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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/17/26 has been entered.
Status of Claims
Claims 1 and 6-7 are rejected. Claims 2-5 and 8-11 are canceled.
Response to Arguments
Claim Rejections - 35 USC § 101
Applicant's arguments filed 8/17/26 have been fully considered but they are not persuasive.
Applicant asserts that like the claims in Desjardins, the present claims reflect an improvement to the technical field of computerized ECG signal analysis and arrhythmia classification when considered as a whole. However, the Examiner disagrees. The limitations are directed to the abstract idea, because they are choices about how to do the data analysis rather than something about how the AI itself is configured or coded.
Applicant asserts that the claimed invention addresses the technical problem by employing a composite artificial neural network comprising a first artificial neural network and a second artificial neural network having different estimation functions. However, utilizing a composite artificial neural network comprising a first artificial neural network and a second artificial neural network is nothing more than the computer implementation/automation of an abstract mental process of screening a patient, which is what a physician typically does with a patient in a diagnostic setting. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Applicant asserts that the claimed mutual verification is not merely an abstract instruction to “verify” information. It is a specific computer-implemented interaction between the outputs of two differently configured artificial neural networks that improves the reliability of ECG signal classification by identifying and correcting inconsistent classification results. However, the Examiner disagrees. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Applicant asserts that the claimed invention introduces a particular and non-conventional architecture for estimating arrhythmia using a composite artificial neural network. However, the Examiner disagrees. The composite neural network is nothing more than the computer implementation/automation of an abstract mental process of screening a patient, which is what a physician typically does with a patient in a diagnostic setting. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Claim Rejections - 35 USC § 103
Applicants’ arguments, see Remarks, filed 8/17/26, with respect to claims 1 and 6-7 have been fully considered and are persuasive. Specifically, that the combination of Li and Chien, either individually or in combination do not teach or suggest (1) a beat class represents a first type of arrhythmia that is capable of being estimated on a beat segment basis or representing a normal ECG; (2) a section class represents a second type of arrhythmia that is capable of being estimated from rhythm changes between consecutive beat segments; and (3) in response to determining that the first type of arrhythmia represented by the beat class cannot be present in a section of the ECG signal in which the second type of arrhythmia represented by the section class occurs, the beat class of the beat segment is corrected on the basis of the section class of the first section, by replacing the beat class with another beat class that is compatible with the section class, while the section class is maintained. The 103 rejection of claims 1 and 6-7 has been withdrawn. See the Examiner’s Note section below for further details.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
While the specification discloses “a microprocessor” (¶22), the specification does not disclose “one or more processors” as recited in claims 1 and 7;
While the specification discloses “a class” (¶9), the specification does not disclose “a beat class” as recited in claims 1 and 7;
While the specification discloses “a class” (¶10), the specification does not disclose “a section class” as recited in claims 1 and 7;
While Fig. 3 shows the 1st Artificial Neural Network and the 2nd Artificial Neural Network working separately, the specification does not disclose “the beat class and the section class are estimated independently of each other” as recited in claims 1 and 7; and
While the specification discloses “may correct one of the estimated class corresponding to the beat segment included in the first section of the ECG signal and the estimated class corresponding to the first section of the ECG signal on the basis of the other, if it is determined from a result of the verification that the class estimation for either the beat segment included in the first section of the ECG signal or the first section of the ECG signal is incorrect (i.e., the estimated class corresponding to the beat segment included in the first section of the ECG signal and the estimated class corresponding to the first section of the ECG signal are incompatible with each other)” (¶42) and “for example, as shown in FIG. 3 , assuming that the second artificial neural network estimates the class corresponding to the first section of the ECG signal is the class representing AFib (S 100 ), and that the first artificial neural network estimates each of the classes corresponding to 11 beat segments among 19 beat segments included in the first section of the ECG signal is the class representing APC (labeled “S”) and each of the classes corresponding to 8 beat segments among the 19 beat segments is the class representing a normal ECG (labeled “N”) (S 200 ), the verification unit 230 may correct the estimated class corresponding to the 11 beat segments (i.e., the class representing APC) to the class representing a normal ECG (i.e., S->N), on the basis of the estimated class corresponding to the first section of the ECG signal (i.e., the class representing AFib) (S 300 )” (¶43), the specification does not disclose “replacing the beat class with another beat class that is compatible with the section class, while the section class is maintained” as recited in claims 1 and 7.
