Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1-2, 8 and 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Benichou (US Pub No.: 2011/0218619) in view of Alkhatib (US Pub No.: 2016/0030170).
Regarding claim 1, Benichou (US Pub No.: 2011/0218619) teaches a prosthetic heart valve for implantation (figure 1 part 100, also shown in figure 4 as part 400 shows a heart valve, with implanting in the abstract) within a native atrioventricular heart valve between an atrium and a ventricle of a heart (implanting of a heart valve and a method thereof in the abstract. As the valve is delivered to a native valve site in the abstract, the prosthetic heart valve would be implanted within a native heart valve. Ventricle in [0092]. While a “suitable location, such as to the abdominal aorta” is disclosed in [0110], the “such as” does not limit the device to only the aorta), the prosthetic heart valve comprising: a self-expanding frame (expanding of the valve disclosed in [0118] with a self-expanding frame disclosed in [0073]) having an annular main body (the stent portion 904 in figures 9-10, detailed in [0105]-[0106]), wherein the main body comprises a plurality of metal struts (struts shown in annotated figure 1 that are depicted as being in a lattice pattern. As per annotated figure 1 and figure 28, the leaflet support frame 113 is shown to be radially outward of 108, to which the struts are located in as per annotated figure 1); a valve member disposed within the main body (the valve portion 910 in figures 9-10, detailed in [0106]); an atrial sealing member (being the sealing member 126 shown in figure 28 and in [0074]) formed by an atrial fabric cover (sealing via a skirt comprising a fabric in [0082]) and a plurality of atrial arms that are arranged side-by-side in a circumferential direction around the main body (parts 2606 and 2608 in figure 26) wherein the atrial fabric cover extends over the atrial arms and spans gaps between adjacent ones of the atrial arms (the fabric sleeve, being part 126 in annotated figure 1 above and figure 28, also disclosed in [0074] and [0082] and claimed in claim 11 of Benichou. Part 126 is shown to cover the main body of the device of Benichou in figure 28. Part 126 is also disclosed as being able to extend over an entire outer surface in [0082] which would have to include the arms of figure 26), wherein, in a deployed state of the atrial sealing member, the atrial sealing member extends radially outwardly from the main body (in figures 9-10 and [0105]) and one or more ventricular anchors extending from the main body (being the anchors in [0074]-[0075]),wherein the one or more ventricular anchors are sized and shaped to capture native leaflet tissue of the native atrioventricular heart valve between a respective one of the ventricular anchors and at least one of the main body or the atrial sealing member (as the anchor is used to fix the replacement valve into a patient’s native valve in [0083], the anchor captures native leaflet tissue between the anchor of the device of Benichou).
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Annotated Figure 1
Benichou does not teach and a peripheral portion of the atrial sealing member curves upwardly and away from the main body such that an outer circumferential edge of the atrial sealing member is oriented in an atrial direction;
Instead, Alkhatib (US Pub No.: 2016/0030170) teaches that a peripheral portion of the atrial sealing member curves upwardly and away from the main body such that an outer circumferential edge of the atrial sealing member is oriented in an atrial direction (in figure 3B and [0048]-[0049], sealing portion 322 comprises legs 320 that curve upward and orient themselves in an atrial direction if said members are implemented on Benichou). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the curved sealing member of Alkhatib into Benichou for the purpose of providing a means to mitigate perivalvular leakage (in [0045]) with Alkhatib teaching that part 322 can be extended and relaxed in [0049].
Regarding claim 2, Benichou in view of Alkhatib teach the prosthetic heart valve of claim 1, wherein Benichou discloses the atrial fabric cover includes a lower layer that covers lower surfaces of the atrial arms (in figures 9-10 and [0105], the fabric being part 902 in Benichou), a folded portion that covers tips of the atrial arms, and an upper layer that covers at least a portion of upper surfaces of the atrial arms (part 126 of Benichou is shown to cover the main body of the device of Benichou in figure 28. Part 126 is also disclosed as being able to extend over an entire outer surface in [0082]. Said fabric can be configured like the fabric sealing member 140 and sleeve 146 of Morriss (in [0155] and figure 10A) to fold and cover up the arms of Morriss shown in figure 10C as parts 114 and 120).
Regarding claim 8, Benichou in view of Alkhatib teach the prosthetic heart valve of claim 1, wherein Benichou discloses the one or more ventricular anchors comprise first and second U-shaped anchors each formed from a single wire (the lower portion 108 in figure 3 of Benichou teach an anchor that is U-shaped).
