DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) or (f) based on an application (Application No. CN202410381083.7) filed in China on 29 Mar 2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 27 Mar 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
Claim Objections
Claims 3, 6, 16, 18, and 20 are objected to because of the following informalities:
“an identification result” should read “the identification result” (claims 3 and 16);
“an imaging parameter” should read “the imaging parameter” (claims 5 and 18); and
“the steps of” should read “steps of” (claim 20).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “automatically identifying suspected regurgitation in the two-dimensional color flow image”. This automatic function, or a computer-implemented limitation, is not disclosed in the original specification of the instant application with an algorithm (i.e., the necessary steps and/or flowcharts) such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. See MPEP 2161.01.I. In particular, [0040] of the original specification merely discloses that the automatic identification may be performed using a trained neural network, but no algorithm is explicitly disclosed. Accordingly, one skilled in the art would not know the algorithm for performing the claimed function of “automatically identifying suspected regurgitation in the two-dimensional color flow image” in view of the original specification of the instant application. Claims 2-13 inherit the deficiency by the nature of their dependency on claim 1.
Claim 14 recites the limitation “automatically identify suspected regurgitation in the two-dimensional color flow image”. This processor-implemented automatic limitation is not disclosed in the original specification of the instant application with an algorithm (i.e., the necessary steps and/or flowcharts) such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. See MPEP 2161.01.I. In particular, [0040] of the original specification merely discloses that the automatic identification may be performed using a trained neural network, but no algorithm is explicitly disclosed. Accordingly, one skilled in the art would not know the algorithm for performing the claimed function of “automatically identify suspected regurgitation in the two-dimensional color flow image” in view of the original specification of the instant application. Claims 15-19 inherit the deficiency by the nature of their dependency on claim 14.
Claim 20 recites the limitation “automatically identifying suspected regurgitation in the two-dimensional color flow image”. This machine-implemented automatic limitation is not disclosed in the original specification of the instant application with an algorithm (i.e., the necessary steps and/or flowcharts) such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. See MPEP 2161.01.I. In particular, [0040] of the original specification merely discloses that the automatic identification may be performed using a trained neural network, but no algorithm is explicitly disclosed. Accordingly, one skilled in the art would not know the algorithm for performing the claimed function of “automatically identifying suspected regurgitation in the two-dimensional color flow image” in view of the original specification of the instant application.
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 1-20 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 1 recites the limitation “automatically identifying suspected regurgitation in the two-dimensional color flow image”. As noted above in the 35 U.S.C. 112(a) rejection, a review of the specification of the instant application does not disclose an algorithm for this computer-implemented limitation. Therefore, the metes and bounds of the claim are unclear in view of this limitation. See MPEP 2161.01.I. Claims 2-13 inherit the deficiency by the nature of their dependency on claim 1. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation in view of the prior art presented below.
Claim 14 recites the limitation “automatically identify suspected regurgitation in the two-dimensional color flow image”. As noted above in the 35 U.S.C. 112(a) rejection, a review of the specification of the instant application does not disclose an algorithm for this processor-implemented limitation. Therefore, the metes and bounds of the claim are unclear in view of this limitation. See MPEP 2161.01.I. Claims 15-19 inherit the deficiency by the nature of their dependency on claim 14. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation in view of the prior art presented below.
Claim 20 recites the limitation “automatically identifying suspected regurgitation in the two-dimensional color flow image”. As noted above in the 35 U.S.C. 112(a) rejection, a review of the specification of the instant application does not disclose an algorithm for this machine-implemented limitation. Therefore, the metes and bounds of the claim are unclear in view of this limitation. See MPEP 2161.01.I. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation in view of the prior art presented below.
Claim Interpretation
Examiner notes that the limitations of claims 2-3 and 5-6; 8-9; 10-11; and 15-16 are currently presented to merely “replace” the respective limitations in their parent claims. For example, claim 2 recites the limitation “wherein the automatically identifying suspected regurgitation in the two-dimensional color flow image (of claim 1) comprises: automatically identifying occurrence of the suspected regurgitation in the two- dimensional color flow image”, and claim 3 recites the limitation “wherein the automatically performing second ultrasound imaging based on an identification result of the suspected regurgitation (of claim 2) comprises: automatically controlling, based on the determined location of the suspected regurgitation, an imaging parameter of the second ultrasound imaging, to correlate the second ultrasound imaging with the location of the suspected regurgitation” Since these limitations in claims 2-3 merely recite “comprises” without reciting any explicit relationship to “automatically identifying suspected regurgitation in the two-dimensional color flow image” recited in claim 1, a broadest reasonable interpretation of the limitations “automatically identifying suspected regurgitation in the two-dimensional color flow image” in claim 1 and “automatically identifying occurrence of the suspected regurgitation in the two- dimensional color flow image” in claim 2 includes merely “automatically controlling, based on the determined location of the suspected regurgitation, an imaging parameter of the second ultrasound imaging, to correlate the second ultrasound imaging with the location of the suspected regurgitation”, as recited in claim 3. Examiner has given a broadest reasonable interpretation to these “replacing” limitations in the dependent claims as at least performing each of explicitly recited functions in the limitations.
