DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Arguments
3. Applicant's arguments filed 12/19/2025 have been fully considered but they are not persuasive.
4. The applicant states that Koblish (U.S. 11,147,617) fails to teach the newly recited amendments in Claim 1. Specifically, they state that Koblish fails to teach “outputting the energy in the linear PFA mode comprises driving a plurality of electrodes proximal to a tip of the particular catheter in an alternative polarity pattern” and “outputting the energy in the focal PFA mode comprises driving the plurality of electrodes proximal to the tip at a common polarity”. While the examiner agrees to this statement, the examiner disagrees with the applicant’s reasoning.
4. The applicant reasons that Koblish creates different lesions by physically deploying different structures of the catheter or activating entirely different sets of electrodes, not by switching the polarity pattern of the “same plurality of electrodes” on a single catheter shaft. However, it is noted that the features upon which applicant relies (i.e. the plurality of electrodes on a single catheter shaft) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). More specifically, there is no language recited in the claims that requires “the plurality of electrodes” to be arranged on a single catheter shaft. Instead, Claim 1 recites “electrodes of the particular catheter”, referencing the catheter as a whole structure, as well as recites “a plurality of electrodes proximal to a tip of the particular catheter”.
5. While Koblish does teach different configurations of the catheter in order to achieve different patterns of ablation (see Figs. 1B, 1C, 5), Koblish also teaches “a plurality of electrodes proximal to a tip of the particular catheter”. All of the electrodes found on the device (Fig. 1C, ref nums 36a, 36b, 48) are considered to be the “plurality of electrodes” since they are all proximal to a tip of the device, no matter the configuration of the device. Since the most distal part of the device is when ref num 52 of elongated member, ref num 46, is fully deployed, then every electrode on the device is proximal to this distal end. Therefore, all of the electrodes read on the limitation “a plurality of electrodes proximal to a tip of the particular catheter”. This language is similarly recited in all independent claims of the present application.
6. However, Applicant’s arguments with respect to claim(s) 1-19 have been considered but are moot because the new ground of rejection does not rely on any reference or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The response to the arguments above is only an explanation of the interpretation of the claim language for clarity of the record in the present office action.
Claim Rejections - 35 USC § 103
7. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
8. Claims 1, 3, 5, 8, 10, 12, 15, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Koblish U.S. 11,147,617 (herein referred to as “Koblish”) and in view of Behzadian U.S. 2009/0125011 (herein referred to as “Behzadian”).
9. Regarding Claim 1, Koblish teaches a method for performing pulsed field ablation (PFA) (Fig. 1C; Col. 6, lines 49-51), the method comprising:
a. determining, by a controller connected to a particular catheter and at a first time, to perform PFA using a linear PFA mode (Fig. 5, ref num 124, 126; Col. 6, lines 21-26 and 33-35; Col. 14, lines 58-63);
b. responsive to determining to use the linear PFA mode, outputting, by the controller and to electrodes of the particular catheter, energy to cause the electrodes to generate a field with a geometry that is linear along an active portion of the particular catheter, wherein outputting the energy in the linear PFA mode comprises driving a plurality of electrodes proximal to a tip of the particular catheter (Col. 14, lines 58-63; Fig. 5, ref num 126; Fig. 6H, ref num 6H-6I, ref nums 210);
c. determining, by the controller and at a second time, to perform PFA using a focal PFA mode (Fig. 5, ref num 112, 114; Col. 6, lines 21-26 and 33-35; Col. 13, lines 47-53); and
d. responsive to determining to use the focal PFA mode, outputting, by the controller and to the electrodes of the particular catheter, energy to cause the electrodes to generate a field with a geometry that is focused at a tip of the particular catheter, wherein outputting the energy in the focal PFA mode comprises driving a plurality of electrodes proximal to a tip of the particular catheter (Col. 13, lines 47-53; Fig. 5, ref num 114; Fig. 6F, ref num 212).
Koblish fails to teach that in the linear PFA mode, the plurality of electrodes are driven in an alternating polarity pattern and in the focal PFA mode, the plurality of electrodes are driven at a common polarity.
Behzadian teaches a method for performing pulsed field ablation of analogous art (para 0055, 0063; Figs. 3A-3B) wherein the method comprises outputting energy to cause the electrodes to generate the field with geometry that is focused at the tip of a catheter (Fig. 3C; para 0066, “resulting in lesion generation 46 in targeted tissue 48 about electrode 22”), such that a tip electrode is driven at a first polarity (Fig. 3C, ref num 22 is driven at a first polarity; para 0066, “dissimilar polarity by electrode 22 being energized with return polarity”) and a middle electrode and proximal electrode are both driven at a second polarity, opposite to the first (Fig. 3C, ref nums 18 and 20 driven at second polarity; para 0066, “electrodes 16 and 20 are being energized with high voltage polarity”). This would satisfy the focal PFA mode. Behzadian also teaches that in another mode, i.e., linear PFA mode, that a plurality of electrodes proximal to the tip are driven in an alternating polarity pattern (see Fig. 3B, ref num 20 and 16 are in an alternating polarity pattern; para 0065, “dissimilar polarity by electrode 20 being energized with return polarity, - and electrodes 16 and 22 being energized with high voltage polarity, +. Item 18 are electrical insulation. Dissimilar surface areas allow the electric field and therefore electric current density to be higher 24 about electrode 20 having a return polarity and lower 44 about electrodes 16 and 22 having high voltage polarity, therefore producing a higher current density 24 and lower current density 44, thus ablation heat generation is greatest about electrode 20 resulting in lesion generation 46 in targeted solid tissue 48 about electrode 20 which has a - polarity and for a time period T. The electrodes may be spaced evenly or unevenly with respect to electrical insulation 18 found in between each electrode. It should be noted that lesion formation has altered from a + polarity electrode to a - polarity electrode, as shown in the figure”). By selectively controlling the plurality of electrodes, users are able to ablate a target area while avoiding ablation to untargeted tissue (para 0014). Therefore, it would have been obvious before the effective filing date of the claimed invention to have modified Koblish to selectively control the polarization of the electrodes in order to uniformly ablate the target region, avoiding damage to untargeted tissue.
