DETAILED ACTION
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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in People’s Republic of China on 12/21/2020. It is noted, however, that applicant has not filed a certified copy of the CN202011521709.8 and CN202023104116.X applications as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed 05/15/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Foreign patent document CN 107613907 A has been placed in the application file, but the information referred to therein has not been considered, because no copy was provided.
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 1-20 are 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.
Regarding claim 1, the last three lines of the claim set forth the parameter of “the outer skirt section, the inner skirt section, and a section of the outer body section between the outer skirt section and the inner skirt section together form a receiving space which opens radially outward”; however, this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by the space “opens radially outward”, radially outward compared to what/which structure. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 2, which, on lines 1-2, sets forth the parameter of “the inflow end of the outer body section is free and suspended” (emphasis added), however, this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by the inflow end being “suspended”; suspended from what, and/or where exactly is it suspended. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 3, which sets forth the parameter of the bottom section, of the outer body section, “extending outwardly away from a central axis of the outer frame and towards the inner skirt section simultaneously” (emphasis added); however, this parameter is found to be confusing since it is not clear what exactly is meant, as far as structure goes, by the term “simultaneously”. Specifically, the term “simultaneously” is traditionally used in terms of time, i.e. something happening at the same time as something else; however, it is not clear what exactly this mean when it comes to the structure of the bottom section. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 5, which, on lines 1-3, sets forth the parameter of the top section, of the outer body section, “extends axially toward the inner skirt section and inwardly toward the central axis of the outer frame simultaneously” (emphasis added); however, this parameter is found to be confusing since it is not clear what exactly is meant, as far as structure goes, by the term “simultaneously”. Specifically, the term “simultaneously” is traditionally used in terms of time, i.e. something happening at the same time as something else; however, it is not clear what exactly this mean when it comes to the structure of the top section. Additionally, the last three lines of the claim set forth limitations in which the top section extends “so as to form a recess in a round”; however, this parameter is found to be confusing since it’s not clear what exactly, structurally, is meant by a recess “in a round”. Does this mean the recess has a round cross-sectional shape, or the recess extends circumferentially around the top section, or something other completely different structure. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 7, which sets forth the parameter of “an included angle formed by two tangent lines of an out flow end…”, on lines 1-2, however, this parameter is found to be confusing since it is not clear what exactly, structurally, is mean by an “included angle”; does the term “included” define any additional structure to the angle, such as having a specific location or type of angle formed by the tangent lines, or is it just a superfluous word that does not add any additional structural limitation. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 9, the term “that”, on lines 4, 5, 8, 9 and 10, is found to be confusing since it is not clear what exact structure of “the outer body section” on lines 4, 5 and 6, and of “the top section” on lines 8 and 9, it is referring to. In order to overcome this rejection it is suggested the word “that” be deleted and replaced with the wording of how the deformation resistance could be achieved, for example instead of line 4 stating “that of the outer body section” it should state “area of openings of the cells of the outer body section”, instead of lines 4-5 stating “greater than that of the outer section” it should state “rigidity of material of the outer body section”, etc. for all the times the term “that is used.
Regarding claim 15, which sets forth the parameter “comprising a marking mechanism disposed on at least one of the outer frame and the inner frame”; however, this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by the term “marking mechanism”. Is a marking mechanism meant to mean a radiopaque mechanism/structure such that it can be seen under fluoroscopy, or does it mean a mechanism which makes markings on tissue and/or the device itself, or does it mean something else completely different. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite. For the purpose of examination, as can best be gleaned from the originally filed disclosure, the term “marking mechanism” shall be interpreted as a type of radiopaque mechanism/structure such that it can be seen under fluoroscopy; and amendment as such is recommended.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Claim Rejections - 35 USC § 102
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.
Claims 1-7, 10, 13, 16, 17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hariton et al. (US PG Pub. 2018/0014930), hereinafter Hariton.
Regarding claim 1, Hariton discloses a stent (22) of prosthetic heart valve (20), illustrated in Figures 1A and 1B, comprising an inner frame (30) and an outer frame (60) connected with each other; the outer frame (60) comprises an outer body section (structures 66,50 & 54), and an outer skirt section (OSS) extending from the outer body section and located at a radially outer side of the outer body section, wherein the outer skirt section (OSS) is located between an inflow end (ends of 54) and an outflow end (at ring 66) of the outer body section; the inner frame (30) comprises an inner body section (32) at least partially within the outer frame (60), and an inner skirt section (40) projecting radially outside the inner body section from an inflow end (34) of the inner body section (32), wherein the inner skirt section (40) projects radially outside the inflow end (ends of 54) of the outer body section, so that the outer skirt section (OSS), the inner skirt section (40), and a section (54) of the outer body section between the outer skirt section (OSS) and the inner skirt section (40) together form a receiving space (49) which opens radially outward, illustrated in Figures 1A, 1B, 2E and modified figures 1A and 1B, below ([0292]; [0293] & [0366]).
