portion and a base portion of the barb. (Figs. 1-1B and ¶¶ [0104]-[0105] depicts barbs 43 protruding from the strut in two directions). 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 the struts of the above combination to incorporate that they protrude from the strut in two directions. The motivation would have been to improve the embedding and drag properties of the anchor (¶¶ [0104]-[0105] of Chobotov)
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Dagan in view of Drasler, Chuter, and Kinkade, as applied to claim 10 above, and further in view of US 2013/0023981 A1 (Dierking) (previously cited).
With regards to claim 15, the above combination is silent with regards to whether each attachment arm comprises an elongate member with a plurality of teeth along a length of the elongate member and defining open spaces between the teeth for a bonding agent to enter and attach to another structure of the vascular implant.
In a system relevant to the problem of attaching elements to each other, Dierking teaches an elongate member with a plurality of teeth along a length of the elongate member (Figs. 1e, 1f depict curved portions 14, 16 (which are teeth) disposed along a length of longitudinal body 13) defining open spaces between the teeth for a bonding agent to enter and attach to another structure of the vascular implant (Figs. 1e, 1f depict open spaces between curved portions 14, 16. The recitation of “for a bonding agent to enter and attach to another structure of the vascular implant” amounts to functional language. The open spaces between 14, 16 of Dierking are sized such that they may allow for a bonding agent to enter and attach to other structures). 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 the attachment arms of Dagan of the above combination to incorporate the elongate member with a plurality of teeth along a length of the elongate member defining open spaces between the saw-teeth for a bonding agent to enter and attach to another structure of the vascular implant as taught by Dierking. The motivation would have been to provide structure for improving the attachment of the anchor to the antenna.
With regards to claim 16, the above combination is silent with regards to whether said attachment arms comprise alternating raised and lowered structure with areas between raised portions providing open spaces for a bonding agent to enter and attach to another structure of the vascular implant.
In a system relevant to the problem of attaching elements to each other, Dierking teaches an attachment arm comprising alternating raised and lowered structure. (Figs. 1e, 1f depict curved portions 14, 16 disposed along a length of longitudinal body 13) with areas between raised portions providing open spaces for a bonding agent to enter and attach to another structure of the vascular implant (Figs. 1e, 1f depict open spaces between curved portions 14, 16. The recitation of “for a bonding agent to enter and attach to another structure of the vascular implant” amounts to functional language. The open spaces between 14, 16 of Dierking are sized such that they may allow for a bonding agent to enter and attach to other structures). 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 the attachment arms of Dagan of the above combination to incorporate alternating raised and lowered structure with areas between raised portions providing open spaces for a bonding agent to enter and attach to another structure of the vascular implant. as taught by Dierking. The motivation would have been to provide structure for improving the attachment of the anchor to the antenna.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Dagan in view of Drasler, Chuter, and Kinkade, as applied to claim 10 above, and further in view of US 2013/0306232 A1 (Hedberg) (previously cited).
With regards to claim 17, the above combination is silent with regards to each of said attachment arms include a series of holes defining open spaces for a bonding agent to enter and attach to another structure of the vascular implant.
In a system relevant to the problem of attaching elements to each other, Hedberg teaches an element including a series of holes defining open spaces for a bonding agent to enter and attach to another structure of a vascular implant (Fig. 7A and ¶ [0070] depict an anchor 700 comprising multiple holes or perforations 710, 712 for enhancing attachment of an element 702, wherein a thermal-plastic, adhesive or thermal-set material may be applied into the holes 712 to attach the anchor to the element 702). 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 the attachment arms of the above combination to incorporate a series of holes defining open spaces for a bonding agent to enter and attach to another structure of the vascular implant as taught by Hedberg. The motivation would have been to improve the attachment of the anchor to the antenna.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Dagan in view of Chuter, and US 2005/0049689 A1 (Gray) (previously-cited).
With regards to claim 26, Dagan discloses a vascular implant adapted to be deployed and implanted in a patient vasculature and positioned at a location in a vascular lumen in with the lumen wall (Figs 6A-B and ¶¶ [0151], [0153] depict a stent 20 attached to an antenna 28), said implant comprising an anchor attached to a vascular device (Figs 6A-B and ¶¶ [0151], [0153] depict a stent 20 attached to an antenna 28), the anchor comprising a resilient zig-zag loop structure formed as a loop structure around an open center, the zig-zag loop structure having multiple straight strut sections joined to one another by rounded crown sections (Figs. 6A-B depict a stent body 90 comprising a first strut portion 32; Figs. 2A-B, 6A-6B, 7A depict the strut portions formed as a single closed loop comprising multiple straight strut sections joined to one another by rounded junctions (i.e., rounded crown sections), said zig-zag structure has two ends, with said rounded crown sections each disposed at one of the two ends with the strut sections in between (Figs. 6A-6B depict top and bottom ends of first strut portion 32, wherein the crowns are at the top and bottom ends), at least one attachment arm is connected to each rounded crown section on at least one of end of said two ends of said zig-zag loop structure (Figs. 6A-B and ¶¶ [0151]-[0152] depict a distal end of first strut portion 32 of the stent body having posts 92 extending from each rounded crown section), and each attachment arm comprises an elongate member attached to a respective section of said vascular device (Fig. 6B depicts the posts 92 being elongated elements and being attached to different portions of the antenna 28).
Dagan teaches the apparatus and methods may be applied to a stent graft, mutatis mutandis (¶ [0179]), wherein a stent graft having strut portions and junctions may be used and/or an antenna may be coupled to the body of the stent graft via posts that longitudinally separate the antenna from a distal end of the body of the stent graft (¶ [0179]).
The above combination is silent with regards to an individual self-supporting resilient elongate strand with opposite ends brought into apposition to form the zig-zag loop structure.
