DETAILED ACTION
The Applicant’s filing, received 02 July 2022, has been fully considered. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
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 .
Status of the Claims
Claims 1-8 are pending.
Claims 1-8 are rejected.
Claims 1-6 are objected to.
Priority
This application is a 371 of PCT/JP2020/000678, filed 10 January 2020.
There are no foreign or provisional applications for which priority is claimed.
Therefore, the effective filing date of the claimed invention is 10 January 2020.
Drawings
The drawings were received 02 July 2022. These drawings are acceptable.
Information Disclosure Statement
The information disclosure statement (IDS) received 02 July 2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Interpretation
Claim 4 recites the limitation “acquire action information indicating a detail of an action of a subject.” This limitation is interpreted as a product-by-process limitation, with the information (i.e., the acquired data) being the product, and further interpreted to not require the active steps of performing the process that generates the information.
Claim Objections
Claim 1 is objected to because of the following informalities: The limitation “a storage medium having computer program instructions stored thereon, when executed by the processor, perform to:” should be amended to recite “a storage medium having computer program instructions stored thereon which, when executed, cause the processor to:”.
Claim 1 is further objected to because of the following informalities: The word “to” at the beginning of line seven should be deleted.
Claim 2 is objected to because of the following informalities: the limitation “wherein the computer program instructions further perform to adjusts” should be amended to recite “wherein the computer program instructions, when executed, further cause the processor to adjust”.
Claim 3 is objected to because of the following informalities: the limitation “wherein the computer program instructions further perform to estimates” should be amended to recite “wherein the computer program instructions, when executed, further cause the processor to estimate”.
Claim 4 is objected to because of the following informalities: the limitation “wherein the computer program instructions further perform to” should be amended to recite “wherein the computer program instructions, when executed, further cause the processor to”.
Claim 5 is objected to because of the following informalities: the limitation “wherein the computer program instructions further perform to calculates” should be amended to recite “wherein the computer program instructions, when executed, further cause the processor to calculate”.
Claim 6 is objected to because of the following informalities: the limitation “wherein the computer program instructions further perform to calculates” should be amended to recite “wherein the computer program instructions, when executed, further cause the processor to calculate”.
Appropriate correction is required.
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite: (a) mathematical concepts, (e.g., mathematical relationships, formulas or equations, mathematical calculations); and (b) mental processes, i.e., concepts performed in the human mind, (e.g., observation, evaluation, judgement, opinion).
Subject matter eligibility evaluation in accordance with MPEP 2106.
Eligibility Step 1: Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter?
Independent claim 1 and dependent claims 2-6 recite an apparatus comprising a processor and a storage medium having instructions stored thereon (i.e., a machine or manufacture); independent claim 7 recites an optimization method (i.e., a process); and independent claim 8 recites a non-transitory computer-readable medium (i.e., a machine or manufacture).
Therefore, these claims are encompassed by the categories of statutory subject matter, and thus, satisfy the subject matter eligibility requirements under step 1.
[Step 1: YES]
Eligibility Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in Prong Two whether the recited judicial exception is integrated into a practical application of that exception.
Eligibility Step 2A Prong One: In determining whether a claim is directed to a judicial exception, examination is performed that analyzes whether the claim recites a judicial exception, i.e., whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim.
Independent claim 7 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
estimating a physiological parameter indicating a physiological state using an estimation model (i.e., mental processes and mathematical concepts);
calculating a first difference value based on a first estimated value of the physiological parameter in a first time interval and an actually measured value of the physiological parameter in the first time interval (i.e., mental processes and mathematical concepts);
calculating a second difference value based on the first estimated value and a second estimated value of the physiological parameter in a second time interval previous to the first time interval (i.e., mental processes and mathematical concepts); and
adjusting the estimation model based on the first difference value and the second difference value (i.e., mental processes and mathematical concepts).
Independent claim 1 recites an apparatus comprising a processor and a storage medium having instructions stored thereon for performing the abstract ideas recited by independent claim 7, as noted above.
Independent claim 8 recites a non-transitory computer-readable medium having computer-executable instructions that, upon execution of the instructions by a processor of a computer, cause the computer to perform the abstract ideas recited by independent claim 7, as noted above.
Dependent claims 2-6 further recite the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas, as noted below.
Dependent claim 2 further recites:
adjust the estimation model by re-calculating a model parameter of the estimation model such that a sum of the first difference value and the second difference value is minimized (i.e., mental processes and mathematical concepts).
Dependent claim 3 further recites:
estimate, as the physiological parameter, a parameter related to intake or discharge of a substance in an organ, and re-calculate, as the model parameter, a parameter related to a change in a concentration of the substance or a volume of the substance in the organ (i.e., mental processes and mathematical concepts).
Dependent claim 4 further recites:
calculate an intake volume or a discharge volume of the substance of the subject based on the action information (i.e., mental processes and mathematical concepts).
Dependent claim 5 further recites:
calculate the first difference value as a total sum of absolute differences between an average value, a maximum value, and a minimum value of the physiological parameter estimated for the first time interval and an average value, a maximum value, and a minimum value of the physiological parameter actually measured for the first time interval (i.e., mental processes and mathematical concepts).
Dependent claim 6 further recites:
calculate the second difference value as a total sum of absolute differences between an average value, a maximum value, and a minimum value of the physiological parameter estimated for the first time interval and an average value, a maximum value, and a minimum value of the physiological parameter estimated for the second time interval (i.e., mental processes and mathematical concepts).
The abstract ideas recited in the claims are evaluated under the broadest reasonable interpretation (BRI) of the claim limitations when read in light of and consistent with the specification. As noted in the foregoing section, the claims are determined to contain limitations that can practically be performed in the human mind with the aid of a pen and paper (e.g., estimate a physiological parameter indicating a physiological state using an estimation model), and therefore recite judicial exceptions from the mental process grouping of abstract ideas. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas (e.g., calculate a first difference value based on a first estimated value of the physiological parameter in a first time interval and an actually measured value of the physiological parameter in the first time interval) are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind.
Therefore, claims 1-8 recite an abstract idea.
[Step 2A Prong One: YES]
Eligibility Step 2A Prong Two: In determining whether a claim is directed to a judicial exception, further examination is performed that analyzes if the claim recites additional elements that when examined as a whole integrates the judicial exception(s) into a practical application (MPEP 2106.04(d)). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed 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 fails to integrate the abstract idea into a practical application (MPEP 2106.04(d)(III)).
The judicial exceptions identified in Eligibility Step 2A Prong One are not integrated into a practical application because of the reasons noted below.
The additional elements in independent claim 1 include:
an apparatus comprising a processor and a storage medium having computer program instructions stored thereon.
The additional elements in independent claim 7 include:
a computer.
The additional elements in independent claim 8 include:
a non-transitory computer-readable medium having computer-executable instructions;
a computer processor; and
the apparatus of independent claim 1.
The additional element in dependent claims 2-6 include:
the apparatus of independent claim 1 (claims 2-6); and
acquire action information indicating a detail of an action of a subject (i.e., obtain/receive data) (claim 4).
The additional elements of an apparatus comprising a processor and a storage medium having computer program instructions stored thereon (claims 1-8); a computer (claim 7); a non-transitory computer-readable medium having computer-executable instructions (claim 8); and a computer processor (claim 8); invoke a computer and/or computer-related components merely as tools for use in the claimed process, and therefore are not an improvement to computer functionality itself, or an improvement to any other technology or technical field, and thus, do not integrate the judicial exceptions into a practical application (MPEP 2106.04(d)(1)).
The additional element of acquire action information indicating a detail of an action of a subject (i.e., obtain/receive data) (claim 4) is merely a pre-solution activity of gathering data for use in the claimed process – a nominal addition to the claims that does not meaningfully limit the claims, and therefore does not add more than insignificant extra-solution activity to the judicial exceptions (MPEP 2106.05(g)).
Thus, the additionally recited elements merely invoke a computer and/or computer related components as tools; and/or amount to insignificant extra-solution activity; and as such, when all limitations in claims 1-8 have been considered as a whole, the claims are deemed to not recite any additional elements that would integrate a judicial exception into a practical application, and therefore claims 1-8 are directed to an abstract idea (MPEP 2106.04(d)).
[Step 2A Prong Two: NO]
Eligibility Step 2B: Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims are probed for a specific inventive concept. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). Identifying whether the additional elements beyond the abstract idea amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they amount to significantly more than the judicial exception (MPEP 2106.05A i-vi).
The claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception(s) because of the reasons noted below.
