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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “delivery state in which the leaflet support is configured to be transluminally advanceable to the valve” of claim 3, the “second pair of wings” of claim 4, and the “third pair of wings” of claim 5 must be shown or the features canceled from the claims. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 10 is objected to because of the following informalities: claim 10 recites “the wings of the pair” when it should state “the pair of wings”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: claim 11 recites “the wings of the pair” when it should state “the pair of wings”. Appropriate correction is required.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chau et al. (US 2015/0230919 A1), “Chau” in view of Kofidis (US 2019/0321168 A1), “Kofidis”.
Regarding claim 1, Chau teaches a system for use with a valve of a heart of a subject (Fig. 8, device 300), the heart cycling between systole and diastole (Figs. 9-10), and the system comprising a leaflet support (Fig. 8, device 300 comprises a strong flexible sheet to support valve leaflets [0102]), the leaflet support comprising: a tissue anchor (Fig. 8, tethers 308 and anchors 312), anchorable to ventricular tissue of a ventricle that is downstream of the valve (Fig. 8, tethers 308 and anchors 312 engage with papillary muscles 310 of the left ventricle 4 [0104]); and a wing (Fig. 9, body 301), defining a medial (Fig. 9, side of body 301 in contact with anterior leaflet 6) and lateral surface (Fig. 10, side of body 301 in contact with posterior leaflet 8), wherein the wing is coupled to the tissue anchor (Fig. 9, first end portion 302 of body 301 is attached to mitral valve annulus above posterior leaflet 8 [0102]) such that, when the tissue anchor is anchored to the ventricular tissue, the tissue anchor flexibly supports the wing at the valve (Figs. 9-10, body 301 inflates and deflates while secured by tethers 308 and anchors 312 in coordination with diastole and systole cycles of the heart [0105-0106]), such that: during systole: the lateral surface of the wing is in contact with the respective leaflet (Fig. 9, during systole the device 300 inflates to expand laterally into contact with anterior leaflet 6 blocking blood flow [0105]), thereby obstructing retrograde blood flow through the valve, and during diastole, the medial surfaces of the wing move out of contact with each other, thereby facilitating antegrade blood flow through the valve (Fig. 10, during diastole device 300 collapses against posterior leaflet 8 allowing blood flow [0106]), but fails to teach a pair of wings, comprising medial and lateral surfaces, and the medial surfaces of the wings of the pair move into contact with each other during systole.
Kofidis teaches a mitral valve prosthesis comprising a pair of wings (Fig. 16A, anterior leaflet 1202A and posterior leaflet 1202P) with medial (Fig. 16B, sides of anterior leaflet 1202A and posterior leaflet 1202P in contact with each other) and lateral surfaces (Fig. 16B, sides of anterior leaflet 1202A and posterior leaflet 1202P opposite the sides in contact with each other), each wing of the pair defining: a medial surface, such that the medial surface of one wing of the pair faces the medial surface of the other wing of the pair (Fig. 16B, sides of anterior leaflet 1202A and posterior leaflet 1202P in contact with each other also face each other), and a lateral surface with the lateral surface of each wing of the pair facing a respective leaflet of the valve (Fig. 16B, sides of anterior leaflet 1202A and posterior leaflet 1202P opposite the sides in contact with each other also face the heart valves [0121-0125]) and during diastole, the medial surfaces of the wings move out of contact with each other (Fig. 16A, leaflets 1202A and 1202P in diastole are located at a distance from each other in order to allow blood to flow through [0121-0125]) and the medial surfaces of the winds of the pair move into contact with each other during systole (Fig. 16B, leaflets 1202A and 1202P in systole phase comprise sides in contact with each other to prevent backflow of blood [0121-0125]). Kofidis discloses that the mitral valve prosthesis conforms in relation to diastolic and systolic phases of the heart and may comprise extension portions to provide enough leaflet to ensure closure of the valve in order to disable backflow of blood in chambers of the heart [0125]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Chau with the pair of wings and diastolic and systolic movement of said wings as taught by Kofidis to prevent leakage or backflow of blood from the ventricle to the atrium.
Regarding claim 2, Chau fails to teach the limitations of claim 2. Kofidis teaches a mitral valve prosthesis wherein the lateral surface comprises an entire area of the wing (Fig. 16B, sides of anterior leaflet 1202A and posterior leaflet 1202P opposite the sides in contact with each other). Kofidis discloses that the mitral valve prosthesis conforms in relation to diastolic and systolic phases of the heart and may comprise extension portions to provide enough leaflet to ensure closure of the valve in order to disable backflow of blood in chambers of the heart [0125]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Chau with the wings and diastolic and systolic movement of said wings as taught by Kofidis to prevent leakage or backflow of blood from the ventricle to the atrium.
