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.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains legal phraseology (i.e. “the interconnected struts comprising” and “is disclosed”). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The attempt to incorporate subject matter into this application by reference to an incorporation by reference statement is ineffective because no new matter can be added to an application after its filing date.
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 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.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Chuter et al. (US 11602428) in view of Nir et al. (US 2021/0369452).
Chuter et al. discloses a prosthetic heart valve comprising: a radially expandable and compressible annular frame comprising: a plurality of interconnected struts (20) defining a plurality of rows of cells arranged between an inflow end (30) and an outflow end (70) of the frame, the plurality of interconnected struts comprising a plurality of outflow struts defining the outflow end (70) and a plurality of inflow struts defining the inflow end (30) (see Col.1, lines 62-64; Figs. 3, 5 and 6 disclosing a medical device (e.g., prosthetic heart valve) comprising a stent and a valve and illustrating the interconnected struts, rows of cells and an inflow/outflow (proximal/distal ends)), but fails to disclose each outflow strut comprises two angled strut portions interconnected by an apex region, each inflow strut comprises two angled strut portions interconnected by an apex region, each apex region curves between a corresponding pair of two angled strut portions, each apex region has a narrowed width and a length that extends along at least 25% of a total length of the outflow strut or inflow strut, and the narrowed width is smaller than a width of the two angled strut portions.
Nir et al. also discloses a non-uniform strut design that creates a narrowed apex width. Nir et al. teaches a modified strut geometry to reduce bulk of a prosthetic valve when it is compressed (crimped) for delivery (see Figs. 15-16, 4 and 27A illustrating the cross-section changes by packing braided wires loosely (wider) or tightly (narrower), and a prosthetic valve frame with intersected angled struts and the resulting apex regions (nodes) where the narrowed features are located, thereby using a routine optimization already known to reduce the crimp profile based on a specific length (e.g., 25%)). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to have an expandable annular frame with the interconnected struts of Chuter et al., wherein a narrowed apex width is used to reduce bulk, as taught by Nir et al. Doing so would offer a design choice in determining exactly how long the narrowed section should be (e.g., 25% vs 10%) for profile and strength in a prosthetic heart valve.
Claim(s) 2-22 are rejected under 35 U.S.C. 103 as being unpatentable over Chuter et al. as in view of Nir et al. applied to claim 1 above, and further in view of Wallace et al. (US 2024/0000566).
Regarding claim(s) 2, 11, 12, and 20, Chuter et al./Nir et al., discloses the prosthetic heart valve of claim 1, but fails to disclose each apex region forms an angle between the two angled strut portions of a corresponding outflow strut or inflow strut that is greater than 120 degrees and up to 140 degrees; radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of cells arranged between a first end and a second end of the frame, the plurality of interconnected struts comprising a plurality of first struts defining the first end and a plurality of second struts defining the second end, wherein each first strut comprises two angled strut portions interconnected by an apex region, wherein the apex region curves between the two angled strut portions and has a narrowed width relative to a width of the two angled strut portions, and wherein the apex region forms an angle between the two angled strut portions that is greater than 120 degrees; the angle is greater than 120 degrees and up to 140 degrees; and the apex region forms an angle between the two angled strut portions that is greater than 120 degrees and less than or equal to 140 degrees.
Wallace et al. also discloses a unibody folded, double-wall stent with expansion control and an apex geometry (see Figs. 2A and 3B illustrating the nodes or apices representing points of folding or connection). Wallace et al. teaches the need for a highly compact and controlled “folded” state to reduce the delivery profile, naturally seeking to flatten the apex angle (e.g., approaching the 120–140-degree range) to allow the struts fold against one another more efficiently without creating bulky overlap (see Fig. 1G illustrating strut segments (110a and 110b) which form a vertex (apex A), inherently allowing the segments to flatten in the fully expanded state and therefore increase their opening angles in order to accommodate the internal leaflet valve). Therefore, it would have been obvious to one having ordinary skill in the art to have the annular frame of Chuter et al., modified by Nir et al., with specific geometric optimizations allowing for varied degrees of open angles in order for the struts to lay flat during crimpling, as taught by Wallace et al. Doing so would provide a means to minimize the delivery profile (crimp diameter) of a prosthetic heart valve while maintaining structural integrity at the folding points.
