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 .
Claims 1-20 are examined in this office action.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. (US Pub No. 20240164834 A1) in view of Thakkar et al. (US Pub No. 20260034361 A1), Yamada et al. (JP 7565048 B2), and Asirvatham et al. (US Pub No. 20130012938 A1).
Regarding claim 1, Olson in view of Thakkar, Yamada, and Asirvatham disclose a tubular probe (Olson, shaft 44, Fig. 1) for non-invasive electrically stimulation of a plurality of target cells in an internal target region of a living body (Olson, "… stimulation is delivered between pairs of electrodes on the catheter …" - Para [0048]), the tubular probe comprising:
a support tube (Olson, shaft 44, Fig. 1) comprising a plurality of openings thereon (Olson, "… apertures defined by annular electrode 373." - Para [0088]), the support tube comprising a distal end (Olson, distal end 48, Fig. 1) and a proximal end (Olson, proximal end 46, Fig. 1), the distal end of the support tube configured to be inserted into the internal target region via guiding the proximal end (Olson, "Handle 42 provides a location for the clinician to hold catheter 14 and may further provide means for steering of the guiding shaft 44 within body 17." - Para [0059]);
a plurality of circumferential rings defining a first set of electrodes (Olson, ring electrodes 206, Fig. 2), the plurality of circumferential rings positioned around the support tube in an axially spaced apart relation from each other along the support tube (Olson, Fig. 2), the first set of electrodes configured to be put in contact with the internal target region (Olson, Fig. 1);
a head part attached to the distal end of the support tube (Olson, catheter assembly 362, Fig. 3D), the head part comprising:
an electrode substrate engaged to the distal end of the support tube (Olson, substrate 374, Fig. 3D), the electrode substrate comprising at least two apertures (Olson, "… circular electrodes 372 are positioned within apertures … substrate 374 insulates circular electrodes 372 …" - Para [0088]); and
at least two electrodes (Olson, circular electrodes 372, Fig. 3D) protruded out from the respective at least two apertures, the at least two electrodes defining a second set of electrodes configured to be put in contact with the internal target region
an electrically conductive line (Olson, Fig. 3D) comprising a distal end attached to a respective electrode of the at least two electrodes.
Olson does not expressly disclose at least two U-shaped wires protruded out from the respective at least two apertures, the at least two U-shaped wires defining a second set of electrodes configured to be put in contact with the internal target region; and a plurality of electrical connectors passing through the support tube, the plurality of electrical connectors comprising: a first set of electrical connectors configured to connect the first set of electrodes to an electrical stimulator device, each respective electrical connector of the first set of electrical connectors comprising an electrically conductive line, a distal end of the electrically conductive line passed through a respective opening of the plurality of openings and attached to a respective circumferential ring of the plurality of circumferential rings, the distal end of the electrically conductive line fastening the respective circumferential ring around the support tube; and a second set of electrical connectors configured to connect the second set of electrodes to the electrical stimulator device, each respective electrical connector of the second set of electrical connectors comprising an electrically conductive line comprising a distal end attached to a respective U-shaped wire of the at least two U-shaped wires, wherein a respective proximal end of each electrically conductive line is in connection with, or capable of connection with, the electrical stimulator device.
Thakkar teaches a plurality of electrical connectors (leads 116, Fig. 2) passing through the support tube (flexible body 102, Fig. 2), the plurality of electrical connectors comprising:
a first set of electrical connectors (See annotated Fig. 2) configured to connect the first set of electrodes (See annotated Fig. 13) to an electrical stimulator device ("An electrical current received by circuit device 100 from an ancillary device (e.g., a power source, etc.) at conductive pads 112 may be delivered to electrodes 114 via conductive leads 116." - Para [0056]), each respective electrical connector of the first set of electrical connectors comprising an electrically conductive line (conductive leads 116, Fig. 5)
a second set of electrical connectors (See annotated Fig. 2) configured to connect the second set of electrodes (See annotated Fig. 13) to the electrical stimulator device ("An electrical current received by circuit device 100 from an ancillary device (e.g., a power source, etc.) at conductive pads 112 may be delivered to electrodes 114 via conductive leads 116." - Para [0056]), each respective electrical connector of the second set of electrical connectors comprising an electrically conductive line (conductive leads 116, Fig. 5)
PNG
media_image1.png
272
828
media_image1.png
Greyscale
PNG
media_image2.png
322
778
media_image2.png
Greyscale
wherein a respective proximal end of each electrically conductive line is in connection with, or capable of connection with, the electrical stimulator device ("An electrical current received by circuit device 100 from an ancillary device (e.g., a power source, etc.) at conductive pads 112 may be delivered to electrodes 114 via conductive leads 116." - Para [0056]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tubular probe of Olson to include a first set of electrical connectors configured to connect the first set of electrodes to an electrical stimulator device, each respective electrical connector of the first set of electrical connectors comprising an electrically conductive line, a second set of electrical connectors configured to connect the second set of electrodes to the electrical stimulator device, each respective electrical connector of the second set of electrical connectors comprising an electrically conductive line, wherein a respective proximal end of each electrically conductive line is in connection with, or capable of connection with, the electrical stimulator device as taught by Thakkar to connect electrodes to a power source (Thakkar, Para [0055]).
