Systems and Methods for Anatomical and Device Optimization

§101 §103

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 1-20 are pending and under examination. Claims 1-20 are rejected. Claims 1, 3-7, 11, 13-15, 17, and 19-20 are amended. Claims 1, 15, and 20 are independent. No claims are allowed, canceled, new, or withdrawn. Office Action Outline Rejections applied Abbreviations 112/b Indefiniteness PHOSITA "a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention" 112/b "Means for" BRI Broadest Reasonable Interpretation 112/a Enablement, Written description CRM "Computer-Readable Media" and equivalent language 112 Other IDS Information Disclosure Statement x 102, 103 JE Judicial Exception x 101 JE(s) 112/a 35 USC 112(a) and similarly for 112/b, etc. 101 Other N:N page:line Double Patenting MM/DD/YYYY date format Priority As detailed in the 12/29/2025 filing receipt, this application claims the benefit of priority to Provisional Application No. 63/725,609, filed 11/27/2024. Claims 1-8, 12, 14-17, and 19-20 are being examined with an effective filing date of 11/27/2024. Claims 9-11, 13, and 18 are being examined with an effective filing date of 11/27/2025, and are not granted the claim to the benefit of priority to U.S. Provisional Application No. 63/725,609, as the following recitations are not supported by the disclosure of U.S. Provisional Application No. 63/725,609: Claim 9: "ranking the modification strategies." Claim 10: "valve-in-valve (ViV) replacement." Claim 11: " the patient-specific data comprises at least one of: native valve morphology, physiologic conditions, patient demographics, structural measurements of aortic root, annulus, sinotubular junction, coronary heights, leaflet calcification, volume and distribution dynamic physiologic parameters, and the pre-procedural medical imaging data from ...MRI, echocardiography (TTE or TEE), fluoroscopy, or catheter-derived hemodynamic recording." Claim 13 and 18: " releasing, incising, thinning, scoring, and/or debulking to alternate native leaflets, commissures, raphe tissue, or calcified regions." Overview of Withdrawal/Revision of Objections/Rejections In view of the amendment and remarks received 07/02/2026: • The objection to the Specification (Title) is withdrawn; the title has been amended. Additionally, the amending of Specification [0073] (regarding the misspelling of physiologic in the 04/02/2026 Office action, ¶16) is acknowledged. • The objections to the claims are withdrawn. • The 112(b) rejections are withdrawn. • The 101 rejection is maintained with revision. • The 103 rejection is withdrawn; a new 103 rejection is applied below. • The Nonstatutory Double Patenting rejections are withdrawn. Claims Interpretation Claims 3 and 17 recite the term "sensor" in the recitation "a sensor system comprising one or more sensors incorporated in the at least one device or a deployment system of the at least one device." The term "sensor" is discussed in Specification paragraphs [0044-0050], [0077], [0083-0087], and is interpreted to read on at least embodiments as disclosed in [0044] and [0083] as "... a sensor system 40, e.g., a pressure sensor or other sensors incorporated in the balloon or the mechanical or bioprosthetic heart valve itself... The sensors may be integrated directly onto the stent frame, embedded within a balloon or catheter structure, or positioned adjacent to the stent to measure local or global deformation..." [0044], and "The sensor system 40 can be configured to collect data or measurements from the balloon or the heart valve itself... the sensor 106 can be an X-ray detector... the sensor system 40 can include a pressure sensor..." [0083]. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more. MPEP 2106 details the following framework to analyze Subject Matter Eligibility: • Step 1: Are the claims directed to a category of statutory subject matter (a process, machine, manufacture, or composition of matter)? (see MPEP § 2106.03) • Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. an abstract idea, a law of nature, or a natural phenomenon? (see MPEP § 2106.04(a)). Note, the MPEP at 2106.04(a)(2) & 2106.04(b) further explains that abstract ideas and laws of nature 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); • mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information); • laws of nature and natural phenomena are naturally occurring principles and/or relations that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature. • Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application? (see MPEP § 2106.04(d)) • Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept? (see MPEP § 2106.05) Step 1: Claims 1-14 are directed to a 101 process, here a method. Claims 15-19 are directed to a 101 machine or manufacture, here a system. Claim 20 is directed to a 101 machine or manufacture, here a non-transitory machine-readable medium. As such, claims 1-20 are directed to a related method, system, and non-transitory machine-readable medium, which fall under categories of statutory subject matter. (See