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 .
Status of Claims
Claims 1-9 were previously pending and subject to a non-final office action filed on November 17, 2025 (the “November 17, 2025 Non-Final Office Action”). Following the November 17, 2025 Non-Final Office Action, Applicant amended claim 1 and added new claims 14 and 15, in an amendment filed on February 10, 2026 (the “February 10, 2026 Amendment”), see Applicant’s amended claims (pp. 2-5 of the February 10, 2026 Amendment). As such, claims 1-9, 14, and 15, as recited in the February 10, 2026 Amendment, are currently pending and subject to the final office action below.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Applicant’s Remarks
Response to Applicant’s Remarks Concerning Rejections under 35 U.S.C. § 101
Applicant’s arguments, see Applicant’s Remarks, pp. 7-8, Claim Rejections - 35 USC §101 Section, filed July 30, 2025, with respect to rejections of claim 1-9 under 35 U.S.C. § 101 have been fully considered, but they are not persuasive. Further, in light of the 2019 Revised Patent Subject Matter Eligibility Guidance (available at MPEP § 2106) (the “2019 Revised PEG”), the § 101 rejections of claims 1-9 are maintained and the § 101 rejections of new claims 14 and 15 are added in this final office action.
First, Applicant argues that the step of calculating a probability for information corresponding to a partial electrocardiographic waveform involves technical processing that is not practically performable in the human mind. Examiner respectfully disagrees. The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. MPEP § 2106.04(a)(2)(III). The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. Id. Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. Id. In Applicant’s claims, the step of calculating a probability that a partial electrocardiographic waveform is suspected of a heart disease is a form of an observation, evaluation, judgment, and/or opinion that a person (such as a cardiologist) can reasonably do either mentally or with the aid of pen and paper, because calculating a probability is a human cognitive action that humans have performed for hundreds of years. Therefore, calculating a probability is deemed to be an abstract mental process. For these reasons, this argument is not persuasive.
Next, Applicant argues that the claims provide a specific technical solution that improves the efficiency of medical diagnosis by enabling a user to view, at a glance, which portions of an electrocardiographic waveform are suspected of indicating heart disease. See Applicant’s Remarks, at p. 7. Examiner respectfully disagrees. When evaluating whether claims recite an improvement to the functioning of a computer or a technical field, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. MPEP § 2106.05(a). The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Id.
Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. An indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art. In the present case, Applicant has not identified a technical problem, nor has Applicant explained the details of an unconventional technical solution expressed in the claims. Specifically, the description in paragraphs [0029] and [0030] of Applicant’s specification does not amount to an improvement to the functioning of a computer, technology, or technical field. For example, paragraph [0029] in Applicant’s specification merely states in a conclusory manner that it is possible to provide more detailed information regarding whether a waveform portion in which the atrial fibrillation is suspected is included in the electrocardiographic waveform W acquired from the subject. Further, the description in paragraph [0030] of Applicant’s specification also states the idea of a solution without describing the details of how that solution is accomplished, by stating in a conclusory manner that it is possible to improve the efficiency of work of confirming whether the waveform portion in which the atrial fibrillation is suspected is included in the electrocardiographic waveform W acquired form the subject.
These are not technical improvements because Applicant has not identified a technical problem that the claimed invention solves and has not identified which limitations in the claim solve such a technical problem. Rather, the list of advantages in paragraphs [0029] and [0030] of Applicant’s specification amount to an improvement to the abstract idea and insignificant extra-solution activity (i.e., receiving and transmitting data over network by simply displaying information on a display). For example, in Trading Technologies Int’l v. IBG, the Federal Circuit court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology. See MPEP § 2106.05(a). Similarly, Applicant’s claims merely provide a display device to display information in the form of an index together with information, the index corresponding to the probability that a waveform portion in which a heart disease is suspected and the information corresponding to a partial electrocardiographic waveform from which the probability is calculated (i.e., merely displaying a probability of the heart disease next to a graph of a wave that the probability corresponds to). This does not amount to an improvement to technology or a technical field. For these reasons, this argument is not persuasive. Please see the amended rejections under the Claim Rejections – 35 U.S.C. § 101 Section below, for further clarification and complete analysis.
Response to Applicant’s Remarks Concerning Rejections under 35 U.S.C. § 103
Applicant’s arguments, see Applicant’s Remarks, pp. 6-7, Claim Rejections - 35 USC §103 Section, filed February 10, 2026, with respect to rejections of claim 1-8 under 35 U.S.C. § 103 have been fully considered, but they are not persuasive. Specifically, Applicant argues that neither Tamura et al. (Pub. No. US 2022/0130548) nor Geng et al. (Pub. No. US 2024/0260882) teaches or suggests the specific coordinated display arrangement described in claim 1. See Applicant’s Remarks, at pp. 6-7. Examiner respectfully disagrees. For example, steps 202-204 of Figure 2A in Geng and paragraphs [0128]-[0132] in Geng discuss generating disease probabilities for ECG segments (i.e., the calculated probabilities) and displaying/presenting a degree/index of heart disease for the segments (i.e., causing a display to display an index together with information corresponding to partial ECG waveform). Further, paragraphs [0202]-[0206] in Geng teach that the heart disease diagnosis result information of the targeted user may be presented on an information presentation device/display device (i.e., causing a display to display an index together with information corresponding to partial ECG waveform among the plurality of partial electrocardiographic waveforms). Accordingly, the display feature described in independent claim 1 is taught in Geng.
In regard to the rejection of claim 9 under 35 U.S.C. § 103, Applicant argues that claim 9 has been amended in a similar manner to claim 1. See Applicant’s Remarks, filed February 10, 2026, at p. 7. However, Examiner notes that claim 9 was not amended in the February 10, 2026 Amendment. As such, the § 103 rejection of claim 9 as being unpatentable over Tamura et al. (Pub. No. US 2022/0130548), in view of Geng et al. (Pub. No. US 2024/0260882), is maintained in this office action. Similarly, Examiner notes that claims 2-8 were not amended in the February 10, 2026 Amendment. Therefore, the § 103 rejections of claims 2-8 are also maintained in this office action. Please see the rejections under the Claim Rejections – 35 U.S.C. § 103 Section below, for further clarification and complete analysis.
