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 .
Information Disclosure Statement
The three information disclosure statements filed 2/28/2025 fail to comply with the provisions of 37 CFR 1.98(a)(4) because they lack the appropriate size fee assertion. They have been placed in the application file, but the information referred to therein has not been considered as to the merits.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, and 5-10 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Morriss et al (US 20160242902 A1) "Morriss".
Regarding Claim 1, Morriss discloses a system (prosthetic treatment apparatus 100, par. [0148], Figs. 2A1 and 2A2) for implantation of a prosthetic valve (valve 150, par. [0148], Figs. 2A1 and 2A2) to a native heart valve, the system comprising: a prosthetic valve including: a plurality of prosthetic valve leaflets (leaflets 152, par. [0155], Fig. 2A4), a valve frame (support 110, par. [0148], Figs. 2A1 and 2A2) supporting the plurality of prosthetic valve leaflets, and one or more anchors (arms 120, par. [0148], Fig. 2A1) for anchoring the prosthetic valve to the native heart valve, wherein at least one of the anchors is axially slidable relative to the valve frame (par. [0184], Fig. 2C2);
a delivery apparatus (delivery catheter 200, par. [0256], Fig. 8A) for delivering the prosthetic valve to the native heart valve, the delivery apparatus including an elongate shaft (inner shaft 204, par. [0256], Fig. 8A) having a retention area (inflation lumen 209, guidewire lumen 210, par. [0256], Fig. 8A) for retaining the prosthetic valve;
and a control mechanism (length adjusting mechanism 136, par. [0196], Fig. 2C2) for actuating the at least one anchor to axially slide relative to the valve frame (par. [0196]), the control mechanism including a tether (hypodermic tube 136T, par. [0197], Fig. 2C2) for controlling retraction of the at least one anchor relative to the valve frame and a pusher shaft (internal compression spring 136S, par. [0197], Fig. 2C2) for controlling advancement of the at least one anchor relative to the valve frame.
Regarding Claim 3, Morriss discloses the system of claim 1, wherein the control mechanism includes at least one actuator operable by a user to axially slide the at least one anchor relative to the valve frame (mechanism 136, par. [0196]).
Regarding Claim 5, Morriss discloses the system of claim 1, wherein the control mechanism is operable to actuate a first one of the anchors to axially slide relative to the valve frame, and is operable to actuate a second one of the anchors to axially slide relative to the valve frame independent from the first one of the anchors (pars. [0093], [0110], and [0196]).
Regarding Claim 6, Morriss discloses the system of claim 1, wherein each of the anchors is formed with a hook shape and is adapted to extend around a downstream end of a leaflet of the native heart valve (par. [0168]).
Regarding Claim 7, Morriss discloses the system of claim 6, wherein each of the anchors extends radially outwardly to a tip (tip portions 122, par. [0170], Fig. 2C).
Regarding Claim 8, Morriss discloses the system of claim 1, wherein the valve frame includes an inner frame (skeleton 140, par. [0148], Fig. 2B-2) and an outer frame (outer surface 110S, par. [0149], Fig. 2A1) positioned radially outward of the inner frame.
Regarding Claim 9, Morriss discloses the system of claim 1, wherein at least a portion of the prosthetic valve is manufactured based on imaging of the native heart valve (par. [0202]).
Regarding Claim 10, Morriss discloses the system of claim 1, wherein the prosthetic valve is sized for replacing a tricuspid or mitral valve (par. [0189]).
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.
Claim(s) 2 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Morriss et al (US 20160242902 A1) "Morriss" in view of Zhang et al (US 20190133757 A1) "Zhang".
Regarding Claim 2, Morriss does not teach the tether adapted to release from an anchor upon deployment. However, Zhang, in the same field of art, teaches a valve prosthesis delivery system (valve prosthesis delivery system 100, par. [0060], Fig. 2), wherein the tether (connection aperture 127, par. [0071], Fig. 2) is adapted to release from the at least one anchor upon deployment of the prosthetic valve to the native heart valve (par. [0131], Fig. 7E). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Morriss to include a tether adapted to release from an anchor upon deployment, as taught by Zhang, in order to allow for the support frame and therefore the valve frame to expand and promote the flow of liquid (Zhang, pars. [0131] and [0133]).
