DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS’s) submitted on February 11, 2026 was filed after the mailing date of the Non-Final Rejection on December 29, 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Terminal Disclaimer
The terminal disclaimer filed on March 25, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Pat. No. 11,974,920 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Amendment
Claims 13-28 are pending in the application. Claims 1-12 were previously cancelled. Claims 13, 19, and 21 have been amended. Claims 13-28 are rejected.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 13-28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Loulmet (US PG Pub 2011/0011917) in view of Kaye et al. (US PG Pub 2008/0288060).
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Regarding claim 13, Loulmet teaches a method of repairing a heart valve (see paragraph [0031]) in a beating heart of a patient (See paragraphs [0004]-[0006]), comprising:
intravascularly inserting a deployment catheter (200) into the beating heart of the patient to a position adjacent a mitral valve leaflet (See Figs. 2-3; paragraphs [0042] and [0045]-[0046]);
inserting a suture (400) through the mitral valve leaflet with the deployment catheter (See Figs. 6, 9, and 10; paragraphs [0032], [0037]-[0038]);
inserting an anchor catheter (1100) into the beating heart of the patient to insert an anchor device (402) adjacent a left ventricle of the heart such that the suture extends from the mitral valve leaflet to the anchor device (See Figs. 6, 9, 10; paragraphs [0033], [0041]);
adjusting a tension of the suture to achieve proper valve function (See paragraphs [0037]-[0038] by sliding the suture through an open space within the anchor device (See Figs. 17D-17I; paragraph [0058]); and
locking the suture at the anchor device at the tension that achieves proper valve function (See paragraphs [0038] and [0058]-[0061]).
Loulmet does not explicitly teach locking the suture at the anchor device is achieved by rotating a portion of the anchor to clamp the suture by eliminating the open space within the anchor device. Loulmet teaches the fastener may be secured “in any suitable way” such as by crimping (See paragraph [0061]).
Kaye teaches an advantageous suture locking device (7) featuring and inner member (13) and outer member (12) having complementary screw threads and a void therein for receiving the sutures (See paragraphs [0046]-[0047]). Kaye teaches the locking device securely holds the sutures in the desired location but also allows for the release of the sutures to “facilitate adjustment of the valve constriction device after implantation” (See paragraph [0045]; annotated Figs. 8A&B above).
It would have been obvious to one of ordinary skill in the art at the time of invention to substitute the threaded locking device as taught by Kaye for the crimped locking device of Loulmet since the threaded locking device of Kaye allows for post-implantation adjustment, thereby ensuring proper valve function is achieved.
Regarding claim 14, modified Loulmet teaches the method of claim 13 above and further teaches withdrawing the anchor catheter from the body with the anchor device engaged with the suture in the heart. (See Paragraphs [0066]-[0069]).
Regarding claim 15, modified Loulmet teaches the method of claim 13 above and further teaches inserting the suture through the anchor device prior to inserting the anchor catheter into the body. (See paragraph [0050]. Note that since the suture is attached to the anchor, they are inserted as one unit into the catheter and then into the body).
Regarding claim 16, modified Loulmet teaches the method of claim 13 above but does not explicitly teach that inserting the anchor device adjacent the left ventricle includes advancing the anchor device along the suture to adjacent the left ventricle.
Loulmet does teach a secondary anchor (700) which slides along the suture to allow for precise placement in the desired tissue location (See Figs. 7, 8A; paragraph [0052]).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the first anchor (402) of Loulmet to be slidable along the suture (as is the case for second anchor 700) rather than fixedly secured to the suture since being able to slide the anchor along the suture allows the surgeon more control and precision to place the anchor in the desired tissue location.
Regarding claim 17, modified Loulmet teaches the method of claim 13 above and further teaches inserting a cutting catheter (1400) having a cutting tool (1402) (See Fig. 14) to adjacent the anchor device after locking the suture and cutting the suture adjacent the anchor device with the cutting tool (See Figs. 14-16C; paragraph [0062])
Regarding claim 18, modified Loulmet teaches the method of claim 13 above and further teaches the step of inserting a suture (4020) through the mitral valve leaflet with the deployment catheter includes:
capturing a heart valve leaflet (4040) with a clamping mechanism (jaw member 4048) of the deployment catheter (See Figs. 8G-8K; paragraphs [0055]-[0056] note that 4058 is a compact single delivery instrument); and
inserting the suture (4020) through the heart valve leaflet with a needle (4022) of the deployment catheter. (See paragraphs [0050] and [0055]-[0068]).
