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 .
Response to Amendment
This office action is responsive to the amendment filed on 07/02/2026. As directed by the amendment: no claims have been amended. Thus, claims 1-20 are presently pending in the application.
Response to Arguments
In light of the amendment to claims 1, 9, 10-14 and 17-18 to address the previous 112(b) rejection for lack of antecedent basis, the examiner has withdrawn the 112(b) rejections as the claims now provide proper antecedent basis for the limitation.
The examiner has maintained the nonstatutory double patenting rejection from the non-final office action since applicant has not amended to overcome the double patenting rejection or submitted a terminal disclaimer.
Applicant's arguments filed 07/02/2026 have been fully considered but they are not persuasive. Applicant argues on page 7, the prior art Marchand is silent about how to use laser cutting to achieve any of its detailed embodiments. The examiner respectfully disagrees. Marchand discloses the anchoring device may be a mesh that is braided from one strand or in alternative, the anchoring device 1 (as seen in Figure 3 below) may be a continuous mesh obtained by the means of laser cutting (see paragraphs [0141] and [0196]). The claim only required that the stent frame is formed from a laser cut expanded tube and did not include any specific number of struts or undulations that form said laser cut mesh which would impart structural differences.
Applicant argues on page 8, a person of skill in the art would not look to combine references comprising fundamentally distinct stent structures, Marchand comprises a braided mesh wire strand design while McLean uses a laser cut tube design. This argument is not persuasive. Marchand discloses a double walled anchoring device that is a mesh, braided from one strand or in alternative, the anchoring device 1 (as seen in Figure 3 below) may be a continuous mesh obtained by the means of laser cutting (see paragraphs [0141] and [0196]). Marchand further discloses the double walled anchoring device includes an inner wall and an outer wall. McLean et al. also teaches a double walled anchoring member in the same field of endeavor for anchoring a prosthetic heart valve inside a heart, the anchoring member 110 comprises a mesh, including a braided mesh formed from a plurality of flexible wires or filaments (paragraph [0197]). McLean et al. teaches the double walled anchoring member includes an inner wall and an outer wall. McLean et al. was used to modify the coupling of the transition wall to be upstream versus downstream.
Applicant argues on page 9, the prior art McLean et al. discloses the anchoring member 110 can be integrally formed with posts 122 of the valve support 120, but then states that “a plurality of separate bands or wires 358 extend around the circumference 150 of the anchoring member 110” thus, the depicted wires 358 are clearly not integrally formed. This argument was not persuasive. Claim 15 in which the McLean et al. reference was applied to was used to teach a plurality of control apertures and at least one suture applied to the control aperture to permit the outer wall to be collapsed inwardly to a low-profile delivery (see rejections below). The recitation was not used to teach integrally extending posts. Furthermore, the claim never recite any structure on the anchor member to be “integrally formed” as argued.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 7-8, 10 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of U.S. Patent No. 11,759,319 in view of Marchand et al. U.S. Publication 2017/0216027.
Regarding claim 1, the Patent discloses a replacement heart valve (column 24, line 29), comprising: a unibody stent frame formed from a laser cut expanded tube (column 24, line 30), the unibody stent frame having a folded double-wall (column 24, lines 30-31) and comprising: an outer wall comprising an open enlarged diameter region, a middle reduced diameter region, and a closed enlarged diameter region opposite the open enlarged diameter region (column 24, lines 34-36); a tubular inner wall with a central lumen (column 24, line 37); a transition wall between the closed enlarged diameter region of the outer wall and the inner wall (column 24, lines 38-39); a replacement leaflet valve located in the central lumen of the inner wall (column 24, line 41). However, the Patent does not expressly disclose wherein: the central lumen includes an opening at the transition wall, and the diameter of the central lumen is less than or equal to the diameter of the opening at the transition wall along the length of the central lumen. Marchand et al. discloses a replacement heart valve 1, comprising: a unibody stent frame formed from a laser cut expanded tube (as seen in Figures 1-2 and paragraphs [0141-0142] and [0196]), the unibody stent frame having a folded double-wall (abstract and paragraphs [0015-0016], [0051] and [0100]) and comprising: an outer wall 4 comprising an open enlarged diameter region, a middle reduced diameter region, and a closed enlarged diameter region opposite the open enlarged diameter region (as seen in the annotated Figure 3B and see Figure 11 and paragraph [0110]); a tubular inner wall 5 with a central lumen and a transition wall (see annotated Figure 3B), wherein the diameter of the central lumen is equal to the diameter of the opening at the transition wall for the purpose of creating a continuous lumen forming a cylindrical cross section (paragraph [0116-0117]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Patent’s central lumen to have a diameter equal to the diameter of the opening at the transitional wall along the length of the central lumen as taught by Marchand for the purpose of creating a continuous lumen forming a cylindrical cross section.
