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
Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/18/2025.
Applicant’s election without traverse of Invention I in the reply filed on 12/18/2025 is acknowledged.
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. Therefore, the “wherein all anchors of said plurality of anchors are movable with respect to said suture” 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.
Claim Rejections - 35 USC § 102
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) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by To et al (US 20060190030 A1), herein referenced to as “To”.
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]); 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]).
Claim 2
To discloses: The implant of claim 1, see 102 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
To discloses: The implant of claim 2, see 102 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
To discloses: The implant of claim 1, see 102 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
To discloses: The implant of claim 1, see 102 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
To discloses: The implant of claim 1, see 102 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
To discloses: The implant of claim 1, see 102 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
To discloses: The implant of claim 1, see 102 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
To discloses: The implant of claim 1, see 102 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 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) 10-13 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 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 11
The combination of To and Douk teaches: The system of claim 10, see 103 rejection above. To further discloses: wherein all anchors of said plurality of anchors are movable with respect to said suture.
The language, " wherein all anchors of said plurality of anchors are movable with respect to said suture," 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 moving all anchors through the pull cord along the suture, including moving with respect to the suture via moving the suture.
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
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 7:00 PM - 3:00 PM.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771