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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 30 March 2026 has been entered.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-5, 11, 13-18, 20, 22, 23-29, 31, 33 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Primeaux; Jonathan (US 20230099410 A1) in view of Magana; Jesus et al. (US 20140052052 A1) in view of Crisco; L. Van Thomas et al. (US 20220096801 A1).
Regarding claim 1, Primeaux discloses a shunting catheter (¶ [0004], systems, devices, and techniques for creating a fluid pathway, or shunt, between the left atrium of a heart of a patient and the coronary sinus of the patient; ¶ [0036], [0045] FIG. 1 … medical system 100);
comprising: a catheter shaft including a shaft lumen (¶ [0045], delivery sheath 106; ¶ [0051], Delivery sheath 106 includes an elongated tubular body 140 defining a sheath inner lumen 142);
a shunting element disposed in the shaft lumen at a first shunting element state and extended from the catheter shaft at a second shunting element state, and at the second shunting element state the shunting element being expandable to enlarge an opening in tissue (¶ [0045], medical system 100 also includes a separate puncturing tool 108 including dilation element 110. In other examples, dilation element 110 can be part of ablation device 102 or a different device); and
an apposition element disposed proximate to the shunting element, the apposition element disposed at the catheter shaft at a first apposition state and extending from the catheter shaft at a second apposition state, the apposition element disposed non-symmetrically around the catheter shaft (¶ [0052], FIG. 1, delivery sheath 106 further includes a positioning element 148 … For instance, positioning element 148 may be located about 150 degrees to about 210 degrees around the circumference of delivery sheath 106 from side opening 146, such as about 180 degrees);
wherein the catheter shaft further includes a guidewire lumen configured to receive a guidewire (¶ [0046], elongated structure 112 defines a device inner lumen configured to receive, e.g., a guidewire 104 and/or puncturing tool 108);
wherein the shunting catheter does not include any implant (¶ [0067] As shown in FIG. 6K, the clinician actuates … a pair of opposing proximal and distal heating elements (e.g., electrodes) 134, 136 on proximal and distal bodies, respectively (196) … As shown in FIG. 6L, the resultant applied heat and pressure from ablation device 104 forms a shunt 138 with welded or coagulated edges 278 defining the perimeter of the shunt opening 138).
Primeaux lacks an apposition element comprising a plurality of movable struts; a plurality of apposition element lumens; a guidewire lumen disposed asymmetrically between a plurality of apposition element lumens; and first, second and third lumen sections. Magana discloses a system and method for neuromodulation (¶ [0001], [0015], [0017], [0045], FIGS. 3-12 … system 10);
comprising: a catheter shaft including a shaft lumen (¶ [0047] The catheter 12 includes a second lumen 18);
a shunting element disposed in the shaft lumen at a first shunting element state and extended from the catheter shaft at a second shunting element state (¶ [0047] The catheter 12 includes a second lumen 18 that is sized to receive a sharpened hypotube 20 having an internal lumen 21 … In a retracted condition, the tip of the needle is withdrawn along the second lumen 18 into the body of the catheter 12 to facilitate advancement of the catheter through the vasculature of the patient. Once the catheter 12 has reached a desired position in the vasculature, the hypotube may be advanced a few millimeters along the lumen 18 … to extend a precise distance "D" from an opening 24 on the outer surface of the catheter, as seen for example in FIGS. 7, 9, 11, and 12); and
an apposition element disposed proximate to the shunting element (¶ [0049] Extending along the length of each positioning lumen is a positioning wire with corresponding identification numerals 28a, 28b, 28c, 28d (or collectively, 28));
the apposition element disposed at the catheter shaft at a first apposition state and extending from the catheter shaft at a second apposition state (¶ [0049], Each positioning wire is preferably made of a shape memory alloy … Under this configuration, when a compressive axial force is applied to each of the positioning wires 28, the wires buckle in the region where they are positioned outside the catheter, and extend radially away from the catheter as shown in FIGS. 6, 7, and 9);
the apposition element comprising a plurality of movable struts disposed non-symmetrically around the catheter shaft (¶ [0049], a positioning wire with corresponding identification numerals 28a, 28b, 28c, 28d (or collectively, 28));
wherein the catheter shaft further includes a plurality of apposition element lumens, and at least one strut of the plurality of movable struts is movably disposed in one of the apposition element lumens of the plurality of apposition element lumens (¶ [0048] In addition to the first and second lumens 16, 18 a further set of lumens is included to extend along the length of the catheter 12 … identified in the figures by the numerals 26a, 26b, 26c, and 26d (or collectively, 26); ¶ [0049] Extending along the length of each positioning lumen is a positioning wire … 28a, 28b, 28c, 28d);
wherein the catheter shaft further includes a guidewire lumen configured to receive a guidewire (¶ [0046], A first lumen 16 is provided that is sized to receive a guidewire 17 of known configuration so that the catheter is threadable over the guidewire previously introduced into the vasculature);
wherein the guidewire lumen is disposed asymmetrically relative to the shaft lumen (Figs. 7, 9, 12, first lumen 16 is disposed asymmetrically relative to second lumen 18);
wherein the guidewire lumen is disposed between the plurality of apposition element lumens (Figs. 9, 12, first lumen 16 is disposed between lumens 26b and 26c).
