DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Response to Arguments
3. Applicant’s arguments with respect to claim(s) 1-19 have been considered but are moot because the new ground of rejection does not rely on any reference or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
4. It is noted that claim 20 is newly added.
Claim Rejections - 35 USC § 112
5. Claims 3, 5, 6, and 18 were previously rejected under 36 U.S.C. 112(b) as being indefinite. However, Claims 3, 5, 6, and 18 have been amended to overcome the rejection. Therefore, the rejections are withdrawn.
Claim Rejections - 35 USC § 103
6. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
7. 1, 2, 4, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Sliwa U.S. 2018/0104003 (herein referred to as “Sliwa”) and in view of Kim U.S. 2010/0331658 (herein referred to as “Kim”).
8. Regarding Claim 1, Sliwa teaches a high-thermal-sensitivity ablation catheter tip (Fig. 1, ref num 124 and Fig. 3, ref num 336), the tip comprising:
a. an ablation electrode (Fig. 3, ref num 355) configured and arranged to deliver an ablation therapy to tissue in contact with or in close proximity thereto (para 0041, “an electrode 355 for conducting tissue ablation therapy”);
b. a flexible electronic circuit coupled to an external surface of the ablation electrode (Fig. 3 and 4, ref num 336 coupled to surface, ref num 365), the flexible electronic circuit including one or more electrodes (Fig. 3, ref num 337A-D) configured and arranged to sense electrophysiology characteristics of the tissue in contact with or in close proximity to the ablation electrode (para 0042, “each of the subelectrodes 337A-D can function as electrophysiology sensors, allowing each subelectrode to receive a signal indicative of electrical signals traveling through myocardial tissue in proximity to the subelectrode”), wherein the flexible electronic circuit is coupled within the trench (Fig. 4, ref num 336/337A-D is coupled within trenches, ref num 362A-D; para 0048, 0053).
Sliwa fails to teach an elongate trench is defined in the ablation electrode, the elongate trench extending onto a distal tip of the ablation electrode.
Kim teaches an ablation catheter tip of analogous art (Figs. 10-11), wherein the tip comprises an ablation electrode (Fig. 10, ref num 1044; para 0045, “tip electrode assembly embodiment 1044”), and an elongate trench defined in the ablation electrode (Fig. 10, ref num 1033; para 0046). The elongate trench extends onto a distal tip of the ablation electrode (see Fig. 10, ref num 1033 extends to the distal tip of ref num 1044 via ref num 1039/1038; para 0045, “The distal insert houses multiple, smaller electrodes in apertures 1038 in the tip electrode to provide localized electrical information”, this indicates that the elongate trench extends onto the distal portion of the electrode”). The elongate trench improves the cooling effects of the ablation electrode has fluid is directed towards the distal tip and the electrodes that provide sensing information (para 0045-0046). Therefore, 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 Sliwa to include an elongate trench extending onto a distal tip of the ablation electrode in order to improve the cooling effects of the tip as fluid is directed towards the tip.
9. Regarding Claims 2 and 4, Sliwa fails to teach the trench aligns a sensing surface of the one or more electrodes flush with the external surface of the ablation electrode and the ablation electrode includes a radially extending access aperture adjacent the trench, the flexible electronic circuit is routed from an inner cavity of the ablation electrode and into the trench on the external surface of the ablation electrode via the radially extending access aperture.
Kim teaches the trench aligns a sensing surface of the one of more electrodes flush with the external surface of the ablation electrode (para 0045, “houses multiple, smaller electrodes in apertures 1038 in the tip electrode to provide localized electrical information”); see Fig. 10, ref num 1038 aligns the sensing surface of electrodes to external surface of ref num 1044”). The ablation electrode includes a radially extending access aperture adjacent the trench (Fig. 10, ref num 1038), such that an electronic circuit is routed from an inner cavity of the ablation electrode and into the trench on the external surface of the ablation electrode via the radially extending access aperture (Fig. 10, ref num 1039 routes the wires of the electronic circuit from ref num 1033 to ref num 1038; para 0045-0046, 0053). The elongate trench improves the cooling effects of the ablation electrode has fluid is directed towards the distal tip and the electrodes that provide sensing information (para 0045-0046). Therefore, 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 Sliwa to include an elongate trench extending onto a distal tip of the ablation electrode in order to improve the cooling effects of the tip as fluid is directed towards the tip.
