DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed 04/15/2026 has been entered. Claims 1-4, 6-7, 10, and 12-20 remain pending in the application. Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 02/06/2026.
Response to Arguments
Applicant’s arguments, see pgs. 7-11, filed 04/15/2026, with respect to the rejections of claim 1-4, 6-7, 10, and 12-20 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the previous rejections have been withdrawn and new grounds of rejection have been set forth below as necessitated by applicant’s amendment received 4/15/2026.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6-7, 10, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Vidlund et al. (US 20220087814 A1), hereinafter referred to as Vidlund (2022), in view of Vidlund et al. (US 20210315694 A1), herein after referred to as Vidlund (2021), and in view of Frazier et al. (US 20100234885 A1).
Regarding claim 1, Vidlund (2022) discloses a prosthetic heart valve system (200) for replacing a native right atrioventricular valve (¶ 0042 - ¶ 0043 disclose a prosthetic heart valve system 200 for the right atrioventricular valve with an inflow or atrial end and an outflow or ventricular end), the system comprising: a collapsible and expandable (¶ 0004 discloses a prosthetic heart valve with a collapsible and expandable outer frame) anchor frame (¶ 0042 discloses that an outer frame 201 comprises anchor members 202/204) including: a support frame (201) that has a central portion (see fig. 2b annotated below), and an atrial portion and ventricular portion each flared radially outwardly from the central portion (paragraph 0028 discloses an atrial portion and ventricular portion flaring radially outwardly from a central portion as seen in fig. 2b), the atrial and ventricular portions sized to sandwich an annulus of the right atrioventricular valve therebetween (¶ 0028 discloses a central portion situated in contact with the native valve annulus);
an atrial sheet coupled to the atrial portion of the support anchor frame and extending radially inwardly to a central aperture in the atrial sheet (fig. 2a annotated below illustrates an atrial sheet S coupled to the atrial portion of the frame and extending radially to a central aperture in the sheet), the atrial sheet being formed of a material that is substantially impermeable to blood (¶ 0026 discloses the disclosed fabrics or tissue skirts provide a seal around the heart valve, thereby substantially impermeable to blood as claimed); a ventricular sheet coupled to the ventricular portion of the anchor frame and extending radially inwardly to a central aperture in the ventricular sheet (fig. 2b illustrates a sheet S extending from a flared ventricular portion radially inwardly to a central aperture, down a central portion, and out towards an atrial aperture and flared portion as seen in fig. 2a); and a generally cylindrical leaflet support structure (fig. 2a annotates bellow illustrates a generally cylindrical leaflet support structure 205), an inflow end of the leaflet support structure coupled to the atrial sheet (fig. 2a illustrates the inflow end of the leaflet support structure 205 coupled to the atrial sheet S).
Vidlund (2022) fails to disclose that the atrial sheet defines an opening positioned radially outside of the leaflet support structure, the ventricular sheet defines an opening positioned radially outside of the leaflet support structure, and a tube extends from the opening in the ventricular sheet to the opening in the atrial sheet to form a shunt so that, upon implantation of the anchor frame into the native right atrioventricular valve, blood flowing around an exterior of the leaflet support structure can pass through the openings and through the shunt in a retrograde direction and an antegrade direction, wherein the tube forming the shunt is either cylindrical, or bean-shaped in transverse cross- section, and wherein a closure member is coupled to the shunt.
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Vidlund (2021) also discloses a prosthetic heart valve system (100) for replacing a native right atrioventricular valve (¶ 0152 discloses and fig. 1 illustrates an upper and lower portion that permits blood flow from the atrium to the ventricle through the inflow end 132 of the prosthetic heart valve 100), the system comprising: a collapsible and expandable anchor frame (¶ 0082 discloses and fig. 1 illustrates an expandable frame 102 with anchor members 268/270) including: a support frame that has a central portion (fig. 1 annotated below), and an atrial portion and ventricular portion each flared radially outwardly from the central portion (¶ 0093 discloses that the annular support frame may have both a flared top and bottom and fig. 1 annotated below illustrates a ventricular portion flared radially outward from the central portion), the atrial and ventricular portions sized to sandwich an annulus of the right atrioventricular valve therebetween (paragraph 0086 discloses a central portion or annular support frame 102 that is seated on the native valve annulus), and an atrial sheet (137).