Magana provides an alternatively shaped apposition element that permits blood to bypass the apposition element and interferes minimally with blood flow (Figs. 7, 9, 12, positioning wires 28a, 28b, 28c, 28d present a minimal cross-section when they extend away from the catheter 12). One would be motivated to modify Primeaux with Magana’s movable non-symmetric struts to preserve blood flow during a procedure since Primeaux generally calls for an apposition element that expands asymmetrically around the catheter shaft but otherwise omits details about its structure (¶ [0052], positioning element 148 may be located about 150 degrees to about 210 degrees around the circumference of delivery sheath 106 from side opening 146). Magana also demonstrates how to integrate the alternatively shaped apposition elements with an offset or eccentrically oriented guidewire lumen. Therefore, it would have been obvious to modify Primeaux with Magana’s non-symmetric struts in order to preserve blood flow during a procedure.
Primeaux and Magana lack a second lumen section being an open structure that includes a groove. Crisco discloses an endovascular access device (¶ [0002], [0006], [0078] FIGS. 1A-1M illustrate a vascular access device 100; ¶ [0096] FIGS. 2A-2V illustrate a vascular access device 200);
comprising: a catheter shaft including a shaft lumen (¶ [0080] The vascular access device 100 includes a catheter 112 … The catheter 112 may include a flexible shaft 114 … The catheter 112 may include a primary lumen 116; ¶ [0098] The vascular access device 200 includes a catheter 212 … flexible shaft 214 … primary lumen 216);
an apposition element disposed at the catheter shaft at a first apposition state and extending from the catheter shaft at a second apposition state; the apposition element comprising a plurality of movable struts disposed non-symmetrically around the catheter shaft (¶ [0087], FIGS. 1C-1G, the vascular access device 100 includes a number of wires 134 … a first wire 134a … a third wire 134c; ¶ [0104] As shown in FIGS. 2D and 2F-2J, the vascular access device 200 includes a number of wires 244 … a first wire 244a … second wire 244b … third wire 244c … The wires 244 each may be configured to move between a first configuration (which also may be referred to as a “delivery configuration”), as shown in FIGS. 2D, 2F, and 2G, and a second configuration (which also may be referred to as a “deployed configuration”), as shown in FIGS. 2H-2J);
wherein the catheter shaft further includes a plurality of apposition element lumens; and at least one strut of the plurality of movable struts is movably disposed in one of the apposition element lumens of the plurality of apposition element lumens (¶ [0104], the first wire 244a may be positioned at least partially within the first secondary lumen 236a and at least partially within the first deployment opening 242a, the second wire 244b may be positioned at least partially within the second secondary lumen 236b and at least partially within the second deployment opening 242b, and the third wire 244c may be positioned at least partially within the third secondary lumen 236c at least partially within the third deployment opening 242c);
wherein each apposition element lumen receives one of the plurality of movable struts and includes: a first lumen section proximate to a proximal end of the shunting catheter and being an enclosed structure (¶ [0101] As shown in FIGS. 2D and 2F, the catheter 212 may include a number of secondary lumens 236 … first secondary lumen 236a … second secondary lumen 236b … and a third secondary lumen 236c);
a second lumen section being an open structure, the open structure including a groove disposed inwardly relative to an outer surface of the catheter shaft, the groove receiving the one of the plurality of movable struts in the first apposition state (¶ [0103] As shown in FIGS. 2A, 2B, 2D, and 2G, the catheter 212 may include a number of deployment openings 242 each defined in the external surface of the shaft 214 and in fluid communication with one of the secondary lumens 236); and
a third lumen section proximate to a distal end of the shunting catheter and being an enclosed structure (¶ [0101], secondary lumens 236);
wherein the second lumen section is disposed between the first lumen section and the third lumen section (annotated Fig. 2I shows that the deployment openings 242 extend between the secondary lumens 236).