10. Regarding Claim 11, Sliwa teaches the one or more electrodes are electrically isolated from the ablation electrode (para 0041, “Insulating material 350, such as a biocompatible material, can be utilized to couple the subelectrodes 337A-D to the ablation catheter tip 336, while providing electrical insulation, and in some cases also providing thermal insulation, from the energy being transmitted by the electrode 355”).
11. Regarding Claim 12, Sliwa teaches the ablation electrode include a conductive tip (Fig. 3, ref num 355; para 0041), a conductive shell (Fig. 3, ref num 366, para 0057, “metal shell catheter tip”; this indicates the shell is conductive), and a transition region therebetween (see Fig. 3, region between ref nums 366 and 355); and wherein the one or more electrodes of the flexible electronic circuit are positioned within the transition region (see Fig. 3, ref num 337A-D are positioned in the region between 366 and 355).
12. Claims 3, 8, 13, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sliwa and Kim, and further in view of Bar-Tal U.S. 2018/0071017 (herein referred to as “Bar-Tal”).
13. Regarding Claim 3, Sliwa teaches a thermocouple (para 0026). However, Sliwa fails to explicitly teach the flexible electronic circuit further includes one or more thermocouples, each of the thermocouples position on an intermediate layer of the flexible electronic circuit beneath one of the respective one or more electrodes.
Bar-Tal teaches an ablation catheter tip of analogous art (Fig. 1), wherein the tip comprising an ablation electrode (Fig. 1, ref num 24) and a flexible electronic circuit including one or more electrodes (Fig. 2, ref num 58 with electrodes, ref nums 40). The flexible electronic circuit further includes one or more thermocouples (Fig. 2, ref num 60), such that each of the thermocouples positioned on an intermediate layer of the flexible electronic circuit (Fig. 2, ref num 60 is on an intermediate layer; para 0111) beneath one of the respective one or more electrodes (Fig. 2, ref num 60 is below ref num 40; para 0111). This facilitates measuring tissue temperature from the one or more electrodes via the respective thermocouple (para 0111). Since Sliwa already teaches measuring tissue temperature (Sliwa, para 0021), 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 Sliwa to have the flexible electronic circuit have one or more thermocouples on an intermediate layer under respective one or more electrodes, as this produces the same expected result of measuring temperature.
14. Regarding Claim 8, Sliwa teaches the ablation electrode includes a conductive tip (Fig. 3, ref num 355; para 0041) and a conductive shell (Fig. 3, ref num 366, para 0057, “metal shell catheter tip”; this indicates the shell is conductive), such that there is an irrigant aperture extending through the conductive shell (Fig. 4, ref num 360) and an irrigation lumen extending through a longitudinal axis (Fig. 4, ref num 361), the irrigation lumen configured and arranged to deliver irrigant (para 0049).
Sliwa fails to teach the conductive shell includes multiple irrigant apertures extending therethrough, the irrigant apertures configured and arranged for irrigant distribution circumferentially about the conductive shell, wherein the high-thermal-sensitivity ablation catheter tip further includes a manifold coupled to a proximal end of the conductive shell, the manifold includes the irrigation lumen, further that the irrigant is delivered into an inner cavity of the conductive shell; and wherein the flexible electronic circuit extends through at least a portion of the irrigation lumen.