Regarding Claim 3, the Patent discloses wherein the tubular outer wall is an everted portion of the laser cut expanded tube (column 24, lines 30-31).
Regarding Claim 7, the Patent discloses wherein the open enlarged diameter region is a downstream open enlarged diameter region (column 24, lines 34-35).
Regarding Claim 8, the Patent discloses the closed enlarged diameter region is an upstream closed diameter region (column 24, line 36).
Regarding Claim 10, the Patent discloses wherein the plurality of circumferential struts includes a circumferential strut in the tubular inner wall (column 24, lines 43-48).
Regarding Claim 14, the Patent discloses wherein the plurality of circumferential struts includes at least 3 circumferential struts in the tubular outer wall (column 25, lines 11-12).
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 and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marchand et al. U.S. Publication 2017/0216027.
PNG
media_image1.png
417
669
media_image1.png
Greyscale
PNG
media_image2.png
229
393
media_image2.png
Greyscale
Regarding Claim 1, Marchand et al. discloses a replacement heart valve 1, comprising:
a unibody stent frame formed from a lasercut expanded tube (as seen in Figures 1-2 and paragraphs [0141-0142] and [0196]), the unibody stent frame having a folded double-wall (abstract and paragraphs [0015-0016], [0051] and [0100]) and comprising: an outer wall 4 comprising an open enlarged diameter region, a middle reduced diameter region, and a closed enlarged diameter region opposite the open enlarged diameter region (as seen in the annotated Figure 3B above and see Figure 11 and paragraph [0110]); a tubular inner wall 5 with a central lumen; a transition wall between the closed enlarged diameter region of the outer wall and the inner wall; a replacement leaflet valve 13 located in the central lumen of the inner wall 5 (abstract, paragraph [0158]), wherein: the central lumen includes an opening at the transition wall (see annotated Figure 2), and a diameter of the central lumen is less than or equal to the diameter of the opening at the transition wall along the length of the central lumen (as seen in the annotated Figure 2 above).
Regarding Claim 2, Marchand et al. discloses wherein the tubular inner wall 5 is an inverted portion of the laser cut expanded tube (see annotated Figure 2 and 3B).
Regarding Claim 3, Marchand et al. discloses wherein the tubular outer wall 4 is an everted portion of the laser cut expanded tube (see annotated Figure 2 and 3B).
Regarding Claim 4, Marchand et al. discloses wherein the diameter D2, D3, D4 of the central lumen varies along the length of the central lumen (as seen in the annotated Figure 2).
Regarding Claim 19, Marchand et al. discloses a replacement heart valve 1, comprising:
a unibody stent frame formed from a laser cut expanded tube (as seen in Figures 1-2 and paragraphs [0141-0142] and [0196]), the unibody stent frame having a folded double-wall (abstract and paragraphs [0015-0016], [0051] and [0100]) and comprising: an outer wall 4 comprising an open enlarged diameter region, a middle reduced diameter region, and a closed enlarged diameter region opposite the open enlarged diameter region (as seen in the annotated Figure 3B above and see Figure 11 and paragraph [0110]); a tubular inner wall 5 with a central lumen; a transition wall between the closed enlarged diameter region of the outer wall and the inner wall; a replacement leaflet valve 13 located in the central lumen of the inner wall 5 (abstract, paragraph [0158]), wherein the tubular inner wall 5 is an inverted portion of the laser cut expanded tube (as seen in the annotated Figure 2 and 3B).
