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 Arguments
Applicant’s argument on Page 13 regarding the objection to the drawings has been fully considered. The objection to the drawings is withdrawn in view of the amendments.
Applicant’s argument on Page 13 regarding the objection to the specification has been fully considered. The objection to the specification is withdrawn in view of the amendments.
Applicant’s argument on Page 13 regarding the objections to Claims 15, 18-22 and 24-26 has been fully considered. While most of the objections are addressed, the objections to Claims 15, 22, and 24 are maintained, as discussed below. Furthermore, the objections to Claims 18-21 and 25-26 are withdrawn.
Applicant’s argument on Page 13 regarding the rejection of Claims 15-27 under 35 U.S.C. 112(b) has been fully considered. However, the amendments do not overcome the rejection under 35 U.S.C. 112(b), as the “medical device, equipped with at least one ultrasound sensor” and “at least three external ultrasound sensors” are not positively recited as part of the tracking system. Therefore, the rejection of Claims 15-27 under 35 U.S.C. 112(b) is maintained.
Applicant’s argument on Pages 14-20 regarding the rejection of Claim 15 under 35 U.S.C. 103 over Duplat in view of Clement and Matsumoto has been fully considered.
On Page 17 Paragraph 1, applicant argues that “Duplat does not disclose a medical device equipped of at least one ultrasound sensor.” However, under broadest reasonable interpretation, an “ultrasound sensor,” is a component that may be detected by ultrasound signals by acting as a reflector. The “ultrasound sensor” as embodied by the claims is required to be attached to the medical device but specifies no further functional limitations.
On Page 17 Paragraph 2, applicant argues that “Duplat does not disclose taking into account that the properties of ultrasounds [sic] propagation in the first and second tissue type are different.” However, such a limitation is not explicitly required by the claims. The limitation of first and second tissue types are taught by Duplat (brain and skull), which are further understood by one of ordinary skill in the art to have different ultrasound propagation properties, as taught in Clement. Therefore, any processing involving such components take into account the ultrasound propagation properties.
On Page 17 Paragraph 3, applicant argues that “Duplat does not disclose at least one input configured to receive information on a predefined geometry of the at least one first tissue layer and a predefined 3D map of speed of ultrasounds in the at least one first tissue layer and the volume of at least one second tissue.” Such is addressed in the rejection as being taught by Matsumoto.
On Page 17 Paragraph 4, applicant argues that “Duplat does not disclose for each external ultrasound sensor, obtaining an associated current local speed in the first tissue using the estimated current path and said 3D map of speed in the first tissue.” Such is addressed in the rejection as being taught by Matsumoto.
On Pages 17-18, applicant argues that [0072] of Duplat does not mention considering the local speed of ultrasounds in the first tissue layer, nor in the second tissue layer, and does not disclose a map of speed in the second tissue layer, and that “[A]ccording to the claim, the two tissue layers have different properties of propagation.” However, as discussed above, the different tissues of skull and brain are understood to have different ultrasound propagation properties, and therefore any processing involving such components take into account the different ultrasound propagation properties. Additionally, Duplat is not cited for teaching the map of speed.
On Page 18 Paragraph 1, applicant argues that “Duplat does not disclose repeat performing location computation using the new position as current position, until an exit criterion is satisfied in order to obtain an optimized estimation of the initial approximated position” and further that the exit criterion “does not relate to the completion of the intervention; rather, it defines the condition under which iterative updating of the estimated position of the medical device should stop as the optimal estimation of the position is obtained.” However, the limitation “exit criterion” is not explicitly defined by the claim, and under broadest reasonable interpretation is interpreted as completing the intervention (and therefore removal or exit of the medical device).
On Pages 18-19, applicant argues that “Matsumoto does not disclose receiving a predefined 3D map of speed.” However, the claim language limitation requires that the input receives a 3D map of speed of ultrasounds, which is not explicitly predefined. Therefore, Matsumoto reads on the claim limitations as having a sound speed map signal from the reception signal, generated from the B mode image signal, as in [0072].
On Page 19 Paragraph 1, applicant argues that Matsumoto does not disclose the other claimed features and does not disclose a medical device. However, the remaining claimed features and the medical device are taught by Duplat, as discussed above.