Bar-Tal teaches an ablation catheter tip of analogous art (Fig. 1), wherein the tip comprising an ablation electrode (Fig. 1, ref num 24) and a flexible electronic circuit including one or more electrodes (Fig. 2, ref num 58 with electrodes, ref nums 40). The ablation electrode includes a conductive tip and conductive shell (Fig. 1, ref nums 42 and 44), such that the conductive shell includes irrigant apertures extending therethrough (Fig. 1, ref num 50). The irrigant apertures are configured and arranged for irrigant distribution circumferentially about the conductive shell (see Fig. 1, ref nums 50; para 0103, 0123). The catheter tip further includes a manifold (Fig. 3, ref num 46) coupled to a proximal end of the conductive shell (see Fig. 4, ref num 46 is coupled to the proximal end of ref num 44). The manifold includes an irrigation lumen extending through a longitudinal axis (para 0123, “fluid passes through tube 46”; see Fig. 4, ref num 46, it is understood there is a lumen in which the irrigant passes through), the irrigation lumen configured and arranged to deliver irrigant into an inner cavity of the conductive shell (para 0123, “the fluid passes through tube 46, and then through conduit 54. Next, the fluid passes through opening 57 of the conduit and through an opening 56 at the distal end of the PCB. The fluid thus reaches distal face 42 of the tip electrode, and is subsequently deflected, by the inner surface 68 of distal face 42, into a space 71 that lies between (i) the PCB and conduit, and (ii) the tip electrode”; Fig. 4, ref num 71). The flexible electronic circuit extends through at least a portion of the irrigation lumen (Fig. 4, ref num 58 extends through irrigation lumen defined by ref num 46). The irrigation lumen delivering irrigant into an inner cavity of the ablation electrodes, as well as the plurality of irrigant apertures distributed about the ablation electrode provide the advantage of absorbing a large amount of heat from the tip electrode (para 0098). Therefore, 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 Sliwa to include a plurality of irrigant apertures and an irrigation lumen to deliver the irrigant to the distal end of the ablation electrode, as this provides the same expected result of facilitating heat transfer between the electrode and irrigant, cooling the tip assembly (see Sliwa, para 0030).
15. Regarding Claim 13, Sliwa teaches the ablation electrode further includes a distal irrigant aperture that extends through the conductive tip (Fig. 4, ref num 360).
Sliwa fails to teach multiple distal irrigant apertures that also are circumferentially interleaved between the one or more electrodes.
Bar-Tal teaches an ablation catheter tip of analogous art (Fig. 1), wherein the tip comprising an ablation electrode (Fig. 1, ref num 24) and a flexible electronic circuit including one or more electrodes (Fig. 2, ref num 58 with electrodes, ref nums 40). The ablation electrode includes a conductive tip and conductive shell (Fig. 1, ref nums 42 and 44), such that the conductive tip includes irrigant apertures (Fig. 1, ref nums 50) that are circumferentially interleaved between the one or more electrodes (see Fig. 1, ref num 50 are between electrodes, ref nums 40; para 0128, “some fluid apertures may be positioned within distal face 42”). The plurality of irrigant apertures distributed at the conductive tip of the ablation electrode provide the advantage of absorbing a large amount of heat from the tip electrode (para 0098). Therefore, 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 Sliwa to include a plurality of irrigant apertures disposed at the conductive tip of the ablation electrode, as this provides the same expected result of facilitating heat transfer between the electrodes and irrigant, cooling the tip assembly (see Sliwa, para 0030).
16. Regarding Claim 20, Sliwa fails to teach the distal tip comprises the conductive tip, and wherein the elongate trench extends from the conductive shell and onto the conductive tip.
Kim teaches an ablation catheter tip of analogous art (Figs. 10-11), wherein the tip comprises an ablation electrode (Fig. 10, ref num 1044; para 0045, “tip electrode assembly embodiment 1044”), and an elongate trench defined in the ablation electrode (Fig. 10, ref num 1033; para 0046). The elongate trench extends onto a distal tip of the ablation electrode (see Fig. 10, ref num 1033 extends to the distal tip of ref num 1044 via ref num 1039/1038; para 0045, “The distal insert houses multiple, smaller electrodes in apertures 1038 in the tip electrode to provide localized electrical information”, this indicates that the elongate trench extends onto the distal portion of the electrode”). The elongate trench also extends from a transition region between the conductive tip and the conductive shell (Fig. 10, ref num 1049 is the transition region between the tip and shell of ref num 1044; para 0047; ref num 1033 has slots 1055 that allow for the trench to extend between the transition region and tip region). The elongate trench improves the cooling effects of the ablation electrode has fluid is directed towards the distal tip and the electrodes that provide sensing information (para 0045-0046). Therefore, 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 Sliwa to include an elongate trench extending onto a distal tip of the ablation electrode in order to improve the cooling effects of the tip as fluid is directed towards the tip.
17. Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Sliwa and Kim, and further in view of Cheung U.S 2016/0113712 (herein referred to as “Cheung”).
