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 .
Response to Amendment
The amendment filed 02/27/2026 has been entered. Claims 1, 11, 16, & 30 are amended. Claims 3 & 24-29 are canceled. Claims 1-2, 4-23, & 30 remain pending; claim 30 is withdrawn from further consideration.
Response to Arguments
Applicant’s arguments with respect to claims 1-2 & 4-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument; as necessitate by amendment.
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, 4-8, & 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over DeSimone et al. (US 20200305946 A1), hereinafter “DeSimone”, in view of Gerrans et al. (US 20110152683 A1), hereinafter “Gerrans”.
Regarding claim 1, DeSimone discloses a tissue treatment system comprising: a pulsed electric field device ([0053] & [0057]; Figure 9—element 400) comprising: an elongate body comprising a distal tip ([0053] & [0054]; Figure 9—element 402); and an expandable member coupled to the elongate body and comprising a compressed configuration, an expanded configuration ([0053] & [0055]; Figure 9—element 404), and an electrode array configured to deliver a pulsed or modulated electric field to tissue ([0053], [0055], & [0057]; Figure 9—element 408).
DeSimone does not disclose wherein the expandable member is configured to allow for unobstructed visualization of the distal tip of the elongate body; a visualization device configured to visualize the expandable member and the distal tip of the elongate body from a proximal side of the expandable member, wherein a distal end of the visualization device is configured to be positioned proximal to a proximal end of the expandable member and configured to visualize tissue proximal to the proximal side of the expandable member.
Gerrans teaches an electrosurgical device ([0086]) comprising an elongate body comprising a distal tip ([0064]; Figures 2A & 4B—element 22); an expandable member coupled to the elongate body ([0064]; Figure 2A & 4B—element 32), wherein the expandable member is configured to allow for unobstructed visualization of the distal tip of the elongate body ([0088]-[0089]; the expandable member is transparent so as to allow viewing of the surrounding area through the transparent wall of the expandable member); a visualization device configured to visualize the expandable member and the distal tip of the elongate body from a proximal side of the expandable member, wherein a distal end of the visualization device is configured to be positioned proximal to a proximal end of the expandable member and configured to visualize tissue proximal to the proximal side of the expandable member ([0021], [0063], [0071], [0088]-[0092], & [0094]; Figures 1, 2A, & 4B—elements 38, 39, & 44; the visualization device 38 is configured to be delivered for through a lumen of the elongate body 22 so that the imaging device can be configured to extend out of one of the openings 44 inside the balloon or out of one of the openings 39 outside of the balloon; the balloon 32 and the distal portion of the catheter are transparent to allow the imaging device to provide visual feedback of the area ahead of the balloon catheter, along the sides of the balloon, or behind the balloon; the imaging device 28 is flexible so that is can be translated linearly or rotationally allowing 360 degree visualization of the surrounding area).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the tissue treatment system, as disclosed by DeSimone, to include wherein the expandable member is configured to allow for unobstructed visualization of the distal tip of the elongate body and a visualization device configured to visualize the expandable member and the distal tip of the elongate body from a proximal side of the expandable member, wherein a distal end of the visualization device is configured to be positioned proximal to a proximal end of the expandable member and configured to visualize tissue proximal to the proximal side of the expandable member, as taught by Gerrans, as both references and the claimed invention are directed toward tissue treatment systems comprising expandable members configured to deliver electrosurgical energy to tissue. As disclosed by Gerrans, the balloon may be transparent in order to allow viewing of the surrounding area through the balloon, the visualization device is configured to be delivered for through a lumen of the elongate body and extend out of openings inside the balloon or outside of the balloon such that the visualization device is configured to allow for 360 degree visualization of the surrounding area, provide for visual feedback with multiple possible views (distal, central, proximal, and within the balloon), and aid in positioning the balloon at the proper location in tissue for treatment ([0021], [0063], [0071], [0088]-[0092], & [0094]). 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 tissue treatment system, as disclosed by DeSimone, to include wherein the expandable member is configured to allow for unobstructed visualization of the distal tip of the elongate body and a visualization device configured to visualize the expandable member and the distal tip of the elongate body from a proximal side of the expandable member, wherein a distal end of the visualization device is configured to be positioned proximal to a proximal end of the expandable member and configured to visualize tissue proximal to the proximal side of the expandable member, as taught by Gerrans, as such a modification would provide for visual feedback that aids in positioning the balloon at the proper location in tissue for treatment, allows for 360 degree visualization of the surrounding area, and provides multiple possible views (distal, central, proximal, and within the balloon).
Regarding claim 2, DeSimone in view of Gerrans disclose all of the limitations of claim 1, as described above.
