DETAILED ACTION
This action is pursuant to the claims filed on 06/19/2023. Claims 1-20 are pending. A first action on the merits of claims 1-20 is as follows.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 12/31/2020. It is noted, however, that applicant has not filed a certified copy of the CN202011644953.3 application as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/19/2023 and 09/09/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claim(s) 1, 14-15, and 19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Harlev (WO 2021/126980).
Regarding claim 1, Harlev teaches An ablation device (see Fig 2), comprising an ablation assembly (Fig 2 expandable portion 250) and an adjustment assembly provided at the proximal end of the ablation assembly (Fig 2 shaft 122 with distal end portion 232), the ablation assembly comprising a support skeleton and an ablation member provided on the support skeleton (Fig 3a and 7A-B [0052]; “All or a portion of the struts 751 form an active portion 752 of the panel 750 through which energy can be delivered to tissue”; struts form support skeleton with ablation members provided thereon); the adjustment assembly comprising an inner sheath catheter, an outer sheath catheter and a diameter adjustment module (Figs 6A-B, deployment member 235 is inner sheath, shaft 122 is outer sheath, and [0050] discloses diameter adjustment module with telescoping feature of 235/122 to expand/contract the basket), the inner sheath catheter being movably mounted in the outer sheath catheter along an axial direction ([0050] Figs 6A-B), the distal end of the outer sheath catheter being connected to the proximal end of the support skeleton (see Fig 6A-B), the distal end of the inner sheath catheter being connected to the distal end of the support skeleton (see Fig 6A-B), the inner sheath catheter being connected to the diameter adjustment module, the diameter adjustment module being movable along the axial direction to drive the inner sheath catheter to move relative to the outer sheath catheter along the axial direction, so as to make the support skeleton deform to change a radial size thereof (Fig 2 [0050]; actuation portion 246 works with deployment member 235).
Regarding claims 14-15, Harlev teaches wherein the support skeleton comprises a bearing frame and a positioning frame, the positioning frame is arranged at a distal end relative to the bearing frame (Fig 3a, positioning frame 355 and bearing frame 352), the distal end of the outer sheath catheter is connected to the proximal end of the bearing frame (Fig 3A, proximal end of 352 is connected to distal end of sheath 122), and the distal end of the inner sheath catheter is connected to the distal end of the positioning frame (Fig 3A, distal end of 235 is connected to distal end of 355), a deformation ratio of the positioning frame being less than that of the bearing frame during deformation of the support skeleton (see Fig 3A, positioning frame 355 deforms less than bearing frame 352); wherein at least one of the bearing frame and the positioning frame is provided with at least one ablation member, and the ablation member is ablation electrode, wherein the bearing frame is provided with the ablation electrode (Fig 3A, bearing frame 352 defines ablation electrodes thereon; [0052]; Fig 3A and 7A-B, “All or a portion of the struts 751 form an active portion 752 of the panel 750 through which energy can be delivered to tissue”; struts form support skeleton with ablation members provided thereon), the bearing frame comprises a plurality of bearing rods arranged along the circumferential direction of the inner sheath catheter (Fig 3A-B, struts of frame 352 are arranged along circumferential direction of deployment member 235), the bearing rod comprises a bearing section arranged adjacent to its distal end, and the ablation electrode is arranged in the bearing section (Fig 7A, portion of struts 751 form an active portion 752; the active portion is interpreted as adjacent a bearing section).
Regarding claim 19, Harlev teaches wherein the ablation member is further configured to contact a tissue wall for detecting electrophysiological signals in the target tissue region (Fig 1 mapping system 112; [0109]).
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.