Claim Rejections - 35 USC § 112(b)
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 14 and 15 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 14 recites “the processing device” in the preamble of the claim. However, claim 14 does not reference another claim, or make it clear that it is an independent claim. As such, if claim 14 is a dependent claim, it is not clear which claim this claim depends on. For examination purposes, the preamble of claim 14 will be interpreted and read the same as “[t]he processing device according to claim 1”.
Claim 15 (which depends on claim 14) is also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention for similar reasons as described in the § 112(b) indefiniteness rejection of claim 14 above.
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 1-9, 14, and 15 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more. See MPEP § 2106 (hereinafter referred to as the “2019 Revised PEG”).
Step 1 of the 2019 Revised PEG
Following Step 1 of the 2019 Revised PEG, claims 1-8, 14, and 15 are directed to a processing device, which is within one of the four statutory categories (i.e., a machine or apparatus). See MPEP § 2106.03. NOTE: Claim Interpretation – In accordance with the analysis in the § 112(b) rejection of claim 14 above, claim 14 is interpreted as being dependent on claim 1. Claim 9 is directed to a non-transitory computer readable storage medium, which is also within one of the four statutory categories (i.e., a manufacture). See id.
Step 2A of the 2019 Revised PEG - Prong One
Following Prong One of Step 2A of the 2019 PEG, the claim limitations are to be analyzed to determine whether they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. See MPEP §2106.04. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: (1) Mathematical Concepts; (2) Certain Methods of Organizing Human Activity, and (3) Mental Processes. See MPEP § 2106.04(a).
Claims 1-9, 14, and 15 are rejected under 35 U.S.C. § 101, because the claimed invention is directed to an abstract idea without significantly more. Representative independent claims 1 and 9 include limitations that recite an abstract idea. Specifically, independent claim 1 recites (and claim 9 similarly recites) the following limitations:
A processing device comprising:
an interface configured to receive electrocardiographic waveform data corresponding to an electrocardiographic waveform of a subject; and
a processor configured to:
divide the electrocardiographic waveform into a plurality of partial electrocardiographic waveforms, based on the electrocardiographic waveform data;
calculate a probability that a waveform portion in which a heart disease is suspected is included in each of the plurality of partial electrocardiographic waveforms; and
cause a display to display an index together with information corresponding to a partial electrocardiographic waveform among the plurality of partial electrocardiographic waveforms, the index being displayed to correspond to the information, the index corresponding to the calculated probability (as described in claim 1)/cause a display to display an index together with information, the index corresponding to the probability, the information corresponding to the partial electrocardiographic waveform from which the probability is calculated (as described in claim 9).
However, the Examiner submits that the foregoing underlined limitations constitute a process that, under its broadest reasonable interpretation, falls within the “Mental Processes” grouping of abstract ideas. See 2019 Revised PEG. The Mental Processes category covers concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper (including an observation, evaluation, judgment, or opinion) (i.e., receiving ECG waveform data; dividing the ECG waveform data into a plurality of segments; and calculating a probability that each segment is indicative of heart disease). See MPEP § 2106.04(a)(2)(III). That is, other than reciting some computer components and functions (the foregoing limitations in claim 1 which are not underlined), the context of claims 1 and 9 encompasses concepts that are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper (including an observation, evaluation, judgment, and/or opinion) (i.e., receiving ECG waveform data; dividing the ECG waveform data into a plurality of segments; and calculating a probability that each segment is indicative of heart disease).
The aforementioned claim limitations described in claims 1 and 9 are analogous to claim limitations directed toward concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper, because they merely recite limitations which encompass a person mentally and/or manually: (1) receiving electrocardiographic (ECG) waveform data (i.e., a type of observation, evaluation, judgment, and/or opinion where a person, such as a cardiologist, could review/evaluate ECG waveform data collected from a patient); (2) dividing the ECG waveform data into a plurality of partial ECG waveforms (i.e., a type of observation, evaluation, judgment, and/or opinion where the cardiologist could divide the ECG waveform data into segments (e.g., dividing the ECG waveform data into 1 second segments); and (3) calculating a probability that each segment is indicative of heart disease (i.e., a type of observation, evaluation, judgment, and/or opinion where the cardiologist could determine that each segment is indicative of heart disease (i.e., based on how “abnormal” each segment looks)).
Further, Applicant’s claims are similar to claims which have been held to recite an abstract mental process. For example, the Federal Circuit held the a claim directed 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 amounted to steps that could practically be performed in the human mind. See MPEP § 2106.04(a)(2)(III)(A) (citing Electric Power Group g. Alstom, S.A.). Similarly, Applicant’s claims recite steps for collecting information (i.e., receiving the ECG waveform data); analyzing the data (dividing the data into plurality of segments and calculating that each segment is indicative of heart disease); and displaying certain results about the collection and analysis (i.e., displaying an index together with information corresponding to the calculated probability), at a high level of generality. Therefore, the aforementioned underlined claim limitations may reasonably be interpreted as mental/manual observations, evaluations, judgments, and/or opinions made by a person, such as a healthcare professional. If a claim limitation, under its broadest reasonable interpretation, covers concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. See 2019 Revised PEG. Accordingly, claims 1 and 9 recite an abstract idea that falls within the Mental Processes category.
Furthermore, Examiner notes that dependent claims 2-8, 14, and 15 include limitations that are deemed to be additional elements, and require further analysis under Prong Two of Step 2A.
Step 2A of the 2019 Revised PEG - Prong Two
Regarding Prong Two of Step 2A of the 2019 Revised PEG, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted in the 2019 Revised PEG, it must be determined whether any additional elements in the claims are indicative of integrating the abstract idea into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” See MPEP § 2106.05(h).