10. Regarding Claim 3, Koblish teaches the method of claim 1, as well as outputting energy to cause the electrodes to generate the field with the geometry that is focused at the tip of the particular catheter (Col. 13, lines 47-53; Fig. 5, ref num 114; Fig. 6F, ref num 212) comprises:
i. driving a tip electrode positioned at a distal tip of the catheter and a tip ring electrode adjacent to the tip electrode (Fig. 1C, ref num 36b and 36a most distal on the shaft ref num 28);
ii. driving electrodes of a pair of ring electrodes (Fig. 1C, any pair of ref num 36b that is not the distal most ref num 36b); and,
iii. driving a coil electrode of the catheter (Fig. 1C, ref num 48 disposed on ref num 52 of ref num 46; Col. 13, lines 48-59; Col. 15, lines 49-56, “the distal section 52… is iteratively disposed…and the ablative loop structure of the inner ablation catheter 22 is iteratively activated (by operating the RF generator 14 in order to convey RF energy to the electrodes 48), thereby creating a series of circumferential lesions 212”).
Koblish fails to teach driving the tip electrode and tip ring electrode at a first polarity, driving the pair of ring electrodes at a second polarity, opposite to the first polarity, driving the coil electrode at the second polarity, and wherein the pair of ring electrodes is disposed longitudinally along an elongated structure of the particular catheter between the tip ring electrode and the coil electrode.
Behzadian teaches a method for performing pulsed field ablation of analogous art (para 0055, 0063; Figs. 3A-3B) wherein the method comprises outputting energy to cause the electrodes to generate the field with geometry that is focused at the tip of a catheter (Fig. 3C; para 0066, “resulting in lesion generation 46 in targeted tissue 48 about electrode 22”), such that a tip electrode is driven at a first polarity (Fig. 3C, ref num 22 is driven at a first polarity; para 0066, “dissimilar polarity by electrode 22 being energized with return polarity”) and a middle electrode and proximal electrode are both driven at a second polarity, opposite to the first (Fig. 3C, ref nums 18 and 20 driven at second polarity; para 0066, “electrodes 16 and 20 are being energized with high voltage polarity”). The middle electrode is also disposed longitudinally along an elongated structure of the catheter between a tip electrode and a proximal electrode (see Fig. 3C, ref num 20 is between 18 and 22). By selectively controlling the plurality of electrodes, users are able to ablate a target area while avoiding ablation to untargeted tissue (para 0014). Therefore, it would have been obvious before the effective filing date of the claimed invention to have modified Koblish to selectively control the polarization of the electrodes in order to uniformly ablate the target region, avoiding damage to untargeted tissue.
Koblish as modified by Behzadian fails to explicitly disclose a tip electrode and tip ring electrode at the first polarity, and a pair of ring electrodes and a coil electrode both driven at the second polarity. However, it has been held that an “obvious to try” rationale when choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is a support for a conclusion of obviousness which is consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham, if the following findings can be established: (1) a finding that at the time of the invention, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem; (2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem; (3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and (4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness. See MPEP § 2143(I)(E).
In the instant case, and as per (1), Behzadian discusses that an improved method of ablation in order to control the geometry of the ablation region is needed (Behzadian, para 0012-0014). As per (2), one of ordinary skill in the art would recognize that the electrodes may be energized to one of two polarities, or not be energized (i.e., neutral), at a singular time (see Behzadian, para 0024, 0039). As per (3), one of ordinary skill in the art would recognize that modifying Koblish based on the finite number of predictable solutions outlined herein can be done without changing the principles of operation of the prior art, and without changing the intended purpose of the prior art. As such, one of ordinary skill in the art would have a reasonable expectation of success when modifying the prior art (see Koblish, Col. 12, lines 45-52). As per (4), one may be motivated to modify the method in order to avoid unnecessary to surrounding tissue that is not targeted (Behzadian, para 0014). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Koblish and have modified them by having both the tip electrode and tip ring electrode be driven at a first polarity, as well as the pair of ring electrodes and the coil electrode be driven at a second, opposite polarity, as a matter of trying a finite number of predictable solutions, in order to control the geometry of the target ablation area and avoid damage to untargeted tissue.
11. Regarding Claim 5, Koblish teaches the method of claim 1, as well as outputting energy to cause the electrodes to generate the field with the geometry that is focused at the tip of the particular catheter (Col. 13, lines 47-53; Fig. 5, ref num 114; Fig. 6F, ref num 212) comprises:
i. driving a tip electrode positioned at a distal tip of the catheter and a tip ring electrode adjacent to the tip electrode (Fig. 1C, ref num 36b and 36a most distal on the shaft ref num 28);
ii. driving electrodes of a pair of ring electrodes (Fig. 1C, any pair of ref num 36b that is not the distal most ref num 36b);
iii. driving electrodes of a second pair of electrodes (Fig. 1C, any other pair of ref num 36b that has not been selected), wherein the first pair of ring electrodes is disposed longitudinally between the second pair of ring electrodes and the tip ring electrode (see Fig. 1C); and,
iv. driving electrodes of a third pair of electrodes (Fig. 1C, any other pair of ref num 36b that has not been selected), wherein the second pair of ring electrodes is disposed longitudinally between the first pair of ring electrodes and the third pair of ring electrodes (see Fig. 1C).
