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
Acknowledgement is made to Applicant’s claim to priority to U.S. Provisional App. No. 62/678,885 filed May 31, 2018; U.S. Provisional App. No. 62/678,868 filed May 31, 2018; and U.S. Provisional App. No. 62/678,854 filed May 31, 2018.
Status of Claims
This Office Action is responsive to the claims filed on 07/30/2025. Claims 1-21, 23, 24, 32, 36, 40, 52, and 53 were previously canceled. Claims 22, 39, 46, and 55 have been amended. Claims 59-70 are newly presented. Claims 22, 25-31, 33-35, 37-39, 41-51, and 54-70 are presently pending in this application.
Claim Objections
Claim 46 is objected to because of the following informalities: claim 46, line 4: “a gel pad that that is configured” should be amended to read “a gel pad that is configured”. Appropriate correction is required.
Claim 67 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 63. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 46 and 64-66 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 46, line 4 recites the claim limitation “a grid having a pattern” which is indefinite because it is unclear if this grid and pattern is the same grid and pattern that are already recited in line 3; OR a different grid and pattern. For the purpose of examination, this is understood to mean the same grid and pattern that are already recited in line 3; OR a different grid and pattern.
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 22, 37, and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider (US 20170181726) in view of Scully (US 20170303894).
Regarding claim 22, Schneider teaches a method for visualizing a target anatomy of a patient (Paragraph [0005]; system for providing navigational guidance to a sonographer… produce an image, Fig. 1; Paragraph [0006]; a method of providing navigational guidance… Fig. 4), the method comprising:
a device comprising a plurality of transducers (Paragraph [0013]; ultrasound probe 60 which includes a two-dimensional matrix array transducer 70, Fig. 1);
receiving, by one or more processors (Paragraph [0007]; instructions… executed by one or more processors; Paragraphs [0014] and [0018]; image line processor 24; image rendering processor 32; tracking processor 42, Fig. 1; Paragraph [0027]; executable file or the like, were provided to a computer… perform the functions of the various systems and methods) from the plurality of transducers defining a grid having a pattern (Paragraph [0013]; two-dimensional matrix array transducer 70, Fig. 1), data associated with the target anatomy (Paragraph [0016]; 3D image rendering processor 32 which receives image lines from the image line processor 24 for the rendering of real-time three dimensional images; Paragraph [0017]; segment a majority of the cardiac anatomy (chambers, vasculature, etc.)… during a biopsy procedure);
generating, by the one or more processors based on the received data, a representation of the target anatomy (Paragraph [0016]; receives image lines… rendering of real-time three dimensional images; 3D images of the anatomy is considered to read on the claimed limitation of a representation in its broadest reasonable interpretation); and
providing for output, by the one or more processors to a user interface (UI) including a display (Paragraph [0016]; display 38, Fig. 1), the representation of the target anatomy (Paragraph [0016]; the 3D images can be displayed as live (real time) 3D images on the display); and
providing for output, by the one or more processors via the UI (Paragraph [0018]; a haptic apparatus 200, Figs. 1 and 2), at least one of haptic or auditory feedback to position the transducer about the target anatomy (Paragraphs [0019] and [0021]-[0024]; physical sensations for conveying where the ultrasound probe 60 should be moved; anatomical analytical model determines that the image is insufficient and provides navigation instruction to the haptic feedback devices).
Schneider does not explicitly teach inserting the device into a gel pad, wherein the gel pad is configured to enclose the plurality of transducers.
Scully, however, teaches a system (Paragraph [0095]; an ultrasound system 100 with an ultrasound probe 110 and a semi-rigid ultrasound coupler 10, Fig. 2D) for visualizing a target anatomy of a patient (Paragraph [0029]; sliding the probe and the coupler together as a unitary member over skin of subject to obtain ultrasound images) comprising inserting a device into a gel pad (Paragraph [0095]; a semi-rigid ultrasound coupler 10, Fig. 2D; Paragraph [0156]-[0161]; A coupler 10 of the present invention may comprise a polyhydric alcohol, a thickening agent, a surfactant, and/or water; a thickening agent may function as a gelling agent; Paragraph [0139]; The probe 110 can be inserted into the coupler cavity 31 and pressed against the bottom of the cavity 10c causing the coupler body 10b to mold against and attach to the ultrasound probe), wherein the device comprises a plurality of transducers (Paragraph [0094];ultrasound system with the transducer/transducer array, Fig. 6 shows a plurality of transducers 125) and the gel pad is configured to enclose the plurality of transducers (Paragraph [0130]; shape of the cavity 10c can correspond to the shape of the end of the probe 110e. The coupler 10 sidewall 10w can extend a short height H that can encase, reside above, an acoustic lens 115, acoustic matching layer 120, and/or transducer 125 in the end of the probe 110e; Fig. 6 shows the coupler 10 is configured to enclose the plurality of transducers 125).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Schneider to have included inserting the device into a gel pad, wherein the gel pad is configured to enclose the plurality of transducers as taught by Scully because it would have been a well-known and understood method of coupling a ultrasound probe to a patient and facilitating ultrasound wave transmission into the patient (Paragraph [0003] and [0140]) and further would have been more comfortable for a patient than a gel interface as it feels less cold to the touch (Paragraph [0138]) and reduce the amount of post ultrasound clean up (Paragraph [0138]).
Regarding claim 37, together Schneider and Scully teach all of the limitations of claim 22 as noted above.
Schneider further teaches the feedback further comprises visual feedback (Paragraphs [0018] and [0024]; While visual cues on the ultrasound probe 60 (for example, LEDs) could be used to indicate to the sonographer how to move the probe 60; alerted to the sufficiency of the image by a visual signal).
Regarding claim 60, together Schneider and Scully teach all of the limitations of claim 22 as noted above.
Scully further teaches the gel pad is further configured to enclose the device (Paragraph [0097]; coupler 10, for respective ultrasound probes 110 of various shapes (e.g., FIGS. 1, 7A, 8A, 9A, and 10A) can have a solid coupler body 10b with a cavity 10c having a semi-rigid, and malleable shape so as to be able to be conform to and/or self-attach to the end of the probe 110e by a user pressing the coupler against the end of the ultrasound probe 110e so that the coupler cavity, e.g., at least the floor 10f thereof and more typically the upwardly extending sidewall as well, takes on the underlying shape of the end of the ultrasound probe 110e).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the gel pad of Schneider in view of Scully to have enclosed the device because it would have allowed more easily and faster assembly of the system thereby improving operation without requiring the use of ultrasound gel, and further would have ensured a secure attachment between the coupler and the ultrasound device (Paragraph [0118]-[0119]).
Claims 25, 26, 35, 48, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider in view of Scully as applied to claim 22 above, and further in view of Chopra (US 20180092698).
Regarding claim 25, together Schneider and Scully teach all of the limitations of claim 22 as noted above.
Together Schneider and Scully do not teach identifying, by the one or more processors based on the received data, at least one medical instrument; and
providing for output, by the one or more processors to the display, a representation of the at least one medical instrument relative to the target anatomy.
Chopra, however, teaches a method for visualizing (Paragraph [0003]; systems and methods for combining various kinds of medical data to produce a new visual reality for a surgeon or health care provider) a target anatomy of a patient (Paragraph [0094] and [0095]; a body part such as an arm or leg; a patient knee, Fig. 3B), the method comprising:
identifying, by the one or more processors (Paragraph [0165]; embodiments of the present disclosure may be implemented using existing computer processors) based on the received data, at least one medical instrument (Paragraphs [0137] and [0138]; An electromagnetic sensor can track the position of various tools and SDD markers inside the patient body #2304, Figs. 23A and 23B); and
providing for output, by the one or more processors to the display, a representation of the at least one medical instrument relative to the target anatomy (Paragraphs [0137] and [0138]; The TCT model is sent to the enhanced reality engine #2314; The tool may have SDD markers along its length allowing for the system to make a sensed tool representation #2360, Figs. 23A and 23B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the method of Schneider in view of Scully to include identifying, based on the received data, at least one medical instrument; and providing for output, to the display, a representation of the at least one medical instrument relative to the target anatomy. This would allow the health care provider to accurately track the position of each medical device in a body (Chopra, Paragraph [0138]).
Regarding claim 26, together Schneider, Scully, and Chopra teach all of the limitations of claim 25 as noted above.
Chopra further teaches providing for output, by the one or more processors to the display, a representation of a target trajectory designating a path for movement of the at least one medical instrument towards and into the target anatomy (Paragraphs [0137] and [0138]; the model also possesses a deformable model path #2366, also based on the scan image data. The deformable model path is the estimated path for a minimally invasive device to follow as it approaches or resides in the vessel for the medical procedure, Fig. 23B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the method of Schneider in view of Scully and Chopra include to providing for output, to the display, a representation of a target trajectory designating a path for movement of the at least one medical instrument towards and into the target anatomy. This would further improve the ability to navigate the instrument through the body.
Regarding claim 48, together Schneider and Scully teach all of the limitations of claim 22 as noted above.
Together Schneider and Scully do not teach receiving, by the one or more processors from one or more sensors, viewing data, wherein the viewing data is different from the data associated with the target anatomy;
determining, by the one or more processors based on the viewing data, a viewing position of at least one user; and
modifying, by the one or more processors, the representation of the target anatomy, based on the determined viewing position of the at least one user, to generate a parallax view of the representation of the target anatomy, the parallax view configured to present the viewer with a three- dimensional view of the representation of the target anatomy on the display.
