DETAILED ACTION
Acknowledgements
This office action is in response to the claims filed March 17, 2026.
Claims 1, 2, 5, 8, and 9 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 .
Request for Continued Examination
Claims 1, 2, 5, 8, and 9 are still pending. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/17/2026 has been entered.
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, 2, 5, 8, and 9 are rejected to under 35 U.S.C 101 as not being directed to eligible subject matter based on the grounds set out in detail below:
Independent Claims 1 and 8:
Eligibility Step 1 (does the subject matter fall within a statutory category?):
Independent Claim 1 falls within the statutory category of machine
Independent Claim 8 falls within the statutory category of process
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Independent claims 1 and 8 claimed invention (claim 1 being representative) is directed to an abstract idea without significantly more.
The claim elements which set forth the abstract idea (claim 1 being representative) are:
calculating cardiovascular disease risk parameters of fractional flow reserve (FFR), and wall shear stress (WSS), of a sleep apnea patient, comprising:
receive biometric information of at least systolic blood pressure, diastolic blood pressure, a cardiovascular computed tomography (CT) image, an upper airway CT image, red blood cell density and blood calcium concentration of a target patient;
transform the biometric information input, into a boundary condition an inlet boundary condition, an outlet boundary condition, and a fluid viscosity condition for performing computational fluid dynamics (CFD),
calculate a pulsatile flow by using the systolic blood pressure and the diastolic blood pressure among the input biometric information, and to transform the calculated pulsatile flow into the inlet boundary condition to set the inlet boundary condition applied during the CFD;
predict an apnea-hypopnea index (AHI) value of the target patient for a period the target patient is sleeping by utilizing the cardiovascular CT image and the upper airway CT image among the input biometric information,
and to apply the predicted AHI value together with the input biometric information to transform a result into the outlet boundary condition applied during the CFD,
wherein predicts the AHI value of the target patient by using, as input data, one or more CFD flow factors obtained by performing computational fluid analysis on upper airway morphology data generated through three-dimensional modeling of an upper airway based on an upper airway CT image and a cardiovascular CT image of a training patient, and by using, as output data, an AHI value measured from the training patient;
calculate a blood viscosity using the red blood cell density and the blood calcium concentration among the input biometric information, and to transform the calculated blood viscosity into the fluid viscosity condition applied during the CFD;
perform cardiovascular CFD simulation of the target patient by applying the inlet boundary condition, the outlet boundary condition, and the fluid viscosity condition converted,
wherein the CFD simulation is to perform a blood flow/vascular simulation for blood vessel modeling with a boundary defined by the inlet boundary condition, the outlet boundary condition, and the fluid viscosity condition;
provide compare the cardiovascular disease risk parameters FFR and WSS of the target patient from a simulation result with a boundary value set in advance for each result variable to determine the cardiovascular disease risk for the target patient based on the target patient's sleep apnea severity diagnostic variable value;
The abstract idea is merely performing computational fluid dynamics mathematical equations and machine learning modelling to generate a quantitative result that is further analyzed mentally or by pen and paper. There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word "calculating" in order to be considered a mathematical calculation. For example, a step of "determining" a variable or number using mathematical methods or "performing" a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation. E.g. “system for calculating cardiovascular disease risk parameters of fractional flow reserve (FFR), and wall shear stress (WSS), of a sleep apnea patient” which falls within “mathematical calculations” See MPEP § 2106.04(a)(2).
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): For Independent claims 1 and 8 this judicial exception is not integrated into a practical application.