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Crisco reduces the catheter’s outer profile when the struts are folded in their first apposition state (¶ [0104], When the wires 244 are in the first configuration, the first wire 244a may be received partially within the first secondary lumen 236a and partially within the first deployment opening 242a without extending outward beyond the external surface of the shaft 214, the second wire 244b may be received partially within the second secondary lumen 236b and partially within the second deployment opening 242b without extending outward beyond the external surface of the shaft 214, and the third wire 244c may be received partially within the third secondary lumen 236c and partially within the third deployment opening 242c without extending outward beyond the external surface of the shaft 214). One would be motivated to modify Primeaux and Magana with Crisco’s lumen sections and groove to compactly store the struts close to the catheter shaft since Magana calls for a low-profile configuration (¶ [0059], The catheter 12 is then threaded over the guidewire percutaneously in a low profile configuration (GIS. 8, 10) in which the distal tip 22 of the needle 20 is retracted into the catheter and the positioning wires 28 are in a collapsed state). Therefore, it would have been obvious to modify Primeaux and Magana with Crisco’s lumen sections and groove in order to more compactly store the struts in their folded or first apposition state.
Regarding claim 20, Primeaux discloses a method for creating a shunt (¶ [0004], systems, devices, and techniques for creating a fluid pathway, or shunt, between the left atrium of a heart of a patient and the coronary sinus of the patient; ¶ [0036], [0045] FIG. 1 … medical system 100);
comprising: deploying a shunting catheter in a patient, the shunting catheter comprising: a catheter shaft comprising a shaft lumen (¶ [0045], delivery sheath 106; ¶ [0059], FIG. 2 illustrates an example target treatment site 150 for forming a shunt 138 between the left atrium 128 of the heart 130 and the coronary sinus 122; ¶ [0063], As shown in FIG. 6B, the clinician may then advance delivery sheath 106 overtop of guidewire 104 toward target treatment site 150 (182)); and
a guidewire lumen configured to receive a guidewire (¶ [0046], elongated structure 112 defines a device inner lumen configured to receive, e.g., a guidewire 104 and/or puncturing tool 108);
a shunting element disposed in the shaft lumen at a first shunting element state (¶ [0045], medical system 100 also includes a separate puncturing tool 108 including dilation element 110. In other examples, dilation element 110 can be part of ablation device 102 or a different device); and
an apposition element disposed proximate to the shunting element, the apposition element disposed non-symmetrically around the catheter shaft (¶ [0052], FIG. 1, delivery sheath 106 further includes a positioning element 148 … For instance, positioning element 148 may be located about 150 degrees to about 210 degrees around the circumference of delivery sheath 106 from side opening 146, such as about 180 degrees); and
wherein the apposition element extends from the catheter shaft at the second apposition state and stabilizes the shunting catheter in the patient proximate the target location (¶ [0052], Positioning element 148 is, for example, configured to engage with one part of a vessel wall (e.g., a coronary sinus wall 120, shown in FIG. 2) to bring opening 146 closer to another part of the vessel wall);
operating the shunting element to a second shunting element state, wherein the shunting element extends from the catheter shaft at the second shunting element state; puncturing, using the shunting element, an opening at the target location of the patient (¶ [0064] As shown in FIG. 6D … the clinician may advance a puncturing tool 108, which may include an electrifiable distal tip 154 … through side opening 146 of delivery sheath 106, in order to form an initial puncture 162 through coronary sinus wall 120 and left atrium wall 126 (186)); and
expanding, by expanding the shunting element at the second shunting element state, the opening (¶ [0064], As shown in FIG. 6E, the clinician positions dilation element 110, such as an inflatable balloon coupled to puncturing tool 108, within punctures 162, and expands dilation element 110 to dilate punctures 162 (188));
wherein the shunt does not include any implant (¶ [0067] As shown in FIG. 6K, the clinician actuates … a pair of opposing proximal and distal heating elements (e.g., electrodes) 134, 136 on proximal and distal bodies, respectively (196) … As shown in FIG. 6L, the resultant applied heat and pressure from ablation device 104 forms a shunt 138 with welded or coagulated edges 278 defining the perimeter of the shunt opening 138).