Regarding claim(s) 3-7, Chuter et al./Nir et al., discloses the prosthetic heart valve of claim 1, but fails to disclose each apex region includes a curved outer surface with a radius of curvature that is greater than 1 mm, the curved outer surface extending between outer surfaces of the two angled strut portions of a corresponding outflow strut or inflow strut; the length of each apex region is in a range of 0.9 mm to 2.2 mm; the length of each apex region is in a range of 1.9 mm to 2.2 mm; the length of each apex region at the outflow end is in a range of 1.8 mm to 2.4 mm, and wherein the length of each apex region at the inflow end is in a range of 0.8 mm to 1.2 mm; and the narrowed width of each apex region is from 0.06 mm to 0.15 mm smaller than the width of the two angled strut portions.
Wallace et al. also discloses an apex curvature, radii, apex length ranges and narrowed width (see Figs. 1A, 1C and 1G illustrating the structural elements of the folded unibody). Wallace et al. teaches the presence of radii (R, R2, R3 and R4) are designed for high-fatigue “folded” regions, folding sections at the inflow and outflow (proximal/distal) ends are inherently a result of scaling the folding geometry to fit standard valve sizes and a narrowed width that can be characterized as a mechanical necessity to ensure that when the valve is folded and recessed the final diameter meets catheter clearance requirements (see Figs. 1A, 1C and 1G illustrating the structural elements of the folded unibody that allows for various ranges within the radii, apex length and width). 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 the curved apex surface of Chuter et al., modified by Nir et al., with varied apex lengths, radii and narrowed widths, as taught by Wallace et al. Doing so would provide a means to construct a double walled, high strength frame that utilizes strategic thinning at optimized lengths and radii to ensure the device does not break during intense stress.
Regarding claim(s) 8, 9, 15-18, 21, and 22, Chuter et al./Nir et al., discloses the prosthetic heart valve of claim 1, but fails to disclose a plurality of leaflets secured to the frame and a plurality of commissure windows formed by struts of the plurality of interconnected struts forming cells of a first row of cells of the plurality of rows of cells, the first row of cells disposed at the outflow end of the frame, and wherein each commissure window is configured to receive commissure tabs of two adjacent leaflets of the plurality of leaflets; each commissure window is defined by axially extending window strut portions that form an upper end portion above the commissure window and a lower end portion below the commissure window, and wherein a length, in an axial direction relative to a central longitudinal axis of the frame, of the upper end portion and the lower end portion is larger than the width of the two angled strut portions; each first strut forms an outflow edge of a cell of a first row of cells disposed at the outflow end of the frame, wherein each second strut forms an inflow edge of a cell of a second row of cells disposed at the inflow end of the frame, and wherein the cell of the first row of cells has a longer axial length, relative to a central longitudinal axis of the frame, than the cell of the second row of cells; the plurality of interconnected struts further comprises a plurality of axial struts extending in a direction of the central longitudinal axis and spaced apart from one another around a circumference of the frame, wherein each axial strut forms an axial side of two adjacent cells of the first row of cells, and wherein each axial strut has a width that is larger than a width of angled struts of the plurality of interconnected struts; a plurality of leaflets secured to the frame and further comprising a plurality of commissure windows formed by struts of the plurality of interconnected struts forming cells of a first row of cells of the plurality of rows of cells, the first row of cells disposed at the first end of the frame, and wherein each commissure window is configured to receive commissure tabs of two adjacent leaflets of the plurality of leaflets; each commissure window is defined by axially extending window strut portions that form an upper end portion above the commissure window and a lower end portion below the commissure window, and wherein the upper end portion includes two apertures disposed therein; the plurality of rows of cells includes a first row of cells disposed at the outflow end of the frame and a second row of cells disposed at the inflow end of the frame and wherein cells of the first row of cells have a longer axial length, relative to a central longitudinal axis of the frame, than cells of the second row of cells; the plurality of interconnected struts further comprises a plurality of axial struts extending in a direction of the central longitudinal axis and spaced apart from one another around a circumference of the frame, wherein each axial strut forms an axial side of two adjacent cells of the first row of cells, and wherein each axial strut has a width that is larger than a width of angled struts of the plurality of interconnected struts, the angled struts including angled struts that form the cells of the first row of cells with the axial struts.