Regarding claim 19, modified Loulmet teaches the method of claim 13 above and further teaches rotating a portion of the anchor causes the portion of the anchor to move longitudinally relative to the anchor device. (See Kaye Figs. 8A & 8B; paragraphs [0045]-[0047]).
Regarding claim 20, modified Loulmet teaches the method of claim 19 above and further teaches the longitudinal movement of the portion of the anchor device eliminates the open space within the anchor device. (See Kaye Figs. 8A & 8B; paragraphs [0045]-[0047]).
Regarding claim 21, Loulmet teaches a method of repairing a heart valve (see paragraph [0031]) in a beating heart of a patient (See paragraphs [0004]-[0006]), comprising:
intravenously advancing a deployment catheter (200) into the left ventricle of beating heart of the patient through a septum in the heart (See Figs. 1-3; paragraphs [0042] and [0045]-[0046]);
inserting a suture (400) through the mitral valve leaflet with the deployment catheter (See Figs. 6, 9, and 10; paragraphs [0032], [0037]-[0038]);
inserting an anchor catheter (1100) into the heart to insert an anchor device (402) adjacent the left ventricle such that the suture extends from the mitral valve leaflet to the anchor device (See Figs. 6, 9, 10; paragraphs [0033], [0041]), the anchor device including a suture lock (fastener 1104) (See paragraph [0058]);
adjusting a tension of the suture to achieve proper valve function (See paragraphs [0037]-[0038]); and
actuating the suture lock to hold the suture at the tension that achieves proper valve function (See paragraphs [0038] and [0058]-[0061]).
Loulmet does not explicitly teach actuating the suture lock includes causing the suture lock to rotate. Loulmet teaches the fastener may be secured “in any suitable way” such as by crimping (See paragraph [0061]).
Kaye teaches an advantageous suture locking device (7) featuring and inner member (13) and outer member (12) having complementary screw threads and a void therein for receiving the sutures (See paragraphs [0046]-[0047]). Kaye teaches the locking device securely holds the sutures in the desired location but also allows for the release of the sutures to “facilitate adjustment of the valve constriction device after implantation” (See paragraph [0045]; annotated Figs. 8A&8B).
It would have been obvious to one of ordinary skill in the art at the time of invention to substitute the threaded locking device as taught by Kaye for the crimped locking device of Loulmet since the threaded locking device of Kaye allows for post-implantation adjustment thereby ensuring proper valve function is achieved.
Regarding claim 22, modified Loulmet teaches the method as required by claim 21 as set forth above and further teaches rotation of the suture lock causes the suture lock to move longitudinally relative to the anchor device. (See Kaye Figs. 8A & 8B; paragraphs [0045]-[0047]).
Regarding claim 23, modified Loulmet teaches the method as required by claim 22 as set forth above and further teaches the suture lock moves longitudinally from an initial position (See Kaye Fig. 8A) to a final position at which the suture is held at the tension that achieves proper valve function. (See Kaye Fig. 8B; paragraphs [0045]-[0047]).
Regarding claim 24, modified Loulmet teaches the method as required by claim 21 as set forth above and further teaches withdrawing the anchor catheter from the body with the anchor device engaged with the suture in the heart. (See Paragraphs [0066]-[0069]).
Regarding claim 25, modified Loulmet teaches the method as required by claim 21 as set forth above and further teaches inserting the suture through the anchor device prior to inserting the anchor catheter into the body. (See paragraph [0050]. Note that since the suture is attached to the anchor, they are inserted as one unit into the catheter and then into the body).
Regarding claim 26, modified Loulmet teaches the method as required by claim 21 as set forth above but does not explicitly teach that inserting the anchor device adjacent the left ventricle includes advancing the anchor device along the suture to adjacent the left ventricle.
