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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 18/608,412, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed application does not appear to teach “generate one or more virtual apex point locations and control acoustic transmissions from the two or more ultrasound transducer arrays using virtual apex point location generation and acoustic transmission adjustment; wherein the processor operatively generates the one or more virtual apex point locations based on the spinal anatomy or one or more anatomical models of a generalized spinal anatomy, to remove or decrease internal acoustic reverberations, image degradation, or both”. For at least this reason the prior-filed application does not disclose the invention currently filed.
Additionally, the disclosure of the prior-filed provisional application. Application No. 63/639,221, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed provisional application does not appear to teach “generate one or more virtual apex point locations and control acoustic transmissions from the two or more ultrasound transducer arrays using virtual apex point location generation and acoustic transmission adjustment; wherein the processor operatively generates the one or more virtual apex point locations based on the spinal anatomy or one or more anatomical models of a generalized spinal anatomy, to remove or decrease internal acoustic reverberations, image degradation, or both”. For at least this reason the prior-filed provisional application does not disclose the invention currently filed.
For at least these reasons the effective filing date of the present application is considered the filing date of the application April 28, 2025.
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.
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.
Claim(s) 1-3, 7-20, 22-25, 28, 30-38, 40-49 and 51-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mauldin et al. (US 20210045715, hereinafter Mauldin) in view of Grim et al. (US 20200305927, hereinafter Grim) and Ishrak et al. (US 20200397511, hereinafter Ishrak).
Regarding claim 1, Mauldin teaches an ultrasound imaging system for imaging a spinal anatomy ([0048]-[0049] and fig. 1 disclose system 10 which is an ultrasound imaging system. The system is used for spinal anatomy analysis) comprising:
a probe housing comprising two or more ultrasound transducer arrays ([0049] and [0055] disclose ultrasound probe 104 which includes a housing and one or more (two) ultrasound transducer arrays); and
a processor (the electronic circuitry of the system 10 in fig. 1) configured to control acoustic transmissions from the two or more ultrasound transducer arrays using acoustic transmission adjustment ([0049] discloses generating an ultrasound beam (acoustic transmission) using the ultrasound probe that is positionally adjusted); and
wherein the acoustic transmission adjustment comprises transmitting acoustic beams from two or more ultrasound transducer arrays of the two or more ultrasound transducer arrays along one or more transmission axes ([0049] discloses generating an ultrasound beam (acoustic transmission) using the ultrasound probe. The axes on which the beam is transmitted is considered the transmission axes), thereby creating real-time or substantially real-time visualization of the spinal anatomy ([0115] discloses viewing the data generated from the probe in real time), enhancement of visualization of one or more medical instruments inserted within or near the spinal anatomy ([0114] discloses rendering the intersection between the therapy applicator (instrument) and the ultrasound plane. Fig. 8 further shows the applicator (800) near the spinal anatomy (810)), and minimizing internal acoustic reverberations, image degradation, or both ([0080] discloses enhancing the obtained ultrasound data, thereby minimizing image degradation).
Mauldin does not specifically teach wherein each ultrasound transducer array of the two or more ultrasound transducer arrays is oriented at selected rotation angles within the probe housing such that a central acoustic axis or axes of the two or more ultrasound transducer arrays intersect to create an overlapping acoustic imaging region configured for imaging the spinal anatomy;
wherein the two or more ultrasound transducer arrays are rotated within the probe housing so that the central axis of each of the two or more ultrasound transducer arrays are angled relative to a contact surface of the probe housing that couples with or is placed on or near a patient contact surface.
However,
Grim in a similar field of endeavor teaches each ultrasound transducer array of the two or more ultrasound transducer arrays is oriented at selected rotation angles within the probe housing such that a central acoustic axis or axes of the two or more ultrasound transducer arrays intersect to create an overlapping acoustic imaging region configured for imaging the anatomy ([0040]-[0045] and fig. 6 show the transducer arrays 108 and 110 are oriented at selected rotation angles within the probe housing where the central axes of the arrays intersect to create an overlapping acoustic imaging region for imaging the anatomy);
wherein the two or more ultrasound transducer arrays are rotated within the probe housing so that the central axis of each of the two or more ultrasound transducer arrays are angled relative to a contact surface of the probe housing that couples with or is placed on or near a patient contact surface ([0047] and figs. 4 and 6 disclose the two arrays are rotated within the probe housing such that the arrays are angled relative to the contact surface of the probe with the skin surface of the patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the ultrasound transducer arrays of Mauldin for the rotated ultrasound transducer arrays of Grim because it amounts to simple substitution of one known element for another in order to obtain the predictable results of ensuring both transducers image the medical instrument, thereby improving the quality of the procedure.
Mauldin in view of Grim does not specifically teach the processor configured to operatively generate one or more virtual apex point locations and control acoustic transmissions from the two or more ultrasound transducer arrays using virtual apex point location generation; wherein the processor operatively generates the one or more virtual apex point locations based on the spinal anatomy or one or more anatomical models of a generalized spinal anatomy, to remove or decrease internal acoustic reverberations, image degradation, or both; and wherein the acoustic transmission adjustment comprises transmitting acoustic beams from two or more ultrasound transducer arrays of the two or more ultrasound transducer arrays along one or more transmission axes starting at the one or more generated virtual apex point locations.
However,
Ishrak in a similar field of endeavor teaches a processor (controller 204 in fig. 4) configured to operatively generate one or more virtual apex point locations and control acoustic transmissions from the two or more ultrasound transducer arrays using virtual apex point location generation ([0305]-[0306] disclose controller 204 adjusts the location of a virtual apex to change the field of view of the ultrasound energy generated by the transducer. “ in a split aperture mode, controller 204 may control the virtual apex for a first subset or array of transducer elements to receive ultrasound energy in a first field of view and control the virtual apex for a second subset or array of transducer elements to receive ultrasound energy in a second field of view different than the first field of view”);
wherein the processor operatively generates the one or more virtual apex point locations based on the anatomy, to remove or decrease internal acoustic reverberations, image degradation, or both ([0305]-[0306] disclose the virtual apex locations are based on the contents of the image (anatomy) and in order to avoid or mitigate the effects of obstructions within the image, thereby decreasing image degradation); and
wherein the acoustic transmission adjustment comprises transmitting acoustic beams from two or more ultrasound transducer arrays of the two or more ultrasound transducer arrays along one or more transmission axes starting at the one or more generated virtual apex point locations ([0305]-[0307] and figs. 24A and 25A show generating acoustic beams staring at the virtual apex, where the transducer is split into a first and second subset).
