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 1-15 are currently pending and under exam herein.
Priority
This application is the U.S. National Phase application under 35 U.S.C. §371 of International Application No. PCT/EP2020/075792, filed on September 16, 2020, which claims the benefit of U.S. Provisional Patent Application No. 62/902,172, filed on September 26, 2019 and European Patent Application No. 19202538.5, filed on October 10, 2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Priority for each of claims 1-15 is acknowledged to the earliest effective filing date of 26 September 2019.
Information Disclosure Statement
The Information Disclosure Statements filed 18 March 2022; 30 April 2024; and 10 March 2025 are compliance with the provisions of 37 CFR 1.97 and have therefore been considered. Signed copies of the IDS documents are included with this Office Action.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show every feature of the invention specified in the claims and the unlabeled rectangular boxes shown in the drawings should be provided with descriptive text labels as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). See Figures 2 and 5.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Note: All references to the Specification herein pertain to the PG publication: US20220370140.
Claim Objections
Claims 2-13 are objected to because of the following informalities: Each of claims 2-13 recite, “A system of claim 1” or the like, wherein it is suggested to comply with US practice that the claims are amended to recite, instead, “The system of claim 1” and others as appropriate herein. Appropriate correction is required.
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.
Claims 1-15 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for a system for determining a real-time mitral valve function by a simulated function of a mitral valve to determine mitral valve function, does not reasonably provide enablement for doing do in the context of any valve in the cardiac system whereby there would be a model described that is a numerical model that is operational for any and all valves of any and all systems in any and all “subjects”, as claimed. 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 instant Specification is specifically directed to discussion of the mitral valve wherein at [0002] the Specification details that, “the MV has two key functions: maintaining a hemodynamic seal during ventricular ejection; and ensuring rapid ventricular re-filling following ventricular ejection. Optimal MV function depends upon several factors, such as the hemodynamic load, the biomechanical properties of the MV connected tissue and the functional anatomy of the left heart. Dysfunction of one or more of these factors may result in suboptimal filling or ejection” and that “mitral valve regurgitation (MVR) is the most common MV dysfunction and accounts for approximately 70% of native MV dysfunctions” [0003] and further, “MVR may be corrected by either: repairing the existing valve; or prosthetic replacement. However, repair has significant benefits, such as reduced mortality rates (2.0% repair, 6.1% replacement) and minimization of other complications such as thromboses. One such repair technique for MVR is the edge-to-edge repair (ETER), which attempts to restore MV coaptation by physically joining prolapsing regions together” [0004]. Further with respect to the invention herein, the Specification discusses that, “although the ETER alleviates MVR, it may negatively affect ventricular filling. Accordingly, the ETER aims to find a balance between reducing retrograde flow into the atrium during ventricular contraction and avoiding a reduction in orifice area that would impair ventricular filling. For this reason a dilemma typically encountered is the decision between placing an additional repair device (thereby further reducing the orifice area and possibly impairing ventricular filling) or accepting the current configuration with the risk of having insufficiently reduced the MVR” [0006] and, as such, the instant invention arises.
More specifically to the disclosed model, the Specification includes mitral valve specific inputs as deployed during ETER procedures [0117]; [0123]; [0132]-[145]-detailing the model therein. Further, the Specification discloses the numerical model framework as applied to ETER procedures and specifies ETER available data at Table 1.
However, the Specification fails to adequately enable said system and method for other valve procedures with data specific for each and every potential model for valve function in a subject.
It is well-established in the art that model generation for systems, such as the cardiovascular system, are difficult, at best and require specific algorithmic frameworks for specific models. For example, Gray et al. (Journal of Cardiovascular Translational Research (2018) Vol. 11:80-88) detail the state of the art in cardiovascular computation modeling that spans all aspects of the cardiovascular system that includes electrophysiology, electromechanics, solid mechanics and fluid dynamics (abstract) and establish that “the clinical utilization of patient-specific modeling involves addressing two very complex approaches (individualized therapy and computer modeling), and the appropriate implementations and evaluations of these approaches remain largely unknown and a matter of ongoing discussion” (p. 80). Further, Gray et al. specifically point to the myriad of challenges involved in modeling, including “we address the mode limited challenges of the patient-specific cardiovascular models presented in this manuscript, which are typically developed according to the following steps: (1) define the problem to be addressed; (2) identify exactly how the model will be used, i.e., its context of use (COU); (3) select the model formulation including the governing equations; (4) decide up on boundary and initial conditions; (5) decide which aspects of the model will be personalized; (6) implement the model, i.e., construct the workflow; and (7) evaluate the predictive capability of the patient-specific simulations. There are challenges accompanying each of these steps. Perhaps, the biggest decision in step 3 is to decide if the model will be a multi physics model (e.g., electromechanics or involve fluid structure interaction) or not. We believe that one of the most challenging aspects of this process is to decide what level of detail to include in the model in step 3, which will depend heavily on the COU and the phenomena the model is meant to reproduce” (p.81, col. 1). Gray et al. further describe the numerous other challenges associated with complex models at pp. 84-86, concluding that “the cardiovascular patient-specific models discussed here are inherently complex because of the difficulty in characterizing the underlying biology and their multiscale nature”.
