DETAILED ACTION
This office action is in response to the communication received on 05/07/2025 concerning application no. 18/117,324 filed on 03/03/2023.
Claims 1-12 are pending.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/07/2025 has been entered.
Claims 1-12 are pending.
Response to Arguments
Applicant's arguments filed 05/07/2025 have been fully considered but they are not persuasive.
Regarding the 101 rejection, Applicant argues that the claimed subject matter cannot be performed by the human mind or with pen and paper. Applicant argues that the as it is allegedly inventive, it is eligible.
Examiner disagrees. Applicant’s argument is conclusory and without support. Mere allegations that it cannot be performed in the human mind or with a pen and paper is insufficient to traverse a 101 rejection. MPEP 716.01(c) establishes “Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).” Regarding the prior art, Applicant misunderstands the 101 analysis. The rejection under 101 is not regarding allowability. Rather, it is regarding eligibility.
Examiner maintains the rejection.
Applicant’s arguments with respect to claims 1 and 7 have been 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.
Claim Interpretation
Claim 7 contains an optional limitation “when a difference or a ratio calculated based on the duration Tn-1 and the duration Tn-2 corresponding to each evaluation target segment n is less than a threshold value”. According to MPEP 2111.04, “The broadest reasonable interpretation of a method (or process) claim having contingent limitation acquires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met”.
Therefore, the claim element starting with “a step of performing a manipulation for changing the segment of interest” and ending with “a step of performing a manipulation for changing the segment of interest” is not required to be performed.
Claim 8 contains an optional limitation “when a going-back manipulation is performed on a time axis”. According to MPEP 2111.04, “The broadest reasonable interpretation of a method (or process) claim having contingent limitation acquires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met”.
Therefore, the claim element starting with “a step of” and ending with “the going-back manipulation being the manipulation for changing the segment of interest” is not required to be performed.
Claim 8 contains an optional limitation “when a going-forward manipulation is performed on the time axis”. According to MPEP 2111.04, “The broadest reasonable interpretation of a method (or process) claim having contingent limitation acquires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met”.
Therefore, the claim element starting with “a step of” and ending with “the going-forward manipulation being the manipulation changing the segment of interest” is not required to be performed.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“image forming unit configured to form…” in claim 1: Paragraph 0024 teaches “The processor functions as the above-noted image forming unit, defining unit, detection unit, display processing unit, determining unit, and selection control unit. The processor may be composed of one or a plurality of physical processors”.
“definer unit configured to define…” in claims 1 and 7: Paragraph 0024 teaches “The processor functions as the above-noted image forming unit, defining unit, detection unit, display processing unit, determining unit, and selection control unit. The processor may be composed of one or a plurality of physical processors”.
“detection unit configured to unit…” in claims 1, 5, and 7: Paragraph 0024 teaches “The processor functions as the above-noted image forming unit, defining unit, detection unit, display processing unit, determining unit, and selection control unit. The processor may be composed of one or a plurality of physical processors”.
“determining unit configured to determine…” in claims 1, 5, and 7: Paragraph 0024 teaches “The processor functions as the above-noted image forming unit, defining unit, detection unit, display processing unit, determining unit, and selection control unit. The processor may be composed of one or a plurality of physical processors”.
“selection control unit…” in claims 1-4 and 7: Paragraph 0024 teaches “The processor functions as the above-noted image forming unit, defining unit, detection unit, display processing unit, determining unit, and selection control unit. The processor may be composed of one or a plurality of physical processors”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 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 is indefinite for the following reasons:
Recites “n”, “Tn-1”, and “Tn-2”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what the cited variables are representative of. It is further unclear as the claim does not utilize a mathematical equation and it is unclear what the variables represent with respect to their relation to one another.
Applicant is encouraged to provide consistent and clear language.
Recites “a difference or a ratio calculated based on the duration Tn-1 and the duration Tn-2”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the claim is establishing a difference or ratio with consideration of the durations or that the difference or ratio is with the durations themselves.
Applicant is encouraged to provide consistent and clear language.
Recites “corresponding to each evaluation target segment n”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art how many evaluation segments there are. In the instant element and the preceding element (“which is a segment among the plurality of segments”), the claim refers to it and establish it as a singular segment. However, the “corresponding to each” language appears to establish a plurality.
Applicant is encouraged to provide consistent and clear language.
Recites “a determining unit configured to determine whether or not each evaluation target segment n, which is a segment among the plurality of segments, is a stable segment, based on a duration Tn-1 of a segment n-1 located one before the evaluation target segment n and a duration Tn-2 of a segment n-2 located two before the evaluation target segment n, said each evaluation target segment n being determined as a stable segment when a difference or a ratio calculated based on the duration Tn-1 and the duration Tn-2 corresponding to each evaluation target segment n is less than a threshold value from the at least two durations”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art how the thresholding of two unrelated segments establishes the stability of another segment. Cardiac waves are temporally established and occur sequentially and generate due to varying biological processes. It is unclear how the data analysis of the two other segments provides an indication of the stability of the another segment.
Applicant is encouraged to provide consistent and clear language.
Recites “evaluation target segment n”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “evaluation target segment n” is the same as the “segment of interest” established the preceding claim elements or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Claim 3 is indefinite for the following reasons:
Recites “evaluation values”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “evaluation values” is the same as the “evaluation target segment” established in claim 1 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “calculate evaluation values corresponding to the stable segments, each of the evaluation values being calculated from the duration Tn-1 and the duration Tn-2 corresponding to each of the stable segments”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the calculation of the valuation values according to the durations is the same as the determination established in claim 1 or a separate calculation. If it is the latter, it is further unclear what the relationship is to the determination such that both use the durations.
Applicant is encouraged to provide consistent and clear language.
Claim 6 is indefinite for the following reasons:
Recites “whether or not each evaluation target segment n is a provisional stable segment”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the evaluation target segment is provisional or not as the claim 1 does not establish it to be provisional. Rather, the claim establishes it as a stable segment..
Applicant is encouraged to provide consistent and clear language.
Recites “determine whether or not each evaluation target segment n is a provisional stable segment based on the duration Tn-1 and the duration Tn- 2 corresponding to each evaluation target segment n, and determine the provisional stable segment as the stable segment”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the determination of the provisional stable segment according to the durations is the same as the determination established in claim 1 or a separate determination. If it is the latter, it is further unclear what the relationship is to the determination such that both use the durations.
