DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see page 6, filed 04/21/2026, with respect to claim objections have been fully considered and are persuasive. The previously-held claim objection has been obviated by an amendment to the claims. The previously-held claim objection has been withdrawn. However, there is a new claim objection herein that is necessitated by Applicant’s claim amendments. Please see claim objections hereinbelow.
Applicant’s arguments, see page 6, filed 04/21/2026, with respect to 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The previously-held 35 U.S.C. 112(b) rejections have been obviated by a amendments to the claims. The previously-held 35 U.S.C. 112(b) rejections have been withdrawn. However, there are new 35 U.S.C. 112(b) rejections herein that are necessitated by Applicant’s claim amendments. Please see 35 U.S.C. 112(b) rejections hereinbelow.
Applicant’s arguments, see pages 7-11, filed 04/21/2026, with respect to 35 U.S.C. 101 rejections have been fully considered but they are not persuasive. The Applicant argues that the claim amendments overcome the 101 rejection. The Applicant argues that amended claim 11 recites additional elements that integrate the judicial exception into a practical application under the second prong of Step 2A because the claim comprises an additional feature or a combination of features which demonstrates an improvement to the conventional medical data processing technology, as discussed in MPEP 2106.05(a). The Applicant argues that the claimed invention addresses technical problems related to the inefficiency and accuracy of processing large volumes of medical signal data, specifically processing long-term electrocardiogram (ECG) monitoring. The Applicant further argues that the claimed invention is a specialized medical data system that solves the problem of information overload in long-term heart monitoring. The Applicant argues that the claimed invention improves the server’s ability to handle high-volume data streams by transforming raw waveforms into a more efficient, structured format. The Applicant argues the server divides the ECG signal into segments based on morphological features like peak points, signal slopes, and widths, as recited in the feature “dividing the electrocardiogram signal into a plurality of signal segments according to signal waveforms by extracting interval sections from the electrocardiogram signal and extracting labels corresponding to each section based on morphology within the interval sections including at least one of peak points, signal slopes, or signal widths, and setting each of the signal segments to one of the pre-set category values”. The Applicant further argues that unlike a general-purpose computer that treats an ECG as a monolithic data file, this system performs real-time data reduction and categorization. The Applicant argues that by pre-calculating the expected analysis time based on detected patterns, the computer manages its own processing and transmission resources more efficiently. The Applicant argues that this is a technical improvement in data throughput management – allowing the system to handle a lengthy measurement period (e.g., manual analysis of 3 to 6 hours for 24 hours of data) that would otherwise crash or bottleneck a standard medical data server.
This is not found persuasive. Claim 11 is still found to be rejected under 35 U.S.C. 101 as being directed to an abstract idea (i.e., mental process) without significantly more and without being integrated into a practical application. The limitation dividing the electrocardiogram signal into a plurality of signal segments according to signal waveforms by extracting interval sections from the electrocardiogram signal and extracting labels corresponding to each section based on morphology within the interval sections including at least one of peak points, signal slopes, or signal widths, and setting each of the signal segments to one of the pre-set category values” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could mentally divide (i.e., observe/evaluate) the electrocardiogram signal into a plurality of signal segments according to signal waveforms and could mentally extract interval sections from the electrocardiogram signal. In this case, a human could also mentally extract labels corresponding to each section based on morphology within the interval sections. In this case, a human could also mentally assign each of the signal segments to one of the pre-set category values. This indicated limitation by the Applicant here is directed to an abstract idea that could be performed mentally or with pen and paper. Abstract ideas cannot provide a practical application or significantly more. It is also noted that claim 11 doesn’t recite any limitations regarding being limited by time.
