DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 30-49 are currently pending and under exam herein.
Claims 1-29 have been cancelled by preliminary amendment.
Priority
This application is a Continuation of 17/713,467, filed 04/05/2022, now US Patent 11,861,831, which is a Continuation of 16/122,328, filed 09/05/2018, now US Patent 11,663,715 which is a Continuation of 15/186,962, filed 06/20/2016, now US Patent 10,096,104, which is a Continuation of 14/011,151, filed 08/27/2013, now US Patent 9,805,463. The Effective Filing Data (EFD) of the instant application for each of claims 30-49 is 27 August 2013.
Information Disclosure Statement
The Information Disclosure Statement filed 23 May 2023 is in compliance with the provisions of 37 CFR 1.97 and has therefore been considered. A signed copy of the IDS is included with this Office Action.
Drawings
The Drawings filed 23 May 2023 have been accepted.
Specification
Note: All references to the Specification herein pertain to the PG publication: US20230298176.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
1. Claims 36 and 48 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention. Claims 36 and 48 include recitation of “wherein the prognosis risk includes at least one of…a metastasis risk” wherein the instant Specification fails to provide any written description for assessment of metastasis, which would indicate that the inventors, at the time the application was filed, had possession of the claimed element of the invention herein. The instant Specification provide support for the assessment of coronary lesions and blood flow rates wherein “location, onset, or change in coronary lesions from factors such as vessel geometry, physiology, and hemodynamics” are disclosed (abstract). The Specification further includes disclosure of detecting change in coronary geometry [0026] and disease location [0024] along with other factors such as size, shape of coronary lesions [0003] and remodeling characteristics [0042] and prediction of growth, shrinkage and onset of plaque [0073]. However, no disclosure related to metastasis is found in the instant Specification and therefore the claim portion lacks written description as filed.
2. Claims 30-49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method, system, and non-transitory computer-readable storage medium for prognosis management based on coronary artery disease as relates to plaque lesions, does not reasonably provide enablement for the scope of the instant claims directed to any medical image data from a patient that pertains to morphology and prediction of progression of any and all conditions to make any and all predictions related to morphology of a condition. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use or make the invention commensurate in scope with these claims. The Specification is directed solely to systems and methods for predicting the location, onset, or change of coronary lesions from factors like vessel geometry, physiology, and hemodynamics. The Specification fails to detail any other conditions nor provides enablement for doing so for all conditions known to man. The instant Specification provides only details for the imaging and assessment using particular algorithms related to cardiac imaging modalities, such as those for geometric models related to the vascular system [0007]; [0048] and hemodynamic parameters such as CFD analyses, wall-shear stress factors, shear indices, Reynold’s number, Womersley number, local flow rate etc. [0039] that pertain specifically to cardiac vasculature dynamics. And most certainly not to any and all known conditions for any and all know prediction and prognoses for disease or condition.
As such, the instant claims are only enabled insofar as the disclosure as pertains to CAD and plaque lesions.
Claim Rejections - 35 USC § 112(b)-Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 30-49 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 30, 38, and 43 recite, “receiving the medical information including at least a medical image of the patient reflecting a morphology of an object associated with the patient at a first time” wherein the claim is unclear with respect to “a medical image reflecting a morphology of an object” as the recitation of “reflecting” in the claim creates indefiniteness as to what about the image “reflects” a morphology as “reflect” could refer to actual “reflection” of an image such as by light reflection or alternatively could pertain to just an image that includes morphology of an object. This issue persists in the third claim element directed to “a prognosis prediction at the second time reflecting the morphology of the object”. Clarification is requested through clearer claim language. Claims 31-37, 39-42, and 44-48 fail to remedy the above and are rejected herein for the same reasoning.
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 30-49 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The instant rejection reflects the framework as outlined in the MPEP at 2106.04:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
Step 1 Analysis: Are claims directed to process, machine, manufacture/composition of matter
With respect to step (1): yes, the claims are directed to a method, a system, and a non-transitory computer-readable storage medium for prognosis management based on medical information of a patient.
Step 2A, Prong 1 Analysis: Do claims recite abstract idea
With respect to step (2A)(1), the claims recite abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the (2A)(1) evaluation, the claims are found herein to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information).
