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 .
Status of Claims
Claims 1 and 3-19 are pending.
Claims 10-14 are withdrawn from prosecution.
Claims 1-9 and 15-19 are currently rejected.
Response to Arguments
Applicant's arguments in Applicant’s responses filed 05/26/2026 with respect to the rejection of claims 1 and 19 under 35 U.S.C. 103 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Specifically, newly found prior art, Sui, et al., US 20050203395 A1 discloses identifying cardiac apical regions ([0049]-[0050]) based on phase analyses involving variance of phase and amplitude information for spatially distribution tissue regions or segments according to [0044]-[0045].
Hence, Olstad, B., US 20040116810 A1 in combination with Sui teaches all the limitations of the claims.
Applicant’s arguments regarding the rejection of claims 1-9 and 15-19 have been fully considered but are not persuasive.
Applicant remarks on pages 13-14 that the amended portions of claims 1 and 19 recite “calculating for each position in the moving image data, a statistical variance of brightness values of the acquired moving image data over time to determine a position of a cardiac apex”, and that this step cannot practically be performed mentally. which is not performable .
Examiner respectfully disagrees.
The limitation merely amounts to a statistical calculation step for moving image data. Such calculation step can be practically performed mentally or by hand as the calculation step merely requires availability of the moving image data acquired over time. A person of ordinary skill in the art merely requires, say, physical copies of the moving image data acquired over time to perform the statistical calculations of variances brightness.
Applicant further asserts on page 13 that the claims transform the ultrasonic moving image data into display information indicating the position cardiac apex.
However, Examiner notes that Applicant’s assertions direct to no more insignificant post-extra-solution of presenting or displaying resultant data from the statistical calculations and hence does not integrate the abstract idea into a practical application as argued. See MPEP 2106.05(g).
Applicant further argues for a specific technical improvement in fetal ultrasound diagnoses and analyses achieved by the claims. However, Examiner notes that the improvement argued for amount to mere recording, transmitting, and archiving digital images by use of conventional or generic technology in a nascent but well-known environment, without any assertion that the invention reflects an inventive solution to any problem presented by combining a camera and a cellular telephone, as demonstrated in TLI Communications, 823 F.3d at 611-12, 118 USPQ2d at 1747. As indicated above, the claims direct to well-understood, routine, conventional steps in fetal ultrasound imaging and analysis and hence such improvements are not imbued upon the current form of the claims.
Applicant intimates on page 15 that although the claims of In re Abele direct to mathematical concepts, it is irrelevant because the transformation of the ultrasonic moving image data into other information for display integrates the claims into a practical application. However, examiner notes that such transformation called for and the display of the result, in fact, remain under the insignificant extra-solution activities umbrella. That is, any ultrasound imaging effectively transforms ultrasound signals into images which through image processing are further transformed. These are routine steps, in the same manner as displaying the fetal ultrasound image on a display.
Applicant further asserts on pages 15-16 that the current form of the claims is analogous to the claim at issue in the In re Abele Federal Circuit case, deemed to be patent eligible. However, Examiner contends that according to MPEP 2106.04(a)(2)(I)(C), the steps in the In re Abele Federal Circuit Court case are categorized as mathematical calculations of difference between local and average data values deemed ineligible.
Applicant further argues that image processing claims directed to processing image data of a physical object obtained from ultrasound imaging or -ray imaging have long been patent eligible. However, Examiner notes that such image processing claims do not recite well-understood, routine, and conventional activity to fetal ultrasound imaging and diagnosis as provided in claims 1-9 and 15-19.
Therefore, the claims are deemed ineligible and hence stand rejected.
Withdrawn Rejections
Pursuant of Applicant’s amendments filed 10/27/2025, the rejection of claims 9-10 under 35 U.S.C. 112(b) have been withdrawn
Claim Objections
Claim 19 is objected to because of the following informalities:
Claim 19 should be amended to include a colon as such: --…method, comprising: --.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 and 15-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: YES – Claim 1 recites An ultrasound diagnosis apparatus comprising processing circuitry and, therefore, is a device.
Step 2A, Prong 1, Judicial Exception: YES - The claim recites the following limitations:
“calculate, for each position in the moving image data, a statistical variance of brightness values of the acquired moving image data over time; and determine a position of a cardiac apex of the fetal heart or a position of an atrial blood flow entrance part of the fetal heart by using information of the calculated statistical variance of the brightness values of the acquired moving image data”.
This limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “processing circuitry”, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “processing circuitry” language, the claim encompasses a user simply obtaining printed copies of the time series of ultrasound moving images and through visual inspection determining positions of the cardiac apex of the fetal heart or a position of an atrial blood flow entrance part of the fetal heart based on brightness or intensity values. The mere nominal recitation of a generic network appliance does not take the claim limitation out of the mental processes grouping. Thus, the claim recites a mental process.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites additional elements: “acquire two- or three-dimensional ultrasonic moving image data rendering a fetal heart and cause a display to display information indicating the determined position of the cardiac apex or the atrial blood flow entrance part”. The image acquisition step is recited at a high level of generality (i.e., as a general means of acquiring and displaying data), and amounts to mere data gathering, which is a form of insignificant pre-extra-solution activity. The processing circuitry that performs the image acquisition step is also recited at a high level of generality, and merely automates the image acquisition step. Each of the additional limitations is no more than mere instructions to apply the exception using a generic computer component (the processing circuitry).
