DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is in response to the communications filed on 11/12/2024, concerning Application No. 18/864,933. The preliminary amendments to the specification and the claims filed on 11/12/2024 are acknowledged. Presently, claims 1-15 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 11/12/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 2-3, 5-7, and 10-15 are objected to because of the following informalities:
Claim 2, lines 5-6, the limitation “generate the signals in response to magnetic fields produced by nerve activity” should be changed to “generate the signals in response to the magnetic fields produced by the nerve activity”;
Claim 3, lines 3-4, the limitation “generate the signals in response to magnetic fields produced by nerve activity” should be changed to “generate the signals in response to the magnetic fields produced by the nerve activity”;
Claim 5, line 4, the limitation “to output a detection result indicative of nerve activity” should be changed to “to output a detection result indicative of the nerve activity”;
Claim 6, lines 5-6, the limitation “generate the signals in response to magnetic fields produced by nerve activity” should be changed to “generate the signals in response to the magnetic fields produced by the nerve activity”;
Claim 7, lines 3-4, the limitation “generate the signals in response to magnetic fields produced by nerve activity” should be changed to “generate the signals in response to the magnetic fields produced by the nerve activity”;
Claim 7, lines 5-7, the limitation “wherein in the relatively lower sensitivity mode an optical property of the background gas is sensed, and wherein in the relatively higher sensitivity mode an optical property of the alkali metal is sensed” should be changed to “wherein in the relatively lower sensitivity mode, an optical property of the background gas is sensed, and wherein in the relatively higher sensitivity mode, an optical property of the alkali metal is sensed”;
Claim 7, line 10, the limitation “in response to magnetic fields produced by nerve activity” should be changed to “in response to the magnetic fields produced by the nerve activity”;
Claim 7, lines 11-13, the limitation “wherein in the relatively lower sensitivity mode an optical property of the first alkali metal is sensed, and wherein in the relatively higher sensitivity mode an optical property of the second alkali metal is sensed” should be changed to “wherein in the relatively lower sensitivity mode, an optical property of the first alkali metal is sensed, and wherein in the relatively higher sensitivity mode, an optical property of the second alkali metal is sensed”;
Claim 10, line 1, the limitation “The system according to claim 5 wherein” should be changed to “The system according to claim 5, wherein”;
Claim 10, line 3, the limitation “wherein each magnetic sensor element is configured to detect” should be changed to “wherein each magnetic sensor element of the plurality of magnetic sensor elements is configured to detect”;
Claim 10, line 6, the limitation “generated by the magnetic sensor elements” should be changed to “generated by the plurality of magnetic sensor elements”;
Claim 10, lines 8-9, the limitation “generate the detection result using the signal(s) from the one or more of the magnetic sensor elements having the highest signal-to-noise ratio” should be changed to “generate the detection result using the signal(s) from one or more of the plurality of magnetic sensor elements having a highest signal-to-noise ratio of the measured signal-to-noise ratio”;
Claim 11, lines 1-5, the limitation “wherein the sensor elements are distributed around an axis of the interventional device such that the sensor elements generate signals in response to magnetic fields produced at different orientations around the axis; and; wherein” should be changed to “wherein the plurality of magnetic sensor elements are distributed around an axis of the interventional device such that the plurality of magnetic sensor elements generate signals in response to magnetic fields produced at different orientations around the axis; and wherein”;
Claim 11, line 6, the limitation “at which the measured signals” should be changed to “at which the generated signals”;
Claim 12, line 3, the limitation “to output the detection result indicative of nerve activity” should be changed to “to output the detection result indicative of the nerve activity”;
Claim 13, line 9, the limitation “in the absence of magnetic fields produced by nerve activity” should be changed to “in the absence of the magnetic fields produced by the nerve activity”;
Claim 13, line 11, the limitation “during the measurement of magnetic fields produced by nerve activity” should be changed to “during the measurement of the magnetic fields produced by the nerve activity”;
Claim 13, line 14, the limitation “applying of signals to the one or more coils” should be changed to “applying of the signals to the one or more coils”;
Claim 14, line 2, the limitation “generated in response to magnetic fields produced by nerve activity” should be changed to “generated in response to the magnetic fields produced by the nerve activity”;
Claim 14, lines 6-9, the limitation “wherein the controller is configured to apply signals to the one or more coils in order to compensate for the background magnetic field during the measurement of magnetic fields produced by nerve activity, by applying time-dependent signals to the one or more coils in synchronisation with the received ECG signal in order to compensate for the cardiac activity” should be changed to “wherein the controller is configured to apply the signals to the one or more coils in order to compensate for the background magnetic field during the measurement of the magnetic fields produced by the nerve activity, by applying time-dependent signals to the one or more coils in synchronization with the received ECG signal in order to compensate for the cardiac activity”; and
Claim 15, lines 10-12, the limitation “wherein the controller is configured to apply signals to the one or more coils in order to compensate for the background magnetic field during the measurement of magnetic fields produced by nerve activity” should be changed to “wherein the controller is configured to apply the signals to the one or more coils in order to compensate for the background magnetic field during the measurement of the magnetic fields produced by the nerve activity”.
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 6-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 6-7 and 9 each recite the limitation “the OPM”. There is insufficient antecedent basis for this limitation in the claims. Claims 1 and 5, which claims 6-7 and 9 depend from, do not recite the limitation “an optically pumped magnetometer, OPM” or “an OPM” before the limitation “the OPM” is recited in each of the claims 6-7 and 9. For examination purposes, the limitation “the OPM” as recited in each of the claims 6-7 and 9 is interpreted as corresponding to the limitation “an optically pumped magnetometer, OPM” as set forth in claim 2. Clarification is required.