Claim(s) 2-6 and 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harlev in view of Tyson (U.S. PGPub No. 2018/0271594)
Regarding claims 2-4, Harlev teaches wherein the diameter adjustment module comprises an operating member (Fig 2 actuation portion 246 is operating member), the proximal end of the inner sheath catheter is fixed to the moving member, and the operating member is capable of being moved to drive the moving member to move along the axial direction so as to make the inner sheath catheter move along the axial direction ([0038] actuation portion 246 drives inner sheath 235), a side wall of the handle defining a travelling groove which extends therethrough to the inner cavity (see Fig 2), the travelling groove extending along the axial direction, and the operating member being inserted in the travelling groove (see Fig 2).
Harlev fails to explicitly teach wherein the diameter adjustment module comprises a moving member and the operating member connected to the moving member, the proximal end of the inner sheath catheter is fixed to the moving member, a hollow handle, the moving member being arranged in an inner cavity of the handle.
In related prior art, Tyson teaches a similar device wherein the diameter adjustment module comprises a moving member and an operating member connected to the moving member (Figs 12-17, actuator 1132 is an operating member connected to slider 1533 as the moving member), the proximal end of the inner sheath catheter is fixed to the moving member ([0152]), and the operating member is capable of being moved to drive the moving member to move along the axial direction, so as to make the inner sheath catheter move along the axial direction (Figs 15-17 and [0152]); a hollow handle, the moving member being arranged in an inner cavity of the handle (Figs 12A and 17, slider 1533 is within hollow cavity of handle); wherein the diameter adjustment module further comprises at least one elastic member connected to the operating member (Fig 17 spring 1535), at least one first rack and at least one second rack that are capable of meshing with each other are provided on surfaces of the handle and the operating member that face to each other along a radial direction (Fig 16, locking pin 1536 and notch 1537 mesh with each other); the elastic member makes the first rack and the second rack mesh with each other to lock the operating member relative to the handle in the axial direction (Fig 15, spring forces the pin 1536 to mesh with notch 1537 to lock actuator 1132 in the axial direction), and the operating member is capable of sliding along the travelling groove when the first rack and the second rack are disengaged from each other (Fig 17, actuator 1132 can slide in direction 1731 when the locks are disengaged). 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 diameter adjustment module of Harlev in view of Tyson to incorporate the moving member and operating member with locking racks as claimed within a hollow handle of the device to arrive at claims 2-4. Doing so would advantageously provide an actuator that can longitudinally move the inner sheath catheter while simultaneously allowing for a locking feature that prevents the unintended actuation of the device ([0152-0155] disclosing advantages of locking features).
Regarding claim 5, in view of the combination of claim 4 as stated above, Tyson further teaches wherein the operating member comprises a connecting portion and a moving portion (Figs 15-17, moving portion is actuator 1132 that a user contacts and connecting portion is lock member 1534), the connecting portion is received in the inner cavity of the handle (see Fig 12A and 17, connecting portion 1534 is in the cavity of handle), and the moving portion is inserted in the travelling groove and connected to the connecting portion (see Fig 12A and 14A), wherein the distal end of the moving member defines a positioning slot, and the connecting portion is at least partially accommodated in the positioning slot (Fig 15-17, lock member 1534 is within slot of actuator 1132). 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 diameter adjustment module of Harlev in view of Tyson to further incorporate the operating member with the connecting and moving portions as claimed to arrive at claims 5. Doing so would advantageously provide an actuator that can longitudinally move the inner sheath catheter while simultaneously allowing for a locking feature that prevents the unintended actuation of the device ([0152-0155] disclosing advantages of locking features).
Regarding claim 6, in view of the combination of claim 5 as stated above, Tyson further teaches wherein the at least one first rack comprises two first racks, the two first racks are respectively arranged at two sides of the travelling groove and extend along a length direction of the travelling (Fig 17 starting notch 1537 and final notch 1739 at leftmost side of Fig 17 are interpreted as two first racks at two sides of traveling groove).
Harlev/Tyson fail to explicitly teach the at least one second rack comprises two second racks at two axial ends of a surface of the connecting portion facing to the moving portion.