Regarding claim 17, Benichou in view of Morriss and Alkhatib teach the prosthetic heart valve of claim 15. Benichou does not teach wherein a peripheral portion of the atrial sealing member curves upwardly and away from the main body such that an outer circumferential edge of the atrial sealing member oriented in an atrial direction.
Instead, Alkhatib (US Pub No.: 2016/0030170) teaches that a peripheral portion of the atrial sealing member curves upwardly and away from the main body such that an outer circumferential edge of the atrial sealing member is oriented in an atrial direction (in figure 3B and [0048]-[0049], sealing portion 322 comprises legs 320 that curve upward and orient themselves in an atrial direction if said members are implemented on Benichou).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the curved sealing member of Alkhatib into Benichou for the purpose of providing a means to mitigate perivalvular leakage (in [0045]) with Alkhatib teaching that part 322 can be extended and relaxed in [0049].
Claim 3-4, 6-7, 9-14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Benichou (US Pub No.: 2011/0218619) in view of and Alkhatib (US Pub No.: 2016/0030170) in further view of Morriss (US Pub No.: 2015/0351903).
Regarding claim 3, Benichou in view of Alkhatib teach the prosthetic heart valve of claim 1, wherein Morriss teaches that each of the one or more ventricular anchors comprises a ventricular anchor cover (part 140 in [0155] of Morriss, shown in figure 10A), wherein the ventricular anchor cover comprises a padding material configured to cushion the native leaflet tissue in a contact region with the ventricular anchor (the materials in [0155] provide a padding, where part 140 is between the anchor and the native leaflet in Morriss).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the ribbed part 114 of Morriss into Benichou for the purpose of providing expandable, flexible ribs that engage a surface near a native valve to hold the device in place, as per [0115]-[0116] of Morriss.
Regarding claim 4, Benichou in view of Alkhatib teach the prosthetic heart valve of claim 1, wherein Morriss teaches the plurality of atrial arms comprises a plurality of atrial loops (plurality of loops shown in figure 10C of Morriss).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the ribbed part 114 of Morriss into Benichou for the purpose of providing flexible ribs that engage a surface near a native valve to hold the device in place, as per [0115]-[0116] of Morriss. Said atrial arms of Morriss are attached to the end of the frame of Benichou like shown in figures 28A-B of Morriss.
Regarding claim 6, Benichou in view of Alkhatib and Morriss teach the prosthetic heart valve of claim 4, wherein Morriss teaches each of the atrial loops has first and second opposing side portions (ends 116 and 117 shown in figure 10C) connected to each other at a curved tip portion (being the curved portion of part 112 in figure 10C) and to respective side portions of two adjacent atrial loops (as parts 112 with 116 and 117 are all interconnected about parts 120, said curved and side portions are connected to other curved and side portions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the ribbed part 114 of Morriss into Benichou for the purpose of providing flexible ribs that engage a surface near a native valve to hold the device in place, as per [0115]-[0116] of Morriss. Said atrial arms of Morriss are attached to the end of the frame of Benichou like shown in figures 28A-B of Morriss.
Regarding claim 7, Benichou in view of Alkhatib and Morriss teach the prosthetic heart valve of claim 4, wherein Morriss teaches the plurality of atrial loops is formed from a single piece of metallic material (metallic material disclosed in [0117]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the ribbed part 114 of Morriss into Benichou for the purpose of providing flexible ribs that engage a surface near a native valve to hold the device in place, as per [0115]-[0116] of Morriss. Said atrial arms of Morriss are attached to the end of the frame of Benichou, shown in figures 28A-B of Morriss.
Regarding claim 9, Benichou in view of Alkhatib and Morriss teach the prosthetic heart valve of claim 1, wherein Morriss teaches the plurality of atrial arms includes exactly twelve atrial arms (12 arms shown in figure 10C of Morriss). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the ribbed part 114 of Morriss into Benichou for the purpose of providing flexible ribs that engage a surface near a native valve to hold the device in place, as per [0115]-[0116] of Morriss. Said atrial arms of Morriss are attached to the end of the frame of Benichou like shown in figures 28A-B of Morriss.
