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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/15/24 and 4/7/25 are being considered by the examiner.
Claim Objections
Claims 3 and 9 are objected to because of the following informalities: the limitation “which of classes representing a first type of arrhythmia the beat segment included in the first section of the ECG signal corresponds to” should recite –which classes the beat segment included in the first section of the ECG signal representing a first type of arrhythmia corresponds to-- for better clarity. Appropriate correction is required.
Claims 4 and 10 are objected to because of the following informalities: the limitation “which of classes” should recite –which classes-. 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…” estimating a class corresponding to a beat segment in claim 1; and
“steps of…” estimating a class corresponding to the first section of the ECG signal 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
a verification unit in claim 7.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
For a verification unit in claim 7, the specification discloses “the arrhythmia estimation system 200 according to one embodiment of the invention may comprise…a verification unit 230” (¶28). Therefore, the Examiner is interpreting the verification unit to be a part of the arrhythmia estimation system.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim5 and 11 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.
In claims 5 and 11, the limitation of “on the basis of the other” seems unclear. It remains unclear what this means for the verifying step. The Examiner is interpreting this limitation to mean that 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 compared and one of the two is corrected based on the comparison.
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 1-11 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 1-11 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 claims 1 and 7, the limitations of “estimating a class corresponding to a beat segment included in a first section of an electrocardiogram (ECG) signal; estimating a class corresponding to the first section of the ECG signal; and mutually verifying 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 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 print out of a beat segment of a first section of an electrocardiogram (ECG) signal to estimate a class, estimating a class based on a print out of a first section of the ECG signal, and further verifying each previously determined class.
Step 2A, Prong Two
For claims 1 and 7, the judicial exception is not integrated into a practical application. In particular, claim 7 recites “a first estimation unit, a second estimation unit, and a verification unit.” The instant specification discloses “the arrhythmia estimation system 200 may be digital equipment having a memory means and a microprocessor for computing capabilities” (¶22) and “the arrhythmia estimation system 200 according to one embodiment of the invention may comprise a first estimation unit 210, a second estimation unit 220, a verification unit 230, a communication unit 240, and a control unit 250” (¶28). The first estimation unit, second estimation unit, and verification unit are a part of the arrhythmia estimation system that uses a microprocessor for computing capabilities. Therefore, the first estimation unit, second estimation unit, and verification unit are recited at a high-level of generality and amount to nothing more than parts of a generic computer. Additionally, Applicant includes 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. 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 claims 2-6 and 8-11, the limitations of claims 1 and 7 further define the limitations already indicated as being directed to the abstract idea.
Claims 2 and 8 further define details about the artificial neural networks 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.
Claims 3 and 9 further define the mental process abstract idea. The limitations of “estimating which of classes representing a first type of arrhythmia the beat segment included in the first section of the ECG signal corresponds to, and wherein the first type of arrhythmia includes arrhythmia capable of being estimated on a beat segment basis” 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 print out of the first section of the ECG signal and determining a first type of arrhythmia based on the class. Additionally, the first 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.
Claims 4 and 10 further the mental process abstract idea. The limitations of “estimating which of classes representing a second type of arrhythmia the first section of the ECG signal corresponds to, and wherein the second type of arrhythmia includes arrhythmia capable of being estimated from rhythm changes between consecutive beat segments” 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 print out of the first section of the ECG signal and determining a second type of arrhythmia based on the class. Additionally, the 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.
Claims 5 and 11, further the mental process abstract idea. The limitations of “wherein in the verifying step, 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 is corrected on the basis of the other, in response to 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 being incompatible with each other” 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 print outs of the respective classes and correcting a class if they are incompatible with each other.
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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Li (US 20220039729 filed on 8/9/21).
