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 .
Response to Amendment
This office action is responsive to the amendment filed on 04/27/2026. As directed by the amendment: claim 1 have been amended, claim 11 has been cancelled and claims 19-20 remain withdrawn. Thus, claims 1-10 and 12-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 1, filed 04/27/2026, with respect to drawing objections have been fully considered and are persuasive. The applicant’s cancellation of claim 11 overcomes the drawing objection of drawings not showing claimed subject matter. The drawing objections has been withdrawn.
Applicant’s arguments, see pages 1-2, filed 04/27/2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(1) as being anticipated by To et al (US 20060190030 A1), herein referenced to as “To” have been fully considered and are persuasive.
The applicant has amended claim 1 to further recite “a push tube slidably disposed within the catheter, the push tube being configured to advance the first anchor through the catheter”.
The examiner agrees that To does not explicitly disclose a push tube slidably disposed within the catheter and being configured to advance the first anchor through the catheter.
The applicant however additionally argues that with claim 10, which recited the push tube, which was rejected under 35 U.S.C. 103 over To in view of Douk is not an obvious combination.
Specifically, they argue that To already discloses a mechanism for deploying the anchors involving a wire, and that modifying To to include a push tube would at least change a principle of operation of To, hence rendering the combination not obvious.
The examiner respectfully disagrees.
To specifically discloses that such a combination would be likely or obvious. While To does not disclose a “push tube”, they do note that instead a of a pull cord a pusher member may be used instead to contact and deploy the anchors (see [0086]). As such, such as modification would not change the principle of operation of To, as To has envisioned for such a modification to begin with.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of To in view of Douk (US 20070027533 A1).
Applicant's arguments, see page 2, filed 04/27/2026, with respect to the rejection(s) of claim(s) 10 under 35 U.S.C. 103 as being unpatentable over To in view of Douk (US 20070027533 A1), herein referenced to as “Douk” have been fully considered but they are not persuasive.
The applicant argues, as with above, that the combination of To in view of Douk is not an obvious combination. They argue that To already discloses a mechanism for deploying the anchors involving a wire, and that modifying To to include a push tube would at least change a principle of operation of To, hence rendering the combination not obvious.
The examiner respectfully disagrees.
To specifically discloses that such a combination would be likely or obvious. While To does not disclose a “push tube”, they do note that instead a of a pull cord a pusher member may be used instead to contact and deploy the anchors (see [0086]). As such, such as modification would not change the principle of operation of To, as To has envisioned for such a modification to begin with.
As such the rejection of claim 10 will be maintained.
Claim Rejections - 35 USC § 103
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) 1-10, 12-13, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over To in view of Douk (US 20070027533 A1), herein referenced to as “Douk”.
Claim 1
To discloses: An implant 520 (see Figs. 9A-10F, [0083]) comprising: a catheter 522 (see Figs. 9A-10F, [0083]) having a tubular body the tubular body of 522 (see Figs. 9A-10F) with a proximal end the proximal end of 522 (see Figs. 9A-10F) and a distal end distal end of 522 (see Figs. 9A-10F) and defining a lumen the lumen of 522 (see Fig. 9B, 533 extends in an out of the lumen of 522) between the proximal end proximal end of 522 and the distal end distal end of 522, and a plurality of openings 528 (see Figs. 9A-10F, [0083], there are multiple openings 528) through a portion the wall of 522 (see Figs. 9A-10F) of said tubular body the tubular body of 522; a suture 534 (see Figs. 9B-10F, [0076], a tether is a suture); a first anchor a first 526 (see Figs. 9A-10F, [0083]) coupled to said suture 534 and configured to be extendable through a first opening a first 528 correlating to a first 526 (see Figs. 9A-10F) through said tubular body the tubular body of 522 of said catheter 522 and into tissue (see Figs. 9A-10F, [0087]); a push element 532 (see Figs. 9A-10F, [0083]-[0084]), translatably disposed within the catheter lumen the lumen of 522 (see Figs. 9A-10F, [0083]-[0084]) and configured to advance (see [0084], causes 526 to exit 522 through one of the 528) the first anchor a first 526 through the catheter 522; and a second anchor a second 526 (see Figs. 9A-10F, [0083]) coupled to said suture 534 to be movable along said suture 534 (see [0087], 534 is slidably coupled to anchors 526 that are not the distal-most anchor) and configured to be extendable through any of the plurality of openings 528 through said tubular body the tubular body of 522 of said catheter 522 proximal to the first opening a first 528 and into tissue (see [0087]).