Applicant is encouraged to provide consistent and clear language.
Recites “a first threshold value”. This claim element is indefinite. Claim 1 already establishes a threshold. It would be unclear to one with ordinary skill in the art if the instant element is the same threshold or a different value. If it is the later, it is further unclear how it is the first threshold value.
Applicant is encouraged to provide consistent and clear language.
Claim 7 is indefinite for the following reasons:
Recites “n”, “Tn-1”, and “Tn-2”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what the cited variables are representative of. It is further unclear as the claim does not utilize a mathematical equation and it is unclear what the variables represent with respect to their relation to one another.
Applicant is encouraged to provide consistent and clear language.
Recites “a difference or a ratio calculated based on the duration Tn-1 and the duration Tn-2”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the claim is establishing a difference or ratio with consideration of the durations or that the difference or ratio is with the durations themselves.
Applicant is encouraged to provide consistent and clear language.
Recites “corresponding to each evaluation target segment n”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art how many evaluation segments there are. In the instant element and the preceding element (“which is a segment among the plurality of segments”), the claim refers to it and establish it as a singular segment. However, the “corresponding to each” language appears to establish a plurality.
Applicant is encouraged to provide consistent and clear language.
Recites “a step of determining, by a determining unit of the ultrasonic diagnosis apparatus, whether or not each evaluation target segment n, which is a segment in the plurality of segments, is a stable segment based on a duration Tn-1 of a segment n-1 located one before the evaluation target segment n and a duration Tn-2 of a segment n-2 located two before the evaluation target segment n, each evaluation target segment n being determined as the stable segment when a difference or a ratio calculated based on the duration Tn-1 and the duration Tn-2 corresponding to each evaluation target segment n is less than a threshold value”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art how the thresholding of two unrelated segments establishes the stability of another segment. Cardiac waves are temporally established and occur sequentially and generate due to varying biological processes. It is unclear how the data analysis of the two other segments provides an indication of the stability of the another segment.
Applicant is encouraged to provide consistent and clear language.
Recites “evaluation target segment n”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “evaluation target segment n” is the same as the “segment of interest” established the preceding claim elements or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Claim 9 is indefinite for the following reasons:
Recites “evaluation values”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “evaluation values” is the same as the “evaluation target segment” established in claim 7 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “a step of calculating evaluation values corresponding to the stable segments, each of the evaluation values being calculated from the duration Tn-1 and the duration Tn-2 corresponding to each of the stable segments”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the calculation of the valuation values according to the durations is the same as the determination established in claim 7 or a separate calculation. If it is the latter, it is further unclear what the relationship is to the determination such that both use the durations.
Applicant is encouraged to provide consistent and clear language.
Claim 12 is indefinite for the following reasons:
Recites “whether or not each evaluation target segment n is a provisional stable segment”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the evaluation target segment is provisional or not as the claim 7 does not establish it to be provisional. Rather, the claim establishes it as a stable segment.
Applicant is encouraged to provide consistent and clear language.
Recites “determining whether or not each evaluation target segment n is a provisional stable segment based on the duration Tn-1 and the duration Tn-2 corresponding to each evaluation target segment n, and determine the provisional stable segment as the stable segment”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the determination of the provisional stable segment according to the durations is the same as the determination established in claim 7 or a separate determination. If it is the latter, it is further unclear what the relationship is to the determination such that both use the durations.
Applicant is encouraged to provide consistent and clear language.
Recites “a first threshold value”. This claim element is indefinite. Claim 7 already establishes a threshold. It would be unclear to one with ordinary skill in the art if the instant element is the same threshold or a different value. If it is the later, it is further unclear how it is the first threshold value.
Applicant is encouraged to provide consistent and clear language.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(b) are also rejected because they inherit the indefiniteness of the claims they respectively depend upon.
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 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is 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 - The claims recite an ultrasound diagnostic apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “define, in units of heartbeat, a plurality of segments in an electrocardiac waveform of an electrocardiac signal obtained from the examinee, the electrocardiac signal being an ECG signal;… detect, based on the electrocardiac waveform, an end- diastole and an end-systole in a segment of interest among the plurality of segments;… determine whether or not each evaluation target segment n, which is a segment among the plurality of segments, is a stable segment, based on a duration Tn-1 of a segment n-1 located one before the evaluation target segment n and a duration Tn-2 of a segment n-2 located two before the evaluation target segment n, said each evaluation target segment n being determined as a stable segment when n segment among the temporally consecutive segments as a stable segment, the stability criterion including a threshold compared to a difference or a ratio calculated based on the duration Tn-1 and the duration Tn-2 corresponding to each evaluation target segment n is less than a threshold value from the at least two durations;… when a manipulation for changing the segment of interest is performed, control selection of the segment of interest after change such that the segment of interest after change is selected from among stable segments determined by the determining unit,… when the manipulation for changing the segment of interest is performed, detect an end-diastole and an end-systole in a specific stable segment among the stable segments, the specific stable segment being the segment of interest after change”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the defining of plurality segments of a ECG signal according to the end diastole and end systole, determining the stability of a segment according to the thresholding of a relationship of two other segments, and the performance of a selection of a segment of interest according to the determination of a stable segment such that the end diastole and systole are considered for the segment of interest. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “an image forming unit configured to form an ultrasound image based on reception data obtained from an examinee; a definer unit configured to… a detection unit configured to…a display processing unit configured to display the electrocardiac waveform together with the ultrasound image and display an end-diastole marker indicating the end-diastole in the segment of interest and an end-systole marker indicating the end-systole in the segment of interest;… a determining unit configured to… a selection control unit configured to… wherein the detection unit is further configured to”. Image formation and the gathering of ECG signals is a form of data gather which is a form of a pre-solution insignificant activity. The display of the waveform with the ultrasound image and the marking of the end diastole and systole is a display step which merely amounts to a post-solution insignificant activity. The use of processing units does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 1 is ineligible.
Claim 2 is 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 - The claims recite an ultrasound diagnostic apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “when a going-back manipulation is performed on a time axis, select, from among the stable segments, as the segment of interest after change, the stable segment located before and closest to the segment of interest on the time axis, the going-back manipulation being the manipulation for changing the segment of interest; and when a going-forward manipulation is performed on the time axis, select, from among the stable segments, as the segment of interest after change, the stable segment located after and closest to the segment of interest on the time axis, the going-forward manipulation being the manipulation for changing the segment of interest”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the selection of a segment of interest by changing the segment that is selected according to a consideration of time with respect to going forward or backwards with respect to time. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the selection control unit is further configured to”. The use of a processing unit does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 2 is ineligible.
