DETAILED ACTION
This action is in response to the claims filed on Dec. 7th, 2022. A summary of this action:
Claims 31-50 have been presented for examination.
Claim 31-35, 38-43, 46-50 are objected to because of informalities:
Claims 31-50 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of both a mathematical concept and mental process without significantly more.
Claim(s) 31-32, 34-40, 42-48, 50 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taylor, US 2012/0041318
Claim(s) 33, 41, 49 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taylor, US 2012/0041318 when a term in the reference has its meaning explained/to show an inherent characteristic (MPEP § 2131.01) by De Bruyne, B., and J. Sarma. "Fractional flow reserve: a review." Heart 94.7 (2008): 949-959.
Claim 31-32, 35-40, 43-48, 50 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1-15 of prior U.S. Patent No. 11547367. This is a statutory double patenting rejection.
Claim 31-50 is/are rejected under 35 U.S.C. 101 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-15 of prior U.S. Patent No. 11547367.
Claim 34 and 42 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 7, and 13 of U.S. Patent No. 11547367 in view of Taylor, US 2012/0041318.
Claims 33, 41, 49 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 3, 7, 9, 13, 15 of U.S. Patent No. 11547367 in view of De Bruyne, B., and J. Sarma. "Fractional flow reserve: a review." Heart 94.7 (2008): 949-959
Claims 31-50 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,092, 247 in view of Taylor, US 2012/0041318.
Claims 31-50 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9,668,700 in view of Taylor, US 2012/0041318.
This action is non-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 .
Note on double patenting
MPEP § 804(I)(B)(1): “As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only compliance with objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Replies with an omission should be treated as provided in MPEP § 714.03.”
MPEP § 714.03, title: “Amendments Not Fully Responsive, Action To Be Taken”
Consideration of Prior Art Cited in Parent Application
As this is a continuation of prior US application, see MPEP § 609.02(II)(A)(2): “The examiner will consider information which has been considered by the Office in a parent application (other than an international application; see subsection I., above) when examining: (A) a continuation application filed under 37 CFR 1.53(b), (B) a divisional application filed under 37 CFR 1.53(b), or (C) a continuation-in-part application filed under 37 CFR 1.53(b). A listing of the information need not be resubmitted in the continuing application unless the applicant desires the information to be printed on the patent.”
Also see MPEP § 2001.06(b): “If the application under examination is identified as a continuation, divisional, or continuation-in-part of an earlier application, the examiner will consider the prior art properly cited in the earlier application. See MPEP § 609 and MPEP § 719.05, subsection (II)(A), example J. The examiner must indicate in the first Office action whether the prior art in a related earlier application has been reviewed. Accordingly, no separate citation of the same prior art need be made in the later application, unless applicant wants a listing of the prior art printed on the face of the patent.”
See MPEP § 707.05(a): “Additionally, copies of references cited in continuation applications if they had been previously cited in the parent application are not furnished”
The prior art in the instant parent application has been reviewed for the prosecution of the instant application.
Notice about inventorship
See 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), which names the instant inventor, and numerous other unnamed inventor. See Page 3196, col. 1, last paragraph: “In this paper, we describe a method to calculate the flow and pressure of three-dimensional coronary vascular beds by considering the models of the left and right sides of the heart, arterial system, and the interactions between them. For each coronary outlet, a lumped parameter coronary vascular bed model was assigned to represent the impedance of downstream coronary vascular networks absent in the computational domain. We solved for coronary flow and pressure as well as aortic flow and pressure in patient specific models for rest and light and moderate exercise conditions. Additionally, to demonstrate that these methods can be utilized in clinical investigation, we studied blood flow and pressure with different degrees of stenosis. We created a stenosis in the left anterior descending coronary artery by reducing the local diameter of the geometric model by 40%, 50%, 60%, and 75% and simulated a baseline (resting) condition and a moderate exercise condition, where in the latter case we assumed that the downstream coronary vascular beds were maximally dilated” and
See Taylor et al., US 2010/0241404, which appears to be a PGPUB, with an associated granted US Patent, of this Kim et al. journal paper.
See 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. In particular, see section “Methods” for “The study was funded by Heartflow, Inc. (Redwood City, California).” Then see section FFRCT interpretation.
See 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. Specifically, § 3.1.2, ¶ 2: “Although 3D cine phase-contrast MRI (4D flow) velocimetry is promising for determining inflow and outflow velocities [47], for many CFD applications, neither flow nor pressure waveforms are known a priori, owing to the difficulty of simultaneous and synchronous measurements of the small sized coronary arteries. In this regard, the development of multiscale simulations in recent years sheds light on mimicking realistic blood flow in vessels by means of 3D CFD simulation coupled with reduced-order (1D or 0D) models at the boundaries, which represent the relationship of pressure and flow rate at the upstream and /or downstream vasculature [48–51]….” And see the remaining portions of this section.
See Taylor, Charles A., Timothy A. Fonte, and James K. Min. "Computational fluid dynamics applied to cardiac computed tomography for noninvasive quantification of fractional flow reserve: scientific basis." Journal of the American College of Cardiology 61.22 (2013): 2233-2241 see this generally, as this is a qualifying § 102(a)(1) reference with no applicable exception for the grace period because it names other authors.
While the Examiner presumes the instant inventorship is correct, the Examiner is noting the above evidence in view of MPEP 2109.01: “It is not necessary that joint inventors physically work together on a project, and it is permissible for one inventor to "take a step at one time, the other an approach at different times." (Monsanto Co. v. Kamp, 269 F. Supp. 818, 824, 154 USPQ 259, 262 (D.D.C. 1967)). However, "the statute neither states nor implies that two inventors can be ‘joint inventors’ if they have had no contact whatsoever and are completely unaware of each other's work." What is required is some "quantum of collaboration or connection." In other words, "[f]or persons to be joint inventors under Section 116, there must be some element of joint behavior, such as collaboration or working under common direction, one inventor seeing a relevant report and building upon it or hearing another’s suggestion at a meeting." Kimberly-Clark Corp. v. Procter & Gamble Distrib. Co., 973 F.2d 911, 916-17, 23 USPQ2d 1921, 1925-26 (Fed. Cir. 1992); Moler v. Purdy, 131 USPQ 276, 279 (Bd. Pat. Inter. 1960) ("it is not necessary that the inventive concept come to both [joint inventors] at the same time")While each joint inventor must generally contribute to the conception of the invention, each joint inventor does not have to "make the same type or amount of contribution" to the invention. "The fact that each of the inventors play a different role and that the contribution of one may not be as great as that of another does not detract from the fact that the invention is joint, if each makes some original contribution, though partial, to the final solution of the problem." Monsanto Co. v. Kamp, 269 F. Supp. at 824, 154 USPQ at 262. When a joint inventor contributed to the conception of an invention, publication of the joint inventor’s contribution before the date of conception of the total invention does not necessarily defeat joint inventorship of that invention. See Dana-Farber Cancer Inst., Inc. v. Ono Pharm. Co., 964 F.3d 1365, 1371-73, 2020 USPQ2d 10775 (Fed. Cir. 2020) ("a collaborative enterprise is not negated by a joint inventor disclosing ideas less than the total invention to others, especially when, as here, the collaborators had worked together for around one year prior to the disclosure, and the disclosure occurred just a few weeks prior to conception. Inventorship of a complex invention may depend on partial contributions to conception over time, and there is no principled reason to discount genuine contributions made by collaborators because portions of that work were published prior to conception for the benefit of the public.").”
