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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an ultrasound image source” in claim 11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. For the purpose of examination and this office action the ultrasound image source will be interpreted as an imaging device or database populated with ultrasound images from previous exams, or an equivalent thereof (see [0038] of the present applications specification).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 17 and 19 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 17 recites the limitation "the correlation coefficients" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. The claims from which claim 17 depend do not previously recite determining correlation coefficients
The term “about” in claim 19 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear how close the diameter needs to be to 0.5 cm or 2.0 cm in order to be considered about 0.5 cm or about 2.0 cm. For that reason the term “about” is considered relative.
Claims dependent upon the rejected claims above, but not directly addressed, are also rejected because they inherit the indefiniteness of the claim(s) they respectively depend upon.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 6, 11, 15, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (US 20230121329, hereinafter Park) in view of Brattain (US 20210022715, hereinafter Brattain).
Regarding claim 1, Park teaches a method of performing stiffness measurements of an anatomical structure in a patient using ultrasound shear wave elastography (fig. 3 and [0062]-[0064] disclose a method for obtaining elastic data (stiffness measurements) using shear waves), the method comprising:
acquiring a plurality of elastography frames from ultrasound images of the anatomical structure ([0062]-[0063] and [0065] step S310 disclose generating a plurality of elastic images from the ultrasound data of the region of interest), wherein the plurality of elastography frames are provided by a cine loop performed by an ultrasound imaging system ([0003] and [0065] disclose the data is acquired several times and in real time meaning the images are acquired by a cine loop);
automatically identifying a preferred elastography frame of the plurality of elastography frames for making stiffness measurements of the anatomical structure ([0072]-[0073] disclose step S330 where a recommended elastic image is determined as part of the method. [0087] further discloses an elastic value is determined from the recommended elastic image, meaning stiffness measurements are made in the preferred frame);
identifying a preferred area of the preferred elastography frame ([0062] and [0088] disclose determining a region of interest);
automatically selecting at least one region of interest (ROI) based on stiffness measurements within the preferred area of the preferred elastography frame ([0087]-[0089] and [0092]-[0095] disclose determining a recommended position (ROI) based on the elasticity of the tissue within the image); and
measuring stiffness of the anatomical structure in the at least one ROI ([0087]-[0090] disclose calculating and displaying the elasticity value of the recommended position).
Park does not specifically teach the preferred area of the preferred elastography frame is automatically identified based on confidence levels.
However,
Brattain in a similar field of endeavor teaches automatically identifying a preferred area of the preferred elastography frame based on confidence levels ([0047] “an automated ROI selection tool 320 is provided” for selecting an ROI based on an inter-pixel variability (confidence level) measurement).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method disclosed by Park to have the preferred area of the preferred elastography frame is automatically identified based on confidence levels in order to increase the quality of the stiffness measurement, as recognized by Brattain ([0047]).
Regarding claim 11, Park teaches a system of performing stiffness measurements of an anatomical structure in a patient using ultrasound shear wave elastography (fig. 1 and [0062]-[0064] disclose an ultrasonic diagnostic apparatus 100 for obtaining elastic data (stiffness measurements) using shear waves), the system comprising:
an ultrasound image source configured to provide ultrasound images of the anatomical structure comprising a plurality of elastography frames([0062]-[0063] and [0065] disclose generating a plurality of elastic images from the ultrasound data of the region of interest using the apparatus 100), wherein the plurality of elastography frames are provided by a cine loop performed by an ultrasound imaging system ([0003] and [0065] disclose the data is acquired several times and in real time meaning the images are acquired by a cine loop);
a processing unit (the electronic circuitry of the apparatus 100 in fig. 1); and
a memory storing instructions that, when executed by the processing unit ([0128] “A program stored in the memory 1320 may include one or more instructions. The program (one or more instructions) or application stored in the memory 1320 may be executed by the processor 1310”), cause the processing unit to:
automatically identify a preferred elastography frame of the plurality of elastography frames for making stiffness measurements of the anatomical structure ([0072]-[0073] disclose step S330 where a recommended elastic image is determined as part of the method. [0087] further discloses an elastic value is determined from the recommended elastic image, meaning stiffness measurements are made in the preferred frame);
identify a preferred area of the preferred elastography frame ([0062] and [0088] disclose determining a region of interest);
automatically select at least one region of interest (ROI) based on stiffness measurements within the preferred area of the preferred elastography frame ([0087]-[0089] and [0092]-[0095] disclose determining a recommended position (ROI) based on the elasticity of the tissue within the image); and
measure stiffness of the anatomical structure in the at least one ROI ([0087]-[0090] disclose calculating and displaying the elasticity value of the recommended position).