As such, due to the nature of the problem herein of providing a model for each and every valve function in the cardiovascular system as herein claimed, the skilled practitioner would first turn to the instant specification for guidance to practice said methods. However, the instant specification only provides specific guidance to practice these embodiments in the context of the mitral valve and edge-to-edge repair techniques. As such, the skilled practitioner would turn to the prior art for such guidance, however, the prior art shows that such modeling is complex and unpredictable, and require substantial additional work and research. Finally, said practitioner would turn to trial and error experimentation. Such represents undue experimentation.
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 1-15 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 1 and 14 recite, “obtain a numerical model of a cardiac system, the numerical model being a 0D numerical model or a 1D numerical model, wherein the numerical model is adapted to receive physiological data as an input and to output a simulated function of the cardiac system in real-time, wherein the simulated function of the cardiac system comprises a simulated function of a valve within the cardiac system”, wherein said step is indefinite with respect to claiming only a functional result (“simulate... in real-time”) without providing the necessary structure or specific methods to achieve the result across the vast, undefined scope of “0D or 1D” models. There are no steps of any actual simulation or any specific algorithm for achieving said method such that a valve function would be elucidated. Further, the claim tries to cover any 0D or 1D model that happens to show a valve function in real-time. According to Nautilus, Inc. v. Biosig Instruments, Inc., a claim is indefinite if it does not “inform those skilled in the art about the scope of the invention with reasonable certainty”. Clarification through clearer claim language is requested. Dependent claims are also rejected as not clarifying the above issues.
Claims 1 and 14 recite, “provide the continuous stream of physiological data as an input to the numerical model of the cardiac system, thereby generating a simulated real-time function of the cardiac system of the subject”, wherein the phrase “thereby generating a simulated real-time function” describes a result rather than the specific structure or algorithm used to achieve it, rending the claim indefinite as to the implementation of said step. Clarification by actual claiming the specific acts, structures, or steps by which to achieve said result. Dependent claims are also rejected as not clarifying the above issues.
Claims 1 and 14 recite, “determine a real-time valve function of the subject based on the simulated real-time function of the cardiac system of the subject”, wherein said phrase describes a result or function without adequate measures by which to “determine” based on the “real-time function”, as there are no metrics compared or other parameters set forth to provide for such. Clarification through clearer claim language is requested. Dependent claims are also rejected as not clarifying the above issues.
Claim 3 recites, “adapted for use while the subject is undergoing a valve repair”, wherein said phrase is indefinite because it fails to define the structural limitations of the system, with reasonable certainty, by which said system is “adapted”. Clarification through clearer claim language is requested.
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 1-15 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): Claims 1-14 are directed to a system and method for determining real-time valve function (yes).
With respect to claim 15, (no) said claim in not appropriately directed, as the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because claim 15 recite, “a computer program comprising computer program code” wherein said claims read on transitory propagating signals which are not proper patentable subject matter because they do not fit within any of the four statutory categories of invention (In re Nuijten, Federal. Circuit, 2006). It is noted that the recitation of a “non-transitory computer-readable medium” would overcome the rejection with respect to this aspect related to claim 15. However, claim 15 would still be subject to the Framework analysis set forth below. Claim 15 is included in the below rejection for purposes of compact prosecution.
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) and in conjunction with mathematical concepts (in particular mathematical relationships and formulas).
The claim steps to abstract ideas are as follows:
Claims 1 and 14: model is adapted to receive physiological data as an input and to output a simulated function of the cardiac system in real-time, wherein the simulated function of the cardiac system comprises a simulated function of a valve within the cardiac system; provide the continuous stream of physiological data as an input to the numerical model of the cardiac system, thereby generating a simulated real-time function of the cardiac system of the subject; determine a real-time valve function of the subject based on the simulated real-time function of the cardiac system of the subject, wherein the steps directed to the “simulated function” and “generation of a simulated function” are processes that are mathematical steps by which said “simulation” as described in the Specification is performed using mathematical models (0D and 1D [0129];[0130]). Steps directed to “determine…a function” are those which are mental in nature by which one can assess particular output to make a determination. No steps are detailed as to what entail said “determination” herein.