On Page 19 Paragraph 2, applicant argues that Matsumoto does not disclose using predefined information on a geometry of the at least one first tissue layer and the volume of at least one second tissue. Such limitation is taught by Duplat.
On Page 19 Paragraph 3, applicant argues that Matsumoto does not disclose for each external ultrasound sensor, obtaining an associated current local speed in the first tissue using the estimated current path and said 3D map of speed in the first tissue. However, in [0072], Matsumoto discloses that the sound speed map signal is obtained from the reception signal, interpreted as the estimated current path, and therefore outputs an associated current local speed via the sound speed map signal from the output of the ultrasound diagnostic apparatus 1 (an external ultrasound sensor).
On pages 19-20, applicant argues that Matsumoto does not disclose repeat performing location computation using the new position as current position, until an exit criterion is satisfied. Such a limitation is taught by Duplat, as discussed above.
Regarding the rejection of all remaining corresponding claims, applicant’s argument submitted on Page 21 relies on the supposed deficiencies with respect to the rejection of parent Claims 15 and 22. Applicant’s argument is moot for the same reasons detailed above.
While differences between the instant application and the prior art are appreciated, they are not embodied in the claims in such a way as to differentiate.
Claim Objections
Claim 15 is objected to because of the following informalities: minor error in antecedent basis and grammatical error. The claim should be amended to “[…] “obtain an approximated current position of the medical device inside the volume of at least one second tissue type […] and a current lateral angle of the medical device with respect to each of the at least three external ultrasound sensors […] between each ultrasound sensor; […].” Appropriate correction is required.
Claim 22 is objected to because of the following informalities: minor error in antecedent basis and grammatical error. The claim should be amended to “[…] “properties of ultrasound[[s]] propagation […] obtain a current position of the medical device inside the volume of at least one second tissue type […].” Appropriate correction is required.
Claim 24 is objected to because of the following informalities: minor error in antecedent basis. The claim should be amended to “[…] using the 3D map of speed in the first tissue layer […].” 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 15-27 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 “optimal” in Claims 15 and 22 is a relative term which renders the claim indefinite. The term “optimal” 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. For purposes of applying prior art, “optimal” is interpreted as an estimation of a 3D position of a medical device that aligns with the functions of the system.
Further regarding Claims 15 and 22, the limitations “a medical device, equipped of at least one ultrasound sensor” and “at least three external ultrasound sensors” render the claim indefinite. The limitations are not positively recited as part of the tracking system, and therefore it is unclear whether the limitations are intended to be part of the tracking system or not. For purposes of applying prior art, the limitations are interpreted as not part of the system, as in Figs. 1 and 2.
Claims not explicitly addressed above are rejected as depending from a rejected claim and failing to cure deficiencies of the parent claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 15, 18, 20-22, 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Duplat et al. (US 20220000454) in view of Clement et al. (“Correlation of ultrasound phase with physical […]”) and Matsumoto et al. (US 20190216441).