In the same field of endeavor of vascular implants and vascular anchors, Chuter teaches an anchor of a graft comprising an individual self-supporting resilient elongate strand with opposite ends brought into apposition to form the zig-zag loop structure (Figs. 2-4 and Col. 9, lines 53-66 depict a spring assembly 6 formed form a continuous piece of fine gauge stainless steel spring wire, wherein two ends of the piece of bent wire are permanently attached end-to-end as to form a circular structure). 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 the zig-zag loop structure of the anchor of the above combination to incorporate that it is formed of an individual self-supporting resilient elongate strand with opposite ends brought into apposition as taught by Chuter. The motivation would have been to provide a simple method that is capable of forming the anchor, thereby improving the ease of manufacturing the device. Additionally or alternatively, it would have been the simple substitution of one method for forming the anchor for another to obtain predictable results.
Dagan is silent regarding said opposite ends brought into apposition are spaced apart to form a nonconducting gap whereby said zig-zag loop structure is electrically discontinuous.
In the same field of endeavor of vascular implants, Gray discloses a nonconducting gap formed in a zig-zag structure such that an anchor frame is electrically discontinuous (Fig. 10 depict a medical stent with conductive strands 221 and junctions 22 which form zig-zag structures; Fig. 11 and ¶ [0101] depict a break between the conductive strands, wherein the break is non-conducting because electrically isolating non-conductive material 234 is between the strands). 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 the apposition of the opposite ends of the above combination to incorporate a nonconducting gap formed between the struts as taught by Gray. Because both elements are capable of connecting strut sections in a stent, it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, because Dagan teaches elements for electrically insulating the antenna from the rest of the stent body (¶ [0152] of Dagan), the motivation would have been to provide further electrical insulation.
The above combination is silent with regards to whether at least a plurality of said strut sections form anchor sections with at least one tissue-engaging barb.
In a related embodiment, Dagan discloses tissue-engaging barb is disposed on a strut section (Fig. 7A and ¶ [0158] disclose anchoring barbs 93 and 95 on the strut sections). 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 the struts of the embodiment of Figs. 6A-B of Dagan to incorporate tissue-engaging barbs as taught by Fig. 7A of Dagan. The motivation would have been to provide a better anchoring of the stent to the blood vessel wall (see ¶ [0158] of Dagan).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Dagan, Chuter, and Gray, as applied to claim 26 above, and in view of US 2016/0199204 A1 (Pung) (previously cited) and 2017/0290686 A1 (Sirhan) (previously cited).
With regards to claim 27, the above combination teaches or suggests the vascular implant of claim 26, wherein the elongate members of the attachment arms define spaces within the structure of said elongate member (¶ [0151] of Dagan teaches through holes 94 within structure of the posts 92)
The above embodiment is silent with regards to whether a bonding agent is disposed within said spaces of each attachment arm elongate member, bonding the attachment arm to the vascular implant.
In a system related to the problem of forming an attachment to an element, Pung discloses providing a bonding agent within spaces of each attachment arm, bonding the attachment arm to a vascular implant (¶ [0081] discloses that ties 30 and their component can be fixed in place via adhesive, welding, or similar mechanisms; Figs. 6A-6E depict spaces between structure of the tie that would be filled with the adhesive or welding material so as to be bonded to the vascular device). 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 the attachment of the antenna to the post of Dagan to incorporate that it is also bonded using a bonding agent as taught by Pung. The motivation would have been to provide a more secure attachment between the antenna and posts of Dagan.
The above combination is silent with regards to whether said bonding agent comprises reflow material melted into the spaces defined by the attachment arm elongate members to secure the attachment arms to the vascular device.
In a system related to the problem of forming an attachment between elements, Sirhan discloses a bonding agent comprises reflow material melted into the spaces defined by members to attach the members (¶ [1381] discloses reflowing a polymer between two elements to bond them together). 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 the bonding of the above combination to incorporate that it comprises melting a reflow material between spaces of the members as taught by Sirhan. Because both elements are capable of bonding elements together, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Dagan, Chuter, and Gray, as applied to claim 26, and further in view of US 2008/0033527 A1 (Nunez) (Previously cited).
With regards to claim 28, the above combination teaches or suggests the vascular device comprises a resilient sensor construct configured to dimensionally expand and contract with natural movement of the lumen wall (Figs. 6B of Dagan depicts an antenna 28; ¶¶ [0176], [0178] of Dagan discloses the annular antenna’s radial expansion is limited by the circumference of the blood vessel, and the circumference of the antenna varies over the course of the cardiac cycle); the resilient sensor construct is attached to the attachment arms (Fig. 6B depicts antenna 28 being attached to the posts); an electrical property of the resilient sensor construct changes in a known relationship to the dimensional expansion and contraction thereof (¶ [0178] of Dagan discloses that variations in inductive current that are measured at the antenna are interpreted as being caused by variations in the geometry of the antenna over the course of the subject’s cardiac cycle).
Although Dagan further teaches a control unit configured to measure the inductive current in the antenna and determine a physiological parameter including a dimension of the vascular lumen of the subject (¶¶ [0050]-[0058] of Dagan; ¶ [0129] of Dagan discloses determining a diameter of the blood vessel at the antenna), Dagan is silent regarding whether said resilient sensor construct produces a wireless signal indicative of said electrical property, said signal being readable wirelessly outside the patient’s body to determine a dimension of the vascular lumen.
In the same field of endeavor of wireless sensors, Nunez discloses a sensor which produces a wireless signal indicative of said electrical property, said signal being readable wirelessly outside said vascular lumen to determine a physiological parameter (¶¶ [0061]-[0062] depict a system 300 comprising sensors 122 which are connected to antennas 308 for transmitting wireless signals to a reader 324). 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 the antenna of Dagan to incorporate the structure for producing a wireless signal readable outside the patient’s body to determine a physiological property as taught by Nunez. The motivation would have been to allow for the unit to be monitored externally to detect a real or potential problem or complication with the unit (¶ [0061] of Nunez).
Claims 50, 51, 53, and 79 are rejected under 35 U.S.C. 103 as being unpatentable over Dagan in view of Chuter, Chobotov, Gray, and Dierking.
