DETAILED ACTION
Claims 1, 3 – 4, 12 – 13, 19, 27 – 29, 37 – 43, 46 – 49, 63, 74 – 75, 83 – 85 and 93 – 94 have been presented for examination. Claims 2, 5 – 11, 14 – 18, 20 – 26, 30 – 36, 44 – 45, 50 – 62, 64 – 73, 76 – 82, and 86 – 92 are cancelled.
This office action is in response to submission of the application on 09/01/2022.
Claims 1, 3 – 4, 12 – 13, 19, 27 – 29, 37 – 43, 46 – 49, 63, 74 – 75, 83 – 85 and 93 – 94 have been considered under “2019 Revised Patent Subject Matter Eligibility Guidance” 84 Fed. Reg. 50 (7 January 2019), the instant claims are viewed as not reciting an abstract idea under step 2A(i). Specifically, there is recited at claim 1 “receiving” and “providing” which data gathering and outputting activities. Claim 74 similarly recites “obtaining” and “providing”. Looking to the dependent claims, they similarly recite limitations that do not recite an abstract idea. Specifically, claim 12 recites “advancing the 1D transport model“ and claim 41 “evolving a 1D simulation in the 1D transport model”. However, the 1D transport model is a machine model which is “instantiated on the first machine”. Accordingly, the claims are deemed eligible under 35 U.S.C. 101.
Specification
The amendments to the specification are accepted as they add cross reference(s) to the related application(s), and further appear to correct typographical errors without adding new matter.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter which is objected to.
None of the prior art of record taken individually or in combination discloses the claim 19, 29, 75, 85 and 93 (by virtue of dependency) method of simulation a trial of a medical device on a patient, the method comprising: “wherein each of: the first 1D transport model input; the first 1D transport model output; and the second 1D transport model output includes a boundary condition record that 0D physiological model component identifier; a 1D transport model component code; an inlet/outlet indicator; and a 0D/1D boundary condition vector”, in combination with the remaining elements and features of the claim. It is for these reasons that the applicant’s invention defines over the prior art of record.
None of the prior art of record taken individually or in combination discloses the claim 27, 42, 43 (by virtue of dependency), and 83 method of simulation a trial of a medical device on a patient, the method comprising: “wherein the providing to the 0D physiological model a first 1D transport model output includes distributing to each 0D physiological model time step in a 0D simulation a fraction of a value of the first 1D transport model output that is defined by:
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”, in combination with the remaining elements and features of the claim. It is for these reasons that the applicant’s invention defines over the prior art of record.
None of the prior art of record taken individually or in combination discloses the
claim 37, 38 (by virtue of dependency), 39 (by virtue of dependency), and 40 (by virtue of dependency) method of simulation a trial of a medical device on a patient, the method comprising: “wherein the second 1D transport model input includes a sum derived from values calculated in each 0D physiological model time step in a sequence of 0D physiological model time steps”, in combination with the remaining elements and features of the claim. It is for these reasons that the applicant’s invention defines over the prior art of record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 46 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With regard to claim 46, it recites “to the 3D model” which lack proper antecedent basis since there are two previously recited models (i.e., a master 3D model, and a slave 3D model). The limitation is interpreted for examination purposes as referring back to either model.
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 12, 13, 28, 41, 46 – 49 are rejected under 35 U.S.C. 103 as being unpatentable over Larrabide et al. “HeMoLab – Hemodynamics Modelling Laboratory: An Application for modelling the human cardiovascular system” (henceforth “Larrabide”) in view of Shi et al. “Review of Zero-D and 1-D Models of Blood Flow in the Cardiovascular System“ (henceforth “Shi”), and further in view of Mansi et al. (US 2013/0197881) (henceforth “Mansi (881)”). Larrabide and Shi and Mansi (881) are analogous art because they solve the same problem of simulating a trial of a medical device on a patient, and because they are from the same field of endeavor of medical simulations of a patient.
