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 December 10, 2025 has been entered. Claims 1-4, 6-17, 19-25, and 27-32 remain pending in the application. Claims 5, 18, and 26 were previously canceled. Applicant’s amendments to the abstract have overcome the objections previously set forth in the Non-Final Office Action mailed September 17, 2025.
Claim Objections
Claim 1 is objected to because of the following informalities: there appears to be a typo regarding “and longitudinal axis therebetween” as opposed to “and a longitudinal axis therebetween” in line 4. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: there appears to be typos regarding “the distal end of the sheath comprises a needle” in line 3 as opposed to “the distal end of the first sheath comprises a needle” and “the longitudinal axis of the sheath” in line 14 as opposed to “the longitudinal axis of the first sheath”. Appropriate correction is required.
Claim 22 is further objected to because of the following informalities: there appears to be a typo regarding “and longitudinal axis therebetween” as opposed to “and a longitudinal axis therebetween” in line 4. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4, 6-17, 19-25, and 27-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the limitation “a spiral comprising at least two revolutions about the longitudinal axis” in line 14 renders the claim indefinite. It is unclear if “the longitudinal axis” is the longitudinal axis of the first sheath or of the second sheath. For examination purposes, “the longitudinal axis” has been interpreted as the longitudinal axis of the first sheath such that the limitation is “a spiral comprising at least two revolutions about the longitudinal axis of the first sheath”.
Regarding claim 3, the limitation “perpendicular to the longitudinal axis” in line 2 renders the claim indefinite. It is unclear if “the longitudinal axis” is the longitudinal axis of the first sheath or of the second sheath. For examination purposes, “the longitudinal axis” has been interpreted as the longitudinal axis of the first sheath such that the limitation is “perpendicular to the longitudinal axis of the first sheath”.
Regarding claim 4, the limitation “perpendicular to the longitudinal axis” in line 2 renders the claim indefinite. It is unclear if “the longitudinal axis” is the longitudinal axis of the first sheath or of the second sheath. For examination purposes, “the longitudinal axis” has been interpreted as the longitudinal axis of the first sheath such that the limitation is “perpendicular to the longitudinal axis of the first sheath”.
Regarding claim 22, the limitations “perpendicular to the longitudinal axis” in line 15 and a spiral comprising at least two revolutions about the longitudinal axis” in line 16 render the claim indefinite. It is unclear if “the longitudinal axis” is the longitudinal axis of the first sheath or of the second sheath. For examination purposes, “the longitudinal axis” has been interpreted as the longitudinal axis of the first sheath such that the limitations are “perpendicular to the longitudinal axis of the first sheath” and “a spiral comprising at least two revolutions about the longitudinal axis of the first sheath”
Regarding claim 31, the limitation “about the longitudinal axis” in line 2 renders the claim indefinite. It is unclear if “the longitudinal axis” is the longitudinal axis of the first sheath or of the second sheath. For examination purposes, “the longitudinal axis” has been interpreted as the longitudinal axis of the first sheath such that the limitation is “about the longitudinal axis of the first sheath”.
Regarding claim 32, the limitation “about the longitudinal axis” in line 2 renders the claim indefinite. It is unclear if “the longitudinal axis” is the longitudinal axis of the first sheath or of the second sheath. For examination purposes, “the longitudinal axis” has been interpreted as the longitudinal axis of the first sheath such that the limitation is “about the longitudinal axis of the first sheath”.
Claims 2, 6-21, 23-25, and 27-30 are rejected for being dependent upon one of claims 1 and 22.
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.
Claims 1-4, 6-7, 10-11, 14-17, 19-25, and 27-32 are rejected under 35 U.S.C. 103 as being unpatentable over Behar-Cohen (US 2014/0316372) in view of Yamamoto et al. (US 2007/0202186) in further view of Laske et al. (US 20140052118).