With regards to claim 50, Dagan discloses an anchor frame for a vascular implant (Figs. 6A-B depict a stent body 90 attached to an antenna 28; see ¶ [0178] with regards to the antenna being a device for measuring physiological parameters of the blood vessel), consisting essentially of a resilient single loop, zig-zag structure formed around an open center by multiple strut sections joined at acute angles to one another by rounded crown sections (Figs. 6A-B depict a stent body 90 comprising a first strut portion 32, wherein the first strut portion 32 is being interpreted to correspond to the resilient single loop and anchor frame; Figs. 2A-B, 6A-6B, 7A depict the strut portions comprising straight strut sections joined at acute angles to one another by rounded crown sections), an attachment arm connected to each rounded crown section at one end of the zig-zag loop structure (Figs. 6A-B and ¶ [0151] discloses posts 92 for attaching the stent body 90 to antenna 28).
The Examiner notes that the transitional phrase “consisting essentially of” will be construed as an equivalent to “comprising” because the specification and claims do not clearly indicate what the basic and novel characteristics of the anchor frame actually are. See MPEP 2111.03 (III).
Dagan teaches the apparatus and methods may be applied to a stent graft, mutatis mutandis (¶ [0179]), wherein a stent graft having strut portions and junctions may be used and/or an antenna may be coupled to the body of the stent graft via posts that longitudinally separate the antenna from a distal end of the body of the stent graft (¶ [0179]).
The above combination is silent with regards to a single self-supporting resilient elongate strand with opposite ends brought into apposition to form the zig-zag loop structure.
In the same field of endeavor of vascular implants and vascular anchors, Chuter teaches an anchor of a graft comprising a single self-supporting resilient elongate strand with opposite ends brought into apposition to form the zig-zag loop structure (Figs. 2-4 and Col. 9, lines 53-66 depict a spring assembly 6 formed form a continuous piece of fine gauge stainless steel spring wire, wherein two ends of the piece of bent wire are permanently attached end-to-end as to form a circular structure). 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 the zig-zag loop structure of the anchor of the above combination to incorporate that it is formed of a single self-supporting resilient elongate strand with opposite ends brought into apposition as taught by Chuter. The motivation would have been to provide a simple method that is capable of forming the anchor, thereby improving the ease of manufacturing the device. Additionally or alternatively, it would have been the simple substitution of one method for forming the anchor for another to obtain predictable results.
The above combination is silent regarding one tissue-engaging barb in each of said strut sections.
In the system relevant to the problem of anchoring elements in a vessel, Chobotov teaches one tissue-engaging barb in each of said strut sections (Fig. 6 and ¶ [0129] depict one barb per strut 71). 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 the each strut of the above combination, based on the teachings of Chobotov to incorporate one barb on each strut. The motivation would have been to improve the engagement of the structure to the tissue wall.
The above combination is silent with regards to whether said barbs extend in opposite directions on alternating strut sections and are angled outward from the strut section in two directions, a first direction at an acute angle with respect to a length of the strut section and a second direction outwardly from a plane in which lies the strut section and a base portion of the barb where attached to the strut section.
In a related embodiment, Dagan discloses barbs extend in opposite directions on alternating strut sections and are angled outward from the strut section in a first direction at an acute angle with respect to a length direction of the straight strut (Fig. 7A and ¶ [0158] disclose anchoring barbs 93 and 95 on the strut sections for facilitating anchoring into the blood vessel, wherein the barbs extend in opposite directions, the barbs extend outward from the longitudinal direction of the stent and along a direction of blood flow). 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 the struts of the above combination to incorporate tissue-engaging barbs as taught by Fig. 7A of Dagan. The motivation would have been to provide a better anchoring of the stent to the blood vessel wall (see ¶ [0158] of Dagan).
The above combination is silent regarding the strut extending in two directions, the second direction being outwardly from a plane in which lies the straight strut portion and a base portion of the barb.
In a system relevant to the problem of anchoring elements in a vessel, Chobotov teaches a strut extending in two directions, the second direction being outwardly from a plane in which lies the straight strut portion and a base portion of the barb. (Figs. 1-1B and ¶¶ [0104]-[0105] depicts barbs 43 protruding from the strut in two directions). 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 the struts of the above combination to incorporate that they protrude from the strut in two directions. The motivation would have been to improve the embedding and drag properties of the anchor (¶¶ [0104]-[0105] of Chobotov)
The above combination is silent regarding said opposite ends brought into apposition are spaced apart to form a nonconducting gap whereby said zig-zag loop structure is electrically discontinuous.
In the same field of endeavor of vascular implants, Gray discloses a nonconducting gap formed in a zig-zag structure such that an anchor frame is electrically discontinuous (Fig. 10 depict a medical stent with conductive strands 221 and junctions 22 which form zig-zag structures; Fig. 11 and ¶ [0101] depict a break between the conductive strands, wherein the break is non-conducting because electrically isolating non-conductive material 234 is between the strands). 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 the apposition of the opposite ends of the above combination to incorporate a nonconducting gap formed between the struts as taught by Gray. Because both elements are capable of connecting strut sections in a stent, it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, because Dagan teaches elements for electrically insulating the antenna from the rest of the stent body (¶ [0152] of Dagan), the motivation would have been to provide further electrical insulation.
The above combination is silent with regards to whether each attachment arm comprises an elongate member with a plurality of open spaces along a length of the attachment arm to form open spaces for a bonding agent to enter and attach to another structure of the vascular implant.
In a system relevant to the problem of attaching elements to each other, Dierking teaches an elongate member with a plurality of teeth along a length of the elongate member (Figs. 1e, 1f depict curved portions 14, 16 (which are teeth) disposed along a length of longitudinal body 13) defining open spaces between the teeth for a bonding agent to enter and attach to another structure of the vascular implant (Figs. 1e, 1f depict open spaces between curved portions 14, 16. The recitation of “for a bonding agent to enter and attach to another structure of the vascular implant” amounts to functional language. The open spaces between 14, 16 of Dierking are sized such that they may allow for a bonding agent to enter and attach to other structures). 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 the attachment arms of Dagan of the above combination to incorporate the elongate member with a plurality of teeth along a length of the elongate member defining open spaces between the saw-teeth for a bonding agent to enter and attach to another structure of the vascular implant as taught by Dierking. The motivation would have been to provide structure for improving the attachment of the anchor to the antenna.