With regard to claim 1, Larrabide teaches a method for simulating on a patient, the method comprising: (Abstract and Page 995 cardiovascular system is modeled including patient specific information)
receiving from a 3D model: a 3D-inflow file; and a 3D-outflow file; providing to the 3D model: a 1D-outflow file; and a 1D-inflow file; and (Figure 3 coupling of model is with input and output files (inflow and outflow files)
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, and Figure 8 1D files are coupled to 3D models
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Larrabide does not appear to explicitly disclose: that the method is for simulating a trial of a medical device on a patient; and that the receiving is at a first machine from a 3D model instantiated on a second machine; that the providing is from the first machine via a network.
However, Shi teaches:
simulating a trial of a medical device on a patient (Page 29, Top “1D models have been successfully applied in the context of clinical diagnosis of pathological changes in the cardiovascular system (such as hypertension, atherosclerosis), and in the context of stent design.”)
receiving at a first machine, from a 3D model instantiated on a second machine: a 3D and 1D files (Page 1, Bottom models are readily available for upload and download for further use “As an example of 0D cardiovascular modelling, a small selection of simple models have been represented in the CellML mark-up language and uploaded to the CellML model repository http://models.cellml.org/. They are freely available to the research and education communities.”, and Page 29, Top models can be published of different complexity “This review examines published 0D and 1D time domain cardiovascular models, and provides an overview of their development and applications, as well as their emerging role in multi-scale modelling.”)
It would have been obvious to one of ordinary skill in the art to combine the cardiovascular modeling methods disclosed by Larrabide with the cloud file distribution disclosed by Shi. One of ordinary skill in the art would have been motivated to make this modification in order to desirably share modeling files for research purposes (Shi Page 29, Top).
Larrabide in view of Shi does not appear to explicitly disclose: receiving from the second machine, via the network, an instruction to advance a 1D transport model instantiated on the first machine.
However, Mansi (881) teaches:
receiving from a second machine, via a network, an instruction to advance a 1D transport model instantiated on a first machine. (Figure 17 and Paragraph 96 master solver coordinates sub solvers at each time step (advance the model) “For example, simulation framework of FIG. 17, in which the master solver 1700 sequentially calls the subs-solvers 1710, 1720, 1730, and 1740, at each time step, can be used to perform the simulation.”, and Paragraph 119 instructions can be read from remote machines or a network (receiving an instruction) “Likewise, processing strategies may include multiprocessing, multitasking, parallel processing and the like. In one embodiment, the instructions are stored on a removable media device for reading by local or remote systems. In other embodiments, the instructions are stored in a remote location for transfer through a computer network or over telephone lines”)
It would have been obvious to one of ordinary skill in the art to combine the cardiovascular modeling methods disclosed by Larrabide in view of Shi with the remote simulator coordination disclosed by Mansi (881). One of ordinary skill in the art would have been motivated to make this modification in order to desirably run sub simulations (Mansi (881) Abstract).
With regard to claim 12 and 47, Larrabide in view of Shi, and further in view of Mansi (881) teaches all the elements of the parent claim 1 and 46, and further teaches: in response to the instruction,
advancing the 1D transport model through a series of 1D transport model time steps. (Mansi (881) Figure 17 and Paragraph 96 master solver coordinates sub solvers at each time step “For example, simulation framework of FIG. 17, in which the master solver 1700 sequentially calls the subs-solvers 1710, 1720, 1730, and 1740, at each time step, can be used to perform the simulation.”)
It would have been obvious to one of ordinary skill in the art to combine the cardiovascular modeling methods disclosed by Larrabide in view of Shi with the remote simulator coordination disclosed by Mansi (881). One of ordinary skill in the art would have been motivated to make this modification in order to desirably run sub simulations (Mansi (881) Abstract).
With regard to claim 13, Larrabide in view of Shi, and further in view of Mansi (881) teaches all the elements of the parent claim 12, and further teaches wherein the advancing comprises:
obtaining from a 0D physiological model a first 1D transport model input; providing to the 0D physiological model a first 1D transport model output; and providing to the 0D physiological model a second 1D transport model output. (Mansi (881) Paragraph 94 data is desirably interchanged between the models “Every component of the multi-scale computational model is designed independently, with data flowing between each component through memory as illustrated by the arrows in FIG. 17. In a possible implementation, the whole simulation can be set up through an XML file. … After every iteration, output data is dumped as requested by the user”)
It would have been obvious to one of ordinary skill in the art to combine the cardiovascular modeling methods disclosed by Larrabide in view of Shi with the remote simulator coordination disclosed by Mansi (881). One of ordinary skill in the art would have been motivated to make this modification in order to desirably run sub simulations (Mansi (881) Abstract).
