DETAILED ACTION
This action is in response to the amendments filed on July 13th, 2026. A summary of this action:
Claims 31-32, 34-40, 42-48, 50-53 have been presented for examination.
Claim 51 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement
Claims 31-32, 34-40, 42-48, 50-53 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of a mathematical concept, a mental process, and certain methods of organizing human activity without significantly more.
Claims not rejected under § 102/103. The closest prior art is the previously relied upon Taylor and De Bruyne references (Feb. 2026 Non-final action, see § 103 rejection of claims 33, 41, and 49), taken in further view of Thompson, Paul D. "Exercise prescription and proscription for patients with coronary artery disease." Circulation 112.15 (2005): 2354-2363 – see section “Exercise Prescription for Patients With Exercise-Induced Ischemia”: “Other patients with asymptomatic exercise-induced ischemia should exercise to 70% to 85% of the HR at the onset of ischemia, usually defined as 1 mm of ST depression.”, but this does not fairly teach the particular subject matter now amended into the claims without the use of impermissible hindsight (from the “determining a threshold value…” limitation to the “providing a recommendation…” limitation when read in full ordered combination). Also see Tanaka, Shinichiro, et al. "Relationship between functional exercise capacity and functional stenosis in patients with stable angina and intermediate coronary stenosis." Circulation Journal 73.12 (2009): 2308-2314. Abstract, p. 2308 col. 2, ¶ 1, and the discussion section in full, but this does not fairly teach the limitations noted above without impermissible hindsight. The next closest references are the below, but these do not fairly teach the same noted limitations:
Suh, Ga-Young, et al. "Hemodynamic changes quantified in abdominal aortic aneurysms with increasing exercise intensity using MR exercise imaging and image-based computational fluid dynamics." Annals of biomedical engineering 39.8 (2011): 2186-2202. Abstract and p. 2199 ¶¶ 2-4, but this does not explicitly teach that the threshold value is determined “corresponding to a population norm or to a hypothetical value of the blood flow characteristic for without coronary artery disease” as claimed. Examiner notes coronary artery disease is interpreted in view of ¶ 2
Koeken, Yvette, Theo Arts, and Tammo Delhaas. "Simulation of the Fontan circulation during rest and exercise." 2012 Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE, 2012. Abstract, then see § IV in particular the paragraph split between pages 6675-6676, but this does not explicitly teach that the threshold value is determined “corresponding to a population norm or to a hypothetical value of the blood flow characteristic for without coronary artery disease” as claimed
This action is Final
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 Arguments/Amendments
Regarding the objections
Withdrawn in view of amendments.
Regarding the double patenting rejections
Withdrawn in view of the terminal disclaimer.
Regarding the § 102/103 remarks
Withdrawn in view of amendments and supporting remarks.
Regarding the § 101 Rejection
Maintained, updated as necessitated by amendment.
With respect to the § 101 remarks regarding the math concept rejection, merely using determining, or other textual placeholders, in lieu of calculating does not overcome the rejection. MPEP § 2106.04(a)(2)(I)(C): “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.” – and the specification conveys that limitation is a math calculation in textual form.
Example 38 is also not instructive, for in that case the background section did not convey that the “simulating” limitation was merely a textual placeholder for calculating. With respect to the discussion of the “bilinear transformation” in example 38, the Examiner notes the recent updated guidance regarding examples 47 and 39 is instructive, for example 38 did not recite expressly the use of the math algorithm, whereas 47 did, and in 38 the claim did not recite the bilinear transformation and thus the claim did not require the math calculation itself to be performed.
In contrast, the instant disclosure of the present invention conveys that to do such a computation/determination (or any other placeholder, e.g. simulating), it is a math calculation, i.e. the determining/computing are merely textual placeholders for “calculate” as “"[w]ords used in a claim operating on data to solve a problem can serve the same purpose as a formula” In re Grams, 888 F.2d 835,837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989). See, e.g., SAP America, Inc. v. lnvestPic, LLC, 898 F.3d 1161, 1163, 127 USPQ2d 1597, 1599 (Fed. Cir. 2018)" per MPEP § 2106.04(a)(2).
With respect to the remarks regarding the mental process rejection, see below for how the newly amended limitations are rejected.
With respect to the creating the 3D model based on the image data, this was an additional element considered as part of the mere necessary data gathering, i.e. it was not considered abstract.
The determining/computing of a blood flow characteristics is a math concept, and the claim then adds a mental process to it. MPEP § 2106.04(II)(A)(2): “RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract");”
The determining a threshold value in the manner claimed is readily a mental process, akin to the mental processes performed by the invention of the computer to determine that the population norm temperature was 98.6 degrees F, or population norm blood pressure is 120/80.
The comparing is readily a mental process, one simply tabulates the results of the math calculations and compares them to a single threshold value.
The providing a recommendation is similarly a mental process, i.e. merely that of a cardiologist in recommending a treatment to a patient.
In summary, these remarks allege that for a mental process all steps must be mental, but such is not the case, for two abstract ideas are still an abstract idea (e.g. a mental process in addition to a math concept), and the additional elements are those additional (i.e. not abstract) to the abstract idea.
With respect to the remarks regarding certain methods of organizing human activity, the mental process claimed herein are, to summarize, the mental steps a cardiologist should follow when using FFR to provide a treatment in the form of a recommendation for a level of exercise to a patient, wherein the math concept is added to this abstract idea, and there are the additional elements of the mere data gathering that were not abstract.
Furthermore, the Examiner notes that the reliance on In re Meyer was the quotation to it in MPEP § 2106.04(II)(C), i.e. its “Other examples of managing personal behavior recited in a claim include…In re Meyer…”.
With respect to the remarks regarding the additional elements of mere data gathering, these are mere data gathering. See example 45, claim 3, and other clarifying MPEP citations in the rejection. Example 45, claim 3, is instructive as mere gathering “cannot make an otherwise nonstatutory claim statutory” at prong 2 and “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more” (quoting MPEP § 2106.05(b)(III), as expressly cited to in example 45, claim 3, prong 2). There are no other PEG examples where mere data gathering alone rendered the claim eligible but for example 45, claim 3, wherein this was expressly a 2B consideration in view of WURC evidence. See MPEP § 2106.05(g) and MPEP § 2106.05(d) for further clarification.
