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 remarks filed on 09/02/2025.
The amendment filed 09/02/2025 has been entered. Claims 1 and 4-19 remain pending in the application, claims 2-3 have been previously canceled, and claims 21-22 have been newly added.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5 recites “wherein generating the spread spectrum signal having the binary pseudo-noise signal scheme includes generating a time varying magnetic field signal between 10 Hz and about 400 kHz”, rather, this should recite “wherein generating the spread spectrum signal having the binary pseudo-noise signal scheme includes generating a time varying magnetic field signal between 10 Hz and [[about]] 400 kHz--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 11 recites the limitation “determining coefficients to remove hardware distortion between each coil of the plurality of coils and the tracking device” in lines 12-13. Paragraph [0091] of the specification discloses that “The equalization is performed by determining coefficients. In particular, an algorithm may be used to determine the coefficients in a test or calibration equalization determination. Equalization may be performed in any appropriate manner, including those generally understood by one skilled in the art. For example, optimize and combine finite impulse response (FIR) and bidirectional infinite impulse response (IIR) filters may be used to equalize channels. The determined coefficients may be used to remove hardware distortion in the equalization between the localizer coil 200 and any coil of the tracking device 66”. However, this does not provide support for the limitation in sufficient detail as to how the coefficients are determined, and it is unclear how FIR or bidirectional IIR filters derives coefficients, which then remove hardware distortion. See MPEP 2161.01, Section I. For examination purposes, this limitation will be interpreted as determining distortion in the signal.
Claims 12-19 are rejected due to dependency on claim 11.
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 and 4-10 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.
The term “of about 1 millisecond to 20 milliseconds ” in claim 1 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 4-10 are rejected due to dependency on claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Wright et. al (US 20090299174 A1, hereinafter "Wright ‘174", previously cited) in view of Wright (US Pub No. 20050154283, hereinafter “Wright ‘283”), and Barnes (US 20080272913 A1).
Regarding claim 1, Wright ‘174 teaches a method of tracking a tracking device with a navigation system in a navigation space (tracking an instrument [0038]), comprising:
generating a spread spectrum signal (the excitation source 60 shown in FIG. 4A produces a pulsed magnetic field at different frequencies (E1-E3) [0054]-[0056]);
connecting a controller (controller [0054]) configured to generate a tracking signal based on the generated spread spectrum signal (the catheter is tracked as it passes through the vessel by (a) wirelessly delivering a pulsed magnetic field to energize the marker, (b) wirelessly transmitting a pulsed location signal from the marker [0040]) to a plurality of coils (source coils 1052 [0098]), each coupled to an H-bridge system (Each H-bridge switch 1050 controls the energy flow between the energy storage device 1042 and one of the source coils 1052 [0098]; each coil 1052 is connected to an H-Bridge system shown in fig. 10 below; fig. 10 [0093]);
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Snippet of fig. 10 of Wright ‘174 reproduced above
transmitting the tracking signal including the generated spread spectrum signal (excitation source 60 can frequency multiplex the magnetic field at a first frequency E1 to energize the first marker 40 a, a second frequency E2 to energize the second marker 40 b, and a third frequency E3 to energize the third marker 40 c. In response to the excitation energy, the markers 40 a-c generate location signals L1-3, respectively, at unique response frequencies [0054]; location signals are analogous to the tracking signals) from the coil (source coils 1052 [0098]);
determining a pose of the tracking device … from the received tracking signal (includes instructions to determine the absolute positions of each of the markers 40 a-c in a three-dimensional reference frame. Based on signals provided by the sensor assembly 70 that correspond to the magnitude of each of the location signals L1-3, the controller 80 and/or a separate signal processor calculate the absolute coordinates of each of the markers 40 a-c in the three-dimensional reference frame [0057]);
Wright ‘174, however, does not teach:
generating a spread spectrum signal [having a binary pseudo-noise signal scheme];
[transmitting the tracking signal including the generated spread spectrum signal] from the plurality of coils having an inter-coil offset of a selected time delay spacing of about 1 millisecond to 20 milliseconds for driving each of the plurality of coils;
demultiplexing and equalizing the received tracking signal, wherein equalizing includes removing distortion from the received signal at the tracking device relative to the generated spread spectrum signal;
recovering an impulse response signal from the demultiplexed and equalized tracking signal from the plurality of coils;
determining a pose of the tracking device with the impulse response recovered from the received tracking signal.
Wright ‘283, is considered analogous to the instant application as a magnetic system is disclosed ([0028]). Wright teaches:
generating a spread spectrum signal (the excitation source 202 has an adjustable frequency that can be tuned… The frequencies of the exciting pulses ranging from Fs to Fe incremented by ΔF constitute a set of frequencies used to excite the marker. [0077]-[0080]; a range of frequencies emitted is analogous to spread spectrum) having a binary pseudo-noise signal scheme (Receiver and Exciting Source Con figured for Pseudo-random Excitation [0099]; the receiver 208 includes a pseudo-random excitation dithering circuit 508… randomly vary the polarity of each exciting pulse 601. For example a first exciting pulse may start with a positive going cycle, while a second exciting pulse may start with a negative going cycle. In other words, the first exciting pulse may be 180 degrees out of phase with the second exciting pulse [0103]; as the signal is switching between two polarities, it is therefore “binary”);
demultiplexing (The effect of the dithering would spread out or "decohere" any periodic noise [0102]; This random polarity of the exciting pulses 601 will also decohere any periodic noise, turning the periodic noise into random noise that can be eliminated by signal processing [0103]) and equalizing (the receiver 208 is adapted to have a narrow bandpass filter to suppress the excitation frequency and pass the returned frequency [0106]) the received tracking signal (determining the location of a marker that is excited with an exciting waveform. A sensing array having coils is used to sense magnetic flux from the resonating marker [abstract]), wherein equalizing includes removing distortion from the received signal at the tracking device relative to the generated spread spectrum signal (removing distortion/noise/interference from the received signal is disclosed in [0063], [0102]-[0103]; [0103] further discloses that eliminating noise, i.e. distortion occurs relative to the generated spread spectrum)
recovering an impulse response signal (The relationship between a signal output by a marker 206 in response to an excitation from the excitation system 202 is modeled as follows… with corresponding impulse response [0139]-[0140]; analytic representation of the impulse response of the resonant marker [0148]; pulse and the marker impulse response [0151]) from the demultiplexed and equalized tracking signal from the plurality of coils (the signal is processed after signal processing as disclosed in: Pseudo-random Excitation [0099]; the receiver 208 includes a pseudo-random excitation dithering circuit 508 [0103]; This random polarity of the exciting pulses 601 will also decohere any periodic noise, turning the periodic noise into random noise that can be eliminated by signal processing [0103]; the receiver 208 is adapted to have a narrow bandpass filter to suppress the excitation frequency and pass the returned frequency [0106]);
determining a pose of the tracking device (three-dimensional coordinates [0054]) with the impulse response recovered from the received tracking signal (After the receiver 208 has completed the signal processing detailed above, the resulting output of the receiver 208 is thirty-two "cleaned up" digital output signals. These digital output signals may then be used to locate the marker [0212]; the signal processing includes demultiplexing and equalizing, as disclosed above).
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 invention of Wright ‘174, to include generating a spread spectrum signal having a binary pseudo-noise signal scheme, demultiplexing and equalizing the received tracking signal, wherein equalizing includes removing distortion from the received signal at the tracking device relative to the generated spread spectrum signal, recovering an impulse response signal from the demultiplexed and equalized tracking signal from the coil, determining a pose of the tracking device with the impulse response recovered from the received tracking signal, as taught by Wright ‘283. Doing so would reduce random noise, as suggested by Wright ‘283 ([0102]).
