DETAILED ACTION
Applicant's response, filed 27 May 2026, has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The Examiner attempted to phone Applicant on 13 August 2026 to discuss potential paths forward. However, the Examiner was unable to leave a voice mail, as the mailbox message indicated that it was not set up for voice mail messages. The Examiner e-mailed Applicant (attorney Yee Jasmine Lau) the same day and requested a call by COB on 17 August 2026. However, no calls were received.
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.
Claims 1-15 are currently amended.
Drawings
Replacement drawings were received on 27 May 2026 and 28 May 2026. However, the submission of 27 May 2026 includes Drawings which were not originally filed in the Specification and are labeled 2022PF0249. The Drawings submitted 28 May 2026 appear to be the correct Drawings as originally filed and Replaced. As such, the Drawings filed 28 May 2026 are considered the Replacement Drawings and are accepted herein. The Drawings of 27 May 2026 are not entered herein.
Specification
Note: All references to the Specification herein pertain to the PG publication: US20220370140.
Claim Objections
The previous Claim objections are hereby withdrawn in view of claim amendment.
Claims 6 and 7 are objected to because of the following informalities:
Claim 6 recites, “wherein the physical parameter comprises one or more of: a systemic circulation parameter; a filling parameter; an ejection parameter; a heart rate parameter; a stiffness parameter; a valve related parameter; and a blood flow parameter”, wherein each of the cited parameters is separated by a semi-colon, and of which should be separated by a comma instead.
Claim 7 recite, “wherein the numerical model is based on a physical parameter, and wherein the processing unit is further adapted to: obtain preliminary physiological data from the subject wherein the imaging modalities include echocardiography performed in real-time 3D: and adjust the physical parameter of the numerical model based on the 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 the claim includes redundant language and the last step should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The rejections under 35 UCS 112(a) are withdrawn in view of the amendments that include the claims directed to “mitral valve” function.
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, 14 and 15 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, 14, and 15 recite, “adjust a physical parameter of the numerical model based on at least a portion of the continuous stream of physiological data” wherein it is unclear as to what adjustment to a physical parameter is intended. The model is not defined in the claim and therefore a physical parameter of an undefined model is also not clear.
Claims 1, 14 and 15 recite, “provide the continuous stream of physiological data as an input to the numerical model of the cardiac system, thereby executing the numerical model in real-time and generating in real-time a simulated real-time function of the cardiac system of the subject”, wherein the phrase “thereby executing a simulated real-time function the numerical model in real-time and generating in real-time 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 is requested. Dependent claims are also rejected as not clarifying the above issues.
Further to the amended step herein, the following step includes that a “continuous stream of physiological data” is provided as an input to the numerical model. However, it appears as if this provision already occurred in the claim at step 2 wherein the steps includes, “obtain a continuous stream of physiological data… and adjust a physical parameter of the numerical model”. It is suggested that the claim step of “provide a continuous stream of physiological data” be amended to recite, “provide a further continuous stream of physiological data as input to the adjusted numerical model of the cardiac system ” and a next step of “execute the adjusted numerical model in real-time thereby generating of the subject” or the like.
Claims 1, 14 and 15 recite, “determine a real-time mitral valve function of the subject undergoing a valve repair 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.
Response to Applicant’s Arguments
1. The outstanding rejection over claim 3 is withdrawn in view of claim amendment.
2. With respect to claims 1-15, Applicant states that the claims are amended “to clarify the model type, the pressure-flow relationship represented by the model, the adjustment of a physical parameter based on the continuous stream of physiological data, and the real-time execution of the model”.
It is respectfully submitted that this is not persuasive as the aspects of the model as “adapted” to receive and output a simulated function are not defined in the claim beyond a 0D or 1D model. Therefore, the claim metes and bounds remain unclear as to a simulation or any specific algorithm for achieving said method such that a mitral valve function would be elucidated. Clarification is requested.
