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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of Claims
This office action is responsive to the amendment filed on 04/28/2026. As directed by the amendment: claims 1-3, 5, 7, 9 and 15 have been amended, no claims have been cancelled and no new claims have been added. Thus, claims 1-20 are presently pending in this application, and currently examined in the Office Action.
Claim Objections
Claim 1 is objected to because of the following informalities: the end of the 4th to last line of claim 1 repeats the word “the”, stating “axial side of the the” (emphasis added); it is suggested the repeating word “the” be deleted. Appropriate correction is required.
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 § 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.
Claims 1-14, 16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Morriss et al. (US PG Pub. 2015/0335429), as previously presented, hereinafter Morriss, in view of Hariton et al. (US PG Pub. 2018/0014930), as previously presented, hereinafter Hariton.
Regarding claim 1, Morriss discloses a stent of prosthetic heart valve (100), illustrated in Figures 10A and 27, comprising an inner frame (120) and an outer frame (110) connected with each other; wherein the outer frame (110) comprises an outer body section, and an outer skirt section (170) extending from the outer body section and located at a radially outer side of the outer body section (422), wherein the outer skirt section (170) is located between an inflow end (424) and an outflow end (111) of the outer body section, illustrated in Figure 27; the inner frame (120) comprises an inner body section (127) at least partially within the outer frame (110), and an inner skirt section (121) at an inflow end of the inner body section (127); a portion of the outer body section between the outer skirt section (170) and the inner skirt section serves as a support section (422), a radial gap is defined between the support section (422) of the outer body section and the inner body section, and the outer skirt section (170), the inner skirt section (121), and the support section (422) together form a receiving space for receiving a valve annulus therein, illustrated in Figures 10A and 27; and wherein, during use, the outer skirt section (170) abuts against an axial side of the valve annulus (AN), and the support section (422) of the outer body section abuts against a radial inner side of the valve annulus (AN), and the radial gap provides a space for the deformation of the support section (422) under a radial pressure of the valve annulus (AN), illustrated in Figure 27 ([0171]; [0173], Lines 1-5; [0183], Lines 1-3 & [0237]); but does not specifically teach the inner skirt section projecting radially outside the inner body section and the inflow end of the outer body section, and abutting against an opposite axial side of the valve annulus.
However, Hariton teaches a stent of prosthetic heart valve, in the same field of endeavor, comprising an inner frame (30) and an outer frame (60), wherein 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), and projecting radially outside the inflow end (ends of 54) of the outer body section, such that during use, the inner skirt section (40) abuts against a superior side of a valve annulus, illustrated in Figures 1A, 1B, 2E and 4F; the radially projecting inner skirt section (40) aid in securing the prosthetic heart valve in place by sandwiching the valve annulus between the superior and inferior sides ([0292]; [0299] & [0362]).
In view of the teachings of Hariton, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the inner skirt section, of the stent of prosthetic heart valve of Morriss, to project radially outside the inner body section from the inflow end, project radially outside the inflow end of the outer body section, and in use, abut against an opposite axial side of the valve annulus, in order to aid in securing the prosthetic heart valve in place by sandwiching the valve annulus between the superior and inferior/the axial and opposite axial sides, as taught by Hariton.
Regarding claims 2 and 14, Morriss in view of Hariton disclose the stent of prosthetic heart valve according to claim 1, wherein Morris further teaches the inflow end (424) of the outer body section (110) is a free end, illustrated in Figure 27, and the outer body section is covered with a flow blocking film (140), illustrated in Figure 10A (Morriss: [0173]); and Hariton teaches the inner skirt section (40) and the inner body section (32) are covered with a flow blocking film (23), illustrated in Figures 1A, 1B, 2E and modified figure 1A, above (Hariton: [0302], Lines 1-4 & [0366]).
Regarding claim 3, Morriss in view of Hariton disclose the stent of prosthetic heart valve according to claim 2, wherein Morris further teaches the outer body section comprises a bottom section (112) extending outwardly away from a central axis of the outer frame (110) in a radial direction and extending towards the inner skirt section in an axial direction, and a top section (422) extending from an inflow end of the bottom section further toward the inner skirt section in the axial direction; wherein the support section (422) of the outer body section is at least partially formed by the top section, illustrated in Figure 27.
Regarding claim 4, Morriss in view of Hariton disclose the stent of prosthetic heart valve according to claim 3, wherein Morris further teaches an outflow end (111) of the bottom section is fixedly connected with an outflow end of the inner body section (Morriss: [0188], Lines 1-10).
Regarding claim 5, Morriss in view of Hariton disclose the stent of prosthetic heart valve according to claim 3, wherein Morris further teaches the top section (422) extends axially toward the inner skirt section, illustrated in Figure 27; and though it does not specifically disclose that the top section extends inwardly toward the central axis of the outer frame, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate shape/form for the top section of the outer frame, including extending axially toward the inner skirt section and inwardly toward the central axis of the outer frame, based on intended use/implantation site and/or specific patient anatomy; and doing so amounts to a mere change in shape/form, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04).
Regarding claim 6, Morriss in view of Hariton disclose the stent of prosthetic heart valve according to claim 3, wherein Morris further teaches the top section (422) has an O-shaped peripheral profile, illustrated in Figure 27.
