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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted January 6th, 2025 has been considered by the Examiner.
Claim Objections
Claims 1-2, 5, 11, 13, 15-17 & 19 objected to because of the following informalities:
Claim 1, line 8: “the shaft” should read --the elongated shaft--,
Claim 1, line 12: “the shaft” should read --the elongated shaft--,
Claim 1, line 13: “the shaft” should read --the elongated shaft--,
Claim 1, line 17: “by surface” should read --by a surface--,
Claim 2, line 2: “the shaft” should read --the elongated shaft--,
Claim 5, line 4: “the shaft” should read --the elongated shaft--,
Claim 11, line 12: “the shaft” should read --the elongated shaft--,
Claim 11, line 15: “the shaft” should read --the elongated shaft--,
Claim 11, lines 18-19: “the shaft” should read --the elongated shaft--,
Claim 11, line 20: “the shaft” should read --the elongated shaft--,
Claim 13, line 2: “the shaft” should read --the elongated shaft--,
Claim 13, line 4: “the shaft” should read --the elongated shaft--,
Claim 15, line 2: “the shaft” should read --the elongated shaft--,
Claim 15, line 4: “the shaft” should read --the elongated shaft--,
Claim 16, line 5: “the shaft” should read --the elongated shaft--,
Claim 16, line 6: “the shaft” should read --the elongated shaft--,
Claim 16, line 10: “the shaft” should read --the elongated shaft--,
Claim 16, line 12: “by surface” should read --by a surface--,
Claim 17, line 2: “the shaft” should read --the elongated shaft--,
Claim 19, line 4: “adjacent coil segments” should read --adjacent coil segments of the plurality of coil segments--,
Claim 19, line 4: “the shaft” should read --the elongated shaft--.
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 1-20 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 claim recites “the shaft” in line 4 and it is unclear if this is the same shaft or is a different shaft from the elongated shaft recited in line 3. For examination purposes, these are the same shafts and the limitation will be interpreted as “the elongated shaft”. For other recitations, see Claim Objections section.
Claim 1 recites the limitation “the length” in line 10. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 1, the claim recites “adjacent pressure sensors” in line 14 and it is unclear if these are the same pressure sensors or are a different set of pressure sensors from the plurality of pressure sensors recited in line 11. For examination purposes, these are the same pressure sensors and the limitation will be interpreted as “adjacent pressure sensors of the plurality of pressure sensors”.
Regarding claim 1, the claim recites “each pressure sensor” in lines 15-16 and it is unclear if these are the same pressure sensors or are a different set of pressure sensors from the plurality of pressure sensors recited in line 11. For examination purposes, these are the same pressure sensors and the limitation will be interpreted as “each pressure sensor of the plurality of pressure sensors”.
Regarding claim 1, the claim recites “target blood vessel” in line 17 and it is unclear if this is the same target blood vessel or is a different target blood vessel from the target blood vessel recited in line 5. For examination purposes, these are the same shafts and the limitation will be interpreted as “the target blood vessel”.
Claims 2-10 are also rejected by virtue of their dependency on claim 1.
Regarding claim 2, the claim recites “a length” in line 4 and it is unclear if this is the same length or is a different length from the length recited in claim 1, from which claim 2 depends. For examination purposes, these are the same shafts and the limitation will be interpreted as “the length”.
Regarding claim 2, the claim recites “at least some of the openings” in lines 4-5 and it is unclear if these are the same openings or are a different set of openings from the plurality of openings recited in claim 1, from which claim 2 depends. For examination purposes, these are the same openings and the limitation will be interpreted as “at least some of the openings of the plurality of openings”.
Claim 3 is rejected by virtue of its dependency on claim 2.
Claim 5 recites the limitation “the second plurality of windings” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 5, the claim recites “adjacent coil segments” in line 2 and it is unclear if these are the same coil segments or are a different set of coil segments from the plurality of coil segments recited in line 2. For examination purposes, these are the same coil segments and the limitation will be interpreted as “adjacent coil segments of the plurality of coil segments”.
Regarding claim 5, the claim recites “each adjacent coil segments” in lines 3-4 and it is unclear if these are the same coil segments or are a different set of coil segments from the plurality of coil segments recited in line 2. For examination purposes, these are the same coil segments and the limitation will be interpreted as “each adjacent coil segment of the plurality of coil segments”.
Regarding claim 5, the claim recites “a length” in line 4 and it is unclear if this is the same length or is a different length from the length recited in claim 1, from which claim 5 depends. For examination purposes, these are the same shafts and the limitation will be interpreted as “the length”.
Regarding claim 5, the claim recites “a temperature sensor” in line 5 and it is unclear if this is the same temperature sensor or is a different temperature sensor from the temperature sensor recited in lines 4-5. For examination purposes, these are the same temperature sensors and the limitation will be interpreted as “the temperature sensor”.
Regarding claim 5, the claim recites “an opening” in line 7 and it is unclear if this is the same opening or is a different opening from the plurality of openings recited in claim 1, from which claim 5 depends. For examination purposes, these are the same openings and the limitation will be interpreted as “an opening of the plurality of openings”.
Regarding claim 5, the claim recites “a coil segment” in line 7 and it is unclear if this is the same coil segment or is a different coil segment from the plurality of coil segments recited in line 2. For examination purposes, these are the same coil segments and the limitation will be interpreted as “a coil segment of the plurality of coil segments”.
Regarding claim 11, the claim recites “the shaft” in line 7 and it is unclear if this is the same shaft or is a different shaft from the elongated shaft recited in line 6. For examination purposes, these are the same shafts and the limitation will be interpreted as “the elongated shaft”. For other recitations, see Claim Objections section.