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 processor disclosed by Mauldin in view of Grim to operatively generate one or more virtual apex point locations and control acoustic transmissions from the two or more ultrasound transducer arrays using virtual apex point location generation; wherein the processor operatively generates the one or more virtual apex point locations based on the spinal anatomy or one or more anatomical models of a generalized spinal anatomy, to remove or decrease internal acoustic reverberations, image degradation, or both; and wherein the acoustic transmission adjustment comprises transmitting acoustic beams from two or more ultrasound transducer arrays of the two or more ultrasound transducer arrays along one or more transmission axes starting at the one or more generated virtual apex point locations in order to avoid or mitigate obstructions within the obtained images, as recognized by Ishrak ([0305]).
Regarding claim 2, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Ishrak further teaches the one or more virtual apex point locations do not coincide with, or wherein the one or more virtual apex locations are different than, any of the physical apexes of the one or more ultrasound transducer arrays, as defined by their geometry ([0307] discloses the virtual apex is located behind the face of the transducer array).
Regarding claim 3, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Ishrak further teaches the one or more virtual apex point locations change a location based on ultrasound data received by the processor ([0279] discloses adjusting the virtual apex based on the position of obstructions within the field of view which corresponds to the ultrasound data received).
Regarding claim 7, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Grim further teaches at least one acoustically transmissive standoff layer positioned between each of the two or more ultrasound transducer arrays and the patient contact surface ([0047] and figs. 3-6 disclose a coupling wedge 142 which is made of an acoustically transparent material that separates the skin surface of the patient and the ultrasound transducers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having at least one acoustically transmissive standoff layer positioned between each of the two or more ultrasound transducer arrays and the patient contact surface of Grim to the system of Mauldin in view of Grim and Ishrak to allow for the predictable results of improving the transmission of ultrasound signals from the transducers to the patient, thereby improving the quality of the obtained images.
Regarding claim 8, Mauldin in view of Grim and Ishrak teaches the system of claim 7, as set forth above. Grim further teaches the at least one acoustically transmissive standoff layer has acoustic impedance characteristics matched or substantially matched within +/- 50% of soft tissue, and wherein the at least one acoustically transmissive standoff layer provides an angled patient interface to minimize internal acoustic reverberations ([0047] discloses the wedge 142 is made of silicone which has an acoustic impedance of 1.1 MRayl which is +/-50% of the acoustic impedance of soft tissue which is 1.6 MRayl).
Regarding claim 9, Mauldin in view of Grim and Ishrak teaches the system of claim 7, as set forth above. Grim further teaches the at least one acoustically transmissive standoff layer comprises a patient contact interface and an acoustic filler material ([0047] and figs. 3-6 disclose a coupling wedge 142 which is made of an acoustically transparent material (filler material) that separates the skin surface of the patient and the ultrasound transducers, therefore the wedge has a patient contact interface).
Regarding claim 10, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Grim further teaches a first central axis of acoustic propagation from a first ultrasound transducer array of the two or more ultrasound transducer arrays and a second central axis of acoustic propagation from a second ultrasound transducer array of the two or more ultrasound transducer arrays are not aligned or co-aligned with an interspinous ligament or a spinous process when the probe housing is centered over all or part of the spinal anatomy such as in a transverse view (fig. 6 shows the angle of the transducer arrays and since the transducers are at a rotated angle they would not be aligned with the interspinous ligament or spinous process when the probe housing is centered over the spinal anatomy).
Regarding claim 11, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Ishrak further teaches a first central axis of sound propagation from a first ultrasound transducer array of the two or more ultrasound transducer arrays differs from a second central axis of sound propagation from a second ultrasound transducer array of the two or more ultrasound transducer arrays ([0247]-[0250] and figs. 18A-23 disclose the central axis of the first transducer is different from the central axis of the second transducer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Mauldin in view of Grim and Ishrak to have a first central axis of sound propagation from a first ultrasound transducer array of the two or more ultrasound transducer arrays differs from a second central axis of sound propagation from a second ultrasound transducer array of the two or more ultrasound transducer arrays in order to ensure the entire imaging region is being images, as recognized by Ishrak ([0249]).
Regarding claim 12, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Mauldin further teaches the configured processor is further operative to receive ultrasound data from the two or more ultrasound transducer arrays or from beamforming electronics that receive ultrasound data from the two or more ultrasound transducer arrays ([0049] discloses acquiring data using two ultrasound transducer arrays), the ultrasound data comprising information related to one or more of: image quality, image quality metrics, image accuracy, the spinal anatomy, a position or track of the one or more inserted medical instruments, or motion created by and/or from intraspinal blood flow ([0104] discloses the ultrasound probe acquires data corresponding the anatomy of interest (spinal anatomy)).
Regarding claim 13, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Grim further teaches an integrated medical instrument guide located between at least two of the two or more ultrasound transducer arrays ([0043]-[0044] and figs. 3-6 disclose channel 130 (instrument guide) located between the two transducer), the integrated medical instrument guide defining a physical gap providing a midline or paramedian trajectory for insertion, guidance, tracking, or combinations thereof, of the one or more medical instruments in-plane with the overlapping acoustic imaging region ([0043]-[0044] and figs. 3-6 disclose the channel is used for guiding the needle 10 to be in-plane with the overlapping acoustic imaging region as shown in fig. 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having an integrated medical instrument guide located between at least two of the two or more ultrasound transducer arrays, the integrated medical instrument guide defining a physical gap providing a midline or paramedian trajectory for insertion, guidance, tracking, or combinations thereof, of the one or more medical instruments in-plane with the overlapping acoustic imaging region of Grim to the system of Mauldin in view of Grim and Ishrak to allow for the predictable results of ensuring the medical instrument is being captured by the ultrasound transducer arrays, thereby making it easier for the user to track the position of the instrument.