MPEP § 2106.03). (Step 1: Yes.) Step 2A, Prong One: The claims are found to recite abstract ideas in the form of mental processes and mathematical concepts, as follows: Independent claim 1 recites a method comprising mental processes of: • generating options of modification strategies comprising device modification and anatomical modifications • simulating the heart medical procedure • generating a simulation outcome for each option (also considered a mathematical concept) • selecting a modification strategy • generating procedural recommendations based on the selected modification strategy Independent claim 15 and independent claim 20 respectively recite a system and a non-transitory machine-readable medium for performing the abstract ideas as recited in independent claim 1. Claim 2 and 16 further limit the device respectively of claims 1 and 15. Claims 3 and 17 further limit the data respectively of claims 1 and 15. Claim 4 further limits the method of claim 1. Claim 5 recites mental processes of generating a selection of at least one modification device. Claim 6 further limits the modification device of claim 5. Claim 8 recites a mental process and mathematical concept in using quantitative risk metrics. Claim 9 recites a mental process in ranking the modification strategies. Claim 10 further limits the heart medical procedure of claim 1. Claim 11 further limits the patient specific data of claim 1. Claim 12 recites mental processes and mathematical concepts in performing a predictive simulation using one or more computational models selected from: nonlinear finite element analysis (FEA), fluid-structure interaction (FSI) modeling, computational fluid dynamics (CFD), reduced-order surrogate models, simplified force-driven particle models, and machine-learning-based risk estimation models. Claims 13 and 18 limit the anatomical modifications respectively of claim 1 and claim 15. Claims 14 and 19 further limit the device modifications respectively of claim 1 and claim 15. Step 2A Prong One Summary: The claims recite mental processes and mathematical concepts. When considering the broadest reasonable interpretation (BRI) of the claims, the mental processes recited in independent claims 1, 15, and 20 (e.g., generating options; simulating the heart medical procedure; generating a simulation outcome for each option; selecting a modification strategy; generating procedural recommendations; etc.) are directed to processes that may be performed in the human mind, or with pen and paper, as there are no particular limitations recited in claims 1, 15, and 20 which would prevent the mental processes from being performed in the human mind or with pen and paper. The claims recite inherent mathematical processes in e.g., generating a simulation outcome; using quantitative risk metrics; using computational models including nonlinear finite element analysis (FEA), fluid-structure interaction (FSI) modeling, computational fluid dynamics (CFD), reduced-order surrogate models, simplified force-driven particle models, and machine-learning-based risk estimation models) while details of which are not explicitly shown in the claims, are discussed throughout the Specification, e.g., at [0074-0075], [00112-00113], [00121-00122], etc. Such analysis performed mentally, or with paper and pencil, may take considerable time and effort, and although a general-purpose computer can perform these calculations at a rate and accuracy that can far exceed the mental performance of a skilled artisan, the nature of the activity is essentially the same, and therefore constitutes an abstract idea. Therefore, the claims recite elements that constitute a judicial exception in the form of an abstract idea(s). (Step 2A, Prong One: Yes.) Step 2A, Prong Two: In Step 2A, Prong One above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs). Here at Step 2A, Prong Two, any remaining steps and/or elements not identified as JEs are therefore in addition to the identified JE(s), and are considered additional elements. Because the claims have been interpreted as being directed to judicial exceptions (abstract ideas in this instance) then Step 2A, Prong Two provides that the claims be examined further to determine whether the judicial exception is integrated into a practical application [see 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. MPEP § 2106.04(d)(I) lists the following five example considerations for evaluating whether a judicial exception is integrated into a practical application: (1) An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a). (2) Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2). (3) Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b). (4) Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c). (5) Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e). The claims recite additional elements as follows: Additional elements of data gathering (including data outputting) steps: Claims 1, 15, and 20 recite the additional element of obtaining data and outputting data (claim 1 and 20) and transmitting data (claim 