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. Election/Restrictions Applicant’s election without traverse of Invention I, Claims 1-18 drawn to a system for valve repair in the reply filed on February 2, 2026 is acknowledged. Claim s 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 2, 2026 . It is noted applicant has cancelled claims 19 & 20. Response to Amendment Claims 1-18 are pending in the application. Claims 19 & 20 have been cancelled. No claims have been amended. Claims 1-18 are rejected. Claim Objections Claims 5, 8, 10 are objected to because of the following informalities: Claim 5 recites: “ The system of claim 4, wherein delivery device includes delivery of the first and second anchors through the cannulated needle to the first and second holes.” For clarity and grammatical correctness, it should read “wherein the delivery device…” Appropriate correction is required. Claim 8 recites: “ The system of claim 6, wherein knot replacement tool further includes a detachable delivery shaft coupled with the locking screw. For clarity and grammatical correctness, it should read: “where the knot replacement tool….” Appropriate correction is required. Claim 10 recites: “ The system of claim 9, wherein cutter device includes…” in line 1 of the claim For clarity and grammatical correctness, it should read: “where the cutter device includes:…” Appropriate correction is required. Applicant is encouraged to carefully review the claims and amend any other similar mistakes accordingly. 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. Claim(s) 1, 4, 5, 11, 12, and 15 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Raschdorf , Jr. et. al. (US PG Pub 2009/0163934) . Regarding claim 1 , Raschdorf teaches a system to repair a tricuspid or mitral valve comprising: an integrated therapy catheter (entire system) configured to engage the annulus of the tricuspid or mitral valve at a first location and a second location having (See Figs. 2A, 2B, and 4): a valve engagement structure (See Figs. 35-43C) at a distal end configured to couple with the annulus at the first location and the second location (See paragraphs [0182]-[0185]) ; a puncture device (220) configured to puncture a first hole in the annulus at the first location and a second hole in the annulus at the second location (See Fig. 38; paragraph [0184]) ; and a delivery device configured to deliver a first anchor (222) through the first hole and a second anchor (222) through the second hole (See Figs. 43A-43C; paragraphs [0184]-[0186]) ; the first anchor having a self-expanding distal end (228) and a proximal tether (226) configured to be delivered through the first hole by the delivery device, the self-expanding distal end configured to expand larger than the first hole and engage the annulus of the tricuspid or mitral valve (See Figs. 43A-43C; paragraphs [0184]-[0186]); a second anchor (222) having a self-expanding distal end (228) and a proximal tether (226) configured to be delivered through the second hole by the delivery device, the self-expanding distal end configured to expand larger than the second hole and engage the annulus of the tricuspid or mitral valve (See Figs. 40A-40D and 43A-43C, note there are two anchors, sutures, pledgets , etc. one for each leaflet; See also paragraphs [0184]-[0186]); and a knot replacement tool (232) configured to couple with the first and second tethers (two tethers 226 – See Figs. 43A-43C) , tension the first and second tethers to bring the first location and the second location toward each other, and lock the first and second tethers. (See paragraph [0186]). Regarding claim 4 , Raschdorf teaches the system as required by claim 1 above and further teaches the puncture device includes a cannulated needle (220) (See Figs. 40A-40D) positioned within the proximal body (catheter 86) configured to extend distally to puncture the first and second holes in the annulus at the first location and the second location. (See Figs. 39, 41, and 42; paragraph [0184]) Regarding claim 5 , Raschdorf teaches the system as required by claim 4 above and further teaches delivery device includes delivery of the first and second anchors through the cannulated needle to the first and second holes. (note anchor is carried within sleeve 224) (See Figs. 40A-40D; paragraphs [0184]-[0185]) Regarding claim 11 , Raschdorf teaches a system to repair a tricuspid or mitral valve comprising: an integrated therapy catheter configured to puncture first and second holes in the valve annulus of the tricuspid or mitral valve at first and second locations (See Figs. 2A, 2B, 4l and 38 – paragraphs [0182]-[0185]; an anchor delivery device configured to deliver first and second anchors (222) to the first and second holes, the first and second anchors having first and second tethers (226) with distal ends configured couple with the first and second holes (See Figs. 40A-40D and 43A-43C, note there are two anchors, sutures, pledgets , etc. one for each leaflet; See also paragraphs [0184]-[0186]) ; and a knot replacement tool (232) configured to couple with the first and second tethers to move the first and second locations toward each other a desired distance and lock the first and second tethers at the desired distance to modify one or more valve leaflets. (See Figs. 43A-43C; paragraph [0186]) . Regarding claim 12 , Raschdorf teaches the system as required by claim 11 above and further teaches the distal end (228) of the first and second anchors (222) are configured to be delivered through the first and second holes by the delivery device and self- expand to engage the annulus. (See Figs. 43A-43C; paragraphs [0184]-[0186]) Regarding claim 15 , Raschdorf teaches the system as required by claim 11 above and further teaches the integrated therapy catheter includes: a valve engagement structure configured to couple with the valve annulus (See Figs. 35-43C) ; and a puncture device (220) configured to puncture the first and second holes in the valve annulus. (See Figs. 39-40D; paragraphs [0133] and [0182]-[0185]) 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. 