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 .
Claim Objections
Claim 8 is objected to because of the following informalities: claim 8 includes a typo win line 2 “a plurality of connecters.” The word should be connectors. Appropriate correction is required.
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.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites “wherein an eyelet provided on the skirt dish; an ear hub provided on the shaft immediately proximal to the valve frame seat; and the eyelet engages the eyelet when the skirt dish is seated round the valve frame seat and the valve support assembly is seated over the balloon.” However, it is unclear how an eyelet engages the eyelet. The specification provides support for an ear hub 704 having one or more notches 720, wherein the notches 720 is adapted to engage the eyelet. For examination purposes the examiner interprets the eyelet to engage the ear hub.
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) 9, 11-12 and 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Morriss et al. WO 2014/144937 A2.
Regarding Claim 9, Morriss et al. discloses a system 18 as seen in Figures 60A-60B comprising: a mitral heart valve assembly 700 comprising: a skirt dish 610 having a tissue skirt 140 sutured to the skirt dish (paragraph [0273] and [0351]); a valve support assembly 120 having a leaflet assembly 130 sutured to the valve support assembly 120 (paragraph [0236-0237]), the leaflet assembly 130 having a plurality of leaflets 132 (as seen in Figures 59A and 59D and paragraph [0235]); wherein the skirt dish 610 is connected to the valve support assembly 120 (paragraphs [0348]); and wherein the skirt dish 610 and valve support assembly 120 are made from different materials (paragraphs [00233], [0352], self-expanding anchor 610 and balloon expandable valve support assembly 120); a delivery system 10 having: a balloon catheter 18 having a shaft 28 having a distal end (as seen in Figures 46A-46B), a balloon 300 provided on the shaft 18 adjacent the distal end, and a valve frame seat (the portion of the shaft holding the skirt dish 610) located on the shaft directly proximal to the balloon 300 (as seen in Figures 60A-60B, the shaft portion holding the skirt dish 610 is proximal to the balloon 300); a capsule 70 (Morriss discloses a sheath 70, see paragraphs [0352] and as seen in Figures 60A, 60B) provided on the shaft of the balloon catheter that slidably covers the balloon 300 and the valve frame seat (as seen in Figures 51A-51B, 60A-60B and paragraphs [0320], [0352]); and wherein the skirt dish 610 is seated around the valve frame seat (the shaft holding the skirt dish constitutes as a valve frame seat, Morriss explains the skirt dish 610 is allowed to self-expand by the retraction of the sheath 70 at a target site as shown in Figures 46A-46B and 60A-60B, while the valve support element 120 is mounted on a balloon 300 and is then expanded to fully deploy after the skirt dish 110 has been released, see paragraph [0327] and [0352]) and the valve support assembly 120 is seated over the balloon 300 (paragraph [0327] and [0352] and as seen in Figures 60A-60B).
Regarding Claim 11, Morriss et al. discloses wherein the skirt dish 610 is made from a self-expanding material (paragraph [0352]) and the valve support assembly 120 is made from a balloon expandable material (paragraph [0233], [0327] and [0352] discloses the valve support 120 is formed from biocompatible metals such as cobalt chromium which applicant claims is a balloon expandable material, see paragraph [0066] in applicant’s publication).
Regarding Claim 12, Morriss et al. discloses wherein the valve support assembly 120 is made from cobalt-chromium (paragraphs [0233], [0318]).
Regarding Claim 14, Morriss et al. discloses wherein the skirt dish and the valve support assembly assume a circular configuration prior to crimping on to a delivery device, and assume an oval configuration after expansion (paragraph [0252] and as seen in Figures 14C-15).