DeSimone further discloses wherein the expandable member further comprises a lumen therethrough, wherein the lumen has a first diameter in the compressed configuration and a second diameter in the expanded configuration, the second diameter larger than the first diameter ([0053] & [0055]; Figure 9—element 404; the examiner is considering the lumen to be the interior of the balloon 404; and the compressed configuration with a first smaller diameter to be the uninflated configuration of the balloon 404 and the expanded configuration with a second larger diameter to be the inflated configuration of the balloon 404).
Regarding claim 4, DeSimone in view of Gerrans disclose all of the limitations of claim 1, as described above.
DeSimone does not disclose wherein the expandable member is configured to receive the visualization device when the expandable member is in the expanded configuration.
Gerrans further teaches wherein the expandable member is configured to receive the visualization device when the expandable member is in the expanded configuration (([0021], [0063], [0071], [0088]-[0092], & [0094]; Figures 1, 2A, & 4B—elements 38, 39, & 44; the visualization device 38 is configured to be delivered for through a lumen of the elongate body 22 so that the imaging device can be configured to extend out of one of the openings 44 inside the balloon or out of one of the openings 39 outside of the balloon; the balloon 32 and the distal portion of the catheter are transparent to allow the imaging device to provide visual feedback of the area ahead of the balloon catheter, along the sides of the balloon, or behind the balloon; the imaging device 28 is flexible so that is can be translated linearly or rotationally allowing 360 degree visualization of the surrounding area).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the tissue treatment system, as disclosed by DeSimone, to include wherein the expandable member is configured to receive the visualization device when the expandable member is in the expanded configuration, as further taught by Gerrans, as both references and the claimed invention are directed toward tissue treatment systems comprising expandable members configured to deliver electrosurgical energy to tissue. As disclosed by Gerrans, the visualization device is configured to be delivered for through a lumen of the elongate body and extend out of openings inside the balloon or outside of the balloon such that the visualization device is configured to allow for 360 degree visualization of the surrounding area, provide for visual feedback with multiple possible views (distal, central, proximal, and within the balloon), and aid in positioning the balloon at the proper location in tissue for treatment ([0021], [0063], [0071], [0088]-[0092], & [0094]). 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 tissue treatment system, as disclosed by DeSimone, to include wherein the expandable member is configured to receive the visualization device when the expandable member is in the expanded configuration, as further taught by Gerrans, as such a modification would provide for visual feedback that aids in positioning the balloon at the proper location in tissue for treatment, allows for 360 degree visualization of the surrounding area, and provides multiple possible views (distal, central, proximal, and within the balloon).
Regarding claim 5, DeSimone in view of Gerrans disclose all of the limitations of claim 1, as described above.
DeSimone further discloses wherein the expandable member further comprises a lumen therethrough and a semi-expanded configuration ([0053] & [0055]; Figure 9—element 404; the examiner is considering the lumen to be the interior of the balloon 404; and the semi-expanded to be a semi-inflated configuration of the balloon (e.g. a configuration between uninflated and fully inflated)).
DeSimone does not disclose wherein an inner surface of the expandable member holds the visualization device in place when the expandable member is in the semi-expanded configuration.
Gerrans further teaches the expandable member comprising a semi-expanded configuration ([0072]; Figure 4A & 4B—element 32); wherein an inner surface of the expandable member holds the visualization device in place when the expandable member is in the semi-expanded configuration ([0089] & [0092]; Figure 4A & 4B—element 44; the imaging device can be extended out of one of the openings 44 in the balloon and may be translated linearly or rotationally; it is the examiners position that the inner surface of the expandable member would be capable of at least partially holding the visualization device in place in the semi-expanded configuration if the imaging device is in contact with the inner surface of the expandable member).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the tissue treatment system, as disclosed by DeSimone, to include wherein an inner surface of the expandable member holds the visualization device in place when the expandable member is in the semi-expanded configuration, as further taught by Gerrans, as both references and the claimed invention are directed toward tissue treatment systems comprising expandable members configured to deliver electrosurgical energy to tissue. As disclosed by Gerrans, the visualization device is configured to be delivered for through a lumen of the elongate body and extend out of openings inside the balloon or outside of the balloon such that the visualization device is configured to allow for 360 degree visualization of the surrounding area, provide for visual feedback with multiple possible views (distal, central, proximal, and within the balloon), and aid in positioning the balloon at the proper location in tissue for treatment ([0021], [0063], [0071], [0088]-[0092], & [0094]). 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 tissue treatment system, as disclosed by DeSimone, to include wherein an inner surface of the expandable member holds the visualization device in place when the expandable member is in the semi-expanded configuration, as further taught by Gerrans, as such a modification would provide for visual feedback that aids in positioning the balloon at the proper location in tissue for treatment, allows for 360 degree visualization of the surrounding area, and provides multiple possible views (distal, central, proximal, and within the balloon).