Primeaux does not disclose a plurality of apposition element lumens; an guidewire lumen disposed asymmetrically between a plurality of apposition element lumens; an apposition element comprising a plurality of movable struts; and first, second and third lumen sections. Magana discloses a system and method for neuromodulation (¶ [0001], [0015], [0017], [0045], FIGS. 3-12 … system 10);
comprising a plurality of apposition element lumens, and wherein at least one strut of a plurality of movable struts is movably disposed in one of the apposition element lumens of the plurality of apposition element lumens (¶ [0048] In addition to the first and second lumens 16, 18 a further set of lumens is included to extend along the length of the catheter 12 … identified in the figures by the numerals 26a, 26b, 26c, and 26d (or collectively, 26); ¶ [0049] Extending along the length of each positioning lumen is a positioning wire … 28a, 28b, 28c, 28d);
a guidewire lumen configured to receive a guidewire (¶ [0046], A first lumen 16 is provided that is sized to receive a guidewire 17 of known configuration so that the catheter is threadable over the guidewire previously introduced into the vasculature);
wherein the guidewire lumen is disposed asymmetrically relative to the shaft lumen (Figs. 7, 9, 12, first lumen 16 is disposed asymmetrically relative to second lumen 18);
wherein the guidewire lumen is disposed between the plurality of apposition element lumens (Figs. 9, 12, first lumen 16 is disposed between lumens 26b and 26c).
Magana provides an alternatively shaped apposition element that interferes minimally with blood flow and can be integrated with an offset guidewire lumen. Regarding the rationale and motivation to modify Primeaux with Magana’s non-symmetrically disposed struts and guidewire disposed between apposition element lumens, see the discussion of claim 1 above.
Primeaux and Magana lack first, second and third lumen sections and a groove. Crisco discloses first, second and third lumen sections and a groove (¶ [0103] As shown in FIGS. 2A, 2B, 2D, and 2G, the catheter 212 may include a number of deployment openings 242 each defined in the external surface of the shaft 214 and in fluid communication with one of the secondary lumens 236; ¶ [0104], the first wire 244a may be positioned at least partially within the first secondary lumen 236a and at least partially within the first deployment opening 242a, the second wire 244b may be positioned at least partially within the second secondary lumen 236b and at least partially within the second deployment opening 242b, and the third wire 244c may be positioned at least partially within the third secondary lumen 236c at least partially within the third deployment opening 242c).
Crisco compactly stores movable struts inside a catheter’s outer profile (¶ [0104]). Regarding the rationale and motivation to modify Primeaux and Magana with Crisco’s lumen sections and groove, see the discussion of claim 1 above.
Regarding claim 28, Primeaux discloses a shunting catheter system (¶ [0004], systems, devices, and techniques for creating a fluid pathway, or shunt, between the left atrium of a heart of a patient and the coronary sinus of the patient; ¶ [0036], [0045] FIG. 1 … medical system 100);
comprising: a shunting catheter, comprising: a catheter shaft including a shaft lumen (¶ [0045], delivery sheath 106; ¶ [0051], Delivery sheath 106 includes an elongated tubular body 140 defining a sheath inner lumen 142);
a guidewire lumen configured to receive a guidewire (¶ [0046], elongated structure 112 defines a device inner lumen configured to receive, e.g., a guidewire 104 and/or puncturing tool 108);
a shunting element disposed in the shaft lumen at a first shunting element state and extended from the catheter shaft at a second shunting element state and, at the second shunting element state, the shunting element being expandable to enlarge an opening in tissue (¶ [0045], medical system 100 also includes a separate puncturing tool 108 including dilation element 110. In other examples, dilation element 110 can be part of ablation device 102 or a different device);
the shunting element including a puncture element (¶ [0053], puncturing element includes a distinct puncturing tool 108);
an apposition element disposed proximate to the shunting element; the apposition element disposed non-symmetrically around the catheter shaft, the apposition element disposed at the catheter shaft at a first apposition state and extending from the catheter shaft at a second apposition state (¶ [0052], FIG. 1, delivery sheath 106 further includes a positioning element 148 … For instance, positioning element 148 may be located about 150 degrees to about 210 degrees around the circumference of delivery sheath 106 from side opening 146, such as about 180 degrees);
an energy source connected to the shunting catheter; and a controller connected to the energy source and comprising a processor; wherein the processor is configured to control the energy source to deliver ablation energy to a target location of a patient via the puncture element (¶ [0056] RF generator 164 includes control circuitry 172 and RF generation circuitry 174. In general, control circuitry 172 is configured to cause RF generation circuitry 174 to generate RF energy (e.g., monopolar and/or bipolar RF energy), and deliver the generated RF energy to proximal and/or distal active heating elements 134, 136; ¶ [0057], control circuitry 172 includes any of a microprocessor, integrated circuitry … or field-programmable gate arrays (FPGAs).);
wherein the shunting catheter system does not include any implant (¶ [0067] As shown in FIG. 6K, the clinician actuates … a pair of opposing proximal and distal heating elements (e.g., electrodes) 134, 136 on proximal and distal bodies, respectively (196) … As shown in FIG. 6L, the resultant applied heat and pressure from ablation device 104 forms a shunt 138 with welded or coagulated edges 278 defining the perimeter of the shunt opening 138).
