DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed December 8, 2025 has been entered. Claims 1-7 and 12-24 remain pending in the application, and claims 8-11 were previously cancelled. Applicant’s amendments to the claims have overcome each and every objection to the drawings and 112 rejection previously set forth in the Non-Final Office Action mailed September 16, 2025. Applicant’s amendments to the claims necessitate new grounds of rejection, as described in the Response to Arguments and 101, 102, and 103 Rejections below.
Claim Rejections - 35 USC § 101
Claims 1-7 and 12-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-7 and 12-24 are directed to a method, apparatus, and system for identifying arteriosclerosis using a computer, which is an abstract idea. Claims 1-7 and 12-24 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a process.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] – “obtaining a type of an arteriosclerosis detector in use”; and
[B1] – “determining an artery detection position corresponding to the type of the arteriosclerosis detector”.
These elements [A1]-[B1] of claim 1 are drawn to an abstract idea since they involve mental processes (“obtaining” and “determining”) that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper. Additionally, this claim does not specify what an arteriosclerosis detector is, therefore, this could be a person (i.e. physician) detecting arteriosclerosis of a patient or a generic sensor or method.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] – “terminal device”
[B2] – “wherein the arteriosclerosis detector is a device that is being used to perform arteriosclerosis measurement”;
[C2] – “displaying, by the terminal device, a detection interface comprising a human artery distribution diagram”; and
[D2] – “displaying, by the terminal device, the artery detection position on the detection interface”.
[E2] – “wherein the arteriosclerosis measurement performed by the arteriosclerosis detector is for an artery segment at the artery detection position in the human artery distribution diagram.”
These elements [A2]-[E2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the elements [C2-D2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere display of data at a high level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitations “display a detection interface” and “displaying the artery detection position on the detection interface” do not qualify as significantly more because these limitations merely describe the display of the artery detection position on an interface based on data collected by a generic arteriosclerosis detector as part of the claimed invention.
The element [A2] does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Also, the limitations [B2] and [E2] do not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the type of the arteriosclerosis detector is nothing more than a watch or a scale. Such types of detectors are conventional as evidenced by:
U.S. Patent Application Publication No. 20200121201 A1 (Redtel, Holger) discloses that a watch and wristband (or smart device) type measuring unit is conventional [0329; 0335] for detecting arterial elasticity and pulse wave velocity indicating arteriosclerosis [0250-0251]; and
U.S. Patent Application Publication No. 20170188885 A1 (Banet et al.) discloses that conventional weight-measuring scale can be used for measuring vital signs and hemodynamic parameters [0029] indicating the stiffness of the patient’s arteries [0143].
Claims 2-7 and 12-13 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exception:
Claims 2-7 and 12-13: “terminal device”;
Claims 5 and 12-13: “arteriosclerosis detector”; and
Claim 12: “watch and body fat scale”.
This claim limitation does not integrate the exception into a practical application. In particular, the element of claims 12 is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Also, each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well-known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the type of the arteriosclerosis detector is nothing more than a watch or a scale. Such types of detectors are conventional as evidenced by Redtel and Banet, as described above.
Also, this limitation from claim 12 is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions (that is, one of display) that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
The analysis of claim 14 is as follows:
Step 1: Claim 14 is drawn to a machine.
Step 2A – Prong One: Claim 14 recites an abstract idea. In particular, claim 14 recites the following limitations:
[A1] – “obtain a type of an arteriosclerosis detector”; and
[B1] – “determine an artery detection position corresponding to the type of the arteriosclerosis detector”.
These elements [A1]-[B1] of claim 14 are drawn to an abstract idea since they involve mental processes (“obtaining” and “determining”) that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper. Additionally, this claim does not specify what an arteriosclerosis detector is, therefore, this could be a person (i.e. physician) detecting arteriosclerosis of a patient or a generic sensor or method.
Step 2A – Prong Two: Claim 14 recites the following limitations that are beyond the judicial exception:
[A2] – “at least one processor and a memory, wherein the memory stores at least one instruction”;
[B2] – “obtain a type of an arteriosclerosis detector in use”; and
[C2] – “display a detection interface comprising a human artery distribution diagram”;
[D2] – “display the artery detection position in the human artery distribution diagram on the detection interface”; and
[E2] – “wherein the arteriosclerosis measurement performed by the arteriosclerosis detector is for an artery segment at the artery detection position in the human artery distribution diagram”.