Koblish fails to teach driving the tip electrode and tip ring electrode at a first polarity, driving the first pair of ring electrodes at the first polarity, driving the second pair of ring electrodes at a second polarity, opposite to the first polarity, and driving the third pair of ring electrodes at the second polarity.
Behzadian teaches a method for performing pulsed field ablation of analogous art (para 0055, 0063; Figs. 3A-3B) wherein the method comprises outputting energy to cause the electrodes to generate the field with geometry that is focused at the tip of a catheter (Fig. 3C; para 0066, “resulting in lesion generation 46 in targeted tissue 48 about electrode 22”), such that a tip electrode is driven at a first polarity (Fig. 3C, ref num 22 is driven at a first polarity; para 0066, “dissimilar polarity by electrode 22 being energized with return polarity”) and a middle electrode and proximal electrode are both driven at a second polarity, opposite to the first (Fig. 3C, ref nums 18 and 20 driven at second polarity; para 0066, “electrodes 16 and 20 are being energized with high voltage polarity”). The middle electrode is also disposed longitudinally along an elongated structure of the catheter between a tip electrode and a proximal electrode (see Fig. 3C, ref num 20 is between 18 and 22). By selectively controlling the plurality of electrodes, users are able to ablate a target area while avoiding ablation to untargeted tissue (para 0014). Therefore, it would have been obvious before the effective filing date of the claimed invention to have modified Koblish to selectively control the polarization of the electrodes in order to uniformly ablate the target region, avoiding damage to untargeted tissue.
Koblish as modified by Behzadian fails to explicitly disclose a tip electrode and tip ring electrode, as well as a first pair of ring electrodes, driven at the first polarity, and a second and third pair of ring electrodes both driven at the second polarity. However, it has been held that an “obvious to try” rationale when choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is a support for a conclusion of obviousness which is consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham, if the following findings can be established: (1) a finding that at the time of the invention, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem; (2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem; (3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and (4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness. See MPEP § 2143(I)(E).
In the instant case, and as per (1), Behzadian discusses that an improved method of ablation in order to control the geometry of the ablation region is needed (Behzadian, para 0012-0014). As per (2), one of ordinary skill in the art would recognize that the electrodes may be energized to one of two polarities, or not be energized (i.e., neutral), at a singular time (see Behzadian, para 0024, 0039). As per (3), one of ordinary skill in the art would recognize that modifying Koblish based on the finite number of predictable solutions outlined herein can be done without changing the principles of operation of the prior art, and without changing the intended purpose of the prior art. As such, one of ordinary skill in the art would have a reasonable expectation of success when modifying the prior art (see Koblish, Col. 12, lines 45-52). As per (4), one may be motivated to modify the method in order to avoid unnecessary to surrounding tissue that is not targeted (Behzadian, para 0014). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Koblish and have modified them by having a tip electrode and tip ring electrode, as well as a first pair of ring electrodes, driven at the first polarity, and a second and third pair of ring electrodes both driven at the second polarity, as a matter of trying a finite number of predictable solutions, in order to control the geometry of the target ablation area and avoid damage to untargeted tissue.
12. Regarding Claims 8 and 15, Koblish teaches a system (Fig. 1C; Col. 6, lines 49-51), the system comprising:
a. a particular catheter (Fig. 1C, ref num 10); and
b. one or more processors of a controller (Figs. 1C, ref nums 12, 14, and 26) OR a computer-readable storage medium storing instruments that, when executed (Fig. 5, ref num 100), cause the controller to:
b.1 determine, at a first time, to perform pulsed field ablation (PFA) using a linear PFA mode (Fig. 5, ref num 124, 126; Col. 6, lines 21-26 and 33-35; Col. 14, lines 58-63);
b.2 output, responsive to determining to use the linear PFA mode, to electrodes of the particular catheter, energy to cause the electrodes to generate a field with a geometry that is linear along an active portion of the particular catheter, wherein, to output the energy in the linear PFA mode, the one or more processors are configured to cause a plurality of electrodes proximal to a tip of the particular catheter to be driven (Col. 14, lines 58-63; Fig. 5, ref num 126; Fig. 6H, ref num 6H-6I, ref nums 210);
b.3 determine, at a second time, to perform PFA using a focal PFA mode (Fig. 5, ref num 112, 114; Col. 6, lines 21-26 and 33-35; Col. 13, lines 47-53); and
b.4 output, responsive to determining to use the focal PFA mode, to the electrodes of the particular catheter, energy to cause the electrodes to generate a field with a geometry that is focused at a tip of the particular catheter, wherein, to output the energy in the linear PFA mode, the one or more processors are configured to cause a plurality of electrodes proximal to a tip of the particular catheter to be driven (Col. 13, lines 47-53; Fig. 5, ref num 114; Fig. 6F, ref num 212).
Koblish fails to teach that in the linear PFA mode, the plurality of electrodes are driven in an alternating polarity pattern and in the focal PFA mode, the plurality of electrodes are driven at a common polarity.