Primeaux lacks a plurality of apposition element lumens; a guidewire lumen disposed asymmetrically between the plurality of apposition element lumens; an apposition element comprising a plurality of movable struts; and first, second and a third lumen sections.
Magana discloses a system and method for neuromodulation (¶ [0001], [0015], [0017], [0045], FIGS. 3-12 … system 10);
comprising a plurality of apposition element lumens, and wherein at least one strut of a plurality of movable struts is movably disposed in one of the apposition element lumens of the plurality of apposition element lumens (¶ [0048] In addition to the first and second lumens 16, 18 a further set of lumens is included to extend along the length of the catheter 12 … identified in the figures by the numerals 26a, 26b, 26c, and 26d (or collectively, 26); ¶ [0049] Extending along the length of each positioning lumen is a positioning wire … 28a, 28b, 28c, 28d);
a guidewire lumen configured to receive a guidewire (¶ [0046], A first lumen 16 is provided that is sized to receive a guidewire 17 of known configuration so that the catheter is threadable over the guidewire previously introduced into the vasculature);
wherein the guidewire lumen is disposed asymmetrically relative to the shaft lumen (Figs. 7, 9, 12, first lumen 16 is disposed asymmetrically relative to second lumen 18);
wherein the guidewire lumen is disposed between the plurality of apposition element lumens (Figs. 9, 12, first lumen 16 is disposed between lumens 26b and 26c).
Magana provides an alternatively shaped apposition element that interferes minimally with blood flow and can be integrated with an offset guidewire lumen. Regarding the rationale and motivation to modify Primeaux with Magana’s non-symmetrically disposed struts and guidewire disposed between apposition element lumens, see the discussion of claim 1 above.
Primeaux and Magana lack first, second and third lumen sections and a groove. Crisco discloses first, second and third lumen sections and a groove (¶ [0103] As shown in FIGS. 2A, 2B, 2D, and 2G, the catheter 212 may include a number of deployment openings 242 each defined in the external surface of the shaft 214 and in fluid communication with one of the secondary lumens 236; ¶ [0104], the first wire 244a may be positioned at least partially within the first secondary lumen 236a and at least partially within the first deployment opening 242a, the second wire 244b may be positioned at least partially within the second secondary lumen 236b and at least partially within the second deployment opening 242b, and the third wire 244c may be positioned at least partially within the third secondary lumen 236c at least partially within the third deployment opening 242c).
Crisco compactly stores movable struts inside a catheter’s outer profile (¶ [0104]). Regarding the rationale and motivation to modify Primeaux and Magana with Crisco’s lumen sections and groove, see the discussion of claim 1 above.
Regarding claims 2, 24 and 29, Primeaux discloses an apposition element (¶ [0052], FIG. 1, delivery sheath 106 further includes a positioning element 148).
Primeaux and Magana lack an outer shaft. Crisco discloses a catheter system wherein the shunting catheter further includes an outer shaft disposed outside of at least a portion of the catheter shaft (¶ [0110] FIGS. 2O-2R illustrate the vascular access device 200 and a sheath 246 … the sheath 246 may be movably positioned over the catheter 212 … In this manner, the sheath 246 may prevent the wires 244 from assuming their curved second configuration and extending outward beyond the external surface of the shaft 214 when the sheath 246 is in the first position … In this manner, the wires 244 may be allowed to assume their curved second configuration and extend outward beyond the external surface of the shaft 214 when the sheath 246 is in the second position);
wherein the shunting catheter further comprises an outer shaft disposed outside of at least a portion of the catheter shaft (¶ [0110] FIGS. 2O-2R illustrate the vascular access device 200 and a sheath 246 … the sheath 246 may be movably positioned over the catheter 212);
the apposition element is disposed within the outer shaft at the first apposition state, and permitting the apposition element to self-expand comprises retracting the outer shaft from the apposition element (¶ [0104], In some embodiments, the wires 244 each have a natural undeformed shape that is curved … In this manner, the wires 244 each may be configured to assume the curved second configuration absent opposing forces prohibitively restraining the wires 244 from doing so; ¶ [0110], In this manner, the wires 244 may be allowed to assume their curved second configuration and extend outward beyond the external surface of the shaft 214 when the sheath 246 is in the second position).