Thakkar does not expressly disclose at least two U-shaped wires protruded out from the respective at least two apertures, the at least two U-shaped wires defining a second set of electrodes configured to be put in contact with the internal target region, a distal end of the electrically conductive line passed through a respective opening of the plurality of openings and attached to a respective circumferential ring of the plurality of circumferential rings, the distal end of the electrically conductive line fastening the respective circumferential ring around the support tube; and an electrically conductive line comprising a distal end attached to a respective U-shaped wire of the at last two U-shaped wires.
Yamada teaches at least two U-shaped wires (bent portion Y1a, Figs. 5, 6, and 22) protruded out from the respective at least two apertures (holes 18, Fig. 5), the at least two U-shaped wires defining a second set of electrodes configured to be put in contact with the internal target region; and an electrically conductive line comprising a distal end attached to a respective U-shaped wire of the at least two U-shaped wires (bent portion Y1a, Figs. 5, 6, and 22).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tubular probe of Olson to include at least two U-shaped wires protruded out from the respective at least two apertures, the at least two U-shaped wires defining a second set of electrodes configured to be put in contact with the internal target region; and an electrically conductive line comprising a distal end attached to a respective U-shaped wire of the at least two U-shaped wires as taught by Yamada so the through hole communicates with the corresponding wire lumen (Yamada, Para [0061]).
Yamada does not expressly disclose a distal end of the electrically conductive line passed through a respective opening of the plurality of openings and attached to a respective circumferential ring of the plurality of circumferential rings, the distal end of the electrically conductive line fastening the respective circumferential ring of the plurality of circumferential rings around the support tube.
Asirvatham teaches a distal end of the electrically conductive line passed through a respective opening of the plurality of openings and attached to a respective circumferential ring of the plurality of circumferential rings, the distal end of the electrically conductive line fastening the respective circumferential ring of the plurality of circumferential rings around the support tube ("… the electrode array 34 including a number of individual electrodes 35, all of which are connected to the link 38." - Para [0050]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tubular probe of Olson to include a distal end of the electrically conductive line passed through a respective opening of the plurality of openings and attached to a respective circumferential ring of the plurality of circumferential rings, the distal end of the electrically conductive line fastening the respective circumferential ring of the plurality of circumferential rings around the support tube as taught by Asirvatham to carry the electrode array on the expandable end (Asirvatham, Para [0050]).
Regarding claim 2, Olson in view of Thakkar, Yamada, and Asirvatham teach the tubular probe (Olson, shaft 44, Fig. 1) as recited above, wherein
the support tube comprises an elongated tube (Olson, shaft 44, Fig. 1) made of a biocompatible flexible material (Olson, "Shaft 44 is an elongated, tubular, flexible member configured for movement within the body." - Para [0059]).
Regarding claim 3, Olson in view of Thakkar, Yamada, and Asirvatham teach the tubular probe (Olson, shaft 44, Fig. 1) as recited above, wherein
the support tube (Olson, shaft 44, Fig. 1) comprises a biocompatible polymeric tube (Olson, "Shaft 44 may be made from conventional materials such as polyurethane …" - Para [0059]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. (US Pub No. 20240164834 A1) in view of Thakkar et al. (US Pub No. 20260034361 A1), Yamada et al. (JP 7565048 B2) Asirvatham et al. (US Pub No. 20130012938 A1), and in further view of Betelia et al. (US Pub No. 20250176987 A1).
Regarding claim 4, Olson in view of Thakkar, Yamada, Asirvatham, and Betelia teach the tubular probe (Olson, shaft 44, Fig. 1) as recited above, wherein
Olson in view of Thakkar, Yamada, and Asirvatham does not expressly disclose that the support tube comprises a tube with a diameter in a range of 0.5 cm to 3 cm.
Betelia teaches that the support tube (rotatable tube 1032, Fig. 10B) comprises a tube (rotatable tube 1032, Fig. 10B) with a diameter in a range of 0.5 cm to 3 cm ("…the outer diameter of the rotatable tube 1032 is at least … 0.20 inches." - Para [0157]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tubular probe of Olson to include that the support tube comprises a tube with a diameter in a range of 0.5 cm to 3 cm as taught by Betelia to delivery high voltage pulses (Betelia, Para [0042]).
Examiner interprets .2 inches to be equivalent to .508 cm.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. (US Pub No. 20240164834 A1) in view of Thakkar et al. (US Pub No. 20260034361 A1), Yamada et al. (JP 7565048 B2) Asirvatham et al. (US Pub No. 20130012938 A1), and in further view of Wang et al. (US Patent No. 12070246 B1).
Regarding claim 5, Olson in view of Thakkar, Yamada, Asirvatham, and Wang teach the tubular probe (Olson, shaft 44, Fig. 1) as recited above, wherein
Olson in view of Thakkar, Yamada, and Asirvatham does not expressly disclose that each opening of the plurality of openings comprises a hole on the support tube with a diameter in a range of 0.1 cm to 0.5 cm, each two adjacent openings arranged within a distance in a range of 0.5 cm to 1.5 cm from each other.
Wang teaches that each opening of the plurality of openings (holes 200, Fig. 3) comprises a hole on the support tube (connection part 20, Fig. 3) with a diameter in a range of 0.1 cm to 0.5 cm ("… a single connection hole 200 or groove has a diameter of .01-25mm …" - Col. 11 Line 15), each two adjacent openings arranged within a distance in a range of 0.5 cm to 1.5 cm from each other ("… the distance between the adjacent connection holes or grooves is .01-25mm …" - Col. 11 Line 15).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tubular probe of Olson to include that each opening of the plurality of openings comprises a hole on the support tube with a diameter in a range of 0.1 cm to 0.5 cm, each two adjacent openings arranged within a distance in a range of 0.5 cm to 1.5 cm from each other as taught by Wang to convey electrical charges (Wang, Col. 1 Line 37).