To does not explicitly disclose: the push element is a push tube.
However, Douk in a similar field of invention teaches a delivery system (see Fig. 5) with a plurality of anchors 112 (see Fig. 5) and a push element 508 (see Fig. 5). Douk further teaches: the push element 508 is a push tube 508 (see Fig. 5, [0032], hollow member having an enlarged end portion).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified To to incorporate the teachings of Douk and teach a delivery system with the push element is a push tube. Motivation for such can be found in Douk as the tube can accommodate the implant and be easily deployed therefrom (see [0032]).
Claim 2
The combination of To and Douk teaches: The implant of claim 1, see 103 rejection above. To further discloses: wherein said second anchor a second 526 is movable along said suture 534 (see [0087], 534 is slidably coupled to anchors 526) and with respect to said first anchor a first 526 (see [0087], 526 then can slidably couple on 534 in relation to the first anchor 526).
Claim 3
The combination of To and Douk teaches: The implant of claim 2, see 103 rejection above. To further discloses: wherein said suture 534 is tied to said first anchor a first 526 (see [0087], when the first 526 is the distal-most 526 it is tied to the suture 534).
Claim 4
The combination of To and Douk teaches: The implant of claim 1, see 103 rejection above. To further discloses: wherein at least one of said first anchor a first 526 or said second anchor a second 526 includes a suture coupler (see Figs. 9A-9C, [0083], eyelet) in the form of an eyelet (see Figs. 9A-9C, [0083], eyelet).
Claim 5
The combination of To and Douk teaches: The implant of claim 1, see 103 rejection above. To further discloses: wherein at least one of said first anchor a first 526 or said second anchor a second 526 is biased towards a configuration that inhibits return (see Figs. 9A-10F, the anchors have an elongated bent shape that when deployed they are wider than when they are within the catheter) of said first anchor a first 526 or said second anchor a second 526 into the catheter lumen the lumen of 522 after being extended through an opening (see Figs. 10D-10F) through said tubular body the tubular body of 522 of said catheter 522.
Claim 6
The combination of To and Douk teaches: The implant of claim 1, see 103 rejection above. To further discloses: wherein said suture 534 has a proximal end the proximal end of 534 which is pulled proximally (see Fig. 10F, [0099], 534 can be tensioned/cinched, which is pulling the proximal end as the distal end is fixedly coupled to the distal-most 526) to draw together said first anchor a first 526 and said second anchor a second 526 to draw together tissue (see [0099], tighten the annulus) into which said first anchor a first 526 and said second anchor a second 526 are anchored.
Claim 7
The combination of To and Douk teaches: The implant of claim 1, see 103 rejection above. To further discloses: wherein the first opening a first 528 and the second opening a second 528 are two of a plurality of spaced apart openings 528 (see Figs. 9A-10F, [0083]) of said catheter 522, wherein the spaced apart openings 528 are evenly spaced (see Figs. 9A-10F, they openings are evenly spaced) or variably spaced (will not be examined here due to being an optional claim limitation).
Claim 8
The combination of To and Douk teaches: The implant of claim 1, see 103 rejection above. To further discloses: wherein said catheter 522 is configured for circumferential disposal about one or more papillary muscles, and at least one of the first opening or the second opening is orientated towards the one or more papillary muscles when circumferentially disposed.