Claim 3 is 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 - The claims recite an ultrasound diagnostic apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “calculate evaluation values corresponding to the stable segments, each of the evaluation values being calculated from the duration Tn-1 and the duration Tn-2 corresponding to each of the stable segments, identify a best stable segment from among the stable segments, the best stable segment corresponding to a best evaluation value among the evaluation values, and select the best stable segment as the segment of interest after change”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the calculation of evaluation parameters for a segment and utilizing it to identify and select the segment that is considered to be best. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the selection control unit is further configured to”. The use of a processing unit does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 3 is ineligible.
Claim 4 is 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 - The claims recite an ultrasound diagnostic apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “identify, from among the stable segments, a closest stable segment which is located closest to a current time phase of interest on the time axis, and select the closest stable segment as the segment of interest after change”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the identification and selection of a segment with respect to time. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the selection control unit is further configured to”. The use of a processing unit does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 4 is ineligible.
Claim 5 is 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 - The claims recite an ultrasound diagnostic apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “determine the stable segments during a real-time operation, and in a freeze state after the real-time operation, detect the end-diastole and the end-systole”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the determination of stable segments in real time and the detection of the end-diastole and the end-systole. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the determining unit is further configured to” and “the detection unit is further configured to”. The use of a processing unit does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 5 is ineligible.
Claim 6 is 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 - The claims recite an ultrasound diagnostic apparatus and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “determine whether or not each evaluation target segment n is a provisional stable segment based on the duration Tn-1 and the duration Tn- 2 corresponding to each evaluation target segment n, and determine the provisional stable segment as the stable segment when a duration of the provisional stable segments greater than a first threshold value corresponding to bradycardia less than a second threshold value corresponding to tachycardia”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the determination of segments to assess the stability for the further determination of a duration of the segment such that it does not correspond with tachycardia or bradycardia. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the determining unit is further configured to”. The use of a processing unit does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 6 is ineligible.
Claim 7 is 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 - The claims recite electrocardiac waveform processing method of an ultrasonic diagnosis apparatus and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “a step of defining, in units of heartbeat…, a plurality of segments in an electrocardiac waveform of an electrocardiac signal obtained from an examinee, the electrocardiac signal being an ECG signal; a step of detecting, based on the electrocardiac waveform…, an end-diastole and an end-systole in a segment of interest among the plurality of segments; a step of determining,…, whether or not each evaluation target segment n, which is a segment in the plurality of segments, is a stable segment based on a duration Tn-1 of a segment n-1 located one before the evaluation target segment n and a duration Tn-2 of a segment n-2 located two before the evaluation target segment n, each evaluation target segment n being determined as the stable segment when a difference or a ratio calculated based on the duration Tn-1 and the duration Tn-2 corresponding to each evaluation target segment n is less than a threshold value; a step of performing a manipulation for changing the segment of interest; a step of, after the manipulation for changing the segment of interest is performed, controlling,…, selection of the segment of interest after change such that the segment of interest after change is selected from among the determined stable segments, and a step of, after the manipulation for changing the segment of interest is performed, detecting,…, an end-diastole and an end-systole in a specific stable segment among the stable segments, the specific stable segment being the segment of interest after change”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the defining of plurality segments of a ECG signal according to the end diastole and end systole, determining the stability of a segment according to the thresholding of a relationship of two other segments, and the performance of a selection of a segment of interest according to the determination of a stable segment such that the end diastole and systole are considered for the segment of interest. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “by a definer unit of the ultrasonic diagnosis apparatus… by a detection unit of the ultrasonic diagnosis apparatus… a step of displaying, by a display processing unit of the ultrasonic diagnosis apparatus, the electrocardiac waveform together with an ultrasound image and displaying an end-diastole marker indicating the end-diastole and an end-systole marker indicating the end-systole;… by a determining unit of the ultrasonic diagnosis apparatus… by a selection control unit of the ultrasonic diagnosis apparatus… by the detection unit”. Image formation and the gathering of ECG signals is a form of data gather which is a form of a pre-solution insignificant activity. The display of the waveform with the ultrasound image and the marking of the end diastole and systole is a display step which merely amounts to a post-solution insignificant activity. The use of processing units does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 7 is ineligible.
Claim 8 is 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 - The claims recite an electrocardiac waveform processing method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “a step of, when a going-back manipulation is performed on a time axis, selecting, from among the stable segments, as the segment of interest after change, the stable segment located before and closest to the segment of interest on the time axis, the going-back manipulation being the manipulation for changing the segment of interest; and a step of, when a going-forward manipulation is performed on the time axis, selecting, from among the stable segments, as the segment of interest after change, the stable segment located after and closest to the segment of interest on the time axis, the going-forward manipulation being the manipulation changing the segment of interest”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the selection of a segment of interest by changing the segment that is selected according to a consideration of time with respect to going forward or backwards with respect to time. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 8 is ineligible.
Claim 9 is 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 - The claims recite an electrocardiac waveform processing method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “a step of calculating evaluation values corresponding to the stable segments, each of the evaluation values being calculated from the duration Tn-1 and the duration Tn-2 corresponding to each of the stable segments; a step of identifying a best stable segment from among the stable segments, the best stable segment corresponding to a best evaluation value among the evaluation values; and a step of selecting the best stable segment as the segment of interest after change”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the calculation of evaluation parameters for a segment and utilizing it to identify and select the segment that is considered to be best. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 9 is ineligible.
Claim 10 is 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 - The claims recite an electrocardiac waveform processing method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “a step of identifying, from among the stable segments, a closest stable segment which is located closest to a current time phase of interest on a time axis; and a step of selecting the closest stable segment as the segment of interest after change”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the identification and selection of a segment with respect to time. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 10 is ineligible.
Claim 11 is 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 - The claims recite an electrocardiac waveform processing method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “a step of determining the stable segments during a real-time operation; and a step of, in a freeze state after the real-time operation, detecting the end-diastole and the end-systole”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the determination of stable segments in real time and the detection of the end-diastole and the end-systole. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 11 is ineligible.