In the present case, for independent claims 1 and 9, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A processing device (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) comprising:
an interface configured to (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) receive electrocardiographic waveform data corresponding to an electrocardiographic waveform of a subject; and
a processor configured to (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)):
divide the electrocardiographic waveform into a plurality of partial electrocardiographic waveforms, based on the electrocardiographic waveform data;
calculate a probability that a waveform portion in which a heart disease is suspected is included in each of the plurality of partial electrocardiographic waveforms; and
cause a display (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) to display an index together with information corresponding to a partial electrocardiographic waveform among the plurality of partial electrocardiographic waveforms, the index being displayed to correspond to the information, the index corresponding to the calculated probability (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)) (as described in claim 1)/cause a display (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) to display an index together with information, the index corresponding to the probability, the information corresponding to the partial electrocardiographic waveform from which the probability is calculated (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)) (as described in claim 9).
However, the recitation of these generic computer components and functions in claims 1 and 9 are recited at a high-level of generality (i.e., using generic computer devices to perform the abstract ideas of: receiving ECG waveform data; dividing the ECG waveform data into a plurality of segments; and calculating a probability that each segment is indicative of heart disease), such that it amounts to no more than: (1) adding the words “apply it” (or is the equivalent of) with the judicial exception; mere instructions to implement an abstract idea on a computer; or merely uses a computer as a tool to perform an abstract idea; (2) adding insignificant extra-solution activity to the judicial exception; and (3) generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP §§ 2106.05(f)-(h). For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
- The following is an example of court decisions that demonstrate merely applying instructions by reciting the computer structure as a tool to implement the claimed limitations (e.g., see MPEP § 2106.05(f)):
- A commonplace business method or mathematical algorithm being applied on a general purpose computer, e.g., see Alice Corp. Pty. Ltd. v. CLS Bank Int’l – similarly, the current invention implements the commonplace medical business method of dividing data into segments and calculating probabilities within the segments using generic computing devices (i.e., the Examiner submits that the additional elements directed to the processing device, comprising an interface; processor; and display; and non-transitory computer readable storage medium storing a computer program comprising instructions, are generic computer devices).
- The following is an example of an insignificant extra-solution activity (e.g., see MPEP § 2106.05(g)):
- Example of Mere Data Gathering/Mere Data Outputting:
- Obtaining information about transactions using the Internet to verify credit card transactions, e.g., see CyberSource v. Retail Decisions, Inc. – similarly, the steps directed to: (1) “displaying an index together with information corresponding to a partial electrocardiographic waveform among the plurality of partial electrocardiographic waveforms, the index being displayed to correspond to the information, the index corresponding to the calculated probability”, described in claim 1, and (2) “displaying an index together with information corresponding to the probability and the information corresponding to the partial EGC waveform”, described in claim 9, are necessary data outputting steps (i.e., displaying the index with the probability and the divided segments is necessary in order to convey this information to a user).
Thus, the additional elements in independent claims 1 and 9 are not indicative of integrating the judicial exception into a practical application. Similarly, Examiner notes that dependent claims 2-8, 14, and 15 recite the following additional elements identified in bold font below (with limitations deemed to be part of the above identified abstract idea identified in underlined font):
wherein the index is a color of the partial electrocardiographic waveform, a color of a background of the partial electrocardiographic waveform, or a color of a graphic displayed together with the partial electrocardiographic waveform (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)) (as described in claim 2);
wherein the information corresponding to the partial electrocardiographic waveform includes a tachogram based on an R-R interval in the electrocardiographic waveform (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)) (as described in claim 3);
wherein the interface is configured to receive an instruction to change the index (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)); and wherein the processor is configured to change the index, based on the instruction (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)) (as described in claim 4);
wherein the interface is configured to receive an instruction to designate a specific
time section in the electrocardiographic waveform displayed on the display (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)); and wherein the processor is configured to change the index included in the time section, in accordance with an occupancy rate, in the time section, of the partial electrocardiographic waveform displayed together with the index (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)) (as described in claim 5);
wherein the interface is configured to receive an instruction to designate a specific time section in the electrocardiographic waveform displayed on the display (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)), and wherein the processor is configured to (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) specify a first partial electrocardiographic waveform that is similar to a second partial electrocardiographic waveform, the first partial electrocardiographic waveform being the partial electrocardiographic waveform that is not included in the time section, the second partial electrocardiographic waveform being the partial electrocardiographic waveform that is included in the time section, and change the index displayed together with the first partial electrocardiographic waveform to the index that is identical to the index displayed together with the second partial electrocardiographic waveform (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)) (as described in claim 6);
wherein the processor is configured to generate a data set in which data and a part of the electrocardiographic waveform data are associated with each other, the data corresponding to the index changed based on the instruction, the electrocardiographic waveform data corresponding to the partial electrocardiographic waveform specified by the index changed based on the instruction (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)) (as described in claim 7);
wherein the probability is calculated by inputting data to a prediction model (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)), the data being acquired based on the electrocardiographic waveform, the prediction model being generated through machine learning using a plurality of electrocardiographic waveforms that is determined to include the waveform portion in which the heart disease is suspected (the Examiner submits that this additional element amounts to generally linking the abstract idea to a particular field of use or technological environment as noted below, see MPEP § 2106.05(h)) (as described in claim 8);
wherein the processor is further configured to cause the display to display a plurality of indexes together with a plurality of information corresponding to the partial electrocardiographic waveforms, each of the plurality of indexes respectively being displayed to correspond to a corresponding one of the plurality of information corresponding to the partial electrocardiographic waveforms, each of the plurality of indexes corresponding to the calculated probability (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)) (as described in claim 14); and
wherein the plurality of indexes are displayed side by side to be aligned with the plurality of information corresponding to the partial electrocardiographic waveforms (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)) (as described in claim 15).
