DETAILED ACTION
This is responsive to remarks filed on 01/05/2026 in which claims 1-4 are presented for examination; claims 1, and 4 are amended.
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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
Terms, “the one-dimensional Electrocardiogram (ECG) data” “the PQRST”, and “the Euclidean distance” lack antecedent basis. In the context of claim, it is clear that these terms refer to first instance, thus these terms should not be preceded by “the.”
Also, Term “PQRST”, first instance should be spelled out.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: Figure 1 is missing , the numerical labels 101, 102, 103, 104, and 105 as recited throughout the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
a filtration module(101)... claims 1, 2: para 0012 “The filtration module (101) filters the one-dimensional ECG datasets to eliminate the presence of noise and artifacts using a plurality of filtration techniques such as and not limited to
Discrete Wavelet Transformation (DWT) techniques.”
a feature extraction module(102)... claim 1: “[0013] Further, the filtered one-dimensional ECG data is provided to a feature extraction module (102) for extracting a set of pre-defined features from the filtered one-dimensional ECG data using techniques such as fiducial points, adaptive thresholding, lifting based schemes and so on, wherein the extracted features include various combinations of the PQRST complex such as RR, SS, QRS complex, QT, ST segment values present in the one-dimensional ECG data. Multiple combinations of the PQRST complex is extracted based on the disease to be identified. The extracted features from the one-dimensional ECG data is provided to a classification module (103) for the purpose of classifying the
extracted features.
a classification module (103)... in claim 1: [0014] The classification module (103) employs interval and peak detection classification techniques for the purpose of data classification.
a conversion module (104)... in claims 1, 4: para 0014, “The classified data from the classification module (103) is provided to a conversion module (104) for converting classified features from one-dimensional ECG signal present in serial format into a matrix format representing a two-dimensional spectrogram image,”
a remote server module (105)... in claim 1: para 0014 states that “the two-dimensional spectrogram image is uploaded to a remote server module (105) using a wired or wireless network infrastructure”; an embodiment with wired infrastructure will provide support that server module is well known hardware module.
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.
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.
Claims 1-4 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 limitations “a classification module (103), a conversion module (104), and a remote server module (105) ” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Regarding a classification module (103)... in claim 1; para 0014 states “the classification module (103) employs interval and peak detection classification techniques for the purpose of data classification.” However, it does not explicitly state which techniques are being applied. Regarding, a conversion module (104); para 0014 states, “the classified data from the classification module (103) is provided to a conversion module (104) for converting classified features from one-dimensional ECG signal present in serial format into a matrix format representing a two-dimensional spectrogram image”, however it does not explicitly disclose what, or how this conversion is performed. Regarding, a remote server module (105); para 0014 states that “the two-dimensional spectrogram image is uploaded to a remote server module (105) using a wired or wireless network infrastructure.” Here, the limitation claims server module, not the server itself, and specification does not disclose what this server modules is, though para 0014 states that this module can use communication via wired or wireless network infrastructure.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. As described above, the disclosure does not provide adequate structure to perform the claimed function of classification, conversion, and server modules. The specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
Claims 1-4 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.
Regarding claim 1, claim 1 states “compares the extracted features with one or more test data to match the Euclidean Distance.” It is not clear what does it mean to “[compare] the extracted features with one or more test data to match the Euclidean distance”? Does this mean that the features are compared to test data and that a difference between the features and the test data is a Euclidean distance? Or does this mean that one Euclidean distance is computed for the extracted features and another Euclidean distance is computed for the test data and that the two Euclidean distances are somehow “matched”? What is the “test data”? What does it mean for the “Euclidean distance of the features and tests data” to be “equal” or “unequal”? Equal or unequal to what? Does this mean it’s assessing whether two different Euclidean distances are equal or unequal?
In addition, with regard to step d in claim 1, If the features are already classified in step “c,” what is the purpose of the classification in step “d”?
Claims 2-4 are rejected based on rejected claim 1.
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 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claim 1:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?” Yes, it’s a machine(system).
Step 2a Prong 1 (judicial exception)
Step 2A (1): “Does the claim recite an abstract idea, law of nature, or natural phenomenon? Yes , the claim comes under mental processes.
Claim 1 recites:
“A system for detection and classification of cardiac diseases using deep neural network techniques, the system (100) comprising: a. a filtration module (101) for filtering one or more datasets pertaining to the one-dimensional Electrocardiogram (ECG) data obtained from a plurality of individuals, wherein the filtration module (101) filters the one-dimensional ECG datasets to eliminate the presence of noise and artifacts; b. a feature extraction module (102) for extracting a set of pre-defined features from the filtered one-dimensional ECG data, wherein the extracted features include various combinations of the PQRST complex present in the one-dimensional ECG data; c. a classification module (103) for classifying the extracted features from the filtered one-dimensional ECG data for the purpose of cardiac disease detection using interval and peak detection techniques, wherein the classification module (103):i. compares the extracted features with one or more test data to match the Euclidean Distance, wherein if the Euclidean Distance of the extracted features and test data is:
1. equal, then no cardiac disease is detected;
2. unequal, then the presence of cardiac disease is detected; d. a conversion module (104) for converting classified features from the one-dimensional ECG signal into a two-dimensional spectrogram image for neural network-based classification, wherein the conversion module (104) deploys the two-dimensional spectrogram image into a custom deep neural network; e. a remote server module (105) for enabling the display of the detected cardiac disease on one or more user interface devices, wherein the remote server module (105) communicates with the conversion module (104) using a wired or wireless network infrastructure.”