These elements [A2]-[E2] of claim 14 do not integrate the exception into a practical application of the exception. In particular, the element [A2] is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). Also, the elements [B2-D2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere gathering and display of data at a high level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: Claim 14 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitations “display a detection interface” and “display the artery detection position on the detection interface” do not qualify as significantly more because these limitations merely describe the display of the artery detection position on an interface based on data collected by a generic arteriosclerosis detector as part of the claimed invention.
Also, each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well-known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the type of the arteriosclerosis detector is nothing more than a watch or a scale. Such types of detectors are conventional as evidenced by Redtel and Banet, as described above.
Claims 15-21 depend from claim 14, and recite the same abstract idea as claim 14. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claim 21: “watch and body fat scale”.
This claim limitation does not integrate the exception into a practical application. In particular, the elements of claims 21 are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Also, each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well-known elements or simply displaying the results of the algorithm that uses conventional, routine, and well-known elements. In particular, the type of the arteriosclerosis detector is nothing more than a watch or a body fat scale. Such detectors are conventional as evidenced by Redtel and Banet (as provided above with respect to the rejection of claim 1).
Also, this limitation from claim 21 is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions (that is, one of display) that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
The analysis of claim 22 is as follows:
Step 1: Claim 22 is drawn to a machine.
Step 2A – Prong One: Claim 22 recites an abstract idea. In particular, claim 22 recites the following limitations:
[A1] – “obtain a type of an arteriosclerosis detector”; and
[B1] – “determine an artery detection position corresponding to the type of the arteriosclerosis detector”.
These elements [A1]-[B1] of claim 22 are drawn to an abstract idea since they involve mental processes (“obtaining” and “determining”) that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 22 recites the following limitations that are beyond the judicial exception:
[A2] – “an arteriosclerosis detector, the arteriosclerosis detector configured to detect a pulse wave velocity of a use”;
[B2] – “an apparatus, wherein the apparatus comprises at least one processor and a memory, and wherein the memory stores at least one instruction”;
[C2] – “wherein the arteriosclerosis detector is a device that is being used to perform arteriosclerosis measurement”;
[D2] – “display a detection interface comprising a human artery distribution diagram”;
[E2] – “display the artery detection position in the human artery distribution diagram on the detection interface”; and
[F2] – “wherein the arteriosclerosis measurement performed by the arteriosclerosis detector is for an artery segment at the artery detection position in the human artery distribution diagram”.
These elements [A2]-[F2] of claim 22 do not integrate the exception into a practical application of the exception. In particular, elements [A2] and [C2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a high level of generality. Element [B2] is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). Also, the elements [D2-E2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere gathering and display of data at a high level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: Claim 22 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “an arteriosclerosis detector, the arteriosclerosis detector configured to detect a pulse wave velocity of a use” does not qualify as significantly more because this limitation merely describes a detector used to collect pulse wave velocity information. Also, the recitation “an arteriosclerosis detector, the arteriosclerosis detector configured to detect a pulse wave velocity of a use” is merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the arteriosclerosis detector is nothing more than a sensor detecting pulse wave velocity. Such sensors are conventional as evidenced by Redtel (as provided above with respect to the rejection of claim 1).
Claims 23-24 depend from claim 22, and recite the same abstract idea as claim 22. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claim 23: “a smart watch, a smart band, and a body fat scale”.
This claim limitation does not integrate the exception into a practical application. In particular, the elements of claims 23 are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Also, each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the type of the arteriosclerosis detector is nothing more than a smart watch, smart band, or a body fat scale. Such detectors are conventional as evidenced by Redtel and Banet (as provided above with respect to the rejection of claim 1).
Also, this limitation from claim 23 is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions (that is, one of display) that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 7, 13-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190254531 A1 (Shadforth et al.).