Furthermore, Examiner noted specifically that it was “mere necessary data gathering with activities in the gathered data” – i.e. its mere data gathering of the 3D geometric model, with the creation of it and receipt of the image data as the activities involved in the data gathering.
The WURC evidence is not addressed in these remarks.
With respect to the practical application remarks (at 19, section E) – see MPEP § 2106.04(d)(2): “Examiners should keep in mind that in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used.” – the claim merely is “providing a recommendation”, akin to the “prescribing” example.
With respect to the remarks in this section alleging an improvement to the mere data gathering, this is a 2B WURC consideration, not a prong 2. See example 45 claim 3 as noted above to further clarify. The WURC evidence is not addressed in these remarks.
With respect to claim 51, see below for how it is rejected under § 101.
With respect to the remarks, section F, regarding the ordered combination of additional elements in view of BASCOM, the remarks allege that the entire claimed invention, including the abstract idea itself, must be considered for this WURC consideration. But this is not the test, rather it is “See also Alice Corp., 573 U.S. at 21-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 78, 101 USPQ2d at 1968 (after determining that a claim is directed to a judicial exception, "we then ask, ‘[w]hat else is there in the claims before us?") (emphasis added)); RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"). Instead, an "inventive concept" is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966).” per MPEP § 2106.05(I)
To further clarify: “Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) ("a claim for a new abstract idea is still an abstract idea”..” (MPEP § 2106.05(I); and see BSG Tech LLC v. Buyseasons, Inc., 899 F.3d 1281, 1287-88, 127 USPQ2d 1688, 1693-94 (Fed. Cir. 2018) as cited to in MPEP § 2106.05(a) to further clarify.
In other words, “after determining that a claim is directed to a judicial exception, "we then ask, ‘[w]hat else is there in the claims before us?" – i.e. what else besides for the abstract idea itself that it is directed to. E.g. see example 45, claim 3, at step 2B for its WURC consideration where the additional element of the mere data gathering provided an inventive concept beyond just the abstract idea itself.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 51 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The dependent claims inherit the deficiencies of the claims they depend upon.
See MPEP 2163(II)(A): "For example, in Hyatt v. Dudas, 492 F.3d 1365, 1371, 83 USPQ2d 1373, 1376-1377 (Fed. Cir. 2007), the examiner made a prima facie case by clearly and specifically explaining why applicant’s specification did not support the particular claimed combination of elements, even though applicant’s specification listed each and every element in the claimed combination. The court found the "examiner was explicit that while each element may be individually described in the specification, the deficiency was lack of adequate description of their combination" and, thus, "[t]he burden was then properly shifted to [inventor] to cite to the examiner where adequate written description could be found or to make an amendment to address the deficiency.""
Also, see MPEP 2163(I) for Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997).
Claim 51 recites: The system of claim 31, wherein the operations further comprise
treating the patient by limiting future exercise to an intensity level of exercise that is less
than the patient-specific maximum intensity level of exercise
This is not sufficiently described. See ¶ 213: “Using this information, the physician may prescribe treatments to the patient, such as an increase in exercise…” to ¶ 219: “Based on this information, the physician may discuss with the patient whether to proceed with the proposed treatment option.”, also see ¶ 249, cf. 24B, # 1309 and accompanying description (pages 80-81), followed by ¶¶ 210-211 – at issue is that the disclosed invention does not describe a positive act of the “treating”, rather what is disclosed is merely that this provides “a recommendation” on exercise level, such as to the patient or the physician.
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 31-32, 34-40, 42-48, 50-53 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of a mathematical concept, a mental process, and certain methods of organizing human activity without significantly more.
Step 1
Claim 39 is directed towards the statutory category of a process.
Claim 31 is directed towards the statutory category of an apparatus.
Claim 47 is directed towards the statutory category of an article of manufacture.
Claims 39, and the dependents thereof, are rejected under a similar rationale as representative claim 1, and the dependents thereof.
Step 2A – Prong 1
The claims recite an abstract idea of both a mental process and mathematical concept.
See MPEP § 2106.04: “...In other claims, multiple abstract ideas, which may fall in the same or different groupings, or multiple laws of nature may be recited. In these cases, examiners should not parse the claim. For example, in a claim that includes a series of steps that recite mental steps as well as a mathematical calculation, an examiner should identify the claim as reciting both a mental process and a mathematical concept for Step 2A Prong One to make the analysis clear on the record.”
To clarify, see the USPTO 101 training examples, available at https://www.uspto.gov/patents/laws/examination-policy/subject-matter-eligibility.
The mathematical concept recited in claim 1 is:
determining, using the three-dimensional geometric model, a first value of a blood flow characteristic of blood flow through the three- dimensional geometric model;… determining, using the three-dimensional geometric model, a plurality of values of the blood flow characteristic at a corresponding plurality of intensity l levels of exercise;…
Math calculations in textual form. E.g. see ¶¶ 14-15: “calculate at least one value of at least one blood flow characteristic within the patient's heart at the first physical activity intensity level based on the three-dimensional, geometric model and the physics-based model”, ¶ 95 for calculating the cFFR; ¶ 252: “Other results may be calculated. For example, the computational analysis may provide results that quantify myocardial perfusion (blood flow through the myocardium). Quantifying myocardial perfusion may assist in identifying areas of reduced myocardial blood flow, such as due to ischemia (a restriction in a blood supply), scarring, or other heart problems.”; ¶ 296: “A plaque rupture vulnerability index may be calculated (step 950).”; ¶ 297: “A myocardial volume risk index (MVRI) may also be calculated (step 952).”, etc.
The term “determining” is merely a textual placeholder for calculating, i.e. math calculations in textual form. See ¶¶ 94-95 for more clarification, also see ¶¶ 99-100, 101, 104, 173-175 for additional clarification.