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 1-5 and 8-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Claim 1 recites automatically identifying suspected regurgitation in the two-dimensional color flow image.
Step 1: Statutory Category: YES - Claim 1 is directed to “a method”.
Step 2A, Prong 1, Judicial Exception: YES - 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 a generic computer component. That is, other than reciting “a processor configured to execute the instructions to”, nothing in the claim element precludes the step from practically being performed in the mind. The limitation of automatically identifying a suspected regurgitation in the two-dimensional color flow image, as drafted, is a process that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a manual performance by a user). If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. According, claim 1 recites an abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: NO - This judicial exception recited in claim 1 is not integrated into a practical application. In particular, the claim recites additional elements of “performing first ultrasound imaging on a heart, to generate a two-dimensional color flow image of the heart” and “automatically performing second ultrasound imaging based on an identification result of the suspected regurgitation, to generate a second ultrasound image containing a suspected regurgitation region, the second ultrasound image being different from the two-dimensional color flow image and containing blood flow information” are mere data gathering with intended use “to generate a two-dimensional color flow image of the heart” and “to generate a second ultrasound image containing a suspected regurgitation region, the second ultrasound image being different from the two-dimensional color flow image and containing blood flow information”, respectively. In particular, automating a manual process is not sufficient to show an improvement in computer-functionality. See MPEP 2106.05(a).I. Accordingly, 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. Therefore, claim 1 is directed to an abstract idea.
Step 2B, Inventive Concept: NO - Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “performing first ultrasound imaging on a heart, to generate a two-dimensional color flow image of the heart” and “automatically performing second ultrasound imaging based on an identification result of the suspected regurgitation, to generate a second ultrasound image containing a suspected regurgitation region, the second ultrasound image being different from the two-dimensional color flow image and containing blood flow information” are mere data gathering with intended use “to generate a two-dimensional color flow image of the heart” and “to generate a second ultrasound image containing a suspected regurgitation region, the second ultrasound image being different from the two-dimensional color flow image and containing blood flow information”, respectively. Therefore, claim 1 is not patent eligible.
For a compact prosecution, Examiner notes that explicit recitations of generating the two-dimensional color flow image and generating the second ultrasound image containing the suspected regurgitation region in claim 1 would overcome this 35 U.S.C. 101 rejection.
Claims 2-5 and 8-13 inherit the deficiencies of claim 1, whose claimed invention is being directed to an abstract idea (see the 35 U.S.C. 101 analysis for claim 1 above), and additionally recite:
wherein the automatically identifying suspected regurgitation in the two-dimensional color flow image comprises: automatically identifying occurrence of the suspected regurgitation in the two- dimensional color flow image, and automatically determining a location of the suspected regurgitation (claims 2-3, 5, and 8-11);
wherein the automatically performing second ultrasound imaging based on an identification result of the suspected regurgitation comprises: automatically controlling, based on the determined location of the suspected regurgitation, an imaging parameter of the second ultrasound imaging, to correlate the second ultrasound imaging with the location of the suspected regurgitation (claims 3 and 5);
wherein the second ultrasound imaging comprises at least one of continuous wave Doppler imaging, pulsed wave Doppler imaging, and four-dimensional color ultrasound imaging (claim 4);
wherein the second ultrasound imaging comprises continuous wave Doppler imaging or pulsed wave Doppler imaging; and the automatically controlling an imaging parameter of the second ultrasound imaging comprises: automatically positioning, based on the location of the suspected regurgitation, a location of a sampling window of the second ultrasound imaging, so that the sampling window passes through the suspected regurgitation region; and automatically performing the second ultrasound imaging on the location of the sampling window, to generate a continuous wave Doppler image or a pulsed wave Doppler image related to the suspected regurgitation region (claim 5);
wherein the automatically identifying suspected regurgitation in the two-dimensional color flow image further comprises: automatically determining the time of the suspected regurgitation and predicting the time of at least one subsequent suspected regurgitation (claims 8-11);
wherein the automatically determining the time of the suspected regurgitation and predicting the time of at least one subsequent suspected regurgitation comprises: acquiring electrocardiogram data while performing the ultrasound imaging, using the electrocardiogram data to determine a cardiac cycle, and determining a time range of the suspected regurgitation in a complete cardiac cycle; and predicting the at least one suspected regurgitation in at least one subsequent cardiac cycle based on the time range of the suspected regurgitation in a complete cardiac cycle (claims 9-11);
displaying the cardiac cycle and the prediction of the at least one suspected regurgitation in real time (claims 10-11);
wherein the displaying in real time comprises: displaying an electrocardiogram waveform of the cardiac cycle in real time, and highlighting an electrocardiogram waveform within the time range of the at least one suspected regurgitation (claim 11);
selecting, in response to an operation by a user, one of a plurality of imaging modes in advance as an imaging mode of the second ultrasound imaging (claims 12-13); and
switching, in response to an operation by the user, the selected one of the imaging modes for the second ultrasound imaging (claim 13).