With regards to claim 51, the above combination teaches or suggests the plurality of open spaces are defined by teeth spaced apart along two sides of the attachment arm, said open spaces being formed between the teeth (Figs. 1e, 1f of Dierking depict open spaces between curved portions 14, 16)
With regards to claim 53, the above combination teaches or suggests wherein said nonconducting gap comprises one said crown section forming a split crown with two crown section pieces separated by a gap and an attachment arm connected to each crown section piece (Fig. 11 and ¶ [0101] of Gray depicts the ends of the strands forming a split crown separated by a break, and a non-conductive material 234 securing the strands together).
With regards to claim 79, the above combination teaches or suggests the vascular implant of claim 50. The above combination teaches that the individual self-supporting resilient elongate strand is formed from a single wire (Figs. 2-4 and Col. 9, lines 53-66 of Chuter depict a spring assembly 6 formed form a continuous piece of fine gauge stainless steel spring wire, wherein two ends of the piece of bent wire are permanently attached end-to-end as to form a circular structure)
The above combination is silent regarding whether the wire is nitinol.
In the same field of endeavor of vascular implants and vascular anchors, Drasler teaches an anchor formed of nitinol wire (¶ [0037]). 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 the wire of the above combination to incorporate that it is nitinol as taught by Drasler. The motivation would have been to improve deformation characteristics.
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Dagan in view of Chuter, Chobotov, Gray, and Dierking, as applied to claim 51 above, and further in view of Wolinsky.
With regards to claim 52, the above combination is silent with regards to whether each attachment arm includes a bent section configured to allow independent motion between the said resilient zig-zag structure and a vascular implant attached thereto.
an anchor isolation section disposed in each attachment arm (Figs. 6A-B and ¶¶ [0151]-[0152] of Dagan depict posts 92 connected to each crown section, wherein the posts comprise a first section adjacent to and connected to the crown, a second section comprising the through holes 94, and a third section between the first and second sections, wherein the third section amounts to an isolation section; ¶ [0152] of Dagan disclose the posts are formed of electrical insulator, which is for electrically isolating the antenna 28 from the stent body 90).
The above combination is silent with regards to the anchor isolation section being configured to allow independent motion between the zig-zag loop structure and another vascular implant component attached by said attachment arms.
In the same field of endeavor of fixing a sensor in a lumen, Wolinsky discloses an anchor isolation section being configured to allow independent motion between an anchor section another vascular implant component (Fig. 1A, 1D, and ¶¶ [0023]-[0025] disclose a connecting element 12 between a crown of struts 10 and an attachment point at sensor 20, which can be flexible to enable movement of the sensor within the movement or rigid to maintain sensor 20 at a constant position, wherein the connecting element 12 comprises a first section adjacent to and connected to the crown of struts 10, a second section adjacent to and connected to the sensor 20, and a central portion between the first and second sections, wherein the central portion amounts to an anchor isolation section. The specification and the claims do not provide any structural or functional limitations that preclude such an interpretation). The Examiner notes that connecting element 12 of Wolinsky is capable of entering a bent state because it is flexible 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 at least the anchor isolation section of Dagan to incorporate that it is flexible as taught by Wolinsky. Because both rigid and flexible materials are capable of connecting a sensor to an anchor, it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, the motivation would have been to prevent extraneous movement of the anchor from interfering with the sensing capabilities of the antenna of Dagan (as described in ¶¶ [0174]-[0178] of Dagan).
In the same field of endeavor of fixing a sensor in a lumen, Wolinsky discloses an anchor isolation section being configured to allow independent motion between a zig-zag structure and an implant attached thereto (Fig. 1A, 1D, and ¶¶ [0023]-[0025] disclose a connecting element 12 between a crown of struts 10 and an attachment point at sensor 20, which can be flexible to enable movement of the sensor within the movement or rigid to maintain sensor 20 at a constant position; Figs. 3A, 4B and ¶ [0046] depict a connecting element being formed of a shape memory alloy or polymer having a convenient shape, wherein Fig. 3A, 4B depict a bend in connecting element 12), wherein the section is capable of taking on a bent configuration because it is flexible. 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 the anchor isolation section of Dagan to incorporate that it is flexible and has a bend as taught by Wolinsky. Because both rigid and flexible materials are capable of connecting a sensor to an anchor, it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, the motivation would have been to prevent extraneous movement of the anchor from interfering with the sensing capabilities of the antenna of Dagan (as described in ¶¶ [0174]-[0178] of Dagan).
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Dagan in view of Chuter, Chobotov, Gray, and Dierking, as applied to claim 50 above, and further in view of Drasler and Kinkade
With regards to claim 54, the above combination teaches or suggests wherein, when deployed in a vascular lumen the anchor frame expands to contact the lumen wall (¶¶ [0125]-[0126] of Dagan disclose deployment of the stent into the blood vessel, indicating that the stent sections are in contact with the vascular lumen wall; The Examiner notes that the strut portions of Dagan are sized and shaped to be in contact with the vascular lumen wall; ¶ [0140] of Dagan discloses the stent being able to accommodate different vessel diameters).