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 . This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 102( a ) (1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Raschdorf , Jr. et. al. (US PG Pub 2009/0163934) . Regarding claim 13 , Raschdorf teaches the system as required by claim 11 above and further teaches the tricuspid valve includes the first location at a junction above the anterior leaflet and posterior leaflet, and the second location at a junction above the posterior leaflet and septal leaflet. Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date to have the first and second holes in the valve be at the recited locations since there are a finite number of locations to engage a heart valve, and it would be obvious for one of ordinary skill in the art to try engaging the valve at a first location above the anterior leaflet and posterior leaflet and a second location at a junction above the posterior leaflet and septal leaflet with a reasonably expectation of success. See also MPEP §2143(I)(E) Regarding claim 1 4 , Raschdorf teaches the system as required by claim 11 above and further teaches the mitral valve includes first and second locations above the posterior leaflet. Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date to have the first and second holes in the valve be at the recited locations since there are a finite number of locations to engage a heart valve, and it would be obvious for one of ordinary skill in the art to try engaging the valve at first and second locations above the posterior leaflet with a reasonably expectation of success. See also MPEP §2143(I)(E) Claim(s) 2, 3, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raschdorf , Jr. et. al. (US PG Pub 2009/0163934) as applied to claim s 1 and 15 respectively above, and further in view of Kuhn et al (US PG Pub 2021/0045773). Regarding claims 2, 3, and 16 , Raschdorf teaches the system of claims 1 and 11 respectively as set forth above, but does not explicitly teach the valve engagement structure includes a spiral needle or corkscrew coupled to a distal end of a body portion, wherein rotation of the spiral needle or corkscrew in a first direction screws the spiral needle or corkscrew into the valve annulus and rotation of the spiral needle or corkscrew in a second direction unscrews the spiral needle or corkscrew from the valve annulus. Kuhn teaches an analogous system to repairing structures inside the heart featuring a spiral needle or corkscrew ( 1210) coupled to a distal end of a body portion wherein rotation of the spiral needle or corkscrew in a first direction screws the spiral needle or corkscrew into the heart tissue (See Figs. 6A-6B) and rotation of the spiral needle or corkscrew (1210) in a second direction unscrews the spiral needle or corkscrew from the heart tissue. (See paragraphs [0118]-[0122]) It would have been obvious to one of ordinary skill in the art before the effective filing date to have the valve engagement structure in the system as taught by Raschdorf be the spiral needle/corkscrew engagement structure as taught by Kuhn since spiral tissue graspers are widely known and used in the medical arts to reliably engage and hold tissue in a particular desired location so an anchor or other medical implant or treatment device can be appropriately deployed to the desired location. Additionally, there are a finite number of tools for engaging and retaining tissue in a desired location and it would be obvious for one of ordinary skill in the art to try a spiral needle or corkscrew with a reasonably expectation of success. See also MPEP §2143(I)(E) Claim(s) 6-8 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raschdorf , Jr. et. al. (US PG Pub 2009/0163934) as applied to claim s 1 and 11 respectively above, and further in view of Ek et al (US Pat. No. 6,086,608). Regarding claim 6 , Raschdorf teaches the system as required by claim 1 above but is silent as to the particular arrangement of the knot replacement tool. Ek teaches an analogous knot replacement tool (collet 10) including a locking cap (ring 12) having a cylindrical body in shape (bore 16) with an internal threaded portion (36) and a closed distal end (See Fig. 6A; Col. 3, lines 50-68 and Col. 4, lines 4-68 – note when the pin 14 is fully inserted, the distal end is closed except for the openings for the suture) having first and second tether locking cap holes (tunnels 24, 26); a locking screw (14) having a cylindrical body in shape with an external threaded portion (ridges 22) and a closed distal end having first and second tether locking screw holes (See Figs. 1-3 and 6A); and wherein the locking screw is configured to be inserted into the locking cap (See Figs. 1-3 and 6A), and the external threaded portion configured to rotating engage with the internal threaded portion so that the locking screw may be screwed into the locking cap. I t would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the knot replacement tool of R a schdorf suc h that it comprises a locking cap is cylindrical body in shape with an internal threaded portion and a closed distal end having first and second tether locking cap holes; and a locking screw is cylindrical body in shape with an external threaded portion and a closed distal end having first and second tether locking screw holes; wherein the locking screw is configured to be inserted into the