These limitations, as drafted, are a process that under their broadest reasonable interpretation, cover performance of the limitations in the mind. In particular, the additional limitations “selecting, in response to an operation by a user, one of a plurality of imaging modes in advance as an imaging mode of the second ultrasound imaging” recited in claims 12-13; and “switching, in response to an operation by the user, the selected one of the imaging modes for the second ultrasound imaging” recited in claim 13, under their broadest reasonable interpretation, includes a user manually selecting and switching an imaging mode. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Furthermore, these additional limitations do not appear to integrate the judicial exception into a practical application and are not sufficient to amount to significantly more than the judicial exception. In particular, the additional elements of “displaying the cardiac cycle and the prediction of the at least one suspected regurgitation in real time” recited in claims 10-11; and “wherein the displaying in real time comprises: displaying an electrocardiogram waveform of the cardiac cycle in real time, and highlighting an electrocardiogram waveform within the time range of the at least one suspected regurgitation” recited in claim 11 are a form of insignificant extra-solution activity. Accordingly, these limitations do not impose any meaningful limits on practicing the abstract idea. Therefore, claims 2-5 and 8-13 are not patent eligible.
Claim 14 recites automatically identifying suspected regurgitation in the two-dimensional color flow image.
Step 1: Statutory Category: YES - Claim 14 is directed to “a system” and is therefore an apparatus.
Step 2A, Prong 1, Judicial Exception: YES - This limitation, as drafted, is a processor-implemented process that under its broadest reasonable interpretation, covers performance of the limitation in the mind. The limitation of automatically identifying a suspected regurgitation in the two-dimensional color flow image, as drafted, is a process that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a manual performance by a user) but for the recitation of a generic computer component. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. According, claim 14 recites an abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: NO - This judicial exception recited in claim 14 is not integrated into a practical application. In particular, the claim recites additional elements of the processor configured to execute instructions to “perform first ultrasound imaging on a heart, to generate a two-dimensional color flow image of the heart” and “automatically perform second ultrasound imaging based on an identification result of the suspected regurgitation, to generate a second ultrasound image containing a suspected regurgitation region, the second ultrasound image being different from the two-dimensional color flow image and containing blood flow information”. The processor in these steps is recited at a high-level of generality (i.e., a generic processor performing a generic computer function of performing first ultrasound imaging on a heart and automatically performing second ultrasound imaging) such that it amounts no more than mere instructions to gather data with intended use “to generate a two-dimensional color flow image of the heart” and “to generate a second ultrasound image containing a suspected regurgitation region, the second ultrasound image being different from the two-dimensional color flow image and containing blood flow information”, respectively. Additionally, the claim recites an additional limitation of a memory storing instructions. The memory is recited at a high-level of generality (i.e., as a general means of storing instructions) and is well known and conventional. In particular, automating a manual process is not sufficient to show an improvement in computer-functionality. See MPEP 2106.05(a).I. Accordingly, 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. Therefore, claim 14 is directed to an abstract idea.
Step 2B, Inventive Concept: NO - Claim 14 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “performing first ultrasound imaging on a heart, to generate a two-dimensional color flow image of the heart” and “automatically performing second ultrasound imaging based on an identification result of the suspected regurgitation, to generate a second ultrasound image containing a suspected regurgitation region, the second ultrasound image being different from the two-dimensional color flow image and containing blood flow information”, but for “a processor” language, are mere data gathering with intended use “to generate a two-dimensional color flow image of the heart” and “to generate a second ultrasound image containing a suspected regurgitation region, the second ultrasound image being different from the two-dimensional color flow image and containing blood flow information”, respectively. Therefore, claim 14 is not patent eligible.
For a compact prosecution, Examiner notes that explicit recitations of generating the two-dimensional color flow image and generating the second ultrasound image containing the suspected regurgitation region in claim 14 would overcome this 35 U.S.C. 101 rejection.