Claim Objections
Claim 31-35, 38-43, 46-50 are objected to because of the following informalities:
Independent claims recite (claim 1 as representative) two separate elements of “a block flow characteristic” and an associated “value”. The Examiner suggests using disambiguating modifiers, e.g. first/second, for these recitations
Representative claim 32 recites, in part: “and computing the blood flow characteristic based on the physics-based model” – but, independent claims recite a plurality of these computations and they are already based on the geometric model. In view of “wherein the physics-based model corresponds to the second intensity level of exercise” the Examiner infers this is only further limiting the second computation, and suggests amending to make this expressly clear. Also, the Examiner suggests making it expressly clear that it requires both the “based on” in the independent claims and this is another “based on” for this limitation (i.e. based on both models)
Parallel dependents objected to for similar reasons
Representative claim 33 recites “hypothetical” – this is a potential subjective term. The Examiner suggests clarifying amendments in view of page 80 last paragraph discussing the “hypothetical case”. Population norm is given its plain meaning to POSITAs in the medical profession (i.e. cardiology), akin to population norm of people’s temperatures is very well-known to be 98.6 degrees Fahrenheit, and blood pressure of 120/80, and thus is not objected to (page 81, ¶ 1).
Parallel dependents objected to for similar reasons
Representative claim 34 recites “the value” however there are two prior recitations. Given the later limitation in claim 34, the Examiner infers that this is referring to the first value, and suggests amending to make this clear
Parallel dependents objected to for similar reasons
Representative claim 35 has similar issues as above, as the independent claims recite a plurality of the computed values. In view of fig. 9-11, the Examiner infers that its further limiting both values.
Parallel dependents objected to for similar reasons
Representative claim 38 recites: “computing the threshold value at a plurality of locations in the plurality of coronary arteries” but “threshold value” is singular. The Examiner interprets this in view of ¶ 185, and suggests amending the claim to more clearly reflect what is actually disclosed (i.e. the computed threshold value is used in a plurality of comparisons in a plurality of locations of the coronary tree)
Parallel dependents objected to for similar reasons
Appropriate correction is required.
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 31-50 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.
Claim Interpretation
The claims are given their broadest reasonable interpretation by a person of ordinary skill in the art. See Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) as discussed in MPEP § 2111; also see in MPEP § 2111: “Because applicant has the opportunity to amend the claims during prosecution, giving a claim its broadest reasonable interpretation will reduce the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Yamamoto, 740 F.2d 1569, 1571 (Fed. Cir. 1984); In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.”) … Further, the broadest reasonable interpretation of the claims must be consistent with the interpretation that those skilled in the art would reach.”
MPEP § 2111.01(I): “Under a broadest reasonable interpretation (BRI), words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the relevant time. The ordinary and customary meaning of a term may be evidenced by a variety of sources, including the words of the claims themselves, the specification, drawings, and prior art. However, the best source for determining the meaning of a claim term is the specification - the greatest clarity is obtained when the specification serves as a glossary for the claim terms. Phillips v. AWH Corp., 415 F.3d 1303, 1315, 75 USPQ2d 1321, 1327 (Fed. Cir. 2005) (en banc) ("[T]he specification ‘is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.’" (quoting Vitronics Corp. v. Conceptronic Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)).”
MPEP § 2111.01(III): “"[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Phillips v. AWH Corp.,415 F.3d 1303, 1313, 75 USPQ2d 1321, 1326 (Fed. Cir. 2005) (en banc); Sunrace Roots Enter. Co. v. SRAM Corp., 336 F.3d 1298, 1302, 67 USPQ2d 1438, 1441 (Fed. Cir. 2003); Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc., 334 F.3d 1294, 1298, 67 USPQ2d 1132, 1136 (Fed. Cir. 2003) ("In the absence of an express intent to impart a novel meaning to the claim terms, the words are presumed to take on the ordinary and customary meanings attributed to them by those of ordinary skill in the art.")… Phillips v. AWH Corp., 415 F.3d 1303, 1317, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) ("Although we have emphasized the importance of intrinsic evidence in claim construction, we have also authorized district courts to rely on extrinsic evidence, which "consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises.")… Any meaning of a claim term taken from the prior art must be consistent with the use of the claim term in the specification and drawings. Moreover, when the specification is clear about the scope and content of a claim term, there is no need to turn to extrinsic evidence for claim interpretation.”
As part of properly determining the broadest reasonable interpretation, one must first determine who is a person of ordinary skill in the art. MPEP § 2141.03(I): “The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the relevant time. Factors that may be considered in determining the level of ordinary skill in the art may include: (A) "type of problems encountered in the art;" (B) "prior art solutions to those problems;" (C) "rapidity with which innovations are made;" (D) "sophistication of the technology; and" (E) "educational level of active workers in the field. In a given case, every factor may not be present, and one or more factors may predominate." In re GPAC, 57 F.3d 1573, 1579, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995); Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962, 1 USPQ2d 1196, 1201 (Fed. Cir. 1986); Environmental Designs, Ltd. V. Union Oil Co., 713 F.2d 693, 696, 218 USPQ 865, 868 (Fed. Cir. 1983)…. "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007)… The level of disclosure in the specification of the application under examination or in relevant references may also be informative of the knowledge and skills of a person of ordinary skill in the art. For example, if the specification is entirely silent on how a certain step or function is achieved, that silence may suggest that figuring out how to achieve that step or function is within the ordinary skill in the art, provided that the specification complies with 35 U.S.C. 112. 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.’"…”
MPEP § 2143.01(II): “If the only facts of record pertaining to the level of skill in the art are found within the prior art of record, the court has held that an invention may be held to have been obvious without a specific finding of a particular level of skill where the prior art itself reflects an appropriate level. Chore-Time Equipment, Inc. v. Cumberland Corp., 713 F.2d 774, 218 USPQ 673 (Fed. Cir. 1983). See also Okajima v. Bourdeau, 261 F.3d 1350, 1355, 59 USPQ2d 1795, 1797 (Fed. Cir. 2001).”
Should further clarification be sought on this level of skill determination during Examination, see (informative) Ex parte Jud, PTAB Appeal No. 2006-1061, available here: https://www.uspto.gov/patents/ptab/precedential-informative-decisions
To further clarify on this, the claims are not read in a vacuum, but rather given their broadest reasonable interpretation by a person of ordinary skill in the art, e.g. a cardiologist with experience in computation modeling.
So, to clarify on how POSITA would read these claims in view of the disclosure numerous discussions of the use of “FFR” as the computed value of a blood flow characteristic, e.g. ¶¶ 6, 92, 95-103, incl.: “The systems and methods disclosed herein may be incorporated into a software tool accessed by physicians to provide a noninvasive means to quantify blood flow in the coronary arteries and to assess the functional significance of coronary artery disease.”, 104, 144-146, etc., including that the only disclosed threshold values are for the FFR/cFFR (¶ 185; ¶ 215), showing the level of skill and common knowledge to those in the field, see:
Abe, Masayuki, et al. "Diastolic fractional flow reserve to assess the functional severity of moderate coronary artery stenoses: comparison with fractional flow reserve and coronary flow velocity reserve." Circulation 102.19 (2000): 2365-2370. See “Conclusions” on page 2365: “In clinical practice, FFR remains the index of choice for assessment of the functional severity of moderate coronary artery stenoses.”
Then see: “Angiograms provide only a 2-dimensional coronary luminal silhouette and have many limitations,1–3 especially in intermediate lesions (ie, those with percent diameter stenosis of 40% to 70%). Physiological assessment of the severity of the coronary lesion is critical for clinical decision making….”