Regarding claim 10, Benichou in view of Alkhatib and Morriss teach the prosthetic heart valve of claim 1, wherein Morriss teaches each of the plurality of atrial arms is independently flexible or bendable relative to of others of the atrial arms (as part 120 is made of a flexible material in [0120] with flexible ribs 114 defined in [0116], it stands to reason that each arm is flexible, where a bending of one rib is not disclosed to cause a bending in another rib directly).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the ribbed part 114 of Morriss into Benichou for the purpose of providing flexible ribs that engage a surface near a native valve to hold the device in place, as per [0115]-[0116] of Morriss. Said atrial arms of Morriss are attached to the end of the frame of Benichou like shown in figures 28A-B of Morriss.
Regarding claim 11, Benichou in view of Alkhatib and Morriss teach the prosthetic heart valve of claim 1, wherein Morriss teaches the plurality of atrial arms comprises a plurality of serpentine atrial arms (the arms in figure 10C are serpentine as per the curved shape of parts 114). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the ribbed part 114 of Morriss into Benichou for the purpose of providing flexible ribs that engage a surface near a native valve to hold the device in place, as per [0115]-[0116] of Morriss. Said atrial arms of Morriss are attached to the end of the frame of Benichou like shown in figures 28A-B of Morriss.
Regarding claim 12, Benichou in view of Alkhatib and Morriss teach the 12. The prosthetic heart valve of claim 11, wherein Morriss teaches each of the serpentine atrial arms comprises a plurality of parallel segments interconnected by a plurality of curved segments (being parts 120 and 114 respectively in Morriss). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the ribbed part 114 of Morriss into Benichou for the purpose of providing flexible ribs that engage a surface near a native valve to hold the device in place, as per [0115]-[0116] of Morriss. Said atrial arms of Morriss are attached to the end of the frame of Benichou, shown in figures 28A-B of Morriss.
Regarding claim 13, Benichou in view of Alkhatib and Morriss teach the prosthetic heart valve of claim 1, wherein Morriss teaches each of the plurality of atrial arms includes a first end portion that is attached to the main body at a junction between two of the metal struts (the bottommost end of part 120). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the ribbed part 114 of Morriss into Benichou for the purpose of providing flexible ribs that engage a surface near a native valve to hold the device in place, as per [0115]-[0116] of Morriss. Said atrial arms of Morriss are attached to the end of the frame of Benichou like shown in figures 28A-B of Morriss.
Regarding claim 14, Benichou in view of Alkhatib and Morriss teach the prosthetic valve of claim 13, wherein Morriss teaches each of the plurality of atrial arms includes a second end portion opposing the first end portion (the portions 117 and 116 in figure 10C of Morriss are depicted as opposing each other), wherein the second end portion is a terminal, distal end of the respective atrial arm (being the bottom end of part 116 where the U-shaped portion attaches to part 120), and wherein a central portion of the respective atrial arm extends between the first end portion and the second end portion (being part 112 in figure 10C), wherein the second end portion comprises a head portion having a greater width than the central portion (the thickness of the bend of 116 is larger than the thickness about the part 112) and having an aperture extending therethrough (being the opening toward the bottom of part 116).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the ribbed part 114 of Morriss into Benichou for the purpose of providing flexible ribs that engage a surface near a native valve to hold the device in place, as per [0115]-[0116] of Morriss. Said atrial arms of Morriss are attached to the end of the frame of Benichou like shown in figures 28A-B of Morriss.
Claim 5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Benichou (US Pub No.: 2011/0218619) in view of Alkhatib (US Pub No.: 2016/0030170) and Morriss (US Pub No.: 2015/0351903) and in further view of Lashinski (US Pub No.: 2006/0020327).
Regarding claim 5, Benichou in view of Morriss and Alkhatib teach the prosthetic heart valve of claim 4. However, Benichou does not teach wherein each of the atrial loops is connected to the main body with sutures.
Instead, Lashinski (US Pub No.: 2006/0020327) teaches wherein each of the atrial loops is connected to the main body with sutures (sutures to attach an anchor to a cuff in [0243], where said sutures are incorporated into Morriss).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the sutures of Lashinski into the combination involving Morriss for the purpose of providing an attachment means for the anchors not defined in Morriss, where the anchor and suture combination of Lashinski provides mechanism that prevents a disengagement in [0243].
Claim 15-16 and 18-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Benichou (US Pub No.: 2011/0218619) in view of Morriss (US Pub No.: 2015/0351903).