Claim 11 recites the limitation “the length of the second coil member” in lines 16-17. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 11, the claim recites “at least two adjacent pressure sensors” in line 22 and it is unclear if these are the same pressure sensors or are a different set of pressure sensors from the plurality of pressure sensors recited in line 18. For examination purposes, these are the same pressure sensors and the limitation will be interpreted as “at least two adjacent pressure sensors of the plurality of pressure sensors”.
Regarding claim 11, the claim recites “each pressure sensor” in lines 23 and it is unclear if these are the same pressure sensors or are a different set of pressure sensors from the plurality of pressure sensors recited in line 18. For examination purposes, these are the same pressure sensors and the limitation will be interpreted as “each pressure sensor of the plurality of pressure sensors”.
Claims 12-15 are also rejected by virtue of their dependency on claim 11.
Claim 13 recites the limitation “the current” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 14 & 15 are also rejected by virtue of their dependency on claim 13.
Regarding claim 16, the claim recites “the shaft” in line 2 and it is unclear if this is the same shaft or is a different shaft from the elongated shaft recited in line 2. For examination purposes, these are the same shafts and the limitation will be interpreted as “the elongated shaft”. For other recitations, see Claim Objections section.
Claim 16 recites the limitation “the length” in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “the heating element” in lines 7-8. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 16, the claim recites “adjacent pressure sensors” in line 10 and it is unclear if these are the same pressure sensors or are a different set of pressure sensors from the plurality of pressure sensors recited in line 13. For examination purposes, these are the same pressure sensors and the limitation will be interpreted as “adjacent pressure sensors of the plurality of pressure sensors”.
Regarding claim 16, the claim recites “each pressure sensors” in line 11 and it is unclear if these are the same pressure sensors or are a different set of pressure sensors from the plurality of pressure sensors recited in line 13. For examination purposes, these are the same pressure sensors and the limitation will be interpreted as “each pressure sensors of the plurality of pressure sensors”.
Regarding claim 16, the claim recites “target blood vessel” in lines 12-13 and it is unclear if this is the same target blood vessel or is a different target blood vessel from the target blood vessel recited in lines 3-4. For examination purposes, these are the same shafts and the limitation will be interpreted as “the target blood vessel”.
Claims 17-20 are also rejected by virtue of their dependency on claim 16.
Claim 17 recites the limitation “the device” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 17, the claim recites “a length” in line 4 and it is unclear if this is the same length or is a different length from the length recited in claim 16, from which claim 17 depends. For examination purposes, these are the same shafts and the limitation will be interpreted as “the length”.
Claims 18 & 19 are also rejected by virtue of their dependency on claim 17.
Claim 18 recites the limitation “the device” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation “the device” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 19, the claim recites “adjacent coil segments” in line 2 and it is unclear if this is the same coil segment or is a different coil segment from the plurality of coil segments recited in line 2. For examination purposes, these are the same coil segments and the limitation will be interpreted as “adjacent coil segments of the plurality of coil segments”. For other recitations see Claim Objections section.
Regarding claim 19, the claim recites “an opening” in line 7 and it is unclear if this is the same opening or is a different opening from the plurality of openings recited in claim 16, from which claim 19 depends. For examination purposes, these are the same openings and the limitation will be interpreted as “an opening of the plurality of openings”.
Regarding claim 19, the claim recites “a coil segment” in line 7 and it is unclear if this is the same coil segment or is a different coil segment from the plurality of coil segments recited in line 2. For examination purposes, these are the same coil segments and the limitation will be interpreted as “a coil segment of the plurality of coil segments”.
Claim 20 recites the limitation “the device” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ku et al. (U.S. Pub. No. 20140276748), herein referred to as “Ku”
Regarding claim 16, Ku teaches a catheter for use in treating varicose veins, the catheter (an intravascular or intraluminal treatment device 12; [0030]: The electrodes are configured to deliver energy (e.g., electrical energy, radio frequency (RF) energy, pulsed electrical energy, or thermal energy) to a vessel wall; wherein the device is capable of treating a varicose vein) comprising:
an elongated shaft (elongated shaft 16) having a proximal end (proximal portion 18) and a distal end (distal portion 20), the shaft being sized and configured such that the distal end can be inserted into a target blood vessel ([0038]: The therapeutic assembly 21 can include a helical push wire electrode 22 and a distal electrode support section 24, which are configured to be delivered to a renal blood vessel);
a coil member (helical push wire electrode 22) disposed at the distal end of the shaft ([0038]: a therapeutic assembly or treatment section 21 at the distal portion 20 of the shaft 16) and comprising a plurality of first windings about the shaft in a first direction, wherein a plurality of openings in the plurality of first windings are defined along the length of the heating element ([0069]: As shown in FIGS. 4A and 4B, a helix may be characterized, at least in part, by its overall diameter D, length L, helix angle .alpha. (an angle between a tangent line to the helix and its axis), pitch HP (longitudinal distance of one complete helix turn measured parallel to its axis), and number of revolutions (number of times the helix completes a 360.degree. revolution about its axis); [0035]: The application of energy to tissue by the helical push wire electrode(s) can induce one or more desired thermal heating effects on localized regions); and
a plurality of pressure sensors longitudinally spaced from one another along the distal end of the shaft, wherein adjacent pressure sensors are circumferentially offset from one another, each pressure sensor being configured to generate an output signal indicative of pressure applied thereto by surface of target blood vessel ([0120]: Energy delivery may be monitored and controlled via data collected with one or more sensors, such as temperature sensors (e.g., thermocouples, thermistors, etc.), impedance sensors, pressure sensors, optical sensors, flow sensors, chemical sensors, etc., which may be incorporated into or on the helical push wire electrode 22, the distal electrode support section 24 … Significant gradients across the electrode in other sensed data (e.g., flow, pressure, impedance, etc.) also are expected; [0121]: multiple sensors may be provided at multiple positions along the electrode or energy delivery element array and/or relative to blood flow. For example, a plurality of circumferentially and/or longitudinally spaced sensors may be provided).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-4 & 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ku in view of Caron et al. (U.S. Pub. No. 20160022159), herein referred to as “Caron”.