Claims 6 and 8 each recite the limitation “the heater”. There is insufficient antecedent basis for this limitation in the claims. Claims 1 and 5, which claims 6 and 8 depend from, do not recite the limitation “a heater” before the limitation “the heater” is recited in each of the claims 6 and 8. For examination purposes, the limitation “the heater” as recited in each of the claims 6 and 8 is interpreted as corresponding to the limitation “a heater” as set forth in claim 4. Clarification is required.
Claims 6-9 each recite the limitation “the optical cell”. There is insufficient antecedent basis for this limitation in the claims. Claims 1 and 5, which claims 6-9 depend from, do not recite the limitation “an optical cell” before the limitation “the optical cell” is recited in each of the claims 6-9. For examination purposes, the limitation “the optical cell” as recited in each of the claims 6-9 is interpreted as corresponding to the limitation “an optical cell” as set forth in claim 2. Clarification is required.
Claim 9 recites the limitation “the magnetic field-dependent optical property”. There is insufficient antecedent basis for this limitation in the claim. Claims 1 and 5, which claim 9 depends from, do not recite the limitation “a magnetic field-dependent optical property” before the limitation “the magnetic field-dependent optical property” is recited in claim 9. For examination purposes, the limitation “the magnetic field-dependent optical property” as recited in claim 9 is interpreted as corresponding to the limitation “a magnetic-field-dependent optical property of the alkali metal” as set forth in claim 2. Clarification is required.
Claim 9 recites the limitation “the alkali metal”. There is insufficient antecedent basis for this limitation in the claim. Claims 1 and 5, which claim 9 depends from, do not recite the limitation “an alkali metal” before the limitation “the alkali metal” is recited in claim 9. For examination purposes, the limitation “the alkali metal” as recited in claim 9 is interpreted as corresponding to the limitation “an alkali metal” as set forth in claim 2. Clarification is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weber et al. (US 2014/0073903 A1, with publication date 03/13/2014, hereinafter Weber).
Regarding claim 1, Weber discloses an interventional device (catheter 150) for detecting nerve activity, the interventional device (150) comprising: a magnetic sensor (magnetic sensor or magnetometer 155); wherein the magnetic sensor (155) is coupled to an insertable portion of the interventional device (150); and wherein the magnetic sensor (155) is configured to generate signals in response to magnetic fields produced by nerve activity (see, e.g., Abstract, “Described herein is an apparatus for locally monitoring nerve activity that may be incorporated into a nerve ablation catheter. Such a catheter is equipped with magnetic sensing for both identifying nerves and assessing the success of the ablation”, and Fig. 1, and Para. [0017], “An example embodiment of an apparatus for performing renal nerve ablation includes a catheter that comprises a flexible shaft or tubing having proximal and distal ends that may be intravascularly guided to the renal artery, an ablation instrument at the distal end of the catheter, and a magnetic sensor at the distal end of the catheter. The magnetic sensor is configured to sense magnetic fields near the renal nerves that may include the fields produced as a result of stimulation by the ablation instrument, and the ablation instrument may be operated in a high-power mode to destroy renal nerves or in a low-power mode to stimulate renal nerves. Such a renal ablation catheter equipped with a magnetometer as the magnetic sensor is shown in FIG. 1. The catheter 150 is shown located in the aorta 100 with its distal end disposed in the renal artery 110. The catheter 150 comprises a flexible shaft or tubing having proximal and distal ends, where the distal end may be intravascularly guided to the renal artery. At the distal end of the catheter is an ablation instrument 160 and a magnetic sensor or magnetometer 155”).
Regarding claim 2, Weber discloses the interventional device according to claim 1, as set forth above. Weber further discloses wherein the magnetic sensor comprises an optically pumped magnetometer, OPM (see, e.g., Para. [0025], “Optical magnetometers work in a few different regimes, but they have some common principles. The ground state of the electrons in an atom is split into hyperfine Zeeman sublevels by a magnetic field. Spins aligned with the magnetic field have a lower energy level than spins aligned opposite to the field, but among a large population this averages out. A medium can be given a macroscopic magnetic moment by aligning spins of gas atoms in the same direction by a process called optical pumping”);
wherein the OPM comprises an optical cell containing an alkali metal in a liquid and/or a gaseous phase; and wherein the OPM is configured to generate the signals in response to magnetic fields produced by nerve activity by measuring a magnetic-field-dependent optical property of the alkali metal (see, e.g., Para. [0013], “an apparatus for locally monitoring nerve activity comprises: a vapor cell containing a sensor gas disposable adjacent selected nerve tissue”, and Para. [0030], “In another embodiment, a fully optical light-storage magnetometer is incorporated into the catheter in which all of the electronics are located externally from the catheter as depicted in FIG. 4. The control beam 401 and signal beam 402 are transmitted from laser sources external to the catheter through a beam splitter 403 to optical fiber 409 within the catheter to the vapor cell 403. In a particular embodiment, a grating stabilized diode laser locked to a wavelength near 795 nm is used a as laser source of both the optical signal as well as the control field. The two beams pass independent acousto-optical modulators to allow for a variation of the difference frequency and intensity of the individual beams. In a particular embodiment, the vapor cell 403 contains rubidium and a neon buffer gas”, and Para. [0031], “To construct a magnetometer such as illustrated in FIG. 4 or according to other particular embodiments, a rubidium gas vapor cell is attached to an optical fiber. […] Such gas cells could be filled with various suitable vapors (e.g., rubinium, cesium, kalium) and buffer gases such as nitrogen. Anodic bonding of the glass optical fiber to the glass cell could be done using one of various intermediate layers such as silicon carbide, silicon nitride, polysilicon, silicon dioxide, amorphous silicon, or hydrogenated amorphous silicon. […] Yet another alternative is to combine a hollow core waveguide filled with the alkali gas with a solid core system”).