The claim steps to abstract ideas are as follows:
Claims 30, 38, and 43
predict(ing), by a processor, a progression condition of the object at a second time based on the medical information of the first time, wherein the progression condition is indicative of a prognosis risk, wherein the second time is after the first time; generat(ing), by the processor, a prognosis prediction at the second time reflecting the morphology of the object at the second time based on the medical information of the first time, wherein steps directed to making a prediction and generating a prognosis based on received data are steps directed to mental activity by which one could merely visually assess image data and make prediction based on observations. Save for processor implementation (computer as a tool) no steps are provided other than to do so at different time points. Thus under the Broadest Reasonable Interpretation (BRI) of the claims herein, said steps are directed to abstract mental processes.
Claim 36:
wherein the prognosis risk includes at least one of an enlargement risk of the object, a deterioration risk of the object, an expansion risk of the object, a metastasis risk of the object, a recurrence risk of the object, a location of the object, a volume of the object, or a subtype of the object, wherein said claim limitation further limits the “prognosis risk” as particular types of risk thus further limiting the judicial exception in claim 30 above.
Claims 37, 42, and 49:
wherein generating the prognosis prediction at the second time based on the medical information of the first time further includes: generating the prognosis prediction at the second time using a machine learning algorithm, based on the medical information of the first time and a time interval between the first time and the second time, wherein the claim limitation further limits the “prognosis prediction” as particular time points and further includes “use” of a machine learning algorithm. The recitation of a machine learning algorithm is merely a tool by which one would generate a prediction by mathematical function and the “use” is not further defined in the claim. Thus “using” a machine learning algorithm is a tool by which to perform said judicially recited abstract idea.
Claim 48:
the object includes a lesion, and the prognosis risk includes an enlargement risk of a lesion, and the first time is after onset of the lesion; and the prognosis risk includes at least one of an enlargement risk of the object, a deterioration risk of the object, an expansion risk of the object, a metastasis risk of the object, a recurrence risk of the object, a location of the object, a volume of the object, or a subtype of the object, wherein said claim limitation further limits the “prognosis risk” as particular types of risk thus further limiting the judicial exception in claim 43 above.
Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined herein to each cover performance in the mind (predicting and generating prognosis and risks). There are no specifics as to the methodology involved in said steps and thus, under the BRI, one could simply, for example, perform said operation with pen and paper, or, alternatively with the aid of a generic computer as a tool to perform said observations. These recitations are similar to the concepts of collecting information, analyzing it and providing certain results from the collection and analysis (Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations (Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in (Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind with pen and paper, and can include mathematical concepts.
Further, see MPEP § 2106.04(a)(2), subsection III. The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation (see, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674: noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016): holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind" (see Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016): holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer").
Step 2A, Prong 2 Analysis: Integration to a Practical Application
Because the claims do recite judicial exceptions, direction under (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (MPEP 2106.04(d). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim is said to fail to integrate the abstract idea into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations, the claims recite the following additional elements:
Claims 30, 38, and 43:
receiv(ing) the medical information including at least a medical image of the patient reflecting a morphology of an object associated with the patient at a first time… providing the progression condition of the object at the second time and the prognosis prediction at the second time to an information management system for presentation to a user, wherein said operations are directed to “getting data” (data gathering) and extra-solution output (providing). With respect to the additional elements in the instant claims, those steps directed to data gathering perform functions of collecting the data needed to carry out the abstract idea. Data gathering does not impose any meaningful limitation on the abstract idea, or on how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g).
Further to “output” (providing…to an information management system) are steps directed to extra-solution activity that are incidental to the process of prediction and generation and do not amount to a limitation that imposes a meaningful limit on the claim. See for example, See Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715-16, 112 USPQ2d 1750, 1755 (Fed. Cir. 2014) (restricting public access to media was found to be insignificant extra-solution activity); Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1242, 120 USPQ2d 1844, 1855 (Fed. Cir. 2016) (in patents regarding electronic menus, features related to types of ordering were found to be insignificant extra-solution activity). This is considered in Step 2A Prong Two and Step 2B.
Claims 30, 38, and 43:
processor; using a machine learning algorithm; system; interface (BRI-“computer)); computer-readable storage medium with a program, wherein recitation herein of said “computer” components are those that are directed to generic computing components and not to a “specific machine” and wherein said recitations do not describe any specific computational steps by which the “computer parts” perform or carry out the abstract idea, nor do they provide any details of how specific structures of the computer, such as the computer-readable recording media, are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc… are recited so generically (i.e., no details are provided) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer. (see MPEP 2106.05(f)).