Regarding claim 1, Ku discloses a device for treating varicose veins (an intravascular or intraluminal treatment device 12; [0030]: The electrodes are configured to deliver energy (e.g., electrical energy, radio frequency (RF) energy, pulsed electrical energy, or thermal energy) to a vessel wall; wherein the device is capable of treating a varicose vein), comprising:
an elongated catheter (treatment device 12) comprising:
an elongated shaft (elongated shaft 16) defining a longitudinal axis ([0056]: the longitudinal axis A-A of the assembly) having a proximal end (proximal portion 18) and a distal end (distal portion 20), the shaft being sized and configured such that the distal end can be inserted into a target blood vessel ([0038]: The therapeutic assembly 21 can include a helical push wire electrode 22 and a distal electrode support section 24, which are configured to be delivered to a renal blood vessel);
a heating element (therapeutic assembly 21; [0044]: At least one supply wire (not shown) passes along the elongated shaft 16 or through a lumen in the elongated shaft 16 to one or more helical push wire electrodes 22 and transmits the treatment energy to one or more helical push wire electrodes 22; [0035]: The application of energy to tissue by the helical push wire electrode(s) can induce one or more desired thermal heating effects on localized regions) disposed near the distal end of the elongated shaft ([0038]: a therapeutic assembly or treatment section 21 at the distal portion 20 of the shaft 16), the heating element comprising a coil member (helical push wire electrode 22) comprising a plurality of first windings about the shaft in a first direction, wherein a plurality of openings in the plurality of first windings are defined along the length of the heating element ([0069]: As shown in FIGS. 4A and 4B, a helix may be characterized, at least in part, by its overall diameter D, length L, helix angle .alpha. (an angle between a tangent line to the helix and its axis), pitch HP (longitudinal distance of one complete helix turn measured parallel to its axis), and number of revolutions (number of times the helix completes a 360.degree. revolution about its axis)); and
a plurality of pressure sensors longitudinally spaced from one another along the shaft, and wherein adjacent pressure sensors are circumferentially offset from one another, each pressure sensor being configured to generate an output signal indicative of pressure applied thereto by surface of target blood vessel ([0120]: Energy delivery may be monitored and controlled via data collected with one or more sensors, such as temperature sensors (e.g., thermocouples, thermistors, etc.), impedance sensors, pressure sensors, optical sensors, flow sensors, chemical sensors, etc., which may be incorporated into or on the helical push wire electrode 22, the distal electrode support section 24 … Significant gradients across the electrode in other sensed data (e.g., flow, pressure, impedance, etc.) also are expected; [0121]: multiple sensors may be provided at multiple positions along the electrode or energy delivery element array and/or relative to blood flow. For example, a plurality of circumferentially and/or longitudinally spaced sensors may be provided).
But Ku fails to disclose wherein each of the pressure sensors is located on the shaft within a respective one of the openings in the plurality of first windings.
However, Caron discloses a plurality of pressure sensors (optical pressure sensors 10) longitudinally spaced from one another along the shaft ([0085]: four optic fiber-based pressure sensors 10 arranged along the length 41 of the distal end portion of the multi-sensor wire), wherein each of the pressure sensors is located on the shaft within a respective one of the openings in the plurality of first windings (see Fig. 6 where the optical pressure sensors 6 are located on the mandrel 31 and within openings of the coil 35), and wherein adjacent pressure sensors are circumferentially offset from one another (see Figs. 1 & 6 where each optical pressure sensor 10 is circumferentially offset from each other; see also Figs. 3A-G & [0101]), each pressure sensor being configured to generate an output signal indicative of pressure applied thereto by surface of target blood vessel ([0085]: the multi-sensor wire 100 is capable of measuring blood pressure simultaneously at several points, in this case four points, using the four optic fiber-based pressure sensors 10 arranged along the length 41 of the distal end portion of the multi-sensor wire. For example, as shown, the sensors are arranged at equal intervals along a length of the distal end portion 101, which length is determined by the dimension of the heart or vascular region to be monitored). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the plurality of pressure sensors of Ku to the plurality of pressure sensors and their positioning, as taught by Caron for the purpose of the pressure sensors enabling pressure sensing along a length of the distal end portion, enabling simultaneous sensing along at each location for the length of the vascular region being monitored (Caron: Abstract, [0085]).
Regarding claim 3, Ku in view of Caron discloses wherein the plurality of pressure sensors include N pressure sensors (Caron: [0083]: four optical pressure sensors 10); wherein two adjacent pressure sensors of the plurality of pressure sensors are circumferentially offset by an offset degree related to N from one another ([0086]: FIGS. 3A, 3B, 3C, 3D, 3E, 3F and 3G show enlarged axial cross-sectional views of the multi-sensor wire 100 taken through planes A-A, B-B, C-C, D-D, E-E, F-F and G-G respectively, of FIG. 1, illustrating the location of the optical fibers 11, pressure sensors 10 and fiber-optic flow sensor 20 within the lumen 106 of polymer tubing 30; [0101]: Thus, the multi-sensor wire 120 of the second embodiment differs from that of the first embodiment in comprising a central core-wire or mandrel 31, and a coiled outer layer 35, i.e. instead of the polymer tubing 30 of sensor wire 100; see Figs. 3A-3G where the sensors 10 are all offset by 90 degrees).