Park does not specifically teach the preferred area of the preferred elastography frame is automatically identified based on confidence levels.
However,
Brattain in a similar field of endeavor teaches automatically identifying a preferred area of the preferred elastography frame based on confidence levels ([0047] “an automated ROI selection tool 320 is provided” for selecting an ROI based on an inter-pixel variability (confidence level) measurement).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus disclosed by Park to have the preferred area of the preferred elastography frame is automatically identified based on confidence levels in order to increase the quality of the stiffness measurement, as recognized by Brattain ([0047]).
Regarding claims 6 and 15, Park in view of Brattain teaches the method of claim 1 and system of claim 11, as set forth above. Park further teaches automatically selecting the at least one ROI comprises:
determining local spatial standard deviations in stiffness in the preferred area of the preferred elastography frame ([0070] discloses utilizing the standard deviation of the elasticity values of the region of interest);
assigning spatial stability scores based on the local spatial standard deviation in stiffness, respectively, wherein lower spatial standard deviations in stiffness are assigned higher spatial stability scores ([0069]-[0070] discloses determining a quality index (spatial stability score) based on the standard deviation, where the calculated index is large when the standard deviation is small); and
selecting a region of the preferred area having a highest spatial stability score as the preferred area ([0072]-[0073] discloses determining the recommended image based on the quality information being the greatest).
Regarding claim 20, Park teaches a non-transitory computer readable medium storing instructions for performing stiffness measurements of an anatomical structure in a patient using ultrasound shear wave elastography that, when executed by one or more processors ([0128] “A program stored in the memory 1320 may include one or more instructions. The program (one or more instructions) or application stored in the memory 1320 may be executed by the processor 1310”. fig. 3 and [0062]-[0064] disclose a method for obtaining elastic data (stiffness measurements) using shear waves), cause the one or more processors to:
Receive ultrasound images of the anatomical structure comprising a plurality of elastography frames ([0062]-[0063] and [0065] step S310 disclose generating a plurality of elastic images from the ultrasound data of the region of interest), wherein the plurality of elastography frames are provided by a cine loop performed by an ultrasound imaging system ([0003] and [0065] disclose the data is acquired several times and in real time meaning the images are acquired by a cine loop);
automatically identify a preferred elastography frame of the plurality of elastography frames for making stiffness measurements of the anatomical structure ([0072]-[0073] disclose step S330 where a recommended elastic image is determined as part of the method. [0087] further discloses an elastic value is determined from the recommended elastic image, meaning stiffness measurements are made in the preferred frame);
identify a preferred area of the preferred elastography frame ([0062] and [0088] disclose determining a region of interest);
automatically select at least one region of interest (ROI) based on stiffness measurements within the preferred area of the preferred elastography frame ([0087]-[0089] and [0092]-[0095] disclose determining a recommended position (ROI) based on the elasticity of the tissue within the image); and
measure stiffness of the anatomical structure in the at least one ROI ([0087]-[0090] disclose calculating and displaying the elasticity value of the recommended position).
Park does not specifically teach the preferred area of the preferred elastography frame is automatically identified based on confidence levels.
However,
Brattain in a similar field of endeavor teaches automatically identifying a preferred area of the preferred elastography frame based on confidence levels ([0047] “an automated ROI selection tool 320 is provided” for selecting an ROI based on an inter-pixel variability (confidence level) measurement).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the instructions disclosed by Park to have the preferred area of the preferred elastography frame is automatically identified based on confidence levels in order to increase the quality of the stiffness measurement, as recognized by Brattain ([0047]).
Claim(s) 2, 12, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Brattain as applied to claims 1 and 11 above, and further in view of Tanigawa et al. (KR20150140611A, hereinafter Tanigawa).
Regarding claims 2 and 12, Park in view of Brattain teaches the method of claim 1 and system of claim 11, as set forth above. Park in view of Brattain does not specifically teach automatically identifying the preferred elastography frame is based on temporal stability, and comprises: calculating a correlation coefficient between each pair of adjacent elastography frames of the plurality of elastography frames; assigning a score to each elastography frame of the plurality of elastography frames based on an average of the correlation coefficient with an immediately preceding elastography frame and the correlation coefficient with an immediately subsequent elastography frame, wherein higher averages of the correlation coefficients are assigned higher scores; and identifying the elastography frame with a highest score as the preferred elastography frame.