15). Claim 7 recites the additional element of outputting (displaying) data. Data gathering steps are additional elements which perform functions of inputting, collecting, and outputting the data needed to carry out the abstract idea. These steps are considered insignificant extra-solution activity, and are not sufficient to integrate an abstract idea into a practical application as they do not impose any meaningful limitation on the abstract idea or how it is performed, nor do they provide an improvement to technology (see MPEP § 2106.04(d)(I)). Additional elements of computer components and surgical devices: Claims 2 and 16 recite additional elements of one or more of a heart valve. Claims 2 and 16 recite additional elements of one or more of a heart valve, a guidewire, a cutting device, an electrosurgical splitter, a catheter, a deployment system of the at least one device, and a left atrial appendage occlusion (LAAO) device. Claims 3 and 17 recite additional elements of a sensor system comprising one or more sensors incorporated in the at least one device or a deployment system of the at least one device. Claims 5 and 6 recite additional elements of modification devices comprising a cutting device and/or a splitter. Claim 7 recites an additional element of a display. Claim 15 recites additional elements of a memory and processor. Claim 20 recites an additional element of a non-transitory machine readable storage media. The claims require only generic computer components, which do not improve computer technology, and do not integrate the recited judicial exception into a practical application (see MPEP § 2106.04(d)(1) and MPEP § 2106.05(f)). Step 2A Prong Two summary: At this point in examination, it is not yet the case that any of the Step 2A Prong Two considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of: (1) an improvement, (2) a treatment, (3) a particular machine, or (4) a transformation is clear in the record. For example, regarding the first consideration for improvement at MPEP 2106.04(d)(1), the record, including the Specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field, and the claims do not yet clearly result in such an improvement. While the specification discloses improvement (e.g. [41]), the relationships are not yet clear between the claim, identified JEs, improvement and practical application. Arguments and evidence may be extrinsic to the original disclosure, including references available after the priority date, as long as it is clear that an argument applies to all embodiments of a properly supported claim. Regarding Step 2A Prong Two, the following issues were observed which, if amended, may move the claims toward reciting a practical application: • Instant claims 1, 15, and 20 do not recite an active step of performing a heart medical procedure informed by the JE result of the selected modification strategy or the generated procedural recommendations, however, amending claims 1, 15, and 20 to include such a step might possibly provide a connection between the judicial exceptions (JEs) and a non-abstract step of surgery, which in turn might point toward an improvement to technology or a particular therapy, and possibly toward overcoming the 101 rejection at Step 2A Prong Two (see MPEP §§ 2106.04(d)(1); 2106.05(a); and 2106.04(d)(2)). • Additionally, in claims 1, 15, and 20, the link between the selected modification strategy and the generated procedural recommendations (including what those recommendations comprise) would need to be made more apparent. As recited, there is not necessarily a connection between the recommendations and the selected modification strategy. The claims have been further analyzed with respect to Step 2A, Prong Two, and no additional elements have been found, alone or in combination, that would integrate the judicial exception into a practical application. (Step 2A, Prong Two: No). Step 2B: Because the additional claim elements do not integrate the abstract idea into a practical application, the claims are further examined under Step 2B, which evaluates whether the additional elements, individually and in combination, amount to significantly more than the judicial exception itself by providing an inventive concept. An inventive concept is furnished by an element or combination of elements that is recited in the claim in addition to the judicial exception, and is sufficient to ensure that the claim, as a whole, amounts to significantly more than the judicial exception itself (see MPEP § 2106.05). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are well-understood, routine, and conventional. Those additional elements are as follows: Additional elements of data gathering, inputting, and outputting steps: The additional elements of obtaining data (claims 1, 15, and 20), and outputting (displaying) data (claim 7) do not cause the claims to rise to the level of significantly more than the judicial exception. The courts have recognized receiving or transmitting data over a network; storing and retrieving information in memory; [see MPEP§2106.05(d)(II)], as well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as extra-solution activity. Additional elements of computer components and heart surgical devices: The additional elements of a heart valve, a guidewire, a cutting device, an electrosurgical splitter, a catheter, a deployment system of the at least one device, and a left atrial appendage occlusion (LAAO) of claims 2 and 16; a sensor system comprising one or more sensors of claims 3 and 17; a cutting device and/or a splitter of claims 5 and 6; a display of claim of claim 7; a memory and processor of claim 15; and a non-transitory machine readable storage media of claim 20, do not cause the claims to rise to the level of significantly more than the judicial exception, and as such do not provide an inventive concept; these are conventional computer and surgical devices. Additionally, the heart surgical devices are shown to be conventional by the following reference: Kattoor, (Cardiology Clinics, vol. 42(3), pp.339-350 (2024); cited in the attached form PTO-892), presents a review on electrosurgery in structural heart interventions, and shows heart valves, guidewires, cutting devices, splitters, catheters, and deployment systems throughout entire document. Further regarding the conventionality of additional elements, the MPEP at 2106.05(b) and 2106.05(d) presents several points relevant to conventional computers and data gathering steps in regard to Step 2A Prong 2 and Step 2B, including: • A general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions, does not qualify as a particular machine (see 2106.05(b)(I)), as in the case of claims 7, 15, and 20, which are interpreted to recite conventional computer components. • Integral use of a machine to achieve performance of a method may integrate the recited judicial exception into a practical application or provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not integrate the exception into a practical application or provide significantly more (see 2106.05(b)(II). In the instant claims, the recited processor and memory are used in performing the method; as such, the processor and memory act only as a tool to perform the steps of data analysis, and do not integrate the exception into a practical application or provide significantly more. • 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 2106.05(b)(III). The processor and memory of claim 15 and 20 used in performing the method does not impose meaningful limitations on the claims. • The courts have recognized “receiving or transmitting data over a network”, “performing repetitive calculations”, and “storing and retrieving information in memory”, as well-understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (see MPEP 2106.05(d)(II)). The obtaining and/or outputting of data in claim 1, 7, 15, and 20 is recited in a generic manner. All limitations of claims 1-20 have been analyzed with respect to Step 2B, and none provides a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception, and thus do not transform the judicial exception into a patent eligible application of the exceptions. (Step2B: NO.) Therefore, claims 1-20, when the limitations are considered individually and as a whole, are rejected under 35 U.S.C. § 101 as being directed to non patent-eligible subject matter. Response to Applicant Arguments - 35 USC § 101 Applicant's arguments filed 07/02/2026 have been fully considered but they are not yet persuasive. Regarding Step 2A Prong One arguments: Applicant asserts, p. 10, that the amended claims are not directed to an abstract idea, as follows: • " As amended, independent claims 1, 15, and 20 recite a specific, integrated computer implemented (executed by one or more processors) workflow..." (p.10, ¶ 2) • "These limitations, taken as an ordered combination, are not steps that can be performed in the human mind or with pen and paper. The claims require a processor to generate integrated recommendations..., and to output those recommendations to specific procedural hardware during an ongoing heart procedure. This is not a generic mathematical concept; it is a defined computer workflow that produces actionable procedural guidance..." (p.10, ¶ 3) The arguments that the amended claims are not directed to an abstract idea are not persuasive. The claims do not recite any level of complexity which would prevent mental performance of the steps for generating options, simulating the procedure, selecting a strategy, and generating recommendations. Although the method is computer implemented and requires a processor, a claim that requires a computer may still recite a mental process [see MPEP 2106.04(a)(2)(III)(C)]. Further, although a general-purpose computer can perform the analysis at a rate and accuracy that can far exceed the mental performance of a skilled artisan, the nature of the activity is essentially the same, and therefore constitutes an abstract idea. Additionally, the steps of obtaining data and outputting recommendations are not abstract ideas but additional elements, identified at Step 2A Prong