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 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 1-2, 5-14, 16, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over
Wang et al. US Pub.: US 2020/0238059 A1, hereinafter Wang.
Regarding claim 1, Wang teaches a shunting catheter (100), comprising:
an ablation shaft (110) (fig. 16; paragraph 198-208); It is disclosed that “As shown in FIG. 16, a trans-catheter interventional interatrial shunt device includes a catheter opening main body 110, and a radially expandable balloon 120 fixed to the distal end of the catheter opening main body 110.” The catheter equates to the ablation shaft.
and an ablation mechanism (101) disposed on the ablation shaft (110) and expandable at the second state, the ablation mechanism comprising: an expandable cage (120) being expandable at the second state (fig. 16; paragraph 198-208); It is disclosed that “twelve electrodes 131 are evenly distributed in the circumferential direction of the balloon 120 of the opening component 101, and the electrodes 131 are respectively parallel to the central axis of the balloon 120.” This is the assembly of the ablation mechanism. When the balloon 120 is expanded, this equates to a cage in the second state.
an electrode structure (130) being expandable with the expandable cage (120) at the second state, the electrode structure (130) comprising: a base (111) surrounding the expandable cage (120) (fig. 16; paragraph 198-208);
wherein the ablation mechanism (101) is configured to receive energy from an energy source and deliver ablation energy to a target location of a patient at the second state (fig. 16; paragraph 198-208). It is disclosed that “The electrode 131 is fixed on the outer surface of the balloon 120 in a circumferential direction, and is electrically connected to the ablation power source and the control mechanism through the connecting line 132.”
However, Wang does not teach a catheter shaft including a shaft lumen; an ablation shaft disposed in the shaft lumen at a first state and extended from the catheter shaft at a second state; a reconfigurable conductor carried by the base; and wherein the reconfigurable conductor is configured to receive energy from an energy source and deliver ablation energy to a target location of a patient at the second state.
The second embodiment of Wang teaches a catheter shaft including a shaft lumen (210); an ablation shaft (24) disposed in the shaft lumen (210) at a first state and extended from the catheter shaft at a second state (fig. 28-30; paragraph 232-247); It is disclosed in fig. 30 that the control tube 240 is within the single cavity tube 210. Therefore, the ablation shaft of the first embodiment is capable of being extended from this single cavity tube 210.
It would have also been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of the first embodiment with the struts from the second embodiment for the benefit of holding the shape of the ablation catheter in a second state to increase the safety and steadiness of the ablation process.
The third embodiment of Wang teaches a reconfigurable conductor (111a-c) carried by the base (110); and wherein the reconfigurable conductor is configured to receive energy from an energy source and deliver ablation energy to a target location of a patient at the second state (fig. 1-3; paragraph 133-150). Since the ablation mechanism 111(a-c) is electrically conductive for ablation of part of the tissue of the opening component 110, it can be electrically conductive only to the corresponding opening tissue, and cannot affect other parts of the heart.
It would have also been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of the first embodiment with the conductive members from the third embodiment for the benefit of providing accurate positioning of the ablation mechanism during surgery, for accurately placing the ablation mechanism at the atrial septal tissue opening.
Regarding claim 2, the first and third embodiment of Wang does not teach wherein the
expandable cage is self-expandable at the second state.
The second embodiment of Wang teaches wherein the expandable cage is self-expandable at the second state (fig. 28-29; paragraph 232-247). It is disclosed that “the opening component 110 is provided with an adjustment mechanism 170 for adjusting the radial diameter of the opening component 110.” The struts are self-expandable and adjusted by the adjustment mechanism 170.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of the first and third embodiment with the struts from the second embodiment for the benefit of providing consistent tissue contact during a large target ablation area process.
Regarding claim 5, the first and second embodiment of Wang does not teach wherein the
reconfigurable conductor is a first reconfigurable conductor, and the ablation mechanism further comprises a second reconfigurable conductor carried by the base.
The third embodiment of Wang teaches wherein the reconfigurable conductor is a first
reconfigurable conductor (111a), and the ablation mechanism further comprises a second reconfigurable conductor (111b) carried by the base (110) (fig. 1-3; paragraph 133-150). Since the ablation mechanism 111(a-c) is electrically conductive for ablation of part of the tissue of the opening component 110, it can be electrically conductive only to the corresponding opening tissue, and cannot affect other parts of the heart.
It would have also been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of the first embodiment with the first and second conductive members from the third embodiment for the benefit of providing accurate positioning of the ablation mechanism during surgery, for accurately placing the ablation mechanism at the atrial septal tissue opening.
Regarding claim 6, the first and second embodiment of Wang does not teach wherein the first
reconfigurable conductor includes a plurality of first fingers, the second reconfigurable conductor includes a plurality of second fingers, the first fingers being interdigitated with the second fingers.