Regarding claim 4, Ku in view of Caron discloses wherein the plurality of pressure sensors (Caron: [0083]: four optical pressure sensors 10) include a first pressure sensor pair (proximal pair of sensors 10, Fig. 6) and a second sensor pair (distal pair of sensors 10, Fig. 6), wherein the first sensor pair includes a first pressure sensor (proximal sensor 10 of proximal pair) and a second pressure sensor adjacent to the first pressure sensor (distal sensor 10 of proximal pair), wherein the second pressure sensor is circumferentially offset by a first offset angle from the first pressure sensor (see Figs. 3A-3G where the sensors 10 are all offset by 90 degrees; see also [0086]), wherein the second sensor pair includes a third pressure sensor (proximal sensor 10 of distal pair) and a fourth pressure sensor (distal sensor 10 of distal pair) adjacent to the third pressure sensor, wherein the fourth pressure sensor is circumferentially offset by a second offset angle from the third pressure sensor (see Figs. 3A-3G where the sensors 10 are all offset by 90 degrees; see also [0086]), wherein the second offset angle is equal to the first offset angle (see Figs. 3A-3G where the sensors 10 are all offset by 90 degrees; see also [0086]).
Regarding claim 11, Ku discloses a device for treating varicose veins (an intravascular or intraluminal treatment device 12; [0030]: The electrodes are configured to deliver energy (e.g., electrical energy, radio frequency (RF) energy, pulsed electrical energy, or thermal energy) to a vessel wall; wherein the device is capable of treating a varicose vein), comprising:
an energy generator (an energy source or console 26) configured to generate an electric signal ([0044]: The energy source or console 26 is configured to generate a selected form and magnitude of energy for delivery to the target treatment site via therapeutic assembly 21);
a controller ([0048]: The energy source 26 can further include a device or monitor that may include processing circuitry such as one or more microprocessors) operatively connected to the energy generator to control the generation of the electric signal ([0046]: The energy source 26 can be configured to deliver the treatment energy under the control of an automated control algorithm 30); and
an elongated catheter (treatment device 12) connected to the energy generator ([0044]: The energy generator 26 can be electrically coupled to the treatment device 12 via a cable 28) comprising:
an elongated shaft (elongated saft 16) defining a longitudinal axis ([0056]: the longitudinal axis A-A of the assembly) having a proximal end (proximal portion 18) and a distal end (distal portion 20), the shaft being sized and configured such that the distal end can be inserted into a target blood vessel ([0038]: The therapeutic assembly 21 can include a helical push wire electrode 22 and a distal electrode support section 24, which are configured to be delivered to a renal blood vessel);
a heating element (therapeutic assembly 21) disposed near the distal end of the elongated shaft ([0044]: At least one supply wire (not shown) passes along the elongated shaft 16 or through a lumen in the elongated shaft 16 to one or more helical push wire electrodes 22 and transmits the treatment energy to one or more helical push wire electrodes 22; [0035]: The application of energy to tissue by the helical push wire electrode(s) can induce one or more desired thermal heating effects on localized regions), the heating element comprising:
a first coil member ([0044]: one or more helical push wire electrodes 22; two shown in Fig. 3A) comprising a first plurality of windings about the shaft, wherein one or more first openings in the first plurality of windings are defined along a length of the first coil member ([0069]: As shown in FIGS. 4A and 4B, a helix may be characterized, at least in part, by its overall diameter D, length L, helix angle .alpha. (an angle between a tangent line to the helix and its axis), pitch HP (longitudinal distance of one complete helix turn measured parallel to its axis), and number of revolutions (number of times the helix completes a 360.degree. revolution about its axis)); and
a second coil member ([0044]: one or more helical push wire electrodes 22; two shown in Fig. 3A) comprising a second plurality of windings about the shaft, wherein one or more second openings in the second plurality of windings are defined along the length of the second coil member ([0069]: As shown in FIGS. 4A and 4B, a helix may be characterized, at least in part, by its overall diameter D, length L, helix angle .alpha. (an angle between a tangent line to the helix and its axis), pitch HP (longitudinal distance of one complete helix turn measured parallel to its axis), and number of revolutions (number of times the helix completes a 360.degree. revolution about its axis)); and
a plurality of pressure sensors longitudinally spaced from one another along the shaft, and wherein at least two adjacent pressure sensors are circumferentially offset from one another, each pressure sensor being configured to generate an output signal indicative of pressure applied thereto by a surface of the target blood vessel ([0120]: Energy delivery may be monitored and controlled via data collected with one or more sensors, such as temperature sensors (e.g., thermocouples, thermistors, etc.), impedance sensors, pressure sensors, optical sensors, flow sensors, chemical sensors, etc., which may be incorporated into or on the helical push wire electrode 22, the distal electrode support section 24 … Significant gradients across the electrode in other sensed data (e.g., flow, pressure, impedance, etc.) also are expected; [0121]: multiple sensors may be provided at multiple positions along the electrode or energy delivery element array and/or relative to blood flow. For example, a plurality of circumferentially and/or longitudinally spaced sensors may be provided);
wherein the first and second coil members are each operatively connected to the energy generator and configured to generate thermal energy when the electric signal generated by the energy generator is delivered thereto ([0055]: When multiple helical push wire electrodes 22 are provided, the helical push wire electrodes 22 may deliver power independently (i.e., may be used in a monopolar fashion), either simultaneously, selectively, or sequentially, and/or may deliver power between any desired combination of the elements (i.e., may be used in a bipolar fashion)).