Claim 12 is 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 - The claims recite an electrocardiac waveform processing method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “determining whether or not each evaluation target segment n is a provisional stable segment based on the duration Tn-1 and the duration Tn-2 corresponding to each evaluation target segment n; and determining the provisional stable segment as the stable segment when a duration of the provisional stable segment which has satisfied the primary determination criterion is greater than a first threshold value corresponding to bradycardia less than a second threshold value corresponding to tachycardia”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the determination of segments to assess the stability for the further determination of a duration of the segment such that it does not correspond with tachycardia or bradycardia. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 12 is ineligible.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4, 7-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (PGPUB No. US 2010/0234731) in view of Brockway et al. (PGPUB No. US 2016/0317073).
Regarding claim 1, Lu teaches an ultrasound diagnostic apparatus, comprising:
an image forming unit configured to form an ultrasound image based on reception data obtained from an examinee (Fig. 5 shows the ultrasound image. Paragraph 0027 teaches that the image is of the anatomy of the blood vessel);
a definer unit configured to define, in units of heartbeat, a plurality of segments in an electrocardiac waveform of an electrocardiac signal obtained from the examinee, the electrocardiac signal being an ECG signal (Fig. 1 shows the ECG electrodes. Paragraph 0021 teaches that the ECG signal is acquired and displayed with the ultrasound image. Paragraph 0026 teaches that the cycle contains a number of beats that indicate the heart rate. Fig. 5A shows the wave form in relation to the time scale. Paragraph 0028 teaches that the heart rate is measured in bpm);
a detection unit configured to detect, based on the electrocardiac waveform, an end- diastole and an end-systole in a segment of interest among the plurality of segments (Paragraphs 0031-32 teaches that the waveform can be traced for the identified waveform. The end systole and end diastole are marked. See Figs. 7 and 9-10. Paragraph 0026 teaches that a heart cycle portion can be marked with the goal posts. See Fig. 5);
a display processing unit configured to display the electrocardiac waveform together with the ultrasound image and display an end-diastole marker indicating the end- diastole in the segment of interest and an end-systole marker indicating the end-systole in the segment of interest (Paragraphs 0031-32 teaches that the waveform can be traced for the identified waveform. The end systole and end diastole are marked. See Figs. 7 and 9-10. Fig. 5A shows the waveform on the display 34 with the ultrasound image. Paragraph 0026 teaches that the goalposts are placed at the end diastoles and the Fig. 5 shows the end systoles),
a selection control unit configured to, when a manipulation for changing the segment of interest is performed, control selection of a segment of interest after change such that the segment of interest after change is selected from among stable segments determined by the determining unit (Paragraph 0028-30 teaches that the click of the button 66 allows for the change of the selected cardiac cycle such that the measurement is made on the highlighted cycle and the goalposts are moved. Paragraphs 0031-32 teaches that the waveform can be traced for the identified waveform. The end systole and end diastole are marked. See Figs. 7 and 9-10. Paragraph 0026 teaches that the goalposts are placed at the end diastoles and the Fig. 5 shows the end systoles); and
wherein the detection unit is further configured to, when the manipulation for changing the segment of interest is performed, detect an end-diastole and an end-systole in a specific stable segment among the stable segments, the specific stable segment being the segment of interest after change (Paragraph 0028-30 teaches that the click of the button 66 allows for the change of the selected cardiac cycle such that the measurement is made on the highlighted cycle and the goalposts are moved. Paragraphs 0031-32 teaches that the waveform can be traced for the identified waveform. The end systole and end diastole are marked. See Figs. 7 and 9-10. Paragraph 0026 teaches that the goalposts are placed at the end diastoles and the Fig. 5 shows the end systoles).
While Lu teaches a determining unit configured to determine, when at least two durations among durations of temporally consecutive segments in the plurality of segments satisfy a stability criterion (Paragraph 0020 teaches that the waveform is noise thresholded to determine the peak of the data and paragraph 0021 teaches that the ECG signal is applied and processed with respect to the Doppler display and image. Fig. 4 shows consecutive signal segments of the ECG), Lu is silent regarding an ultrasound diagnostic apparatus, a determining unit configured to determine whether or not each evaluation target segment n, which is a segment among the plurality of segments, is a stable segment, based on a duration Tn-1 of a segment n-1 located one before the evaluation target segment n and a duration Tn-2 of a segment n-2 located two before the evaluation target segment n, said each evaluation target segment n being determined as a stable segment when n segment among the temporally consecutive segments as a stable segment, the stability criterion including a threshold compared to a difference or a ratio calculated based on the duration Tn-1 and the duration Tn-2 corresponding to each evaluation target segment n is less than a threshold value from the at least two durations.
In an analogous imaging field of endeavor, regarding the utilization of ECG data and optimizing data extraction, Brockway teaches an ultrasound diagnostic apparatus, a determining unit configured to determine whether or not each evaluation target segment n, which is a segment among the plurality of segments, is a stable segment, based on a duration Tn-1 of a segment n-1 located one before the evaluation target segment n and a duration Tn-2 of a segment n-2 located two before the evaluation target segment n, said each evaluation target segment n being determined as a stable segment when n segment among the temporally consecutive segments as a stable segment, the stability criterion including a threshold compared to a difference or a ratio calculated based on the duration Tn-1 and the duration Tn-2 corresponding to each evaluation target segment n is less than a threshold value from the at least two durations (Paragraph 0069 teaches that the ratio of the axial information is taken according to long-term variability of successive RR intervals. See Fig. 7. This ratio is thresholded and in the case that the ratio is less than the threshold, the autonomic tone is erratic and the entropy is high. This is dispositive of the fact that the patient is in a cardiac risk. Paragraph 0070 teaches that the cardiac risk can be associated with the calculated metrics. Paragraph 0030 teaches that the time series of the cardiac intervals is calculated from the heart beat of the subject. In a case that there is cardiac risk, the subsequent intervals would also be impacted by the cardiac issue. Paragraph 0032 teaches that the characteristics can be from the group of ventricular arrhythmias, atrial fibrillation).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lu with Brockway’s teaching of thresholding with cardiac segments. This modified apparatus would allow the user to improve analysis of patient data (Paragraph 0037 of Brockway). Furthermore, the modification can assess stress, CMND, and cardiac risk (Paragraph 0042 of Brockway).
Regarding claim 2, modified Lu teaches the ultrasound diagnostic apparatus in claim 1, as discussed above.