The above combination is silent with regards to whether the strut sections are straight to permit apposition of each entire straight strut section and each crown section against the vascular lumen wall for a plurality of vascular lumen diameters with a single size anchor frame
In the same field of endeavor of vascular implants and vascular anchors, Drasler teaches a vascular implant comprising straight strut sections (Figs. 9A-9C and ¶¶ [0141]-[0143] depict an attachment anchor 245 comprising nodes 365 and struts 370, wherein Figs. 9A-9B depict the struts 370 being straight in nondeployed and deployed states), wherein said straight strut sections and said crown sections are configured permit apposition of each entire straight strut section and each crown section against the vascular lumen wall for a plurality of vascular lumen diameters with a single size anchor frame (Figs. 9A-9B depict the struts 370 being straight in nondeployed and deployed states, thereby indicating that the struts are configured to be straight in different circumferential ranges between the nondeployed and deployed states; ¶ [0032] discloses deployment of the attachment anchor such that it comes into contact with the vessel wall; The Examiner notes that the strut portions of Drasler are sized and shaped to be in contact with the vascular lumen wall when the anchor is deployed; ¶¶ [0033], [0144] discloses that the hinges allow for the anchor to be applied to a wider range of vessel diameters. Finally, the Examiner notes that the recitation of “configured to position each entire straight strut section and each crown section in contact with the vascular lumen wall when deployed in vascular lumens of different sizes” amounts to functional language. The disclosure of Figs. 9A-9B and ¶¶ [0032], [0033], [0144], as cited above, teach that the anchor of Drasler is capable of maintaining straight strut sections in a variety of anchor diameters, thereby indicating that Drasler is capable of performing the claimed functional limitation). 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 strut and crown sections of Dagan with the strut and crown sections of Drasler such that said straight strut sections and said crown sections are configured to position each entire straight strut section and each crown section in contact with the vascular lumen wall when deployed in vascular lumens of different sizes. Because both structures are capable of being used as an anchor in vascular lumens of different sizes (¶ [0140] of Dagan; ¶¶ [0033], [0144] of Drasler), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
The above combination is silent with regards to whether the straight strut sections are shape set to be straight upon deployment.
In a system relevant to the problem forming vessel attachment elements, Kinkade teaches a ring comprising a plurality of crowns and a plurality of struts or straight segments (Fig. 18 and ¶ [0053] depict a ring 1807 formed of a self-expanding or spring material such as Nitinol comprising crowns 1852 and straight segments 1854), wherein the straight strut sections are shape set to maintain the straight configuration upon deployment (¶ [0053] discloses a shape-set sinusoidal pattern, wherein the ring is provided with a mechanical memory to return or recoil from a delivery configuration to an expanded deployed configuration). 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 the method of forming the struts of the above combination, based on the teachings of Kinkade, to incorporate that it is shape-set. The motivation would have been to provide a more resilient structure that is more capable of maintaining its shape. Additionally or alternatively, it would have been the simple substitution of one known method for forming the anchor for another to obtain predictable results.
Claim 63 is rejected under 35 U.S.C. 103 as being unpatentable over Dagan in view of Dagan, Chuter, and Gray, as applied to respective claim 26 above, and further in view of US 2013/0289703 A1 (Kinkade) (previously cited).
With regards to claim 63, the above combination teaches the anchor frame and vascular implant being formed of Nitinol (see at least ¶ [0127] of Dagan).
The above combination is silent with regards to whether said straight strut sections are set to maintain each entire straight strut section and each crown section in contact with the vascular lumen wall when deployed in vascular lumens of different sizes, whereby a plurality of vascular lumen diameters may be accommodated with a single size vascular implant.
In the same field of endeavor of vascular implants and vascular anchors, Drasler teaches said straight strut sections are set to maintain each entire straight strut section and each crown section in contact with the vascular lumen wall when deployed in vascular lumens of different sizes, whereby a plurality of vascular lumen diameters may be accommodated with a single size vascular implant (Figs. 9A-9B depict the struts 370 being straight in nondeployed and deployed states, thereby indicating that the struts are configured to be straight in different circumferential ranges between the nondeployed and deployed states. ¶ [0032] discloses deployment of the attachment anchor such that it comes into contact with the vessel wall. ¶¶ [0033], [0144] discloses that the hinges allow for the anchor to be applied to a wider range of vessel diameters for the same attachment anchor. The Examiner notes that the recitation of “said straight strut sections and said crown sections position each entire straight strut section and each crown section in contact with the vascular lumen wall when deployed in vascular lumens of different sizes, whereby a plurality of vascular lumen diameters may be accommodated with a single size vascular implant” amounts to functional language. The specification indicates that the “straight strut sections provide an advantage of the strut section always being in contact with the vessel wall over its entire length, irrespective of the size of vessel into which it is deployed”. Therefore, one of ordinary skill would reasonably conclude that the function is a result of the strut sections being straight. The above disclosures of Figs. 9A-9B and ¶¶ [0032], [0033], [0144] of Drasler teaches straight strut sections which are capable of performing the functional language. Additionally, the similarity in size and shape of the structure of Drasler to that of the anchor frame of the Applicant’s invention suggests that the structure of Drasler is capable of performing the function.). 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 the implant of Dagan such that the stent of Dagan is substituted with the stent graft comprising the anchor of Drasler. Because both stents and stent grafts are capable of being used in conjunction with the invention of Dagan (¶ [0179] of Dagan), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
The above combination is silent with regards to whether the straight strut sections are shape set to be straight upon deployment.
In a system relevant to the problem forming vessel attachment elements, Kinkade teaches a ring comprising a plurality of crowns and a plurality of struts or straight segments (Fig. 18 and ¶ [0053] depict a ring 1807 formed of a self-expanding or spring material such as Nitinol comprising crowns 1852 and straight segments 1854), wherein the straight strut sections are shape set to maintain the straight configuration upon deployment (¶ [0053] discloses a shape-set sinusoidal pattern, wherein the ring is provided with a mechanical memory to return or recoil from a delivery configuration to an expanded deployed configuration). 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 the method of forming the struts of the above combination, based on the teachings of Kinkade, to incorporate that it is shape-set. The motivation would have been to provide a more resilient structure that is more capable of maintaining its shape. Additionally or alternatively, it would have been the simple substitution of one known method for forming the anchor for another to obtain predictable results.
Claim 78 is rejected under 35 U.S.C. 103 as being unpatentable over Dagan in view of Chuter and Gray, as applied to claim 26 above, and further in view of Chobotov.
With regards to claim 78, the above combination is silent regarding one tissue-engaging barb in each of said strut sections.