Regarding claim 14, Mauldin in view of Grim and Ishrak teaches the system of claim 13, as set forth above. Mauldin further teaches the one or more medical instruments are one or more of a needle, a catheter, a trocar, an ablation instrument, a cutting instrument, or a therapy applicator ([0062] discloses the therapy applicator 116 is a needle).
Regarding claim 15, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Ishrak further teaches the configured processor is further operative to adaptively reconfigure a direction of sound propagation from at least one of the two or more ultrasound transducer arrays to optimize or enhance system sensitivity to the one or more medical instruments based on output of a medical instrument detection sensor and/or algorithm ([0074] and [0078]-[0079] disclose steering the ultrasound beam in order to avoid the medical instrument based on an EM tracking technique).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Mauldin in view of Grim and Ishrak to have the configured processor is further operative to adaptively reconfigure a direction of sound propagation from at least one of the two or more ultrasound transducer arrays to optimize or enhance system sensitivity to the one or more medical instruments based on output of a medical instrument detection sensor and/or algorithm in order to ensure the correct image is being acquired, as recognized by Ishrak ([0078]).
Regarding claim 16, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Grim further teaches the probe housing is configured to accept the one or more medical instruments in a lateral separation space between two or more of the two or more ultrasound transducer arrays (figs. 3-6 show the probe housing is configured to accept the medical instrument in a lateral separation space between the two ultrasound transducer arrays).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the probe housing is configured to accept the one or more medical instruments in a lateral separation space between two or more of the two or more ultrasound transducer arrays of Grim to the system of Mauldin in view of Grim and Ishrak to allow for the predictable results of ensuring the medical instrument is being captured by the ultrasound transducer arrays, thereby making it easier for the user to track the position of the instrument.
Regarding claim 17, Mauldin in view of Grim and Ishrak teaches the system of claim 16, as set forth above. Mauldin further teaches the one or more medical instruments is one or more focused ultrasound therapy transducers ([0043] discloses the therapy applicator is a high intensity focused ultrasound transducer).
Regarding claim 18, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Grim further teaches the two or more ultrasound transducer arrays do not make direct physical contact with the patient contact surface ([0047] and fig. 6 discloses coupling wedge 142 is between the transducers and the skin surface of the patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the two or more ultrasound transducer arrays do not make direct physical contact with the patient contact surface of Grim to the system of Mauldin in view of Grim and Ishrak to allow for the predictable results of improving the coupling between the probe and the patient.
Regarding claim 19, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Mauldin further teaches the configured processor is further operative to adaptively reconfigure a direction of sound propagation of at least one of the two or more ultrasound transducer arrays to modify one or more angles of acoustic incidence from the at least one of the two or more ultrasound transducer arrays, relative to one or more of the spinal anatomy, a spinal anatomical target, or the one or more medical instruments. ([0024] and [0049] disclose electronically adjusting the position of the ultrasound beam from the ultrasound probe to the anatomy).
Regarding claim 20, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Mauldin further teaches the configured processor is further operative to direct or re-direct transmitted energy along an axis that minimizes sound travel distance to an epidural space relative to (a) the probe housing, (b) one or more ultrasound transducer arrays of the two or more ultrasound transducer arrays, (c) the two or more ultrasound transducer arrays, or (d) combinations thereof ([0119]-[0120] and fig. 5 show the location that minimizes sound travel distance (epidural space depth 530) from the skin surface (probe housing location) to the epidural space is determined. [0049] further discloses directing the ultrasound beam to the epidural space).
Regarding claim 22, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Mauldin further teaches the configured processor is further operative to adaptively reconfigure a direction of sound propagation of at least one of the two or more ultrasound transducer arrays to optimize or enhance system sensitivity to a posterior complex based on output of an anatomical detection sensor and/or algorithm ([0024] and [0049] disclose the ultrasound beam is electronically adjusted to acquire ultrasound images of the target anatomical region which includes spinal anatomy (posterior complex). The part of the processor that controls the electronic adjusting is considered the algorithm).
Regarding claim 23, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Mauldin further teaches the configured processor is further operative to adaptively reconfigure a direction of sound propagation of at least one of the two or more ultrasound transducer arrays to optimize or enhance system sensitivity to an anterior complex based on output of an anatomical detection sensor and/or algorithm ([0024] and [0049] disclose the ultrasound beam is electronically adjusted to acquire ultrasound images of the target anatomical region which includes spinal anatomy (anterior complex). The part of the processor that controls the electronic adjusting is considered the algorithm).
Regarding claim 24, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Mauldin further teaches the configured processor is further operative to control a propagation direction of sound waves from the two or more ultrasound transducer arrays at one or more non-zero angles relative to (a) a central axis of the probe housing, (b) one or more ultrasound transducer arrays of the two or more ultrasound transducer arrays, (c) the two or more ultrasound transducer arrays, or (d) combinations thereof, using automated electronic beam steering ([0024] and [0049] disclose electronically adjusting the position of the ultrasound beam from the ultrasound probe).
Regarding claim 25, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Mauldin further teaches the configured processor is further operative to adaptively reconfigure a direction of sound propagation of at least one of the two or more ultrasound transducer arrays to modify a field of view or to adjust an extent, an amount, or a percentage, of one or more overlapping regions between imaging planes of the two or more ultrasound transducer arrays ([0024] and [0049] disclose electronically adjusting the position of the ultrasound beam from the ultrasound probe to the anatomy, thereby modifying a field of view of the planes).
Regarding claim 28, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Grim further teaches each ultrasound transducer array of the two or more ultrasound transducer arrays is rotated within the probe housing at angles between about 100 and about 450 relative to the patient contact surface contacted by the probe housing (fig. 6 shows the transducer arrays are rotated at an angle of 10 degrees).
