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
In light of the amendments, the previous claim interpretation remains.
In light of the amendments, the previous 112(b) rejection has been withdrawn.
In light of the amendments, the claims are rejected under 35 U.S.C. 101.
In light of the amendments, the claims are rejected under 35 U.S.C. 103.
Notice to Applicant
In the amendment dated 04/28/2026, the following has occurred: claims 1, 4, 6-7, 10-11, and 17-18 have been amended; claims 3, 5, and 9 have been canceled; claims 2, 8, and 12-16 remain unchanged; and no new claims have been added.
Claims 1-2, 4, 6-8, and 10-18 are pending.
Effective Filing Date: 08/25/2022
Response to Arguments
35 U.S.C. 112(b) Rejections:
Applicant amended the claims to overcome the previous 112(b) claim rejection. Examiner withdraws this rejection.
35 U.S.C. 101 Rejections:
Step 2A, Prong One:
Applicant argues that the amended claims do not recite a judicial exception. Applicant points to the pre-trained artificial intelligence model that extracts features on an electrocardiogram waveform and individually outputs indicators for predicting a health condition as not being something that a human could perform in their mind. Examiner however respectfully disagrees that the claims are not directed towards a judicial exception. The claims are also not being directed towards mental processes, rather, they are being directed towards certain methods of organizing human activity. The claims however only actively recite that there is a dynamic switching between an OFF state to an ON state according to an analysis result. The determination of this analysis result using a pre-trained model is not actively being claimed, and based on the current claims, this feature is part of the abstract idea as it is a descriptor related to how this analysis result is obtained. As for the switching of colors, a human can choose what color to display information in.
Step 2A, Prong Two:
Applicant argues that the claims are directed towards a practical application. Applicant points to Example 37 and Example 42 and states that the present claims are similar to these examples. Examiner however respectfully disagrees. The disclosure and claim 1 of Example 37 reflect a technical solution to a technical problem, where there is a clear nexus between the specification and the claim. Claim 1 discusses automatic moving of icons to improve the display itself. The present claims however merely display information in a manner to convey information, not to improve the display. The specification also supports this statement as there is a lack of discussion of the display being improved. Claim 1 of Example 42 discusses a standardization of data in order to provide remote access to that data. Again, there is discussion of the technical solution and problem in the disclosure, and a clear nexus between the disclosure and the claim. This example provided a specific improvement over prior art systems. The present invention is different in that there is no technical improvement. Applicant argues that the problem here is that a prior art system would have to separately run an AI analysis tool, apply rule-based diagnostic criteria, and perform their own manual assessment. This is not necessarily a technical improvement if the answer to running separately is to run processes together.
Step 2B:
Lastly, Applicant argues that the claims include significantly more than the abstract idea. The sub-control graphics and the dynamic switching of colors is being argued as not well-understood. Examiner however would like to point out that the dynamic switching aspect is part of the abstract idea, while the sub-control graphics are indeed additional elements. Furthermore, these additional elements recent generic computing components which are being used to apply the abstract idea. There is no stance on the additional elements being directed to well-understood, routine, or conventional activities by Examiner.
35 U.S.C. 102/103 Rejections:
Examiner withdraws the previous art rejections.
Foreign Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/28/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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 limitation(s) is/are: “input/output unit” in claim 18.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The input/output unit is described as software, hardware, etc. in page 11.
If applicant does not intend to have this/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 it/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 it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-2, 4, 6-8, and 10-18 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. Claims 1-2, 4, 6-8, and 10-16 are drawn to a method, claim 17 is drawn to a method, and claim 18 is drawn to a computing device, each of which is within the four statutory categories. Claims 1-2, 4, 6-8, and 10-18 are further directed to an abstract idea on the grounds set out in detail below. As discussed below, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea (Step 1: YES).