Regarding claim 1, Shadforth teaches a method for generating an arteriosclerosis detection interface ([0002-0003] “the present disclosure relates to methods to visualize localization and severity coronary artery blockages”; Atherosclerosis is a common type of arteriosclerosis characterized by blockages in the arteries), wherein the method comprises:
obtaining, by a terminal device, a type of an arteriosclerosis detector in use ([0005]; [0084] “The graphical user interface 100 can be used, for example, to direct diagnostics and treatment of a patient with coronary disease at least in part along with other studies and assessments.”; [0086-0090] “each of the available cardiac assessment studies are presented with a header region”), wherein the arteriosclerosis detector is a device that is being used to perform arteriosclerosis measurement;
displaying, by the terminal device, a detection interface comprising a human artery distribution diagram ([0008] “a display (e.g., a graphical user interface and/or a report) to present summary information and visualizations of myocardial tissue overlaid with visualizations of data (e.g., generated from phase space tomography analysis) that identifies myocardium at risk and/or coronary arteries that are blocked (e.g., to be used, at least in part, to direct treatment of a patient associated with the data)”; [0084] “The visualizations, for a given report of a study, include multiple depictions of a rotatable three-dimensional anatomical map 106 of cardiac regions of affected myocardium, an equivalent, corresponding two-dimensional view of the major coronary artery 114, and an equivalent, corresponding two-dimensional 17-segment view 116”; Figs. 1-5A, 9-13);
determining, by the terminal device, an artery detection position corresponding to the type of the arteriosclerosis detector ([0008] “visualization, from a data set that identifies myocardium at risk and coronary arteries that are blocked, the data set comprising a plurality of parameters (e.g., coronary risk values or artery blockage percent values, etc.) each associated with a corresponding heart segment of a plurality of heart segments, wherein each of the heart segments correspond to an anatomical structure of the heart”);
displaying, by the terminal device, the artery detection position in the human artery distribution diagram on the detection interface ([0008] “the plurality of graphical visualizations to be presented (e.g., in the graphical user interface or as the report) on a display of a computing device or to be stored as a report file (e.g., an electronic file or a tangible file)”; Figs. 1-5A, 9-13), wherein the arteriosclerosis measurement performed by the arteriosclerosis detector is for an artery segment at the artery detection position in the human artery distribution diagram ([0007] “The analysis of the physiological signals predicts the presence and location of significant coronary artery disease”; [0082] “Varying degrees of locational sensitivity may also be presented, such as distinguishing between occlusions that occur on the proximal, mid, or distal locations on each artery and their distributions or focusing only on identifying the major artery.”).
Regarding claim 2, Shadforth teaches the method according to claim 1, wherein displaying, by the terminal device, the artery detection position in the human artery distribution diagram on the detection interface comprises:
highlighting, by the terminal device, the artery segment at the artery detection position in the human artery distribution diagram ([0008] “one or more second graphical elements (e.g., a coloration, surface texture, or animation) that are overlaid over, or that replaces, a surface area of the plurality of surfaces areas of the first graphical element, the surface area corresponding a given heart segment having a parameter that identifies myocardium at risk (or include one or more coronary arteries that are blocked).”).
Regarding claim 3, Shadforth teaches the method according to claim 2, wherein before displaying, by the terminal device, the detection interface, the method further comprises:
obtaining, by the terminal device, gender information of a to-be-detected user ([0120] “a report 400, as a non-limiting example, includes the patient data and medical record data. The patient data may include patient name, gender, and age”); and
determining, by the terminal device, a type of the human artery distribution diagram based on the gender information of the to-be-detected user ([0120] “a report 400, as a non-limiting example, includes the patient data and medical record data. The patient data may include patient name, gender, and age. The medical record data may include a record identifier 410 and attending doctor identifier 412. Report 400 as shown in FIG. 4 also includes summary information (as previously discussed), such as caption 415 and the “Findings” section 417 of summary information (which may or may not include a key 419 for the reader mapping segment identifiers to the name of a given artery as well as any footnotes or other information or indicia).”).
Regarding claim 4, Shadforth teaches the method according to claim 2, wherein highlighting, by the terminal device, the artery segment at the artery detection position on the detection interface comprises:
enabling, by the terminal device, the artery segment at the artery detection position in the human artery distribution diagram to blink ([0008] “one or more second graphical elements (e.g., a coloration, surface texture, or animation) that are overlaid over, or that replaces, a surface area of the plurality of surfaces areas of the first graphical element, the surface area corresponding a given heart segment having a parameter that identifies myocardium at risk (or include one or more coronary arteries that are blocked).”); or
displaying, by the terminal device, the artery segment at the artery detection position in the human artery distribution diagram, and hiding, by the terminal device, remaining artery segments ([0154] “the graphical user interface 100 can present depictions of the model 902 with only the three-dimensional objects associated with the left-side segments of the heart model presented, or both the left-side segments and the right-side segments of the heart model presented”).
Regarding claim 5, Shadforth teaches the method according to claim 2, wherein the method further comprises:
obtaining, by the terminal device, a detection result from the arteriosclerosis detector ([0120] “Report 400 as shown in FIG. 4 also includes summary information (as previously discussed), such as caption 415 and the “Findings” section 417 of summary information (which may or may not include a key 419 for the reader mapping segment identifiers to the name of a given artery as well as any footnotes or other information or indicia).”); and
generating, by the terminal device, a detection result interface based on the detection result, wherein the detection result interface comprises the human artery distribution diagram, and the detection result pops up at the artery detection position in the human artery distribution diagram ([0019] “the graphical user interface and the report is caused to be displayed (e.g., via a web portal) on a stationary or a mobile computing device associated with a client (e.g., a physician, a clinician, a technician, a patient, an administrator, etc.)”).