Regarding claim 1, Behar-Cohen discloses a device (electrode device 10; Figures 1 and 6-7) comprising:
(a) a first sheath (support 25) having a proximal end (connected to handling part 14), a distal end (axial opening 72; Figure 6), and a longitudinal axis (axis Y-Y) therebetween (Figure 1);
(b) a second sheath (sheath 66) having a proximal end, a distal end, and longitudinal axis therebetween (“The cable 60 may comprise, or even be formed by the wires 20…it preferably comprises a sheath 66 maintaining the wires together, like an electrical multistrand cable.” [0096]; Figure 5 showing example of cable 60 having sheath 66) and
(c) an elongate conductor (one of wires 20) having a proximal portion (proximal end 54) within the first sheath (Figure 6) and a distal portion (plug 52, for example), wherein the elongate conductor comprises a preformed shape memory material (“the wires 20 are elastic, in particular may have a shape memory” [0081]) and is retractable within the first sheath from a proximal position (Figure 6) to a distal position (Figure 7), wherein:
(i) in the proximal position, the distal portion of the elongate conductor is substantially straight (Figure 6); and
(ii) in the distal position, the distal portion of the elongate conductor extends beyond the distal end of the first sheath (Figure 7), and the shape memory material of the distal portion of the elongate conductor is relaxed radially to form a substantially planar electrode (surface X, formed by wires 20 in Figure 7) at an angle to the longitudinal axis of the first sheath (Figures 4A and 7, wherein the wires 20 extend from the axial opening 72 only along a single plane),
wherein the elongate conductor passes through the distal end of the sheath when moving between the proximal position and the distal position (Figures 6-7),
wherein the second sheath (sheath 66) is connected to the elongate conductor (“The cable 60 may comprise, or even be formed by the wires 20…it preferably comprises a sheath 66 maintaining the wires together, like an electrical multistrand cable.” [0096]), wherein the second sheath is surrounded by at least a portion of the first sheath (Figure 5 showing example of cable 60 having sheath 66 surrounded by support 25).
Behar-Cohen fails to explicitly teach wherein the distal end of the first sheath comprises a needle; wherein in the distal position, the elongate conductor is relaxed radially to form a substantially planar electrode at a substantially right angle to the longitudinal axis of the first sheath; wherein the substantially planar electrode is a spiral comprising at least two revolutions about the longitudinal axis, and (iii) wherein the elongate conductor passes through the needle when moving between the proximal position and the distal position.
Yamamoto teaches an ocular device (Figure 6) comprising: a sheath (access cannula 17), wherein a distal end of the sheath comprises a needle (“The access cannula 17 comprises a beveled sharp distal tip for tissue access.” [0050]); and an elongate conductor (microendoscope 18) retractable within the sheath, wherein the elongate conductor passes through the needle when moving between the proximal position and the distal position (“The endoscope is sized to fit slidably in an access cannula 17” [0050]; Figure 2 showing the microendoscope moved through the needle to its distal position).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the first sheath of the device of Behar-Cohen to include that the distal end of the first sheath comprises a needle based on the teachings of Yamamoto to provide minimally invasive access to deliver an instrument to the suprachoroidal space using only a single device rather than requiring multiple devices and steps (Yamamoto Figure 6, [0050], [0074]).
Modified Behar-Cohen fails to explicitly teach wherein in the distal position, the elongate conductor is relaxed radially to form a substantially planar electrode at a substantially right angle to the longitudinal axis of the first sheath; wherein the substantially planar electrode is a spiral comprising at least two revolutions about the longitudinal axis.