Regarding claim 3, Chau teaches wherein the leaflet support (Fig. 8, device 300 comprises a strong flexible sheet to support valve leaflets [0102]) has a delivery state in which the leaflet support is configured to be transluminally advanceable to the valve (the prosthetic device may be retained in a collapsed delivery state inside a delivery catheter during transcatheter delivery to a patient’s heart [0009]).
Regarding claim 4, Chau teaches the leaflet support (Fig. 8, device 300 comprises a strong flexible sheet to support valve leaflets [0102]) but fails to teach a first or second pair of wings. Kofidis teaches a mitral valve prosthesis wherein the pair of wings is a first pair of wings (Fig. 16A, anterior leaflet 1202A and posterior leaflet 1202P), and wherein the leaflet support further comprises a second pair of wings (Fig. 9A, secondary cords 1104P). Kofidis discloses that addition of secondary cords allows the leaflets to withstand pressure applied during the systole phase [0108]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Chau with the first and second pair of wings as taught by Kofidis to prevent leakage or backflow of blood from the ventricle to the atrium.
Regarding claim 5, Chau teaches the leaflet support (Fig. 8, device 300 comprises a strong flexible sheet to support valve leaflets [0102]) but fails to teach a third pair of wings.
Kofidis teaches a mitral valve prosthesis comprising a third pair of wings (Fig. 6D, chords 604, 606, 608 of leaflets 602A and 602P). Kofidis discloses that the leaflets and chords may be sized based off the patient’s own heart [0079]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the leaflets support taught by Chau with the multiple pairs of wings taught by Kofidis in order to provide a prosthesis with the best fit to the patient’s heart.
Regarding claim 6, Chau teaches wherein the wing is configured such that, when the tissue anchor is anchored to the ventricular tissue (Fig. 8, tethers 308 and anchors 312), the wing remains in contact with its respective leaflet during diastole (Fig. 10, during diastole device 300 collapses against posterior leaflet 8 allowing blood flow [0106]) but fails to teach a pair of wings.
Kofidis teaches a mitral valve prosthesis comprising a pair of wings (Fig. 16A, anterior leaflet 1202A and posterior leaflet 1202P). Kofidis discloses that the mitral valve prosthesis conforms in relation to diastolic and systolic phases of the heart and may comprise extension portions to provide enough leaflet to ensure closure of the valve in order to disable backflow of blood in chambers of the heart [0125]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Chau with the pair of wings and diastolic and systolic movement of said wings as taught by Kofidis to prevent leakage or backflow of blood from the ventricle to the atrium.
Regarding claim 7, Chau teaches wherein the wing is configured such that, when the tissue anchor is anchored to the ventricular tissue (Fig. 8, tethers 308 and anchors 312), the lateral surface of the wing remains in contact with its respective leaflet during diastole (Fig. 10, during diastole device 300 collapses against posterior leaflet 8 allowing blood flow [0106]), but fails to teach a pair of wings.
Kofidis teaches a mitral valve prosthesis comprising a pair of wings (Fig. 16A, anterior leaflet 1202A and posterior leaflet 1202P). Kofidis discloses that the mitral valve prosthesis conforms in relation to diastolic and systolic phases of the heart and may comprise extension portions to provide enough leaflet to ensure closure of the valve in order to disable backflow of blood in chambers of the heart [0125]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Chau with the pair of wings and diastolic and systolic movement of said wings as taught by Kofidis to prevent leakage or backflow of blood from the ventricle to the atrium.
Regarding claim 8, Chau teaches wherein the leaflet support (Fig. 8, device 300 comprises a strong flexible sheet to support valve leaflets [0102]) but fails to teach a flexible frame, and the wing is fixed upon the frame, and a pair of wings.
Kofidis teaches a mitral valve prosthesis comprising a pair of wings (Fig. 16A, anterior leaflet 1202A and posterior leaflet 1202P), a flexible frame (Fig. 1, asymmetrical ring 1), and each wing of the pair is fixed upon the frame (Fig. 1, leaflets 2 suspended from asymmetrical ring 1 [0065]). Kofidis discloses that the asymmetrical ring mimics the shape of the natural mitral valve and is configured to coapt with the movement of the heart cycles [0009-0010]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Chau with the wings and frame taught by Kofidis in order to create a more fitted and adaptable prosthesis.