Under the broadest reasonable interpretation, the claim recites a mathematical concept – the above limitations are steps in a mathematical concept such as mathematical relationships, mathematical formulas or equations, and mathematical calculations. If a claim, under its broadest reasonable interpretation, is directed towards a mathematical concept, then it falls within the Mathematical Concepts grouping of abstract ideas. In addition, as per MPEP § 2106.04(a)(2): “It is important to note that a mathematical concept need not be expressed in mathematical symbols, because "[w]ords used in a claim operating on data to solve a problem can serve the same purpose as a formula." In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989). See, e.g., SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163, 127 USPQ2d 1597, 1599 (Fed. Cir. 2018)”
See MPEP § 2106.04(a)(2).
To clarify, see the USPTO 101 training examples, available at https://www.uspto.gov/patents/laws/examination-policy/subject-matter-eligibility.
The mental process recited in claim 1 is:
…
determining a threshold value for the blood flow characteristic corresponding to a population norm or to a hypothetical value of the blood flow characteristic for the patient without coronary artery disease; - a mental process. See page 81 ¶ 1. See ¶ 215. To clarify, doctors have long routinely mentally determined threshold values for population norms/a hypothetical normal state mentally, e.g. for blood pressure it is 120/80, for body temperature it is 98.6 degrees F, etc. E.g. by mentally observing tabulated results from a plurality of patients, and mentally evaluating a mean/median value of them, such as by pen and paper or a calculator.
…
comparing each of the plurality of values of the blood flow characteristic to the threshold value to identify an intensity level of exercise at which the blood flow characteristic is at or exceeds the threshold value; - Mental comparisons, e.g. observing a table of values, and comparing each of them to a threshold value by mental evaluation/judgement.
and providing a recommendation of a patient specific maximum intensity level of exercise based on the identified intensity level of exercise at which the blood flow characteristic is at or exceeds the determined threshold value. – a mental process, such as a cardiologist providing advice to a patient regarding the amount of snow shoveling or other forms of exercise they may safely do.
The above are mental processes, e.g. those performed by a cardiologist.
¶ 16: “determine at least one value of at least one blood flow characteristic within the patient's heart at the first level of exercise based on the model and the physics-based model; normalize the at least one value by relating it to at least one hypothetical value of the at least one blood flow characteristic were the patient without coronary artery disease; and compare the at least one normalized value to at least one threshold value to determine whether the at least one normalized value is above the at least one threshold value, and selectively classify the first exercise level as one at which the at least one blood flow characteristic exceeds a level identified as within an acceptable level of risk. If the at least one normalized value is above the at least one threshold value, the at least one computer system is further configured to recommend a level of exercise appropriate for the patient. If the at least one normalized value is at or below the at least one threshold value, the at least one computer system is further configured to update the physics-based model of blood flow through the patient's heart simulated during a second level of exercise.”
¶¶ 208-210: “As noted above, patients with known coronary artery disease may be subject to limitations in physical activity or exercise due to reductions in blood flow or perfusion pressure, or concerns of plaque disruption related to elevated blood pressure or elevated plaque stress. Nevertheless, patients with coronary artery disease may be undergoing cardiac rehabilitation, which often includes a physical activity program…Non-limiting examples of physical activity or exercise include aerobic and anerobic activity. Physical activity or exercise may also include intimacy…or the first level of exercise to a threshold or threshold value (step 1306). In at least one embodiment, the threshold or threshold value may be, or derived from, a hypothetical normal state or a population norm, for example…. Using this information, a recommendation optionally may be made to the patient regarding an appropriate (e.g., a maximum) level of physical activity, intensity, or exercise (optional step 1309)… The patient with coronary artery disease might therefore receive a recommendation to engage in exercises below the patient-specific maximum physical activity level (for example, those deemed "light" or "moderate" in the library) and avoid those at or above the patient specific maximum physical activity level (for example, those deemed "vigorous") as too risky for the patient.”
A cardiologist is readily able to mentally review results from a patient, e.g. from lab-work using routine methods of data gathering (see discussion of Mayo in MPEP § 2106.05(d) for its measurement step), wherein post-measurement calculations are performed using the data from the labs (MPEP § 2106.05(g) for In re Grams), wherein the cardiologist simply knows by their own knowledge, or looks-up in a reference, a population normal or hypothetical normal state (akin to most people known a normal blood pressure is 120/80; a normal temperature is 98.6 degrees F; etc.), and compares the calculation result to the norm threshold.
Then, and having obtained more calculated results based on the routine lab work, the cardiologist provides their opinion/judgement to a patient on the maximum level of exercise based on the gathered data, e.g. noting that based on the patient’s lab-work and other medical history that the patient should refrain from marathon training, and instead do walking as their heart does not appear to be in good condition from the lab results.
Thus, this is also certain methods of organizing human activity – akin to MPEP § 2106.04(II)(C): “Other examples of managing personal behavior recited in a claim include:…iii. a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982).
As to the data gathering steps, these are additional elements. To clarify on the analysis of these additional elements in the § 101 analysis, see MPEP § 2106.05(g): “Mere Data Gathering: i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989);… vi. Determining the level of a biomarker in blood, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968. See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) (assessing or measuring data derived from an ultrasound scan, to be used in a diagnosis)…”, see MPEP § 2106.05(d): “Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 67, 101 USPQ2d 1961, 1964 (2010) provides an example of additional elements that were not an inventive concept because they were merely well-understood, routine, conventional activity previously known to the industry, which were not by themselves sufficient to transform a judicial exception into a patent eligible invention. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 79-80, 101 USPQ2d 1969 (2012) (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 199 (1978) (the additional elements were "well known" and, thus, did not amount to a patentable application of the mathematical formula)). In Mayo, the claims at issue recited naturally occurring correlations (the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that a drug dosage will be ineffective or induce harmful side effects) along with additional elements including telling a doctor to measure thiopurine metabolite levels in the blood using any known process. 566 U.S. at 77-79, 101 USPQ2d at 1967-68. The Court found this additional step of measuring metabolite levels to be well-understood, routine, conventional activity already engaged in by the scientific community because scientists "routinely measured metabolites as part of their investigations into the relationships between metabolite levels and efficacy and toxicity of thiopurine compounds." 566 U.S. at 79, 101 USPQ2d at 1968. Even when considered in combination with the other additional elements, the step of measuring metabolite levels did not amount to an inventive concept, and thus the claims in Mayo were not eligible. 566 U.S. at 79-80, 101 USPQ2d at 1968-69” in MPEP § 2106.05(d); e.g. see example 45, claim 3, prong 2, citation to MPEP § 2106.05(b)(III): “Whether its involvement is extra-solution activity or a field-of-use, i.e., the extent to which (or how) the machine or apparatus imposes meaningful limits on the claim. Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citations omitted) ("[N]othing in claim 3 requires an infringer to use the Internet to obtain that data. The Internet is merely described as the source of the data. We have held that mere ‘[data-gathering] step[s] cannot make an otherwise nonstatutory claim statutory.’" 654 F.3d at 1375, 99 USPQ2d at 1694 (citation omitted)). See MPEP § 2106.05(g) & (h) for more information on insignificant extra-solution activity and field of use, respectively” and MPEP § 2106.05(I): “See also Alice Corp., 573 U.S. at 21-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 78, 101 USPQ2d at 1968 (after determining that a claim is directed to a judicial exception, "we then ask, ‘[w]hat else is there in the claims before us?") (emphasis added));”
Under the broadest reasonable interpretation, these limitations are process steps that cover mental processes including an observation, evaluation, judgment or opinion that could be performed in the human mind or with the aid of physical aids but for the recitation of a generic computer component. If a claim, under its broadest reasonable interpretation, covers a mental process but for the recitation of generic computer components, then it falls within the "Mental Process" grouping of abstract ideas. A person would readily be able to perform this process either mentally or with the assistance of physical aids. See MPEP § 2106.04(a)(2).