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Vidlund (2021) teaches the atrial sheet defines an opening (135) positioned radially outside of the leaflet support structure (fig. 1 illustrates an opening positioned radially outside of the leaflet support structure 231) and as previously discussed, Vidlund (2022) discloses both an atrial and ventricular sheet coupled to the atrial and ventricular portions of the support frame extending radially inwardly to a central aperture in the sheet (fig. 2b illustrates a sheet S extending from a flared ventricular portion radially inwardly to a central aperture, down a central portion, and out towards an atrial aperture and flared portion as seen in fig. 2a). Vidlund (2021) further teaches that an opening (135) in the atrial sheet is surrounded/further defined by a tube (139) having a lumen to form a shunt (see fig. 4) in order to direct blood through the opening (see ¶ 0104).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Vidlund’s (2022) prosthetic heart valve with a tube extending from the opening in the atrial sheet to an opening in the ventricular sheet radially outside of the leaflet support structure to form a shunt as Vidlund (2021) teaches that the shunt/tube provides a fluid conduit through an atrial sheet and an person of ordinary skill in the art would have expected success in routing the shunt/tube through additional layers of valve material, such as a ventricular sheet, and still provide the intended function of providing a blood/fluid flow path.
Vidlund (2021) also teaches that upon implantation of the anchor frame into the native right atrioventricular valve the shunt/tube is capable of allowing blood to flow around an exterior of the leaflet support structure and pass through the openings and through the shunt in a retrograde direction and an antegrade direction as the shunt/second regurgitation drum comprises a tubular structure, allowing fluid passage, and flow controlling elements (¶ 0104). Vidlund (2021) further wherein the tube forming the shunt is either cylindrical, or bean-shaped in transverse cross- section (see figs. 1-4; 139), and wherein a closure member is coupled to the shunt (¶ 0104 discloses that the shunt’s opening/perforation can be sealed using a closure device or functionally similar devices used to treat patent foramen ovale).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve of Vidlund (2022) to include that the atrial sheet defines an opening positioned radially outside of the leaflet support structure, the ventricular sheet defines an opening positioned radially outside of the leaflet support structure, and a tube extends from the opening in the ventricular sheet to the opening in the atrial sheet to form a shunt so that, upon implantation of the anchor frame into the native right atrioventricular valve, blood flowing around an exterior of the leaflet support structure can pass through the openings and through the shunt in a retrograde direction and an antegrade direction, wherein the tube forming the shunt is either cylindrical, or bean-shaped in transverse cross- section, and wherein a closure member is coupled to the shunt in order to provide a regurgitation means such as a shunt, tube, frame, etc., when needed by the patient (Vidlund (2021) – see ¶ 0165 and ¶ 0210).
Vidlund (2022) in view of Vidlund (2021) fails to disclose that the closure member includes a bioabsorbable member maintaining the closure member in an open condition in which blood is free to flow through the shunt. Frazier also discloses a closure member (500; fig. 28). Frazier teaches that the closure member includes a bioabsorbable member maintaining the closure member in an open condition in which blood is free to flow through the shunt (¶ 0162 discloses that the device may be formed of bioabsorbable/biodegradable material and ¶ 0159 discloses that the closure member 500 is capable of keeping the closure in an open condition in which blood is free to flow through the shunt as the closure member 500 comprises sealing arms 510, which may be made of nitinol (often used in shape-setting), that in an uncompressed configuration of the stent remain unexpanded and where the sealing arms 510 expand upon compression of the device and thereby closing the shunt).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the closure member of Vidlund (2022) in view of Vidlund (2021) to include that the closure member includes a bioabsorbable member maintaining the closure member in an open condition in which blood is free to flow through the shunt as taught by Frazier as the modification merely involves a combination of known methods of utilizing closure devices that achieve predictable results of closing a perforation, lumen, or cavity (Frazier – ¶ 0003).
Regarding claim 2, Vidlund (2022) in view of Vidlund (2021) and Frazier disclose the invention as claimed as discussed with respect to claim 1. Vidlund (2022) further discloses that the leaflet support structure (205) is the central portion of the anchor frame (fig. 2a illustrates a leaflet support structure 205 in the center portion of the anchor frame), and that an outer sealing fabric (S) extends between the atrial and ventricular portions of the anchor frame (paragraphs 0026 and 0040 describing the sealing fabric S may be included on the inner frame 205, outer frame 201, and may be formed of multiple pieces of material over the luminal and abluminal surfaces of both frames).