Regarding claim 3, Weber discloses the interventional device according to claim 2, as set forth above. Weber further discloses wherein the optical cell further contains a background gas; and wherein the OPM is further configured to generate the signals in response to magnetic fields produced by nerve activity by measuring a magnetic-field-dependent optical property of the background gas (see, e.g., Para. [0030], “In another embodiment, a fully optical light-storage magnetometer is incorporated into the catheter in which all of the electronics are located externally from the catheter as depicted in FIG. 4. The control beam 401 and signal beam 402 are transmitted from laser sources external to the catheter through a beam splitter 403 to optical fiber 409 within the catheter to the vapor cell 403. In a particular embodiment, a grating stabilized diode laser locked to a wavelength near 795 nm is used a as laser source of both the optical signal as well as the control field. The two beams pass independent acousto-optical modulators to allow for a variation of the difference frequency and intensity of the individual beams. In a particular embodiment, the vapor cell 403 contains rubidium and a neon buffer gas”, and Para. [0031], “To construct a magnetometer such as illustrated in FIG. 4 or according to other particular embodiments, a rubidium gas vapor cell is attached to an optical fiber. […] Such gas cells could be filled with various suitable vapors (e.g., rubinium, cesium, kalium) and buffer gases such as nitrogen”).
Regarding claim 4, Weber discloses the interventional device according to claim 2, as set forth above. Weber further discloses wherein the OPM further comprises a heater; and wherein the heater is configured to supply heat to the optical cell (see, e.g., Para. [0013], “The vapor cell may be incorporated into a catheter with fiber optic cable running through one or more lumens of the catheter for transmitting and receiving light to and from the vapor cell. The sensor gas may be an element such as rubidium that needs to be heated so as to be in a vapor state. Light transmitted by the fiber optic cable may be used for this purpose where the vapor cell contains particles that are heated by the light”).
Regarding claim 5, Weber discloses the interventional device according to claim 1, as set forth above. Weber further discloses a system comprising the interventional device according to claim 1, and a controller; wherein the controller is configured to receive the signals generated by the magnetic sensor, and to output a detection result indicative of nerve activity in response to the received signals (see, e.g., Abstract, “Described herein is an apparatus for locally monitoring nerve activity that may be incorporated into a nerve ablation catheter. Such a catheter is equipped with magnetic sensing for both identifying nerves and assessing the success of the ablation”, and Fig. 1, and Para. [0017], “Such a renal ablation catheter equipped with a magnetometer as the magnetic sensor is shown in FIG. 1. The catheter 150 is shown located in the aorta 100 with its distal end disposed in the renal artery 110. The catheter 150 comprises a flexible shaft or tubing having proximal and distal ends, where the distal end may be intravascularly guided to the renal artery. At the distal end of the catheter is an ablation instrument 160 and a magnetic sensor or magnetometer 155. The proximal end of the catheter connects to a control unit 170 that contains the equipment for steering the catheter and the electronics for actuating the ablation instrument 160 and for receiving and analyzing the signals from the magnetometer 155”).
Regarding claim 6, Weber discloses the system according to claim 5, as set forth above. Weber further discloses wherein the controller is further configured to selectively operate the OPM in a relatively lower sensitivity mode and in which a relatively lower power level is supplied by the heater to the optical cell, and in a relatively higher sensitivity mode and in which a relatively higher power level is supplied by the heater to the optical cell, in order to generate the signals in response to magnetic fields produced by nerve activity (see, e.g., Para. [0012], “wherein the ablation instrument may be operated in a low-power stimulation mode to stimulate nervous tissue or may be operated in a high-power ablation mode to destroy nervous tissue, and a magnetic sensor near the distal end of the catheter wherein the magnetic sensor is configured to sense magnetic fields produced by nervous tissue as a result of stimulation by the ablation instrument […] The power levels of the ablation instrument for the low-power stimulation mode and the high-power ablation mode may be defined by a specified threshold power level”, and Para. [0017], “The ablation instrument can have two modes: a nerve stimulating mode with lower energy where the energy is applied to cause local heating and expansion below the cell necrotizing temperature and a nerve ablation mode that causes local heating above the cell necrotizing temperature. As noted above, the power threshold for the two modes may be determined empirically. The magnetometer 155 is miniaturized as described below and can detect nerve activity through analyzing the generated B field around the nerve when the nerve conducts an impulse”).
