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 .
Claim Objections
Claims 3, 16-17, and 23 are objected to because of the following informalities:
Claim 3 recites “wherein the capture structure comprises a hook or a loop structure, and optionally wherein the hoop or the loop…” which appears to contain an error as there is no antecedent basis for “the hoop”. It is recommended the claim be amended to recite “wherein the capture structure comprises a hook or a loop structure, and optionally wherein the hook or the loop…” instead.
Claims 16 and 23 each recite “the first position”, which lacks antecedent basis in respective independent claims 1 and 17. It is recommended that these claims be amended to recite “the first location” instead, which has basis in the independent claims.
Claim 17 recites “wherein the first anchor is coupled to the first anchor at a first end of the bridging element” in lines 15-16, which is believed to contain mistake and further does not include antecedent basis for “the bridging element”. It is recommended that the line be amended to recite “wherein the first anchor is coupled to a first end of a bridging element” instead, since it is unclear how the first anchor can be coupled to itself at a first end of the bridging element.
Appropriate correction is required.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because Figs. 1-2G and 6A-12B are not legible and do not clearly show the structures of the invention. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Orlov (US PGPub 2010/0298930 A1).
With respect to claim 1, Orlov discloses a method for traversing a vessel wall (see Figs. 6F-J) comprising:
advancing a catheter (70 in Fig. 5A) into a first anatomical lumen having a vessel wall to a first location (52 in Fig. 6F, see catheter body 72 extending into sinus 52 through cardiac ostum 54), the catheter (70 in Fig. 6A) comprising a lumen extending along a length of the catheter (PP [0169]: “Catheter body 72 is substantially a 5 mm (15 French) catheter tube defining a main lumen 80”), a distally disposed opening (82), and a stabilizing element (90 in Figs. 6G-H, PP [0171]: “On the side of catheter body 72 and opposite side port 82 is an inflatable balloon 90 configured to function as a reversible anchoring component. When balloon 90 is in a first state (not or only slightly inflated) balloon 90 has a low profile allowing passage through the vascular system. When balloon 90 is in a second state (inflated), the walls of balloon 90 expand outwards and adopt a higher profile. When balloon 90 is found in a coronary sinus 52 in the second inflated state (FIGS. 5D and 5E), balloon 90 engages the luminal walls of coronary sinus 52, stabilizing the position of distal end 76 and side port 82 inside coronary sinus 52”);
stabilizing the catheter (70) within the first lumen via the stabilizing element (90) at the first location (52, see Figs. 6G-H and PP [0171] cited above);
advancing a penetrating guidewire (100 in Fig. 6F) along the lumen of the catheter (70) toward the distally disposed opening to the first location, wherein the penetrating guidewire (100) comprises a tip, the tip having shape memory (PP [0187]: “A piercing component 100, substantially a 1.5 mm diameter Nitinol wire with a sharpened end”) and configured to form a capture structure upon crossing the vessel wall (100 bends to emerge through side port 82, forming a hook or loop shape upon crossing the vessel wall since 100 comprises a nitinol wire); and
penetrating the vessel wall by advancing the penetrating guidewire (100) out of the distally disposed opening (82) and traversing the vessel wall into a second anatomical lumen or tissue, thereby traversing the vessel wall (PP [0187]: “A piercing component 100, substantially a 1.5 mm diameter Nitinol wire with a sharpened end is placed into main lumen 80 from proximal end 74 of catheter body 72 and guided through main lumen 80 to emerge out through side port 82, puncturing tissue of wall 98 separating coronary sinus 52 from left atrium 24 to emerge into left atrium 24 above the plane defined by mitral valve annulus 34 above posterior leaflet 40”).
Regarding claim 2, Orlov further discloses wherein the stabilizing element (90 in Fig. 6A) comprises an expandable balloon or stent (PP [0211]: “Balloon 90 inflated to a second anchoring state to stabilize the position of distal end 76 and side port 82 in coronary sinus 52 as described above for device 70 and depicted in FIG. 6D”).
Regarding claim 3, Orlov further discloses wherein the capture structure (100 in Figs. 6B-F) comprises a hook or a loop structure (100 bends to emerge through side port 82, forming a hook or loop shape upon crossing the vessel wall since 100 comprises a nitinol wire), and optionally wherein the [hook] or the loop comprises a bent section having an angle of greater than about 90, 100, 110, 120, 130, 140, 150, 160, 170, 180 or 190 degrees (see Fig. 6F, 100 bends greater than 90 degrees relative to 78 to enter the vessel wall).
