DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I: claims 1-15 in the reply filed on 26 February 2026 is acknowledged.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26 February 2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. The “pair of seams” of claim 14 must be shown or the features canceled from the claims. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: the term “plurality of cords” is only used in the background section of the specification, while the Detailed Description section uses the terminology “sutures”, “connectors” and “suture connectors” to describe the elements 600 of the drawings. Claims 1, 4, 9-12 and 14 recite the term “plurality of cords” and “second plurality of cords”, which causes confusion due to the difference in terminology in the specification. Consistent terminology should be used for the same component throughout the specification and claims for clarity. Appropriate correction is required.
Claim Objections
Claims 1, 4, 9-12 and 14 are objected to because of the following informalities:
Claims 1, 4, 9-12 and 14 recite the term “plurality of cords” and “second plurality of cords”, but the detailed description of the specification uses the terms “suture”, “connectors” and “suture connectors” for the corresponding element 600. Consistent terminology should be used for the same component throughout the specification and claims for clarity. 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.
Claims 1-10 and 13-14 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.
The term “substantially” in claim 1 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what qualifies as “substantially blocking blood” and the specification provides a definition in [0021] that offers no further clarification. Claims 2-10 are rejected by dependency.
The term “generally” in claims 13-14 is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what qualifies as “generally cylindrical”, and the specification provides a definition in [0021] that offers no further clarification.
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.
Claims 1-2 and 4-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dibie (US 2018/0333259 A1), “Dibie”.
Regarding claim 1, Dibie teaches
A prosthetic heart valve (Fig. 4A) comprising:
a collapsible and expandable frame (Fig. 1A, frame 100 is extensible and deformable [0087]) that,
in an expanded condition, includes a central portion (Fig. 1A, region of native cardiac annulus 131),
an atrial portion flaring radially outwardly from the central portion (Fig. 1A, region 132), and
a ventricular portion flaring radially outwardly from the central portion (Fig. 1A, region 133);
a tube positioned within the frame (Fig. 4A, bioprosthesis 210),
the tube having a lumen extending along a longitudinal axis from the atrial portion toward the ventricular portion of the frame (Fig. 4B, bioprosthesis 210 is positioned inside the frame 100 and extends from region 132 to 133),
wherein the tube is formed of tissue or fabric (Fig. 4A, bioprosthesis 210 is made from animal tissue or synthetic fabric [0091]);
a plurality of prosthetic leaflets directly coupled to the tube to form a valve (Fig. 2B, bioprosthesis 210 comprises leaflets 211, 212, 213),
the valve allowing blood to flow through the lumen of the tube in an antegrade direction but substantially blocking blood from flowing through the lumen of the tube in a retrograde direction (Fig. 4A, bioprosthesis 210 functions as valve in the physiological direction of blood flow [0021, 0091]); and
a plurality of cords each having a first portion coupled to the frame and a second portion coupled to the tube (Fig. 4B, strands 411, 412, 413, 414 hold stent 200, comprising bioprosthesis 210, to frame 100 [0100]),
each of the plurality of cords extending in a radial direction toward the longitudinal axis (Fig. 4A, strands 411, 412, 413, 414 extends radially from stent 200 to frame 100).
Regarding claim 2, Dibie teaches
wherein the tube excludes any metal structure directly attached to the tube (Fig. 4A, bioprosthesis 210 excludes stent 200).
Regarding claim 4, Dibie teaches
wherein each of the plurality of cords is a suture (Fig. 4B, strands 411, 412, 413, 414 comprise nitinol (known in the art for sutures) [0031]; wherein the thin elongate filaments meet the broadest reasonable interpretation of “suture”).
Regarding claim 5, Dibie teaches
further comprising a skirt coupled to the frame (Fig. 6B, skirt 610 bears on frame 100 and covers stent 200 [0112]),
the skirt including an atrial portion extending radially inwardly from the frame and being connected to a first end of the tube (Fig. 6B, region of skirt nearest fold 6110), and
a ventricular portion extending radially inwardly from the frame and being connected to a second end of the tube (Fig. 6B, region of skirt nearest starting point 6101).