Independent claim 1 recites the additional claim elements below:
A computer implemented system
a biometric information input unit
a boundary condition transforming unit
a first transforming unit
a second transforming unit
a pretrained learning model
a pre-set transformation model
a third transforming unit
a CFD performing unit
a result analyzing unit
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
Within the noted above additional claim elements, a computer implemented system, is recited as performing the abstract idea and is merely invoking the element as a tool to “apply-it” or an equivalent and therefore is no more than using these generic computer elements as a tool to implement the abstract idea. (see instant application [0040])
Within the noted above additional claim elements, a biometric information input unit, is recited in the manner of merely invoking the element as a tool to “apply-it” or an equivalent (e.g. configured to) to gather and analyze data
Within the noted above additional claim elements, a boundary condition transforming unit, is recited in the manner of merely invoking the element as a tool to “apply-it” or an equivalent (e.g. configured to) to gather and analyze data
Within the noted above additional claim elements, a CFD performing unit, is recited in the manner of merely invoking the element as a tool to “apply-it” or an equivalent (e.g. configured to) to gather and analyze data
Within the noted above additional claim elements, a result analyzing unit, is recited in the manner of merely invoking the element as a tool to “apply-it” or an equivalent (e.g. configured to) to gather and analyze data
Within the noted above additional claim elements, a first, second, and third transforming unit, are recited in the manner of merely invoking the element as a tool to “apply-it” or an equivalent (e.g. configured to) to gather and analyze data
Within the noted above additional claim elements, a pre-trained learning model and a pre-set transformation model, are recited in the manner of merely invoking the element as a tool to “apply-it” or an equivalent to analyze data
Independent claim 8 recites the additional element below not already recited in claim 1:
integrated mathematical processing unit of a computer
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
Within the noted above additional claim elements, integrated mathematical processing unit of a computer, is recited in the manner of merely invoking the element as a tool to “apply-it” or an equivalent to execute the abstract idea
Eligibility Step 2B (Does the claim amount to significantly more?): The independent claims 1 and 8 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as analyzed above in step 2A prong 2, these additional elements, are claimed with a high level of generality whether viewing the claim as a whole, each additional element individually, or as an ordered combination with the abstract idea, amounting to no more than merely using the additional elements as “apply-it” therefore, the claims do not amount to significantly more. The claims are patent ineligible.
Dependent Claims 2, 5, and 9:
Eligibility Step 1 (does the subject matter fall within a statutory category?):
The dependent claims 2 and 5 are fall within the statutory category of machine
The dependent claim 9 falls within the statutory category of process
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Dependent claims 2, 5, and 9 claimed invention is directed to an abstract idea without significantly more. The claims further limit the abstract idea by (1) the equation used and (2) the data required thus inheriting the same abstract idea which falls within “mathematical calculations”. See MPEP § 2106.04(a)(2).
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): For claims 2, 5, and 9 this judicial exception is not integrated into a practical application.
The claims recite no additional elements not already recited in the independent claims and purely recite the abstract idea.
The claims do not overcome eligibility step 2A-2 and do not integrate into a practical application.
Eligibility Step 2B (Does the claim amount to significantly more?): There are no additional elements considered not already considered in the independent claims thus the dependent claims do not amount to significantly more than the judicial exception. The claims are not patent eligible.
Claim Interpretation - 35 USC § 112
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.
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 limitations in claim 1, 2, 5, and 8 are:
a biometric information input unit configured to receive…[…]…
a boundary condition transforming unit configured to transform…[…]…
a first transforming unit configured to calculate …[…]…
a second transforming unit configured to predict…[…]…
and a third transforming unit configured to calculate…[…]…
a CFD performing unit configured to perform …[…]…
and a result analyzing unit configured to provide …[…]…
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 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 them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Subject Matter Free of Prior Art
