CTNF 18/596,062 CTNF 89723 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any specific references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action. Drawings 06-36 AIA The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the heart valve prosthesis comprising a frame body having an intermediate anchoring feature surrounding an intermediate region of the frame body, wherein the intermediate anchoring feature is formed by a wire mesh, and the wire mesh is coupled to the frame body by an intermediate fabric layer (claim 4) must be shown or the feature(s) canceled from the claim(s). 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. Examiner’s Notes It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114). Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1, 6, 7, 13-18 and 20 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Kovalsky et al. (US PG Pub. 2014/0222142), as disclosed in the IDS dated 02/28/2025, hereinafter Kovalsky . Regarding claims 1, 6 and 7, Kovalsky discloses a replacement heart valve prosthesis (200), illustrated in Figures 2-4A, comprising a valve body (220) including a plurality of flexible leaflets (224) made from pericardium; and a self-expanding metallic frame (210), comprising a shape-memory metal, surrounding and supporting the valve body (220), the frame (210), sized for deployment in a native heart valve, and comprises a frame body (204) formed with a cylindrical shape having a substantially constant diameter, the frame body (204) including an upper region (203), a lower region (205), and an intermediate region (portion between 203 and 205); an upper anchoring feature (202) extending from the upper region (203) of the frame body and providing a flared shoulder portion for placement above the native heart valve annulus; an intermediate anchoring feature formed by a wire mesh (i.e. the wire mesh forming the intermediate region, i.e. the portion between 203 and 205, of the frame body), surrounding the intermediate region of the frame body and conformable to adapt to a shape of the native heart valve annulus; and a lower anchoring feature (206A&B) extending from the lower region (205) of the frame body, the lower anchoring features forming arms adapted to capture native heart valve leaflets between the arms and the wire mesh, illustrated in Figures 2-4A ([0101]; [0103]; [0216]; [0217], Lines 9-13). Regarding claim 13, Kovalsky discloses the prosthesis of claim 1, wherein the prosthesis is adapted for replacing a native mitral valve ([0101], Lines 1-2 & [0231], 3 rd to last Line). Regarding claim 14, Kovalsky discloses the prosthesis of claim 1, wherein the prosthesis is adapted for replacing a native tricuspid valve ([0231], 2 nd to last Line). Regarding claim 15, Kovalsky discloses the prosthesis of claim 1, wherein a skirt (226) covers at least a portion of the upper anchoring feature (202), illustrated in Figures 2 and 2A ([0101]). Regarding claim 16, Kovalsky discloses the prosthesis of claim 1, wherein the lower anchoring features (206A&B) are not aligned with the upper anchoring features (202), illustrated in Figures 2-4A. Regarding claim 17, Kovalsky discloses a replacement heart valve prosthesis (200), illustrated in Figures 2-4A, comprising a valve body (220) including a plurality of flexible leaflets (224) made from pericardium; and a self-expanding metallic frame (210) surrounding and supporting the valve body (220), the frame (210), sized for deployment in a native heart valve annulus, and comprises a tubular frame body (204) having an upper region (203), a lower region (205), and an intermediate region (portion between 203 and 205) ; an upper anchoring feature (202) extending from the upper region (203) of the frame body and providing a flared shoulder portion for placement upstream of the native heart valve annulus; an intermediate anchoring feature formed by a wire mesh (i.e. the wire mesh forming the intermediate region, i.e. the portion between 203 and 205, of the frame body) surrounding the intermediate region of the frame body and conforming to a shape of the native heart valve annulus; and a lower anchoring feature (206A&B) comprising a plurality of curved struts, wherein each strut is attached to the lower region (205) of the frame body and wherein each strut extends toward the upper region of the frame body (204), wherein the struts are shaped for capturing native heart valve leaflets between the struts and the intermediate anchoring feature, illustrated in Figures 2-4A ([0101]; [0103]; [0216]; [0217], Lines 9-13). Regarding claim 18, Kovalsky discloses the prosthesis of claim 17, wherein a skirt (226) covers at least a portion of the upper anchoring feature (202) for enhanced sealing, illustrated in Figures 2 and 2A ([0101]). Regarding claim 20, Kovalsky discloses the prosthesis of claim 17, wherein positions of the lower anchoring features (206A&B) alternate with positions of the upper anchoring features (202) along the circumference of the frame, illustrated in Figures 2-4A . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kovalsky as applied to claim 1 above, and in view of Montorfano et al. (US Patent No. 8,728,155), as disclosed in the IDS dated 02/28/2025, hereinafter Montorfano . Regarding claim 5, Kovalsky discloses the prosthesis of claim 1, but does not specifically disclose the wire mesh is a braided mesh. However, Montorfano teaches a heart valve prosthesis, in the same field of endeavor, wherein the frame body comprises a braided wire mesh, illustrated in Figure 1 (Column 1, Lines 54-56). In view of the teaching of Montorfano, it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate form/type of wire mesh, for the heart valve prosthesis of Kovalsky, including a braided mesh, since this is well-known form/type of wire mesh used in prosthetic heart valves, as taught by Montorfano . 