Regarding claim 30, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Mauldin further teaches the configured processor is further operative to adaptively generate, move, or change a location of the one or more virtual apex point locations, adaptively select or adjust one or more acoustic transmission powers, adaptively select or adjust one or more acoustic transmission angles, adaptively select or adjust the one or more transmission axes, adaptively select or adjust beam steering angles, adaptively select or adjust virtual apex geometry, or combinations thereof, based on an analysis of ultrasound data, image quality feedback derived from the ultrasound data, image quality metrics derived from the ultrasound data, or combinations thereof ([0104] and [0108] discloses it is determined which locations require additional scan information based on the received ultrasound data and further guides the probe to acquire additional views. [0049] discloses the ultrasound beam is adjusted electronically (beam steered)).
Regarding claim 31, Mauldin in view of Grim and Ishrak teaches the system of claim 30, as set forth above. Mauldin further teaches the configured processor is further operative to utilize a pre- acquired patient anatomical model to optimize or enhance the adaptive generation, movement, or changing of the location of the one or more virtual apex point locations, the adaptive selection or adjustment of the one or more acoustic transmission powers, the adaptive selection or adjustment of the one or more acoustic transmission angles, the adaptive selection or adjustment of the one or more transmission axes, the adaptive selection or adjustment of the beam steering angles, the adaptive selection or adjustment of the virtual apex geometry, or combinations thereof ([0104] discloses the use of a 3D model to determine which locations require additional scan information (adjustment of beam steering angles)).
Regarding claim 32, Mauldin in view of Grim and Ishrak teaches the system of claim 30, as set forth above. Ishrak further teaches the configured processor is further operative to utilize an artificial intelligence or machine learning model that receives as input the ultrasound data, for producing an output that optimizes or enhances the adaptive generation, movement, or changing of the location of the one or more virtual apex point locations, the adaptive selection or adjustment of the one or more acoustic transmission powers, the adaptive selection or adjustment of the one or more acoustic transmission angles, the adaptive selection or adjustment of the one or more transmission axes, the adaptive selection or adjustment of the beam steering angles, the adaptive selection or adjustment of the virtual apex geometry, or combinations thereof ([0127] discloses using machine learning to adjust the trajectory of the ultrasound, thereby adjusting at least the virtual apex location and the beam steering angle).
Regarding claim 33, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Grim further teaches at least one of the two or more ultrasound transducer arrays are selectively operated in Doppler mode, elastography mode, or both, so that the configured processor is further operative to dynamically evaluate tissue properties of the anatomy along a medical instrument insertion path ([0053] discloses one or both of the ultrasound transducers implement doppler imaging).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Mauldin in view of Grim and Ishrak to have at least one of the two or more ultrasound transducer arrays are selectively operated in Doppler mode, elastography mode, or both, so that the configured processor is further operative to dynamically evaluate tissue properties of the anatomy along a medical instrument insertion path in order to have the instrument avoid vascular structures in its path, as recognized by Grim ([0053]).
Regarding claim 34, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Mauldin further teaches the configured processor is further operative to provide virtual medical instrument guidance images or information during neuraxial anesthesia procedures, including epidural injections, spinal anesthesia, or lumbar punctures ([0102] discloses providing guidance for the therapeutic process which includes neuraxial anesthesia in the epidural space. Also see [0120]-[0121]).
Regarding claim 35, Mauldin teaches a computer-implemented method of ultrasound imaging for visualizing spinal anatomy (method 20 in fig. 2 and [0048]-[0049] discloses the procedure is analyzing spinal anatomy), the method comprising:
positioning an ultrasound imaging probe housing comprising two or more ultrasound transducer arrays on, near, or against a patient contact surface ([0049] “a user places the ultrasound probe 104 on the subject's skin proximal to the target anatomical region”, where the probe includes one or more (two) transducer arrays);
transmitting acoustic signals from each ultrasound transducer array into the spinal anatomy by using a processor operative to automatically steer acoustic beams from each ultrasound transducer array, the automatic steering determined by the processor generating ([0049] “The user then moves or scans (e.g., mechanically and/or electronically), through positional adjustments, the ultrasound probe 104 along the subject's skin, in the vicinity of the target anatomical region, to acquire ultrasound images of the target anatomical region” and “where a two-dimensional array transducer is utilized, then the ultrasound beam produced by the ultrasound transducer can be positionally adjusted electronically using a programmable electronic transmit circuit, which applies time delays to particular elements of the two-dimensional array”);
receiving ultrasound data ([0059] discloses receiving data output from the ultrasound probe); and
acquiring and displaying ultrasound image or video of all or a part of the spinal anatomy, one or more inserted medical instruments, or both ([0059] “ The main processing unit 136 can process this data and output image data to display 140”. [0098] discloses the display is of the spinal anatomy).
Mauldin does not specifically teach each ultrasound transducer array of the two or more ultrasound transducer arrays is oriented at a rotation angle within the ultrasound imaging probe housing such that central acoustic axes of the two or more ultrasound transducer arrays intersect to define an overlapping acoustic imaging region of the spinal anatomy.
However,
Grim in a similar field of endeavor teaches each ultrasound transducer array of the two or more ultrasound transducer arrays is oriented at a rotation angle within the ultrasound imaging probe housing such that central acoustic axes of the two or more ultrasound transducer arrays intersect to define an overlapping acoustic imaging region of the spinal anatomy ([0040]-[0045] and fig. 6 show the transducer arrays 108 and 110 are oriented at selected rotation angles within the probe housing where the central axes of the arrays intersect to create an overlapping acoustic imaging region for imaging the anatomy).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the ultrasound transducer arrays of Mauldin for the rotated ultrasound transducer arrays of Grim because it amounts to simple substitution of one known element for another in order to obtain the predictable results of ensuring both transducers image the medical instrument, thereby improving the quality of the procedure.
Mauldin in view of Grim does not specifically teach optionally adjusting, a virtual apex point location, wherein acoustic beam transmission axes are automatically selected by the processor, and wherein the automatically selected acoustic beam transmission axes are outside of or out of alignment with each ultrasound transducer array's central acoustic axis, as defined by each ultrasound transducer array's geometry.
