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 . Claims 1-15 are pending and examined below. Claims 16-20 is/are withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 & 10 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation “at an inflow end of the commissure portions” in lines 2-3. It is unclear how the commissure portions are coupled to the plurality of interconnected struts at an inflow end of the commissure portions.
Claim 10 recites the limitation “to the a plurality of interconnected struts” in lines 2-3. It is unclear if this is a typographical error or a new plurality of interconnected struts.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, 9-11, & 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tuval et al. (US 20100262231 A1) hereinafter, Tuval.
Regarding claim 1, Tuval teaches a frame (12, Fig. 1) for a prosthetic heart valve (10, Fig. 1), the frame comprising:
a plurality of interconnected struts (see annotated Fig. 2B below) forming an annular shape extending circumferentially around a central flow axis (center of 10, Fig. 1),
the frame having an inflow end (portion near 30, Fig. 2B) facing one axial direction and an outflow end facing (portion near 34, Fig. 2B) an opposite axial direction, and the frame (12, Fig. 2B) having a radially inner side facing inwardly toward the central flow axis (Fig. 2B) and a radially outer side face away from the central flow axis (Fig. 2B); wherein
the plurality of interconnected struts (see annotated Fig. 2B below) are configured such that the frame (12, Fig. 1) is radially compressible to a compressed configuration (Fig. 5C) and radially expandable to one or more expanded configurations (Fig. 7A); and
commissure portions (30, Fig. 2B) that are offset radially outwardly (30 is diverging, Fig. 2B, ¶0579) relative to the plurality of interconnected struts (see annotated Fig. 2B below).
Regarding claim 2, Tuval teaches
wherein the commissure portions (30, Fig. 2B) are coupled to the plurality of interconnected struts (see annotated Fig. 2B below) at an inflow end (portion near 30, Fig. 2B) of the commissure portions (30, Fig. 2B).
Regarding claim 3, Tuval teaches
wherein the commissure portions (30, Fig. 2B) comprise a leaflet attachment portion comprising an opening (130, Fig. 4A) defined between two axial struts of the commissure portions (struts on either side of 30, Fig. 2B).
Regarding claim 4, Tuval teaches
wherein the commissure portions (30, Fig. 2B) comprise an axially extending leaflet attachment portion (portion where 104 or 105 is inserted, Fig. 4A) and an offsetting portion (see annotated Fig. 2B below) that extends radially outwardly from the plurality of interconnected struts (see annotated Fig. 2B below) to the leaflet attachment portion (portion where 104 or 105 is inserted, Fig. 4A), wherein
the offsetting portion (see annotated Fig. 2B below) extends both radially outwardly and axially toward the outflow end (portion near 34, Fig. 2B) from the plurality of interconnected struts to the leaflet attachment portion (see annotated Fig. 2B below).
Regarding claim 6, Tuval teaches
wherein the commissure portions (30, Fig. 2B) are coupled to the plurality of interconnected struts (see annotated Fig. 2B below) at one axial end of the commissure portions (Fig. 2B) and free from the plurality of interconnected struts at an opposite, free axial end of the commissure portions (Fig. 2B) and at lateral sides of the commissure portions (Fig. 2B), such that the commissure portions (30, Fig. 2B) are cantilevered (Fig. 2B).
Regarding claim 9, Tuval teaches a prosthetic heart valve (10, Fig. 1) comprising:
a frame (12, Fig. 1) comprising:
a plurality of interconnected struts (see annotated Fig. 2B below) forming an annular shape extending circumferentially around a central flow axis (center of 10, Fig. 1),
the frame having an inflow end (portion near 30, Fig. 2B) facing one axial direction and an outflow end (portion near 34, Fig. 2B) facing an opposite axial direction, and the frame (12, Fig. 2B) having a radially inner side facing inwardly toward the central flow axis (Fig. 2B) and a radially outer side face away from the central flow axis (Fig. 2B); and
commissure portions (30, Fig. 2B) that are offset radially outwardly (30 is diverging, Fig. 2B, ¶0579) relative to the plurality of interconnected struts (see annotated Fig. 2B below); and
a leaflet valve structure (104 or 105, Fig. 1) positioned within the frame and secured to the commissure portions of the frame (Fig. 4A); wherein
the prosthetic heart valve (10, Fig. 1) is radially compressible to a compressed configuration (Fig. 5C) and radially expandable to one or more expanded configurations (Fig. 7A).