18. Regarding Claim 5, Sliwa fails to teach the ablation electrode includes additional trenches extending into the external surface of the ablation electrode and additional radially extending access apertures adjacent the additional trenches; wherein the flexible electronic circuit includes a body member and a plurality of fingers which extend from the body member, the plurality of fingers extend through the radially extending access apertures in the ablation electrode and are routed along respective additional trenches; and wherein each of the plurality of fingers include one or more electrodes, and the fingers are coupled within the respective additional trenches.
Cheung teaches an ablation catheter tip of analogous art (Figs. 1 and 2), the tip comprising an ablation electrode (Fig. 2, ref num 124) and a flexible electronic circuit (Figs. 2 and 3, ref num 130) including one or more electrodes (Figs. 2 and 3, ref nums 132). The ablation electrode includes additional trenches extending into an external surface of the ablation electrode (Fig. 4, the trenches that are defined via ref nums 140a/140b; para 0097, “an interior of distal ablation tip 124”) and additional radially extending access apertures adjacent to the additional trenches (Fig. 4, ref num 140a/140b). The flexible electronic circuit includes a body member (see Fig. 3, ref num 130 has a body) and a plurality of fingers which extend from the body member (Fig. 3, ref nums 136a-d), such that the plurality of fingers extend through the additional radially extending access apertures in the ablation electrode and are routed along respective trenches (see progression between Figs. 4-6, the fingers, ref nums 136a-d, are inserted into respective ref nums 140 and routed through those trenches). Each of the plurality of fingers include one or more electrodes (Fig. 3, ref num 132a-d on respective fingers, ref nums 136a-d), and the fingers are coupled within the respective additional trenches (see Figs. 4-6, ref nums 136a-d are coupled to their respective trench shown through openings, ref nums 140). This configuration secures the flexible electronic circuit to the tip assembly (para 0097). Therefore, 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 Sliwa to include additional trenches and apertures to secure the flexible electronic circuit to the tip assembly, as this also provides the benefit of minimizing energy edge effects (Cheung, para 0093).
19. Regarding Claim 6, Sliwa teaches each of the sensing surfaces of the one or more electrodes are flush with the external surface of the ablation electrode (Figs. 3 and 4, ref num 365 is the line that ‘defines’ the external surface of the ablation electrode, ref num 355; para 0045, “subelectrodes 337 are cut into, and set substantially flush with the tip shell surface”).
However, Sliwa fails to teach the plurality of fingers of the flexible electronic circuit are coupled to the additional trenches, and the additional trenches align each of the sensing surfaces of the one or more electrodes with the external surface of the ablation electrode; and wherein the additional trenches are located on an ablation tip of the of the ablation electrode, and extend distally and radially inward along the external surface of the ablation electrode from respective radially extending access apertures.
Cheung teaches the plurality of fingers of the flexible electronic circuit (Fig. 3, ref num 136a-d), such that they are coupled to the additional trenches (para 0096, “may allow mechanical interconnecting members 138a/138b/138c/138d to be passed through an opening and, by interference, being sufficiently captured within the opening”). The additional trenches the align the respective sensing surfaces of the one or more electrodes (see top surfaces of ref nums 136a-d; Figs. 2 and 3) with the external surface of the ablation electrode (see Fig. 6). The additional trenches are located on an ablation tip of the ablation electrode (see Fig. 6, trenches are on a tip of ref num 124) and extend distally and radially inward along the external surface of the ablation electrode from respective radially extending access apertures (see Figs. 4-6, each aperture, ref nums 140, have respect trenches within the ablation electrode (para 0097, “an interior of distal ablation tip 124”; also see alternative embodiment, Figs. 15-17, para 0108). This configuration secures the flexible electronic circuit to the tip assembly (para 0097). Therefore, 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 Sliwa to include additional trenches and apertures to align the electrodes to the surface of the ablation electrode, as this secures the flexible electronic circuit to the tip assembly and also provides the benefit of minimizing energy edge effects (Cheung, para 0093).
20. Regarding Claim 7, Sliwa fails to teach the trench is located on an ablation tip of the ablation electrode and extends distally and radially inward along the external surface of the ablation electrode.