The third embodiment of Wang teaches wherein the first reconfigurable conductor (111a)
includes a plurality of first fingers, the second reconfigurable conductor (111b) includes a plurality of second fingers, the first fingers being interdigitated with the second fingers (fig. 1-3; paragraph 133-150). Since the ablation mechanism 111(a-c) is electrically conductive for ablation of part of the tissue of the opening component 110, it can be electrically conductive only to the corresponding opening tissue, and cannot affect other parts of the heart. The plurality of fingers for each conductor is represented by the horizontal lines as shown in figure 1b.
It would have also been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of the first and second embodiment with the first and second conductive members with their fingers from the third embodiment for the benefit of providing accurate positioning of the ablation mechanism during surgery, for accurately placing the ablation mechanism at the atrial septal tissue opening.
Regarding claim 7, the first and second embodiment of Wang does not teach wherein the first
fingers and the second fingers extend longitudinally relative to the base.
The third embodiment of Wang teaches wherein the first fingers and the second fingers extend
longitudinally relative to the base (110) (fig. 1-3; paragraph 133-150). Since the ablation mechanism 111(a-c) is electrically conductive for ablation of part of the tissue of the opening component 110, it can be electrically conductive only to the corresponding opening tissue, and cannot affect other parts of the heart. The plurality of fingers for each conductor is represented by the horizontal/longitudinal lines as shown in figure 1b.
It would have also been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of the first and second embodiment with the first and second conductive members with their fingers from the third embodiment for the benefit of providing accurate positioning of the ablation mechanism during surgery, for accurately placing the ablation mechanism at the atrial septal tissue opening.
Regarding claim 8, the first and second embodiment of Wang does not teach wherein the first
fingers and the second fingers extend circumferentially relative to the base.
The third embodiment of Wang teaches wherein the first fingers and the second fingers extend
circumferentially relative to the base (110) (fig. 1-3; paragraph 133-150). Since the ablation mechanism 111(a-c) is electrically conductive for ablation of part of the tissue of the opening component 110, it can be electrically conductive only to the corresponding opening tissue, and cannot affect other parts of the heart. The plurality of fingers for each conductor is represented by the horizontal/longitudinal lines as shown in figure 1b. which extends circumferentially.
It would have also been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of the first and second embodiment with the first and second conductive members with their fingers from the third embodiment for the benefit of providing accurate positioning of the ablation mechanism during surgery, for accurately placing the ablation mechanism at the atrial septal tissue opening.
Regarding claim 9, the first and third embodiment of Wang does not teach wherein the base is
an open-ended tube.
The second embodiment of Wang teaches wherein the base is an open-ended tube (240) (fig. 28-30; paragraph 232-247); It is disclosed in fig. 30 that the control tube 240 is within the single cavity tube 210. Therefore, the ablation shaft of the first embodiment is capable of being extended from this single cavity tube 210. This tube is open-ended.
It would have also been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of the first and third embodiment with the struts from the second embodiment for the benefit of holding the shape of the ablation catheter in a second state to increase the safety and steadiness of the ablation process.
Regarding claim 10, the first and second embodiment of Wang does not teach wherein the base
is constructed of an insulating material.
The third embodiment of Wang teaches wherein the base (110) is constructed of an insulating material (fig. 1-3; paragraph 142). An insulating layer is coated on the surfaces of the opening main body 101 and the opening component 110.
It would have also been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of the first and second embodiment with the insulation material from the third embodiment for the benefit increasing the safety and steadiness of the ablation process and focus energy into the conductive materials.
Regarding claims 11 and 20, the first, second and third embodiment of Wang teaches the
claimed invention and the first embodiment further teaches wherein the electrode structure has an expanded diameter in a range of 2mm to 10mm at the second state (paragraph 245). Size of the opening component 110 to the required size, and the size adjustment range is 2 mm-14 mm.
Regarding claim 12, the first embodiment of Wang teaches a method for creating a shunt,
comprising:
an ablation shaft (110) (fig. 16; paragraph 198-208); It is disclosed that “As shown in FIG. 16, a trans-catheter interventional interatrial shunt device includes a catheter opening main body 110, and a radially expandable balloon 120 fixed to the distal end of the catheter opening main body 110.” The catheter equates to the ablation shaft.
an ablation mechanism (101) disposed on the ablation shaft (110) and in the catheter shaft at the first state, the ablation mechanism (101) comprising: an expandable cage (120) (fig. 16; paragraph 198-208); It is disclosed that “twelve electrodes 131 are evenly distributed in the circumferential direction of the balloon 120 of the opening component 101, and the electrodes 131 are respectively parallel to the central axis of the balloon 120.” This is the assembly of the ablation mechanism. When the balloon 120 is expanded, this equates to a cage in the second state.
