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 .
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.
Response to Amendment
The amendment filed 05/11/2026 has been entered. Claims 1-16 remain pending in the
application.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
Regarding Claim 1, "coves" in line 14 should read as "covers". Appropriate correction is required.
Regarding Claim 1. Appropriate correction is required.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over US 20180296341 A1 (hereafter --Noe--), in further view of US 20120123529 A1 (hereafter --Levi--).
Regarding Claim 1, Noe discloses an artificial heart valve prosthesis, comprising: a stent comprising at least two commissures spaced circumferentially around the stent (see annotated valve prosthesis, stent, and commissures in Figure 10 below), wherein each of the commissures is provided with a first window and a second window, which are arranged along an axial direction of the stent (see annotated first and second windows in Figure 18B below), and wherein the first window is located closer to an outflow end of the stent (see annotated outflow end in Figure 18B below); and at least two leaflets arranged circumferentially around the stent (see annotated leaflets in Figure 10 below), wherein each of the leaflets comprises a main segment and flaps arranged on opposite circumferential sides of the main segment (see annotated main segment in Figure 10, see annotated flaps in Figure 18B below), wherein the main segment is disposed on an inner side of the stent (see annotated main segment in Figure 10 below), each of the flaps passed through the second window and at least partially covering an outer surface of the commissure (see annotated flaps, outer surface, and second window in Figure 18B below, see also paragraph [0133]), and wherein the flap is sutured at the first window and the second window (see paragraph [0133]). Noe discloses the flap is sutured into the holes 1819 and therefore the flap is sutured “at” the first window and second window). The term “at” is interpreted broadly, meaning “along”, “adjacent”, or “alongside” (see Merriam Webster Online for “at”). Since the suture passes through holes “at” or adjacent to the first window and second window, the prior art reads on the claim.
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Noe fails to disclose at least two hinge sheets, wherein each of the hinge sheets is at least partially located between the commissure and the flap of the leaflet, and wherein the hinge sheet surrounds and coves three surfaces of the side support arm by bending the hinge sheet.
Levi discloses an artificial heart valve prosthesis comprising at least two commissures spaced circumferentially around the stent (see annotated valve prosthesis, stent, and commissures in Figure 60 below), wherein each of the commissures is provided with a second window, the second window being surrounding by side support arms (see annotated side support arms 320 in Figure 60A below) which are arranged along an axial direction of the stent (see annotated second window and leaflets in Figures 60 and 65 below). Levi teaches at least two hinge sheets (see annotated hinge sheet 386, one being at each commissure as denoted in paragraphs [0100] and [0101]), wherein each of the hinge sheets is at least partially located between the commissure and the flap of the leaflet (see annotated commissure, flap, and hinge sheet in Figure 65, see also paragraphs [0101]] and [0102]), and wherein the hinge sheet surrounds and covers three surfaces of the side support arm by bending the hinge sheet (see paragraph [0102] denoting each end portion 386 of the sheet extends between a respective side tab 366 and the exterior, medial and interior surfaces 324, 328, 326, respectively, of a respective side strut 320).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the prosthesis to further include at least two hinge sheets, wherein each of the hinge sheets is at least partially located between the commissure and the flap of the leaflet, and wherein the hinge sheet surrounds and covers three surfaces of the side support arm by bending the hinge sheet, as by doing so enables the hinge sheets to protects the flex hinges 370 (leaflet flaps) from damage caused by the interior-medial edges 332 of the struts 320 as the leaflets articulate between open and closed positions, as taught as Levi (see paragraph [0105]).
Regarding Claim 2, Noe as modified discloses the artificial heart valve prosthesis according to claim 1.
Noe as modified fails to disclose wherein the hinge sheet is provided with a through hole for passage therethrough of the flap, and wherein the hinge sheet is sutured at the first window.