Lu further teaches an ultrasound diagnostic apparatus, wherein the selection control unit is further configured to:
when a going-back manipulation is performed on a time axis, select, from among the stable segments, as the segment of interest after change, the stable segment located before and closest to the segment of interest on the time axis, the going-back manipulation being the manipulation for changing the segment of interest (Paragraph 0028 teaches that the button 66 has a previous or next cycle to control the selected cardiac cycle to go to the one adjacent to the current heart cycle in the before or after direction in a temporal context. Paragraph 0029 teaches that the button can be used for changing the selected cycle and performing measurements. See Fig. 5 that shows the segments of ECG in temporal order); and
when a going-forward manipulation is performed on the time axis, select, from among the stable segments, as the segment of interest after change, the stable segment located after and closest to the segment of interest on the time axis, the going-forward manipulation being the manipulation for changing the segment of interest (Paragraph 0028 teaches that the button 66 has a previous or next cycle to control the selected cardiac cycle to go to the one adjacent to the current heart cycle in the before or after direction in a temporal context. Paragraph 0029 teaches that the button can be used for changing the selected cycle and performing measurements. See Fig. 5 that shows the segments of ECG in temporal order).
Regarding claim 4, modified Lu teaches the ultrasound diagnostic apparatus in claim 1, as discussed above.
Lu further teaches an ultrasound diagnostic apparatus, wherein the selection control unit is further configured to identify, from among the stable segments, a closest stable segment which is located closest to a current time phase of interest on the time axis, and select the closest stable segment as the segment of interest after change (Paragraph 0028 teaches that the button 66 has a previous or next cycle to control the selected cardiac cycle to go to the one adjacent to the current heart cycle in the before or after direction in a temporal context. Paragraph 0029 teaches that the button can be used for changing the selected cycle and performing measurements. See Fig. 5 that shows the segments of ECG in temporal order).
Regarding claim 7, Lu teaches an electrocardiac waveform processing method of an ultrasonic diagnosis apparatus, the electrocardiac waveform processing method comprising:
a step of defining, in units of heartbeat and by a definer unit of the ultrasonic diagnosis apparatus, a plurality of segments in an electrocardiac waveform of an electrocardiac signal obtained from an examinee, the electrocardiac signal being an ECG signal (Fig. 1 shows the ECG electrodes. Paragraph 0021 teaches that the ECG signal is acquired and displayed with the ultrasound image. Paragraph 0026 teaches that the cycle contains a number of beats that indicate the heart rate. Fig. 5A shows the wave form in relation to the time scale. Paragraph 0028 teaches that the heart rate is measured in bpm);
a step of detecting, based on the electrocardiac waveform and by a detection unit of the ultrasonic diagnosis apparatus, an end-diastole and an end-systole in a segment of interest among the plurality of segments (Paragraphs 0031-32 teaches that the waveform can be traced for the identified waveform. The end systole and end diastole are marked. See Figs. 7 and 9-10. Paragraph 0026 teaches that a heart cycle portion can be marked with the goal posts. Fig. 5 shows the ultrasound image. Paragraph 0027 teaches that the image is of the anatomy of the blood vessel);
a step of displaying, by a display processing unit of the ultrasonic diagnosis apparatus, the electrocardiac waveform together with an ultrasound image and displaying an end-diastole marker indicating the end-diastole and an end-systole marker indicating the end-systole (Paragraphs 0031-32 teaches that the waveform can be traced for the identified waveform. The end systole and end diastole are marked. See Figs. 7 and 9-10. Fig. 5A shows the waveform on the display 34 with the ultrasound image. Paragraph 0026 teaches that the goalposts are placed at the end diastoles and the Fig. 5 shows the end systoles),
a step of performing a manipulation for changing the segment of interest (Paragraph 0028-30 teaches that the click of the button 66 allows for the change of the selected cardiac cycle such that the measurement is made on the highlighted cycle and the goalposts are moved. Paragraphs 0031-32 teaches that the waveform can be traced for the identified waveform. The end systole and end diastole are marked. See Figs. 7 and 9-10. Paragraph 0026 teaches that the goalposts are placed at the end diastoles and the Fig. 5 shows the end systoles);
a step of, after the manipulation for changing the segment of interest is performed, controlling, by a selection control unit of the ultrasonic diagnosis apparatus, selection of a segment of interest after change such that the segment of interest after change is selected from among the determined stable segments (Paragraph 0028-30 teaches that the click of the button 66 allows for the change of the selected cardiac cycle such that the measurement is made on the highlighted cycle and the goalposts are moved. Paragraphs 0031-32 teaches that the waveform can be traced for the identified waveform. The end systole and end diastole are marked. See Figs. 7 and 9-10. Paragraph 0026 teaches that the goalposts are placed at the end diastoles and the Fig. 5 shows the end systoles); and
a step of, after the manipulation for changing the segment of interest is performed, detecting, by the detection unit, an end-diastole and an end-systole in a specific stable segment among the stable segments, the specific stable segment being the segment of interest after change (Paragraph 0028-30 teaches that the click of the button 66 allows for the change of the selected cardiac cycle such that the measurement is made on the highlighted cycle and the goalposts are moved. Paragraphs 0031-32 teaches that the waveform can be traced for the identified waveform. The end systole and end diastole are marked. See Figs. 7 and 9-10. Paragraph 0026 teaches that the goalposts are placed at the end diastoles and the Fig. 5 shows the end systoles).
While Lu teaches a step of determining, by a determining unit of the ultrasonic diagnosis apparatus when at least two durations among durations of temporally consecutive segments in the plurality of segments, satisfy a stability criterion (Paragraph 0020 teaches that the waveform is noise thresholded to determine the peak of the data and paragraph 0021 teaches that the ECG signal is applied and processed with respect to the Doppler display and image. Fig. 4 shows consecutive signal segments of the ECG), Lu is silent regarding a method, a step of determining, by a determining unit of the ultrasonic diagnosis apparatus, whether or not each evaluation target segment n, which is a segment in the plurality of segments, is a stable segment based on a duration Tn-1 of a segment n-1 located one before the evaluation target segment n and a duration Tn-2 of a segment n-2 located two before the evaluation target segment n, each evaluation target segment n being determined as the stable segment when a difference or a ratio calculated based on the duration Tn-1 and the duration Tn-2 corresponding to each evaluation target segment n is less than a threshold value.