Chopra, however, teaches a method for visualizing (Paragraph [0003]; systems and methods for combining various kinds of medical data to produce a new visual reality for a surgeon or health care provider) a target anatomy of a patient (Paragraph [0094] and [0095]; a body part such as an arm or leg; a patient knee, Fig. 3B), the method comprising:
receiving, by the one or more processors (Paragraph [0165]; embodiments of the present disclosure may be implemented using existing computer processors) from one or more sensors, viewing data, wherein the viewing data is different from the data associated with the target anatomy (Paragraph [0135]; system reads the marker depth data (Dm) 2204 and computes a depth of the virtual deformable model with respect to the marker depth (Dmd) 2206; The computer can determine “vergence”; Fig. 22A);
determining, by the one or more processors based on the viewing data, a viewing position of at least one user (Paragraph [0135]; In some embodiments, the Dmd may be estimated from other cues in the user environment, including but not limited to the depth of the HCP's hands from her eyes; In other embodiments, other parameters (e.g. length and direction of gaze, knowledge of workspace location on the OR table, etc.); and
modifying, by the one or more processors, the representation of the target anatomy (Paragraph [0135]; The system then reads model; M′I, I′C, TCT, #2210 which are received from other processes and uses all of them to render a left and right enhanced reality image using the correct vergence information), based on the determined viewing position of the at least one user (Paragraph [0135]; focused at depth Dmd #2212), to generate a parallax view of the representation of the target anatomy, the parallax view (Paragraph [0135]; The computer can determine “vergence” corresponding to the model depth… the angle between the lines of sight for the left and right eyes to a target object being looked at; uses all of them to render a left and right enhanced reality image; Examiner notes the left and right image formed from the vergence of Chopra is considered to be a parallax view in its broadest reasonable interpretation) configured to present the viewer with a three-dimensional view (Paragraphs [0096], [0111], [0145], and [0147]; providing an enhanced reality surgical vision to a HCP… a first virtual 3D map R1 of the patient volume) of the representation of the target anatomy on the display (Paragraphs [0096], [0111], [0136]-[0138], [0145], and [0147]; 3D model of the surgical sight projected onto the user display).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Schneider in view of Scully to include receiving, from one or more sensors, viewing data, wherein the viewing data is different from the data associated with the target anatomy; determining, based on the viewing data, a viewing position of at least one user; and modify the representation of the target anatomy, based on the determined viewing position of the at least one user, to generate a parallax view of the representation of the target anatomy, the parallax view configured to present the viewer with a three-dimensional view of the representation of the target anatomy on the display as taught by Chopra. Doing so would have allowed the HCP can see any aspect of the image data from the proper orientation of height, direction, angle and orientation to the patient thereby improve the ability of the operator to accurately perform a medical procedure (Chopra, Paragraph [0145]).
Regarding claim 35, together Schneider, Scully, and Chopra teach all of the limitations of claim 48 as noted above.
Chopra further teaches a device (Chopra, Paragraphs [0094]-[0103]; wearable device, Fig. 3H #308) comprising the sensor (Chopra, Paragraphs [0101] and [0102]; one or more cameras which may be incorporated into the electromagnetic sensor #304; the wearable device #308 may contain electronics and sensors capable of replacing the function the sensor device #304, Figs. 3A-H) and the display (Chopra, Paragraphs [0101] and [0102]; wearable reusable device #308, Fig. 3H); and
wherein at least one of the one or more sensors is a camera (Chopra, Paragraphs [0101] and [0102]; one or more cameras) configured to track the viewing position of the at least one user (Paragraphs [0078], [0122], and [0135]; This marker embedded camera can also be used to sense the focus and direction of the HCP's gaze by directly observing him/her from the marker's vantage point; In some embodiments, the Dmd may be estimated from other cues in the user environment, including but not limited to the depth of the HCP's hands from her eyes; In other embodiments, other parameters (e.g. length and direction of gaze, knowledge of workspace location on the OR table, etc.) about the HCP may be sensed and used to refine the estimate of Dmd).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the device of Schneider in view of Scully and Chopra to further comprise the sensor and the display; and wherein at least one of the one or more sensors is a camera configured to track the viewing position of the at least one user. This would have allowed the operator to see the target anatomy on the probe while moving the probe and further allowed the HCP can see any aspect of the image data from the proper orientation of height, direction, angle and orientation to the patient thereby improve the ability of the operator to accurately perform a medical procedure (Chopra, Paragraph [0145]).
Regarding claim 49, together Schneider, Scully, and Chopra teach all of the limitations of claim 48 as noted above.
Chopra further teaches receiving by the one or more processors, a user input to rotate the parallax view of the representation (Paragraphs [0086], [0144], and [0148]; the method starts #2602 on a user command; The control unit can adjust for the point of view); and
updating, by the one or more processors based on the received user input, the parallax view of the representation (Paragraphs [0086], [0144], and [0148]; These commands may then be relayed to the control unit and the enhanced reality display adjusted accordingly; render virtual objects with correct disparity #2612).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further configured the processors of Schneider in view of Scully and Chopra to receive a user input to rotate the parallax view of the virtual representation; and update, based on the received user input, the parallax view of the virtual representation as this would allow the user to view parts of the anatomy for planning the procedure (Chopra, Paragraph [0086]).
Claims 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider in view of Scully and Chopra as applied to claim 26, respectively, and further in view of Steins (US 6733458).
Regarding claim 27, together Schneider, Scully, and Chopra teach all of the limitations of claim 26 as noted above.
The method of Schneider in view of Scully and Chopra does not explicitly teach the representation of the target anatomy and the at least one medical instrument includes colors, patterns, shapes, shading, or any combination thereof, to provide a representation which appears to have three-dimensions.
Steins, in the same field of endeavor in the subject of ultrasound system and methods, teaches the representation of the target anatomy and the medical instrument includes colors, patterns, shapes, shading, or any combination thereof, to provide a representation which appears to have three-dimensions (Figure 2, Col. 12, Ln. 20-45; giving the clinician graphical cues which consider changes in elevation profile due to beam formation or inadvertent ultrasound transducer #104 movement. Such cues include graphical indicators, such as lines, dots, dashes, shaded and colored regions which indicate the deformation of the invasive device #132 as it passes through the ultrasound image with differing elevational thicknesses.)
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of Schneider in view of Scully and Chopra to incorporate the teachings of Steins to provide a target trajectory designating a path for movement of the medical instrument towards and into the target anatomy. This modification will provide the user with an opportunity to modify the transducer and the needle position and orientation prior to moving the needle to minimize the patient further pain and discomfort as taught within Steins in Col. 11, Ln. 20-55.
Regarding claim 28, together Schneider, Scully, Chopra, and Steins teach all of the limitations of claim 27 as noted above.
Steins further teaches at least one of the colors, patterns, shapes, shading, or any combination thereof is adapted to change as the at least one medical instrument moves towards and into the target anatomy (Figure 2, Col. 12, Ln. 20-45; giving the clinician graphical cues which consider changes in elevation profile due to beam formation or inadvertent ultrasound transducer #104 movement. Such cues include graphical indicators, such as lines, dots, dashes, shaded and colored regions which indicate the deformation of the invasive device #132 as it passes through the ultrasound image with differing elevational thicknesses).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have further modified the method of Schneider in view of Scully, Chopra, and Steins to incorporate the teachings of Steins to provide at least one of the colors, patterns, shapes, shading, or any combination thereof is adapted to change as the medical instrument moves towards and into the target anatomy. This modification will help to inform the user of the success of the device reaching the target anatomy as taught within Steins in Col. 12, Ln. 20-45.
Regarding claim 29, together Schneider, Scully, Chopra, and Steins teach all of the limitations of claim 27 as noted above.
Steins further teaches at least one of the colors, patterns, shapes, shading, or any combination thereof is adapted to change as the medical instrument moves along a trajectory other than the target trajectory, wherein such a change provides a warning to an operator of misalignment of the at least one medical instrument within the target anatomy (Figure 2, Col. 12, Ln. 20-45; giving the clinician graphical cues which consider changes in elevation profile due to beam formation or inadvertent ultrasound transducer #104 movement. Such cues include graphical indicators, such as lines, dots, dashes, shaded and colored regions which indicate the deformation of the invasive device #132 as it passes through the ultrasound image with differing elevational thicknesses).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have further modified the method of Schneider in view of Scully, Chopra, and Steins to incorporate the teachings of Steins to provide at least one of the colors, patterns, shapes, shading, or any combination thereof is adapted to change as the medical instrument moves along a trajectory other than the target trajectory, wherein such a change provides a warning to the operator of misalignment of the medical instrument within the target anatomy. This modification will help to inform the user of the success or failure of the device reaching the target anatomy as taught within Steins in col 12, lines 20-45.
Regarding claim 30, together Schneider, Scully, and Chopra teach all of the limitations of claim 26 as noted above.
The method of Schneider in view of Scully and Chopra does not explicitly teach the representation is adapted to illustrate at least a portion of the target anatomy as a cross-section, such that the representation is adapted to toggle between a virtual representation of the entirety of the portion of the target anatomy and a cross-section of the portion of the target anatomy.
Steins, in the same field of endeavor in the subject of ultrasound system and methods, teaches the representation is adapted to illustrate at least a portion of the target anatomy as a cross-section, such that the representation is adapted to toggle between a virtual representation of the entirety of the portion of the target anatomy and a cross-section of the portion of the target anatomy (Col. 15, Ln. 20-43; The clinician can indicate via user interface control whether or not to image the needle #132 in its longitudinal axis or to rotate the plane #904 of the image, as shown in FIGS. 9A and 9B, to the short axis for visualization of the needle #132 tip #910. This allows the clinician the full confidence and opportunity to visualize the progress of the invasive device #132 in two planes #804, 904 under ultrasound image guidance which is not possible with prior art embodiments).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have further modified the method of Schneider in view of Scully and Chopra to incorporate the teachings of Steins to provide virtual representation is adapted to illustrate at least a portion of the target anatomy as a cross-section, such that the virtual representation is adapted to toggle between a virtual representation of the entirety of the portion of the target anatomy and a cross-section of the portion of the target anatomy. This modification will enable the user to view two different planes as taught within Steins in Col. 15, Ln. 20-43.
Regarding claim 31, together Schneider, Scully, and Chopra teach all of the limitations of claim 26 as noted above.
The method of Schneider in view of Scully and Chopra does not explicitly teach including an icon at an end of the path designating a final position along the target trajectory of the medical instrument relative to the target anatomy.
Steins, in the same field of endeavor in the subject of ultrasound system and methods, teaches an icon at an end of the path designating a final position along the target trajectory of the medical instrument relative to the target anatomy (Col. 15, Ln. 20-43; the display #118 indicates the predicted #814 and actual #808 trajectory; short axis for visualization of the needle #132 tip #910).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have further modified the method of Schneider in view of Scully and Chopra to incorporate the teachings of Steins to provide an icon at the end of the path designating the final position along the target trajectory of the medical instrument relative to the target anatomy. This modification will provide the user with a reference of the marked target as taught within Steins in Col. 15, Ln. 20-43.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Schneider in view of Scully as applied to claim 22 above, and further in view of Pinkovich (US 20210077061).
Regarding claim 33, together Schneider and Scully teach all of the limitations of claim 22 as noted above.
Together Schneider and Hayakawa do not explicitly teach determining, by the one or more processors based on the received data, a tissue characterization associated with the target anatomy,
wherein the representation of the target anatomy is further based on the determined tissue characterization, and
wherein the representation includes designated colors, patterns, shapes, shading, or any combination thereof based on the determined tissue characterization associated with the target anatomy.