Regarding claim 7, Weber discloses the system according to claim 6, as set forth above. Weber further discloses wherein: the optical cell contains an alkali metal in a liquid and/or a gaseous phase, and a background gas (see, e.g., Para. [0013], “an apparatus for locally monitoring nerve activity comprises: a vapor cell containing a sensor gas disposable adjacent selected nerve tissue”, and Para. [0030], “In another embodiment, a fully optical light-storage magnetometer is incorporated into the catheter in which all of the electronics are located externally from the catheter as depicted in FIG. 4. The control beam 401 and signal beam 402 are transmitted from laser sources external to the catheter through a beam splitter 403 to optical fiber 409 within the catheter to the vapor cell 403. In a particular embodiment, a grating stabilized diode laser locked to a wavelength near 795 nm is used a as laser source of both the optical signal as well as the control field. The two beams pass independent acousto-optical modulators to allow for a variation of the difference frequency and intensity of the individual beams. In a particular embodiment, the vapor cell 403 contains rubidium and a neon buffer gas”, and Para. [0031], “To construct a magnetometer such as illustrated in FIG. 4 or according to other particular embodiments, a rubidium gas vapor cell is attached to an optical fiber. […] Such gas cells could be filled with various suitable vapors (e.g., rubinium, cesium, kalium) and buffer gases such as nitrogen. Anodic bonding of the glass optical fiber to the glass cell could be done using one of various intermediate layers such as silicon carbide, silicon nitride, polysilicon, silicon dioxide, amorphous silicon, or hydrogenated amorphous silicon. […] Yet another alternative is to combine a hollow core waveguide filled with the alkali gas with a solid core system”); and the OPM is configured to generate the signals in response to magnetic fields produced by nerve activity by measuring a magnetic-field-dependent optical property of the alkali metal and the background gas, and wherein in the relatively lower sensitivity mode an optical property of the background gas is sensed, and wherein in the relatively higher sensitivity mode an optical property of the alkali metal is sensed (see, e.g., Para. [0030], “In another embodiment, a fully optical light-storage magnetometer is incorporated into the catheter in which all of the electronics are located externally from the catheter as depicted in FIG. 4. The control beam 401 and signal beam 402 are transmitted from laser sources external to the catheter through a beam splitter 403 to optical fiber 409 within the catheter to the vapor cell 403. In a particular embodiment, a grating stabilized diode laser locked to a wavelength near 795 nm is used a as laser source of both the optical signal as well as the control field. The two beams pass independent acousto-optical modulators to allow for a variation of the difference frequency and intensity of the individual beams. In a particular embodiment, the vapor cell 403 contains rubidium and a neon buffer gas”, and Para. [0031], “To construct a magnetometer such as illustrated in FIG. 4 or according to other particular embodiments, a rubidium gas vapor cell is attached to an optical fiber. […] Such gas cells could be filled with various suitable vapors (e.g., rubinium, cesium, kalium) and buffer gases such as nitrogen”); or the optical cell contains a first alkali metal in a liquid and/or a gaseous phase, and a second alkali metal in a liquid and/or a gaseous phase; and the OPM is configured to generate the signals in response to magnetic fields produced by nerve activity by measuring a magnetic-field-dependent optical property of the first alkali metal and the second alkali metal, and wherein in the relatively lower sensitivity mode an optical property of the first alkali metal is sensed, and wherein in the relatively higher sensitivity mode an optical property of the second alkali metal is sensed.
Regarding claim 8, Weber discloses the system according to claim 5, as set forth above. Weber further discloses wherein the interventional device further comprises a temperature sensor; wherein the temperature sensor is in thermal contact with i) an outer surface of the interventional device, or ii) the optical cell; and wherein the controller is configured to operate the heater in response to a temperature measured by the temperature sensor (see, e.g., Para. [0013], “The vapor cell may be incorporated into a catheter with fiber optic cable running through one or more lumens of the catheter for transmitting and receiving light to and from the vapor cell. The sensor gas may be an element such as rubidium that needs to be heated so as to be in a vapor state. Light transmitted by the fiber optic cable may be used for this purpose where the vapor cell contains particles that are heated by the light”).
Regarding claim 9, Weber discloses the system according to claim 5, as set forth above. Weber further discloses wherein the OPM comprises an optical source configured to provide an optical pump beam (see, e.g., Para. [0025], “Optical magnetometers work in a few different regimes, but they have some common principles. The ground state of the electrons in an atom is split into hyperfine Zeeman sublevels by a magnetic field. Spins aligned with the magnetic field have a lower energy level than spins aligned opposite to the field, but among a large population this averages out. A medium can be given a macroscopic magnetic moment by aligning spins of gas atoms in the same direction by a process called optical pumping”), and wherein the OPM is configured to measure the magnetic field-dependent optical property of the alkali metal in response to an excitation of the alkali metal within the optical cell by the optical pump beam; wherein the controller is configured to modulate an intensity of the optical pump beam between a relatively lower intensity and a relatively higher intensity; and wherein the OPM is configured to measure the magnetic field-dependent optical property of the alkali metal by determining a transmission of the optical pump beam through the optical cell whilst the optical pump beam excites the alkali metal at the relative higher intensity (see, e.g., Para. [0013], “an apparatus for locally monitoring nerve activity comprises: a vapor cell containing a sensor gas disposable adjacent selected nerve tissue”, and Para. [0030], “In another embodiment, a fully optical light-storage magnetometer is incorporated into the catheter in which all of the electronics are located externally from the catheter as depicted in FIG. 4. The control beam 401 and signal beam 402 are transmitted from laser sources external to the catheter through a beam splitter 403 to optical fiber 409 within the catheter to the vapor cell 403. In a particular embodiment, a grating stabilized diode laser locked to a wavelength near 795 nm is used a as laser source of both the optical signal as well as the control field. The two beams pass independent acousto-optical modulators to allow for a variation of the difference frequency and intensity of the individual beams. In a particular embodiment, the vapor cell 403 contains rubidium and a neon buffer gas”, and Para. [0031], “To construct a magnetometer such as illustrated in FIG. 4 or according to other particular embodiments, a rubidium gas vapor cell is attached to an optical fiber. […] Such gas cells could be filled with various suitable vapors (e.g., rubinium, cesium, kalium) and buffer gases such as nitrogen. Anodic bonding of the glass optical fiber to the glass cell could be done using one of various intermediate layers such as silicon carbide, silicon nitride, polysilicon, silicon dioxide, amorphous silicon, or hydrogenated amorphous silicon. […] Yet another alternative is to combine a hollow core waveguide filled with the alkali gas with a solid core system”).