Two. Regarding Step 2A Prong Two arguments: Applicant asserts, p. 10-11, that the claims integrate any exception into a practical application., as follows: • "The amended claims do not merely analyze data and then generically "display" a result...The procedural recommendations comprise device deployment instructions and modification parameters that guide a specific type of real-world intervention (a heart medical procedure)." (p.11, ¶ 1) • " This constitutes computer-generated procedural guidance that is applied during a structural-heart intervention to assist physician-performed treatment, not merely post-hoc informational display. Under MPEP §2106.04(d), integrating the analysis into a practical application is demonstrated where the claim applies or uses the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition..." (p.11, ¶ 2) The arguments that the claim applies or uses the judicial exception to effect a particular treatment or prophylaxis is not yet persuasive. The amending of claim 1 to include the outputting step to display recommendations during the heart procedure is acknowledged as a positive step as there is now nearly a transformation (see MPEP 2106.05(c)) recited in the claims. However, the nexus between the outputting/displaying recommendations to guide the heart medical procedures and the actual heart medical procedure falls short, as the recommendations are displayed, but there is no physical link between the displaying and the heart medical procedure. It may help to amend to require physical actions taken by the recommendations (e.g., a further step of using the outputted procedural recommendations to guide the heart medical procedure). Independent claims 15 and 20 should be amended similarly with the goal of reciting a transformation. Applicant is encouraged to request an interview to discuss this topic and others if it would be helpful. 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. 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. Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sivakumar, (Structural Heart, vol. 5(sup1), pp.34-34 (2021); cited in the 02/26/2026 IDS), in view of Esmailie, (Structural Heart, vol. 6(2):100032,pp. 1-11 (2022); cited in the 02/26/2026 IDS), in view of Avisar, (US 2021/0287779, published 09/16/2021; cited in the 02/26/2026 IDS), in view of Kim (US 2019/0095589 A1, published 03/28/2019; cited on the attached form PTO-892). Note, claims 15 and 20 are rejected as is claim 1 below, as claims 15 and 20 recite a system (memory and processor) and storage medium for performing similar steps as recited in the method of claim 1. The memory, processor, and storage medium are considered to be inherent in patient specific computational modeling but are also specifically shown by Avisar at [0065]. Regarding the claim 1 elements for: obtaining patient specific data of 3D computational analysis generated from pre-procedural medical imaging, and device data; the claim 2 and 16 element of a device compromising a heart valve; and the claim 11 element of measurements of aortic roots, Sivakumar shows patient CT images were imported to Mimics 21.0 (Materialise NV) and geometries of the aortic root and the bioprosthetic valve were generated by segmentation (p.1, col.1, ¶ 2). Regarding the claim 1 element of generating options of modification strategies, and the claim 12 element for finite element analysis, Sivakumar shows lacerations were introduced in the geometry at the center and near the commissure of the left coronary leaflet (Figure 1 d-e). Using Abaqus Explicit (Dassault Systems), an idealized Transcatheter Aortic Valve (TAV) was expanded inside the valve geometry by finite element methods for all three cases. Regarding the claim 1 element for simulating the heart medical procedure and generating a simulation outcome having a desired medical procedure result, Sivakumar shows patient specific computational modeling in Transcatheter Aortic Valve Replacement (TAVR) planning for ViV patients with high risk of coronary obstruction (p.1, col.1, ¶ 2). Sivakumar shows cross-sectional views were generated using 3-Matic postprocessing tools (Figure 1 f-h). From Figure 1, deployment of idealized TAV without laceration of the bioprosthetic leaflet resulted in complete obstruction of the left coronary artery. Figure 1 g-h show that a laceration at the center of the bioprosthetic leaflet does not mitigate the obstruction and one close to the commissure of the bioprosthetic valve removes the risk of obstruction, establishing a path for left coronary flow (p.1, col.2, ¶ 1; and Figs.(f)-(h)). Regarding the claim 1 element for selecting a modification strategy and generating recommendations, and the claim 7 element for displaying recommendations, Sivakumar shows providing the necessary visualization for successful planning of TAVR procedures in valve-in-valve patients (p.1, col.2, ¶ 2), and displays cross-sectional simulation (p.1, col.2, Figs.