Claims 15-19 inherit the deficiencies of claim 14, whose claimed invention is being directed to an abstract idea (see the 35 U.S.C. 101 analysis for claim 1r above), and additionally recite:
wherein the automatically identifying suspected regurgitation in the two-dimensional color flow image comprises: automatically identifying occurrence of the suspected regurgitation in the two- dimensional color flow image, and automatically determining a location of the suspected regurgitation (claims 15-16 and 19);
wherein the automatically performing second ultrasound imaging based on an identification result of the suspected regurgitation comprises: automatically controlling, based on the determined location of the suspected regurgitation, an imaging parameter of the second ultrasound imaging, to correlate the second ultrasound imaging with the location of the suspected regurgitation (claim 16);
wherein the second ultrasound imaging comprises at least one of continuous wave Doppler imaging, pulsed wave Doppler imaging, and four-dimensional color ultrasound imaging (claims 17-18);
wherein the second ultrasound imaging comprises continuous wave Doppler imaging or pulsed wave Doppler imaging; and the automatically controlling an imaging parameter of the second ultrasound imaging comprises: automatically positioning, based on the location of the suspected regurgitation, a location of a sampling window of the second ultrasound imaging, so that the sampling window passes through the suspected regurgitation region; and automatically performing the second ultrasound imaging on the location of the sampling window, to generate a continuous wave Doppler image or a pulsed wave Doppler image related to the suspected regurgitation region (claim 18); and
wherein the automatically identifying suspected regurgitation in the two-dimensional color flow image further comprises: automatically determining the time of the suspected regurgitation and predicting the time of at least one subsequent suspected regurgitation (claim 19).
These limitations, as drafted, are a process that under their broadest reasonable interpretation, cover performance of the limitations in the mind, as noted above for claim 14. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Furthermore, these additional limitations do not appear to integrate the judicial exception into a practical application and are not sufficient to amount to significantly more than the judicial exception, as noted above for claim 14. Accordingly, these limitations do not impose any meaningful limits on practicing the abstract idea. Therefore, claims 15-19 are not patent eligible.
Claim 20 recites automatically identifying suspected regurgitation in the two-dimensional color flow image.
Step 1: Statutory Category: YES - Claim 14 is directed to “a non-transitory computer-readable medium” and is therefore a product.
Step 2A, Prong 1, Judicial Exception: YES - This limitation, as drafted, is a “machine”-implemented process that under its broadest reasonable interpretation, covers performance of the limitation in the mind. The limitation of automatically identifying a suspected regurgitation in the two-dimensional color flow image, as drafted, is a process that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a manual performance by a user) but for the recitation of “a machine”, or a generic computer component. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. According, claim 20 recites an abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: NO - This judicial exception recited in claim 20 is not integrated into a practical application. In particular, the claim recites additional elements of the machine to perform steps of “performing first ultrasound imaging on a heart, to generate a two-dimensional color flow image of the heart” and “automatically performing second ultrasound imaging based on an identification result of the suspected regurgitation, to generate a second ultrasound image containing a suspected regurgitation region, the second ultrasound image being different from the two-dimensional color flow image and containing blood flow information”. The “machine”, or a processor, in these steps is recited at a high-level of generality (i.e., a generic processor performing a generic computer function of performing first ultrasound imaging on a heart and automatically performing second ultrasound imaging) such that it amounts no more than mere instructions to gather data with intended use “to generate a two-dimensional color flow image of the heart” and “to generate a second ultrasound image containing a suspected regurgitation region, the second ultrasound image being different from the two-dimensional color flow image and containing blood flow information”, respectively. Additionally, the claim recites an additional limitation of a computer program having at least one code segment that is being executable. This additional limitation is no more than mere instructions to apply the judicial exception using a generic computer component. In particular, automating a manual process is not sufficient to show an improvement in computer-functionality. See MPEP 2106.05(a).I. Accordingly, 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. Therefore, claim 20 is directed to an abstract idea.
Step 2B, Inventive Concept: NO - Claim 20 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “performing first ultrasound imaging on a heart, to generate a two-dimensional color flow image of the heart” and “automatically performing second ultrasound imaging based on an identification result of the suspected regurgitation, to generate a second ultrasound image containing a suspected regurgitation region, the second ultrasound image being different from the two-dimensional color flow image and containing blood flow information”, but for “a machine” language, are mere data gathering with intended use “to generate a two-dimensional color flow image of the heart” and “to generate a second ultrasound image containing a suspected regurgitation region, the second ultrasound image being different from the two-dimensional color flow image and containing blood flow information”, respectively. Mere instructions – in this case, a computer program having at least one code segment, the at least one code segment being executable by a machine – to apply an exception using a generic computer component cannot provide an inventive concept. Therefore, claim 20 is not patent eligible.
For a compact prosecution, Examiner notes that explicit recitations of generating the two-dimensional color flow image and generating the second ultrasound image containing the suspected regurgitation region in claim 20 would overcome this 35 U.S.C. 101 rejection.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 8-10, and 12-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chono (US PG Pub No. 2017/0014105).