Regarding claim 7, Shadforth teaches the method according to claim 1, wherein the method further comprises:
generating, by the terminal device, prompt information for viewing personal information of a user ([0121] “As shown in the embodiments of FIGS. 1-3, the report 400 may be viewed electronically, e.g., in a portable document format (PDF), as an image file, or as any number of other document types, when the button 144 (“View Report” 144) is selected by the user”); and
expanding and displaying, by the terminal device, the personal information of the user according to a tap-to-view instruction of the user ([0087] “each of the header regions 140a, 140b includes a corresponding graphical widget (shown as 138a and 138b) that expands or collapses the report for that study”; [0189] “A user of the healthcare provider portal 2420 can select a patient, which triggers the healthcare provider portal 2420 to deliver subset or all of the acquired measurement and analysis for that patient. The analysis reports include, in some embodiments, an HTML templated report and interactive 3D objects.”), wherein the personal information of the user comprises one or more of name, gender, age, contact information, and historical medical treatment data ([0120] “The patient data may include patient name, gender, and age”).
Regarding claim 13, Shadforth teaches the method according to claim 1, wherein the method further comprises:
displaying, by the terminal device, an identifier of the arteriosclerosis detector, wherein the identifier corresponds to the type of the arteriosclerosis detector ([0120] “The medical record data may include a record identifier 410 and attending doctor identifier 412.”).
Regarding claim 14, Shadforth teaches an apparatus, comprising:
at least one processor ([0031] “processor”) and a memory ([0170] “RAM, ROM, storage”), wherein the memory stores at least one instruction which, when executed by the at least one processor ([0170] “The processor may be communicatively coupled to RAM, ROM, storage, database, I/O devices, and interface. The processor may be configured to execute sequences of computer program instructions to perform various processes.”), causes the apparatus to:
obtain a type of an arteriosclerosis detector, wherein the arteriosclerosis detector is a device that is being used to perform arteriosclerosis measurement ([0005]; [0084] “The graphical user interface 100 can be used, for example, to direct diagnostics and treatment of a patient with coronary disease at least in part along with other studies and assessments.”; [0086-0090] “each of the available cardiac assessment studies are presented with a header region”);
display a detection interface comprising a human artery distribution diagram ([0008] “a display (e.g., a graphical user interface and/or a report) to present summary information and visualizations of myocardial tissue overlaid with visualizations of data (e.g., generated from phase space tomography analysis) that identifies myocardium at risk and/or coronary arteries that are blocked (e.g., to be used, at least in part, to direct treatment of a patient associated with the data)”; [0084] “The visualizations, for a given report of a study, include multiple depictions of a rotatable three-dimensional anatomical map 106 of cardiac regions of affected myocardium, an equivalent, corresponding two-dimensional view of the major coronary artery 114, and an equivalent, corresponding two-dimensional 17-segment view 116”; Figs. 1-5A, 9-13);
determine an artery detection position corresponding to the type of the arteriosclerosis detector ([0008] “visualization, from a data set that identifies myocardium at risk and coronary arteries that are blocked, the data set comprising a plurality of parameters (e.g., coronary risk values or artery blockage percent values, etc.) each associated with a corresponding heart segment of a plurality of heart segments, wherein each of the heart segments correspond to an anatomical structure of the heart”); and
display the artery detection position in the human artery distribution diagram on the detection interface ([0008] “the plurality of graphical visualizations to be presented (e.g., in the graphical user interface or as the report) on a display of a computing device or to be stored as a report file (e.g., an electronic file or a tangible file)”; Figs. 1-5A, 9-13), wherein the arteriosclerosis measurement performed by the arteriosclerosis detector is for an artery segment at the artery detection position in the human artery distribution diagram ([0007] “The analysis of the physiological signals predicts the presence and location of significant coronary artery disease”; [0082] “Varying degrees of locational sensitivity may also be presented, such as distinguishing between occlusions that occur on the proximal, mid, or distal locations on each artery and their distributions or focusing only on identifying the major artery.”).
Regarding claim 15, Shadforth teaches the apparatus according to claim 14, wherein the at least one instruction causes the apparatus to:
highlight the artery segment at the artery detection position in the human artery distribution diagram ([0008] “one or more second graphical elements (e.g., a coloration, surface texture, or animation) that are overlaid over, or that replaces, a surface area of the plurality of surfaces areas of the first graphical element, the surface area corresponding a given heart segment having a parameter that identifies myocardium at risk (or include one or more coronary arteries that are blocked).”).