Laske teaches a device (medical device 12 having distal portion 20; Figures 1 and 7) comprising: a sheath (elongate body 18); and an elongate conductor (distal portion 20 having electrodes 24; Figure 7), wherein the elongate conductor comprises a preformed shape memory material (“the distal portion 20 may be composed of a resilient and deformable material, and may assume a first position for allowing passage through the vasculature to the region of interest and a second extended position for mapping and/or treatment.” [0035]), wherein: (i) in a proximal position, the distal portion of the elongate conductor is substantially straight (“The distal portion 20 may be affixed to a shaft 58 that is slidably movable within the elongate body 18 of the device 12…the distal portion 20 may be composed of a resilient and deformable material, and may assume a first position for allowing passage through the vasculature to the region of interest” [0035]); and (ii) in a distal position (Figure 7), the distal portion of the elongate conductor extends beyond the distal end of the sheath (Figure 7), and the shape memory material of the distal portion of the elongate conductor is relaxed radially to form a substantially planar electrode (concentric spiral 54 of distal portion 20; Figure 7) at a substantially right angle to the longitudinal axis of the sheath (“The distal portion 20 may have a coil or concentric spiral configuration 54 with a plurality of turns. The coil or concentric spiral 54 may lie in a plane that is substantially orthogonal to the longitudinal axis 28 of the device 12.” [0035]); wherein the substantially planar electrode is a spiral (concentric spiral 54) comprising at least two revolutions about the longitudinal axis (Figure 7 showing at least two revolutions).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Behar-Cohen to include that in the distal position, the elongate conductor is relaxed radially to form a substantially planar electrode that is a spiral comprising at least two revolutions about the longitudinal axis at a substantially right angle to the longitudinal axis of the first sheath based on the teachings of Laske to enhance surface area and tissue contact of the elongate conductor (Laske [0035]).
Regarding claim 2, modified Behar-Cohen teaches the device of claim 1, wherein the elongate conductor has a diameter of about 100 µm to about 200 µm (“The diameter of any wire 20 is preferably more than 0.01 mm and less than 0.3 mm, preferably less than 0.1 mm.” [0080], equivalent to 10-300 µm).
Regarding claim 3, modified Behar-Cohen teaches the device of claim 1, wherein the substantially planar electrode is 2 to 15 mm in one or more dimensions perpendicular to the longitudinal axis (“The length of the outside parts 64 is preferably more than 1 mm, more than 3 mm, more than 4 mm and/or less than 15 mm, less than 12 mm, less than 10 mm, less than 8 mm, or less than 6 mm.” [0086]; Figure 7, see labeled in Figure 5).
Regarding claim 4, modified Behar-Cohen teaches the device of claim 3, wherein the substantially planar electrode is 2 to 15 mm in both dimensions perpendicular to the longitudinal axis (“The length of the outside parts 64 is preferably more than 1 mm, more than 3 mm, more than 4 mm and/or less than 15 mm, less than 12 mm, less than 10 mm, less than 8 mm, or less than 6 mm.” [0086]; Figure 7, see labeled in Figure 5).
Regarding claim 6, modified Behar-Cohen teaches the device of claim 1, further comprising a handle (handling portion 14) having a proximal end and a distal end, wherein the first sheath is connected to the handle (Figure 1).
Regarding claim 7, modified Behar-Cohen teaches the device of claim 6, wherein the proximal end of the first sheath is connected to the handle (Figure 1).
Regarding claim 10, modified Behar-Cohen teaches the device of claim 1, further comprising an actuator (control handle 16 and cable 60), wherein the proximal end of the first sheath and/or the elongate conductor is connected to the actuator (“the support 25 may be tubular and the cable 60, attached to the proximal ends 54 of the wires, may exit from the proximal part of the support, so that an operator may push or pull the cable in the service position (see FIG. 15).” [0094]), and the actuator is configured to slide the elongate conductor between the proximal position and the distal position (“the cable 60 may slide inside the lumen of the tubular support 25, axially, so as to push or pull the set of wires, and move said wires from the deployed position to the retracted position.” [0094]; Figure 15).
Regarding claim 11, modified Behar-Cohen teaches the device of claim 10, wherein the actuator is a slider (cable 60), and wherein the slider has a proximal end (right end of cable 60; Figure 15) and a distal end attached to the elongate conductor (“the cable 60, attached to the proximal ends 54 of the wires” [0094]), wherein the slider is configured to retract the elongate conductor from the distal position to the proximal position along the longitudinal axis of the first sheath (“the cable 60, attached to the proximal ends 54 of the wires, may exit from the proximal part of the support, so that an operator may push or pull the cable in the service position (see FIG. 15). In this embodiment, the cable 60 may slide inside the lumen of the tubular support 25, axially, so as to push or pull the set of wires, and move said wires from the deployed position to the retracted position.” [0094]).