Regarding claim 6, DeSimone in view of Gerrans disclose all of the limitations of claim 1, as described above.
DeSimone further discloses wherein the expandable member comprises one or more openings therethrough configured for one or more of fluid egress, fluid suction, and tissue suction ([0053] & [0056]; Figure 9—elements 406).
Regarding claim 7, DeSimone in view of Gerrans disclose all of the limitations of claim 1, as described above.
DeSimone does not disclose wherein the visualization device is positioned adjacent an external surface of the elongate body.
Gerrans further teaches wherein the visualization device is positioned adjacent an external surface of the elongate body ([0059] & [0063]; Figure 1—elements 22 & 38 the examiner is considering the visualization device 38 to be positioned adjacent an external surface of the elongate body 22 at the proximal end of the visualization device near the connected port 36, as shown in Figure 1).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the tissue treatment system, as disclosed by DeSimone, to include wherein the visualization device is positioned adjacent an external surface of the elongate body, as further taught by Gerrans, as both references and the claimed invention are directed toward tissue treatment systems comprising expandable members configured to deliver electrosurgical energy to tissue. As disclosed by Gerrans, the visualization device is configured to be delivered for through a lumen of the elongate body via a connection port and extend out of openings inside the balloon or outside of the balloon such that the visualization device is configured to allow for 360 degree visualization of the surrounding area, provide for visual feedback with multiple possible views (distal, central, proximal, and within the balloon), and aid in positioning the balloon at the proper location in tissue for treatment ([0021], [0063], [0071], [0088]-[0092], & [0094]). 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 tissue treatment system, as disclosed by DeSimone, to include wherein the visualization device is positioned adjacent an external surface of the elongate body, as further taught by Gerrans, as such a modification would provide for visual feedback that aids in positioning the balloon at the proper location in tissue for treatment, allows for 360 degree visualization of the surrounding area, and provides multiple possible views (distal, central, proximal, and within the balloon).
Regarding claim 8, DeSimone in view of Gerrans disclose all of the limitations of claim 1, as described above.
DeSimone does not disclose wherein the pulsed electric field device is configured to be translated independently of the visualization device.
Gerrans further teaches wherein the pulsed electric field device is configured to be translated independently of the visualization device ([0088]-[0092]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the tissue treatment system, as disclosed by DeSimone, to include wherein the pulsed electric field device is configured to be translated independently of the visualization device, as further taught by Gerrans, as both references and the claimed invention are directed toward tissue treatment systems comprising expandable members configured to deliver electrosurgical energy to tissue. As disclosed by Gerrans, the visualization device is configured to be delivered for through a lumen of the elongate body such that it can be translated linearly or rotationally to extend out of openings inside the balloon or outside of the balloon such that the visualization device is configured to allow for 360 degree visualization of the surrounding area, provide for visual feedback with multiple possible views (distal, central, proximal, and within the balloon), and aid in positioning the balloon at the proper location in tissue for treatment ([0021], [0063], [0071], [0088]-[0092], & [0094]). 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 tissue treatment system, as disclosed by DeSimone, to include wherein the pulsed electric field device is configured to be translated independently of the visualization device, as further taught by Gerrans, as such a modification would provide for visual feedback that aids in positioning the balloon at the proper location in tissue for treatment, allows for 360 degree visualization of the surrounding area, and provides multiple possible views (distal, central, proximal, and within the balloon).
Regarding claim 15, DeSimone in view of Gerrans disclose all of the limitations of claim 1, as described above.
DeSimone further discloses wherein the electrode array comprises a plurality of suction openings ([0053] & [0056]; Figure 9—elements 406).
Regarding claim 16, DeSimone discloses a tissue treatment system comprising: a pulsed electric field device ([0053] & [0057]; Figure 9—element 400) comprising an elongate body ([0053] & [0054]; Figure 9—element 402) and an expandable member coupled to the elongate body, wherein the expandable member comprises a lumen therethrough ([0053] & [0055]; Figure 9—element 404; the lumen being the interior lumen of the balloon 404) and an electrode array ([0053], [0055], & [0057]; Figure 9—element 408).
DeSimone does not disclose a visualization device, wherein a first portion of the visualization device is configured to be releasably received within the lumen of the expandable member and a second portion of the visualization device is positioned adjacent to an external surface of the elongate body and positionable proximal to a proximal end of the expandable member to enable visualization of tissue that is proximal of the expandable member.