Claim Rejections - 35 USC § 101
The outstanding rejections under 35 USC 101 are withdrawn in view of the claim amendments that include “adjust a physical parameter of the numerical model based on at least a portion of the continuous stream of physiological data…determine a real-time mitral valve function of the subject undergoing a valve repair based on the simulated real-time function of the cardiac system of the subject” wherein said operations provide for a practical application of the numerical model herein in a subject undergoing valve repair.
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 1-2 and 4-15 are rejected under 35 U.S.C. 103 as being unpatentable over US2018/0174068 to Dahl et al. (IDS reference) in view of CN105796348A (see English translation portion at pages 29-52 attached). This rejection is newly recited and is necessitated by claim amendment herein.
Claim 1 is directed to:
A system for determining a real-time mitral 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 represents cardiac pressure-flow relationships and 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 mitral valve within the cardiac system;
obtain a continuous stream of physiological data from the subject wherein the physiological data comprises at least one of pressure data, volume data, flow data, or electrocardiographic data;
adjust a physical parameter of the numerical model based on at least a portion of the continuous stream of physiological data;
provide the continuous stream of physiological data as an input to the numerical model of the cardiac system, thereby executing the numerical model in real-time and generating in real- time a simulated real-time function of the cardiac system of the subject; and
determine a real-time mitral valve function of the subject undergoing a valve repair 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 represents cardiac pressure-flow relationships and 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 mitral 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]; said applications are applicable to the mitral valve [0013]; [0178]-[0179].
Dahl et al. teach, “obtain a continuous stream of physiological data from the subject wherein the physiological data comprises at least one of pressure data, volume data, flow data, or electrocardiographic data”, wherein Dahl et al. disclose, “a model that pertains to blood flow…and structural features…pressure” [0044]; [0045]; [0047]; [0050]“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 “adjust a physical parameter of the numerical model based on at least a portion of the continuous stream of physiological data”, wherein Dahl et al. disclose, “real-time signal processing of input data [0104] and real-time assessment of flow and pressure for modeling [0131];
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 mitral valve function of the subject undergoing a valve repair 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.
Dahl et al. do not specifically disclose determining the real-time mitral valve function of a subject undergoing a valve repair as now claimed in the context of the adjusted numerical model that is a 0D or 1D model However, the prior art to CN105976348A discloses actions performed in real-time (during surgical procedure) wherein information may be estimated during procedure and said information include that of pressure, volume and physiological data. Further, parameters are input into the model and models may include those of lumped-parameter models (0D models) (pages 31, 33-36-English translation).
As such, it would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have utilized lumped parameter modeling in the techniques as disclosed by Dahl et al. for simplification of computationally expensive 3D modeling, as described by CN105976348A at p. 37. One would have been motivated to do so because Dahl et al. specifically include that 0D and 1D modeling may be used in the aspects of the invention [0138]. Further, determining real-time data in operative scenarios is motivated by Dahl et al. at [0093]; [0125]; and [0193] at the least and one would readily implement those techniques as disclosed in CN105976348A in so doing. As such, one would have had a reasonable expectation of success in combing said references that are in the same field of endeavor.
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 mitral valve function, and wherein the real-time mitral valve function determined from the simulated real-time function of the cardiac system is representative of the change in mitral valve function” [0209]-[0230] detailing mitral valve function and change.
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 physical parameter comprises one or more of: a systemic circulation parameter, a filling parameter, an ejection parameter, a heart rate parameter, a stiffness parameter, a valve related parameter, and a blood flow parameter”, wherein Dahl et al. disclose blood flow parameters at [0050].
With respect to claim 7, Dahl et al. disclose, “wherein the numerical model is based on a physical parameter, and wherein the processing unit is further adapted to: obtain preliminary physiological data from the subject wherein the imaging modalities include echocardiography performed in real-time 3D: and adjust the physical parameter of the numerical model based on the 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]. Further, imaging modalities include 3D echocardiography [0239].
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 claims 1-2 and 4-15 are obvious over the art to Dahl et al. in view CN105976348A.
2. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over US2018/0174068 to Dahl et al. (IDS reference) in view of CN105796348A (see English translation portion at pages 29-52 attached), as pertains to claims 1 and 2 and in further view of Alfieri et al. (J. Card. Surg. (2010) Vol. 25:536-541). This rejection is newly recited and is necessitated by claim amendment herein.