Regarding claim 14, modified Behar-Cohen teaches the device of claim 1, wherein the substantially planar electrode is convex (“The "convex surface" defined by the outside parts of the wires is the surface of the convex envelope of these outside parts…A convex surface X is represented, for instance, in FIGS. 7 and 9.” [0043]).
Regarding claim 15, modified Behar-Cohen teaches the device of claim 1, wherein the elongate conductor is a wire (wire 20) having a proximal portion (at proximal end 54) within the first sheath and a distal portion (at plug 52, for example), wherein the substantially planar electrode comprises the distal portion of the wire (Figure 7).
Regarding claim 16, modified Behar-Cohen teaches the device of claim 15, wherein the distal portion of the wire (wire 20) comprises a preformed angle (angle between proximal end 54 and plug 52) on a longitudinal plane (Figure 7, see labeled in Figure 5), wherein the preformed angle is between the substantially planar electrode and the proximal portion of the wire (Figure 7, see labeled in Figure 5).
Regarding claim 17, modified Behar-Cohen teaches the device of claim 16, wherein the substantially planar electrode extends no further than 1 mm distal or proximal to the preformed angle (“The diameter of any wire 20 is preferably more than 0.01 mm and less than 0.3 mm, preferably less than 0.1 mm.” [0080]; The length of the outside parts 64 is preferably more than 1 mm, more than 3 mm, more than 4 mm and/or less than 15 mm, less than 12 mm, less than 10 mm, less than 8 mm, or less than 6 mm. [0086]; Figure 7, wherein the diameter of the wire corresponds to how distal or proximal the planar electrode would extend from the preformed angle, and the diameter is 0.1-0.3 mm).
Regarding claim 19, modified Behar-Cohen teaches the device of claim 1, wherein the device comprises nothing distal to the substantially planar electrode (Figure 7).
Regarding claim 20, modified Behar-Cohen teaches the device of claim 1, wherein the device is monopolar (“all the wires 20 which are electrically connected to the electrical generator 26 have the same polarity.” [0118]; “Electric pulses may be unipolar or bipolar wave pulses. They may be selected for example from…oscillating unipolar wave pulses of limited duration.” [0194]).
Regarding claim 21, modified Behar-Cohen teaches the device of claim 1, wherein the proximal portion of the elongate conductor is connected to a voltage source and/or a waveform controller (electrical generator 26; “an electrical conductor intended to enable the establishment of an electrical connection of the wires 20 with an electrical generator 26.” [0059]; Figure 1).