Regarding claim 3, Vidlund (2022) in view of Vidlund (2021) and Frazier disclose the invention as claimed as discussed with respect to claim 1. Vidlund (2022) further discloses that the anchor frame (201) is an outer stent (paragraph 0045 discloses that the support frame or outer frame is a stent), and the leaflet support structure (205) is an inner stent (paragraph 0048 discloses that an expandable inner stent/frame 205 may be positioned radially within the outer stent/frame 201).
Regarding claim 4, Vidlund (2022) in view of Vidlund (2021) disclose the invention as claimed as discussed with respect to claim 1. Vidlund (2022) further discloses that the anchor frame (201) is an outer stent, and the leaflet support structure (205) is a fabric tube (Paragraph 0045 discloses an anchor frame 201 that is an outer stent. Paragraph 0040 discloses a fabric may extend over the luminal and abluminal surfaces of the outer frame 201 and that an inner frame 205 with leaflets L coupled to its interior may be positioned radially within the luminal surface of outer frame 201).
Regarding claim 6, Vidlund (2022) in view of Vidlund (2021) and Frazier disclose the invention as claimed as discussed with respect to claim 4. Vidlund (2022) further discloses a collapsible and expandable prosthetic heart valve including a stent and a plurality of prosthetic leaflets (paragraphs 0048-0049 discloses a collapsible/expandable prosthetic heart valve including a stent 205 and a plurality of prosthetic leaflets L), the prosthetic heart valve configured to be expanded into and received within the fabric tube of the anchor frame (paragraph 0040 discloses a fabric may extend over the luminal and abluminal surfaces of the outer frame 201 and that an inner frame 205 with leaflets L coupled to its interior may be positioned radially within the luminal surface of outer frame 201).
Regarding claim 7, Vidlund (2022) in view of Vidlund (2021) and Frazier disclose the invention as claimed as discussed with respect to claim 1. Vidlund (2022) further discloses a plurality of prosthetic leaflets directly coupled to the leaflet support structure forming a valve (fig. 2a illustrates a plurality of prosthetic leaflets L directly coupled to the leaflet support structure 205) that allows blood to flow from the inflow end of the leaflet support structure to the outflow end of the leaflet support structure, but generally blocks blood from flowing from the outflow end of the leaflet support structure to the inflow end of the leaflet support structure (function of a heart valve).
Regarding claim 10, Vidlund (2022) in view of Vidlund (2021) and Frazier disclose the invention as claimed as discussed with respect to claim 1. Vidlund (2022) as modified fails to disclose a radiopaque marker coupled to the atrial sheet adjacent to the opening. Vidlund (2021) further teaches a radiopaque marker coupled to the sheet adjacent to the opening in the atrial sheet (fig. 11 illustrates radiopaque markers 144 coupled to a sheet or cover 137 adjacent to an opening 135 on the atrial side; also see fig. 10 and ¶ 0161). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve system of Vidlund (2022) in view of Vidlund (2021) and Frazier to further include radiopaque markers coupled to the sheet adjacent to the opening as further taught by Vidlund (2021) in order to guide a delivery devices such as a catheter cutting or balloon tool (Vidlund 2021, paragraph 0105) and provide positioning information of the valve or the perforation (Vidlund 2021, paragraph 0106).
Regarding claim 18, Vidlund (2022) in view of Vidlund (2021) and Frazier disclose the invention as claimed as discussed with respect to claim 1. Vidlund (2021) further teaches that the tube (139) forming the shunt is cylindrical (fig. 4).
Regarding claim 19, Vidlund (2022) in view of Vidlund (2021) and Frazier disclose the invention as claimed as discussed with respect to claim 1. Vidlund (2022) as modified fails to disclose the tube (139) forming the shunt is bean-shaped in transverse cross-section. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the tube forming the shunt having a bean-shaped in transverse cross-section because Applicant has not disclosed that a bean-shaped in transverse cross-section provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Vidlund’s device, and applicant’s invention, to perform equally well with either the cylindrical shape taught by Vidlund, the claimed bean-shape, or any other suitable shape because Applicant discloses both shapes, as well as other shapes, are suitable (¶ 0008 and 0068) and both shapes would perform the same function of a shunt for blood flow. Finally, a person having ordinary skill in the art, being faced with modifying the shape of Vidlund’s tube as needed for the intended application, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended given the claimed shape.
