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.
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 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) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Subramanian et al. (US 2010/0121435), and further in view of Levi et al. (US 2019/0159894).
Regarding claim(s) 1, 11, 12 and 18, Subramanian et al. discloses a transcatheter heart valve implant apparatus comprising: a frame extending along a frame axis and radially expandable between a first position, in which the frame comprises a first cross-sectional size, and a second position, in which the frame comprises a second cross-sectional size different than the first cross-sectional size (see [0019]; [0020] disclosing an implant used for heart valve annulus placement, and a frame that is transformable between two radial sizes), the frame comprising: a wire extending circumferentially around the frame axis to define a lumen (see [0180] disclosing a support (333) having a central opening with a zigzag wire structure that surrounds the opening through which blood flows, effectively defining a lumen).
Subramanian et al. fails to disclose the wire comprising a first peak portion comprising a first amplitude measured from a plane that is perpendicular to the frame axis and intersects the wire, a second peak portion comprising a second amplitude measured from the plane, and a valley portion attaching the first peak portion and the second peak portion, wherein: the first amplitude is different than the second amplitude, and the first peak portion and the second peak portion are positioned on a first side of the plane and the valley portion is positioned on an opposing second side of the plane; the first peak portion attached to a first axially-offset valley portion of the wire at a first attachment location; a second peak portion comprising a second amplitude measured from the plane, the second peak portion attached to a second axially-offset valley portion of the wire at a second attachment location; and a valley portion attaching the first peak portion and the second peak portion, the valley portion attached to a first axially-offset peak portion of the wire at a third attachment location, wherein: the first amplitude is different than the second amplitude, and the first attachment location, the second attachment location, and the third attachment location are axially-offset along the frame axis; wherein: the wire extends continuously to form the first peak portion, the second peak portion, the valley portion, the first axially-offset valley portion, the second axially-offset valley portion, and the first axially-offset peak portion; the first wire portion comprising a waveform shape comprising a plurality of first peak portions and a plurality of first valley portions; a second wire portion extending circumferentially around the frame axis to define a second portion of the lumen, the second wire portion comprising the waveform shape comprising a plurality of second peak portions and a plurality of second valley portions, the first wire portion axially offset from the second wire portion along the frame axis; and an attachment wire extending along the frame axis and attached at a first end to the first wire portion and at a second end to the second wire portion; and a cover extending along the frame axis and covering an outer radial side of the wire opposite the lumen.
Levi et al. also discloses a frame (12) made of angled struts (22, 24, 26, 28, 32) with upper and lower vertices, and an outer skirt (18) (see [0051]; [0057] disclosing the components of the prosthetic heart valve (10)). Levi et al. teaches the frame (12) being cut from a single piece of material to form a metal tube which inherently results in a tubular strut configuration that is structurally equivalent to a wire-form when it functions as a continuous filament, a strut connection between the angled struts (22, 24, 26, 28, 32) and nodes (44, 46, 64) inherently creating an axial-offset along the frames (12) axis, which creates different amplitudes (e.g., peaks, valleys and waveforms) in order to prevent the struts from colliding when the valve is collapsed into the catheter, reduce the crimped profile and distribute mechanical strain along the frame (12) axis at multiple attachment locations; and an outer skirt (18) which acts as a cover that is secured to the outer surface of the frame to prevent perivalvular leakage (see [0055] disclosing the tapered anatomy fit and variable row sizing that creates amplitude of the undulations which must vary circumferentially or axially in order to create a tapered cylinder using a wire-form). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Subramanian et al.’s radially expandable frame made from a serpentine wire that defines a lumen and includes a fabric mesh cover, wherein rows of openings can have different sizes to create the specific differential amplitude which necessitates different strut (22, 24, 26, 28, 32) amplitudes, as taught by Levi et al. Doing so would provide a means to optimize the radial profile and nesting capability of the device during delivery.
