DETAILED ACTION
The Applicant’s response, received 29 June 2026, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They 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, 5-9, 12 and 13 are pending.
Claims 1, 5-9, 12 and 13 are rejected.
Priority
There are no domestic applications for which benefit is claimed.
This application claims benefit of foreign application JAPAN 2021-147667,
filed 10 September 2021.
Information Disclosure Statement
The information disclosure statement (IDS) received on 22 April 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this information disclosure statement has been considered by the examiner.
Claim Interpretation
The claim limitations being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, in the Office action mailed 08 April 2026 have been maintained with modification in view of the amendment received 29 June 2026, as noted below.
The claim interpretations have been modified in view of amended claim 6 and deleted claim 10.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
a reception device configured to receive…, in claims 1 and 6;
a processing device configured to input…, in claims 1 and 6; and
an output device configured to output…, in claims 1 and 6;
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The specification discloses a corresponding structure for the non-structural generic placeholder:
a reception device configured to receive…, in claims 1 and 6 at para. [0011] in the Specification (i.e., reception control circuitry);
a processing device configured to input…, in claims 1 and 6 at para. [0050] in the Specification (i.e., a general-purpose microprocessor that operates in cooperation with a general-purpose memory); and
an output device configured to output…, in claims 1 and 6 at para. [0023] in the Specification (i.e., a display).
If applicant does not intend to have these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The rejection of claim 10 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, in the Office action mailed 08 April 2026 has been withdrawn in view of claim 10 having been canceled in the amendment received 29 June 2026.
The rejection of claims 3 and 10 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, in the Office action mailed 08 April 2026 has been withdrawn in view of claims 3 and 10 having been canceled in the amendment received 29 June 2026.
The amendment received 29 June 2026 has been fully considered, however after further consideration, new grounds of rejection are raised under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, in view of the amendment.
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, 5-9, 12 and 13 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 at least one characteristic parameter" in lines twelve and thirteen. There is insufficient antecedent basis for this limitation in the claim, because the amended claim only recites “a plurality of characteristic parameters.”
Claims 5 and 7-9 are indefinite for depending from claim 1 and failing to remedy the indefiniteness of claim 1.
Claim 6 recites the limitation "the at least one characteristic parameter" in line fourteen. There is insufficient antecedent basis for this limitation in the claim, because the amended claim only recites “a plurality of characteristic parameters.”
Claims 12 and 13 are indefinite for depending from claim 6 and failing to remedy the indefiniteness of claim 6.
Claim Rejections - 35 USC § 101
The rejection of claims 1-11 under 35 U.S.C. 101 in the Office action mailed 08 April 2026 has been maintained with modification in view of the amendment received 29 June 2026, as noted below.
The rejection of claims 2-4, 10 and 11 has been withdrawn in view of these claims having been canceled in the amendment.
The rejection has been modified to incorporate the newly amended limitations and the newly added claims.
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, 5-9, 12 and 13 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).
Claim Interpretations
Claims 1 and 6 recite the limitation “input the values of the plurality of characteristic parameters to a machine-learned model.” The limitation “a machine-learned model” is interpreted to be a product-by-process limitation with the product being the machine-learned model, and further interpreted to not require the active steps of performing the process of creating the machine-learned model (e.g., steps of training the model).
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?
Claims 1, 5 and 7-9 recite an apparatus that acquires physiological information of a subject (i.e., a machine and/or a manufacture); and claims 6, 12 and 13 recite an apparatus that acquires physiological information of a subject (i.e., a machine and/or a 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 1 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
acquire values of a plurality of characteristic parameters associated with the measurement waveform based on the waveform data (i.e., mental processes);
input the values of the plurality of characteristic parameters to a machine-learned model (i.e., mental processes);
acquire a prediction result for at least one of a plurality of classes into which the waveform data is classified (i.e., mental processes and mathematical concepts);
specify a level of importance of each of the plurality of characteristic parameters for the prediction result (i.e., mental processes and mathematical concepts);
an index indicating the level of importance specified for the at least one characteristic parameter (i.e., mental processes and mathematical concepts); and
display the index so as to overlap at least one portion of the measurement waveform with which the at least one characteristic parameter is associated (i.e., mental processes).