Regarding claim 16, Shadforth teaches the apparatus according to claim 15, wherein the at least one instruction causes the apparatus to:
obtain gender information of a to-be-detected user ([0120] “a report 400, as a non-limiting example, includes the patient data and medical record data. The patient data may include patient name, gender, and age”); and
determine a type of the human artery distribution diagram based on the gender information of the to-be-detected user ([0120] “a report 400, as a non-limiting example, includes the patient data and medical record data. The patient data may include patient name, gender, and age. The medical record data may include a record identifier 410 and attending doctor identifier 412. Report 400 as shown in FIG. 4 also includes summary information (as previously discussed), such as caption 415 and the “Findings” section 417 of summary information (which may or may not include a key 419 for the reader mapping segment identifiers to the name of a given artery as well as any footnotes or other information or indicia).”).
Regarding claim 17, Shadforth teaches the apparatus according to claim 15, wherein the at least one instruction causes the apparatus to:
enable the artery segment at the artery detection position in the human artery distribution diagram to blink ([0008] “one or more second graphical elements (e.g., a coloration, surface texture, or animation) that are overlaid over, or that replaces, a surface area of the plurality of surfaces areas of the first graphical element, the surface area corresponding a given heart segment having a parameter that identifies myocardium at risk (or include one or more coronary arteries that are blocked).”); or
display the artery segment at the artery detection position in the human artery distribution diagram, and hide remaining artery segments ([0154] “the graphical user interface 100 can present depictions of the model 902 with only the three-dimensional objects associated with the left-side segments of the heart model presented, or both the left-side segments and the right-side segments of the heart model presented”).
Regarding claim 18, Shadforth teaches the apparatus according to claim 15, wherein the at least one instruction causes the apparatus to:
obtain a detection result from the arteriosclerosis detector ([0120] “Report 400 as shown in FIG. 4 also includes summary information (as previously discussed), such as caption 415 and the “Findings” section 417 of summary information (which may or may not include a key 419 for the reader mapping segment identifiers to the name of a given artery as well as any footnotes or other information or indicia).”); and
generate a detection result interface based on the detection result, wherein the detection result interface comprises the human artery distribution diagram, and the detection result pops up at the artery detection position in the human artery distribution diagram ([0019] “the graphical user interface and the report is caused to be displayed (e.g., via a web portal) on a stationary or a mobile computing device associated with a client (e.g., a physician, a clinician, a technician, a patient, an administrator, etc.)”).
Regarding claim 20, Shadforth teaches the apparatus according to claim 14, wherein the at least one instruction causes the apparatus to:
generate prompt information for viewing personal information of a user ([0121] “As shown in the embodiments of FIGS. 1-3, the report 400 may be viewed electronically, e.g., in a portable document format (PDF), as an image file, or as any number of other document types, when the button 144 (“View Report” 144) is selected by the user”); and
display the personal information of the user according to a tap-to-view instruction of the user, wherein the personal information of the user comprises one or more of name, gender, age, contact information, and historical medical treatment data ([0087] “each of the header regions 140a, 140b includes a corresponding graphical widget (shown as 138a and 138b) that expands or collapses the report for that study”; [0189] “A user of the healthcare provider portal 2420 can select a patient, which triggers the healthcare provider portal 2420 to deliver subset or all of the acquired measurement and analysis for that patient. The analysis reports include, in some embodiments, an HTML templated report and interactive 3D objects.”), wherein the personal information of the user comprises one or more of name, gender, age, contact information, and historical medical treatment data ([0120] “The patient data may include patient name, gender, and age”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 6 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190254531 A1 (Shadforth et al.) in view of US 20090030328 A1 (Harpas et al.)
Regarding claim 6, Shadforth teaches the method according to claim 5, wherein the method further comprises:
after the detection result pops up, generating, by the terminal device, prompt information for viewing an arteriosclerosis degree at a heart position in the human artery distribution diagram ([0137] “via buttons 906a, 906b, 906c, 906d, to review detail structures of the segments and arteries of interest”; [0028] “the plurality of heart segments comprises 17 heart segments each corresponding to an anatomical structure of the heart.); and
popping up, by the terminal device, arteriosclerosis degree information at the heart position in the human artery distribution diagram according to a tap-to-view instruction of a user ([0008] “visualization, from a data set that identifies myocardium at risk and coronary arteries that are blocked, the data set comprising a plurality of parameters (e.g., coronary risk values or artery blockage percent values, etc.) each associated with a corresponding heart segment of a plurality of heart segments, wherein each of the heart segments correspond to an anatomical structure of the heart”; [0121] “the report 400 may be viewed electronically, e.g., in a portable document format (PDF), as an image file, or as any number of other document types, when the button 144 (“View Report” 144) is selected by the user”)
Shadforth does not teach an aortic arteriosclerosis degree and wherein the aortic arteriosclerosis degree information comprises an aortic pulse wave velocity and an aortic condition analysis result.