Dependent claims herein serve to further limit the judicial exceptions recited above, for example at claims 6-8. 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 either in the mind and performance by mathematical operation. There are no specifics as to the methodology involved in “simulation” or in “determining” 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 calculations or determinations. 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 1 and 14: obtain a numerical model of a cardiac system, the numerical model being a OD numerical model or a 1D numerical model; obtain a continuous stream of physiological data from the subject; provide the continuous stream of physiological data as an input…; system; processing unit.
Claim 15: computer (program product)
Dependent claims serve to further limit the claim steps of “obtaining data” by defining said data, as in claims 2-5, 9-13. Claim 4 further comprises a “sensor”.
With respect to the additional elements in the instant claims, those steps directed to data gathering (obtain data and input data) 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, the system, processor, instructions are part of a general purpose computer system and there are no details herein wherein of how the specific computer structures are used to implement the judicial exceptions beyond generic computing operations, i.e., the computer elements of the claims do not provide improvements to the functioning of the computer itself (see: DDR Holdings, LLC v. Hotels.com LP); they do not provide improvements to any other technology or technical field (see: Diamond v. Diehr); nor do they utilize a particular machine (see: Eibel Process Co. v. Minn. & Ont. Paper Co.). Hence, these are mere instructions to apply the judicial exception using a computer, and therefore the claim does not provide integration into a practical application of any judicial exception.
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 Gray et al. (cited above) disclose computer modeling techniques by which data gathering elements are essential for cardiac modeling techniques. Further, obtaining a model by which to run simulations is also provided (see Gray et al. at least at p. 81; Figure 1; p. 82).
With respect to the claims to the system and processor, memory and instruction, the computer-related elements or the general purpose computer do not rise to the level of significantly more than the judicial exception. Further, the specification also discloses that computer processors and systems, as example, are generic computing systems [0156]. 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.
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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
1. Claims 1-15 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US2018/0174068 to Dahl et al. (IDS reference).
Claim 1 is directed to:
A system for determining a real-time valve function of a subject, the system comprising:
a processing unit adapted to:
obtain a numerical model of a cardiac system, the numerical model being a OD numerical model or a 1D numerical model, wherein the numerical model is adapted to receive physiological data as an input and to output a simulated function of the cardiac system in real-time, wherein the simulated function of the cardiac system comprises a simulated function of a valve within the cardiac system;
obtain a continuous stream of physiological data from the subject;
provide the continuous stream of physiological data as an input to the numerical model of the cardiac system, thereby generating a simulated real-time function of the cardiac system of the subject; and
determine a real-time valve function of the subject based on the simulated real-time function of the cardiac system of the subject.
The prior at to Dahl et al. teach, “system for determining a real-time valve function of a subject, the system comprising”, wherein Dahl et al. disclose a method for providing a subject-specific computational model of at least one component in the cardiovascular system for simulating blood flow and/or structural features that includes customized devices [0001]. Dahl et al. further disclose systems including machine learning systems [0069]; computer simulation [0091]; planning systems [0123].
Dahl et al. teach, “a processing unit adapted to: obtain a numerical model of a cardiac system, the numerical model being a OD numerical model or a 1D numerical model, wherein the numerical model is adapted to receive physiological data as an input and to output a simulated function of the cardiac system in real-time, wherein the simulated function of the cardiac system comprises a simulated function of a valve within the cardiac system”, wherein Dahl et al. disclose “workstation may further comprise means with statistical data and options for history matching. This provides a basis for optimal diagnostics and choice of treatment more objective and reproducible than otherwise possible” [0185] and “the station can for example be implemented in the operating theatre” [0186]. Further Dahl et al. disclose, “a method for providing a subject-specific computational model of at least one component in the cardiovascular system for simulating blood flow and/or structural features. The model comprises transient geometry and is created by: acquiring subject-specific measurement data of said at least one component; generating the computational model based on the subject-specific data, and letting the transient geometry of the model define at least one boundary condition or source term for the model when running a simulation” [0047]… “the term “computational model” as used herein refers to mathematical model in computational science that makes it possible to study the behaviour of a complex system by computer simulation” [0091]. Further, Dahl et al. disclose a real-time system in, “the term “real-time” as used herein refers to digital signal processing (DSP) where input data is continuously analysed for generating output data in the time it takes to input and output the same set of samples independent of the processing delay” [0104].