Although Wright ’283 discloses offsetting the time of the pulse (the receiver 208 includes a pseudo-random excitation dithering circuit 508 (see FIG. 5) that will randomly offset the start timing of each exciting pulse 601 relative to previous or future exciting pulses. In one embodiment, the dithering circuit 508 will offset the timing of each exciting pulse 601 by a random fraction of one period of the carrier frequency of the exciting pulse 601, e.g., at 400 KHz dither from 0 to 2.5 microseconds [0098]), the combined invention still does not teach: [transmitting the tracking signal including the generated spread spectrum signal] from the plurality of coils having an inter-coil offset of a selected time delay spacing of about 1 millisecond to 20 milliseconds for driving each of the plurality of coils.
Barnes is considered analogous to the instant application as a surgical device is disclosed ([0002]). Barnes teaches:
transmitting the tracking signal including the generated spread spectrum signal (The custom logic in the FPGA 108 generates the timing and control signals for each pulse 410. …. A dither portion 410 e of the pulse 410 has a random variable length of time, and may, for example be generated by a pseudo-noise (PN) sequence generator [0014]) from the plurality of coils having an inter-coil offset (a transponder detection system includes transmitting means for transmitting electromagnetic interrogation signals [0015]; The transponder 26 a includes a miniature ferrite rod 30 with a conductive coil 32 [0058]) of a selected time delay spacing of about … milliseconds for driving each of the plurality of coils (FIG. 9 illustrates pulse timing [0113]; . A dither portion 410 e of the pulse 410 has a random variable length of time, and may, for example be generated by a pseudo-noise (PN) sequence generator. Adding a random length of time between pulses de-correlates the response signal received from the transponder 26 from constant frequency sources of interference, if any…within each of 150 millisecond measurement intervals discussed above, the custom logic of the FPGA 108 [0114]-[0115]).
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 invention of Wright ‘174, to include transmitting the tracking signal including the generated spread spectrum signal from the plurality of coils having an inter-coil offset of a selected time delay spacing of milliseconds for driving each of the plurality of coils, as taught by Barnes. Doing so would de-correlates the response signal received from the transponder from constant frequency sources of interference, as suggested by Barnes ([0114]).
Although the reference is silent regarding transmitting the tracking signal including the generated spread spectrum signal from the plurality of coils having an inter-coil offset of a selected time delay spacing of about 1 millisecond to 20 milliseconds for driving each of the plurality of coils, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, through routine optimization, to change the time delay spacing of Wright ‘174 to 1 millisecond to 20 milliseconds in order to de-correlate the response signal received from the transponder 26 from constant frequency sources of interference, as suggested by Barnes ([0114]). See MPEP 2144.05, II.A
Regarding claim 6, modified Wright ‘174 teaches the method of claim 1, as discussed above. Although Wright ‘174 teaches generating the spread spectrum signal (the excitation source 60 shown in FIG. 4A produces a pulsed magnetic field at different frequencies (E1-E3) [0054]-[0056]), the combined invention does not teach [wherein generating the spread spectrum signal] having the binary pseudo-noise signal scheme is a binary orthogonal or near orthogonal signal.
Wright ‘283, however, teaches the generating the spread spectrum signal having the binary pseudo-noise signal scheme is a binary pseudo-noise signal scheme (Receiver and Exciting Source Con figured for Pseudo-random Excitation [0099]; the receiver 208 includes a pseudo-random excitation dithering circuit 508… randomly vary the polarity of each exciting pulse 601. For example a first exciting pulse may start with a positive going cycle, while a second exciting pulse may start with a negative going cycle. In other words, the first exciting pulse may be 180 degrees out of phase with the second exciting pulse [0103]; as the signal is switching between two polarities, it is therefore “binary”) is a binary orthogonal or near orthogonal signal (Frequency Orthogonality… the excitation intervals and observation intervals are orthogonal temporally [0106]-[0107]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the modified the combined invention of Wright ‘174, to include generating the spread spectrum signal having the binary pseudo-noise signal scheme is a binary orthogonal or near orthogonal signal, as taught by Wright ‘283. Doing so would avoid interference, as suggested by Wright ‘283 ([0106]).
Regarding claim 7, modified Wright ‘174 teaches the method of claim 6, as discussed above. Wright ‘174, however, does not teach the method wherein generating the binary orthogonal or near orthogonal signal includes generating a plurality of pseudo-noise signals that are binary orthogonal or near orthogonal signals.
Wright ‘283, however, teaches: wherein generating the binary orthogonal or near orthogonal signal (Receiver and Exciting Source Con figured for Pseudo-random Excitation [0099]; the receiver 208 includes a pseudo-random excitation dithering circuit 508… randomly vary the polarity of each exciting pulse 601. For example a first exciting pulse may start with a positive going cycle, while a second exciting pulse may start with a negative going cycle. In other words, the first exciting pulse may be 180 degrees out of phase with the second exciting pulse [0103]; as the signal is switching between two polarities, it is therefore “binary” ) includes generating a plurality of pseudo-noise signals (Receiver and Exciting Source Con figured for Pseudo-random Excitation [0099]; the receiver 208 includes a pseudo-random excitation dithering circuit 508… randomly vary the polarity of each exciting pulse 601. For example a first exciting pulse may start with a positive going cycle, while a second exciting pulse may start with a negative going cycle. In other words, the first exciting pulse may be 180 degrees out of phase with the second exciting pulse [0103]; as the signal is switching between two polarities, it is therefore “binary”) that are binary orthogonal or near orthogonal signals (Frequency Orthogonality… the excitation intervals and observation intervals are orthogonal temporally [0106]-[0107]; the sensing array has thirty-two sensing coils 302. After the receiver 208 has completed the signal processing detailed above, the resulting output of the receiver 208 is thirty-two "cleaned up" digital output signals [0212]; para. [0034] discloses that a plurality of signals are emitted).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the modified the combined invention of Wright ‘174, to include generating the binary orthogonal or near orthogonal signal includes generating a plurality of pseudo-noise signals that are binary orthogonal or near orthogonal signals, as taught by Wright ‘283. Doing so would avoid interference, as suggested by Wright ‘283 ([0106]).
Regarding claim 8, modified Wright ‘174 teaches the method of Claim 7, as discussed above. Wright ‘174 further teaches:
wherein transmitting the generated spread spectrum signal as the tracking signal from the plurality of coils includes transmitting from a first localizer coil of a plurality of localizer coils a first tracking signal (excitation source 60 can frequency multiplex the magnetic field at a first frequency E1 to energize the first marker 40 a, a second frequency E2 to energize the second marker 40 b, and a third frequency E3 to energize the third marker 40 c. In response to the excitation energy, the markers 40 a-c generate location signals L1-3, respectively, at unique response frequencies [0054]; location signals are analogous to tracking signals; Each H-bridge switch 1050 controls the energy flow between the energy storage device 1042 and one of the source coils 1052 [0098]; plurality of localizer coils are used)
wherein receiving the tracking signal includes receiving the first tracking signal with a first tracking device coil of the tracking device (plurality of coils to sense the location signals L1 [0055]);
Wright ‘174, however, does not teach: evaluating the recovered impulse response signal to determine if a distorting object is present at least by determining if a residual signal is present in addition to an initial impulse of the recovered impulse response signal, [wherein transmitting the generated spread spectrum signal as the tracking signal from the plurality of coils includes transmitting from a first localizer coil of a plurality of localizer coils a first tracking signal] as the tracking signal that is at least one generated binary pseudo-noise signal of the generated plurality of the binary orthogonal or near orthogonal signals; and wherein processing the received tracking signal includes de-multiplexing and equalizing the received first tracking signal and recovering the impulse response from the received first tracking signal between the first localizer coil and the first tracking device coil.