Regarding claim 22, Behar-Cohen discloses a device (electrode device 10; Figures 1 and 6-7) comprising:
(a) a first sheath (support 25) having a proximal end (connected to handling part 14), a distal end (axial opening 72; Figure 6), and a longitudinal axis (axis Y-Y) therebetween (Figure 1);
(b) a second sheath (sheath 66) having a proximal end, a distal end, and longitudinal axis therebetween (“The cable 60 may comprise, or even be formed by the wires 20…it preferably comprises a sheath 66 maintaining the wires together, like an electrical multistrand cable.” [0096]; Figure 5 showing example of cable 60 having sheath 66); and
(c) an elongate conductor (one of wires 20) having a proximal portion (proximal end 54) within the first sheath (Figure 6) and a distal portion (plug 52, for example), wherein the elongate conductor has a diameter of about 100 µm to about 200 µm (“The diameter of any wire 20 is preferably more than 0.01 mm and less than 0.3 mm, preferably less than 0.1 mm.” [0080], equivalent to 10-300 µm) and comprises a preformed shape memory material (“the wires 20 are elastic, in particular may have a shape memory” [0081]) and is retractable within the first sheath from a proximal position (Figure 6) to a distal position (Figure 7), wherein:
(i) in the proximal position, the distal portion of the elongate conductor is substantially straight (Figure 6); and
(ii) in the distal position, the distal portion of the elongate conductor extends beyond the distal end of the first sheath (Figure 7), and the shape memory material of the distal portion of the elongate conductor is relaxed radially to form a substantially planar electrode (surface X, formed by wires 20 in Figure 7) at an angle to the longitudinal axis of the sheath (Figures 4A and 7, wherein the wires 20 extend from the axial opening 72 only along a single plane), wherein the substantially planar electrode is 2 to 15 mm in both dimensions perpendicular to the longitudinal axis (“The length of the outside parts 64 is preferably more than 1 mm, more than 3 mm, more than 4 mm and/or less than 15 mm, less than 12 mm, less than 10 mm, less than 8 mm, or less than 6 mm.” [0086]; Figure 7, see labeled in Figure 5),
wherein the elongate conductor passes through the distal end of the sheath when moving between the proximal position and the distal position (Figures 6-7),
wherein the second sheath (sheath 66) is connected to the elongate conductor (“The cable 60 may comprise, or even be formed by the wires 20…it preferably comprises a sheath 66 maintaining the wires together, like an electrical multistrand cable.” [0096]), wherein the second sheath is surrounded by at least a portion of the first sheath (Figure 5 showing example of cable 60 having sheath 66 surrounded by support 25).
Behar-Cohen fails to explicitly teach wherein the distal end of the sheath comprises a needle; and wherein in the distal position, the elongate conductor is relaxed radially to form a substantially planar electrode at a substantially right angle to the longitudinal axis of the sheath; wherein the substantially planar electrode is a spiral comprising at least two revolutions about the longitudinal axis; and wherein the elongate conductor passes through the needle when moving between the proximal position and the distal position.
Yamamoto teaches an ocular device (Figure 6) comprising: a sheath (access cannula 17), wherein a distal end of the sheath comprises a needle (“The access cannula 17 comprises a beveled sharp distal tip for tissue access.” [0050]); and an elongate conductor (microendoscope 18) retractable within the sheath, wherein the elongate conductor passes through the needle when moving between the proximal position and the distal position (“The endoscope is sized to fit slidably in an access cannula 17” [0050]; Figure 2 showing the microendoscope moved through the needle to its distal position).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the first sheath of the device of Behar-Cohen to include that the distal end of the first sheath comprises a needle based on the teachings of Yamamoto to provide minimally invasive access to deliver an instrument to the suprachoroidal space using only a single device (Yamamoto Figure 6, [0050], [0074]).
Modified Behar-Cohen fails to explicitly teach wherein in the distal position, the elongate conductor is relaxed radially to form a substantially planar electrode at a substantially right angle to the longitudinal axis of the sheath; wherein the substantially planar electrode is a spiral comprising at least two revolutions about the longitudinal axis.
Laske teaches a device (medical device 12 having distal portion 20; Figures 1 and 7) comprising: a sheath (elongate body 18); and an elongate conductor (distal portion 20 having electrodes 24; Figure 7), wherein the elongate conductor comprises a preformed shape memory material (“the distal portion 20 may be composed of a resilient and deformable material, and may assume a first position for allowing passage through the vasculature to the region of interest and a second extended position for mapping and/or treatment.” [0035]), wherein: (i) in a proximal position, the distal portion of the elongate conductor is substantially straight (“The distal portion 20 may be affixed to a shaft 58 that is slidably movable within the elongate body 18 of the device 12…the distal portion 20 may be composed of a resilient and deformable material, and may assume a first position for allowing passage through the vasculature to the region of interest” [0035]); and (ii) in a distal position (Figure 7), the distal portion of the elongate conductor extends beyond the distal end of the sheath (Figure 7), and the shape memory material of the distal portion of the elongate conductor is relaxed radially to form a substantially planar electrode (concentric spiral 54 of distal portion 20; Figure 7) at a substantially right angle to the longitudinal axis of the sheath ( “The distal portion 20 may have a coil or concentric spiral configuration 54 with a plurality of turns. The coil or concentric spiral 54 may lie in a plane that is substantially orthogonal to the longitudinal axis 28 of the device 12.” [0035]); wherein the substantially planar electrode is a spiral (concentric spiral 54) comprising at least two revolutions about the longitudinal axis (Figure 7 showing at least two revolutions).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Behar-Cohen to include that in the distal position, the elongate conductor is relaxed radially to form a substantially planar electrode that is a spiral comprising at least two revolutions about the longitudinal axis at a substantially right angle to the longitudinal axis of the sheath based on the teachings of Laske to enhance surface area and tissue contact of the elongate conductor (Laske [0035]).