With regard to claim 28, Larrabide in view of Shi, and further in view of Mansi (881) teaches all the elements of the parent claim 13, and further teaches: using the first machine communicating to the 0D physiological model:
a 1D transport model time step; and
an instruction to return a second 1D transport model input after the 0D physiological model advances through a series of 0D physiological model time steps. (Figure 17 and Paragraph 96 master solver coordinates sub solvers at any desired sequence of steps “For example, simulation framework of FIG. 17, in which the master solver 1700 sequentially calls the subs-solvers 1710, 1720, 1730, and 1740, at each time step, can be used to perform the simulation.”, and Paragraph 119 instructions can be read from remote machines or a network (receiving an instruction) “Likewise, processing strategies may include multiprocessing, multitasking, parallel processing and the like. In one embodiment, the instructions are stored on a removable media device for reading by local or remote systems. In other embodiments, the instructions are stored in a remote location for transfer through a computer network or over telephone lines”)
It would have been obvious to one of ordinary skill in the art to combine the cardiovascular modeling methods disclosed by Larrabide in view of Shi with the remote simulator coordination disclosed by Mansi (881). One of ordinary skill in the art would have been motivated to make this modification in order to desirably run sub simulations (Mansi (881) Abstract).
With regard to claim 41, Larrabide in view of Shi, and further in view of Mansi (881) teaches all the elements of the parent claim 12, and further teaches: further comprising evolving a 1D simulation in the 1D transport model for each of the time steps. (Mansi (881) Figure 17 and Paragraph 96 master solver coordinates sub solvers at each time step “For example, simulation framework of FIG. 17, in which the master solver 1700 sequentially calls the subs-solvers 1710, 1720, 1730, and 1740, at each time step, can be used to perform the simulation.”)
It would have been obvious to one of ordinary skill in the art to combine the cardiovascular modeling methods disclosed by Larrabide in view of Shi with the remote simulator coordination disclosed by Mansi (881). One of ordinary skill in the art would have been motivated to make this modification in order to desirably run sub simulations (Mansi (881) Abstract).
With regard to claim 46, Larrabide in view of Shi, and further in view of Mansi (881) teaches all the elements of the parent claim 1, and further teaches: when the 3D model is a master 3D model: receiving at the first machine from a slave 3D model: a 3D-inflow slave file; and a 3D-outflow slave file; and providing from the first machine to the 3D model: a 1D-outflow slave file; a 1D-inflow slave file; and an instruction to advance a slave 3D simulation on the slave 3D model. (see Claim Rejections - 35 USC § 103) (Mansi (881) Figure 17 and Paragraph 96 master solver coordinates sub solvers at each time step, where the subsolvers can desirably be 3D models “For example, simulation framework of FIG. 17, in which the master solver 1700 sequentially calls the subs-solvers 1710, 1720, 1730, and 1740, at each time step, can be used to perform the simulation.”)
It would have been obvious to one of ordinary skill in the art to combine the cardiovascular modeling methods disclosed by Larrabide in view of Shi with the remote simulator coordination disclosed by Mansi (881). One of ordinary skill in the art would have been motivated to make this modification in order to desirably run sub simulations (Mansi (881) Abstract).
With regard to claim 48, Larrabide in view of Shi, and further in view of Mansi (881) teaches all the elements of the parent claim 46, and further teaches: wherein the slave 3D model is of a plurality of slave 3D models in communication with the first machine. (Mansi (881) Figure 17 and Paragraph 96 master solver coordinates sub solvers at each time step “For example, simulation framework of FIG. 17, in which the master solver 1700 sequentially calls the subs-solvers 1710, 1720, 1730, and 1740, at each time step, can be used to perform the simulation.”)
It would have been obvious to one of ordinary skill in the art to combine the cardiovascular modeling methods disclosed by Larrabide in view of Shi with the remote simulator coordination disclosed by Mansi (881). One of ordinary skill in the art would have been motivated to make this modification in order to desirably run sub simulations (Mansi (881) Abstract).
