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) 1-20 have been considered but are moot in view of the new grounds for rejection.
Applicant has amended claim 1 to recite an alternating of first and second segments “around a circumference of the frame” with the segments “being oriented parallel to a longitudinal axis.” In response to Applicant’s amendment Examiner has added reference Benichou (2008/0154355).
Applicant's arguments filed 07/07/2026 have been fully considered but they are not persuasive.
With respect to claim 10, it is argued that Flaction remains silent on the porosity of the fibers as the fibers with a coating is what is argued to be non-porous in [0153] of Flaction. Examiner disagrees. As per the language in cited paragraph [0153], it is stated that “The regions 110 of the fabric may be rendered generally non-porous to liquids by the presence of the polymeric material occluding the fabric pores.” As such, the polymer occludes pores in the fabric which then render the fabric to be non-porous or 0% porosity, reading on the limitation of having a porosity of less than 5%. The presented limitations of claim 10 do not require the fabric to be unmodified.
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) 1, 4-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh (US Pub No.: 2015/0245909) in view of Yang (US Pub No.: 2022/0331095) and Benichou (US Pub No.: 2008/0154355).
Regarding claim 1, Salahieh (US Pub No.: 2015/0245909) discloses a prosthesis having a radially expanded configuration and a radially compressed configuration (a prosthetic valve with expandable lip and skirt regions in the abstract. Expandable regions imply that the regions are compressible), the prosthesis comprising: a frame (being the device in the entirety of figure 1A. Part 1022 in [0156] is also defined as a frame) including a plurality of crowns (the crowns being the parts 40 at the top of figure 1A) and a plurality of struts (parts 32 in figure 1A) with each crown being formed between a pair of opposing struts (in figure 1A, parts 40 are depicted as being formed between a pair of parts 32 at the top end of figure 1A), wherein a plurality of side openings is defined by the plurality of crowns and the plurality of struts (as parts 40 are defined as being circular with an opening in the middle, a plurality of side openings are in figure 1A).
However, Salahieh does not teach a composite skirt coupled to a surface of the frame, wherein the composite skirt extends over at least one opening of the plurality of side openings of the frame, wherein the composite skirt is formed by alternating first and second segments of a first stiffness and a second stiffness, respectively, that alternate in a circumferential direction, the second stiffness being higher than the first stiffness, each segment of the alternating first and second segments extending in an axial direction for substantially an entire length of the composite skirt.
Instead, Yang (US Pub No.: 2022/0331095) teaches a composite skirt (in the abstract) coupled to a surface of the frame (the skirt, defined in [0027], is coupled to a valve prosthesis. The skirt of Yang is also couplable to the frame of Salahieh), wherein the composite skirt extends over at least one opening of the plurality of side openings of the frame (The skirt of Yang can be implemented into Salahieh such that it extends over the plurality of side openings), wherein the composite skirt is formed by alternating first and second segments of a first stiffness and a second stiffness (in [0040], where a first skirt material and a second skirt material are present, with a transition at part 102 in [0042] detailing an alternation of segments), respectively, that alternate in a circumferential direction, the second stiffness being higher than the first stiffness (as a first skirt material has a better stretch performance in [0040]-[0041], a second skirt material has a higher stiffness), each segment of the alternating first and second segments extending in an axial direction for substantially an entire length of the composite skirt (the layers of Yang in figures 1, 2, in view of paragraph [0040] extend along an axis of the stent in said figures).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate material details of the composite skirt of Yang into the skirt of Salahieh for the purpose of providing a skirt for a prosthetic heart valve (in the abstract) where the skirts are designed for reducing regurgitation (in [0010]) via a composite skirt that has multiple parts with different material properties (multiple parts in [0016] with material properties in [0040]-[0041]).
From here, Salahieh does not teach that the first and second segments of the skirt alternate in a circumferential direction around a circumference of a frame, or that the first and second segments are being oriented parallel to a longitudinal axis of the prosthesis.
Instead, Benichou (US Pub No.: 2008/0154355) teach first and second segments (figure 4, with skirt part 106. The skirt has multiple portions 134 and 138 in figure 5, with suture parts 130 in figure 4. It stands to reason that suture parts 130 have a greater stiffness due to the sutures) of the skirt alternate in a circumferential direction around a circumference of a frame (shown in figure 5, where parts 134 and 138 alternate), or that the first and second segments are being oriented parallel to a longitudinal axis of the prosthesis (parts 134 and 138 are parallel to the longitudinal axis of the rest of the device in figure 4).