Independent claim 6 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
acquire values of a plurality of characteristic parameters associated with the measurement waveform based on the waveform data (i.e., mental processes);
input the values of the plurality of characteristic parameters to a machine-learned model (i.e., mental processes);
acquire a prediction result for at least one of a plurality of classes into which the waveform data is classified (i.e., mental processes and mathematical concepts);
specify a level of importance of each of the plurality of characteristic parameters for the prediction result (i.e., mental processes and mathematical concepts); and
an index indicating the level of importance specified for the at least one characteristic parameter in association with at least one of a plurality of body parts of the subject (i.e., mental processes and mathematical concepts).
Dependent claims 5, 7-9, 12 and 13 further recite the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas, as noted below.
Dependent claim 5 further recites:
displays at least one name of the at least one characteristic parameter so as to overlap at least one portion of the measurement waveform with which the at least one characteristic parameter is associated (i.e., mental processes).
Dependent claim 7 further recites:
in a case where two or more characteristic parameters are associated with a specific portion in the measurement waveform, display a name of one of the characteristic parameters for which a highest level of the importance is specified (i.e., mental processes).
Dependent claims 8 and 12 further recite:
the index includes a value of the at least one characteristic parameter (i.e., mental processes).
Dependent claims 9 and 13 further recite:
the machine-learning model is generated by machine learning using a neural network (i.e., 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., input the values of the plurality of characteristic parameters to a machine-learned 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., using a machine-learned model to acquire a prediction result) are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind.
Therefore, claims 1, 5-9, 12 and 13 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.
In the instant application, the claims provide additional elements (i.e., ‘devices’) to receive, process, and output ‘data’, however, the claims do not recite any limitations to which the data output (i.e., the index) is practically applied.
Dependent claims 8, 9, 12 and 13 do not further recite any elements in addition to the judicial exception, and thus are part of the judicial exception.
The additional elements in independent claim 1 include:
a reception device configured to receive (i.e., reception control circuitry, e.g., Specification, para. [0011]);
receive waveform data corresponding to a measurement waveform of the physiological information from a sensor (i.e., receive data);
a processing device configured to input (i.e., a general-purpose microprocessor that operates in cooperation with a general-purpose memory, e.g., Specification, para. [0050]); and
an output device configured to output (i.e., a display, e.g., Specification, para. [0023]).
The additional elements in independent claim 6 include:
a reception device configured to receive (i.e., reception control circuitry, e.g., Specification, para. [0011]);
receive waveform data corresponding to a measurement waveform of the physiological information from a sensor (i.e., receive data);
a processing device configured to input (i.e., a general-purpose microprocessor that operates in cooperation with a general-purpose memory, e.g., Specification, para. [0050]); and
an output device configured to output (i.e., a display, e.g., Specification, para. [0023]).
The additional elements in dependent claims 5 and 7 include:
output device (i.e., a display) (claims 5 and 7).
The additional elements of a reception device (claims 1 and 6); a processing device (claims 1 and 6); and an output device (claims 1, 5, 6 and 7); 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 receive waveform data corresponding to a measurement waveform of the physiological information from a sensor (i.e., receive data) (claims 1 and 6); 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, 5-9, 12 and 13 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, 5-9, 12 and 13 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.
Dependent claims 8, 9, 12 and 13 do not further recite any elements in addition to the judicial exception(s).
The additional elements recited in independent claims 1 and 6 and dependent claims 5 and 7 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 a reception device (claims 1 and 6); a processing device (claims 1 and 6); an output device (claims 1, 5, 6 and 7); and receive data (claims 1 and 6); 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).
The additional element of receive waveform data corresponding to a measurement waveform of the physiological information from a sensor (i.e., receiving data) (claims 1 and 6); is conventional. Evidence of conventionality is shown by Serhani et al. (“ECG Monitoring Systems: Review, Architecture, Processes, and Key Challenges.” Sensors, 2020, Vol. 20, No. 1796, pp. 1-40, as cited in the Office action mailed 08 April 2026). Serhani et al. reviews ECG (electrocardiogram) monitoring systems for assessing and diagnosing cardiovascular diseases (Abstract), and shows using electrodes for monitoring of physiological signals such as electrocardiogram (ECG) signals (Figure 1, Sensing Platforms – Acquisition Layer; and page 23, Section 4.5.).