Gerrans teaches an electrosurgical device ([0086]) comprising an elongate body ([0064]; Figures 2A & 4B—element 22); an expandable member comprising a lumen ([0064]; Figure 2A & 4B—element 32), a visualization device, wherein a first portion of the visualization device is configured to be releasably received within the lumen of the expandable member and a second portion of the visualization device is positioned adjacent to an external surface of the elongate body and positionable proximal to a proximal end of the expandable member to enable visualization of tissue that is proximal of the expandable member ([0021], [0059], [0063], [0071], [0088]-[0092], & [0094]; Figures 1, 2A, & 4B—elements 38, 39, & 44; the visualization device 38 is configured to be delivered for through a lumen of the elongate body 22 via a connection port 36 so that the imaging device can be configured to extend out of one of the openings 44 inside the balloon or out of one of the openings 39 outside of the balloon to allow the imaging device to provide visual feedback of the area ahead of the balloon catheter, along the sides of the balloon, or behind the balloon; the imaging device 28 is flexible so that is can be translated linearly or rotationally allowing 360 degree visualization of the surrounding area; the examiner is considering the first portion to be the distal portion of the visualization device 38 that is configured to extend out of one of the openings 39 & 44 and the second portion to be the proximal end of the visualization device 38 that is located within and proximally of connection port 36, which is shown in Figure 1 to be adjacent to the an external surface of the elongate body 22).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the tissue treatment system, as disclosed by DeSimone, to include a visualization device, wherein a first portion of the visualization device is configured to be releasably received within the lumen of the expandable member and a second portion of the visualization device is positioned adjacent to an external surface of the elongate body and positionable proximal to a proximal end of the expandable member to enable visualization of tissue that is proximal of the expandable member, as taught by Gerrans, as both references and the claimed invention are directed toward tissue treatment systems comprising expandable members configured to deliver electrosurgical energy to tissue. As disclosed by Gerrans, the visualization device is configured to be delivered for through a lumen of the elongate body via a connection port and extend out of openings inside the balloon or outside of the balloon such that the visualization device is configured to allow for 360 degree visualization of the surrounding area, provide for visual feedback with multiple possible views (distal, central, proximal, and within the balloon), and aid in positioning the balloon at the proper location in tissue for treatment ([0021], [0063], [0071], [0088]-[0092], & [0094]). 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 tissue treatment system, as disclosed by DeSimone, to include a visualization device, wherein a first portion of the visualization device is configured to be releasably received within the lumen of the expandable member and a second portion of the visualization device is positioned adjacent to an external surface of the elongate body and positionable proximal to a proximal end of the expandable member to enable visualization of tissue that is proximal of the expandable member, as taught by Gerrans, as such a modification would provide for visual feedback that aids in positioning the balloon at the proper location in tissue for treatment, allows for 360 degree visualization of the surrounding area, and provides multiple possible views (distal, central, proximal, and within the balloon).
Regarding claim 17, DeSimone in view of Gerrans disclose all of the limitations of claim 16, as described above.
DeSimone further discloses wherein the expandable member further comprises a compressed configuration and an expanded configuration, wherein the lumen has a first diameter in the compressed configuration and a second diameter in the expanded configuration, and wherein the second diameter is larger than the first diameter ([0053] & [0055]; Figure 9—element 404; the examiner is considering the compressed configuration with a first smaller diameter to be the uninflated configuration of the balloon 404 and the expanded configuration with a second larger diameter to be the inflated configuration of the balloon 404).
Regarding claim 18, DeSimone in view of Gerrans disclose all of the limitations of claim 16, as described above.
DeSimone further discloses wherein the expandable member further comprises a semi-expanded configuration ([0053] & [0055]; Figure 9—element 404; the examiner is considering the semi-expanded to be a semi-inflated configuration of the balloon (e.g. a configuration between uninflated and fully inflated)).
DeSimone does not disclose wherein an inner surface of the expandable member contacts the visualization device when the expandable member is in the semi-expanded configuration.
Gerrans further teaches the expandable member comprising a semi-expanded configuration ([0072]; Figure 4A & 4B—element 32); wherein an inner surface of the expandable member contacts the visualization device when the expandable member is in the semi-expanded configuration ([0089] & [0092]; Figure 4A & 4B—element 44; the imaging device can be extended out of one of the openings 44 in the balloon and may be translated linearly or rotationally; it is the examiners position that the inner surface of the expandable member would be capable of contacting the visualization device in the semi-expanded if the visualization device is extended out of an opening 44 within the balloon).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the tissue treatment system, as disclosed by DeSimone, to include wherein an inner surface of the expandable member contacts the visualization device when the expandable member is in the semi-expanded configuration, as further taught by Gerrans, as both references and the claimed invention are directed toward tissue treatment systems comprising expandable members configured to deliver electrosurgical energy to tissue. As disclosed by Gerrans, the visualization device is configured to be delivered for through a lumen of the elongate body and extend out of openings inside the balloon or outside of the balloon such that the visualization device is configured to allow for 360 degree visualization of the surrounding area, provide for visual feedback with multiple possible views (distal, central, proximal, and within the balloon), and aid in positioning the balloon at the proper location in tissue for treatment ([0021], [0063], [0071], [0088]-[0092], & [0094]). 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 tissue treatment system, as disclosed by DeSimone, to include wherein an inner surface of the expandable member contacts the visualization device when the expandable member is in the semi-expanded configuration, as further taught by Gerrans, as such a modification would provide for visual feedback that aids in positioning the balloon at the proper location in tissue for treatment, allows for 360 degree visualization of the surrounding area, and provides multiple possible views (distal, central, proximal, and within the balloon).