It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have further modified Harlev in view of Tyson to incorporate a second rack at two axial ends of the connecting portion and facing the moving portion, since applicant has not disclosed that the second rack and orientation of the second rack solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a single second rack that is configured to engage with the first rack(s) to enable sliding of the actuator. Doing so would have been a mere matter of duplication of parts as it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Providing the second racks facing the moving portion would be a simple rearrangement of parts as it has been held that the particular placement of a switch were held unpatentable because shifting the position of the starting switch would not have modified operation of the device. In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). In the instant case, switching the orientation of the first and second racks such that the second racks face the moving portion would not modify the operation of the device.
Harlev/Tyson fail to teach a width of the connecting portion is greater than that of the travelling groove in a width direction of the travelling groove.
It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have further modified Harlev in view of Tyson to incorporate the connecting portion having a greater width than that of the travelling groove, since applicant has not disclosed that the width of the connecting portion solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a single second rack that is configured to engage with the first rack(s) to enable sliding of the actuator.
Regarding claim 8, in view of the combination of claim 2 as stated above, Tyson further teaches wherein the moving member comprises opposing first and second surfaces, a first flange is arranged at the proximal end of the moving member and extends away from the first surface (Fig 17 member 1533 has first flange at proximal end extending away from a first surface), a tail end of the first flange protrudes out from the second surface of the moving member (Fig 17 flange of member 1533 protrudes out from second surface) and defines a through hole therein, and the inner sheath catheter is fixed to the through hole and is capable of moving along with the moving member ([0152] slider 1533 is mechanically coupled to the primary electrode 207). 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 further modified the diameter adjustment module of Harlev in view of Tyson to incorporate the moving member with a first flange fixed to the inner sheath catheter to enabling selective movement of said inner sheath catheter. Doing so would advantageously provide an actuator that can longitudinally move the inner sheath catheter while simultaneously allowing for a locking feature that prevents the unintended actuation of the device ([0152-0155] disclosing advantages of locking features).
Harlev/Tyson fail to teach a through hole in the tail end of the first flange fixed to the inner sheath catheter.
However, it would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to provide the moving member linked to the inner sheath via a through hole, since applicant has not disclosed that the through hole linkage solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with any other mechanical coupling that enables concurrent movement of the moving member and inner sheath as disclosed by Tyson [0152].
Regarding claim 9, in view of the combination of claim 3 as stated above, Tyson further teaches wherein the adjustment assembly further comprises a three-way module received in the inner cavity of the handle, the proximal end of the outer sheath catheter is connected to the distal end of the three-way module, the inner sheath catheter is movably inserted in the three-way module, and the inner sheath catheter is fixed to the moving member after extending through the three-way module from its distal end to its proximal end (Figs 12-17 and 21-22 and [0017]; inside of handle defines “three-way module” connected to proximal end of outer sheath electrode at a distal end, the inner sheath electrode is movably inserted within handle, and the inner sheath electrode is fixed to slider 1533).
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harlev in view of Bowe (U.S. PGPub No. 2002/0177765).
Regarding claim 10, Harlev teaches the system of claim 1 as stated above, and further teaches wherein the adjustment assembly is capable of bending ([0042]).
Harlev fails to teach the adjustment assembly further comprises a bending module, the bending module comprises a sliding member and a driving member, a pulling member is provided on a side wall of the outer sheath catheter with one end thereof connected to the distal end of the outer sheath catheter and the other end thereof connected to the sliding member, and the driving member is configured for driving the sliding member to slide along the axial direction, so as to bend the distal end of the outer sheath catheter.
In related prior art, Bowe teaches the adjustment assembly further comprises a bending module, the bending module comprises a sliding member and a driving member (Fig 1, steering controller 40 with rotating knob 42), a pulling member is provided on a side wall of the outer sheath catheter with one end thereof connected to the distal end of the outer sheath catheter and the other end thereof connected to the sliding member (steering tendons 36, 38), and the driving member is configured for driving the sliding member to slide along the axial direction, so as to bend the distal end of the outer sheath catheter (Fig 1, knob 42 slides axially to bend distal end). 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 device of Harlev in view of Bowe to incorporate the bending module as claimed to arrive at claim 10. Doing so would advantageously enable the device to bend on command to advance through the tortuous anatomy of the human body.