To clarify, see the USPTO 101 training examples, available at https://www.uspto.gov/patents/laws/examination-policy/subject-matter-eligibility. In particular, with respect to the physical aids, see example # 45, analysis of claim 1 under step 2A prong 1, including: “Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation.”; also see example # 49, analysis of claim 1, under step 2A prong 1: “Moreover, the recited mathematical calculation is simple enough that it can be practically performed in the human mind. Even if most humans would use a physical aid, like a pen and paper or a calculator, to make such calculations, the use of a physical aid would not negate the mental nature of this limitation.”
As such, the claims recite an abstract idea of both a mental process and mathematical concept.
Step 2A, prong 2
The claimed invention does not recite any additional elements that integrate the judicial exception into a practical application. Refer to MPEP §2106.04(d).
The following limitations are merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f), including the “Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more”:
The preambles recite a computer and other generic computer components used as a tool to perform the abstract idea
The following limitations are adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP § 2106.05(g):
receiving patient-specific anatomical image data regarding geometry of a patient's vasculature; creating a three-dimensional geometric model based on the patient-specific anatomical image data, the three- dimensional geometric model reflecting the geometry of the patient's vasculature; - mere necessary data gathering with activities in the gathered data. As a point of clarity on prong 2 analysis for mere data gathering, see example 45, claim 3, prong 2, and its particular citation to MPEP § 2106.05(b)(III): “Whether its involvement is extra-solution activity or a field-of-use, i.e., the extent to which (or how) the machine or apparatus imposes meaningful limits on the claim. Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citations omitted) ("[N]othing in claim 3 requires an infringer to use the Internet to obtain that data. The Internet is merely described as the source of the data. We have held that mere ‘[data-gathering] step[s] cannot make an otherwise nonstatutory claim statutory.’" 654 F.3d at 1375, 99 USPQ2d at 1694 (citation omitted))”
A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception. See MPEP § 2106.04(d).
MPEP 2106.04(II)(A)(2) “…Instead, under Prong Two, a claim that recites a judicial exception is not directed to that judicial exception, if the claim as a whole integrates the recited judicial exception into a practical application of that exception. Prong Two thus distinguishes claims that are "directed to" the recited judicial exception from claims that are not "directed to" the recited judicial exception…Because a judicial exception is not eligible subject matter, Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06 (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)), if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. See, e.g., RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"); Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016) (eligibility "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself."). For a claim reciting a judicial exception to be eligible, the additional elements (if any) in the claim must "transform the nature of the claim" into a patent-eligible application of the judicial exception, Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1981, either at Prong Two or in Step 2B” and MPEP § 2106(I): “Mayo, 566 U.S. at 80, 84, 101 USPQ2dat 1969, 1971 (noting that the Court in Diamond v. Diehr found “the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole,”” – and see MPEP § 2106.05(e).
To further clarify, MPEP § 2106.04(II)(A)(1): “Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980 (citing Mayo, 566 US at 71, 101 USPQ2d at 1965). Yet, the Court has explained that ‘‘[a]t some level, all inventions embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas,’’ and has cautioned ‘‘to tread carefully in construing this exclusionary principle lest it swallow all of patent law” See also Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335, 118 USPQ2d 1684, 1688 (Fed. Cir. 2016) ("The ‘directed to’ inquiry, therefore, cannot simply ask whether the claims involve a patent-ineligible concept, because essentially every routinely patent-eligible claim involving physical products and actions involves a law of nature and/or natural phenomenon").”
As a point of clarity, RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"); Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016) (eligibility "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself." discussed in MPEP § 2106.04(II)(A)(2) as well as MPEP § 2106.04(I): “Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) ("a new abstract idea is still an abstract idea") (emphasis in original).
The claimed invention does not recite any additional elements that integrate the judicial exception into a practical application. Refer to MPEP §2106.04(d).
Step 2B
The claimed invention does not recite any additional elements/limitations that amount to significantly more.