Wright ‘283 however, teaches the method:
evaluating the recovered impulse response signal to determine if a distorting object is present at least by determining if a residual signal is present in addition to an initial impulse of the recovered impulse response signal (The relationship between a signal output by a marker 206 in response to an excitation from the excitation system 202 is modeled as follows… with corresponding impulse response [0139]-[0140]; analytic representation of the impulse response of the resonant marker [0148]; pulse and the marker impulse response [0151]; an impulse response signal is recovered from the processed signal, [0148]-[0149] discloses the entire impulse response, i.e. residual signal and impulse response);
wherein transmitting the generated spread spectrum signal as the tracking signal from the plurality of coils (Receiver and Exciting Source Con figured for Pseudo-random Excitation [0099]; the receiver 208 includes a pseudo-random excitation dithering circuit 508… randomly vary the polarity of each exciting pulse 601. For example a first exciting pulse may start with a positive going cycle, while a second exciting pulse may start with a negative going cycle. In other words, the first exciting pulse may be 180 degrees out of phase with the second exciting pulse [0103]; a sensing assembly 301 having a plurality of coils 302 [0036]; as the signal is switching between two polarities, it is therefore “binary” ) includes transmitting from a first localizer coil of a plurality of localizer coils a first tracking signal as the tracking signal that is at least one generated binary pseudo-noise signal (Receiver and Exciting Source Con figured for Pseudo-random Excitation [0099]; the receiver 208 includes a pseudo-random excitation dithering circuit 508… randomly vary the polarity of each exciting pulse 601. For example a first exciting pulse may start with a positive going cycle, while a second exciting pulse may start with a negative going cycle. In other words, the first exciting pulse may be 180 degrees out of phase with the second exciting pulse [0103]; as the signal is switching between two polarities, it is therefore “binary”) of the generated plurality of the binary orthogonal or near orthogonal signals (Frequency Orthogonality… the excitation intervals and observation intervals are orthogonal temporally [0106]-[0107]; the sensing array has thirty-two sensing coils 302. After the receiver 208 has completed the signal processing detailed above, the resulting output of the receiver 208 is thirty-two "cleaned up" digital output signals [0212]);
and wherein processing the received tracking signal includes de-multiplexing (The effect of the dithering would spread out or "decohere" any periodic noise [0102]; This random polarity of the exciting pulses 601 will also decohere any periodic noise, turning the periodic noise into random noise that can be eliminated by signal processing [0103]) and equalizing (the receiver 208 is adapted to have a narrow bandpass filter to suppress the excitation frequency and pass the returned frequency [0106]) the received first tracking signal (determining the location of a marker that is excited with an exciting waveform. A sensing array having coils is used to sense magnetic flux from the resonating marker (abstract) and recovering the impulse response (The relationship between a signal output by a marker 206 in response to an excitation from the excitation system 202 is modeled as follows… with corresponding impulse response [0139]-[0140]; analytic representation of the impulse response of the resonant marker [0148]; pulse and the marker impulse response [0151]) from the received first tracking signal (the signal is processed after signal processing as disclosed in: Pseudo-random Excitation [0099]; the receiver 208 includes a pseudo-random excitation dithering circuit 508 [0103]; This random polarity of the exciting pulses 601 will also decohere any periodic noise, turning the periodic noise into random noise that can be eliminated by signal processing [0103]; the receiver 208 is adapted to have a narrow bandpass filter to suppress the excitation frequency and pass the returned frequency [0106]) between the first localizer coil and the first tracking device coil (the sensing array has thirty-two sensing coils 302. After the receiver 208 has completed the signal processing detailed above, the resulting output of the receiver 208 is thirty-two "cleaned up" digital output signals. These digital output signals may then be used to locate the marker. [0212]).
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 combined invention of Wright ‘174 to include evaluating the recovered impulse response signal to determine if a distorting object is present at least by determining if a residual signal is present in addition to an initial impulse of the recovered impulse response signal, wherein transmitting the generated spread spectrum signal as the tracking signal from the plurality of coils includes transmitting from a first localizer coil of a plurality of localizer coils a first tracking signal as the tracking signal that is at least one generated binary pseudo-noise signal of the generated plurality of the binary orthogonal or near orthogonal signals, and wherein processing the received tracking signal includes de-multiplexing and equalizing the received first tracking signal and recovering the impulse response from the received first tracking signal between the first localizer coil and the first tracking device coil, as taught by Wright ‘283. Doing so would avoid interference, as suggested by Wright ‘283 ([0106]).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Wright et. al (US 20090299174 A1, hereinafter "Wright ‘174", previously cited) in view of Wright (US Pub No. 20050154283, hereinafter “Wright ‘283”), Barnes (US 20080272913 A1), and Schneider et al. (US 20190226826 A1, hereinafter "Schneider", previously cited).
Regarding claim 4, modified Wright ‘174 teaches the method of claim 1, as discussed above. Wright further teaches generating a spread spectrum signal (the excitation source 60 shown in FIG. 4A produces a pulsed magnetic field at different frequencies (E1-E3) [0054]-[0056]). Wright, however, does not teach the binary pseudo-noise signal scheme includes generating a time varying magnetic field signal between 10 Hz and 30 Mhz.
Wright ‘283 teaches the binary pseudo-noise signal scheme (Receiver and Exciting Source Con figured for Pseudo-random Excitation [0099]; the receiver 208 includes a pseudo-random excitation dithering circuit 508… randomly vary the polarity of each exciting pulse 601. For example a first exciting pulse may start with a positive going cycle, while a second exciting pulse may start with a negative going cycle. In other words, the first exciting pulse may be 180 degrees out of phase with the second exciting pulse [0103]; as the signal is switching between two polarities, it is therefore “binary”).
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 combined invention of Wright ‘174, to include a binary pseudo-noise signal scheme, as taught by Wright ‘283. Doing so would reduce random noise, as suggested by Wright ‘283 ([0102]).
Modified Wright ‘174 still does not teach generating a time varying magnetic field signal between 10 Hz and 30 MHz. Schneider discloses “Calibrating a Magnetic Sensor” (title) and is in applicant’s field of endeavor of A61B2034/2051. Schneider teaches generating a time varying magnetic field signal between 10 Hz and 30Mhz (magnetic fields generated at a relatively low frequency of about 90 Hz [0031]).
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 combined invention of Wright ‘174 to include generating a time varying magnetic field signal between 10 Hz and 30Mhz, as taught by Schneider, in order to reduce or eliminate the occurrence of eddy currents, thereby allowing the sensor to receive the intended (e.g., true) magnetic fields, as taught by Schneider ([0031]).
Regarding claim 5, modified Wright ‘174 teaches the method of claim 1, as discussed above. Wright further teaches generating a spread spectrum signal (the excitation source 60 shown in FIG. 4A produces a pulsed magnetic field at different frequencies (E1-E3) [0054]-[0056]). Wright, however, does not teach the binary pseudo-noise signal scheme includes generating a time varying magnetic field signal between 10 Hz and 400 kHz.
Wright ‘283 teaches a binary pseudo-noise signal scheme (Receiver and Exciting Source Con figured for Pseudo-random Excitation [0099]; the receiver 208 includes a pseudo-random excitation dithering circuit 508… randomly vary the polarity of each exciting pulse 601. For example a first exciting pulse may start with a positive going cycle, while a second exciting pulse may start with a negative going cycle. In other words, the first exciting pulse may be 180 degrees out of phase with the second exciting pulse [0103]; as the signal is switching between two polarities, it is therefore “binary”).
