DETAILED ACTION
Non-Final Rejection
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/15/2025, 02/12/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The lengthy specification (more than 20 pages) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Election/Restriction
Applicant’s election without traverse of Invention II. Claim(s) 9-21, drawn to a system and method to construct 2D and 3D ultrasonic images in attenuating media and a method to increase the signal strength from a first transmitting sensor array, classified in A61B8/483 in the reply filed on 06/05/2026 is acknowledged.
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.
Claim(s) 9-21 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(s) 9 recites the limitation “the ultrasonic measurements” in Line(s) 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim(s) 12 recites the limitation “the internal structure” in Line(s) 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim(s) 21 recites the limitation “the ultrasonic measurements” in Line(s) 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 9-21 are rejected under 35 U.S.C. 102“(a)(1)” or “(a)(2)” or both as being anticipated by Applicant presented Prior Art in IDS, DOYLE (US 2013/0269441 A1).
Referring to Claim 9, DOYLE teaches a system to construct 2D and 3D ultrasonic images in attenuating media, where the ultrasonic measurements and data are multifrequency and/or broadband in nature, and the 2D/3D ultrasonic images retain the multifrequency and/or broadband characteristics of the ultrasonic measurements and/or data ([0063]: The ultrasonic transducers each have a center frequency of 50 MHz and are broadband transducers (providing a range of 20-80 MHz), providing a short pulse length and enhanced signal-to-noise in highly scattering or attenuating materials. The broadband characteristics of the transducers are desirable for obtaining an ultrasonic tissue response across a wide frequency band), and comprising:
a tunable ultrasonic pulsing module ([0008]: transducers are controllable; a controller operatively coupled to the transducers);
a controller that tunes the ultrasonic pulsing module for each selected frequency step in the multifrequency and/or broadband ultrasonic spectrum ([0061]: The computer 160 may act as a controller to carry out the functions of the systems or steps of the methods of the invention);
a multiplexer that switches through the sensors in a transmitting sensor array and selects combinations of transmitting array elements to generate each ultrasonic beam geometry ([0064]; fig. 13b: the arrays are linked to the HF pulser-receiver using a high-voltage radio-frequency switch system (e.g. a design based on Model #50S-1256 by JFW Industries). The switch system permits the operation of individual array element pairs by the data acquisition computer to construct a linear map of the tissue);
a first ultrasonic sensor array that generates and broadcasts ultrasonic waves with multifrequency and/or broadband characteristics ([0064]: transmitter array, fig. 13b; the ultrasonic transducers comprise a pair of high-frequency (HF) ultrasonic linear arrays);
a second ultrasonic sensor array (fig. 13b: receiver array) that receives and detects ultrasonic waves with multifrequency and/or broadband characteristics ([0064]: the ultrasonic transducers comprise a pair of high-frequency (HF) ultrasonic linear arrays; the HF pulser-receiver);
a multiplexer that switches through the sensors in the second ultrasonic sensor array and selects combinations of receiving array elements to correspond to each ultrasonic beam geometry ([0064]; fig. 13b: the arrays are linked to the HF pulser-receiver using a high voltage radio-frequency switch system (e.g. a design based on Model #50S-1256 by JFW Industries). The switch system permits the operation of individual array element pairs by the data acquisition computer to construct a linear map of the tissue);
an ultrasonic receiving module ([0064]: ultrasonic transducer; the HF pulser-receiver) to amplify, filter, and/or rectify a received ultrasonic signal from the combinations of receiving array elements ([0072]: Attenuation calculations accounted for receiver gain);
a computational device ([0061]: The computer includes a microprocessor);
a data storage device that stores frequency steps, beam geometries, sensor element combinations, and sensor element delays ([0061]: The computer includes a microprocessor, memory, data storage); and
a computational device that uses the beam pattern geometries, receiving array element measurements, and broadband ultrasonic spectrum analysis to construct a 2D or 3D image of the internal structure or property distribution of the medium ([0061]: the microprocessor is programmed to carry out the methods and to control the systems of the invention).
Referring to Claim 10, DOYLE teaches The system of claim 9 wherein the computational device calculates at least one of frequency steps for a multifrequency and/or broadband ultrasonic spectrum ([0071]: the pulse-echo measurements, FIG. 2(c), the ultrasonic data consisted of time-domain waveforms of ultrasonic pulses, FIG. 3(b), that were transmitted from the top transducer, passed through the specimen, reflected from the surface of the bottom transducer, passed through the specimen a second time, and received by the top transducer), beam geometry combinations required to reconstruct a 2D or 3D image of an internal structure or property distribution of a medium, sensor element combinations for each ultrasonic beam geometry, or corresponding sensor element delays for each frequency step or for each beam geometry.
Referring to Claim 11, DOYLE teaches the system of claim 10 further comprising an image fixing and/or projection device to capture and/or distribute a constructed image ([0061]: output (e.g. monitor or other display, speaker, tactile device, printer, etc.)).