But Ku fails to disclose wherein each pressure sensor of the plurality of pressure sensors is located on the shaft within a respective opening of the first openings in the first plurality of windings or the second openings in the second plurality of windings.
However, Caron discloses a plurality of pressure sensors (optical pressure sensors 10) longitudinally spaced from one another along the shaft ([0085]: four optic fiber-based pressure sensors 10 arranged along the length 41 of the distal end portion of the multi-sensor wire), wherein each pressure sensor of the plurality of pressure sensors is located on the shaft within a respective opening of the first openings in the first plurality of windings or the second openings in the second plurality of windings (see Fig. 6 where the optical pressure sensors 6 are located on the mandrel 31 and within openings of the coil 35), and wherein at least two adjacent pressure sensors are circumferentially offset from one another (see Figs. 1 & 6 where each optical pressure sensor 10 is circumferentially offset from each other; see also Figs. 3A-G & [0101]), each pressure sensor being configured to generate an output signal indicative of pressure applied thereto by a surface of the target blood vessel ([0085]: the multi-sensor wire 100 is capable of measuring blood pressure simultaneously at several points, in this case four points, using the four optic fiber-based pressure sensors 10 arranged along the length 41 of the distal end portion of the multi-sensor wire. For example, as shown, the sensors are arranged at equal intervals along a length of the distal end portion 101, which length is determined by the dimension of the heart or vascular region to be monitored). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the plurality of pressure sensors of Ku to the plurality of pressure sensors and their positioning, as taught by Caron for the purpose of the pressure sensors enabling pressure sensing along a length of the distal end portion, enabling simultaneous sensing along at each location for the length of the vascular region being monitored (Caron: Abstract, [0085]).
Regarding claim 12, Ku in view of Caron discloses wherein the heating element further comprises a third coil member comprising a third plurality of windings about the shaft, wherein one or more third openings in the third plurality of windings are defined along a length of the third coil member (Ku: [0044]: In other embodiments, however, two or more helical push wire electrodes 22 may be electrically coupled to the same supply wire; [0069]: As shown in FIGS. 4A and 4B, a helix may be characterized, at least in part, by its overall diameter D, length L, helix angle .alpha. (an angle between a tangent line to the helix and its axis), pitch HP (longitudinal distance of one complete helix turn measured parallel to its axis), and number of revolutions (number of times the helix completes a 360.degree. revolution about its axis)); wherein one or more of the plurality of pressure sensors are located on the shaft within one or more of the third openings (Caron: see Fig. 6 where the optical pressure sensors 6 are located on the mandrel 31 and within openings of the coil 35).
Claims 2 & 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ku in view of Caron as applied to claims 1 & 11 above, and further in view of Dong et al. (U.S. Pub. No. 20240366300, earliest effective filing date), herein referred to as “Dong”.
Regarding claim 2, Ku discloses wherein the coil member further comprises a plurality of second windings about the shaft ([0044]: two or more helical push wire electrodes 22 may be electrically coupled to the same supply wire), but fails to disclose wherein the coil member further comprises a plurality of second windings about the shaft in a second direction different than the first direction, wherein at least some of the plurality of second windings cross over the plurality of first windings at locations spaced along a length of the heating element, and wherein at least some of the openings are defined between the plurality of first windings and the plurality of second windings.
However, Dong discloses wherein the coil member (carrier 6) further comprises a plurality of second windings about the shaft in a second direction different than the first direction ([0057]: the carrier 6 may be helically braided with right-handed helix wires and left-handed helix wires; see also [0070]), wherein at least some of the plurality of second windings cross over the plurality of first windings at locations spaced along a length of the heating element ([0072]: intersectional points), and wherein at least some of the openings are defined between the plurality of first windings and the plurality of second windings (interstices 15; [0052]: As shown in FIG. 5, the carrier 6 includes structural elements, e.g., wires 24 (or strands, filaments or fibers) arranged to define interstices 15 (or interstitial spaces) therebetween). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the heating element of Ku in view of Caron to include a plurality of second windings, as taught by Dong, for the purpose of stabilizing said at least one interstice, to maintain structural integrity of the carrier, and to prevent tangling of wire helixes, when the carrier is being distorted intravascularly (Dong: [0006]).
Regarding claim 13, Ku discloses ([0050]: Furthermore, the energy source or console 26 can be configured to communicate with the treatment device 12 via cable 28. For example, the therapeutic assembly 21 of the treatment device 12 can include a sensor (not shown) (e.g., a recording electrode, a temperature sensor, a pressure sensor, or a flow rate sensor) and a sensor lead (not shown) (e.g., an electrical lead or a pressure lead) configured to carry a signal from the sensor to the handle 34. The cable 28 can be configured to carry the signal from the handle 34 to the energy source or console 26; [0065]: Supply wires 35 connect the electrodes to an energy source (not shown) and deliver energy (e.g., RF electrical current) to the electrodes 22) but fails to explicitly disclose wherein the controller is configured to adjust the current generated by the energy generator based on the output signal indicative of pressure applied thereto generated by each pressure sensor of the plurality of pressure sensors.