Regarding claim 10, Weber discloses the system according to claim 5, as set forth above. Weber further discloses wherein the magnetic sensor comprises a plurality of magnetic sensor elements; wherein each magnetic sensor element is configured to detect magnetic fields intercepting a different volume of the interventional device; and wherein the controller is further configured to: measure a signal-to-noise ratio of the signals generated by the magnetic sensor elements; and to generate the detection result using the signal(s) from the one or more of the magnetic sensor elements having the highest signal-to-noise ratio (see, e.g., Abstract, “Described herein is an apparatus for locally monitoring nerve activity that may be incorporated into a nerve ablation catheter. Such a catheter is equipped with magnetic sensing for both identifying nerves and assessing the success of the ablation”, and Fig. 1, and Para. [0017], “Such a renal ablation catheter equipped with a magnetometer as the magnetic sensor is shown in FIG. 1. The catheter 150 is shown located in the aorta 100 with its distal end disposed in the renal artery 110. The catheter 150 comprises a flexible shaft or tubing having proximal and distal ends, where the distal end may be intravascularly guided to the renal artery. At the distal end of the catheter is an ablation instrument 160 and a magnetic sensor or magnetometer 155. The proximal end of the catheter connects to a control unit 170 that contains the equipment for steering the catheter and the electronics for actuating the ablation instrument 160 and for receiving and analyzing the signals from the magnetometer 155”, and Para. [0033], “The renal nerve ablation procedure as described above may need to be done in a room shielded against the static earth magnetic field that is around 0.5 Gauss, as well as against low and high frequency magnetic fields produced by electronic equipment. The former is established by covering the measurement space (room) using high-permeability foils (in single or multiple layers with spacing) that are commercially available. Shielding against higher frequency can be achieved using foils including high conductivity materials. However, if the optical magnetic sensor has a large enough dynamic range, so that nerve signals that arise in a given frequency band are larger than noise in that band, a band pass filter may be used to eliminate the Earth's magnetic field and higher frequency signals from interfering sources. In addition, two magnetometers may be configured in a gradiometer configuration to eliminate static fields such as the Earth's field that do not vary appreciably over the base line of the gradiometer. For example, in the case of magnetic field sensing from a catheter placed at the center of the renal artery separated by 5 mm from the nerve, the difference in magnetic field sensed by two identical atomic magnetometers placed 5 mm apart on the catheter would cancel static magnetic fields while sensing the nerve signal at it passes over each of the magnetometers. The two magnetometers would need to be separated by a rigid structure. The combination of a gradiometer configuration and band-pass filtering may obviate the need for a magnetically shielded environment”).
Regarding claim 11, Weber discloses the system according to claim 10, as set forth above. Weber further discloses wherein the sensor elements are distributed around an axis of the interventional device such that the sensor elements generate signals in response to magnetic fields produced at different orientations around the axis; and wherein the controller is further configured to identify an orientation around the axis of the interventional device at which the measured signals have a maximum signal-to-noise ratio (see, e.g., Para. [0033], “The renal nerve ablation procedure as described above may need to be done in a room shielded against the static earth magnetic field that is around 0.5 Gauss, as well as against low and high frequency magnetic fields produced by electronic equipment. The former is established by covering the measurement space (room) using high-permeability foils (in single or multiple layers with spacing) that are commercially available. Shielding against higher frequency can be achieved using foils including high conductivity materials. However, if the optical magnetic sensor has a large enough dynamic range, so that nerve signals that arise in a given frequency band are larger than noise in that band, a band pass filter may be used to eliminate the Earth's magnetic field and higher frequency signals from interfering sources. In addition, two magnetometers may be configured in a gradiometer configuration to eliminate static fields such as the Earth's field that do not vary appreciably over the base line of the gradiometer. For example, in the case of magnetic field sensing from a catheter placed at the center of the renal artery separated by 5 mm from the nerve, the difference in magnetic field sensed by two identical atomic magnetometers placed 5 mm apart on the catheter would cancel static magnetic fields while sensing the nerve signal at it passes over each of the magnetometers. The two magnetometers would need to be separated by a rigid structure. The combination of a gradiometer configuration and band-pass filtering may obviate the need for a magnetically shielded environment”).