The combination of these additional elements is no more than mere instructions to apply the exception using a generic computer component (processing circuitry). Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to the abstract idea.
Step 2B, Inventive Concept: No - As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B. Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B. Here, the image acquisition and displaying steps were considered to be extra-solution activity in Step 2A, and thus it is re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The background of the example does not provide any indication that the processing circuitry is anything other than a generic, off-the-shelf computer component, and the Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well‐understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here). Accordingly, a conclusion that the ultrasonic image acquisition and displaying steps are well-understood, routine, conventional activity is supported under Berkheimer Option 2. For these reasons, there is no inventive concept in the claim, and thus it is ineligible.
Claim 3 recites “wherein the processing circuitry is further configured to estimate (1) a long axis of the fetal heart, (2) both of the long axis and a short axis of the fetal heart, or (3) a center position of the fetal heart, and the processing circuitry is further configured to determine the position of the cardiac apex or the position of the atrial blood flow entrance part based on the estimated long axis, both the estimated long axis and the estimated short axis, or the estimated center position” which comprises further mental steps of estimating regions of interest within the image that fail to integrate the earlier mental steps into a practical application.
Claim 4 recites “wherein the processing circuitry is further configured to cause the display to display the information indicating the position of the cardiac apex or the information indicating the position of the atrial blood flow entrance part at a position along a long axis direction of the fetal heart” which is mere data presentation comprising insignificant post-extrasolution activity and hence fails to incorporate the judicial exception into a practical application.
Claim 5 recites “wherein the processing circuitry is further configured to estimate information about a position of the fetal heart or information about a posture of the fetal heart” which comprises further mental steps of estimating regions of interest within the image that fail to integrate the earlier mental steps into a practical application.
Claim 6 recites “wherein the processing circuitry is further configured to estimate a region satisfying a condition where the statistical variance of brightness values of the moving image data over time exceeds a threshold value as a region of a tissue of the fetal heart” which comprises thresholding steps to estimate the region of interest. This step is a mental step and also fails to integrate the determination step of claim 1 into a practical application.
Claim 7 recites “wherein the processing circuitry is further configured to cause a display to display an image in which information indicating the position of the cardiac apex or information indicating the position of the atrial blood flow entrance part is superimposed on the region”. The recitation comprises further image processing steps to extract features within the region of interest in the image, tantamount to mental step identified for claim 1. The claim further include data presentation steps that comprise insignificant post-extrasolution activity and hence fails to incorporate the judicial exception into a practical application.
Claim 8 recites “wherein the processing circuitry is further configured to estimate (1) a long axis of the fetal heart, (2) both of the long axis and a short axis of the fetal heart, or (3) a center position of the fetal heart, and the processing circuitry is further configured to cause the display to display the information indicating the position of the cardiac apex or the information indicating the position of the atrial blood flow entrance part based on the estimated long axis, both of the estimated long axis and the estimated short axis, or the estimated center position”. The recitation comprises further image processing steps to extract features within the region of interest in the image, tantamount to mental step identified for claim 1. The claim further include data presentation steps that comprise insignificant post-extrasolution activity and hence fails to incorporate the judicial exception into a practical application.
Claim 9 recites “wherein the processing circuitry is further configured to: obtain distribution information of a tissue position of the fetal heart by regarding a region satisfying a condition where the statistical variance of brightness values of the moving image data over time exceeds a threshold value as a region of a tissue of the fetal heart, obtain a plurality of eigenvectors from a principal component analysis related to the distribution information of the tissue position, set a plurality of regions extending parallel to directions of the plurality of eigenvectors respectively, each having a width, in a surrounding of the center position, detect, from among the plurality of regions, a region in which either a sum or an average value of the statistical variance of brightness values is largest as a fetal heart valve region, as the region of the tissue of the fetal heart, determine a direction of an eigenvector parallel to the fetal heart valve region as the short axis of the fetal heart, and determines a direction perpendicular to a width direction of the fetal heart valve region as the long axis of the fetal heart”. The recitation comprises further image processing steps to extract features within the region of interest in the image, tantamount to mental step identified for claim 1, and fail to integrate the mental step in claim 1 into a practical application.
Claim 15 recites “wherein the processing circuitry is further configured to: determine a region of a tissue of the fetal heart by using information about the statistical variance of brightness values of the moving image data over time; and estimate the position of the cardiac apex of the fetal heart within the region of the tissue of the fetal heart or the position of the atrial blood flow entrance part of the fetal heart within the determined region of the tissue of the fetal heart”, which comprise further mental steps of region of interest determinations, which fail to integrate the mental step in claim 1 into a practical application.
Claim 16 recites “wherein the processing circuitry is further configured to estimate the position of the cardiac apex of the fetal heart or the position of the atrial blood flow entrance part of the fetal heart by using distribution information of statistical variance of the brightness values in the determined region of the tissue of the fetal heart”, which comprises a mental step of position estimation of the cardiac apex, hence failing to incorporate the mental step in claim 1 into a practical application.