Regarding claim 1, Chono discloses an ultrasound imaging method for assisting in determining cardiac regurgitation (at least Fig. 1 and 6) comprising:
performing first ultrasound imaging on a heart, to generate a two-dimensional color flow image of the heart ([0028]: tomographic image and color Doppler image showing distribution of blood flow within target tissue (heart) are captured; [0031]-[0030]: two-dimensional tomographic image and color Doppler image are combined to form a color flow mapping (CFM) image);
automatically identifying suspected regurgitation in the two-dimensional color flow image ([0067]: the velocity of the blood flow in a retrograde flow position is compared to determine whether it is equal to a predetermined value or greater (for identification of suspected regurgitation) and to change the Doppler mode from pulsed Doppler mode to the continuous wave Doppler mode); and
automatically performing second ultrasound imaging based on an identification result of the suspected regurgitation, to generate a second ultrasound image containing a suspected regurgitation region (Fig. 6: retrograde continuous wave Doppler waveform 112 and [0067]: when the measurement item is “the mitral regurgitation”, for example, and the Doppler measurement position 100 for measuring the retrograde flow is specified, the mode of the Doppler measurement at Doppler measurement position is automatically changed from the pulsed Doppler mode to the continuous wave Doppler mode),
the second ultrasound image being different from the two-dimensional color flow image and containing blood flow information (Fig. 6: retrograde continuous wave Doppler waveform 112 and [0067]: the velocity of the blood flow in a retrograde flow position is equal to a predetermined value or greater and mode of Doppler measurement is automatically changed from the pulsed Doppler mode to the continuous wave Doppler mode).
Regarding claim 2, Chono discloses all limitations of claim 1, as discussed above, and Chono further discloses:
automatically identifying occurrence of the suspected regurgitation in the two-dimensional color flow image ([0067]: the velocity of the blood flow in a retrograde flow position is compared to determine whether it is equal to a predetermined value or greater and to change the Doppler mode from pulsed Doppler mode to the continuous wave Doppler mode), and
automatically determining a location of the suspected regurgitation (Fig. 6 and [0067]: Doppler measurement position 110 in continuous wave Doppler mode (suspected regurgitation) is indicated in color flow map 80).
Regarding claim 3, Chono discloses all limitations of claim 2, as discussed above, and Chono further discloses:
automatically controlling, based on the determined location of the suspected regurgitation, an imaging parameter of the second ultrasound imaging, to correlate the second ultrasound imaging with the location of the suspected regurgitation (Fig. 5-6 and [0067]: the mode of the Doppler measurement at Doppler measurement position is automatically changed from the pulsed Doppler mode to the continuous wave Doppler mode, and the shape of the cursor in the continuous wave Doppler mode (at Doppler measurement position 110 in Fig. 5) is different from that of the cursor in the pulsed Doppler mode (at Doppler measurement position 64d in Fig. 5)).
Regarding claim 4, Chono discloses all limitations of claim 1, as discussed above, and Chono further discloses:
wherein the second ultrasound imaging comprises at least one of continuous wave Doppler imaging, pulsed wave Doppler imaging, and four-dimensional color ultrasound imaging (Fig. 6 and [0067]: mode of Doppler measurement is automatically changed to the continuous wave Doppler mode).
Regarding claim 5, Chono discloses all limitations of claim 3, as discussed above, and Chono further discloses:
wherein the second ultrasound imaging comprises continuous wave Doppler imaging or pulsed wave Doppler imaging (Fig. 6 and [0067]: mode of Doppler measurement is automatically changed to the continuous wave Doppler mode); and
automatically positioning, based on the location of the suspected regurgitation, a location of a sampling window of the second ultrasound imaging, so that the sampling window passes through the suspected regurgitation region (Fig. 5-6 and [0067]: the mode of the Doppler measurement at Doppler measurement position is automatically changed from the pulsed Doppler mode to the continuous wave Doppler mode, and the shape of the cursor in the continuous wave Doppler mode (at Doppler measurement position 110 in Fig. 5) is different from that of the cursor in the pulsed Doppler mode (at Doppler measurement position 64d in Fig. 5); and
automatically performing the second ultrasound imaging on the location of the sampling window, to generate a continuous wave Doppler image or a pulsed wave Doppler image related to the suspected regurgitation region (Fig. 6 and [0067]: the mode of the Doppler measurement at Doppler measurement position 100 is automatically changed from the pulsed Doppler mode to the continuous wave Doppler mode).
Regarding claim 8, Chono discloses all limitations of claim 2, as discussed above, and Chono further discloses:
automatically determining the time of the suspected regurgitation ([0074]: time phase which is the most suitable for measuring the measurement target indicated by that measurement item is specified) and
predicting the time of at least one subsequent suspected regurgitation ([0074]: When the measurement item is “the mitral valve regurgitation”, the time phase is specified to the systole phase).
It is noted that Chono discloses detection of a mitral valve regurgitation specifically at a systolic phase of a cardiac cycle.
Regarding claim 9, Chono discloses all limitations of claim 8, as discussed above, and Chono further discloses:
acquiring electrocardiogram data while performing the ultrasound imaging (Fig. 6: electrocardiographic waveform 68; [0059]: electrocardiographic waveform 68 enables understanding the relationship between the Doppler waveform 66 and the time phase in the pulsation cycle of the heart 52),
using the electrocardiogram data to determine a cardiac cycle ([0014]: position specification unit specifies the Doppler measurement position based on the reference portion and the blood flow information in a specific time selected in a pulsation cycle of the target tissue), and
determining a time range of the suspected regurgitation in a complete cardiac cycle ([0074]: When the measurement item is “the mitral valve regurgitation”, the time phase is specified to the systole phase); and
predicting the at least one suspected regurgitation in at least one subsequent cardiac cycle based on the time range of the suspected regurgitation in a complete cardiac cycle ([0074]: time phase which is the most suitable for measuring the measurement target indicated by that measurement item is specified, and when the measurement item is “the mitral valve regurgitation”, the time phase is specified to the systole phase).