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Regarding claim 2, Hariton discloses the stent of prosthetic heart valve according to claim 1, wherein the inflow end (tips of 54) of the outer body section is free and suspended, and a radial gap (49) is formed between the section (54) of the outer body section between the outer skirt section (OSS) and the inner skirt section (40) and the inner body section (32), and the inner skirt section (40) is covered with a flow blocking film (23), illustrated in Figures 1A, 1B, 2E and modified figure 1A, above ([0302], Lines 1-4 & [0366]).
Regarding claim 3, Hariton discloses the stent of prosthetic heart valve according to claim 2, wherein the outer body section comprises a bottom section (66) extending outwardly away from a central axis (ax1) of the outer frame and towards the inner skirt section (40), illustrated in Figure 2E, and a top section (50/54) extending from an inflow end of the bottom section (66) further toward the inner skirt section (40); wherein the section (54) of the outer body section between the outer skirt section (OSS) and the inner skirt section (40) is at least partially formed by the top section (50/54), illustrated in Figures 1A, 1B and 2E.
Regarding claim 4, Hariton discloses the stent of prosthetic heart valve according to claim 3, wherein an outflow end (61) of the bottom section is fixedly connected (at 52) with an outflow end (31) of the inner body section, illustrated in Figures 1A and 1B ([0293]).
Regarding claim 5, Hariton discloses the stent of prosthetic heart valve according to claim 3, wherein the top section (50/54) extends axially toward the inner skirt section (40), while first extending inwardly (via portion 50 which has a slightly curved shape that extends inward) toward the central axis (ax1) of the outer frame (60) and then outwardly away (via portion 54) from the central axis (ax1) of the outer frame so as to form a recess (49) in a round, illustrated in Figures 1A, 1B and 2E.
Regarding claim 6, Hariton discloses the stent of prosthetic heart valve according to claim 3, wherein the top section (50/54) has an O- shaped outer peripheral profile, illustrated in Figures 1A and 1B.
Regarding claim 7, Hariton discloses the stent of prosthetic heart valve according to claim 3, wherein an included angle (A) formed by two tangent lines (T1&T2) of an outflow end of the bottom section (66) that are radially opposite to each other ranges from 90 degrees to 150 degrees, illustrated in Figures 1A, 3A and modified figure 3A, below.
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Regarding claim 10, Hariton discloses the stent of prosthetic heart valve according to claim 1, wherein the minimum axial distance between the inner skirt section (40) and the outer skirt section (OSS) ranges from 5 mm to 15 mm, illustrated in Figures 1A, 2E and modified figure 1A, above ([0315], Line 11 – to clarify, it is stated that distance d4 may be 2-15mm, and the distance between the inner skirt section 40 and the outer skirt OSS is slightly greater than that, as illustrated in the figures; thus the minimum axial distance between the inner and outer skirt sections would fall within the range of 5 mm to 15mm).
Regarding claim 13, Hariton discloses the stent of prosthetic heart valve according to claim 1, wherein an angle between a starting end of the inner skirt (40) section and a central axis (ax1) of the inner frame (30) ranges from 45 degrees to 90 degrees, illustrated in Figures 1A and 1B ([0318]).
Regarding claim 16, Hariton discloses the stent of prosthetic heart valve according to claim 1, wherein the outer skirt section (OSS) comprises a plurality of support units (78) distributed in a circumferential direction, each of said support units (78) comprises two outwardly extending support rods (78A&78B), each of said support rods comprises a first end (1E) away from said outer body section (rods 50/54) and a second end (2E) adjacent to and connected to said outer body section (rods 50/54), the first ends (1E) of the two support rods (78A&78B) of each support unit are connected and smoothly transited to each other, and the second ends (2E) of two adjacent support rods of two adjacent support units are spaced apart from with each other, illustrated in Figures 1A, 3A and modified figures 1A and 3A, above.
Regarding claim 17, Hariton discloses the stent of prosthetic heart valve according to claim 1, wherein the outer skirt section (OSS) comprises a plurality of support units (78) spaced from each other in a circumferential direction, each of the support units (78) is substantially rod-shaped, and a free end of the support unit is a blunt end (1E), illustrated in Figures 1A, 3A and modified figures 1A and 3A, above.