Regarding Claim 20, Marchand et al. discloses a replacement heart valve 1, comprising: a unibody stent frame formed from a laser cut expanded tube (as seen in Figures 1-2 and paragraphs [0141-0142] and [0196]), the unibody stent frame having a folded double-wall (abstract and paragraphs [0015-0016], [0051] and [0100]) and comprising: an outer wall 4 comprising an open enlarged diameter region, a middle reduced diameter region, and a closed enlarged diameter region opposite the open enlarged diameter region (as seen in the annotated Figure 3B above and see Figure 11 and paragraph [0110]); a tubular inner wall 5 with a central lumen; a transition wall between the closed enlarged diameter region of the outer wall and the inner wall; and a replacement leaflet valve 13 located in the central lumen of the inner wall 5 (abstract, paragraph [0158]); wherein the outer wall is an everted portion of the laser cut expanded tube (as seen in the annotated Figure 2 and 3B).
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.
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marchand et al. U.S. Publication 2017/0216027.
Regarding Claim 5, in the embodiment used in the rejection above, Figures 2-3B does not expressly disclose wherein the central lumen extends beyond the open enlarged end of the outer wall. In an alternative embodiment as seen in Figures 7A-B, Marchand et al. teaches the tubular inner wall having a central lumen extends beyond the open enlarged end of the outer wall for the purpose of aiding in anchoring the device downstream of the replacement valve (paragraph [0194] and [0199]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Figures 2-3B to further include inner wall having a central lumen extends beyond the open enlarged end of the outer wall as taught in Figures 7A-7B for the purpose of aiding in anchoring the device downstream of the replacement valve.
Claim(s) 6-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marchand et al. U.S. Publication 2017/0216027 in view of McLean et al. U.S. Publication 2015/0328002.
Regarding Claim 6, Marchand et al. does not expressly disclose wherein the transition wall is upstream of the replacement leaflet valve. McLean et al. teaches a replacement heart valve 1600 in the same field of endeavor comprising a stent frame with a folded double-wall (as seen in Figure 71) having an outer wall comprising an open enlarged diameter region (portion by 110), a closed enlarged diameter (portion by the replacement heart valve), a tubular inner wall with a central lumen and a replacement leaflet valve 130 located in the central lumen of the tubular inner wall 120 and a transition wall 1610 between the closed enlarged diameter region of the outer wall and the tubular inner wall, wherein the transition wall is upstream of the replacement valve (as seen in Figure 71) for the purpose of retaining the prosthetic valve within the valve support (e.g. inner tubular wall) and having the transition wall 1610 to be mechanically isolated from the valve support such that the forces generated at the native valve are absorbed or translated by the transition wall to allow the valve to remain substantially undeformed (paragraph [0344]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Marchand’s transition wall to be upstream from the replacement valve as taught by McLean et al. for the purpose of having a transition wall that is mechanically isolated from the valve support such that the forces generated at the native valve are absorbed or translated by the transition wall to allow the valve to remain substantially undeformed.
Regarding Claim 7, Marchand et al. does not expressly disclose the open enlarged diameter region is a downstream open enlarged diameter region. McLean et al. teaches a replacement heart valve 1400 in the same field of endeavor comprising a stent frame with a folded double-wall (as seen in 69C), the stent frame includes a tubular inner wall 120 and an outer wall 110 having an open enlarged diameter that is a downstream open enlarged diameter region 115 (as seen in Figure 69C), wherein McLean et al. teaches coupling the outer wall to the inner wall at an upstream end can prevent the device from migrating in an upstream direction and allow the outer wall that is uncoupled (downstream) can mechanically isolate the tubular inner wall from radially compressive forces exerted on the device from the heart valve tissue (paragraph [0342]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Marchand’s outer wall to be coupled at upstream end to the tubular inner wall as taught by McLean et al. for the purpose of mechanically isolating isolate the tubular inner wall from radially compressive forces exerted on the device from the heart valve tissue and prevent migration of the device in an upstream direction.
Regarding Claim 8, Marchand et al. does not expressly disclose the closed enlarged diameter region is an upstream closed diameter region. McLean et al. teaches a replacement heart valve 1600 in the same field of endeavor comprising a stent frame with a folded double-wall (as seen in Figure 71) having an outer wall comprising an open enlarged diameter region (portion by 110), a closed enlarged diameter (portion by the replacement heart valve) and a transition wall 1610 between the closed enlarged diameter region of the outer wall and the tubular inner wall, wherein the closed enlarged diameter is an upstream closed diameter region 121 for the purpose of having an enlarged closed region that can be an extension of the upstream end to mechanically isolate the tubular inner wall from forces generated at the native valve and further allowing the enlarger diameter be able to engage tissue at or near the native annulus (paragraph [0344]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Marchand’s outer wall to be coupled to the tubular inner wall at an upstream region and have a closed enlarged diameter at an upstream region as taught by McLean et al. for the purpose of having an enlarged closed region that can be an extension of the upstream end to mechanically isolate the tubular inner wall from forces generated at the native valve and further allowing the enlarger diameter be able to engage tissue at or near the native annulus.