Behzadian teaches a method for performing pulsed field ablation of analogous art (para 0055, 0063; Figs. 3A-3B) wherein the method comprises outputting energy to cause the electrodes to generate the field with geometry that is focused at the tip of a catheter (Fig. 3C; para 0066, “resulting in lesion generation 46 in targeted tissue 48 about electrode 22”), such that a tip electrode is driven at a first polarity (Fig. 3C, ref num 22 is driven at a first polarity; para 0066, “dissimilar polarity by electrode 22 being energized with return polarity”) and a middle electrode and proximal electrode are both driven at a second polarity, opposite to the first (Fig. 3C, ref nums 18 and 20 driven at second polarity; para 0066, “electrodes 16 and 20 are being energized with high voltage polarity”). This would satisfy the focal PFA mode. Behzadian also teaches that in another mode, i.e., linear PFA mode, that a plurality of electrodes proximal to the tip are driven in an alternating polarity pattern (see Fig. 3B, ref num 20 and 16 are in an alternating polarity pattern; para 0065, “dissimilar polarity by electrode 20 being energized with return polarity, - and electrodes 16 and 22 being energized with high voltage polarity, +. Item 18 are electrical insulation. Dissimilar surface areas allow the electric field and therefore electric current density to be higher 24 about electrode 20 having a return polarity and lower 44 about electrodes 16 and 22 having high voltage polarity, therefore producing a higher current density 24 and lower current density 44, thus ablation heat generation is greatest about electrode 20 resulting in lesion generation 46 in targeted solid tissue 48 about electrode 20 which has a - polarity and for a time period T. The electrodes may be spaced evenly or unevenly with respect to electrical insulation 18 found in between each electrode. It should be noted that lesion formation has altered from a + polarity electrode to a - polarity electrode, as shown in the figure”). By selectively controlling the plurality of electrodes, users are able to ablate a target area while avoiding ablation to untargeted tissue (para 0014). Therefore, it would have been obvious before the effective filing date of the claimed invention to have modified Koblish to selectively control the polarization of the electrodes in order to uniformly ablate the target region, avoiding damage to untargeted tissue.
13. Regarding Claims 10 and 17, Koblish teaches wherein outputting energy to cause the electrodes to generate the field with the geometry that is focused at the tip of the particular catheter (Col. 13, lines 47-53; Fig. 5, ref num 114; Fig. 6F, ref num 212) comprises:
i. driving a tip electrode positioned at a distal tip of the catheter and a tip ring electrode adjacent to the tip electrode (Fig. 1C, ref num 36b and 36a most distal on the shaft ref num 28);
ii. driving electrodes of a pair of ring electrodes (Fig. 1C, any pair of ref num 36b that is not the distal most ref num 36b); and,
iii. driving a coil electrode of the catheter (Fig. 1C, ref num 48 disposed on ref num 52 of ref num 46; Col. 13, lines 48-59; Col. 15, lines 49-56, “the distal section 52… is iteratively disposed…and the ablative loop structure of the inner ablation catheter 22 is iteratively activated (by operating the RF generator 14 in order to convey RF energy to the electrodes 48), thereby creating a series of circumferential lesions 212”).
Koblish fails to teach driving the tip electrode and tip ring electrode at a first polarity, driving the pair of ring electrodes at a second polarity, opposite to the first polarity, driving the coil electrode at the second polarity, and wherein the pair of ring electrodes is disposed longitudinally along an elongated structure of the particular catheter between the tip ring electrode and the coil electrode.
Behzadian a system for performing pulsed field ablation of analogous art (para 0055, 0063; Figs. 3A-3B) wherein the system comprises outputting energy to cause the electrodes to generate the field with geometry that is focused at the tip of a catheter (Fig. 3C; para 0066, “resulting in lesion generation 46 in targeted tissue 48 about electrode 22”), such that a tip electrode is driven at a first polarity (Fig. 3C, ref num 22 is driven at a first polarity; para 0066, “dissimilar polarity by electrode 22 being energized with return polarity”) and a middle electrode and proximal electrode are both driven at a second polarity, opposite to the first (Fig. 3C, ref nums 18 and 20 driven at second polarity; para 0066, “electrodes 16 and 20 are being energized with high voltage polarity”). The middle electrode is also disposed longitudinally along an elongated structure of the catheter between a tip electrode and a proximal electrode (see Fig. 3C, ref num 20 is between 18 and 22). By selectively controlling the plurality of electrodes, users are able to ablate a target area while avoiding ablation to untargeted tissue (para 0014). Therefore, it would have been obvious before the effective filing date of the claimed invention to have modified Koblish to selectively control the polarization of the electrodes in order to uniformly ablate the target region, avoiding damage to untargeted tissue.
Koblish as modified by Behzadian fails to explicitly disclose a tip electrode and tip ring electrode at the first polarity, and a pair of ring electrodes and a coil electrode both driven at the second polarity. However, it has been held that an “obvious to try” rationale when choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is a support for a conclusion of obviousness which is consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham, if the following findings can be established: (1) a finding that at the time of the invention, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem; (2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem; (3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and (4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness. See MPEP § 2143(I)(E).
In the instant case, and as per (1), Behzadian discusses that an improved method of ablation in order to control the geometry of the ablation region is needed (Behzadian, para 0012-0014). As per (2), one of ordinary skill in the art would recognize that the electrodes may be energized to one of two polarities, or not be energized (i.e., neutral), at a singular time (see Behzadian, para 0024, 0039). As per (3), one of ordinary skill in the art would recognize that modifying Koblish based on the finite number of predictable solutions outlined herein can be done without changing the principles of operation of the prior art, and without changing the intended purpose of the prior art. As such, one of ordinary skill in the art would have a reasonable expectation of success when modifying the prior art (see Koblish, Col. 12, lines 45-52). As per (4), one may be motivated to modify the method in order to avoid unnecessary to surrounding tissue that is not targeted (Behzadian, para 0014). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Koblish and have modified them by having both the tip electrode and tip ring electrode be driven at a first polarity, as well as the pair of ring electrodes and the coil electrode be driven at a second, opposite polarity, as a matter of trying a finite number of predictable solutions, in order to control the geometry of the target ablation area and avoid damage to untargeted tissue.