Examiner interprets .01 - 25mm to be equivalent to .01-2.5cm.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. (US Pub No. 20240164834 A1) in view of Thakkar et al. (US Pub No. 20260034361 A1), Yamada et al. (JP 7565048 B2) Asirvatham et al. (US Pub No. 20130012938 A1), and in further view of Weissberg et al. (WO 2014133870 A1).
Regarding claim 6, Olson in view of Thakkar, Yamada, Asirvatham, and Weissberg teach the tubular probe (Olson, shaft 44, Fig. 1) as recited above, wherein
each electrode of the first set of electrodes comprises an electrically conductive biocompatible ring (Olson, ring electrodes 206, Fig. 2)
Olson in view of Thakkar, Yamada, and Asirvatham does not expressly disclose an electrically conductive biocompatible ring with an internal diameter in a range of 0.5 cm to 3 cm and an external diameter in a range of 0.7 cm to 3.5 cm.
Weissberg teaches an electrically conductive biocompatible ring with an internal diameter in a range of 0.5 cm to 3 cm (“the inner diameter of the ground electrode was about 8mm.” – Para [0084]) and an external diameter in a range of 0.7 cm to 3.5 cm (“… and its outer diameter was about 8.6mm.” – Para [0084]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tubular probe of Olson to include an electrically conductive biocompatible ring with an internal diameter in a range of 0.5 cm to 3 cm and an external diameter in a range of 0.7 cm to 3.5 cm as taught by Weissberg for electrical pulse delivery (Weissberg, Para [0044]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. (US Pub No. 20240164834 A1) in view of Thakkar et al. (US Pub No. 20260034361 A1), Yamada et al. (JP 7565048 B2) Asirvatham et al. (US Pub No. 20130012938 A1), and in further view of Kessman et al. (US Pub No. 20250387068 A1).
Regarding claim 7, Olson in view of Thakkar, Yamada, Asirvatham, and Kessman teach the tubular probe (Olson, shaft 44, Fig. 1) as recited above, wherein
Olson in view of Thakkar and Asirvatham does not expressly disclose that each U-shaped wire of the at least two U-shaped wires comprises a biocompatible electrically conductive wire with a diameter in a range of about 0.5 mm to about 3 mm.
Yamada teaches each U-shaped wire of the least two U-shaped wires (bent portion Y1a, Figs. 5, 6, and 22).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tubular probe of Olson to include each U-shaped wire of the least two U-shaped wires as taught by Yamada so the through hole communicates with the corresponding wire lumen (Yamada, Para [0061]).
Yamada does not expressly disclose that each U-shaped wire of the at least two U-shaped wires comprises a biocompatible electrically conductive wire with a diameter in a range of about 0.5 mm to about 3 mm.
Kessman teaches that each U-shaped wire of the at least two U-shaped wires comprises a biocompatible electrically conductive wire with a diameter in a range of about 0.5 mm to about 3 mm (… the conductive wire has a nominal diameter of at least about .2millimeters and no more than 1mm." - Para [0040]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tubular probe of Olson to include that each U-shaped wire of the at least two U-shaped wires comprises a biocompatible electrically conductive wire with a diameter in a range of about 0.5 mm to about 3 mm as taught by Kessman to deliver treatment (Kessman, Para [0003]).
Claim(s) 8 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. (US Pub No. 20240164834 A1) in view of Thakkar et al. (US Pub No. 20260034361 A1), Yamada et al. (JP 7565048 B2) Asirvatham et al. (US Pub No. 20130012938 A1), and in further view of Govari et al. (US Pub No. 20210386996 A1).
Regarding claim 8, Olson in view of Thakkar, Yamada, Asirvatham, and Govari teach the tubular probe (Olson, shaft 44, Fig. 1) as recited above, wherein
Olson in view of Thakkar and Asirvatham does not expressly disclose that the at least two U-shaped wires are arranged in parallel to each other with a distance in a range of 0.5 cm to 1.5 cm between each two adjacent U-shaped wires of the at least two U-shaped wires.
Yamada teaches the at least two U-shaped wires (bent portion Y1a, Figs. 5, 6, and 22) are arranged in parallel to each other (Fig. 22).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tubular probe of Olson to include each U-shaped wire of the least two U-shaped wires are arranged in parallel to each other as taught by Yamada so the through hole communicates with the corresponding wire lumen (Yamada, Para [0061]).
Yamada does not expressly disclose that the at least two U-shaped wires are arranged in parallel to each other with a distance in a range of 0.5cm to 1.5 cm between each two adjacent U-shaped wires of the at least two U-shaped wires.
Govari teaches that the at least two electrodes are arranged in parallel to each other with a distance in a range of 0.5cm to 1.5 cm between each two adjacent electrodes of the at least two electrodes ("the distance between the center of the two electrodes 52 may be any suitable distance, such as in the range of 5mm to 20mm …" - Para [0070]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tubular probe of Olson to include that the at least two electrodes are arranged in parallel to each other with a distance in a range of 0.5cm to 1.5 cm between each two adjacent electrodes of the at least two electrodes as taught by Govari for applying the current of the electroporation pulse (Govari, Para [0042]).