The following limitations are merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f), including the “Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more”:
The preambles recite a computer and other generic computer components used as a tool to perform the abstract idea
The following limitations are adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP § 2106.05(g):
receiving patient-specific anatomical image data regarding geometry of a patient's vasculature; creating a three-dimensional geometric model based on the patient-specific anatomical image data, the three- dimensional geometric model reflecting the geometry of the patient's vasculature; - mere necessary data gathering with activities in the gathered data. As a point of clarity on prong 2 analysis for mere data gathering, see example 45, claim 3, prong 2, and its particular citation to MPEP § 2106.05(b)(III): “Whether its involvement is extra-solution activity or a field-of-use, i.e., the extent to which (or how) the machine or apparatus imposes meaningful limits on the claim. Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citations omitted) ("[N]othing in claim 3 requires an infringer to use the Internet to obtain that data. The Internet is merely described as the source of the data. We have held that mere ‘[data-gathering] step[s] cannot make an otherwise nonstatutory claim statutory.’" 654 F.3d at 1375, 99 USPQ2d at 1694 (citation omitted))”
In addition, the above insignificant extra-solution activities are also considered as well-understood, routine, and conventional activities, as discussed in MPEP § 2106.05(d):
receiving patient-specific anatomical image data regarding geometry of a patient's vasculature; creating a three-dimensional geometric model based on the patient-specific anatomical image data, the three- dimensional geometric model reflecting the geometry of the patient's vasculature;
Such techniques are well-known in the art such as multi-scale modeling, and to clarify on the BRI of this limitation see instant fig. 12-16, see ¶ 100: “Each inflow boundary 322 may be assigned, e.g., with a prescribed value or field for velocity, flow rate, pressure, or other characteristic, by coupling a heart model and/or a lumped parameter model to the boundary, etc. The outflow boundaries 324 may include the boundaries through which flow is directed outward from the anatomy of the three dimensional model, such as at an end of the aorta near the aortic arch (e.g., end B shown in Fig. 16), and the downstream ends of the main coronary arteries and the branches that extend therefrom (e.g., ends a-m shown in Fig. 16). Each outflow boundary can be assigned, e.g., by coupling a lumped parameter or distributed (e.g., a one-dimensional wave propagation) model, as will be described in detail below.”; ¶¶ 163-164, etc. And the claim is not even limited to what is disclosed, nor does it express anything beyond that which is already well-known in the art (evidence below).
Furthermore, the received images are WURC, see ¶ 111: “…The resulting imaging data (e.g., provided by CCTA, MRI, etc.) may be provided by a third-party vendor, such as a radiology lab or a cardiologist, by the patient's physician, etc.”, i.e. using standard off-the-shelf medical imaging technology commonly found in radiology and cardiology offices. Additional evidence is below for this in combination with the modeling.
Also, with respect to any below evidence that is merely contemporaneous invention, see MPEP § 2141.03(I): “References which are not prior art may be relied upon to demonstrate the level of ordinary skill in the art at or around the relevant time. See In re Merck & Co., Inc., 800 F.2d 1091, 1098, 231 USPQ 375, 380 (Fed. Cir. 1986) ("Evidence of contemporaneous invention is probative of ‘the level of knowledge in the art at the time the invention was made.’" (citing In re Farrenkopf, 713 F.2d 714, 720, 219 USPQ 1, 6 (Fed. Cir. 1983)));”
For evidence, see the below, and in particular note that while it appears such a technique as disclosed (Examiner noting the claim is substantially broader than the disclosed technique) was originally discovered and published on in Kim, H.J., Vignon-Clementel, I.E., Coogan, J.S. et al. Patient-Specific Modeling of Blood Flow and Pressure in Human Coronary Arteries. Ann Biomed Eng 38, 3195–3209 (2010) (specifically, journal names co-author of the instant inventor), the evidence below indicates that by the time this application was effectively filed such a practice had become commercially available and had become routine, at least for those with knowledge of cardiology and computer modeling of the coronary tree.
Kim, H.J., Vignon-Clementel, I.E., Coogan, J.S. et al. Patient-Specific Modeling of Blood Flow and Pressure in Human Coronary Arteries. Ann Biomed Eng 38, 3195–3209 (2010). Introduction: “Computational simulations have been proven useful in studying blood flow in the cardiovascular system24: assessing hemodynamics of healthy and diseased blood vessels,4,6 helping in the design and evaluation of vascular medical devices,1,14 planning of vascular surgeries, and the prediction of the outcomes of interventions. 16,23 As the computing capacity and numerical methods for simulation of blood flow advance, further applications are anticipated….”
Kwon, Soon-Sung, et al. "A novel patient-specific model to compute coronary fractional flow reserve." Progress in biophysics and molecular biology 116.1 (2014): 48-55. § 1: “Kim et al. (2010) proposed a non-invasive computer simulation method to evaluate the FFR value based on patients’ computed tomography (CT) images and the physiological data. The method uses a computational fluid dynamics (CFD) approach for the hemodynamics of the aorta and the coronary arteries coupled with the lumped parameter model (LPM) of the entire cardiovascular system. Several validation studies (Min et al., 2012; Koo et al., 2011) using the method have been conducted, showing its clinical relevance and usefulness”
Taelman, Liesbeth, et al. "Modeling hemodynamics in vascular networks using a geometrical multiscale approach: numerical aspects." Annals of biomedical engineering 41.7 (2013): 1445-1458. Abstract: “On the one hand the heterogeneity of the circulatory system requires the use of different models in its different compartments, featuring different assumptions on the spatial degrees of freedom. On the other hand, the mutual interactions between its compartments imply that these models should preferably not be considered separately. These requirements have led to the concept of geometrical multiscale modeling, where the main idea is to couple 3D models with reduced 1D and/or 0D models. As such detailed information on the flow field in a specific region of interest can be obtained while accounting for the global circulation…This review aims to give an overview of the most important aspects concerning 3D–1D–0D coupled models.” – then see page 1446, starting in col. 1 at: “This heterogeneous composition of the cardiovascular system triggered the development of three classes of models (3D, 1D and 0D ones), featuring different assumptions on the spatial degrees of freedom. Three-dimensional (3D) models are usually applied when detailed information on the flow field (e.g., the wall shear stress distribution) is needed in a specific region. As the local blood flow is associated with the initiation and progression of certain CVDs, such as atherosclerosis,14,51 these 3D models provide a great contribution to the understanding of these diseases. Mathematically, the blood dynamics are described by the Navier–Stokes equations for incompressible fluids. These equations can be coupled to the equations of motion of the vessel wall to include the fluid–structure interaction (FSI). In Bazilevs et al.,6 Crosetto et al.17 and Long et al.43 FSI simulations of the blood flow in cerebral aneurysms, a healthy aorta and Fontan patients are compared to rigid wall simulations, demonstrating the importance of including the flexible wall modeling, in particular with respect to the simulation of wall shear stress (which is overestimated in the rigid wall case of all three studies)… This limitation motivates the adoption of one dimensional (1D) models, as they allow to compute the fluid dynamics in a large part of the arterial tree at a reasonable computational cost.23,47 The reduced model is obtained by assuming axial symmetry and by restricting the spatial variation of the degrees of freedom to the axial direction…A further simplification in the mathematical modeling is obtained by eliminating the variation in space. Zero-dimensional (0D) models, also called lumped parameter models, allow to describe the time evolution of the pressure and flow in a specific compartment of the circulatory system, like the heart or the capillary bed, although these models may also be used to describe the systemic or pulmonary circulation, or large parts of it…Thus, on the one hand the heterogeneity and extent of the circulatory system requires the use of different models in its different compartments. On the other hand, the mutual interactions between its compartments imply that these models should preferably not be considered separately. These requirements have led to the concept of geometrical multiscale modeling, 7,13,18,20,24,48 where the main idea is to couple dimensionally heterogeneous models, representing different physical compartments, to study the interaction between different geometrical scales. This approach applies 3D models only in those regions where a detailed knowledge of the flow field is needed, whereas 1D and 0D models are applied to represent the remaining part of the vascular tree….” – e.g. fig. 1. See section “NUMERICAL METHODS TO MODEL THE FLUID DYNAMICS AT DIFFERENT SCALES” to further clarify; then see section “THE GEOMETRICAL MULTISCALE APPROACH—COUPLING ISSUES”, and page 1456: “When applying 3D–1D–0D coupled models for patient-specific modeling approaches, it is important to use a patient-specific geometry of the arterial tree (extracted from medical images) and to properly fit the mechanical and lumped parameters of the models to noninvasive measurements (e.g., MRI, Doppler,…).”