In an analogous imaging field of endeavor, regarding the utilization of ECG data and optimizing data extraction, Brockway teaches a method, a step of determining, by a determining unit of the ultrasonic diagnosis apparatus, whether or not each evaluation target segment n, which is a segment in the plurality of segments, is a stable segment based on a duration Tn-1 of a segment n-1 located one before the evaluation target segment n and a duration Tn-2 of a segment n-2 located two before the evaluation target segment n, each evaluation target segment n being determined as the stable segment when a difference or a ratio calculated based on the duration Tn-1 and the duration Tn-2 corresponding to each evaluation target segment n is less than a threshold value (Paragraph 0069 teaches that the ratio of the axial information is taken according to long-term variability of successive RR intervals. See Fig. 7. This ratio is thresholded and in the case that the ratio is less than the threshold, the autonomic tone is erratic and the entropy is high. This is dispositive of the fact that the patient is in a cardiac risk. Paragraph 0070 teaches that the cardiac risk can be associated with the calculated metrics. Paragraph 0030 teaches that the time series of the cardiac intervals is calculated from the heart beat of the subject. In a case that there is cardiac risk, the subsequent intervals would also be impacted by the cardiac issue. Paragraph 0032 teaches that the characteristics can be from the group of ventricular arrhythmias, atrial fibrillation).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lu with Brockway’s teaching of thresholding with cardiac segments. This modified method would allow the user to improve analysis of patient data (Paragraph 0037 of Brockway). Furthermore, the modification can assess stress, CMND, and cardiac risk (Paragraph 0042 of Brockway).
Regarding claim 8, modified Lu teaches the electrocardiac waveform processing method in claim 7, as discussed above.
Lu further teaches an electrocardiac waveform processing method, further comprising:
a step of, when a going-back manipulation is performed on a time axis, selecting, from among the stable segments, as the segment of interest after change, the stable segment located before and closest to the segment of interest on the time axis, the going-back manipulation being the manipulation for changing the segment of interest (Paragraph 0028 teaches that the button 66 has a previous or next cycle to control the selected cardiac cycle to go to the one adjacent to the current heart cycle in the before or after direction in a temporal context. Paragraph 0029 teaches that the button can be used for changing the selected cycle and performing measurements. See Fig. 5 that shows the segments of ECG in temporal order); and
a step of, when a going-forward manipulation is performed on the time axis, selecting, from among the stable segments, as the segment of interest after change, the stable segment located after and closest to the segment of interest on the time axis, the going-forward manipulation being the manipulation changing the segment of interest (Paragraph 0028 teaches that the button 66 has a previous or next cycle to control the selected cardiac cycle to go to the one adjacent to the current heart cycle in the before or after direction in a temporal context. Paragraph 0029 teaches that the button can be used for changing the selected cycle and performing measurements. See Fig. 5 that shows the segments of ECG in temporal order).
Regarding claim 10, modified Lu teaches the electrocardiac waveform processing method in claim 7, as discussed above.
Lu further teaches an electrocardiac waveform processing method, further comprising: a step of identifying, from among the stable segments, a closest stable segment which is located closest to a current time phase of interest on a time axis; and a step of selecting the closest stable segment as the segment of interest after change (Paragraph 0028 teaches that the button 66 has a previous or next cycle to control the selected cardiac cycle to go to the one adjacent to the current heart cycle in the before or after direction in a temporal context. Paragraph 0029 teaches that the button can be used for changing the selected cycle and performing measurements. See Fig. 5 that shows the segments of ECG in temporal order).
Claims 3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (PGPUB No. US 2010/0234731) in view of Brockway et al. (PGPUB No. US 2016/0317073) further in view of Badilini (PGPUB No. US 2007/0265538).
Regarding claim 3, modified Lu teaches the ultrasound diagnostic apparatus in claim 1, as discussed above.
However, the combination of Lu and Brockway is silent regarding an ultrasound diagnostic apparatus, wherein the selection control unit is further configured to
calculate evaluation values corresponding to the stable segments, each of the evaluation values indicating a stability level of each of the stable segments,
identify a best stable segment from among the stable segments, the best stable segment corresponding to a best evaluation value among the evaluation values, and
select the best stable segment as the segment of interest after change.
In an analogous imaging field of endeavor, regarding the utilization of ECG data and optimizing data extraction, Badilini teaches an ultrasound diagnostic apparatus, wherein the selection control unit is further configured to
calculate evaluation values corresponding to the stable segments, each of the evaluation values being calculated from the duration Tn-1 and the duration Tn-2 corresponding to each of the stable segments (Paragraph 0039 teaches that the best ECG is extracted based on the determined best candidates that have the lowest noise and most stable preceding hear rate. This extraction can be repeated to collect multiple data points and determine segments in different orders prior to extraction. Paragraph 0048 teaches the collection of the ECG data of 3 minutes prior to the timepoint. The operation of the data can be according to ECG that is spaced apparat by two minutes),
identify a best stable segment from among the stable segments, the best stable segment corresponding to a best evaluation value among the evaluation values (Paragraph 0039 teaches that the best ECG is extracted based on the determined best candidates that have the lowest noise and most stable preceding heart rate. This extraction can be repeated to collect multiple data points and determine segments in different orders prior to extraction), and
select the best stable segment as the segment of interest after change (Paragraph 0039 teaches that the best ECG is extracted based on the determined best candidates that have the lowest noise and most stable preceding hear rate. This extraction can be repeated to collect multiple data points and determine segments in different orders prior to extraction).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Lu and Brockway with Badilini’s teaching of the determination and extraction of the best ECG segments. This modified apparatus would allow the user to shift through hours of ECG data to identify the necessary best extractions within the recorded ECG data (Paragraph 0017 of Badilini). Furthermore, the modification allows for accurate extraction and without bias (Paragraph 0047 of Badilini).
Regarding claim 9, modified Lu teaches the electrocardiac waveform processing method in claim 7, as discussed above.
However, the combination of Lu and Brockway is silent regarding an electrocardiac waveform processing method, further comprising:
a step of calculating evaluation values corresponding to the stable segments, each of the evaluation values indicating a stability level of each of the stable segments;
a step of identifying a best stable segment from among the stable segments, the best stable segment corresponding to a best evaluation value among the evaluation values; and
a step of selecting the best stable segment as the segment of interest after change.