Regarding claim 15, Benichou teaches a prosthetic heart valve for implantation (figure 1 part 100, also shown in figure 4 as part 400 shows a heart valve, with implanting in the abstract) within a native atrioventricular heart valve between an atrium and a ventricle of a heart (implanting of a heart valve and a method thereof in the abstract. As the valve is delivered to a native valve site in the abstract, the prosthetic heart valve would be implanted within a native heart valve), the prosthetic heart valve comprising: a self-expanding frame (expanding of the valve disclosed in [0118] with a self-expanding frame disclosed in [0073]) having an annular main body (the stent portion 904 in figures 9-10, detailed in [0105]-[0106]), wherein the main body comprises a plurality of metal struts (struts shown in annotated figure 1 that are depicted as being in a lattice pattern. As per annotated figure 1 and figure 28, the leaflet support frame 113 is shown to be radially outward of 108, to which the struts are located in as per annotated figure 1); a valve member disposed within the main body (the valve portion 910 in figures 9-10, detailed in [0106]); and an atrial sealing member (being the sealing member 126 shown in figure 28 and in [0074]) formed by an atrial fabric cover (sealing via a skirt comprising a fabric in [0082]) wherein the atrial fabric cover extends over the serpentine atrial arms and spans gaps between adjacent ones of the serpentine atrial arms (the fabric sleeve, being part 126 in annotated figure 1 above and figure 28, also disclosed in [0074] and [0082] and claimed in claim 11 of Benichou. Part 126 is shown to cover the main body of the device of Benichou in figure 28. Part 126 is also disclosed as being able to extend over an entire outer surface in [0082]), and wherein, in a deployed state of the atrial sealing member, the atrial sealing member extends radially outwardly from the main body (in figures 9-10 and [0105]).
Benichou does not teach a plurality of serpentine atrial arms that are arranged side-by-side in a circumferential direction around the main body, wherein each of the serpentine atrial arms comprises a plurality of parallel segments interconnected by a plurality of curved segments.
Instead, Morriss (US Pub No.: 2015/0351903) teaches a plurality of serpentine atrial arms that are arranged side-by-side in a circumferential direction around the main body (in figure 10C and [0115]-[0116], with the ribs being part 114 in figures 10C and 10D. As the arms are bent in a rounded fashion, forming a C or U shape, a serpentine shape is present), wherein each of the serpentine atrial arms comprises a plurality of parallel segments interconnected by a plurality of curved segments (shown in figure 10C, where part 112 is the curved portion and the vertical part 120 that extend across H1 are the parallel segments). Said atrial arms of Morriss are attached to the end of the frame of Benichou like shown in figures 28A-B of Morriss.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the ribbed part 114 of Morriss into Benichou for the purpose of providing expandable, flexible ribs that engage a surface near a native valve to hold the device in place, as per [0115]-[0116] of Morriss.
Regarding claim 16, Benichou in view of Morriss teach the prosthetic heart valve of claim 15, wherein Morriss teaches that each of the serpentine atrial arms is independently flexible or bendable relative to others of the serpentine atrial arms (as part 120 is made of a flexible material in [0120] with flexible ribs 114 defined in [0116], it stands to reason that each arm is flexible, where a bending of one rib is not disclosed to cause a bending in another rib directly), and wherein each of the serpentine atrial arms comprises: a first end portion that is attached to the main body at a junction between two of the metal struts (the bottommost end of part 120); a second end portion opposing the first end portion, wherein the second end portion is a terminal, distal end of the respective atrial arm (the portions 117 and 116 in figure 10C of Morriss are depicted as opposing a first end portion); and a central portion extending between the first end portion and the second end portion (being part 112 in figure 10C), wherein the second end portion has a greater width than the central portion (being the opening toward the bottom of part 116). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the ribbed part 114 of Morriss into Benichou for the purpose of providing expandable, flexible ribs that engage a surface near a native valve to hold the device in place, as per [0115]-[0116] of Morriss. Said atrial arms of Morriss are attached to the end of the frame of Benichou like shown in figures 28A-B of Morriss.
Regarding claim 18, Benichou in view of Morriss teach prosthetic heart valve of claim 15, with Benichou further comprising one or more ventricular anchors extending from the main body (being the anchors in [0074]-[0075]), wherein the one or more ventricular anchors are sized and shaped to capture native leaflet tissue of the native atrioventricular heart valve between a respective one of the ventricular anchors and at least one of the main body or the atrial sealing member (as the anchor is used to fix the replacement valve into a patient’s native valve in [0083], the anchor captures native leaflet tissue between the anchor of the device of Benichou).