Pinkovich, however, teaches method for visualizing a target anatomy of a patient (Paragraph [0012]; method and system for analyzing ultrasound scenes to provide needle guidance and warnings… identifying and highlighting biological structures) comprising: generating, by the one or more processors based on the received data, a representation of the target anatomy (Paragraph [0027]; signal processor 132 may comprise suitable logic, circuitry, interfaces and/or code that may be operable to process ultrasound scan data (i.e., summed IQ signal) for generating ultrasound images for presentation on a display system 134); and
providing for output, by the one or more processors to a user interface (UI) including a display, the representation of the target anatomy (Paragraph [0027]; the signal processor 132 may be operable to perform display processing and/or control processing; processed image data can be presented at the display system 134);
and determining, by the one or more processors based on the received data, a tissue characterization associated with the target anatomy (Paragraph [0028]; the signal processor 132 may comprise an organ detection processor 140; Paragraph [0030]; analyze acquired ultrasound images to identify and segment organs, such as nerves, vessels, or any suitable biological structures.),
wherein the representation of the target anatomy is further based on the determined tissue characterization (Paragraph [0039]; display and warning processor 170 may comprise suitable logic, circuitry, interfaces and/or code that may be operable to highlight and display the biological and/or artificial structures identified and segmented by the organ detection processor 140, Fig 2 nerve 210 and vessel 220), and
wherein the representation includes designated colors, patterns, shapes, shading, or any combination thereof based on the determined tissue characterization associated with the target anatomy (Paragraph [0039]; highlight the identified and segmented structures… highlighting may include colorizing the pixels of the segmented structure, outlining the edges of the segmented structure, or any suitable highlighting for drawing attention to one or more structures identified and segmented by the organ detection processor, Fig. 2 highlighting 212, 222).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Schneider in view of Scully to include determining, by the one or more processors based on the received data, a tissue characterization associated with the target anatomy, wherein the representation of the target anatomy is further based on the determined tissue characterization, and wherein the representation includes designated colors, patterns, shapes, shading, or any combination thereof based on the determined tissue characterization associated with the target anatomy as taught by Pinkovich. This would allow distinguishing whether a type of tissue is a nerve or a blood vessel and further warning the user about nerves in an area to safely perform intervention with a needle (Pinkovich, Paragraph [0040]).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Schneider in view of Scully as applied to claim 22 above, and further in view of Steins (US 6733458).
Regarding claim 34, together Schneider and Scully teach all of the limitations of claim 22 as noted above.
Together Schneider and Scully do not teach the representation of the target anatomy includes colors, patterns, shapes, shading, or any combination thereof, to provide a representation which appears to have three-dimensions.
Steins, in the same field of endeavor in the subject of ultrasound system and methods, teaches the representation of the target anatomy includes colors, patterns, shapes, shading, or any combination thereof, to provide a representation which appears to have three-dimensions (Figure 2, Col. 12, Ln. 20-45; giving the clinician graphical cues which consider changes in elevation profile due to beam formation or inadvertent ultrasound transducer #104 movement. Such cues include graphical indicators, such as lines, dots, dashes, shaded and colored regions which indicate the deformation of the invasive device #132 as it passes through the ultrasound image with differing elevational thicknesses).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have further modified the method of Schneider in view of Scully to incorporate the teachings of Steins to provide a virtual representation of the target anatomy includes colors, patterns, shapes, shading, or any combination thereof, to provide a representation which appears to have three-dimensions. This modification will help to inform the user of the success of the device reaching the target anatomy as taught within Steins in Col. 12, Ln. 20-45.
Claims 38, 58, and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider in view of Scully as applied to claim 22 above, and further in view of Walker (US 20150011884).
Regarding claim 38, together Schneider and Scully teach all of the limitations of claim 22 as noted above.
Together Schneider and Scully do not explicitly teach the plurality of transducers are capacitive micromachined ultrasonic transducers (CMUT), piezoelectric micromachined ultrasonic transducers (PMUT), ultrasonic transducers, piezoelectric transducers, or any combination thereof, disposed on a substrate, the substrate disposed within a probe surface area.
Walker, however, teaches a system for visualizing (Paragraphs [0012] and [0027]; ultrasonic imaging system capable of producing C-Mode images and/or collecting 3D image data of a target, Fig. 1) a target anatomy of a patient (Paragraphs [0012], [0041], and [0045]; target, patient, Fig. 1 #1), comprising a plurality of transducers are capacitive micromachined ultrasonic transducers (CMUT) (Paragraph [0036]; Capacitive Micromachined Ultrasonic Transducer Arrays) or piezoelectric transducers (Paragraph [0055]; two-dimensional piezoelectric transducer array 60) disposed on a substrate (Paragraphs [0036] and [0055]; constructed by using a commercially available wafer), the substrate disposed within a probe surface area (Paragraph [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the two-dimensional matrix array transducer of Schneider in view of Scully with the two-dimensional transducer array of Walker such that the plurality of transducers are capacitive micromachined ultrasonic transducers (CMUT) or piezoelectric transducers disposed on a substrate, the substrate disposed within a probe surface area because it would have been a simple substitution that would have had the predictable result of allowing the probe to perform ultrasound transmission and reception, and further would have been easily fabricated at a low cost (Walker, Paragraph [0055]).
Regarding claim 58, together Schneider and Scully teach all of the limitations of claim 22 as noted above.
Schneider does not explicitly teach the device comprises a plurality of side surfaces extending from a base surface,
the plurality of transducers are positioned on the base surface,
each side surface having a height, and
a length and a width of the base surface is larger than the height of the side surface.
Walker, however, teaches the device comprises a plurality of side surfaces (Paragraph [0042]; The enclosure has four sides 12, 13, 14, 15, Fig. 2) extending from a base surface (Paragraph [0042]; and a bottom side 8, Fig. 2),
the plurality of transducers are positioned on the base surface (Paragraph [0042]; transducer array 60 is on the bottom side 8),
each side surface having a height (Paragraph [0049]; housing 2 with the dimensions (height, length and width), Fig. 2), and
a length and a width of the base surface is larger than the height of the side surface (Paragraph [0042]; in inches of about 1x2x2, respectively. In another instance, the dimensions (height, length and width) in inches may be about 2x6x4, respectively, Fig. 2 shows the sides are wider and longer than the height).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Schneider in view of Scully such that the device comprises a plurality of side surfaces extending from a base surface, the plurality of transducers are positioned on the base surface, each side surface having a height, and a length and a width of the base surface is larger than the height of the side surface as taught by Walker because it would have allowed the ultrasonic system to be light weight and easier to handle (Paragraph [0049]) and further would have allowed images of blood vessels projected on the surface display to be closer to an actual position of the blood vessel, thereby improving ease of blood vessel access (Paragraph [0038] and Figs. 3A-B).
Regarding claim 59, together Schneider, Scully, and Walker teach all of the limitations of claim 58 as noted above.
Scully further teaches the gel pad comprises sidewalls (Paragraph [0095]; In some embodiments, the coupler 10 has a cavity 10c with a floor 10f and/or sidewall 10w, Fig. 4), and
after the device is inserted into the gel pad, the sidewalls of the gel pad extend a second height (Paragraph [0125]; The sidewall 10w can define a cavity with a height H, Fig. 5) along the side surface of the device (Paragraph [0130]; The coupler 10 sidewall 10w can extend a short height H that can encase, reside above, an acoustic lens 115, acoustic matching layer 120, and/or transducer 125 in the end of the probe 110e, Fig. 5 and 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the gel pad of Schneider in view of Scully and Walker to have comprised sidewalls, and after the device is inserted into the gel pad, the sidewalls of the gel pad extend a second height along the side surface of the device as taught by Scully because it would have ensured a proper fit with the ultrasound device (Paragraph [0130]-[0132]).
Claim 39, 61-63, and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Walker (US 20150011884) in view of Scully (US 20170303894), Rohling (US 20120289820, and Pinkovich (US 20210077061).
Regarding claim 39, Walker teaches a method of forming a virtual representation (Paragraph [0013]; a method of imaging a target to produce C-Mode ultrasonic images and/or collect ultrasonic 3D image data) of a target anatomy (Paragraphs [0012], [0041], and [0045]; target, patient, Fig. 1 #1) of a target anatomy (Paragraphs [0012], [0041], and [0045]; target, patient, Fig. 1 #1), the method comprising the steps of:
receiving (Paragraph [0060]; echo data coming out of the beam former would be processed further by a general purpose digital signal processor), by one or more processors (Paragraphs [0060] and [0061]; digital signal processors, control unit, Fig. 7 #41 and 80) from a plurality of transducers (Paragraphs [0027] and [0055]; transducer array, Figs. 1 and 7 #60) having a first footprint (Paragraph [0055]; transducer array #60 consists of a 32x32 element array of 500x500 um elements #62, Fig. 7), data associated with the target anatomy (Paragraphs [0027]-[0030]; a variety of tissue information may be obtained through judicious pulse transmission and signal processing of received echoes), the first footprint being based on a first length (Paragraph [0055]; 32 elements of 500 um in length) and a first width (Paragraph [0055]; 32 elements of 500 um in width);
generating (Paragraph [0060]; This DSP #41 processes the focused line data by performing envelope detection and mapping the envelope detected data to the appropriate location in the image display), by the one or more processors based on the received data (Paragraph [0060]; processes the focused line data), a representation of the target anatomy (Paragraphs [0025]-[0030] and [0052]; a C-Mode or 3-D display #20; The present invention sonic window would offer a new method and system of observing Subcutaneous tissues); and
providing for output (Paragraphs [0060] and [0061]; Finally, the image data would be displayed using an LCD screen #20), by the one or more processors to a user interface (UI) (Paragraphs [0026], [0042], and [0044]; include a simple user control… also include a simple display indicating the depth selected) including a display (Paragraphs [0027] and [0060]; display, Figs. 1 and 7 #20), the representation of the target anatomy (Paragraphs [0025]-[0030] and [0052]; a C-Mode or 3-D display #20; sonic window… observing Subcutaneous tissues), wherein the display has a second length and a second width equal to or greater than the first length and the first width of the pattern of transducers (Paragraphs [0042]-[0044] and [0050]; Examiner notes the display #20 appears to be the same size as the transducer array #60 as shown in Figs. 3A, 3B, 3C, 8B, and 9B).