an electrode structure (130) comprising: a base (111) surrounding the expandable cage (120) (fig. 16; paragraph 198-208);
disposing the shunting catheter proximate to a target location of a patient (fig. 16; paragraph 198-208); The position of the balloon 120 is adjusted so that the developing member is just located in the atrial septal tissue, so that the electrode 131 is just attached to the atrial septal tissue which is expanded, thereby achieving accurate ablation of the opening.
operating the shunting catheter to a second state, wherein the ablation shaft (110) and the ablation mechanism (101) extend from the catheter shaft (fig. 16; paragraph 198-208); The balloon 120 is provided for passing through the atrial septum and radially expanding the opening component 101 that expands the atrial septal tissue.
expanding an opening at the target location of the patient by expanding the expandable cage (120), the base (111) (fig. 16; paragraph 198-208); A trans-catheter interventional interatrial shunt device includes a catheter opening main body 110, and a radially expandable balloon 120 fixed to the distal end of the catheter opening main body 110. The balloon 120 is provided for passing through the atrial septum and radially expanding the opening component 101 that expands the atrial septal tissue.
and delivering ablation energy to the target location of the patient (fig. 16; paragraph 198-208). It is disclosed that “The electrode 131 is fixed on the outer surface of the balloon 120 in a circumferential direction, and is electrically connected to the ablation power source and the control mechanism through the connecting line 132.”
However, the first embodiment of Wang does not teach deploying a shunting catheter in a first state, the shunting catheter comprising: a catheter shaft including a shaft lumen; an ablation shaft disposed in the shaft lumen at the first state; a reconfigurable conductor carried by the base; expanding the conductor; and delivering ablation energy via the reconfigurable conductor to the target location of the patient.
The second embodiment of Wang teaches deploying a shunting catheter in a first state, the shunting catheter comprising: a catheter shaft including a shaft lumen (210); an ablation shaft (240) disposed in the shaft lumen (210) at the first state (fig. 28-30; paragraph 232-247); It is disclosed in fig. 30 that the control tube 240 is within the single cavity tube 210. Therefore, the ablation shaft of the first embodiment is capable of being extended from this single cavity tube 210.
It would have also been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of the first embodiment with the struts from the second embodiment for the benefit of holding the shape of the ablation catheter in a second state to increase the safety and steadiness of the ablation process.
The third embodiment of Wang teaches a reconfigurable conductor (111a-c) carried by the base (110); expanding the conductor (111a-c); and delivering ablation energy via the reconfigurable conductor to the target location of the patient (fig. 1-3; paragraph 133-150). Since the ablation mechanism 111(a-c) is electrically conductive for ablation of part of the tissue of the opening component 110, it can be electrically conductive only to the corresponding opening tissue, and cannot affect other parts of the heart.
It would have also been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of the first embodiment with the conductive members from the third embodiment for the benefit of providing accurate positioning of the ablation mechanism during surgery, for accurately placing the ablation mechanism at the atrial septal tissue opening.
Regarding claim 13, the first, second, and third embodiment of Wang teaches the claimed
invention and the first embodiment further teaches wherein expanding the expandable cage comprises permitting the expandable cage to self-expand (fig. 1-6; paragraph 152). The cage can automatically expand to the desired shape and size, and can produce some radial supporting functions for the tissue in contact.
Regarding claim 14, the first, second, and third embodiment of Wang teaches the claimed
invention and the first embodiment further teaches wherein permitting the expandable cage to self-expand comprises retracting a crimping shaft from the expandable cage (fig. 1-6; paragraph 152). The opening main body 101 is an elastic bracket that is capable of radially contracting and expanding.
Regarding claim 16, the first, second, and third embodiment of Wang teaches the claimed
invention and the first embodiment further teaches wherein the target location is at an atrial septum of the patient (fig. 16; paragraph 198-208); A trans-catheter interventional interatrial shunt device includes a catheter opening main body 110, and a radially expandable balloon 120 fixed to the distal end of the catheter opening main body 110. The balloon 120 is provided for passing through the atrial septum and radially expanding the opening component 101 that expands the atrial septal tissue.