Regarding claim 20, Olson in view of Thakkar, Yamada, Asirvatham, and Govari teach the tubular probe (Olson, shaft 44, Fig. 1) as recited above, wherein
Olson in view of Thakkar and Asirvatham does not expressly disclose that the at least two U-shaped wires are arranged in parallel to each other with a distance in a range of 0.5 cm to 1.5 cm between each two adjacent U-shaped wires of the at least two U-shaped wires.
Yamada teaches the at least two U-shaped wires (bent portion Y1a, Figs. 5, 6, and 22) are arranged in parallel to each other (Fig. 22).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tubular probe of Olson to include each U-shaped wire of the least two U-shaped wires are arranged in parallel to each other as taught by Yamada so the through hole communicates with the corresponding wire lumen (Yamada, Para [0061]).
Yamada does not expressly disclose that the at least two U-shaped wires are arranged in parallel to each other with a distance in a range of 0.5cm to 1.5 cm between each two adjacent U-shaped wires of the at least two U-shaped wires.
Govari teaches that the at least two electrodes are arranged in parallel to each other with a distance in a range of 0.5cm to 1.5 cm between each two adjacent electrodes of the at least two electrodes ("the distance between the center of the two electrodes 52 may be any suitable distance, such as in the range of 5mm to 20mm …" - Para [0070]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tubular probe of Olson to include that the at least two electrodes are arranged in parallel to each other with a distance in a range of 0.5cm to 1.5 cm between each two adjacent electrodes of the at least two electrodes as taught by Govari for applying the current of the electroporation pulse (Govari, Para [0042]). ‘
Claim(s) 9-11 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. (US Pub No. 20240164834 A1) in view of Thakkar et al. (US Pub No. 20260034361 A1), Yamada et al. (JP 7565048 B2) Asirvatham et al. (US Pub No. 20130012938 A1), and Scherman (US 20070242743 A1).
Regarding claim 9, Olson in view of Yamada, Thakkar, Asirvatham, and Scherman disclose a system for in-vivo electroporation of a plurality of target cells in an internal target region of a living body (Olson, system 10 for electroporation therapy, Fig. 1), the system comprising:
a tubular probe (Olson, shaft 44, Fig. 1) configured to transfer a pulsed electric field to the plurality of target cells, the tubular probe comprising:
a support tube (Olson, shaft 44, Fig. 1) comprising a plurality of openings thereon (Olson, "… apertures defined by annular electrode 373." - Para [0088]), the support tube comprising a distal end (Olson, distal end 48, Fig. 1) and a proximal end (Olson, proximal end 46, Fig. 1), the distal end of the support tube configured to be inserted into the internal target region via guiding the proximal end (Olson, "Handle 42 provides a location for the clinician to hold catheter 14 and may further provide means for steering of the guiding shaft 44 within body 17." - Para [0059]);
a plurality of circumferential rings defining a first set of electrodes (Olson, ring electrodes 206, Fig. 2), the plurality of circumferential rings positioned around the support tube in an axially spaced apart relation from each other along the support tube (Olson, Fig. 2), the first set of electrodes configured to be put in contact with the internal target region (Olson, Fig. 1);
a head part attached to the distal end of the support tube (Olson, catheter assembly 362, Fig. 3D), the head part comprising:
an electrode substrate engaged to the distal end of the support tube (Olson, substrate 374, Fig. 3D), the electrode substrate comprising at least two apertures (Olson, "… circular electrodes 372 are positioned within apertures … substrate 374 insulates circular electrodes 372 …" - Para [0088]); and
at least two electrodes (Olson, circular electrodes 372, Fig. 3D) protruded out from the respective at least two apertures, the at least two electrodes defining a second set of electrodes configured to be put in contact with the internal target region
an electrically conductive line (Olson, Fig. 3D) comprising a distal end attached to a respective electrode of the at least two electrodes.
an electrical pulse generator (Olson, electroporation generator 26, Fig. 1) configured to apply a pulsed electric field between at least two electrodes (Olson, "… generator 26 may be configured to produce an electric current that is delivered via electrode assembly 12 as a pulsed electric field in the form of short-duration DC pulses … between closely spaced electrodes capable of delivering an electric field ..." - Para [0053]) of at least one of the first set of electrodes (Olson, ring electrodes 206, Fig. 2), the second set of electrodes (Olson, circular electrodes 372, Fig. 3D), and combinations thereof,
a method, the method comprising:
inducing electroporation to the plurality of target cells by generating the pulsed electric field between the at least two electrodes of at least one of the first set of electrodes, the second set of electrodes, and combinations thereof inside the internal target region (Olson, "Electrode assembly 12 is incorporated as part of a medical device such as a catheter 14 for electroporation therapy of tissue 16 in a body 17 of a patient." - Para [0051]) via applying at least one sequence of electric voltage pulses between the at least two electrodes utilizing the electrical pulse generator (Olson, "… generator 26 may be configured to produce an electric current that is delivered via electrode assembly 12 as a pulsed electric field in the form of short-duration DC pulses … between closely spaced electrodes capable of delivering an electric field ..." - Para [0053]).
Furthermore, the method of forming the system if not germane to the issue of patentability of the system itself.