(f)-(h)). With regard to the claim 8 for risk metrics, the claim 9 element for ranking strategies, the claim 10 element for transcatheter aortic valve replacement (TAVR) Sivakumar shows computational patient specific modeling of TAVR planning which inherently includes risk assessment, shown by the three cross-sectional models ranked in order of risk of obstruction (p.1, col.2, ¶ 1, and Figs.(f)-(h)). Regarding the claim 5 and 6 elements for cutting device, for heart valve implantation, and the claim 13 and 18 element for anatomical modification, Sivakumar shows BASILICA (a technique using electrosurgical wire to lacerate or cut the anatomy and create flow paths, see instant Spec. [0033]). While Sivakumar shows generating options of modification strategies, Sivakumar does not specifically show device modifications of claim 1, 14, and 19 (shown by Esmailie below). Sivakumar does not show the real time data or sensor data of claim 3, 4, and 17 (shown by Esmailie below). Sivakumar does not show interactive input from medical personnel of claim 1 (shown by Avisar below). Sivakumar does not show outputting the procedural recommendations to a display interface or proximate control module during the heart medical procedure of claim 1 (shown by Kim below). Regarding the claim 1 element for generating modification strategies including device modifications, and the claim 14 and 19 element for device modification adjustments, Esmailie shows CoreValve deployment was modeled with 3 orientations, 3 deployment heights, 2 skirt shapes, and 3 stent thicknesses (p.6, col.1, ¶ 2). Regarding the claim 3 and 17 element for real time data from sensor system and the claim 4 element for real-time, Esmailie shows a machine learning (ML) model trained on finite element (FE) simulations, capable of estimating constitutive parameters of the aortic wall within a significantly reduced computational time, i.e., a matter of seconds. In combination with the model order reduction (MOR), such ML methods can rapidly provide material properties from patient-specific geometries that are necessary for the off-line phase of the MOR, thus resulting in a hybrid approach that is dramatically more accurate than standard MOR methods. In essence, this hybrid, data-driven ML-MOR approach provides a paradigm of predictive computational models in a real-time fashion and on local computational resources for clinical problems, including TAVR deployment (p.8, col.1, ¶ 1). Regarding the claim 1 elements for interactive input from medical personnel of Avisar shows the surgeon has the ability to “ fine tune ” the models and adjust the modeling parameters of the simulation by changing the mechanical properties [0102]. Avisar shows providing a surgical tool interface to the user, wherein said surgical tool interface provides realistic user interaction with the biological tissues of the biological model via user interaction with the surgical tool model (Avisar, claim 1). Regarding the claim 1 element of outputting the procedural recommendations to a display interface during the heart medical procedure, Kim shows "presenting one or more of the outcomes of the surgical technique simulations (i.e., recommendations) to a user for selection of an optimal surgical technique for repairing the mitral valve" (Kim, claim 15) and "generating a visual representation of each of the one or more outcomes of the surgical technique simulations and presenting to the user a graphical display of the visual representations (i.e., recommendations) of the one or more outcomes of the surgical technique simulations" (Kim, claim 24). Additionally, regarding the claim 1 elements " options of modification strategies comprising device modifications to the at least one device and anatomical modifications to the patient's anatomy," Kim shows "FIG. 2 depicts a flow diagram of one method for simulating a virtual MV repair (step 150 of FIG. 1). Simulation of a virtual MV repair may involve simulation module 350 interacting with a virtual modeling module 320 to get information about a particular patient's heart. (Kim, [0045]). Additionally, FIG. 2 depicts a process 150 of virtual MV repair simulation and evaluation. In this example, one or more surgical treatments may be selected for simulation. At step 151, embodiments may select a surgical treatment involving an annuloplasty, a resection, mitral clipping, neochordoplasty, plication, patching, chordae transposition, papillary muscle transposition, or some other technique to simulate (i.e., anatomical modifications). Various surgical treatments may be simulated using embodiments of a virtual MV repair simulation system. The process shown in FIG. 2 can be interactive, in that a user (for example, a surgeon) can interact with the system to achieve desired results (Kim, [0046]). Kim shows "at step 152, a determination may be made (for example, by a surgeon) whether implantation is required. An implantation may include the selection of a particular annuloplasty ring, artificial chordae, patch, clip, etc. (i.e., device modifications) If it is determined that an implant should be used, at step 153, a surgical parameter may be selected. A surgical selection may include