Again, it is noted that Chono discloses detection of a mitral valve regurgitation specifically at a systolic phase of a cardiac cycle.
Regarding claim 10, Chono discloses all limitations of claim 9, as discussed above, and Chono further discloses:
displaying the cardiac cycle and the prediction of the at least one suspected regurgitation in real time (Fig. 6: electrocardiographic waveform 68 displaying at least 2 systole phases throughout at least 2 cardiac cycles).
Regarding claim 12, Chono discloses all limitations of claim 1, as discussed above, and Chono further discloses:
selecting, in response to an operation by a user (Fig. 1 and [0051]: input unit 34 for setting the measurement item with respect to which the Doppler measurement is performed), one of a plurality of imaging modes in advance as an imaging mode of the second ultrasound imaging ([0067]: measurement item is set to "the mitral regurgitation" and only when the velocity of the blood flow in a retrograde flow position is equal to a predetermined value or greater, the Doppler mode is automatically changed from the pulsed Doppler mode to the continuous wave Doppler mode).
Regarding claim 13, Chono discloses all limitations of claim 12, as discussed above, and Chono further discloses:
switching, in response to an operation by the user, the selected one of the imaging modes for the second ultrasound imaging (Fig. 5 and [0064]: measurement item is set to “antegrade flow and retrograde flow of the mitral valve”, thus Doppler mode would be switched to pulsed Doppler mode; Fig. 7 and [0068]: the measurement item is “left ventricular inflow blood”, thus Doppler mode would be switched to pulsed Doppler mode; Fig. 8 and [0069]: the measurement item is set to “left ventricular inflow blood and the mitral valve annulus velocity”, thus Doppler mode would be switched to pulsed Doppler mode).
Regarding claim 14, Chono discloses an ultrasound imaging system (at least Fig. 1) comprising:
a memory storing instructions (Fig. 1: storage unit 36; [0052]-[0053]: storage unit 36 storing programs, calculation operation systems, and estimation operation systems for actuating various functions of the ultrasonic diagnostic device); and
a processor configured to execute the instructions ([0053]: CPU and processor to implement units of the ultrasonic diagnostic device, including software (program) which regulates the operation of the CPU and the processor):
perform first ultrasound imaging on a heart, to generate a two-dimensional color flow image of the heart ([0028]: tomographic image and color Doppler image showing distribution of blood flow within target tissue (heart) are captured; [0031]-[0030]: two-dimensional tomographic image and color Doppler image are combined to form a color flow mapping (CFM) image);
automatically identify suspected regurgitation in the two-dimensional color flow image ([0067]: the velocity of the blood flow in a retrograde flow position is compared to determine whether it is equal to a predetermined value or greater (for identification of suspected regurgitation) and to change the Doppler mode from pulsed Doppler mode to the continuous wave Doppler mode); and
automatically perform second ultrasound imaging based on an identification result of the suspected regurgitation, to generate a second ultrasound image containing a suspected regurgitation region (Fig. 6: retrograde continuous wave Doppler waveform 112 and [0067]: when the measurement item is “the mitral regurgitation”, for example, and the Doppler measurement position 100 for measuring the retrograde flow is specified, the mode of the Doppler measurement at Doppler measurement position is automatically changed from the pulsed Doppler mode to the continuous wave Doppler mode),
the second ultrasound image being different from the two-dimensional color flow image and containing blood flow information (Fig. 6: retrograde continuous wave Doppler waveform 112 and [0067]: the velocity of the blood flow in a retrograde flow position is equal to a predetermined value or greater and mode of Doppler measurement is automatically changed from the pulsed Doppler mode to the continuous wave Doppler mode).
Regarding claim 15, Chono discloses all limitations of claim 14, as discussed above, and Chono further discloses:
automatically identifying occurrence of the suspected regurgitation in the two-dimensional color flow image ([0067]: the velocity of the blood flow in a retrograde flow position is compared to determine whether it is equal to a predetermined value or greater and to change the Doppler mode from pulsed Doppler mode to the continuous wave Doppler mode), and
automatically determining a location of the suspected regurgitation (Fig. 6 and [0067]: Doppler measurement position 110 in continuous wave Doppler mode (suspected regurgitation) is indicated in color flow map 80).