Olson does not expressly disclose at least two U-shaped wires protruded out from the respective at least two apertures, the at least U-shaped wires defining a second set of electrodes configured to be put in contact with the internal target region; and a plurality of electrical connectors passing through the support tube, the plurality of electrical connectors comprising: a first set of electrical connectors, each respective electrical connector of the first set of electrical connectors comprising an electrically conductive line comprising a distal end and a proximal end, the respective distal end passed through a respective opening of the plurality of openings and attached to a respective circumferential ring of the plurality of circumferential rings, the distal end of the electrically conductive line fastening the respective circumferential ring around the support tube; and a second set of electrical connectors, each respective electrical connector of the second set of electrical connectors comprising an electrically conductive line comprising a distal end and a proximal end, the respective distal end attached to a respective U-shaped wire of the at least two U-shaped wires, each respective proximal end of each electrically conductive line of the at least two electrodes being connected to a different pole of two poles of the electrical pulse generator; and a processing unit electrically connected to the electrical pulse generator, the processing unit comprising: a memory having processor-readable instructions stored therein; and a processor configured to access the memory and execute the processor- readable instructions, which, when executed by the processor configures the processor to perform a method.
Thakkar teaches a plurality of electrical connectors (conductive leads 116, Fig. 5) passing through the support tube (flexible body 102, Fig. 2), the plurality of electrical connectors comprising: a first set of electrical connectors (See annotated Fig. 2 above), each respective electrical connector of the first set of electrical connectors comprising an electrically conductive line comprising a distal end and a proximal end (conductive leads 116, Fig. 5), and a second set of electrical connectors (See annotated Fig. 2 above), each respective electrical connector of the second set of electrical connectors comprising an electrically conductive line comprising a distal end and a proximal end (conductive leads 116, Fig. 5) the respective distal end attached to a respective electrode (electrode 114, Fig. 2) of the at least two electrodes.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Olson to include a plurality of electrical connectors passing through the support tube, the plurality of electrical connectors comprising: a first set of electrical connectors, each respective electrical connector of the first set of electrical connectors comprising an electrically conductive line comprising a distal end and a proximal end, and a second set of electrical connectors, each respective electrical connector of the second set of electrical connectors comprising an electrically conductive line comprising a distal end and a proximal end the respective distal end attached to a respective electrode of the at least two electrodes as taught by Thakkar to connect electrodes to a power source (Thakkar, Para [0055]).
Thakkar does not expressly disclose an electrically conductive line comprising a distal end and a proximal end the respective distal end passed through a respective opening of the plurality of openings and attached to a respective circumferential ring of the plurality of circumferential rings, the distal end of the electrically conductive line fastening the respective circumferential ring around the support tube; the respective distal end of the conductive line attached a respective U-shaped wire of the at least two U-shaped wires, each respective proximal end of each electrically conductive line of the at least two electrodes being connected to a different pole of two poles of the electrical pulse generator; and a processing unit electrically connected to the electrical pulse generator, the processing unit comprising: a memory having processor-readable instructions stored therein; and a processor configured to access the memory and execute the processor- readable instructions, which, when executed by the processor configures the processor to perform a method.
Yamada teaches at least two U-shaped wires (bent portion Y1a, Figs. 5, 6, and 22) protruded out from the respective at least two apertures (holes 18, Fig. 5), the at least two U-shaped wires defining a second set of electrodes configured to be put in contact with the internal target region; and an electrically conductive line comprising a distal end and a proximal end the respective distal end attached to a respective U-shaped wire (bent portion Y1a, Figs. 5, 6, and 22) of the at least two U-shaped wires (bent portion Y1a, Figs. 5, 6, and 22).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Olson to include at least two U-shaped wires protruded out from the respective at least two apertures, the at least two U-shaped wires defining a second set of electrodes configured to be put in contact with the internal target region; and an electrically conductive line comprising a distal end and a proximal end the respective distal end attached to a respective U-shaped wire of the at least two U-shaped wires as taught by Yamada so the through hole communicates with the corresponding wire lumen (Yamada, Para [0061]).
Yamada does not expressly disclose an electrically conductive line comprising a distal end a proximal end the respective distal end passed through a respective opening of the plurality of openings and attached to a respective circumferential ring of the plurality of circumferential rings, the distal end of the electrically conductive line fastening the respective circumferential ring around the support tube, each respective proximal end of each electrically conductive line of the at least two electrodes being connected to a different pole of two poles of the electrical pulse generator; and a processing unit electrically connected to the electrical pulse generator, the process unit comprising: a memory having a processor-readable instructions stored therein; and a processor configured to access the memory and execute the processor-readable instructions which when executed by the processor configured the processor to perform a method.
Asirvatham teaches an electrically conductive line comprising a distal end a proximal end the respective distal end passed through a respective opening of the plurality of openings and attached to a respective circumferential ring of the plurality of circumferential rings, the distal end of the electrically conductive line fastening the respective circumferential ring around the support tube ("… the electrode array 34 including a number of individual electrodes 35, all of which are connected to the link 38." - Para [0050]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Olson to include an electrically conductive line comprising a distal end a proximal end the respective distal end passed through a respective opening of the plurality of openings and attached to a respective circumferential ring of the plurality of circumferential rings, the distal end of the electrically conductive line fastening the respective circumferential ring around the support tube as taught by Asirvatham to carry the electrode array on the expandable end (Asirvatham, Para [0050]).
Asirvatham does not expressly disclose each respective proximal end of each electrically conductive line of the at least two electrodes being connected to a different pole of two poles of the electrical pulse generator; and a processing unit electrically connected to the electrical pulse generator, the process unit comprising: a memory having a processor-readable instructions stored therein; and a processor configured to access the memory and execute the processor-readable instructions which when executed by the processor configured the processor to perform a method.