Claims 1, 2, 5, 8 and 9 would be allowable if they overcame the 35 U.S.C 101 rejection of record. The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within the independent claims (Claim 1 recited here as representative). In particular, the cited prior art of record fails to expressly teach or suggest the combination of: “A computer implemented system for calculating cardiovascular disease risk parameters of fractional flow reserve (FFR), and wall shear stress (WSS), of a sleep apnea patient, the system comprising: a biometric information input unit configured to receive biometric information of at least systolic blood pressure, diastolic blood pressure, a cardiovascular computed tomography (CT) image, an upper airway CT image, red blood cell density and blood calcium concentration of a target patient; a boundary condition transforming unit configured to transform the biometric information input to the biometric information input unit, into a boundary condition an inlet boundary condition, an outlet boundary condition, and a fluid viscosity condition for performing computational fluid dynamics (CFD), wherein the boundary condition transforming unit includes: a first transforming unit configured to calculate a pulsatile flow by using the systolic blood pressure and the diastolic blood pressure among the input biometric information, and to transform the calculated pulsatile flow into the inlet boundary condition to set the inlet boundary condition applied during the CFD; a second transforming unit configured to predict an apnea-hypopnea index (AHI) value of the target patient for a period the target patient is sleeping by utilizing the cardiovascular CT image and the upper airway CT image among the input biometric information through a learning model, and to apply the predicted AHI value together with the input biometric information to a pre-set transformation model to transform a result of the learning model into the outlet boundary condition applied during the CFD, wherein the learning model that predicts the AHI value of the target patient is pretrained by using, as input data, one or more CFD flow factors obtained by performing computational fluid analysis on upper airway morphology data generated through three-dimensional modeling of an upper airway based on an upper airway CT image and a cardiovascular CT image of a training patient, and by using, as output data, an AHI value measured from the training patient; a third transforming unit configured to calculate a blood viscosity using the red blood cell density and the blood calcium concentration among the input biometric information, and to transform the calculated blood viscosity into the fluid viscosity condition applied during the CFD; a CFD performing unit configured to perform computer assisted cardiovascular CFD simulation of the target patient by applying the inlet boundary condition, the outlet boundary condition, and the fluid viscosity condition converted in the boundary condition transforming unit, wherein the CFD simulation is to perform a blood flow/vascular computer simulation for blood vessel modeling with a boundary defined by the inlet boundary condition, the outlet boundary condition, and the fluid viscosity condition; and a result analyzing unit configured to provide compare the cardiovascular disease risk parameters FFR and WSS of the target patient from a simulation result from the CFD performing unit with a boundary value set in advance for each result variable to determine the cardiovascular disease risk for the target patient based on the target patient's sleep apnea severity diagnostic variable value; ” Specifically examiner notes the limitation of apply the predicted AHI value together with the input biometric information to a pre-set transformation model to transform a result of the learning model into the outlet boundary condition applied during the CFD was not found as positively recited in the prior art. For additional reasons of allowance, see page 8-10 of applicant’s remarks filed 03/17/2026.
The most remarkable prior art of record is as follows:
• Taylor (hereinafter Taylor) (US2021/0282860Al)
o Embodiments include a system for determining cardiovascular
information for a patient. The system may include at
least one computer system configured to receive patient specific
data regarding a geometry of the patient's heart, and
create a three-dimensional model representing at least a
portion of the patient's heart based on the patient-specific
data. The at least one computer system may be further
configured to create a physics-based model relating to a
blood flow characteristic of the patient's heart and determine
a fractional flow reserve within the patient's heart based on
the three-dimensional model and the physics-based model.
• Bafkar et. al (US2022/0222823A1)
o Described herein are systems and methods for the simulation of the upper airway of a subject . One embodiments provides a method ( 100 ) including the initial step ( 101 ) of receiving one or more tomographic images of the subject . At step ( 102 ) a three dimensional geometric model of the upper airway is generated from the one or more tomographic images . The geometric model includes a network of inter connected deformable mesh elements collectively defining a fluid domain ( 310 ) and a solid domain ( 320 ) . The solid domain ( 320 ) defining a single unitary model of the entire upper airway region segmented into a plurality of predefined geometric regions , each being defined by one or more common anatomical parameters . At step ( 103 ) , a computer simulation is performed on the geometric model to simulate behaviour of the upper airway when the subject is positioned in a predefined position . The computer simulation includes ( 103a ) performing a Computational Fluid Dynamics ( CFD ) analysis on the fluid domain and then ( 103b ) performing a Fluid - Structure Interaction ( FSI ) analysis between the fluid and solid domains under the influence of applied gravity effect . Finally , at step ( 104 ) , subject - specific parameters are output which are indicative of the behaviour of the upper airway
Lui MM, Sau-Man M. OSA and atherosclerosis. J Thorac Dis. 2012 Apr 1;4(2):164-72. doi: 10.3978/j.issn.2072-1439.2012.01.06. PMID: 22833822; PMCID: PMC3378220
US20170329927 – Taherian et. al
A CFD - based diagnostic system can be used as a non invasive diagnostic and monitoring tool for ECAC , central airway obstruction diseases , OSA and airway stenosis . The process is expected to reduce the time of diagnosis , number of tests , and hospitalization time .