Regarding claim 23, modified Behar-Cohen teaches the device of claim 22, wherein the elongate conductor is a wire (wire 20) having a proximal portion (at proximal end 54) within the first sheath (Figure 6) and a distal portion (at plug 52, for example), wherein the substantially planar electrode comprises the distal portion of the wire (Figure 7, see labeled in Figure 5).
Regarding claim 24, modified Behar-Cohen teaches the device of claim 23, wherein the distal portion of the wire (wire 20) comprises a preformed angle (angle between proximal end 54 and plug 52) on a longitudinal plane (Figure 7, see labeled in Figure 5), wherein the preformed angle is between the substantially planar electrode and the proximal portion of the wire.
Regarding claim 25, modified Behar-Cohen teaches the device of claim 24, wherein the substantially planar electrode extends no further than 1 mm distal or proximal to the preformed angle (“The diameter of any wire 20 is preferably more than 0.01 mm and less than 0.3 mm, preferably less than 0.1 mm.” [0080]; The length of the outside parts 64 is preferably more than 1 mm, more than 3 mm, more than 4 mm and/or less than 15 mm, less than 12 mm, less than 10 mm, less than 8 mm, or less than 6 mm. [0086]; Figure 7, wherein the diameter of the wire corresponds to how distal or proximal the planar electrode would extend from the preformed angle, and the diameter is 0.1-0.3 mm).
Regarding claim 27, modified Behar-Cohen teaches the device of claim 22, wherein the device comprises nothing distal to the substantially planar electrode (Figure 7).
Regarding claim 28, modified Behar-Cohen teaches the device of claim 22, wherein the device is monopolar (“all the wires 20 which are electrically connected to the electrical generator 26 have the same polarity.” [0118]; “Electric pulses may be unipolar or bipolar wave pulses. They may be selected for example from…oscillating unipolar wave pulses of limited duration.” [0194]).
Regarding claim 29, modified Behar-Cohen teaches the device of claim 22, wherein the proximal portion of the elongate conductor is connected to a voltage source and/or a waveform controller (electrical generator 26; “an electrical conductor intended to enable the establishment of an electrical connection of the wires 20 with an electrical generator 26.” [0059]; Figure 1).
Regarding claim 30, modified Behar-Cohen teaches the device of claim 22, further comprising an actuator (control handle 16 and cable 60), wherein the proximal end of the first sheath and/or the elongate conductor is connected to the actuator (“the support 25 may be tubular and the cable 60, attached to the proximal ends 54 of the wires, may exit from the proximal part of the support, so that an operator may push or pull the cable in the service position (see FIG. 15).” [0094]), and the actuator is configured to slide the elongate conductor between the proximal position and the distal position (“the cable 60 may slide inside the lumen of the tubular support 25, axially, so as to push or pull the set of wires, and move said wires from the deployed position to the retracted position.” [0094]; Figure 15).
Regarding claim 31, modified Behar-Cohen teaches the device of claim 1.
Modified Behar-Cohen fails to explicitly teach the spiral comprises from 2 to 5 revolutions about the longitudinal axis.