The language, "wherein said catheter is configured for circumferential disposal about one or more papillary muscles, and at least one of the first opening or the second opening is orientated towards the one or more papillary muscles when circumferentially disposed," merely recites an intended use of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of To meets the structural limitations of the claim, and is capable of bending for circumferential disposable (see Figs. 9A-10F, the device of To being able to be bend into a circular configuration) and since the application of the device is within the art, especially in the left ventricle, it would be able to be placed around one or more papillary muscles when circumferentially disposed such that the openings would face the muscles.
Claim 9
The combination of To and Douk teaches: The implant of claim 1, see 103 rejection above. To further discloses: wherein the first opening a first 528 and the second opening a second 528 are aligned along a common longitudinal axis a longitudinal axis of 522 of the catheter 522 or are disposed along different longitudinal axes (will not be examined here due to being an optional claim limitation) of the catheter 522.
Claim 10
To discloses: A delivery system 520 (see Figs. 9A-10F, [0083]) comprising: a catheter 522 (see Figs. 9A-10F, [0083]) having a proximal end the proximal end of 522 (see Figs. 9A-10F), a distal end distal end of 522 (see Figs. 9A-10F), and a tubular wall the tubular body of 522 (see Figs. 9A-10F) defining a lumen the lumen of 522 (see Fig. 9B, 533 extends in an out of the lumen of 522) extending between the proximal end proximal end of 522 to the distal end distal end of 522, a distal portion the distal portion of 522 (see Figs. 9A-10F) of said catheter 522 defining a plurality of spaced apart openings 528 (see Figs. 9A-10F, [0083], there are multiple openings 528) extending through said tubular wall the tubular body of 522 of said catheter 522; a suture 534 (see Figs. 9B-10F, [0076], a tether is a suture); a plurality of anchors 526 (see Figs. 9A-10F, [0083] and [0087]) carried by said suture 526, at least one a proximal 526 (see Figs. 9A-10F, [0087], slidably coupled) of said plurality of anchors 526 being movable with respect to said suture 534; and a push element 532 (see Figs. 9A-10F, [0083]-[0084]), translatably disposed within the catheter lumen the lumen of 522 (see Figs. 9A-10F, [0083]-[0084]) and configured to advance (see [0084], causes 526 to exit 522 through one of the 528) at least one of said plurality of anchors 526 with respect to said catheter 522 and said suture to advance through one of said plurality of openings 528 through said tubular wall the tubular body of 522.
To does not explicitly disclose: the push element is a push tube.
However, Douk in a similar field of invention teaches a delivery system (see Fig. 5) with a plurality of anchors 112 (see Fig. 5) and a push element 508 (see Fig. 5). Douk further teaches: the push element 508 is a push tube 508 (see Fig. 5, [0032], hollow member having an enlarged end portion).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified To to incorporate the teachings of Douk and teach a delivery system with the push element is a push tube. Motivation for such can be found in Douk as the tube can accommodate the implant and be easily deployed therefrom (see [0032]).
Claim 12
The combination of To and Douk teaches: The system of claim 10, see 103 rejection above. To further discloses: wherein said suture 534 is tied to said first anchor a first 526 (see [0087], when the first 526 is the distal-most 526 it is tied to the suture 534).
Claim 13
The combination of To and Douk teaches: The system of claim 12, see 103 rejection above. To further discloses: wherein the remaining anchors other anchors 526 of said plurality of anchors 526 are movable with respect to said suture 534 (see [0087], 526 then can slidably couple on 534 in relation to the first anchor 526).
Claim 18
The combination of To and Douk teaches: The system of claim 12, see 103 rejection above. To further discloses: wherein said suture 534 is cinchable to draw together said plurality of anchors 526 when said plurality of anchors 526 have been deployed with respect to tissue (see Fig. 10F, [0099], can be tensioned/cinched).
Claim(s) 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over To in view of Douk as applied to claim 10 above, and further in view of Serina et al (US 20140148849 A1), herein referenced to as “Serina”.