With regard to claim 49, Larrabide in view of Shi, and further in view of Mansi (881) teaches all the elements of the parent claim 46, and further teaches: wherein the receiving of: the 3D-inflow slave file; and the 3D-outflow slave file includes a receiving via an electronic communication network; and the providing of: the 1D-outflow slave file; the 1D-inflow slave file; and the instruction to advance a slave 3D simulation on the slave 3D model includes a providing via the network. (Mansi (881) Paragraph 119 instructions can be read from remote machines or a network (receiving an instruction) “Likewise, processing strategies may include multiprocessing, multitasking, parallel processing and the like. In one embodiment, the instructions are stored on a removable media device for reading by local or remote systems. In other embodiments, the instructions are stored in a remote location for transfer through a computer network or over telephone lines”)
It would have been obvious to one of ordinary skill in the art to combine the cardiovascular modeling methods disclosed by Larrabide in view of Shi with the remote simulator coordination disclosed by Mansi (881). One of ordinary skill in the art would have been motivated to make this modification in order to desirably run sub simulations (Mansi (881) Abstract).
Claims 3 – 4 and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Larrabide in view of Shi , and further in view of Mansi (881), and further in view of Jezeck et al. “Lumped models of the cardiovascular system of various complexity” (henceforth “Jezeck”). Larrabide and Shi and Mansi (881) and Jezeck are analogous art because they solve the same problem of simulating a trial of a medical device on a patient, and because they are from the same field of endeavor of medical simulations of a patient.
With regard to claim 3, Larrabide in view of Shi, and further in view of Mansi (881) teaches all the elements of the parent claim 1 and further teaches:
receiving over the network a configuration file defining: (Mansi (881) Paragraph 119 instructions can be read from remote machines or a network (receiving a configuration file).
a simulate device (Shi Page 29, Top “1D models have been successfully applied in the context of clinical diagnosis of pathological changes in the cardiovascular system (such as hypertension, atherosclerosis), and in the context of stent design.”)
Larrabide in view of Shi, and further in view of Mansi (881) does not appear to explicitly disclose: that the file defines an upstream interface between a simulated medical device and anatomy of a digitally simulated patient; and a downstream interface between the simulated medical device and the anatomy.
However, Jezeck teaches:
an upstream interface between a organ and anatomy of a digitally simulated patient; and a downstream interface between the organ and the anatomy. (Jezek Figure 4 model components are interchangeable, such that the medical device of Shi can be simulated as custom model
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, and Figure 3 models are implementable using commercially available software that can be configured to produce desired behavior
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It would have been obvious to one of ordinary skill in the art to combine the cardiovascular modeling methods disclosed by Larrabide in view of Shi, and further in view of Manshi (881) with the modular cardiovasculator simulator with interchangeable components disclosed by Jezeck. One of ordinary skill in the art would have been motivated to make this modification in order to desirably run cardiovascular simulations (Jezeck Abstract).
With regard to claim 4, Larrabide in view of Shi, and further in view of Mansi (881), and further in view of Jezeck teaches all the elements of the parent claim 3, and further teaches wherein each of the: the 3D-outflow file; the 3D-inflow file; the 1D-outflow file; and the 1D-inflow file includes a boundary condition record that includes: (Larrabide Page 995, Right a plurality of boundary in the model coupling)
a flow interface identifier referring to either of the upstream interface and the downstream interface; and (Jezeck Figure 6 connections have an identifier between model components
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a boundary condition vector (Larrabide Page 995, Right a plurality of boundary conditions)
With regard to claim 63, Larrabide in view of Shi, and further in view of Mansi (881) teaches all the elements of the parent claim 46, and further teaches:
receiving over the network at a digital trial platform a slave configuration file defining: (Mansi (881) Paragraph 119 instructions can be read from remote machines or a network (receiving over a network) on a computer (a digital trial platform) “Likewise, processing strategies may include multiprocessing, multitasking, parallel processing and the like. In one embodiment, the instructions are stored on a removable media device for reading by local or remote systems. In other embodiments, the instructions are stored in a remote location for transfer through a computer network or over telephone lines”)
a slave device and anatomy of a digitally simulated patient (Larrabide Figure 3 coupling of model between elements of the cardiovascular system of a patient
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Larrabide in view of Shi, and further in view of Mansi (881) does not appear to explicitly disclose: a simulated upstream interface between a slave simulated device and anatomy of a digitally simulated patient; and a simulated downstream interface between the slave simulated device and the anatomy.