Response to Arguments Regarding 35 U.S.C § 101 Rejection
Applicant argues on pages 1-8 of the remarks that claims 1, 2, 5, 8, and 9 rejected under 35 U.S.C. § 101 as directed to non-statutory subject matter should be withdrawn in view of the following. Applicant respectfully disagrees and asserts that the claimed invention is not directed to an abstract idea. The two-part analysis for abstract ideas described in the 2014 Interim Guidance on Subject Matter Eligibility ("Interim Guidance") requires (1) a determination of whether the claims are directed to an abstract idea and (2) whether any element or combination of elements in the claims are sufficient to ensure that the claims amount to significantly more than the abstract idea itself. Step 1: The Pending Claims are Directed to Statutory Categories of Subject Matter under Step 1 of Interim Guidance As explained in M.P.E.P. § 2106(1), the claimed subject matter constitutes patentable subject matter if directed to one of four statutory categories: a process, machine, manufacture, or a composition of matter. Applicant respectfully submits that all of the current claims are clearly directed to statutory categories of subject matter. Claims 1, 2, and 5 are directed to a machine and claims 8 and 9 to a process. Thus, the first step of the analysis is satisfied. Step 2A: All Currently Pending Claims Satisfy the Test for Patentable Subject Matter Under Step 2A of Interim Guidance (a) The claims are rooted in computer technology Abstract ideas have been identified by the courts by way of example, including fundamental economic practices, certain method of organizing human activities, an idea 'of itself', and mathematical relationships/formulas. Alice Corp., 134 S. Ct. at 2355-56 quoted by the Interim Guidance. The Federal Circuit indicated that in the absence of a "definitive rule to determine what constitutes an 'abstract idea'," the claims at issue should be compared "to those claims already found to be directed to an abstract idea in previous cases." Enfish, ILC v. Microsoft Corp. (Fed. Cir. 2016). Accordingly, the 2019 Revised Patent Subject Matter Eligibility Guidance ("2019 PEG") requires the Examiner to "identify the judicial exception (i.e., abstract idea enumerated in Section I of the 2019 PEG, laws of nature, or a natural phenomenon) by referring to what is recited )i.e., set forth or described) in the claim and explaining why it is considered to be an exception." The 2019 PEG explicitly requires an Examiner to either recite one of the enumerated groupings of abstract ideas or a justification as to why the claim is being treated as an abstract idea if it does not fall within the enumerated groupings of abstract ideas.
Applicant submits that claims 1 and 8 are not directed to a patent-ineligible abstract idea. In DDR Holdings v. Hotels.com, the Federal Circuit affirmed the patent eligibility of U.S. Patent No. 7,818,399 (the '399 patent) under the two-part Alice test. Particularly, the Federal Circuit held that the claims in the '399 patent are not directed to a patentable-ineligible abstract idea because the claims "do not merely recite the performance of some business practice known from the pre-Internet world along with the requirement to perform it on the Internet." DDR Holdings .v Hotels.com, L.P., Case No. 2013-1505, at 20 (Fed. Cir. 2014). Rather, "the claimed solution is necessarily rooted in computer technology in order to overcome a problem specifically arising in the realm of computer networks." (Id.)
In distinguishing the '399 patent's claims from the claims in Alice and other claims directed to an abstract idea, the Federal Circuit reasoned that "the '399 patent's asserted claims do not recite a mathematical algorithm" and that the '399 patent's claims do not recite "a fundamental economic or longstanding commercial practice." (DDR Holdings, at 19.) The Federal Circuit further reasoned that "[a]lthough the claims address a business challenge (retaining website visitors), it is a challenge particular to the Internet." (Id., emphasis added.) In distinguishing the '399 patent's claims from Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 2014 WL 5904902 (Fed. Cir. Nov. 14, 2014), the Federal Circuit reasoned that the "claims at issue here specify how interactions with the Internet are manipulated to yield a desired result-a result that overrides the routine and conventional sequence of events." (DDR Holdings, at 23).
Similar to the claims at issue in DDR Holdings, rejected claims 1 and 8 not abstract and instead necessarily rooted in the computer technology. The Office Action alleges that Claims 1 and 8 "are directed to mathematical calculations." Office Action, p. 4-5.
However, Applicant respectfully refers to Example 39 of the Subject Matter Eligibility Examples on Abstract Ideas provided by the USPTO in January 2019. Example 39 relates to a method for training a neural network for facial detection. That is, the claim in Example 39 recites in part features such as "A computer-implemented method of training a neural network for facial detection comprising," "creating a first training set comprising the collected set of digital facial images, the modified set of digital facial images, and a set of digital non-facial images," "training the neural network in a first stage using the first training set," etc.