Regarding Claims 15, 22, and 27, Duplat teaches a tracking system for obtaining an optimal estimation of a 3-dimensional position of a medical device, ([0055] “The position, orientation, or both, of the microrobot 11 in the brain 4 may be accurately identified using an ultrasound-based localization system 1”), equipped with at least one ultrasound sensor, ([0056] “two bubbles 10 attached to the microrobot”), inside an anatomical region of a subject, (Fig. 2), comprising at least one layer of a first tissue type at least partially surrounding a volume, ([0058] “skull 6”), comprising at least one second tissue type, ([0055] “brain 4”), wherein properties of ultrasound propagation in the first and second tissue type are different, (Where one of ordinary skill in the art would understand that different tissue types, e.g., skull and brain tissue, will have different ultrasound propagation properties. See Clement NPL.), said system comprising:
a) at least one input configured to receive a position for each of at least three external ultrasound sensors with respect to the at least one first tissue layer ([0071] “the three ultrasound transducers 12 are positioned on the skull 6 of the subject, each positioned in a hole 61 in the outer table and the diploe of the skull 6 of the subject.”); and
b) at least one processor, ([0061] “processing unit 13”), configured to:
i) obtain an approximated current position of the medical device inside the volume of at least one second tissue ([0062] “The processing unit 13 is generally implemented with one or more hardware processors and a memory. A trilateration module 15 of the processing unit 13 is configured to receive signal data from the ultrasound transducers 12 and process the signal data. In particular, the trilateration module 15 is configured to compute times of flight of ultrasound signals deflected at the surface of the bubbles 10 and received by the ultrasound transducers 12, so as to yield the position of each bubble 10, thus making it possible to determine a position and an orientation of the microrobot 11.”);
ii) perform location computation comprising:
1) using the obtained approximated current position and the positions of the at least three external ultrasound sensors to calculate a current elevation angle and a current lateral angle of the medical device with respect to each of the at least three external ultrasound sensor, ([0024] “the processing unit of the localization system comprises a trilateration module configured to determine a spatial position and/or orientation of the object from a distance between each ultrasound transducer and the bubble(s). In the case of the determination of the orientation of the object, at least two bubbles attached to the object are required, and for each bubble a distance between each ultrasound transducer and the bubble is determined. Trilateration is the process of determining the absolute or relative location of a point in space by measurement of distances, using the geometry of circles, spheres or triangles. In contrast to triangulation, it does not involve the measurement of angles, although triangulation techniques may also be employed. It is understood that, within the frame of the invention, the term “trilateration” refers to trilateration or triangulation.”), and using said current elevation angle and current lateral angle to estimate a current path traveled by the ultrasounds through the at least one first tissue layer between each external ultrasound sensor and the medical device, (Figs. 1-2 and [0066] “The position of the bubble 10 is at an intersection of three spheres 22, 24, 26 each centered respectively on one of the ultrasound transducers 12 and with radii determined by the measured time of flight between the bubble 10 and the ultrasound transducer 12. In FIG. 1, for the clarity of the drawing, the time-of-flight spheres 22, 24, 26 are shown schematically, with the intersection projected in the plane of the figure, only for the bubble 10 in solid lines, it being understood that similar spheres are determined for the bubble 10 in dotted lines.”)
2) calculating a current distance between each external ultrasound sensor and the medical device by considering the current local speed in the at least one first tissue layer associated to the corresponding external ultrasound sensor and the estimated current path associated to the corresponding external ultrasound sensor, a speed of ultrasounds in the volume of the at least one second tissue and a measured time of propagation of the ultrasounds between each external ultrasound sensor and the medical device ([0072] “The trilateration module 15 then automatically generates localization data, based on the deflected ultrasound signals detected by the ultrasound transducers 12, and the registration module 16 matches the coordinates of each point of the localization data generated by the trilateration module 15 with the coordinates of corresponding elements on a reference image obtained with the imaging system 17. The image obtained from the imaging system 17 is displayed on the display 18, together with the position and orientation of the microrobot 11. In this way, the position and orientation of the microrobot 11 in the brain 4 of the subject can be monitored, during its insertion and its displacement in the brain 4 of the subject.” Where time of flight within the tissue utilizes a known speed of sound of the tissue/material.); and
3) estimating a new position of the medical device inside the volume of at least one second tissue using the current distance between each external ultrasound sensor and the medical device ([0072] “the position and orientation of the microrobot 11 in the brain 4 of the subject can be monitored, during its insertion and its displacement in the brain 4 of the subject.” Where the position of the medical device/microrobot 11 is continuously estimated/monitored utilizing the distance between the transducers 12 and microrobot 11.);
4) repeating performing location computation using the new position as current position, until an exit criterion is satisfied (Where the process of monitoring the microrobot is repeated until the intervention/surgery is complete (exit criterion), see [0002]-[0003] and [0072]. The microrobot 11 does not remain within the patient.);
c) at least one output configured to provide as the optimal estimation of the 3D position of the medical device the approximated current position satisfying the exit criterion, wherein the measured time of propagation of the ultrasounds between each external ultrasound sensor and the medical device is based on a direct time of flight measure measured using each external ultrasound sensor and the at least one ultrasound sensor of the medical device ([0064] “the processing unit 13 includes a display 18 for […] display [sic] the position and orientation of the microrobot 11 in the anatomical images” and [0072] “The image obtained from the imaging system 17 is displayed on the display 18, together with the position and orientation of the microrobot 11. In this way, the position and orientation of the microrobot 11 in the brain 4 of the subject can be monitored, during its insertion and its displacement in the brain 4 of the subject.”).