Then see the “Discussion” section incl.: “FFR has emerged as an important clinical decision-making tool and is widely used in the assessment of the functional severity of intermediate stenoses, as an alternative to noninvasive testing for ischemia, and as the end point for coronary intervention…FFR has an unequivocal value of 1.0 in every normal coronary artery and is independent of changes in heart rate, blood pressure, and myocardial contractility and microvascular disease.22,25,26 An FFR cutoff value of 0.75 is thought to reliably distinguish functionally significant coronary stenoses. 26–28…”
Wherein the use of FFR for assessment of cardiovascular health has been a long-standing practice since the early 1990’s in cardiology. E.g. Pijls, Nico HJ, et al. "Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses." New England Journal of Medicine 334.26 (1996): 1703-1708. Page 1703, ¶¶ 1-3, and see references 1-10 for their dates. See section “Pressure Measurements and Calculation of FFR” for: “If the FFR was 0.75 or higher, no revascularization procedure was performed. If the FFR was below 0.75, myocardial revascularization was recommended”
Asrress, Kaleab N., et al. "Tools & Techniques: Physiological assessment of coronary haemodynamics: fractional flow reserve and beyond." (2012). Section Introduction, pages 1-3, including: “In an article published that same year, 1993, Pijls and colleagues used a canine model to report for the first time the use of this novel pressure wire to assess coronary stenosis severity, flow reserve, and collateral flow under maximal coronary vasodilation They went on to express the coronary flow reserve of a stenotic artery as a “fraction” of the normal value of that same vessel in the absence of an obstruction to flow – and so the term fractional flow reserve (FFR) was coined. FFR is a lesion-specific index defined as the ratio of maximal hyperaemic myocardial blood flow across a stenotic artery to the maximal myocardial blood flow across the same artery in the theoretical absence of the stenosis…Pijls and colleagues went on to determine the range of FFR values that would help to identify the physiological significance of a particular coronary stenosis, and whether or not this would correspond to the presence of inducible myocardial ischaemia6. The investigators found an FFR of ≤0.74 in all patients pre PCI and observed it to be >0.74 following successful angioplasty. FFR measurements were also taken in a total of 18 normal coronary arteries from five patients with no discernible cardiovascular risk. The FFR was found to be near 1.0 in all cases, indicating no significant decline in pressure along the length of normal epicardial arteries. By 1996, Pijls and colleagues published their landmark paper in the New England Journal of Medicine, in which they compared the validity of FFR (with an inducible ischaemia cut-off now set at <0.75) accurately to detect haemodynamically significant lesions that appeared only moderate in severity (defined as approximately 50% by visual assessment alone)… Two landmark randomised trials followed…These would put the validity and reliability of FFR as a lesion-specific tool to determine the need for revascularization beyond reproach…Secondly, revascularisation in those patients found to have lesions that reduce FFR to <0.75 generated significantly greater improvements in functional class and freedom from angina…”
With respect to the implications on exercise from a FFR value at or below 0.75, this is also part of the common knowledge of POSITA.
See Bishop, Andrew H., and Habib Samady. "Fractional flow reserve: critical review of an important physiologic adjunct to angiography." American Heart Journal 147.5 (2004): 792-802. Section FFR, subsection “Human validation of FFR”: “Much of the complexity of validating FFRmyo in patients stems from the difficulty of accurately defining ischemia. An FFRmyo ≤0.75 correlates with ischemia, as defined by combinations of non-invasive tests of ischemia… DeBruyne found the lower limit of FFRmyo that correlated with a negative exercise test to be 0.72… These data led to the landmark study published in 1996, in which Pijls et al demonstrated that an FFRmyo ≤0.75 correlates with non-invasively defined ischemia in patients with stable angina and single-vessel disease. 18”
To clarify, as demonstrated above an FFR value >0.75 is routine clinical determination that a patient has coronary artery disease. People with coronary artery disease are routine warned by cardiologists to be careful with intensive exercise, e.g.
ABC News, “Risks of Snow Shoveling Highlighted in New Study”, Jan. 11th, 2011, abcnews(dot)go(dot)com/Health/risks-snow-shoveling-stressed-study/story?id=12590482: “"The risk of heart attack is increased by the combination of heavy, upper body exertion and cold weather encountered while shoveling snow," said Dr. William Abraham, director of the division of cardiovascular medicine at Ohio State University. "People, especially those at risk for coronary heart disease, should avoid heavy exertion in cold weather conditions."… That's because people can be unaware of their own heart blockages, and even an insignificant heart condition can suddenly become significant in certain weather, said Dr. Randy Zusman, director of the hypertension program at the Massachusetts General Hospital Heart Center….So, if a blood vessel is 20 percent to 30 percent blocked, it can become up to 70 percent to 80 percent blocked due to the constricting walls in the cold weather conditions, said Zusman. And once the shovel comes out of the garage, things can often get much worse…."Lifting heavy snow is like heavy weight lifting," said Zusman. "It puts a strain on the heart, and the blood pressure and heart rate go up in response to it."”.
Similarly, that there is some well-known variation on this threshold. De Bruyne, B., and J. Sarma. "Fractional flow reserve: a review." Heart 94.7 (2008): 949-959. Subsection “FFR has a well defined cut-off value with a narrow ‘‘grey zone’’ between 0.75 and 0” on page 950: “Cut-off or threshold values are values that distinguish normal from abnormal levels for a given measurement. To enable adequate clinical decision making in individual patients it is paramount that any level of uncertainty is reduced to a minimum. Stenoses with an FFR <0.75 are almost invariably able to induce myocardial ischaemia, while stenoses with an FFR >0.80 are almost never associated with exercise induced ischaemia (table 2). This means that the ‘‘grey zone’’ for FFR (between 0.75–0.80) spans over, 10% of the entire range of FFR values.” And see table 2.
See instant disclosure, ¶ 185: “For example, the upper limit (violet) may indicate a cFFR of 1.0, and the lower limit (red) may indicate approximately 0.7 (or 0.75 or 0.8) or less, with green indicating approximately 0.85 (or other value approximately halfway between the upper and lower limits). For example, the lower limit may be determined based on a lower limit (e.g., 0.7, 0.75, or 0.8) used for determining whether the cFFR measurement indicates a functionally significant lesion or other feature that may require intervention.”
¶ 215: “Treatment may be proposed if a cFFR value is, for example, less than 0.75.”
Should further clarification be sought on the common knowledge for those in the field of cardiology (POSITAs) with providing exercise recommendations for stenosed arteries, see
Höllriegel, Robert, et al. "Physical exercise training and coronary artery disease." Reviews in Health Care 4.3 (2013): 175-191. Section “Exercise program for patients with CAD”: “…Aerobic physical activity in patients with known CAD is usually included into CR program. As already mentioned above, a lot of observational studies have been published regarding the relation between participation in a CR program and the CV prognosis in post-myocardial infarction, post-coronary intervention, and elderly CAD patients showing in particular an inverse dose-response relation between session attendance and mortality/cardiovascular risk [34-38]. In patients with CAD, exercise prescription needs to be tailored to the individual profile after adequate exercise-related risk stratification [1]. The most common modes of aerobic exercise include walking, jogging, cycling, swimming, rowing, stair climbing, or treadmill. Many approaches may be used to determine aerobic exercise intensity [97]. They include % of peak heart rate, heart rate reserve, or the Borg Perceived Exertion Scale…In general, low-risk patients, e.g. after uncomplicated MI, should exercise with moderate to vigorous intensity for 3-5 sessions per week, each about 30 minutes [1]… In severely deconditioned individuals, accumulated bouts of exercises for 10 minutes can produce similar benefits than described for longer exercise sessions [99]…” and so on, i.e. see the section “What is in the guidelines?”: “In relation to the before mentioned, both European and American guidelines for CVD prevention, describe recommendations for physical activity and CR participation in the means of primary and secondary prevention in independent sections [1,95]…” – i.e. it is in “American Heart Association/American College of Cardiology Foundation” (table I) as well as the “European Society of Cardiology” guidelines, thus POSITAs experienced in the field of cardiology would have had it in their common knowledge that specific exercise regiments should be recommended by cardiologists once they diagnose a patient with stenoses.