Importantly, the analysis for the provided example states that the "claim does not recite any of the judicial exceptions enumerated in the 2019 PEG. For instance, the claim does not recite any mathematical relationships, formulas, or calculations. While some of the limitations may be based on mathematical concepts, the mathematical concepts are not recited in the claims. Further, the claim does not recite a mental process because the steps are not practically performed in the human mind." Example 39, pages 8-9. The claim itself also recites additional steps such as "applying one or more transformations to each digital face image including mirroring, rotating, smoothing, or contrast, reduction to create a modified set of digital facial images," "creating a second training set for a second stage comprising the first training set and digital non-facial images that are incorrectly detected as facial images after the first stage of training" and "training the neural network in a second stage using the second training set." The example limitations provided of Example 39 are similar to the amended claim 1 proposed above. For example, the above independent claim 1 also provides for "a boundary condition transforming operation transforming the biometric information input in the biometric information input operation into an inlet condition, an outlet boundary condition, and a fluid viscosity condition for performing computational fluid dynamics (CFD), wherein the boundary condition transforming operation includes" and "wherein the learning model that predicts the AHI value of the target patient is pre-trained by using, an input data, one or more CFD flow factors obtained by performing computational fluid analysis on upper airway morphology data generated through three-dimensional modeling of an upper airway based on upper airway CT image and a cardiovascular CT image of a training patient, and by using, as output data, an AHI value measured from the training patient." The independent claim then goes on to provide all the steps of how the boundary condition is transformed, as well as training the model based on the training data, and applying it in a subsequent CFD simulation. Accordingly, because the limitations of independent claim 1 are similar to those of Example 39, it should be held that independent claim 1 also does not recite any of the judicial exceptions.
That is, claim 1 also does not recite any mathematical concepts, even if claim 1 is based on such concepts. Additionally, claim 1 cannot be practically performed in the human mind. Indeed, it is impossible for a human mind to cause "a CFD performing unit configured to perform computer assisted cardiovascular CFD simulation of the target patient by applying the inlet boundary condition, the outlet boundary condition, and the fluid viscosity condition converted in the boundary condition transforming unit, wherein the CFD simulation is to perform a blood flow/vascular computer simulation for blood vessel modeling with a boundary defined by the inlet boundary condition, the outlet boundary condition, and the fluid viscosity condition" let alone any of the other annotation limitations performed "a result analyzing unit configured to compare the cardiovascular disease risk parameters FFR and WSS of the target patient from a simulation result from the CFD performing unit with a boundary value set in advance for each result variable to determine the cardiovascular disease risk for the target patient based on the target patient's sleep apnea severity diagnostic variable value," even with pen and paper.
Accordingly, Claim 1 is necessarily rooted in computer technology-e.g., a "computer implemented system" which enables the determination of cardiovascular disease risk assessment. In addition to being necessarily rooted in computer technology, the claimed invention is also directed to an improvement. (b) The claims provide an improvement in computer-related technology and provide a particular solution to a problem "The Supreme Court has suggested that claims purport[ing] to 'improve the functioning of the computer itself,' or 'improv[ing] an existing technological process' might not succumb to the abstract idea exception." Enfish, slip op. at 10, quoting Alice, 134 S.Ct. at 2358-59. Accordingly, the 2019 PEG instructs the Patent Examining Corps: If the additional limitations reflect an improvement in the functioning of a computer, or an improvement to another technology or technical field, the claim integrates the judicial exception into a practical application and thus imposes a meaningful limit on the judicial exception. No further analysis is required. (Emphasis added.) Here, the Applicant's claims are directed to a specific improvement to provide an automatic detection system for power facilities. For example, the Specification recites the following problems:
When cardiovascular disease occurs, myocardial ischemia may be alleviated through a vasodilation procedure based on a stent, and a doctor decides whether to perform the stent procedure generally by calculating a fractal flow reserve (FFR) of a target patient, specifically, a pressure ratio of a lesion-based proximal and distal on the basis of 0.8 Various methods may be used to measure such FFR, and there are mainly an invasive measurement method through a catheter and a non-invasive method that performs vascular modeling through a computational fluid. The invasive measurement method through a catheter, which measures pressure by directly inserting a pressure sensor in a blood vessel, is known as the most accurate method of FFR measurement, and a decision on stent insertion is made in a final clinical stage. This method is disadvantageous in that it incurs high measurement cost and a location of the lesion should be accurately known in advance. In the case of the non-invasive measurement method that performs vascular modeling through computational fluid, after CT image modeling of a target patient is performed, a computational fluid analysis is performed. In this method, various flow analyses (WSS, OSI, blood pressure, blood flow, etc.), as well as FFR, may be performed which has the advantage of locating a lesion through analysis. This method, however, requires a computational fluid analysis time and skill professional for analysis. Specification, [0005]-[0007]. The Specification goes on to say that "in order to perform computational fluid, a user should directly set all boundary conditions, so that a professional manpower is required." Specification, [0037]. The problems the Specification targets describe that: However, in the cardiovascular disease risk analysis system and method considering sleep apnea factors according to an exemplary embodiment of the present disclosure, biometric information of a target patient (sleep apnea patient) may be received and automatically transformed into a boundary condition and a result may be derived through the performance of CFD through this, and thus, the result may be utilized even if a user is not a professional who is proficient in CFD. Specification, [0038]. That is, the Specification describes the key improvement here is being able to automatically derive the boundary conditions from information of the target patient rather than having to manually set the boundary conditions. Indeed the Specification goes on to distinguish that "in the related art, in order to acquire an AHI value, sensing information acquired during actual sleep should be utilized/analyzed, but in the cardiovascular disease risk analysis system considering sleep apnea factors according to an exemplarily embodiment of the present disclosure, the AHI value of the target patient may be predicted using the biometric information input through the biometric information input unit 100." Specification, [0055]. In detail, the Specification discusses that "the second transforming unit 220 preferably predicts an AHI value of the target patient using the cardiovascular CT image and the upper airway CT image along with the biometric information input through the biometric information input unit 100 and applies the predicted AHI value and the input biometric information to the transformation model formula." Id. at [0047].