Step 2A:
Prong One:
Claim 1 recites a method of providing a) a user interface (if tied to an electronic device) for electrocardiogram analysis, the method comprising:
1) obtaining bio-data of an electrocardiogram reading target; and
2) displaying, in a first area of the user interface, b) a first control graphic comprising:
b1) a first sub-control graphic configured to dynamically switch between an OFF state and an ON state according to an analysis result obtained by inputting electrocardiogram data, included in the obtained bio-data, to a pre-trained artificial intelligence model that extracts features of an electrocardiogram waveform included in the electrocardiogram data and individually outputs indicators for predicting a health condition based on the extracted features;
b2) a second sub-control graphic configured to dynamically switch between an OFF state and an ON state according to an analysis result obtained according to a logic predetermined for each type of disease or electrocardiogram feature that can be read from an electrocardiogram; and
b3) a third sub-control graphic configured to dynamically switch between an OFF state and an ON state based on a user operation for inputting an analysis result obtained by a user who analyzes the electrocardiogram,
wherein each of the first sub-control graphic, the second sub-control graphic, and the third sub-control graphic dynamically switches a color according to severity of a detected disease condition when switched from the OFF state to the ON state.
Claim 1 recites, in part, performing the steps of 1) obtaining bio-data of an electrocardiogram reading target and 2) displaying, in a first area of the user interface (when considered a pen and paper), comprising: something configured to dynamically switch between an OFF state and an ON state according to an analysis result obtained by inputting electrocardiogram data, included in the obtained bio-data, to a pre-trained artificial intelligence model that extracts features of an electrocardiogram waveform included in the electrocardiogram data and individually outputs indicators for predicting a health condition based on the extracted features, something configured to dynamically switch between an OFF state and an ON state according to an analysis result obtained according to a logic predetermined for each type of disease or electrocardiogram feature that can be read from an electrocardiogram, and something configured to dynamically switch between an OFF state and an ON state based on a user operation for inputting an analysis result obtained by a user who analyzes the electrocardiogram, wherein each of the things dynamically switches a color according to severity of a detected disease condition when switched from the OFF state to the ON state. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, a person can determine how to display data on a sheet of paper after obtaining it.
Claim 17 recites a method of providing a user interface for electrocardiogram analysis, the method comprising:
3) providing c) a first user interface (if tied to an electronic device) that implements d) a visualized computing environment in which a first user can perform electrocardiogram analysis in order to generate basic reading information based on bio-data of an electrocardiogram reading target; and
4) providing e) a second user interface (if tied to an electronic device) that implements d) a visualized computing environment in which a second user can perform electrocardiogram analysis in order to generate final reading information based on the bio-data and the basic reading information generated via c) the first user interface;
2) wherein c) the first user interface and e) the second user interface each include a first area adapted to display b) a first control graphic that switches a visual representation and state according to a result of electrocardiogram analysis, the first control graphic comprising:
b1) a first sub-control graphic configured to dynamically switch between an OFF state and an ON state according to an analysis result obtained by inputting electrocardiogram data, included in the obtained bio-data, to a pre-trained artificial intelligence model that extracts features of an electrocardiogram waveform included in the electrocardiogram data and individually outputs indicators for predicting a health condition based on the extracted features;
b2) a second sub-control graphic configured to dynamically switch between an OFF state and an ON state according to an analysis result obtained according to a logic predetermined for each type of disease or electrocardiogram feature that can be read from an electrocardiogram; and
b3) a third sub-control graphic configured to dynamically switch between an OFF state and an ON state based on a user operation for inputting an analysis result obtained by a user who analyzes the electrocardiogram,
wherein each of the first sub-control graphic, the second sub-control graphic, and the third sub-control graphic dynamically switches a color according to severity of a detected disease condition when switched from the OFF state to the ON state..