Regarding claim 4, Orlov further discloses advancing a first anchor (104 in Figs. 6E-H) to the first location via the lumen of the catheter (PP [0206]: “First leaflet-engaging component 104 comprises: i) the distal end of a 1.8 mm pipe 104a that functions both as a first vacuum conduit and as a first leaflet-engaging component director and ii) a soft silicon rubber sleeve 104b defining a first suction port 104c”, PP [0208]: “The proximal end of pipe 104a passes through main lumen 80 to proximal end 74 of catheter body 72 and can be used to move first leaflet-engaging component 104 in and out of main lumen 80 through port 82”).
Regarding claim 5, Orlov further discloses wherein the first anchor (104 in Figs. 6E-H) includes a bridging element coupled to the anchor at a first end of the bridging element (upper part of 110 in Fig. 6E, PP [0206]: “Encircling pipes 104a and 106a is a retainer ring 110 that keeps the pipes close together but allows one to slide past the other”).
Regarding claim 6, Orlov further discloses advancing a second end of the bridging element (110 in Fig. 6E) through the penetrated vessel wall at the first location (see Figs. 6G-H, 104 and 106 advance through the vessel wall and 110 advances with them).
Regarding claim 7, Orlov further discloses advancing a second anchor (106 in Fig. 6E) to a second location within or proximate the second lumen and deploying the second anchor at the second location (see Figs. 6G-H, 106 is deployed past the vessel wall), wherein the first anchor (104) is coupled to the first end of the bridging element (upper part of 110 in Fig. 6E) and the second anchor (106) is coupled to the second end of the bridging element (lower end of 110).
Regarding claim 8, Orlov further discloses tensioning the bridging element (110 in Fig. 6E, PP [0206]: “Encircling pipes 104a and 106a is a retainer ring 110 that keeps the pipes close together but allows one to slide past the other. In such a way, first leaflet-engaging component 104 and second leaflet-engaging component 106 are independently maneuverable”, maneuvering 104a and 106a relative to one another applies friction to 110 thus tensioning it).
Regarding claim 9, Orlov further discloses wherein the first location (52 in Fig. 6F) is proximate a heart chamber (coronary sinus 52 is proximate a heart chamber).
Regarding claim 10, Orlov further discloses wherein the second location (24 in Fig. 6F) is within or proximate the heart chamber (24 is a left atrium, within a heart chamber).
Regarding claim 11, Orlov further discloses wherein the heart chamber is the left atrium (PP [0212]: “puncturing the tissue making up wall 98 separating coronary sinus 52 from left atrium 24 to emerge into left atrium 24”) and the first location (52) is within a great cardiac vein (see Fig. 6F which shows coronary sinus 52 encircling mitral valve 26 and draining into right atrium 12 via ostium 54, PP [0008]).
Regarding claim 12, Orlov further discloses wherein the bridging element (110 in Fig. 6E) spans the heart chamber (see Figs. 6G-J, 110 enters the heart chamber with 104 and 106 and extends across a portion of it, thus spanning it) and tensioning of the bridging element (110) reshapes the heart chamber (PP [0206]: “Encircling pipes 104a and 106a is a retainer ring 110 that keeps the pipes close together but allows one to slide past the other. In such a way, first leaflet-engaging component 104 and second leaflet-engaging component 106 are independently maneuverable”, maneuvering 104 and 106 tensions the bridging element 110, PP [0218]: “The first leaflet-engaging component 104 has engaged the anterior leaflet 38, and the second leaflet-engaging component 106 has engaged the posterior leaflet 40. Optionally, the first leaflet-engaging component 104 has slid along a face of the anterior leaflet 38 in order to achieve the engagement of the anterior leaflet 38 depicted in FIG. 6K. Optionally, the second leaflet-engaging component 106 has slid along a face of the posterior leaflet 40 in order to achieve the engagement of the posterior leaflet 40 depicted in FIG. 6K”, PP [0220]: “Once the mobility of anterior mitral valve leaflet 38 and posterior mitral valve 40 is limited as described above by engagement with first leaflet-engaging component 104 and second leaflet-engaging component 106, respectively, a desired additional intervention may be performed. For example, in some embodiments, an additional device is directed into heart 50 to proximity with mitral valve or mitral valve leaflets 38 and 40, for example to treat mitral valve 26 or mitral valve leaflet 38 and/or 40”, maneuvering 104 and 106 enables reshaping of the heart chamber and more specifically the mitral valve).
Regarding claim 13, Orlov further discloses coupling a guidewire (84 in Figs. 6A and 6F) to the capture structure (100 in Figs. 6B-F).
Regarding claim 14, Orlov further discloses wherein the first anchor (104 in Fig. 6F) is advanced to the first location via a guidewire (108, PP [0260]: “leaflet-engaging components 104 and 106 are guided to a desired location on the atrial face of leaflets 38 and 40 with the help of leaflet-engaging component guide wire 108 that passes through the lumen of first vacuum conduit 104a”).