Scherman teaches each respective proximal end of each electrically conductive line of the at least two electrodes being connected to a different pole of two poles of the electrical pulse generator ("…the generator may deliver each pulse alternately to each pair of electrodes—pairs 101, 11 and 100,11 –wherein each pair is linked to its terminals." – Para [0301]); and a processing unit (computer means 510, Fig. 1) electrically connected to the electrical pulse generator (source 530, Fig. 1), the process unit comprising: a memory having a processor-readable instructions stored therein ("Pulse sequence programming can be stored in computer memory …" – Para [0251]); and a processor (processor 510, Fig. 1) configured to access the memory and execute the processor-readable instructions which when executed by the processor configured the processor to perform a method ("It can be generated by computer means 510. By computer means, we include the processors …" – Para [0173]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Olson to include each respective proximal end of each electrically conductive line of the at least two electrodes being connected to a different pole of two poles of the electrical pulse generator; and a processing unit electrically connected to the electrical pulse generator, the process unit comprising: a memory having a processor-readable instructions stored therein; and a processor configured to access the memory and execute the processor-readable instructions which when executed by the processor configured the processor to perform a method as taught by Scherman for generating series of square unipolar pulses (Scherman, Abstract).
Regarding claim 10, Olson in view of Thakkar, Yamada, Asirvatham, and Scherman disclose the system (Olson, system 10 for electroporation therapy, Fig. 1) as recited above, wherein
applying the at least one sequence of electric voltage pulses between the at least two electrodes (Olson, "… generator 26 may be configured to produce an electric current that is delivered via electrode assembly 12 as a pulsed electric field in the form of short-duration DC pulses … between closely spaced electrodes capable of delivering an electric field ..." - Para [0053]) comprises a magnitude in a range of 500 V/cm to 1500 V/cm (Olson, “For example, in some embodiments, the systems and methods described herein may include pulses with amplitudes from about 500V to about 4,000V …” – Para [0054]) and a duration of 100 µs between the at least two electrodes (Olson, “… a pulse width of 100 microseconds …” – Para [0121]).
Olson does not expressly disclose applying at least one sequence of eight square-wave electric voltage pulses.
Scherman teaches applying at least one sequence of eight square-wave electric voltage pulses ("The main function of such a generator is to emit a series of unipolar square pulses of a number of pulses 133 …" - Col. Line) ("…the number of pulses (133) transmitted per series is less than 25 …" – Para [0177]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Olson to include applying at least one sequence of eight square-wave electric voltage pulses as taught by Scherman for generating series of square unipolar pulses (Scherman, Abstract).
Regarding claim 11, Olson in view of Thakkar, Yamada, Asirvatham, and Scherman disclose the system (Olson, system 10 for electroporation therapy, Fig. 1) as recited above, wherein the method further comprises:
generating the pulsed electric field between every two electrodes of at least one of the first set of electrodes, the second set of electrodes, and combinations thereof (Olson, "… generator 26 may be configured to produce an electric current that is delivered via electrode assembly 12 as a pulsed electric field in the form of short-duration DC pulses … between closely spaced electrodes capable of delivering an electric field ..." - Para [0053]).
Olson in view of Thakkar, Yamada, and Asirvatham does not expressly disclose generating the pulsed electric field … by periodically changing a connection of at least one of the first set of electrodes, the second set of electrodes, and combinations thereof to the two poles of the electrical pulse generator.
Scherman teaches generating the pulsed electric field … by periodically changing a connection of at least one of the first set of electrodes, the second set of electrodes, and combinations thereof to the two poles of the electrical pulse generator ("…the generator may deliver each pulse alternately to each pair of electrodes—pairs 101, 11 and 100,11 –wherein each pair is linked to its terminals." – Para [0301]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Olson to include generating the pulsed electric field … by periodically changing a connection of at least one of the first set of electrodes, the second set of electrodes, and combinations thereof to the two poles of the electrical pulse generator as taught by Scherman for generating series of square unipolar pulses (Scherman, Abstract).
Regarding claim 13, Olson in view of Thakkar, Yamada, Asirvatham, and Scherman disclose the system (Olson, system 10 for electroporation therapy, Fig. 1) as recited above, wherein
Olson does not expressly disclose periodically changing the connection of at least one of the first set of electrodes, the second set of electrodes, and combinations thereof to the two poles of the electrical pulse generator comprises stepwise changing the connection of at least one of the first set of electrodes, the second set of electrodes, and combinations thereof to the two poles of the electrical pulse generator during a plurality of time steps.
Scherman teaches periodically changing the connection of at least one of the first set of electrodes, the second set of electrodes, and combinations thereof to the two poles of the electrical pulse generator ("…the generator may deliver each pulse alternately to each pair of electrodes—pairs 101, 11 and 100,11 –wherein each pair is linked to its terminals." – Para [0301]) comprises stepwise changing the connection of at least one of the first set of electrodes, the second set of electrodes, and combinations thereof to the two poles of the electrical pulse generator during a plurality of time steps ("The duration between two pulses is less than 600 sec, and the number of sequences is less than 25." – Para [0202]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Olson to include periodically changing the connection of at least one of the first set of electrodes, the second set of electrodes, and combinations thereof to the two poles of the electrical pulse generator comprises stepwise changing the connection of at least one of the first set of electrodes, the second set of electrodes, and combinations thereof to the two poles of the electrical pulse generator during a plurality of time steps as taught by Scherman for generating series of square unipolar pulses (Scherman, Abstract).