Regarding claim 19, Hariton discloses a prosthetic heart valve (20), illustrated 1A, comprising at least two prosthetic leaflets (58) and the stent (22) of prosthetic heart valve according to claim 1, wherein the prosthetic leaflets are fixedly connected within the inner body section of the inner frame (30), and edges of the at least two prosthetic leaflets are circumferentially engaged with each other, illustrated in Figure 1A ([0292], Lines 1-10 & [0294]).
Regarding claim 20, Hariton discloses a prosthetic heart valve replacement system, illustrated in Figures 4A-4F, comprising the prosthetic heart valve (20) according to claim 19, and a delivery device (89) for delivering the prosthetic heart valve (20); the prosthetic heart valve (20) has a delivery condition being radially compressed, illustrated in Figure 4A, and a natural condition being radially expanded, illustrated in Figures 4E and 4F; the delivery device comprises an outer sheath/delivery tube and an inner core/control rod passing through, and axially movable relative to, the outer sheath/delivery tube; the prosthetic heart valve is radially compressed and received in a gap between a distal portion of the inner core and a distal portion of the outer sheath ([0295], Last 5 Lines).
Claim Rejections - 35 USC § 103
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hariton.
Regarding claim 8, Hariton discloses the stent of prosthetic heart valve according to claim 4, and though it is not specifically stated that the inner body section (32) and the bottom section of the outer body have a higher deformation resistance than the outer body section (structures 66,50 & 54) and the top section of the outer body section, respectively; these parameters would have been obvious to one having ordinary skill in the art before the effective filing date of the invention, due to the inner body section (32) being formed/having the structure of small closed cells while the outer body section is formed/has the structure of large open-ended cells defined on the bottom by struts (70), of ring portion (66), and by sidewalls of struts/rods (50/54), illustrated in Figures 1A and 1B; therefore, the overall structure of the outer body section (66,50 & 54) would have a lower deformation resistance than that of the overall structure of the inner body section (32). It would further have been obvious to one having ordinary skill in the art before the effective filing date of the invention that the bottom section (66) of the outer body section would have a higher deformation resistance than the top section (50/54) of the outer body section since the bottom section is formed by connected struts (70) which form a closed ring (66), as opposed to the top section (50/54) which is formed of individual rods/struts (50/54) which are not connected to one another except at the base by the bottom section/ring (66), illustrated in Figures 1A and 1B.
Claims 14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hariton as applied to claims 1 and 2 above, and in view of Morriss et al. (US PG Pub. 2015/0335429), hereinafter Morriss.
Regarding claims 14 and 18, Hariton discloses the stent of prosthetic heart valve according to claim 2, wherein the inner body section (32) is covered with a flow blocking film (23), illustrated in Figure 1A ([0301]); but does not specifically teach the outer body section and the outer skirt section being covered with a flow blocking film.
However, Morriss teaches a stent of prosthetic heart valve, in the same filed of endeavor, comprising an outer frame (110), surrounding and connected to, an inner frame (120), wherein the outer frame, in addition to the inner frame, are covered by a flow blocking film/sealing members (140), illustrated in Figure 10A; the flow blocking film/sealing member aids in preventing paravalvular leaks between the prosthetic heart valve and native tissue and/or between the inner and outer frames ([0173]).
In view of the teachings of Morriss, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the outer body section and the outer skirt section, of the outer frame of the stent of prosthetic heart valve of Hariton, to also be covered with a flow blocking film, in order to aid in preventing paravalvular leaks between the prosthetic heart valve and native tissue and/or between the inner and outer frames, as taught by Morriss.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hariton as applied to claim 1 above, and in view of Navia et al. (US PG Pub. 2008/0177381), hereinafter Navia.
Regarding claim 15, Hariton discloses the stent of prosthetic heart valve according to claim 1, but does not specifically teach a marking mechanism disposed on at least one of the outer frame and the inner frame.
However, Navia teaches a stent of prosthetic heart valve, in the same filed of endeavor, which comprises a radiopaque marking mechanism such that it can be visible on fluoroscopy, in order to aid in the positioning of the prosthetic heart valve ([0056]).
In view of the teachings of Navia, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for at least one of the outer or inner frames, of the stent of prosthetic heart valve of Hariton, to further comprise a radiopaque marking mechanism such that it can be visible on fluoroscopy, in order to aid in the positioning of the stent/prosthetic heart valve, as taught by Navia.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774