14. Regarding Claims 12 and 19, Koblish teaches wherein outputting energy to cause the electrodes to generate the field with the geometry that is focused at the tip of the particular catheter (Col. 13, lines 47-53; Fig. 5, ref num 114; Fig. 6F, ref num 212) comprises:
i. driving a tip electrode positioned at a distal tip of the catheter and a tip ring electrode adjacent to the tip electrode (Fig. 1C, ref num 36b and 36a most distal on the shaft ref num 28);
ii. driving electrodes of a pair of ring electrodes (Fig. 1C, any pair of ref num 36b that is not the distal most ref num 36b);
iii. driving electrodes of a second pair of electrodes (Fig. 1C, any other pair of ref num 36b that has not been selected), wherein the first pair of ring electrodes is disposed longitudinally between the second pair of ring electrodes and the tip ring electrode (see Fig. 1C); and,
iv. driving electrodes of a third pair of electrodes (Fig. 1C, any other pair of ref num 36b that has not been selected), wherein the second pair of ring electrodes is disposed longitudinally between the first pair of ring electrodes and the third pair of ring electrodes (see Fig. 1C).
Koblish fails to teach driving the tip electrode and tip ring electrode at a first polarity, driving the first pair of ring electrodes at the first polarity, driving the second pair of ring electrodes at a second polarity, opposite to the first polarity, and driving the third pair of ring electrodes at the second polarity.
Behzadian teaches a system for performing pulsed field ablation of analogous art (para 0055, 0063; Figs. 3A-3B) wherein the system comprises outputting energy to cause the electrodes to generate the field with geometry that is focused at the tip of a catheter (Fig. 3C; para 0066, “resulting in lesion generation 46 in targeted tissue 48 about electrode 22”), such that a tip electrode is driven at a first polarity (Fig. 3C, ref num 22 is driven at a first polarity; para 0066, “dissimilar polarity by electrode 22 being energized with return polarity”) and a middle electrode and proximal electrode are both driven at a second polarity, opposite to the first (Fig. 3C, ref nums 18 and 20 driven at second polarity; para 0066, “electrodes 16 and 20 are being energized with high voltage polarity”). The middle electrode is also disposed longitudinally along an elongated structure of the catheter between a tip electrode and a proximal electrode (see Fig. 3C, ref num 20 is between 18 and 22). By selectively controlling the plurality of electrodes, users are able to ablate a target area while avoiding ablation to untargeted tissue (para 0014). Therefore, it would have been obvious before the effective filing date of the claimed invention to have modified Koblish to selectively control the polarization of the electrodes in order to uniformly ablate the target region, avoiding damage to untargeted tissue.
Koblish as modified by Behzadian fails to explicitly disclose a tip electrode and tip ring electrode, as well as a first pair of ring electrodes, driven at the first polarity, and a second and third pair of ring electrodes both driven at the second polarity. However, it has been held that an “obvious to try” rationale when choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is a support for a conclusion of obviousness which is consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham, if the following findings can be established: (1) a finding that at the time of the invention, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem; (2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem; (3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and (4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness. See MPEP § 2143(I)(E).
In the instant case, and as per (1), Behzadian discusses that an improved method of ablation in order to control the geometry of the ablation region is needed (Behzadian, para 0012-0014). As per (2), one of ordinary skill in the art would recognize that the electrodes may be energized to one of two polarities, or not be energized (i.e., neutral), at a singular time (see Behzadian, para 0024, 0039). As per (3), one of ordinary skill in the art would recognize that modifying Koblish based on the finite number of predictable solutions outlined herein can be done without changing the principles of operation of the prior art, and without changing the intended purpose of the prior art. As such, one of ordinary skill in the art would have a reasonable expectation of success when modifying the prior art (see Koblish, Col. 12, lines 45-52). As per (4), one may be motivated to modify the method in order to avoid unnecessary to surrounding tissue that is not targeted (Behzadian, para 0014). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Koblish and have modified them by having a tip electrode and tip ring electrode, as well as a first pair of ring electrodes, driven at the first polarity, and a second and third pair of ring electrodes both driven at the second polarity, as a matter of trying a finite number of predictable solutions, in order to control the geometry of the target ablation area and avoid damage to untargeted tissue.
15. Claims 2, 6, 7, 9, 13, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Koblish and Behzadian, and further in view of Howard U.S. 2018/0214202 (herein referred to as “Howard”) and Grasse U.S. 2013/0338467 (herein referred to as “Grasse”).
16. Regarding Claim 2, Koblish teaches the method of claim 1, as well as wherein outputting energy to cause the electrodes to generate the field with the geometry that is linear along the active portion of the particular catheter (Col. 14, lines 58-63; Fig. 5, ref num 126; Fig. 6H, ref num 6H-6I, ref nums 210) comprises:
i. driving a tip electrode positioned at a distal tip of the catheter and a tip ring electrode adjacent to the tip electrode (Fig. 1C, ref num 36b and 36a most distal on the shaft ref num 28; Col. 15, lines 4-11);
ii. driving electrodes of a pair of ring electrodes (Fig. 1C, any pair of ref num 36b that is not the distal most ref num 36b; Col. 15, lines 4-11); and
iii. not driving a coil electrode of the catheter (Fig. 1C, ref num 48 disposed on ref num 52 of ref num 46; Col. 14, lines 26-29).
Koblish fails to teach driving the tip electrode and tip ring electrode at a first polarity, driving the pair of ring electrodes at a second polarity, opposite to the first polarity, and wherein the pair of ring electrodes is disposed longitudinally along an elongated structure of the particular catheter between the tip ring electrode and the coil electrode.