Regarding claim 12, Weber discloses the system according to claim 5, as set forth above. Weber further discloses wherein the controller is further configured to identify a signature in the received signals; and to output the detection result indicative of nerve activity in response to the received signals by outputting a measure of renal nerve sympathetic overdrive based on the identified signature (see, e.g., Para. [0003], “Signals from renal afferent sympathetic nerves are also believed to contribute to hypertension by acting on the brain to increase sympathetic drive. Adequate renal function is not dependent on these nerves, as evidenced by patients who undergo transplantation with denervated kidneys and survive without complications. Catheter-based renal sympathetic nerve ablation has been shown to be a viable therapeutic approach for the treatment of hypertension in certain patients. In this procedure, an intravascular catheter with an ablating instrument is introduced into the renal artery”, and Para. [0017], “An example embodiment of an apparatus for performing renal nerve ablation includes a catheter that comprises a flexible shaft or tubing having proximal and distal ends that may be intravascularly guided to the renal artery, an ablation instrument at the distal end of the catheter, and a magnetic sensor at the distal end of the catheter. The magnetic sensor is configured to sense magnetic fields near the renal nerves that may include the fields produced as a result of stimulation by the ablation instrument, and the ablation instrument may be operated in a high-power mode to destroy renal nerves or in a low-power mode to stimulate renal nerves. Such a renal ablation catheter equipped with a magnetometer as the magnetic sensor is shown in FIG. 1”).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Weber (US 2014/0073903 A1), as applied to claim 5 above, in view of Ledbetter et al. (US 2021/0244329 A1, of record, hereinafter Ledbetter).
Regarding claim 13, Weber discloses the system according to claim 5, as set forth above. Weber does not specifically disclose the system further comprising one or more coils configured to generate a magnetic field for compensating for a background magnetic field detected by the magnetic sensor; and wherein the interventional device further comprises a motion sensor; wherein the motion sensor is mechanically coupled to the interventional device for detecting a motion of the magnetic sensor; and wherein the controller is further configured to: measure the background magnetic field based on signals generated by the magnetic sensor in the absence of magnetic fields produced by nerve activity; apply signals to the one or more coils in order to compensate for the background magnetic field during the measurement of magnetic fields produced by nerve activity; and repeat the measurement of the background magnetic field, and the corresponding applying of signals to the one or more coils, in response to a detection of a motion of the interventional device by the motion sensor.
However, in the same field of endeavor of optically pumped magnetometers, Ledbetter discloses the system further comprising one or more coils configured to generate a magnetic field for compensating for a background magnetic field detected by the magnetic sensor (see, e.g., Para. [0007-0009], more particularly, Para. [0009], “SERF OPMs typically amplitude modulate the vapor polarization using magnetic coils that generate oscillating magnetic fields that vary at a frequency (e.g., 2000 Hz) much greater than the relaxation rate of the vapor (approximately 100 Hz). The amplitude modulated MEG signal can then be demodulated using lock-in detection to recover the MEG signal”, and Para. [0079], “To this end, the neural activity measurement system 10 generally comprises a signal acquisition unit 18 configured for at least partially cancelling a relatively strong outside magnetic field B.sub.OUT within an environmental magnetic field […] The outside magnetic field B.sub.OUT may emanate from global sources (e.g., the Earth's magnetic field), and from localized sources, including, but not limited to, […] biomagnetics unrelated to neural signals (such as facial muscles, magnetic fields produced by the heart or nerves firing), […] user motion/rotation/translation in a background field (earth field), […] active implantable medical devices (pacemakers)”, and Para. [0173], “Referring to FIG. 9, the set of magnetic field actuators 28 comprises three uniform magnetic field actuators 28a-28c, such that 0.sup.th spatial order cancellation of the outside magnetic field B.sub.OUT in the x, y, and z directions can be achieved. The three uniform magnetic field actuators 28a-28c respectively comprise Helmholtz coils 82a-82c (coil.sub.x, coil.sub.y, coil.sub.z) that are orthogonally arranged relative to each other to generate actuated magnetic fields […] which combine to create the actuated magnetic field”); and
wherein the interventional device further comprises a motion sensor; wherein the motion sensor is mechanically coupled to the interventional device for detecting a motion of the magnetic sensor (see, e.g., Para. [0126], “The management control loop 54 may perform calibration techniques prior to operating the neural activity measurement system 10, or calibration techniques may be performed in real-time as the neural activity measurement system 10 operates. For example, prior to usage, the signal acquisition unit 18a may be calibrated by applying a known magnetic field in a controlled shielded setting (e.g., to characterize the coarse magnetometers 26a for their offsets and gain measurements). However, the properties of coarse magnetometers 26a, fine magnetometers 26b, or set of magnetic field actuators 28 may vary due to environmental variations, such as, e.g., variations in temperature, laser power (for magnetometers that utilize lasers), motion or deformation of the support structure 24, or other deformations, such as bending of the coarse magnetometers 26a, fine magnetometers 26b, or offset of magnetic field actuators 28 due to temperature or mechanical stresses. Thus, in addition to performing calibrations ahead of time, the management control loop 54 may perform calibrations techniques during system operation”); and
wherein the controller is further configured to: measure the background magnetic field based on signals generated by the magnetic sensor in the absence of magnetic fields produced by nerve activity; apply signals to the one or more coils in order to compensate for the background magnetic field during the measurement of magnetic fields produced by nerve activity; and repeat the measurement of the background magnetic field, and the corresponding applying of signals to the one or more coils, in response to a detection of a motion of the interventional device by the motion sensor (see, e.g., Para. [0016-0018], and Para. [0085-0088], more particularly, Para. [0087], “Each of the magnetometers 26 is configured for detecting a spatial component of the total residual magnetic field B.sub.TOT, and outputting a corresponding electrical signal representative of the spatial component of the total residual magnetic field”, and Para. [0100], “As shown in FIG. 4, one embodiment of a signal acquisition unit 18a takes advantage of the high dynamic range of the coarse magnetometers 26a to compensate for the relatively low dynamic range of the fine magnetometers 26b to cancel the large outside magnetic field B.sub.OUT, while also taking advantage of high sensitivity of the fine magnetometers 26b to compensate for the low sensitivity of the coarse magnetometers 26a to measure the MEG signal”, and Para. [0126], “the signal acquisition unit 18a may be calibrated by applying a known magnetic field in a controlled shielded setting […] the properties of coarse magnetometers 26a, fine magnetometers 26b, or set of magnetic field actuators 28 may vary due to environmental variations, such as, e.g., […] other deformations, such as bending of the coarse magnetometers 26a, fine magnetometers 26b, or offset of magnetic field actuators 28 due to temperature or mechanical stresses. Thus, in addition to performing calibrations ahead of time, the management control loop 54 may perform calibrations techniques during system operation”, and Para. [0142], “the signal acquisition unit 18c takes advantage of the high dynamic range of the coarse magnetometers 26a to compensate for the relatively low dynamic range of the fine magnetometers 26b to cancel the large outside magnetic field”, and Para. [0173], “Referring to FIG. 9, the set of magnetic field actuators 28 comprises three uniform magnetic field actuators 28a-28c, such that 0.sup.th spatial order cancellation of the outside magnetic field B.sub.OUT in the x, y, and z directions can be achieved. The three uniform magnetic field actuators 28a-28c respectively comprise Helmholtz coils 82a-82c (coil.sub.x, coil.sub.y, coil.sub.z) that are orthogonally arranged relative to each other to generate actuated magnetic fields […] which combine to create the actuated magnetic field”).