However, Dong discloses wherein the controller is configured to adjust the current generated by the energy generator based on the output signal indicative of pressure applied thereto generated by each pressure sensor of the plurality of pressure sensors ([0041]: The generator 8 may be part of a device or monitor that may include processing circuitry, such as a microprocessor. The processing circuitry may be configured to execute stored instructions relating to the control algorithm. The monitor may be configured to communicate with the catheter apparatus 1 to control power to the therapeutic member 7 and/or to obtain signals from the therapeutic member 7 or any associated sensors within or outside the therapeutic assembly 70; [0045]: In various embodiments, energy delivery may be controlled and monitored via data collected with the sensor(s), such as temperature sensors (e.g., thermocouples, thermistors, etc.), impedance sensors, pressure sensors, optical sensors, flow sensors, chemical sensors, etc., which may be incorporated into or on the therapeutic member 7, e.g. within the therapeutic assembly 70, the carrier 6, and/or in/on adjacent areas on the distal portion 5; [0040]: For example, an RF electric field causes lesion formation via resistive heating of tissue exposed to the electric field; wherein it is known that resistive heating is application of a current; [0047]: The monitored data may be used in a feedback loop to better control therapy, e.g., to determine whether to continue or stop treatment, and it may facilitate controlled delivery of therapy with an increased or reduced power, or a longer or shorter duration). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Ku in view of Caron to include the controller of Dong for the purpose of enabling the monitored data to be used in a feedback loop to better control therapy, e.g., to determine whether to continue or stop treatment, and it may facilitate controlled delivery of therapy with an increased or reduced power, or a longer or shorter duration (Dong: [0047]).
Regarding claim 14, Ku discloses wherein the controller is configured to control current generated by the energy generator to be selectively delivered to one or both of the first and second coil members ([0055]: When multiple helical push wire electrodes 22 are provided, the helical push wire electrodes 22 may deliver power independently (i.e., may be used in a monopolar fashion), either simultaneously, selectively, or sequentially, and/or may deliver power between any desired combination of the elements (i.e., may be used in a bipolar fashion); [0065]: Supply wires 35 connect the electrodes to an energy source (not shown) and deliver energy (e.g., RF electrical current) to the electrodes 22).
Regarding claim 15, Ku discusses a temperature sensor ([0120]: Energy delivery may be monitored and controlled via data collected with one or more sensors, such as temperature sensors (e.g., thermocouples, thermistors, etc.), impedance sensors, pressure sensors, optical sensors, flow sensors, chemical sensors, etc., which may be incorporated into or on the helical push wire electrode 22, the distal electrode support section 24) but Ku fails to disclose further comprising a temperature sensor disposed on the shaft within an opening of the first openings or the second openings, wherein the temperature sensor is longitudinally spaced from one of the plurality of pressures sensors along the shaft.
However, Caron discloses a temperature sensor disposed on the shaft within an opening of the first openings or the second openings, wherein the temperature sensor is longitudinally spaced from one of the plurality of pressures sensors along the shaft ([0102]: a flow sensor 25 in the form of a temperature sensitive resistor, i.e. a resistive thermoconvection sensor, or thermistor; see Fig. 6 where the flow sensor 25 is within an opening of the coil 35 and is longitudinally spaced apart from three out of the four optical pressure sensors 10). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the device of Ku to include a temperature sensor, as taught by Caron, for the purpose of enabling temperature sensing (Caron: [0131]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ku in view of Caron as applied to claim 1 above, and further in view of Javier et al. (U.S. Pub. No. 20240293176, earliest effective filing date), herein referred to as “Javier”.
Regarding claim 5, Ku in view of Caron discloses wherein at least one pressure sensor of the plurality of pressure sensors (Caron: optical pressure sensors 10) is disposed in an opening within a coil segment (see Fig. 6 where an optical pressure senor 10 is located within an opening of coil 35) and Ku and Caron disclose a temperature sensor (Ku: [0120]: Energy delivery may be monitored and controlled via data collected with one or more sensors, such as temperature sensors (e.g., thermocouples, thermistors, etc.), impedance sensors, pressure sensors, optical sensors, flow sensors, chemical sensors, etc., which may be incorporated into or on the helical push wire electrode 22, the distal electrode support section 24; Caron: [0102]: a flow sensor 25 in the form of a temperature sensitive resistor, i.e. a resistive thermoconvection sensor, or thermistor) but Ku in view of Caron fails to disclose wherein the first and second plurality of windings are arranged to define a plurality of coil segments; wherein adjacent coil segments are longitudinally spaced from one another, defining one or more segment gaps between each adjacent coil segments along a length of the shaft; wherein the device further comprising a temperature sensor; wherein a temperature sensor is disposed within a segment gap of the one or more segments gaps; wherein at least one pressure sensor of the plurality of pressure sensors is disposed in an opening within a coil segment.
However, Javier discloses wherein the first and second plurality of windings are arranged to define a plurality of coil segments (proximal electrode 133 & distal electrode 132); wherein adjacent coil segments are longitudinally spaced from one another (distance 135), defining one or more segment gaps between each adjacent coil segments along a length of the shaft (see Fig. 5A); wherein the device further comprising a temperature sensor; wherein a temperature sensor is disposed within a segment gap of the one or more segments gaps ([0115]: Any of the ablation catheters herein may in some embodiments include another temperature sensor that may be positioned between proximal and distal electrodes). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the device of Ku in view of Caron to comprise a plurality of coil segments with a temperature sensor, as taught by Javier for the purpose of enabling each electrode/winding to be independently energized in a monopolar mode or bipolar mode, the segment gap providing for continuous lesion formation and the temperature sensor providing signals that may be used in an energy delivery control algorithm (Javier: [0112], [0114], [0115]).
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ku in view of Caron as applied to claim 1 above, and further in view of Weber et al. (U.S. Pub. No. 20130090563), herein referred to as “Weber”.