Claim 1 is directed to:
A system for determining a real-time mitral 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 represents cardiac pressure-flow relationships and 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 mitral valve within the cardiac system;
obtain a continuous stream of physiological data from the subject wherein the physiological data comprises at least one of pressure data, volume data, flow data, or electrocardiographic data;
adjust a physical parameter of the numerical model based on at least a portion of the continuous stream of physiological data;
provide the continuous stream of physiological data as an input to the numerical model of the cardiac system, thereby executing the numerical model in real-time and generating in real- time a simulated real-time function of the cardiac system of the subject; and
determine a real-time mitral valve function of the subject undergoing a valve repair 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 represents cardiac pressure-flow relationships and 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 mitral 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]; said applications are applicable to the mitral valve [0013]; [0178]-[0179].
Dahl et al. teach, “obtain a continuous stream of physiological data from the subject wherein the physiological data comprises at least one of pressure data, volume data, flow data, or electrocardiographic data”, wherein Dahl et al. disclose, “a model that pertains to blood flow…and structural features…pressure” [0044]; [0045]; [0047]; [0050]“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 “adjust a physical parameter of the numerical model based on at least a portion of the continuous stream of physiological data”, wherein Dahl et al. disclose, “real-time signal processing of input data [0104] and real-time assessment of flow and pressure for modeling [0131];
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 mitral valve function of the subject undergoing a valve repair 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].
Dahl et al. do not specifically disclose determining the real-time mitral valve function of a subject undergoing a valve repair as now claimed in the context of the adjusted numerical model that is a 0D or 1D model However, the prior art to CN105976348A discloses actions performed in real-time (during surgical procedure) wherein information may be estimated during procedure and said information include that of pressure, volume and physiological data. Further, parameters are input into the model and models may include those of lumped-parameter models (0D models) (pages 31, 33-36-English translation).
As such, it would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have utilized lumped parameter modeling in the techniques as disclosed by Dahl et al. for simplification of computationally expensive 3D modeling, as described by CN105976348A at p. 37. One would have been motivated to do so because Dahl et al. specifically include that 0D and 1D modeling may be used in the aspects of the invention [0138]. Further, determining real-time data in operative scenarios is motivated by Dahl et al. at [0093]; [0125]; and [0193] at the least and one would readily implement those techniques as disclosed in CN105976348A in so doing. As such, one would have had a reasonable expectation of success in combing said references that are in the same field of endeavor.
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 mitral valve function, and wherein the real-time mitral valve function determined from the simulated real-time function of the cardiac system is representative of the change in mitral valve function” [0209]-[0230] detailing mitral valve function and change.
Neither Dahl et al. nor CN105976348A specifically disclose that the mitral valve repair comprises edge-to-edge (E-to-E) repair (claim 3). However, the prior art to Alfieri et al. disclose that E-to-E repair is a widely known surgical technique for the repair of the mitral valve and is informed by echocardiography (p. 536, col. 2; p. 537, col. 2).
As such, it would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have utilized the combined techniques as disclosed in Dahl et al. and CN105976348A to inform E-to-E repair as it was a well-known technique for mitral valve complications. One of skill in the art would have had a reasonable expectation of success in so doing because modeling for mitral valve repair as disclosed in Dahl. et al. and in CN105976348A would fairly include any repair, including the E-to-E well-known procedure, as is disclosed in the Alfieri et al. reference.
As such, the claim is obvious over the cited prior art.
Response to Applicant’s Arguments
Applicant’s arguments have been respectfully considered but are moot in view of the new grounds of rejection set forth above and necessitated by claim amendment
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).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Inquiries
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the PTO Fax Center. The faxing of such papers must conform to the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central Fax Center Number is (571) 273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lori A. Clow, whose telephone number is (571) 272-0715. The examiner can normally be reached on Monday-Thursday from 11:00AM to 9:00PM ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz Skowronek can be reached on (571) 272-9047.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public.
/Lori A. Clow/Primary Examiner, Art Unit 1687
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