To be more particular, in the United States, the act of the recommendation step (i.e. recommending a maximum amount of exercise (see ABC news above), along with, per claim 36, an “elevated intensity level of exercise” (¶ 10: “Optionally, at least one computer system may be further configured to recommend a level of physical activity appropriate for the patient. If the one or more normalized values of the at least one blood flow characteristic are at or below the threshold, the at least one computer system is configured to increase the simulated level of physical activity.”), is presumably part of the standard of care for cardiologists.
See Aetna, “Clinical Policy Bulletin: Cardiac Rehabilitation”, accessed via Wayback Machine with archive date of Feb. 2012, URL: aetna(dot)com/cpb/medical/data/1_99/0021(dot)html: “Aetna considers outpatient cardiac rehabilitation medically necessary as described below….Entry into such programs is based on the demonstrated limitation of functional capacity on exercise stress testing, and the expectation that medically supervised exercise training will improve functional capacity to a clinically significant degree. The exercise test in cardiac rehabilitation is a vital component of the overall rehabilitative process as it provides continuous follow-up in a noninvasive manner and adds information to the overall physical evaluation. In general, testing is performed before entering the cardiac rehabilitation exercise program, and sequentially during the program to provide information on the changes in cardiac status, prognosis, functional capacity, and evidence of training effect. The central component of cardiac rehabilitation is a prescribed regimen of physical exercises intended to improve functional work capacity and to increase the patient's confidence and well-being. Depending on the degree of debilitation, cardiac patients may or may not require a full or supervised rehabilitation program.”
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:
computing, using the three-dimensional geometric model, a value of a blood flow characteristic of blood flow through the three-dimensional geometric model for the first intensity level of exercise; computing, using the three-dimensional geometric model, a blood flow characteristic of blood flow through the three-dimensional geometric model for a second intensity level of exercise, different from the first intensity level 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 “computing” is merely a textual placeholder for calculating, i.e. math calculations in textual form.
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 quantifying a limitation of exercise of the patient based on the value of the blood flow characteristic at the first intensity level of exercise; - a
and providing a recommendation of a maximum level of exercise based on the determined threshold value, the first intensity level of exercise, and the second intensity level of exercise.
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.
To further clarify on the mental nature of this, and as the claims are not read in a vacuum but rather for their BRI to a person of ordinary skill in the art, when POSITA with a knowledge of cardiology was reading the present claims in view of the disclosure, POSITA would view the claims as being directed to obtaining some “value of a blood flow characteristic”, e.g. claim 35: “chosen from coronary blood flow, blood pressure, plaque stress, myocardial perfusion, plaque vulnerability, and FFR” for the purpose of diagnosing coronary artery disease (¶¶ 2-8: “…These noninvasive tests, however, typically do not provide a direct assessment of coronary lesions or assess blood flow rates… Thus, patients may also require an invasive test, such as diagnostic cardiac catheterization, to visualize coronary lesions… During diagnostic cardiac catheterization, the functional significance of a coronary lesion may be assessed invasively by measuring the fractional flow reserve (FFR) of an observed lesion. FFR is defined as the ratio of the mean blood pressure downstream of a lesion divided by the mean blood pressure upstream from the lesion, e.g., the aortic pressure, under conditions of increased coronary blood flow, e.g., induced by intravenous administration of adenosine… Thus, a need exists for a method for assessing coronary anatomy, myocardial perfusion, and coronary artery flow noninvasively… Moreover, 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…” in a non-invasive manner to replace prior invasive measurements, followed by the standard clinical practices cardiologists routinely perform in providing recommendations and treatments to patients with diagnosed heart disease (but these steps done on a computer).
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 representing the geometry of the patient's vasculature, the three- dimensional geometric model reflecting vascular geometry at a first intensity level of exercise; - 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 representing the geometry of the patient's vasculature, the three- dimensional geometric model reflecting vascular geometry at a first intensity level of exercise; - 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 representing the geometry of the patient's vasculature, the three- dimensional geometric model reflecting vascular geometry at a first intensity level of exercise
Such techniques are well-known in the art 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.
As an initial point of clarity, the Examiner does note, and suggest, amending the claims in view of example 45, claim 3, at step 2B, so as to overcome the WURC evidence of record, should sufficiently support for an inventive concept in the mere data gathering exist (that is not merely a claim to the math itself which would be ineligible at step one, e.g. ¶ 94: “For example, the equations 30 may be determined and solved using any numerical method, e.g., finite difference, finite volume, spectral, lattice Boltzmann, particle-based, level set, finite element methods, etc. The equations 30 may be solvable to determine information (e.g., pressure, velocity, FFR, etc.) about the coronary blood flow in the patient's anatomy at various points in the anatomy represented by the model 10.”), e.g. as either an improvement to technology over what is WURC in the manner the raw image data is processed (e.g. see Thales in MPEP § 2106.05(a); see XY, LLC in the July 2024 Fed. Register Notice); or some other unconventional combination of additional elements in the mere data gathering (noting BASCOM in MPEP § 2106.05(I)(B); also example 45 claim 3 at 2B).
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 additional evidence, see the below, and in particular note that while it appears such a 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 “computing” is merely math calculations in textual form based on results gathered from the simulation
Claim 33 is further limiting the abstract idea itself for similar reasons as discussed above
Claim 34 is merely adding another mental judgement/evaluation of comparing two numbers, and then doing more mere WURC (evidence above) data gathering in a contingent limitation.
Claim 35 is merely specifying a range of metrics to be calculated, thus just further limiting the math calculations themselves
Claim 36 is merely further limiting the mere data gathering and WURC in view of the above. To clarify, and as discussed above, increasing exercise levels (e.g. recommending to patients to do exercise training) following a diagnosis of stenosis such as by obtaining an FFR value and comparing it to 0.75 to do the diagnosis is a long-standing mental process for cardiologists, and this merely is a limitation to do a simulation at an increased exercise level (e.g. to simulate the treatment of exercise therapy, and then see if the exercise therapy would mitigate the stenosis by checking the FFR a second time using conventional data gathering so as to do the FFR calculation (a simple ratio of two numbers; ¶ 6) with the results of the gathered data).
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.
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.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 31-32, 34-40, 42-48, 50 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taylor, US 2012/0041318
Regarding Claim 31.
Taylor teaches:
A system for quantifying limitations in coronary artery blood flow during exercise in a patient with coronary artery disease, the system comprising: at least one processor; and at least one memory storing instructions that, when executed by the at least one processor, perform operations comprising: (Taylor, abstract and fig. 24, #635, also ¶ 8, and below citations for the intended use to further clarify)
[a] receiving patient-specific anatomical image data regarding geometry of a patient's vasculature; [b] creating a three-dimensional geometric model based on the patient-specific anatomical image data representing the geometry of the patient's vasculature, the three- dimensional geometric model reflecting vascular geometry at a first intensity level of exercise; (Taylor, fig. 24 # 611 and 621; and accompanying description, e.g. ¶¶ 219-220: “The inputs 610 may include medical imaging data 611 of the patient's aorta, coronary arteries (and the branches that extend therefrom), and heart, such as CCTA data (e.g., obtained in step 100 of FIG. 2)… As noted above, one or more models 620 may be generated based on the inputs 610. For example, the method 600 may include generating one or more patient-specific three-dimensional geometric models of the patient's anatomy ( e.g., the aorta, coronary arteries, and branches that extend therefrom) based on the imaging data 611 (step 621). For example, the geometric model may be the solid model 320 of FIG. 8 generated in step 306 of FIG. 3, and/or the mesh 380 of FIGS. 17-19 generated in step 312 of FIG. 3.” – then, ¶ 227: “Referring back to FIG. 24, the method 600 may include adjusting the boundary conditions based on one or more physical conditions of the patient (step 635). For example, the parameters determined in steps 631-634 may be modified based on whether the solution 640 is intended to simulate rest, varying levels of hyperemia, varying levels of exercise or exertion, different medications, etc. Based on the inputs 610, the models 620, and the conditions 630, a computational analysis may be performed, e.g., as described above in connection with step 402 of FIG. 3, to determine the solution 640 that includes information about the patient's coronary blood flow under the physical conditions selected in step 635 (step 641). Examples of information that may be provided from the solution 640 will now be described.”