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 the system of Weber by including the system further comprising one or more coils configured to generate a magnetic field for compensating for a background magnetic field detected by the magnetic sensor; and wherein the interventional device further comprises a motion sensor; wherein the motion sensor is mechanically coupled to the interventional device for detecting a motion of the magnetic sensor; and wherein the controller is further configured to: measure the background magnetic field based on signals generated by the magnetic sensor in the absence of magnetic fields produced by nerve activity; apply signals to the one or more coils in order to compensate for the background magnetic field during the measurement of magnetic fields produced by nerve activity; and repeat the measurement of the background magnetic field, and the corresponding applying of signals to the one or more coils, in response to a detection of a motion of the interventional device by the motion sensor, as disclosed by Ledbetter. One of ordinary skill in the art would have been motivated to make this modification in order to desirably cancel the large outside magnetic field within the environmental magnetic field, as recognized by Ledbetter (see, e.g., Para. [0079], [0100], [0142], and [0173]).
Regarding claim 14, Weber modified by Ledbetter discloses the system according to claim 13, as set forth above. Weber does not specifically disclose wherein the signals are generated in response to magnetic fields produced by nerve activity in a subject, and wherein the background magnetic field is generated at least in part by cardiac activity in the subject; and wherein the controller is further configured to receive an electrocardiogram, ECG, signal for the subject; and wherein the controller is configured to apply signals to the one or more coils in order to compensate for the background magnetic field during the measurement of magnetic fields produced by nerve activity, by applying time-dependent signals to the one or more coils in synchronization with the received ECG signal in order to compensate for the cardiac activity.
However, in the same field of endeavor of optically pumped magnetometers, Ledbetter discloses wherein the signals are generated in response to magnetic fields produced by nerve activity in a subject, and wherein the background magnetic field is generated at least in part by cardiac activity in the subject; and wherein the controller is further configured to receive an electrocardiogram, ECG, signal for the subject; and wherein the controller is configured to apply signals to the one or more coils in order to compensate for the background magnetic field during the measurement of magnetic fields produced by nerve activity, by applying time-dependent signals to the one or more coils in synchronization with the received ECG signal in order to compensate for the cardiac activity (see, e.g., Para. [0079], “To this end, the neural activity measurement system 10 generally comprises a signal acquisition unit 18 configured for at least partially cancelling a relatively strong outside magnetic field B.sub.OUT within an environmental magnetic field […] The outside magnetic field B.sub.OUT may emanate from global sources (e.g., the Earth's magnetic field), and from localized sources, including, but not limited to, […] biomagnetics unrelated to neural signals (such as facial muscles, magnetic fields produced by the heart or nerves firing), […] user motion/rotation/translation in a background field (earth field), […] active implantable medical devices (pacemakers)”, and Para. [0173], “Referring to FIG. 9, the set of magnetic field actuators 28 comprises three uniform magnetic field actuators 28a-28c, such that 0.sup.th spatial order cancellation of the outside magnetic field B.sub.OUT in the x, y, and z directions can be achieved. The three uniform magnetic field actuators 28a-28c respectively comprise Helmholtz coils 82a-82c (coil.sub.x, coil.sub.y, coil.sub.z) that are orthogonally arranged relative to each other to generate actuated magnetic fields […] which combine to create the actuated magnetic field”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the system of Weber modified by Ledbetter by including wherein the signals are generated in response to magnetic fields produced by nerve activity in a subject, and wherein the background magnetic field is generated at least in part by cardiac activity in the subject; and wherein the controller is further configured to receive an electrocardiogram, ECG, signal for the subject; and wherein the controller is configured to apply signals to the one or more coils in order to compensate for the background magnetic field during the measurement of magnetic fields produced by nerve activity, by applying time-dependent signals to the one or more coils in synchronization with the received ECG signal in order to compensate for the cardiac activity, as disclosed by Ledbetter. One of ordinary skill in the art would have been motivated to make this modification in order to desirably cancel the large outside magnetic field within the environmental magnetic field, as recognized by Ledbetter (see, e.g., Para. [0079], [0100], [0142], and [0173]).