Regarding claim 15, Orlov further discloses releasing the first anchor (104 in Fig. 6F) from the guidewire (108) by withdrawing the guidewire (108) along the lumen of the catheter (see Figs. 6G-H, 108 is withdrawn after 104 and 106 are extended).
Regarding claim 16, Orlov further discloses determining the depth of insertion of the catheter (70 in Fig. 6A) into the first lumen to determine the first [location] (see Fig. 6F, PP [0286]: “a distal end 76 of a catheter body 72 of a device 70 or 102 is placed into the right jugular vein of a human subject, and from there directed through the superior vena cava, past left atrium 12, to enter coronary sinus 52 from cardiac ostium 54”, the proper depth is determined at insertion to deliver catheter 70 to the target area).
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.
Claims 17-23 are rejected under 35 U.S.C. 103 as being unpatentable over Orlov (US PGPub 2010/0298930 A1) in view of Machold et al. (US PGPub 2016/0067043 A1).
With respect to claim 17, Orlov discloses a method of treating mitral valve regurgitation in a subject (claim 1: “A method for engaging mitral valve leaflets”) comprising:
inserting, through a vascular access site (PP [0163]: “Percutaneous vascular access is achieved by conventional methods into the femoral or jugular vein”), a catheter (70 in Fig. 5A), and advancing the catheter (70) along a first anatomical lumen having a vessel wall to a first location proximate a heart of the subject (52 in Fig. 6F, see catheter body 72 extending into sinus 52 through cardiac ostum 54), the catheter (70) comprising a lumen extending along a length of the catheter (PP [0169]: “Catheter body 72 is substantially a 5 mm (15 French) catheter tube defining a main lumen 80”), a distally disposed opening (82), and a stabilizing element (90 in Figs. 6G-H, PP [0171]: “On the side of catheter body 72 and opposite side port 82 is an inflatable balloon 90 configured to function as a reversible anchoring component. When balloon 90 is in a first state (not or only slightly inflated) balloon 90 has a low profile allowing passage through the vascular system. When balloon 90 is in a second state (inflated), the walls of balloon 90 expand outwards and adopt a higher profile. When balloon 90 is found in a coronary sinus 52 in the second inflated state (FIGS. 5D and 5E), balloon 90 engages the luminal walls of coronary sinus 52, stabilizing the position of distal end 76 and side port 82 inside coronary sinus 52”);
stabilizing the catheter (70) within the first lumen via the stabilizing element (90) at the first location (52, see Figs. 6G-H and PP [0171] cited above);
advancing a penetrating guidewire (100 in Fig. 6F) along the lumen of the catheter (70) toward the distally disposed opening to the first location (see 100 extending through catheter in Fig. 6F);
penetrating the vessel wall by advancing the penetrating guidewire (100) out of the distally disposed opening (82) and traversing the vessel wall into a heart chamber (PP [0187]: “A piercing component 100, substantially a 1.5 mm diameter Nitinol wire with a sharpened end is placed into main lumen 80 from proximal end 74 of catheter body 72 and guided through main lumen 80 to emerge out through side port 82, puncturing tissue of wall 98 separating coronary sinus 52 from left atrium 24 to emerge into left atrium 24 above the plane defined by mitral valve annulus 34 above posterior leaflet 40”), wherein the penetrating guidewire (100) comprises a tip, the tip having shape memory (PP [0187]: “A piercing component 100, substantially a 1.5 mm diameter Nitinol wire with a sharpened end”) and configured to form a capture structure upon crossing the vessel wall (100 bends to emerge through side port 82, forming a hook or loop shape upon crossing the vessel wall since 100 comprises a nitinol wire);
advancing a first anchor (104 in Figs. 6G-J) to the first location via the lumen of the catheter (70), wherein the first anchor (104) is coupled to the first anchor (104) at a first end of [a] bridging element (110 in Fig. 6E);
advancing a second end of the bridging element (110) through the penetrated vessel wall at the first location (see Figs. 6G-J, 104 and 106 including 110 are advanced through the vessel wall);
advancing a second anchor (106) along the bridging element (110) and deploying the second anchor (106) at a second location in or proximate the heart (see Figs. 6G-J), the bridging element (110) spanning across the heart chamber (see Figs. 6G-J, 110 enters the heart chamber with 104 and 106 and extends across a portion of it, thus spanning it).
However, Orlov fails to disclose shortening a length of the bridging element thereby reshaping the chamber of the heart and coupling the second end of the bridging element to the deployed second anchor while the chamber of the heart is reshaped so that the chamber of the heart remains reshaped, thereby treating mitral valve regurgitation in the subject, since the bridging element of Orlov cannot be shortened.
