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 Arguments
Applicant’s arguments with respect to the 35 U.S.C. § 102 and 103 rejections of claim(s) 18-39 have been considered but are moot in view of the new grounds for rejection.
Applicant has amended claim to recite “teaches wherein the inflow edge is rotatable relative to the outflow edge.” In response to Applicant’s amendment Examiner has added reference Kovalsky (US Pub No.: 2014/0222142), with Morin (US Pub No.: 2015/0327995) also relied upon in dependent claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 18 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. While a rotation of a ring part 532 with respect to an outflow portion 520 and an inflow end 506 is present in [0096], examiner notes that an edge is not defined. While an inflow and outflow parts are present, an “inflow edge” and “outflow edge” are not recited in the specification.
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.
Claim(s) 18-22, 25, and 29-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Accola (US Pub No.: 2013/0261741) in view of Kovalsky (US Pub No.: 2014/0222142).
Regarding claim 18, Accola (US Pub No.: 2013/0261741) discloses a heart valve prosthesis comprising: a frame (being the device shown in figure 2, shown in annotated figure 1 below), wherein the frame is radially compressible and radially expandable (radial expansion disclosed in [0022], where radial expansion implies radial compression. Compression of valve in [0060]), the frame comprising: an inflow rim defining an inflow edge of the frame; and an outflow portion defining an outflow edge of the frame (shown in annotated figure 1 below. The bottommost part of the inflow portion and the topmost part of the outflow portion define an edge), wherein the inflow rim flares radially outward from the outflow portion (shown in annotated figure 1 below where the inflow rim flares outward); and a prosthetic heart valve coupled to an inner surface of the outflow portion of the frame (in [0032], as the heart valve is surrounded by support members, the valve is coupled to an inner portion of the outflow portion), wherein the inflow rim is rotatable relative to the outflow portion of the frame (disclosed in [0023] and [0038]).
However, Accola does not teach an instance such that the inflow edge is rotatable relative to the outflow edge
Instead, Kovalsky (US Pub No.: 2014/0222142) teaches wherein the inflow edge is rotatable relative to the outflow edge (in [0108]).
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 rotatable frame details of Kovalsky into Acola for the purpose of providing a means to adjust the shape of the frame of Acola. Examiner notes that Kovalsky teaches a rotation as a part of a processing of a device.
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Annotated Figure 1
Regarding claim 19, Accola in view of Kovalsky teach the heart valve prosthesis of 18, with Accola further comprising barbs extending from the inflow rim (shown in annotated figure 1 above), wherein the barbs are configured to engage tissue by rotation of the inflow rim relative to the outflow portion in situ (fasteners on the assembly ring in [0023] that engage a tissue, fasteners are barbs as per claim 5 of Accola).
Regarding claim 20, Accola in view of Kovalsky teach the heart valve prosthesis of claim 19, wherein Accola discloses the barbs extend from a downstream surface of the inflow rim (shown in annotated figure 1).
Regarding claim 21, Accola in view of Kovalsky teach the heart valve prosthesis of claim 19, wherein Accola discloses the barbs extend circumferentially (shown in annotated figure 1) such that rotation thereof causes the barbs to engage tissue (as fasteners are on the assembly ring in [0023] that engage a tissue, a rotation will cause the barbs to engage a tissue).
Regarding claim 22, Accola in view of Kovalsky teach the heart valve prosthesis of claim 17, wherein Accola discloses the inflow rim is rotatably coupled to the outflow portion at a joint (being the pivot points 105, and 119, pivot points disclosed in [0035]. A pivot point is also assumed to be at part 107 as per figure 3).
Regarding claim 25, Accola in view of Kovalsky teach the heart valve prosthesis of claim 22, wherein Accola discloses the joint is configured to enable rotation between the inflow rim and the outflow portion (rotation of an annular ring between the inflow and outflow portion in [0023]), but not longitudinal separation of the inflow rim and the outflow portion (no separation between the inflow rim and outflow portion is disclosed).