The Applicant further argues that along with the division step of the ECG signal, the claimed classification features (“wherein the data includes pattern information regarding the electrocardiogram signal of the target object when the target object feels pain, frequencies of patterns occurring in the electrocardiogram signal, an occurrence period of the patterns, and data regarding the patterns per a predetermined unit period of the electrocardiogram signal, and wherein the symptom detection information at the time of measurement includes symptom detection information that is input by the object, questionnaire data in communication with the object, and past medical history information of the object; generate a second classification data regarding the electrocardiogram signal based on the data and the symptom information”) improves the computer’s search and retrieval functionality with its specific signal processing technique applied to ECG waveform morphology.
This is not found persuasive. As indicated hereinabove, claim 11 is still found to be rejected under 35 U.S.C. 101 as being directed to an abstract idea (i.e., mental process) without significantly more and without being integrated into a practical application. It is noted that the indicated limitations are directed to a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a person may mentally generate data and symptom detection information by using the received first classification data and by recognizing events in the signal. A person may also mentally generate second classification data by using the generated data and symptom information. This indicated limitation by the Applicant here is directed to an abstract idea that could be performed mentally or with pen and paper. Abstract ideas cannot provide a practical application or significantly more. It is also noted that claim 11 doesn’t recite any limitations regarding being limited by time. The Examiner notes that if the limitation “wherein the data includes pattern information regarding the electrocardiogram signal of the target object when the target object feels pain, frequencies of patterns occurring in the electrocardiogram signal, an occurrence period of the patterns, and data regarding the patterns per a predetermined unit period of the electrocardiogram signal, and wherein the symptom detection information at the time of measurement includes symptom detection information that is input by the object, questionnaire data in communication with the object, and past medical history information of the object” was intended to be interpreted as information that was simply received, instead of generated, such a limitation would simply amount to transmitting/receiving various pieces of data to a computer in a network. It is noted that “use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) … does not integrate a judicial exception into a practical application” (MPEP 2106.05(f)(2)). Hence this limitation would simply amount to generic computers executing insignificant extra-solution activity. The Examiner also notes that the courts have recognized receiving or transmitting data over a network as well-understood, routine, and conventional computer functions (MPEP 2106.05(d)(II)(i.)). Please see 35 U.S.C. 101 rejections hereinbelow.
Applicant’s arguments, see pages 11-16, filed 04/21/2026, with respect to 35 U.S.C. 103 rejections have been fully considered and are persuasive. The 35 U.S.C. 103 rejections have been obviated by amendments to the claims. The 35 U.S.C. 103 rejections have been withdrawn. Further search and consideration was conducted and it was determined that the claims are currently free of prior art, as indicated hereinbelow.
Claim Objections
Claim 11 objected to because of the following informalities:
Page 3, line 14: “the first classification data, and the second classification data” should be changed to “the first classification data and the second classification data”. Please remove comma.
Appropriate correction is required.
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 11 and 15-16 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 11 recites the limitation “an object” in line 11, whereas an object was already introduced in claim 11 (line 3). It is unclear whether the Applicant intended to claim the same or a different object. Consider changing to “the object”.
Claim 11 recites the limitation "the first target object" on page 3 (lines 2-3). There is insufficient antecedent basis for this limitation in the claim. It is unclear if “the first target object” is supposed to correspond to “the object” as previously introduced in the claim.
Claim 11 recites the limitation "the target object" on page 3 (lines 4-5 – 2 instances). There is insufficient antecedent basis for this limitation in the claim. It is unclear if “the target object” is supposed to correspond to “the first target object” or “the object” as previously included in the claim.
Claim 11 recites the limitation “questionnaire” in line 16, whereas a questionnaire was previously introduced in claim 11 (Page 3, line 9). It is unclear whether the Applicant intended to claim the same or a different questionnaire.
Claim 11 recites the limitation "the first target object" on page 3 (line 16). It is unclear if “the first target object” is supposed to correspond to “the object” or “the target object” as previously introduced in the claim.
Claim 11 recites the limitation “one or more labels” on page 4 (lines 10-11), whereas labels (first and second) were already introduced in claim 11. It is unclear whether the Applicant intended to claim the same or a different labels.