Regarding claim 19, DeSimone in view of Gerrans disclose all of the limitations of claim 16, as described above.
DeSimone does not disclose wherein the visualization device is configured to visualize a distal tip of the elongate body.
Gerrans further teaches wherein the visualization device is configured to visualize a distal tip of the elongate body ([0021] & [0088]-[0092]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the tissue treatment system, as disclosed by DeSimone, to include wherein the visualization device is configured to visualize a distal tip of the elongate body, as further taught by Gerrans, as both references and the claimed invention are directed toward tissue treatment systems comprising expandable members configured to deliver electrosurgical energy to tissue. As disclosed by Gerrans, the visualization device is configured to be delivered for through a lumen of the elongate body and extend out of openings inside the balloon or outside of the balloon such that the visualization device is configured to allow for 360 degree visualization of the surrounding area, provide for visual feedback with multiple possible views (distal, central, proximal, and within the balloon), and aid in positioning the balloon at the proper location in tissue for treatment ([0021], [0063], [0071], [0088]-[0092], & [0094]). 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 tissue treatment system, as disclosed by DeSimone, to include wherein the visualization device is configured to visualize a distal tip of the elongate body, as further taught by Gerrans, as such a modification would provide for visual feedback that aids in positioning the balloon at the proper location in tissue for treatment, allows for 360 degree visualization of the surrounding area, and provides multiple possible views (distal, central, proximal, and within the balloon).
Regarding claim 20, DeSimone in view of Gerrans disclose all of the limitations of claim 16, as described above.
Gerrans further teaches wherein the first portion of the visualization device is distal to the second portion of the visualization device (see above rejection of claim 16).
Regarding claim 21, DeSimone in view of Gerrans disclose all of the limitations of claim 16, as described above.
DeSimone further discloses wherein the expandable member defines one or more openings through the expandable member configured for one or more of fluid egress, fluid suction, and tissue suction ([0053] & [0056]; Figure 9—elements 406).
Regarding claim 22, DeSimone in view of Gerrans disclose all of the limitations of claim 16, as described above.
DeSimone does not disclose wherein the pulsed electric field device is translatable independently of the visualization device.
Gerrans further teaches wherein the pulsed electric field device is translatable independently of the visualization device ([0088]-[0092]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the tissue treatment system, as disclosed by DeSimone, to include wherein the pulsed electric field device is configured to be translated independently of the visualization device, as further taught by Gerrans, as both references and the claimed invention are directed toward tissue treatment systems comprising expandable members configured to deliver electrosurgical energy to tissue. As disclosed by Gerrans, the visualization device is configured to be delivered for through a lumen of the elongate body such that it can be translated linearly or rotationally to extend out of openings inside the balloon or outside of the balloon such that the visualization device is configured to allow for 360 degree visualization of the surrounding area, provide for visual feedback with multiple possible views (distal, central, proximal, and within the balloon), and aid in positioning the balloon at the proper location in tissue for treatment ([0021], [0063], [0071], [0088]-[0092], & [0094]). 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 tissue treatment system, as disclosed by DeSimone, to include wherein the pulsed electric field device is configured to be translated independently of the visualization device, as further taught by Gerrans, as such a modification would provide for visual feedback that aids in positioning the balloon at the proper location in tissue for treatment, allows for 360 degree visualization of the surrounding area, and provides multiple possible views (distal, central, proximal, and within the balloon).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over DeSimone in view of Gerrans and Melsky et al. (previously presented-US 20110082452 A1), hereinafter “Melsky”.
Regarding claim 9, DeSimone in view of Gerrans disclose all of the limitations of claim 1, as described above.
DeSimone in view of Gerrans do not disclose wherein the visualization device is an endoscope.