As such, the additional elements in claims 1-9, 14, and 15 are not indicative of integrating the judicial exception into a practical application. Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, unlike the claims that have been held as a whole to be directed to an improvement or otherwise directed to something more than the abstract idea, claims 1-9, 14, and 15: (1) are not directed to improvements to the functioning of a computer, or to any other technology or technical field similar to the Enfish, LLC v. Microsoft Corp. case (see MPEP § 2106.05(a)); (2) do not apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (see MPEP § 2106.04(d)(2)); (3) do not apply the judicial exception with, or by use of, a particular machine (see MPEP § 2106.05(b)); (4) do not effect a transformation or reduction of a particular article to a different state or thing (see MPEP § 2106.05(c)); nor do they (5) apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as whole is more than a drafting effort designed to monopolize the exception (see MPEP § 2106.05(e) and MPEP § 2106.04(d)(2)). For these reasons, claims 1-9, 14, and 15 do not recite additional elements that integrate the judicial exception into a practical application.
Step 2B of the 2019 Revised PEG
Regarding Step 2B of the 2019 Revised PEG, claims 1-9, 14, and 15 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 abstract idea into a practical application, the additional elements of claims 1-9, 14, and 15 amount to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP § 2106.05(h). Further the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than limitations consistent with what the courts recognize, or those having ordinary skill in the art would recognize, to be well-understood, routine, and conventional computer components. See MPEP § 2106.05 (d).
Specifically, the Examiner submits that the additional elements of claims 1-9, 14, and 15, as recited, the processing device, interface, processor, display, non-transitory computer readable storage medium storing a computer program comprising instructions; and the steps directed to: “cause a display to display an index together with information corresponding to a partial electrocardiographic waveform among the plurality of partial electrocardiographic waveforms, the index being displayed to correspond to the information, the index corresponding to the calculated probability”; “causing a display to display an index together with information, the index corresponding to the probability, the information corresponding to the partial electrocardiographic waveform from which the probability is calculated”; “wherein the index is a color of the partial electrocardiographic waveform, a color of a background of the partial electrocardiographic waveform, or a color of a graphic displayed together with the partial electrocardiographic waveform”; “wherein the information corresponding to the partial electrocardiographic waveform includes a tachogram based on an R-R interval in the electrocardiographic waveform”; “wherein the interface is configured to receive an instruction to change the index”; “wherein the processor is configured to change the index, based on the instruction”; “wherein the interface is configured to receive an instruction to designate a specific time section in the electrocardiographic waveform displayed on the display”; “wherein the processor is configured to change the index included in the time section, in accordance with an occupancy rate, in the time section, of the partial electrocardiographic waveform displayed together with the index”; “wherein the interface is configured to receive an instruction to designate a specific time section in the electrocardiographic waveform displayed on the display”; “wherein the processor is configured to change the index displayed together with the first partial electrocardiographic waveform to the index that is identical to the index displayed together with the second partial electrocardiographic waveform”; “wherein the processor is configured to generate a data set in which data and a part of the electrocardiographic waveform data are associated with each other, the data corresponding to the index changed based on the instruction, the electrocardiographic waveform data corresponding to the partial electrocardiographic waveform specified by the index changed based on the instruction”; “wherein the probability is calculated by inputting data to a prediction model”; “the data being acquired based on the electrocardiographic waveform, the prediction model being generated through machine learning using a plurality of electrocardiographic waveforms that is determined to include the waveform portion in which the heart disease is suspected”; “wherein the processor is further configured to cause the display to display a plurality of indexes together with a plurality of information corresponding to the partial electrocardiographic waveforms, each of the plurality of indexes respectively being displayed to correspond to a corresponding one of the plurality of information corresponding to the partial electrocardiographic waveforms, each of the plurality of indexes corresponding to the calculated probability”; and “wherein the plurality of indexes are displayed side by side to be aligned with the plurality of information corresponding to the partial electrocardiographic waveforms”, are well-understood, routine, and conventional functions. See MPEP § 2106.05(d)(II).
- In regard to the processing device, interface, processor, display, non-transitory computer readable storage medium storing a computer program comprising instructions; and the steps directed to “the data being acquired based on the electrocardiographic waveform, the prediction model being generated through machine learning using a plurality of electrocardiographic waveforms that is determined to include the waveform portion in which the heart disease is suspected”, these additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than well-understood, routine, and conventional activities previously known to the industry, because:
- Applicant’s disclosure supports this assertion. For example, Applicant discloses that: (1) each of the processors of the processing devices may be realized by a general-purpose microprocessor, such as a CPU, an MPU, and a GPU (see Applicant’s original specification, as filed on October 31, 2023, paragraph [0076]); (2) the machine learning can include a neural network, a decision tree, a random forest, and a support vector machine (see Applicant’s original specification, as filed on October 31, 2023, paragraph [0052]); and (3) an external server is an example of a non-transitory computer readable storage medium that stores the computer program (see Applicant’s original specification, as filed on October 31, 2023, paragraph [0076]). The Examiner submits that these devices represent well-understood, routine, and conventional computer devices which are known in the medical industry.
- The Examiner submits that these limitations amount to merely using a computer or other machinery as tools for performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f) and analysis of these limitations under Step 2A, Prong Two above).
- The Examiner submits that these limitations generally link the use of the judicial exception to a particular technological environment or field of use – for example, the limitations directed to “the data being acquired based on the electrocardiographic waveform, the prediction model being generated through machine learning using a plurality of electrocardiographic waveforms that is determined to include the waveform portion in which the heart disease is suspected”, amount to limiting the abstract idea to the field of machine learning models/algorithms (see MPEP § 2106.05(h) and analysis of these limitations under Step 2A, Prong Two above).
Therefore, these limitations are also deemed to be well-understood, routine, and conventional under Step 2B for similar reasons since they are claimed in a generic manner.