Dahl et al. teach, “obtain a continuous stream of physiological data from the subject”, wherein Dahl et al. disclose, “a 3D screen is available during surgery, and the data it displays may be streamed real-time from the echo machine. Immediately after valve repair, the results are tested with pre-surgery simulation. When the result is not satisfactory, a correction of the repair or valve” [0158]; “3D CFD model based on real-time 3D echocardiography (RT3DE). The model may be based on a surface-tracking method of the heart chambers from 3D echocardiographic data. The 3D CFD model of the invention may include a physiologically representation of the mitral valve… Such real-time CFD simulations have the potential to improve and change clinical practice” [0178]-[0179].
Dahl et al. teach, “provide the continuous stream of physiological data as an input to the numerical model of the cardiac system, thereby generating a simulated real-time function of the cardiac system of the subject”, wherein Dahl et al. disclose, “the model is created by inputting data from both subject-specific and non-subject-specific data of the cardiovascular system and components thereof, where the non-subject-specific data represent data being applicable to many individuals. These data can be input to the model prior to generating the model or during generation of the model for further optimization” [0181]; “the model provided according to the invention can be arranged as a machine learning model for continuously optimizing treatment planning and/or decision making and/or for diagnostic purposes by inputting at least one of the following: prior simulation results, patient history, and pre-, peri- or post-operative effects” [0182].
Dahl et al. teach, “determine a real-time valve function of the subject based on the simulated real-time function of the cardiac system of the subject”, wherein Dahl et al. disclose, for example, “modelling of the mitral valve” [0209]-[0217], further disclosing, “by obtaining a better fundamental understanding of how the valve geometry affects leaflet stress distribution and LV flow dynamics it is possible to assess the consequences of BML. As changes in leaflet curvature also occurs due to MV pathology or surgical interventions, this knowledge may be used to optimize the outcome of surgery…with the increased use of such repair techniques, a better understanding of both the structural and the hemodynamic implications of leaflet curvature is desired. This is obtained by the simulation model according to the invention”. [0218] and “the algorithm is tested in a 2D simulation of the mitral valve during diastolic filling, where the valve is modelled as two rigid, asymmetric leaflets” [0231].
With respect to independent claim 14, directed to the method as run by the system and claim 15 directed to the computer program, the prior art to Dahl et al. disclose computer implementation as described above and also anticipate each of said claims as such.
With respect to claim 2, Dahl et al. disclose, “wherein the continuous stream of physiological data is obtained from a subject undergoing a change in valve function, and wherein the real-time valve function determined from the simulated real-time function of the cardiac system is representative of the change in valve function” [0209]-[0230] detailing mitral valve function and change.
With respect to claim 3, Dahl et al. teach, “adapted for use while the subject is undergoing a valve repair”, wherein Dahl et al. disclose mitral valve repair functions in real-time as described at [0209]-[0230].
With respect to claims 4 and 9, Dahl et al. teach, “wherein the system further comprises a physiological sensor adapted to obtain physiological data from the subject, wherein the physiological sensor comprises one or more of: an electrocardiogram sensor, wherein the physiological data comprises electrocardiogram data; a blood pressure measurement device, wherein the physiological data comprises numerical pressure data and/or pressure waveform data; and a volume waveform sensor, wherein the physiological data comprises volume waveform data”, wherein Dahl et al. disclose at the least, “flow measurement” as used herein refers to using an instrument to record data from a fluid flow, such as recording velocities, pressures, turbulence levels, temperatures or other quantities” [0099]; “Cardiac ultrasound, often referred to as echocardiography, is, among medical doctors, the most applied method for diagnosing the heart. The particular strength of ultrasound is its ability to record moving structures in real-time and it can therefore be used to help guide invasive procedures. It is also a relatively easy and cost effective imaging technique. Another important advantage of echocardiography, which is highly valuable in respect of this invention, is the clear visualization of the cardiac valves. Echocardiography may yield a larger inter-subject variation in image quality than MRI, but is still most feasible in regards to model building purposes” [0200].
With respect to claim 5, Dahl et al. teach, “wherein the volume waveform sensor comprises one or more of: an ultrasound transducer, wherein the volume waveform data comprises ultrasound data; an inflatable cuff, adapted to be worn by the subject; and a thermistor-tipped catheter, wherein the volume waveform data is derived using a thermodilution technique” wherein Dahl et al. disclose, “cardiac ultrasound, often referred to as echocardiography, is, among medical doctors, the most applied method for diagnosing the heart. The particular strength of ultrasound is its ability to record moving structures in real-time and it can therefore be used to help guide invasive procedures. It is also a relatively easy and cost effective imaging technique. Another important advantage of echocardiography, which is highly valuable in respect of this invention, is the clear visualization of the cardiac valves. Echocardiography may yield a larger inter-subject variation in image quality than MRI, but is still most feasible in regards to model building purposes” [0200].