locking cap and the external threaded portion configured to rotating engage with the internal threaded portion so that the locking screw may be screwed into the locking cap as taught by Ek in order to provide a simple , reliable mechanism to lock the suture in place when desired. Additionally, a wide variety of suture knot replacement mechanisms are known and used in the art. As stated in KSR Int'l Co. v. Teleflex Inc. , 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United State s v. Adams , 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B). Regarding claim 7 , modified Raschdorf teaches the system of claim 6 as set forth above and further teaches wherein as the locking screw is rotated in the locking cap, the first and second tether locking screw holes and the first and second tether locking cap holes are rotated in opposite directions and the first tether and second tether are twisted around each other and are locked in place. (See Ek Figs. 1-3; Col. 9, lines 43-60) Regarding claim 8 , modified Raschdorf teaches the system of claim 6 as set forth above and further teaches knot replacement tool further includes a detachable delivery shaft (84) coupled with the locking screw (pin 14). (See Ek Figs. 7-8; Col. 5, lines 39-48). Regarding claim 17 , Raschdorf teaches the system of claim 11 as set forth above but is silent as to the particulars of the knot replacement tool. Ek teaches an analogous knot replacement tool (collet 10) including a locking cap (ring 12) having first and second tether locking cap holes (18 and 20); and a locking screw (14) having first and second tether locking screw holes (tunnels 24, 26); wherein the locking screw is configured to be screwed into the locking cap and the first and second tether locking cap holes and first and second tether locking screw holes are rotated in opposite directions and the first tether and second tether are twisted around each other and are locked in place. I t would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the knot replacement tool of Raschdorf suc h that it includes a locking cap having first and second tether locking cap holes; and a locking screw having first and second tether locking screw holes; wherein the locking screw is configured to be screwed into the locking cap and the first and second tether locking cap holes and first and second tether locking screw holes are rotated in opposite directions and the first tether and second tether are twisted around each other and are locked in place as taught by Ek in order to provide a simple , reliable mechanism to lock the suture in place when desired. Additionally, a wide variety of suture knot replacement mechanisms are known and used in the art. As stated in KSR Int'l Co. v. Teleflex Inc. , 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United State s v. Adams , 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B). Claim(s) 9, 10, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raschdorf , Jr. et. al. (US PG Pub 2009/0163934) as applied to claim s 1 and 11 respectively above, and further in view of Findlay (US PG Pub 2007/0005081). Regarding claims 9, 10, and 18 , Raschdorf teaches the system of claims 1 and 11 respectively as set forth above, but is silent as to a cutter device configured to cut the first and second tethers or the particular arrangement of the cutter device as recited in claim 10 . Findlay teaches an analogous system featuring a suture cutting device (device for securing and cutting a suture via catheter, paragraph [0008]) configured to cut the first and second tethers including: an outer body (12) with an outer body side opening (38) (see Fig 2b, paragraph [0043]); and an inner body (26) with an inner body side opening (34) (see Fig 2a, paragraph [0043]) slidably positioned within the outer body (longitudinally slidable inner body 26 within main body 12, paragraph [0042]), the inner body side opening and the outer body side opening are positioned to provide an opening to a center lumen (see how openings 34 and 38 are aligned to provide an opening to a center lumen for suture 50, Fig 5a), wherein the first and second tethers enter a distal end of the center lumen and exit out through the inner body side opening and outer body side opening (see how suture strands 50a and 50b enter a right end of the center lumen and exit out the side openings 34 and 38, Fig 5b), and axial movement of the inner body in relation to the outer body side opening closes the opening to the center lumen and scissor cuts the first and second tethers (see how axial movement of inner body 26 closes the opening to cut the suture strands 50a and 50b, Fig 5c, as inner body 26 is retracted the suture leads 50a, 50b are cut, paragraph [0053]) in order to provide the mechanism to cut the suture (to provide a device capable of cutting suture, paragraph [0008]). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the mitral valve repair system as taught by Raschdorf so as to include a cutter device with the recited sliding inner and outer bodies with a side opening for cutting sutures, as taught by Findlay, in order to provide a reliable and low profile mechanism for cutting the first and second tethers as desired during the procedure. Furthermore, cutting devices are widely known and employed in the medical arts to sever the unnecessary lengths of suture after an implant or anchor has been deployed and properly secured. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT RACHEL S. HIGHLAND whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3254 . 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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. /R.S.H/ Examiner, Art Unit 3774 /MELANIE R TYSON/ Supervisory Patent Examiner, Art Unit 3774