Furthermore, the cited actions are computer implemented, which necessitate associated computer-implemented method and computer-readable media, as in [0049]-[0050] (“The invention also relates to a computer program comprising instructions for the implementation of the calculation steps of the method described above when the program is executed by a computer. The invention also relates to a non-transitory computer readable medium comprising instructions for the implementation of the calculation steps of the method described above when the instructions are executed by a computer.”).
However, Duplat does not explicitly teach at least one input configured to receive information on a geometry of the at least one first tissue layer and a 3D map of speed of ultrasounds in the at least one first tissue layer and the volume of at least one second tissue type; at least one processor configured to: perform location computation comprising: for each external ultrasound sensor, obtaining an associated current local speed in the first tissue type using the estimated current path and said 3D map of speed in the first tissue layer.
In an analogous ultrasound acquisition field of endeavor, Matsumoto teaches a tracking system for estimating a 3D position of a medical device, ([0003] “Conventionally, an ultrasound diagnostic apparatus is known as an apparatus that obtains an image of the inside of a subject by applying a transducer array to the subject. A general ultrasound diagnostic apparatus acquires element data by transmitting an ultrasound beam from a transducer array, in which a plurality of elements are arranged, to the inside of a subject and receiving ultrasound echoes from the subject in the transducer array. Then, the ultrasound diagnostic apparatus electrically processes the obtained element data to obtain an ultrasound image of the relevant part of the subject” and [0022] “ultrasound diagnostic apparatus 1”), said system comprising:
a) at least one input configured to receive information on a geometry of the at least one first tissue layer and a 3D map of speed of ultrasounds in the at least one first tissue layer and the volume of at least one second tissue type ([0072] “The image generation unit 7 of the image acquisition unit 3 generates the B mode image signal from the reception signal output from the reception circuit 5, but may generate image signals other than the B mode image signal from the reception signal. For example, although not shown, in order to generate […] a sound speed map signal from the reception signal, the B mode processing unit 19 of the image generation unit 7 may be replaced with a processing unit that generates […] the sound speed map signal.”);
b) at least one processor configured to: perform location computation comprising: for each external ultrasound sensor, obtaining an associated current local speed in the first tissue type using the estimated current path and said 3D map of speed in the first tissue layer ([0072] “The image generation unit 7 of the image acquisition unit 3 generates the B mode image signal from the reception signal output from the reception circuit 5, but may generate image signals other than the B mode image signal from the reception signal. For example, although not shown, in order to generate […] a sound speed map signal from the reception signal, the B mode processing unit 19 of the image generation unit 7 may be replaced with a processing unit that generates […] the sound speed map signal.”).
Furthermore, the cited actions are computer implemented, which necessitate associated computer-implemented method and computer-readable media, as in [0041] “The storage unit 16 stores an operation program and the like of the ultrasound diagnostic apparatus 1, and recording media, such as a hard disc drive (HDD), a solid state drive (SSD), a flexible disc (FD), a magneto-optical disc (MO), a magnetic tape (MT), a random access memory (RAM), a compact disc (CD), a digital versatile disc (DVD), a secure digital card (SD card), and a universal serial bus memory (USB memory), or a server can be used.”) and [0042] (“The image generation unit 7 of the image acquisition unit 3, the display control unit 8, the probe movement amount calculation unit 11 of the movement amount detection unit 4, the image analysis unit 12, the part determination unit 13, and the device control unit 14 are configured by a central processing unit (CPU) and an operation program causing the CPU to execute various kinds of processing.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Duplat with Matsumoto because the modification to include a speed of sound map because it enhances the image quality and accuracy, provides information on tissue characteristics, which may be important for diagnosis and/or treatment planning, and can also be utilized by an operator to ensure correct acoustic speed to avoid distorted images.