Walker does not teach inserting a device comprising a plurality of transducers into a gel pad that is configured to enclose the plurality of transducers;
a field of view associated with the data having a second footprint greater than the first footprint;
identifying, by the one or more processors based on the received data, various types of tissue present at the target anatomy, wherein the various types of tissue include two or more of blood vessel, nerve, muscle, organ tissue, soft tissue, hard tissue, bone, or body fluid;
annotating, by the one or more processors based on the identified types of tissue, the data to such that each type of tissue present at the target anatomy comprises respective colors, patterns, shapes, shading, or any combination thereof; and
generating a representation of the target anatomy based on the annotations;
wherein the representation of the target anatomy has a third footprint greater than the first footprint.
Scully, however, teaches a system (Paragraph [0095]; an ultrasound system 100 with an ultrasound probe 110 and a semi-rigid ultrasound coupler 10, Fig. 2D) for visualizing a target anatomy of a patient (Paragraph [0029]; sliding the probe and the coupler together as a unitary member over skin of subject to obtain ultrasound images) comprising inserting a device into a gel pad (Paragraph [0095]; a semi-rigid ultrasound coupler 10, Fig. 2D; Paragraph [0156]-[0161]; A coupler 10 of the present invention may comprise a polyhydric alcohol, a thickening agent, a surfactant, and/or water; a thickening agent may function as a gelling agent; Paragraph [0139]; The probe 110 can be inserted into the coupler cavity 31 and pressed against the bottom of the cavity 10c causing the coupler body 10b to mold against and attach to the ultrasound probe), wherein the device comprises a plurality of transducers (Paragraph [0094];ultrasound system with the transducer/transducer array, Fig. 6 shows a plurality of transducers 125) and the gel pad is configured to enclose the plurality of transducers (Paragraph [0130]; shape of the cavity 10c can correspond to the shape of the end of the probe 110e. The coupler 10 sidewall 10w can extend a short height H that can encase, reside above, an acoustic lens 115, acoustic matching layer 120, and/or transducer 125 in the end of the probe 110e; Fig. 6 shows the coupler 10 is configured to enclose the plurality of transducers 125).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Walker to have included inserting the device into a gel pad, wherein the gel pad is configured to enclose the plurality of transducers as taught by Scully because it would have been a well-known and understood method of coupling a ultrasound probe to a patient and facilitating ultrasound wave transmission into the patient (Paragraph [0003] and [0140]) and further would have been more comfortable for a patient than a gel interface as it feels less cold to the touch (Paragraph [0138]) and reduce the amount of post ultrasound clean up (Paragraph [0138]).
Together Walker and Scully do not teach a field of view associated with the data having a second footprint greater than the first footprint;
identifying, by the one or more processors based on the received data, various types of tissue present at the target anatomy, wherein the various types of tissue include two or more of blood vessel, nerve, muscle, organ tissue, soft tissue, hard tissue, bone, or body fluid;
annotating, by the one or more processors based on the identified types of tissue, the data to such that each type of tissue present at the target anatomy comprises respective colors, patterns, shapes, shading, or any combination thereof; and
generating a representation of the target anatomy based on the annotations;
wherein the representation of the target anatomy has a third footprint greater than the first footprint.
Rohling, however, teaches a method of forming a virtual representation (Paragraph [0003]; method for imaging a medical instrument, particularly while being inserted inside a patient) of a target anatomy (Paragraph [0011]; to a target in a body) wherein the data (Paragraph [0082]; 3-D volumetric dataset, Fig. 6 #402), wherein
a field of view associated with the data (Paragraph [0082]; 3-D volumetric dataset… obtaining a wide field of view of the anatomy, Fig. 6 #402) has a second footprint (Paragraph [0082]; the size and shape of the wide field of view of the 3-D volume #402, Fig. 6) greater than the first footprint (Paragraphs [0059] and [0082]; curved shape of the probe #202; Examiner notes the width of the imaging volumetric data is larger than the width of the probe and is considered to read on the claimed limitation of the data having a second footprint greater than the first footprint); and
the representation of the target anatomy has a third footprint (Paragraphs [0068] and [0082]; displays the images obtained by the apparatus #200; the size and shape of the 3-D volume #402, Fig. 6) greater than the first footprint (Paragraphs [0059] and [0082]; curved shape of the probe #202; Examiner notes the width of the imaging volumetric data is larger than the width of the probe and is considered to read on the claimed limitation of the representation of the target anatomy having a third footprint greater than the first footprint).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Walker in view of Scully such that a field of view associated with the data has a second footprint greater than the first footprint and the representation of the target anatomy has a third footprint greater than the first footprint as this embodiment has the advantage of obtaining a wide field of view of the anatomy with a relatively small footprint of the probe. This embodiment also has the advantage of directing the ultrasound beams toward the needle at an angle that is closer to perpendicular to the needle, resulting in a stronger echo from the needle and a better depiction of the needle in the 3-D volumetric dataset (Rohling, Paragraph [0082]).
The method of Walker in view of Scully and Rohling further fails to teach identifying, by the one or more processors based on the received data, various types of tissue present at the target anatomy, wherein the various types of tissue include two or more of blood vessel, nerve, muscle, organ tissue, soft tissue, hard tissue, bone, or body fluid;
annotating, by the one or more processors based on the identified types of tissue, the data to such that each type of tissue present at the target anatomy comprises respective colors, patterns, shapes, shading, or any combination thereof; and
generating a representation of the target anatomy based on the annotations.
Pinkovich, however, teaches method for visualizing a target anatomy of a patient (Paragraph [0012]; method and system for analyzing ultrasound scenes to provide needle guidance and warnings… identifying and highlighting biological structures) comprising:
identifying, by the one or more processors based on the received data, various types of tissue present at the target anatomy (Paragraph [0028]; the signal processor 132 may comprise an organ detection processor 140; Paragraph [0030]; analyze acquired ultrasound images to identify and segment organs, such as nerves, vessels, or any suitable biological structures.), wherein the various types of tissue include two or more of blood vessel, nerve, muscle, organ tissue, soft tissue, hard tissue, bone, or body fluid (Paragraph [0030]; segment organs, such as nerves, vessels, or any suitable biological structures; Paragraph [0052]-[0054]; segmented structure nerves 210 and vessel 220 identified at step 304);
annotating, by the one or more processors based on the identified types of tissue, the data (Paragraph [0039]; display and warning processor 170 may comprise suitable logic, circuitry, interfaces and/or code that may be operable to highlight and display the biological and/or artificial structures identified and segmented by the organ detection processor 140, Fig 2 nerve 210 and vessel 220) such that each type of tissue present at the target anatomy comprises respective colors, patterns, shapes, shading, or any combination thereof (Paragraph [0039]; highlight the identified and segmented structures… highlighting may include colorizing the pixels of the segmented structure, outlining the edges of the segmented structure, or any suitable highlighting for drawing attention to one or more structures identified and segmented by the organ detection processor; Paragraph [0052]; the highlighting of different structures 210, 220, 230 may be different colors and/or different types; Fig. 2 shows highlighting 212 of nerves 210 is a different color compared to highlighting 222 of vessel 220); and
generating a representation of the target anatomy based on the annotations (Paragraph [0027]; signal processor 132 may comprise suitable logic, circuitry, interfaces and/or code that may be operable to process ultrasound scan data (i.e., summed IQ signal) for generating ultrasound images for presentation on a display system 134; Paragraph [0059]; The method 300 may comprise presenting 308, by the at least one processor 132, 170, the highlighted ultrasound image 200 at a display system 134.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Walker in view of Scully and Rohling to include identifying, by the one or more processors based on the received data, various types of tissue present at the target anatomy, wherein the various types of tissue include two or more of blood vessel, nerve, muscle, organ tissue, soft tissue, hard tissue, bone, or body fluid; annotating, by the one or more processors based on the identified types of tissue, the data to such that each type of tissue present at the target anatomy comprises respective colors, patterns, shapes, shading, or any combination thereof; and generating a representation of the target anatomy based on the annotations as taught by Pinkovich. This would allow a user to distinguish whether a type of tissue is a nerve or a blood vessel and further warning the user about nerves in an area to safely perform intervention with a needle (Pinkovich, Paragraph [0040]).
Regarding claim 61, together Walker, Scully, Rohling, and Pinkovich teach all of the limitations of claim 39 as noted above.
Walker further teaches the device comprises a plurality of side surfaces (Paragraph [0042]; The enclosure has four sides 12, 13, 14, 15, Fig. 2) extending from a base surface (Paragraph [0042]; and a bottom side 8, Fig. 2),
the plurality of transducers are positioned on the base surface (Paragraph [0042]; transducer array 60 is on the bottom side 8),
each side surface having a height (Paragraph [0049]; housing 2 with the dimensions (height, length and width), Fig. 2), and
a length and a width of the base surface is larger than the height of the side surface (Paragraph [0042]; in inches of about 1x2x2, respectively. In another instance, the dimensions (height, length and width) in inches may be about 2x6x4, respectively, Fig. 2 shows the sides are wider and longer than the height).
Regarding claim 62, together Walker, Scully, Rohling, and Pinkovich teach all of the limitations of claim 61 as noted above.
Scully further teaches the gel pad comprises sidewalls (Paragraph [0095]; In some embodiments, the coupler 10 has a cavity 10c with a floor 10f and/or sidewall 10w, Fig. 4), and
after the device is inserted into the gel pad, the sidewalls of the gel pad extend a second height (Paragraph [0125]; The sidewall 10w can define a cavity with a height H, Fig. 5) along the side surface of the device (Paragraph [0130]; The coupler 10 sidewall 10w can extend a short height H that can encase, reside above, an acoustic lens 115, acoustic matching layer 120, and/or transducer 125 in the end of the probe 110e, Fig. 5 and 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the gel pad of Walker in view of Scully, Rohling, and Pinkovich to have comprised sidewalls, and after the device is inserted into the gel pad, the sidewalls of the gel pad extend a second height along the side surface of the device as taught by Scully because it would have ensured a proper fit with the ultrasound device (Paragraph [0130]-[0132]).
Regarding claims 63 and 67, together Walker, Scully, Rohling, and Pinkovich teach all of the limitations of claim 39 as noted above.