Levi teaches wherein the hinge sheet is provided with a through hole for passage therethrough of the flap (see annotated flaps and through hole in Figure 65 below), and wherein the hinge sheet is sutured at the first window (see paragraph [0102] denoting that the hinge sheet is sutured by sutures 390 can secure each side tab 366 and one end of the sheet 378 to a respective strut 320).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the prosthesis to further comprise of the hinge sheet being provided with a through hole for passage therethrough of the flap, and wherein the hinge sheet is sutured at the first window, as by doing so would enable the sutures 390 to secure the sheet 378 to the side tab end portions 368 and tighten the sheet end portions 386 around the side struts 320, thereby securing the side tabs 366 to the side struts 320 and securing the leaflet structure 314 to the frame 312 (see paragraph [0102]).
Regarding Claim 3, Noe as modified discloses the artificial heart valve prosthesis according to claim 2, [wherein the hinge sheet covers the first window,] or wherein the flap is sutured to the hinge sheet (see claim 2 rejection above).
Regarding Claim 4, Noe as modified discloses the artificial heart valve prosthesis according to claim 2, wherein: the hinge sheet at least partially surrounds and covers an outer surface, an outer side face and an inner surface of the side support arm (see claim 1 rejection above), and each of the flaps comprises a head portion, a middle portion and a trailing portion, which are sequentially joined (see annotated head, middle, and trailing portion in Figures 18B and 18D below), wherein the head portion is inserted in the second window and the through hole (see annotated head portion being inserted into second window in Figure 18B below, and see Figure 15B and 15C showing the flaps inserted into the through hole of Noe, see through hole and flaps in Figure 65 above, as Noe has been modified by Levi to include the hinge sheet with the through hole for the flaps in the second window of Noe), wherein the middle portion extends over the outer surface (see annotated middle portion and outer surface in Figure 18B below), the outer side face and the inner surface of the side support arm so as to wrap a portion of the hinge sheet arranged on the side support arm (see annotated middle portion in Figure 18B below, outer side face, and inner surface in Figure 18B below) and wherein the trailing portion overlaps a portion of the main segment in the leaflet (see annotated trailing portion in Figure 18B below, the trailing portion defined as the rest of the flap of the leaflet until the main segment in the leaflet, see also paragraph [0133] denoting that 1822a,b are the arms of the leaflets inside of the stent).
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Regarding Claim 5, Noe as modified discloses artificial heart valve prosthesis according to claim 4, wherein the flap is sutured at the second window (see paragraph [0133], Noe discloses the flap is sutured into the holes 1819 (through hole) and therefore the flap is sutured “at” the second window). The term “at” is interpreted broadly, meaning “along”, “adjacent”, or “alongside” (see Merriam Webster Online synonyms for “at”; since the suture passes through holes “at” or adjacent to the first window and second window, the prior art reads on the claim, wherein each of the hinge sheets is at least partially arranged between the commissure and the flap (see annotated flap and hinge sheet in Figures 18A-18E below).
This embodiment of Noe fails to disclose sutured by a suture thread successively passed through the main segment of the leaflet, the second window, the through hole and the trailing portion of the flap.
Another embodiment of Noe teaches by a suture thread successively passed through the main segment of the leaflet, the second window, the through hole and the trailing portion of the flap (see annotated main segment, second window, through hole, and trailing portion in Figure 11E below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have a suture thread successively passed through the main segment of the leaflet, the second window, the through hole and the trailing portion of the flap, as this method distributes strains along the length of the commissures, thereby reducing tearing or strain propagation through the tissue as taught by Noe (see paragraph [0130]).
Regarding Claim 6, Noe as modified discloses the artificial heart valve prosthesis according to claim 2, wherein in a circumferential direction of the stent, edges of the through hole are coincident with the edge of the second window (see Figures 15A-15B above).
Although not required due to the “or” clause, the embodiment of the hinge sheet 1515 has a through hole that is shaped the same as the second window (see annotated through hole in Figure 15B above, see also second window in 18E above). Since the hinge sheet of Noe as modified has this through hole, as modified by claim 2 above, it would have been obvious to one of ordinary skill to have the limitation wherein in a circumferential direction of the stent the edges of the through hole are lateral to edge of the second window,
Regarding Claim 7, Noe as modified discloses the artificial heart valve prosthesis according to claim 2, wherein the flap is provided with an engagement notch on a side thereof proximate an inflow end of the stent, wherein the engagement notch is located at a junction of the flap with the main segment (see annotated flap and notch in Figure 21 below, see also paragraph [0128]) and is configured to engage the through hole and the second window (see annotated flap being inserted into second window in Figure 18B below, and see Figure 15B and 15C showing the flaps inserted into the through hole as modified by Levi, showing that this notch could “engage” the second window and through hole since the flap is inserted into both).