Claim 17 recites “wherein the processing circuitry is further configured to estimate at least one of a long axis of the fetal heart, both the long axis and a short axis of the fetal heart, and a center position of the fetal heart by using distribution information of the statistical variance of the brightness values in the determined region of the tissue of the fetal heart, and estimate the position of the cardiac apex of the fetal heart or the position of the atrial blood flow entrance part of the fetal heart based on the at least one of the long axis of the fetal heart, both the long axis and the short axis of the fetal heart, and the center position of the fetal heart, which together comprise further mental steps of region of interest determinations in a manner which fails to integrate the mental steps in claim 1 into a practical application.
Claim 18 recites “wherein the processing circuitry is further configured to estimate the position of the cardiac apex of the fetal heart or the position of the atrial blood flow entrance part of the fetal heart by using a result of principal component analysis concerning distribution information of the statistical variance of the brightness values in the determined region of the tissue of the fetal heart.
Step 1: Statutory Category: YES – Claim 19 recites An ultrasonic diagnostic method and, therefore, is a process.
Step 2A, Prong 1, Judicial Exception: YES - The claim recites the following limitations:
“calculating, for each position in the moving image data, a statistical variance of brightness values of the acquired over time; and determining a position of a cardiac apex of the fetal heart or a position of an atrial blood flow entrance part of the fetal heart by using information of the calculated statistical variance of the brightness values of the acquired moving image data”.
This limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. That is nothing in the claim element precludes the step from practically being performed in the mind. For example, the claim encompasses a user simply obtaining printed copies of the time series of ultrasound moving images and through visual inspection determining positions of the cardiac apex of the fetal heart or a position of an atrial blood flow entrance part of the fetal heart based on brightness or intensity values.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites additional elements: “acquiring two- or three-dimensional ultrasonic moving image data rendering a fetal heart and causing a display to display information indicating the determined position of the cardiac apex or the atrial blood flow entrance part”. The image acquisition step is recited at a high level of generality (i.e., as a general means of acquiring and displaying data), and amounts to mere data gathering, which is a form of insignificant pre-extra-solution activity.
The combination of these additional elements is no more than mere instructions to apply the judicial exception. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to the abstract idea.
Step 2B, Inventive Concept: No - As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the judicial exception. The same analysis applies here in 2B, i.e., mere instructions to apply an exception cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B. Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B. Here, the image acquisition and displaying steps were considered to be extra-solution activity in Step 2A, and thus it is re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well‐understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here). Accordingly, a conclusion that the ultrasonic image acquisition and displaying steps are well-understood, routine, conventional activity is supported under Berkheimer Option 2. For these reasons, there is no inventive concept in the claim, and thus it is ineligible.
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.
Claims 1-2, 5-7, 15-16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Olstad, B., US 20040116810 A1 in view of Sui, et al., US 20050203395 A1.
Regarding claim 1, Olstad teaches an ultrasound diagnosis apparatus comprising processing circuitry (see fig. 1 and [0022] for the ultrasonic machine 5 comprising a Doppler processor and a non-Doppler processor) configured to:
acquire two- or three-dimensional ultrasonic moving image data rendering a fetal heart ([0028]-[0029] disclose acquiring ultrasound images in a tissue velocity imaging mode of a moving cardiac structure. NB: while the claims include a fetal heart, it is not deemed to change the scope of the claims so prior art the only mention heart or cardiac tissue are interpreted to read on the claims);
determine a position of a cardiac apex of the fetal heart or a position of an atrial blood flow entrance part of the fetal heart ([0021] indicates that the “moving structure is characterized by a set of analytic parameter values corresponding to anatomical points within a myocardial segment of the heart. The set of analytic parameter values may comprise, for example, tissue velocity values, time-integrated tissue velocity values, B-mode tissue intensity values…”. [0034] then indicates tracking an exemplary analytic parameter value, that is tissue velocity, over time, as shown in fig. 5. Meaning the B-mode tissue intensity values are tracked over time, much the same way that the tissue velocity is tracked over time); and
cause a display to display information indicating the determined position of the cardiac apex or the atrial blood flow entrance part ([0050] states “discrete anatomical points in the image at the longitudinal depths 298 and 299 of the anatomical landmarks (apex 292 and AV-plane 296) are automatically labeled with indicia 410 and 420 as shown in FIG. 7. The anatomical points are continually tracked, using the techniques described previously, as imaging continues. The positions of the indicia 410 and 420 are continuously updated and displayed to follow the tracked anatomical points corresponding to the anatomical landmarks”).
Olstad does not explicitly state calculate, for each position in the moving image data, a statistical variance of brightness values of the acquired moving image data over time to determine a position of a cardiac apex.
However, within the same field of endeavor, Sui teaches methods and systems for medical imaging with motion analysis. The phase or associated amplitude analysis of a sequence of images is improved by, first, providing a quantification. For example, a value or values representing asynchrony between different locations through a sequence of images may provide useful diagnostic information ([0007]). Siu teaches calculate, for each position in the moving image data, a statistical variance of brightness values of the acquired moving image data over time to determine a position of a cardiac apex: [0026] discloses receiving a sequence of ultrasound images; [0027] discloses that each image in the sequence represents a two- or three-dimensional region; [0029] indicates that In act 20 of a method for medical imaging with motion analysis, the method implemented on the system 10 of FIG. 1, that phase and amplitude information are identified from the sequence of images. For a given spatial location throughout the sequence of images, the imaging value may vary relative to a cycle. For example, as the heart contracts and expands in an apical four chamber or other view, intensity values may vary. The phase of the variation relative to the heart cycle is identified. Different spatial locations may be associated with variation that occurs at different portions within the heart cycle. The phase analysis is performed for one or more spatial locations. [0043] describes segmentation of myocardial wall into segments 50, [0044]-[0045] describe, with respect to act 30, determination of mean and variance of phase and amplitude information for each tissue region or segment 50, resultantly identifying cardiac apical regions according to [0049]-[0050].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Olstad to calculate, for each position in the moving image data, a statistical variance of brightness values of the acquired moving image data over time, as taught by Sui, as such modification would provide improved detection of the regions of interest according to [0006], with a reasonable expectation of success, as Olstad is also concerned with increasing the objectivity and accuracy of cardiac wall function visualization [0014] and evaluation [0010]-[0011].