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 combined invention of Wright ‘174, to include a binary pseudo-noise signal scheme, as taught by Wright ‘283. Doing so would reduce random noise, as suggested by Wright ‘283 ([0102]).
Modified Wright ‘174 still does not teach generating a time varying magnetic field signal between 10 Hz and 400 Hz. Schneider discloses “Calibrating a Magnetic Sensor” (title) and is in applicant’s field of endeavor of A61B2034/2051. Schneider teaches generating a time varying magnetic field signal between 10 Hz and 400 kHz (magnetic fields generated at a relatively low frequency of about 90 Hz [0031]).
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 combined invention of Wright ‘174 to include generating a time varying magnetic field signal between 10 Hz and 400 kHz, as taught by Schneider, in order to reduce or eliminate the occurrence of eddy currents, thereby allowing the sensor to receive the intended (e.g., true) magnetic fields, as taught by Schneider ([0031]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Wright et. al (US 20090299174 A1, hereinafter "Wright ‘174", previously cited) in view of Wright (US Pub No. 20050154283, hereinafter “Wright ‘283”), Barnes (US 20080272913 A1), and Lorraine et al. (US 20160015292 A1, hereinafter "Lorraine") .
Regarding claim 9, modified Wright ‘174 teaches the method of claim 7, as discussed above. Wright further teaches a method wherein transmitting the tracking signal includes transmitting the plurality of tracking signals from one of a plurality of localizer coils by transmitting singly one of the tracking signals from each localizer coil (excitation source 60 can frequency multiplex the magnetic field at a first frequency E1 to energize the first marker 40 a, a second frequency E2 to energize the second marker 40 b, and a third frequency E3 to energize the third marker 40 c. In response to the excitation energy, the markers 40 a-c generate location signals L1-3, respectively, at unique response frequencies [0054]; location signals are analogous to tracking signals; Each H-bridge switch 1050 controls the energy flow between the energy storage device 1042 and one of the source coils 1052 [0098]).
Wright ‘174, however, does not teach wherein the plurality of tracking signals include the same binary pseudo-noise signal that is delayed by a different amount for each coil of the plurality of localizer coil.
Lorraine is considered analogous to the instant application as “Magnetic tracker system and method for use for surgical navigation” is disclosed (title). Lorraine teaches:
the plurality of tracking signals (a magnetic tracking system for tracking a device of interest. The system includes a transmitter circuit configured to generate a plurality of magnetic fields based on corresponding pre-determined multi-frequency signal [0009]) include the same binary pseudo-noise signal that is delayed by a different amount for each coil of the plurality of localizer coil (the pre-determined multi-frequency signals may be a non-sinusoidal waveform such as a square wave or binary code/sequence. For example, each of the multi-frequency signals may be a separate pseudo-random sequence of bits or binary Golay code. [0037])
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 combined invention of Wright ‘174, to include wherein the plurality of tracking signals include the same binary pseudo-noise signal that is delayed by a different amount for each coil of the plurality of localizer coil, as taught by Lorraine. Doing so would allow for a desired signal to noise ratio, as suggested by Lorraine ([0037]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wright et. al (US 20090299174 A1, hereinafter "Wright ‘174", previously cited) in view of Wright (US Pub No. 20050154283, hereinafter “Wright ‘283”), Barnes (US 20080272913 A1), and Valdastri et al. (US 20190104994 A1, hereinafter, "Valdastri", previously cited).
Regarding claim 10, modified Wright ‘174 teaches the method of claim 7, as discussed above. Wright ‘174, however does not teach does not teach a method wherein receiving the of tracking signal includes receiving a plurality of tracking signals with a first tracking device coil of the tracking device; wherein demultiplexing and equalizing the received tracking signal includes de- multiplexing and equalizing each received tracking signal of the plurality of tracking signals received first tracking signal and recovering the impulse response from the received plurality of tracking signals between each localizer coil of the plurality of localizer coils and the first tracking device coil.
Valdastri discloses “Robotic Capsule System with Magnetic Actuation and Localization” (title) and is in applicant’s field of endeavor of A61B2034/2051. Valdastri teaches a method wherein receiving the of tracking signal includes receiving a plurality of tracking signals with a first tracking device coil of the tracking device (the signal is demodulated at the capsule to recover the original virtual DC signal from the electromagnetic coil [0039]; The pose of the capsule is then determined based at least in part on a combination of magnetic field signals applied by the electromagnetic coil to each of the magnetic field sensors [0007] ;one coil receives a signal that is demodulated, therefore it is implicit that the coil receives a plurality of signals).
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 combined invention of Wright ‘174, to include receiving the of tracking signal includes receiving a plurality of tracking signals with a first tracking device coil of the tracking device, as taught by Valdastri, in order solve the problem of singularity in the magnetic field wherein, due to symmetry in the field, the capsule can be located in a number of different positions and the localization is not able to identify the correct one, as suggested by Valdastri ([0005]).
Modified Wright ‘174 sill does not teach demultiplexing and equalizing the received tracking signal includes demultiplexing and equalizing each received tracking signal of the plurality of tracking signals received first tracking signal and recovering the impulse response from the received plurality of tracking signals between each localizer coil of the plurality of localizer coils and the first tracking device coil.
Wright ‘283, however teaches demultiplexing and equalizing the received tracking signal includes demultiplexing (The effect of the dithering would spread out or "decohere" any periodic noise [0102]; This random polarity of the exciting pulses 601 will also decohere any periodic noise, turning the periodic noise into random noise that can be eliminated by signal processing [0103]) and equalizing each received tracking signal of the plurality of tracking signals received first tracking signal (the receiver 208 is adapted to have a narrow bandpass filter to suppress the excitation frequency and pass the returned frequency [0106]) and recovering the impulse response from the received plurality of tracking signals (The relationship between a signal output by a marker 206 in response to an excitation from the excitation system 202 is modeled as follows… with corresponding impulse response [0139]-[0140]; analytic representation of the impulse response of the resonant marker [0148]; pulse and the marker impulse response [0151]) between each localizer coil of the plurality of localizer coils and the first tracking device coil(the sensing array has thirty-two sensing coils 302. After the receiver 208 has completed the signal processing detailed above, the resulting output of the receiver 208 is thirty-two "cleaned up" digital output signals. These digital output signals may then be used to locate the marker. [0212])..