In the system relevant to the problem of anchoring elements in a vessel, Chobotov teaches one tissue-engaging barb in each of said strut sections (Fig. 6 and ¶ [0129] depict one barb per strut 71). 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 the each strut of the above combination, based on the teachings of Chobotov to incorporate one barb on each strut. The motivation would have been to improve the engagement of the structure to the tissue wall.
The above combination is silent with regards to whether the tissue engaging barbs on alternating strut sections extend in opposite directions; and the tissue engaging barbs are angled outward from the strut section in two directions, a first direction at an acute angle with respect to a length of the strut section and a second direction outwardly from a plane in which lies the strut section and a base portion of the barb where attached to the strut section.
In a related embodiment, Dagan discloses said barbs extend in opposite directions on alternating strut sections and are angled outward from the strut section a first direction at an acute angle with respect to a length direction of the straight strut (Fig. 7A and ¶ [0158] disclose anchoring barbs 93 and 95 on the strut sections for facilitating anchoring into the blood vessel, wherein the barbs extend in opposite directions, the barbs extend outward from the longitudinal direction of the stent). 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 the struts of the above combination to incorporate tissue-engaging barbs as taught by Fig. 7A of Dagan. The motivation would have been to provide a better anchoring of the stent to the blood vessel wall (see ¶ [0158] of Dagan).
The above combination is silent regarding the strut extending in two directions, the second direction being outwardly from a plane in which lies the straight strut portion and a base portion of the barb.
In a system relevant to the problem of anchoring elements in a vessel, Chobotov teaches a strut extending in two directions, the second direction being outwardly from a plane in which lies the straight strut portion and a base portion of the barb. (Figs. 1-1B and ¶¶ [0104]-[0105] depicts barbs 43 protruding from the strut in two directions). 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 the struts of the above combination to incorporate that they protrude from the strut in two directions. The motivation would have been to improve the embedding and drag properties of the anchor (¶¶ [0104]-[0105] of Chobotov)
Claim 80 is rejected under 35 U.S.C. 103 as being unpatentable over Dagan in view of Chuter, Gray, and Dierking, as applied to claim 50 above, and further in view of Wolinsky
With regards to claim 80, the above combination teaches or suggests the vascular implant of claim 10 (see the above §103 rejection of claim 10).
The above combination is silent with regards to whether the individual self-supporting resilient elongate strand is laser cut from a nitinol tube.
In the same field of endeavor of fixing a sensor in a lumen, Wolinsky discloses that an anchor can be manufactured from a wire or a laser cut tube made of, for example, nickel-titanium alloy (¶ [0022]; also see Fig. 1A). 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 the individual self-supporting resilient elongate strand of the above combination to incorporate that it is laser cut from a nitinol tube as taught by Wolinsky. Because a laser cut tube (¶ [0022] of Wolinksy) and a wire (Col. 9, lines 53-66 of Chuter) are capable of being used to produce an anchor, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
No Prior Art Rejections of Claims 29-31, and 72-77
With regards to claims 29 and 72, the prior art does not teach or suggest a second individual self-supporting resilient elongate strand with opposite ends brought into apposition to form a zig-zag loop frame around an open center having multiple straight strut sections joined to one another by rounded crown sections, and a multistrand coil wrapped on said zig-zag loop frame.
There are no prior art rejections of claims 30-31 by virtue of their dependence on claim 29.
There are no prior art rejections of claims 73-77 by virtue of their dependence on claim 72.
US 2008/0033527 A1 (Nunez) (previously cited) teaches a zig-zag frame around which a coil wrapped (Fig. 10 and ¶ [0069] depict an induction coil coupled to frame 402). However, Nunez does not teach or suggest that the zig-zag loop frame is a second individual self-supporting resilient elongate strand with opposite ends brought into apposition.
Claim 29-31 and 72-77 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
There are new grounds of rejections necessitated by the claim amendments filed 01/23/2026. To the extent that the Applicant’s arguments are applicable to the current rejections, the Examiner makes the following comments.
Applicant's arguments filed 01/23/2026 have been fully considered but they are not persuasive.
On page 12 of the remarks filed 01/23/2026, the Applicant asserts:
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These arguments are not persuasive. The claimed function stems from the strut sections being straight and the combination of Dagan in view of Drasler and Kinkade teaches such straight strut sections. MPEP 2114 (II) indicates that “a claim containing a ‘recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus’ if the prior art apparatus teaches all the structural limitations of the claim. The recitation of “said straight strut sections and said crown sections position each entire straight strut section and each crown section in contact with the vascular lumen wall when deployed in vascular lumens of different sizes, whereby a plurality of vascular lumen diameters may be accommodated with a single size vascular implant” amounts to functional language. The specification indicates that the “straight strut sections provide an advantage of the strut section always being in contact with the vessel wall over its entire length, irrespective of the size of vessel into which it is deployed”. Therefore, one of ordinary skill would reasonably conclude that the function is a result of the strut sections being straight. The above combination of Drasler in view of Dagan and Kinkade teaches the zig-zag loop structure comprising the straight strut sections. Specifically, Drasler teaches a zig-zag loop structure having multiple straight strut sections joined to one another by rounded crown sections (Figs. 9A-9C and ¶¶ [0141]-[0143] depict an attachment anchor 245 comprising nodes 365 and struts 370 arranged in a ring structure, wherein Figs. 9A-9B depict the struts 370 being straight in nondeployed and deployed states). Therefore, one of ordinary skill would conclude that the combination of Drasler in view of Dagan and Kinkade teaches or suggests the straight strut sections that are capable of performing the claimed functions. Additionally, the similarity in size and shape of the structure of Drasler to that of the anchor frame of the Applicant’s invention suggests that the structure of Drasler is capable of performing the function.
The Applicant’s arguments with respect to the shape-setting are moot in view of the rejections in view of Kinkade.