Regarding claim(s) 2-3, Subramanian et al./Levi et al., discloses the transcatheter heart valve implant apparatus of claim 1, but fails to disclose wherein: the first peak portion is attached to a first axially-offset valley portion of the wire at a first attachment location, the second peak portion is attached to a second axially-offset valley portion of the wire at a second attachment location, and the valley portion is attached to a first axially-offset peak portion of the wire at a third attachment location; and wherein: the wire extends continuously to form the first peak portion, the second peak portion, the valley portion, the first axially-offset valley portion, the second axially-offset valley portion, and the first axially-offset peak portion.
Levi et al. also discloses a frame (12) with multiple interconnecting rows of circumferentially extending angled struts (22, 24, 26, 28, 32), and an outer skirt (18) (see [0055]; [0051] disclosing the struts with interconnected rows within the frame (12) and an outer skirt (18) acting as an outer cover that interacts with an inner skirt (16)). Levi et al. teaches the frame (12) being cut from a single piece of material to form a metal tube which inherently results in a tubular strut configuration that is structurally equivalent to a wire-form when it functions as a continuous filament, and that securing the frame (12) portions at their upper and lower ends to adjacent rows of the struts (22, 24, 26, 28, 32) enhances fatigue resistance under cycling and reduces the crimp diameter of the frame, which requires multiple attachment locations, and the slack in the outer (18) and inner (16) skirt allows the frame (18) to elongate axially during crimping (see [0056]; [0071] disclosing fatigue resistance and the crimped state of the frame (12)). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Subramanian et al.’s radially expandable frame made from a serpentine wire that defines a lumen and includes a fabric mesh cover, wherein a complex, multi-row prosthetic heart valve frame (12) with adjacent rows of angled struts (22, 24, 26, 28, 32) are connected at their vertices to for a tubular structure, as taught by Levi et al. Doing so would provide a means to create a multi-level, stable, and fatigue-resistant tubular frame from a single or multiple wire form structure, ensuring the valve remains anchored and functional within the heart.
Regarding claim(s) 4 and 13, Subramanian et al./Levi et al., discloses the transcatheter heart valve implant apparatus of claim 1, but fails to disclose wherein: the frame further comprises an attachment wire extending in an axial direction substantially parallel to the frame axis, the attachment wire attached to a plurality of different locations of the wire.
Levi et al. also discloses a frame (312) comprising of axially oriented side struts (320) extending in an axial direction substantially parallel to the frame axis, nodes that serve as multiple attachment points along the frame, and commissure windows (318) (see [0099] disclosing the frame components). Levi et al. teaches that commissure windows (318) consist of first and second axially oriented side struts (320) which are inherently tubular from the frame construction, and is the structural equivalent to a wire-form, secures the leaflet structure, thereby providing the means to distribute the closing pressure of the valve leaflets across multiple rows of the frame (312) at multiple locations (see [0098]; [0099] disclosing axial stability and function of the side struts). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Subramanian et al.’s radially expandable frame made from a serpentine wire that defines a lumen and includes a fabric mesh cover, wherein axially oriented side struts (320) acts as integrating axial attachment wires in the frame (312), as taught by Levi et al. Doing so would provide a means to stabilize the frame height and provide a non-deforming platform for leaflet attachment.
Regarding claim(s) 5, 14, and 19, Subramanian et al./Levi et al., discloses the transcatheter heart valve implant apparatus of claim 1, but fails to disclose wherein: the cover comprises one or more of an expanded polytetrafluoroethylene, a thermoplastic polyurethane, silicone, elastane, a thermoplastic polyolefin, or a thermoplastic elastomer.
Levi et al. also discloses an outer skirt (18) made of high-performance polymers. (see [0084] disclosing materials used for the outer skirt). Levi et al. teaches the outer skirt (18) acts as an outer cover that is secured to the outer radial side of the frame (12), and provides elasticity, crimp profile and fluid impermeability based on its chosen materials (see [0016]; [0062] disclosing the location and function of the outer skirt (18)). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Subramanian et al.’s radially expandable frame made from a serpentine wire that defines a lumen and includes a fabric mesh cover, wherein specific polymers are used in the construction of an outer skirt (18), as taught by Levi et al. Doing so would allow a transcatheter to have the unique ability to handle the mechanical stresses of crimping while simultaneously facilitating the biological healing process once deployed.