Regarding claim 10, Tuval teaches
wherein commissures of the leaflet valve structure (104 or 105, Fig. 4A) are positioned radially outwardly relative to the a plurality of interconnected struts (Figs. 3G & 4A); and wherein
the leaflet valve structure (104 or 105, Figs. 10A-10B) articulates about articulation axes that are located at a radial dimension that is equal to or greater than a radial dimension of the plurality of interconnected struts (105 of valve 104 is configured to collapse inwardly, Figs. 10A-10B, ¶0581).
Regarding claim 11, Tuval teaches
wherein the commissure portions (30, Fig. 2B) comprise an axially extending leaflet attachment portion (portion where 104 or 105 is inserted, Fig. 4A) and an offsetting portion (see annotated Fig. 2B below) that extends radially outwardly from the plurality of interconnected struts (see annotated Fig. 2B below) to the leaflet attachment portion (portion where 104 or 105 is inserted, Fig. 4A), wherein
the offsetting portion (see annotated Fig. 2B below) extends both radially outwardly and axially toward the outflow end (portion near 34, Fig. 2B) from the plurality of interconnected struts to the leaflet attachment portion (see annotated Fig. 2B below).
Regarding claim 15, Tuval teaches
wherein when the prosthetic heart valve (10, Fig. 1) is in an expanded configuration, the commissure portions (30, Fig. 2B) of the frame (12, Fig. 1) are configured to flex radially inwardly relative to the plurality of interconnected struts when the leaflet valve structure closes during diastole to help the leaflet valve structure fully coapt and prevent retrograde flow.
The phrase “…configured to flex radially inwardly relative to the plurality of interconnected struts when the leaflet valve structure closes during diastole to help the leaflet valve structure fully coapt and prevent retrograde flow” is a functional recitation that is not given full patentable weight. The implant is not positively recited here, but is instead merely recited as part of the intended use of the implantation device. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability of being used to delivery such an implant in order to meet the claim requirements.
In this case, the Tuval device discloses all the claimed structural features and is considered to be capable of flexing radially inwardly relative to the plurality of interconnected struts when the leaflet valve structure closes during diastole to help the leaflet valve structure fully coapt and prevent retrograde flow.
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) 5 & 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuval in view of Dasi et al. (US 20210145573 A1) hereinafter, Dasi.
Regarding claim 5, Tuval does not teach the plurality of interconnected struts form six diamond-shaped cells that extend between the inflow end of the frame and the outflow end of the frame. However, Dasi teaches a transcatheter prosthetic heart valve (abstract, Dasi)
wherein the plurality of interconnected struts (54, Fig. 3, Dasi) form six diamond-shaped cells that extend between the inflow end of the frame and the outflow end of the frame (10, Fig. 3, Dasi), wherein the six diamond-shaped cells are connected laterally by six mid-frame junctions (see annotated Fig. 3 below, Dasi) positioned between the cells, and the commissure portions (56, Fig. 3, Dasi) extend radially outwardly from three of the six mid-frame junctions (Fig. 3, Dasi).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tuval by incorporating the teachings above as taught by Dasi in order to connect to form a tubular stent frame that can be inserted into the body of a patient (¶0036, Dasi).
Regarding claim 12, Tuval teaches
wherein the commissure portions (30, Fig. 2B, Tuval) but he does not disclose the commissure portion define a maximum radial extent of the frame. However, Dasi teaches
wherein the commissure portions (56, Fig. 3, Dasi) define a maximum radial extent of the frame (Fig. 2, Dasi).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tuval by incorporating the teachings above as taught by Dasi in order to meet with better conformity to achieve better coaptation and ensure minimal reverse flow of the blood when the leaflets are closed (¶0044, Dasi).
Claim(s) 7 & 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuval in view of Yohanan et al. (US 20130150956 A1) hereinafter, Yohanan.
Regarding claim 7, Tuval teaches
wherein the commissure portions (30, Fig. 2B, Tuval) terminate at the free axial ends (Fig. 2B, Tuval).
Tuval does not teach the free axial ends are short of the outflow end of the frame, such that the free axial ends of the commissure portions are positioned axially between the inflow end of the frame and the outflow end of the frame. However, Yohanan teaches a prosthetic heart valve (abstract, Yohanan) wherein
the free axial ends (ends of 602, Fig. 34, Yohanan) are short of the outflow end of the frame (end portion by 608, Fig. 29, Yohanan), such that the free axial ends of the commissure portions (ends of 602, Fig. 34, Yohanan) are positioned axially between the inflow end of the frame and the outflow end of the frame (Fig. 34, Yohanan).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tuval by incorporating the teachings above as taught by Yohanan in order to support the moveable portions of the leaflets away from the inner surface of the frame 600 when the leaflets are in the open position (¶0099, Yohanan).