Regarding Claim 16, Morriss discloses a system (prosthetic treatment apparatus 100, par. [0148], Figs. 2A1 and 2A2) for implantation of a prosthetic valve to a native heart valve, the system comprising: a prosthetic valve (valve 150, par. [0148], Figs. 2A1 and 2A2) including: a plurality of prosthetic valve leaflets (leaflets 152, par. [0155], Fig. 2A4), a valve frame (support 110, par. [0148], Figs. 2A1 and 2A2) supporting the plurality of prosthetic valve leaflets, and one or more anchors (arms 120, par. [0148], Fig. 2A1) for anchoring the prosthetic valve to the native heart valve;
a delivery apparatus (delivery catheter 200, par. [0256], Fig. 8A) for delivering the prosthetic valve to the native heart valve, the delivery apparatus including an elongate shaft (inner shaft 204, par. [0256], Fig. 8A) having a retention area (inflation lumen 209, guidewire lumen 210, par. [0256], Fig. 8A) for retaining the prosthetic valve, but does not disclose sutures for coupling to and adjusting anchors.
However, Zhang, in the same field of art, teaches a valve prosthesis delivery system (valve prosthesis delivery system 100, par. [0060], Fig. 2), wherein one or more sutures (suture 170, par. [0077], Fig. 2) for coupling to at least one of the anchors (valve anchor 120 and anchoring legs 122, par. [0077], Fig. 2) and for adjusting a position of the at least one anchor. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Morriss to include sutures for coupling to and adjusting anchors, as taught by Zhang, in order to help guide and secure the position of the support frame via the valve anchor (Zhang, par. [0132]).
Regarding Claim 17, Morriss does not teach sutures that move the anchors radially inward independent of other anchors. However, Zhang, in the same field of art, teaches a valve prosthesis delivery system (valve prosthesis delivery system 100, par. [0060], Fig. 2), further comprising a plurality of the sutures, each suture for moving one of the anchors of the prosthetic valve radially inward independent of another anchor of the prosthetic valve (pars. [0129] and [0132]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Morriss to include sutures that move the anchors radially inward independent of other anchors, as taught by Zhang, in order to provide potential relief to the proximal end portion of the valve anchor through the radial restriction created by the sutures (Zhang, par. [0129]).
Regarding Claim 18, Morriss does not teach sutures forming a circumferential loop around the anchors. However, Zhang, in the same field of art, teaches a valve prosthesis delivery system (valve prosthesis delivery system 100, par. [0060], Fig. 2), wherein the one or more sutures are shaped to form a loop extending circumferentially around the one or more anchors (pars. [0077] and [0160], Fig. 2). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Morriss to include sutures forming a circumferential loop around the anchors, as taught by Zhang, in order for the suture to slide along the anchoring legs during expansion of the valve prosthesis, which helps compact the support frame and valve anchor (Zhang, pars. [0077] and [0160]).
Regarding Claim 19, Morriss further discloses the system of claim 16, wherein the one or more anchors each have a distal tip, at least one of the distal tips adapted to be inflated to have a greater diameter than another of the distal tips (tip portion 122, pressure reducing tip portion 122PR, pars. [0093], [0110], [0153] and [0196], Fig. 2C).
Regarding Claim 20, Morriss further discloses the system of claim 16, further comprising an inflatable body (sealing members 160A and 160B, par. [0207], Figs. 2F1-A and 2F1-B) adapted to inflate radially outward from the delivery apparatus for securing the delivery apparatus in a desired position (par. [0207]).
Claim(s) 4 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Morriss et al (US 20160242902 A1) "Morriss" in view of Becerra et al (WO 2020219459 A1) "Becerra".
Regarding Claim 4, Morriss does not teach a handle and at least one actuator positioned on the handle. However, Becerra, in the same field of art, teaches a motorized implant delivery system (delivery system 10, par. [0082], Fig. 1), wherein the delivery apparatus includes a handle (handle 14, par. [0086], Fig. 1) and the at least one actuator is positioned on the handle (Fig. 10). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Morriss to include a handle and at least one actuator positioned on the handle, as taught by Becerra, in order to help control movement of various device assemblies (Becerra, par. [0093]).