- Regarding the steps and features directed to: “cause a display to display an index together with information corresponding to a partial electrocardiographic waveform among the plurality of partial electrocardiographic waveforms, the index being displayed to correspond to the information, the index corresponding to the calculated probability”; “causing a display to display an index together with information, the index corresponding to the probability, the information corresponding to the partial electrocardiographic waveform from which the probability is calculated”; “wherein the index is a color of the partial electrocardiographic waveform, a color of a background of the partial electrocardiographic waveform, or a color of a graphic displayed together with the partial electrocardiographic waveform”; “wherein the information corresponding to the partial electrocardiographic waveform includes a tachogram based on an R-R interval in the electrocardiographic waveform”; “wherein the interface is configured to receive an instruction to change the index”; “wherein the processor is configured to change the index, based on the instruction”; “wherein the interface is configured to receive an instruction to designate a specific time section in the electrocardiographic waveform displayed on the display”; “wherein the processor is configured to change the index included in the time section, in accordance with an occupancy rate, in the time section, of the partial electrocardiographic waveform displayed together with the index”; “wherein the interface is configured to receive an instruction to designate a specific time section in the electrocardiographic waveform displayed on the display”; “wherein the processor is configured to change the index displayed together with the first partial electrocardiographic waveform to the index that is identical to the index displayed together with the second partial electrocardiographic waveform”; “wherein the processor is configured to generate a data set in which data and a part of the electrocardiographic waveform data are associated with each other, the data corresponding to the index changed based on the instruction, the electrocardiographic waveform data corresponding to the partial electrocardiographic waveform specified by the index changed based on the instruction”; “wherein the probability is calculated by inputting data to a prediction model”; “wherein the processor is further configured to cause the display to display a plurality of indexes together with a plurality of information corresponding to the partial electrocardiographic waveforms, each of the plurality of indexes respectively being displayed to correspond to a corresponding one of the plurality of information corresponding to the partial electrocardiographic waveforms, each of the plurality of indexes corresponding to the calculated probability”; and “wherein the plurality of indexes are displayed side by side to be aligned with the plurality of information corresponding to the partial electrocardiographic waveforms” - The following represents an example that courts have identified to be well-understood, routine, and conventional activities (e.g., see MPEP § 2106.05(d)):
- Receiving or transmitting data over a network, e.g., see Intellectual Ventures v. Symantec – the aforementioned limitations directed to: “cause a display to display an index together with information corresponding to a partial electrocardiographic waveform among the plurality of partial electrocardiographic waveforms, the index being displayed to correspond to the information, the index corresponding to the calculated probability”; “causing a display to display an index together with information, the index corresponding to the probability, the information corresponding to the partial electrocardiographic waveform from which the probability is calculated”; “wherein the index is a color of the partial electrocardiographic waveform, a color of a background of the partial electrocardiographic waveform, or a color of a graphic displayed together with the partial electrocardiographic waveform”; “wherein the information corresponding to the partial electrocardiographic waveform includes a tachogram based on an R-R interval in the electrocardiographic waveform”; “wherein the interface is configured to receive an instruction to change the index”; “wherein the processor is configured to change the index, based on the instruction”; “wherein the interface is configured to receive an instruction to designate a specific time section in the electrocardiographic waveform displayed on the display”; “wherein the processor is configured to change the index included in the time section, in accordance with an occupancy rate, in the time section, of the partial electrocardiographic waveform displayed together with the index”; “wherein the interface is configured to receive an instruction to designate a specific time section in the electrocardiographic waveform displayed on the display”; “wherein the processor is configured to change the index displayed together with the first partial electrocardiographic waveform to the index that is identical to the index displayed together with the second partial electrocardiographic waveform”; “wherein the processor is configured to generate a data set in which data and a part of the electrocardiographic waveform data are associated with each other, the data corresponding to the index changed based on the instruction, the electrocardiographic waveform data corresponding to the partial electrocardiographic waveform specified by the index changed based on the instruction”; “wherein the probability is calculated by inputting data to a prediction model”; “wherein the processor is further configured to cause the display to display a plurality of indexes together with a plurality of information corresponding to the partial electrocardiographic waveforms, each of the plurality of indexes respectively being displayed to correspond to a corresponding one of the plurality of information corresponding to the partial electrocardiographic waveforms, each of the plurality of indexes corresponding to the calculated probability”; and “wherein the plurality of indexes are displayed side by side to be aligned with the plurality of information corresponding to the partial electrocardiographic waveforms”, are similarly deemed to be well-understood, routine, and conventional activity in the medical field, because they also represent mere collection and transmission of data over a network (i.e., “receiving” instructions, data, etc.; generating a data set; and displaying the various data are the equivalent of receiving or transmitting data over a network).
Therefore, the additional limitations described in claims 1-9, 14, and 15 are deemed to be additional elements which do not amount to significantly more than the abstract idea identified above.
Thus, taken alone, the additional elements of claims 1-9, 14, and 15 do not amount to significantly more than the above-identified judicial exception (the abstract idea). Furthermore, 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 functionality of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation. Therefore, whether taken individually or as an ordered combination, claims 1-9, 14, and 15 are nonetheless rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1, 8, 9, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over:
- Tamura et al. (Pub. No. US 2022/0130548), in view of:
- Geng et al. (Pub. No. US 2024/0260882).
Regarding claims 1 and 9,
- Tamura et al. (Pub. No. US 2022/0130548) teaches:
- a processing device comprising (as described in claim 1) (Tamura, paragraph [0024] and FIG. 1; Paragraph [0024] teaches that FIG. 1 illustrates an outline of an electrocardiogram display system S (i.e., a processing device).):
- a non-transitory computer readable storage medium storing a computer program, the computer program comprising instructions which, when executed by a processor mounted on a processing device, cause the processing device to (as described in claim 9) (Tamura, paragraph [0009]; Paragraph [0009] teaches a non-transitory storage medium storing a program which cause a computer to execute.):
- an interface configured to receive electrocardiographic waveform data corresponding to an electrocardiographic waveform of a subject (as described in claim 1); and receive electrocardiographic waveform data corresponding to an electrocardiographic waveform of a subject (as described in claim 9) (Tamura, paragraphs [0025] and [0027]; Paragraph [0027] teaches that an electrocardiograph display apparatus 3 (i.e., an interface) acquires the electrocardiogram data generated by the electrocardiograph 1, where paragraph [0025] teaches that the electrocardiogram data includes a heartbeat waveform for a patient (i.e., the received electrocardiogram data includes electrocardiographic waveform data of a subject).); and
- a processor configured to (as described in claim 1) (Tamura, paragraph [0032]; Paragraph [0032] teaches a processor.):
- divide the electrocardiographic waveform into a plurality of partial electrocardiographic waveforms, based on the electrocardiographic waveform data (as described in claims 1 and 9) (Tamura, paragraph [0036]; Paragraph [0036] teaches that the input processing part 341 divides the acquired electrocardiogram data into a plurality of pieces of electrocardiogram data (i.e., dividing the electrocardiographic waveform into a plurality of partial electrocardiographic waveforms) each having a predetermined time length (e.g., 30 seconds) shorter than the predetermined time period.).