Regarding Claim 9, Marchand et al. does not expressly disclose wherein [the tubular inner wall comprises a plurality of longitudinal struts], the plurality of longitudinal struts includes at least 3 longitudinal struts. McLean et al. teaches a replacement heart valve 1400 in the same field of endeavor comprising a stent frame with a folded double-wall (as seen in 69C), the stent frame includes a tubular inner wall 120 and an outer wall 110, wherein Figures 11B and 11D teaches the tubular inner wall 120 can comprise of a plurality of longitudinal struts 128 which includes at least 3 longitudinal struts 128 for the purpose of forming commissural attachment structures that align with the prosthetic valve commissures to facilitate attachment of the prosthetic valve 130 to the tubular inner wall 120 (as seen in Figures 11B and 11D and paragraph [0203]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Marchand’s tubular inner wall to further include 3 longitudinal struts as taught by McLean et al. for the purpose of forming commissural attachment structures that align with the prosthetic valve commissures to facilitate attachment of the prosthetic valve to the tubular inner wall.
Regarding Claims 10, 11, Marchand et al. does not expressly disclose wherein the unibody stent frame further comprises a plurality of circumferential struts, wherein the plurality of circumferential struts comprises at least one circumferential strut in the tubular inner wall, wherein the plurality of circumferential struts includes at least 3 circumferential struts in the tubular inner wall. McLean et al. teaches a replacement heart valve 1400 in the same field of endeavor comprising a stent frame with a folded double-wall (as seen in 69C), the stent frame includes a tubular inner wall 120 and an outer wall 110, wherein Figures 11B and 11D teaches the tubular inner wall 120 can comprise of a plurality of circumferential struts 124 (undulating struts), including at least 3 circumferential struts (see Figures 11B and 11D) for the purpose of creating a geometrical pattern that can expand and provide sufficient resilience and column strength for maintaining the integrity of the prosthetic valve 130 (as seen in Figures 11B and 11D and paragraph [0198]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Marchand’s tubular inner wall to further include a plurality of circumferential struts as taught by McLean et al. for the purpose of creating a geometrical pattern that can expand and provide sufficient resilience and column strength for maintaining the integrity of the prosthetic valve.
Regarding Claim 12, Marchand et al. does not expressly disclose wherein the plurality of circumferential struts includes at least one circumferential strut in the transition wall. McLean et al. teaches a replacement heart valve 1600 in the same field of endeavor comprising a stent frame with a folded double-wall (as seen in Figure 71) having an outer wall comprising an open enlarged diameter region (portion by 110), a closed enlarged diameter (portion by the replacement heart valve) and a transition wall 1610 between the closed enlarged diameter region of the outer wall and the tubular inner wall, wherein the transition wall 1610 comprises at least one circumferential strut (see curved strut in Figure 71) for the purpose of creating a transition wall that forms an extension of the upstream end 121 of the valve support 120 and that is curved for the purpose of deforming under radial forces exerted on the transitional wall while the valve support remains substantially undeformed (paragraph [0344]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Marchand’s transition wall that comprises at least one circumferential strut as taught by McLean et al. for the purpose of having a transition wall that is curved and capable of deforming under radial forces exerted on the transitional wall while the valve support remains substantially undeformed.