Regarding claim 6, Dibie teaches
wherein the skirt is formed of a woven synthetic fabric (Fig. 6B, skirt 610 is formed of synthetic material [0114]).
Regarding claim 7, Dibie teaches
wherein the skirt is formed of PET, PTFE, or UHMWPE (Fig. 6B, skirt is made of PET [0114]).
Regarding claim 8, Dibie teaches
wherein the skirt includes an outer section attached to the frame (Fig. 6B, portion of skirt 610 along outer wall of frame 6103),
the outer section being configured to contact a native valve annulus upon implantation to help seal against the native valve annulus and to prevent paravalvular leakage (Fig. 6B, skirt 610 envelopes frame 100 and reinforces the frame 100 in the narrowest region pressed against the native tissue 6104 to prevent per-prosthetic leaks [0113]).
Regarding claim 9, Dibie teaches
wherein the plurality of cords only provide support in tension (Fig. 4B, strands 411, 412, 413, 414 may be rigid, elastic, flexible, or deformable, or a combination of each depending on the behavior of the assembly [0103]; the capability of the cords to perform the function of “only providing support in tension” meets the functional requirement);
helping to minimize movement of the tube and the plurality of prosthetic leaflets directly coupled to the tube during normal operation of the prosthetic heart valve (Fig. 4B, strands 411, 412, 413, 414 join stent 200 to frame 100 and provide torsional stability of the stent [0101]).
Regarding claim 10, Dibie teaches
wherein upon compression of the frame, compressive force is not translated via the plurality of cords to the tube (Fig. 8, assembly in compressed delivery state provided by delivery catheter 800 [0123]).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Dibie (US 2018/0333259 A1), “Dibie” in view of Christianson et al. (US Pat. No. 10405976 B2), “Christianson”.
Regarding claim 3, Dibie teaches the prosthetic leaflets and the tube (Fig. 2B, bioprosthesis 210 comprises leaflets 211, 212, 213) but fails to teach at least one metal underwire disposed between.
Christianson teaches a prosthetic valve leaflet assembly comprising at least one metal underwire disposed between (Fig. 1, leaflet wire support structure 136 comprises outer cylindrical wrap 152 disposed about it (col. 3, par. 2 and col. 5, par. 7). Christianson discloses that the wire support structure allows for the leaflet structure to be compressed when the prosthesis is compressed and then spring open into functional shape when deployed (col. 5, par. 7). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the prosthetic leaflets and tube taught by Dibie with the metal underwire taught by Christianson in order to avoid deployment malfunctions of the valve.
Claims 11-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Dibie (US 2018/0333259 A1), “Dibie” in view of Vidlund (US 2022/0087814 A1), “Vidlund”.
Regarding claim 11, Dibie teaches a prosthetic heart valve (Fig. 4A) comprising:
a collapsible and expandable frame (Fig. 1A, frame 100 is extensible and deformable [0087]) that, in an expanded condition, includes a central portion (Fig. 1A, region of native cardiac annulus 131), an atrial portion flaring radially outwardly from the central portion (Fig. 1A, region 132), and a ventricular portion flaring radially outwardly from the central portion (Fig. 1A, region 133); a tube positioned within the frame (Fig. 4A, bioprosthesis 210), the tube having a lumen extending along a longitudinal axis from an inflow end to an outflow end (Figs. 1A and 4B, bioprosthesis 210 is positioned inside the frame 100 and extends from atrium AD (inflow end) to ventricle VD (outflow end) indicated by blood flow 199), wherein the tube is formed of tissue or fabric (Fig. 4A, bioprosthesis 210 is made from animal tissue or synthetic fabric [0091]); a plurality of first cords each having a first portion coupled to the frame (Fig. 4B, portions of strands 411, 412, coupled to frame 100) and a second portion coupled to the inflow end of the tube (Fig. 4A, portions strands 411, 412, coupled to atrium AD end of stent 200 comprising bioprosthesis 210) the first plurality of cords maintaining the inflow end of the tube in an open condition (Fig. 4A, strands 411, 412, 413, 414 may be rigid, elastic, flexible, or deformable, or a combination of each depending on the behavior of the assembly [0103]); and a pair of second cords each having a first portion coupled to the frame (Fig. 4B, portions of strands 413, 414 coupled to frame 100) and a second portion coupled to the outflow end of the tube (Fig. 4B, portions of strands 413, 414 coupled to stent 200 comprising bioprosthesis 210), but fails to teach the pair of second cords coupled to diametrically opposed portions of the outflow end of the tube so that two free edges of the outflow end of the tube are capable of collapsing toward each other and opening away from each other.