However,
Tanigawa in a similar field of endeavor teaches identifying the preferred elastography frame is based on temporal stability ([0016] discloses selecting an elastic data frame based on calculating a correlation coefficient over temporally different echo data), and comprises:
calculating a correlation coefficient between each pair of adjacent elastography frames of the plurality of elastography frames ([0051] discloses performing a correlation calculation between each of the correlation windows);
assigning a score to each elastography frame of the plurality of elastography frames based on an average of the correlation coefficient with an immediately preceding elastography frame and the correlation coefficient with an immediately subsequent elastography frame, wherein higher averages of the correlation coefficients are assigned higher scores ([0095] discloses calculating an average value CAV of the correlation coefficient C, where the determined average value is considered the score); and
identifying the elastography frame with a highest score as the preferred elastography frame ([0095] discloses the frame selection unit selects the frame having the highest average CAV as the frame to be output).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the identifying of the preferred frame of Park in view of Brattian for the identifying of the preferred frame using a correlation coefficient of Tanigawa because it amounts to simple substitution of one known element for another to obtain the predictable results of identifying the preferred elastography frame.
Regarding claim 17, Park in view of Brattain teaches the system of claim 11, as set forth above. Park in view of Brattain does not specifically teach the instructions cause the processing unit to automatically select the at least one ROI by: selecting a most temporally stable region as the at least one ROI using the correlation coefficients between the pairs of adjacent elastography frames calculated for automatically identifying the preferred elastography frame.
However,
Tanigawa in a similar field of endeavor teaches instructions that cause the processing unit to automatically select the at least one ROI ([0058] and fig. 5 disclose a region of interest R is determined) by: selecting a most temporally stable region as the at least one ROI using the correlation coefficients between the pairs of adjacent elastography frames calculated for automatically identifying the preferred elastography frame ([0051] discloses performing a correlation calculation between each of the correlation windows. [0095] further discloses calculating an average value CAV of the correlation coefficient C and determining the frame that contains the region of interest R based on which frame has the highest calculated CAV).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the identifying of an ROI of Park in view of Brattian for the identifying of the ROI using a correlation coefficient of Tanigawa because it amounts to simple substitution of one known element for another to obtain the predictable results of identifying the preferred elastography frame.
Claim(s) 3-4 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Brattain as applied to claims 1 and 11 above, and further in view of Cao et al. (US 20190357886, hereinafter Cao).
Regarding claims 3 and 13, Park in view of Brattain teaches the method of claim 1 and system of claim 11, as set forth above. Park in view of Brattain does not specifically teach automatically identifying the preferred elastography frame is based on confidence-based thresholding, and comprises: eliminating each elastography frame of the plurality of elastography frames in which more than 60 percent of pixels in the elastography frame have low confidence scores; and identifying a remaining elastography frame having a highest confidence score as the preferred elastography frame.
However,
Cao in a similar field of endeavor teaches automatically identifying the preferred elastography frame is based on confidence-based thresholding ([0020] discloses the process of obtaining tissue stiffness displays is based on thresholding of a confidence map), and comprises:
eliminating each elastography frame of the plurality of elastography frames in which more than 60 percent of pixels in the elastography frame have low confidence scores ([0020] and [0038] disclose filtering out tissue stiffness values that have a confidence level below 60%); and
identifying a remaining elastography frame having a highest confidence score as the preferred elastography frame ([0020] and [0038] disclose directing the user to viewing regions with a high confidence level).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and system disclosed by Park in view of Brattain to have automatically identifying the preferred elastography frame is based on confidence-based thresholding, and comprises: eliminating each elastography frame of the plurality of elastography frames in which more than 60 percent of pixels in the elastography frame have low confidence scores; and identifying a remaining elastography frame having a highest confidence score as the preferred elastography frame in order to guide the user to more reliable tissue stiffness data, as recognized by Cao ([0020]).
Regarding claims 4 and 14, Park in view of Brattain teaches the method of claim 1 and system of claim 11, as set forth above. Park in view of Brattain does not specifically teach automatically identifying the preferred area of the preferred elastography frame comprises: creating a confidence map of the selected elastography frame; and eliminating regions of low confidence from the confidence map based on a previously defined confidence threshold, wherein the preferred area of the preferred elastography frame comprises remaining regions of the confidence map after eliminating the regions of low confidence.