Claim Objections
Claim 7 is objected to because of the following informalities: “bases” in line 8 should recite –basis--. Appropriate correction is required.
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” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
steps of…receiving, estimating, estimating, and mutually verifying in claim 1; and
the verifying step in claim 1.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 7 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 7 includes the limitation of “receive an electrocardiogram (ECG) signal measured from a human body by a wearable monitoring device.” As such, the limitation requires that a wearable monitoring device would encompass being in contact with a patient (human organism) under the broadest reasonable interpretation. Applicant should be recommended to change the claimed limitation to --receive an electrocardiogram (ECG) signal configured to be measured from a human body by a wearable monitoring device-- in order to overcome this 101 rejection.
Claims 1 and 6-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea.
Step 1
The claimed invention in claims 1 and 6-7 are directed to statutory subject matter as the claims recite a method and a system for estimating arrhythmia using a composite artificial neural network.
Step 2A, Prong One
Regarding claims 1 and 7, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsection (III)).
Regarding claim 1, the limitations of “estimating…a beat class of each of a plurality of beat segments included in a first section of, the ECG signal, the beat class representing a first type of arrhythmia that is capable of being estimated on a beat segment basis or representing a normal ECG; estimating…a section class of the first section of the ECG signal, the section class representing a second type of arrhythmia that is capable of being estimated from rhythm changes between consecutive beat segments; and mutually verifying…the beat class of each beat segment included in the first section of the ECG signal and the section class of the first section of the ECG signal by determining whether the beat class and the section class are incompatible with each other, wherein the beat class is determined to be incompatible with the section class in response to determining that the first type of arrhythmia represented by the beat class cannot be present in a section of the ECG signal in which the second type of arrhythmia represented by the section class occurs, and wherein in the verifying step, in response to the beat class of a beat segment included in the first section of the ECG signal being determined to be incompatible with the section class of the first section of the ECG signal, the beat class of the beat segment is corrected on the basis of the section class of the first section, by replacing the beat class with another beat class that is compatible with the section class, while the section class is maintained” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional analyzing a printout of an ECG signal and estimating a first type of arrhythmia from the beat segments, estimating a second type of arrhythmia estimated from rhythm changes between consecutive beat segment of the ECG signal, determining whether the first arrhythmia type and the second arrhythmia type are incompatible with each other, wherein the beat class is determined to be incompatible with the section class in response to determining that the first type of arrhythmia represented by the beat class cannot be present in a section of the ECG signal in which the second type of arrhythmia represented by the section class occurs, and in response to the beat class of a beat segment included in the first section of the ECG signal being determined to be incompatible with the section class of the first section of the ECG signal, the beat class of the beat segment is corrected on the basis of the section class of the first section, by replacing the beat class with another beat class that is compatible with the section class, while the section class is maintained.
Regarding claim 7, the limitations of “estimate a beat class of each of a plurality of beat segments included in a first section of the ECG signal, the beat class representing a first type of arrhythmia that is capable of being estimated on a beat segment bases or representing a normal ECG; estimate a section class of the first section of the ECG signal, the section class representing a second type of arrhythmia that is capable of being estimated from rhythm changes between consecutive beat segments; and mutually verify the beat class of each beat segment included in the first section of the ECG signal and the section class of the first section of the ECG signal by determining whether the beat class and the section class are incompatible with each other, wherein the beat class is determined to be incompatible with the section class in response to determining that the first type of arrhythmia represented by the beat class cannot be present in a section of the ECG signal in which the second type of arrhythmia represented by the section class occurs, and in response to the beat class of a beat segment included in the first section of the ECG signal being determined to be incompatible with the section class of the first section of the ECG signal, correct the beat class of the beat segment on the basis of the section class of the first section, by replacing the beat class with another beat class that is compatible with the section class, while the section class is maintained” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional analyzing a printout of an ECG signal and estimating a first type of arrhythmia from the beat segments, estimating a second type of arrhythmia estimated from rhythm changes between consecutive beat segment of the ECG signal, determining whether the first arrhythmia type and the second arrhythmia type are incompatible with each other, wherein the beat class is determined to be incompatible with the section class in response to determining that the first type of arrhythmia represented by the beat class cannot be present in a section of the ECG signal in which the second type of arrhythmia represented by the section class occurs, and in response to the beat class of a beat segment included in the first section of the ECG signal being determined to be incompatible with the section class of the first section of the ECG signal, the beat class of the beat segment is corrected on the basis of the section class of the first section, by replacing the beat class with another beat class that is compatible with the section class, while the section class is maintained.