Regarding claim 2, Olstad in view of Sui teaches all the limitations of claim 1 above.
Olstad further teaches wherein the processing circuitry further causes a display ([0024] discloses a display) to display information indicating the position of the cardiac apex or information indicating the position of the atrial blood flow entrance part
Regarding claim 5, Olstad in view of Sui teaches all the limitations of claim 1 above.
Olstad wherein the processing circuitry is further configured to estimate information about a position of the fetal heart or information about a posture of the fetal heart ([0047] states that “In step 130 of FIG. 2, the time integrated velocity parameter value S.sub.int for each of the designated and tracked anatomical points 290 (the motion gradient profile 370) is used by processor 50 to locate the longitudinal depth position 299 of the apex 292 and the longitudinal depth position 298 of the AV-plane 296 of the heart in the image”).
Regarding claim 6, Olstad in view of Sui teaches all the limitations of claim 1 above.
Olstad fails to teach wherein the processing circuitry is further configured to estimate a region satisfying a condition where the statistical variance of brightness values of the moving image data over time exceeds a threshold value as a region of a tissue of the fetal heart.
However, Sui further teaches wherein the processing circuitry (processor 12 of [0025]) is further configured to estimate a region satisfying a condition where the statistical variance of brightness values of the moving image data over time exceeds a threshold value as a region of a tissue of the fetal heart ([0033] discloses that the phase and/or amplitude information is identified for a plurality of spatial locations providing various examples for accomplishing the identification of tissue regions of interest including identifying in frequency domain, amplitudes at the given frequency or frequencies of interest of the imaging values for the spatial locations within a sequence of images).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Olstad wherein the processing circuitry is further configured to estimate a region satisfying a condition where the statistical variance of brightness values of the moving image data over time exceeds a threshold value as a region of a tissue of the fetal heart, as taught by Sui, as such modification would provide improved detection of the regions of interest according to [0006], with a reasonable expectation of success, as Olstad is also concerned with increasing the objectivity and accuracy of cardiac wall function visualization [0014] and evaluation [0010]-[0011].
Regarding claim 7, Olstad in view of Sui teaches all the limitations of claim 6 above.
Olstad further teaches wherein the processing circuitry is further configured to cause a display to display an image in which information indicating the position of the cardiac apex or information indicating the position of the atrial blood flow entrance part is superimposed on the region ([0006]-[0007] disclose overlaying indicia onto the image of the heart corresponding to positions of the anatomical landmarks).
Regarding claim 15, Olstad in view of Sui teaches all the limitations of claim 1 above.
Olstad further teaches estimate the position of the cardiac apex of the fetal heart within the region of the tissue of the fetal heart or the position of the atrial blood flow entrance part of the fetal heart within the determined region of the tissue of the fetal heart ([0047] states that “In step 130 of FIG. 2, the time integrated velocity parameter value S.sub.int for each of the designated and tracked anatomical points 290 (the motion gradient profile 370) is used by processor 50 to locate the longitudinal depth position 299 of the apex 292 and the longitudinal depth position 298 of the AV-plane 296 of the heart in the image in accordance with an embodiment of the present invention”).
Olstad fails to teach wherein the processing circuitry is further configured to: determine a region of a tissue of the fetal heart by using information about the statistical variance of brightness values of the moving image data over time.
However, Sui further teaches wherein the processing circuitry (processor 12 of [0025]) is further configured to: determine a region of a tissue of the fetal heart by using information about the statistical variance of brightness values of the moving image data over time ([0029] indicates that In act 20 of a method for medical imaging with motion analysis, the method implemented on the system 10 of FIG. 1, that phase and amplitude information are identified from the sequence of images. For a given spatial location throughout the sequence of images, the imaging value may vary relative to a cycle. For example, as the heart contracts and expands in an apical four chamber or other view, intensity values may vary. The phase of the variation relative to the heart cycle is identified. Different spatial locations may be associated with variation that occurs at different portions within the heart cycle. The phase analysis is performed for one or more spatial locations. [0043] describes segmentation of myocardial wall into segments 50, [0044]-[0045] describe, with respect to act 30, determination of mean and variance of phase and amplitude information for each tissue region or segment 50, resultantly identifying cardiac apical regions according to [0049]-[0050]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Olstad wherein the processing circuitry is further configured to: determine a region of a tissue of the fetal heart by using information about the statistical variance of brightness values of the moving image data over time, as taught by Sui, as such modification would provide improved detection of the regions of interest according to [0006], with a reasonable expectation of success, as Olstad is also concerned with increasing the objectivity and accuracy of cardiac wall function visualization [0014] and evaluation [0010]-[0011].