Regarding claim 7, Morriss in view of Hariton disclose the stent of prosthetic heart valve according to claim 3, wherein Morris further teaches an angle formed by two tangent lines of an outflow end of the bottom section (112) that are radially opposite to each other ranges from 90 degrees to 150 degrees, illustrated in Figure 27.
Regarding claim 8, Morriss in view of Hariton disclose the stent of prosthetic heart valve according to claim 4, wherein Morris further teaches the inner body section, of the inner frame (120), has a higher deformation resistance than the outer body section, of the outer frame (110) - (Morriss[0177]); and though it is not specifically stated that the bottom section of the outer body section has a higher deformation resistance than the top section of the outer body section, this parameter would have been obvious to one having ordinary skill in the art before the effective filing date of the invention, due to the cell size/ area of openings of cells of the bottom section (112) being smaller than the cell size/ area of openings of cells of the top section (422), illustrated in Figure 27.
Regarding claim 9, Morriss in view of Hariton disclose the stent of prosthetic heart valve according to claim 8, wherein Morris further teaches the inner body section, of the inner frame (120), having a higher deformation resistance than the outer body section, of the outer frame (110), is achieved by a rigidity of material of the inner body section, of the inner frame (120), being greater than a rigidity of material of the outer body section, of the outer frame (110) - (Morriss[0177]); and the bottom section (112) of the outer body section having a higher deformation resistance than the top section (422) of the outer body section is achieved by an area of openings of cells of the bottom section (112) being smaller than an area of openings of cells of the top section (422), illustrated in Figure 27.
Regarding claim 10, Morriss in view of Hariton disclose the stent of prosthetic heart valve according to claim 1, and though it is not specifically disclosed that the minimum axial distance between the inner skirt section and the outer skirt section ranges from 5 mm to 15 mm, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate distance between the inner skirt section and the outer skirt section, including between 5 mm to 15 mm, depending on intended use and/or specific patient anatomy to ensure a secure attachment to an annulus.
Regarding claim 11, Morriss in view of Hariton disclose the stent of prosthetic heart valve according to claim 1, wherein Morris further teaches the outer skirt section (170) extends outward from the outer body section at the largest diameter, illustrated in Figure 27.
Regarding claim 12, Morriss in view of Hariton disclose the stent of prosthetic heart valve according to claim 1, wherein Morris further teaches an angle between a starting end/tangent line to the starting end of the outer skirt section (170) and a central axis of the outer frame (110) ranges from 60 degrees to 120 degrees; an angle between a terminal end/tangent line to the terminal end of the outer skirt section (170) and the central axis of the outer frame ranges from 60 to 120 degrees, illustrated in Figure 27.
Regarding claim 13, Morriss in view of Hariton disclose the stent of prosthetic heart valve according to claim 1, wherein Hariton further teaches 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 (Hariton: [0318]).
Regarding claim 16, Morriss in view of Hariton disclose the stent of prosthetic heart valve according to claim 1, wherein Morris further teaches the outer skirt section (170) comprises a plurality of support units (170) distributed in a circumferential direction, each of said support units comprises two outwardly extending support rods, each of said support rods comprises a first end away from said outer body section and a second end adjacent to and connected to said outer body section, wherein the second ends of two adjacent support rods of two adjacent support units are spaced apart from each other, illustrated in Figure 27; and though it does not specifically disclose that the first ends of the two support rods of each support unit are connected and smoothly transited to each other, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate shape/form of the support units, including having the first ends of the two support rods of each support unit are connected and smoothly transited to each other, since doing so amounts to a mere change in shape/form, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04).
Regarding claim 18, Morriss in view of Hariton disclose the stent of prosthetic heart valve according to claim 1, wherein Morris further teaches the outer skirt section is covered with a protective film (Morris: [0265], Last 4 Lines).
Regarding claim 19, Morriss in view of Hariton disclose the stent of prosthetic heart valve according to claim 1, and Morris further teaches at least two prosthetic leaflets (132) fixedly connected within the inner body section of the inner frame (120) of the stent of prosthetic heart valve, and edges of the at least two prosthetic leaflets (132) are circumferentially engaged with each other, illustrated in Figures 10E, 10F and 11B-E (Morriss: [0183] & [0184]).
Regarding claim 20, Morriss in view of Hariton disclose the prosthetic heart valve replacement system comprising the prosthetic heart valve according to claim 19, and Morriss further teaches a delivery device for delivering the prosthetic heart valve; the prosthetic heart valve has a delivery condition being radially compressed and a natural condition being radially expanded; the delivery device comprises an outer sheath/catheter and an inner core/plunger passing through the outer sheath, and the inner core and the outer sheath are axially movable relative to each other; 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 (Morriss: [0143] & [0174], Lines 1-4).
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 15 is rejected under 35 U.S.C. 103 as being unpatentable over Morriss in view of Hariton as applied to claim 1 above, and further in view of Navia et al. (US PG Pub. 2008/0177381), as previously disclosed, hereinafter Navia.
Regarding claim 15, Morriss in view of Hariton disclose the stent of prosthetic heart valve according to claim 1, but do not specifically teach a radiopaque 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 Morriss in view 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.
Response to Arguments
Applicant’s arguments with respect to independent claim 1 have been considered but are moot because the arguments do not apply to the current rejections presently used in the Office Action. Specifically, in response to Applicant’s amendment, Examiner now rejects independent claim 1, and those claims that depend from it, as being unpatentable over Morriss in view of Hariton.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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 05/20/2026
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