Therefore, when taken alone, all additional elements in claims 1, 5-9, 12 and 13 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, 5-9, 12 and 13 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]
Response to Arguments
The Applicant’s arguments/remarks received 29 June 2026 have been fully considered, but are not persuasive.
The Applicant states on page 8 (para. 1) of the Remarks that claim 1 is patent eligible at least because it is integrated into a practical application in that it is directed to a technical improvement. The Applicant further states that when non-structured data, such as the waveform data corresponding to the measurement waveform of the physiological information, is subjected to prediction processing, it is generally difficult to visualize the basis of the prediction result, however, in the medical field, the inability to visually understand the basis of the prediction result can lead to misdiagnosis. The Applicant further states (para. 2) that according to the index recited in amended claim 1, it is possible to cause a user to recognize which characteristic parameter in the measurement waveform contributes to the prediction result, and further states that the level of importance of the characteristic parameter (the degree of contribution to the prediction result) is displayed so as to overlap a portion of the measurement waveform with which the characteristic parameter is associated, and accordingly, a user can recognize which portion of the measurement waveform contributes to the prediction result. The Applicant further states that therefore, the claimed apparatus is directed to specific improvement of the interpretability of the processing result of the physiological information.
These arguments/remarks are not persuasive, because first, regarding the Applicant’s statement that “the claimed apparatus is directed to specific improvement of the interpretability of the processing result of the physiological information,” it is noted that interpretability (i.e., evaluation) of the processing result (i.e., data) of the physiological information (i.e., data) is a purported improvement to the abstract idea of evaluating data, i.e., performing mental processes, and therefore is not an improvement to computer functionality itself, or another technology or technical field. Second, overlaying one type of data against a second type of data is an abstract idea of data analysis, e.g., plotting discrete data values (e.g., Shapley values) against a continuous waveform (e.g., an ECG waveform) is an abstract process of analyzing data.
The Applicant states on page 8 (para. 3) of the Remarks that claim 1 is similar to the claims in Core Wireless S.A.R.L. v. LG Elecs., Inc., in which the Federal Circuit found a specific interface to be patent eligible because the claims recite a specific improvement over prior systems, resulting in an improved user interface for electronic devices and are directed to a particular manner of summarizing and presenting information in electronic devices and that the claims do not use conventional user interface methods to display a generic index on a computer. The Applicant further states that the Core Wireless decision was based on a problem with smaller, portable display devices, and that likewise, the present claims are directed to a non-abstract improvement in the functioning of the apparatus with a particular manner of displaying a measurement waveform of the physiological information.
These arguments/remarks are not persuasive, because first, regarding the Applicant’s attempt at analogizing the instant claims to the Core Wireless decision, the instant claims are not analogous to the claims in Core Wireless, because the instant claims broadly recite receiving waveform data corresponding to a measurement waveform of the physiological information of a subject, and performing data analysis techniques on the waveform data to generate various data values (i.e., output results), e.g., a prediction result for at least one of a plurality of classes into which the waveform data is classified, and an index indicating the level of importance specified for the at least on characteristic parameter in association with at least one of a plurality of body parts of the subject, whereas in contrast, the improvement recited in Core Wireless was directed to an improved user interface for computing devices, not to the abstract idea of an index, and more particularly, the claim in Core Wireless was directed to an application summary that can be reached directly from the menu, specifying a particular manner by which the summary window must be accessed, and further requires the application summary window list a limited set of data, each of the data in the list being selectable to launch the respective application and enable the selected data to be seen within the respective application, and finally, the claim recites that the summary window is displayed while the one or more applications are in an un-launched state, i.e., a requirement that the device applications exist in a particular state. Second, regarding the Applicant’s assertion that “the present claims are directed to a non-abstract improvement in the functioning of the apparatus with a particular manner of displaying a measurement waveform of the physiological information,” it is noted that the instant claims recite steps of analyzing data that culminate in a final step of displaying the results of the data analysis steps, which is not an improvement to computer functionality itself, or to another technology or technical field, but instead, is a purported improvement to the abstract idea (i.e., data analysis).