Claim 14
The combination of To and Douk teaches: The system of claim 10, see 103 rejection above.
The combination of To and Douk does not explicitly disclose: further comprising a delivery catheter having a proximal end, a distal end, and a delivery catheter wall defining a delivery lumen extending between the proximal end to the distal end, wherein said plurality of anchors are delivered within said delivery catheter to one of the plurality of openings through said tubular wall of said catheter.
However, Serina in a similar field of invention teaches a delivery system (see Figs 17A-17J) with a catheter 1000 (see Figs. 17F-17J) with a plurality of openings 1010 + 1017 (see Figs. 17F-17J, [0091]) and a plurality of anchors (see [0092], anchor delivery catheter, which delivers anchors 526, see Figs. 9-10).
Serina further teaches: further comprising a delivery catheter 1018 (see Figs. 17A-17J, [0092]) having a proximal end proximal end of 1018 (see Figs. 17A-17J, [0092]), a distal end distal end of 1018 (see Figs. 17A-17J), and a delivery catheter wall the wall of 1018 (see Figs. 17A-17J, [0092]) defining a delivery lumen the lumen of 1018 (see [0092], can direct infusion of contrast agent and can deliver the anchors) extending between the proximal end to the distal end, wherein said plurality of anchors (see [0092]) are delivered within said delivery catheter 1018 (see [0092]) to one of the plurality of openings 1010 + 1017 (see [0092], through 1020 and then through 1017) through said tubular wall of said catheter 1000.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified To to incorporate the teachings of Serina and teach a delivery system with a delivery catheter having a proximal end, a distal end, and a delivery catheter wall defining a delivery lumen extending between the proximal end to the distal end, wherein said plurality of anchors are delivered within said delivery catheter to one of the plurality of openings through said tubular wall of said catheter. Motivation for such can be found in Serina as this also allows the infusion of contrast agent to a desired area to facilitate fluoroscopic viewing of the surrounding anatomy during anchor delivery (see [0092]).
Claim 15
The combination of To, Douk, and Serina teaches: The system of claim 14, see 103 rejection above. The combination of To and Serina further teaches: wherein the distal end the distal end of 1018 of said delivery catheter 1018 defines a delivery port 1020 (see Figs. 17A-17J, [0092], Serina) that extends through said delivery catheter wall the wall of 1018 (see [0092]), said delivery catheter 1018 translatably disposed within said catheter lumen the lumen of 1000 to enable alignment of the delivery port 1020 with one or more of the plurality of openings 1010 + 1017 (see Figs. 17I-17K, [0092]) through said tubular wall of said catheter 1000 for extension of an anchor of said plurality of anchors 526 of To can go through the delivery port 1020 as described in Serina (see [0092], that delivery anchors can be accommodated by 1020) through the delivery port 1020 and one of the plurality of openings 1010 + 1017 through said tubular wall of said catheter.
Claim 16
The combination of To, Douk, and Serina teaches: The system of claim 15, see 103 rejection above. The combination of To and Douk teaches: wherein said push tube 532 of To is modified to be 508 of Douk is translatably disposed within the delivery lumen 532 modified by 508 to be a push tube is within the delivery lumen of 522 of To.
Claim 17
The combination of To, Douk, and Serina teaches: The system of claim 15, see 103 rejection above. To further discloses: wherein each of the plurality of anchors 526 has a first configuration (see Figs. 9A-10C, in this configuration the anchors can go through openings) enabling translation through the delivery catheter and delivery port, and a second configuration (see Figs. 10E-F, in this configuration the anchors cannot go through openings) that inhibits translation through the delivery port.
The language, "the first configuration enabling translation through the delivery catheter and delivery port and the second configuration that inhibits translation through the delivery port," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of To meets the structural limitations of the claim, and is capable of the anchors in the first configuration being linear and thin to go through openings while in the second configuration expanded and circular to no longer able to go through the same openings.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Nobles (US 20200268373 A1) teaches a bendable catheter for papillary suturing
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 RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
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