Regarding claim 13, Tuval teaches
wherein the commissure portions (30, Fig. 2B) are coupled to the plurality of interconnected struts (see annotated Fig. 2B below) at one axial end of the commissure portions and free from the plurality of interconnected struts at an opposite, free axial end of the commissure portions and at lateral sides of the commissure portions, such that the commissure portions are cantilevered (Fig. 2B); and wherein the commissure portions terminate at the free axial ends, and the free axial ends are short of the outflow end of the frame (30, Fig. 2B).
Tuval does not teach the free axial ends of the commissure portions are positioned axially between the inflow end of the frame and the outflow end of the frame. However, Yohanan teaches
such that the free axial ends of the commissure portions (ends of 602, Fig. 34, Yohanan) are positioned axially between the inflow end of the frame and the outflow end of the frame (Fig. 34, Yohanan).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tuval by incorporating the teachings above as taught by Yohanan in order to support the moveable portions of the leaflets away from the inner surface of the frame 600 when the leaflets are in the open position (¶0099, Yohanan).
Claim(s) 8 & 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuval in view of Dasi and further in view of Yohanan.
Regarding claim 8, Tuval does not teach lateral arms. However, Dasi teaches
further comprising lateral arms (46, Fig. 3, Dasi) that extend circumferentially from axial ends of the commissure portions (56, Fig. 3, Dasi) to adjacent outflow end apices of the frame; wherein
the frame (10, Fig. 3, Dasi) comprises two of the lateral arms (46, Fig. 3, Dasi) for each of the commissure portions (56, Fig. 3, Dasi); wherein
when the frame (10, Fig. 3, Dasi) is in a partially radially expanded state, the lateral arms extend both circumferentially and radially inwardly from axial ends of the commissure portions to adjacent outflow end apices of the frame (Figs. 3 & 4, Dasi).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tuval by incorporating the teachings above as taught by Dasi in order to meet with better conformity to achieve better coaptation and ensure minimal reverse flow of the blood when the leaflets are closed (¶0044, Dasi).
Tuval in view of Dasi does not teach the lateral arms pull the commissure portions radially inwardly. However, Yohanan teaches
the lateral arms (618, Fig. 34, Yohanan) pull the commissure portions (602, Fig. 34, Yohanan) radially inwardly (602 to bend inwardly, Fig. 34, ¶0101, Yohanan), relative to the outflow end apices (620, Fig. 29, Yohanan), as the outflow end apices move apart from each other when the frame radially expands (Fig. 29, Yohanan).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tuval and Dasi by incorporating the teachings above as taught by Yohanan in order to limit the extent of inward displacement of the upper end portions of the posts (¶0101, Yohanan).
Regarding claim 14, Tuval does not teach lateral arms. However, Dasi teaches
further comprising lateral arms (46, Fig. 3, Dasi) that extend circumferentially from axial ends of the commissure portions (56, Fig. 3, Dasi) to adjacent outflow end apices of the frame; wherein
the frame (10, Fig. 3, Dasi) comprises two of the lateral arms (46, Fig. 3, Dasi) extending from each of the commissure portions; wherein
when the frame (10, Fig. 3, Dasi) is in a partially radially expanded state, the lateral arms (46, Fig. 3, Dasi) extend both circumferentially and radially inwardly from axial ends of the commissure portions to adjacent outflow end apices of the frame (Figs. 3 & 4, Dasi).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tuval by incorporating the teachings above as taught by Dasi in order to meet with better conformity to achieve better coaptation and ensure minimal reverse flow of the blood when the leaflets are closed (¶0044, Dasi).
Tuval in view of Dasi does not teach the lateral arms pull the commissure portions radially inwardly. However, Yohanan teaches
the lateral arms (618, Fig. 34, Yohanan) pull the commissure portions (602, Fig. 34, Yohanan) radially inwardly (602 to bend inwardly, Fig. 34, ¶0101, Yohanan), relative to the outflow end apices (620, Fig. 29, Yohanan), as the outflow end apices move apart from each other when the prosthetic heart valve radially expands (Fig. 29, Yohanan); and wherein
when the prosthetic heart valve is radially expanded to maximum extent, the commissure portions (602, Fig. 34, Yohanan) of the frame are radially even with the outflow end apices of the frame, and the lateral arms (618, Fig. 34, Yohanan) extend horizontally between the axial ends of the commissure portions and the outflow end apices (Fig. 29, Yohanan).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tuval and Dasi by incorporating the teachings above as taught by Yohanan in order to limit the extent of inward displacement of the upper end portions of the posts (¶0101, Yohanan).
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Conclusion
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/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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