Cheung teaches a trench (Fig. 2, ref num 128) that is located on an ablation tip of the ablation electrode (Fig. 2, ref num 128 is found on the tip of ablation electrode, ref num 124), such that the trench extends distally and radially inward along the external surface of the ablation electrode (Fig. 4, ref num 128 extends distally and radially inward of ref num 124). This configuration secures the flexible electronic circuit to the tip assembly (para 0097). Therefore, 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 the trench taught by Sliwa to extend distally and radially inward of the ablation electrode in order to secure the flexible electronic circuit to the tip assembly, as this also provides the benefit of minimizing energy edge effects (Cheung, para 0093).
21. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Sliwa and Kim, and further in view of Rao U.S. 2020/0030024 (herein referred to as “Rao”) and Bar-Tal.
22. Regarding Claim 9, Sliwa fails to teach a second flexible electronic circuit circumferentially coupled to an inner surface of the ablation electrode, the second flexible electronic circuit including a second plurality of electrodes distributed along a length of the second flexible electronic circuit; and wherein the second plurality of electrodes extend radially outward through apertures in the ablation electrodes.
teaches an ablation tip of analogous art (Fig. 1, ref num 18), wherein the tip comprises a first flexible electronic circuit and a second flexible electronic circuit (Fig. 2, ref num 100 and 104). The first flexible electronic circuit includes one or more electrodes (Fig. 1 and 3, ref num 32) and the second flexible electronic circuit includes a second plurality of electrodes (Fig. 2, ref num 120, 126, 132; para 0040). The second plurality of electrodes are distributed along a length of the second flexible electronic circuit (Fig. 2, ref nums 120, 126, 132). The plurality of flexible electronic circuits allows for the ablation tip to be controlled to delivery different power levels to different portions of the tip (para 0049). Therefore, it would have been obvious to have modified Sliwa to include a second flexible electronic circuit coupled to a second plurality of electrodes in order to control the energy levels at different sections of the ablation tip.
However, Sliwa as modified by Rao fails to teach the second flexible electronic circuit is coupled to the inner surface of the ablation electrode and that the second plurality of electrodes extend radially outward through apertures in the ablation electrode.
Bar-Tal teaches an ablation tip of analogous art (Fig. 1, ref num 22), wherein the ablation tip comprises a flexible electronic circuit coupled to an inner surface of an electrode (Fig. 1, ref num 24 = electrode; Fig. 2, ref num 58 = flexible printed circuit). There is a second plurality of electrodes (Fig. 2, ref num 40) coupled with the flexible electronic circuit (para 0109). The electrodes extend radially outward through apertures in the ablation electrode (Fig. 1, ref num 32 = apertures, ref num 40 extend through apertures; para 0102). The second plurality of electrodes are used to acquire signals from the tissue in order to assess the electrical activity of the tissue (para 0096-0097). Therefore, 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 Sliwa to have the second flexible electronic circuit be coupled to the inner surface of the ablation electrode, as well as have the second plurality of electrodes extend radially outward through apertures of the ablation electrode in order to acquire signals from the tissue in order to assess the electrical activity of the tissue.
23. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Sliwa and Kim, and further in view of Tegg U.S. 2018/0092688 (herein referred to as “Tegg”).
24. Regarding Claim 10, Sliwa teaches a thermocouple (para 0026), but fails to teach the flexible electronic circuit includes the one or more thermocouples; and the high-thermal-sensitivity ablation catheter tip further includes a distal insert that is configured and arranged to position the flexible electronic circuit within an inner cavity of the ablation electrode and to position the one or more thermocouples into thermally transmissive contact with the ablation electrode.
Tegg teaches an ablation catheter tip of analogous art (Fig. 1), wherein the tip comprises an ablation electrode (Fig. 8 or 32, ref num 42) and a flexible electronic circuit (Fig. 32, ref num 290). The flexible electronic circuit is positioned within an inner cavity of the ablation cavity (see Fig. 32). The tip also comprises a distal insert (Fig. 31, ref num 58) as well as the flexible electronic circuit includes one or more thermocouples (Fig. 32, ref num 68). The insert is configured to position the thermocouple into thermally transmissive contact with the ablation electrode (para 0125). This provides the ablation control system with control inputs to prevent over ablation/heating of the tissue (para 0112). Therefore, 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 Sliwa to have the flexible electronic circuit include one or more thermocouples and an insert to arrange the flexible electronic circuit within an inner cavity of the ablation electrode and to position the one or more thermocouples into thermally transmissive contact with the ablation electrode in order to provide the ablation control system with control inputs and prevent over ablation of the tissue.