[c] computing, using the three-dimensional geometric model, a value of a blood flow characteristic of blood flow through the three-dimensional geometric model for the first intensity level of exercise; [d] determining a threshold value quantifying a limitation of exercise of the patient based on the value of the blood flow characteristic at the first intensity level of exercise; [e] computing, using the three-dimensional geometric model, a blood flow characteristic of blood flow through the three-dimensional geometric model for a second intensity level of exercise, different from the first intensity level of exercise; [f] and providing a recommendation of a maximum level of exercise based on the determined threshold value, the first intensity level of exercise, and the second intensity level of exercise. (¶ 232: “As described above, the cFFR model 54 shown in FIGS. 1 and 23 indicates the cFFR values throughout the patient's anatomy represented by the mesh 380 of FIGS. 17-19 in an untreated state and under simulated hyperemia conditions. Using this information, the physician may prescribe treatments to the patient, such as an increase in exercise, a change in diet, a prescription of medication, surgery on any portion of the modeled anatomy or other portions of the heart ( e.g., coronary artery bypass grafting, insertion of one or more coronary stents, etc.), etc…To determine which treatment(s) to prescribe, the computer system may be used to predict how the information determined from the computational analysis would change based on such treatment(s).”
¶ 239 to clarify: “Other treatment options may not involve modifying the solid model 320. For example, an increase in exercise or exertion, a change in diet or other lifestyle change, a prescription of medication, etc., may involve changing the boundary conditions determined in step 310, e.g., due to vasoconstriction, dilation, decreased heart rate, etc. For example, the patient's heart rate, cardiac output, stroke volume, blood pressure, coronary microcirculation function, the configurations of the lumped parameter models, etc., may depend on the medication prescribed, the type and frequency of exercise adopted ( or other exertion), the type oflifestyle change adopted ( e.g., cessation of smoking, changes in diet, etc.), thereby affecting the boundary conditions determined in step 310 in different ways.” – similarly, see ¶ 242; ¶ 292: “A computational analysis may be performed, e.g., as described above in connection with step 402 of FIG. 3, to determine a solution that includes information about the patient's coronary blood flow under a physical condition determined by the user (step 882). For example, the physical condition may include rest, a selected level of hyperemia, a selected level of exercise or exertion, or other conditions”; ¶ 300: “…More accurate patient-specific coronary artery blood flow computations may be provided, and cardiologists may be enabled to predict coronary artery blood flow and myocardial perfusion under circumstances where measured data may be unavailable, such as when simulating the patient under maximum exercise or exertion, simulated treatments, or other conditions.”
And ¶ 227: “Referring back to FIG. 24, the method 600 may include adjusting the boundary conditions based on one or more physical conditions of the patient (step 635). For example, the parameters determined in steps 631-634 may be modified based on whether the solution 640 is intended to simulate rest, varying levels of hyperemia, varying levels of exercise or exertion, different medications, etc. Based on the inputs 610, the models 620, and the conditions 630, a computational analysis may be performed, e.g., as described above in connection with step 402 of FIG. 3, to determine the solution 640 that includes information about the patient's coronary blood flow under the physical conditions selected in step 635 (step 641). Examples of information that may be provided from the solution 640 will now be described.”
As to limitation [d], ¶ 234: “For example, the cFFR model 54 shown in FIGS. 1 and 23 indicates that the lowest cFFR value in the LAD artery is 0.66, the lowest cFFR value in the LCX artery is 0.72, the lowest cFFR value in the RCA artery is 0.80. Treatment may be proposed if a cFFR value is, for example, less than 0.75”; also ¶¶ 205-206: “In an exemplary embodiment, the cFFR model 54 may be provided in color, and a color spectrum may be used to indicate variations in pressure throughout the model 54. The color spectrum may include red, orange, yellow, green, blue, indigo, and violet, in order from lowest cFFR (indicating functionally significant lesions) to highest cFFR. For example, the upper limit (violet) may indicate a cFFR of 1.0, and the lower limit (red) may indicate approximately 0. 7 ( or 0.75 or 0.8) or less, with green indicating approximately 0.85 ( or other value approximately halfway between the upper and lower limits). For example, the lower limit may be determined based on a lower limit (e.g., 0.7, 0.75, or 0.8) used for determining whether the cFFR measurement indicates a functionally significant lesion or other feature that may require intervention…After determining that the cFFR has dropped below the lower limit used for determining the presence of a functionally significant lesion or other feature that may require intervention, the artery or branch may be assessed to locate the functionally significant lesion( s ).” And see ¶¶ 3-4 and 8 to clarify, i.e. this indicates they have “coronary heart disease”
To be more particular on limitations [d and f], see ¶ 228, in particular: “The combined model may also be used to determine the effect on coronary artery blood flow of alternate forms and/or varying levels of physical activity or risk of exposure to potential extrinsic force, e.g., when playing football, during space flight, when scuba diving, during airplane flights, etc. Such information may be used to identify the types and level of physical activity that may be safe and efficacious for a specific patient” – thus, it would have been inferred from this, and ¶ 232 and similar citations as above, that when “Using this information, the physician may prescribe treatments to the patient, such as an increase in exercise” (¶ 232) the physician would also have been provided a recommendation of the “safe and efficacious” [i.e. a maximum] “level of physical activity” that the patient would be able to do.
Regarding Claim 32.
Taylor teaches:
The system of claim 31, wherein the at least one processor is further configured for: generating a physics-based model based on the three-dimensional geometric model; and computing the blood flow characteristic based on the physics- based model , wherein the physics-based model corresponds to the second intensity level of exercise. (Taylor, as cited above teaches this, e.g. fig. 24, # 622 and accompanying description, in combination with # 635 and 641 and their accompanying descriptions; as taken in view of ¶¶ 227-228 as cited above)
Regarding Claim 34.
Taylor teaches:
The system of claim 31, wherein the operations further comprise:
determining whether the value of the blood flow characteristic is at or below the determined threshold value; and wherein the second intensity level of exercise is simulated based on determining that the value of the blood flow characteristic is at or below the determined threshold value. (Taylor, as cited above, i.e. when the FFR is at or below 0.75, it indicates stenosis (¶ 205); wherein ¶ 232 clarifies that a prescribed treatment is to “increase in exercise”, and ¶ 233: “To determine which treatment(s) to prescribe, the computer system may be used to predict how the information determined from the computational analysis would change based on such treatment(s).” and ¶¶ 227-228 as cited above for “varying levels of exercise” to “…Such information may be used to identify the types and level of physical activity that may be safe and efficacious for a specific patient…”, i.e. if the FFR indicates stenoses, then trial treatments of exercise levels, while making sure its at a “safe and efficacious” “level of physical activity”.
Regarding Claim 35.