Regarding claim(s) 6-7, 15, and 20, Subramanian et al./Levi et al., discloses the transcatheter heart valve implant apparatus of claim 1, but fails to disclose a jacket extending along the frame axis and covering an inner radial side of the wire; and wherein: the jacket comprises one or more of a polyester fabric material or a polymeric material.
Levi et al. also discloses a multi-layered assembly where the frame (12) is sandwiched between an outer skirt (18) and an inner skirt (16) (see [0016]; [0020]; [0064] disclosing the location of the skirts relative to the frame, and the material used in the construction of the inner skirt). Levi et al. teaches the inner skirt (16), which is made of a tear resistant material, extends axially along the frame (12) from the inflow end to the outflow end, thereby covering internal struts to prevent blood from contacting with the metal, and to create a smooth, non-thrombogenic surface for blood flow. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Subramanian et al.’s wire-frame valve structure, wherein a dual-skirt design includes an inner skirt positioned within the frame (12), as taught by Levi et al. Doing so would provide a means to optimize hemodynamics and protect the internal valve components with a durable inner liner.
Regarding claim 8, Subramanian et al./Levi et al., discloses the transcatheter heart valve implant apparatus of claim 1, but fails to disclose wherein: the wire comprises one or more of nickel titanium or stainless steel.
Levi et al. also discloses a frame (12) made from different metals (see [0053]; [0054] disclosing materials used in the construction of the frame). Levi et al. teaches the materials used are inherently provided in the form of a tube that is laser-cut to form wire-like struts (e.g., side struts) which provide similar function to wires. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Subramanian et al.’s heart valve implant with a frame made from flexible materials, wherein a frame (12) is made from nickel alloys or stainless steel based on specific mechanical behaviors, as taught by Levi et al. Doing so would provide a means to achieve predictable mechanical transformation and long-term biocompatibility in the cardiac environment.
Regarding claim(s) 9-10 and 16-17, Subramanian et al./Levi et al., discloses the transcatheter heart valve implant apparatus of claim 1, but fails to disclose wherein: the frame comprises a braided shape with a first braided portion positioned at an inner radial side of a first wire portion of the wire and a second braided portion positioned at an outer radial side of the first wire portion, and the first braided portion positioned at the outer radial side of a second wire portion of the wire and the second braided portion positioned at the inner radial side of the second wire portion; and wherein: an end portion of the wire is embedded in a tip of the transcatheter heart valve implant apparatus.
Levi et al. also discloses a frame (12) with an inflow and outflow end, with rows of angled struts (22, 24, 26, 28, 32) that cross or intersect at nodes (44, 46, 64) (see [0055]; [0058] disclosing the inflow and outflow ends of the frame and the intersecting rows of struts and nodes). Levi et al. teaches the inflow end of the frame has a reduced diameter and is covered by the outer skirt (18), thereby creating a tip assembly when the valve is in a crimped state, the frame has a sequential radial offset with a repeating pattern of struts and nodes which are configured as an “inner-to-outer” and “outer-to-inner” alternating radial fashion, similar to a braided configuration, which is inherently disclosed as part of the frames (12) circumferential continuity in order to share the mechanical load across the entire lattice, preventing any single joint from becoming a failure point (see [0055] disclosing the circumferential arrangement of the struts). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Subramanian et al.’s transcatheter heart valve with a frame comprising of a single or multiple lengths of wire, wherein a frame (12) with overlapping struts and specific assembly techniques for the inflow and outflow ends, as taught by Levi et al. Doing so would provide a means to maximize radial strength while ensuring vascular safety during navigation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEFAN BRADLEY CAMPBELL whose telephone number is (571)272-3498. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/STEFAN BRADLEY CAMPBELL/ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799
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