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 combined invention of Wright ‘174, to include teach demultiplexing and equalizing the received tracking signal includes demultiplexing and equalizing each received tracking signal of the plurality of tracking signals received first tracking signal and recovering the impulse response from the received plurality of tracking signals between each localizer coil of the plurality of localizer coils and the first tracking device coil, as taught by Wright ‘283. Doing so would reduce random noise, as suggested by Wright ‘283 ([0102]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Wright (US Pub No. 20050154283, hereinafter “Wright ‘283”) in view of Wright et. al (US 20090299174 A1, hereinafter "Wright ‘174", previously cited), and Barnes (US 20080272913 A1),
Regarding claim 11, Wright ‘283 teaches a method of determining whether a distorting object is present when tracking a tracking device with a navigation system in a navigation space, comprising:
generating a binary pseudo-noise signal (Receiver and Exciting Source Con figured for Pseudo-random Excitation [0099]; the receiver 208 includes a pseudo-random excitation dithering circuit 508… randomly vary the polarity of each exciting pulse 601. For example a first exciting pulse may start with a positive going cycle, while a second exciting pulse may start with a negative going cycle. In other words, the first exciting pulse may be 180 degrees out of phase with the second exciting pulse [0103]; as the signal is switching between two polarities, it is therefore “binary”);
transmitting the tracking signal (determining the location of a marker that is excited with an exciting waveform. A sensing array having coils is used to sense magnetic flux from the resonating marker [abstract]) including a spread spectrum signal (the excitation source 202 has an adjustable frequency that can be tuned… The frequencies of the exciting pulses ranging from Fs to Fe incremented by ΔF constitute a set of frequencies used to excite the marker. [0077]-[0080]; a range of frequencies emitted is analogous to spread spectrum) having the generated binary pseudo-noise signal (Receiver and Exciting Source Con figured for Pseudo-random Excitation [0099]; the receiver 208 includes a pseudo-random excitation dithering circuit 508… randomly vary the polarity of each exciting pulse 601. For example a first exciting pulse may start with a positive going cycle, while a second exciting pulse may start with a negative going cycle. In other words, the first exciting pulse may be 180 degrees out of phase with the second exciting pulse [0103]; as the signal is switching between two polarities, it is therefore “binary”) with the coil (coils [0038]);
demultiplexing (The effect of the dithering would spread out or "decohere" any periodic noise [0102]; This random polarity of the exciting pulses 601 will also decohere any periodic noise, turning the periodic noise into random noise that can be eliminated by signal processing [0103]) and equalizing (the receiver 208 is adapted to have a narrow bandpass filter to suppress the excitation frequency and pass the returned frequency [0106]) the received tracking signal (determining the location of a marker that is excited with an exciting waveform. A sensing array having coils is used to sense magnetic flux from the resonating marker [abstract]) based on the spread spectrum signal (the excitation source 202 has an adjustable frequency that can be tuned… The frequencies of the exciting pulses ranging from Fs to Fe incremented by ΔF constitute a set of frequencies used to excite the marker. [0077]-[0080]; a range of frequencies emitted is analogous to spread spectrum), wherein equalizing includes removing distortion from the received signal at the tracking device relative to the generated spread spectrum signal (removing distortion/noise/interference from the received signal is disclosed in [0063], [0102]-[0103]; [0103] further discloses that eliminating noise, i.e. distortion occurs relative to the generated spread spectrum);
recovering a full impulse response signal (The relationship between a signal output by a marker 206 in response to an excitation from the excitation system 202 is modeled as follows… with corresponding impulse response [0139]-[0140]; analytic representation of the impulse response of the resonant marker [0148]; pulse and the marker impulse response [0151]) from the equalized tracking signal (the signal is processed after signal processing as disclosed in: Pseudo-random Excitation [0099]; the receiver 208 includes a pseudo-random excitation dithering circuit 508 [0103]; This random polarity of the exciting pulses 601 will also decohere any periodic noise, turning the periodic noise into random noise that can be eliminated by signal processing [0103]; the receiver 208 is adapted to have a narrow bandpass filter to suppress the excitation frequency and pass the returned frequency [0106]);
evaluating the recovered full impulse response signal for residual signal in addition to an initial impulse (The relationship between a signal output by a marker 206 in response to an excitation from the excitation system 202 is modeled as follows… with corresponding impulse response [0139]-[0140]; analytic representation of the impulse response of the resonant marker [0148]; pulse and the marker impulse response [0151]; an impulse response signal is recovered from the processed signal, [0148]-[0149] discloses the entire impulse response, i.e. residual signal and impulse response);
evaluating the evaluated residual signal (determining the location of a marker that is excited with an exciting waveform. A sensing array having coils is used to sense magnetic flux from the resonating marker [abstract]) of the received tracking signal for whether the distorting object is present (detect the presence of interference due to the operation of the radiation delivery apparatus, or any other interfering device [0098]; sources of noise and interference that may have the periodicity include computer equipment, cathode ray tube monitors, medical equipment, and other electronics [0101]); and
determining a pose (locate the marker [0212]), which can include at least some coordinates of at least one of a position or an orientation of the tracking device (three-dimensional coordinates [0054]) based at least on a corrected impulse recovered from the received tracking signal (The relationship between a signal output by a marker 206 in response to an excitation from the excitation system 202 is modeled as follows… with corresponding impulse response [0139]-[0140]; analytic representation of the impulse response of the resonant marker [0148]; pulse and the marker impulse response [0151]) based on the evaluation of the received tracking signal (After the receiver 208 has completed the signal processing detailed above, the resulting output of the receiver 208 is thirty-two "cleaned up" digital output signals. These digital output signals may then be used to locate the marker [0212]).
Wright ‘283, however, does not teach connecting a controller, which is configured to generate a tracking signal, to a plurality of coils, each coil couple to an H-bridge system; [transmitting the tracking signal including a spread spectrum signal having the generated binary pseudo-noise signal] with the plurality of coils having an inter-coil offset of a selected time delay spacing for driving each of the plurality of coils; and receiving the tracking signal at the tracking device.
Wright ‘174 is considered analogous to the instant application, as Wright discloses “Instruments with location markers and methods for tracking instruments through anatomical passageways” (title).
Wright ‘174 teaches:
connecting a controller (controller [0054]), which is configured to generate a tracking signal (the catheter is tracked as it passes through the vessel by (a) wirelessly delivering a pulsed magnetic field to energize the marker, (b) wirelessly transmitting a pulsed location signal from the marker [0040]), to a plurality of coils, each coil couple to with an H-bridge system (H-bridge switches 1050 (identified individually by reference numbers 1050 a-d), and the coil assembly 1046 includes individual source coils 1052 [0098]; location signal [0108] each coil 1052 is connected to an H-Bridge system shown in fig. 10 below; fig. 10 [0093]);
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Snippet of fig. 10 of Wright ‘174 reproduced above
receiving the tracking signal at the tracking device (The sensor assembly 70 can include a plurality of coils to sense the location signals L1-3 from the markers [0055]; the sensor assembly 70 is the tracking device as claimed).
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 invention of Wright ‘283 to include connecting a controller, which is configured to generate a tracking signal, to a plurality of coils, each coil couple to an H-bridge system, and receiving the tracking signal at the tracking device, taught in Wright ‘174. Doing so would eliminate blind spots in the excitation volume, as suggested by Wright ([0107]).
Although Wright ’283 discloses the time of the pulse being offset ( the receiver 208 includes a pseudo-random excitation dithering circuit 508 (see FIG. 5) that will randomly offset the start timing of each exciting pulse 601 relative to previous or future exciting pulses. In one embodiment, the dithering circuit 508 will offset the timing of each exciting pulse 601 by a random fraction of one period of the carrier frequency of the exciting pulse 601, e.g., at 400 KHz dither from 0 to 2.5 microseconds [0098]), the combined invention still does not teach:
determining coefficients to remove hardware distortion between each coil of the plurality of coils and the tracking device;
[transmitting the tracking signal including the generated spread spectrum signal] from the plurality of coils having an inter-coil offset of a selected time delay spacing for driving each of the plurality of coils.
Barnes is considered analogous to the instant application as a surgical device is disclosed ([0002]). Barnes teaches:
determining coefficients to remove hardware distortion between each coil of the plurality of coils and the tracking device (detection threshold adjustment means for adjusting a detection threshold of the transponder detection system based at least in part on at least one value indicative of at least one of the noise levels [0015]; The frequency adjustment means may include adjustment determination means for automatically determining at least a first adjustment to spread energy across a first frequency band centered around a first center frequency and a second adjustment to spread energy across a second frequency band centered around a second center frequency and adjusting means for adjusting the spread of energy in response to the adjustment determination mean [0018])
transmitting the tracking signal including the generated spread spectrum signal (The custom logic in the FPGA 108 generates the timing and control signals for each pulse 410. …. A dither portion 410 e of the pulse 410 has a random variable length of time, and may, for example be generated by a pseudo-noise (PN) sequence generator [0014]) from the plurality of coils having an inter-coil offset (a transponder detection system includes transmitting means for transmitting electromagnetic interrogation signals [0015]; The transponder 26 a includes a miniature ferrite rod 30 with a conductive coil 32 [0058]) of a selected time delay spacing for driving each of the plurality of coils (FIG. 9 illustrates pulse timing [0113]; . A dither portion 410 e of the pulse 410 has a random variable length of time, and may, for example be generated by a pseudo-noise (PN) sequence generator. Adding a random length of time between pulses de-correlates the response signal received from the transponder 26 from constant frequency sources of interference, if any…within each of 150 millisecond measurement intervals discussed above, the custom logic of the FPGA 108 [0114]-[0115]).