Regarding Claim 18, the modified system of Duplat teaches all limitations of Claim 15, as discussed above. Furthermore, Duplat teaches wherein obtaining the approximated current position of the medical device inside the volume of at least one second tissue, for a first iteration, comprises: using medical imaging data ([0072] “The trilateration module 15 then automatically generates localization data, based on the deflected ultrasound signals detected by the ultrasound transducers 12, and the registration module 16 matches the coordinates of each point of the localization data generated by the trilateration module 15 with the coordinates of corresponding elements on a reference image obtained with the imaging system 17.”).
Regarding Claims 20 and 26, the modified system and method of Duplat teaches all limitations of Claims 15 and 22, as discussed above. Furthermore, Duplat teaches wherein each of the at least three external ultrasound sensors are ultrasound emitters configured to modify a direction of emission of the ultrasounds and the medical device is equipped with an ultrasound receiver, and wherein the at least one processor is further configured to use the estimated position of the medical device so as to modify the direction of emission of the ultrasounds in order to focus the ultrasounds of the at least three external ultrasound sensors on the position of the medical device ([0067] “For each bubble 10, the intersection of the three spheres 22, 24, 26 results in two points, symmetric with respect to the imaged plane, as long as the centers of the three spheres are not aligned with respect to the bubble 10. Thus, the time-of-flight spheres 22, 24, 26 preferably have centers, corresponding to the positions of the ultrasound transducers 12, that are not aligned relative to the bubble 10. However, in case of alignment, beamforming may be employed for the emitted ultrasound signals from one or more of the ultrasound transducers 12 to provide a new origin for the emitted ultrasound signal and eliminate the alignment.”).
Regarding Claim 21, the modified system of Duplat teaches all limitations of Claim 15, as discussed above. Furthermore, Duplat teaches wherein the at least one layer of a first tissue type is a skull of the subject and the volume of at least one second tissue is a brain of the subject, (Fig. 2), or the at least one layer of a first tissue type is layer of fat and the at least one volume is a liver (Claim 1 “A system for real-time localization of a millimetric or submillimetric object, such as a microrobot, in a viscoelastic medium, in particular in an organ of a subject such as […] a liver,” where one of ordinary skill would understand that the liver is surrounded by a protective layer fat (peritoneum).).
Claims 16 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Duplat et al. (US 20220000454) in view of Clement et al. (“Correlation of ultrasound phase with physical […]”) and Matsumoto et al. (US 20190216441), as applied to Claims 15 and 22 above, further in view of Merdes et al. (“Locating a Catheter Transducer in a […]”).
Regarding Claims 16 and 23, the modified system and method of Duplat teach all limitations of Claims 15 and 22, as discussed above. However, the modified system and method of Duplat do not explicitly teach calculating the current distance comprises using numerical simulations of the propagation of the ultrasound in the at least one first tissue layer and the volume of at least one second tissue of the subject, said numerical simulations being based on medical imaging data of at least one portion of the anatomical region of the subject.
In an analogous real-time ultrasound imaging field of endeavor, Merdes teaches a tracking system for estimating a 3D position of a medical device, (II. Methods “The position of the catheter transducer in the 3-D ultrasound field was found in terms of the (ρ, θ, φ) coordinates used in the 3-D beam steering coordinate system”), wherein calculating the current distance comprises using numerical simulations of the propagation of the ultrasound in the at least one first tissue layer and the volume of at least one second tissue of the subject, said numerical simulations being based on medical imaging data of at least one portion of the anatomical region of the subject (II. Methods “The simulated receive profile was obtained by using the ultrasonic simulation program FIELD II Version 2.60 (Jorgen Jensen, Lyngby, Denmark). FIELD uses the convolution method developed by Tupholme and Stepanishen. It has been shown that FIELD can be used to simulate arbitrarily shaped and apodized transducers with any transducer excitation. […] For all simulations, the focus of the 2.5-MHz transducer was set at a range of 12 cm, with each scan line having a specific angular direction given in terms of azimuth and elevation. Fig. 2(a) and (b) were generated by FIELD to show a densely sampled receive profile and a receive profile appearing as it would when measured by the catheter transducer,” II. Methods, A. Simulation Study of Feasibility and Sensitivity to Noise “The catheter transducer’s angular position was varied while was held constant at 70 mm. Catheter transducer data was simulated for 256 angular locations,” and IV. Discussion “The results of the feasibility study using simulated data and the in vitro study in the water tank indicate that this localization method can be used to determine the position of a catheter transducer in a 3-D ultrasound imaging field and confirmed our hypothesis that the catheter location corresponded to the peak of the receive profile.”).