an implant type, shape, size, location, or the like" (Kim, [0047]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the computational modeling method of Sivakumar, with the device modification in computational modeling of Esmailie, with the surgeon input of Avisar, and with the outputting/displaying of surgical simulations (i.e., recommendations) of Kim to come to a method for patient specific computational modeling in heart valve procedures because Sivakumar shows patient specific computational structural modeling in combination with computational fluid dynamic simulations has immense potential; Esmailie discusses well-developed computational model can provide physicians with a tool to make accurate decisions; Avisar states overcoming the visual and other challenges allow a more efficient microsurgery procedure and superior guidance provided to the surgeon, based on his own plan; and Kim shows a method potentially improving the diagnosis and treatment of mitral valve (MV) pathology. One would have had a reasonable expectation of success in modifying Sivakumar with Esmailie, Avisar, and Kim, because the references are drawn to related teaching of patient specific computational modeling, and one of ordinary skill in the art would have understood how to and would have been motivated to modify Sivakumar with Esmailie, Avisar, and Kim, and as such, the combination would have been obvious. Response to Applicant Arguments - 35 USC § 103 Applicant's arguments filed 07/02/2026 have been fully considered but they are not yet persuasive. Regarding Sivakumar, Applicant asserts: "Sivakumar does not: • Generate options of modification strategies comprising device modifications and anatomical modifications; • Select a modification strategy from among simulated options based on a desired heart medical procedure result; • Generate procedural recommendations comprising device deployment instructions and modification parameters based on the selected strategy; or • Output such recommendations to a display interface or proximate control module during a heart medical procedure." (top half of p.13) The arguments are not persuasive. Sivakumar shows lacerations were introduced in the geometry at the center and near the commissure of the left coronary leaflet (Figure 1 d-e) (i.e., anatomical modifications). Using Abaqus Explicit (Dassault Systems), an idealized Transcatheter Aortic Valve (TAV) was expanded inside the valve geometry by finite element methods for all three cases (i.e., three options for modification strategies). Sivakumar shows providing the necessary visualization (i.e., options) for successful planning (i.e., selecting) of TAVR procedures in valve-in-valve patients (p.1, col.2, ¶ 2), and displays cross-sectional simulation (p.1, col.2, Figs.(f)-(h)). Regarding Esmailie, Applicant asserts: • "Esmailie does not disclose the claimed integrated workflow in which paired anatomy-and-device strategies are generated, evaluated, selected, and used to generate and output procedural recommendations during the procedure." (p.13, under "Esmailie...") The arguments are not persuasive. Esmailie is only relied upon for showing the claim 1 element of generating modification strategies of device modifications (Esmailie shows Core Valve deployment was modeled with 3 orientations, 3 deployment heights, 2 skirt shapes, and 3 stent thicknesses (Esmailie, p.6, col.1, ¶2). Esmailie is also relied upon for showing real time data from a sensor of claim 1 (Esmailie shows predictive computational models in a real-time fashion and on local computational resources for clinical problems, including TAVR deployment (Esmailie, p.8, col.1, ¶ 1). Regarding Avisar, Applicant asserts: • "Avisar does not disclose the claimed integrated workflow in which paired anatomy-and-device strategies are generated, evaluated, selected, and used to generate and output procedural recommendations during the procedure." (p.13, under "Avisar...") The arguments are not persuasive. Avisar was only relied upon for showing interactive input from medical personnel (Avisar shows the surgeon has the ability to" fine tune "the models and adjust the modeling parameters of the simulation by changing the mechanical properties (Avisar, [0102]). Avisar shows providing a surgical tool interface to the user, wherein said surgical tool interface provides realistic user interaction with the biological tissues of the biological model via user interaction with the surgical tool model (Avisar, claim 1).) Regarding the references taken together, Applicant asserts: • " The cited combination...does not teach or suggest the claimed integrated workflow in which device modification and anatomical-modification strategy options are generated within the same procedural recommendation framework." (p.14, ¶ 1) The arguments are not persuasive as a new 103 rejection has been applied above which adds the Kim reference to show outputting recommendations. Conclusion No claims are allowed. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). 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