All of the above non-underlined limitations are practically mentally performable with pen and paper. For instance, a user could visually review a plot of ECG signals, filter/remove noisy parts of the signals (e.g., crossing them out or otherwise not considering such portions), extract/identify certain portions of the PSRST complex as interesting features, generate Euclidean distances, and analyze the distances to determine with disease is detected or not (classifying).
Step 2A(2): Prong Two: evaluate whether the claim recites additional elements that integrate the exception into a practical application of the exception. NO
The claim does recite additional elements; however they don’t integrate the exception into a practical application of the exception.
The various “modules” are just using computers as tools to carry out the abstract idea (2106.05(f)(2)) while converting the classified 1D ECG features into a 2D spectrogram image for input to the NN is just reciting the “idea of a solution” (2106.05(f)(1)). Similarly server is being applied in network environment to communicate data.
Step 2B: evaluate whether the claim recites additional elements that amount to an inventive concept (aka “significantly more”) than the recited judicial exception? NO
As discussed previously with respect to Step 2A Prong Two, the additional element in the claim amounts to no more than mere instructions to apply the exception using a generic computer component.
The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Claim 2 is a mathematical concept, claim 3 is mentally performable, and claim 4 appears to be just reciting the “idea of a solution” (2106.05(f)(1)).
Response to Arguments
With regard to prior art, Applicant’s arguments, see Pg. 8-15, filed on 01/05/2026, with respect to prior art have been fully considered and are persuasive. The prior art rejection for claims 1-4 has been withdrawn.
With regard to 35 USC 101, Applicant's arguments filed 01/05/2026 have been fully considered but they are not persuasive.
Remarks, Pg. 5, applicant contends “these operations cannot be practically performed in the human mind. In particular, a) generation of a two-dimensional spectrogram from physiological signals requires computational signal processing; b) deployment of a spectrogram into a deep neural network requires execution of trained machine-learning models; c) and neural network inference cannot be replicated mentally.
The examiner agree that these limitation cannot be practically performed in the human mind, thus these limitations have been addressed as additional limitation in the 35 USC 101 analysis above as just reciting the “idea of a solution” (2106.05(f)(1)). Even, if the limitations above are treated more than idea of solution, it is merely applying the computational signal processing, and machine learning.
Regarding arguments under step 2A, Prong 2, the applicant is arguing more of why the claim limitations are not abstract idea, and correlates limitations not being abstract idea to practical application. Applicant can show that additional limitations integrate the abstract idea into practical application by pointing out Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a), or Applying or using 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 a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e) and Vanda Memo. The claims and specification is devoid of such details; in fact, the specification makes it clear that majority of modules are using well known techniques to perform the claimed function.
Remarks, Pg. 8, applicant contends “specifically, converting one-dimensional ECG signals into two-dimensional spectrogram images changes the structure of the data being processed, enables neural network-based classification that is not feasible on raw 1D signals alone, and allows processing of cardiac signal datasets.
This constitutes an improvement in signal processing and system capability, not merely an improvement in the abstract idea of diagnosing disease. The Office Action states the claims as equivalent to "apply it on a computer." The Applicant respectfully submits that this oversimplifies the claim limitations. The claims do not state "apply ECG analysis on a computer." Instead, they recite how the system processes ECG signals, how the signals are transformed, and how the transformed signals are used by a neural network.”
In making this determination, examiners should determine whether
There is a technical explanation as to how to implement the invention in the specification; and
The claim itself reflects the improvement in technology.
The applicant states “this constitutes an improvement in signal processing and system capability, not merely an improvement in the abstract idea of diagnosing disease.”
However, the claims and specification is devoid of any technical detail that reflects an improvement in signal processing and system capability. Instant specification, para 0014 states: “[0014] The classification module (103) employs interval and peak detection classification techniques for the purpose of data classification. Further, the
classification module (103) compares the extracted features with one or more test data to match the Euclidean Distance, wherein if the Euclidean Distance of the extracted features and test data is equal, then no cardiac disease is detected. In an event where the Euclidean Distance of the extracted features and test data is unequal, then the presence of cardiac disease is detected. The classified data from the classification module (103) is provided to a conversion module (104) for converting classified features from one-dimensional ECG signal present in serial format into a matrix format representing a two-dimensional spectrogram image, wherein the two-dimensional spectrogram image is deployed into a custom layer of a neural network such as a hybrid model of a Convolutional Neural Network (CNN) and Recurrent Neural Network (RNN). Further, the two-dimensional spectrogram image is uploaded to a remote server module (105) using a wired or wireless network infrastructure for enabling the display and/or further analysis of the detected cardiac disease on one or more user interface devices such as mobile phone, tablet and so on. In one embodiment, the user interface device may be an independent and standalone device with a display unit developed for
implementing the system (100).” As can be seen, the specification merely discloses conversion from serial format to matrix format; and provides no details as to how the signal; processing capabilities are being improved.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20210100468 A1 “Methods and systems are provided for automatically diagnosing an electrocardiogram (ECG) using a hybrid system comprising a rule-based system and one or more deep neural networks. In one embodiment, by mapping ECG data to a plurality of features using a convolutional neural network, mapping the plurality of features to a preliminary diagnosis using a decision network, and determining a diagnosis based on the ECG data and the preliminary diagnosis using the rule-based system, a more accurate diagnosis may be determined. In another example, by incorporating both a rule-based system and one or more deep neural networks into the hybrid system, the hybrid system may be more easily adapted for use in various contexts/communities, as the one or more deep learning networks may be trained using context/community specific ECG data.”
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/HUMA WASEEM/Examiner, Art Unit 3686
Supervisory Patent Examiner, Art Unit 3686
/JASON B DUNHAM/
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