Melsky teaches an ablation device comprising an expandable member ([0050]; Figure 1—element 26) and a visualization device ([0050] & [0055]; Figure 1—element 76), wherein the visualization device is an endoscope ([0050], [0055], & [0058]; Figure 1—element 76).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the visualization device, as disclosed by DeSimone in view of Gerrans, to include wherein the visualization device is an endoscope, as taught by Melsky, as both references and the claimed invention are directed toward ablation devices comprising visualization devices disposed within an expandable member. As disclosed by Gerrans, the visualization device can be any device suitable for viewing the target area, such as a coherent fiber bundle or appropriate optical element and lens assembly in conjunction with an imaging sensor ([0092]). As disclosed by Melsky, the visualization device the visualization device may be in the form of endoscopes, fiberscopes, cardioscopes, angioscopes and other optical fiber-based imaging device ([0019] & [0058]). 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 visualization device, as disclosed by DeSimone in view of Gerrans, to include wherein the visualization device is an endoscope, as taught by Melsky, as providing a visualization device in the form of an endoscope is a known and suitable alternative to providing a visualization device in the form of a fiber bundle and would produce the predictable result of providing a visualization device that permits visualization during a surgical procedure.
Claims 10 & 23 are rejected under 35 U.S.C. 103 as being unpatentable over DeSimone in view of Gerrans and Willard et al. (US 20140378967 A1), hereinafter “Willard”.
Regarding claim 10, DeSimone in view of Gerrans disclose all of the limitations of claim 1, as described above.
DeSimone does not disclose a handle coupled to the elongate body and wherein the handle is configured to transition the expandable member between a rolled configuration and an unrolled configuration.
Willard teaches an expandable member coupled to an elongate body and comprising a compressed configuration, an expanded configuration ([0038]; Figure 2—element 130); a handle coupled to the elongate body and wherein the handle is configured to transition the expandable member between a rolled configuration and an unrolled configuration ([0120] & [0122]; Figures 7B-9C—with said handle being the proximal portion of the shaft 27 that is configured to rotate to cause the expandable member to move between a twisted/rolled configuration and a non-twisted/unrolled configuration).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the tissue treatment system, as disclosed by DeSimone, to include a handle coupled to the elongate body and wherein the handle is configured to transition the expandable member between a rolled configuration and an unrolled configuration, as taught by Willard, as both references and the claimed invention are directed toward expandable members for ablating tissue. As disclosed by Willard, the shaft may be rotated to twist and wrap the balloon to a lower profile which aids in facilitating movement of the device to different treatment zones and reduces damage to the electrodes and the expandable member ([0120]-[0122]). 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 tissue treatment system, as disclosed by DeSimone, to include a handle coupled to the elongate body and wherein the handle is configured to transition the expandable member between a rolled configuration and an unrolled configuration, as taught by Willard, as such a modification would allow for the balloon to be twisted and wrapped to a lower profile which aids in facilitating movement of the device to different treatment zones and reduces damage to the electrodes and the expandable member.
Regarding claim 23, DeSimone in view of Gerrans disclose all of the limitations of claim 16, as described above.
DeSimone does not disclose a handle coupled to the elongate body, and wherein the handle configured to transition the expandable member between a rolled configuration and an unrolled configuration.
Willard teaches an expandable member coupled to an elongate body and comprising a compressed configuration, an expanded configuration ([0038]; Figure 2—element 130); a handle coupled to the elongate body, and wherein the handle configured to transition the expandable member between a rolled configuration and an unrolled configuration ([0120] & [0122]; Figures 7B-9C—with said handle being the proximal portion of the shaft 27 that is configured to rotate to cause the expandable member to move between a twisted/rolled configuration and a non-twisted/unrolled configuration).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the tissue treatment system, as disclosed by DeSimone, to include a handle coupled to the elongate body and wherein the handle is configured to transition the expandable member between a rolled configuration and an unrolled configuration, as taught by Willard, as both references and the claimed invention are directed toward expandable members for ablating tissue. As disclosed by Willard, the shaft may be rotated to twist and wrap the balloon to a lower profile which aids in facilitating movement of the device to different treatment zones and reduces damage to the electrodes and the expandable member ([0120]-[0122]). 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 tissue treatment system, as disclosed by DeSimone, to include a handle coupled to the elongate body and wherein the handle is configured to transition the expandable member between a rolled configuration and an unrolled configuration, as taught by Willard, as such a modification would allow for the balloon to be twisted and wrapped to a lower profile which aids in facilitating movement of the device to different treatment zones and reduces damage to the electrodes and the expandable member.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over DeSimone in view of Gerrans and Jackson et al. (previously presented-US 20060095032 A1), hereinafter “Jackson”.
Regarding claim 11, DeSimone in view of Gerrans discloses all of the limitations of claim 1, as described above.
DeSimone further discloses wherein the electrode array further comprises a plurality of elongate electrodes coupled to the expandable member ([0057]; Figure 9—elements 408).
DeSimone does not disclose the plurality of elongate electrodes comprising a ratio of a center-to-center distance between adjacent electrodes of the plurality of elongate electrodes to a width of the electrodes between about 2.3:1 and about 3.3:1.