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Regarding Claim 8, Noe as modified discloses the artificial heart valve prosthesis according to claim 2, wherein the commissure is further provided with a third window, wherein the third window is located on a side of the second window proximate an inflow end of the stent (see annotated third window in Figure 18E above).
Noe as modified fails to disclose wherein the hinge sheet is sutured at the third window.
Levi teaches wherein the hinge sheet is sutured at the commissure window (see paragraph [0103] denoting that second sutures 392 can secure the hinge sheet to the commissure, being helical whip stitches that intersect the commissures 376 at a plurality of different longitudinal positions).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the prosthesis to further comprise of the hinge sheet being sutured at the third window, as Levi teaches it to be well known in the art to use secondary sutures at different longitudinal areas of the commissure, and as by doing so would secure the loose portions of the sheet 378 tightly against the lateral surfaces 330 of the side struts (see paragraph [0103]).
Regarding Claim 9, Noe as modified discloses the artificial heart valve prosthesis according to claim 1, wherein each of the flaps comprises a head portion, a middle portion and a trailing portion, which are sequentially joined (see annotated head, middle, and trailing portion in Figures 18B and 18D below), wherein the head portion is inserted in the through hole (see annotated head portion being inserted into second window in Figure 18B below, and see Figure 15B and 15C showing the flaps inserted into the through hole, as modified by Levi), wherein the middle portion extends over the outer surface (see annotated middle portion and outer surface in Figure 18B below), an outer side face and an inner surface of the side support arm (see annotated middle portion in Figure 18B below, outer side face, and inner surface in Figure 18B below) and wherein the trailing portion overlaps a portion of the main segment in the leaflet (see annotated trailing portion in Figure 18B below, the trailing portion defined as the rest of the flap of the leaflet until the main segment in the leaflet, see also paragraph [0133] denoting that 1822a,b are the arms of the leaflets inside of the stent).
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Regarding Claim 10, Noe as modified discloses artificial heart valve prosthesis according to claim 9, wherein the flap is sutured at the second window (see paragraph [0133], Noe discloses the flap is sutured into the holes 1819 (through hole) and therefore the flap is sutured “at” the second window). The term “at” is interpreted broadly, meaning “along”, “adjacent”, or “alongside” (see Merriam Webster Online synonyms for “at”; since the suture passes through holes “at” or adjacent to the first window and second window, the prior art reads on the claim, wherein each of the hinge sheets is at least partially arranged between the commissure and the flap (see annotated flap and hinge sheet in Figures 18A-18E below).
This embodiment of Noe fails to disclose sutured by a suture thread successively passed through the main segment of the leaflet, the second window, and the trailing portion of the flap.
Another embodiment of Noe teaches by a suture thread successively passed through the main segment of the leaflet, the second window, and the trailing portion of the flap (see annotated main segment, second window, through hole, and trailing portion in Figure 11E below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have a suture thread successively passed through the main segment of the leaflet, the second window, and the trailing portion of the flap, as this method distributes strains along the length of the commissures, thereby reducing tearing or strain propagation through the tissue as taught by Noe (see paragraph [0130]).