Regarding claim 29, Accola in view of Kovalsky teach the heart valve prosthesis of claim 17, with Accola further comprising a plurality of arms coupled to the outflow portion of the frame (being the being the linkers 114, 116, and 123 in figure 3 and [0035]-[0036], where part 123 and 120 in figure 3 are also depicted as linkers).
Regarding claim 30, Accola in view of Kovalsky teach the heart valve prosthesis of claim 29, wherein Accola discloses the plurality of arms are coupled to an outflow end of the outflow portion (shown in figure 3 where parts 114, 116, 123 (disclosed as linkers in [0036] and part 124 in figure 3 are coupled to the outflow portion at parts 104 and 106).
Regarding claim 31, Accola in view of Kovalsky teach the heart valve prosthesis of claim 30, wherein Accola discloses the plurality of arms are configured to capture native leaflets of a native heart valve between the plurality of arms and the outflow portion of the frame (as per the arrangement of figure 3, the arms disclosed in figure 3 and [0036] will interface with the leaflets and valve portions of the device).
Regarding claim 32, Accola in view of Kovalsky teach the heart valve prosthesis of claim 30, wherein Accola discloses the arms extend longitudinally away from the outflow end of outflow portion (shown in figure 3, where the top part 106 is toward the outflow end) with the frame in a radially compressed configuration (as parts 104 and 106 expand in the body, the interfacing between the arms and parts 104 and 106 will be when they are compressed as the arms are used for an implanting of the device. The arms are used in a linkage device used for deployment of a heart valve in [0028]), and are configured to fold back to extend towards the inflow rim in a radially expanded configuration of the frame (folding toward an inflow rim shown in figure 3, inflow rim is about part 104, with 104 shown in figures 1 and 3).
Claim(s) 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Accola (US Pub No.: 2013/0261741) in view of Kovalsky (US Pub No.: 2014/0222142) in further view of Flaction (US Pub No.: 2018/0263765).
Regarding claim 23, Accola in view of Kovalsky teach the heart valve prosthesis of claim 22, wherein the joint is a flexible material.
Instead, Flaction (US Pub No.: 2018/0263765) discloses wherein the joint is a flexible material (in [0021] and [0031], a joint made of fabric or fibers is present). 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 material for a valve joint as presented in Flaction for the purpose of providing a joint that provides a reliable fastening between a valve and something else (fastening to a film in [0021]) with the fabric (with a polymeric material in [0037]) allowing for a recapture and reshaping of the device in [0037].
Regarding claim 24, Accola in view of Kovalsky and Flaction teach the heart valve prosthesis of claim 23, wherein the flexible material is a fabric material. However, Accola does not teach wherein the flexible material is a fabric material(in [0021] and [0031]). 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 material for a valve joint as presented in Flaction for the purpose of providing a joint that provides a reliable fastening between a valve and something else (fastening to a film in [0021]) with the fabric (with a polymeric material in [0037]) allowing for a recapture and reshaping of the device in [0037].
Claim(s) 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Accola (US Pub No.: 2013/0261741) in view of Kovalsky (US Pub No.: 2014/0222142) in further view of Salahieh (US Pub No.: 2007/0244552).
Regarding claim 26, Accola in view of Kovalsky teach the heart valve prosthesis of claim 22, wherein Accola discloses the joint comprises a groove in one of the inflow rim or the outflow portion (being the indentation at parts 105 and 119). However, Accola does not teach and a lip in the other of the inflow rim or the outflow portion (shown visually in figure 3 where a rim is the wall parts of part 104 and 106 present about parts 105 and 119), wherein the lip is disposed in the groove to enable rotation and restrain longitudinal movement of the inflow rim and the outflow portion relative to each other (the lips extend within the groove parts 119 and 104 to which parts 114 and 116 extend within).