On pages 12-13 of the response filed 01/23/2026, the Applicant asserts:
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This argument is not persuasive. First, these arguments do not appear to be commensurate with the scope of the rejection because it is not clear how the eliminations of ovalization and local lift-off and shape-setting relate to the proposed combination. Second, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, 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 the implant of Dagan such that the stent of Dagan is substituted with the stent graft comprising the anchor of Drasler. Because both stents and stent grafts are capable of being used in conjunction with the invention of Dagan (¶ [0179] of Dagan), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
On page 13 of the response filed 01/23/2026, the Applicant asserts:
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These arguments are not persuasive. First, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “straight strut sections are shape-set to maintain straightness at any degree of expansion or collapse”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The Examiner maintains that the claimed function of “position each entire straight strut section and each crown section in contact with the vascular lumen wall when deployed in vascular lumens of different sizes, whereby a plurality of vascular lumen diameters may be accommodated with a single size vascular implant” stems from the strut sections being straight, and the combination of Dagan in view of Drasler and Kinkade teaches such straight strut sections upon deployment. See the above arguments. Specifically, Drasler teaches a zig-zag loop structure having multiple straight strut sections joined to one another by rounded crown sections (Figs. 9A-9C and ¶¶ [0141]-[0143] depict an attachment anchor 245 comprising nodes 365 and struts 370 arranged in a ring structure, wherein Figs. 9A-9B depict the struts 370 being straight in nondeployed and deployed states). Drasler further teaches that the straight strut sections are straight upon deployment in Fig. 9B. Kinkade teaches a plurality of crowns and a plurality of struts or straight segments (Fig. 18 and ¶ [0053] depict a ring 1807 formed of a self-expanding or spring material such as Nitinol comprising crowns 1852 and straight segments 1854), wherein the straight strut sections are shape set to maintain the straight configuration upon deployment (¶ [0053] discloses a shape-set sinusoidal pattern including crowns and a plurality of struts or straight segments, wherein the ring is provided with a mechanical memory to return or recoil from a delivery configuration to an expanded deployed configuration). Therefore, the combination in view of Kinkade teaches that the shape-set straight sections. See the rejection above. Applicant provides similar arguments regarding the following claims which are not persuasive for similar reasons:
Claim 54 on pages 29-30; and
Claim 63 on pages 21-22.
On page 13 of the remarks filed 01/23/2026, the Applicant asserts:
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This argument is not persuasive because the Applicant's arguments amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of claim 18 patentably distinguishes them from the references.
On page 14 of the remarks filed 01/23/2026, the Applicant asserts:
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These arguments are not persuasive. Wolinsky teaches a connecting element 12 which includes an isolation section. Specifically, Fig. 1A, 1D, and ¶¶ [0023]-[0025] disclose a connecting element 12 between a crown of struts 10 and an attachment point at sensor 20, which can be flexible to enable movement of the sensor within the movement or rigid to maintain sensor 20 at a constant position. The Examiner asserts that the connecting element 12 comprises a first section adjacent to and connected to the crown of struts 10, a second section adjacent to and connected to the sensor 20, and a central portion between the first and second sections, wherein the central portion amounts to an anchor isolation section. The specification and the claims do not provide any structural or functional limitations that preclude such an interpretation. Dagan teaches an analogous connection member. Specifically, Figs. 6A-B and ¶¶ [0151]-[0152] of Dagan depict posts 92 connected to each crown section, wherein the posts comprise a first section adjacent to and connected to the crown, a second section comprising the through holes 94, and a third section between the first and second sections, wherein the third section amounts to an isolation section the posts are formed of electrical insulator. However, Dagan does not teach that the anchor isolation section being configured to allow independent motion between the zig-zag loop structure and another vascular implant component attached by said attachment arms. 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 at least the anchor isolation section of Dagan to incorporate that it is flexible as taught by Wolinsky. Because both rigid and flexible materials are capable of connecting a sensor to an anchor, it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, the motivation would have been to prevent extraneous movement of the anchor from interfering with the sensing capabilities of the antenna of Dagan (as described in ¶¶ [0174]-[0178] of Dagan). Applicant provides similar arguments regarding claim 52 on page 28 which are not persuasive for similar reasons.
On pages 14-15 of the remarks filed 01/23/2026, the Applicant asserts:
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These arguments are not persuasive.
First, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Dagan teaches the plurality of arms, and Wolinsky teaches a flexible connection. 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 at least the anchor isolation sections of the plurality of arms of Dagan to incorporate that they are flexible as taught by Wolinsky. Because both rigid and flexible materials are capable of connecting a sensor to an anchor, it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, the motivation would have been to prevent extraneous movement of the anchor from interfering with the sensing capabilities of the antenna of Dagan (as described in ¶¶ [0174]-[0178] of Dagan).
Second, Applicant provides arguments regarding the isolation section in the attachment arm that are similar to the arguments of page 14 of the remarks, which are not persuasive for the reasons listed above. These arguments are not persuasive for similar reasons.
Third, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a compliant isolation bend within the arm itself) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Finally, the Applicant’s arguments regarding the combination altering Dagan’s post function of maintaining longitudinal separation and electrical isolation amounts to mere attorney argument without evidence that the flexibility would render the posts unsatisfactory for its intended purpose. The Examiner maintains that the flexibility of the section of the above combination may allow for longitudinal separation and electrical isolation. There are no indications within Wolinsky that such a modification would render the posts of Dagan unsatisfactory for its intended purpose.
On page 15 of the remarks filed 01/23/2026, the Applicant asserts:
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This argument is not persuasive. Chuter are not limited only to wire-based fabrication because the method for forming the end-to-end circular structure of Col. 9, line 44 to Col. 10, line 19 of Chuter are applicable to elongated element. For example, an elongated strip of laser cut material may be bent end-to-end to form a circular structure. There are no indications within Chuter that teach away from the use of other elongated elements. Wolinsky discloses that an anchor can be manufactured from a wire or a laser cut tube made of, for example, nickel-titanium alloy (¶ [0022]; also see Fig. 1A). It would have been obvious for one of ordinary skill to have modified Chuter to use the laser cut tube to arrive at the claimed invention for the reasons listed in the above rejection.