Regarding Claim 11, Noe discloses an artificial heart valve prosthesis, comprising: a stent comprising at least two commissures spaced circumferentially around the stent (see annotated stent and commissures in Figure 10 below), wherein the commissure is provided with a second window (see annotated second window in Figure 18E below); at least two leaflets arranged circumferentially around the stent (see annotated leaflets in Figure 10 below), wherein each of the leaflets comprises a main segment and flaps arranged on opposite circumferential sides of the main segment (see annotated main segment in Figure 10 below and flaps in Figure 18E below), wherein the main segment is disposed on an inner side of the stent (see annotated main segment in Figure 10 below), wherein the flap is passed through the second window (see annotated flap and second window in Figure 18B below), and wherein the second window is delimited by side support arms arranged circumferentially around the stent (see side arms annotated Figure 18E below). Noe discloses the flap is sutured into the holes 1819 (through hole) and therefore the flap is sutured “at” the second window). The term “at” is interpreted broadly, meaning “along”, “adjacent”, or “alongside” (see Merriam Webster Online synonyms for “at”; since the suture passes through holes “at” or adjacent to the first window and second window, the prior art reads on the claim, wherein each of the hinge sheets is at least partially arranged between the commissure and the flap (see annotated flap and hinge sheet in Figures 18A-18E below).
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Noe fails to disclose hinge sheets at least partially covering an outer surface of the commissure and provided with a through hole, wherein each hinge sheet is at least partially located between the commissure and the flap of the leaflet; wherein the flap of the leaflet passes through the through hole, therefore having the flap cover at least a part of an outer surface of the hinge sheet, wherein the hinge sheet is sutured at the second window, and wherein the hinge sheet surrounds and covers three surfaces of the side support arm by bending the hinge sheet.
Levi discloses an artificial heart valve prosthesis comprising at least two commissures spaced circumferentially around the stent (see annotated valve prosthesis, stent, and commissures in Figure 60 below), wherein each of the commissures is provided with a second window, the second window being surrounding by side support arms (see annotated side support arms 320 in Figure 60A below) which are arranged along an axial direction of the stent (see annotated second window and leaflets in Figures 60 and 65 below). Levi teaches hinge sheets at least partially covering an outer surface of the commissure and provided with a through hole (see annotated hinge sheet 386, one being at each commissure as denoted in paragraphs [0100] and [0101], see annotated commissure, through hole, and hinge sheet in Figures 60 and 65 below), wherein the flap of the leaflet passes through the through hole, therefore having the flap cover at least a part of an outer surface of the hinge sheet (see annotated through hole, flap, and hinge sheet in Figure 64 below), wherein each of the hinge sheets is at least partially located between the commissure and the flap of the leaflet (see annotated commissure, flap, and hinge sheet in Figure 65, see also paragraphs [0101]] and [0102]), and wherein the hinge sheet surrounds and covers three surfaces of the side support arm by bending the hinge sheet (see paragraph [0102] denoting each end portion 386 of the sheet extends between a respective side tab 366 and the exterior, medial and interior surfaces 324, 328, 326, respectively, of a respective side strut 320).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the prosthesis to further include hinge sheets at least partially covering an outer surface of the commissure and provided with a through hole, wherein each hinge sheet is at least partially located between the commissure and the flap of the leaflet; wherein the flap of the leaflet passes through the through hole, therefore having the flap cover at least a part of an outer surface of the hinge sheet, wherein the hinge sheet is sutured at the second window, and wherein the hinge sheet surrounds and covers three surfaces of the side support arm by bending the hinge sheet, as by doing so enables the hinge sheets to protects the flex hinges 370 (leaflet flaps) from damage caused by the interior-medial edges 332 of the struts 320 as the leaflets articulate between open and closed positions, as taught as Levi (see paragraph [0105]).
Regarding Claim 12, Noe as modified discloses the artificial heart valve prosthesis according to claim 11, wherein: the hinge sheet at least partially surrounds and covers an outer surface, an outer side face and an inner surface of the side support arm (see claim 11 rejection above), and each of the flaps comprises a head portion, a middle portion and a trailing portion, which are sequentially joined (see annotated head, middle, and trailing portion in Figures 18B and 18D below), wherein the head portion is inserted in the second window and the through hole (see annotated head portion being inserted into second window in Figure 18B below, and see Figure 15B and 15C showing the flaps inserted into the through hole as modified by Levi), wherein the middle portion extends over the outer surface (see annotated middle portion and outer surface in Figure 18B below), the outer side face and the inner surface of the side support arm so as to wrap a portion of the hinge sheet arranged on the side support arm (see annotated middle portion in Figure 18B below, outer side face, and inner surface in Figure 18B below, hinge sheet being present around the surfaces of the side arm as modified by Levi) and wherein the trailing portion overlaps a portion of the main segment in the leaflet (see annotated trailing portion in Figure 18B below, the trailing portion defined as the rest of the flap of the leaflet until the main segment in the leaflet, see also paragraph [0133] denoting that 1822a,b are the arms of the leaflets inside of the stent).