Howard teaches a method of analogous art (para 0004, 0086; Fig. 1), wherein the method comprises outputting energy to cause electrodes to generate a field with geometry that is linear along an active portion of a catheter (Fig. 25; para 0116, “energy delivery configuration… current may flow from one side of the treatment element 32 to the opposite side of the treatment element 32, thereby creating an ablation pattern that is at least substantially linear”; para 0082, “measured signals may be transferred from the device electrode energy distribution system 16… may be included in or integrated with the generator 14…device electrode energy distribution system 16 may include high speed relays to disconnect/reconnected specific electrodes 38”). Outputting the energy comprises driving a set of electrodes at a first polarity (Fig. 25, ref num 38a; para 0116, “a first plurality of electrodes 38a that is connected to a first polarity of the generator 14, such as a positive polarity”), driving another set of electrodes at a second polarity that is opposite the first polarity (Fig. 25, ref num 38b; para 0116, “a second [plurality] of electrodes 38b is connected to a second polarity of the generator 14, such as a negative polarity”). This creates an ablation pattern that is linear (para 0117). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Koblish to have the tip electrode and tip ring electrode be driven at a first polarity and the pair of ring electrodes driven at a second, opposite polarity, as this produces the expected result of ablating tissue in a linear pattern.
Grasse teaches a method of analogous art (para 0036, 0045), comprising driving a tip electrode and a tip ring electrode (Fig. 1, ref num 36 and the distal most ref num 16; also see Fig. 4A), driving a set of ring electrodes along an elongated structure (Fig. 1, any combination of ref num 16 except the distal most ref num 16; also see Fig. 4A, ref nums 16’’’ disposed about 12’’’), and a coil electrode (Fig. 1, ref num 40; also see Fig. 4A), such that the pair of ring electrodes is disposed longitudinally along an elongated structure of the particular catheter between the tip ring electrode and the coil electrode (see Fig. 1, ref nums 16 are between the distal most ref num 16 and ref num 40; also see Fig. 4A). This arrangement of the various electrodes decreases the effect of voltage gradients when power is delivered, promoting uniformity over the catheter (para 0039). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the pair of ring electrodes disposed longitudinally along the elongated structure of the catheter between the tip ring electrode and the coil electrode, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
17. Regarding Claim 6, Koblish teaches the method of claim 1, but fails to teach the first polarity is positive and the second polarity is negative.
Howard teaches the first polarity is positive (para 0116, “a first plurality of electrodes 38a that is connected to a first polarity of the generator 14, such as a positive polarity”) and the second polarity is negative (para 0116, “a second [plurality] of electrodes 38b is connected to a second polarity of the generator 14, such as a negative polarity”). It is commonly known in the art that opposite polarities are that of positive and negative (para 0078), therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Koblish to have the first polarity be positive and the second polarity be negative.
18. Regarding Claim 7, Koblish teaches the method of claim 1, but fails to teach the first polarity is negative and the second polarity is positive.
Howard teaches that the first and second polarities are opposite to one another (para 0116), but fails to explicitly teach that the first polarity is negative and the second polarity is positive. However, Howard does discuss that the polarity configurations may be opposite to what is shown/described in the current disclosure (para 0098, “polarity delivered through particular groups of electrodes may be opposite of what is described), as this still produces the same expected result (para 0098). It is also held that it is commonly known in the art that opposite polarities are that of positive and negative (para 0078), therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Koblish to have the first polarity be negative and the second polarity be positive.
19. Regarding Claims 9 and 16, Koblish teaches wherein outputting energy to cause the electrodes to generate the field with the geometry that is linear along the active portion of the particular catheter (Col. 14, lines 58-63; Fig. 5, ref num 126; Fig. 6H, ref num 6H-6I, ref nums 210) comprises:
i. driving a tip electrode positioned at a distal tip of the catheter and a tip ring electrode adjacent to the tip electrode (Fig. 1C, ref num 36b and 36a most distal on the shaft ref num 28; Col. 15, lines 4-11);
ii. driving electrodes of a pair of ring electrodes (Fig. 1C, any pair of ref num 36b that is not the distal most ref num 36b; Col. 15, lines 4-11); and
iii. not driving a coil electrode of the catheter (Fig. 1C, ref num 48 disposed on ref num 52 of ref num 46; Col. 14, lines 26-29).
Koblish fails to teach driving the tip electrode and tip ring electrode at a first polarity, driving the pair of ring electrodes at a second polarity, opposite to the first polarity, and wherein the pair of ring electrodes is disposed longitudinally along an elongated structure of the particular catheter between the tip ring electrode and the coil electrode.
Howard teaches a system of analogous art (para 0004, 0086; Fig. 1), wherein the system comprises outputting energy to cause electrodes to generate a field with geometry that is linear along an active portion of a catheter (Fig. 25; para 0116, “energy delivery configuration… current may flow from one side of the treatment element 32 to the opposite side of the treatment element 32, thereby creating an ablation pattern that is at least substantially linear”; para 0082, “measured signals may be transferred from the device electrode energy distribution system 16… may be included in or integrated with the generator 14…device electrode energy distribution system 16 may include high speed relays to disconnect/reconnected specific electrodes 38”). Outputting the energy comprises driving a set of electrodes at a first polarity (Fig. 25, ref num 38a; para 0116, “a first plurality of electrodes 38a that is connected to a first polarity of the generator 14, such as a positive polarity”), driving another set of electrodes at a second polarity that is opposite the first polarity (Fig. 25, ref num 38b; para 0116, “a second [plurality] of electrodes 38b is connected to a second polarity of the generator 14, such as a negative polarity”). This creates an ablation pattern that is linear (para 0117). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Koblish to have the tip electrode and tip ring electrode be driven at a first polarity and the pair of ring electrodes driven at a second, opposite polarity, as this produces the expected result of ablating tissue in a linear pattern.