Therefore, it would have been prima facie obvious to modify Vidlund to obtain the invention as specified in claim 19 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Vidlund.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Vidlund (2022) et al. (US 20220087814 A1), in view of Vidlund (2021) et al. (US 20210315694 A1), and Frazier et al. (US 20100234885 A1) as applied to claim 1 above, and further in view of Zuo (CN 114224402 A).
Regarding claim 12, Vidlund (2022) in view of Vidlund (2021) and Frazier disclose the invention as claimed as discussed with respect to claim 1. Frazier further discloses that the closure member (500) is formed of a shape-memory material (¶ 0162 discloses that the device/closure member 500 is preferably formed of Nitinol, i.e. shape-memory material). Vidlund (2022) in view of Vidlund (2021) and Frazier fails to disclose that the closure member including two apices and two "C"-shaped sides, the two "C"-shaped sides nesting with each other in the absence of applied forces.
Zuo also discloses a closure member (see figs. 12-13). Zuo teaches that the closure member includes two apices and two "C"-shaped sides, the two "C"-shaped sides capable of nesting with each other in the absence of applied forces (fig. 13 annotated below illustrates a closure member with two c-shaped sides that nest with each other in absence of applied forces as the device is deformed to form a pre-tightening force and no applied force is required to nest the C-shaped sides).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the closure member of Vidlund (2022) in view of Vidlund (2021) and Frazier to include two apices and two "C"-shaped sides, the two "C"-shaped sides nesting with each other in the absence of applied forces as taught by Zuo, as Vidlund (2021) discloses that the shunt’s opening/perforation can be sealed using a closure device or functionally similar devices used to treat patent foramen ovale (¶ 0104), as the modification merely involves a combination of known methods of utilizing closure devices that achieve predictable results of closing and/or plugging an opening, lumen, or gap (Zuo – pg. 2 – background/disclosure).
Regarding claim 13, Vidlund (2022) in view of Vidlund (2021), Frazier, and Zuo disclose the invention as claimed as discussed with respect to claim 12. Frazier discloses that the closure device (500) may be made of biodegradable/bioabsorbable material. Zuo further discloses that a wire-like/connecting member is connected to the two apices of the closure member (see fig. 12 below), the wire-like/connecting member capable of maintaining the closure member in an open condition in which the two "C"-shaped sides form a generally circular passageway, the tube of the shunt passing through the generally circular passageway as the wire-like/connecting member can comprise tightening mechanisms/bands that may create an open generally circular passageway that closes after sometime.
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Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Vidlund (2022) et al. (US 20220087814 A1), in view of Vidlund (2021) et al. (US 20210315694 A1), and Frazier et al. (US 20100234885 A1) as applied to claim 1 above, and further in view of Chanduszko et al. (US 7842053 B2).
Regarding claim 14, Vidlund (2022) in view of Vidlund (2021) and Frazier disclose the invention as claimed as discussed with respect to claim 1. Frazier further discloses that the closure member (500) is formed of a shape-memory material (¶ 0162 discloses that the device/closure member 500 is preferably formed of Nitinol, i.e. shape-memory material), and the closure member capable of having a closed condition in the absence of applied forces as the closure device 500 may comprise nitinol, a shape-memory material which can have a pre-set shape such as a closed shape/condition in the absence of applied forces. Vidlund (2022) in view of Vidlund (2021) and Frazier fails to disclose that the closure member forming a spiral shape with an interior diameter when in the closed condition.
Chanduszko also discloses a closure member (100). Chanduszko further teaches that the closure member (100) is capable of forming a spiral shape with an interior diameter (see fig. 10) when in the closed condition (col. 2 lines 9-12 disclose a closure member with a coiled/spiral shape and in a closed/compressed condition).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the closure member of Vidlund (2022) in view of Vidlund (2021) and Frazier to include that the closure member forming a spiral shape with an interior diameter when in the closed condition as taught by Chanduszko, as Vidlund (2021) discloses that the shunt’s opening/perforation can be sealed using a closure device or functionally similar devices used to treat patent foramen ovale (¶ 0104), and the modification merely involves a combination of known methods of utilizing closure devices that achieve predictable results of closing and/or compressing an opening (see col. 1 lines 27-30 and col. 3 lines 1-5).