Larrabide, Ignacio, et al. "HeMoLab–Hemodynamics Modelling Laboratory: An application for modelling the human cardiovascular system." Computers in biology and medicine 42.10 (2012): 993-1004. Abstract, then see § 1 including: “As a consequence of the multi-scale nature of the Human Cardiovascular System (HCVS), which integrates different levels of circulation (systemic arteries, arterioles, capillaries), it is possible to identify different types of studies in the context of numerical simulations. As far as mathematical models are concerned, it is possible to discern between: (i) the use of simple models to simulate global hemodynamics phenomena [8–13] (the so-called 1D–0D models) and (ii) the simulation of local phenomena related to blood flow circulation in specific arterial districts [14–18] (the so-called 3D models). These two kinds of models are mathematical representations which provide insights about different aspects of the hemodynamics phenomena taking place in the HCVS. Thus, a third generation of models has been a matter of research in the last years which is (iii) the use of a proper combination of models (i) and (ii) to couple local and global phenomena in order to represent the systemic response of the HCVS [19–22] (the so-called 3D–1D–0D models). This third class of computational models has allowed the setting of more complex physiological and pathophysiological scenarios of potential clinical interest [23–25]”; also see § 2: “In this section we briefly present the computational models which were integrated into HeMoLab. The reader interested is directed to [21,22,26–30] for a detailed account of the mathematical formulation, numerical approximation and models calibration”
Sharma, Puneet, et al. "A framework for personalization of coronary flow computations during rest and hyperemia." 2012 Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE, 2012. § I ¶ 1, fig. 1 and fig. 3.
Blanco, P. J., and R. A. Feijóo. "A dimensionally-heterogeneous closed-loop model for the cardiovascular system and its applications." Medical Engineering & Physics 35.5 (2012): 652. Abstract, then see § 1, including ¶¶ 2-6 and fig. 1. See § 2.7.6: “The geometrical data corresponding to set up three-dimensional models of arterial vessels is obtained either by resorting to a standard geometry or to medical images. In the case of patient specific vessels, the extraction of the anatomical structures is done following standard procedures for the segmentation of the corresponding medical images”
Blanco, Pablo J., and Raúl A. Feijóo. "A 3D-1D-0D computational model for the entire cardiovascular system." Mecánica Computacional 29.59 (2010): 5887-5911. Abstract, then § 1 including ¶¶ 1-4, including the listing of models on page 5889. Of note was that this was contemporaneous to the publication of the above cited journal paper Kim et. Al. 2010, but on page 5889: “Following Blanco et al. (2007, 2009, 2010), we can consider the existence of 3D models accounting for all the complexity of three-dimensional blood flow in specific vessels of interest.”
Blanco, P. J., S. A. Urquiza, and R. A. Feijóo. "Assessing the influence of heart rate in local hemodynamics through coupled 3D‐1D‐0D models." International Journal for Numerical Methods in Biomedical Engineering 26.7 (April 2010): 890-903. Abstract, then see § 1 including page 891, ¶¶ 2-3 incl.: “All the aspects mentioned above highlight the relevance of coupled dimensionally-heterogeneous models (3D-1D-0D models for instance) in this application. Certainly, throughout the last years there have been an increasing interest in using such models to account for the multi-scale aspects of the systemic circulation [2–5]. It is pertinent to note here that this approach is also referred to in the literature as the ‘geometrical multi-scale approach’ [6]. The derivation of this kind of models can stem from areas such as partial differential equations [2], variational principles [3] or impedance-based analysis [4]. Moreover, such an approach unfolds a much wider range of possibilities in terms of the predictive capabilities of the mathematical model. As far as applications are concerned, recent evidence has shown the potential of these models in specific studies [1, 6–8]. Particularly, in [7] some guidelines for future research which exploit the qualities of these coupled models were given, some of which are expanded in this study”
Blanco, Pablo J., et al. "On the potentialities of 3D–1D coupled models in hemodynamics simulations." Journal of biomechanics 42.7 (2009): 919-930. § 1 incl. ¶¶ 2-4 which discusses the history of modeling the coronary tree.