Referring to Claim 12, DOYLE teaches a method to increase the signal strength from a first transmitting sensor array (fig. 13b: transmitter array), broadcasting a ultrasound through an attenuating medium (fig. 13b: pathology; [0047-0048]: ultrasonic waveform), to a second receiving sensor array (fig. 13b: receiver array), and obtaining two-dimensional and three-dimensional images of the internal structure ([0105]: FIG. 17 shows a 3D rendering of a cell model with the cells arranged into structures representing normal ducts, malignant ducts, and clusters of adipose cells. Ultrasonic spectra were calculated for mammary ducts modeled as layered cylinders (FIGS. 15 and 16)) or distribution of material, physical, chemical, or biological properties of the medium, the method comprising:
calculate a frequency for a broadband spectrum ([0071]: the pulse-echo measurements, FIG. 2(c), the ultrasonic data consisted of time domain waveforms of ultrasonic pulses, FIG. 3(b), that were transmitted from the top transducer, passed through the specimen, reflected from the surface of the bottom transducer, passed through the specimen a second time, and received by the top transducer);
select a frequency step for executing a measurement ([0100]: The peak density results (FIGS. 6 and 12) indicate that disrupted ductal architectures produce higher peak densities in selected frequency ranges as compared to normal breast tissue);
tune a pulser (pulser/receiver 160) for the selected frequency step;
select an ensemble of transmitting elements and receiving elements for a selected beam pattern ([0064]: The switch system permits the operation of individual array element pairs by the data acquisition computer to construct a linear map of the tissue; para [0065]: the HF ultrasonic arrays include two-dimensional (2D) arrays of transducers that can be operated simultaneously or individually);
calculate delay times for pulsing the transmitting elements in the ensemble for the selected frequency ([0007]: analyzing at least one of the pulse-echo ultrasonic measurement and the through-transmission ultrasonic measurement using time domain analysis);
broadcast ultrasound ([0007]: acquiring a pulse-echo ultrasonic measurement and a through transmission ultrasonic measurement of the tissue sample using the ultrasonic transducers);
pulse the transmitting elements in the ensemble using a multiplexer ([0065] (the HF ultrasonic arrays include two- dimensional (2D) arrays of transducers that can be operated simultaneously or individually);
collect and store the signals from the receiving elements in the ensemble using a multiplexer ([0064]: The switch system permits the operation of individual array element pairs by the data acquisition computer to construct a linear map of the tissue; [0061]: a digital storage oscilloscope 150, and a computer 160);
loop to stored frequencies to select the next frequency step (fig. 15: pulses to create layers, layers create cylinder model);
use beam pattern geometries ([0068]: the ultrasonic beam in the tissue through an electronic approach that pulses the array elements in concert to create constructive and destructive interference of wave fields) and receiver element measurements to reconstruct broadband CT images ([0105]: FIG. 17 shows a 3D rendering of a cell model with the cells arranged into structures representing normal ducts, malignant ducts, and clusters of adipose cells. Ultrasonic spectra were calculated for mammary ducts modeled as layered cylinders (FIGS. 15 and 16)).
Referring to Claim 13, DOYLE teaches The method of claim 12 wherein a broadband ultrasonic CT image is 2D, 3D ([0105]: FIG. 17 shows a 3D rendering of a cell model with the cells arranged into structures representing normal ducts, malignant ducts, and clusters of adipose cells. Ultrasonic spectra were calculated for mammary ducts modeled as layered cylinders (FIGS. 15 and 16)), or 4D.
Referring to Claim 14, DOYLE teaches the method of claim 13 wherein a use of both on-axis and off-axis phasing combinations focuses the ultrasonic pulses creating 2D projections are either perpendicular or non-perpendicular to a 2D, square-grid, transmitting array ([0105]: FIG. 17 shows a 3D rendering of a cell model with the cells arranged into structures representing normal ducts, malignant ducts, and clusters of adipose cells. Ultrasonic spectra were calculated for mammary ducts modeled as layered cylinders (FIGS. 15 and 16)).
Referring to Claim 15, DOYLE teaches the method of claim 13 wherein the attenuating medium comprises animal tissue, human tissue, or other tissue (Abstract: A method for determining a pathology of a tissue sample).
Referring to Claim 16, DOYLE teaches the method of claim 15 further comprising use of broadband spectrum analysis to at least one of construct a 3D pathology image of a tested tissue or region and to ablate the region with the focused ultrasound intensity ([0105]: FIG. 17 shows a 3D rendering of a cell model with the cells arranged into structures representing normal ducts, malignant ducts, and clusters of adipose cells. Ultrasonic spectra were calculated for mammary ducts modeled as layered cylinders (FIGS. 15 and 16)).