Laske teaches a device (medical device 12 having distal portion 20; Figures 1 and 7) comprising: a sheath (elongate body 18); and an elongate conductor (distal portion 20 having electrodes 24; Figure 7), wherein the elongate conductor is relaxed radially to form a substantially planar electrode (concentric spiral 54 of distal portion 20; Figure 7) that is a spiral (concentric spiral 54) comprising from 2 to 5 revolutions about the longitudinal axis (Figure 7 showing at least 2 revolutions).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the device of Behar-Cohen to include that in the distal position, the elongate conductor is relaxed radially to form a substantially planar electrode that is a spiral comprising from 2 to 5 revolutions about the longitudinal axis based on the teachings of Laske to enhance surface area and tissue contact of the elongate conductor (Laske [0035]).
Regarding claim 32, modified Behar-Cohen teaches the device of claim 22.
Modified Behar-Cohen fails to explicitly teach the spiral comprises from 2 to 5 revolutions about the longitudinal axis.
Laske teaches a device (medical device 12 having distal portion 20; Figures 1 and 7) comprising: a sheath (elongate body 18); and an elongate conductor (distal portion 20 having electrodes 24; Figure 7), wherein the elongate conductor is relaxed radially to form a substantially planar electrode (concentric spiral 54 of distal portion 20; Figure 7) that is a spiral (concentric spiral 54) comprising from 2 to 5 revolutions about the longitudinal axis (Figure 7 showing at least 2 revolutions).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the device of Behar-Cohen to include that in the distal position, the elongate conductor is relaxed radially to form a substantially planar electrode that is a spiral comprising from 2 to 5 revolutions about the longitudinal axis based on the teachings of Laske to enhance surface area and tissue contact of the elongate conductor (Laske [0035]).
Claims 8-9 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Behar-Cohen (US 2014/0316372) in view of Yamamoto et al. (US 2007/0202186) in further view of Laske et al. (US 20140052118) as applied to claims 6 and 11 above, and further in view of Gehl et al. (US 2009/0254019).
Regarding claims 8 and 9, modified Behar-Cohen teaches the device of claim 6.
Modified Behar-Cohen fails to explicitly teach wherein the distal end of the handle comprises a hollow region between an inner surface of the handle and the elongate conductor therewithin, and wherein the proximal end of the first sheath is disposed within the hollow region, as required by claim 8; and wherein the proximal end of the first sheath is disposed at least 1 mm within the hollow region as required by claim 9.
Gehl teaches a device (device 1) comprising a sheath (introducer shaft 10); and an elongate conductor (electrode 60); the device further comprising a handle (handle section 100) having a proximal end and a distal end (Figures 1 and 6), wherein the distal end of the handle comprises a hollow region between an inner surface of the handle and the elongate conductor therewithin (Figure 6; “the proximal part of the shaft 10, as well as the adaptor plate 90 and the deployment slider 102, all lie within the housing 101.” [0092]), and wherein the proximal end of the sheath (proximal end 12) is disposed within the hollow region; and wherein the proximal end of the sheath is disposed at least 1 mm within the hollow region (Figure 6 and 8; “The introducer shaft 10 comprises the following: An outer tube 15…the length of the tube is preferably between 50 mm and 500 mm depending on the particular application.” [0083-0084]; “Approximately 20 mm from the proximal 62 end of each electrode 60, a supporting sheath (not shown) 20 mm long may in be provided, the sheath surrounding a part of the intermediate zone 63 of the electrode 60.” [0086]; “Insertion is done so that the proximal ends 62 of the electrodes 60 protrude approximately 30 mm from the proximal ends of the guide sheaths 30” [0087]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the device of Behar-Cohen to include the distal end of the handle comprises a hollow region between an inner surface of the handle and the elongate conductor therewithin, and wherein the proximal end of the first sheath is disposed at least 1 mm within the hollow region based on the teachings of Gehl to securely connect the sheath to the handle in order to provide the user control over movement of the elongate conductor within the sheath (Gehl [0083-0096] and Figure 6).
