DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments filed 6/29/2026 have been considered but are moot in view of the new grounds for rejection. Applicant has amended claims 1 and 6 to recite the native valve leaflets are disposed between the portions of the valve clasper and the support frame and the support frame contacts the native valve leaflets. Because Salahieh’s valve frame does not contact the native leaflets, the claim amendments have overcome the rejections under Salahieh alone. A new rejection is presented under Section 103 over Rowe et al. (Pub. No.: US 2009/0319037) in view of Salahieh et al. (Pub. No.: US 2005/0137689) in response to Applicant’s amendments.
New claims 21-32 are addressed below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 29-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. New claim 29 states, in relevant part, “inserting a delivery device into a patient, the delivery device carrying a valve prosthesis comprising an expandable support frame and an expandable valve component having a support frame and a plurality of prosthetic leaflets supported inside of the support frame” (emphasis added). This limitation is indefinite as it implies multiple support frames. Furthermore, subsequent references to “the support frame” compound this indefiniteness as it is unclear which support frame is being referred to.
Claim 29 recites the limitation "the valve clasper" in lines 6, 9-11, 13, 16. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4-8, 10, 21-32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rowe et al. (Pub. No.: US 2009/0319037) in view of Salahieh et al. (Pub. No.: US 2005/0137689).
Rowe et al. (hereinafter, Rowe) discloses a method for deploying a heart valve prosthesis within a native heart valve having a native valve leaflet (abstract), the method comprising:
inserting an implantation device 100 into a femoral artery of a patient (e.g., para. 57), the implantation device carrying (not disclosed) a valve prosthesis THV having an expandable support frame 250, a plurality of prosthetic leaflets supported inside of the support frame (para. 46, referencing 6,730,118), and a valve clasper 10 (e.g., fig. 8-10) movably coupled to the support frame (not disclosed);
advancing the implantation device to the native heart valve (e.g., fig. 7); and
releasing the valve prosthesis at the native heart valve (fig. 10-13);
wherein the releasing comprises interposing the native valve leaflet 210 between the valve clasper 10 and the support frame 250 such that the support frame contacts the native valve leaflet.
As provided in italicized text above, the implantation device 100 of Rowe does not carry the valve prosthesis, nor is the valve clasper movably coupled to the support frame. Instead, delivery device 100 delivers valve clasper, and delivery device 220 delivers the valve prosthesis. Salahieh teaches delivering an outer support frame and inner valve using one delivery catheter 700 (e.g., fig. 45A-I) which allows percutaneous delivery of both components and does not require puncturing the apex of the heart to deliver the prosthetic valve. Prosthetic valve 600 is removably connected to the valve clasper 550 (e.g., fig. 45F). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the implants of Rowe as delivered using the same delivery system as taught by Salahieh for the purpose of reducing operative complexity while avoiding the need to puncture the heart. This modification would have occurred using known methods and would have yielded predictable results.
For claim 2, Rowe teaches the method of claim 1, further comprising adjusting a position of the support frame such that a distal edge of the support frame is disposed longitudinally adjacent to the valve clasper (e.g., fig. 8-10).
For claim 4, Rowe teaches the method of claim 1, wherein the native heart valve is an aortic valve 210, and the method further comprises positioning a U-shaped member of the valve clasper 10 behind the native valve leaflet such that it contacts a floor of an aortic valve sinus (e.g., fig. 8-13).
For claim 5, Rowe in view of Salahieh teaches the method of claim 1, wherein the valve clasper 10 is movably coupled to the support frame (e.g., Salahieh fig. 45A-I) to permit the valve clasper to be movable relative to the support frame from an engagement configuration in which the valve clasper and the support frame are collapsed against the implantation device (e.g., Salahieh fig. 45A) to a configuration in which the support frame is offset from the valve clasper (e.g., Rowe, fig. 8-13).