Step 2A, Prong Two
For claims 1 and 7, the judicial exception is not integrated into a practical application. In particular, claims 1 and 7 recite one or more processors and receiving an electrocardiogram (ECG) signal measured from a human body by a wearable monitoring device. The one or more processors are recited at a high-level of generality and amount to nothing more than parts of a generic computer. Receiving an ECG signal from a wearable monitoring device amounts to nothing more than pre-solution activity of data gathering. Additionally, Applicant includes details of a composite artificial neural network, a first artificial neural network, and a second artificial neural network which are nothing more than the computer implementation/automation of an abstract mental process of screening a patient, which is what a physician typically does with a patient in a diagnostic setting. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
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 element of receiving an ECG signal from a wearable monitoring device amounts to nothing more than pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, the wearable monitoring device is recited at a high level of generality and is a well-understood, routine, and conventional structure as evidenced by US 20020072682 (¶26-a conventional ECG monitor; ¶27-these components interpose between conventional electrodes worn by a patient and a conventional lead-wire cable of a conventional ECG monitor), US 20220369983 (Abstract-a wearable ECG acquisition unit (40) recording 12-lead ECG from torso positions of electrode sensors on user's body thereby permitting unrestrained free movement during recording without compromising on accuracy achieved by conventional 12-lead ECG system), US 20210121114 (¶3-a known electrocardiograph measures the electrocardiographic waveform of a user by detecting voltage at the surface of the skin of a living body caused by cardiac activity), and US 20130345539 (¶4-an electrocardiograph (ECG) system monitors the electrical heart activity of a patient. Conventional ECG systems utilize electrodes or sensors which are placed on a patient's chest in specific locations to detect the electrical impulses generated by the heart during each beat). Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Regarding dependent claim 6, the limitations of claims 1 and 7 further define the limitations already indicated as being directed to the abstract idea.
Claim 6 further recites a non-transitory computer-readable recording medium which is recited at a high-level of generality and amounts to nothing more than a part of a generic computer.
Examiner’s Note
Claims 1 and 6-7 distinguish over the prior art but are still rejected under 35 USC § 101.
The following is a statement of reasons for the indication of overcoming the prior art:
The scope of the beat class representing a first type of arrhythmia that is capable of being estimated on a beat segment basis or representing a normal ECG; the section class representing a second type of arrhythmia that is capable of being estimated from rhythm changes between consecutive beat segments; mutually verifying the beat class of each beat segment included in the first section of the ECG signal and the section class of the first section of the ECG signal by determining whether the beat class and the section class are incompatible with each other; and in response to the beat class of a beat segment included in the first section of the ECG signal being determined to be incompatible with the section class of the first section of the ECG signal, the beat class of the beat segment is corrected on the basis of the section class of the first section, by replacing the beat class with another beat class that is compatible with the section class, while the section class is maintained were not found in the prior art alone or in combination with one another to be obvious over the prior art of record. The closest prior art of record is US 20220039729; however it fails to recite the beat class representing a first type of arrhythmia that is capable of being estimated on a beat segment basis or representing a normal ECG; the section class representing a second type of arrhythmia that is capable of being estimated from rhythm changes between consecutive beat segments; mutually verifying the beat class of each beat segment included in the first section of the ECG signal and the section class of the first section of the ECG signal by determining whether the beat class and the section class are incompatible with each other; and in response to the beat class of a beat segment included in the first section of the ECG signal being determined to be incompatible with the section class of the first section of the ECG signal, the beat class of the beat segment is corrected on the basis of the section class of the first section, by replacing the beat class with another beat class that is compatible with the section class, while the section class is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20240164692: ¶71-the first analysis divided waveform data, together with the segment type information derived by the second derivation unit 11 G using the segmentation estimation model 13 D input with the second analysis divided waveform data; ¶121-corrects the electrocardiographic condition information.
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/LAURA HODGE/Examiner, Art Unit 3792
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