Regarding claims 11-12, in view of the combination of claim 10 above, Harlev further teaches wherein the bending module further comprises a main shaft with an inner cavity extending axially through two opposite ends thereof, the outer sheath catheter is inserted in the inner cavity (Fig 2, outer sheath 122 is received within a main shaft of handle assembly).
Harlev fails to teach a wire outlet in the side wall of the main section of the outer sheath catheter, and the pulling member extends out via the wire outlet to connect the sliding member.
Bowe further teaches a main shaft with an inner cavity extending axially through two opposite ends thereof, the outer sheath catheter is inserted in the inner cavity (Fig 1, outer sheath 32 is received within main shaft ), a wire outlet in the side wall thereof, and the pulling member extends out via the wire outlet to connect the sliding member (Fig 1 steering tendons 36, 38 in inner cavity of main shaft are mechanically coupled with the rotation knob 42 to provide bending, this configuration necessarily requires a wire outlet in the side wall to connect to the knob 42); wherein the outer sheath catheter comprises a curved section and a main section connected to the proximal end of the curved section (Fig 1, main section 32 with curved distal section), the main section is inserted in the inner cavity of the main shaft (Fig 1 main proximal section of shaft 32 is connected to internal cavity of main shaft at handle), , the one end of the pulling member is fixedly connected to the distal end of the curved section (Fig 1 and [0050] steering tendons 36/38 are attached to distal end of 26).. 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 device of Harlev in view of Bowe to incorporate the bending module as claimed to arrive at claim 11-12. Doing so would advantageously enable the device to bend on command to advance through the tortuous anatomy of the human body. Specifically, providing the pulling member through a wire outlet of the side wall of the proximal end of the outer sheath catheter to connect to the sliding member would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention, since applicant has not disclosed that the pulling wire connected to the sliding member via side wall wire outlet solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with any other configuration in which the pulling wire is mechanically coupled with the sliding member to provide a bending ability to the device.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harlev in view of Byrd (U.S. PGPub No. 2021/0161582).
Regarding claims 16-17, Harlev further teaches wherein the bearing rod further comprises a connecting section arranged adjacent to its proximal end (Fig 7A proximal section of strut 757), and a connection position of the connecting section and the bearing section is provided with the ablation electrode (Fig 7A, active portion 752 is provided at position between connection of connecting section and bearing section), wherein at least one of the bearing rods is provided with the ablation electrode at a position thereof farthest from the axis of the support skeleton (Fig 6A-B, position of ablation section is at position farthest from axis (i.e., position with largest diameter)), wherein the ablation electrode is connected to an external pulsed energy source to ablate the target tissue region ([0132] disclosing pulsed field ablation).
Harlev fails to teach each of the bearing rods is provided with a plurality of ablation electrodes along its axial direction, among the plurality of bearing rods, the ablation electrodes correspond one to one along the axial direction, and are arranged around the axis of the support skeleton and at intervals along the circumferential direction.
In related prior art, Byrd teaches each of the bearing rods is provided with a plurality of ablation electrodes along its axial direction (Fig 4 [0035] each strut 408 has axial ablation electrodes thereon), among the plurality of bearing rods, the ablation electrodes correspond one to one along the axial direction (see Fig 4), and are arranged around the axis of the support skeleton and at intervals along the circumferential direction (see Fig 4); comprising one of the following features: the polarities of the ablation electrodes on each of the bearing rods being the same, and the polarities of neighboring ablation electrodes on two neighboring bearing rods being opposite ([0036] adjacent splines have opposite polarities); the polarities of two neighboring ablation electrodes on the same bearing rod being opposite, and the polarities of neighboring ablation electrodes on two neighboring bearing rods being opposite; and the polarities of two neighboring ablation electrodes on the same bearing rod being opposite, and the polarities of neighboring ablation electrodes on two neighboring bearing rods being the same (examiner notes preceding limitations need not be taught given the limitation requiring “one of the following features). 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 bearing rods of Harlev in view of Tyson and Byrd to incorporate the bearing rods with distinct axial electrodes thereon with opposing polarities on adjacent rods to arrive at claims 16-17. Doing so would advantageously enable the device to provide bipolar ablation and/or IRE ablation with a complete circumferential effect ([0035-0036]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harlev in view of Byrd, and in further view of Eliason (U.S. PGPub No. 2014/0257069).