*All other claims are rejected due to their dependency on rejected claims.
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 11 and 15-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process of receiving information, analyzing it, communicating/transmitting results of analysis for displaying, and transmitting a further analysis request to an analyst) without significantly more.
Step 1
Independent claim 11 is directed to an electrocardiogram monitoring system (i.e., system/machine) and thus meets the requirements for step 1.
Step 2A, Prong 1
Claim 11 recites the following limitations which are interpreted as potentially inclusive of an abstract idea:
“classifying labels according to pre-set category values with respect to the electrocardiogram signal of the object” – This limitation is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could mentally classify labels according to pre-set category values with respect to the electrocardiogram signal of the object.
“dividing the electrocardiogram signal into a plurality of signal segments according to signal waveforms by extracting interval sections from the electrocardiogram signal” – This limitation is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could mentally divide (i.e., observe/evaluate) the electrocardiogram signal into a plurality of signal segments according to signal waveforms and could mentally extract interval sections from the electrocardiogram signal.
“extracting labels corresponding to each section based on morphology within the interval sections including at least one of peak points, signal slopes, or signal widths” – A person may mentally extract labels corresponding to each section based on morphology within the interval sections.
“setting each of the signal segments to one of the pre-set category values” – A person may mentally assign each of the signal segments to one of the pre-set category values.
“generate data and symptom detection information at a time of measurement of the first target object using the first classification data, wherein the data includes pattern information regarding the electrocardiogram signal of the target object when the target object feels pain, frequencies of patterns occurring in the electrocardiogram signal, an occurrence period of the patterns, and data regarding the patterns per a predetermined unit period of the electrocardiogram signal, and wherein the symptom detection information at the time of measurement includes symptom detection information that is input by the object, questionnaire data in communication with the object, and past medical history information of the object” – A person may mentally generate data and symptom detection information by using the received first classification data and by recognizing events in the signal.
“generate a second classification data regarding the electrocardiogram signal based on the data and the symptom information” – A person may mentally generate second classification data by using the generated data and symptom information.
“generate output data associated with the electrocardiogram signal based on the first classification data, and the second classification data, wherein the output data includes the electrocardiogram signal, the first and second classification data, and a result data of a questionnaire of the first target object” – A person may mentally generate output data by recognizing events in the signal and based on generated classification data.
“generate first labels by classifying the electrocardiogram signal based on morphological characteristics of signal segments” – A person may mentally generate first labels by recognizing events in the signal.
“modify second labels based on the first label” – A person may mentally modify/generate second labels based on first labels
“calculate an expected analysis time based on an analysis condition received from the medical staff terminal” – An expected analysis time is simply an estimate of how long it will take an analyst to analyze the data (Specification – Par. [0064). A person may mentally estimate an expected analysis time based on previous experience or benchmarks
"...indicating whether the expected analysis time is within a pre-set target time wherein the expected analysis time is calculated based on the analysis condition” – A human may mentally/mathematically compare the expected analysis time with a pre-set target time to determine whether the expected time exceeds a target time
Step 2A, Prong 2
Claim 11 recites additional elements which do not amount to a practical application for the abstract idea when analyzed individually or in combination:
an electrocardiogram measuring device configured to measure an electrocardiogram signal from an object and transmit the electrocardiogram signal to an electrocardiogram data processing server – insignificant pre-solution activity, i.e. mere data gathering
an electrocardiogram data processing server, comprising: a processor; a computer readable memory configured to store computer readable instructions executable by the processor; a communication unit; a medical staff terminal; and an analyst terminal -– These are all interpreted as general purpose computers recited at a high level of generality. They amount to no more than applying the abstract idea on a generic computer.