However,
Cao in a similar field of endeavor teaches automatically identifying the preferred area of the preferred elastography frame comprises:
creating a confidence map of the selected elastography frame ([0019]-[0020] discloses the process of obtaining tissue stiffness displays is based on thresholding of a created confidence map); and
eliminating regions of low confidence from the confidence map based on a previously defined confidence threshold ([0020] and [0038] disclose filtering out tissue stiffness values that have a confidence level below a predetermined threshold value),
wherein the preferred area of the preferred elastography frame comprises remaining regions of the confidence map after eliminating the regions of low confidence ([0020] and [0038] disclose directing the user to viewing regions with a high confidence level).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and system disclosed by Park in view of Brattain to have automatically identifying the preferred area of the preferred elastography frame comprises: creating a confidence map of the selected elastography frame; and eliminating regions of low confidence from the confidence map based on a previously defined confidence threshold, wherein the preferred area of the preferred elastography frame comprises remaining regions of the confidence map after eliminating the regions of low confidence in order to guide the user to more reliable tissue stiffness data, as recognized by Cao ([0020]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Brattain and Cao as applied to claim 4 above, and further in view of Kanayama (US 20150250446).
Regarding claim 5, Park in view of Brattain and Cao teaches the method of claim 4, as set forth above. Park in view of Brattain and Cao does not specifically teach automatically identifying the preferred area of the preferred elastography frame further comprises: performing Doppler imaging interleaved with acquiring the plurality of elastography frames to capture blood flow signals in the anatomical structure; and eliminating regions of the preferred elastography frame having Doppler signals from the Doppler imaging indicating high blood flow, wherein the preferred area of the preferred elastography frame further comprises remaining regions after eliminating the regions having high blood flow.
However,
Kanayama in a similar field of endeavor teaches identifying the preferred area of the preferred elastography frame further comprises:
performing Doppler imaging interleaved with acquiring the plurality of elastography frames to capture blood flow signals in the anatomical structure ([0056] discloses generating doppler images in step S103. [0054] discloses alternating between the transmission/reception of the doppler image data and the other ultrasound image data. Claim 3 further discloses the ultrasound image comprises an elastography image); and
eliminating regions of the preferred elastography frame having Doppler signals from the Doppler imaging indicating high blood flow ([0080] discloses excluding images where average velocity (blood flow) is high in step S108),
wherein the preferred area of the preferred elastography frame further comprises remaining regions after eliminating the regions having high blood flow ([0066]-[0067] and fig. 2 disclose selecting the candidate image in S109 from the remaining images after the exclusion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the identifying of the preferred frame of Park in view of Brattian and Cao for the identifying of the preferred frame using a Doppler imaging of Kanayama because it amounts to simple substitution of one known element for another to obtain the predictable results of identifying the preferred elastography frame.
Claim(s) 7-8 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Brattain as applied to claims 1 and 11 above, and further in view of Matsumara (US 20090143676).
Regarding claims 7 and 16, Park in view of Brattain teaches the method of claim 1 and system of claim 11, as set forth above. Park in view of Brattain does not specifically teach automatically selecting the at least one ROI comprises: assessing distribution of pixel-wise stiffness values within the preferred area of the preferred elastography frame; identifying local stiffness regions in the preferred area; and selecting a local stiffness region that represents a majority stiffness value based on the distribution of pixel-wise stiffness values as the least one ROI.
However,
Matsumara in a similar field of endeavor teaches selecting the at least one ROI comprises:
assessing distribution of pixel-wise stiffness values within the preferred area of the preferred elastography frame ([0080] discloses each of the measurement points (pixels) inside the image have their elastic modulus (stiffness) extracted as shown in fig. 7. Also see fig. 6 which shows each pixel within the image being color coded which corresponds to the stiffness);
identifying local stiffness regions in the preferred area (figs. 6-7 show identifying local stiffness region in the preferred area); and
selecting a local stiffness region that represents a majority stiffness value based on the distribution of pixel-wise stiffness values as the least one ROI (fig. 13 shows selecting region 41 that represents a majority stiffness value based on the distribution of the pixel stiffness values).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the selecting of a ROI of Park in view of Brattian for the selecting of an ROI using pixel-wise stiffness values of Matsumara because it amounts to simple substitution of one known element for another to obtain the predictable results of selecting an ROI to be examined.
Regarding claim 8, Park in view of Brattain in view of Matsumara teaches the method of claim 7, as set forth above. Matsumara further teaches categorizing stiffness probabilities of the anatomical structure at each pixel in the preferred elastography frame ([0080] discloses each of the measurement points (pixels) inside the image have their elastic modulus (stiffness) extracted as shown in fig. 7. Also see fig. 6 which shows each pixel within the image being color coded which corresponds to the stiffness); and
displaying the categorized stiffness probabilities in a histogram comprising a plurality of bars associated with the categorized stiffness probabilities ([0020] “the histogram indicating the elastic distribution of the tissue in the interest region is displayed”. See fig. 8),
wherein selecting the local stiffness region that represents a majority stiffness value comprises identifying a highest bar in the histogram (fig. 13 shows the selected region 41 corresponds to the highest bar in the histogram).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the selecting of a ROI of Park in view of Brattian and Matsumara for the selecting of an ROI using a histogram of Matsumara because it amounts to simple substitution of one known element for another to obtain the predictable results of selecting an ROI to be examined.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Brattain and Cao as applied to claim 3 above, and further in view of Tanigawa et al. (KR20150140611A, hereinafter Tanigawa).