Zhang, Jun-Mei, et al. "Area stenosis associated with non-invasive fractional flow reserve obtained from coronary CT images." 2013 35th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC). IEEE, 2013. § 1 ¶ 3: “Among the physiological parameters, FFR has been used as the gold standard to assess the significance of CAD. However, it is invasive and the results are negative in the majority of patients with obstructive CAD [4]. With the advancement of CFD technologies, numerical simulation has been used to study CAD. Kim and colleagues [8, 9] simulated patient-specific coronary arteries with sophisticated lumped parameter models. Based on their CFD technologies, non-invasive FFRCT was derived from CT imagines and it was demonstrated to have high diagnostic performance [10]. As the invasive measurement of FFR is based on the mean pressure and the determination of the numerous parameters introduced in the lumped parameter models [10] is confusing, in this study the FFRCT was obtained by CFD simulation on steady state with simplified resistance boundary conditions at the outlets to reduce the computational cost…” – see § II, including subsection B: “Commercial software ANSYS workbench was used in this study to discretize the flow domain with tetrahedral shaped elements”
Koo, Bon-Kwon, et al. "Diagnosis of ischemia-causing coronary stenoses by noninvasive fractional flow reserve computed from coronary computed tomographic angiograms: results from the prospective multicenter DISCOVER-FLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional Flow Reserve) study." Journal of the American College of Cardiology 58.19 (2011): 1989-1997. Abstract, page 1990, col. 1, ¶ 2: “Computational fluid dynamics (CFD), as applied to CCTA images, represents a novel method that enables prediction of blood flow and pressure fields in coronary arteries and calculation of lesion-specific FFR (14–16). The FFR can be computed from typically acquired CCTA scans (FFRCT) without any modification of CCTA protocols, additional image acquisition, or administration of medications.” And ¶ 4: “The DISCOVER-FLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional FLOW Reserve) study was conducted at 4 sites (Seoul National University Hospital, Seoul, Korea; Pauls Stradins Clinical University Hospital, Riga, Latvia; Inje University Ilsan Paik Hospital, Goyang, Korea; Stanford University Medical Center, Palo Alto, California). The study protocol was approved by the Institutional Review Boards of each center. The study was funded by Heartflow, Inc. (Redwood City, California).” And page 1991 col. 1 ¶ 3 to col. 2 ¶ 2. Then page 1993: “Importantly, the calculation of FFRCT required no modification of CCTA acquisition protocols, no additional imaging, and no additional administration of medications”
Zhang, Jun‐Mei, et al. "Perspective on CFD studies of coronary artery disease lesions and hemodynamics: a review." International journal for numerical methods in biomedical engineering 30.6 (2014): 659-680. Abstract: “With the development of computational technologies and CFD methods, tremendous progress has been made in applying image-based CFD simulation techniques to elucidate the effects of hemodynamics in vascular pathophysiology toward the initialization and progression of CAD. So then, we review the advancements of CFD technologies in patient-specific modeling, involving the development of geometry reconstruction, boundary conditions, and fluid–structure interaction. Next, we review the applications of CFD to stenotic sites, in order to compute their hemodynamic parameters and study the relationship between the hemodynamic conditions and the clinical indices, to thereby assess the amount of viable myocardium and candidacy for percutaneous coronary intervention.” Followed by § 1, ¶ 3: “Hence, with the advancement of computational sciences and resources, CFD has been extensively employed in conjunction with noninvasive and invasive imaging techniques in CAD studies, for elucidating the role of hemodynamics in vascular pathophysiology toward the development of CAD. Therefore, the next section addresses the advances in CFD techniques in recent decades, including the following: (i) the development of ideal to patient-specific image-based geometric modeling; (ii) incorporation of prescribed to sophisticated boundary conditions; and (iii) assumption of vessel walls from rigid to compliant in the 3D computational model” then see § 3, including its subsections which provide a details chronology in this technology.
Pantos, Ioannis, and Demosthenes Katritsis. "Fractional flow reserve derived from coronary imaging and computational fluid dynamics." Interventional Cardiology: Reviews, Research, Resources 9.3 (2014): 145. Section “Computation Fluid Dynamics” incl.: “In order to perform a CFD simulation of flow in a coronary vessel, a 3D description of the vessel lumen is required. Several methods have been used for this purpose, the most widely applied of which are coronary vessel reconstruction based on biplanar coronary angiography,14,15 rotational coronary angiography,16 intravascular ultrasound and biplanar coronary angiography,17 optical coherence tomography (OCT) imaging,18 3D quantitative coronary angiography19 and computed tomography coronary angiography.20,21” and section “novel Techniques of FFR Calculation”: “By taking advantage of the exceptional capabilities of modern modalities for coronary imaging coupled with CFD methodologies, various investigators have presented alternative methods of FFR calculation. In these studies the imaging modality, either a multislice computed tomography (CT) scanner,20,21,26–29 an angiography unit capable of rotational coronary angiography,16 or 3D quantitative coronary angiography (3DQCA) were employed for the acquisition of vessel models of diseased coronary arteries. On the acquired models suitable boundary conditions are applied, the blood is appropriately modelled and the incompressible Navier-Stokes equations are solved with a finite element method using CFD techniques and appropriate hardware. From the simulation results the “virtual” fractional flow reserve is calculated.” Section “Coronary Computed Tomographic Angiography Derived FFR” describing “A dedicated algorithm has been developed which facilitated the derivation of FFR based of CCTA (FFRCT) (HeartFlow™; HeartFlow Inc., Redwood City, CA, USA).37,38” and its use in various clinical trials; then section: “3D QCA and TIMI Frame Count Derived FFR” for: “A methodology for FFR computation based on 3D quantitative coronary angiography (QCA) and thrombolysis in myocardial infarction (TIMI) was recently presented.19 The methodology uses 3D QCA (QAngio® XA 3D, Medis Special BV43,44)…” and provides an addition a summary of it.
Wong, Jerry T., and Sabee Molloi. "Determination of fractional flow reserve (FFR) based on scaling laws: a simulation study." Physics in Medicine & Biology 53.14 (2008): 3995. Abstract and introduction, including page 3997 and §§ 2.1-2.7 and § 4.
Schrauwen, J. T. C., et al. "Geometry-based pressure drop prediction in mildly diseased human coronary arteries." Journal of biomechanics 47.8 (March 2014): 1810-1815. Abstract, § 1, and in particular see §§ 2.3-2.4
In patent literature, see:
Kassab et al., US 2010/0299077, abstract, fig. 4, and starting at ¶ 53 the discussion and use of “a set of scaling laws determined from a developed minimum energy hypothesis” which is “Similar to Murray's law,” (¶ 124); also ¶ 129. See ¶ 101 as well. And see the results section, starting in ¶ 110.