Additionally, Wolinsky teaches the use of a laser cut tube, made from a shape memory metal (Nickel-Titanium alloy, cobalt-based alloy) or a polymer that can be combined with any known and/or convenient method for having any convenient shape (¶ [0022]), which strongly suggests that further shape-setting an element from a laser cut tube. Finally, the proposed combination is known throughout the art as evidenced by ¶ [0038] of US 2006/0025846 A1 (Feller); ¶ [0067] of US 2008/0275536 A1 (Zarins); and ¶ [0023] of US 2011/0022149 A1 (Cox).
Applicant provides similar arguments regarding claim 80 on pages 31-32 which are not persuasive for similar reasons.
On page 16 of the remarks filed 01/23/2026, the applicant asserts:
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This argument is not persuasive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a gap which does not create a closed loop) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In this case, the claim recites “said opposite ends brought into apposition are spaced apart to form a nonconducting gap”. There is no indication that there the space between the ends of the strand must be empty.
Applicant provides similar arguments regarding the following claims which are not persuasive for similar reasons:
Claim 13 on pages 16-17;
Claim 26 on pages 20-21;
Claim 28 on page 24;
Claim 50 on page 25;
Claim 53 on pages 26-27;
On pages 17-18 of the remarks filed 01/23/2026, the Applicant asserts:
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These arguments are not persuasive. Chobotov teaches the above elements in Figs. 1-1B and ¶¶ [0104]-[0105]. Specifically, Figs. 1 and 1A and ¶ [0104] depict an elevation angle with regards to the plane containing the barb base. Fig. 1B and ¶ [0105] depict a kick angle with respect to the strut longitudinal axis, which is depicted in Fig. 1B to be an acute angle. ¶ [0105] further indicates that the kick angle allows for the barb to be oriented in a position generally parallel to the axis of the lumen in which they are deployed so that they are in a position to best resist the drag loads imposed by the flow field in vivo in applications. 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 the struts of the above combination including Dagan to incorporate that they protrude from the strut in two directions. The motivation would have been to improve the embedding and drag properties of the anchor (¶¶ [0104]-[0105] of Chobotov). Applicant provides similar arguments regarding claim 50 on page 25 and claim 78 on page 31, which are not persuasive for similar reasons.
On page 18 of the response filed 01/23/2026, the Applicant asserts:
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This argument is not persuasive. First, the recitation of “open spaces between the teeth for a bonding agent to enter and attach to another structure of the vascular implant” amounts to functional language. The teeth of Dierking are sized and shaped to allow for a bonding agent to be enter and attach to other features. Second, even if the bonding agent is a required element of the claim, Dierking does not affirmatively teach away from using bonding agents. ¶ [0008] of Dierking merely indicates that the anchor is preferably be attached to a support structure without adhesive. However, other embodiments teach fastening the anchor to a stent by laser weld, adhesive, soldering, or friction fit (¶¶ [0058], [0072]), which clearly show that Dierking does not teach away from the use of a bonding agent. Applicant provides similar arguments on pages 26-27 regarding claims 50-51, which are not persuasive for similar reasons.
On page 19 of the response filed 01/23/2026, the Applicant asserts:
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This argument is not persuasive. First, Figs. 1e, 1f of Dierking depict open spaces between curved portions 14, 16, which contain alternating raised/recessed portions. The recitation of “for a bonding agent to enter and attach to another structure of the vascular implant” amounts to functional language. The open spaces between 14, 16 of Dierking are sized such that they may allow for a bonding agent to enter and attach to other structures. Second, Dierking does not affirmatively teach away from using bonding agents. ¶ [0008] of Dierking merely indicates that the anchor is preferably be attached to a support structure without adhesive. However, other embodiments teach fastening the anchor to a stent by laser weld, adhesive, soldering, or friction fit (¶¶ [0058], [0072]), which clearly show that Dierking does not teach away from the use of a bonding agent.
On pages 19-20, the applicant asserts:
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This argument is not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Furthermore, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, Dagan teaches posts which are configured to hold an annular antenna 29 to a stent body (Figs. 6A-6B; ¶¶ [0151]-[0152]). Hedberg teaches an anchor 700 comprising holes 712 for enhancing attachment of an element 702. To enhance the attachment between the posts and the annular antenna of Dagan, one of ordinary skill in the art would have been motivated to look to the teachings of Hedberg and incorporate the holes of Hedberg in the posts of Dagan.
On pages 22-23, the applicant asserts:
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These arguments are not persuasive. The through-holes amount to spaces within the structure of the elongate member because each through-hole comprises empty sections or spaces and amounts to an arm-internal space.
On pages 23, the applicant asserts that Pung and Sirhan do not teach arm-internal cavity for receiving a bonding agent or reflow material. This argument is not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Dagan teaches the claimed spaces.
On pages 24-25 of the remarks filed 01/23/2026, the Applicant asserts:
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This argument is not persuasive. MPEP 2111.03 (III) indicates that the transitional phrase “consisting essentially of” is construed as equivalent to “comprising” absent a clear indication in the specification or claims of what the basic and novel characteristics actually are. In this case, there is no indication within the specification or claims of what the basic and novel characteristics of the anchor frame are. Additionally, the applicant does not clearly indicate any of the specific features of the cited references which would materially affect the basic and novel characteristics of the claimed invention.
On page 26, the Applicant asserts:
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This argument is not persuasive. First, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “arm-internal open spaces”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Second, Dierking does not affirmatively teach away from using bonding agents. ¶ [0008] of Dierking merely indicates that the anchor is preferably be attached to a support structure without adhesive. However, other embodiments teach fastening the anchor to a stent by laser weld, adhesive, soldering, or friction fit (¶¶ [0058], [0072]), which clearly show that Dierking does not teach away from the use of a bonding agent.
On pages 27-28, the applicant asserts that, with regards to claim 79, the combination does not teach substituting nitinol into a single-strand zig-zag loop of the claimed invention. This argument is not persuasive because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C KIM whose telephone number is (571)272-8637. The examiner can normally be reached M-F 8:00 AM - 5:00 PM EST.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791