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 Group I, claims 1-20, in the reply filed on 12/29/2025 is acknowledged.
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.
Claims 1, 8, 10, 12-13, 16-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20170209686 A1 Kim.
Regarding claim 1, Kim discloses a method of creating a transvenous access pathway into an interventricular septum of a patient's heart (paragraph 42, 47, 50), comprising:
having a catheter device (lumen catheter, Fig. 7-8) comprising a main tube (12, Fig. 6, 8, paragraph 57); wherein the main tube comprises a distal end segment (distal segment of tube 12, Fig. 6, 8), a distal tip (distal tip of tube 12, Fig. 6, 8), and a lumen (lumen of tube 12, Fig. 6, 8); wherein the catheter device further comprises a puncture tool that travels through the lumen (Fig. 8, paragraph 58, intervention wire 22 is inserted into the second tube 12 to bore interventricular septum);
inserting the main tube into an entry vein (Fig. 7-8, paragraph 48, 53,);
advancing the catheter device so that the main tube travels into a coronary sinus and is positioned at a target site inside a coronary vein (Fig. 7-8, paragraph 62, 64);
the distal tip points at an angle towards a wall of the coronary vein (seen in Fig. 8, distal tip of tube 12 points toward wall of septal vein);
pushing the puncture tool out of the main tube to puncture through the wall of the coronary vein (Fig. 8, paragraph 65);
advancing the puncture tool through myocardium towards the interventricular septum to create an entry passageway to the interventricular septum (Fig. 8, paragraph 65).
Kim is silent on specifically bending the distal end segment of the main tube.
However, Kim teaches an embodiment of a catheter 100 (Fig. 9) with a distal segment being bent by fixture 130 into a boring position as seen in Fig. 9a-c (paragraph 75-77).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim with the alternate embodiment taught by Kim to have bending the distal end segment of the main tube in order to provide for boring of a precise location.
Regarding claim 8, Kim teaches the limitations of claim 1, and further discloses wherein the bend angle is at least 45° relative to the longitudinal axis of the main tube (seen in Fig. 9c).
Regarding claim 10, Kim teaches the limitations of claim 1, and further discloses applying a force to the puncture tool in advancing the puncture tool through the vein wall (paragraph 50, intervention wire is passed through the interventricular septum by external force).
Kim is silent on specifically applying a force of 0.205 - 1.25 N (newtons) to the puncture tool in advancing the puncture tool through the vein wall.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to achieve an application force of 0.205 – 1.25 N, through routine optimization, in order to provide sufficient force to puncture the tissue (see MPEP 2144.05(II)).
Regarding claim 12, Kim teaches the limitations of claim 1, and further discloses wherein the coronary vein is a septal perforating vein (paragraph 50, septal vein), and the method further comprising applying a force in advancing the puncture tool through the vein wall (paragraph 50, intervention wire is passed through the interventricular septum by external force).
Kim is silent on specifically applying a force of less than 0.20 N (newtons) in advancing the puncture tool through the vein wall.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to achieve an application force of 0.20 N, through routine optimization, in order to provide sufficient force to puncture the tissue (see MPEP 2144.05(II)).
Regarding claim 13, Kim teaches the limitations of claim 1, and further discloses further comprising performing a pressurized venogram of the coronary vein (paragraph 50).
Regarding claim 16, Kim teaches the limitations of claim 1, and further discloses wherein the access pathway is for positioning an electrode lead inside the interventricular septum (paragraph 113); and wherein the method further comprises:
withdrawing the puncture tool out of the catheter device (paragraph 110-111; intervention wire 22 is implicitly withdrawn from the catheter after the procedure is complete);
inserting the electrode lead through the lumen so that it travels into the coronary sinus and through the coronary vein (paragraph 113-114);
advancing the electrode lead through the puncture hole in the vein wall and into the entry passageway of the interventricular septum (paragraph 113-114).
Regarding claim 17, Kim teaches the limitations of claim 16, and Kim further discloses wherein the electrode lead is a pacing lead (paragraph 113) and the method further comprises activating pacing stimulation to cause pacing of the heart (paragraph 6, 129, the lead is implicitly activated to enable pacing).
Regarding claim 20, Kim teaches the limitations of claim 1, and further discloses further comprising using an opposing wall of the coronary vein as a buttress for applying pushing force to the puncture tool (paragraph 76, the balloon pushes the inner side of the coronary so that the body is fixed in contact to prevent the boring position from being changed when the intervention wire moves forward and bores the boring position).
Claims 2-7 are rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claim 1 above, and further in view of US 5439006 A Brennen et al. (hereinafter Brennen).
Regarding claim 2, Kim teaches the limitations of claim 1.
Kim is silent on wherein the catheter device further comprises a steering wire that is fixed at the distal end segment of the main tube;
wherein the step of bending the distal end segment of the main tube comprises pushing or pulling the steering wire.