Referring to Claim 17, DOYLE teaches the method of claim 12 wherein the attenuating medium comprises at least one of biological (Abstract: A method for determining a pathology of a tissue sample), mineral, geologic, rock, soil, landform, machine, construction, metals, ceramics, glasses, polymers, elastomers, composites, manufactured objects and parts in nondestructive evaluation (NDE), or parcels and baggage in aviation security.
Referring to Claim 18, DOYLE teaches the method of claim 12 further comprising use of broadband spectrum analysis, including lower acoustic frequencies in the audible and infrasonic range, to construct a 3D image of an inclusion of the attenuating medium and wherein the inclusion comprises at least one of oil, metal, fossil, drill core, industrial metal, stones, water, or other inclusion ([0090]: FIG. l l(b): inclusion of a pathology category and exclusion of the other four categories in FIGS. l l(a) and l l(b): F=fat necrosis/fibroadenoma/tubular adenoma; B=benign pathology; N=normal breast tissue; M=malignant breast tissue).
Referring to Claim 19, DOYLE teaches the method of claim 11 further comprising oceanographic imaging with floating and submerged acoustic arrays, and geologic imaging of the Earth’s upper crust including using cross-well borehole methods ([0090]: FIG. l l(b): inclusion of a pathology category and exclusion of the other four categories in FIGS. l l(a) and l l(b): F=fat necrosis/fibroadenoma/tubular adenoma; B=benign pathology; N=normal breast tissue; M=malignant breast tissue)..
Referring to Claim 20, DOYLE teaches the method of claim 19 wherein the geological imaging is of least one of a fault line, a sink hole, a cavern, a well, a rock type, a soil type, a geological stratum, an archaeological structure or other geological structure or feature ([0090]: FIG. l l(b): inclusion of a pathology category and exclusion of the other four categories in FIGS. l l(a) and l l(b): F=fat necrosis/fibroadenoma/tubular adenoma; B=benign pathology; N=normal breast tissue; M=malignant breast tissue)..
Referring to Claim 21, DOYLE teaches a method to construct 2D and 3D ultrasonic images in attenuating media, including a pathology, where the ultrasonic measurements and data are multifrequency and/or broadband in nature, and the 2D/3D ultrasonic images retain the multifrequency and/or broadband characteristics of the ultrasonic measurements and/or data, and comprising:
providing a first transmitting sensor array (fig. 13b: transmitter array) comprising multiple array elements arranged in a square or other configuration ([0064]: the ultrasonic transducers comprise a pair of high-frequency (HF) ultrasonic linear arrays);
broadcasting ultrasound through an attenuating medium ([0047-0048]: pathology, fig. 13b; ultrasonic waveforms) to a second receiving sensor array (receiver array, fig. 13b);
providing a first ultrasonic sensor array that generates and broadcasts ultrasonic waves with multifrequency and/or broadband characteristics ([0063]: The ultrasonic transducers each have a center frequency of 50 MHz and are broadband transducers (providing a range of 20-80 MHz), providing a short pulse length and enhanced signal-to-noise in highly scattering or attenuating materials. The broadband characteristics of the transducers are desirable for obtaining an ultrasonic tissue response across a wide frequency band);
providing a second ultrasonic sensor array that receives and detects ultrasonic waves with multifrequency and/or broadband characteristics ([0047]: each transducer functions as both a transmitter and receiver; [0063]: The ultrasonic transducers each have a center frequency of 50 MHz and are broadband transducers (providing a range of 20-80 MHz), providing a short pulse length and enhanced signal-to-noise in highly scattering or attenuating materials. The broadband characteristics of the transducers are desirable for obtaining an ultrasonic tissue response across a wide frequency band), the second ultrasonic sensor array comprising at least one of a plurality of strip elements or a single large area element ([0064]: transmitter array, fig. 13b; the ultrasonic transducers comprise a pair of high-frequency (HF) ultrasonic linear arrays); and
obtaining two-dimensional and three-dimensional images of an internal structure or distribution of material, physical, chemical, biological, or other properties of the medium ([0105]: FIG. 17 shows a 3D rendering of a cell model with the cells arranged into structures representing normal ducts, malignant ducts, and clusters of adipose cells. Ultrasonic spectra were calculated for mammary ducts modeled as layered cylinders (FIGS. 15 and16)).
Examiner’s Note
Examiner has pointed out particular references contained in the prior art of record in the body of this action for the convenience of the Applicant. However, any citation to specific, pages, columns, lines, or figures in the prior art references and any interpretation of the references should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). Applicant, in preparing the response, should consider fully the entire reference as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMIE M N'DURE whose telephone number is (571)272-6031. The examiner can normally be reached on 8AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Isam Alsomire can be reached on 571-272-6970. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMIE M NDURE/Examiner, Art Unit 3645
/ABDALLAH ABULABAN/Primary Examiner, Art Unit 3645
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