However,
Harpas teaches an aortic arteriosclerosis degree ([0005] “PWV is suggested as a marker of arteriosclerotic load or cardiovascular risk”; [0089] “aortic PWV is calculated”) and wherein the aortic arteriosclerosis degree information comprises an aortic pulse wave velocity and an aortic condition analysis result ([0061] “The features from these waves relate to aortic pulse wave velocity (PWV) or to aortic arterial stiffness directly.”; [0070]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Shadforth to include an aortic arteriosclerosis degree, an aortic pulse wave velocity, and an aortic condition analysis result. One would have been motivated to make this modification because aortic pulse wave velocity is strongly associated with the presence and extent of atherosclerosis and with aortic structural breakdown and constitutes a forceful marker and predictor of cardiovascular risk in hypertensive patients, as suggested by Harpas [0005].
Regarding claim 19, Shadforth teaches the apparatus according to claim 18, wherein the at least one instruction causes the apparatus to:
after the detection result pops up, generate prompt information for viewing an arteriosclerosis degree at a heart position in the human artery distribution diagram ([0137] “via buttons 906a, 906b, 906c, 906d, to review detail structures of the segments and arteries of interest”; [0028] “the plurality of heart segments comprises 17 heart segments each corresponding to an anatomical structure of the heart.); and
pop up arteriosclerosis degree information at the heart position in the human artery distribution diagram according to a tap-to-view instruction of a user ([0008] “visualization, from a data set that identifies myocardium at risk and coronary arteries that are blocked, the data set comprising a plurality of parameters (e.g., coronary risk values or artery blockage percent values, etc.) each associated with a corresponding heart segment of a plurality of heart segments, wherein each of the heart segments correspond to an anatomical structure of the heart”; [0121] “the report 400 may be viewed electronically, e.g., in a portable document format (PDF), as an image file, or as any number of other document types, when the button 144 (“View Report” 144) is selected by the user”).
Shadforth does not explicitly teach an aortic arteriosclerosis degree and wherein the aortic arteriosclerosis degree information comprises an aortic pulse wave velocity and an aortic condition analysis result.
However,
Harpas teaches an aortic arteriosclerosis degree ([0005] “PWV is suggested as a marker of arteriosclerotic load or cardiovascular risk”; [0089] “aortic PWV is calculated”) and wherein the aortic arteriosclerosis degree information comprises an aortic pulse wave velocity and an aortic condition analysis result ([0061] “The features from these waves relate to aortic pulse wave velocity (PWV) or to aortic arterial stiffness directly.”; [0070]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus taught by Shadforth to include an aortic arteriosclerosis degree, an aortic pulse wave velocity, and an aortic condition analysis result. One would have been motivated to make this modification because aortic pulse wave velocity is strongly associated with the presence and extent of atherosclerosis and with aortic structural breakdown and constitutes a forceful marker and predictor of cardiovascular risk in hypertensive patients, as suggested by Harpas [0005].
Claims 12 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190254531 A1 (Shadforth et al.) in view of US 20200121201 A1 (Redtel, Holger).
Regarding claim 12, Shadforth teaches the method according to claim 1 wherein the method further comprises,
displaying, by the terminal device, a first artery detection position and displaying a second artery detection position ([0091] “Two data sets are presented in the exemplary visualizations of the embodiment of the graphical user interface 100—regions of myocardium at risk and blockages of major arteries in the heart. The two-dimensional view of the major coronary artery 114 presents location information associated with the blockage within the major arteries and the severity of the blockage(s)”).
Shadforth does not teach displaying, by the terminal device, a first artery detection position when the type of the arteriosclerosis detector is watch; and displaying, by the terminal device, a second artery detection position when the type of the arteriosclerosis detector is body fat scale.