Regarding claim 6, Ku in view of Caron fail to disclose wherein the plurality of pressure sensors include six pressure sensors.
However, Weber discloses wherein the plurality of pressure sensors include six pressure sensors (any six of sensors 306, Fig. 3; [0038]: The support structure may fix the one or more FBG sensors 306 against the wall of vessel 302 such that at least one, some, or all of the one or more FBG sensors is in effective contact with the vessel wall at its corresponding sensor location … In the context of a FBG pressure sensor, "effective contact" may mean mechanical contact). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the plurality of pressure sensors of Ku in view of Caron to be six pressure sensors, as taught by Weber, for the purpose of allowing for a real-time, local blood pressure measurement to be made (Weber: [0044]).
Regarding claim 7, Ku in view of Caron and Weber wherein two adjacent pressure sensors of the plurality of pressure sensors are circumferentially offset by 60 degrees from one another (Weber: [0039]: The FBG sensors 306 may be spaced such that 0 has a value of about 90, 60, 45, 30, or 120 degrees, or any other suitable value).
Regarding claim 8, Ku in view of Caron and Weber disclose wherein two adjacent pressure sensors of the plurality of pressure sensors are circumferentially offset by 120 degrees from one another (Weber: [0039]: The FBG sensors 306 may be spaced such that 0 has a value of about 90, 60, 45, 30, or 120 degrees, or any other suitable value).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ku in view of Caron and Weber as applied to claim 1 above, and further in view of Govari (U.S. Pub. 2014/0024970), herein referred to as “Govari”.
Regarding claim 9, Ku in view of Caron and Weber fail to disclose wherein the plurality of pressure sensors include at least one selected from a group consisting of a piezoelectric pressure sensor, a capacitive pressure sensor, an inductive pressure sensor, a strain gauge pressure sensor, and a potentiometric pressure sensor.
However, Govari discloses wherein the plurality of pressure sensors include at least one selected from a group consisting of a piezoelectric pressure sensor, a capacitive pressure sensor, an inductive pressure sensor, a strain gauge pressure sensor, and a potentiometric pressure sensor ([0050]: A plurality of strain gauges 44A, 44B, 44C, . . . are fixedly attached to a surface 48 of sensor tube 42). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the plurality of pressure sensors of Ku in view of Caron and Weber to include a strain gauge, as taught by Govari, for the purpose of stain gauges providing a reliable, accurate, pressure sensing device that is simpler and cheaper to manufacture than other pressure sensing devices (Govari: [0042]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ku in view of Caron and Weber as applied to claim 1 above, and further in view of Cao et al. (U.S. Pub. No. 20190053848), herein referred to as “Cao”.
Regarding claim 10, Ku in view of Caron and Weber fail to disclose wherein the heating element is controlled to deliver ablative energy when an output signal indicative of pressure generated by one pressure sensor of the plurality of pressure sensors is greater than a predetermined threshold.
However, Cao discloses wherein the heating element is controlled to deliver ablative energy when an output signal indicative of pressure generated by one pressure sensor of the plurality of pressure sensors is greater than a predetermined threshold ([0008]: The catheter may include a controller configured to receive each of the output signals from the plurality of tactile sensors, wherein the controller analyzes the output signals and assesses a degree of contact between the ablation electrode and the tissue to be ablated. The ablation electrode is preferably electrically coupled to an ablation energy source such that the controller generates a control signal to activate the ablation energy source when the controller determines that the degree of contact between the ablation electrode and the tissue exceeds a preset contact threshold). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the device of Ku in view of Caron and Weber to include a controller, as taught by Cao for the purpose of inhibiting delivery of ablation energy if the degree of contact is below a preset contact threshold and activating delivery of ablation energy if the degree of contact is above a preset contact threshold (Cao: [0009]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ku as applied to claim 16 above, and further in view of Dong.
Regarding claim 17, Ku discloses wherein the coil member further comprises a plurality of second windings about the shaft ([0044]: two or more helical push wire electrodes 22 may be electrically coupled to the same supply wire), but fails to disclose wherein the coil member further comprises a plurality of second windings about the shaft in a second direction different than the first direction, wherein at least some of the plurality of second windings cross over the plurality of first windings at locations spaced along a length of the heating element.
However, Dong discloses wherein the coil member (carrier 6) further comprises a plurality of second windings about the shaft in a second direction different than the first direction ([0057]: the carrier 6 may be helically braided with right-handed helix wires and left-handed helix wires; see also [0070]), wherein at least some of the plurality of second windings cross over the plurality of first windings at locations spaced along a length of the heating element ([0072]: intersectional points; [0052]: As shown in FIG. 5, the carrier 6 includes structural elements, e.g., wires 24 (or strands, filaments or fibers) arranged to define interstices 15 (or interstitial spaces) therebetween). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the heating element of Ku to include a plurality of second windings, as taught by Dong, for the purpose of stabilizing said at least one interstice, to maintain structural integrity of the carrier, and to prevent tangling of wire helixes, when the carrier is being distorted intravascularly (Dong: [0006]).
Claims 18 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ku in view of Dong as applied to claim 16 above, and further in view of Caron.
Regarding claim 18, Ku in view of Dong fails to disclose wherein the plurality of pressure sensors include N pressure sensors; wherein two adjacent pressure sensors of the plurality of pressure sensors are circumferentially offset by an offset degree related to N from one another.