Accordingly, the present invention describes a manner in which to automatically set boundary conditions from biometric input data. Specifically, the present invention describes predicting an AHI value that serves as intermediate data for deriving an outlet boundary condition that is then used in a subsequent CFD process to improve the accuracy of predicting cardiovascular health.
Therefore, the present invention provides a technical solution. That is, the present invention provides a "system and method considering sleep apnea factors . . .biometric information of a target patient (sleep apnea patient) may be received and automatically transformed into a boundary condition and a result may be derived through the performance of CFD through this, and thus, overall blood vessel pre-screening and treatment planning may be made by utilizing the result even if a user is not a professional manpower who is proficient in CFD." Specification, [0114]. Step 2B: The Claims Amount to Significantly More than the Judicial Exception under Step 2B of Interim Guidance"
The applicant further submits that the claims amount to significantly more than an abstract idea, and thus would satisfy the second part of the analysis even if it is determined that the first part of the analysis is not satisfied. (a) The Ordered Combination of the Claims as Presented Amount to Significantly More Than the Judicial Exception under Step 2B of Interim Guidance Further, the ordered combination of the claims as presented amount to significantly more than the judicial exception. As held by the Federal Circuit in McRo, Inc. v. Bandai Namco Games America Inc., Federal Circuit, Case No. 15-1080, September 13, 2016 (herein "McRo"), "an ordered combination of claimed steps, using unconventional rules... is not directed to an abstract idea and is therefore patent-eligible subject matter under§ 101." (McRo, page 4.) In holding that the claims were patent eligible, the Federal Circuit cautioned against "oversimplifying the claims by looking at them generally and failing to account for the specific requirements of the claims." (McRo, page 21.) The Federal Circuit further instructed that "[w]hether at step one or step two of the Alice test, in determining the patentability of a method, a court must look to the claims as an ordered combination, without ignoring the requirements of the individual steps." (McRo, pages 21-22.)
In McRo, the court held that "processes that automate tasks that humans are capable of performing are patent eligible if properly claimed." (McRo, page 22, emphasis added.) Like the claims in McRo, claim 1 of the present application "uses an ordered combination of specific rules that renders information into a specific format that is then used and applied to create desired results." (McRo, page 25; emphasis added.) "We hold that the ordered combination of claimed steps, using unconventional rules that relate sub- sequences of phonemes, timings, and morph weight sets, is not directed to an abstract idea and is therefore patent eligible subject matter under# 101." (McRo at 1302-1303.) The Court found the specification to confirm the claimed improvement as "allowing computers to produce 'accurate and realistic lip synchronization and facial expressions in animated characters' that previously could only be produced by human animators." (Id. at 1313.) More specifically, the Defendants in McRo concedes that "an animator's process was driven by subjective determinations rather than specific, limited mathematical rules." (Id. at 1314.) The Federal Circuit further stated that "the computer here is employed to perform a distinct process to automate a task previously performed by humans."