However,
Redtel teaches displaying, by the terminal device, a first artery detection position when the type of the arteriosclerosis detector is watch; and displaying, by the terminal device, a second artery detection position when the type of the arteriosclerosis detector is body fat scale ([0340]; [0345] “The mobile solution, such as a smart device, for example a watch or smartphone, is preferred here.”; [0363] “output data or calculated results are transmitted to an analysis unit or display unit by wireless means, e.g., with the Bluetooth standard.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Shadforth to include a watch or a body fat scale. One would have been motivated to make this modification because a structure such as a watch band allows for optimal adjustment of the applied pressure of the watch against the wrist for easy positioning on the surface of the skin to measure parameters of the cardiovascular system (including arteriosclerosis ([0251]) in a mobile way, as suggested by Redtel [0335-0337].
Regarding claim 21, Shadforth teaches the apparatus according to claim 14, wherein the at least one instruction causes the apparatus to:
display a first artery detection position and display a second artery detection position ([0091] “Two data sets are presented in the exemplary visualizations of the embodiment of the graphical user interface 100—regions of myocardium at risk and blockages of major arteries in the heart. The two-dimensional view of the major coronary artery 114 presents location information associated with the blockage within the major arteries and the severity of the blockage(s)”).
Shadforth does not teach display a first artery detection position when the type of the arteriosclerosis detector is watch; and display a second artery detection position when the type of the arteriosclerosis detector is body fat scale.
However,
Redtel teaches display a first artery detection position when the type of the arteriosclerosis detector is watch; and display a second artery detection position when the type of the arteriosclerosis detector is body fat scale ([0340]; [0345] “The mobile solution, such as a smart device, for example a watch or smartphone, is preferred here.”; [0363] “output data or calculated results are transmitted to an analysis unit or display unit by wireless means, e.g., with the Bluetooth standard.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus taught by Shadforth to include a watch or a body fat scale. One would have been motivated to make this modification because a structure such as a watch band allows for optimal adjustment of the applied pressure of the watch against the wrist for easy positioning on the surface of the skin to measure parameters of the cardiovascular system (including arteriosclerosis ([0251]) in a mobile way, as suggested by Redtel [0335-0337].
Regarding claim 22, Shadforth teaches an arteriosclerosis detection system, wherein the system comprises:
an arteriosclerosis detector ([0005] “measurements of the heart in a non-invasive procedure (e.g., via phase space tomography analysis)”); and
an apparatus, wherein the apparatus comprises at least one processor ([0031] “processor”) and a memory ([0170] “RAM, ROM, storage”), and wherein the memory stores at least one instruction ([0170] “The processor may be communicatively coupled to RAM, ROM, storage, database, I/O devices, and interface. The processor may be configured to execute sequences of computer program instructions to perform various processes.”) which, when executed by the at least one processor, causes the apparatus to:
obtain a type of the arteriosclerosis detector, wherein the arteriosclerosis detector is a device that is being used to perform arteriosclerosis measurement ([0084] “The graphical user interface 100 can be used, for example, to direct diagnostics and treatment of a patient with coronary disease at least in part along with other studies and assessments.”; [0086-0090] “each of the available cardiac assessment studies are presented with a header region”);
display a detection interface comprising a human artery distribution diagram ([0008] “a display (e.g., a graphical user interface and/or a report) to present summary information and visualizations of myocardial tissue overlaid with visualizations of data (e.g., generated from phase space tomography analysis) that identifies myocardium at risk and/or coronary arteries that are blocked (e.g., to be used, at least in part, to direct treatment of a patient associated with the data)”; [0084] “The visualizations, for a given report of a study, include multiple depictions of a rotatable three-dimensional anatomical map 106 of cardiac regions of affected myocardium, an equivalent, corresponding two-dimensional view of the major coronary artery 114, and an equivalent, corresponding two-dimensional 17-segment view 116”; Figs. 1-5A, 9-13);
determine an artery detection position corresponding to the type of the arteriosclerosis detector ([0008] “visualization, from a data set that identifies myocardium at risk and coronary arteries that are blocked, the data set comprising a plurality of parameters (e.g., coronary risk values or artery blockage percent values, etc.) each associated with a corresponding heart segment of a plurality of heart segments, wherein each of the heart segments correspond to an anatomical structure of the heart”); and
display the artery detection position on the detection interface in the human artery distribution diagram ([0008] “the plurality of graphical visualizations to be presented (e.g., in the graphical user interface or as the report) on a display of a computing device or to be stored as a report file (e.g., an electronic file or a tangible file)”; Figs. 1-5A, 9-13), wherein the arteriosclerosis measurement performed by the arteriosclerosis detector is for an artery segment at the artery detection position in the human artery distribution diagram ([0007] “The analysis of the physiological signals predicts the presence and location of significant coronary artery disease”; [0082] “Varying degrees of locational sensitivity may also be presented, such as distinguishing between occlusions that occur on the proximal, mid, or distal locations on each artery and their distributions or focusing only on identifying the major artery.”).