Taylor teaches:
The system of claim 31, wherein the computed blood flow characteristic is chosen from coronary blood flow, blood pressure, plaque stress, myocardial perfusion, plaque vulnerability, and FFR. (Taylor, as cited above for the “FFR”, ¶ 227 for “coronary blood flow”; ¶ 7 defines FFR to be blood pressure of the coronary flow; ¶¶ 303-305 incl.: “The computational analysis may also provide results that quantify patient-specific biomechanical forces acting on plaque that may build up in the patient's aorta and coronary arteries (and the branches that extend therefrom), e.g., coronary atherosclerotic plaque… The plaque rupture risk [plaque vulnerability; ¶ 302 heading: “Assessing Plaque Vulnerability”] may be defined as a ratio of simulated plaque stress to a plaque strength estimated using material composition data derived from CCTA or MRI (e.g., determined in step 100 of FIG. 2).” And ¶ 307: “FIGS. 35 and 36 are schematic diagrams showing aspects of a method 920 for providing various information relating to assessing plaque vulnerability, myocardial volume risk, and myocardial perfusion risk in a specific patient, according to an exemplary embodiment.”
Regarding Claim 36.
Taylor teaches:
The system of claim 31, wherein the second intensity level of exercise comprises an elevated intensity level of exercise relative to the first intensity level of exercise. (Taylor, as cited above, for the treatment being an increase in exercise levels, and the other citations related to this)
Regarding Claim 37.
Taylor teaches:
The system of claim 31, wherein the three-dimensional geometric model represents at least a portion of a heart of the patient that includes at least a portion of an aorta and at least a portion of a plurality of coronary arteries emanating from the portion of the aorta. (Taylor, as cited above, also ¶ 110: “The method may include obtaining patient-specific anatomical data, such as information regarding the patient's anatomy (e.g., at least a portion of the aorta and a proximal portion of the main coronary arteries ( and the branches extending therefrom) connected to the aorta), and preprocessing the data (step 100).”
Regarding Claim 38.
Taylor teaches:
The system of claim 37, wherein the at least one processor is further configured for:
computing the threshold value at a plurality of locations in the plurality of coronary arteries. (Taylor, ¶ 205 as cited above)
Regarding Claims 39-40, 42-48, 50
Rejected under a similar rationale as representative claim 31 and the representative dependent claims of claim 31.
Claim(s) 33, 41, 49 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taylor, US 2012/0041318 when a term in the reference has its meaning explained/to show an inherent characteristic (MPEP § 2131.01) by De Bruyne, B., and J. Sarma. "Fractional flow reserve: a review." Heart 94.7 (2008): 949-959.
Regarding Claim 33.
Taylor teaches:
The system of claim 31, wherein the threshold value is one of a hypothetical normal state or a population norm. (Taylor, as cited above, teaches this, specifically the “0.75” in ¶ 234; also see ¶ 205, for comparing the FFR value, wherein ¶ 205 clarifies that above 0.85 should be “green”, and an upper limit of “1.0”, and some other numbers in between).
When the meaning of this combination to POSITA is explained/an inherency showing of what the values are to POSITA:
See De Bruyne, section: “FFR has a theoretical normal value of 1 for every patient, for every artery and for every myocardial bed”: “An unequivocally normal value is easy to refer to but is rare in clinical medicine. Since in a normal epicardial artery there is virtually no decline in pressure, not even during maximal hyperaemia,6 it is obvious that Pd/Pa will equal or be very close to unity. This means that normal epicardial arteries do not contribute to the total resistance to coronary blood flow. The lowest value found in a total of 65 strictly normal coronary arteries was 0.92.6 7 Yet it is important to realise that in normal looking coronary arteries in patients with proven atherosclerosis elsewhere, the epicardial coronary arteries may contribute to total resistance to coronary blood flow even though there is no discrete stenosis visible on the angiogram. In approximately 50% of these arteries, FFR is lower than the lowest value found in strictly normal individuals. In approximately 10% of atherosclerotic arteries, FFR will be lower than the ischaemic threshold.“
Followed by section: “FFR has a well defined cut-off value with a narrow ‘‘grey zone’’ between 0.75 and 0.80” (see Taylor ¶ 205 which has about the same range; and in the exemplary Taylor is “0.75” in ¶ 234): “Cut-off or threshold values are values that distinguish normal from abnormal levels for a given measurement. To enable adequate clinical decision making in individual patients it is paramount that any level of uncertainty is reduced to a minimum. Stenoses with an FFR ,0.75 are almost invariably able to induce myocardial ischaemia, while stenoses with an FFR .0.80 are almost never associated with exercise induced ischaemia (table 2). This means that the ‘‘grey zone’’ for FFR (between 0.75–0.80) spans over ,10% of the entire range of FFR values”
To be clear, see table 2 of De Bruyne:
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263
1034
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Greyscale
In other words, the threshold values of Taylor for the FFR (same as the instant disclosure, ¶¶ 185 and 215) would have been readily recognized by POSITA as being the clinical population norm, and the upper ratio of “1.0” of Taylor would have been the hypothetic norm (to clarify, in Taylor, ¶ 7: “FFR is defined as the ratio of the mean blood pressure downstream of a lesion divided by the mean blood pressure upstream from the lesion, e.g., the aortic pressure, under conditions of increased coronary blood flow, e.g., induced by intravenous administration of adenosine.”, i.e. a perfect pipe with no narrowing/friction or the like with this ratio would have a hypothetical max of 1, i.e. pressure in = pressure out.
Should it be found that Taylor alone does not anticipate this, then the Examiner submits that it would have been obvious to use the “grey zone” of De Bruyne in combination with Taylor’s FFR calculation. Motivation to combine would have been that: “To enable adequate clinical decision making in individual patients it is paramount that any level of uncertainty is reduced to a minimum. Stenoses with an FFR ,0.75 are almost invariably able to induce myocardial ischaemia, while stenoses with an FFR .0.80 are almost never associated with exercise induced ischaemia (table 2). This means that the ‘‘grey zone’’ for FFR (between 0.75–0.80) spans over ,10% of the entire range of FFR values.” (De Bruyne, as cited above)
Regarding Claim 41.
Rejected under similar rationale as claim 33
Regarding Claim 49.
Rejected under similar rationale as claim 33
Non-statutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claim 34 and 42 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 7, and 13 of U.S. Patent No. 11547367 in view of Taylor, US 2012/0041318.
Independent claims of US 11547367 do not expressly recite the claimed inventions of the dependent’s claims noted above, but these would have been obvious when the claimed invention of the ‘367 was taken in view of Taylor.
Taylor teaches (claim 34 as representative):
The system of claim 31, wherein the operations further comprise:
determining whether the value of the blood flow characteristic is at or below the determined threshold value; and wherein the second intensity level of exercise is simulated based on determining that the value of the blood flow characteristic is at or below the determined threshold value. (Taylor, when the FFR is at or below 0.75, it indicates stenosis (¶ 205); wherein ¶ 232 clarifies that a prescribed treatment is to “increase in exercise”, and ¶ 233: “To determine which treatment(s) to prescribe, the computer system may be used to predict how the information determined from the computational analysis would change based on such treatment(s).” and ¶¶ 227-228 as cited above for “varying levels of exercise” to “…Such information may be used to identify the types and level of physical activity that may be safe and efficacious for a specific patient…”, i.e. if the FFR indicates stenoses, then trial treatments of exercise levels, while making sure its at a “safe and efficacious” “level of physical activity”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings from the ‘367 claimed invention with the teachings from Taylor on a similar such system (Taylor, abstract). The motivation to combine would have been that “Thus, a need exists for a method for assessing coronary anatomy, myocardial perfusion, and coronary artery flow noninvasively. Such a method and system may benefit cardiologists who diagnose and plan treatments for patients with suspected coronary artery disease. In addition, a need exists for a method to predict coronary artery flow and myocardial perfusion under conditions that cannot be directly measured, e.g., exercise, and to predict outcomes of medical, interventional, and surgical treatments on coronary artery blood flow and myocardial perfusion.” (Taylor, ¶ 8) and “The systems and methods disclosed herein may be incorporated into a software tool accessed by physicians to provide a noninvasive means to quantify blood flow in the coronary arteries and to assess the functional significance of coronary artery disease. In addition, physicians may use the software tool to predict the effect of medical, interventional, and/or surgical treatments on coronary artery blood flow. The software tool may prevent, diagnose, manage, and/or treat disease in other portions of the cardiovascular system including arteries of the neck (e.g., carotid arteries), arteries in the head ( e.g., cerebral arteries), arteries in the thorax, arteries in the abdomen (e.g., the abdominal aorta and its branches), arteries in the arms, or arteries in the legs ( e.g., the femoral and popliteal arteries). The software tool may be interactive to enable physicians to develop optimal personalized therapies for patients.” (Taylor, ¶ 116)
Also, see ¶ 182 as well.