Furthermore, the cited actions are computer implemented, which necessitate an associated computer-implemented method, as in II. Methods (“ultrasonic simulation program FIELD II Version 2.60”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Merdes because the modification of utilizing numerical simulations ensures that the imaging process and treatment are most accurate, especially in instances where the procedure is navigating complex anatomy, as taught by Merdes in I. Introduction.
Claims 17 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Duplat et al. (US 20220000454) in view of Clement et al. (“Correlation of ultrasound phase with physical […]”) and Matsumoto et al. (US 20190216441), as applied to Claims 15 and 22 above, further in view of Minh et al. (“Estimation of Thickness and Speed of Sound […]”).
Regarding Claim 17 and 24, the modified system and method of Duplat teach all limitations of Claims 15 and 22, as discussed above. Furthermore, Duplat teaches wherein obtaining the current approximated position of the medical device inside the volume of second tissue for a first iteration comprises:
a) for each of the at least three external ultrasound sensors, estimating a first distance between one of the at least three external ultrasound sensors and the medical device based on the corresponding obtained local speed in the at least one first tissue layer propagating through the at least one first tissue layer for a path equal to the corresponding obtained thickness, the speed of ultrasound in the volume of the at least one second tissue and a measured time of propagation of the ultrasounds between each of the at least three external ultrasound sensors and the medical device ([0072] “The trilateration module 15 then automatically generates localization data, based on the deflected ultrasound signals detected by the ultrasound transducers 12, and the registration module 16 matches the coordinates of each point of the localization data generated by the trilateration module 15 with the coordinates of corresponding elements on a reference image obtained with the imaging system 17. The image obtained from the imaging system 17 is displayed on the display 18, together with the position and orientation of the microrobot 11. In this way, the position and orientation of the microrobot 11 in the brain 4 of the subject can be monitored, during its insertion and its displacement in the brain 4 of the subject.”);
b) wherein the approximated current position of the medical device inside the volume of at least one second tissue, for the first iteration, is obtained using the estimated first distances between the medical device and each of the at least three external ultrasound sensors ([0072] “The trilateration module 15 then automatically generates localization data, based on the deflected ultrasound signals detected by the ultrasound transducers 12, and the registration module 16 matches the coordinates of each point of the localization data generated by the trilateration module 15 with the coordinates of corresponding elements on a reference image obtained with the imaging system 17. The image obtained from the imaging system 17 is displayed on the display 18, together with the position and orientation of the microrobot 11. In this way, the position and orientation of the microrobot 11 in the brain 4 of the subject can be monitored, during its insertion and its displacement in the brain 4 of the subject.”).
However, the modified system and method of Duplat does not explicitly teach obtaining a current position of the medical device inside the volume of second tissue for the first iteration comprises: obtaining a thickness of the at least one first tissue layer at the position of each external ultrasound sensor using the 3D geometry of the at least one first tissue layer of the subject; for each of the at least three external ultrasound sensors, using the 3D map of speed in the first tissue layer to obtain a local speed in the first tissue type, corresponding to the speed of propagation of ultrasounds through the at least one first tissue layer in correspondence to the external ultrasound sensor position; for each of the at least three external ultrasound sensors, estimating a first distance between one of the at least three external ultrasound sensors and the medical device based on the corresponding obtained local speed in the at least one first tissue layer propagating through the at least one first tissue layer for a path equal to the corresponding obtained thickness, the speed of ultrasound in the second tissue and a measured time of propagation of the ultrasounds between each of the at least three external ultrasound sensors and the medical device; wherein the approximated current position of the medical device inside the volume of at least one second tissue, for the first iteration, is obtained using the estimated first distances between the medical device and each of the at least three external ultrasound sensors.