07-21-aia AIA Claim s 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kovalsky as applied to claims 1 and 17 above, and in view of Karapetian et al. (US PG Pub. 2015/0148896), as disclosed in the IDS dated 01/06/2026, hereinafter Karapetian . Regarding claims 8 and 19, Kovalsky discloses the prosthesis of claims 1 and 17, but does not specifically disclose the lower anchoring features are covered by cushions. However, Karapetian teaches a prosthetic heart valve, in the same field of endeavor, wherein a plurality of anchoring features (3840/3842) are covered with a cushion, in order to absorb/cushion the load applied to natural tissue and promote ingrowth of surrounding tissue, illustrated in Figure 121 ([0370]). In view of the teaching of Karapetian, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the lower anchoring features, of the heart valve prosthesis of Kovalsky, to be covered by cushions, in order to absorb/cushion the load applied to natural tissue and promote ingrowth of surrounding tissue, as taught by Karapetian . 07-21-aia AIA Claim s 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kovalsky . Regarding claim 9, Kovalsky discloses the prosthesis of claim 1, wherein the upper anchoring feature (202) extends radially outwardly from the upper region (203) of the frame body (204), illustrated in Figures 2, 3, 4 and 4A; and though this embodiment does not specifically disclose the upper region then bends radially inwardly, the embodiment illustrated in Figure 15 teaches the upper anchoring feature (1502) extending radially outwardly and then bending radially inwardly, in order to prevent damage to atrial tissue ([0129]). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the upper anchoring feature, of the prosthesis of the embodiment illustrated in Figures 2-4A, to bend radially inwardly, after extending radially outwardly form the upper region, in order to prevent damage to atrial tissue, as taught by Kovalsky. Regarding claims 10 and 11, Kovalsky discloses the prosthesis of claim 9, wherein the upper anchoring feature (202) comprises a plurality of struts having tips with enlarged heads (TH), formed with central eyelets, sized to be positioned within corresponding slots in a delivery catheter, illustrated in Figures 2, 3, 4, 4A and modified figure 4, below. PNG media_image1.png 375 586 media_image1.png Greyscale Regarding claim 12, Kovalsky discloses the prosthesis of claim 10, wherein at least some of the plurality of struts (S1 & S2) have different lengths, illustrated in Figures 2, 3, 4, 4A and modified figure 3, below . PNG media_image2.png 427 628 media_image2.png Greyscale 07-21-aia AIA Claim s 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Kovalsky in view of Dale et al. (US PG Pub. 2014/0371844), as disclosed in the IDS dated 02/28/2025, hereinafter Dale . Regarding claims 1-3 and 5-7, Kovalsky discloses a replacement heart valve prosthesis (3100), illustrated in Figure 31, comprising a valve body (3120) including a plurality of flexible leaflets (3124) made from pericardium; and a self-expanding metallic frame (3110), comprising a shape-memory metal, surrounding and supporting the valve body (3120) and sized for deployment in a native heart valve annulus, the frame (3110) comprising a frame body formed with a cylindrical shape having a substantially constant diameter and including an upper region (3102), a lower region (3104), and an intermediate region (portion between 3102 and 3104); an upper anchoring feature (UAF) extending from the upper region of the frame body, the upper anchoring feature (UAF) providing a flared shoulder portion for placement above the native heart valve annulus; an intermediate anchoring feature (3240), formed by a mesh/fabric, surrounding the intermediate region of the frame body (3110), the anchoring feature (3240) formed separately from the frame body (3110) and coupled to the frame body (3110) with sutures; and a lower anchoring feature (3106) extending from the lower region (3104) of the frame body, the lower anchoring feature (3106) forming arms adapted to capture native heart valve leaflets between the arms and the mesh/fabric, illustrated in Figure 31 and modified figure 31, below ([0161] – [0163]; [0216]; [0217], Lines 9-13); but does not specifically disclose the mesh/fabric is a braided wire mesh conformable for adapting to a shape of the native heart valve annulus. PNG media_image3.png 493 480 media_image3.png Greyscale However, Dale teaches a heart valve prosthesis, in the same field of endeavor, comprising an intermediate anchoring feature (370) formed by a mesh/fabric, wherein the mesh/fabric is a braided wire mesh, made of shape memory alloys, such that it is conformable for adapting to a shape, illustrated in Figures 3A-3C ([0046] & [0047]). In view of the teaching of Dale, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the mesh/fabric, of the intermediate anchoring feature of the heart valve prosthesis of Kovalsky, to be a braided wire mesh made of a shape memory alloy such that it is conformable for adapting to a shape of the native heart valve annulus, since this is a known form/type of mesh/fabric in the art, as taught by Dale. Regarding claim 4, Kovalsky in view of Dale discloses the prosthesis of claim 2, and though it is not specifically disclosed that the wire mesh is coupled to the frame body by an intermediate fabric layer, Kovalsky does state the intermediate anchoring feature/mesh (3240) can be attached by any suitable means (Kovalsky: [0163]). Thus, it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate way to couple the intermediate anchoring feature/wire mesh, of the heart valve prosthesis of Kovalsky in view of Dale, to the frame body, including by an intermediate fabric layer, since this is considered a suitable means. Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the wire mesh being coupled to the frame body by an intermediate fabric layer, as opposed to being coupled any other way. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /DINAH BARIA/Primary Examiner, Art Unit 3774 05/30/2026 Application/Control Number: 18/596,062 Page 2 Art Unit: 3774 Application/Control Number: 18/596,062 Page 3 Art Unit: 3774 Application/Control Number: 18/596,062 Page 4 Art Unit: 3774 Application/Control Number: 18/596,062 Page 5 Art Unit: 3774 Application/Control Number: 18/596,062 Page 6 Art Unit: 3774 Application/Control Number: 18/596,062 Page 7 Art Unit: 3774 Application/Control Number: 18/596,062 Page 9 Art Unit: 3774 Application/Control Number: 18/596,062 Page 10 Art Unit: 3774 Application/Control Number: 18/596,062 Page 11 Art Unit: 3774 Application/Control Number: 18/596,062 Page 12 Art Unit: 3774
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