Loulmet does teach a secondary anchor (700) which slides along the suture to allow for precise placement in the desired tissue location (See Figs. 7, 8A; paragraph [0052]).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the first anchor (402) of Loulmet to be slidable along the suture (as is the case for second anchor 700) rather than fixedly secured to the suture since being able to slide the anchor along the suture allows the surgeon more control and precision to place the anchor in the desired tissue location.
Regarding claim 27, modified Loulmet teaches the method as required by claim 21 as set forth above and further teaches inserting a cutting catheter (1400) having a cutting tool (1402) (See Fig. 14) to adjacent the anchor device after locking the suture and cutting the suture adjacent the anchor device with the cutting tool (See Figs. 14-16C; paragraph [0062])
Regarding claim 28, modified Loulmet teaches the method as required by claim 21 as set forth above and further teaches the step of inserting a suture (4020) through the mitral valve leaflet with the deployment catheter includes:
capturing a heart valve leaflet (4040) with a clamping mechanism (jaw member 4048) of the deployment catheter (See Figs. 8G-8K; paragraphs [0055]-[0056] note that 4058 is a compact single delivery instrument); and
inserting the suture (4020) through the heart valve leaflet with a needle (4022) of the deployment catheter. (See paragraphs [0050] and [0055]-[0068]).
Response to Arguments
Applicant’s amendments have overcome the objections to the claims.
Applicant's arguments filed March 25, 2026 have been fully considered but they are not persuasive.
Applicant argues the cited references Loulmet (US PG Pub 2011/0011917) in view of Kaye et al. (US PG Pub 2008/0288060) are not combinable because Kaye teaches the anchors are inserted into the annulus while Loulmet teaches the suture is placed through the leaflet and locked into place (as is also recited in the claim). This is unpersuasive. Loulmet explicitly states the suture lock (fastener) may be secured “in any suitable way” such as by crimping (See Loulmet paragraph [0061]). Kaye teaches a lock which secures sutures in the desired location and also allows for later adjustment. (See Kaye paragraphs [0045]-[0047]; annotated Figs. 8A&8B above). One of ordinary skill in the art would recognize the advantage of being able to further adjust the sutures. Additionally, a person of ordinary skill in the art would have recognized the interchangeability of the threaded rotatable suture lock taught by Kaye for the crimp as mentioned in Loulmet. (See MPEP §2183)
In response to applicant's argument that the suture lock of Kaye could not be used on the sutures as taught by Loulmet, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Inherent in the combination of references is the understanding that one skilled in the art would know and understand a suitable way to combine the teachings so as to make an appropriately sized and proportioned device with the desired characteristics from each of the references. Further KSR International Co. v. Teleflex, Inc. 82 USPQ2d 1385, 1396-1397 (2007) (as recited in the MPEP §2141.03(I)) states “a person of ordinary skill in the art is also a person of ordinary creativity, not an automaton”. And further states “in many cases, a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle”.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant's argument suggests that the proposed modification involves tradeoffs; however, such considerations do not necessarily prevent the proposed combination. See Medichem, S.A. v. Rolabo, S. L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) ("a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine"); Winner Int 'l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n. 8 (Fed. Cir. 2000) ("The fact that the motivating benefit comes at the expense of another benefit, however, should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another."). See MPEP §2141.02 and §2143.01 The Examiner has identified an advantage to using the suture lock as taught by Kaye i.e., (additional adjustability of tension). We note that Kaye explicitly teaches the desirability additional adjustability That this advantage comes at a purported expense as argued by applicant does not necessarily mean that the modification would not have been obvious.
Applicant argues that the lock as taught by Kaye holds multiple sutures together and as such is not combinable with the method as taught by Loulmet. This is also unpersuasive. It is noted there’s no structure which would prevent the lock as seen in Figs. 8A&8B of Kaye from being used on a single suture. When the inner portion 13 is rotated to eliminate the space in outer member 12, it also pushes down on gasket 14 which securely grips the suture.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The remainder of applicant’s arguments amount to an allegation of patentability based on the alleged deficiencies of the primary reference. For the reasons set forth above, this is unpersuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL S. HIGHLAND whose telephone number is (571)270-3254. The examiner can normally be reached on Monday through Thursday between 9:30am and 2:30pm .
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/R.S.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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