25. Claims 14, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Sliwa and Kim, and further in view of Rao and Bar-Tal.
26. Regarding Claim 14, Sliwa teaches a high-thermal-sensitivity ablation catheter tip (Fig. 1, ref num 124 and Fig. 3, ref num 336), the tip comprising:
a. an ablation electrode (Fig. 3, ref num 355) configured and arranged to deliver an ablation therapy to tissue in contact with or in close proximity thereto (para 0041, “an electrode 355 for conducting tissue ablation therapy”), the ablation electrode including a conductive tip (Fig. 3, ref num 355; para 0041), a conductive shell (Fig. 3, ref num 366, para 0057, “metal shell catheter tip”; this indicates the shell is conductive), and a transition region between the conductive tip and the conductive shell (see Fig. 3, region between ref nums 366 and 355);
c. a distal flexible electronic circuit (Fig. 3 and 4, ref num 336) including a first plurality of electrodes ((Fig. 3, ref num 337A-D) which extend through first apertures that are defined through the transition region of the ablation electrode (Fig. 4, electrodes, ref nums ref num 337A-D, extend through apertures, ref nums 362A-D, found at region between ref nums 366 and 355).
Sliwa fails to teach (b) an elongate trench is defined in the ablation electrode, the elongate trench extending from the transition region between the conductive tip and the conductive shell and onto a distal tip of the ablation electrode; and (d) a proximal flexible electronic circuit including a second plurality of electrodes which extend through second apertures that are defined through the conductive shell at a proximal end of the conductive shell.
Kim teaches an ablation catheter tip of analogous art (Figs. 10-11), wherein the tip comprises an ablation electrode (Fig. 10, ref num 1044; para 0045, “tip electrode assembly embodiment 1044”), and an elongate trench defined in the ablation electrode (Fig. 10, ref num 1033; para 0046). The elongate trench extends onto a distal tip of the ablation electrode (see Fig. 10, ref num 1033 extends to the distal tip of ref num 1044 via ref num 1039/1038; para 0045, “The distal insert houses multiple, smaller electrodes in apertures 1038 in the tip electrode to provide localized electrical information”, this indicates that the elongate trench extends onto the distal portion of the electrode”). The elongate trench also extends from a transition region between the conductive tip and the conductive shell (Fig. 10, ref num 1049 is the transition region between the tip and shell of ref num 1044; para 0047; ref num 1033 has slots 1055 that allow for the trench to extend between the transition region and tip region). The elongate trench improves the cooling effects of the ablation electrode has fluid is directed towards the distal tip and the electrodes that provide sensing information (para 0045-0046). Therefore, 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 Sliwa to include an elongate trench extending onto a distal tip of the ablation electrode in order to improve the cooling effects of the tip as fluid is directed towards the tip.
Rao teaches an ablation tip of analogous art (Fig. 1, ref num 18), wherein the tip comprises a distal flexible electronic circuit and a proximal flexible electronic circuit (Fig. 2, ref num 100 and 104). The distal flexible electronic circuit includes one or more electrodes (Fig. 1 and 3, ref num 32) and the proximal flexible electronic circuit includes a second plurality of electrodes (Fig. 2, ref num 120, 126, 132; para 0040). The second plurality of electrodes are distributed along a length of the proximal flexible electronic circuit (Fig. 2, ref nums 120, 126, 132). The plurality of flexible electronic circuits allows for the ablation tip to be controlled to delivery different power levels to different portions of the tip (para 0049). Therefore, it would have been obvious to have modified Sliwa to include a proximal flexible electronic circuit coupled to a second plurality of electrodes in order to control the energy levels at different sections of the ablation tip.
However, Sliwa as modified by Rao fails to teach the second plurality of electrodes extend through second apertures that are defined through the conductive shell.