However, Caron discloses wherein the plurality of pressure sensors include N pressure sensors ([0083]: four optical pressure sensors 10); wherein two adjacent pressure sensors of the plurality of pressure sensors are circumferentially offset by an offset degree related to N from one another ([0086]: FIGS. 3A, 3B, 3C, 3D, 3E, 3F and 3G show enlarged axial cross-sectional views of the multi-sensor wire 100 taken through planes A-A, B-B, C-C, D-D, E-E, F-F and G-G respectively, of FIG. 1, illustrating the location of the optical fibers 11, pressure sensors 10 and fiber-optic flow sensor 20 within the lumen 106 of polymer tubing 30; [0101]: Thus, the multi-sensor wire 120 of the second embodiment differs from that of the first embodiment in comprising a central core-wire or mandrel 31, and a coiled outer layer 35, i.e. instead of the polymer tubing 30 of sensor wire 100; see Figs. 3A-3G where the sensors 10 are all offset by 90 degrees). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the plurality of pressure sensors of Ku in view of Dong to the plurality of pressure sensors and their positioning, as taught by Caron for the purpose of the pressure sensors enabling pressure sensing along a length of the distal end portion, enabling simultaneous sensing along at each location for the length of the vascular region being monitored (Caron: Abstract, [0085]).
Regarding claim 20, Ku in view of Dong fails to disclose wherein the plurality of pressure sensors include a first pressure sensor pair and a second sensor pair, wherein the first sensor pair includes a first pressure sensor and a second pressure sensor adjacent to the first pressure sensor, wherein the second pressure sensor is circumferentially offset by a first offset angle from the first pressure sensor, wherein the second sensor pair includes a third pressure sensor and a fourth pressure sensor adjacent to the third pressure sensor, wherein the fourth pressure sensor is circumferentially offset by a second offset angle from the third pressure sensor, wherein the second offset angle is equal to the first offset angle.
However, Caron discloses wherein the plurality of pressure sensors (Caron: [0083]: four optical pressure sensors 10) include a first pressure sensor pair (proximal pair of sensors 10, Fig. 6) and a second sensor pair (distal pair of sensors 10, Fig. 6), wherein the first sensor pair includes a first pressure sensor (proximal sensor 10 of proximal pair) and a second pressure sensor adjacent to the first pressure sensor (distal sensor 10 of proximal pair), wherein the second pressure sensor is circumferentially offset by a first offset angle from the first pressure sensor (see Figs. 3A-3G where the sensors 10 are all offset by 90 degrees; see also [0086]), wherein the second sensor pair includes a third pressure sensor (proximal sensor 10 of distal pair) and a fourth pressure sensor adjacent to the third pressure sensor (distal sensor 10 of distal pair), wherein the fourth pressure sensor is circumferentially offset by a second offset angle from the third pressure sensor (see Figs. 3A-3G where the sensors 10 are all offset by 90 degrees; see also [0086]), wherein the second offset angle is equal to the first offset angle (see Figs. 3A-3G where the sensors 10 are all offset by 90 degrees; see also [0086]). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the plurality of pressure sensors of Ku in view of Dong to the plurality of pressure sensors and their positioning, as taught by Caron for the purpose of the pressure sensors enabling pressure sensing along a length of the distal end portion, enabling simultaneous sensing along at each location for the length of the vascular region being monitored (Caron: Abstract, [0085]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Ku in view of Dong as applied to claim 16 above, and further in view of Javier and Caron.
Regarding claim 19, Ku discloses a temperature sensor (Ku: [0120]: Energy delivery may be monitored and controlled via data collected with one or more sensors, such as temperature sensors (e.g., thermocouples, thermistors, etc.), impedance sensors, pressure sensors, optical sensors, flow sensors, chemical sensors, etc., which may be incorporated into or on the helical push wire electrode 22, the distal electrode support section 2) but fails to disclose wherein the first and second plurality of windings are arranged to define a plurality of coil segments; wherein adjacent coil segments are longitudinally spaced from one another, defining one or more segment gaps between each adjacent coil segments along a length of the shaft; wherein the device further comprising a temperature sensor; wherein a temperature sensor is disposed within a segment gap of the one or more segments gaps; wherein at least one pressure sensor of the plurality of pressure sensors is disposed in an opening within a coil segment.
However, Javier discloses wherein the first and second plurality of windings are arranged to define a plurality of coil segments (proximal electrode 133 & distal electrode 132); wherein adjacent coil segments are longitudinally spaced from one another (distance 135), defining one or more segment gaps between each adjacent coil segments along a length of the shaft (see Fig. 5A); wherein the device further comprising a temperature sensor; wherein a temperature sensor is disposed within a segment gap of the one or more segments gaps ([0115]: Any of the ablation catheters herein may in some embodiments include another temperature sensor that may be positioned between proximal and distal electrodes). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the device of Ku in view of Dong to comprise a plurality of coil segments with a temperature sensor, as taught by Javier for the purpose of enabling each electrode/winding to be independently energized in a monopolar mode or bipolar mode, the segment gap providing for continuous lesion formation and the temperature sensor providing signals that may be sed in an energy delivery control algorithm (Javier: [0112], [0114], [0115]).
But Ku in view of Dong and Javier fail to disclose wherein at least one pressure sensor of the plurality of pressure sensors is disposed in an opening within a coil segment.
However, Caron discloses wherein at least one pressure sensor of the plurality of pressure sensors is disposed in an opening within a coil segment (see Fig. 6 where the optical pressure sensors 10 are located on the mandrel 31 and within openings of the coil 35). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the plurality of pressure sensors of Ku in view of Dong and Javier to the plurality of pressure sensors and their positioning, as taught by Caron for the purpose of the pressure sensors enabling pressure sensing along a length of the distal end portion, enabling simultaneous sensing along at each location for the length of the vascular region being monitored (Caron: Abstract, [0085]).
Conclusion
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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