Crisco protects a catheter while advancing it through a patient’s vasculature and provides a way to deploy the apposition element (¶ [0110]). A skilled artisan would have been able to modify Primeaux and Magana with Crisco’s outer shaft by enclosing Primeaux’s shunting catheter inside Crisco’s outer shaft, and advancing the overall assembly through the patient’s vasculature. Each of Primeaux and Magana describe an apposition element that is configured to collapse substantially flush against the shunting catheter’s outer surface and will therefore fit inside Crisco’s outer shaft during the first apposition state. One would have been able to modify Primeaux and Magana with Crisco’s outer shaft in order to guard the balloon or wires and to more easily advance the catheter through the patient’s vasculature.
Regarding claims 3, 5, 16, 17, 22, 26 and 27, Primeaux discloses a shunting catheter wherein the apposition element has a first height from the catheter shaft at the first apposition state and a second height from the catheter shaft at the second apposition state, wherein the second height is greater than the first height; wherein the second height is user-selectable (¶ [0063], As shown in FIG. 6C, the clinician may then actuate positioning element 148 of delivery sheath 106 to position side opening 146 of delivery sheath 106 proximate, or even in contact with, target treatment site 150 (184));
wherein the catheter shaft defines a first axis; wherein the shunting element defines a second axis at the second shunting element state; wherein the second axis and the first axis form an angle greater than zero degrees (¶ [0064] As shown in FIG. 6D … the clinician may advance a puncturing tool 108 … through side opening 146 of delivery sheath 106; ¶ [0065] As shown in FIGS. 6F-6H, the clinician advances an ablation device 102 … out from side opening 146, and through dilated punctures 162 (190));
wherein the shunting element includes a puncture element (¶ [0064] As shown in FIG. 6D … the clinician may advance a puncturing tool 108);
wherein the target location is at a blood vessel of the patient (¶ [0046], Distal-facing surface 118 is configured to contact an interior surface of a coronary sinus wall 120 (FIG. 2) of a coronary sinus 122 of a patient); and
operating the apposition element to the second apposition state causes the shunting catheter to be positioned substantially non-concentrically in the blood vessel (¶ [0052], positioning element 148 may be located about 150 degrees to about 210 degrees around the circumference of delivery sheath 106 from side opening 146, such as about 180 degrees);
wherein the shunting element comprises a puncture element, and puncturing the opening at the target location of the patient comprises using the puncture element (¶ [0053] Medical system 100 includes a puncturing element configured to form an initial puncture through coronary sinus wall 120 and left atrium wall 126 … the puncturing element includes a distinct puncturing tool 108; ¶ [0054] As shown in FIG. 1, puncturing tool 108 includes an elongated structure 152, such as a guidewire, a hypotube, a catheter body, or the like, and an electrifiable distal tip 154);
wherein the target location is at a coronary sinus of the patient (¶ [0053] Medical system 100 includes a puncturing element configured to form an initial puncture through coronary sinus wall 120 and left atrium wall 126).
Regarding claim 4, Primeaux discloses an apposition element that extends first and second heights from the catheter shaft, wherein the second height is greater than the first height (¶ [0052], Positioning element 148 is, for example, configured to engage with one part of a vessel wall (e.g., a coronary sinus wall 120, shown in FIG. 2) to bring opening 146 closer to another part of the vessel wall; ¶ [0063], As shown in FIG. 6C, the clinician may then actuate positioning element 148 of delivery sheath 106 to position side opening 146 of delivery sheath 106 proximate, or even in contact with, target treatment site 150 (184)).
Primeaux is silent whether the second height is at least two times the first height.
The apposition element’s second height is interpreted as a result-effective variable, subject to experimentation and testing. A result-effective variable is a parameter which achieves a recognized result. These results are obtained by the determination of optimum or workable ranges of said variable through routine experimentation. The second height depends on the diameters of the catheter shaft and target vessel, along with a desired degree of anchoring and can be optimized through routine experimentation.