Regarding claim 18, Harlev/Byrd teach the device of claim 17 as stated above.
Harlev/Byrd fail to teach wherein each of the bearing rods is a spiral rod with a spiral angle of 10 to 70 degrees, wherein the spiral angle of the bearing rod at a midpoint between the proximal and distal ends is greater than the spiral angle of the bearing rod at its proximal end or distal end, wherein the spiral angles of the bearing rod are symmetrically distributed about the midpoint of the bearing rod.
In related prior art, Eliason teaches a similar device wherein each of the bearing rods is a spiral rod with a spiral angle of 10 to 70 degrees (See Fig 3), wherein the spiral angle of the bearing rod at a midpoint between the proximal and distal ends is greater than the spiral angle of the bearing rod at its proximal end or distal end (Fig 7, splines have greater spiral angle at midpoint than at proximal or distal ends), wherein the spiral angles of the bearing rod are symmetrically distributed about the midpoint of the bearing rod (see Fig 6). 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 bearing rods of Harlev in view of Byrd and Eliason to incorporate a symmetric spiral angle of 10 to 70 degrees with a greater spiral angle at a midpoint than proximal or distal end to arrive at the device of claim 18. Providing the spiral configuration would advantageously reduce the tendency for splines nearest the point of tissue contact to move away from one another as is the case with traditional, non-spiral rods ([0034]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harlev in view of Schuler (U.S. PGPub No. 2017/0189106)
Regarding claim 20, Harlev teaches An ablation system, comprising a mapping device (Fig 1 mapping system 112) and the ablation device according to claim 1 (see rejection of claim 1 above).
Harlev fails to teach the details of the mapping device comprising a mapping catheter and a mapping member provided at the distal end of the mapping catheter, the mapping catheter being inserted in the inner sheath catheter, and the mapping member extending out from the distal end of the inner sheath catheter to contact a tissue wall for detecting electrophysiological signals in the target tissue region.
In related prior art, Schuler teaches the mapping device comprising a mapping catheter and a mapping member provided at the distal end of the mapping catheter (Fig 3 mapping catheter 330 with recording electrodes 324), the mapping catheter being inserted in the inner sheath catheter, and the mapping member extending out from the distal end of the inner sheath catheter to contact a tissue wall for detecting electrophysiological signals in the target tissue region (Fig 3 mapping catheter 330 within inner sheath and extending out from distal end to contact tissue for mapping). 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 Harlev in view of Schuler to incorporate the mapping catheter within the inner sheath to arrive at claim 20. Doing so would advantageously enable the device to integrate both mapping and ablation capabilities within a single system to provide for the simultaneous introduction and deployment into the target region ([0029])
Allowable Subject Matter
Claims 7 and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claims 7 and 13, the Harlev, Tyson, Bowe, Byrd, and Schuler references fail to teach the devices of claim 7 or 13. None of the references of record disclose the detail recited in claims 7 or 13, such that any combination of the above noted references to arrive at either claim 7 or 13 would necessarily rely on impermissible hindsight benefit using information gleaned from the applicant’s specification. No other pertinent prior art reference were found that would overcome the above deficiencies. Therefore, there is no motivation (either in these references or elsewhere in the art) for making such specific and significant modifications thereto to arrive at claim(s) 7 and 13.
Conclusion
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794