Instead, Salahieh teaches a lip in the other of the inflow rim or the outflow portion (lip disclosed in [0155]), wherein the lip is disposed in the groove to enable rotation and restrain longitudinal movement of the inflow rim and the outflow portion relative to each other (the lip part 560 may be “dynamically repositioned until it properly engages the valve leaflets) in [0171] with a rotation in [0178]. A restraining of longitudinal movement is also implied as the lip doubles over the groove section in [0155] and shown in figures 39A and 41A). 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 lip and groove arrangement of Salahieh into Accola to which the lip will be about the outflow portion of Accola for the purpose of providing a portion on an outflow portion that will have locking elements to lock with a valve portion, as disclosed in [0092] and shown in figure 41A.
Regarding claim 27, Accola in view of Kovalsky teach the heart valve prosthesis of claim 22. However, Accola does not teach wherein the joint comprises a tubular portion of the inflow rim extending towards outflow portion, a lip of the tubular portion, and a groove disposed at an inflow end of the outflow portion, wherein the lip is disposed in the groove to enable relative rotation between the inflow rim and the outflow portion.
Instead, Salahieh (US Pub No.: 2007/0244552) discloses wherein the joint (the bending sections shown in figures 39A-39B, detailed in [0155]) comprises a tubular portion of the inflow rim extending towards outflow portion (figure 39B forms a tubular portion, shown in figures 41A-41B), a lip of the tubular portion (lip disclosed in [0155]), and a groove disposed at an inflow end of the outflow portion (shown in figure 41A and in [0155]), wherein the lip is disposed in the groove (in figure 41A) to enable relative rotation between the inflow rim and the outflow portion (the lip part 560 may be “dynamically repositioned until it properly engages the valve leaflets) in [0171] with a rotation in [0178]). 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 lip and groove arrangement of Salahieh into Accola to which the lip will be about the outflow portion of Accola for the purpose of providing a portion on an outflow portion that will have locking elements to lock with a valve portion, as disclosed in [0092] and shown in figure 41A.
Regarding claim 28, Accola in view of Kovalsky and Salahieh teaches the heart valve prosthesis of claim 27. However, Accola does not teach wherein the lip extends radially inward from the tubular portion of the inflow rim.
Instead, Salahieh teaches wherein the lip extends radially inward from the tubular portion of the inflow rim (shown in figure 41A-41B, where the lip is part 560). 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 lip and groove arrangement of Salahieh into Accola to which the lip will be about the outflow portion of Accola for the purpose of providing a portion on an outflow portion that will have locking elements to lock with a valve portion, as disclosed in [0092] and shown in figure 41A.
Regarding claim 33, Accola discloses a heart valve prosthesis (in the abstract) comprising: a frame (being the device shown in figure 2, shown in annotated figure 1 below), wherein the frame is radially compressible and radially expandable (radial expansion disclosed in [0022], where radial expansion implies radial compression. Compression of valve in [0060]), the frame comprising: an inflow portion (shown in annotated figure 1 above), the inflow portion including an inflow tubular portion and an inflow rim flaring radially outward from an inflow end of the inflow tubular portion (shown in annotated figure 1, where the inflow rim is depicted as flaring radially outward );
an outflow portion (shown in annotated figure 1 above) to and extending distally from the inflow tubular portion (distal extension shown in figure 1 where the topmost portion is the distal end of annotated figure 1); and barbs coupled to the inflow portion (shown in annotated figure 1 above); and a prosthetic heart valve coupled to an inner surface of the outflow portion of the frame (in [0032], as the heart valve is surrounded by support members, the valve is coupled to an inner portion of the outflow portion),.
However, Accola does not teach that the outflow portion is rotatably coupled to the inflow tubular portion such that the inflow tubular portion and the inflow rim are rotatable relative to the outflow portion.
Instead, Kovalsky (US Pub No.: 2014/0222142) teaches wherein the outflow portion is rotatably coupled to the inflow tubular portion such that the inflow tubular portion and the inflow rim are rotatable relative to the outflow portion (in [0108]).