Too low
The apposition element will not span the coronary sinus, or the catheter will occupy too much of the coronary sinus
Optimized range
The catheter will be thin enough to maneuver through the coronary sinus and also strong enough to retain its integrity
Too high
The catheter will be too thin to accommodate the shunting element, guidewire and apposition element lumens
A skilled artisan would have been able to select a second height that adequately bridges the diameter of coronary sinus 122 in order to anchor delivery sheath 106, while retaining its ability to collapse against the outer wall of delivery sheath 106. Therefore, it would have been obvious to adjust the second height in order to adequately anchor the catheter. See MPEP 2144.05(II)(A,B). Also see in re Boesch and Slaney, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claims 11, 13-15, 18, 23, 25, 31, 33 and 34, Primeaux lacks a symmetrical apposition element that comprises wires, struts, holes or is self-expandable. Magana discloses a shunting catheter and method wherein each strut of the plurality of movable struts includes a first strut portion and a second strut portion, wherein the first strut portion and an axis defined by the catheter shaft form an expansion angle at the second apposition state, and the expansion angle is greater than zero degrees (annotated Fig. 7 of Magana shows an expansion angle greater than zero degrees);
wherein the apposition element is self-expandable (annotated Fig. 7, wires 28 form a pair of angles in their second expanded state);
wherein the apposition element includes a first end and a second end, the first end being secured to the catheter shaft and the second end being disposed apart from the catheter shaft (annotated Fig. 7, the first end of each wire 28 is secured to the catheter 12 and the second end is free to move);
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wherein the apposition element includes a first end and a second end, the first end being movable relative to the catheter shaft and the second end being secured to the catheter shaft (annotated Fig. 7 shows one secured end and one free end; this claim reverses the labels of the first and second ends);
wherein the puncture element includes a hollow needle (¶ [0047] The catheter 12 includes a second lumen 18 that is sized to receive a sharpened hypotube 20 having an internal lumen 21);
wherein operating the apposition element to the second apposition state comprises permitting the apposition element to self-expand (¶ [0049], Each positioning wire is preferably made of a shape memory alloy, such as nickel titanium alloy, and is configured to emerge from its associated lumen near the distal end of the catheter and to extend along the exterior of the catheter for a short distance "E" (as indicated in FIGS. 6, 8) before the distal tip of each wire is fixedly attached to the body of the catheter);
wherein operating the apposition element to the second apposition state comprises permitting blood flow through the apposition element (Figs. 7, 9, 12, positioning wires 28a-28d present a minimal cross-section when they extend away from the catheter 12, which will permit blood to bypass the wires 28a-28d);
wherein the plurality of movable struts include a plurality of wires (¶ [0049] Extending along the length of each positioning lumen is a positioning wire with corresponding identification numerals 28a, 28b, 28c, 28d (or collectively, 28));
wherein each of the plurality of movable struts includes: a proximal end portion; an intermediate portion extending outwardly from the catheter shaft at the second apposition state; and a distal end portion inhibited from moving distally relative to the catheter shaft at the second apposition state (annotated Fig. 7, the proximal, intermediate and distal portions of the movable struts correspond to the third, second and first sections of the apposition element lumen);
wherein the proximal end portion is movable distally relative to the catheter shaft to cause the intermediate portion to bow and extend outwardly from the catheter shaft at the second apposition state (¶ [0049], Under this configuration, when a compressive axial force is applied to each of the positioning wires 28, the wires buckle in the region where they are positioned outside the catheter, and extend radially away from the catheter as shown in FIGS. 6, 7, and 9).
Magana provides an alternatively shaped apposition element that preserves blood flow and can be integrated with an offset guidewire lumen. Regarding the rationale and motivation to modify Primeaux with Magana’s non-symmetrically disposed struts, guidewire disposed between apposition element lumens and other features, see the discussion of claim 1 above.
Claims 10 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Primeaux, Magana and Crisco in view of Cully; Edward H. (US 20120136385 A1).
Regarding claims 10 and 36, Primeaux, Magana and Crisco lack a strut including a hole or struts including a rectangular cross-sectional shape. Cully discloses methods and apparatuses for guiding an endovascular tool (¶ [0009], [0022], [0030], FIGS. 1A, 1B, 2A and 2B, a guide device 200);
comprising an apposition element comprising a plurality of movable struts (¶ [0032] Expandable member 210 comprises a radially expandable or outwardly extending structure; ¶ [0045], expandable member 210 may comprise at least one slat 211);
wherein at least one strut of the plurality of movable struts includes at least one hole (¶ [0051], expandable member 210 may comprise an aperture 213. Aperture 213 is any opening located on expandable member 210 that permits an endovascular tool to pass through guide tube 240 with obstruction from expandable member 210);
wherein at least one of the plurality of movable struts includes a rectangular cross-sectional shape (¶ [0045], Similarly, expandable member 210 may comprise at least one slat 211 connected at one end to first elongate member 220 and connected at the other end to second elongate member 230).