Regarding claim 16, Chono discloses all limitations of claim 15, as discussed above, and Chono further discloses:
automatically controlling, based on the determined location of the suspected regurgitation, an imaging parameter of the second ultrasound imaging, to correlate the second ultrasound imaging with the location of the suspected regurgitation (Fig. 5-6 and [0067]: the mode of the Doppler measurement at Doppler measurement position is automatically changed from the pulsed Doppler mode to the continuous wave Doppler mode, and the shape of the cursor in the continuous wave Doppler mode (at Doppler measurement position 110 in Fig. 5) is different from that of the cursor in the pulsed Doppler mode (at Doppler measurement position 64d in Fig. 5)).
Regarding claim 17, Chono discloses all limitations of claim 14, as discussed above, and Chono further discloses:
wherein the second ultrasound imaging comprises at least one of continuous wave Doppler imaging, pulsed wave Doppler imaging, and four-dimensional color ultrasound imaging (Fig. 6 and [0067]: mode of Doppler measurement is automatically changed to the continuous wave Doppler mode).
Regarding claim 18, Chono discloses all limitations of claim 17, as discussed above, and Chono further discloses:
wherein the second ultrasound imaging comprises continuous wave Doppler imaging or pulsed wave Doppler imaging (Fig. 6 and [0067]: mode of Doppler measurement is automatically changed to the continuous wave Doppler mode); and
automatically positioning, based on the location of the suspected regurgitation, a location of a sampling window of the second ultrasound imaging, so that the sampling window passes through the suspected regurgitation region (Fig. 5-6 and [0067]: the mode of the Doppler measurement at Doppler measurement position is automatically changed from the pulsed Doppler mode to the continuous wave Doppler mode, and the shape of the cursor in the continuous wave Doppler mode (at Doppler measurement position 110 in Fig. 5) is different from that of the cursor in the pulsed Doppler mode (at Doppler measurement position 64d in Fig. 5); and
automatically performing the second ultrasound imaging on the location of the sampling window, to generate a continuous wave Doppler image or a pulsed wave Doppler image related to the suspected regurgitation region (Fig. 6 and [0067]: the mode of the Doppler measurement at Doppler measurement position 100 is automatically changed from the pulsed Doppler mode to the continuous wave Doppler mode).
Regarding claim 19, Chono discloses all limitations of claim 15, as discussed above, and Chono further discloses:
automatically determining the time of the suspected regurgitation ([0074]: time phase which is the most suitable for measuring the measurement target indicated by that measurement item is specified) and
predicting the time of at least one subsequent suspected regurgitation ([0074]: When the measurement item is “the mitral valve regurgitation”, the time phase is specified to the systole phase).
It is noted that Chono discloses detection of a mitral valve regurgitation specifically at a systolic phase of a cardiac cycle.
Regarding claim 20, Chono discloses a non-transitory computer-readable medium, having a computer program stored therein, wherein the computer program has at least one code segment, the at least one code segment being executable by a machine to cause the machine ([0053]: CPU, a processor, and a memory, and software (program) to implement units of the ultrasonic diagnostic device, including software (program) which regulates the operation of the CPU and the processor)to perform the steps of comprising:
performing first ultrasound imaging on a heart, to generate a two-dimensional color flow image of the heart ([0028]: tomographic image and color Doppler image showing distribution of blood flow within target tissue (heart) are captured; [0031]-[0030]: two-dimensional tomographic image and color Doppler image are combined to form a color flow mapping (CFM) image);
automatically identifying suspected regurgitation in the two-dimensional color flow image ([0067]: the velocity of the blood flow in a retrograde flow position is compared to determine whether it is equal to a predetermined value or greater (for identification of suspected regurgitation) and to change the Doppler mode from pulsed Doppler mode to the continuous wave Doppler mode); and
automatically performing second ultrasound imaging based on an identification result of the suspected regurgitation, to generate a second ultrasound image containing a suspected regurgitation region (Fig. 6: retrograde continuous wave Doppler waveform 112 and [0067]: when the measurement item is “the mitral regurgitation”, for example, and the Doppler measurement position 100 for measuring the retrograde flow is specified, the mode of the Doppler measurement at Doppler measurement position is automatically changed from the pulsed Doppler mode to the continuous wave Doppler mode),
the second ultrasound image being different from the two-dimensional color flow image and containing blood flow information (Fig. 6: retrograde continuous wave Doppler waveform 112 and [0067]: the velocity of the blood flow in a retrograde flow position is equal to a predetermined value or greater and mode of Doppler measurement is automatically changed from the pulsed Doppler mode to the continuous wave Doppler mode).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Chono, as applied to claim 3 above, and further in view of Allaire et al. (US PG Pub No. 2022/0079551) – hereinafter referred to as Allaire.
Regarding claim 6, Chono discloses all limitations of claim 3, as discussed above, and Chono does not disclose:
wherein the second ultrasound imaging comprises four-dimensional color ultrasound imaging; and
generating a four-dimensional color ultrasound image of the heart,
mapping the location of the suspected regurgitation in the two-dimensional color flow image into the four-dimensional color ultrasound image, and
highlighting the location.