The Applicant states on page 9 (para. 3) that claim 6 is also directed to a practical application, and further states that according to the index recited in amended claim 6, it is also possible to cause a user to recognize which characteristic parameter in the measurement waveform contributes to the prediction result. The Applicant further states that in addition, the level of importance of the characteristic parameter (the degree of contribution to the prediction result) is displayed in association with at least one body part of the subject, and that accordingly, it is possible for a user to recognize which body part of the subject is associated with the characteristic parameter that contributes to the prediction result, and therefore, the apparatus of claim 6 is also directed to specific improvement of the interpretability of the processing result of the physiological information.
These arguments/remarks are not persuasive, because first, as discussed in the foregoing responses to arguments, regarding the Applicant’s statement that “the claimed apparatus is directed to specific improvement of the interpretability of the processing result of the physiological information,” it is noted that interpretability (i.e., evaluation) of the processing result (i.e., data) of the physiological information (i.e., data) is a purported improvement to the abstract idea of evaluating data, i.e., performing mental processes, and therefore is not an improvement to computer functionality itself, or another technology or technical field. Second, evaluating whether judicial exceptions are integrated into a practical application comprises: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application, using one or more of the considerations introduced in subsection I at 2106.04(d) of the MPEP, and discussed in more detail in MPEP §§ 2106.04(d)(1), 2106.04(d)(2), 2106.05(a) through (c) and 2106.05(e) through (h). As noted in the rejection above, when all limitations in claims 1, 5-9, 12 and 13 have been considered as a whole (i.e., the analysis takes into consideration all the claim limitations and how those limitations interact and impact each other when evaluating whether the exception is integrated into a practical application), they are deemed to not recite any additional elements that would integrate a judicial exception into a practical application, i.e., the claims are not integrated into a practical application because the claims do not recite any additional elements that apply, rely on, or use the judicial exception(s) in a manner that imposes a meaningful limit on the judicial exception(s) (MPEP 2106.04(d)). Third, an index that allows a user to recognize which characteristic parameter in the measurement waveform contributes to the prediction result is an abstract idea of evaluating data (i.e., a mental process). Fourth, overlaying one type of data against a second type of data is an abstract idea of data analysis, e.g., plotting discrete data values of features (e.g., Shapley values) against a continuous waveform (e.g., an ECG waveform of a subject’s heart) is an abstract process of analyzing data.
Claim Rejections - 35 USC § 103
The rejection of claims 1-11 under 35 U.S.C. 103 as being unpatentable over Sakai et al. and Ibrahim et al. in the Office action mailed 08 April 2026 has been maintained with modification in view of the amendment received 29 June 2026, as noted below.
The rejection of claims 2-4, 10 and 11 has been withdrawn in view of these claims having been canceled in the amendment.
The rejection has been modified to incorporate the newly amended limitations and the newly added claims.
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, 5-9, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Sakai et al. (“Physiological information processing apparatus and physiological information processing method.” US 2019/0298180, as cited in the Office action mailed 08 April 2026) and Ibrahim et al. (“Explainable Prediction of Acute Myocardial Infarction Using Machine Learning and Shapley Values.” IEEE Access, 2020, vol. 8, pp. 210410-210417, as cited in the Office action mailed 08 April 2026).
Independent claim 1 encompasses a device for receiving physiological information from a sensor in the form of waveform data, further acquiring values of characteristic parameters associated with the waveform information, and using a machine-learned model to generate a prediction result for at least one of a plurality of classes into which the waveform data is classified, and to specify a level of importance of the characteristic parameters used to generate the prediction result, and outputting an index indicating the level of importance specified for the at least one characteristic parameter, wherein the output device displays the index so as to overlap at least one portion of the measurement waveform with which the at least one characteristic parameter is associated.