Shadforth does not explicitly teach the arteriosclerosis detector configured to detect a pulse wave velocity of a user.
However,
Redtel teaches the arteriosclerosis detector configured to detect a pulse wave velocity of a user ([0058] “the system is configured to measure … pulse wave velocity”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system taught by Shadforth to include the arteriosclerosis detector configured to detect a pulse wave velocity of a user. One would have been motivated to make this modification because the elasticity of the arteries, causing arteriosclerosis, is closely related to the pulse wave velocity [0250-0252], which can help monitor impending heart attacks and/or blood pressure, as suggested by Redtel.
Regarding claim 23, Shadforth teaches the arteriosclerosis detection system according to claim 22.
Shadforth does not explicitly teach wherein the arteriosclerosis detector comprises one or more of a smart watch, a smart band, and a body fat scale.
However,
Redtel teaches wherein the arteriosclerosis detector comprises one or more of a smart watch, a smart band, and a body fat scale ([0345] “The mobile solution, such as a smart device, for example a watch or smartphone, is preferred here.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system taught by Shadforth to include a smart watch, smart band, or body fat scale. One would have been motivated to make this modification because a structure such as a watch band allows for optimal adjustment of the applied pressure of the watch against the wrist for easy positioning on the surface of the skin to measure parameters of the cardiovascular system (including arteriosclerosis ([0251]) in a mobile way, as suggested by Redtel [0335-0337].
Regarding claim 24, Shadforth teaches the arteriosclerosis detection system according to claim 22, wherein displaying the artery detection position in the human artery distribution diagram on the detection interface comprises:
highlighting the artery segment at the artery detection position in the human artery distribution diagram ([0008] “one or more second graphical elements (e.g., a coloration, surface texture, or animation) that are overlaid over, or that replaces, a surface area of the plurality of surfaces areas of the first graphical element, the surface area corresponding a given heart segment having a parameter that identifies myocardium at risk (or include one or more coronary arteries that are blocked).”).
Response to Arguments
Applicant's arguments filed December 8, 2025 have been fully considered but they are not persuasive. With respect to the 101 Rejections in the Non-Final Office Action (See Pages 9-10 of Applicant’s Response “Claim Rejection – 35 U.S.C. §101”), Applicant argues that the amended claims do not include a mental process and provide a practical application of arteriosclerosis measurement and contributes to an improved technical solution of a practical problem as described in the specification.
With respect to the 102/103 Rejections in the Non-Final Office Action (See Pages 10-12 of Applicant’s Response “Claim Rejection – 35 U.S.C. §102/103”), Applicant argues that Shadforth does not teach the amended claim limitation reciting “wherein the arteriosclerosis measurement performed by the arteriosclerosis detector is for an artery segment at the artery detection position in the human artery distribution diagram” and “displaying, by the terminal device, the artery detection position in the human artery distribution diagram on the detection interface”.
MPEP § 2111 discusses proper claim interpretation, including giving claims their broadest reasonable interpretation in light of the specification during examination. Under broadest reasonable interpretation (BRI), the words of a claim must be given their plain meaning unless such meaning is inconsistent with the specification, and it is improper to import claim limitations from the specification into the claim. The requirements for anticipation are discussed in MPEP § 2131. MPEP § 2131 notes that “To reject a claim as anticipated by a reference, the disclosure must teach every element required by the claim under its broadest reasonable interpretation.”
Under BRI, the “human artery distribution diagram” may be interpreted to be any visualization of human arteries. Shadforth depicts human artery distribution diagrams in Figs.1-5A, 9-13. Additionally, under BRI, the terminal device is merely a generic computer, as described in the 101 rejections above. Under BRI, the arteriosclerosis detector is a generic sensor, as described in the 101 rejections above. Claims 12 and 21 describe the arteriosclerosis detector as being a watch or a body fat scale, which are conventional in the art as disclosed by Redtel and Banet cited above. Claim 22 describes the arteriosclerosis detector being configured to detect a pulse wave velocity of a user, which is conventional in the art as disclosed by Redtel cited above. Therefore, the arteriosclerosis measurement and artery detection position are mental processes but for the recitation of generic computer components and sensors. As written, the claims are merely gathering data with generic sensors and displaying the output.
Claims 2-7, 12-13, 15-21, and 23-24 are rejected because the rejections of claims 1, 1,4, and 22 are proper and the prior art teaches or suggests all the features of these claims for the reasons described in the 102 and 103 Rejections.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791