Scully further teaches the gel pad is further configured to enclose the device (Paragraph [0097]; coupler 10, for respective ultrasound probes 110 of various shapes (e.g., FIGS. 1, 7A, 8A, 9A, and 10A) can have a solid coupler body 10b with a cavity 10c having a semi-rigid, and malleable shape so as to be able to be conform to and/or self-attach to the end of the probe 110e by a user pressing the coupler against the end of the ultrasound probe 110e so that the coupler cavity, e.g., at least the floor 10f thereof and more typically the upwardly extending sidewall as well, takes on the underlying shape of the end of the ultrasound probe 110e).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the gel pad of Walker, Scully, Rohling, and Pinkovich to have enclosed the device because it would have allowed more easily and faster assembly of the system thereby improving operation without requiring the use of ultrasound gel, and further would have ensured a secure attachment between the coupler and the ultrasound device (Paragraph [0118]-[0119]).
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Walker in view of Scully, Rohling, and Pinkovich as applied to claim 39 above, and further in view of Martin (US 20120116218).
Regarding claim 41, together Walker, Scully, Rohling, and Pinkovich teach all of the limitations of claim 39 as noted above.
The method of Walker in view of Scully, Rohling, and Pinkovich does not explicitly teach when identifying the various types of tissue further uses Quantitative Ultrasound (QUS) to distinguish and identify various tissue types.
Martin, in the same field of endeavor in the subject of displaying ultrasound data, teaches when identifying the various types of tissue further uses Quantitative Ultrasound (QUS) to distinguish and identify various tissue types (Abstract, Paragraphs [0035], [0044], and [0045]).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of Walker in view of Scully, Rohling, and Pinkovich to incorporate the teachings of Martin to provide Quantitative Ultrasound. This modification will help quantifying each pixel in the image to determine the blood flow in the ROI as taught within Martin in paragraph [0024].
Claims 42 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Walker in view of Scully, Rohling, and Pinkovich as applied to claim 39 above, and further in view of Chopra (US 20180092698).
Regarding claim 42, together Walker, Scully, Rohling, and Pinkovich teach all of the limitations of claim 39 as noted above.
Together Walker, Scully, Rohling, and Pinkovich do not teach modifying the virtual representation based on a viewing position of a viewer to display a parallax view of the virtual representation, the parallax view configured to present the viewer with a three-dimensional view of the virtual representation on the display,
wherein parallax view allows an operator to view portions of the target anatomy which may be underneath other portions of the target anatomy.
Chopra, however, teaches a method of forming a virtual representation (Paragraph [0003]; systems and methods for combining various kinds of medical data to produce a new visual reality for a surgeon or health care provider) of a target anatomy (Paragraph [0094] and [0095]; a body part such as an arm or leg; a patient knee, Fig. 3B) comprising modifying the virtual representation (Paragraph [0135]; The system then reads model; M′I, I′C, TCT, #2210 which are received from other processes and uses all of them to render a left and right enhanced reality image using the correct vergence information) based on a viewing position of a viewer (Paragraph [0135]; focused at depth Dmd #2212) to display a parallax view (Paragraphs [0135] and [0144]; stereo image #2614; The computer can determine “vergence” corresponding to the model depth… the angle between the lines of sight for the left and right eyes to a target object being looked at; uses all of them to render a left and right enhanced reality image; Examiner notes the left and right image formed from the vergence of Chopra is considered to be a parallax view in its broadest reasonable interpretation) of the virtual representation (Paragraphs [0135] and [0145]; deformable model; enhanced reality vision of the internal anatomy of a patient (partial or whole anatomy)), the parallax view configured to present the viewer with a three-dimensional view of the virtual representation on the display (Paragraphs [0096], [0111], [0136]-[0138], [0145], and [0147]; 3D model of the surgical sight projected onto the user display),
wherein parallax view allows an operator to view portions of the target anatomy which may be underneath other portions of the target anatomy (Paragraphs [0135] and [0136]; This allows a user to “see” the scan image model #2250 at the proper depth; Examiner notes Figs. 3H and 5C show the target anatomy is beneath the skin which is considered to be other portions of the anatomy in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the method of Walker in view of Scully, Rohling, and Pinkovich to include modifying the virtual representation based on a viewing position of a viewer to display a parallax view of the virtual representation, the parallax view configured to present the viewer with a three-dimensional view of the virtual representation on the display, wherein parallax view allows an operator to view portions of the target anatomy which may be underneath other portions of the anatomy. This would have allowed the HCP can see any aspect of the image data from the proper orientation of height, direction, angle and orientation to the patient (Chopra, Paragraph [0145]).
Regarding claim 43, together Walker, Scully, Rohling, Pinkovich, and Chopra teach all of the limitations of claim 42 as noted above.
Rohling further teaches the target anatomy may be under bone or body fluids (Paragraph [0028]; target can be an epidural space. The probe can be placed at a paramedian location with respect to the spine).
Claims 44 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Walker in view of Scully, Rohling, and Pinkovich as applied to claim 39 above, and further in view of Wang (US 20090024039).
Regarding claim 44, together Walker, Scully, Rohling, and Pinkovich teach all of the limitations of claim 39 as noted above.
The method of Walker in view of Scully, Rohling , and Pinkovich does not explicitly teach the representation is a real-time representation, the representation being refreshed at regular intervals, of at least 10 volumes/second.
Wang, in the same field of endeavor in the subject of ultrasound scanning device, teaches the representation is a real-time representation, the representation being refreshed at regular intervals, of at least 10 volumes/second (Paragraph [0041]; By limiting the translation distance (i.e., the physical range in the x-direction that the ultrasound transducer #624 is translated), the translation frequency (i.e., the number of times the ultrasound transducer is translated back and forth per second) can be increased for obtaining higher volumetric frame rates (volume refreshes per second), which is particularly useful for procedures in which the biopsy instrument #104 might be moved around quickly. In one preferred embodiment, the translation frequency can be up to 30 translations per second for obtaining volumetric frame rates up to 30 translations per second when the translation distance is limited to about 1 cm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Walker in the view of Scully, Rohling, and Pinkovich to incorporate the teachings of Wang to provide a virtual representation is a real-time virtual representation, the virtual representation being refreshed at regular intervals, of at least 10 volumes/second. This modification will help in obtaining a higher volumetric rates which is useful for procedures in which the instrument is moved around quickly to display a real time image data as each sweep of the ultrasound transducer acquires the most current data volume as taught within Wang in paragraphs [0032] and [0041].
Regarding claim 45, together Walker, Scully, Rohling, Pinkovich, and Wang teach all of the limitations of claim 44 as noted above.
Wang, in the same field of endeavor in the subject of ultrasound scanning device, further teaches the regular intervals are at least 30 vols/second (Paragraphs [0032] and [0041]; By limiting the translation distance (i.e., the physical range in the x-direction that the ultrasound transducer #624 is translated), the translation frequency (i.e., the number of times the ultrasound transducer is translated back and forth per second) can be increased for obtaining higher volumetric frame rates (volume refreshes per second), which is particularly useful for procedures in which the biopsy instrument #104 might be moved around quickly. In one preferred embodiment, the translation frequency can be up to 30 translations per second for obtaining volumetric frame rates up to 30 translations per second when the translation distance is limited to about 1 cm. Particularly for smaller-area preferred embodiments and/or preferred embodiments in which the translation distance is kept relative small (e.g., a few centimeters or less), the volumetric scanning rate (and corresponding display refresh rate) can optionally be made even higher than 30 Hz).
It would have been obvious to one in the ordinary skill in the art before the effective filling date of the claimed invention to have further modified the method of Walker in the view of Scully, Rohling, Pinkovich, and Wang to incorporate the teachings of Wang to provide a regular interval is at least 30 vols/second. This modification will help in obtaining a higher volumetric rates which is useful for procedures in which the instrument is moved around quickly to display a real time image data as each sweep of the ultrasound transducer acquires the most current data volume as taught within Wang in paragraphs [0032] and [0041].
Claims 46 and 64-66 are rejected under 35 U.S.C. 103 as being unpatentable over Walker (US 20150011884) in view of Scully (US 20170303894) and Pinkovich (US 20210077061).
Regarding claim 46, Walker teaches a system for visualizing (Paragraphs [0012] and [0027]; ultrasonic imaging system capable of producing C-Mode images and/or collecting 3D image data of a target, Fig. 1) a target anatomy of a patient (Paragraphs [0012], [0041], and [0045]; target, patient, Fig. 1 #1), comprising:
a device (Paragraph [0042]; hand held imaging system 10, Fig. 2A) comprising a plurality of transducers defining a grid having a pattern (Paragraph [0055]; a two-dimensional piezoelectric transducer array 60 is utilized; Fig. 7 shows the transducer array is a grid pattern);
one or more processors (Paragraphs [0060] and [0061]; digital signal processors, control unit, Fig. 7 #41 and 80), the one or more processors configured to:
receive (Paragraph [0060]; echo data coming out of the beam former would be processed further by a general purpose digital signal processor), from a plurality of transducers (Paragraphs [0027] and [0055]; transducer array, Figs. 1 and 7 #60) defining a grid (Paragraph [0055]; Examiner notes the transducer array #60 is in a 32x32 grid) having a pattern (Paragraph [0055]; 32x32 element array; Examiner notes the 32x32 array is considered to be a grid pattern in its broadest reasonable interpretation), data associated with the target anatomy (Paragraphs [0027]-[0030]; a variety of tissue information may be obtained through judicious pulse transmission and signal processing of received echoes); and
provide for output (Paragraphs [0060] and [0061]; Finally, the image data would be displayed using an LCD screen #20), to a user interface (UI) (Paragraphs [0026], [0042], and [0044]; include a simple user control… also include a simple display indicating the depth selected) including a display (Paragraphs [0027] and [0060]; display, Figs. 1 and 7 #20) including a display (Paragraphs [0027] and [0060]; display, Figs. 1 and 7 #20), the representation of the target anatomy (Paragraphs [0025]-[0030] and [0052]; a C-Mode or 3-D display #20; sonic window… observing Subcutaneous tissues).
Walker does not teach a gel pad that that is configured to enclose the plurality of transducers defining a grid having a pattern,
identifying, based on the received data, various types of tissue present at the target anatomy, wherein the various types of tissue include two or more of blood vessel, nerve, muscle, organ tissue, soft tissue, hard tissue, bone, or body fluid;
annotating, based on the identified types of tissue, the data such that each type of tissue present at the target anatomy comprises respective colors, patterns, shapes, shading, or any combination thereof;
generating, based on the annotated data, the representation of the target anatomy comprising the respective colors, patterns, shapes, shading, or any combination thereof.
