DETAILED ACTION
Response to Amendment
This action is in response to the amendment filed on May 8, 2026. Claims 1, 6, 8-9, 11-12, and 14 have been amended. Claim 5 has been cancelled. Claims 1-4, 6-14, and 16-17 have been examined and are currently pending.
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 .
Inventorship
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.
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 1-4, 6-14, and 16-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
ALICE/ MAYO: TWO-PART ANALYSIS
2A. First, a determination whether the claim is directed to a judicial exception (i.e., abstract idea).
Prong 1: A determination whether the claim recites a judicial exception (i.e., abstract idea).
Groupings of abstract ideas enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Mathematical concepts- mathematical relationships, mathematical formulas or equations, mathematical calculations.
Certain methods of organizing human activity- fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions).
Mental processes- concepts performed in the human mind (including an observation, evaluation, judgement, opinion).
Prong 2: A determination whether the judicial exception (i.e., abstract idea) is integrated into a practical application.
Considerations indicative of integration into a practical application enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Improvement to the functioning of a computer, or an improvement to any other technology or technical field
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition
Applying the judicial exception with, or by use of a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception
Considerations that are not indicative of integration into a practical application enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea.
Adding insignificant extra-solution activity to the judicial exception.
Generally linking the use of the judicial exception to a particular technological environment or field of use.
2B. Second, a determination whether the claim provides an inventive concept (i.e., Whether the claim(s) include additional elements, or combinations of elements, that are sufficient to amount to significantly more than the judicial exception (i.e., abstract idea)).
Considerations indicative of an inventive concept (aka “significantly more”) enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Improvement to the functioning of a computer, or an improvement to any other technology or technical field
Applying the judicial exception with, or by use of a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception NOTE: The only consideration that does not overlap with the considerations indicative of integration into a practical application associated with step 2A: Prong 2.
Considerations that are not indicative of an inventive concept (aka “significantly more”) enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea.
Adding insignificant extra-solution activity to the judicial exception.
Generally linking the use of the judicial exception to a particular technological environment or field of use.
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. NOTE: The only consideration that does not overlap with the considerations that are not indicative of integration into a practical application associated with step 2A: Prong 2.
See also, 2019 Revised Patent Subject Matter Eligibility Guidance; Federal Register; Vol. 84, No. 4; Monday, January 7, 2019
Claims 1-4, 6-14, and 16-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
1: Statutory Category
Applicant’s claimed invention, as described in independent claim 1 is directed to a method, independent claim 12 is directed to a system, and independent claim 14 is directed to a hand-held device.
2(A): The claim(s) are directed to a judicial exception (i.e., an abstract idea).
PRONG 1: The claim(s) recite a judicial exception (i.e., an abstract idea).
Mental Processes
Independent claims 1 and 14 recite the limitations, “evaluating the at least one value of the at least one first parameter using the mathematical model, the evaluation being based on at least one of said combinations of parameter values while retrieving at least one of said multitude of combinations of parameter values, wherein the combination or combinations retrieved from the clinical database include(s) the value of the received at least one second parameter; based on a result of said evaluating, step outputting a prediction of a future development of at least one physiological state of the patient or at least one of the parameters of the patient; and suggesting a future behavior or a treatment for the patient, wherein suggesting the feature behavior or the treatment comprises suggesting water and salt intake in an interdialytic period”. Independent claim 12 recites the limitations, “an evaluating device for evaluating the at least one value of the at least one first parameter using the mathematical model based on at least one of said combinations of parameter values while retrieving at least one of said multitude of combinations of parameter values, wherein the at least one combination retrieved from the clinical database comprises the at least one value of the at least second parameter; and an output device for, based on a result of said evaluating step, outputting a prediction of a future development of at least one physiological state of the patient or at least one of the parameters of the patient, and suggesting future behavior or treatment of the patient, wherein the suggesting the future behavior or the treatment comprises suggesting a particular water and salt intake in an interdialytic period.” The limitations described above in claims 1, 12 and 14 are directed to the abstract idea of mental processes. The limitations are directed to evaluating a value based on a mathematical model and a combination of values, predicting the state or parameters associated with a patient based on the evaluation, and suggesting a particular water and salt intake in an interdialytic period. These limitations can be performed in the human mind through observation, evaluation, and judgment of a value using a mathematical model and a combination of parameters. Additionally, the suggestion of water and salt intake in an interdialytic period can be period performed in the human mind through observation, evaluation, and judgment.
Mathematical Concepts
Independent claims 1 and 14 recite the limitations, “providing a mathematical model for evaluating the at least one value of the at least one first parameter based on at least one of said multitude of combinations of parameter values comprised by the clinical database; evaluating the at least one value of the at least one first parameter using the mathematical model, the evaluation being based on at least one of said combinations of parameter values while retrieving at least one of said multitude of combinations of parameter values, wherein the combination or combinations retrieved from the clinical database include(s) the value of the received at least one second parameter; based on a result of said evaluating step, outputting a prediction of a future development of at least one physiological state of the patient or at least one of the parameters of the patient”. Independent claim 12 recites the limitations, “a mathematical model for evaluating the at least one value of the at least one first parameter based on at least one of said multitude of combinations of parameter values comprised by the clinical database; an evaluating device for evaluating the at least one value of the at least one first parameter using the mathematical model based on at least one of said combinations of parameter values while retrieving at least one of said multitude of combinations of parameter values, wherein the at least one combination retrieved from the clinical database comprises the at least one value of the at least second parameter; and an output device for, based on a result of said evaluating step, outputting a prediction of a future development of at least one physiological state of the patient or at least one of the parameters of the patient, and suggesting future behavior or treatment of the patient, wherein suggesting the future behavior or the treatment comprises suggesting a particular water and salt intake in an interdialytic period.” The limitations described above in claims 1, 12 and 14 are directed to the abstract idea of mathematical concepts. The limitations are applying mathematical concepts (e.g., mathematical relationships, mathematical formulas, or mathematical calculations) to determine and predict a future state or parameters associated with a patient.
PRONG 2: The judicial exception (i.e., an abstract idea) is not integrated into a practical application.
The applicant has not shown or demonstrated any of the requirements described above under "integration into a practical application" under step 2A. Specifically, the applicant's limitations are not "integrated into a practical application" because they are adding words "apply it" with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea (see MPEP 2106.05(f)). Additionally, improvements to the functioning of a computer or any other technology or technical field has not been shown or disclosed (see MPEP 2106.05(a)). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Specifically, the applicant’s limitations are not “significantly more” because they are adding words “apply it” with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea (see MPEP 2106.05(f)). The applicant’s claimed limitations do not demonstrate an improvement to another technology or technical field, an improvement to the functioning of the computer itself, effecting a transformation or reduction of particular article to a different state or thing. The current application does not amount to 'significantly more' than the abstract idea as described above. The claim does not include additional elements or limitations individually or in combination that are sufficient to amount to significantly more than the judicial exception. Specifically, the individual elements of patient monitor, interdialytic measuring device, blood treatment apparatus, reporting tool, reading device, receiving device, evaluating device, output device, hand-held device, and control device amount to no more than implementing an idea with a computerized system and they are adding words “apply it” with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea. The additional elements taken in combination add nothing more than what is present when the elements are considered individually. Therefore, based on the two-part Alice Corp. analysis, there are no meaningful limitations in the claims that transform the exception (i.e., abstract idea) into a patent eligible application.
Since the claim(s) recite a judicial exception and fails to integrate the judicial exception into a practical application, the claim(s) is/are “directed to” the judicial exception. Thus, the claim(s) must be reviewed under the second step of the Alice/ Mayo analysis to determine whether the abstract idea has been applied in an eligible manner.
2(B): The claims do not provide an inventive concept (i.e., The claim(s) do not include additional elements, or combinations of elements, that are sufficient to amount to significantly more than the judicial exception (i.e., abstract idea)).
As discussed with respect to Step 2A Prong Two, the additional element(s) in the claim amounts to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
For these reasons, there is no invention concept in the claim, and thus the claim is ineligible.
Dependent claims 2-4, 6-11, 13, and 16-17 are rejected as ineligible subject matter under 35 U.S.C. 101 based on a rationale similar to the claims from which they depend. Dependent claim 2 recites “wearable”, “bioimpedance sensor”, “photoplethysmograph”, “accelerometer”, “blood glucose sensor”, “hemoglobin sensor”, “potassium sensor”, “calcium sensor”, “pulsometer”, “skin conductance sensor”, and “actigraph”. Dependent claim 3 recites “blood treatment apparatus” and “patient monitor”. Dependent claim 4 recites “smartphones” and “tablets”. Dependent claim 13 recites “smartphone”, “smart watch”, and “wearable”. Dependent claims 2-4 and 13 do not recite additional elements that amount to significantly more than the judicial exception.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
suggesting a future behavior or a treatment for the patient, wherein suggesting the future behavior or the treatment comprises suggesting a particular water and salt intake in an interdialytic period;
Response to Arguments
Applicant's arguments filed May 8, 2026 have been fully considered but they are not persuasive.
A. According to applicant’s arguments on pages 10-11 of the remarks disclose, “First, to the extent that the claims could be considered as reciting a mental process (Action at page 8) or mathematical concept (Action at page 9) the claims are not directed to merely this alleged judicial exception and instead integrate the alleged judicial exception into a practical application of outputting a prediction of a future development of at least one physiological state of the patient or at least one of the parameters of the patient and suggesting a future behavior or a treatment for the patient, wherein suggesting the future behavior or the treatment comprises suggesting a particular water and salt intake in an interdialytic period…” and “These claim recitations represent a technological improvement to medical devices. See M.P.E.P. § 2106.04(d)(1) ("[T]f the specification sets forth an improvement in technology, the claim must be evaluated to ensure that the claim itself reflects the disclosed improvement. That is, the claim includes the components or steps of the invention that provide the improvement described in the specification. The claim itself does not need to explicitly recite the improvement described in the specification "). For example, the specification describes the following non- limiting example scenarios: Complications during hemodialysis (HD) sessions remain one of the main challenges in the dialytic patients' management. Intradialytic hypotension (IDH) is among the most frequent adverse events in HD treatments. The IDH incidence varies widely across studies from less than 10% up to almost 70% of HD sessions, because of the lack of a univocal IDH definition. Inadequate IDH management can lead to adverse outcome including increased mortality risk, hospitalization and vascular access thrombosis. This risk may advantageously be minimized or eliminated by the present disclosure a possible advantage of the present disclosure may be that it offers an intensified strategy for IDH prevention by predicting the occurrence of these events as one example of a physiological state, or the development of that state, of the patient. (Current Application, [0097- 0100]). Under this scenario, implementing the claimed computer-implemented method of claim 1 improves medical treatment devices. To the extent that processing data related to a medical treatment is conventional (which Applicant does not concede), the claims are not directed to merely this concept. Instead, the claims are directed to a specific technological improvement over this alleged conventional activity as discussed above.” The examiner respectfully disagrees.
Independent claim 1, 12, and 14 do not reflect an improvement in the technology or functioning of a computer as required per MPEP 2106.04(d)(1). In particular, it is unclear to the examiner what the applicant claims to be the improvement. The applicant has cited paragraphs 0097-0100 of the applicant’s specification, however, the paragraphs do not provide sufficient details such that one ordinary skill in the art would recognize the claimed invention as providing an improvement. It appears the paragraphs disclose complications with hemodialysis (including intradialytic hypotension) and peritoneal dialysis. Further, the paragraphs disclose a strategy for preventing intradialytic hypotension, but do not provide sufficient details. Therefore, the examiner maintains the rejection.
Objections to claims 1, 6, 8-9, 12, and 14 have been withdrawn.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW L HAMILTON whose telephone number is (571)270-1837. The examiner can normally be reached Monday-Thursday 9:30-5:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at (571)270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW L HAMILTON/Primary Examiner, Art Unit 3682
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