Regarding claim 16, Olstad in view of Sui teaches all the limitations of claim 1 above.
Olstad fails to teach wherein the processing circuitry (processor 12 of [0025]) is further configured to estimate the position of the cardiac apex of the fetal heart ([0029] indicates that In act 20 of a method for medical imaging with motion analysis, the method implemented on the system 10 of FIG. 1, that phase and amplitude information are identified from the sequence of images. For a given spatial location throughout the sequence of images, the imaging value may vary relative to a cycle. For example, as the heart contracts and expands in an apical four chamber or other view, intensity values may vary. The phase of the variation relative to the heart cycle is identified. Different spatial locations may be associated with variation that occurs at different portions within the heart cycle. The phase analysis is performed for one or more spatial locations) or the position of the atrial blood flow entrance part of the fetal heart by using distribution information of the statistical variance of the brightness values in the determined region of the tissue of the fetal heart ([0045] and [0050] disclose calculating a standard deviation, which characterizes the distribution of variances, for the various segments 50 at the apex region).
However, Sui further teaches wherein the processing circuitry is further configured to estimate the position of the cardiac apex of the fetal heart or the position of the atrial blood flow entrance part of the fetal heart by using distribution information of the statistical variance of the tissue velocity values in the determined region of the tissue of the fetal heart.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Olstad wherein the processing circuitry is further configured to estimate the position of the cardiac apex of the fetal heart or the position of the atrial blood flow entrance part of the fetal heart by using distribution information of the statistical variance of the tissue velocity values in the determined region of the tissue of the fetal heart, as taught by Sui, as such modification would provide improved detection of the regions of interest according to [0006], with a reasonable expectation of success, as Olstad is also concerned with increasing the objectivity and accuracy of cardiac wall function visualization [0014] and evaluation [0010]-[0011].
Regarding claim 19, Olstad teaches an ultrasonic diagnostic method (the abstract discloses “a method and apparatus for generating an image responsive to moving cardiac structure and for locating anatomical landmarks of the heart by generating received signals in response to ultrasound waves transmitted into and then backscattered from the moving cardiac structure over a time period”), comprising
acquiring two- or three-dimensional ultrasonic moving image data rendering a fetal heart ([0028]-[0029] disclose acquiring ultrasound images in a tissue velocity imaging mode of a moving cardiac structure. NB: while the claims include a fetal heart, it is not deemed to change the scope of the claims so prior art the only mention heart or cardiac tissue are interpreted to read on the claims);
determining a position of a cardiac apex of the fetal heart or a position of an atrial blood flow entrance part of the fetal heart ([0021] indicates that the “moving structure is characterized by a set of analytic parameter values corresponding to anatomical points within a myocardial segment of the heart. The set of analytic parameter values may comprise, for example, tissue velocity values, time-integrated tissue velocity values, B-mode tissue intensity values…”. [0034] then indicates tracking an exemplary analytic parameter value, that is tissue velocity, over time, as shown in fig. 5. Meaning the B-mode tissue intensity values are tracked over time, much the same way that the tissue velocity is tracked over time); and
causing a display to display information indicating the determined position of the cardiac apex or the atrial blood flow entrance part ([0050] states “discrete anatomical points in the image at the longitudinal depths 298 and 299 of the anatomical landmarks (apex 292 and AV-plane 296) are automatically labeled with indicia 410 and 420 as shown in FIG. 7. The anatomical points are continually tracked, using the techniques described previously, as imaging continues. The positions of the indicia 410 and 420 are continuously updated and displayed to follow the tracked anatomical points corresponding to the anatomical landmarks”).
Olstad does not explicitly state calculating, for each position in the moving image data, a statistical variance of brightness values of the acquired moving image data over time to determine a position of a cardiac apex.
However, within the same field of endeavor, Sui teaches methods and systems for medical imaging with motion analysis. The phase or associated amplitude analysis of a sequence of images is improved by, first, providing a quantification. For example, a value or values representing asynchrony between different locations through a sequence of images may provide useful diagnostic information ([0007]). Siu teaches calculating, for each position in the moving image data, a statistical variance of brightness values of the acquired moving image data over time to determine a position of a cardiac apex: [0026] discloses receiving a sequence of ultrasound images; [0027] discloses that each image in the sequence represents a two- or three-dimensional region; [0029] indicates that In act 20 of a method for medical imaging with motion analysis, the method implemented on the system 10 of FIG. 1, that phase and amplitude information are identified from the sequence of images. For a given spatial location throughout the sequence of images, the imaging value may vary relative to a cycle. For example, as the heart contracts and expands in an apical four chamber or other view, intensity values may vary. The phase of the variation relative to the heart cycle is identified. Different spatial locations may be associated with variation that occurs at different portions within the heart cycle. The phase analysis is performed for one or more spatial locations. [0043] describes segmentation of myocardial wall into segments 50, [0044]-[0045] describe, with respect to act 30, determination of mean and variance of phase and amplitude information for each tissue region or segment 50, resultantly identifying cardiac apical regions according to [0049]-[0050].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Olstad for calculating, for each position in the moving image data, a statistical variance of brightness values of the acquired moving image data over time, as taught by Sui, as such modification would provide improved detection of the regions of interest according to [0006], with a reasonable expectation of success, as Olstad is also concerned with increasing the objectivity and accuracy of cardiac wall function visualization [0014] and evaluation [0010]-[0011].