In an analogous imaging field of endeavor, regarding the utilization of ECG data and optimizing data extraction, Badilini teaches an electrocardiac waveform processing method, further comprising:
a step of calculating evaluation values corresponding to the stable segments, each of the evaluation values being calculated from the duration Tn-1 and the duration Tn-2 corresponding to each of the stable segments (Paragraph 0039 teaches that the best ECG is extracted based on the determined best candidates that have the lowest noise and most stable preceding hear rate. This extraction can be repeated to collect multiple data points and determine segments in different orders prior to extraction. Paragraph 0048 teaches the collection of the ECG data of 3 minutes prior to the timepoint. The operation of the data can be according to ECG that is spaced apparat by two minutes);
a step of identifying a best stable segment from among the stable segments, the best stable segment corresponding to a best evaluation value among the evaluation values (Paragraph 0039 teaches that the best ECG is extracted based on the determined best candidates that have the lowest noise and most stable preceding hear rate. This extraction can be repeated to collect multiple data points and determine segments in different orders prior to extraction); and
a step of selecting the best stable segment as the segment of interest after change (Paragraph 0039 teaches that the best ECG is extracted based on the determined best candidates that have the lowest noise and most stable preceding hear rate. This extraction can be repeated to collect multiple data points and determine segments in different orders prior to extraction).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Lu and Brockway with Badilini’s teaching of the determination and extraction of the best ECG segments. This modified method would allow the user to shift through hours of ECG data to identify the necessary best extractions within the recorded ECG data (Paragraph 0017 of Badilini). Furthermore, the modification allows for accurate extraction and without bias (Paragraph 0047 of Badilini).
Claims 5 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (PGPUB No. US 2010/0234731) in view of Brockway et al. (PGPUB No. US 2016/0317073) further in view of Chenal et al. (PGPUB No. US 2002/0072670).
Regarding claim 5, modified Lu teaches the ultrasound diagnostic apparatus in claim 1, as discussed above.
Lu further teaches an ultrasound diagnostic apparatus, wherein the determining unit is further configured to determine the stable segments during a real-time operation (Paragraph 0020 teaches the application of real time acquisition of the waveforms and the noise filtering).
However, the combination of Lu and Brockway is silent regarding an ultrasound diagnostic apparatus, the detection unit is further configured to, in a freeze state after the real-time operation, detect the end-diastole and the end-systole.
In an analogous imaging field of endeavor, regarding heart rate and ECG tracking of a patient, Chenal teaches an ultrasound diagnostic apparatus, the detection unit is further configured to, in a freeze state after the real-time operation, detect the end-diastole and the end-systole (Paragraphs 0024-25 teach that the view with the images can be frozen and the images of the current heart cycle can be retained. Once a loop has been selected, the ABD protocol is actuated and the protocol allows for a marker to indicate the end diastole and the end systole phases. Abstract teaches the operation of the system in real time).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Lu and Brockway with Chenal’s teaching of detecting end diastole and end systole in a freeze state. This modified apparatus would allow the user to specify specific anatomy and provide a cardiac diagnosis such that it improves obstetrical procedures (Paragraph 0002 of Chenal). Furthermore, the modification allows for the calculation of ejection fractions and the reduce tracking that is typically a painstaking, time-consuming task (Paragraphs 0002 and 0004 of Chenal).
Regarding claim 11, modified Lu teaches the electrocardiac waveform processing method in claim 7, as discussed above.
Lu further teaches a method, further comprising: a step of determining the stable segments during a real-time operation (Paragraph 0020 teaches the application of real time acquisition of the waveforms and the noise filtering).
However, the combination of Lu and Brockway is silent regarding an electrocardiac waveform processing method, a step of, in a freeze state after the real-time operation, detecting the end-diastole and the end-systole.
In an analogous imaging field of endeavor, regarding heart rate and ECG tracking of a patient, Chenal teaches an electrocardiac waveform processing method, a step of, in a freeze state after the real-time operation, detecting the end-diastole and the end-systole (Paragraphs 0024-25 teach that the view with the images can be frozen and the images of the current heart cycle can be retained. Once a loop has been selected, the ABD protocol is actuated and the protocol allows for a marker to indicate the end diastole and the end systole phases. Abstract teaches the operation of the system in real time).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Lu and Brockway with Chenal’s teaching of detecting end diastole and end systole in a freeze state. This modified method would allow the user to specify specific anatomy and provide a cardiac diagnosis such that it improves obstetrical procedures (Paragraph 0002 of Chenal). Furthermore, the modification allows for the calculation of ejection fractions and the reduce tracking that is typically a painstaking, time-consuming task (Paragraphs 0002 and 0004 of Chenal).
Claims 6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (PGPUB No. US 2010/0234731) in view of Brockway et al. (PGPUB No. US 2016/0317073) further in view of Masuda et al. (PGPUB No. US 2022/0028060).
Regarding claim 6, modified Lu teaches the ultrasound diagnostic apparatus in claim 1, as discussed above.
While Lu teaches a determining unit configured to determine, when at least two durations among durations of temporally consecutive segments in the plurality of segments satisfy a stability criterion (Paragraph 0020 teaches that the waveform is noise thresholded to determine the peak of the data and paragraph 0021 teaches that the ECG signal is applied and processed with respect to the Doppler display and image. Fig. 4 shows consecutive signal segments of the ECG), Lu is silent regarding an ultrasound diagnostic apparatus, wherein the determining unit is further configured to determine whether or not each evaluation target segment n is a provisional stable segment based on the duration Tn-1 and the duration Tn- 2 corresponding to each evaluation target segment n, and determine the provisional stable segment as the stable segment when a duration of the provisional stable segments greater than a first threshold value corresponding to bradycardia less than a second threshold value corresponding to tachycardia.
In an analogous imaging field of endeavor, regarding the utilization of ECG data and optimizing data extraction, Brockway teaches an ultrasound diagnostic apparatus, wherein the determining unit is further configured to determine whether or not each evaluation target segment n is a provisional stable segment based on the duration Tn-1 and the duration Tn- 2 corresponding to each evaluation target segment n (Paragraph 0069 teaches that the ratio of the axial information is taken according to long-term variability of successive RR intervals. See Fig. 7. This ratio is thresholded and in the case that the ratio is less than the threshold, the autonomic tone is erratic and the entropy is high. This is dispositive of the fact that the patient is in a cardiac risk. Paragraph 0070 teaches that the cardiac risk can be associated with the calculated metrics. Paragraph 0030 teaches that the time series of the cardiac intervals is calculated from the heart beat of the subject. In a case that there is cardiac risk, the subsequent intervals would also be impacted by the cardiac issue. Paragraph 0032 teaches that the characteristics can be from the group of ventricular arrhythmias, atrial fibrillation).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lu with Brockway’s teaching of thresholding with cardiac segments. This modified apparatus would allow the user to improve analysis of patient data (Paragraph 0037 of Brockway). Furthermore, the modification can assess stress, CMND, and cardiac risk (Paragraph 0042 of Brockway).