Step 2B Analysis: Do Claims Provide an Inventive Concept
The claims are lastly evaluated using the (2B) analysis, wherein it is determined that because the claims recite abstract ideas, and do not integrate that abstract ideas into a practical application, the claims also lack a specific inventive concept. Applicant is reminded that the judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements of data gathering described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims, the prior art to, for example, Stone et al. (Circulation (2012) Vol. 126:172-181) disclose steps that include getting image data for use in coronary modeling (p. 173, col. 2). Further prior art to, for example, Ricotta et al. (Med Biol Eng Comput (2008) 46:1059–1068) diagnostic testing that includes physiological and anatomical measurements from image analysis (p. 1059-abstract; p. 1060, col. 1; entire reference) and provide that getting such data encompasses steps that are routine, well-understood and conventional in the art. With respect to outputting or providing data, said operations are akin to computer provision of said data and further wherein the computer-related elements or the general purpose computer do not rise to the level of significantly more than the judicial exception. The instant specification provides evidence that computer processors and systems, as example, are generic in nature (see, for example [0082]). The additional elements are set forth at such a high level of generality that they can be met by a general purpose computer. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than an abstract idea (see MPEP 2106.05(b)I-III).
The dependent claims have been analyzed with respect to step 2B and none of these claims provide a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception as they are directed to further definition of the “data” herein, such as to types of data that include non-image data (claims 31 and 44); gender, age, time, etc. data (claims 32 and 45); types of output as in presentation of time assessed data (claims 33, 39, and 46); presentation of volume and subtype, etc. (claims 34 and 47); object data (claims 35, 41, and 48).
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 30-49 are rejected under 35 U.S.C. 103 as being unpatentable over Stone et al. (Circulation (2012) Vol. 126:172-181), in view of Cilla et al. (IEEE Transactions on Biomedical Engineering, Vol. 59, No. 4, pp. 1155-1161).
Claim 30 is directed to:
A method for prognosis management based on medical information of a patient, comprising:
receiving the medical information including at least a medical image of the patient reflecting a morphology of an object associated with the patient at a first time (Stone et al. disclose “coronary angiography and intravascular ultrasound, was used to reconstruct each artery and calculate endothelial shear stress and plaque/remodeling characteristics in vivo”, thus disclosing getting image data for a patient that include morphology of a vessel including an “object” (plaque)-abstract)
predicting, by a processor, a progression condition of the object at a second time based on the medical information of the first time, wherein the progression condition is indicative of a prognosis risk, wherein the second time is after the first time (Stone et al. disclose, “Three-vessel vascular profiling (2.7 arteries per patient) was performed at baseline in 506 patients with an acute coronary syndrome treated with a percutaneous coronary intervention and in a subset of 374 (74%) consecutive patients 6 to 10 months later to assess plaque natural history”-abstract)
generating, by the processor, a prognosis prediction at the second time reflecting the morphology of the object at the second time based on the medical information of the first time; and (Stone et al. disclose, “increase in plaque area (primary end point) was predicted by baseline large plaque burden; decrease in lumen area (secondary end point) was independently predicted by baseline large plaque burden and low endothelial shear stress”,-abstract)
providing the progression condition of the object at the second time and the prognosis prediction at the second time to an information management system for presentation to a user (Stone et al. provide presentation of data at least at Figure 1).