Regarding claim 18, the first embodiment of Wang teaches shunting catheter system (100),
comprising:
an ablation mechanism (101) disposed on the ablation shaft (110) (fig. 16; paragraph 198-208); It is disclosed that “As shown in FIG. 16, a trans-catheter interventional interatrial shunt device includes a catheter opening main body 110, and a radially expandable balloon 120 fixed to the distal end of the catheter opening main body 110.” The catheter equates to the ablation shaft.
the ablation mechanism (101) comprising: an expandable cage (120) being expandable at the second state (fig. 16; paragraph 198-208); It is disclosed that “twelve electrodes 131 are evenly distributed in the circumferential direction of the balloon 120 of the opening component 101, and the electrodes 131 are respectively parallel to the central axis of the balloon 120.” This is the assembly of the ablation mechanism. When the balloon 120 is expanded, this equates to a cage in the second state.
an electrode structure (130) being expandable with the expandable cage (120) at the second state, the electrode structure (130) comprising: a base (111) surrounding the expandable cage (120) (fig. 16; paragraph 198-208);
an energy source connected to the shunting catheter; and a controller connected to the energy source and comprising a processor; wherein the processor is configured to control the energy source to deliver ablation energy to a target location of a patient at the second state (fig. 16; paragraph 198-208). It is disclosed that “The electrode 131 is fixed on the outer surface of the balloon 120 in a circumferential direction, and is electrically connected to the ablation power source and the control mechanism through the connecting line 132.”
However, the first embodiment of Wang does not teach an ablation shaft disposed in the shaft lumen at a first state and extended from the catheter shaft at a second state; an ablation shaft disposed in the shaft lumen at the first state, and expandable at the second state; a reconfigurable conductor carried by the base; deliver ablation energy to a target location of a patient via the reconfigurable conductor at the second state.
The second embodiment of Wang teaches an ablation shaft (240) disposed in the shaft lumen (210) at a first state and extended from the catheter shaft at a second state; an ablation shaft (240) disposed in the shaft lumen (210) at the first state, and expandable at the second state; (fig. 28-30; paragraph 232-247); It is disclosed in fig. 30 that the control tube 240 is within the single cavity tube 210. Therefore, the ablation shaft of the first embodiment is capable of being extended from this single cavity tube 210.
It would have also been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of the first embodiment with the struts from the second embodiment for the benefit of holding the shape of the ablation catheter in a second state to increase the safety and steadiness of the ablation process.
The third embodiment of Wang teaches a reconfigurable conductor (111a-c) carried by the base (110); deliver ablation energy to a target location of a patient via the reconfigurable conductor (111a-c) at the second state (fig. 1-3; paragraph 133-150). Since the ablation mechanism 111(a-c) is electrically conductive for ablation of part of the tissue of the opening component 110, it can be electrically conductive only to the corresponding opening tissue, and cannot affect other parts of the heart.
It would have also been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of the first embodiment with the conductive members from the third embodiment for the benefit of providing accurate positioning of the ablation mechanism during surgery, for accurately placing the ablation mechanism at the atrial septal tissue opening.
Claims 3-4, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in
view of Belalcazar et al. US Pub.: US 20220257318 A1, hereinafter Belalcazar.
Regarding claim 3, the three embodiment of Wang does not teach wherein the expandable cage
comprises at least one selected from a group consisting of nitinol, stainless steel, titanium, platinum-iridium, and cobalt-chromium.
Belalcazar teaches a high voltage ablation catheter and further teaches wherein the expandable
cage comprises at least one selected from a group consisting of nitinol, stainless steel, titanium, platinum-iridium, and cobalt-chromium fig. 1; paragraph 81). The flexible splines 341 may include metallic members that are made from materials such as Nitinol.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the balloon cage of the three embodiments of Wang with the nitinol material from Belalcazar for the benefit of increasing the effect of the expansion of the splines towards the tissue when the splines are expanded in the heart.
Regarding claims 4, 17, and 19, the three embodiment of Wang does not teach wherein the
reconfigurable conductor has a serpentine shape.
Belalcazar teaches a high voltage ablation catheter and further teaches wherein the reconfigurable conductor has a serpentine shape (fig. 1;paragraph 46).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the balloon cage of the three embodiments of Wang with the serpentine shaped conductors from Belalcazar for the benefit of allowing the interconnects of the cage balloon to adapt to membrane expansion.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Rafiee et
al. US Pub.: US 20220330975 A1, hereinafter Rafiee.
Regarding claim 15, the first, second, and third embodiment of Wang does not teach wherein
the target location is at a coronary sinus of the patient.
Rafiee teaches an access catheter and further teaches wherein the target location is at a coronary sinus of the patient (paragraph 82); In general, a concentric balloon may be positioned proximally on the first distal segment to seal the coronary sinus for the ability to do contrast injections to visualize the coronary sinus and the distal perforator veins.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the system of the three embodiments of Wang to target the coronary sinus from Rafiee for the benefit of providing coronary sinus treatments such as unroofed coronary sinus and coronary sinus thrombosis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THIEN J TRAN whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.J.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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