Cully provides a passage for a shunting element (¶ [0051], Aperture 213 is any opening located on expandable member 210 that permits an endovascular tool to pass through guide tube 240 with obstruction from expandable member 210). Cully’s perforated apposition element also holds a shunting element more securely against a target tissue, since it emerges directly from aperture 213 before contacting the tissue. Cully also demonstrates how to make struts with an alternative cross-section.
One would be motivated to modify Primeaux, Magana and Crisco with Cully’s perforated struts, strut portions or rectangular cross-section to anchor a catheter with another known structure, and to anchor the shunting element more securely to the target tissue. A skilled artisan would have been able to modify Primeaux, Magana and Crisco with Cully’s rectangular cross-section by altering the shape of Magana’s wires and their respective apposition element lumens. Therefore, it would have been obvious to modify Primeaux, Magana and Crisco with Cully’s perforated struts and rectangular cross-section in order to anchor a catheter and shunting element more securely.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Primeaux, Magana and Crisco in view of Alvarez; Jeffery B. et al. (US 20130006167 A1).
Regarding claim 19, Primeaux, Magana and Crisco are silent whether the puncture element includes a hollow needle, and lack a plurality of voids along the puncture element. Alvarez discloses a medical device and method for crossing a chronic occlusion including a shunting catheter (¶ [0002], [0017], [0018], [0050], FIG. 1, a reentry catheter … The catheter 100);
comprising a puncture element including a hollow needle (¶ [0059], The reentry member 112 is hollow with a lumen 128);
wherein the puncture element includes a plurality of voids, the plurality of voids facilitating bending of a shunting element in a second shunting element state (¶ [0058] FIGS. 2A-2C, reentry member 112 is constructed with at least one void or cut geometry 124 that enables flexing … a diamond pattern 124 along the axis of the reentry member 112 is formed at least along a distal region of the reentry member 112).
Alvarez makes a puncture element easier to bend along a preferential path by arranging a plurality of voids along its length (¶ [0058], As more cut geometry 124 are used, it is easier to flex the reentry member 112 upon application of a force). Alvarez’s hollow needle also permits other devices to advance through the shunting element (¶ [0055] The reentry member 112 may be configured to permit other devices … may include a balloon, a cutting device, thrombectomy device, a guide wire, a filters, e.g., an embolic filter, optical devices, e.g., RF or laser ablation devices, combinations and the like). One would be motivated to modify Primeaux, Magana and Crisco with Alvarez’s lumen and plurality of voids to facilitate bending since Primeaux calls for different versions of the puncture element (¶ [0048], In some examples, guidewire 132, in addition to, or instead of, puncturing tool 108, is configured to function as a puncturing element configured to puncture through tissue of a patient to enable advancement of at least distal body 116 through the tissue; ¶ [0055] As detailed further below with respect to FIG. 4, in some examples, puncturing tool 108 further includes a dilation element 110). Therefore, it would have been obvious to modify Primeaux, Magana and Crisco with Alvarez’s lumen and voids in order to more easily bend the puncture element, or to advance other surgical tools through the shunting element.
Response to Arguments
Applicant’s arguments filed 30 March 2026 regarding the rejection of claims 1-5, 10-11, 13-20, 22-29, 31, 33, 34 and 36 as amended, under 35 USC § 103 over Valdez, Magana, Crisco, Cully and Alvarez, have been fully considered and are persuasive. After further consideration, the amended claims are rejected on new grounds under 35 USC § 103 over Primeaux, Magana, Crisco, Cully and Alvarez (see above).
Applicant’s arguments regarding Valdez have been considered but are moot because the reference is no longer cited in the current rejection.
Applicant submits that the cited references do not disclose or suggest "at the second shunting element state, the shunting element being expandable to enlarge an opening in tissue" or "the shunting catheter does not include any implant" as in claim 1 (remarks p. 11). Examiner responds that Primeaux is cited in the new grounds of rejection as teaching an expandable shunting element that enlarges an opening in tissue (¶ [0055], dilation element 110 may be at least partially advanced through the puncture and expanded radially outward to dilate the puncture (forming a dilated puncture)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Arevalos; Christopher Alexander et al. US 20190374254 A1
Vardi; Gil M. et al. US 20200170662 A1
Vardi; Gil M. et al. US 20230181214 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
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