…
…
- While Tamura teaches that the machine learning model can output a result of determining whether or not there is a portion suspected of indicating heart disease (see Tamura, paragraph [0032]), Tamura does not explicitly teach, however, in analogous art of processing devices and methods for predicting heart diseases, Geng et al. (Pub. No. US 2024/0260882), teaches a processing device and non-transitory computer readable storage medium, with instructions which cause a processor to:
- calculate a probability that a waveform portion in which a heart disease is suspected is included in each of the plurality of partial electrocardiographic waveforms (as described in claims 1 and 9) (Geng, paragraph [0095]; Paragraph [0095] teaches that for each electrocardiogram data segment to be analyzed/acquired in step 201, input the electrocardiogram data segment to be analyzed into the pre-trained first electrocardiogram analysis model to obtain the heart disease suffering probability vector corresponding to the electrocardiogram data segment to be analyzed. Here, the heart disease suffering probability vector is used to characterize a probability of suffering from each of K preset heart diseases (i.e., calculating a probability of a heart disease in the waveform portion in which a heart disease is suspected).); and
- cause a display to display an index together with information corresponding to a partial electrocardiographic waveform among the plurality of partial electrocardiographic waveforms, the index being displayed to correspond to the information, the index corresponding to the calculated probability (as described in claim 1); and cause a display to display an index together with information, the index corresponding to the probability, the information corresponding to the partial electrocardiographic waveform from which the probability is calculated (as described in claim 9) (Geng, paragraphs [0088], [0128]-[0132], [0202]-[0206], and [0295], FIG. 2A; Paragraph [0295] teaches that the paroxysmal heart disease prediction results of the target user generated for different preset paroxysmal heart diseases in step 804 may be presented on an information presentation device locally connected to the executive subject (i.e., the index is displayed with corresponding probability together with information corresponding to the partial electrocardiographic waveform from which the probability is calculated). Steps 202-204 of Figure 2A and paragraphs [0128]-[0132] discuss generating disease probabilities for ECG segments (i.e., the calculated probabilities) and displaying/presenting a degree/index of heart disease for the segments (i.e., causing a display to display an index together with information corresponding to partial ECG waveform). Specifically, paragraphs [0202]-[0206] teach that the heart disease diagnosis result information of the tarted user may be presented on an information presentation device/display device (i.e., causing a display to display an index together with information corresponding to partial ECG waveform among the plurality of partial electrocardiographic waveforms). Paragraph [0088] teaches that this feature is beneficial for improving the accuracy of the generated heart disease diagnosis result information.).
Therefore, it would have been obvious to one of ordinary skill in the art of processing devices and methods for predicting heart diseases at the time of the effective filing date of the claimed invention to modify the electrocardiogram display system and non-transitory storage medium taught by Tamura, to incorporate steps and features directed to: (i) calculating the probability of occurrence of atrial fibrillation in a subject as a prediction result; and (ii) displaying the heart disease prediction results with the information corresponding to the partial electrocardiographic waveform from which the probability is calculated, as taught by Geng, in order to improve the accuracy of the generated heart disease diagnosis result information. See Geng, paragraph [0088]; see also MPEP § 2143 G.
Regarding claim 8,
- The combination of: Tamura, as modified in view of Geng, teaches the limitations of claim 1 (which claim 8 depends on), as described above.
- Geng further teaches a device, wherein:
- the probability is calculated by inputting data to a prediction model, the data being acquired based on the electrocardiographic waveform (Geng, paragraph [0037]; Paragraph [0037] teaches inputting each unacknowledged condition electrocardiogram data segment into the first electrocardiogram analysis model to obtain a corresponding heart disease suffering probability vector (i.e., the probability is calculated by inputting the data into a prediction model that is generated through machine learning).), the prediction model being generated through machine learning using a plurality of electrocardiographic waveforms that is determined to include the waveform portion in which the heart disease is suspected (Geng, paragraphs [0110] and [0111]; Paragraphs [0110] and [0111] teach that the electrocardiogram analysis model is based on various machine learning models (i.e., the prediction model that is generated through machine learning).).
The motivations and rationales for modifying the electrocardiogram display system and non-transitory storage medium taught by Tamura, in view of Geng, described in the analysis of the obviousness rejection of claims 1 and 9 similarly apply to this obviousness rejection, and are incorporated herein by reference.
Regarding claim 14,
- The combination of: Tamura, as modified in view of Geng, teaches the limitations of claim 1 (which claim 14 depends on), as described above.
- Tamura further teaches a processing device, wherein:
- the processor is further configured to cause the display to display a plurality of indexes together with a plurality of information corresponding to the partial electrocardiographic waveforms, each of the plurality of indexes respectively being displayed to correspond to a corresponding one of the plurality of information corresponding to the partial electrocardiographic waveforms, each of the plurality of indexes corresponding to the calculated probability (Tamura, paragraph [0043]; Paragraph [0043] teaches that the display control part 343 identifies one or more pieces of abnormal electrocardiogram data including the waveform portion suspected of indicating heart disease from the plurality of pieces of divided electrocardiogram data on the basis of the determination result acquired from the machine learning model (i.e., each of the plurality of indexes are displayed with the corresponding electrocardiographic waveforms) by the result acquisition part 342. The display control part 343 causes the doctor’s device 2 to display a waveform image of at least one of the pieces of abnormal electrocardiogram data from among the identified one or more pieces of abnormal electrocardiogram data (i.e., displaying a plurality of indexes together with a plurality of information corresponding to the partial electrocardiographic waveforms).).