For claim 6, Rowe discloses a method for deploying a heart valve prosthesis within a native heart valve having native valve leaflets (abstract), the method comprising:
inserting a delivery device 100 into a patient, the delivery device carrying (not disclosed) a valve prosthesis THV with an expandable support frame 250 of the prosthesis being longitudinally offset from (not disclosed) a valve clasper 10 of the prosthesis along the delivery device (not disclosed), wherein the valve prosthesis 250 comprises a plurality of prosthetic leaflets supported inside of the support frame (para. 46, referencing 6,730,118);
advancing the delivery device 100 to the native heart valve (e.g., fig. 7); deploying the valve clasper 10 from the delivery device (e.g., fig. 7-8);
positioning portions of the valve clasper behind the native valve leaflets (e.g., fig. 7-8);
after positioning portions of the valve clasper behind the native valve leaflets, longitudinally positioning the support frame inside the native valve leaflets and within the valve clasper (e.g., fig. 9-13);
deploying the support frame from the delivery device, thereby expanding the support frame to a radially expanded state in which the native valve leaflets are disposed between the portions of the valve clasper and the support frame and the support frame contacts the native valve leaflets (e.g., fig. 9-13); and
removing the delivery device from the patient (e.g., fig. 13).
As provided in italicized text above, the implantation device 100 of Rowe does not carry the valve prosthesis, nor is the valve clasper movably coupled to the support frame. Instead, delivery device 100 delivers valve clasper, and delivery device 220 delivers the valve prosthesis. Salahieh teaches delivering an outer support frame and inner valve using one delivery catheter 700 (e.g., fig. 45A-I) which allows percutaneous delivery of both components and does not require puncturing the apex of the heart to deliver the prosthetic valve. Prosthetic valve 600 is removably connected to the valve clasper 550 (e.g., fig. 45F). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the implants of Rowe as delivered using the same delivery system as taught by Salahieh for the purpose of reducing operative complexity while avoiding the need to puncture the heart. This modification would have occurred using known methods and would have yielded predictable results.
For claim 7, Rowe teaches the method of claim 6, wherein the native heart valve is an aortic valve 210, and positioning portions of the valve clasper behind the native valve leaflets comprises proximally retracting (fig. 7-8) the valve clasper relative to the aortic valve to engage the portions of the valve clasper with valve sinuses of the aortic valve (e.g., fig. 8).
For claim 8, Rowe teaches the method of claim 6, wherein the native heart valve is an aortic valve 210, and positioning portions of the valve clasper behind the native valve leaflets comprises distally advancing the valve clasper
For claim 10, Rowe in view of Salahieh teaches the method of claim 6, wherein during the longitudinal positioning, the valve clasper is movably coupled to the support frame for permitting relative movement of the valve clasper relative to the support frame (e.g., Salahieh fig. 45F).
For claim 21, Rowe teaches the method of claim 1, wherein the valve clasper comprises exactly three U-shaped members (e.g., fig. 1) and the native valve leaflet comprises a plurality of native valve leaflets 210, and the releasing comprises sandwiching the native valve leaflets between the U- shaped members and the support frame (e.g., fig. 8-13).
For claim 22, Rowe teaches the method of claim 1, wherein the releasing comprises: deploying the valve clasper from a first sheath 100 of the implantation device to allow the valve clasper to radially expand; and deploying the support frame from a second sheath 220 of the implantation device to allow the support from to radially expand (e.g., fig. 11).
For claim 23, Rowe in view of Salahieh teaches the method of claim 22, wherein during the inserting, the valve clasper is at a location along the implantation device proximal to the support frame (e.g., Salahieh fig. 45F).
For claim 24, Rowe teaches the method of claim 6, wherein the portions of the valve clasper positioned behind the native valve leaflets are U-shaped members of the valve clasper (e.g., fig. 1, 8).
For claim 25, Rowe teaches the method of claim 24, wherein after the support frame is deployed from the delivery device, the U-shaped members engage outer surfaces of the native valve leaflets and the support frame engages inner surfaces of the native valve leaflets (e.g., fig. 8-13).