Grasse teaches a system of analogous art (para 0036, 0045), comprising driving a tip electrode and a tip ring electrode (Fig. 1, ref num 36 and the distal most ref num 16; also see Fig. 4A), driving a set of ring electrodes along an elongated structure (Fig. 1, any combination of ref num 16 except the distal most ref num 16; also see Fig. 4A, ref nums 16’’’ disposed about 12’’’), and a coil electrode (Fig. 1, ref num 40; also see Fig. 4A), such that the pair of ring electrodes is disposed longitudinally along an elongated structure of the particular catheter between the tip ring electrode and the coil electrode (see Fig. 1, ref nums 16 are between the distal most ref num 16 and ref num 40; also see Fig. 4A). This arrangement of the various electrodes decreases the effect of voltage gradients when power is delivered, promoting uniformity over the catheter (para 0039). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the pair of ring electrodes disposed longitudinally along the elongated structure of the catheter between the tip ring electrode and the coil electrode, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
20. Regarding Claim 13, Koblish fails to teach the first polarity is positive and the second polarity is negative.
Howard teaches the first polarity is positive (para 0116, “a first plurality of electrodes 38a that is connected to a first polarity of the generator 14, such as a positive polarity”) and the second polarity is negative (para 0116, “a second [plurality] of electrodes 38b is connected to a second polarity of the generator 14, such as a negative polarity”). It is commonly known in the art that opposite polarities are that of positive and negative (para 0078), therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Koblish to have the first polarity be positive and the second polarity be negative.
21. Regarding Claim 14, Koblish fails to teach the first polarity is negative and the second polarity is positive.
Howard teaches that the first and second polarities are opposite to one another (para 0116), but fails to explicitly teach that the first polarity is negative and the second polarity is positive. However, Howard does discuss that the polarity configurations may be opposite to what is shown/described in the current disclosure (para 0098, “polarity delivered through particular groups of electrodes may be opposite of what is described), as this still produces the same expected result (para 0098). It is also held that it is commonly known in the art that opposite polarities are that of positive and negative (para 0078), therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Koblish to have the first polarity be negative and the second polarity be positive.
22. Claims 4, 11, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Koblish and Behzadian, and further in view Swanson U.S. 6,001,093 (herein referred to as “Swanson”).
23. Regarding Claim 4, Koblish teaches the method of claim 1, as well as wherein outputting energy to cause the electrodes to generate the field with the geometry that is linear along the active portion of the particular catheter (Col. 14, lines 58-63; Fig. 5, ref num 126; Fig. 6H, ref num 6H-6I, ref nums 210) comprises:
i. driving a tip electrode positioned at a distal tip of the catheter and a tip ring electrode adjacent to the tip electrode (Fig. 1C, ref num 36b and 36a most distal on the shaft ref num 28; Col. 15, lines 4-11);
ii. driving electrodes of a first pair of ring electrodes (Fig. 1C, any pair of ref num 36b that is not the distal most ref num 36b; Col. 15, lines 4-11);
iii. driving electrodes of a second pair of electrodes (Fig. 1C, any other pair of ref num 36b that has not been selected), wherein the first pair of ring electrodes is disposed longitudinally between the second pair of ring electrodes and the tip ring electrode (see Fig. 1C); and,
iv. driving electrodes of a third pair of electrodes (Fig. 1C, any other pair of ref num 36b that has not been selected), wherein the second pair of ring electrodes is disposed longitudinally between the first pair of ring electrodes and the third pair of ring electrodes (see Fig. 1C).
Koblish fails to teach driving the tip electrode and tip ring electrode at a first polarity, driving the first pair of ring electrodes at a second polarity, opposite to the first polarity, driving the second pair of ring electrodes at the first polarity, and driving the third pair of ring electrodes at the second polarity.
Behzadian teaches a method for performing pulsed field ablation of analogous art (para 0055, 0063; Figs. 3A-3B) wherein the method comprises outputting energy to cause the electrodes to generate the field with geometry that is linear along the active portion of a catheter (Fig. 3B; para 0065), such that a tip electrode and a proximal electrode are driven at a first polarity (Fig. 3B, ref num 22 is driven at a first polarity; para 0065, “electrodes 16 and 22 are being energized with high voltage polarity”) and a middle electrode is driven at a second polarity, opposite to the first (Fig. 3B, ref num 20 driven at second polarity; para 0065, “dissimilar polarity by electrode 20 being energized with return polarity”). By selectively controlling the plurality of electrodes, users are able to ablate a target area while avoiding ablation to untargeted tissue (para 0014). Therefore, it would have been obvious before the effective filing date of the claimed invention to have modified Koblish to selectively control the polarization of the electrodes in order to uniformly ablate the target region, avoiding damage to untargeted tissue.
Swanson teaches a method of analogous art (Fig. 28 and 30; Col. 23, lines 13-18), wherein the method comprises generating a field with geometry that is linear along an active portion of the catheter (Col. 23, lines 55-62), such that there are a plurality of electrodes that are alternate between polarities (Col. 23, lines 55-62; Fig. 30, ref nums 192 alternate between a first polarity, positive, and a second polarity, negative; also sees Fig. 59 and 65). This produces the same expected result of ablating the target region along a linear portion of the catheter (Figs. 30, 59; Col. 23, lines 55-62). Therefore, it would have been obvious before the effective filing date of the claimed invention to have further modified Koblish to selectively control the polarization of the electrodes in an alternating fashion in order to selectively ablate the target tissue to a certain geometry.
Koblish as modified by Behzadian and Swanson fails to explicitly disclose a tip electrode and tip ring electrode, as well as a second pair of ring electrodes, at the first polarity, and a first pair of ring electrodes and a third pair of ring electrodes driven at the second polarity. However, it has been held that an “obvious to try” rationale when choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is a support for a conclusion of obviousness which is consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham, if the following findings can be established: (1) a finding that at the time of the invention, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem; (2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem; (3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and (4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness. See MPEP § 2143(I)(E).