Regarding claim 15, Weber modified by Ledbetter discloses the system according to claim 13, as set forth above. Weber does not specifically disclose wherein the controller is further configured to: receive tracking data representing a position of the magnetic sensor within a sensing region; receive a 3D background magnetic field map representing a background magnetic field distribution in the sensing region; and estimate a magnitude of the background magnetic field distribution at the position of the magnetic sensor within the sensing region based on the received tracking data and the received 3D background magnetic field map; and wherein the controller is configured to apply signals to the one or more coils in order to compensate for the background magnetic field during the measurement of magnetic fields produced by nerve activity, based at least in part on the estimated magnitude of the background magnetic field distribution at the position of the magnetic sensor.
However, in the same field of endeavor of optically pumped magnetometers, Ledbetter discloses wherein the controller is further configured to: receive tracking data representing a position of the magnetic sensor within a sensing region (see, e.g., Para. [0126], “The management control loop 54 may perform calibration techniques prior to operating the neural activity measurement system 10, or calibration techniques may be performed in real-time as the neural activity measurement system 10 operates. For example, prior to usage, the signal acquisition unit 18a may be calibrated by applying a known magnetic field in a controlled shielded setting (e.g., to characterize the coarse magnetometers 26a for their offsets and gain measurements). However, the properties of coarse magnetometers 26a, fine magnetometers 26b, or set of magnetic field actuators 28 may vary due to environmental variations, such as, e.g., variations in temperature, laser power (for magnetometers that utilize lasers), motion or deformation of the support structure 24, or other deformations, such as bending of the coarse magnetometers 26a, fine magnetometers 26b, or offset of magnetic field actuators 28 due to temperature or mechanical stresses. Thus, in addition to performing calibrations ahead of time, the management control loop 54 may perform calibrations techniques during system operation”); receive a 3D background magnetic field map representing a background magnetic field distribution in the sensing region; and estimate a magnitude of the background magnetic field distribution at the position of the magnetic sensor within the sensing region based on the received tracking data and the received 3D background magnetic field map; and wherein the controller is configured to apply signals to the one or more coils in order to compensate for the background magnetic field during the measurement of magnetic fields produced by nerve activity, based at least in part on the estimated magnitude of the background magnetic field distribution at the position of the magnetic sensor (see, e.g., Para. [0079], “To this end, the neural activity measurement system 10 generally comprises a signal acquisition unit 18 configured for at least partially cancelling a relatively strong outside magnetic field B.sub.OUT within an environmental magnetic field […] The outside magnetic field B.sub.OUT may emanate from global sources (e.g., the Earth's magnetic field), and from localized sources, including, but not limited to, […] biomagnetics unrelated to neural signals (such as facial muscles, magnetic fields produced by the heart or nerves firing), […] user motion/rotation/translation in a background field (earth field), […] active implantable medical devices (pacemakers)”, and Para. [0100], “As shown in FIG. 4, one embodiment of a signal acquisition unit 18a takes advantage of the high dynamic range of the coarse magnetometers 26a to compensate for the relatively low dynamic range of the fine magnetometers 26b to cancel the large outside magnetic field B.sub.OUT, while also taking advantage of high sensitivity of the fine magnetometers 26b to compensate for the low sensitivity of the coarse magnetometers 26a to measure the MEG signal”, and Para. [0126], “the signal acquisition unit 18a may be calibrated by applying a known magnetic field in a controlled shielded setting […] the properties of coarse magnetometers 26a, fine magnetometers 26b, or set of magnetic field actuators 28 may vary due to environmental variations, such as, e.g., […] other deformations, such as bending of the coarse magnetometers 26a, fine magnetometers 26b, or offset of magnetic field actuators 28 due to temperature or mechanical stresses. Thus, in addition to performing calibrations ahead of time, the management control loop 54 may perform calibrations techniques during system operation”, and Para. [0142], “the signal acquisition unit 18c takes advantage of the high dynamic range of the coarse magnetometers 26a to compensate for the relatively low dynamic range of the fine magnetometers 26b to cancel the large outside magnetic field”, and Para. [0173], “Referring to FIG. 9, the set of magnetic field actuators 28 comprises three uniform magnetic field actuators 28a-28c, such that 0.sup.th spatial order cancellation of the outside magnetic field B.sub.OUT in the x, y, and z directions can be achieved. The three uniform magnetic field actuators 28a-28c respectively comprise Helmholtz coils 82a-82c (coil.sub.x, coil.sub.y, coil.sub.z) that are orthogonally arranged relative to each other to generate actuated magnetic fields […] which combine to create the actuated magnetic field”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the system of Weber modified by Ledbetter by including wherein the controller is further configured to: receive tracking data representing a position of the magnetic sensor within a sensing region; receive a 3D background magnetic field map representing a background magnetic field distribution in the sensing region; and estimate a magnitude of the background magnetic field distribution at the position of the magnetic sensor within the sensing region based on the received tracking data and the received 3D background magnetic field map; and wherein the controller is configured to apply signals to the one or more coils in order to compensate for the background magnetic field during the measurement of magnetic fields produced by nerve activity, based at least in part on the estimated magnitude of the background magnetic field distribution at the position of the magnetic sensor, as disclosed by Ledbetter. One of ordinary skill in the art would have been motivated to make this modification in order to desirably cancel the large outside magnetic field within the environmental magnetic field, as recognized by Ledbetter (see, e.g., Para. [0079], [0100], [0142], and [0173]).
Conclusion
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/T.D./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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