Regarding Claims 13, 14, Marchand et al. does not expressly disclose wherein the unibody stent frame comprises a plurality of circumferential struts, wherein the plurality of circumferential struts comprises a circumferential strut in the outer wall, wherein the plurality of circumferential comprises at least 3 circumferential struts in the outer wall. McLean et al. teaches a replacement heart valve 1400 in the same field of endeavor comprising a stent frame with a folded double-wall (as seen in 69C), the stent frame includes a tubular inner wall 120 and an outer wall 110, wherein Figure 10A teaches the outer wall 110 includes a plurality of undulations, including at least 3 circumferential struts for forming a framework for the outer wall that serves as an anchoring member that can prevent the device from migrating in an upstream direction (paragraphs [0341-0342]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Marchand’s outer wall to further include a plurality of circumferential struts as taught by McLean et al. for the purpose of forming a framework for the outer wall that serves as an anchoring member that can prevent the device from migrating in an upstream direction
Regarding Claim 15, Marchand et al. does not expressly disclose wherein the unibody stent frame further comprises a plurality of control apertures and at least one suture coupled to at least one control aperture of the plurality control apertures. McLean et al. teaches a replacement heart valve 100 comprising a tubular inner wall 120 and an outer wall 110 and a transitional wall 356, wherein the stent frame comprises a plurality of control apertures 360 and at least one suture 358 coupled to the at least one control aperture 360 for the purpose of permitting the outer wall 110 to be collapsed inwardly to a low-profile delivery configuration and limiting the outward deflection of the outer wall struts when in the expanded configuration (paragraph [0250]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Marchand’s outer wall to further include a plurality of control apertures and at least one suture coupled to at least one control aperture as taught by McLean et al. for the purpose of permitting the outer wall to be collapsed inwardly to a low-profile delivery configuration and limiting the outward deflection of the outer wall struts when in the expanded configuration.
Regarding Claim 16, Marchand does not expressly disclose a suture extending over the exterior of the outer wall. McLean et al. teaches a sealing member 140 can be disposed on the outer wall 142 or disposed on the inner wall 141 and can be fixed and coupled to any surface of the anchoring member via a suture (paragraph [0223]) for the purpose of attaching and adhering the skirt between the anchoring member and valve support to promote in-growth of adjacent tissue (see Figures 19A-19B, paragraph [0240]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Marchand to further include a skirt covering an outer surface and inner surface of the open enlarged diameter region and having the skirt be attached via a suture as taught by McLean et al. for the purpose of attaching and adhering the skirt between the anchoring member and valve support to promote in-growth of adjacent tissue.
Regarding Claim 17, Marchand et al. does not expressly disclose wherein commissures of the replacement leaflet valve are sutured to the plurality of longitudinal struts. McLean et al. teaches a replacement heart valve 1400 in the same field of endeavor comprising a stent frame with a folded double-wall (as seen in 69C), the stent frame includes a tubular inner wall 120 and an outer wall 110, wherein Figures 11B and 11D teaches the tubular inner wall 120 can comprise of a plurality of longitudinal struts 128 for the purpose of forming commissural attachment structures that align with the prosthetic valve commissures to facilitate attachment of the prosthetic valve 130 to the tubular inner wall 120 (as seen in Figures 11B and 11D and paragraph [0203]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Marchand’s tubular inner wall to further include longitudinal struts as taught by McLean et al. for the purpose of forming commissural attachment structures that align with the prosthetic valve commissures to facilitate attachment of the prosthetic valve to the tubular inner wall.
Regarding Claim 18, Marchand does not expressly disclose wherein commissures of the replacement leaflet valve are sutured to the plurality of circumferential struts. McLean et al. teaches a replacement heart valve 100 as seen in Figures 10A-19C in the same field of endeavor comprising an tubular inner wall 120 and tubular outer wall 110, wherein the inner wall comprises a plurality of circumferential struts (the undulations forming peaks and valleys) and a replacement leaflet valve 130, wherein the commissure of the replacement leaflet valve is sutured to the plurality of circumferential struts using a sealing member 140 disposed on the inner wall 120 and can be fixed and coupled to any surface of the anchoring member via a suture (paragraph [0223] and [0240]) for the purpose of securing the replacement leaflet valve to the plurality of circumferential struts of the inner wall using a sealing member for the purpose of coupling the replacement leaflet valve to the inner wall and provide a blood flow-inhibiting seal between the inner wall and the native tissue (see Figures 19A-19B, paragraph [0240]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Marchand to further include a plurality of circumferential struts on the inner wall and suturing the replacement leaflet valve to the plurality of circumferential struts as taught by McLean et al. for the purpose of securing the replacement leaflet valve to the plurality of circumferential struts of the inner wall using a sealing member for the purpose of coupling the replacement leaflet valve to the inner wall and provide a blood flow-inhibiting seal between the inner wall and the native tissue.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
Prosecution Insights