Claim 17 recites, in part, performing the steps of 3) providing a first user interface (when considered a pen and paper) that implements an environment in which a first user can perform electrocardiogram analysis in order to generate basic reading information based on bio-data of an electrocardiogram reading target, 4) providing a second user interface (when considered a pen and paper) that implements an environment in which a second user can perform electrocardiogram analysis in order to generate final reading information based on the bio-data and the basic reading information generated via the first user interface, and 2) wherein the first user interface and the second user interface each include a first area that switches a visual representation and state according to a result of electrocardiogram analysis, comprising: something configured to dynamically switch between an OFF state and an ON state according to an analysis result obtained by inputting electrocardiogram data, included in the obtained bio-data, to a pre-trained artificial intelligence model that extracts features of an electrocardiogram waveform included in the electrocardiogram data and individually outputs indicators for predicting a health condition based on the extracted features, something configured to dynamically switch between an OFF state and an ON state according to an analysis result obtained according to a logic predetermined for each type of disease or electrocardiogram feature that can be read from an electrocardiogram, and something configured to dynamically switch between an OFF state and an ON state based on a user operation for inputting an analysis result obtained by a user who analyzes the electrocardiogram, wherein each of things dynamically switches a color according to severity of a detected disease condition when switched from the OFF state to the ON state.. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, a person can determine how to display data on a sheet of paper after obtaining it.
Claim 18 recites f) a computing device for providing a user interface for electrocardiogram analysis, the computing device comprising:
f1) a processor including at least one core;
f2) memory including program codes executable by f1) the processor; and
f3) an input/output unit configured to 5) provide a) a user interface (if tied to an electronic device);
2) wherein a) the user interface includes a first area adapted to display b) a first control graphic that switches a visual representation and state according to a result of electrocardiogram analysis performed based on bio-data of an electrocardiogram reading target, the first control graphic comprising:
b1) a first sub-control graphic configured to dynamically switch between an OFF state and an ON state according to an analysis result obtained by inputting electrocardiogram data, included in the obtained bio-data, to a pre-trained artificial intelligence model that extracts features of an electrocardiogram waveform included in the electrocardiogram data and individually outputs indicators for predicting a health condition based on the extracted features;
b2) a second sub-control graphic configured to dynamically switch between an OFF state and an ON state according to an analysis result obtained according to a logic predetermined for each type of disease or electrocardiogram feature that can be read from an electrocardiogram; and
b3) a third sub-control graphic configured to dynamically switch between an OFF state and an ON state based on a user operation for inputting an analysis result obtained by a user who analyzes the electrocardiogram,
wherein each of the first sub-control graphic, the second sub-control graphic, and the third sub-control graphic dynamically switches a color according to severity of a detected disease condition when switched from the OFF state to the ON state.
Claim 18 recites, in part, performing the steps of 5) provide a user interface (if pen and paper) and 2) wherein the user interface includes a first area that switches a visual representation and state according to a result of electrocardiogram analysis performed based on bio-data of an electrocardiogram reading target, the first control graphic comprising: a first sub-control graphic configured to dynamically switch between an OFF state and an ON state according to an analysis result obtained by inputting electrocardiogram data, included in the obtained bio-data, to a pre-trained artificial intelligence model that extracts features of an electrocardiogram waveform included in the electrocardiogram data and individually outputs indicators for predicting a health condition based on the extracted features, a second sub-control graphic configured to dynamically switch between an OFF state and an ON state according to an analysis result obtained according to a logic predetermined for each type of disease or electrocardiogram feature that can be read from an electrocardiogram, and a third sub-control graphic configured to dynamically switch between an OFF state and an ON state based on a user operation for inputting an analysis result obtained by a user who analyzes the electrocardiogram, wherein the first control graphic is constructed for each type of disease or electrocardiogram feature that can be read from an electrocardiogram, wherein each of the first sub-control graphic, the second sub-control graphic, and the third sub-control graphic dynamically switches a color according to severity of a detected disease condition when switched from the OFF state to the ON state. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, a person can determine how to display data on a sheet of paper after obtaining it.