Jackson teaches an expandable ablation device comprising an array of electrodes ([0008] & [0082]; Figure 9), the plurality of elongate electrodes comprising a ratio of a center-to-center distance between adjacent electrodes of the plurality of elongate electrodes to a width of the electrodes between about 2.3:1 and about 3.3:1 ([0035] & [0088]; depending on the desired treatment effected the electrodes are arranged to control depth and pattern of treatment; the electrodes widths are in the range from 0.1mm to 3mm, and adjacent electrodes are space apart in the range from 0.1mm to 3mm; it is the examiners position that a ratio of center-to-center distance to a width of at least one electrode is capable of being selected between 2.3:1 and 3.3:1, based on the electrode separation ranges and electrode widths).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the electrode spacing and size, as disclosed by DeSimone, to include the electrode spacing and size, as taught by Jackson, as both references and the claimed invention are directed toward expandable ablation devices. As disclosed by Jackson, depending on the desired treatment effect, the electrodes may be arranged to control the depth and pattern of treatment, for treatment of esophageal tissue, the electrode widths are less than 3 mm, typically a width in the range from 0.1 mm to 3 mm, preferably 0.1 mm to 0.3 mm, and adjacent electrodes are spaced apart less than 3 mm, typically in the range from 0.1 mm to 3 mm, preferably from 0.1 mm to 0.3 mm ([0035]). 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 electrode spacing and size, as disclosed by DeSimone, to include the electrode spacing and size, as taught by Jackson, as such a modification would provide for a known and suitable electrode size and spacing that would allow for the electrodes to be arranged to control the depth and the pattern of treatment.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over DeSimone in view of Gerrans, Long (previously presented-US 20160100879 A1), hereinafter “Long”, and Jaafar (previously presented-US 20010044596 A1), hereinafter “Jaafar”.
Regarding claim 12, DeSimone in view of Gerrans discloses all of the limitations of claim 1, as described above.
DeSimone further discloses wherein the system further comprises a signal generator operatively coupled to the electrode array, wherein the signal generator is configured to deliver a pulse waveform to the electrode array to generate a pulsed or modulated electric field configured to generate cell lysis ([0006] & [0057]).
DeSimone does not disclose limiting thermal heating of tissue to less than 13°C up to a tissue depth of about 1.5 mm.
Long teaches a pulsed electric field device configured to deliver a pulse waveform that is configured to limit thermal heating of tissue to less than 13°C ([0118]; a series of electrical pulses may be delivered to target tissue to induce IRE, the IRE dose may increase the temperature of tissue by a few degrees such as 0-10°C).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the pulsed or modulated electric field, as disclosed by DeSimone, to include the pulsed or modulated electric field parameters for limiting thermal heating of tissue to less than 13°C, as taught by Long, as both references and the claimed invention are directed toward pulsed electric field devices for delivering a pulse waveform to tissue. As disclosed by DeSimone, the electrodes are configured to perform Irreversible electroporation or reversible electroporation ([0057]). As disclosed by Long, the device may deliver a series of pulses to induce IRE, such that the IRE dose may increase the temperature of tissue by a few degrees (e.g. 0-10°C) over a period of time ([0118]). 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 pulsed or modulated electric field, as disclosed by DeSimone, to include the pulsed or modulated electric field parameters for limiting thermal heating of tissue to less than 13°C, as taught by Long, as such a modification would provide for a known and suitable thermal limit for inducing IRE. The examiner further notes that it would have been obvious to one having ordinary skill in the art at the time the invention was made to include the limiting of thermal heating of tissue to less than 13°C, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Jaafar teaches a pulsed electric field device configured to deliver a pulse waveform that is configured to generate cell lysis up to a tissue depth of about 1.5 mm ([0016]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the pulsed or modulated electric field, as disclosed by DeSimone, to include the pulsed or modulated electric field parameters configured to generate cell lysis up to a tissue depth of about 1.5 mm, as taught by Jaafar, as both references and the claimed invention are directed toward pulsed electric field devices for delivering a pulse waveform to tissue. As disclosed by DeSimone, the electrodes are configured to perform Irreversible electroporation or reversible electroporation ([0057]). As disclosed by Jaafar, the device may deliver electroporation energy to tissue to inflict irreversible damage, the amplitude of the electric pulses may be selected to provide the electric field and pulse duration product above an upper electroporation limit at a depth of 1mm or less into vascular tissue so as to kill smooth muscle cells in the cylindrical layer of vascular tissue about 1 mm thick, while only causing temporary reversible changes to vascular tissue beyond 1 mm ([0015] & [0016]). 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 pulsed or modulated electric field, as disclosed by DeSimone, to include the pulsed or modulated electric field parameters configured to generate cell lysis up to a tissue depth of about 1.5 mm, as taught by Jaafar, as such a modification would provide for a known and suitable tissue depth for generating cell lysis so as to kill smooth muscle cells in the cylindrical layer of vascular tissue about 1mm thick, while only causing temporary reversible changes to vascular tissue beyond 1 mm. The examiner further notes that it would have been obvious to one having ordinary skill in the art at the time the invention was made to include the pulsed or modulated electric field parameters configured to generate cell lysis up to a tissue depth of about 1.5 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over DeSimone in view of Gerrans and Fraasch et al. (previously presented-US 20200138506 A1), hereinafter “Fraasch”.