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 invention of Wright ‘174, to include determining coefficients to remove hardware distortion between each coil of the plurality of coils and the tracking device, and transmitting the tracking signal including the generated spread spectrum signal] from the plurality of coils having an inter-coil offset of a selected time delay spacing for driving each of the plurality of coils, as taught by Barnes. Doing so would de-correlates the response signal received from the transponder from constant frequency sources of interference, as suggested by Barnes ([0114]).
Claims 12-13 is rejected under 35 U.S.C. 103 as being unpatentable over Wright (US Pub No. 20050154283, hereinafter “Wright ‘283”) in view of Wright et. al (US 20090299174 A1, hereinafter "Wright ‘174", previously cited), Barnes (US 20080272913 A1), and Gilbert et al. (US 20140258800 A1, of record, hereinafter "Gilbert").
Regarding claim 12, modified Wright ‘283 teaches the method of claim 11, as discussed above. Wright ‘283 , however does not teach wherein the distorting object is determined to not be present when the evaluation of the recovered impulse response includes no residual signal.
Gilbert is considered analogous to the instant application as a method of abnormality detection is disclosed (title).
Gilbert, however, teaches a method further comprising wherein the distorting object is determined to not be present (the abnormality detector 234 outputs no abnormality and, if the results are not within the tolerance range, outputs abnormality [0042]; detecting an abnormality within the circuit as a function of the impulse response [0009]) when the evaluation of the recovered impulse response includes no residual signal (The compensator 240 receives the filtered samples from the compensator sampler 238 and compensates fluctuations of the filtered samples [0040]; the fluctuations of the filtered samples is implicitly functions as the residual signal; The generator reference setter 242 receives the compensated results from the compensator 240 and sets an appropriate reference power profile that can be used as a reference in detecting abnormalities in the output circuit 201 [0042]).
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 combined invention of Wright ‘283 to include the distorting object is determined to not be present when the evaluation of the recovered impulse response includes no residual signal, as taught by Gilbert, in order to achieve having an improved signal-to-noise ratio, as taught by Gilbert ([0012]).
Regarding claim 13, modified Wright ‘283 teaches the method of claim 11, as discussed above. Wright ‘283, however does not teach determining a distortion impulse response if the residual signal is determined to be present when evaluating the recovered impulse response.
Gilbert is considered analogous to the instant application as a method of abnormality detection is disclosed (title).
Gilbert, however, teaches determining a distortion impulse response if the residual signal is determined to be present when evaluating the recovered impulse response signal (The test signal 360 may incorporate a minimum or maximum length sequence (MLS) and may be used to extract the impulse response of the circuit being tested [0096]; abnormality that is manifest as distortion [0052]); The compensator 240 receives the filtered samples from the compensator sampler 238 and compensates fluctuations of the filtered samples [0040]; the fluctuations of the filtered samples is implicitly functions as the residual signal; The generator reference setter 242 receives the compensated results from the compensator 240 and sets an appropriate reference power profile that can be used as a reference in detecting abnormalities in the output circuit 201 [0042]).
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 combined invention of Wright ‘283 to include determining a distortion impulse response if the residual signal is determined to be present when evaluating the recovered impulse response, as taught by Gilbert, in order to achieve having an improved signal-to-noise ratio, as taught by Gilbert ([0012]).
Claims 14-16 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wright (US Pub No. 20050154283, hereinafter “Wright ‘283”) in view of Wright et. al (US 20090299174 A1, hereinafter "Wright ‘174", previously cited), Barnes (US 20080272913 A1), and Felblinger et al (EP 3552545 A1, and citing a machine translation of EP 3552545 A1, previously cited).
Regarding claim 14, modified Wright ‘283 teaches the method of claim 13, as discussed above. Wright ‘283 however, does not teach reconstructing the distortion impulse response when the evaluated residual signal is present. Felblinger discloses “Method and Device for Real-time Correction of Magnetic Field” (title).
Felblinger teaches reconstructing the distortion impulse response (the invention relates first of all to a method for real-time correction of measurements of variations of at least one characteristic of the existing electromagnetic environment [0016]) when the evaluated residual signal is present (M points denoted UM(n) of the signal SG [0032]).
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 combined invention of Wright ‘283 to include reconstructing the distortion impulse response when the evaluated residual signal is present, as taught by Felblinger, in order to have the ability to control the form of the signals collected, in real time, by eliminating certain undesirable artifacts or by separating what comes from different sources in order to obtain at least one clear signal, as suggested by Felblinger ([0005]).
Regarding claim 15, modified Wright ‘283 teaches the method of claim 14, as discussed above. Gordy, however, does not teach reconstructing the distortion impulse response with the evaluated residual signal includes adding the residual signal to a determined initial impulse value. Felblinger teaches reconstructing the distortion impulse response with the evaluated residual signal includes adding the residual signal (M points denoted UM(n) of the signal SG [0032]) to a determined initial impulse value (The coefficients that constitute these M points are continuously updated, and are used to add to the impulse response [0032]).
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 combined invention of Wright ‘283 to include reconstructing the distortion impulse response with the evaluated residual signal includes adding the residual signal to a determined initial impulse value, as taught by Felblinger, in order to have the ability to control the form of the signals collected, in real time, by eliminating certain undesirable artifacts or by separating what comes from different sources in order to obtain at least one clear signal, as suggested by Felblinger ([0005]).
Regarding claim 16, modified Wright ‘283 teaches the method of claim 15, as discussed above. Wright ‘283, however, does not teach removing or deconvoluting the reconstructed distortion impulse. response from the full impulse response to determine a corrected impulse response. Felblinger, however, teaches removing or deconvoluting the reconstructed distortion impulse response from the full impulse response to determine a corrected impulse response (artifact identified as corresponding to parameters of a measurement then being separated and then removed from the signal resulting from the measurement of the variations in the characteristic of the electromagnetic environment [0020]).
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 combined invention of Wright ‘283 to include removing or deconvoluting the reconstructed distortion impulse response from the full impulse response to determine a corrected impulse response, as taught by Felblinger, in order to have the ability to control the form of the signals collected, in real time, by eliminating certain undesirable artifacts or by separating what comes from different sources in order to obtain at least one clear signal, as suggested by Felblinger ([0005]).
Regarding claim 18, modified Wright ‘283 teaches the method of claim 14, as discussed above. Gordy, however, does not teach a method wherein reconstructing the distortion impulse response with the evaluated residual signal includes fitting the distortion impulse per at least one of (i) a parameterized impulse response due to the distorting object or (ii) expected contributions from the distorting object. Felblinger teaches a method wherein reconstructing the distortion impulse response with the evaluated residual signal includes fitting the distortion impulse per at least one of (i) a parameterized impulse response due to the distorting object or (ii) expected contributions from the distorting object (corrective stage for reconstructing a corrected signal based on the signal from at least one Hall effect sensor [0027]; the Hall effect sensor is implicitly used to show the expected contributions from the distorting object; a Hall effect sensor is - according to this solution -placed as close as possible to the ECG sensor, in order to measure the magnetic field variations which actually cause the artifacts measured by this sensor [0009]).