However, Jezeck teaches:
an upstream interface between a organ and anatomy of a digitally simulated patient; and a downstream interface between the organ and the anatomy. (Jezek Figure 4 model components are interchangeable, such that the medical device of Shi can be simulated as custom model
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, and Figure 3 models are implementable using commercially available software that can be configured to produce desired behavior
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It would have been obvious to one of ordinary skill in the art to combine the cardiovascular modeling methods disclosed by Larrabide in view of Shi, and further in view of Manshi (881) with the modular cardiovasculator simulator with interchangeable components disclosed by Jezeck. One of ordinary skill in the art would have been motivated to make this modification in order to desirably run cardiovascular simulations (Jezeck Abstract).
Claim 74, 84 and 94 is rejected under 35 U.S.C. 103 as being unpatentable over Larrabide in view of Shi. Larrabide and Shi are analogous art because they solve the same problem of simulating a trial of a medical device on a patient, and because they are from the same field of endeavor of medical simulations of a patient.
With regard to claim 74, Larrabide teaches a method for simulating a patient, the method comprising advancing on a first machine a 1D transport model through a series of 1D transport model time steps, the advancing comprising: obtaining from a 0D physiological model a first 1D transport model input; providing to the 0D physiological model a first 1D transport model output; and providing to the 0D physiological model a second 1D transport model output. (Figure 3 coupling of model is with input and output files (inflow and outflow files)
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, and Page 995, Left 0D and 1D models are coupled and inputs/outputs desirably flow between them
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Larrabide does not appear to explicitly disclose: that the simulating is of a medical device.
However, Shi teaches:
simulating a trial of a medical device on a patient (Page 29, Top “1D models have been successfully applied in the context of clinical diagnosis of pathological changes in the cardiovascular system (such as hypertension, atherosclerosis), and in the context of stent design.”)
It would have been obvious to one of ordinary skill in the art to combine the cardiovascular modeling methods disclosed by Larrabide with the cloud file distribution disclosed by Shi. One of ordinary skill in the art would have been motivated to make this modification in order to desirably share modeling files for research purposes (Shi Page 29, Top).
With regard to claim 84, Larrabide in view of Shi teaches all the elements of the parent claim 74, and further teaches: using the first machine communicating to the 0D physiological model: a 1D transport model time step; and an instruction to return a second 1D transport model input after the 0D physiological model advances through a series of 0D physiological model time steps. (Larrabide Figure 3 coupling of model is with input and output files (inflow and outflow files)
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With regard to claim 94, Larrabide in view of Shi teaches all the elements of the parent claim 74, and further teaches: further comprising evolving a 1D simulation corresponding to a 1D transport model time step.(Larrabide Figure 3 solver produces time domain results (model time step)
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Examiner General Comments
With regard to the prior art rejection(s), any cited portion of the relied upon reference(s), either by pointing to specific sections or as quotations, is intended to be interpreted in the context of the reference(s) as a whole as would be understood by one of ordinary skill in the art. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in their entirety as potentially teaching all or part of the claimed invention since the entire reference is considered to provide disclosure relating to the cited portions. Further, the claims and only the claims form the metes and bounds of the invention. Office personnel are to give the claims their broadest reasonable interpretation in light of the supporting disclosure. Unclaimed limitations appearing in the specification are not read into the claim. Prior art was referenced using terminology familiar to one of ordinary skill in the art. Such an approach is broad in concept and can be either explicit or implicit in meaning. Examiner’s notes are provided with the cited references to assist the applicant to better understand how the examiner interprets the applied prior art. Such comments are entirely consistent with the intent and spirit of compact prosecution.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALFRED H. WECHSELBERGER whose telephone number is (571)272-8988. The examiner can normally be reached M - F, 10am to 6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emerson Puente can be reached at 571-272-3652. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALFRED H. WECHSELBERGER/ExaminerArt Unit 2187
/EMERSON C PUENTE/Supervisory Patent Examiner, Art Unit 2187
Prosecution Insights