However, Brennan teaches a catheter device (Fig. 1, abstract, col. 1 line 10-18) having a main tube (10, Fig. 1) with a steerable distal end segment (22, Fig. 1) that comprises a steering wire (12, Fig. 1) that is fixed at the distal end segment (22) of the main tube (10) (Fig. 1, 8, col. 6 line 47-49);
wherein the step of bending the distal end segment of the main tube comprises pushing or pulling the steering wire (col. 5, line 2-7, col. 6 line 18-23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim with the teachings of Brennan to have wherein the catheter device further comprises a steering wire that is fixed at the distal end segment of the main tube; wherein the step of bending the distal end segment of the main tube comprises pushing or pulling the steering wire, in order to impart a desired curvature to the distal end segment of the catheter device and guide it through a patient’s vascular system to a desired target site as disclosed by Brennan (col. 1 line 10-18).
Regarding claim 3, the combination of Kim and Brennen teaches the limitations of claim 2, and Brennen further discloses wherein steering wire is fixed at a point that is within 1.0 cm of the distal tip of the main tube (Fig. 1, 8, col. 6 line 47-49, the pull wire (12) is fixedly attached at the distal end (22)).
Regarding claim 4, the combination of Kim and Brennen teaches the limitations of claim 2, and Brennen further discloses wherein the catheter device further comprises a handle assembly (28, Fig. 1), which comprises a steering actuator (32, 34, Fig. 1, col. 6 line 53-57);
wherein the steering wire is coupled to the steering actuator which acts to push or pull the steering wire (col. 6 line 60 – col. 7 line 29).
Regarding claim 5, the combination of Kim and Brennen teaches the limitations of claim 4, and Kim further discloses wherein the lumen is a first lumen for the puncture tool (seen in Fig. 8); wherein the main tube further comprises a second lumen that is separate from the first lumen (lumen of tube 11, Fig. 8, paragraph 57); wherein the steering wire travels through the separate second lumen of main tube (wire 21 inserted through tube 11, Fig. 8, paragraph 58).
Regarding claim 6, the combination of Kim and Brennen teaches the limitations of claim 4, and the combination further discloses wherein the main tube comprises an exit hole out of the second lumen (Kim: seen in Fig. 6a, an exit hole out of tube 11; Brennen: aperture 18 out of lumen 13, Fig. 1, col. 6 line 40-47), and wherein the steering wire exits the second lumen out of the exit hole (Kim: seen in Fig. 6a, wire 21 exits the exit hole out of tube 11; Brennen: Fig. 1, col. 6 line 40-47).
Regarding claim 7, of claim 4, wherein the steering actuator comprises a slider (34, Fig. 1, col. 6 line 60-62) and the steering wire is fixed to the slider (col. 6 line 60-62); wherein the method further comprises:
moving the slider back and forth to push or pull the steering wire (Fig. 2-3, col. 7 line 5-12, 16-29).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claim 1 above, and further in view of US 20080262342 A1 Averbruch.
Regarding claim 9, Kim teaches the limitations of claim 1.
Kim teaches the lumen catheter having a radiopaque marker (14, Fig. 6-8, paragraph 60), however, is silent on wherein the distal end segment of the main tube comprises three or more radiopaque markers, and the method further comprises:
observing the alignment of the radiopaque markers under x-ray fluoroscopy to determine the amount of bending at the distal end segment of the main tube.
However, Averbruch teaches a method for enhanced imaging for remote areas (abstract) that comprises a catheter (70, Fig. 7a-b, paragraph 57) having a main tube (main tube of 70, Fig. 7a-b) wherein a distal end segment of the main tube comprises three or more radiopaque markers (72, Fig. 7a-b, paragraph 57), and the method further comprises:
observing the alignment of the radiopaque markers under x-ray fluoroscopy to determine the amount of bending at the distal end segment of the main tube (paragraph 57-60, visualizing using a fluoroscopic image to determine whether a section of the catheter has a z-axis component).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim with the teachings of Averbruch to have wherein the distal end segment of the main tube comprises three or more radiopaque markers, and the method further comprises: observing the alignment of the radiopaque markers under x-ray fluoroscopy to determine the amount of bending at the distal end segment of the main tube, in order to improve the quality of fluoroscopic imaging that allows fluoroscopic imaging to be used as an accurate measuring modality as disclosed by Averbruch (paragraph 19).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claim 10 above, and further in view of US 5545204 A Cammilli et al. (hereinafter Cammilli).
Regarding claim 11, Kim teaches the limitations of claim 10.
Kim is silent on wherein the coronary vein is a great cardiac vein.