Regarding claims 12 and 13, modified Behar-Cohen teaches the device of claim 11, wherein the slider (cable 60) comprises a proximal portion (right end of cable 60; Figure 15) and a distal portion (“the cable 60, attached to the proximal ends 54 of the wires” [0094]; Figure 15), wherein the slider is mounted to the first sheath (“the control handle 16 may be slidably mounted on the support 25 and be fixed onto the cable 60, for instance through a longitudinal slot of the support 25.” [0095]).
Modified Behar-Cohen fails to explicitly teach wherein (a) in the proximal position, the proximal end of the first sheath is disposed at or proximal to the distal end of the slider; and (b) in the distal position, the proximal end of the first sheath is disposed between the proximal end of the slider and the distal end of the slider, as required by claim 12; and wherein the slider is configured to stop upon sliding to the distal position and/or the proximal position, as required by claim 13.
Gehl teaches a device (device 1) comprising a sheath (introducer shaft 10 and handle section 100) having a proximal end (handle section 100) and a distal end (introducer shaft 10); and an elongate conductor (electrode 60) retractable within the sheath from a proximal position (“a first retracted position, as shown in FIG. 3” [0055]) to a distal position (“a second extended position, as shown in FIG. 4.” [0055]); the device further comprising an actuator that is a slider (deployment slider 102) comprising a proximal portion (proximal end of finger grip 108; Figure 1) and a distal portion (distal end of finger grip 108; Figure 1); wherein (a) in the proximal position (Figures 1 and 3), the proximal end of the sheath (handle section 100) is disposed at or proximal to the distal end of the slider (Figure 1); and (b) in the distal position (Figures 1 and 4), the proximal end of the sheath (handle section 100) is disposed between the proximal end of the slider and the distal end of the slider (Figure 1, wherein at least a portion of the handle section 100 is located between the proximal and distal ends of the slider 102); wherein the slider is configured to stop upon sliding to the distal position and/or the proximal position (Figure 1; “Deployment is done by moving the deployment slider 102 from its first retracted position towards its second advanced position until further movement is prevented by the end of the motion control slots 112.” [0096]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the actuator of the device of Behar-Cohen to include that in the proximal position, the proximal end of the first sheath is disposed at or proximal to the distal end of the slider; and in the distal position, the proximal end of the first sheath is disposed between the proximal end of the slider and the distal end of the slider, and wherein the slider is configured to stop upon sliding to the distal position and/or the proximal position based on the teachings of Gehl to provide a simple and smooth deployment and retraction of the elongate conductor from the sheath (Gehl [0096]).
Response to Arguments
Applicant’s arguments with respect to claims 1-4, 6-17, 19-25, and 27-32 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.
Regarding the argument that the prior art of record “do not disclose, suggest, or otherwise render obvious a fails to anticipate or render obvious a device as presently claimed by independent claims 1 and 22, including a device comprising "(b) a second sheath having a proximal end, a distal end, and longitudinal axis therebetween," "wherein the second sheath is connected to the elongate conductor, wherein the second sheath is surround by at least a portion of the first sheath."” (Remarks, page 8-9), the examiner respectfully disagrees. As detailed above, Behar-Cohen (US 2014/0316372) discloses a device (10) comprising: a first sheath (25); a second sheath (66) having a proximal end, a distal end, and longitudinal axis therebetween (“The cable 60 may comprise, or even be formed by the wires 20…it preferably comprises a sheath 66 maintaining the wires together, like an electrical multistrand cable.” [0096]; Figure 5 showing example of cable 60 having sheath 66) and an elongate conductor (one of wires 20), wherein the second sheath (66) is connected to the elongate conductor, wherein the second sheath is surrounded by at least a portion of the first sheath ([0096]; Figure 5 showing example of cable 60 having sheath 66 surrounded by support 25).
Regarding the argument that “Applicant further incorporates and reasserts its arguments in its Response dated March 26, 2025” (Remarks, page 8), the examiner maintains the response to these previous arguments as detailed in the Non-Final Rejection mailed 09/17/25 on pages 18-20.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783