For claim 26, Rowe teaches the method of claim 6, wherein the valve clasper is releasably connected to a plurality of track wires 141, 142, 143 of the delivery device during the acts of inserting the delivery device into the patient, advancing the delivery device to the native heart valve, deploying the valve clasper from the delivery device, and positioning the portions of the valve clasper behind the native valve leaflets (e.g., fig. 5, 7-13), and the method further comprises releasing the valve clasper from the track wires after deploying the support frame from the delivery device (e.g., fig. 6, 13).
For claim 27, Rowe teaches the method of claim 6, wherein: deploying the valve clasper from the delivery device comprises deploying the valve clasper from a first sheath 100 of the delivery device to allow the valve clasper to radially expand; and deploying the support frame from the delivery device comprises deploying the support frame from a second sheath 220 of the delivery device to allow the support from to radially expand.
For claim 28, Rowe in view of Salahieh teaches the method of claim 27, wherein during the act of inserting, the valve clasper is at a location along the implantation device proximal to the support frame (e.g., Salahieh, fig. 45F).
For claim 29, Rowe discloses a method for deploying a heart valve prosthesis within a native heart valve having native valve leaflets (abstract), the method comprising:
inserting a delivery device 100 into a patient, the delivery device carrying (not disclosed) a valve prosthesis THV comprising an expandable support frame 250 and an expandable valve component having a support frame and a plurality of prosthetic leaflets (para. 46, referencing 6,730,118) supported inside of the support frame, wherein the valve component is longitudinally offset from the valve clasper along the delivery device (not disclosed);
advancing the delivery device to the native heart valve (e.g., fig. 7);
deploying the valve clasper 10 from a first sheath 100 of the delivery device; positioning portions of the valve clasper behind the native valve leaflets (e.g., fig. 7-9);
after positioning the portions of the valve clasper behind the native valve leaflets, longitudinally positioning the valve component inside the native valve leaflets and within the valve clasper (e.g., fig. 9-13); and
deploying the valve component from a second sheath 220 of the delivery device, thereby expanding the valve component to a radially expanded state in which the valve component contacts inner surfaces of the native valve leaflets and the valve clasper contacts outer surfaces of the native valve leaflets (e.g., fig. 9-13).
As provided in italicized text above, the implantation device 100 of Rowe does not carry the valve prosthesis, nor is the valve component longitudinally offset from the valve clasper along the delivery device. Instead, delivery device 100 delivers valve clasper, and delivery device 220 delivers the valve prosthesis. Salahieh teaches delivering an outer support frame and inner valve using one delivery catheter 700 (e.g., fig. 45A-I) which allows percutaneous delivery of both components and does not require puncturing the apex of the heart to deliver the prosthetic valve. Prosthetic valve 600 is removably connected to the valve clasper 550 (e.g., fig. 45F). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the implants of Rowe as delivered using the same delivery system as taught by Salahieh for the purpose of reducing operative complexity while avoiding the need to puncture the heart. This modification would have occurred using known methods and would have yielded predictable results.
For claim 30, Rowe teaches the method of claim 29, wherein the portions of the valve clasper that are positioned behind the native valve leaflets comprise exactly three U-shaped members (e.g., fig. 1).
For claim 31, Rowe in view of Salahieh teaches the method of claim 29, during the act of inserting the delivery device into the patient, the valve clasper is located proximally of the valve component (e.g., Salahieh fig. 45F).
For claim 32, Rowe teaches the method of claim 29, wherein the valve clasper is releasably connected to a plurality of track wires 141, 142, 143 during the act of inserting the delivery device into the patient, and the act of positioning the portions of the valve clasper behind the native valve leaflets comprises moving the track wires to move the portions of the valve clasper behind the native valve leaflets (e.g., fig. 5, 7-13), and the method further comprises releasing the valve clasper from the track wires after deploying the valve component from the second sheath (e.g., fig. 6, 13).
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 SUBA GANESAN whose telephone number is (571)272-3243. The examiner can normally be reached Monday-Friday, 8 AM - 5 PM Mountain Time.
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/SUBA GANESAN/Primary Examiner, Art Unit 3774