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 arrangement of the skirt of Benichou into the combination of Salahieh in view of Yang such that the reinforcing segments of Salahieh in view of Yang are on the first and second segments of Benichou for the purpose of providing a skirt that is able to expand and act as an attachment aid with respect to the valve assembly and frame, as per [0045].
Regarding claim 4, Salahieh in view of view of Yang and Benichou teach the prosthesis of claim 1, wherein Salahieh in view of Yang teach the alternating first and second segments include between five and twenty first segments and between five and twenty second segments (in figure 1A of Salahieh, where part 34 can be divided into segments based off of every V segment such that there are at least 5 first and second segments. As the skirt of Yang is disposed over part 34, each segment of the skirt of Yang over a V segment of Salahieh can be considered its own segment such that there is between five and twenty first and second segments in Yang).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate material details of the composite skirt of Yang into the skirt of Salahieh for the purpose of providing a skirt for a prosthetic heart valve (in the abstract) where the skirts are designed for reducing regurgitation (in [0010]) via a composite skirt that has multiple parts with different material properties (multiple parts in [0016] with material properties in [0040]-[0041]).
Regarding claim 5, Salahieh in view of view of Yang and Benichou teach the prosthesis of claim 1, wherein Salahieh in view of Yang teaches each of the first and second segments are the same size (in figure 1A of Salahieh, where each V shaped segment of part 34 is the same size, meaning that the skirt of Yang over said V segments are also the same size).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate material details of the composite skirt of Yang into the skirt of Salahieh for the purpose of providing a skirt for a prosthetic heart valve (in the abstract) where the skirts are designed for reducing regurgitation (in [0010]) via a composite skirt that has multiple parts with different material properties (multiple parts in [0016] with material properties in [0040]-[0041]).
Regarding claim 6, Salahieh in view of view of Yang and Benichou teach the prosthesis of claim 1, wherein Yang teaches that the second stiffness is at least two times greater than the first stiffness (in Yang, the first skirt material may be a knitted PET as per [0041] where the materials for the second skirt can be polyester fabric, PTFE, or ePTFE). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate material details of the composite skirt of Yang into the skirt of Salahieh for the purpose of providing a skirt for a prosthetic heart valve (in the abstract) where the skirts are designed for reducing regurgitation (in [0010]) via a composite skirt that has multiple parts with different material properties (multiple parts in [0016] with material properties in [0040]-[0041]).
Regarding claim 7, Salahieh in view of view of Yang and Benichou teach the prosthesis of claim 1, wherein Salahieh discloses the at least one opening of the plurality of side openings is substantially diamond-shaped and is defined by a total of four struts (diamond shaped openings with four defined sides shown in figure 1A of Salahieh).
Regarding claim 8, Salahieh in view of view of Yang and Benichou teach the prosthesis of claim 7, wherein Salahieh discloses each opening of the plurality of side openings is substantially diamond-shaped and is defined by a total of four struts (diamond shaped openings with four defined sides shown in figure 1A of Salahieh).
Regarding claim 9, Salahieh in view of view of Yang and Benichou teach the prosthesis of claim 8, wherein Salahieh discloses a perimeter of the frame includes a row of side openings, the row including between six side openings and nine side openings (from the top end of figure 1A to the bottom end of figure 1A, nine diamond shaped openings are present).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh (US Pub No.: 2015/0245909) in view of Yang (US Pub No.: 2022/0331095) in further view of Tayeb (US Pub No.: 2021/0322162).
Regarding claim 2, Salahieh in view of Yang and Benichou teach the prosthesis of claim 1, wherein Yang teaches that the first segments of the composite skirt are configured to fold radially inward when the prosthesis is in the radially compressed configuration (in [0040]-[0041], as both the skirt segments are disclosed as being stretchable, a folding radially inward is present in Yang).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate material details of the composite skirt of Yang into the skirt of Salahieh for the purpose of providing a skirt for a prosthetic heart valve (in the abstract) where the skirts are designed for reducing regurgitation (in [0010]) via a composite skirt that has multiple parts with different material properties (multiple parts in [0016] with material properties in [0040]-[0041]).
However, Salahieh in view of Yang and Benichou does not teach a folding such that the composite skirt has a pleated configuration when the prosthesis is in the radially compressed configuration.
Instead, Tayeb (US Pub No.: 2021/0322162) teaches teach a folding such that the composite skirt has a pleated configuration when the prosthesis is in the radially compressed configuration (pleats in [0155] and [0168] where the pleats are part of a skirt 30 that can fold inwardly in [0155]).