Receive the electrocardiogram signal from the electrocardiogram measuring device; receive a first classification data regarding the electrocardiogram signal of the object; output the electrocardiogram signal and the label information to an output unit of medical staff terminal; … transmit the expected analysis time to the medical staff terminal; transmit result data to the medical staff terminal …; connect to an analyst terminal selected from among a plurality of analyst terminals to allow input of an analysis comment on the electrocardiogram signal; transmit an analysis request signal to the analyst terminal after receiving confirmation of the expected analysis time from the medical staff terminal; connect to the electrocardiogram data processing server via a network; receive … electrocardiogram output data including the electrocardiogram signal and label information; receive an input for the analysis condition including at least a first label and a second label; and transmit the analysis condition to the electrocardiogram data processing server; connect to the electrocardiogram data processing server; and receive interface data for inputting analysis data received from the electrocardiogram data processing server. – These limitations describe transmitting/receiving various pieces of data to various computers in the network. The communication of information among computers is considered ordinary functionality of a computer. “Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) … does not integrate a judicial exception into a practical application” (MPEP 2106.05(f)(2)). Hence these limitations amount to generic computers executing insignificant extra-solution activity.
…by a classification algorithm – The classification algorithm is described at a high level of generality in the Applicant’s specification, with “classification algorithm” is explained to be generated through learning by various machine learning, reinforcement learning algorithms, and neural networks (Par. [0060]). The involvement of the “classification algorithm” is insignificant extra-solution activity in that it amounts to generic computer implementation of the abstract idea [MPEP 2106.04(a)(2)(III)(C)].
Display electrocardiogram output data including the electrocardiogram signal and label information – insignificant post-solution activity that does not meaningfully limit the claim. Hence the claim is directed to an abstract idea without a practical application.
Step 2B
Claim 11 recites additional elements which do not amount to significantly more than the abstract idea when analyzed individually or in combination for the same reasons identified above. Any limitations which were considered insignificant extra-solution activity are reconsidered in step 2B to determine if they are also well-understood, routine, and conventional.
an electrocardiogram measuring device configured to measure an electrocardiogram signal from an object and transmit the electrocardiogram signal to an electrocardiogram data processing server – Eikefjord, et al. (U.S. Patent No. 5,097,830), Col. 9, lines 28-53: “The first transfer relay switch 16 has a terminal 100 connected by a line 102 to one input of a conventional ECG monitoring circuit 104, such as of the type as used in the Heartstart 1000 defibrillator. … When the relays 16 and 18 are in a patient monitoring position as …, the ECG circuit 104 is coupled by the electrodes 22, 24 to the patient for picking up ECG signals from the patient.”
Receive the electrocardiogram signal from the electrocardiogram measuring device; receive a first classification data regarding the electrocardiogram signal of the object; output the electrocardiogram signal and the label information to an output unit of medical staff terminal; … transmit the expected analysis time to the medical staff terminal; transmit result data to the medical staff terminal …; connect to an analyst terminal selected from among a plurality of analyst terminals to allow input of an analysis comment on the electrocardiogram signal; transmit an analysis request signal to the analyst terminal after receiving confirmation of the expected analysis time from the medical staff terminal; connect to the electrocardiogram data processing server via a network; receive … electrocardiogram output data including the electrocardiogram signal and label information; receive an input for the analysis condition including at least a first label and a second label; and transmit the analysis condition to the electrocardiogram data processing server; connect to the electrocardiogram data processing server; and receive interface data for inputting analysis data received from the electrocardiogram data processing server. – MPEP 2106.05(d)(II)(“i. Receiving or transmitting data over a network”)
…by a classification algorithm – MPEP 2106.05(d)(II)(“i. Receiving or transmitting data over a network); Elghazzawi (US 5,819,007) – Comparison of the classification results between neural networks and conventional algorithms illustrate that the use of conventional algorithms for ECG beat classification is still more desirable because they generally score higher in sensitivity and accuracy than neural networks (Col. 3, lines 8-12).
display electrocardiogram output data including the electrocardiogram signal and label information – Eikefjord, et al. (U.S. Patent No. 5,097,830), Col. 19, lines 54-58: “This display may be a conventional split screen display with the lower half of the screen containing commands and messages and the upper half of the screen displaying ECG signals.”