Stone et al. do not specifically disclose processors and computer implementation wherein said data are provided to an information management system (interpreted herein as a “computer output). However, the prior art to Cilla et al. disclose application that include computational technologies to aid in assessment of cardiovascular disease including plaque determinations (abstract). Said operations include computing system and machine learning wherein, for example, Cilla et al. disclose, “The machine learning techniques use an intelligent algorithm to model the atheroma plaque rupture in terms of four of the most influential geometrical factors in the plaque rupture: 1) fibrous cap thickness; 2) stenosis ratio; 3) lipid core width; and 4) lipid core length. The output predicted is the maximum MPS occurred in an atherosclerotic coronary vessel with the input dimensions” (p. 1156, col. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have presented data as assessed by Stone et al. with machine implementation and computerization as disclosed by Cilla et al. as both references are in the same field of endeavor and would have expected reasonable success in so doing because Stone et al. specifically include that “identification of an early coronary atherosclerotic plaque likely to acquire high-risk characteristics and precipitate a new coronary event may allow for development of preemptive strategies to avert adverse events. The recent Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT) Study10 demonstrated that coronary lesions responsible for new cardiac events in patients following a percutaneous coronary intervention (PCI) for an acute coronary syndrome (ACS) were associated with large plaque burden, a small lumen area, thin-cap fibroatheroma (TCFA) morphology, as assessed by intravascular ultrasound (IVUS), and minimal obstruction by angiography” (p. 173, col. 1) and further that, “our predictive analyses use both continuous and categorical baseline variables, because the continuous variables are essential to prove the pathobiological relationship between baseline vascular characteristics and outcomes, but the categorical variables, derived either by nonbiased terciles or cut points determined by receiver operator characteristic analyses, provide a way to compare the quantitative relationships we observed to the relationships in similar studies performed by investigators who use categorical baseline variables (p. 179, col. 2). Finally, Stone et al. conclude that, “it remains to be confirmed whether early identification of high-risk lesions is enhanced by determination of local ESS and whether such insights will be clinically useful to guide patient management” (p. 180), thus motivating more robust assessment such as the computer implemented machine learning as provided by Cilla et al. and further including teaching by Cilla et al. that provide for operation using IVUS images, “The ultimate goal of this paper is to develop a quantitative
method for cumulative risk assessment of vulnerable patients based on atheroma plaque morphology which could replace the time-consuming biomechanical simulations used in cardiovascular mechanics. Summing up, the procedure proposed would be carried as follows: for a specific patient, clinical staff should measure just four parameters in standard IVUS images, and then, by using the ANN or SVM techniques, they would have
an immediate response on the atheroma plaque vulnerability” (p. 1156, col. 1).
With respect to claims 31-32 and 44-45, Stone et al. disclose patient data that includes, e.g., patient aged 18 or older; history of heart disease status (p. 173, col. 1; further data at Table 1).
With respect to claims 33, 39, and 46, Stone et al. disclose, “We chose 3-mm segments because this length was methodologically reliable and would also accurately reflect the local hemodynamic and plaque characteristics, and the heterogeneous and highly focal changes occurring within the plaque over time, as well. Within each 3D segment we assessed local ESS,
plaque characteristics, and vascular remodeling… Coronary artery natural history outcomes were analyzed by utilizing a variety of different approaches to represent different magnitudes of
CAD progression. (1) Each 3-mm segment was evaluated to determine the effect of the baseline local ESS and plaque characteristics (as continuous variables) on the change in vascular outcome variables (as continuous variables) in the same segment. (2) We analyzed the natural
history of obstructions at baseline, because arterial areas with a lumen narrowing at baseline may be particularly likely to exhibit worsening obstruction in follow-up” (p. 173, col. 1).
With respect to claims 34 and 47, Cilla et al. disclose, “A 3-D Fig. 1. (a) Idealized geometry of an atherosclerotic arterial model. Transversal section. (b) Geometrical parameters shown on the cross central section of the atherosclerotic vessel. FEM was developed using the commercial FE code ABAQUS 6.9, taking into account both the composition and dimensions of the different layers of the tissue (media and adventitia), the fibrous plaque, and the lipid core. The arterial wall was approximated as a hollow cylinder with a circular lumen. The atherosclerotic plaque was modeled as a symmetric volume with respect to the central cross section (longitudinal axis), located inside the vessel. Finally, the lipid core was approximated as a blunt volume (see Fig. 1)” (p. 1156, col. 2). Further Cilla et al. disclose sub-type (atheroma plaque-p.1157) and location of plaque parameters (p. 1156, col. 2).
With respect to claims 35, 41, and 48, Stone et al. disclose assessment of plaque enlargement at (p. 173, col. 1).
With respect to claims 36 and 48, Stone et al. disclose, e.g., risk of enlargement of plaque burden (p. 173, col. 1).
With respect to claims 37, 42, and 49, Cilla et al. disclose the use of machine learning in prognosis and prediction for plaque progression and assessment (see entire reference) and further recitations above as pertain to claims 30, 38, and 43.
Conclusion
No claims are allowed.
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