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 folded configuration of figures 6-7 with the pleats of figure 3 of Tayeb into the combination involving Salahieh in order to provide a structure to a frame that allows for a radial compression and expansion for implanting of a valve in the abstract, with Tayeb detailing an actuator to compress a skirt in [0032] to control an expansion and a compression of a stent and skirt.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh (US Pub No.: 2015/0245909) in view of Yang (US Pub No.: 2022/0331095) in further view of Hariton (US Pub No.: 2010/0036484).
Regarding claim 3, Salahieh in view of view of Yang and Benichou teach the prosthesis of claim 1. However, Salahieh does not teach wherein the second segments of the composite skirt are configured to prevent billowing of the composite skirt when the prosthesis is in the radially expanded configuration.
Instead, Hariton (US Pub No.: 2010/0036484) teaches wherein the second segments of the composite skirt are configured to prevent billowing of the composite skirt when the prosthesis is in the radially expanded configuration (skirt-reinforcement members 68 for reinforcing a leaflet and a skirt in [0061]).
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 reinforcing member of Hariton into the combination involving Salahieh for the purpose of providing “a secure suturing and protects the pericardial tissue of the leaflet structure from tears” in [0057].
Claim(s) 10-17 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh (US Pub No.: 2015/0245909) in view of Flaction (US Pub No.: 2018/0263765).
Regarding claim 10, Salahieh (US Pub No.: 2015/0245909) discloses a prosthesis having a radially expanded configuration and a radially compressed configuration (a prosthetic valve with expandable lip and skirt regions in the abstract. Expandable regions imply that the regions are compressible), the prosthesis comprising: a frame (being the device in the entirety of figure 1A. Part 1022 in [0156] is also defined as a frame) including a plurality of crowns (the crowns being the parts 40 at the top of figure 1A) and a plurality of struts (parts 32 in figure 1A) with each crown being formed between a pair of opposing struts (in figure 1A, parts 40 are depicted as being formed between a pair of parts 32 at the top end of figure 1A), wherein a plurality of side openings is defined by the plurality of crowns and the plurality of struts (as parts 40 are defined as being circular with an opening in the middle, a plurality of side openings are in figure 1A); and a multi-layer skirt coupled to a surface of the frame, wherein the multi-layer skirt extends over at least one opening of the plurality of side openings of the frame.
However, Salahieh does not teach wherein a multi-layer skirt coupled to a surface of the frame, wherein the multi-layer skirt extends over at least one opening of the plurality of side openings of the frame wherein the multi-layer skirt is formed by a fabric material and a polymeric coating covering the fabric material such that the polymeric coating defines an inner circumferential surface of the multi-layer skirt, the fabric material having a plurality of fibers with a porosity less than 5% and the polymeric coating having a thickness between 2 and 10 um.
Instead, Flaction (US Pub No.: 2018/0263765) teaches a multi-layer skirt (in [0034]) coupled to a surface of the frame (skirt sutured to a stent in [0034]), wherein the multi-layer skirt extends over at least one opening of the plurality of side openings of the frame (the skirt with a polymeric layer in [0034] can be implemented onto the stent of Salahieh such that it extends over the side openings of Salahieh) wherein the multi-layer skirt (in the abstract and [0034] of Flaction) is formed by a fabric material (fabric in [0034]) and a polymeric coating covering the fabric material such that the polymeric coating defines an inner circumferential surface of the multi-layer skirt (polymeric coating on the fabric in [0034]. The fabric coating is on a first region, which is defined as 110 in figure 17 and in [0149], where the coating is on an inner surface in said figures), the fabric material having a plurality of fibers with a porosity less than 5% (as the skirt is defined as having a first region in [0034] and [0038] made of fabric being non-porous in [0153], the fabric with the polymeric coating has a porosity of less than 5%), and as Flaction defines a first region comprising a fabric and the polymeric coating having a thickness between 2 and 10 um (fabric thickness of 10 microns in [0112], where said fabric is of a skirt described in [0106]-[0112]).
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 polymeric material on a fabric skirt of a valve for the purpose of providing “a welded joint to another fabric wall portion and/or may reinforce the fabric and/or may occlude pores of the fabric,” where the occlusion of pores prevents an enlarging of pores in [0036]-[0037] and will stop a “crack propagation” as per [0038].
Regarding claim 11, Salahieh in view of Flaction teach the prosthesis of claim 10, wherein Flaction teaches the polymeric coating is formed from polyurethane, polycarbonate urethane, or polytetrafluoroethylene (polyurethane in [0035] of Flaction). 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 polymeric material on a fabric skirt of a valve for the purpose of providing “a welded joint to another fabric wall portion and/or may reinforce the fabric and/or may occlude pores of the fabric,” where the occlusion of pores prevents an enlarging of pores in [0036]-[0037] and will stop a “crack propagation” as per [0038].