Claims 33, 41, 49 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 3, 7, 9, 13, 15 of U.S. Patent No. 11547367 in view of De Bruyne, B., and J. Sarma. "Fractional flow reserve: a review." Heart 94.7 (2008): 949-959
Independent claims of US 11547367 do not expressly recite the claimed inventions of the dependent’s claims noted above, but these would have been obvious when the claimed invention of the ‘367 was taken in view of De Bruyne.
In particular, note dependent claims 3, 9, and 15 which have “FFR” as one of the example computed values
De Bruyne teaches (claim 33 as representative):
The system of claim 31, wherein the threshold value is one of a hypothetical normal state or a population norm (De Bruyne, section: “FFR has a theoretical normal value of 1 for every patient, for every artery and for every myocardial bed”: “An unequivocally normal value is easy to refer to but is rare in clinical medicine. Since in a normal epicardial artery there is virtually no decline in pressure, not even during maximal hyperaemia,6 it is obvious that Pd/Pa will equal or be very close to unity. This means that normal epicardial arteries do not contribute to the total resistance to coronary blood flow. The lowest value found in a total of 65 strictly normal coronary arteries was 0.92.6 7 Yet it is important to realise that in normal looking coronary arteries in patients with proven atherosclerosis elsewhere, the epicardial coronary arteries may contribute to total resistance to coronary blood flow even though there is no discrete stenosis visible on the angiogram. In approximately 50% of these arteries, FFR is lower than the lowest value found in strictly normal individuals. In approximately 10% of atherosclerotic arteries, FFR will be lower than the ischaemic threshold.“
Followed by section: “FFR has a well defined cut-off value with a narrow ‘‘grey zone’’ between 0.75 and 0.80” (see Taylor ¶ 205 which has about the same range; and in the exemplary Taylor is “0.75” in ¶ 234): “Cut-off or threshold values are values that distinguish normal from abnormal levels for a given measurement. To enable adequate clinical decision making in individual patients it is paramount that any level of uncertainty is reduced to a minimum. Stenoses with an FFR ,0.75 are almost invariably able to induce myocardial ischaemia, while stenoses with an FFR .0.80 are almost never associated with exercise induced ischaemia (table 2). This means that the ‘‘grey zone’’ for FFR (between 0.75–0.80) spans over ,10% of the entire range of FFR values” – see table 2 to further clarify
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings from the ‘367 claimed invention with the teachings from De Bruyne on hypothetical and population norm values of FFR that have previously been determined. The motivation to combine would have been that “To enable adequate clinical decision making in individual patients it is paramount that any level of uncertainty is reduced to a minimum”, also “An unequivocally normal value is easy to refer to but is rare in clinical medicine” (De Bruyne, as cited above).
Claims 31-50 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,092, 247 in view of Taylor, US 2012/0041318.
The ‘247 patent contains narrower claims then the breadth of the claims currently recited, thus this is an anticipatory non-statutory double patenting.
See representative claim 1 of the ‘247, contrast with instant representative claim 31.
The ‘247 adds several features into its claim 1, but nonetheless anticipates most of the instant independent claims, or at least an obvious variant thereof (e.g. “physical activity” as an obvious variant of “exercise”).
There is a distinction: ‘247 independent claims do not recite “image data” but rather only “data describing a geometry…”, however this would have been obvious when taken in view of Taylor, ¶¶ 121-124.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings from the ‘247 claimed invention with the teachings from Taylor on a similar such system (Taylor, abstract). The motivation to combine would have been that “Thus, a need exists for a method for assessing coronary anatomy, myocardial perfusion, and coronary artery flow noninvasively. Such a method and system may benefit cardiologists who diagnose and plan treatments for patients with suspected coronary artery disease. In addition, a need exists for a method to predict coronary artery flow and myocardial perfusion under conditions that cannot be directly measured, e.g., exercise, and to predict outcomes of medical, interventional, and surgical treatments on coronary artery blood flow and myocardial perfusion.” (Taylor, ¶ 8) and “The systems and methods disclosed herein may be incorporated into a software tool accessed by physicians to provide a noninvasive means to quantify blood flow in the coronary arteries and to assess the functional significance of coronary artery disease. In addition, physicians may use the software tool to predict the effect of medical, interventional, and/or surgical treatments on coronary artery blood flow. The software tool may prevent, diagnose, manage, and/or treat disease in other portions of the cardiovascular system including arteries of the neck (e.g., carotid arteries), arteries in the head ( e.g., cerebral arteries), arteries in the thorax, arteries in the abdomen (e.g., the abdominal aorta and its branches), arteries in the arms, or arteries in the legs ( e.g., the femoral and popliteal arteries). The software tool may be interactive to enable physicians to develop optimal personalized therapies for patients.” (Taylor, ¶ 116)
A second, but obvious, distinction is the two exercise levels in the present claims – obvious in view of Taylor, Taylor ¶¶ 227-228: “For example, the parameters determined in steps 631-634 may be modified based on whether the solution 640 is intended to simulate rest, varying levels of hyperemia, varying levels of exercise or exertion, different medications, etc…Such information may be used to optimize medical therapy or avert potentially dangerous consequences of medications. The combined model may also be used to determine the effect on coronary artery blood flow of alternate forms and/or varying levels of physical activity or risk of exposure to potential extrinsic force, e.g., when playing football, during space flight, when scuba diving, during airplane flights, etc. Such information may be used to identify the types and level of physical activity that may be safe and efficacious for a specific patient” as well as ¶¶ 232, 242, 292, 300
Regarding the dependent claims (for conciseness, the representative dependent claims are of claim 31, and parallel claims are rejected under a similar rationale):
Representative Claim 32 is rejected in view of the claim 1 of the ‘247, note the “determine a physics-based model…” limitation followed by the “update”, as taken in view of Taylor as discussed above.
Representative Claim 33 – see dependent claim 9 in the ‘247, and its parallels at 20 and 30.
Representative Claim 34 – see claim 1 of the ‘247, last three limitations, as taken in view of Taylor as discussed above.
Representative Claim 35 – dependent claims 5, 16, and 27.
Representative Claim 36 – see claim 1 of the ‘247, taken in view of Taylor as cited above.
Representative Claim 37 – dependent claims 10, 22 (note the instant claims don’t have a CRM parallel claim; but even if they did statutory category of invention is an obvious variant).
Representative Claim 38 - see claim 1 of the ‘247, taken in view of Taylor, ¶¶ 204-206, motivation to combine would have been similar to above, wherein such a color coding of the resulting comparisons with the threshold would have provided a better arrangement of the information so users would more quickly process the information.