Bar-Tal teaches an ablation tip of analogous art (Fig. 1, ref num 22), wherein the ablation tip comprises a first plurality of electrodes (Fig. 1, ref nums 40 disposed on distal end, ref num 42) and a second plurality of electrodes (fig. 1, ref nums 40 disposed on proximal face, ref num 44; para 0102, “any number of microelectrode apertures 32—and hence, microelectrodes 40—may be located along… the circumferential face 44 of the tip electrode… catheter 22 comprises six microelectrodes—three at distal face 42, and three at circumferential face 44, the latter three microelectrodes being spaced apart from each other”). The second plurality of electrodes extend through second apertures that are defined through the conductive shell (Fig. 1, ref num 32 defined through conductive shell, ref num 44; para 0102). This facilitates the coupling of the second plurality of electrodes to the tip assembly (para 0097). Therefore, it would have been obvious to one of ordinary skill in the art to provide second apertures that the second plurality of electrodes extend through, as this facilitates the coupling of the electrodes to the tip assembly.
27. Regarding Claim 17, Sliwa fails to teach the distal and proximal electronic circuits are communicatively coupled to one another.
Rao teaches an ablation tip of analogous art (Fig. 1, ref num 18), wherein the tip comprises a first flexible electronic circuit and a second flexible electronic circuit (Fig. 2, ref num 100 and 104). The first flexible electronic circuit includes one or more electrodes (Fig. 1 and 3, ref num 32) and the second flexible electronic circuit includes a second plurality of electrodes (Fig. 2, ref num 120, 126, 132; para 0040). The flexible electronic circuits are communicatively coupled to one another (para 0037). The plurality of flexible electronic circuits allows for the ablation tip to be controlled to delivery different power levels to different portions of the tip (para 0049). Therefore, it would have been obvious to have modified Cheung to include a second flexible electronic circuit that is communicatively coupled to the other flexible electronic circuit in order to control the energy levels at different sections of the ablation tip.
28. Regarding Claim 19, Sliwa teaches the conductive shell includes an irrigant aperture (Fig. 4, ref num 360) and an irrigation lumen extending through a longitudinal axis (Fig. 4, ref num 361), the irrigation lumen configured and arranged to deliver irrigant (para 0049).
Sliwa fails to teach the conductive shell includes multiple irrigant apertures extending therethrough, the irrigant apertures configured and arranged for irrigant distribution circumferentially about the conductive shell, wherein the high-thermal-sensitivity ablation catheter tip further includes a manifold coupled to a proximal end of the conductive shell, the manifold includes the irrigation lumen, further that the irrigant is delivered into an inner cavity of the conductive shell; and wherein at least one of the distal and proximal flexible electronic circuits extend through at least a portion of the irrigation lumen.
Bar-Tal teaches an ablation catheter tip of analogous art (Fig. 1), wherein the tip comprising an ablation electrode (Fig. 1, ref num 24) and a flexible electronic circuit including one or more electrodes (Fig. 2, ref num 58 with electrodes, ref nums 40). The ablation electrode includes a conductive tip and conductive shell (Fig. 1, ref nums 42 and 44), such that the conductive shell includes irrigant apertures extending therethrough (Fig. 1, ref num 50). The irrigant apertures are configured and arranged for irrigant distribution circumferentially about the conductive shell (see Fig. 1, ref nums 50; para 0103, 0123). The catheter tip further includes a manifold (Fig. 3, ref num 46) coupled to a proximal end of the conductive shell (see Fig. 4, ref num 46 is coupled to the proximal end of ref num 44). The manifold includes an irrigation lumen extending through a longitudinal axis (para 0123, “fluid passes through tube 46”; see Fig. 4, ref num 46, it is understood there is a lumen in which the irrigant passes through), the irrigation lumen configured and arranged to deliver irrigant into an inner cavity of the conductive shell (para 0123, “the fluid passes through tube 46, and then through conduit 54. Next, the fluid passes through opening 57 of the conduit and through an opening 56 at the distal end of the PCB. The fluid thus reaches distal face 42 of the tip electrode, and is subsequently deflected, by the inner surface 68 of distal face 42, into a space 71 that lies between (i) the PCB and conduit, and (ii) the tip electrode”; Fig. 4, ref num 71). The flexible electronic circuit extends through at least a portion of the irrigation lumen (Fig. 4, ref num 58 extends through irrigation lumen defined by ref num 46). The irrigation lumen delivering irrigant into an inner cavity of the ablation electrodes, as well as the plurality of irrigant apertures distributed about the ablation electrode provide the advantage of absorbing a large amount of heat from the tip electrode (para 0098). Therefore, 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 Sliwa to include a plurality of irrigant apertures and an irrigation lumen to deliver the irrigant to the distal end of the ablation electrode, as this provides the same expected result of facilitating heat transfer between the electrode and irrigant, cooling the tip assembly (see Sliwa, para 0030).
29. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Sliwa, Kim Rao, and Bar-Tal, and further in view of Govari U.S. 2015/0342671 (herein referred to as “Govari”).
30. Regarding Claim 15, Sliwa fails to teach the distal flexible electronic circuit further includes an additional electrode extending through the conductive tip and positioned along a longitudinal axis of the catheter tip.
Govari teaches an ablation tip of analogous art (Fig. 1), wherein the tip comprises a distal electronic circuit board (para 0038) that includes an electrode extending through a conductive tip (Fig. 4, ref num 64 extends through conductive tip, ref num 60) and positioned along a longitudinal axis of the catheter tip (Fig. 4, ref num 64; para 0038). This electrode senses the electrical potential in order to determine the temperature at the time (para 0038). Therefore, it would have been obvious to one of ordinary skill in before the effective filing date of the claimed invention to have modified Cheung to have an additional electrode extending through the conductive tip in order to measure the temperature of the ablation tip.
31. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Sliwa, Kim Rao, and Bar-Tal, and further in view of Tegg.
32. Regarding Claim 16, Sliwa teaches a thermocouple (para 0026). However, Sliwa fails to explicitly teach a plurality of thermocouples communicatively coupled to the distal flexible electronic circuit, and a distal tip insert configured and arranged to position the distal flexible electronic circuit within an inner cavity of the ablation electrode and to position the plurality of thermocouples into thermally transmissive contact with the ablation electrode.
Tegg teaches an ablation catheter tip of analogous art (Fig. 1), wherein the tip comprises an ablation electrode (Fig. 8 or 32, ref num 42) and distal flexible electronic circuit (Fig. 32, ref num 290). The flexible electronic circuit is positioned within an inner cavity of the ablation cavity (see Fig. 32). The tip also comprises a distal tip insert (Fig. 31, ref num 58) as well as the flexible electronic circuit includes one or more thermocouples (Fig. 32, ref num 68). The insert is configured to position the thermocouple into thermally transmissive contact with the ablation electrode (para 0125). This provides the ablation control system with control inputs to prevent over ablation/heating of the tissue (para 0112). Therefore, 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 Sliwa to have the distal flexible electronic circuit include a plurality of thermocouples and a distal tip insert to arrange the distal flexible electronic circuit within an inner cavity of the ablation electrode and to position the plurality of thermocouples into thermally transmissive contact with the ablation electrode in order to provide the ablation control system with control inputs and prevent over ablation of the tissue.
33. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Sliwa, Kim, Rao, and Bar-Tal, and further in view of de la Rama (herein referred to as “de la Rama”).
34. Regarding Claim 18, Sliwa fails to teach the first and second plurality of electrodes are configured in two circumferential rings about the ablation electrode, the two circumferential rings comprising a first circumferential ring and a second circumferential ring, such that the first plurality of electrodes are configured as the first circumferential ring, and the second plurality of electrodes are configured as the second circumferential ring, where the first plurality of electrodes of the first circumferential ring are radially offset by approximately 60o relative to the second plurality of electrodes of the second circumferential ring
de la Rama teaches an ablation tip of analogous art (Figs. 4A and 4B), wherein the ablation tip comprises a first plurality of electrodes configured in a circumferential ring (Fig. 4A, ref nums 68-1, 68-2, 68-3) and a second plurality of electrodes configured in a circumferential ring and offset by approximately 60o relative to the electrodes of the first circumferential ring (para 0062, “a second row of mapping electrodes can be disposed proximally and/or distally with respect to the set mapping electrodes 68-1, 68-2, 68-3 and radially disposed from the set by a particular amount (e.g., 60 degrees)”). This provides greater circumferential density of the electrodes (para 0062). Therefore, it would have been obvious to have modified Sliwa to include have the first plurality and second plurality of electrodes be each in a circumferential ring and offset from one another, as this provides a greater circumferential density of the electrodes.
Conclusion
35. 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.
36.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794