Regarding claim 15, Vidlund (2022) in view of Vidlund (2021), Frazier, and Chanduszko disclose the invention as claimed as discussed with respect to claim 14. Chanduszko further discloses that in the open condition of the closure member, two ends of the closure member are capable of overlapping as the closure member (100) comprises flexible properties, e.g. upon delivery from a sheath it resumes its coiled condition from an expanded condition as it is made from shape-memory material (col. 2 lines 54-59; also see fig. 10 annotated below for a spiral/coil with overlapping ends), the two ends capable of being coupled together by the bioabsorbable member (fig. 10 illustrates and col. 3 lines 40-62 two ends being coupled together by a bioresorbable member) so that an interior diameter of the closure member in the open condition is larger than the interior diameter of the closure member in the closed condition as Chanduszko discloses a closure device including a coil and a bioresorbable material. Further that the bioresorbable material may be placed at any suitable location on the device, including around portions of the device (surrounding or encapsulating it; see col. 3 lines 41-48). Because of this structure, the bioresorbable material is considered capable of engaging the coil and restricting its radial movement, e.g. if placed around expanded parts of the coil, the bioresorbable material is capable of maintaining the coil in an expanded configuration while present, and upon degradation of the bioresorbable material, this restraining effect may lessen and therefore allow the coil to resume its original small-diameter configuration.
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Regarding claim 16, Vidlund (2022) in view of Vidlund (2021), Frazier, and Chanduszko disclose the invention as claimed as discussed with respect to claim 15. Chanduszko further discloses that the bioabsorbable member is a sheath capable of receiving the two ends of the closure member within the sheath as the bioresorbable material may be placed at any suitable location on the device, including around portions of the device, surrounding or encapsulating it, i.e. a sheath (see col. 3 lines 41-48).
Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Vidlund (2022) et al. (US 20220087814 A1), in view of Vidlund (2021) et al. (US 20210315694 A1), Frazier et al. (US 20100234885 A1), and Chanduszko et al. (US 7842053 B2) as applied to claim 15 above, and further in view of Moaddeb et al. (US 20070142907 A1).
Regarding claim 17, Vidlund (2022) in view of Vidlund (2021), Frazier, and Chanduszko disclose the invention as claimed as discussed with respect to claim 15. Chanduszko further discloses that the bioabsorbable member is capable of wrapping around the two ends of the closure member, as the bioresorbable material may be placed at any suitable location on the device, including around portions of the device (surrounding/encapsulating/wrapping); see col. 3 lines 41-48). Chanduszko fails to disclose that the bioabsorbable member is specifically a wire.
Moaddeb also discloses a prosthetic heart valve system (200) and a closure member (1310). Moaddeb further teaches that a wire wraps around the closure member (fig. 13a illustrates a wire 1320 wrapping around a closure member 1310). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve of Vidlund (2022) in view of Vidlund (2021), Frazier, and Chanduszko to provide the bioresorbable member as a wire as taught by Moaddeb in order to enable proper adjustment (Moaddeb paragraphs 0158-159).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Vidlund (2022) et al. (US 20220087814 A1), in view of Vidlund (2021) et al. (US 20210315694 A1), and Frazier et al. (US 20100234885 A1) as applied to claim 1 above, and further in view of Nitzan et al. (US 11135054 B2).
Regarding claim 20, Vidlund (2022) in view of Vidlund (2021) disclose the invention as claimed as discussed with respect to claim 1. Vidlund (2021) discloses a shunt (135). Vidlund (2022) in view of Vidlund (2021) fails to disclose a semi-permeable membrane positioned within the shunt. Nitzan also discloses a shunt (100). Nitzan teaches a semi-permeable membrane positioned within the shunt (col. 17 lines 53-59 disclose a covering or sheets of semi-permeable membranes such as animal tissues). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve of Vidlund (2022) in view of Vidlund (2021) and Frazier to include a semi-permeable membrane positioned within the shunt as taught by Nitzan in order to form a strong continuous coating that covers the inner and outer surfaces on the stent (col. 17 line 67 – col. 18 line 1).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.G.B./Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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