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Regarding Claim 13, Noe as modified discloses artificial heart valve prosthesis according to claim 12, wherein the flap is sutured at the second window (see paragraph [0133], Noe discloses the flap is sutured into the holes 1819 (through hole) and therefore the flap is sutured “at” the second window). The term “at” is interpreted broadly, meaning “along”, “adjacent”, or “alongside” (see Merriam Webster Online synonyms for “at”; since the suture passes through holes “at” or adjacent to the first window and second window, the prior art reads on the claim, wherein each of the hinge sheets is at least partially arranged between the commissure and the flap (see annotated flap and hinge sheet in Figures 18A-18E below).
This embodiment of Noe fails to disclose sutured by a suture thread successively passed through the main segment of the leaflet, the second window, the through hole and the trailing portion of the flap.
Another embodiment of Noe teaches by a suture thread successively passed through the main segment of the leaflet, the second window, the through hole and the trailing portion of the flap (see annotated main segment, second window, through hole, and trailing portion in Figure 11E below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have a suture thread successively passed through the main segment of the leaflet, the second window, the through hole and the trailing portion of the flap, as this method distributes strains along the length of the commissures, thereby reducing tearing or strain propagation through the tissue as taught by Noe (see paragraph [0130]).
Regarding Claim 14, Noe as modified discloses the artificial heart valve prosthesis according to claim 11, wherein in a circumferential direction of the stent, edges of the through hole are coincident with the edge of the second window (see Figures 15A-15B above).
Although not required due to the “or” clause, the embodiment of the hinge sheet 1515 has a through hole that is shaped the same as the second window (see annotated through hole in Figure 15B above, see also second window in 18E above). Since the hinge sheet of Noe as modified has this through hole, as modified by claim 2 above, it would have been obvious to one of ordinary skill to have the limitation wherein in a circumferential direction of the stent the edges of the through hole are lateral to edge of the second window,
Regarding Claim 15, Noe as modified discloses the artificial heart valve prosthesis according to claim 11, wherein that the flap is provided with an engagement notch on a side thereof proximate an inflow end of the stent, wherein the engagement notch is located at a junction of the flap with the main segment (see annotated flap and notch in Figure 21 below, see also paragraph [0128]) and is configured to engage the through hole and the second window (see annotated flap being inserted into second window in Figure 18B below, and see Figure 15B and 15C showing the flaps inserted into the through hole, as modified by Levi, showing that this notch could “engage” the second window and through hole since the flap is inserted into both).
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Regarding Claim 16, Noe as modified discloses the artificial heart valve prosthesis according to claim 11, wherein the commissure is further provided with a third window, wherein the third window is located on a side of the second window proximate an inflow end of the stent (see annotated third window in Figure 18E above),
Noe as modified fails to disclose wherein the hinge sheet is sutured at the third window.
Levi teaches wherein the hinge sheet is sutured at the commissure window (see paragraph [0102] denoting that the hinge sheet is sutured by sutures 390 can secure each side tab 366 and one end of the sheet 378 to a respective strut 320, see also paragraph [0103] denoting that second sutures 392 can secure the hinge sheet to the commissure, being helical whip stitches that intersect the commissures 376 at a plurality of different longitudinal positions).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the prosthesis to further comprise of the hinge sheet being sutured at the third window, as Levi teaches it to be well known in the art to use secondary sutures at different longitudinal areas of the commissure, and as by doing so would enable the sutures 390 to secure the sheet 378 to the side tab end portions 368 and tighten the sheet end portions 386 around the side struts 320, thereby securing the side tabs 366 to the side struts 320 and securing the leaflet structure 314 to the frame 312 (see paragraph [0102]), as well as would secure the loose portions of the sheet 378 tightly against the lateral surfaces 330 of the side struts (see paragraph [0103]).
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 PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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