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 rotatable frame details of Kovalsky into Accola for the purpose of providing a means to adjust the shape of the frame of Accola. Examiner notes that Kovalsky teaches a rotation as a part of a processing of a device.
Regarding claim 34, Accola in view of Kovalsky teach the heart valve prosthesis of claim 33, wherein Accola discloses inflow rim includes an inflow surface and an outflow surface configured to engage tissue (being the topmost end of the inflow rim in annotated figure 1 that is closest to the outflow portion), the barbs coupled to the outflow surface of the inflow rim (in annotated figure 1, the barbs are attached to a ring that are on the outflow end of the inflow rim).
Regarding claim 38, Accola in view of Kovalsky teach the heart valve prosthesis of claim 33, with Accola further comprising a plurality of arms coupled to the outflow portion of the frame (being the being the linkers 114, 116, and 123 in figure 3 and [0035]-[0036], where part 123 and 120 in figure 3 are also depicted as linker.
Regarding claim 39, Accola in view of Kovalsky teach the heart valve prosthesis of claim 33, wherein Accola discloses the plurality of arms are coupled to an outflow end of the outflow portion (shown in figure 3 where parts 114, 116, 123 (disclosed as linkers in [0036] and part 124 in figure 3 are coupled to the outflow portion at parts 104 and 106).
Claim(s) 35-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Accola (US Pub No.: 2013/0261741) in view of Kovalsky (US Pub No.: 2014/0222142) in further view of Morin (US Pub No.: 2015/0327995).
Regarding claim 35, Accola in view of Kovalsky teach the heart valve prosthesis of claim 17. However, Accola does not teach wherein the outflow portion is rotatably coupled to the inflow tubular portion at a joint.
Instead, Morin (US Pub No.: 2015/0327995) teaches wherein the outflow portion is rotatably coupled to the inflow tubular portion at a joint (a pivoting of a ring part 350 in [0079], where the sealing ring that is attached to the inflow end pivots away from a distal end of the device 700 where the outflow end is, shown in figures 9A-E. As a pivoting is present, a joint is present).
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 rotating ring of Morin into Accola to allow for the device to fold away to be loaded into an implantation device as per [0079].
Regarding claim 36, Accola in view of Kovalsky and Morin teach the heart valve prosthesis of claim 35, where Morin teaches the joint is a flexible material (in [0079], as a rotation and pivoting is present, with a folding/unfolding shown in figures 9A-9E, a flexibility is present). 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 rotating ring of Morin into Accola to allow for the device to fold away to be loaded into an implantation device as per [0079].
Regarding claim 37, Accola in view of Kovalsky and Morin teach the heart valve prosthesis of claim 35. However, Accola does not teach the joint comprises a groove in one of the inflow tubular portion or the outflow portion and a lip the other of the inflow tubular portion or the outflow portion, wherein the lip is disposed in the groove to enable rotation and restrain longitudinal movement of the inflow rim and the outflow portion relative to each other.
Instead, Morin teaches wherein the joint comprises a groove in one of the inflow tubular portion or the outflow portion (the sealing ring of Morin can be placed on the inflow tubular portion of Accola) and a lip the other of the inflow tubular portion or the outflow portion (if the ring of Morin is placed about the inflow tubular portion of Accola, wherein the lip is disposed in the groove to enable rotation and restrain longitudinal movement of the inflow rim and the outflow portion relative to each other ([0079] discloses a rotation, while the ring portion itself is not depicted or disclosed as promoting a longitudinal movement of the ring). 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 rotating ring of Morin into Accola to allow for the device to fold away to be loaded into an implantation device as per [0079].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hacohen (US Patent No.: 11,141,268) considered for a prosthetic valve with joints and folding segments in column 2 lines 33-43. Cox (US Pub No.: 2014/0303719) considered for an expandable prosthetic valve in the abstract with barbs 160 in figure 3.
THIS ACTION IS MADE FINAL. 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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/AREN PATEL/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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