Regarding claim 13, DeSimone in view of Gerrans disclose all of the limitations of claim 1, as described above.
DeSimone further discloses wherein the system further comprises a signal generator operatively coupled to the electrode array, wherein the signal generator is configured to generate a pulse waveform configured to generate a pulsed or modulated electric field ([0006] & [0057]).
DeSimone does not disclose the pulsed or modulated electric field comprising a power of between about 16,200 W to about 96,800 W.
Fraasch teaches a pulsed electric field device configured to generate a pulse waveform configured to generate a pulsed or modulated electric field ([0085]), the pulsed or modulated electric field comprising a power of between about 16,200 W to about 96,800 W ([0013]; pulse field ablation therapy can deliver an enormous amount of power over short period of time (e.g. dozens of kilowatts in pulses)).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the pulsed or modulated electric field, as disclosed by DeSimone, to include wherein the pulsed or modulated electric field comprises a power between 16,200 W and 96,800 W, as taught by Fraasch, as both references and the claimed invention are directed toward pulsed electric field devices for delivering a pulse waveform to tissue. As disclosed by Fraasch, pulse field ablation therapy can deliver an enormous amount of power over short period of time (e.g. dozens of kilowatts in pulses) ([0013]). 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 pulsed or modulated electric field, as disclosed by DeSimone, to include wherein the pulse waveform comprises a power between 16,200 W and 96,800 W, as taught by Fraasch, as such a modification would provide for a known and suitable energy delivery parameters for delivering PFA therapy. The examiner further notes that it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the pulse waveform comprises a power between 16,200 W and 96,800 W, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over DeSimone in view of Gerrans and Jaafar.
Regarding claim 14, DeSimone in view of Gerrans all of the limitations of claim 1, as described above.
DeSimone further discloses wherein the system further comprises a signal generator operatively coupled to the electrode array, wherein the signal generator is configured to deliver a pulse waveform to the electrode array to generate a pulsed or modulated electric field ([0006] & [0057]).
DeSimone does not disclose the pulsed or modulated electric field with a magnitude that is substantially uniform at a predetermined distance from the electrode array, wherein the predetermined distance is from about 0.5 mm to about 1.5 mm, and wherein the electric field magnitude is below a therapeutic threshold at a distance beyond the predetermined distance.
Jaafar teaches a pulsed electric field device configured to generate a pulsed or modulated electric field with a magnitude that is substantially uniform at a predetermined distance from the electrode array, wherein the predetermined distance is from about 0.5 mm to about 1.5 mm, and wherein the electric field magnitude is below a therapeutic threshold at a distance beyond the predetermined distance ([0016]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the pulsed or modulated electric field, as disclosed by DeSimone, to include the pulsed or modulated electric field with a magnitude that is substantially uniform at a predetermined distance from the electrode array, wherein the predetermined distance is from about 0.5 mm to about 1.5 mm, and wherein the electric field magnitude is below a therapeutic threshold at a distance beyond the predetermined distance, as taught by Jaafar, as both references and the claimed invention are directed toward pulsed electric field devices for delivering a pulse waveform to tissue. As disclosed by DeSimone, the electrodes are configured to perform irreversible electroporation or reversible electroporation ([0057]). As disclosed by Jaafar, the device may deliver electroporation energy to tissue to inflict irreversible damage, the amplitude of the electric pulses may be selected to provide the electric field and pulse duration product above an upper electroporation limit at a depth of 1mm or less into vascular tissue so as to kill smooth muscle cells in the cylindrical layer of vascular tissue about 1 mm thick, while only causing temporary reversible changes to vascular tissue beyond 1 mm ([0015] & [0016]). 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 pulsed or modulated electric field, as disclosed by DeSimone, to include the pulsed or modulated electric field with a magnitude that is substantially uniform at a predetermined distance from the electrode array, wherein the predetermined distance is from about 0.5 mm to about 1.5 mm, and wherein the electric field magnitude is below a therapeutic threshold at a distance beyond the predetermined distance, as taught by Jaafar, as such a modification would provide for a known and suitable tissue depth to kill smooth muscle cells in the cylindrical layer of vascular tissue about 1mm thick, while only causing temporary reversible changes to vascular tissue beyond 1 mm.
Conclusion
Accordingly, claims 1-2, 4-23 are rejected.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm EST.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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