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 .
Response to Arguments
Applicant has cancelled the claims that were subject to interpretation under 35 USC 112(f), and no pending claims remain that are being interpreted under 35 USC 112(f).
Applicant has amended claim 20 to improve clarity, and the objection to that claim is overcome and withdrawn.
Applicant has amended claim 20 to recite a “non-transitory” computer readable medium, overcoming the rejection of that claim under 35 USC 101 as not directed to a statutory category of invention.
Applicant notes the addition of the “conducting research” limitation at the end of the independent claims, but a person can perform this step mentally, and it falls within the scope of an abstract idea (as a mental process). This does not provide significantly more or a practical application, as it is part of the abstract idea. Further, generally linking the use of the exception to the technical field of cardiac medicine (diagnostics specifically) does not confer eligibility, as noted in the rejection.
None of applicant’s arguments on p.13-14 of the remarks address the substance of the rejection, and do not provide any rationale as to why the claim limitations fall outside the scope of mathematical relationships.
Applicant argues on p.15 of the remarks that a technical improvement is recited in the claims, but it is unclear what this improvement is. Applicant mentions diagnosing cardiac-aortic conditions which can allow for treatment, but neither treatment nor diagnosis are claimed. The conduct of research is not the same as diagnosis, let alone applying treatment (and it is unclear if even these would provide significantly more or a practical application). It is maintained that a person can conduct such research mentally. In view of this, the improvement provided by the claims is abstract in nature, not technical. Applicant alleges that “claim 1 of the present invention recites practical applications,” but does not actually specify what those practical applications are. This argument is not persuasive.
The 35 USC 101 rejections are maintained, with additional analysis provided for the new claim limitation added to the independent claims.
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 1-7 and 13-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mathematical relationships and mental processes) without significantly more. Claim 1 recites:
A method for simulating a physiological dynamic blood flow, comprising the following steps: (this falls within the statutory categories of invention)
acquiring related parameters of a cardio-aortic system in a complete cardiac cycle under a normal physiological state, and acquiring morphological and motion imaging data of the cardio-aortic system in the complete cardiac cycle; (insignificant extra-solution activity in the form of mere data gathering as per MPEP 2106.05(g). The link to a cardiac system is generally linking the use of the exception to a technical field of cardiac medicine as per MPEP 2106.05(h), as it is merely what the gathered data is intended to represent. The actual data gathered is numerical data that is later used in mathematical calculations.)
constructing a circulation dynamic loading function for cyclic dynamic contraction of a left ventricle according to the morphological and motion imaging data of the cardio-aortic system in the complete cardiac cycle; (explicit recitation of mathematical functions being generated and used to process the gathered numerical data, within the scope of mathematical relationships. The link to the heart parameters are, as described above, merely generally linking the use of the exception (in this case the mathematical equations/functions) to the technical field of cardiac medicine (by reciting what the math represents))
constructing a function between a left ventricular (LV) dynamic blood pressure and an LV dynamic volume according to the morphological and motion imaging data of the cardio-aortic system in the complete cardiac cycle; (explicit recitation of mathematical functions being generated and used to process the gathered numerical data, within the scope of mathematical relationships)
constructing a dynamic arterial blood flow volume function according to the related parameters of the cardio-aortic system in the complete cardiac cycle under the normal physiological state; (explicit recitation of mathematical functions being generated and used to process the gathered numerical data, within the scope of mathematical relationships)
constructing a cyclic opening and closing activation function of an aortic valve based on the morphological and motion imaging data of the cardio-aortic system in the complete cardiac cycle; and (explicit recitation of mathematical functions being generated and used to process the gathered numerical data, within the scope of mathematical relationships)
constructing a physiological dynamic blood flow model according to the circulation dynamic loading function, the function between the LV dynamic blood pressure and the LV dynamic volume, the dynamic arterial blood flow volume function and the cyclic opening and closing activation function of the aortic valve, and (the model is constructed by a sequence of mathematical functions being combined according to a mathematical algorithm, and this remains within the scope of mathematical relationships)
simulating the physiological dynamic blood flow according to the physiological dynamic blood flow model, and (as the model has been defined in terms of the mathematical functions that comprise it, executing a simulation with it is equivalent to solving the mathematical functions and outputting the numerical data results. This remains within the scope of mathematical relationships)
conducting research on the physiological characteristics, functional injuries, and injury mechanisms of the cardiac-aortic system, based on the simulated physiological dynamic blood flow. (a person can accomplish this mentally by observing the results of the mathematical calculations of the prior steps, then using their professional expertise to evaluate and judge the behavior of the cardiac-aortic system)
This judicial exception is not integrated into a practical application. In particular, the claim only recites the following additional elements: 1) mere instructions to apply the exception using generic computer components (the computer including a processor/memory of claims 13 and 20), 2) generally linking the use of the exception to the technical field of cardiac medicine, and 3) insignificant extra-solution activity in the form of mere data gathering (acquiring the images and measurements used to generate the mathematical functions). The processor/memory is recited at a high-level of generality (i.e., as a generic processor/memory performing a generic computer function of executing instructions and storing data) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception cannot integrate a judicial exception into a practical application. The specification that data is acquired is only tangentially linked to the calculation and analysis steps, and does not meaningfully limit the claim. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor/memory to perform the claimed steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself. The addition of insignificant extra-solution activity does not amount to an inventive concept. The claim is not patent eligible.
Claims 2-7 recite only further details of the insignificant extra-solution activity in the form of mere data gathering and mathematical relationships analyzed above. They remain ineligible for the reasons above.
Claim 13 is substantially similar to claim 1, and rejected under the same grounds
Claims 14-19 recite only further details of the insignificant extra-solution activity in the form of mere data gathering and mathematical relationships analyzed above. They remain ineligible for the reasons above.
Claim 20 is substantially similar to claim 1 with the addition of generic computer components (already addressed above in the rejection of claim 1), and rejected under the same grounds
Allowable Subject Matter
Claims 1-7 and 13-20 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 101 set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art as a whole does not teach or render obvious the claims as recited, notably the feature of "constructing a circulation dynamic loading function for cyclic dynamic contraction of a left ventricle according to the morphological and motion imaging data of the cardio-aortic system in the complete cardiac cycle;" which is then used for the physiological blood flow model in conjunction with simulation of "cyclic opening and closing activation function of the aortic valve". The closest prior art set forth below with a discussion of what it does and does not disclose.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20210093382 A1 discusses aortic valve operation simulation including shape details of the left ventricle, but is silent regarding loading functions for the dynamic contraction of the left ventricle.
US 20120232386 A1 discusses valve simulation including detailed left atrium and left ventricle modeling, but as above is silent regarding loading functions for the dynamic contraction of the left ventricle.
US 20150245776 A1 discusses modeling blood vessels and analyzing them, including determining loading conditions of the vessel. The loading condition analysis is limited to the blood vessel, however, and while the system makes brief mention of relation to left ventricle function, the ventricle is not modeled.
CN 111818852 A discusses measuring heart parameters including left ventricle loading, but does not perform any simulations or modeling to generate this data, instead measuring the data directly.
Conclusion
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.
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/BIJAN MAPAR/ Primary Examiner, Art Unit 2189