In the instant case, and as per (1), Behzadian discusses that an improved method of ablation in order to control the geometry of the ablation region is needed (Behzadian, para 0012-0014). As per (2), one of ordinary skill in the art would recognize that the electrodes may be energized to one of two polarities, or not be energized (i.e., neutral), at a singular time (see Behzadian, para 0024, 0039). As per (3), one of ordinary skill in the art would recognize that modifying Koblish based on the finite number of predictable solutions outlined herein can be done without changing the principles of operation of the prior art, and without changing the intended purpose of the prior art. As such, one of ordinary skill in the art would have a reasonable expectation of success when modifying the prior art (see Koblish, Col. 12, lines 45-52). As per (4), one may be motivated to modify the method in order to avoid unnecessary to surrounding tissue that is not targeted (Behzadian, para 0014). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Koblish and have modified them by having a tip electrode and tip ring electrode, as well as a second pair of ring electrodes, at the first polarity, and a first pair of ring electrodes and a third pair of ring electrodes driven at the second polarity, as a matter of trying a finite number of predictable solutions, in order to control the geometry of the target ablation area and avoid damage to untargeted tissue.
24. Regarding Claims 11 and 18, Koblish teaches wherein outputting energy to cause the electrodes to generate the field with the geometry that is linear along the active portion of the particular catheter (Col. 14, lines 58-63; Fig. 5, ref num 126; Fig. 6H, ref num 6H-6I, ref nums 210) comprises:
i. driving a tip electrode positioned at a distal tip of the catheter and a tip ring electrode adjacent to the tip electrode (Fig. 1C, ref num 36b and 36a most distal on the shaft ref num 28; Col. 15, lines 4-11);
ii. driving electrodes of a first pair of ring electrodes (Fig. 1C, any pair of ref num 36b that is not the distal most ref num 36b; Col. 15, lines 4-11);
iii. driving electrodes of a second pair of electrodes (Fig. 1C, any other pair of ref num 36b that has not been selected), wherein the first pair of ring electrodes is disposed longitudinally between the second pair of ring electrodes and the tip ring electrode (see Fig. 1C); and,
iv. driving electrodes of a third pair of electrodes (Fig. 1C, any other pair of ref num 36b that has not been selected), wherein the second pair of ring electrodes is disposed longitudinally between the first pair of ring electrodes and the third pair of ring electrodes (see Fig. 1C).
Koblish fails to teach driving the tip electrode and tip ring electrode at a first polarity, driving the first pair of ring electrodes at a second polarity, opposite to the first polarity, driving the second pair of ring electrodes at the first polarity, and driving the third pair of ring electrodes at the second polarity.
Behzadian teaches a system for performing pulsed field ablation of analogous art (para 0055, 0063; Figs. 3A-3B) wherein the system comprises outputting energy to cause the electrodes to generate the field with geometry that is linear along the active portion of a catheter (Fig. 3B; para 0065), such that a tip electrode and a proximal electrode are driven at a first polarity (Fig. 3B, ref num 22 is driven at a first polarity; para 0065, “electrodes 16 and 22 are being energized with high voltage polarity”) and a middle electrode is driven at a second polarity, opposite to the first (Fig. 3B, ref num 20 driven at second polarity; para 0065, “dissimilar polarity by electrode 20 being energized with return polarity”). By selectively controlling the plurality of electrodes, users are able to ablate a target area while avoiding ablation to untargeted tissue (para 0014). Therefore, it would have been obvious before the effective filing date of the claimed invention to have modified Koblish to selectively control the polarization of the electrodes in order to uniformly ablate the target region, avoiding damage to untargeted tissue.
Swanson teaches a system of analogous art (Fig. 28 and 30; Col. 23, lines 13-18), wherein the system comprises generating a field with geometry that is linear along an active portion of the catheter (Col. 23, lines 55-62), such that there are a plurality of electrodes that are alternate between polarities (Col. 23, lines 55-62; Fig. 30, ref nums 192 alternate between a first polarity, positive, and a second polarity, negative; also sees Fig. 59 and 65). This produces the same expected result of ablating the target region along a linear portion of the catheter (Figs. 30, 59; Col. 23, lines 55-62). Therefore, it would have been obvious before the effective filing date of the claimed invention to have further modified Koblish to selectively control the polarization of the electrodes in an alternating fashion in order to selectively ablate the target tissue to a certain geometry.
Koblish as modified by Behzadian and Swanson fails to explicitly disclose a tip electrode and tip ring electrode, as well as a second pair of ring electrodes, at the first polarity, and a first pair of ring electrodes and a third pair of ring electrodes driven at the second polarity. However, it has been held that an “obvious to try” rationale when choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is a support for a conclusion of obviousness which is consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham, if the following findings can be established: (1) a finding that at the time of the invention, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem; (2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem; (3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and (4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness. See MPEP § 2143(I)(E).
In the instant case, and as per (1), Behzadian discusses that an improved method of ablation in order to control the geometry of the ablation region is needed (Behzadian, para 0012-0014). As per (2), one of ordinary skill in the art would recognize that the electrodes may be energized to one of two polarities, or not be energized (i.e., neutral), at a singular time (see Behzadian, para 0024, 0039). As per (3), one of ordinary skill in the art would recognize that modifying Koblish based on the finite number of predictable solutions outlined herein can be done without changing the principles of operation of the prior art, and without changing the intended purpose of the prior art. As such, one of ordinary skill in the art would have a reasonable expectation of success when modifying the prior art (see Koblish, Col. 12, lines 45-52). As per (4), one may be motivated to modify the method in order to avoid unnecessary to surrounding tissue that is not targeted (Behzadian, para 0014). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Koblish and have modified them by having a tip electrode and tip ring electrode, as well as a second pair of ring electrodes, at the first polarity, and a first pair of ring electrodes and a third pair of ring electrodes driven at the second polarity, as a matter of trying a finite number of predictable solutions, in order to control the geometry of the target ablation area and avoid damage to untargeted tissue.
Conclusion
25. 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.
26. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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