Depending claims 2, 4, 6-7, and 10-16 include all of the limitations of claim 1, and therefore likewise incorporate the above described abstract idea. Depending claims 2, 12, and 14 add additional display icon steps. Claim 6 adds the additional step of “wherein, when a user input for a selection method is received, the first sub-control graphic is switched to an ON state or an OFF state” and claim 7 adds the additional steps of “derives a feature associated with at least one of a rhythm and shape of an electrocardiogram signal included in the obtained bio-data” and “determines whether a condition preset to determine an onset of a specific disease is satisfied by analyzing the derived feature”. Additionally, the limitations of depending claims 4, 10-11, 13, and 15-16 further specify elements from the claims from which they depend on without adding any additional steps. These additional limitations only further serve to limit the abstract idea. Thus, depending claims 2, 4, 6-7, and 10-16 are nonetheless directed towards fundamentally the same abstract idea as independent claim 1 (Step 2A (Prong One): YES).
Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of – using a) a user interface, b) a first control graphic (with sub-control graphics b1), b2), and b3)), wherein the first control graphic is constructed for each type of disease or electrocardiogram feature that can be read from an electrocardiogram, c) a first user interface, d) a visualized computing environment, e) a second user interface, f) a computing device for providing a user interface for electrocardiogram analysis, the computing device comprising: f1) a processor including at least one core, f2) memory including program codes executable by the processor, and f3) an input/output unit to perform the claimed steps.
The a) user interface, b) first control graphic with sub-control graphics b1), b2), and b3), c) first user interface, d) visualized computing environment, e) second user interface, f) computing device for providing a user interface for electrocardiogram analysis, the computing device comprising: f1) a processor including at least one core, f2) memory including program codes executable by the processor, and f3) an input/output unit in these steps are recited at a high-level of generality (i.e., as generic components performing generic computer functions) such that they amount to no more than mere instructions to apply the exception using generic computer components (see: Applicant’s specification, pages 14-15 where there are generic computing components for these elements, see MPEP 2106.05(f)).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination 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 and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea (Step 2A (Prong Two): NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a) a user interface, b) a first control graphic (with sub-control graphics b1), b2), and b3)), wherein the first control graphic is constructed for each type of disease or electrocardiogram feature that can be read from an electrocardiogram, c) a first user interface, d) a visualized computing environment, e) a second user interface, f) a computing device for providing a user interface for electrocardiogram analysis, the computing device comprising: f1) a processor including at least one core, f2) memory including program codes executable by the processor, and f3) an input/output unit to perform the claimed steps amounts to no more than mere instructions to apply the exception using generic computer components that do not offer “significantly more” than the abstract idea itself because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of any computer itself, or provide meaningful limitations beyond generally linking an abstract idea to a particular technological environment. It should be noted that the claims do not include additional elements that amount to significantly more than the judicial exception because the Specification recites mere generic computer components, as discussed above that are being used to apply certain mental steps, certain method steps of organizing human activity, or certain mathematical steps. Specifically, MPEP 2106.05(f) recites that the following limitations are not significantly more:
Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 134 S. Ct. at 2360, 110 USPQ2d at 1984 (see MPEP § 2106.05(f)).
The current invention generates a display utilizing a) a user interface, b) a first control graphic (with sub-control graphics b1), b2), and b3)), wherein the first control graphic is constructed for each type of disease or electrocardiogram feature that can be read from an electrocardiogram, c) a first user interface, d) a visualized computing environment, e) a second user interface, f) a computing device for providing a user interface for electrocardiogram analysis, the computing device comprising: f1) a processor including at least one core, f2) memory including program codes executable by the processor, and f3) an input/output unit, thus these computing components are adding the words “apply it” with mere instructions to implement the abstract idea on a computer.
Mere instructions to apply an exception using generic computer components cannot provide an inventive concept. The claims are not patent eligible (Step 2B: NO).
Claims 1-2, 4, 6-8, and 10-18 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
No Art Rejections
Claims 1-2, 4, 6-8, and 10-18 do not have art rejections.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Steven G.S. Sanghera whose telephone number is (571)272-6873. The examiner can normally be reached M-F 7:30-5:00 (alternating Fri).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684