The motivations and rationales for modifying the electrocardiogram display system and non-transitory storage medium taught by Tamura, in view of Geng, described in the analysis of the obviousness rejection of claims 1 and 9 similarly apply to this obviousness rejection, and are incorporated herein by reference.
Regarding claim 15,
- The combination of: Tamura, as modified in view of Geng, teaches the limitations of claim 1 (which claim 15 depends on), as described above.
- Tamura further teaches a processing device, wherein:
- the plurality of indexes are displayed side by side to be aligned with the plurality of information corresponding to the partial electrocardiographic waveforms (Tamura, paragraph [0047] and FIG. 4; Paragraph [0047] teaches that the divided electrocardiogram segments are displayed on a display screen in area R3 along with the IDs of the electrocardiogram portions that are suspected of indicating heart disease (i.e., the plurality of indexes are displayed side by side with the plurality of information corresponding to the partial electrocardiographic waveforms).).
The motivations and rationales for modifying the electrocardiogram display system and non-transitory storage medium taught by Tamura, in view of Geng, described in the analysis of the obviousness rejection of claims 1 and 9 similarly apply to this obviousness rejection, and are incorporated herein by reference.
Claims 2 and 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over:
- The combination of: Tamura et al. (Pub. No. US 2022/0130548), as modified in view of: Geng et al. (Pub. No. US 2024/0260882), as applied to claim 1 above, and further in view of:
- Lou et al. (Pub. No. US 2022/0287615).
Regarding claim 2,
- The combination of: Tamura, as modified in view of Geng, teaches the limitations of claim 1 (which claim 2 depends on), as described above.
- The combination of: Tamura, as modified in view of Geng, does not explicitly teach, however, in analogous art of electrocardiogram monitoring devices and methods, Lou et al. (Pub. No. US 2022/0287615) teaches a device, wherein:
- the index is a color of the partial electrocardiographic waveform, a color of a background of the partial electrocardiographic waveform, or a color of a graphic displayed together with the partial electrocardiographic waveform (Lou, paragraphs [0236] and [0237]; Paragraph [0237] teaches that the image processor 720 may generate a diagnostic image showing the degree of change in the target by using colors to differentiate the stages (i.e., the index is a color of a graphic displayed with the partial electrocardiographic waveform). For example, referring to FIG. 9, the degree of change in a bone that is a target is classified into three stages, and the diagnostic image 940 distinctly shows a stage when no change occurs in the target, a stage when a change occurs in the direction in which the target is formed, and a stage when a change occurs in the direction in which the target is destroyed by using green, red, and blue colors, respectively (i.e., the index is a color of a graphic displayed with the partial electrocardiographic waveform). Paragraph [0236] teaches that this feature is beneficial for distinguishing between a plurality of stages in an image.).
Therefore, it would have been obvious to one of ordinary skill in the art of electrocardiogram monitoring devices and methods at the time of the effective filing date of the claimed invention to further modify the electrocardiogram display system and non-transitory storage medium taught by Tamura, as modified in view of Geng, to incorporate a step and feature directed to using color in an image, as taught by Lou, in order to distinguish between a plurality of stages in an image. See Lou, paragraph [00236]; see also MPEP § 2143 G.
Regarding claim 4,
- The combination of: Tamura, as modified in view of Geng, teaches the limitations of claim 1 (which claim 4 depends on), as described above.
- The combination of: Tamura, as modified in view of Geng, does not explicitly teach, however, in analogous art of electrocardiogram monitoring devices and methods, Lou et al. (Pub. No. US 2022/0287615) teaches a device, wherein:
- the interface is configured to receive an instruction to change the index; and wherein the processor is configured to change the index, based on the instruction (Lou, paragraphs [0031] and [0055]; Paragraph [0055] teaches that the time interval for which the output data/maps are computed can be selected based on user input (i.e., receiving an instruction to change the time interval of the index and processor the change to the index based on the instruction), such as via GUI. Paragraph [0055] further teaches that parameters associated with the graphical representation, corresponding to an output visualization of the computed map, such as including selecting a time interval, a type of information that is to be presented in the visualization and the like can be selected in response to a user input via the GUI 840 (i.e., the processor changes the index based on the instruction to change the time interval of the index). Paragraph [0031] teaches that this feature is beneficial for identifying desired time values by defining variable temporal thresholds in response to user input setting the temporal threshold.).
Therefore, it would have been obvious to one of ordinary skill in the art of electrocardiogram monitoring devices and methods at the time of the effective filing date of the claimed invention to further modify the electrocardiogram display system and non-transitory storage medium taught by Tamura, as modified in view of Geng, to incorporate a step and feature directed to receiving user input to change settings in a graphical user interface, as taught by Lou, in order to identify desired time values by defining variable temporal thresholds in response to user input setting the temporal threshold. See Lou, paragraph [0031]; see also MPEP § 2143 G.
Regarding claim 5,
- The combination of: Tamura, as modified in view of: Geng and Lou, teaches the limitations of claim 4 (which claim 5 depends on), as described above.
- Lou further teaches a device, wherein:
- the interface is configured to receive an instruction to designate a specific time section in the electrocardiographic waveform displayed on the display (Lou, paragraph [0055]; Paragraph [0055] teaches that the time interval for which the output data/maps are computed can be selected based on user input (i.e., this passage is also interpreted as teaching receiving an instruction to designate a specific time section in the electrocardiographic waveform), such as via GUI.); and
- wherein the processor is configured to change the index included in the time section, in accordance with an occupancy rate, in the time section, of the partial electrocardiographic waveform displayed together with the index (Lou, paragraph [0055]; Paragraph [0055] further teaches that parameters associated with the graphical representation, corresponding to an output visualization of the computed map, such as including selecting a time interval, a type of information that is to be presented in the visualization and the like can be selected in response to a user input via the GUI 840 (i.e., the processor changes the index based on the instruction to change the time interval of the index).).