Similarly, the claimed invention uses an ordered combination of specific rules that amount to more than the judicial exception. As described in the Specification, using the provided method utilizes a computer to perform a distinct process to automate the task of setting the boundary conditions that was previously performed by humans. That is, the provided method uses a distinct method of predicting AHI values from biometric information of the target patient and then using the AHI value as intermediate data to transform it into an outlet boundary condition for a subsequent CFD operation. By performing this distinct process, not only is the boundary condition selection automated, but also, the subsequent CFD operation is more accurately performed.
Accordingly, because the claimed invention is 1.) necessarily rooted in computer technology, 2.) the claimed invention is directed to an improvement, and 3.) the claimed invention amounts to significantly more than the judicial exception, Applicant respectfully submits the rejection under 101 be withdrawn.
Examiner appreciates applicants arguments but does not find them persuasive. The MPEP 2106 states The enumerated groupings of abstract ideas are defined as:
1) Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations (see MPEP § 2106.04(a)(2), subsection I); (Mathematical Calculations - A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the "mathematical concepts" grouping. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation. There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word "calculating" in order to be considered a mathematical calculation. For example, a step of "determining" a variable or number using mathematical methods or "performing" a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation.)
2) Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) (see MPEP § 2106.04(a)(2), subsection II); and
3) Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).
Examiners should determine whether a claim recites an abstract idea by (1) identifying the specific limitation(s) in the claim under examination that the examiner believes recites an abstract idea, and (2) determining whether the identified limitations(s) fall within at least one of the groupings of abstract ideas listed above.
Furthermore, the MPEP state in 2106.04(d), “Examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical applications.
The instant application claims are directed to a judicial exception (i.e. mathematical calculations of computational fluid dynamics) to determine a variable (e.g. AHI or cardiovascular disease risk). In response to applicant’s first argument, the instant application claims have no nexus with DDR Holdings as there is no identified technical problem rooted in computer technology with claims which reflect or recite this improvement confined to the computer environment, rather the claims apply machine learning modelling to process information mathematically utilizing calculations output from the units claimed which as described in the specification is performing computational fluid dynamics simulations (e.g. 0012). And this is further limited by the mathematical calculation positively recited in the dependent claims. Furthermore, the judicial exception (abstract idea) cannot integrate itself into a practical application.
In response to applicant’s second argument, the instant application claims have no nexus with Example 39 as the subject matter and fact pattern are different. The mere recitation of a pretrained model trained by data in the instant application for machine learning does not automatically make the claim an improvement rooted in computer technology rather the claims recite the calculation of cardiovascular disease risk abstract as it is a mathematical calculation and although it may be implemented by a computer to execute the math more efficiently than a human it does not preclude it from being math. There is no unconventional or recited improvement to computer functionality or the machine learning or additional elements which would improve a technological environment of computer confinement which the claim recites. Further the use of a computer does not make the claim dispositive of being abstract as its what a person could do not what they would do and computational fluid dynamic modelling as recited in the claims is directed to an abstract idea of math and does not recite additional elements which within the confines of the computer environment are an improvement to the computer functionality rather utilizing the computer to make the math more efficient. The abstract idea cannot bring forth the practical application.
In response to additional arguments by applicant, the recited claims do not reflect or recite a specific improvement to provide an automatic detection system for power facilities as stated or an improvement to prediction accuracy of cardiovascular health. Rather the claims apply machine learning modelling utilizing abstract mathematical computational fluid dynamics to output risk data. Again unlike Enfish this recitation/ reflection in the current claims has no improvement rooted in computer technology or unconventional improvement to machine learning modelling or training of CFD or even the data structures for computational fluid dynamics, rather the claims recite and reflect improvement to the abstract idea.
Finally, the recited claims have no nexus with McRo, there are no specific non-generic additional elements recited in the claims which follow unconventional rules rooted in the computer automation itself. Rather the generic computer elements recited in the instant application as units which execute and transform the data using the additional element of machine learning are simply “apply-it” or an equivalent to execute the abstract idea to process and analyze data thus not leading to a technological environment improvement of the machine learning, the CFD data structures, or the computer itself therefore cannot bring forward significantly more. Examiner maintains the claims are directed to an abstract idea and do not integrate into a practical application. Therefore, they also do not amount to significantly more. Examiner maintains the rejection under 35 U.S.C 101.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashley Elizabeth Evans whose telephone number is (571) 270-0110. The examiner can normally be reached Monday – Friday 8:00 AM – 5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached on (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center. Should you have questions on access to the Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/ASHLEY ELIZABETH EVANS/Examiner, Art Unit 3687
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687
Prosecution Insights