However,
Ishrak in a similar field of endeavor teaches optionally adjusting, a virtual apex point location, wherein acoustic beam transmission axes are automatically selected by the processor, and wherein the automatically selected acoustic beam transmission axes are outside of or out of alignment with each ultrasound transducer array's central acoustic axis, as defined by each ultrasound transducer array's geometry ([0305]-[0307] disclose controller 204 adjusts the location of a virtual apex to change the field of view of the ultrasound energy generated by the transducer. “in a split aperture mode, controller 204 may control the virtual apex for a first subset or array of transducer elements to receive ultrasound energy in a first field of view and control the virtual apex for a second subset or array of transducer elements to receive ultrasound energy in a second field of view different than the first field of view”. Additionally, the apex is located behind the ultrasound transducer array).
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 method disclosed by Mauldin in view of Grim to optionally adjusting, a virtual apex point location, wherein acoustic beam transmission axes are automatically selected by the processor, and wherein the automatically selected acoustic beam transmission axes are outside of or out of alignment with each ultrasound transducer array's central acoustic axis, as defined by each ultrasound transducer array's geometry in order to avoid or mitigate obstructions within the obtained images, as recognized by Ishrak ([0305]).
Regarding claim 36, Mauldin in view of Grim and Ishrak teaches the method of claim 35, as set forth above. Mauldin further teaches based on the received ultrasound data, the method further comprises: (a) automatically adjusting the automatic steering of the acoustic beams from each ultrasound transducer array, (b) automatically adjusting the virtual apex point location, (c) automatically adjusting the selected acoustic beam transmission axes, or (d) combinations thereof, to produce a visualization, either virtual or real, of the spinal anatomy ([0049] discloses electronically adjusting the position of the ultrasound beam based on the ultrasound data. [0098] discloses generating a display of the spinal anatomy).
Regarding claim 37, Mauldin in view of Grim and Ishrak teaches the method of claim 35, as set forth above. Mauldin further teaches the displayed image or video comprises an overlaying of the received ultrasound data from the spinal anatomy, the one or more inserted medical instruments, or both, with a virtual representation of the spinal anatomy, a virtual representation of the one or more medical instruments, or both the virtual representation of the spinal anatomy and the virtual representation of the one or more medical instruments, or an overlaying of the virtual representation of the spinal anatomy, the virtual representation of the one or more medical instruments, or both the virtual representation of the spinal anatomy and the virtual representation of the one or more medical instruments, with the received ultrasound data from the spinal anatomy, the one or more inserted medical instruments, or both (figs. 7 and 8 show displaying the image includes an overlay of the medical instrument with the received ultrasound data of the spinal anatomy).
Regarding claim 38, Mauldin in view of Grim and Ishrak teaches the method of claim 35, as set forth above. Mauldin further teaches generating and displaying a compounded ultrasound image or video by automatically selectively fusing all or parts of the received ultrasound data, thereby enhancing visualization of the spinal anatomy, the one or more inserted medical instruments, or both the spinal anatomy and the one or more inserted medical instruments ([0074] discloses generating and displaying a combined image of the received ultrasound data).
Regarding claim 40, Mauldin in view of Grim and Ishrak teaches the method of claim 35, as set forth above. Mauldin further teaches at least one acoustically transmissive standoff layer located between at least one ultrasound transducer array of the two or more ultrasound transducer arrays and the patient contact surface ([0047] and figs. 3-6 disclose a coupling wedge 142 which is made of an acoustically transparent material that separates the skin surface of the patient and the ultrasound transducers).
Regarding claim 41, Mauldin in view of Grim and Ishrak teaches the method of claim 40, as set forth above. Grim further teaches the acoustically transmissive standoff layer matches or substantially matches an acoustic impedance within +50% of soft tissue, and wherein the acoustically transmissive standoff layer includes an angled patient interface configured to reduce internal acoustic reverberations ([0047] discloses the wedge 142 is made of silicone which has an acoustic impedance of 1.1 MRayl which is +/-50% of the acoustic impedance of soft tissue which is 1.6 MRayl).
Regarding claim 42, Mauldin in view of Grim and Ishrak teaches the method of claim 35, as set forth above. Ishrak further teaches at least one of the virtual apex point location or the selected acoustic beam transmission axes are adjusted based on real-time or substantially real-time analysis of the received ultrasound data to optimize or enhance visibility of the spinal anatomy, including anatomical targets, the one or more inserted medical instruments, or both the spinal anatomy and the one or more inserted medical instruments ([0279] discloses adjusting the virtual apex based on the position of obstructions within the field of view which corresponds to the ultrasound data received. Thereby enhancing the visibility of the spinal anatomy).
Regarding claim 43, Mauldin in view of Grim and Ishrak teaches the non-transitory computer readable medium of claim 35, as set forth above. Grim further teaches the identifying intraspinal blood flow or tissue properties by processing the received ultrasound data, and wherein the data includes Doppler imaging information and/or elastography imaging information ([0053] discloses one or both of the ultrasound transducers implement doppler imaging which allows the system to identify tissue properties by processing the received doppler images).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Mauldin in view of Grim and Ishrak to identify intraspinal blood flow or tissue properties by processing the received ultrasound data, and wherein the data includes Doppler imaging information and/or elastography imaging information in order to have the instrument avoid vascular structures in its path, as recognized by Grim ([0053]).
Regarding claim 44, Mauldin in view of Grim and Ishrak teaches the method of claim 35, as set forth above. Ishrak further teaches adaptively modifying the acoustic beam transmission axes based on real-time or substantially real-time anatomical feature detection provided by an anatomical feature detection sensor, a machine learning algorithm, or both ([0127] discloses using machine learning to adjust the trajectory of the ultrasound, thereby adjusting the acoustic beam transmission axes).
Regarding claim 45, Mauldin in view of Grim and Ishrak teaches the method of claim 35, as set forth above. Mauldin further teaches comparing and/or contrasting one or more acquired ultrasound images to a pre-acquired anatomical model to optimize or enhance (a) the automatic adjustment of the automatic steering of the acoustic beams from each ultrasound transducer array, (b) the automatic adjustment of the virtual apex point location, (c) the automatic adjustment of the selected acoustic beam transmission axes, or (d) combinations thereof ([0104] and [0108] discloses it is determined which locations require additional scan information based on the received ultrasound data and a previously acquired 3D model and further guides the probe to acquire additional views. [0049] discloses the ultrasound beam is adjusted electronically. This enhances the automatic adjustment of the automatic steering of the acoustic beams).