Regarding claims 1 and 7, Li teaches a method and a system for estimating arrhythmia using a composite artificial neural network, comprising: a first estimation unit configured to estimate a class corresponding to a beat segment included in a first section of an electrocardiogram (ECG) signal, using a first artificial neural network (¶26-applies the ECG data to a first neural network for delineation and may further quantify a likelihood of a presence of at least one of a P-wave, QRS complex, or T-wave at each of the plurality of time points); a second estimation unit configured to estimate a class corresponding to the first section of the ECG signal, using a second artificial neural network (¶27-applies the ECG data to a second neural network for classification, the second plurality of instructions may quantify a likelihood of a presence of the one or more abnormalities, conditions, or descriptors, and may apply a threshold to at least one value in the output of the second neural network and assign at least one label corresponding to the one or more abnormalities, conditions, or descriptors if the value exceeds a threshold); and a verification unit configured to mutually verify 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 (¶144-an exemplary process for determining certainty in a classification system and automatically generating a report regarding the presence of an anomaly and/or condition is illustrated; ¶151-the certainty of the classification algorithm may alternatively be determined by, or may be further informed by, determining the area under the curve (AUC) for a Receiver Operating Characteristic (ROC) Curve. Specifically, the sensitivity of the neural network may be plotted against 1-specificity and the area under the curve may inform the accuracy of the model. The specificity may be determined by dividing the number of true positives by the sum of the true positives and the false negatives. Further “1-specificity” may be determined by the number false positives by the sum of false positives plus true negatives. An area under the curve value close to 1 may indicate an accurate model).
Regarding claims 2 and 8, Li teaches the method and the system of claims 1 and 7, wherein the first artificial neural network and the second artificial neural network are configured in parallel, and the same ECG signal is inputted to the first artificial neural network and the second artificial neural network (¶88-apply pre-processed ECG data 55 to the first neural network; ¶99-classification at step 58 involves applying a second neural network (i.e., classification neural network) to pre-processed ECG data 55; Fig. 4-see multiple pathways involving ECG data 55).
Regarding claims 3 and 9, Li teaches the method and the system of claims 1 and 7, wherein the first artificial neural network is capable of estimating which of classes representing a first type of arrhythmia the beat segment included in the first section of the ECG signal corresponds to, and wherein the first type of arrhythmia includes arrhythmia capable of being estimated on a beat segment basis (¶104-atrial fibrillation (AFIB), right bundle branch block (RBBB) and, and premature ventricular complex (PVC); ¶101-classifier 41 may recover the output of the classification neural network as a vector of size q. The values in the vector correspond to the presence of each label at each time point or each time window. For example, the output of the classification neural network may be the vector [0.98: 0.89; 0.00] with the corresponding labels for each element of the vector: Right Bundle Branch Block; Atrial Fibrillation; Normal ECG).
Regarding claims 4 and 10, Li teaches the method and the system of claims 1 and 7, wherein the second artificial neural network is capable of estimating which of classes representing a second type of arrhythmia the first section of the ECG signal corresponds to, and wherein the second type of arrhythmia includes arrhythmia capable of being estimated from rhythm changes between consecutive beat segments (¶99-the input of the second neural network may be one or more multi-lead cardiac signals with variable length that is pre-processed; ¶33-classification on the ECG data to classify beats of the plurality of beats as normal, premature atrial complexes (PAC) or premature ventricular complexes (PVC); ¶187; Fig. 4).
Regarding claims 5 and 11, Li teaches the method and the system of claims 1 and 7, wherein in the verifying step, 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 is corrected on the basis of the other, in response to 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 being incompatible with each other (¶106-the output of the convolutional neural network identified four labels at various time points including premature ventricular complex (PVC) and Normal. Those labels were then applied to the second neural network which produced the refined output “premature ventricular complex.” In this example, the network correctly recognized a premature ventricular complex (PVC, the fifth and largest beat) in the first part of the signal while the second part of the signal is considered normal. As the cardiac signal includes abnormality, it cannot therefore be considered as normal, and the accumulated output is therefore PVC).
Regarding claim 6, Li teaches a non-transitory computer-readable recording medium having stored thereon a computer program for executing the method of claim 1 (¶72-hardware and software components of system device 14; claim 25-non-transitory computer-readable memory medium).
Conclusion
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/L.N.H./Examiner, Art Unit 3792 /AMANDA L STEINBERG/Examiner, Art Unit 3792