With respect to claim 6, Dahl et al. disclose, “wherein the numerical model is based on a physical parameter, and wherein the processor is further adapted to adjust the physical parameter of the numerical model based on at least a portion of the continuous stream of physiological data”, wherein Dahl et al. disclose, as example, “by use of the CFD model according to the invention it is possible to further investigate and quantify in detail how the systolic AML curvature influence LV flow dynamics. Four different AML curvatures will be investigated for this purpose. The CFD-model, according to the invention, is based on Real Time 3D Echocardiography (RT3DE) recordings and uses a dynamic, moving mesh that adapts to the time-varying geometry of the heart. This model is the first subject-specific 3D CFD model of the LV based on RT3DE” [0221].
With respect to claim 7, Dahl et al. disclose, “wherein the numerical model is based on a physical parameter, and wherein the processor is further adapted to: obtain preliminary physiological data from the subject; and adjust the physical parameter of the numerical model based on the preliminary physiological data from the subject”, wherein Dahl et al. disclose, “a model can be tested and assessed by performing history matching, meaning that simulation results from the model is compared with history data. This can be a continuous and iterative process contributing to optimization of the model and a specific prosthesis design based on the model” [0227].
With respect to claim 8, Dahl et al. disclose, “wherein the numerical model is based on a physical parameter, wherein the processor is further adapted to: adjust the physical parameter of the numerical model, thereby generating a predictive numerical model; provide the continuous stream of physiological data as an input to the predictive numerical model, thereby simulating a predictive function of the cardiac system of the subject; and predict the future hemodynamic function of the subject based on the simulated predictive function of the cardiac system of the subject”, wherein Dahl et al. disclose, “flow simulations, using the subject-specific model provided by the inventive method, were performed using the commercial finite volume package Ansys Fluent 15.0 (Ansys Inc.). The CFD solver was extended with dedicated UDFs in order to include the systolic movement of the 3D model in the simulations. The prescribed subject-specific wall motion drives the flow. The ALE formulation was used to express the Navier-Stokes equations on the moving grid. Because we use prescribed wall motion we only need to compute the pressure gradients rather than the absolute pressure, this is appropriate since a pressure gradient is a relative and not an absolute variable. The base pressure can be set to any value, as it will not influence the hemodynamics, in our simulations the base pressure was chosen to be zero. However, the absolute pressure is important if one would like to estimate the hemodynamic work, or calculate fluid structure interaction” [0267].
With respect to claims 10 and 11, Dahl et al. teach, “wherein the volume waveform data comprises one or more of: a ventricular volume waveform; and an atrial volume waveform” and “wherein the volume waveform data comprises ultrasound data”, wherein Dahl et al. disclose, “due to the complexity of the heart, the LA and the MV are often neglected in simulations of ventricular filling. However, it is important to know what impact such limitations might have on the resulting flow pattern. A qualitative investigation of the influence of left atrial inlet conditions and flow driven mitral leaflets on the diastolic ventricular flow pattern was performed. Three 2D models were created. In the reference model both the LA and the flow driven leaflets were included, while in the two other models, either the LA or the leaflets were excluded. The transient geometry of the LV was rendered from 2D echocardiographic recordings and the same wall motion was implemented in all the three models. It is important to notice that although the investigated 2D models cannot simulate the real 3D filling process, some qualitative information can be obtained” [0233].
With respect to claim 12, Dahl et al. teach, “wherein the pressure waveform data comprises one or more of: an atrial pressure waveform; and an arterial pressure waveform”, wherein Dahl et al. disclose, “the method further comprises using flow and/or pressure measurement data for acquiring flow and/or pressure specific data related to the at least one component in the cardiovascular system. Such flow and/or pressure specific data can in some cases improve the accuracy of the simulation model and/or be necessary in order to run a subject-specific simulation. In other cases, such subject-specific data can be necessary in order to validate the simulation results” [0144].
With respect to claim 13, Dahl et al. teach, “wherein the physiological data comprises estimated physiological data”, wherein Dahl et al. disclose, “the CFD results were also validated by using approximate analytical methods, using the continuity and Bernoulli equations to estimate velocity and pressure” [0279].
As such, the prior art to Dahl et al. anticipate claims 1-15.
Conclusion
No claims are allowed.
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