Regarding claim 46, Mauldin in view of Grim and Ishrak teaches the method of claim 35, as set forth above. Mauldin further teaches the computer-implemented method of ultrasound imaging for visualizing spinal anatomy is used in interventional procedures selected from a group consisting of: lumbar punctures, epidural injections, nerve stimulation, ablation therapies, and chronic pain therapy injections ([0034] discloses the procedure includes epidural injections).
Regarding claim 47, Mauldin teaches a non-transitory computer-readable medium storing executable program instructions ([0198] discloses a non-transitory computer memory for implementing the invention) which, when executed by at least one processor, cause the at least one processor to perform a method of ultrasound imaging for visualizing spinal anatomy (method 20 in fig. 2 and [0048]-[0049] discloses the procedure is analyzing spinal anatomy), the method comprising:
positioning the ultrasound imaging probe housing comprising two or more distance- separated ultrasound transducer arrays on, near, or against a patient contact surface ([0049] “a user places the ultrasound probe 104 on the subject's skin proximal to the target anatomical region”, where the probe includes one or more (two) transducer arrays);
automatically controlling acoustic signals transmitted from the two or more ultrasound transducer arrays into the spinal anatomy by automatically steering acoustic beams from the first at least one ultrasound transducer array and the second at least one ultrasound transducer array ([0049] “The user then moves or scans (e.g., mechanically and/or electronically), through positional adjustments, the ultrasound probe 104 along the subject's skin, in the vicinity of the target anatomical region, to acquire ultrasound images of the target anatomical region” and “where a two-dimensional array transducer is utilized, then the ultrasound beam produced by the ultrasound transducer can be positionally adjusted electronically using a programmable electronic transmit circuit, which applies time delays to particular elements of the two-dimensional array”); and
receiving and displaying ultrasound data related to the spinal anatomy, one or more inserted medical instruments inserted into the spinal anatomy, or both the spinal anatomy and the one or more inserted medical instruments.
Mauldin does not specifically teach wherein at least one first ultrasound transducer array of the two or more ultrasound transducer arrays is oriented at a rotation angle within the probe housing such that a central acoustic axis of the at least one first ultrasound transducer array of the two or more ultrasound transducer arrays intersects with a central acoustic axis of a second at least one ultrasound transducer array of the two or more ultrasound transducer arrays, to define an overlapping acoustic imaging region.
However,
Grim in a similar field of endeavor teaches at least one first ultrasound transducer array of the two or more ultrasound transducer arrays is oriented at a rotation angle within the probe housing such that a central acoustic axis of the at least one first ultrasound transducer array of the two or more ultrasound transducer arrays intersects with a central acoustic axis of a second at least one ultrasound transducer array of the two or more ultrasound transducer arrays, to define an overlapping acoustic imaging region ([0040]-[0045] and fig. 6 show the transducer arrays 108 and 110 are oriented at selected rotation angles within the probe housing where the central axes of the arrays intersect to create an overlapping acoustic imaging region for imaging the anatomy).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the ultrasound transducer arrays of Mauldin for the rotated ultrasound transducer arrays of Grim because it amounts to simple substitution of one known element for another in order to obtain the predictable results of ensuring both transducers image the medical instrument, thereby improving the quality of the procedure.
Mauldin in view of Grim does not specifically teach using a virtual apex transmit aperture technique, the technique comprising automatically selecting acoustic beam transmission axes that are outside of the first at least one ultrasound transducer array's central axis and the second at least one ultrasound transducer array's central axis, as defined by the first at least one ultrasound transducer array's geometry and the second at least one ultrasound transducer array's geometry, thereby generating a virtual apex point using the first and the second distance-separated ultrasound transducer arrays.
However,
Ishrak in a similar field of endeavor teaches using a virtual apex transmit aperture technique, the technique comprising automatically selecting acoustic beam transmission axes that are outside of the first at least one ultrasound transducer array's central axis and the second at least one ultrasound transducer array's central axis, as defined by the first at least one ultrasound transducer array's geometry and the second at least one ultrasound transducer array's geometry, thereby generating a virtual apex point using the first and the second distance-separated ultrasound transducer arrays ([0305]-[0307] disclose controller 204 adjusts the location of a virtual apex to change the field of view of the ultrasound energy generated by the transducer. “in a split aperture mode, controller 204 may control the virtual apex for a first subset or array of transducer elements to receive ultrasound energy in a first field of view and control the virtual apex for a second subset or array of transducer elements to receive ultrasound energy in a second field of view different than the first field of view”. Additionally, the apex is located behind the ultrasound transducer array).
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 method disclosed by Mauldin in view of Grim to use a virtual apex transmit aperture technique, the technique comprising automatically selecting acoustic beam transmission axes that are outside of the first at least one ultrasound transducer array's central axis and the second at least one ultrasound transducer array's central axis, as defined by the first at least one ultrasound transducer array's geometry and the second at least one ultrasound transducer array's geometry, thereby generating a virtual apex point using the first and the second distance-separated ultrasound transducer arrays in order to avoid or mitigate obstructions within the obtained images, as recognized by Ishrak ([0305]).
Regarding claim 48, Mauldin in view of Grim and Ishrak teaches the non-transitory computer readable medium of claim 47, as set forth above. Mauldin further teaches sending control signals to and from the two or more distance-separated ultrasound transducer arrays, wherein the first at least one ultrasound transducer array and/or the second at least one ultrasound transducer array comprise at least one acoustically transmissive standoff layer positioned between the first at least one ultrasound transducer array and the patient contact surface and/or between the second at least one ultrasound transducer array and the patient contact surface ([0047] and figs. 3-6 disclose a coupling wedge 142 which is made of an acoustically transparent material that separates the skin surface of the patient and the ultrasound transducers).