Vidlund teaches a prosthetic heart valve wherein the pair of second cords coupled to diametrically opposed portions of the outflow end of the tube (Fig. 5B, diametrically opposed pairs of constraining members 400 extend from outflow end of inner frame 205 [0054]) so that two free edges of the outflow end of the tube are capable of collapsing toward each other and opening away from each other (Fig. 5B, constraining members 400 apply equal force to prosthetic heart valve 100 and allow for repeatable deployment within the desired position and orientation (i.e., opening and closing) [0058]). Vidlund discloses that the constraining members work to delay prosthesis deployment to ensure proper positioning and orientation of the device [0055]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the prosthetic heart valve taught by Dibie with the second cords taught by Vidlund in order to ensure proper positioning and orientation of the device when implanted.
Regarding claim 12, Dibie teaches wherein the plurality of first cords are sutures, and the pair of second cords are sutures (Fig. 4B, strands 411, 412, 413, 414 comprise nitinol (known in the art for sutures) [0031]; wherein the thin elongate filaments meet the broadest reasonable interpretation of “suture”).
Regarding claim 13, Dibie teaches wherein the tube is formed of tissue that is rolled into a generally cylindrical shape (Fig. 2B, bioprosthesis 210 comprises a circular cross-section (i.e., cylindrical in length); the prior art is not required to disclose a “rolled” as it pertains to a step of manufacture, which is not germane to the issue of patentability of the final product).
Regarding claim 15, Dibie teaches wherein the prosthetic heart valve excludes prosthetic leaflets separate from the tube (Fig. 2B, leaflets 211, 212, 213 are attached to the bioprosthesis 210 [0091]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Dibie (US 2018/0333259 A1), “Dibie” in view of Vidlund (US 2022/0087814 A1), “Vidlund”, as applied to claim 11 above, and further in view of Salahieh et al. (US 2022/0175522 A1), “Salahieh”.
Regarding claim 14, Dibie teaches wherein the tube is formed of fabric to form a generally cylindrical shape (Fig. 4A, bioprosthesis 210 is made from animal tissue or synthetic fabric [0091] and comprises a circular cross-section (i.e., cylindrical shape, Fig. 2B)), but fails to teach it is formed as two pieces of fabric that are coupled together, via a pair of seams, the pair of seams aligning with the pair of second cords.
Vidlund teaches a pair of second cords (Fig. 5B, constraining members 400). Vidlund discloses that the constraining members may couple to the frame at any location from the central waist portion to the tips of the ventricular anchors and may take many suitable forms [0054] and further that the constraining members work to delay prosthesis deployment to ensure proper positioning and orientation of the device [0055]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the tube taught by Dibie with the pair of second cords taught by Vidlund in order to ensure proper positioning and orientation of the device when implanted. However, Dibie in view of Vidlund fails to teach two pieces of fabric that are coupled together, via a pair of seams.
Salahieh teaches a valve segment comprising two pieces of fabric that are coupled together, via a pair of seams (Fig. 28, skirt 230 is manufactured from a flat sheet of material that is laser cut and sewn together along seam 231 [0132]). Salahieh discloses that the unitary skirt can help prevent bunching or folding that may occur with separate skirts [0132]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the prosthetic heart valve taught by Dibie with the second cords taught by Vidlund and the sewing of two pieces of fabric together taught by Salahieh in order to prevent malfunctions of the device during deployment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
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/G.G.R./Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774