Regarding Claim 15, Morriss et al. discloses a method of delivering a heart valve assembly to a mitral annulus which has native mitral leaflets (paragraphs [0167-0169], [0196-0197], [0227], [0237-0238], [0287-0288], [0319-0320], [0324], [0327]) as seen in Figures 58A-60B, comprising: providing a heart valve assembly 700 as seen in Figures 59A-60B comprising: a skirt dish 610 having a tissue skirt 140 sutured to the skirt dish (paragraph [0273] and [0351]); a valve support assembly 120 having a leaflet assembly 130 sutured to the valve support assembly 120 (paragraph [0236-0237]), the leaflet assembly 130 having a plurality of leaflets 132 (as seen in Figures 59A and 59D and paragraph [0235]); wherein the skirt dish 610 is connected to the valve support assembly 120 (paragraphs [0348]); and wherein the skirt dish 610 and valve support assembly 120 are made from different materials (paragraphs [00233], [0352], self-expanding anchor 610 and balloon expandable valve support assembly 120); providing a delivery system 10 having: a balloon catheter 18 having a shaft 28 having a distal end (as seen in Figures 46A-46B), a balloon 300 provided on the shaft 18 adjacent the distal end, and a valve frame seat located on the shaft directly proximal to the balloon (as seen in Figures 60A-60B, the portion of the shaft that holds the skirt dish); a capsule 70 (Morriss discloses a sheath 70, see paragraphs [0352] and as seen in Figures 60A, 60B) provided on the shaft of the balloon catheter (as seen in Figures 51A-51B, 60A-60B and paragraphs [0320], [0352]); crimping the heart valve assembly 700 on to the balloon catheter by seating the skirt dish around the valve frame seat and the valve support assembly 120 over the balloon 300 (as seen in Figures 60A-60B and paragraphs [0320], [0352]); sliding the capsule 70 to cover the balloon 300 and the valve frame seat (as seen in Figure 60A); advancing the delivery system with the heart valve assembly ensheathed by the capsule to the location of a mitral annulus in a human heart (as seen in Figure 58A); withdrawing the capsule 70 such that the capsule does not cover the skirt dish (paragraph [0327] and [0352], such that the skirt dish begins to self-expand while the valve support assembly remains crimped (paragraph [0327] and [0352]); inflating the balloon to expand the valve support assembly (paragraph [0327] and [0352]). It is inherent, that the delivery system 10 having an expanded balloon to fully expand the valve support assembly needs to undergo deflation of the balloon to withdraw the balloon catheter from the body to complete the surgical procedure.
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) 1-6 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morriss et al. WO 2014/144937.
Regarding Claim 1, Morris et al. discloses a mitral heart valve assembly 2100 in Figures 86A, 86B, 88A-88B comprising: a skirt dish 2130 having a tissue skirt 2120 sutured to the skirt dish (as seen in Figure 86B forming a collective unit 2110 and paragraphs [00433], [00435]); a valve support assembly 120 having a leaflet assembly 130 sutured to the valve support assembly 120 (paragraph [00212], [00224], [00228]), the leaflet assembly 130 having a plurality of leaflets (as seen in Figure 86B and paragraph [0212]); and wherein the skirt dish 2130 (the skirt dish is formed of Nitinol, see paragraph [0429], [0435]) and valve support assembly 120 are made from different materials (paragraphs [00233] and [0327]). In the embodiment used in the rejection above, Figures 86A and 86B does not expressly disclose wherein the skirt dish is connected to the valve support assembly in a manner such that the skirt dish defines a blood inflow side and the valve support assembly is downstream from the skirt dish. In an alternative embodiment as seen in Figure 106B Morriss et al. teaches a skirt dish 2110 having a tissue skirt 2124 (paragraph [00471]) and a valve support assembly 110 comprising a plurality of leaflets and wherein the skirt dish 2110 is coupled to the valve support member 120 (paragraph [00471]) such that the skirt dish 2110 defines a inflow upstream side 121 (paragraph [0471]) and the valve support assembly is downstream from the skirt dish for the purpose of allowing for higher placement of the skirt dish above the valve annulus (paragraph [0471]). 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 86A-86B to having a skirt dish 2130 with tissue skirt 2120 (collectively forming portion 2110) to be attached at an inflow or upstream end of the valve support assembly 110 as taught in Figure 106B for the purpose of anchoring the skirt dish and tissue skirt into a higher placement above the valve annulus.
Regarding Claim 2, Morriss et al. discloses wherein the skirt dish 2130 is made from a self- expanding material (paragraph [0429], [0435]) and the valve support assembly is made from a balloon expandable material (paragraph [0233] discloses the valve support 120 is formed from biocompatible metals such as cobalt chromium which applicant claims is a balloon expandable material, see paragraph [0066] in applicant’s publication).
Regarding Claim 3, Morriss et al. discloses wherein the valve support assembly 120 is made from cobalt-chromium (paragraph [0233]).
Regarding Claim 4, Morriss et al. discloses wherein the skirt dish 2130 (comprises struts 48) is made from Nitinol (paragraph [0429], [0435])
Regarding Claim 5, Morriss et al. discloses wherein the skirt dish and the valve support assembly assume a circular configuration prior to crimping on to a delivery device, and assume an oval configuration after expansion (paragraph [0252] and as seen in Figures 14C-15).
Regarding Claim 6, Morriss et al. discloses wherein the leaflet assembly 130 has two leaflets (paragraph [0237]).