In an analogous estimation thickness and speed of sound in cortical bone field of endeavor, Minh teaches wherein obtaining a current position of the medical device inside the volume of second tissue for the first iteration, (Fig. 3, where one of ordinary skill in the art would understand that ultrasound is known as an apparatus that obtains an image of the inside of a subject by applying a transducer array to the subject. Therefore, any device inserted into the patient within the range of the ultrasound will be visible and the current position will be able to be obtained.), comprises:
a) obtaining a thickness of the at least one first tissue layer at the position of each external ultrasound sensor using the 3D geometry of the at least one first tissue layer of the subject (IV. Discussion “This study describes a simple method that allows the simultaneous estimation of thickness and compressional sound velocity in plate-shaped cortical bone samples using a phased-array ultrasound. The method uses refraction occurring at the interface between the soft and hard materials and refraction-corrected focusing to provide a multifocus image of both interfaces of the plate. We applied confocal transmit and receive beamforming, peak detection, and signal tracking algorithms, and an iterative approximation of an effective aperture to retrieve Ct.ν
M
F
11
and Ct.ThMF.”); and
b) for each of the at least three external ultrasound sensors, using the 3D map of speed in the first tissue layer to obtain a local speed in the first tissue type, corresponding to the speed of propagation of ultrasounds through the at least one first tissue layer in correspondence to the external ultrasound sensor position (Figs. 6-7).
Furthermore, the cited actions are computer implemented, which necessitate an associated computer-implemented method, as in II. Materials and Methods, A. Numerical Ultrasound Propagation Model (“Ultrasound wave propagation in water and bone was simulated using the 2-D FDTD method with Simsonic”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Minh because determining the thickness of the tissue (bone and brain) is crucial to properly imaging the region of interest, as difference thicknesses have different effects on the propagation of ultrasound acoustics, which affect the quality of images.
Claims 19 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Duplat et al. (US 20220000454) in view of Clement et al. (“Correlation of ultrasound phase with physical […]”) and Matsumoto et al. (US 20190216441), as applied to Claims 15 and 22 above, further in view of McGee (US 20060247520).
Regarding Claims 19 and 25, the modified system and method of Duplat teach all limitations of Claims 15 and 22, as discussed above. However, the modified system and method of Duplat do not explicitly teach wherein the exit criterion is configured to stop iterations for a given number of iterations when the difference between the approximated current position and the new position is inferior to a predefined threshold.
In an analogous tracked medical device position field of endeavor, McGee teaches a tracking system for estimating a 3D position of a medical device, ([0034] “The medical system 100 generally comprises (1) a mapping/ablation subsystem 102 for mapping and ablating tissue within the heart; (2) an imaging subsystem 104 for generating medical images of select regions of the patient's body; (3) a tracking subsystem 106 for tracking movable objects, such as catheters and the imaging components of the imaging subsystem 104; (4) an imager positioning subsystem 108 for mechanically manipulating the imaging subsystem 104 based on tracking information acquired from the tracking subsystem 106, such that only the relevant regions of the patient are imaged; and (5) an imager activating subsystem 109 for activating the imaging subsystem 104 based on tracking information acquired from the tracking subsystem 106, such that the patient is imaged only during relevant times.”), wherein the exit criterion is configured to stop iterations for a given number of iterations when the difference between the approximated current position and the new position is inferior to a predefined threshold ([0063] “If the location parameter difference does not surpass the threshold value, the activation processor 152 sends a deactivation signal to the activation controller 154, which will deactivate the imaging device 122, if currently activated.”).
Furthermore, the cited actions are computer implemented, which necessitate an associated computer-implemented method, as in [0001] (“The present inventions generally relate to systems and methods for navigating medical probes within anatomical organs or other structures.”) and Fig. 1.
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of McGee because the modification of including stopping for the iterations (deactivation) ensures that imaging is only performed when needed, as taught by McGee in [0013], thereby decreasing risk to the patient, from ultrasound risks, like heat or gas bubbles within the patient. Additionally, the modification may offer a customized navigation plan for each patient, as the anatomy varies, allowing for an increase or decrease in required energy or focus of the ultrasound, as taught by McGee in [0076].
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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