However, the combination of Lu and Brockway is silent regarding an ultrasound diagnostic apparatus, determine the provisional stable segment as the stable segment when a duration of the provisional stable segments greater than a first threshold value corresponding to bradycardia less than a second threshold value corresponding to tachycardia.
In an analogous imaging field of endeavor, regarding the utilization of ECG data and optimizing data extraction, Masuda teaches an ultrasound diagnostic apparatus, determine the provisional stable segment as the stable segment when a duration of the provisional stable segments greater than a first threshold value corresponding to bradycardia less than a second threshold value corresponding to tachycardia (Paragraph 0095 teaches that the cardio vibrational measurements can be performed and the temporal component can be used to assess if the ECG readings are changing or are remaining stable. See step 306 of Fig. 3. Paragraph 0102 teaches that the arrhythmia can be determined and the measurements are assessed to check for tachycardia or bradycardia identification. See steps 322-324 of Fig. 3. Paragraphs 0130-31 teaches that the classier is able to associate the conditions to tachycardia and bradycardia according to the cardiac cycle features associated to the conditions. Paragraph 0135 teaches that the system is able to determine the type of arrythmia or the lack thereof. Fig. 3 shows steps 322-324 to be subsequent to the step 306).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Lu and Brockway with Masuda’s teaching of the application of a primary and secondary criterion on ECG data for medical diagnosis. This modified apparatus would allow the user to have quick and accurate medical diagnosis (Paragraph 0089 of Masuda). Furthermore, the modification ECG registration provides precision in the calculation of certain metrics, such as electromechanical activation time (EMAT) or left ventricular systolic time (LVST) (Paragraph 0081 of Masuda).
Regarding claim 12, modified Lu teaches the electrocardiac waveform processing method in claim 7, as discussed above.
While Lu teaches a determining unit configured to determine, when at least two durations among durations of temporally consecutive segments in the plurality of segments satisfy a stability criterion (Paragraph 0020 teaches that the waveform is noise thresholded to determine the peak of the data and paragraph 0021 teaches that the ECG signal is applied and processed with respect to the Doppler display and image. Fig. 4 shows consecutive signal segments of the ECG), Lu is silent regarding an electrocardiac waveform processing method, determining whether or not each evaluation target segment n is a provisional stable segment based on the duration Tn-1 and the duration Tn-2 corresponding to each evaluation target segment n; and determining the provisional stable segment as the stable segment when a duration of the provisional stable segment which has satisfied the primary determination criterion is greater than a first threshold value corresponding to bradycardia less than a second threshold value corresponding to tachycardia.
In an analogous imaging field of endeavor, regarding the utilization of ECG data and optimizing data extraction, Brockway teaches an electrocardiac waveform processing method, determining whether or not each evaluation target segment n is a provisional stable segment based on the duration Tn-1 and the duration Tn-2 corresponding to each evaluation target segment n (Paragraph 0069 teaches that the ratio of the axial information is taken according to long-term variability of successive RR intervals. See Fig. 7. This ratio is thresholded and in the case that the ratio is less than the threshold, the autonomic tone is erratic and the entropy is high. This is dispositive of the fact that the patient is in a cardiac risk. Paragraph 0070 teaches that the cardiac risk can be associated with the calculated metrics. Paragraph 0030 teaches that the time series of the cardiac intervals is calculated from the heart beat of the subject. In a case that there is cardiac risk, the subsequent intervals would also be impacted by the cardiac issue. Paragraph 0032 teaches that the characteristics can be from the group of ventricular arrhythmias, atrial fibrillation).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Lu with Brockway’s teaching of thresholding with cardiac segments. This modified method would allow the user to improve analysis of patient data (Paragraph 0037 of Brockway). Furthermore, the modification can assess stress, CMND, and cardiac risk (Paragraph 0042 of Brockway).
However, the combination of Lu and Brockway is silent regarding an electrocardiac waveform processing method, determining the provisional stable segment as the stable segment when a duration of the provisional stable segment which has satisfied the primary determination criterion is greater than a first threshold value corresponding to bradycardia less than a second threshold value corresponding to tachycardia.
In an analogous imaging field of endeavor, regarding the utilization of ECG data and optimizing data extraction, Masuda teaches an electrocardiac waveform processing method, determining the provisional stable segment as the stable segment when a duration of the provisional stable segment which has satisfied the primary determination criterion is greater than a first threshold value corresponding to bradycardia less than a second threshold value corresponding to tachycardia (Paragraph 0095 teaches that the cardio vibrational measurements can be performed and the temporal component can be used to assess if the ECG readings are changing or are remaining stable. See step 306 of Fig. 3. Paragraph 0102 teaches that the arrhythmia can be determined and the measurements are assessed to check for tachycardia or bradycardia identification. See steps 322-324 of Fig. 3. Paragraphs 0130-31 teaches that the classier is able to associate the conditions to tachycardia and bradycardia according to the cardiac cycle features associated to the conditions. Paragraph 0135 teaches that the system is able to determine the type of arrythmia or the lack thereof. Fig. 3 shows steps 322-324 to be subsequent to the step 306).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Lu and Brockway with Masuda’s teaching of the application of a primary and secondary criterion on ECG data for medical diagnosis. This modified method would allow the user to have quick and accurate medical diagnosis (Paragraph 0089 of Masuda). Furthermore, the modification ECG registration provides precision in the calculation of certain metrics, such as electromechanical activation time (EMAT) or left ventricular systolic time (LVST) (Paragraph 0081 of Masuda).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
John et al. (PGPUB No. US 2007/0213600): Teaches the assessment of the segments of the ECG according to preceding elements’ differential relationship being thresholded.
Richardson (PGPUB No. US 2007/0156030): Teaches the assessment of the segments of the ECG according to preceding elements’ differential relationship being thresholded.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798
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