Regarding Claim 13, Morriss et al. discloses the skirt dish is self-expandable (paragraph [0352]). However, in the embodiment used in the rejection above, Figures 59A-60B does not expressly disclose wherein the skirt dish is made from Nitinol. In an alternative embodiment as seen in Figure 10A, Morriss et al. teaches a skirt dish 110 having a tissue skirt 140 and a valve support assembly 120, wherein the skirt dish is formed from a self-expanding material such as Nitinol (paragraph [0230], [0307] and [0318]) for the purpose of allowing the anchoring member to be collapsed into a lower profile delivery configuration and allowed to self-expand to a deployed configuration to replace the target valve (paragraph [0233]). 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 skirt dish of Figures 60A-60B to be formed from a Nitinol as taught in Figure 10A for the purpose of allowing the anchoring member to be collapsed into a lower profile delivery configuration and allowed to self-expand to a deployed configuration to replace the target valve.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morriss et al. WO 2014/144937 in view of Gross et al. U.S. Publication 2014/0324164 A1.
Regarding Claim 7, Morriss et al. discloses a skirt dish (86A, 86B). However, Morriss et al. does not expressly disclose wherein the skirt dish has a frame assembly that has two hook-shaped anchors extending in the outflow direction. Gross et al. teaches a mitral heart valve assembly in the same field of endeavor comprising a skirt dish 40 and a valve support assembly 42, wherein the skirt dish 40 has a frame assembly 1134 that has two hook-shaped anchors extending in the outflow direction (see Figures 42A-42B) for the purpose of having a hook element that secures the skirt dish to valve support assembly (paragraph [0408]). 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 Morriss’s skirt dish to further include a frame assembly having two hook-shaped anchors extending in the outflow direction as taught by Gross et al. for the purpose of having hook elements to secure the skirt dish to the valve support assembly. 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 Morriss’s skirt dish to further include a frame assembly having two hook-shaped anchors as taught by Gross et al. for the purpose of having hook elements to secure the skirt dish to the valve support assembly.
Regarding Claim 8, Morriss et al. discloses a skirt dish 2130 and a valve support assembly 120 having a support skeleton (see Figures 72, 78 showing the inner stent 120 comprises a plurality of cells forming said skeleton). Morriss et al. does not expressly disclose wherein the skirt dish has a frame assembly that has a plurality of connecters extending in the outflow direction, and the valve support assembly has a support skeleton having a ring of cells that define a plurality of inflow apices, wherein each of the plurality of connectors is connected with a corresponding one of the plurality of inflow apices when the skirt dish is connected with the valve support assembly. Gross et al. teaches a mitral heart valve assembly in the same field of endeavor comprising a skirt dish 40 and a valve support assembly 42 having a support skeleton having a ring of cells that define a plurality of apices, wherein the skirt dish 40 has a frame assembly 1124 that has connectors 1126, wherein each of the plurality of connectors is connected with a corresponding one of the plurality of apices (see Figure 41B, at least one of the prong/connector 1126 extends to contact the apices of a cell) for the purpose of coupling the skirt dish with the valve support assembly (paragraphs [0405-0406]). 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 Morriss’s skirt dish to further include a frame assembly having a plurality of connectors extending in the outflow direction, wherein each of the plurality of connectors is connected to a corresponding one of the plurality of inflow apices when the skirt dish is connected with the valve support assembly as taught by Gross et al. for the purpose of coupling the skirt dish with the valve support assembly.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morriss et al. WO2014/144937 in view of Oba et al. U.S. Publication 2020/0038180 A1.
Regarding Claim 10, Morriss et al. does not expressly disclose wherein an eyelet provided on the skirt dish; an ear hub provided on the shaft immediately proximal to the valve frame seat; and the eyelet engages the eyelet when the skirt dish is seated round the valve frame seat and the valve support assembly is seated over the balloon. Oba et al. teaches a system 600 as seen in Figures 26-33 comprising: a mitral heart valve assembly 500 comprising: a skirt dish 502 having a tissue skirt 512 (paragraph [0137]); a valve support assembly 504 having a leaflet assembly 550 (paragraph [0143]), the skirt dish 502 further includes an eyelet 524 (as seen in Figure 26 and paragraph [0134]) for the purpose of assisting in positioning and delivery of the mitral heart valve assembly (paragraph [0077]). Oba et al. further teaches the eyelet/positioner member is shown in use with the delivery system 200 in Figure 4, comprising eyelets 38 that engages an ear hub 205 via cords 206 (the catheter shaft 205 is considered to read on said “ear hub” having cords 206 to couple to the eyelet to said hub) for the purpose of releasably coupling the eyelet of the skirt dish to the ear hub to aid in the positioning and delivery of the mitral valve assembly (paragraphs [0077], [0088-0089]). 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 Morriss’s system to have a skirt dish having eyelet that engages an ear hub on the system as taught by Oba et al. for the purpose of releasably coupling the eyelet of the skirt dish to the ear hub to aid in the positioning and delivery of the mitral valve assembly.
Conclusion
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.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774