Regarding Claim 11, Morriss discloses a system (prosthetic treatment apparatus 100, par. [0148], Figs. 2A1 and 2A2) comprising: a prosthetic valve (valve 150, par. [0148], Figs. 2A1 and 2A2) including: a plurality of prosthetic valve leaflets (leaflets 152, par. [0155], Fig. 2A4), a valve frame (support 110, par. [0148], Figs. 2A1 and 2A2) supporting the plurality of prosthetic valve leaflets, and a plurality of anchors (arms 120, par. [0148], Fig. 2A1) for anchoring the prosthetic valve to a native heart valve, wherein each of the plurality of anchors is movable relative to the valve frame (par. [0184], Fig. 2C2), but does not disclose a control mechanism with a motor adapted to actuate the movement of anchors independently.
However, Becerra, in the same field of art, teaches a motorized implant delivery system (delivery system 10, par. [0082], Fig. 1), with a control mechanism (actuation mechanism 506, par. [0126], Fig. 10) including a motor (motor 500, par. [0124], Fig. 10) for actuating movement of the plurality of anchors (anchors 80, par. [0084], Fig. 3A) relative to the valve frame, the motor adapted to actuate movement of at least one of the plurality of anchors independent of a movement of at least one other anchor of the plurality of anchors (pars. [0093] and [0126]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Morriss to include a control mechanism with a motor adapted to actuate the movement of anchors independently, as taught by Becerra, in order to help control movement of various device assemblies for deploying and releasing the implant at the treatment site (Becerra, par. [0126]).
Regarding Claim 12, Morriss discloses the system of claim 11, wherein the at least one of plurality the anchors is axially slidable relative to the valve frame (par. [0184], Fig. 2C2), but does not disclose a motor adapted to slide anchors relative to the valve frame.
However, Becerra, in the same field of art, teaches a motorized implant delivery system (delivery system 10, par. [0082], Fig. 1), wherein the motor (motor 500, par. [0124], Fig. 10) is adapted to axially slide the at least one of plurality the anchors relative to the valve frame (pars. [0093] and [0126]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Morriss to include a motor adapted to slide the anchors relative to the valve frame, as taught by Becerra, in order to help control movement of various device assemblies for deploying and releasing the implant at the treatment site (Becerra, par. [0126]).
Regarding Claim 13, Morriss does not disclose a gear system operated by the motor to actuate movement of the anchors. However, Becerra, in the same field of art, teaches a motorized implant delivery system (delivery system 10, par. [0082], Fig. 1), further comprising a gear system (drive rods 518a-g, par. [0132], Fig. 10) adapted to be operated by the motor to actuate movement of the at least one of the plurality of anchors (par. [0132]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Morriss to include a gear system operated by the motor to actuate movement of the anchors, as taught by Becerra, in order to help control movement of various device assemblies for deploying and releasing the implant at the treatment site (Becerra, pars. [0126] and [0134]).
Regarding Claim 14, Morriss does not disclose the motor adapted to control deflection of the anchors relative to the valve frame. However, Becerra, in the same field of art, teaches a motorized implant delivery system (delivery system 10, par. [0082], Fig. 1), wherein the motor is adapted to control a deflection of the at least one of the plurality of anchors relative to the valve frame (par. [0147], control device 504 can control deflection and send direct signals to motor 500 to control movements). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Morriss to include the motor adapted to control deflection of the anchors relative to the valve frame, as taught by Becerra, in order to help control movement of various device assemblies based on user input (Becerra, pars. [0147]).
Regarding Claim 15, Morriss further discloses the system of claim 14, wherein the control mechanism includes an offset controller (elbow portion 126, par. [0192], Fig. 2A1) configured to control the deflection of the at least one of the plurality of anchors relative to the valve frame simultaneously with a deflection of the at least one other anchor of the plurality of anchors with a deflection offset between the at least one of the plurality of anchors and the at least one other anchor (pars. [0104] and [0192]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE NICOLE THOMAS whose telephone number is (571)272-0004. The examiner can normally be reached Monday - Friday 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATALIE N THOMAS/Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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