Regarding claim 9, Park in view of Brattain and Cao teaches the method of claim 3, as set forth above. Park in view of Brattain and Cao does not specifically teach automatically selecting the at least one ROI comprises: determining correlation coefficients between pairs of temporally adjacent elastography frames; averaging correlation coefficients between the preferred elastography frame and the temporality adjacent elastography frames; determining a temporal stability score for each of the regions based on the averaged correlation coefficients; and selecting the at least one ROI as the region having a highest temporal stability score.
However,
Tanigawa in a similar field of endeavor teaches selecting the at least one ROI ([0058] and fig. 5 disclose a region of interest R is determined) comprises:
determining correlation coefficients between pairs of temporally adjacent elastography frames ([0051] discloses performing a correlation calculation between each of the correlation windows);
averaging correlation coefficients between the preferred elastography frame and the temporality adjacent elastography frames; determining a temporal stability score for each of the regions based on the averaged correlation coefficients ([0095] discloses calculating an average value CAV of the correlation coefficient C, where the determined average value is considered the temporal stability score); and
selecting the at least one ROI as the region having a highest temporal stability score ([0095] discloses the frame selection unit selects the frame having the highest average CAV as the frame to be output).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the identifying of the preferred frame of Park in view of Brattian and Cao for the identifying of the preferred frame using a correlation coefficient of Tanigawa because it amounts to simple substitution of one known element for another to obtain the predictable results of identifying the preferred elastography frame.
Claim(s) 10 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Brattain as applied to claims 1 and 11 above, and further in view of Meral et al. (US 20210113192, hereinafter Meral).
Regarding claims 10 and 18, Park in view of Brattain teaches the method of claim 1 and system of claim 11, as set forth above. Park in view of Brattain does not specifically teach automatically selecting the at least one ROI comprises: deriving an ROI placement heatmap from a smoothness heatmap, a stiffness frequency heatmap, and a temporal stability heatmap; and selecting the at least one ROI using the ROI placement heatmap.
However,
Meral in a similar field of endeavor teaches selecting the at least one ROI comprises: deriving an ROI placement heatmap from a smoothness heatmap, a stiffness frequency heatmap, and a temporal stability heatmap ([0066] discloses combining the qualitative maps of figs. 6A-6B with at least one quantitative elasticity map. The quantitative map represents the stiffness frequency heatmap and the qualitative maps represent the smoothness heatmap and temporal stability heatmap); and selecting the at least one ROI using the ROI placement heatmap (Abstract discloses using the combined map to determine the boundary of a region of interest).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and system disclosed by Park in view of Brattain to have derived an ROI placement heatmap from a smoothness heatmap, a stiffness frequency heatmap, and a temporal stability heatmap; and selected the at least one ROI using the ROI placement heatmap in order to generate improved elasticity data, as recognized by Meral ([0066]).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Brattain and Tanigawa as applied to claim 12 above, and further in view of Konofagou et al. (US 20190167233, hereinafter Konofagou).
Regarding claim 19, Park in view of Brattain and Tanigawa teaches the system of claim 12, as set forth above. Park in view of Brattain and Tanigawa does not specifically teach the at least one ROI is circular having a diameter of in a range of about 0.5 cm to about 2.0 cm set by a sampling caliper.
However,
Konofagou in a similar field of endeavor teaches the at least one ROI is circular having a diameter of in a range of about 0.5 cm to about 2.0 cm set by a sampling caliper ([0102] and [0104] discloses the ROI is set as a circle with a diameter of 14mm (1.4cm)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have to apply the known technique of having the at least one ROI be circular having a diameter of in a range of about 0.5 cm to about 2.0 cm set by a sampling caliper of Konofagou to the system of Park in view of Brattain and Tanigawa to allow for the predictable results of making sure that the ROI only includes pertinent information and not additional information that can interfere with the analysis, thereby increasing the quality of the analysis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW BEGEMAN whose telephone number is (571)272-4744. The examiner can normally be reached Monday-Thursday 8:30-5:00.
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, Keith Raymond can be reached at 5712701790. 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.
/ANDREW W BEGEMAN/Examiner, Art Unit 3798
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