Hence the claim is directed to an abstract idea without a practical application and without significantly more.
Dependent claims
Regarding dependent claim 15, the limitations only further define insignificant extra-solution activity of generic computer implementation of the abstract idea.
Regarding dependent claim 16, the limitations only further define the abstract idea.
Therefore, claims 15 and 16 are unpatentable under 35 U.S.C. 101.
Prior Art
Claims 11 and 15-16 are currently free of the prior art.
The prior art of record (namely Li, et al. and Sadeghi, et al.) does not disclose either or fairly suggest either singly or in combination an electrocardiogram monitoring system comprising: an electrocardiogram measuring device configured to measure an electrocardiogram signal from an object and transmit the electrocardiogram signal to an electrocardiogram data processing server;
the electrocardiogram data processing server, comprising:
a processor;
a computer readable memory configured to store computer readable instructions executable by the processor; and
a communication unit,
wherein the computer readable instructions include:
receive the electrocardiogram signal of an object from the electrocardiogram measuring device;
receive a first classification data regarding the electrocardiogram signal of the object, wherein the first classification data comprises labels classified according to pre-set category values with respect to the electrocardiogram signal of the object, and wherein the receiving the first classification data further comprises: dividing the electrocardiogram signal into a plurality of signal segments according to signal waveforms by extracting interval sections from the electrocardiogram signal and extracting labels corresponding to each section based on morphology within the interval sections including at least one of peak points, signal slopes, or signal widths, and setting each of the signal segments to one of the pre-set category values;
generate data and symptom detection information at a time of measurement of the first target object using the first classification data, wherein the data includes pattern information regarding the electrocardiogram signal of the target object when the target object feels pain, frequencies of patterns occurring in the electrocardiogram signal, an occurrence period of the patterns, and data regarding the patterns per a predetermined unit period of the electrocardiogram signal, and wherein the symptom detection information at the time of measurement includes symptom detection information that is input by the object, questionnaire data in communication with the object, and past medical history information of the object;
generate a second classification data regarding the electrocardiogram signal based on the data and the symptom information;
generate output data associated with the electrocardiogram signal based on the first classification data, and the second classification data, wherein the output data includes the electrocardiogram signal, the first and second classification data, and a result data of a questionnaire of the first target object, wherein first labels are generated by a classification algorithm that classifies the electrocardiogram signal based on morphological characteristics of signal segments, and second labels are labels modified by an analyst based on the first labels;
output the output data to an output unit of a medical staff terminal;
calculate an expected analysis time based on an analysis condition received from the medical staff terminal and transmit the expected analysis time to the medical staff terminal;
transmit result data to the medical staff terminal indicating whether the expected analysis time is within a pre-set target time, wherein the expected analysis time is calculated based on the analysis condition;
connect to an analyst terminal selected from among a plurality of analyst terminals to allow input of an analysis comment on the electrocardiogram signal; and
transmit an analysis request signal to the analyst terminal after receiving confirmation of the expected analysis time from the medical staff terminal;
wherein the medical staff terminal is configured to:
connect to the electrocardiogram data processing server via a network;
receive and display electrocardiogram output data including the electrocardiogram signal and label information;
receive an input for the analysis condition including one or more labels; and
transmit the analysis condition to the electrocardiogram data processing server; and
wherein the analyst terminal is configured to:
connect to the electrocardiogram data processing server; and
receive interface data for inputting analysis data received from the electrocardiogram data processing server.
No other prior art reference or combination of prior art references could currently be found that teaches or renders obvious the limitations of instant claim 11. Due to their dependency on independent claim 11, instant claims 15-16 are also considered to currently be free of the prior art.
As the instant claims are currently considered to be free of the prior art, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a). In particular, the 35 U.S.C. 112 and 101 rejections hereinabove must be overcome. If scope of the claims are changed by any future amendments, the Examiner would need to revisit prior art.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796
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