In the same field of identifying a cardiac regurgitation, Allaire, however, teaches:
performing four-dimensional color ultrasound imaging ([0093]-[0094]: obtaining 4D ultrasound data comprising a time sequence of 3D ultrasound images of a cardiac valve); and
generating a four-dimensional color ultrasound image of the heart ([0097]-[0098]: perform image stabilization (step 120) on 4D ultrasound provides a stabilized 3D time sequence of stabilized images, in B-mode and color Doppler data modes, to obtain a stabilized visualization of a jet, a valve and/or an orifice),
mapping the location of previously identified regurgitation in the four-dimensional color ultrasound image ([0104]-[0111]: dynamic regurgitant orifice identified by performing a search through the 4D volume along the valve surface), and
highlighting the location ([0111]: flow convergence model on identified regurgitant orifice is visualized as a wireframe object).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chono’s method to include Allaire’s method of at least generating a four-dimensional color ultrasound image of the heart. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., generating a four-dimensional color ultrasound image of the heart and processing the image, as disclosed by Allaire), and the combination would have yielded a reasonable expectation of success since both Chono and Allaire are directed to identifying a cardiac regurgitation. The motivation for the combination would have been to allow a “direct estimation of the regurgitant volume”, as taught by Allaire ([0090]), in assessing the suspected regurgitation.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Chono in view of Allaire, as applied to claim 6 above, and further in view of Voigt et al. (US PG Pub No. 2015/0366532) – hereinafter referred to as Voigt.
Regarding claim 7, Chono in view of Allaire discloses all limitations of claim 6, as discussed above, and Chono in view of Allaire does not disclose:
simultaneously displaying the two-dimensional color flow image, the location of the suspected regurgitation in the two-dimensional color flow image, the four-dimensional color ultrasound image, and the location of the suspected regurgitation in the four-dimensional color ultrasound image.
In the same field of identifying a cardiac regurgitation, Voigt, however, teaches:
simultaneously displaying the two-dimensional color flow image, the location of the suspected regurgitation in the two-dimensional color flow image, the four-dimensional color ultrasound image, and the location of the suspected regurgitation in the four-dimensional color ultrasound image (Fig. 3: displaying flow sampling and quantification in 2D images (acts 42, 48) and regurgitant flow detection and visualization (3D+t, or 4D images; acts 40 44) and [0026]: acts 40, 44 performed simultaneously with acts 42, 48; [0097]-[0099]: images include highlighting).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chono’s method to include Voigt’s method of simultaneously displaying 2D color flow image and 4D color ultrasound image, each including a location of suspected regurgitation. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., displaying different dimensional images, as disclosed by Voigt), and the combination would have yielded a reasonable expectation of success since both Chono and Voigt are directed to identifying a cardiac regurgitation. The motivation for the combination would have been to allow “Pathology via anatomy and regurgitant jet (e.g., for surgical planning of mitral leaflet resection) is visualized without occluding the anatomical view with flow rendering”, as taught by Voigt ([0022]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Chono, as applied to claim 10 above, and further in view of Kwon et al. (US PG Pub No. 2020/0155121) – hereinafter referred to as Kwon.
Regarding claim 11, Chono discloses all limitations of claim 10, as discussed above, and Chono further discloses:
displaying an electrocardiogram waveform of the cardiac cycle in real time (Fig. 6: electrocardiographic waveform 68 displaying at least 2 systole phases throughout at least 2 cardiac cycles).
Chono does not disclose:
highlighting an electrocardiogram waveform within the time range of the at least one suspected regurgitation.
In the same field of identifying a cardiac regurgitation, Kwon, however, teaches:
highlighting an electrocardiogram waveform within the time range of the at least one suspected regurgitation (Fig. 17: arrow in EKG at which the cine image 1700 is captured; [0219]: frame in which a size of a regurgitant jet area is largest and a velocity of blood flow is highest is displayed).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chono’s method to include Kwon’s method of highlighting an electrocardiogram waveform. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., highlighting an electrocardiogram waveform representative of a regurgitation, as disclosed by Kwon), and the combination would have yielded a reasonable expectation of success since both Chono and Kwon are directed to identifying a cardiac regurgitation. The motivation for the combination would have been to allow “a user to more easily view an image related to a lesion to be diagnosed in the cine image 1700” and providing the timing of the cardiac phase at which the size of the regurgitant jet area and the velocity of blood flow are highest ([0219] of Kwon).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kang et al. (US PG Pub No. 2019/0209134) disclosing identifying a suspected regurgitation in two-dimensional color flow image and further providing Doppler waveform at the suspected regurgitation (see at least Fig 6A); and
Takimoto et al. (US PG Pub No. 2011/0092819) disclosing identifying a suspected regurgitation in two dimensional color flow image and further providing blood flow velocity at the suspected regurgitation (at least Fig. 7).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Younhee Choi whose telephone number is (571)272-7013. The examiner can normally be reached M-F 9AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Y.C./Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
04/24/26
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