Edic et al., US 2013/0226003, Abstract, then see fig. 3-5 and accompanying descriptions. Also ¶ 16.
Itu et al., US 2015/0374243, ¶ 4: “In recent years, there has been considerable focus on computational approaches for modeling the flow of blood in the human cardiovascular system. When used in conjunction with patient-specific anatomical models extracted from medical images, such computational techniques can provide important insights into the structure and function of the cardiovascular system. To predict the outcome of PCI and to plan it optimally, techniques relying on computational modeling have been proposed to perform virtual placement of the stent in an anatomical geometrical model extracted from medical images and to compute blood flow and pressure in the modified post-stenting geometry.”
Sharma et al., US 2013/0132054, fig. 2, ¶ 3.
Spilker et al., US 2012/0259608. Abstract, fig. 1 and accompanying description.
Goshen et al., US 2015/0282765, abstract, then see fig. 2-5 and accompanying description. See ¶ 4 as well: “A non-invasive approach to estimating the FFR index is through computational fluid dynamic (CFD) simulations in which blood flow and pressure through the coronaries is simulated. For this approach, the 3D coronary geometry is based on a cardiac CT scan of the patient. Unfortunately, with this approach, the boundary conditions (i.e., flow, pressure and/or resistance) outside the extracted geometry are not well-defined, and the values of flow and pressure at the inlet (ostium) and vessel-outlets greatly affect the FFR estimation accuracy. This approach is also time costly, requiring inten sive computations (e.g., up to hours) and assumes very high-quality geometrical data (e.g., coronary segmentation), which often implies significant manual editing.
The claimed invention is directed towards an abstract idea of a mathematical concept, a mental process, and certain methods of organizing human activity without significantly more.
Regarding the dependent claims
Claim 32 – the generation of a physics-based model is considered as part of the mere data gathering that is WURC in view of the above evidence, and the “determining” is merely math calculations in textual form based on results gathered from the simulation
Claim 34 – see fig. 24B, this is merely repeating the abstract idea as well as the mere data gathering in an iterative loop, i.e. do the mere WURC data gathering, perform abstract idea with the gathered data, wherein when mental judgement/evaluation indicates that it is still below the threshold (#1307 in fig. 24B, the “determining that the value of the blood flow characteristic at a prior intensity level of exercise does not exceed the threshold value.” in the claim), gather more data in a conventional manner, then repeat the abstract idea. To clarify, the simulating is math calculations in textual form – see above citations for the determining/computing of the blood flow characteristic to clarify, as simulating is also another placeholder for math calculations in textual form, e.g. ¶¶ 94-95, 104, and other citations above
Claim 35 is merely specifying a range of metrics to be calculated, thus just further limiting the math calculations themselves
Claim 36 is further limiting the abstract idea itself.
Claim 37 is merely further specifying what data is gathered, wherein this is WURC in view of evidence above
Claim 38 is merely repeating the determining of the threshold value a plurality of times for a plurality of mental comparisons of two numbers (¶ 185). For compact prosecution, see MPEP § 2106.05(a)(I): “Examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality: viii. Arranging transactional information on a graphical user interface in a manner that assists traders in processing information more quickly, Trading Technologies v. IBG LLC, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019).”
The remaining dependent claims are rejected under similar rationales as their representative claims 32-38 discussed above.
Claim 51 is considered a manual step as part of the mental process, as this merely requires the patient to limit future exercise, i.e. it requires the patient themselves to perform this treatment in their own physical activity. Contrast with the examples in MPEP § 2106.04(d)(2), wherein the treatments are administrations of particular drugs, i.e. “Examples of "treatment" and prophylaxis" limitations encompass limitations that treat or prevent a disease or medical condition, including, e.g., acupuncture, administration of medication, dialysis, organ transplants, phototherapy, physiotherapy, radiation therapy, surgery, and the like.” See examples 43 and 49 as well. Should this be found not to be abstract, then it would be considered as mere instructions to “apply it”, in view of MPEP § 2106.04(d)(2): “For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient… Alternatively, consider a claim that recites the same law of nature and also recites "treating a patient having a blood glucose level over 250 mg/dl with aspirin." Aspirin is not known in the art as a treatment for ketoacidosis or diabetes, although some patients with diabetes may be on aspirin therapy for other medical reasons (e.g., to control pain or inflammation, or to prevent blood clots)… In the context of this claim and the recited correlation between high blood glucose levels and the risk of ketoacidosis, administration of aspirin has at best a nominal connection to the law of nature, because aspirin does not treat or prevent ketoacidosis. This step therefore does not apply or use the exception in any meaningful way. Thus, this step of administering aspirin does not integrate the law of nature into a practical application...” to clarify, this is administering limitations on the maximum amount of exercise a patient with coronary artery disease can do, which does not treat coronary artery disease itself or prevent it. Furthermore, to clarify, the claimed “exercise” is not particular, i.e. its akin to administering a pharmaceutical composition without specifically identifying what composition. To contrast, a common particular exercise to treat/prevent plantar fasciitis is the soleus stretch (commonly recommended, along with other particular exercise routines, by physical therapists for treating plantar fasciitis). The claim does not recite any particular exercise at all, but rather any exercise, akin to any pharmaceutical composition, without limiting what in particular is to actually be administered.
Examiner suggests amending to a particular treatment for the particular disease of stenosis, e.g. ¶ 213: “coronary artery bypass grafting, insertion of one or more coronary stents”, that would fall under the examples noted above in MPEP § 2106.04(d)(2)
Claim 52 is further limiting the math concept by reducing a value of a variable (a resistance) in the math calculations of the act of simulating
Claim 53 is a mental evaluation/judgement such as by a cardiologist, e.g. a cardiologist evaluating the risk of whether or not a patient may have a heart attack/myocardial infarction based on the abstract idea above.
The claimed invention is directed towards an abstract idea of a mathematical concept, a mental process, and certain methods of organizing human activity without significantly more.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/David A Hopkins/Primary Examiner, Art Unit 2188