Claims 31-50 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9,668,700 in view of Taylor, US 2012/0041318.
The independent claims are rejected under a similar rationale as the above discussed rejection in view of US Patent No. 10,092, 247, with similar distinctions, wherein the ‘247 is an obvious variant of the ‘700 independent claims (and also, somewhat broader, but still anticipatory/an obvious variant for the instant claims under a similar rationale as above).
Regarding the dependent claims (for conciseness, the representative dependent claims are of claim 31, and parallel claims are rejected under a similar rationale):
Representative Claim 32 is rejected in view of the claim 1 of the ‘700, note the “determine a physics-based model…” limitation followed by the “update” , as taken in view of Taylor as discussed above.
Representative Claim 33 – see dependent claim 8 in the ‘700, and its parallels at 18. With respect to instant claim 49, this is an obvious variant of dependent claims 8 and 18 by merely being in a different statutory category.
Representative Claim 34 – see claim 1 of the ‘700, last three limitations, as taken in view of Taylor as discussed above.
Representative Claim 35 – dependent claims 4, 14, and 24.
Representative Claim 36 – see claim 1 of the ‘700, taken in view of Taylor as cited above.
Representative Claim 37 – dependent claims 9, 20 (note the instant claims don’t have a CRM parallel claim; but even if they did statutory category of invention is an obvious variant).
Representative Claim 38 - see claim 1 of the ‘700, taken in view of Taylor, ¶¶ 204-206, motivation to combine would have been similar to above, wherein such a color coding of the resulting comparisons with the threshold would have provided a better arrangement of the information so users would more quickly process the information.
Claim 31-50 is/are rejected under 35 U.S.C. 101 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-15 of prior U.S. Patent No. 11547367.
The ‘367 instant independent claims are narrower than the instant claims and thus anticipate the instant claims.
To clarify, while the instant claims in representative dependent claims 33 and 34 recite the features found in claim 1 of the ‘367 patent, there is not, at present, a single instant claim that requires in combination both the features of instant representative claims 33 and 34, for they have distinct dependency trees.
Instant Application
US Patent # 11547367
Regarding Claim 31.
A system for quantifying limitations in coronary artery blood flow during exercise in a patient with coronary artery disease, the system comprising:
at least one processor;
and at least one memory storing instructions that, when executed by the at least one processor, perform operations comprising:
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 representing the geometry of the patient's vasculature, the three- dimensional geometric model reflecting vascular geometry at a first intensity level of exercise;
computing, using the three-dimensional geometric model, a value of a blood flow characteristic of blood flow through the three-dimensional geometric model for the first intensity level of exercise;
determining a threshold value quantifying a limitation of exercise of the patient based on the value of the blood flow characteristic at the first intensity level of exercise;
computing, using the three-dimensional geometric model, a blood flow characteristic of blood flow through the three-dimensional geometric model for a second intensity level of exercise, different from the first intensity level of exercise;
and providing a recommendation of a maximum level of exercise based on the determined threshold value, the first intensity level of exercise, and the second intensity level of exercise.
Regarding Claim 1
A system for quantifying limitations in coronary artery blood flow during exercise in a patient with coronary artery disease, the system comprising:
at least one processor; and
at least one memory storing instructions that, when executed by the at least one processor, perform operations comprising:
receiving patient-specific anatomical image data regarding geometry of a patient's vasculature;
creating a three-dimensional geometric model based on the received patient- specific anatomical image data representing the geometry of the patient's vasculature, the three-dimensional geometric model reflecting vascular geometry at a first intensity level of exercise;
computing, using the three-dimensional geometric model, a value of a blood flow characteristic of blood flow through the three-dimensional geometric model for the first intensity level of exercise;
determining a threshold value quantifying a limitation of exercise of the patient based on the value of the blood flow characteristic at the first intensity level of exercise, wherein the threshold value is one of a hypothetical normal state or a population norm;
determining whether the value of the blood flow characteristic is at or below the determined threshold value;
upon determining that the value of the blood flow characteristic is at or below the determined threshold value, simulating a second intensity level of exercise;
computing, using the three-dimensional geometric model, a blood flow characteristic of blood flow through the three-dimensional geometric model for the second intensity level of exercise, different from the first intensity level of exercise;
and providing a recommendation of a maximum level of exercise based on the determined threshold value, the first intensity level of exercise, and the second intensity level of exercise.
Regarding Claim 32.
The system of claim 31, wherein the at least one processor is further configured for:
generating a physics-based model based on the three-dimensional geometric model;
and computing the blood flow characteristic based on the physics- based model , wherein the physics-based model corresponds to the second intensity level of exercise.
Regarding Claim 2.
The system of claim 31, wherein the at least one processor is further configured for:
generating a physics-based model based on the three-dimensional geometric model;
and computing the blood flow characteristic based on the physics-based model, wherein the physics-based model corresponds to the second intensity level of exercise.
Regarding Claim 33.
The system of claim 31, wherein the threshold value is one of a hypothetical normal state or a population norm.
Claim 1: “wherein the threshold value is one of a hypothetical normal state or a population norm;”
Regarding Claim 34.
The system of claim 31, wherein the operations further comprise:
determining whether the value of the blood flow characteristic is at or below the determined threshold value;
and wherein the second intensity level of exercise is simulated based on determining that the value of the blood flow characteristic is at or below the determined threshold value.
Claim 1
determining whether the value of the blood flow characteristic is at or below the determined threshold value;
upon determining that the value of the blood flow characteristic is at or below the determined threshold value, simulating a second intensity level of exercise;
Regarding Claim 35.
The system of claim 31, wherein the computed blood flow characteristic is chosen from coronary blood flow, blood pressure, plaque stress, myocardial perfusion, plaque vulnerability, and FFR.
Regarding Claim 3.
The system of claim 31, wherein the computed blood flow characteristic is chosen from coronary blood flow, blood pressure, plaque stress, myocardial perfusion, plaque vulnerability, and FFR.
Regarding Claim 36.
The system of claim 31, wherein the second intensity level of exercise comprises an elevated intensity level of exercise relative to the first intensity level of exercise.
Regarding Claim 4.
The system of claim 31, wherein the second intensity level of exercise comprises an elevated intensity level of exercise relative to the first intensity level of exercise.
Regarding Claim 37.
The system of claim 31, wherein the three-dimensional geometric model represents at least a portion of a heart of the patient that includes at least a portion of an aorta and at least a portion of a plurality of coronary arteries emanating from the portion of the aorta.
Regarding Claim 5.
The system of claim 31, wherein the three- dimensional geometric model represents at least the portion of a heart of the patient that includes at least a portion of an aorta and at least a portion of a plurality of coronary arteries emanating from the portion of the aorta.
Regarding Claim 38.
The system of claim 37, wherein the at least one processor is further configured for:
computing the threshold value at a plurality of locations in the plurality of coronary arteries.
Regarding Claim 6.
The system of claim 37, wherein the at least one processor is further configured for:
computing the threshold value at a plurality of locations in the plurality of coronary arteries.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Uhlemann, Madlen, et al. "Impact of different exercise training modalities on the coronary collateral circulation and plaque composition in patients with significant coronary artery disease (EXCITE trial): study protocol for a randomized controlled trial." Trials 13.1 (2012): 167. Abstract, page 2-3, incl. last paragraph on page 3, section on the measurement of FFR, and page 7 col. 1. Also the discussion and conclusion sections.
Zbinden, Rainer, et al. "Coronary collateral flow in response to endurance exercise training." European Journal of Preventive Cardiology 14.2 (2007): 250-257. Abstract, section “Methods” in particular the subsection “Study Protocol”, then see the “Results” section including the tables.
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/David A Hopkins/ Primary Examiner, Art Unit 2188