Regarding claim 19, Benichou discloses a self-expanding prosthetic heart valve for implantation (figure 1 part 100, also shown in figure 4 as part 400 shows a heart valve, with implanting in the abstract, a self-expanding frame disclosed in [0073]) within a native atrioventricular heart valve between an atrium and a ventricle of a heart(implanting of a heart valve and a method thereof in the abstract. As the valve is delivered to a native valve site in the abstract, the prosthetic heart valve would be implanted within a native heart valve), the prosthetic heart valve comprising: a frame having an annular main body (self-expanding frame disclosed in [0073], annular body in figures including annotated figure 1 above), wherein the main body comprises a plurality of metal struts (struts shown in annotated figure 1 that are depicted as being in a lattice pattern. As per annotated figure 1 and figure 28, the leaflet support frame 113 is shown to be radially outward of 108, to which the struts are located in as per annotated figure 1); a valve member disposed within the main body (the valve portion 910 in figures 9-10, detailed in [0106]); wherein the one or more ventricular anchors are configured to be deployed from the radially compressed state into a leaflet capture configuration to capture native leaflet tissue of the native atrioventricular heart valve (as the anchor is used to fix the replacement valve into a patient’s native valve in [0083], the anchor captures native leaflet tissue between the anchor of the device of Benichou. As the entire device is radially expanded after delivery in [0073], a radial expansion of the anchors occurs after implantation); an atrial sealing member (being the sealing member 126 shown in figure 28 and in [0074]) wherein the self-expanding prosthetic heart valve is configured to be radially compressed into a radially compressed state for delivery to the native atrioventricular heart valve (in [0010] and [0032] of Benichou); wherein the atrial sealing member is configured to be deployed from the radially compressed state into a radially extending and atrially curved configuration (as the device is self-expandable in [0110]), wherein, in the radially extending and atrially curved configuration, the atrial sealing member extends radially outwardly from the main body and a peripheral portion of the atrial sealing member curves in an atrial direction (as a bending of the device is disclosed in [0125], and wherein the main body is configured to be deployed from the radially compressed state to a radially expanded state to cause retention of the native leaflet tissue between a respective one of the ventricular anchors and at least one of the main body or the atrial sealing member (as the anchor is used to fix the replacement valve into a patient’s native valve in [0083], the anchor captures native leaflet tissue between the anchor of the device of Benichou).
Benichou does not teach comprising a plurality of atrial arms that are arranged side-by-side in a circumferential direction around the main body and a fabric cover extending over the atrial arms; and one or more ventricular anchors extending from the main body toward an inlet portion of the prosthetic heart valve.
Instead, Morris teaches a plurality of atrial arms that are arranged side-by-side in a circumferential direction around the main body (shown in figure 10C with parts 114 and 120) and a fabric cover extending over the atrial arms (the fabric cover of Benichou can cover the atrial arms of Morriss as part 126 of Benichou is also disclosed as being able to extend over an entire outer surface in [0082]); and one or more ventricular anchors extending from the main body toward an inlet portion of the prosthetic heart valve; wherein the peripheral portion is configured to be seated with the atrium (atrium placement in [0088]-[0090], where a preventing of leakage between a left ventricle to a left atrium implies a partial placement of the device in an atrium).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the ribbed part 114 of Morriss into Benichou for the purpose of providing expandable, flexible ribs that engage a surface near a native valve to hold the device in place, as per [0115]-[0116] of Morriss. Said atrial arms of Morriss are attached to the end of the frame of Benichou like shown in figures 28A-B of Morriss.
Regarding claim 20, Benichou in view of Morriss teach prosthetic heart valve of claim 19, wherein Benichou teaches the prosthetic heart valve is configured for sequential deployment of the ventricular anchors, the atrial sealing member, and the main body (as the device of Benichou is implanted into a patient via a delivery system in [0025] and a catheter in [0070], examiner argues that the device and parts Benichou with the modifications of Morriss is deployed in a sequence).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Alkhatib (US Pub No.: 2010/0249911) discloses a metal frame for an annular ring in [0031]. Morriss (US Pub No.: 2013/0310928) discloses a heart valve with incision details in [0224].
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/AREN PATEL/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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