Regarding claim 49, Mauldin in view of Grim and Ishrak teaches the non-transitory computer readable medium of claim 48, as set forth above. Grim further teaches the at least one acoustically transmissive standoff layer matches or substantially matches an acoustic impedance within +50% of soft tissue ([0047] discloses the wedge 142 is made of silicone which has an acoustic impedance of 1.1 MRayl which is +/-50% of the acoustic impedance of soft tissue which is 1.6 MRayl), and wherein the first at least one ultrasound transducer array and/or the second at least one ultrasound transducer array include an angled patient interface configured to minimize acoustic reverberations in the probe housing, in one or more of the two or more ultrasound transducer arrays, or combinations thereof (figs. 3-6 further show the transducer arrays include an angled patient interface).
Regarding claim 51, Mauldin in view of Grim and Ishrak teaches the non-transitory computer readable medium of claim 47, as set forth above. Mauldin further teaches generating and displaying compounded ultrasound images or videos by selectively fusing ultrasound information acquired directly or indirectly from the two or more ultrasound transducer arrays, thereby enhancing visualization of the spinal anatomy and/or the one or more inserted medical instruments ([0074] discloses generating and displaying a combined image of the received ultrasound data).
Regarding claim 52, Mauldin in view of Grim and Ishrak teaches the non-transitory computer readable medium of claim 47, as set forth above. Ishrak further teaches adaptively adjusting at least one of beam steering angles or virtual apex geometry based on real-time or substantially real-time analysis of the received ultrasound data to optimize or enhance the visualization of the spinal anatomy, visualization of anatomical targets, visualization of the one or more inserted medical instruments, or combinations thereof s ([0279] discloses adjusting the virtual apex based on the position of obstructions within the field of view which corresponds to the ultrasound data received. Thereby enhancing the visibility of the spinal anatomy).
Regarding claim 53, Mauldin in view of Grim and Ishrak teaches the non-transitory computer readable medium of claim 47, as set forth above. Grim further teaches the instructions further cause the processor to identify intraspinal blood flow or tissue properties by processing the received ultrasound data, and wherein the data includes Doppler imaging information and/or elastography imaging information ([0053] discloses one or both of the ultrasound transducers implement doppler imaging which allows the system to identify tissue properties by processing the received doppler images).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Mauldin in view of Grim and Ishrak to have the instructions further cause the processor to identify intraspinal blood flow or tissue properties by processing the received ultrasound data, and wherein the data includes Doppler imaging information and/or elastography imaging information in order to have the instrument avoid vascular structures in its path, as recognized by Grim ([0053]).
Regarding claim 54, Mauldin in view of Grim and Ishrak teaches the non-transitory computer readable medium of claim 47, as set forth above. Ishrak further teaches the instructions further cause the processor to adaptively modify beam steering angles, the acoustic beam transmission axes, or both, based on real-time or substantially real-time spinal anatomy detection provided by a spinal anatomy detecting sensor and/or machine learning algorithm ([0127] discloses using machine learning to adjust the trajectory of the ultrasound, thereby adjusting the acoustic beam transmission axes).
Regarding claim 55, Mauldin in view of Grim and Ishrak teaches the non-transitory computer readable medium of claim 47, as set forth above. Mauldin further teaches the instructions further cause the processor to compare and/or contrast the received ultrasound data, the overlapping acoustic imaging region, ultrasound images, or combinations thereof, to a pre-acquired anatomical model for optimizing or enhancing beam steering angles, virtual apex geometry, the acoustic beam transmission axes, the virtual apex point, a virtual apex point location, or combinations thereof ([0104] and [0108] discloses it is determined which locations require additional scan information based on the received ultrasound data and a previously acquired 3D model and further guides the probe to acquire additional views. [0049] discloses the ultrasound beam is adjusted electronically. This enhances the automatic adjustment of the automatic steering of the acoustic beams).
Regarding claim 56, Mauldin in view of Grim and Ishrak teaches the non-transitory computer readable medium of claim 47, as set forth above. Mauldin further teaches the computer-implemented method of ultrasound imaging for visualizing spinal anatomy is used in interventional procedures selected from a group consisting of: lumbar punctures, epidural injections, nerve stimulation, ablation therapies, and chronic pain therapy injections ([0034] discloses the procedure includes epidural injections).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mauldin in view of Grim and Ishrak as applied to claim 1 above, and further in view of Hettrick et al. (US 20180116723, hereinafter Hettrick).
Regarding claim 4, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Mauldin in view of Grim and Ishrak does not specifically teach the controlled acoustic transmissions include controlling one or more acoustic transmission powers, and wherein the configured processor operatively selects the one or more acoustic transmission powers based on the spinal anatomy or the one or more anatomical models of generalized spinal anatomy, to remove or decrease the internal acoustic reverberations, the image degradation, or both, wherein the one or more transmission powers are automatically adjusted based on ultrasound data received by the processor.
However,
Hettrick in a similar field of endeavor teaches controlling one or more acoustic transmission powers, and wherein the configured processor operatively selects the one or more acoustic transmission powers based on the anatomy o, to remove or decrease the internal acoustic reverberations, the image degradation, or both, wherein the one or more transmission powers are automatically adjusted based on ultrasound data received by the processor ([0088] discloses identifying an anatomical position target location and adjusting the power of the transmission in order to generate an ultrasound focus at the target location).
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 processor disclosed by Mauldin in view of Grim and Ishrak to have controlled acoustic transmissions include controlling one or more acoustic transmission powers, and wherein the configured processor operatively selects the one or more acoustic transmission powers based on the spinal anatomy or the one or more anatomical models of generalized spinal anatomy, to remove or decrease the internal acoustic reverberations, the image degradation, or both, wherein the one or more transmission powers are automatically adjusted based on ultrasound data received by the processor in order to ensure the target location is in focus, as recognized by Hettrick ([0088]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mauldin in view of Grim and Ishrak as applied to claim 1 above, and further in view of Poland (US 20210282747, hereinafter Poland).
Regarding claim 5, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Mauldin in view of Grim and Ishrak does not specifically teach the controlled acoustic transmissions include controlling one or more acoustic transmission angles, and wherein the configured processor operatively selects the one or more acoustic transmission angles based on the spinal anatomy or the one or more anatomical models of generalized spinal anatomy, to remove or decrease the internal acoustic reverberations, the image degradation, or both, and wherein the one or more acoustic transmission angles are automatically adjusted based on ultrasound data received by the processor.