Independent claim 6 encompasses a device for receiving physiological information from a sensor in the form of waveform data, further acquiring values of characteristic parameters associated with the waveform information, and using a machine-learned model to generate a prediction result for at least one of a plurality of classes into which the waveform data is classified, and to specify a level of importance of the characteristic parameters used to generate the prediction result, and outputting an index indicating the level of importance specified for the at least one characteristic parameter in association with at least one of a plurality of body parts of the subject.
Dependent claims 5, 7-9, 12 and 13 further define the index that is output by the model and how the index is displayed, and further define the machine-learned model.
Sakai et al. teaches a physiological information processing apparatus and method for acquiring electrocardiogram data and pulse wave data of a subject and performing various calculations based on the acquired data.
Ibrahim et al. teaches using machine learning and Shapley values to determine an explainable (i.e., identifying the features that contributed the most to the prediction result) prediction of acute myocardial infarction using electrocardiogram (ECG) data.
Regarding independent claims 1 and 6, Sakai et al. shows acquiring electrocardiogram data of a subject (para. [0007]); acquiring pulse wave data of the subject (para. [0008]); measuring a heart rate based on the electrocardiogram data (para. [0009]); measuring a pulse wave transit time based on the electrocardiogram data and the pulse wave data (para. [0010]); calculating a cardiac output based on the pulse wave transit time and heart rate which have been measured (para. [0011]); calculating a vascular distensibility parameter relating to a vascular distensibility (para. [0012]); and correcting the calculated cardiac output based on the vascular distensibility parameter (para. [0013]). Sakai et al. further shows a patient monitor or the like which is to be attached to the body of a medical person (para. [0033]); various vital sensors such as the electrocardiogram sensor (paras. [0040] & [0041]); example parameter(s) (para. [0069]); and a processor and a memory (para. [0034]).
Regarding independent claims 1 and 6, Sakai et al. does not show using a machine-learned model to generate a prediction result or determining a level of importance to the parameters used by the model to generate the prediction result (claims 1 and 6), outputting an index indicating the level of importance specified for the at least one characteristic parameter, wherein the output device displays the index so as to overlap at least one portion of the measurement waveform with which the at least one characteristic parameter is associated (claim 1), or output an index indicating the level of importance specified for the at least one characteristic parameter in association with at least one of a plurality of body parts of the subject (claim 6).
Regarding dependent claims 5, 7-9, 12 and 13, Sakai et al. does not show wherein the output device displays at least one name of the at least one characteristic parameter so as to overlap at least one portion of the measurement waveform with which the at least one characteristic parameter is associated (claim 5), wherein in a case where two or more characteristic parameters are associated with a specific portion in the measurement waveform, the output device displays a name of one of the characteristic parameters for which a highest level of the importance is specified (claim 7), wherein the index includes a value of the at least one characteristic parameter (claims 8 and 12), or wherein the machine-learning model is generated by machine learning using a neural network (claims 9 and 13).
Regarding independent claims 1 and 6, Ibrahim et al. shows the application of explainable machine learning in the field of cardiovascular disease prediction, and presents a machine learning framework to the predict the onset of acute myocardial infarction (AMI) using extracted ECG samples and associated auxiliary data (Abstract); using ECG measurements to generate a final tabular dataset consisting of 12 features (page 210412, Section IV.); and further shows outputting the relative importance of model features in deriving the model’s prediction of AMI onset (page 210411, col. 2, Section III.), and using Shapley values to reveal the contribution of each feature to an individual prediction (page 210414, col. 2, paras. 2-3; and Fig. 5); and plotting the Shapley values (SHAP value, i.e., impact on model output) against each of the 12 features (Fig 6(a) and Fig. 6(b)) (e.g., a P-wave axis on an electrocardiogram (ECG) measures the average direction and angle that electricity travels as it depolarizes (activates) the heart’s upper chambers, i.e., the atria).