Regarding claim 14, Olson in view of Thakkar, Yamada, Asirvatham, and Scherman disclose the system (Olson, system 10 for electroporation therapy, Fig. 1) as recited above, wherein
Olson does not expressly disclose that each time step of the plurality of time steps comprises a time interval between 0.5 second and 5 seconds.
Scherman teaches that each time step of the plurality of time steps comprises a time interval between 0.5 second and 5 seconds ("The duration between two pulses is less than 600 sec, and the number of sequences is less than 25." – Para [0202]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Olson to include that each time step of the plurality of time steps comprises a time interval between 0.5 second and 5 seconds as taught by Scherman for generating series of square unipolar pulses (Scherman, Abstract).
Regarding claim 15, Olson in view of Thakkar, Yamada, Asirvatham, and Scherman disclose the system (Olson, system 10 for electroporation therapy, Fig. 1) as recited above, wherein
the support tube (Olson, shaft 44, Fig. 1) comprises an elongated biocompatible flexible tube (Olson, "Shaft 44 is an elongated, tubular, flexible member configured for movement within the body." - Para [0059]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. (US Pub No. 20240164834 A1) in view of Thakkar et al. (US Pub No. 20260034361 A1), Yamada et al. (JP 7565048 B2) Asirvatham et al. (US Pub No. 20130012938 A1), Scherman (FR 2893256 A1), and in further view of Stewart et al. (US Pub No. 20190030328 A1).
Regarding claim 12, Olson in view of Thakkar, Yamada, Asirvatham, Scherman, and Stewart disclose the system (Olson, system 10 for electroporation therapy, Fig. 1) as recited above, wherein
Olson in view of Thakkar, Yamada, and Asirvatham does not expressly disclose periodically changing the connection of at least one of the first set of electrodes, the second set of electrodes, and combinations thereof to the two poles of the electrical pulse generator comprises periodically substituting connection of at least one electrode of the at least two electrodes by a different electrode of at least one of the first set of electrodes and the second set of electrodes, substituting connection of the at least one electrode of the at least two electrodes by the different electrode of at least one of the first set of electrodes and the second set of electrodes comprises: disconnecting the at least one electrode of the at least two electrodes from a first pole of the electrical pulse generator; and electrically connecting the different electrode of at least one of the first set of electrodes and the second set of electrodes to the first pole of the electrical pulse generator.
Scherman teaches periodically changing the connection of at least one of the first set of electrodes, the second set of electrodes, and combinations thereof to the two poles of the electrical pulse generator ("…the generator may deliver each pulse alternately to each pair of electrodes—pairs 101, 11 and 100,11 –wherein each pair is linked to its terminals." – Para [0301]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Olson to include periodically changing the connection of at least one of the first set of electrodes, the second set of electrodes, and combinations thereof to the two poles of the electrical pulse generator as taught by Scherman for generating series of square unipolar pulses (Scherman, Abstract).
Scherman does not expressly disclose periodically substituting connection of at least one electrode of the at least two electrodes by a different electrode of at least one of the first set of electrodes and the second set of electrodes, substituting connection of the at least one electrode of the at least two electrodes by the different electrode of at least one of the first set of electrodes and the second set of electrodes comprises: electrically disconnecting the at least one electrode of the at least two electrodes from a first pole of the electrical pulse generator; and electrically connecting the different electrode of at least one of the first set of electrodes and the second set of electrodes to the first pole of the electrical pulse generator.
Stewart teaches periodically substituting connection of at least one electrode of the at least two electrodes by a different electrode of at least one of the first set of electrodes and the second set of electrodes, substituting connection of the at least one electrode of the at least two electrodes by the different electrode of at least one of the first set of electrodes and the second set of electrodes comprises: electrically disconnecting the at least one electrode of the at least two electrodes from a first pole of the electrical pulse generator ("… selectively deactivating one or more electrodes 18 (such as disconnecting those electrodes 18 from both the positive and negative polarities of the generator 14) " - Para [0075]); and electrically connecting the different electrode of at least one of the first set of electrodes and the second set of electrodes to the first pole of the electrical pulse generator ("...and/or activating one or more electrodes 18 (such as by connecting each of those electrodes to either the positive or negative polarity of the generator 14) …" - Para [0075]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Olson to include periodically substituting connection of at least one electrode of the at least two electrodes by a different electrode of at least one of the first set of electrodes and the second set of electrodes, substituting connection of the at least one electrode of the at least two electrodes by the different electrode of at least one of the first set of electrodes and the second set of electrodes comprises: electrically disconnecting the at least one electrode of the at least two electrodes from a first pole of the electrical pulse generator; and electrically connecting the different electrode of at least one of the first set of electrodes and the second set of electrodes to the first pole of the electrical pulse generator as taught by Stewart to selectively connect each of the plurality of electrodes (Stewart, Para [0010]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. (US Pub No. 20240164834 A1) in view of Thakkar et al. (US Pub No. 20260034361 A1), Yamada et al. (JP 7565048 B2) Asirvatham et al. (US Pub No. 20130012938 A1), Scherman (FR 2893256 A1), and in further view of Betelia et al. (US Pub No. 20250176987 A1).
Regarding claim 16, Olson in view of Thakkar, Yamada, Asirvatham, Scherman, and Betelia disclose the system (Olson, system 10 for electroporation therapy, Fig. 1) as recited above, wherein
Olson in view of Thakkar, Yamada, Asirvatham, and Scherman does not expressly disclose that the support tube comprises a tube with a diameter in a range of 0.5 cm to 3 cm.