Regarding claim 9, Chau fails to teach the limitations of claim 9. Kofidis teaches a mitral valve prosthesis wherein the frame is elastically deformable (Fig. 1, asymmetrical ring 1 moves with the natural distortion of the heart during the cardiac cycle [0009]). Kofidis discloses that the asymmetrical ring mimics the shape of the natural mitral valve and is configured to coapt with the movement of the heart cycles [0009-0010]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Chau with the frame taught by Kofidis in order to create a more fitted and adaptable prosthesis.
Regarding claim 10, Chau fails to teach the limitations of claim 10. Kofidis teaches a mitral valve prosthesis wherein the frame (Fig. 1, asymmetrical ring 1) is configured to bias the wings of the pair away from each other (Fig. 16B, leaflets 1202A and 1202P curve away from each other when nearing ring at the top of the prosthesis). Kofidis discloses that the asymmetrical ring mimics the shape of the natural mitral valve and is configured to coapt with the movement of the heart cycles [0009-0010]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Chau with the frame taught by Kofidis in order to create a more fitted and adaptable prosthesis.
Regarding claim 11, Chau fails to teach the limitations of claim 11. Kofidis teaches a mitral valve prosthesis wherein the frame (Fig. 1, asymmetrical ring 1) is sufficiently flexible that the wings of the pair can be pushed into contact with each other by a total converging force of less than 30 g (Fig. 9A-B, leaflets are able to withstand the pressure applied onto the posterior leaflet during systole phase [0108] (i.e., systolic blood pressure is equivalent to 120 mmHg which equals 163 g/cm2 and diastolic blood pressure is equivalent to 80 mmHg which equals 109 g/cm2 (see https://www.ncbi.nlm.nih.gov/books/NBK482408/))). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a converging force of less than 30 g, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable range involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either design, these modifications are a matter of design choice. Absent a teaching as to criticality of converging force, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 12, Chau fails to teach the limitations of claim 11. Kofidis teaches a mitral valve prosthesis wherein the frame (Fig. 1, asymmetrical ring 1) is sufficiently flexible that the wings of the pair can be pushed into contact with each other by a total converging force of less than 20 g (Fig. 9A-B, leaflets are able to withstand the pressure applied onto the posterior leaflet during systole phase [0108] (i.e., systolic blood pressure is equivalent to 120 mmHg which equals 163 g/cm2 and diastolic blood pressure is equivalent to 80 mmHg which equals 109 g/cm2 (see https://www.ncbi.nlm.nih.gov/books/NBK482408/))). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a converging force of less than 30 g, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable range involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either design, these modifications are a matter of design choice. Absent a teaching as to criticality of converging force, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 13, Chau fails to teach the limitations of claim 11. Kofidis teaches a mitral valve prosthesis wherein the frame (Fig. 1, asymmetrical ring 1) is sufficiently flexible that the wings of the pair can be pushed into contact with each other by a total converging force of less than 10 g (Fig. 9A-B, leaflets are able to withstand the pressure applied onto the posterior leaflet during systole phase [0108] (i.e., systolic blood pressure is equivalent to 120 mmHg which equals 163 g/cm2 and diastolic blood pressure is equivalent to 80 mmHg which equals 109 g/cm2 (see https://www.ncbi.nlm.nih.gov/books/NBK482408/))). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a converging force of less than 30 g, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable range involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either design, these modifications are a matter of design choice. Absent a teaching as to criticality of converging force, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 14, Chau fails to teach the limitations of claim 11. Kofidis teaches a mitral valve prosthesis wherein the frame (Fig. 1, asymmetrical ring 1) is sufficiently flexible that the wings of the pair can be pushed into contact with each other by a total converging force of less than 0.1-10 g (Fig. 9A-B, leaflets are able to withstand the pressure applied onto the posterior leaflet during systole phase [0108] (i.e., systolic blood pressure is equivalent to 120 mmHg which equals 163 g/cm2 and diastolic blood pressure is equivalent to 80 mmHg which equals 109 g/cm2 (see https://www.ncbi.nlm.nih.gov/books/NBK482408/))). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a converging force of less than 30 g, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable range involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either design, these modifications are a matter of design choice. Absent a teaching as to criticality of converging force, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 15, Chau fails to teach the limitations of claim 11. Kofidis teaches a mitral valve prosthesis wherein the frame (Fig. 1, asymmetrical ring 1) is sufficiently flexible that the wings of the pair can be pushed into contact with each other by a total converging force of less than 1-10 g (Fig. 9A-B, leaflets are able to withstand the pressure applied onto the posterior leaflet during systole phase [0108] (i.e., systolic blood pressure is equivalent to 120 mmHg which equals 163 g/cm2 and diastolic blood pressure is equivalent to 80 mmHg which equals 109 g/cm2 (see https://www.ncbi.nlm.nih.gov/books/NBK482408/))). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a converging force of less than 30 g, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable range involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either design, these modifications are a matter of design choice. Absent a teaching as to criticality of converging force, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 16, Chau fails to teach the limitations of claim 11. Kofidis teaches a mitral valve prosthesis wherein the frame (Fig. 1, asymmetrical ring 1) is sufficiently flexible that the wings of the pair can be pushed into contact with each other by a total converging force of less than 5 g (Fig. 9A-B, leaflets are able to withstand the pressure applied onto the posterior leaflet during systole phase [0108] (i.e., systolic blood pressure is equivalent to 120 mmHg which equals 163 g/cm2 and diastolic blood pressure is equivalent to 80 mmHg which equals 109 g/cm2 (see https://www.ncbi.nlm.nih.gov/books/NBK482408/))). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a converging force of less than 30 g, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable range involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either design, these modifications are a matter of design choice. Absent a teaching as to criticality of converging force, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 17, Chau fails to teach the limitations of claim 17. Kofidis teaches a mitral valve prosthesis wherein each wing of the pair comprises an integrin-binding ligand (Fig. 16B, the material which forms the leaflets and valve ring is a natural polymer such as collagen [0070]). Kofidis discloses that the use of natural material in the implant, such as collagen, avoids the inclusion of foreign material [0070]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Chau with the wings comprising an integrin-binging ligand as taught by Kofidis in order to avoid rejection of the implant by the body.