Claims 3-4, 8, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Olstad in view of Sui, as applied to claim 1 above, and further in view of Lotjonen, J., US 20070088209 A1.
Regarding claim 3, Olstad in view of Sui teaches all the limitations of claim 1 above.
Olstad in view of Sui fails to teach wherein the processing circuitry is further configured to estimate (1) a long axis of the fetal heart, (2) both of the long axis and a short axis of the fetal heart, or (3) a center position of the fetal heart, and the processing circuitry determines the position of the cardiac apex or the position of the atrial blood flow entrance part based on the estimated long axis, both the estimated long axis and the estimated short axis, or the estimated center position.
However, Lotjonen teaches a method, implemented on a computer with computer readable medium (claim 41) for cardiac analysis where during scanning (i.e. imaging sessions) the subject, a short-axis (SA) and a long-axis (LA) image volumes are acquired using a known imaging protocol adopted for cardiac subjects e.g. magnetic resonance imaging or other imaging system producing slice images of different levels of the region of interest. Image sets in this description refers to such an image sets that are formed of image slices. Claim 29 indicates that the imaging modality is ultrasound imaging. Also see [0018]. Lotjonen further states in [0019] that “Simultaneous tracking of short-axis (SA) and long-axis (LA) images broadens the heart image processing. The LA images provide comprehensive information especially on tracking the movement of the basal and apical regions of the ventricles in the heart's long-axis direction” and [0020] states that “The image sets that are acquired at least from short-axis and long-axis contribute differently on various regions in the algorithm. For example, the information on the apex of the heart can be extracted from long-axis images as the information on the medial parts of the heart can be retrieved from short-axis images. The simultaneous tracking of two image orientations allows to track more precisely the basal and apical movement of the ventricles. In addition, the motion of the atria can be tracked”.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Olstad, as modified by Sui, wherein the processing circuitry is further configured to estimate (1) a long axis of the fetal heart, (2) both the long axis and a short axis of the fetal heart, or (3) a center position of the fetal heart, and the processing circuitry is further configured to determine the position of the cardiac apex or the position of the atrial blood flow entrance part based on the estimated long axis, both the estimated long axis and the estimated short axis, or the estimated center position, as taught by Lotjonen, as such modification allows to track more precisely the basal and apical movement of the ventricles ([0020]), with a reasonable expectation of success, as modified Olstad is also concerned with increasing the objectivity and accuracy of cardiac wall function visualization [0014] and evaluation [0010]-[0011].
Regarding claim 4, Olstad in view of Sui and Lotjonen teaches all the limitations of claim 3 above.
Olstad further teaches wherein the processing circuitry is further configured to cause the display to display the information indicating the position of the cardiac apex or the information indicating the position of the atrial blood flow entrance part at a position along a long axis direction of the fetal heart ([0047] discloses that, regarding the method 200 in fig. 2, in step 201, anatomical landmarks (e.g., the AV-plane and apex) are identified within the heart while imaging the heart, and [0049] states that FIG. 3 illustrates a real-time application where a normal B-mode acquisition is conducted and, hidden for a user, tissue velocity information is gathered in a region of interest around the assumed AV-plane location. The two AV-plane locations are then identified in real-time and indicated with tracking markers 301 and 302).
Regarding claim 8, Olstad in view of Sui teaches all the limitations of claim 7 above.
Olstad in view of Sui fails to teach wherein the processing circuitry is further configured to estimate (1) a long axis of the fetal heart, (2) both the long axis and a short axis of the fetal heart, or (3) a center position of the fetal heart, and the processing circuitry is further configured to cause the display to display the information indicating the position of the cardiac apex or the information indicating the position of the atrial blood flow entrance part based on the estimated long axis, both the estimated long axis and the estimated short axis, or the estimated center position.
However, Lotjonen teaches a method, implemented on a computer with computer readable medium (claim 41) for cardiac analysis where during scanning (i.e. imaging sessions) the subject, a short-axis (SA) and a long-axis (LA) image volumes are acquired using a known imaging protocol adopted for cardiac subjects e.g. magnetic resonance imaging or other imaging system producing slice images of different levels of the region of interest. Image sets in this description refers to such an image sets that are formed of image slices. Claim 29 indicates that the imaging modality is ultrasound imaging. Also see [0018]. Lotjonen further states in [0019] that “Simultaneous tracking of short-axis (SA) and long-axis (LA) images broadens the heart image processing. The LA images provide comprehensive information especially on tracking the movement of the basal and apical regions of the ventricles in the heart's long-axis direction” and [0020] states that “The image sets that are acquired at least from short-axis and long-axis contribute differently on various regions in the algorithm. For example, the information on the apex of the heart can be extracted from long-axis images as the information on the medial parts of the heart can be retrieved from short-axis images. The simultaneous tracking of two image orientations allows to track more precisely the basal and apical movement of the ventricles. In addition, the motion of the atria can be tracked”. See fig. 1 [0032] depict a representation of images with segmented volumes in the short axis and long axis directions. Claim 39 recites a displaying means for presenting images.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Olstad, as modified by Sui, wherein the processing circuitry is further configured to estimate (1) a long axis of the fetal heart, (2) both the long axis and a short axis of the fetal heart, or (3) a center position of the fetal heart, and the processing circuitry is further configured to cause the display to display the information indicating the position of the cardiac apex or the information indicating the position of the atrial blood flow entrance part based on the estimated long axis, both the estimated long axis and the estimated short axis, or the estimated center position, as taught by Lotjonen, as such modification allows to track more precisely the basal and apical movement of the ventricles ([0020]), with a reasonable expectation of success, as modified Olstad is also concerned with increasing the objectivity and accuracy of cardiac wall function visualization [0014] and evaluation [0010]-[0011].