Scully, however, teaches a system (Paragraph [0095]; an ultrasound system 100 with an ultrasound probe 110 and a semi-rigid ultrasound coupler 10, Fig. 2D) for visualizing a target anatomy of a patient (Paragraph [0029]; sliding the probe and the coupler together as a unitary member over skin of subject to obtain ultrasound images) comprising inserting a device into a gel pad (Paragraph [0095]; a semi-rigid ultrasound coupler 10, Fig. 2D; Paragraph [0156]-[0161]; A coupler 10 of the present invention may comprise a polyhydric alcohol, a thickening agent, a surfactant, and/or water; a thickening agent may function as a gelling agent; Paragraph [0139]; The probe 110 can be inserted into the coupler cavity 31 and pressed against the bottom of the cavity 10c causing the coupler body 10b to mold against and attach to the ultrasound probe), wherein the device comprises a plurality of transducers (Paragraph [0094];ultrasound system with the transducer/transducer array, Fig. 6 shows a plurality of transducers 125) and the gel pad is configured to enclose the plurality of transducers (Paragraph [0130]; shape of the cavity 10c can correspond to the shape of the end of the probe 110e. The coupler 10 sidewall 10w can extend a short height H that can encase, reside above, an acoustic lens 115, acoustic matching layer 120, and/or transducer 125 in the end of the probe 110e; Fig. 6 shows the coupler 10 is configured to enclose the plurality of transducers 125);
and the gel pad is configured to enclose the plurality of transducers defining a grid having a pattern (Paragraph [0097]; for respective ultrasound probes 110 of various shapes… a cavity 10c having a semi-rigid, and malleable shape so as to be able to be conform to and/or self-attach to the end of the probe 110e by a user pressing the coupler against the end of the ultrasound probe 110e so that the coupler cavity, e.g., at least the floor 10f thereof and more typically the upwardly extending sidewall as well, takes on the underlying shape of the end of the ultrasound probe 110e, Figs. 8, 9, and 23; Paragraph [0098]; an inner portion of the coupler body 10b surrounding the cavity 10c may be square or rectangular).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Walker to have included inserting the device into a gel pad such that the gel pad is configured to enclose the plurality of transducers defining a grid having a pattern as taught by Scully because it would have been a well-known and understood method of coupling a ultrasound probe to a patient and facilitating ultrasound wave transmission into the patient (Paragraph [0003] and [0140]) and further would have been more comfortable for a patient than a gel interface as it feels less cold to the touch (Paragraph [0138]) and reduce the amount of post ultrasound clean up (Paragraph [0138]).
Together Walker and Scully do not teach identifying, based on the received data, various types of tissue present at the target anatomy, wherein the various types of tissue include two or more of blood vessel, nerve, muscle, organ tissue, soft tissue, hard tissue, bone, or body fluid;
annotating, based on the identified types of tissue, the data such that each type of tissue present at the target anatomy comprises respective colors, patterns, shapes, shading, or any combination thereof;
generating, based on the annotated data, the representation of the target anatomy comprising the respective colors, patterns, shapes, shading, or any combination thereof.
Pinkovich, however, teaches a system for visualizing a target anatomy of a patient (Paragraph [0012]; method and system for analyzing ultrasound scenes to provide needle guidance and warnings… identifying and highlighting biological structures) comprising:
identifying, based on the received data, various types of tissue present at the target anatomy (Paragraph [0028]; the signal processor 132 may comprise an organ detection processor 140; Paragraph [0030]; analyze acquired ultrasound images to identify and segment organs, such as nerves, vessels, or any suitable biological structures.), wherein the various types of tissue include two or more of blood vessel, nerve, muscle, organ tissue, soft tissue, hard tissue, bone, or body fluid (Paragraph [0030]; segment organs, such as nerves, vessels, or any suitable biological structures; Paragraph [0052]-[0054]; segmented structure nerves 210 and vessel 220 identified at step 304);
annotating, based on the identified types of tissue, the data (Paragraph [0039]; display and warning processor 170 may comprise suitable logic, circuitry, interfaces and/or code that may be operable to highlight and display the biological and/or artificial structures identified and segmented by the organ detection processor 140, Fig 2 nerve 210 and vessel 220) such that each type of tissue present at the target anatomy comprises respective colors, patterns, shapes, shading, or any combination thereof (Paragraph [0039]; highlight the identified and segmented structures… highlighting may include colorizing the pixels of the segmented structure, outlining the edges of the segmented structure, or any suitable highlighting for drawing attention to one or more structures identified and segmented by the organ detection processor; Paragraph [0052]; the highlighting of different structures 210, 220, 230 may be different colors and/or different types; Fig. 2 shows highlighting 212 of nerves 210 is a different color compared to highlighting 222 of vessel 220);
generating, based on the annotated data, the representation of the target anatomy comprising the respective colors, patterns, shapes, shading, or any combination thereof (Paragraph [0027]; signal processor 132 may comprise suitable logic, circuitry, interfaces and/or code that may be operable to process ultrasound scan data (i.e., summed IQ signal) for generating ultrasound images for presentation on a display system 134; Paragraph [0059]; The method 300 may comprise presenting 308, by the at least one processor 132, 170, the highlighted ultrasound image 200 at a display system 134.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Walker in view of Scully to include identifying, by the one or more processors based on the received data, various types of tissue present at the target anatomy, wherein the various types of tissue include two or more of blood vessel, nerve, muscle, organ tissue, soft tissue, hard tissue, bone, or body fluid; annotating, by the one or more processors based on the identified types of tissue, the data to such that each type of tissue present at the target anatomy comprises respective colors, patterns, shapes, shading, or any combination thereof; and generating a representation of the target anatomy based on the annotations as taught by Pinkovich. This would allow a user to distinguish whether a type of tissue is a nerve or a blood vessel and further warning the user about nerves in an area to safely perform intervention with a needle (Pinkovich, Paragraph [0040]).
Regarding claim 64, together Walker, Scully, and Pinkovich teach all of the limitations of claim 46 as noted above.
Walker further teaches the device comprises a plurality of side surfaces (Paragraph [0042]; The enclosure has four sides 12, 13, 14, 15, Fig. 2) extending from a base surface (Paragraph [0042]; and a bottom side 8, Fig. 2),
the plurality of transducers are positioned on the base surface (Paragraph [0042]; transducer array 60 is on the bottom side 8),
each side surface having a height (Paragraph [0049]; housing 2 with the dimensions (height, length and width), Fig. 2), and
a length and a width of the base surface is larger than the height of the side surface (Paragraph [0042]; in inches of about 1x2x2, respectively. In another instance, the dimensions (height, length and width) in inches may be about 2x6x4, respectively, Fig. 2 shows the sides are wider and longer than the height).
Regarding claim 65, together Walker, Scully, and Pinkovich teach all of the limitations of claim 64 as noted above.
Scully further teaches the gel pad comprises sidewalls (Paragraph [0095]; In some embodiments, the coupler 10 has a cavity 10c with a floor 10f and/or sidewall 10w, Fig. 4), and
after the device is inserted into the gel pad, the sidewalls of the gel pad extend a second height (Paragraph [0125]; The sidewall 10w can define a cavity with a height H, Fig. 5) along the side surface of the device (Paragraph [0130]; The coupler 10 sidewall 10w can extend a short height H that can encase, reside above, an acoustic lens 115, acoustic matching layer 120, and/or transducer 125 in the end of the probe 110e, Fig. 5 and 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the gel pad of Walker in view of Scully, and Pinkovich to have comprised sidewalls, and after the device is inserted into the gel pad, the sidewalls of the gel pad extend a second height along the side surface of the device as taught by Scully because it would have ensured a proper fit with the ultrasound device (Paragraph [0130]-[0132]).
Regarding claim 66, together Walker, Scully, and Pinkovich teach all of the limitations of claim 46 as noted above.
Scully further teaches the gel pad is further configured to enclose the device (Paragraph [0097]; coupler 10, for respective ultrasound probes 110 of various shapes (e.g., FIGS. 1, 7A, 8A, 9A, and 10A) can have a solid coupler body 10b with a cavity 10c having a semi-rigid, and malleable shape so as to be able to be conform to and/or self-attach to the end of the probe 110e by a user pressing the coupler against the end of the ultrasound probe 110e so that the coupler cavity, e.g., at least the floor 10f thereof and more typically the upwardly extending sidewall as well, takes on the underlying shape of the end of the ultrasound probe 110e).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the gel pad of Walker, Scully, and Pinkovich to have enclosed the device because it would have allowed more easily and faster assembly of the system thereby improving operation without requiring the use of ultrasound gel, and further would have ensured a secure attachment between the coupler and the ultrasound device (Paragraph [0118]-[0119]).
Claims 47 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Walker (US 20150011884) in view of Pinkovich (US 20210077061) and Nozaki (US 20120136256).
Regarding claim 47, Walker teaches a system for visualizing (Paragraphs [0012] and [0027]; ultrasonic imaging system capable of producing C-Mode images and/or collecting 3D image data of a target, Fig. 1) a target anatomy of a patient (Paragraphs [0012], [0041], and [0045]; target, patient, Fig. 1 #1), comprising:
one or more processors (Paragraphs [0060] and [0061]; digital signal processors, control unit, Fig. 7 #41 and 80), the one of more processors configured to:
receive (Paragraph [0060]; echo data coming out of the beam former would be processed further by a general purpose digital signal processor), from a plurality of transducers (Paragraphs [0027] and [0055]; transducer array, Figs. 1 and 7 #60), data about the target anatomy (Paragraphs [0027]-[0030]; a variety of tissue information may be obtained through judicious pulse transmission and signal processing of received echoes);
generate (Paragraph [0060]; This DSP #41 processes the focused line data by performing envelope detection and mapping the envelope detected data to the appropriate location in the image display), based on the received data (Paragraph [0060]; processes the focused line data), a visualization of the target anatomy (Paragraphs [0025]-[0030] and [0052]; a C-Mode or 3-D display #20; The present invention sonic window would offer a new method and system of observing Subcutaneous tissues) comprising at least one virtual representation of the target anatomy based on the data collected by the plurality of transducers (Paragraphs [0025]-[0030] and [0052]; a C-Mode or 3-D display #20; The present invention sonic window would offer a new method and system of observing Subcutaneous tissues);
provide for output (Paragraphs [0060] and [0061]; Finally, the image data would be displayed using an LCD screen #20), to a first display (Paragraphs [0027] and [0060]; display, Figs. 1 and 7 #20).