Regarding claim 18, Chau fails to teach the limitations of claim 17. Kofidis teaches a mitral valve prosthesis wherein each wing of the pair comprises at least one of fibronectin, vitronectin, collagen, and laminin (Fig. 16B, the material which forms the leaflets and valve ring is a natural polymer such as collagen [0070]). Kofidis discloses that the use of natural material in the implant, such as collagen, avoids the inclusion of foreign material [0070]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Chau with the wings comprising an integrin-binging ligand as taught by Kofidis in order to avoid rejection of the implant by the body.
Regarding claim 19, Chau teaches wherein the wing comprises a material that is impermeable to blood (Fig. 8, the device 300 comprises a strong, flexible sheet of blood-impermeable material [0102]) but fails to teach a pair of wings.
Kofidis teaches a mitral valve prosthesis comprising a pair of wings (Fig. 16A, anterior leaflet 1202A and posterior leaflet 1202P). Kofidis discloses that the mitral valve prosthesis conforms in relation to diastolic and systolic phases of the heart and may comprise extension portions to provide enough leaflet to ensure closure of the valve in order to disable backflow of blood in chambers of the heart [0125]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Chau with the pair of wings and diastolic and systolic movement of said wings as taught by Kofidis to prevent leakage or backflow of blood from the ventricle to the atrium.
Regarding claim 20, Chau fails to teach the limitations of claim 20. Kofidis teaches a mitral valve prosthesis teaches wherein each wing of the pair comprises pericardial tissue (Fig. 16B, material which forms the valve ring and leaflets includes human, bovine, or porcine pericardium [0070]). Kofidis discloses that the use of natural material in the implant, such as pericardium, avoids the inclusion of foreign material [0070]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Chau with the wings comprising an integrin-binging ligand as taught by Kofidis in order to avoid rejection of the implant by the body.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Chau et al. (US 2015/0230919 A1), “Chau” in view of Kofidis (US 2019/0321168 A1), “Kofidis”, and further in view of Subramanian et al. (US 2020/0276017 A1), “Subramanian”.
Regarding claim 21, Chau fails to teach the limitations of claim 21. Kofidis teaches a mitral valve prosthesis comprising a pair of wings (Fig. 16A, anterior leaflet 1202A and posterior leaflet 1202P). Kofidis discloses that the mitral valve prosthesis conforms in relation to diastolic and systolic phases of the heart and may comprise extension portions to provide enough leaflet to ensure closure of the valve in order to disable backflow of blood in chambers of the heart [0125]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Chau with the pair of wings and diastolic and systolic movement of said wings as taught by Kofidis to prevent leakage or backflow of blood from the ventricle to the atrium. However, Chau in view of Kofidis fails to teach a fabric.
Subramanian teaches transvalvular bridge comprising a fabric (Fig. 57A, transvalvular bridge 500 comprises layers 515 of velour material such as polyester double velour fabric [0269]). Subramanian discloses that the material promotes tissue ingrowth [0269]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the system taught by Chau with the wings taught by Kofidis and the fabric taught by Subramanian in order to promote biointegration of the device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. WO 2020/148755 A1, US 2018/0036119 A1, US 2016/0030176 A1, US 2015/0112433 A1, and US 2008/0125861 A1.
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/G.G.R./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799