Regarding claim 17, Olstad in view of Sui teaches all the limitations of claim 15 above.
Olstad does not teach wherein the processing circuitry is further configured to estimate at least one of a long axis of the fetal heart, both the long axis and a short axis of the fetal heart, and a center position of the fetal heart by using distribution information of the statistical variance of the brightness values in the determined region of the tissue of the fetal heart, and estimate the position of the cardiac apex of the fetal heart or the position of the atrial blood flow entrance part of the fetal heart based on the at least one of the long axis of the fetal heart, both the long axis and the short axis of the fetal heart, and the center position of the fetal heart.
However, Lotjonen further teaches wherein the processing circuitry is further configured to estimate at least one of a long axis of the fetal heart, both the long axis and a short axis of the fetal heart, and a center position of the fetal heart by using distribution information of the statistical variance of the brightness values in the determined region of the tissue of the fetal heart, and estimate the position of the cardiac apex of the fetal heart or the position of the atrial blood flow entrance part of the fetal heart based on the at least one of the long axis of the fetal heart, both the long axis and the short axis of the fetal heart, and the center position of the fetal heart. Lotjonen states in [0019] that “Simultaneous tracking of short-axis (SA) and long-axis (LA) images broadens the heart image processing. The LA images provide comprehensive information especially on tracking the movement of the basal and apical regions of the ventricles in the heart's long-axis direction” and [0020] states that “The image sets that are acquired at least from short-axis and long-axis contribute differently on various regions in the algorithm. For example, the information on the apex of the heart can be extracted from long-axis images as the information on the medial parts of the heart can be retrieved from short-axis images. The simultaneous tracking of two image orientations allows to track more precisely the basal and apical movement of the ventricles. In addition, the motion of the atria can be tracked”. [0004] discloses using gray-value of each pixel exemplified in [0047].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Olstad wherein the processing circuitry is further configured to estimate at least one of a long axis of the fetal heart, both the long axis and a short axis of the fetal heart, and a center position of the fetal heart by using distribution information of the time variance of the brightness values in the determined region of the tissue of the fetal heart, and estimate the position of the cardiac apex of the fetal heart or the position of the atrial blood flow entrance part of the fetal heart based on the at least one of the long axis of the fetal heart, both the long axis and the short axis of the fetal heart, and the center position of the fetal heart, as taught by Lotjonen, as such modification allows to track more precisely the basal and apical movement of the ventricles ([0020]), with a reasonable expectation of success, as modified Olstad is also concerned with increasing the objectivity and accuracy of cardiac wall function visualization [0014] and evaluation [0010]-[0011].
Claims 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Olstad in view of van der Kouwe, et al., US 20080103383 A1.
Regarding claim 9, Olstad in view of Sui and Lotjonen teaches all the limitations of claim 3 above.
Olstad fails to teach wherein the processing circuitry is further configured to: obtain distribution information of a tissue position of the fetal heart by regarding a region satisfying a condition where the statistical variance of brightness values of the moving image data over time exceeds a threshold value as a region of a tissue of the fetal heart, detect, from among the plurality of regions, a region in which either a sum or an average value of the statistical variance of brightness values is largest as a fetal heart valve region, the region of the tissue of the fetal heart.
However, Sui further teaches wherein the processing circuitry is further configured to: obtain distribution information of a tissue position of the fetal heart by regarding a region satisfying a condition where the statistical variance of brightness values of the moving image data over time exceeds a threshold value as a region of a tissue of the fetal heart ([0022] describes phase analysis using maximum deviation of intensities to identifying contraction velocity. [0033] discloses the phase analysis requiring thresholding of amplitudes for identifying various spatial locations of interest), detect, from among the plurality of regions, a region in which either a sum or an average value of the statistical variance of brightness values is largest as a fetal heart valve region, the region of the tissue of the fetal heart ([0022] describes phase analysis using maximum deviation of intensities to identifying contraction velocity. [0044] then discloses that The mean, variance or other quantity of the phase and/or amplitude information for each tissue region or segment 50 is determined. Where multiple phases are determined within a same tissue region, the average or weighted average is calculated for the region. In one embodiment, the quantities associated with each segment 50 are displayed as numerical values or a graph as shown in FIG. 6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Olstad wherein the processing circuitry is further configured to: obtain distribution information of a tissue position of the fetal heart by regarding a region satisfying a condition where the statistical variance of brightness values of the moving image data over time exceeds a threshold value as a region of a tissue of the fetal heart, detect, from among the plurality of regions, a region in which either a sum or an average value of the statistical variance of brightness values is largest as a fetal heart valve region, the region of the tissue of the fetal heart, as taught by Sui, as such modification would provide improved detection of the regions of interest according to [0006], with a reasonable expectation of success, as Olstad is also concerned with increasing the objectivity and accuracy of cardiac wall function visualization [0014] and evaluation [0010]-[0011].