Wallace et al. also discloses a heart valve stent with specialized attachment points for leaflets (516a-c) (see [0097]; Figs. 1A, 1C, 1G, 2A and 3B disclosing a bi-leaflet or tri-leaflet structure that is secured in the inner wall of the stent and illustrating the plurality of struts forming a row of cells and specific points between the interconnected struts, which functionally serve as the commissure windows for the commissure tabs). Wallace et al. teaches a row of cells with specific placement of the valve leaflets (516a-c) and their tabs at the inflow (proximal) end and an outflow (distal) end, that forms the first row which provides structural support to maintain the valves circularity of the folded double-wall frame (see Fig. 1G illustrating axial alignment, upper and lower end portions formed by nodes (A, A2, A3 and A4) and its struts (110a and 110b), and the associated transition zones between the nodes that are shown to be significantly greater than the horizontal width of the individual strut segments and having a longer axial length at the outflow (distal) end). 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 the baseline expandable frame and rows of cells of Chuter et al., modified by Nir et al., with a prosthetic heart valve that includes a leaflet structure secured to the frame, as taught by Wallace et al. Doing so would optimize the geometry of commissure windows in the first row of cells at the outflow end, leading to a predictable arrangement for any prosthetic heart valve with elongated folded nodes to manage resulting strain and keep axial pillars wider to support valve leaflets.
Regarding claim(s) 10, 13, and 19 Chuter et al./Nir et al., discloses the prosthetic heart valve of claim 9, but fails to disclose the upper end portion includes a concave region disposed therein, adjacent to a convex curve at a base of a first angled strut portion of the two angled strut portions to which the upper end portion connects, and wherein the convex curve extends from a concave curve in the first angled strut portion; the apex region comprises a curved, axially facing outer surface that is continuous with axially facing outer surfaces of the two angled strut portions and an axially facing inner depression, the inner depression depressed toward the curved outer surface from axially facing inner surfaces of the two angled strut portions; a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of cells arranged between an inflow end and an outflow end of the frame, the plurality of interconnected struts comprising a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end, wherein each of the plurality of outflow struts and plurality of inflow struts comprises: two angled strut portions; and an apex region disposed between the two angled strut portions, the apex region comprising a curved, axially facing outer surface forming a single curve between axially facing outer surfaces of the two angled strut portions and an axially facing, inner depression that is depressed inward from axially facing inner surfaces of the two angled strut portions toward the curved outer surface of the apex region such that a width of the apex region is smaller than a width of the two angled strut portions.
Wallace et al. also discloses complex curves geometries at the apex regions. Wallace et al. teaches the folding nodes (A, A2, A3 and A4) act as apex regions where the unibody folds back on itself, a non-linear transition between the angled strut segments (110a and 110b) and the curved folding nodes, inherently creating a series of curves (convex at the tip of the node and concave where the node meets the strut) in order to distribute stress across multiple curved surfaces (see Fig. 1G illustrating the concave and convex geometries at the folding nodes, the axially facing surfaces of the stent, and a functional inner depression to which the inner wall (104) struts nest against the outer wall (102) struts, allowing the inner side of the apex to be depressed and allow the folding wall to sit within the profile of the outer wall). 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 the baseline annular frame structure of Chuter et al., modified by Nir et al., with a “folded” or “low-profile” design, using a series of concave and convex curves at the apex to manage mechanical strain, as taught by Wallace et. al. Doing so would utilize a specific curve arrangement as a routine refinement for stress-management geometries in a prosthetic heart valve.
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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