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 combined invention of Wright ‘283 to include reconstructing the distortion impulse response with the evaluated residual signal includes fitting the distortion impulse per at least one of (i) a parameterized impulse response due to the distorting object or (ii) expected contributions from the distorting object, as taught by Felblinger, in order to have the ability to control the form of the signals collected, in real time, by eliminating certain undesirable artifacts or by separating what comes from different sources in order to obtain at least one clear signal, as suggested by Felblinger ([0005]).
Regarding claim 19, modified Wright ‘283 teaches the method of claim 14, as discussed above. Wright ‘283, however, does not teach a method wherein reconstructing the distortion impulse response with the evaluated residual signal includes fitting the distortion impulse response to expected response of the distorting object with concurrent evaluating the impulse response residual and adding the impulse response residual.
Felblinger teaches wherein reconstructing the distortion impulse response with the evaluated residual signal includes fitting the distortion impulse response to expected response of the distorting object (the means for measuring the characteristic of the electromagnetic environment consist of at least one Hall effect sensor [0025]; corrective stage for reconstructing a corrected signal based on the signal from at least one Hall effect sensor [0027]; the distortion impulse is implicitly fitted to the expected response of the distorting object based off of the Hall Effect Sensor) with concurrent evaluating the impulse response residual and adding the impulse response residual (The coefficients that constitute these M points are continuously updated, and are used to add to the impulse response [0032]).
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 combined invention of Wright ‘283, to include a method wherein reconstructing the distortion impulse response with the evaluated residual signal includes fitting the distortion impulse response to expected response of the distorting object with concurrent evaluating the impulse response residual and adding the impulse response residual, as taught by Felblinger, in order to have the ability to control the form of the signals collected, in real time, by eliminating certain undesirable artifacts or by separating what comes from different sources in order to obtain at least one clear signal, as suggested by Felblinger ([0005]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Wright (US Pub No. 20050154283, hereinafter “Wright ‘283”) in view of Wright et. al (US 20090299174 A1, hereinafter "Wright ‘174", previously cited), Barnes (US 20080272913 A1), and Berman et al. (US 20190000560 A1, previously cited, hereinafter "Berman").
Regarding claim 17, modified Wright ‘283 teaches the method of claim 16, as discussed above. Wright ‘283, however, does not teach determining the pose, which can include at least some coordinates of position and/or orientation, of the tracking device based on the corrected impulse.
Berman is considered analogous to the instant application as “Electromagnetic distortion detection” is disclosed (title).
Berman, however, teaches determining the pose, which can include at least some coordinates of position and/or orientation, of the tracking device based on the corrected impulse. (estimates a location of one or more elements of the robotic systems of FIGS. 1-10, such as the location of the instrument [0026]; coordinates of position and/or orientation are implicit; The EM tracking system may also determine whether one of the patient and the EM field generator 110 receives an impulse [0169]).
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 combined invention of Wright ‘283 to include determining the pose, which can include at least some coordinates of position and/or orientation, of the tracking device based on the corrected impulse, as taught by Berman, in order to have a system with enhanced imaging and guidance to assist the physician, as suggested by Berman ([0045]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Wright (US Pub No. 20050154283, hereinafter “Wright ‘283”) in view of Wright et. al (US 20090299174 A1, hereinafter "Wright ‘174", previously cited), Barnes (US 20080272913 A1), and Felblinger et al (EP 3552545 A1, and citing a machine translation of EP 3552545 A1, previously cited).
Regarding claim 20, Wright ‘283 teaches a method of tracking a tracking device with a navigation system in a navigation space, comprising:
generating a spread spectrum signal having a binary pseudo-noise signal scheme signal (Receiver and Exciting Source Con figured for Pseudo-random Excitation [0099]; the receiver 208 includes a pseudo-random excitation dithering circuit 508… randomly vary the polarity of each exciting pulse 601. For example a first exciting pulse may start with a positive going cycle, while a second exciting pulse may start with a negative going cycle. In other words, the first exciting pulse may be 180 degrees out of phase with the second exciting pulse [0103]; as the signal is switching between two polarities, it is therefore “binary”);;
transmitting the tracking signal including the generated spread spectrum signal (determining the location of a marker that is excited with an exciting waveform. A sensing array having coils is used to sense magnetic flux from the resonating marker [abstract]) from the plurality of coils (coils [0038]);
demultiplexing (The effect of the dithering would spread out or "decohere" any periodic noise [0102]; This random polarity of the exciting pulses 601 will also decohere any periodic noise, turning the periodic noise into random noise that can be eliminated by signal processing [0103]) and equalizing (the receiver 208 is adapted to have a narrow bandpass filter to suppress the excitation frequency and pass the returned frequency [0106]) the received tracking signal (determining the location of a marker that is excited with an exciting waveform. A sensing array having coils is used to sense magnetic flux from the resonating marker [abstract]), wherein equalizing includes removing distortion from the received signal at the tracking device relative to the generated spread spectrum signal (removing distortion/noise/interference from the received signal is disclosed in [0063], [0102]-[0103]; [0103] further discloses that eliminating noise, i.e. distortion occurs relative to the generated spread spectrum), wherein removing distortion comprises:
recovering an impulse response signal (The relationship between a signal output by a marker 206 in response to an excitation from the excitation system 202 is modeled as follows… with corresponding impulse response [0139]-[0140]; analytic representation of the impulse response of the resonant marker [0148]; pulse and the marker impulse response [0151]) from the demultiplexed and equalized tracking signal from the plurality of coils (the signal is processed after signal processing as disclosed in: Pseudo-random Excitation [0099]; the receiver 208 includes a pseudo-random excitation dithering circuit 508 [0103]; This random polarity of the exciting pulses 601 will also decohere any periodic noise, turning the periodic noise into random noise that can be eliminated by signal processing [0103]; the receiver 208 is adapted to have a narrow bandpass filter to suppress the excitation frequency and pass the returned frequency [0106]);;
determining a pose (locate the marker [0212]), of the tracking device with the impulse response recovered from the received tracking signal (The relationship between a signal output by a marker 206 in response to an excitation from the excitation system 202 is modeled as follows… with corresponding impulse response [0139]-[0140]; analytic representation of the impulse response of the resonant marker [0148]; pulse and the marker impulse response [0151]) based on the evaluation of the received tracking signal (After the receiver 208 has completed the signal processing detailed above, the resulting output of the receiver 208 is thirty-two "cleaned up" digital output signals. These digital output signals may then be used to locate the marker [0212]).
Wright ‘283, however does not teach:connecting a controller configured to generate a tracking signal based at least on the generated spread spectrum signal to a plurality of coils, each coupled to an H-bridge system;
having an inter-coil offset of a selected time delay spacing for driving each of the plurality of coils;
receiving the tracking signal at the tracking device;
reconstructing a distortion impulse response when the evaluated residual signal is present by adding the residual signal to a determined initial impulse value; and
removing the reconstructed distortion impulse response from the full impulse response to determine the corrected impulse response;
Wright ‘174 is considered analogous to the instant application, as Wright discloses “Instruments with location markers and methods for tracking instruments through anatomical passageways” (title).
Wright ‘174 teaches:
connecting a controller (controller [0054]) configured to generate a tracking signal (the catheter is tracked as it passes through the vessel by (a) wirelessly delivering a pulsed magnetic field to energize the marker, (b) wirelessly transmitting a pulsed location signal from the marker [0040]) based at least on the generated spread spectrum signal to a plurality of coils, each coupled to an H-bridge system (H-bridge switches 1050 (identified individually by reference numbers 1050 a-d), and the coil assembly 1046 includes individual source coils 1052 [0098]; location signal [0108] each coil 1052 is connected to an H-Bridge system shown in fig. 10 below; fig. 10 [0093]);
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Snippet of fig. 10 of Wright ‘174 reproduced above
receiving the tracking signal at the tracking device (The sensor assembly 70 can include a plurality of coils to sense the location signals L1-3 from the markers [0055]; the sensor assembly 70 is the tracking device as claimed);
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 invention of Wright ‘283 to include connecting a controller configured to generate a tracking signal based at least on the generated spread spectrum signal to a plurality of coils, each coupled to an H-bridge system, and receiving the tracking signal at the tracking device, taught in Wright ‘174. Doing so would eliminate blind spots in the excitation volume, as suggested by Wright ([0107]).