However, Cammilli teaches an electrocatheter for cardiostimulation (abstract) wherein atrial electrodes are positioned within the great cardiac vein (abstract, col. 1 line 16-21, 59-64, col. 2 line 1-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim with the teachings of Cammilli to have wherein the coronary vein is a great cardiac vein in order to allow correct positioning of the electrocatheter and a proper cardiac stimulation as disclosed by Cammilli (col. 1 line 30-33).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claim 1 above, and further in view of Cammilli.
Regarding claim 14, Kim teaches the limitations of claim 1.
Kim is silent on wherein the main tube further comprises a pre-formed C-shape curve segment; wherein the C-shape curve segment follows the natural curve path of the coronary sinus.
However, Cammilli teaches an electrocatheter for cardiostimulation (abstract) wherein the electrocathether has a main tube (12, Fig. 2) that further comprises a pre-formed C-shape curve segment (13, Fig. 2, col. 2 line 44-45); wherein the C-shape curve segment follows the natural curve path of the coronary sinus (col. 1 line 16-21, col. 2 line 49-51).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim with the teachings of Cammilli to have wherein the main tube further comprises a pre-formed C-shape curve segment; wherein the C-shape curve segment follows the natural curve path of the coronary sinus, in order to facilitate the insertion of the electrocatheter into the coronary sinus and into the great cardiac vein as disclosed by Cammilli (col. 1 line 16-21, col. 2 line 49-51).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claim 1 above, and further in view of US 20090043299 A1 Racz.
Regarding claim 15, Kim teaches the limitations of claim 1.
Kim is silent on wherein the main tube comprises a coil element at the distal end segment, wherein the bending occurs at the coil element.
However, Racz teaches a medical catheter (abstract) having a main tube (main tube of medical catheter 10, Fig. 1) that comprises a coil element (36, Fig. 2-3) at the distal end segment (16, Fig. 2-3) (paragraph 23), wherein the bending occurs at the coil element (seen in Fig. 5b, paragraph 36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim with the teachings of Racz to have wherein the main tube comprises a coil element at the distal end segment, wherein the bending occurs at the coil element, in order to provide reinforcement and increase resistance to kinking as disclosed by Racz (paragraph 29).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claim 1 above, and further in view of US 20110313283 A1 Kapadia.
Regarding claim 18, Kim teaches the limitations of claim 16.
Kim is silent on wherein the electrode lead is a radiofrequency (RF) ablation lead and the method further activating the electrode to ablate heart tissue.
However, Kapadia teaches an apparatus and method for targeting areas within a patient’s heart (abstract, paragraph 2-13) wherein the electrode lead is a radiofrequency (RF) ablation lead (paragraph 9) and the method further activating the electrode to ablate heart tissue (paragraph 9, the lead is implicitly activated to enable ablation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim with the teachings of Kapadia to have wherein the electrode lead is a radiofrequency (RF) ablation lead and the method further activating the electrode to ablate heart tissue in order to eradicate inappropriate electrical pathways affecting the heart function as disclosed by Kapadia (paragraph 9).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claim 1 above, and further in view of US 20190240022 A1 Rafiee et al. (hereinafter Rafiee).
Regarding claim 19, Kim teaches the limitations of claim 1. Kim discloses wherein the access pathway is for positioning an electrode lead inside the interventricular septum (paragraph 113); and wherein the method further comprises: withdrawing the puncture tool out of the catheter device (paragraph 110-111; intervention wire 22 is implicitly withdrawn from the catheter after the procedure is complete); inserting the electrode lead through the lumen so that it travels into the coronary sinus and through the coronary vein (paragraph 113-114); advancing the electrode lead through the puncture hole in the vein wall and into the entry passageway of the interventricular septum (paragraph 113-114).
Kim is silent on wherein the access pathway is for a mitral loop cerclage wire in performing a mitral valve cerclage procedure; and wherein the method further comprises:
inserting the cerclage wire through the lumen so that it travels into the coronary sinus and through the coronary vein;
advancing the cerclage wire through the puncture hole in the vein wall and into the entry passageway of the interventricular septum.
However, Rafiee teaches devices and methods for mitral valve annuloplasty and treating mitral valve regurgitation (abstract, paragraph 2), involving placing cerclage tethers through the coronary sinus (paragraph 82), and placing cerclage annuloplasty ligatures through the coronary sinus and around the mitral valve (paragraph 128), the cerclage wire entering through the superior vena cava, extending through the coronary sinus and the septal vein into the interventricular septum (Fig. 7a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kim with the teachings of Rafiee to have wherein the access pathway is for a mitral loop cerclage wire in performing a mitral valve cerclage procedure; and wherein the method further comprises: inserting the cerclage wire through the lumen so that it travels into the coronary sinus and through the coronary vein; advancing the cerclage wire through the puncture hole in the vein wall and into the entry passageway of the interventricular septum, in order to improve the repair of damaged or malfunctioning cardiac valves as disclosed by Rafiee (paragraph 109).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771