The additional elements recited in independent claims 1, 7, and 8 and dependent claims 2-6 are identified above, and carried over from Step 2A Prong Two along with their conclusions for analysis at Step 2B. Any additional element or combination of elements that was considered to be insignificant extra-solution activity at Step 2A Prong Two was re-evaluated at Step 2B, because if such re-evaluation finds that the element is unconventional or otherwise more than what is well-understood, routine, conventional activity in the field, this finding may indicate that the additional element is no longer considered to be insignificant; and all additional elements and combination of elements were evaluated to determine whether any additional elements or combination of elements are other than what is well-understood, routine, conventional activity in the field, or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, per MPEP 2106.05(d).
The additional elements of an apparatus comprising a processor and a storage medium having computer program instructions stored thereon (claims 1-8); a computer (claim 7); a non-transitory computer-readable medium having computer-executable instructions (claim 8); a computer processor (claim 8); and obtaining data (claim 4); are conventional computer components and/or functions (see MPEP at 2106.05(b) and 2106.05(d)(II) regarding conventionality of computer components and computer processes).
Therefore, when taken alone, all additional elements in claims 1-8 do not amount to significantly more than the above-identified judicial exception(s). Even when evaluated as a combination, the additional elements fail to transform the exception(s) into a patent-eligible application of that exception. Thus, claims 1-8 are deemed to not contribute an inventive concept, i.e., amount to significantly more than the judicial exception(s) (MPEP 2106.05(II)).
[Step 2B: NO]
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.
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.
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Sarai et al. (WO 2007/105420).
Independent claims 1, 7, and 8 are broadly directed to a system and method of using a computational model to estimate a physiological parameter that indicates a physiological state by calculating a first difference value based on a first estimated value of the physiological parameter in a first time interval and an actual measured value of the physiological parameter in the first time interval, a subsequent step of calculating a second difference value based on the first estimated value and a second estimated value of the physiological parameter in a second time interval previous to the first time interval, and optimizing the model based on the first and second difference values.
Dependent claims 2-6 further define the calculations used in the model.
Sarai et al. is directed to a physiological parameter determining device that comprises a simulation performing section for receiving a physiological parameter set, simulating a cardiac motion, and acquiring the action potential information representing the action potential of the heart, a degree-of-difference computing section for computing the degree of the difference between the acquired action potential information and experimental action potential information, an allowable parameter set determining section for determining on the basis of the degree of difference whether or not the physiological parameter set is within an allowable range, and an allowable parameter set output section for outputting the physiological parameter set within the allowable range (Abstract),
Regarding independent claims 1, 7, and 8, Sarai et al. shows a computer system to execute the functions of a biological parameter determination system (e.g., para. [0172]); determining a steady state (i.e., a physiological state) (para. [0009]); obtaining action potential information at time intervals (paras. [0055] & [0039]); absolute value difference determination between action potential information and acquired experimental action potential information (para. [0075] Step S404); using a previous determined range of values to narrow the data for determining a biological parameter (paras. [0020] & [0022]); an algorithm for selecting a biological parameter (e.g., para. [0105]) (i.e., a model); and updating the algorithm with an optimal solution, i.e., the biological parameter set having the smallest difference among the optimal solutions (para. [0112]).
Regarding independent claims 1, 7, and 8, Sarai et al. does not show the exact method in the exact order as recited by the instant claims.
Regarding dependent claims 2-6, Sarai et al. shows steps for calculating absolute value difference information and change difference information between parameter values (e.g., paras. [0104], [0146] & [0148]).
Regarding dependent claims 2-6, Sarai et al. does not show the exact steps for calculating the absolute differences for determining the physiological parameter.
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method shown by Sarai et al. by incorporating alternative calculations and/or sequences of steps in calculating the differences between an estimated physiological parameter and an actual measurement of the physiological parameter, as shown by Sarai et al., and discussed above. One of ordinary skill in the art would have been motivated to modify the methods of Sarai et al. because Sarai et al. shows algorithms for determining an estimated physiological parameter using calculations to determine absolute differences in parameter values from different time intervals, and optimizing the algorithm based on the minimum differences between optimal parameter calculations. This modification would have had a reasonable expectation of success given that Sarai et al. discloses a system and method for determining a physiological parameter.
Conclusion
No claims are allowed.
This Office action is a Non-Final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this application.
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/S.W.B./Examiner, Art Unit 1687
/Joseph Woitach/Primary Examiner, Art Unit 1687