Walker does not teach identifying, based on the received data, various types of tissue present at the target anatomy, wherein the various types of tissue include two or more of blood vessel, nerve, muscle, organ tissue, soft tissue, hard tissue, bone, or body fluid;
annotating, processors based on the identified types of tissue, the data such that each type of tissue present at the target anatomy comprises respective colors, patterns, shapes, shading, or any combination thereof;
generating the visualization based on the received and the annotations comprising the respective colors, patterns, shapes, shading, or any combination thereof;
providing for output a first virtual representation of a first portion of the target anatomy located underneath a second portion of the target anatomy, wherein the first virtual representation is generated based on the received data and the annotations; and
provide for output, to a second display, a second virtual representation of the first and second portions of the target anatomy, wherein:
the second virtual representation is generated based on the received data and the annotations.
Pinkovich, however, teaches a system for visualizing a target anatomy of a patient (Paragraph [0012]; method and system for analyzing ultrasound scenes to provide needle guidance and warnings… identifying and highlighting biological structures) comprising:
identifying, based on the received data, various types of tissue present at the target anatomy (Paragraph [0028]; the signal processor 132 may comprise an organ detection processor 140; Paragraph [0030]; analyze acquired ultrasound images to identify and segment organs, such as nerves, vessels, or any suitable biological structures.), wherein the various types of tissue include two or more of blood vessel, nerve, muscle, organ tissue, soft tissue, hard tissue, bone, or body fluid (Paragraph [0030]; segment organs, such as nerves, vessels, or any suitable biological structures; Paragraph [0052]-[0054]; segmented structure nerves 210 and vessel 220 identified at step 304);
annotating, processors based on the identified types of tissue, the data (Paragraph [0039]; display and warning processor 170 may comprise suitable logic, circuitry, interfaces and/or code that may be operable to highlight and display the biological and/or artificial structures identified and segmented by the organ detection processor 140, Fig 2 nerve 210 and vessel 220) such that each type of tissue present at the target anatomy comprises respective colors, patterns, shapes, shading, or any combination thereof (Paragraph [0039]; highlight the identified and segmented structures… highlighting may include colorizing the pixels of the segmented structure, outlining the edges of the segmented structure, or any suitable highlighting for drawing attention to one or more structures identified and segmented by the organ detection processor; Paragraph [0052]; the highlighting of different structures 210, 220, 230 may be different colors and/or different types; Fig. 2 shows highlighting 212 of nerves 210 is a different color compared to highlighting 222 of vessel 220);
generating the visualization based on the received comprising the annotations and the respective colors, patterns, shapes, shading, or any combination thereof (Paragraph [0027]; signal processor 132 may comprise suitable logic, circuitry, interfaces and/or code that may be operable to process ultrasound scan data (i.e., summed IQ signal) for generating ultrasound images for presentation on a display system 134; Paragraph [0059]; The method 300 may comprise presenting 308, by the at least one processor 132, 170, the highlighted ultrasound image 200 at a display system 134.);
providing for output a first virtual representation (Paragraph [0059]; The method 300 may comprise presenting 308, by the at least one processor 132, 170, the highlighted ultrasound image 200 at a display system 134) of a first portion of the target anatomy (Paragraph [0052]-[0054]; Fig. 2, vessel 220) located underneath a second portion of the target anatomy (Paragraph [0052]-[0054]; Fig. 2, nerve 210), wherein the first virtual representation is generated based on the received data and the annotations (Paragraph [0059]; The method 300 may comprise presenting 308, by the at least one processor 132, 170, the highlighted ultrasound image 200 at a display system 134).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Walker to include identifying, based on the received data, various types of tissue present at the target anatomy, wherein the various types of tissue include two or more of blood vessel, nerve, muscle, organ tissue, soft tissue, hard tissue, bone, or body fluid; annotating, processors based on the identified types of tissue, the data such that each type of tissue present at the target anatomy comprises respective colors, patterns, shapes, shading, or any combination thereof; generating the visualization based on the received and the annotations comprising the respective colors, patterns, shapes, shading, or any combination thereof; providing for output a first virtual representation of a first portion of the target anatomy located underneath a second portion of the target anatomy, wherein the first virtual representation is generated based on the received data and the annotations as taught by Pinkovich. This would allow a user to distinguish whether a type of tissue is a nerve or a blood vessel and further warning the user about nerves in an area to safely perform intervention with a needle (Pinkovich, Paragraph [0040]).
The system of Walker in view of Pinkovich does not teach providing for output, to a second display, a second virtual representation of the first and second portions of the target anatomy, wherein:
the second virtual representation is generated based on the received data and the annotations.
Nozaki, however, teaches a system for visualizing a target anatomy of a patient (Paragraph [0003]; ultrasonic diagnostic apparatus displays the condition of a target object) comprising:
providing for output (Paragraph [0041]; creates B-mode image or Doppler image of the sound ray data by image processing), to a first display (Paragraph [0113]; probe display unit 13a, Fig. 9), a first virtual representation;
providing for output, to a second display (Paragraph [0113]; probe display unit 13b, Fig. 9), a second virtual representation of the first and second portions of the target anatomy (Paragraph [0094]; display region PA1 and the display region PA2; Paragraphs [0110] and [0118]; Same numberings are used for the same configurations previously; probe display unit 13b displays the position of the specific index MK in the Y-axis direction), wherein:
the second virtual representation is generated based on the received data and the annotations (Paragraphs [0114] and [0117]; Image processing unit 31 generates the rendering image of the region of interest based on preset perspective… position output unit converts the specific index MK into the real-size coordinates).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Walker in view of Pinkovich to have included providing for output, to a second display, a second virtual representation of the first and second portions of the target anatomy, wherein: the second virtual representation is generated based on the received data and the annotations as taught by Nozaki. Doing so would have more accurately determine the exact coordinates of structures in the body with respect to the ultrasonic probe, thereby allowing the operator to accurately determine where on the surface of the body to position a needle for extracting the tumor or other material (Nozaki, Paragraph [0081]).
Regarding claim 57, together Walker, Pinkovich, and Nozaki teach all of the limitations of claim 47 as noted above.
Nozaki further teaches the second display is transverse to the first display (Paragraph [0118]; probe display unit 13a displays the position of the specific index MK in the X-axis direction… probe display unit 13b displays the position of the specific index MK in the Y-axis direction; Fig. 9), and
at least one of:
the first and second displays are part of the same device (Paragraph [0119]; the probe display unit 13a and the probe display unit 13b are fixed to the two-dimensional ultrasonic probe 11d; Fig. 9), or the first virtual representation corresponds to a first point of view and the second virtual representation corresponds to a second point of view different than the first point of view (Paragraph [0118]; probe display unit 13a displays the X-axis direction and probe display 13b displays the Y-axis direction).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Walker in view of Pinkovich and Nozaki to have included the second display is transverse to the first display, and at least one of: the first and second displays are part of the same device, or the first virtual representation corresponds to a first point of view and the second virtual representation corresponds to a second point of view different than the first point of view as taught by Nozaki. Doing so would have more accurately determine the exact coordinates of specific blood vessels an tumors being imaged with respect to the ultrasonic probe, thereby allowing the operator to accurately determine where on the surface of the body to position a needle for extracting the tumor or other material (Nozaki, Paragraph [0081]).
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Schneider in view of Scully as applied to claim 22 above, and further in view of Rohling (US 20120289820).
Regarding claim 50, together Schneider and Scully teach all of the limitations of claim 22 as noted above.
Together Schneider and Scully do not explicitly teach the plurality of transducers are configured to move around a probe surface area.
Rohling, however, teaches a plurality of transducers are configured to move around a probe surface area (Paragraphs [0061]; A specialized 3-D probe is constructed by combining a 2-D probe with a motorized mechanism for rapidly moving the 2-D probe so that the 2-D image sweeps repeatedly through a volume of interest).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Schneider in view of Scully such that the plurality of transducers are configured to move around a probe surface area as it would allow rapidly sweeping 2D image planes to produce a 3D ultrasound volume (Rohling, Paragraphs [0060]-[0063]).
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Schneider in view of Scully and Chopra as applied to claim 25 above, and further in view of Walker (US 20150011884).
Regarding claim 51, together Schneider, Scully, and Chopra teach all of the limitations of claim 25 as noted above.
Together Schneider, Scully, and Chopra do not teach the plurality of transducers includes a slot to allow for the at least one medical instrument, and one or more of the plurality of transducers adjacent to the slot are angled towards the target anatomy.
Walker, however, teaches a plurality of transducers includes a slot to allow for the at least one medical instrument (Paragraphs [0038]-[0040]; In clinical use an instrument or needle could be inserted into the access port entry #63, pass through the device through a passage #65, and enter the tissue near the outlet #64; Examiner notes the passage #65 passes through the transducer array #60, shown in Fig. 3B), and
one or more of the plurality of transducers adjacent to the slot are angled towards the target anatomy (Paragraphs [0038]-[0040]; Examiner notes the transducer array #60 is directed toward the target anatomy intersection point #4 as shown in Figs. 3A and 3B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the plurality of transducers of Schneider in view of Scully and Chopra to include a slot to allow for the at least one medical instrument, and one or more of the plurality of transducers adjacent to the slot are angled towards the target anatomy as taught by Walker. Doing so would have allowed the needle to readily access the target area and thus more accurately reach the target area while imaging (Walker, Paragraph [0038]).
Claims 54, 55, and 68-70 rejected under 35 U.S.C. 103 as being unpatentable over Walker in view of Pinkovich and Nozaki as applied to claim 47 above, and further in view of Scully (US 20170303894).
Regarding claim 54, together Walker, Pinkovich, and Nozaki teach all of the limitations of claim 47 as noted above.
Together Walker, Pinkovich, and Nozaki do not teach a gel pad removably couplable to the plurality of transducers.
Scully, however, teaches a system (Paragraph [0095]; an ultrasound system 100 with an ultrasound probe 110 and a semi-rigid ultrasound coupler 10, Fig. 2D) for visualizing a target anatomy of a patient (Paragraph [0029]; sliding the probe and the coupler together as a unitary member over skin of subject to obtain ultrasound images) comprising a gel pad (Paragraph [0095]; a semi-rigid ultrasound coupler 10, Fig. 2D; Paragraph [0156]-[0161]; A coupler 10 of the present invention may comprise a polyhydric alcohol, a thickening agent, a surfactant, and/or water; a thickening agent may function as a gelling agent; Paragraph [0139]; The probe 110 can be inserted into the coupler cavity 31 and pressed against the bottom of the cavity 10c causing the coupler body 10b to mold against and attach to the ultrasound probe) removably couplable to the plurality of transducers (Paragraph [0139]; To remove the coupler 30, a user can simply pull the coupler body away from the probe 20.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Walker in view of Pinkovich and Nozaki to have included a gel pad removably couplable to the plurality of transducers as taught by Scully because it would have been a well-known and understood method of coupling a ultrasound probe to a patient and facilitating ultrasound wave transmission into the patient (Paragraph [0003] and [0140]) and further would have been more comfortable for a patient than a gel interface as it feels less cold to the touch (Paragraph [0138]) and reduce the amount of post ultrasound clean up (Paragraph [0138]).