Regarding dependent claims 5, 7-9, 12 and 13, Ibrahim et al. further shows using Shapley values to reveal the contribution of each feature to an individual prediction (page 210414, col. 2, paras. 2-3; and Fig. 5); and plotting the Shapley values (SHAP value, i.e., impact on model output) against each of the 12 features (Fig 6(a) and Fig. 6(b)) and shows using the Shapley value method to interpret machine learning performance in terms of relative feature importance, and that by applying the Shapley value method in AMI prediction from ECG signals, the importance of physiological factors to the development of this specific cardiovascular disease can be discussed (page 210411, col. 2, para. 3; and page 210413, col. 2, Section VI.) (claims 5 and 7); using Shapley values to reveal the contribution to an individual prediction (page 210414, col. 2, paras. 2-3; and Fig. 5) (claims 8 and 12); and a recurrent neural network model architecture (page 210413, col. 1, Section B.) (claims 9 and 13).
Therefore, 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 Sakai et al. by incorporating machine learning and further using the Shapley value method to interpret machine learning performance in terms of relative feature importance, as shown by Ibrahim et al. and discussed above. One of ordinary skill in the art would have been motivated to combine the methods of Sakai et al. with the methods of Ibrahim et al., because Ibrahim et al. shows that by applying the Shapley value method in AMI prediction from ECG signals, the importance of physiological factors to the development of this specific cardiovascular disease can be discussed. This modification would have had a reasonable expectation of success given that both Sakai et al. and Ibrahim et al. disclose methods for analyzing electrocardiogram (ECG) data.
Response to Arguments
The Applicant’s arguments/remarks received 29 June 2026 have been fully considered, but are not persuasive.
The Applicant states on page 6 (bottom) and page 7 (top) of the Remarks that claim 1 as amended recites “the output device displays the index so as to overlap at least one portion of the measurement waveform with which the at least one characteristic parameter is associated.” The Applicant further states on page 7 (para. 2) that there is no disclosure in any of the applied references regarding displaying the index so as to overlap an associated portion of the waveform, and further states that claim 1 is patentable at least for these reasons.
These arguments/remarks are not persuasive, because first, in the above rejection, Ibrahim et al. shows plotting Shapley values against various features including features from an ECG dataset, and explains that Shapely values are useful in revealing the contribution of a feature to an individual prediction. Second, although Ibrahim et al. does not explicitly show plotting Shapley values on an ECG waveform, Ibrahim et al. does show plotting Shapley values against 12 different features from the Electrocardiogram Vigilance with Electronic data Warehouse, which contains 979,273 of extracted ECG measurements and other information regarding diagnoses, drug prescriptions, and selected laboratory test results collected from 371,401 patients over a period of 19 years. Thus, the combination of Sakai et al. and Ibrahim et al. suggests that it would have been prima facie obvious before the effective filing date of the claimed invention to plot Shapley values on a waveform.
The Applicant points to Fig. 7 of the instant application, and states on page 7 (para. 3) of the Remarks that independent claim 6 recites “output an index indicating the level of importance specified for the at least one characteristic parameter in association with at least one of a plurality of body parts of the subject. The Applicant further states (para. 4) that there is no disclosure in any of the applied references regarding outputting the index “in association with at least one of a plurality of body parts of the subject” so as to overlap an associated portion of a waveform, and further states that claim 6 is patentable at least for these reasons.
These arguments/remarks are not persuasive, because first, and as discussed in the foregoing response to arguments, Ibrahim et al. shows plotting Shapley values against various features including features from an ECG dataset, and explains that Shapely values are useful in revealing the contribution of a feature to an individual prediction. Second, although Ibrahim et al. does not explicitly show plotting Shapley values on an ECG waveform, Ibrahim et al. does show plotting Shapley values against 12 different features from the Electrocardiogram Vigilance with Electronic data Warehouse, which contains 979,273 of extracted ECG measurements and other information regarding diagnoses, drug prescriptions, and selected laboratory test results collected from 371,401 patients over a period of 19 years. Third, at least the P-wave axis feature is associated with the heart, i.e., a body part of the subject. Thus, the combination of Sakai et al. and Ibrahim et al. suggests that it would have been prima facie obvious before the effective filing date of the claimed invention to plot Shapley values on a waveform measuring a body part of the subject.
Conclusion
No claims are allowed.
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.
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/S.W.B./Examiner, Art Unit 1687
/Joseph Woitach/Primary Examiner, Art Unit 1687
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