In the same field of mitral valve manipulation (abstract), Machold et al. teaches a method of advancing a first anchor (18 in Fig. 33) to a first location, wherein the first anchor (18) is coupled to the first anchor (18) at a first end of [a] bridging element (12);
advancing a second end of the bridging element (12) through the penetrated vessel wall at the first location (see 12 extend through 14 in Fig. 33);
advancing a second anchor (20 and 16) along the bridging element (12) and deploying the second anchor (20 and 16) at a second location in or proximate the heart (20 and 16 are placed through the left atrium and into the septum), the bridging element (12) spanning across the heart chamber (see 12 extend across left atrium in Fig. 33); and
shortening a length of the bridging element (12) thereby reshaping the chamber of the heart and coupling the second end of the bridging element (12) to the deployed second anchor (20 and 16) while the chamber of the heart is reshaped so that the chamber of the heart remains reshaped, thereby treating mitral valve regurgitation in the subject (PP [0148]: “It should be appreciated that the spanning region or bridging element 12 can be preformed or otherwise configured with various medial/lateral and/or inferior/superior deviations to achieve targeted annulus and/or atrial structure remodeling, which takes into account the particular therapeutic needs and morphology of the patient”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Orlov method to incorporate the teachings of Machold et al. and include the anchors and bridging element as claimed. One of ordinary skill in the art would have been motivated to perform this modification because doing so constitutes the application of a known technique to a known method ready for improvement to yield predictable results. The modification as proposed would not alter the Orlov method, as Orlov contemplates that “Once one or both of the leaflets 38 40 are engaged, various operations described herein may optionally be performed” (PP [0227]), and incorporating the anchoring method of Machold et al. would simply enable structural remodeling of a patient’s atrial structure (see PP [0148] of Machold et al.).
Regarding claim 18, Orlov as modified by Machold et al. further discloses wherein the stabilizing element (90 in Fig. 6A of Orlov) comprises an expandable balloon or stent (PP [0211]: “Balloon 90 inflated to a second anchoring state to stabilize the position of distal end 76 and side port 82 in coronary sinus 52 as described above for device 70 and depicted in FIG. 6D”).
Regarding claim 19, Orlov as modified by Machold et al. further discloses wherein the capture structure (100 in Figs. 6B-F of Orlov) comprises a hook or a loop structure (100 bends to emerge through side port 82, forming a hook or loop shape upon crossing the vessel wall since 100 comprises a nitinol wire), and optionally wherein the [hook] or the loop comprises a bent section having an angle of greater than about 90, 100, 110, 120, 130, 140, 150, 160, 170, 180 or 190 degrees (see Fig. 6F, 100 bends greater than 90 degrees relative to 78 to enter the vessel wall).
Regarding claim 20, Orlov as modified by Machold et al. further discloses wherein the heart chamber is the left atrium (PP [0212]: “puncturing the tissue making up wall 98 separating coronary sinus 52 from left atrium 24 to emerge into left atrium 24”) and the first location (52) is within a great cardiac vein (see Fig. 6F which shows coronary sinus 52 encircling mitral valve 26 and draining into right atrium 12 via ostium 54, PP [0008]).
Regarding claim 21, Orlov as modified by Machold et al. further discloses wherein the first anchor (104 in Fig. 6F of Orlov) is advanced to the first location via a guidewire (108, PP [0260]: “leaflet-engaging components 104 and 106 are guided to a desired location on the atrial face of leaflets 38 and 40 with the help of leaflet-engaging component guide wire 108 that passes through the lumen of first vacuum conduit 104a”, see also Machold et al. PP [0188]: “Both the LA guide wire 74 and the GCV guide wire 54 are now in position for the next step of establishing the trans-septal bridging element 12”).
Regarding claim 22, Orlov as modified by Machold et al. further discloses releasing the first anchor (104 in Fig. 6F) from the guidewire (108) by withdrawing the guidewire (108) along the lumen of the catheter (see Figs. 6G-H, 108 is withdrawn after 104 and 106 are extended, see also Machold et al. PP [0198]: “The deployment catheter 24 and the guide wire 74 may then be removed (see FIG. 28)”).
Regarding claim 23, Orlov as modified by Machold et al. further discloses determining the depth of insertion of the catheter (70 in Fig. 6A of Orlov) into the first lumen to determine the first [location] (see Fig. 6F, PP [0286]: “a distal end 76 of a catheter body 72 of a device 70 or 102 is placed into the right jugular vein of a human subject, and from there directed through the superior vena cava, past left atrium 12, to enter coronary sinus 52 from cardiac ostium 54”, the proper depth is determined at insertion to deliver catheter 70 to the target area).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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