Regarding claim 55, together Walker, Pinkovich, Nozaki, and Scully teach all of the limitations of claim 47 as noted above.
Together Walker further teaches system comprises:
a device (Walker, Paragraphs [0041]-[0044]; system #10 comprises a housing, Fig. 2) comprising:
the plurality of transducers (Walker, Paragraphs [0041]-[0044]; transducer array #60 is on the bottom side #8, Fig. 2); and
at least one of the first display (Walker, Paragraphs [0041]-[0044]; The display unit #20 is on the top side #6, Fig. 2).
Scully further teaches the gel pad is configured to enclose the plurality of transducers (Paragraph [0130]; shape of the cavity 10c can correspond to the shape of the end of the probe 110e. The coupler 10 sidewall 10w can extend a short height H that can encase, reside above, an acoustic lens 115, acoustic matching layer 120, and/or transducer 125 in the end of the probe 110e; Fig. 6 shows the coupler 10 is configured to enclose the plurality of transducers 125).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Walker in view of Pinkovich and Nozaki such that the gel pad is configured to enclose the plurality of transducers as taught by Scully because it would have been a well-known and understood method of coupling a ultrasound probe to a patient and facilitating ultrasound wave transmission into the patient (Paragraph [0003] and [0140]) and further would have been more comfortable for a patient than a gel interface as it feels less cold to the touch (Paragraph [0138]) and reduce the amount of post ultrasound clean up (Paragraph [0138]).
Regarding claim 68, together Walker, Pinkovich, Nozaki, and Scully teach all of the limitations of claim 55 as noted above.
Walker further teaches the device comprises a plurality of side surfaces (Paragraph [0042]; The enclosure has four sides 12, 13, 14, 15, Fig. 2) extending from a base surface (Paragraph [0042]; and a bottom side 8, Fig. 2),
the plurality of transducers are positioned on the base surface (Paragraph [0042]; transducer array 60 is on the bottom side 8),
each side surface having a height (Paragraph [0049]; housing 2 with the dimensions (height, length and width), Fig. 2), and
a length and a width of the base surface is larger than the height of the side surface (Paragraph [0042]; in inches of about 1x2x2, respectively. In another instance, the dimensions (height, length and width) in inches may be about 2x6x4, respectively, Fig. 2 shows the sides are wider and longer than the height).
Regarding claim 69, together Walker, Pinkovich, Nozaki, and Scully teach all of the limitations of claim 68 as noted above.
Scully further teaches the gel pad comprises sidewalls (Paragraph [0095]; In some embodiments, the coupler 10 has a cavity 10c with a floor 10f and/or sidewall 10w, Fig. 4), and
after the device is inserted into the gel pad, the sidewalls of the gel pad extend a second height (Paragraph [0125]; The sidewall 10w can define a cavity with a height H, Fig. 5) along the side surface of the device (Paragraph [0130]; The coupler 10 sidewall 10w can extend a short height H that can encase, reside above, an acoustic lens 115, acoustic matching layer 120, and/or transducer 125 in the end of the probe 110e, Fig. 5 and 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the gel pad of Walker, Pinkovich, Nozaki, and Scully to have comprised sidewalls, and after the device is inserted into the gel pad, the sidewalls of the gel pad extend a second height along the side surface of the device as taught by Scully because it would have ensured a proper fit with the ultrasound device (Paragraph [0130]-[0132]).
Regarding claim 70, together Walker, Pinkovich, Nozaki, and Scully teach all of the limitations of claim 55 as noted above.
Scully further teaches the gel pad is further configured to enclose the device (Paragraph [0097]; coupler 10, for respective ultrasound probes 110 of various shapes (e.g., FIGS. 1, 7A, 8A, 9A, and 10A) can have a solid coupler body 10b with a cavity 10c having a semi-rigid, and malleable shape so as to be able to be conform to and/or self-attach to the end of the probe 110e by a user pressing the coupler against the end of the ultrasound probe 110e so that the coupler cavity, e.g., at least the floor 10f thereof and more typically the upwardly extending sidewall as well, takes on the underlying shape of the end of the ultrasound probe 110e).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the gel pad of Walker, Pinkovich, Nozaki, and Scully to have enclosed the device because it would have allowed more easily and faster assembly of the system thereby improving operation without requiring the use of ultrasound gel, and further would have ensured a secure attachment between the coupler and the ultrasound device (Paragraph [0118]-[0119]).
Claim 56 is rejected under 35 U.S.C. 103 as being unpatentable over Schneider in view of Scully as applied to claim 22 above, and further in view of Rohling (US 20120289820) and Walker (US 20150011884).
Regarding claim 56, together Schneider and Hayakawa teach all of the limitations of claim 22 as noted above.
Schneider further teaches the pattern has a first footprint based on a first length and a first width (Paragraph [0013]; two-dimensional matrix array; The size of the array is considered a footprint in its broadest reasonable interpretation).
Together Schneider and Scully does not teach the pattern a field of view of the data has a second footprint greater than the first footprint,
the display has a second length and a second width equal to or greater than the first length and the first width of the pattern of transducers, and
the representation of the target anatomy has a third footprint greater than the first footprint.
Rohling, however, teaches a field of view of the data (Paragraph [0082]; 3-D volumetric dataset, Fig. 6 #402) has a second footprint (Paragraph [0082]; the size and shape of the 3-D volume #402, Fig. 6) greater than the first footprint (Paragraphs [0059] and [0082]; curved shape of the probe #202; Examiner notes the width of the imaging volumetric data is larger than the width of the probe and is considered to read on the claimed limitation of the data having a second footprint greater than the first footprint), and
the representation of the target anatomy has a third footprint (Paragraphs [0068] and [0082]; displays the images obtained by the apparatus #200; the size and shape of the 3-D volume #402, Fig. 6) greater than the first footprint (Paragraphs [0059] and [0082]; curved shape of the probe #202; Examiner notes the width of the imaging volumetric data is larger than the width of the probe and is considered to read on the claimed limitation of the representation of the target anatomy having a third footprint greater than the first footprint).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Schneider in view of Scully such that a field of view of the data has a second footprint greater than the first footprint, and the representation of the target anatomy has a third footprint greater than the first footprint as taught by Rohling as this embodiment has the advantage of obtaining a wide field of view of the anatomy with a relatively small footprint of the probe. This embodiment also has the advantage of directing the ultrasound beams toward the needle at an angle that is closer to perpendicular to the needle, resulting in a stronger echo from the needle and a better depiction of the needle in the 3-D volumetric dataset (Rohling, Paragraph [0082]).
Together Schneider, Hayakawa, and Rohling do not explicitly teach the display has a second length and a second width equal to or greater than the first length and the first width of the pattern of transducers.
Walker, however, teaches a plurality of transducers (Paragraphs [0027] and [0055]; transducer array, Figs. 1 and 7 #60) defining a grid (Paragraph [0055]; Examiner notes the transducer array #60 is in a 32x32 grid) having a pattern (Paragraph [0055]; 32x32 element array; Examiner notes the 32x32 array is considered to be a grid pattern in its broadest reasonable interpretation) with a first footprint (Paragraph [0055]; transducer array #60 consists of a 32x32 element array of 500x500 um elements #62, Fig. 7) based on a first length (Paragraph [0055]; 32 elements of 500 um in length) and a first width (Paragraph [0055]; 32 elements of 500 um in width), and a display (Paragraphs [0027] and [0060]; display, Figs. 1 and 7 #20) having a second length and a second width equal to the first length and the first width of the pattern of transducers (Paragraphs [0042]-[0044] and [0050]; Examiner notes the display #20 appears to be the same size as the transducer array #60 as shown in Figs. 3A, 3B, 3C, 8B, and 9B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Schneider in view of Hayakawa and Rohling such that the display has a second length and a second width equal to the first length and the first width of the pattern of transducers as taught by Walker because it would have allowed conveniently presenting the image to the operator during the operation (Walker, Paragraph [0011]) and further allowed the display to depict the target in a location it is acquired (Walker, Paragraph [0024]).
Response to Arguments
Claim Objections
The amendments to the claims raise new objections which are now presented.
Claim Rejections under – 35 U.S.C. § 112(b)
The amendments to the claims raise new rejections under 35 USC 112(b) which are now presented.
Claim Rejections under – 35 U.S.C. § 102 and 103
Applicant’s arguments with respect to the previous 35 U.S.C. §103 rejections over claims 22, 25-31, 33-35, 37-39, 41-46, 48-51, and 54-56 have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
Applicant's arguments filed 07/30/2025 with respect to claim 47 have been fully considered but they are not persuasive.
Applicant argues the references of record do not teach displaying a first portion of the target anatomy located underneath a second portion of the target anatomy, and further a second visual representation of the first and second portions of the target anatomy. Applicant argues the imaged portions of the blood vessel and nerve as imaged in Pinkovich comprise two different target anatomies and not a first portion and a second portion of a target anatomy. Examiner respectfully disagrees. Examiner would like to point out there is no claim limitations which require the portions of the anatomy to be the same tissue or structure. Furthermore, as described in Applicant Specification paragraph [0030] a target anatomy includes various tissues. As understood in its broadest reasonable interpretation and in view of Applicant Specification, the target anatomy is considered to be various tissue positioned adjacent to the plurality of tissue, and that the first and second portion of the target anatomy is portions of the target anatomy. The imaged tissue of blood vessel and nerve tissue are considered to be portions of the target anatomy as understood in its broadest reasonable interpretation. Furthermore, the reference of Pinkovich describes providing for output a virtual representation of the blood vessel located underneath the nerve tissue which, as noted in paragraph [0057] and fig. 2, which is considered to read on the claimed limitation as understood in its broadest reasonable interpretation. For these reasons rejections of claim 47 under 35 USC 103 is maintained.
Rejections of claims 47 and 57 under 35 USC 103 are maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dean N Edun whose telephone number is (571)270-3745. The examiner can normally be reached M-F 8am-5:30pm.
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, Anh Tuan Nguyen can be reached at (571)272-4963. 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.
/DEAN N EDUN/Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
12/03/25
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