However,
Poland teaches controlling one or more acoustic transmission angles, and wherein the configured processor operatively selects the one or more acoustic transmission angles based on the anatomy, to remove or decrease the internal acoustic reverberations, the image degradation, or both, and wherein the one or more acoustic transmission angles are automatically adjusted based on ultrasound data received by the processor ([0062] “the handheld medical scanning device 102 may automatically adjust the angle of a scan based on the location of the handheld medical scanning device 102 relative to, e.g., an anatomical structure to be imaged. For example, the handheld medical scanning device 102 may adjust the emission of ultrasonic waves such that a scanning angle is adjusted”).
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 processor disclosed by Mauldin in view of Grim and Ishrak to have the controlled acoustic transmissions include controlling one or more acoustic transmission angles, and wherein the configured processor operatively selects the one or more acoustic transmission angles based on the spinal anatomy or the one or more anatomical models of generalized spinal anatomy, to remove or decrease the internal acoustic reverberations, the image degradation, or both, and wherein the one or more acoustic transmission angles are automatically adjusted based on ultrasound data received by the processor in order to advantageously expand the area which may be considered a suitable imaging location and reduce frustration by the user, as recognized by Poland ([0062]).
Claim(s) 6, 26-27, 39, and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mauldin in view of Grim and Ishrak as applied to claims 1, 35, and 50 above, and further in view of Sandy et al. (US 20140187945, hereinafter Sandy).
Regarding claims 6, 39, and 50, Mauldin in view of Grim and Ishrak teaches the system of claim 1, method of claim 35, and non-transitory computer readable medium of claim 47, as set forth above. Mauldin in view of Grim and Ishrak does not specifically teach each of the two or more ultrasound transducer arrays is physically separated by at least about 1 mm.
However,
Sandy in a similar field of endeavor teaches each of the two or more ultrasound transducer arrays is physically separated by at least about 1 mm ([0025] discloses the gap between the two arrays is between 2mm and 15mm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the known technique of having each of the two or more ultrasound transducer arrays be physically separated by at least about 1 mm of Sandy to the system, method, and medium of Mauldin in view of Grim and Ishrak to allow for the predictable results of providing more maneuverability to the instrument placement, thereby making it easier for the user to place the instrument at the correct location.
Regarding claim 26, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Mauldin in view of Grim and Ishrak does not specifically teach the configured processor is further operative to selectively combine ultrasound image data from the two or more ultrasound transducer arrays using weighted ultrasound image fusion to produce a compound image or video.
However,
Sandy in a similar field of endeavor teaches the configured processor is further operative to selectively combine ultrasound image data from the two or more ultrasound transducer arrays using weighted ultrasound image fusion to produce a compound image or video ([0028] discloses creating a cohesive image from the image data using weighted pixel selection).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the combining process of Mauldin in view of Grim and Ishrak for the weighted ultrasound image fusion of Sandy because it amounts to simple substitution of one known element for another to obtain the predictable results of generating a compound image.
Regarding claim 27, Mauldin in view of Grim, Ishrak, and Sandy teaches the system of claim 26, as set forth above. Sandy further teaches the compound image or video are obtained using multiple configurations of sound wave propagation direction from at least one of the two or more ultrasound transducer arrays ([0028] discloses the cohesive image is generated by capturing images from different views as shown in figs. 1-3).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mauldin in view of Grim and Ishrak as applied to claim 1 above, and further in view of Gertner et al. (US 20120253239, hereinafter Gertner).
Regarding claim 21, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Mauldin in view of Grim and Ishrak does not specifically teach the configured processor is further operative to adaptively reconfigure a direction of sound propagation of at least one of the two or more ultrasound transducer arrays to optimize or enhance system sensitivity to an intraspinal blood flow based on output of a blood flow sensor and/or detection algorithm.
However,
Gertner in a similar field of endeavor teaches a processor is operative to adaptively reconfigure a direction of sound propagation of at least one of the two or more ultrasound transducer arrays to optimize or enhance system sensitivity to an intraspinal blood flow based on output of a blood flow sensor and/or detection algorithm .(claim 74, “the processor is configured to change a focus location of the ultrasound energy in response to a movement of the blood vessel”. [0213] discloses detecting the blood flow of the vessels. [0272] discloses the blood vessels are part of the spinal column).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the known technique of having the configured processor be further operative to adaptively reconfigure a direction of sound propagation of at least one of the two or more ultrasound transducer arrays to optimize or enhance system sensitivity to an intraspinal blood flow based on output of a blood flow sensor and/or detection algorithm of Gertner to the system of Mauldin in view of Grim and Ishrak to allow for the predictable results of ensuring the target location is constantly within the ultrasound image.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mauldin in view of Grim and Ishrak as applied to claim 1 above, and further in view of Akramov et al. (US 20150297181, hereinafter Akramov).
Regarding claim 29, Mauldin in view of Grim and Ishrak teaches the system of claim 1, as set forth above. Mauldin in view of Grim and Ishrak does not specifically teach the probe housing further comprises internal acoustic absorption materials positioned to absorb acoustic energy reflected within the probe housing.
However,
Akramov in a similar field of endeavor teaches the probe housing further comprises internal acoustic absorption materials positioned to absorb acoustic energy reflected within the probe housing ([0051] “The sound absorbing layer 112 may support the piezoelectric element unit 114 at the back surface of the piezoelectric element unit 114, and absorb ultrasound waves”. Fig. 1A shows the absorbing layer 112 is in the probe housing).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the known technique of having the probe housing further comprises internal acoustic absorption materials positioned to absorb acoustic energy reflected within the probe housing of Akramov to the probe housing of Mauldin in view of Grim and Ishrak in order to allow for the predictable results of protecting the inner components of the ultrasound probe from the acoustic energy, thereby prolonging the life of the probe.
Conclusion
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/ANDREW W BEGEMAN/Examiner, Art Unit 3798
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