The motivations and rationales for modifying the electrocardiogram display system and non-transitory storage medium taught by Tamura, in view of: Geng and Lou, described in the analyses of the obviousness rejections of claims 1, 4, and 9 similarly apply to this obviousness rejection, and are incorporated herein by reference.
Regarding claim 6,
- The combination of: Tamura, as modified in view of Geng and Lou, teaches the limitations of claim 4 (which claim 6 depends on), as described above.
- Lou further teaches a device, wherein:
- the interface is configured to receive an instruction to designate a specific time section in the electrocardiographic waveform displayed on the display (Lou, paragraph [0055]; Paragraph [0055] teaches that the time interval for which the output data/maps are computed can be selected based on user input (i.e., this passage is also interpreted as teaching receiving an instruction to designate a specific time section in the electrocardiographic waveform, as described above for the similar limitation recited in claim 5), such as via GUI.).
- Tamura further teaches a device, wherein the processor is configured to:
- specify a first partial electrocardiographic waveform that is similar to a
second partial electrocardiographic waveform, the first partial electrocardiographic waveform
being the partial electrocardiographic waveform that is not included in the time section, the
second partial electrocardiographic waveform being the partial electrocardiographic waveform that is included in the time section (Tamura, paragraph [0055]; Paragraph [0055] teaches that when the operation information acquisition part 344 acquires operation information indicating that the operation bar is moved upward, the display control part 343 causes the doctor’s device 2 to display a waveform image of the abnormal electrocardiogram data that was acquired at a time prior to the time when the abnormal electrocardiogram data whose waveform image is displayed was acquired (i.e., specifying a first partial electrocardiographic waveform that is similar to a second partial electrocardiographic waveform, where the similarity is identifying partial electrocardiographic waveforms that both display abnormal electrocardiogram data).), and change the index displayed together with the first partial electrocardiographic waveform to the index that is identical to the index displayed together with the second partial electrocardiographic waveform (Tamura, paragraph [0055]; Paragraph [0055] teaches that as described above [referencing a similar feature in paragraph [0051]], the display control part 343 causes the doctor’s device 2 to simultaneously display the waveform images of the plurality of pieces of abnormal electrocardiogram data (i.e., the data corresponding to the index and the electrocardiographic waveform changes based on the instruction received from the user, where the change displays the first partial electrocardiographic waveform together with the second partial electrocardiographic waveform because both partial electrocardiographic waveforms similarly display abnormal electrocardiogram data). This enables the doctor to easily grasp the trend of the abnormality appearing in the electrocardiogram of the patient.).
The motivations and rationales for modifying the electrocardiogram display system and non-transitory storage medium taught by Tamura, in view of: Geng and Lou, described in the analyses of the obviousness rejections of claims 1, 4, and 9 similarly apply to this obviousness rejection, and are incorporated herein by reference.
Regarding claim 7,
- The combination of: Tamura, as modified in view of Geng and Lou, teaches the limitations of claim 4 (which claim 7 depends on), as described above.
- Tamura further teaches a device, wherein:
- the processor is configured to generate a data set in which data and a part of the electrocardiographic waveform data are associated with each other (Tamura, paragraph [0025]; Paragraph [0025] teaches that the electrocardiogram data is associated with time information indicating the time at which the heartbeat is measured (i.e., the processor generates time data that is associated with the electrocardiographic waveform data).), the data corresponding to the index changed based on the instruction, the electrocardiographic waveform data corresponding to the partial electrocardiographic waveform specified by the index changed based on the instruction (Tamura, paragraph [0051]; Paragraph [0051] teaches that the doctor can switch the divided electrocardiogram data whose waveform image is displayed by moving an operation bar shown in black in the area R4 in the vertical direction. For example, when the operation information acquisition part 344 acquires operation information indicating that the operation bar is moved upward, the display control part 343 causes the doctor’s device 2 to display a waveform image of the divided electrocardiogram data that was acquired at a time prior to the time when the divided electrocardiogram data whose waveform image is displayed was acquired (i.e., the data corresponding to the index and the electrocardiographic waveform changes based on the instruction received from the user). In this manner, the doctor can check the desired divided electrocardiogram data using the operation bar.).
The motivations and rationales for modifying the electrocardiogram display system and non-transitory storage medium taught by Tamura, in view of: Geng and Lou, described in the analyses of the obviousness rejections of claims 1, 4, and 9 similarly apply to this obviousness rejection, and are incorporated herein by reference.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over:
- The combination of: Tamura et al. (Pub. No. US 2022/0130548), as modified in view of: Geng et al. (Pub. No. US 2024/0260882), as applied to claim 1 above, and further in view of:
- Bhatkar et al. (Pub. No. US 2013/0274616).
Regarding claim 3,
- The combination of: Tamura, as modified in view of Geng, teaches the limitations of claim 1 (which claim 3 depends on), as described above.
- The combination of: Tamura, as modified in view of Geng, does not explicitly teach, however, in analogous art of electrocardiogram monitoring devices and methods, Bhatkar et al. (Pub. No. US 2013/0274616) teaches a device, wherein:
- the information corresponding to the partial electrocardiographic waveform includes a tachogram based on an R-R interval in the electrocardiographic waveform (Bhatkar, paragraph [0024]; Paragraph [0024] generally teaches that it is desired to convert R-R intervals into an instantaneous heart rate, where unevenly sampled intervals include R-R interval tachograms (i.e., the partial electrocardiographic waveform includes a tachogram based on an R-R interval). Paragraph [0024] teaches that this feature is beneficial for identifying incorrect beats.).
Therefore, it would have been obvious to one of ordinary skill in the art of electrocardiogram monitoring devices and methods at the time of the effective filing date of the claimed invention to further modify the electrocardiogram display system and non-transitory storage medium taught by Tamura, as modified in view of Geng, to incorporate a step and feature directed to including a tachogram based on an R-R interval in the electrocardiographic waveform, as taught by Bhatkar, in order to identify incorrect beats. See Bhatkar, paragraph [0024]; see also MPEP § 2143 G.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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.
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/N.A.A./Examiner, Art Unit 3686
/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686
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