Although Wright ’283 discloses the time of the pulse being offset ( the receiver 208 includes a pseudo-random excitation dithering circuit 508 (see FIG. 5) that will randomly offset the start timing of each exciting pulse 601 relative to previous or future exciting pulses. In one embodiment, the dithering circuit 508 will offset the timing of each exciting pulse 601 by a random fraction of one period of the carrier frequency of the exciting pulse 601, e.g., at 400 KHz dither from 0 to 2.5 microseconds [0098]), the combined invention still does not teach:
having an inter-coil offset of a selected time delay spacing for driving each of the plurality of coils;
reconstructing a distortion impulse response when the evaluated residual signal is present by adding the residual signal to a determined initial impulse value; and
removing the reconstructed distortion impulse response from the full impulse response to determine the corrected impulse response.
Barnes is considered analogous to the instant application as a surgical device is disclosed ([0002]). Barnes teaches:
having an inter-coil offset of a selected time delay spacing for driving each of the plurality of coils (FIG. 9 illustrates pulse timing [0113]; . A dither portion 410 e of the pulse 410 has a random variable length of time, and may, for example be generated by a pseudo-noise (PN) sequence generator. Adding a random length of time between pulses de-correlates the response signal received from the transponder 26 from constant frequency sources of interference, if any…within each of 150 millisecond measurement intervals discussed above, the custom logic of the FPGA 108 [0114]-[0115]);
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 invention of Wright ‘174, to include having an inter-coil offset of a selected time delay spacing for driving each of the plurality of coils, as taught by Barnes. Doing so would de-correlates the response signal received from the transponder from constant frequency sources of interference, as suggested by Barnes ([0114]).
The combined invention still does not teach:
reconstructing a distortion impulse response when the evaluated residual signal is present by adding the residual signal to a determined initial impulse value; and
removing the reconstructed distortion impulse response from the full impulse response to determine the corrected impulse response;
Felblinger discloses “Method and Device for Real-time Correction of Magnetic Field” (title).
Felblinger teaches: reconstructing a distortion impulse response (the invention relates first of all to a method for real-time correction of measurements of variations of at least one characteristic of the existing electromagnetic environment [0016]) when the evaluated residual signal is present by adding the residual signal to a determined initial impulse value (The coefficients that constitute these M points are continuously updated, and are used to add to the impulse response [0032]); and
removing the reconstructed distortion impulse response from the full impulse response to determine the corrected impulse response (artifact identified as corresponding to parameters of a measurement then being separated and then removed from the signal resulting from the measurement of the variations in the characteristic of the electromagnetic environment [0020]).
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 combined invention of Wright ‘283 to include reconstructing a distortion impulse response when the evaluated residual signal is present by adding the residual signal to a determined initial impulse value, removing the reconstructed distortion impulse response from the full impulse response to determine the corrected impulse response, as taught by Felblinger, in order to have the ability to control the form of the signals collected, in real time, by eliminating certain undesirable artifacts or by separating what comes from different sources in order to obtain at least one clear signal, as suggested by Felblinger ([0005]).
Regarding claim 22, Wright ‘283 teaches the method of claim 20, as discussed above. Wright ‘283 further teaches generating the spread spectrum signal having the binary pseudo-noise signal scheme (Receiver and Exciting Source Con figured for Pseudo-random Excitation [0099]; the receiver 208 includes a pseudo-random excitation dithering circuit 508… randomly vary the polarity of each exciting pulse 601. For example a first exciting pulse may start with a positive going cycle, while a second exciting pulse may start with a negative going cycle. In other words, the first exciting pulse may be 180 degrees out of phase with the second exciting pulse [0103]; as the signal is switching between two polarities, it is therefore “binary”) is a binary orthogonal or near orthogonal signal (Frequency Orthogonality… the excitation intervals and observation intervals are orthogonal temporally [0106]-[0107]) .
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Wright (US Pub No. 20050154283, hereinafter “Wright ‘283”) in view of Wright et. al (US 20090299174 A1, hereinafter "Wright ‘174", previously cited), Barnes (US 20080272913 A1), Felblinger et al (EP 3552545 A1, and citing a machine translation of EP 3552545 A1, previously cited), and Schneider et al. (US 20190226826 A1, hereinafter "Schneider", previously cited)..
Regarding claim 21, Wright ‘283 teaches the method of Claim 20, as discussed above. Wright ‘283 further teaches the binary pseudo-noise signal scheme (Receiver and Exciting Source Con figured for Pseudo-random Excitation [0099]; the receiver 208 includes a pseudo-random excitation dithering circuit 508… randomly vary the polarity of each exciting pulse 601. For example a first exciting pulse may start with a positive going cycle, while a second exciting pulse may start with a negative going cycle. In other words, the first exciting pulse may be 180 degrees out of phase with the second exciting pulse [0103]; as the signal is switching between two polarities, it is therefore “binary”). Wright, ‘283, however, does not teach generating a time varying magnetic field signal between 10 Hz and 30 MHz. Schneider discloses “Calibrating a Magnetic Sensor” (title) and is in applicant’s field of endeavor of A61B2034/2051. Schneider teaches generating a time varying magnetic field signal between 10 Hz and 30Mhz (magnetic fields generated at a relatively low frequency of about 90 Hz [0031]).
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 combined invention of Wright ‘174 to include generating a time varying magnetic field signal between 10 Hz and 30Mhz, as taught by Schneider, in order to reduce or eliminate the occurrence of eddy currents, thereby allowing the sensor to receive the intended (e.g., true) magnetic fields, as taught by Schneider ([0031]).
Response to Arguments
Applicant's arguments filed 04/10/2025 have been fully considered but they are moot.
Applicant argument’s on pages 8-11, regarding 35 USC 103 rejections of claim 1, are premised upon the assertion that the prior art does not teach the newly added limitations regarding “transmitting the tracking signal including the generated spread spectrum signal from the plurality of coils having an inter-coil offset of a selected time delay spacing of about 1 millisecond to 20 milliseconds for driving each of the plurality of coils” is moot in view of new grounds of rejection which relies upon Barnes et al (US 20080272913 A1) to teach this limitation. Accordingly, this argument is moot.
Applicant argument’s on pages 12-14, regarding 35 USC 103 rejections of claim 11, applicant argues that the prior art does not teach the amendments regarding “determining coefficients to remove hardware distortion between each coil of the plurality of coils and the tracking device”, a well as “transmitting the tracking signal including a spread spectrum signal having the generated binary pseudo-noise signal with the plurality of coils having an inter-coil offset of a selected time delay spacing for driving each of the plurality of coils”. This argument is not persuasive as “determining coefficients to remove hardware distortion between each coil of the plurality of coils and the tracking device” contains 112(a) issues, as discussed in the rejection above. Further, these limitations relies upon Barnes et al (US 20080272913 A1) to teach this limitation. Accordingly, this argument is moot.
The applicant argues on page 14 that the remaining claims that depend from claims 1 and 11 are in condition for allowance in light of the amendments and remarks, and the examiner respectfully disagrees for the reasons discussed above. Accordingly, the arguments are not persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/N.B./Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
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