Betelia teaches that the support tube comprises a tube (rotatable tube 1032, Fig. 10B) with a diameter in a range of 0.5 cm to 3 cm ("…the outer diameter of the rotatable tube 1032 is at least … 0.20 inches." - Para [0157]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Olson to include that the support tube comprises a tube with a diameter in a range of 0.5 cm to 3 cm as taught by Betelia to delivery high voltage pulses (Betelia, Para [0042]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. (US Pub No. 20240164834 A1) in view of Thakkar et al. (US Pub No. 20260034361 A1), Yamada et al. (JP 7565048 B2) Asirvatham et al. (US Pub No. 20130012938 A1), Scherman (FR 2893256 A1), and in further view of Wang et al. (US Patent No. 12070246 B1).
Regarding claim 17, Olson in view of Thakkar, Yamada, Asirvatham, Scherman, and Wang disclose the system (Olson, system 10 for electroporation therapy, Fig. 1) as recited above, wherein
Olson in view of Thakkar, Yamada, Asirvatham, and Scherman does not expressly disclose that each opening of the plurality of openings comprises a hole on the support tube with a diameter in a range of 0.1 cm to 0.5 cm, each two adjacent openings arranged within a distance in a range of 0.5 cm to 1.5 cm from each other.
Wang teaches that each opening of the plurality of openings (holes 200, Fig. 3) comprises a hole on the support tube (connection part 20, Fig. 3) with a diameter in a range of 0.1 cm to 0.5 cm ("… a single connection hole 200 or groove has a diameter of .01-25mm …" - Col. 11 Line 15), each two adjacent openings arranged within a distance in a range of 0.5 cm to 1.5 cm from each other ("… the distance between the adjacent connection holes or grooves is .01-25mm …" - Col. 11 Line 19).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tubular probe of Olson to include that each opening of the plurality of openings comprises a hole on the support tube with a diameter in a range of 0.1 cm to 0.5 cm, each two adjacent openings arranged within a distance in a range of 0.5 cm to 1.5 cm from each other as taught by Wang to convey electrical charges (Wang, Col. 1 Line 37).
Examiner interprets .01 - 25mm to be equivalent to .01-2.5cm.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. (US Pub No. 20240164834 A1) in view of Thakkar et al. (US Pub No. 20260034361 A1), Yamada et al. (JP 7565048 B2) Asirvatham et al. (US Pub No. 20130012938 A1), Scherman (FR 2893256 A1), and in further view of Weissberg et al. (WO 2014133870 A1).
Regarding claim 18, Olson in view of Thakkar, Yamada, Asirvatham, Scherman, and Weissberg disclose the system (Olson, system 10 for electroporation therapy, Fig. 1) as recited above, wherein
each electrode of the first set of electrodes comprises an electrically conductive biocompatible ring (Olson, ring electrodes 206, Fig. 2)
Olson in view of Thakkar, Yamada, Asirvatham, and Scherman does not expressly disclose an electrically conductive biocompatible ring with an internal diameter in a range of 0.5 cm to 3 cm and an external diameter in a range of 0.7 cm to 3.5 cm.
Weissberg teaches an electrically conductive biocompatible ring with an internal diameter in a range of 0.5 cm to 3 cm (“the inner diameter of the ground electrode was about 8mm.” – Para [0084]) and an external diameter in a range of 0.7 cm to 3.5 cm (“… and its outer diameter was about 8.6mm.” – Para [0084]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tubular probe of Olson to include an electrically conductive biocompatible ring with an internal diameter in a range of 0.5 cm to 3 cm and an external diameter in a range of 0.7 cm to 3.5 cm as taught by Weissberg for electrical pulse delivery (Weissberg, Para [0044]).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. (US Pub No. 20240164834 A1) in view of Thakkar et al. (US Pub No. 20260034361 A1), Yamada et al. (JP 7565048 B2) Asirvatham et al. (US Pub No. 20130012938 A1), Scherman (US 20070242743 A1) and in further view of Kessman et al. (US Pub No. 20250387068 A1).
Regarding claim 19, Olson in view of Thakkar, Yamada, Asirvatham, Scherman, and Kessman disclose the system (Olson, system 10 for electroporation therapy, Fig. 1) as recited above, wherein
Olson in view of Thakkar, Asirvatham, and Scherman does not expressly disclose that each U-shaped wire of the at least two U-shaped wires comprises a biocompatible electrically conductive wire with a diameter in a range of about 0.5 mm to about 3 mm.
Yamada teaches each U-shaped wire of the least two U-shaped wires (bent portion Y1a, Figs. 5, 6, and 22).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tubular probe of Olson to include each U-shaped wire of the least two U-shaped wires as taught by Yamada so the through hole communicates with the corresponding wire lumen (Yamada, Para [0061]).
Yamada does not expressly disclose that each U-shaped wire of the at least two U-shaped wires comprises a biocompatible electrically conductive wire with a diameter in a range of about 0.5 mm to about 3 mm.
Kessman teaches that each U-shaped wire of the at least two U-shaped wires comprises a biocompatible electrically conductive wire with a diameter in a range of about 0.5 mm to about 3 mm (… the conductive wire has a nominal diameter of at least about .2millimeters and no more than 1mm." - Para [0040]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tubular probe of Olson to include that each U-shaped wire of the at least two U-shaped wires comprises a biocompatible electrically conductive wire with a diameter in a range of about 0.5 mm to about 3 mm as taught by Kessman to deliver treatment (Kessman, Para [0003]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights