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 Amendment
The amendment, filed 01/21/2026, has been entered. The examiner notes claims 1-14 are pending with claims 13-14 withdrawn from further consideration.
Response to Arguments
There are new 35 USC 112 rejections in view of the amendment.
Applicant’s arguments, filed 01/21/2026, with respect to the claim objections to claims 1 and 7 have been fully considered and are persuasive. The examiner notes the applicant has amended the claims to overcome the objections. The claim objections to claims 1 and 7 has been withdrawn.
Applicant's arguments, filed 03/24/2026, with respect to the 35 USC 101 rejection of claims 1-12 have been fully considered but they are not persuasive.
In response to the applicant’s argument that the examiner jumped straight to step 2A prong 1, the examiner respectfully disagrees. The examiner notes that on page 6 of the previous office action, dated 10/29/2025, analyzes the claims under step 1 of the Alice/Mayo test, which found claims 1-6 drawn to a machine and claims 7-12 drawn to a method.
In response to the applicant’s argument that the “measuring” step cannot practically be performed in the human mind, the examiner agrees but believes there may be confusion on the examiner’s position. The examiner notes the “measuring” step and the output step (“displaying” step) in claims 1 and 7 and the “reading” step in claim 7 are insignificant extra solution activities (see previous office action page 8). The examiner contends that the abstract idea of the claims is the “calculating” step in claims 1 and 7. The examiner further notes that the abstract idea is part of the mathematical concepts group.
In response to the applicant’s argument that the claims should be found eligible subject matter at step 2A prong 2, the examiner respectfully disagrees. The examiner again reiterates the “measuring” and “displaying” are insignificant extra-solution activities. Even if one were to interpret the calculating a redox potential being done by the “measuring” means or the “display” means (which, for clarity, the examiner is not interpreting the calculation of a redox potential this way), the measurement device and various “means”, when interpreted under broadest reasonable interpretation, cannot reasonably be considered a particular machine. Instead, the measurement device and various “means” essentially encompass a general computer/computer components. Instead, the claims simply use “apply it" (or an equivalent) with the judicial exception or mere instructions to implement an abstract idea on a computer, which the courts have not found to be enough to qualify as “significantly more”. See MPEP 2106.05(f).
Therefore, for the reasons provided above, the 35 USC 101 rejection of claims 1-12 is maintained.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 1-12 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.
Claim 1 recites the limitation "the environment" in line 11. There is insufficient antecedent basis for this limitation in the claim. Claims 2-6 are rejected due to their dependence upon rejected claim 1.
Claim 1 recites the limitation "the endogenous metabolic demands" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the metabolic state" in line 14. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the environment" in line 12. There is insufficient antecedent basis for this limitation in the claim. Claims 8-12 are rejected due to their dependence upon rejected claim 7.
Claim 7 recites the limitation "the endogenous metabolic demands" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the metabolic state" in line 15. There is insufficient antecedent basis for this limitation in the claim.
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 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent Claim 1 recites:
An in vivo redox potential measurement device, in a case where a hydrogen gas index pH2 is defined as a logarithm of a reciprocal of hydrogen gas partial pressure (Pa)/101.3 kPa (pH2 = -log[hydrogen gas partial pressure/101.3 kPa]), comprising:
a means that measures a hydrogen gas index pH2 of a person to be subjected to measurement;
a storage means that stores a predetermined calculation equation;
a calculation means that calculates a redox potential by the predetermined calculation equation stored in the storage means, by using the hydrogen gas index pH2 measured by the means that measures the hydrogen gas index to repeatedly measure changes in the environment and changes in the endogenous metabolic demands of the person; and
a display means that displays the redox potential calculated by the calculation means as an indicator for evaluating the metabolic state of the person and possible diseases the person may have.
Independent Claim 7 recites:
An in vivo redox potential measurement method, in a case where a hydrogen gas index pH2 is defined as a logarithm of a reciprocal of hydrogen gas partial pressure (Pa)/101.3 kPa (pH2 = -log[hydrogen gas partial pressure/101.3 kPa]), comprising:
a step of measuring a hydrogen gas index pH2 of a person to be subjected to measurement;
a step of reading out a predetermined calculation equation stored in a predetermined storage means;
a calculation step of calculating a redox potential by the predetermined calculation equation read out from the predetermined storage means, by using the hydrogen gas index pH2 measured by the means that measures the hydrogen gas index to repeatedly measure changes in the environment and changes in the endogenous metabolic demands of the person; and
a display step of displaying the redox potential calculated in the calculation step as an indicator for evaluating the metabolic state of the person and possible diseases the person may have.
Step 1:
The examiner determines claims 1-6 are drawn to a machine and claims 7-12 are drawn to a method.
Step 2A Prong 1:
The above claim limitations constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
“A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018).
The claimed steps of measuring, storing, calculating, and displaying recite mental processes and mathematical concepts (i.e., mathematical relationships, mathematical formulas or equations, and mathematical calculations).
The step of “measuring” a hydrogen gas index in independent Claims 1 and 7 is a mental process capable of being performed by the human mind. For example, the human mind is capable of measuring the approximate distance from one object to another. The step of “storing” a predetermined calculation equation in independent Claim 1 is a mental process capable of being performed in the human mind. For example, the human mind is capable of storing information as memories. The step of “calculating” a redox potential in independent Claims 1 and 7 is an example of a mathematical concept, specifically mathematical calculation(s). The step of “displaying” the redox potential is an example of a mental process capable of being performed by the human mind. For example, the human mind is capable of displaying mental imagery, such as seeing pictures, scenes, and/or objects in the mind.
The claimed steps of measuring, storing, calculating, and displaying can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
“[T]he ‘mental processes’ abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.” MPEP 2106.04(a)(2) III. The pending claims merely recite steps for estimation that include observations, evaluations, and judgments.
Examples of ineligible claims that recite mental processes include:
• a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind,
Electric Power Group, LLC v. Alstom, S.A.;
• claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind,
University of Utah Research Foundation v. Ambry Genetics Corp.
• a claim to collecting and comparing known information, which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Regarding the dependent claims 2-6 and 8-12, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
Step 2A Prong 2:
This judicial exception (abstract idea) in Claims 1-12 is not integrated into a practical application because:
• The abstract idea amounts to simply implementing the abstract idea on a computing device. For example, the recitations regarding the generic computing components for measuring, storing, calculating, and displaying merely invoke a computer as a tool.
• The data-gathering step (measuring) and the data-output step (displaying) do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
• There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computing device that is used as a tool for measuring, storing, calculating, and displaying.
• The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to estimate bio-information.
• The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computing device for measuring, storing, calculating, and displaying. The claims do not apply the obtained prediction to a particular machine. Rather, the data is merely output in a post-solution step.
Step 2B:
The additional elements are identified as follows: measurement device, means that measures, storage means, calculation means, display means.
The measurement device and various “means”, when interpreted under BRI, cannot reasonably be considered a particular machine. Instead, the measurement device and various “means” essentially encompass a general computer/computer components. Instead, the claims simply use “apply it" (or an equivalent) with the judicial exception or mere instructions to implement an abstract idea on a computer, which the courts have not found to be enough to qualify as “significantly more”. See MPEP 2106.05(f).
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional generic computer components as those claimed. See option III. A. 2. in the Berkheimer memorandum.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the units associated with the steps do not add meaningful limitation to the abstract idea. A computer, processor, memory, or equivalent hardware is merely used as a tool for executing the abstract idea(s). The process claimed does not reflect an improvement in the functioning of the computer.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
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 JONATHAN M HANEY whose telephone number is (571)272-0985. The examiner can normally be reached Monday through Friday, 0730-1630 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571)272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HANEY/Examiner, Art Unit 3791
/JUSTIN XU/Primary Examiner, Art Unit 3791