Olstad in view of Sui fails to teach that the processing circuitry is configured to obtain a plurality of eigenvectors from a principal component analysis related to the distribution information of the tissue position, the processing circuitry is configured to set a plurality of regions extending parallel to directions of the plurality of eigenvectors respectively and each having a width, in a surrounding of the center position, the processing circuitry is configured to determine a direction of an eigenvector parallel to the fetal heart valve region as the short axis of the fetal heart, and the processing circuitry is configured to determine a direction perpendicular to a width direction of the fetal heart valve region as the long axis of the fetal heart.
However, within the same field of endeavor, van der Kouwe teaches an image segmentation process (abstract) wherein a processing circuitry (processor of [0019]) is configured to obtain a plurality of eigenvectors from a principal component analysis related to the distribution information of the tissue position ([0048] describes a centroid method of calculating position, orientation, and shape of anatomical structures of interest [0047], [0048] stating that “The centroid method also calculates the covariance matrix for the voxel coordinates. The principal eigenvector is considered as the long axis of the structure. The second eigenvector is the wide axis of the structure and the cross product (remaining perpendicular direction) is the short axis”),
the processing circuitry is configured to set a plurality of regions extending parallel to directions of the plurality of eigenvectors respectively and each having a width, in a surrounding of the center position([0048] describes a centroid method of calculating position, orientation, and shape of anatomical structures of interest [0047], [0048] stating that “The centroid method also calculates the covariance matrix for the voxel coordinates. The principal eigenvector is considered as the long axis of the structure. The second eigenvector is the wide axis of the structure and the cross product (remaining perpendicular direction) is the short axis”. Here one eigenvector is normal to a second eigenvector),
the processing circuitry is configured to determine a direction of an eigenvector parallel to the target structure as the short axis of the target structure, and the processing circuitry is configured to determine a direction perpendicular to a width direction of the target structure region as the long axis of the target structure([0048] describes a centroid method of calculating position, orientation, and shape of anatomical structures of interest [0047], [0048] stating that “The centroid method also calculates the covariance matrix for the voxel coordinates. The principal eigenvector is considered as the long axis of the structure. The second eigenvector is the wide axis of the structure and the cross product (remaining perpendicular direction) is the short axis”. Here one eigenvector is normal to a second eigenvector).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Olstad wherein the processing circuitry is configured to obtain a plurality of eigenvectors from a principal component analysis related to the distribution information of the tissue position, the processing circuitry is configured to set a plurality of regions extending parallel to directions of the plurality of eigenvectors respectively and each having a width, in a surrounding of the center position, the processing circuitry is configured to determine a direction of an eigenvector parallel to the fetal heart valve region as the short axis of the fetal heart, and the processing circuitry is configured to determine a direction perpendicular to a width direction of the fetal heart valve region as the long axis of the fetal heart, as taught by van der Kouwe, to optimize the segmentation and identification of the structures of interest ([006]-[0007]), with a reasonable expectation of success, as modified Olstad is also concerned with increasing the objectivity and accuracy of cardiac wall function visualization [0014] and evaluation [0010]-[0011].
Regarding claim 18, Olstad in view of Sui teaches all the limitations of claim 15 above.
Olstad fails to teach wherein the processing circuitry is further configured to estimate the position of the cardiac apex of the fetal heart or the position of the atrial blood flow entrance part of the fetal heart by using a result of principal component analysis concerning distribution information of the statistical variance of the brightness values in the determined region of the tissue of the fetal heart.
However, Kouwe further teaches wherein the processing circuitry is further configured to estimate the position of the cardiac apex of the fetal heart or the position of the atrial blood flow entrance part of the fetal heart by using a result of principal component analysis concerning distribution information of the statistical variance of the brightness values in the determined region of the tissue of the fetal heart ([0048] describes a centroid method of calculating position, orientation, and shape of anatomical structures of interest [0047], [0048] stating that “The centroid method also calculates the covariance matrix for the voxel coordinates. The principal eigenvector is considered as the long axis of the structure. The second eigenvector is the wide axis of the structure and the cross product (remaining perpendicular direction) is the short axis” and [0020] states that “The image sets that are acquired at least from short-axis and long-axis contribute differently on various regions in the algorithm. For example, the information on the apex of the heart can be extracted from long-axis images as the information on the medial parts of the heart can be retrieved from short-axis images.”)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Olstad wherein the processing circuitry is further configured to estimate the position of the cardiac apex of the fetal heart or the position of the atrial blood flow entrance part of the fetal heart by using a result of principal component analysis concerning distribution information of the statistical variance of the brightness values in the determined region of the tissue of the fetal heart, as taught by van der Kouwe, to optimize the segmentation and identification of the structures of interest ([006]-[0007]), with a reasonable expectation of success, as modified Olstad is also concerned with increasing the objectivity and accuracy of cardiac wall function visualization [0014] and evaluation [0010]-[0011].
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 Farouk A Bruce whose telephone number is (408)918-7603. The examiner can normally be reached Mon-Fri 8-5pm PST.
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, Christopher Koharski can be reached at (571) 272-7230. 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.
/FAROUK A BRUCE/ Examiner, Art Unit 3797
Prosecution Insights