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 .
Application Status
This is the first non-final action on the merits. Claims 1-3 as originally filed on June 17, 2025 are currently pending and considered below.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on June 17, 2025, February 20, 2026 and April 9, 2026 are being considered by the examiner. The submissions are in compliance with the provisions of 37 CFR 1.97.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
As to claim 3, the claim recites outputting a second specified state variable “indicating a matter for improving the patient's lifestyle”. However, the specification lacks adequate written description for indicating a “matter”. The specification discloses the “the estimation value of the second specified state variable p2 for improving the patient's lifestyle” ([0024]), but fails to describe evaluating, indicating or outputting a “matter”. For the purposes of compact prosecution, the claim will be interpreted in a manner as best understood by the examiner and in light of the specification as a second specified state variable “for improving the patient's lifestyle”.
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
Claims 1-3 are 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.
As to claim 1, the claim recites a measurement result indicating a patient’s condition “immediately before and immediately after blood purification treatment” which renders the claim indefinite because “immediately” is an undefined term of degree. The term “immediately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification fails to provide a standard or guideline to determine the time frame of what constitutes “immediately” in the context of dialysis treatment.
As to claim 1, the claim recites “a score indicating suitability of patient's lifestyle”. There is insufficient antecedent basis for “patient’s” in the claim. Claim 1 initially introduces “a first specified state variable indicating a patient's condition”, thereby establishing “a patient” in the claim. Subsequently, the claim recites “a score indicating suitability of patient's lifestyle”. Because the subsequent recitation of “patient’s lifestyle” lacks an article (such as “the”), it is unclear whether the score indicates the lifestyle suitability of the same patient whose condition was measured, or whether it refers to a different patient. As best understood by the Examiner, the recitation of “a score indicating suitability of patient's lifestyle” in claims 1 will be treated as “a score indicating suitability of the patient's lifestyle” for the purposes of compact prosecution.
Claims 2 and 3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph due to their dependence on claim 1.
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 1-3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. an abstract idea) without significantly more.
Claims 1-3 recite a medical care assistance system, which is within the statutory category of a machine.
Step 2A - Prong One:
Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they "recite" a judicial exception or in other words whether a judicial exception is "set forth" or "described" in the claims. An "abstract idea" judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes. Representative independent claim 1 includes limitations that recite at least one abstract idea.
Specifically, independent claim 1 recites: A medical care assistance system that inputs, into a model, a measurement result of a first specified state variable indicating a patient's condition of at least one of immediately before and immediately after blood purification treatment as input data, and outputs, from the model, a score indicating suitability of patient's lifestyle during a specified period that includes a non-treatment period when the blood purification treatment was not performed in the past, as output data.
The underlined limitations are directed to methods of organizing human activity. The claim recites the step of outputting a score indicating suitability of a patient’s lifestyle during a specified period. This step, under its broadest reasonable interpretation, is categorized as methods of organizing human activity, specifically associated with managing personal behavior or relationships or interactions between people (e.g. evaluating the lifestyle of a patient undergoing blood purification treatment). The claim encompasses a person following rules or instructions to receive and process data in the manner described in the abstract idea. If the claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a). The Examiner further notes that “Certain Methods of Organizing Human Activity” includes a person's interaction with a computer (see October 2019 Update: Subject Matter Eligibility at Pg. 5). In addition, the claim encompasses an abstract idea that falls under the mathematical concepts grouping because inputting into a model a measurement result of a first specified state variable indicating a patient's condition of at least one of immediately before and immediately after blood purification treatment and outputting, from the model, a score under its broadest reasonable interpretation, represents mathematical calculations and relationships (see MPEP 2106.04(a)(2)).
Similarly, dependent claims 2-3 recite at least one abstract idea. Claim 2 outputs a determination result. Claim 3 outputs an estimation value of a second specified variable. These limitations only serve to further limit the abstract idea and hence, are directed toward fundamentally the same abstract ideas as independent claim 1, even when considered individually and as an ordered combination.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. It must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a "practical application."
In the present case, claims 1-3 as a whole do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea. The additional elements or combination of additional elements, beyond the above-noted at least one abstract idea will be described as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the “abstract idea(s)”).
Specifically, independent claim 1 recites: A medical care assistance system that inputs, into a model, a measurement result of a first specified state variable indicating a patient's condition of at least one of immediately before and immediately after blood purification treatment as input data, and outputs, from the model, a score indicating suitability of patient's lifestyle during a specified period that includes a non-treatment period when the blood purification treatment was not performed in the past, as output data.
The claim recites the additional element of a system. The system is not described by the applicant and is recited at a high-level of generality such that it amounts to no more than mere instructions to apply the exception using a generic computer component (i.e., merely invoking the computer structure as a tool used to execute the limitations, MPEP 2106.05(f)).
The dependent claims do not recite any additional element(s) beyond those already recited in the independent claims.
Accordingly, the claims as a whole do not integrate the abstract idea into a practical application as they do not impose any meaningful limits on practicing the abstract idea.
Step 2B
Regarding Step 2B, representative independent claim 1 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
When viewed as a whole, claims 1-3 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite processes that are abstract and simply implements the process on a computer(s) is not enough to qualify as "significantly more."
As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a system to perform the noted steps amount 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 (“significantly more”).
The dependent claims do not recite any additional element(s) beyond those already recited in the independent claims.
Therefore, claims 1-3 are rejected under 35 USC §101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraph of 35 U.S.C. 102 that forms the basis for the rejections under this section set forth in this Office action:
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kommala (US 2018/0353670 A1).
Regarding claim 1, Kommala teaches: A medical care assistance system (e.g. see [0009])
that inputs, into a model, a measurement result of a first specified state variable indicating a patient's condition of at least one of immediately before and immediately after blood purification treatment as input data, and (“Data collected from the sensors is transmitted to one or more software algorithm that analyzes the data to look for certain results.” (i.e. a model), e.g. see [0010]; “a data analytics device separate from the sensor and including at least one algorithm configured to analyze the sensor data and provide an analyzed data outcome”, e.g. see [0054]; “For patient volume, one deviation evaluation includes determining how far the patient's actual weight is from the patient's dry weight just before treatment”, e.g. see [0028]; “For the goal of patient volume, patient weight data via a weigh scale is delivered on a periodic basis, including patient weight before and after each dialysis treatment. For the goal of patient blood pressure, patient blood pressure data via a blood pressure monitor is delivered on a periodic basis, including patient blood pressure before and after each dialysis treatment. For the goal of patient blood sugar, patient blood sugar data via a glucose monitor is delivered on a periodic basis, including patient blood sugar before and after each dialysis treatment.”, e.g. see [0157])
outputs, from the model, a score indicating suitability of patient's lifestyle during a specified period that includes a non-treatment period when the blood purification treatment was not performed in the past, as output data. (“controllable variables for patient volume include (i) limit the weight of food consumed per day to a certain amount, (ii) limit the weight of liquid consumed per day to a certain amount” (evaluating lifestyle and nutritional variables), e.g. see [0153]; “The evaluation may be performed at smartphone 40 or computer 50, on an algorithm 64a to 64n…The evaluation in one embodiment determines a deviation from a desired or expected value. For patient volume, for example, one goal of dialysis treatment is to return patient 12 to his or her dry weight…Thus one deviation evaluation is determining how far the patient's actual weight from the patient's dry weight just before treatment.” (The mathematical deviation constitutes the claimed score.), e.g. see [0159]; “Falling within the deviation amount yields a favorable result [i.e. suitability] according to one embodiment of method 150. Falling outside the deviation amount yields a nonfavorable result”, e.g. see [0160]; “Method 110 may be performed while patient 12 is or is not being treated by medical fluid delivery machine 90.”, e.g. see [0151]; “patient 12 performs the selected control variable modification over a suitable time period, e.g., twenty days or a month and if applicable enters compliance confirmation…at a desired interval, e.g., daily”; “regulate the amount of food and/or liquid consumed after treatment, so that a greater percentage of food and/or liquid is consumed, e.g., closer to (or farther from) the next dialysis treatment, or if dialysis treatment is daily to ingest food on a daily basis closer to (or farther from) the next treatment” (i.e. during a specific period), e.g. see [0156], [0153])
Regarding claim 2, Kommala teaches the medical care assistance system of claim 1 as described above.
Kommala further teaches:
wherein the system outputs a determination result of whether the score is equal to or more than a threshold value (“Method 150 in an embodiment sets an allowable deviation amount from the desired amounts. Falling within the deviation amount yields a favorable result according to one embodiment of method 150. Falling outside the deviation amount yields a nonfavorable result” (The threshold value is the allowable deviation amount.), e.g. see [0160]).
Regarding claim 3, Kommala teaches the medical care assistance system of claim 1 as described above.
Kommala further teaches:
wherein based on the score, the system outputs an estimation value of a second specified state variable indicating a matter for improving the patient's lifestyle (“When there is no additional trial…method 150 at diamond 168 determines whether the deviation evaluation result…indicate(s) that the co-morbidity goal is being aided or assisted…then the current control variable for patient 12 at block 172 is determined to be part of the patient's overall kidney maintenance plan” (i.e. a matter for improving the patient's lifestyle), e.g. see [0163]; “Smartphone 40 or computer 50 thereafter implements, monitors and controls the overall kidney maintenance plan.”, e.g. see [0166]; “For example, controllable variables for patient volume include (i) limit the weight of food consumed per day to a certain amount, (ii) limit the weight of liquid consumed per day to a certain amount”; “Controllable variables for patient blood pressure include (i) limit sodium intake…(iii) limit fatty foods, and (iv) limit alcohol intake. Controllable variables for patient blood sugar include (i) limiting sugar intake” (The specific controllable lifestyle variables are the second state variable.), e.g. see [0153]-[0154])
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Reference Goto (US 2019/0255239 A1) discloses a blood purification treatment support system. Reference Garcia (US 2021/0134431 A1) discloses a medical fluid delivery system including analytics for managing patient engagement and treatment compliance. Reference Yu (US 2020/0268959 A1) discloses a dialysis system having adaptive prescription generation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aaisha Abdullah whose telephone number is (571)272-5668. The examiner can normally be reached Monday through Friday 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Choi can be reached on (469) 295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A./
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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