Regarding claim 12, Salahieh in view of Flaction teach the prosthesis of claim 10, wherein Flaction teaches the polymeric coating is configured to prevent billowing of the multi-layer skirt when the prosthesis is in the radially expanded configuration (while a prevention of billowing is not explicitly disclosed in Flaction, as the polymeric coating is used to reinforce a fabric skirt in [0034], an outward swelling is inhibited by the coating). 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 polymeric material on a fabric skirt of a valve for the purpose of providing “a welded joint to another fabric wall portion and/or may reinforce the fabric and/or may occlude pores of the fabric,” where the occlusion of pores prevents an enlarging of pores in [0036]-[0037] and will stop a “crack propagation” as per [0038].
Regarding claim 13, Salahieh in view of Flaction teach the prosthesis of claim 10, wherein Salahieh discloses the at least one opening of the plurality of side openings is substantially diamond-shaped and is defined by a total of four struts (diamond shaped openings with four defined sides shown in figure 1A of Salahieh).
Regarding claim 14, Salahieh in view of Flaction teach the prosthesis of claim 13, wherein Salahieh discloses that each opening of the plurality of side openings is substantially diamond-shaped and is defined by a total of four struts (diamond shaped openings with four defined sides shown in figure 1A of Salahieh, where each opening is diamond shaped in figure 14).
Regarding claim 15, Salahieh in view of Flaction teach the prosthesis of claim 14, wherein Salahieh discloses a perimeter of the frame includes a row of side openings, the row including between six side openings and nine side openings (from the top end of figure 1A to the bottom end of figure 1A in Salahieh, nine diamond shaped openings are present).
Regarding claim 16, Salahieh in view of Flaction teach the prosthesis of claim 10, wherein Flaction teaches that the multi-layer skirt is coupled to an inner surface or an outer surface of the frame and wherein the multi-layer skirt extends over each opening of the plurality of side openings of the frame (the skirt of Flaction part 30 and fabric region 110 in figure 15 can extend over the side openings of Salahieh as the skirt of Flaction extends over struts of Flaction in [0097]). 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 polymeric material on a fabric skirt of a valve for the purpose of providing “a welded joint to another fabric wall portion and/or may reinforce the fabric and/or may occlude pores of the fabric,” where the occlusion of pores prevents an enlarging of pores in [0036]-[0037] and will stop a “crack propagation” as per [0038].
Regarding claim 17, Salahieh in view of Flaction teach the prosthesis of claim 10, wherein Salahieh discloses the frame is formed from a self-expanding material (self-expanding of the device of Salahieh in [0070]).
Regarding claim 19, Salahieh in view of Flaction teach the prosthesis of claim 10, wherein Salahieh discloses the prosthesis is a heart valve prosthesis (in the abstract of Salahieh) and the prosthesis further comprises a prosthetic valve component disposed within and secured to the frame (in [0121]), the prosthetic valve component being configured to block blood flow in one direction to regulate blood flow through a central lumen of the frame (as a normal blood flow between a left ventricle and aorta is provided for in [0082], a blocking of blood flow in one direction is required).
Regarding claim 20, Salahieh in view of Flaction teach the prosthesis of claim 19, wherein Salahieh discloses the heart valve prosthesis is configured for placement within a mitral heart valve or a tricuspid heart valve in situ (mitral heart valve in [0008] and [0076].
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh (US Pub No.: 2015/0245909) in view of Flaction (US Pub No.: 2018/0263765) in further view of McLean (US Patent No.: 9,034,032).
Regarding claim 18, Salahieh in view of Flaction teach the prosthesis of claim 10. However, Salahieh does not teach wherein the frame is an inner frame and the prosthesis further comprises an outer frame coupled to the inner frame, the outer frame radially surrounding the inner frame.
Instead, McLean (US Patent No.: 9,034,032) teaches wherein the frame is an inner frame and the prosthesis further comprises an outer frame coupled to the inner frame, the outer frame radially surrounding the inner frame (in column 13 lines 49-61, an inner frame and outer frame, where the frames are engaged to a valve. The frames are parts 110 and 120 in figure 82A as per column 26 lines 16-46).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate both an inner frame and an outer frame as presented in McLean for the purpose of providing a valve support means independent to an outer anchoring means (in column 26 lines 16-46) allowing for the outer frame 110 to be deformable the inner frame that supports the valve remains “sufficiently stable” as per column 26 lines 16-46.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cooper (US Pub No.: 2019/0262129) discloses a mitral valve with an inner and outer frame in the abstract and a skirt in [0009]. Stiehm (US Pub No.: 2023/0372103) discloses a valve prosthesis with a skirt in the abstract.
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
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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