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 with respect to claims 7 and 15 have been considered but are moot because the claims have been cancelled. The Examiner has acknowledged the amended independent claims 1 and 9 contain the amended subject matter of claims 7 and 15, respectively. The Examiner agrees that the amendments to the subject matter now incorporated into claims 1 and 9 overcome the rejections under 35 USC 112(b).
2. Applicant's arguments filed 06/22/2026 have been fully considered but they are not persuasive in regards to the rejections of claim 1 and 9 under 35 USC 101. On pg. 9 of Remarks, the Applicant asserts that, “amended claim 1 is not directed to an abstract of idea of merely imputing electrocardiogram data into a model and mathematically calculating a risk.” The Examiner respectfully disagrees. The Applicant recites that the amended claims 1 includes, “concrete technical processing flow…”. However, the Examiner contends that the steps recited in the method of claim 1 are not concrete signal processing steps, but rather abstract and based on mathematical concepts. Further, the Applicant asserts that the acquisition and preprocessing of ECG data are not insignificant pre-solution activity or mere data gathering since the amended claim 1 removes a portion of the ECG signal; The Applicant further asserts that the amended claim 1 is based on “concrete ECG signal processing steps that generate valid wave analysis of the normal sinus rhythm ECG data.” The Examiner contends that the amended claim 1 is insignificant pre-solution data gathering, and that the steps of processing the signal are abstract mathematical concepts. The Examiner further contends that the method of signal processing is not concrete, nor is an ECG a concrete object.
On pg. 10-12 of the Remarks filed 06/22/2026, the Applicant asserts that the amended claim 1 and 9 risk determination process does not recite a generic mental process judgement abstract idea or mathematical calculation abstract idea. The Examiner respectfully disagrees. The Examiner has detailed the mathematical concept and mental process abstract ideas in the rejection of amended claims 1 and 9 below (see rejections of claim 1 and 9 under 35 USC 101 in Response to Amendments section).
On pg. 10-12 of the Remarks filed 06/22/2026, the Applicant asserts that “weights to at least some values of the ST segments and QRS complexes operates on concrete morphological features…amended claims 1 and 9 provide a concrete data-preprocessing and risk determination structure…”. The Examiner respectfully disagrees that the weights are based on concrete morphological features, but rather the abstract signal and data obtained from measurements of the features. Further, the Examiner contends that the data-preprocessing is based on abstract mathematical concepts that are not concrete. In summary, the Examiner maintains the rejection of independent claims 1 and 9 under 35 USC 101.
Applicant’s arguments, see pg. 13-20, filed 06/22/2026, with respect to the rejection of claims 1 and 9 under 35 USC 102 have been fully considered and are persuasive. The Examiner agrees that neither Li, Umemoto, or Choi anticipate amended claim 1, nor do any combination of references teach the deficiencies of amended claim 1. The rejections of claims 1 and 9 under 35 USC 102 and 103 have been withdrawn.
Response to Amendment
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
7. Claims 4-6 and 12-14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 is dependent on claim 3, which is cancelled. Similarly, claim 12 is dependent on claim 11, which is cancelled. Therefore, the claims are improper. Claims 5, 6, 13, and 14 are rejected for being dependent on claims 4 and 12. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 5, 6, 9, 12, 13, and 14 are rejected under 35 U.S.C. 101 because the claimed subject matter is directed towards an abstract idea without significantly more than an abstract idea.
Step 1- Is the claim to a statutory category of invention?
Claims 1, 4, 5, and 6 recite a method. Claims 9, 12, 13, and 14 recite a machine (i.e., a device).
Step 2A, prong 1- Does the claim recite a judicial exception?
Regarding claim 1, the claim recites “determining a patient’s risk of developing atrial fibrillation based on the preprocessed electrocardiogram data representing normal sinus rhythm by inputting the preprocessed electrocardiogram data and into a pretrained atrial fibrillation determination model.” The recitation is both a mental process and mathematical concept abstract idea in that the determination of a risk of AFIB can be done based on a judgement or opinion by one of ordinary skill in the art, such as a physician. Further, although the judgement or opinion is “based on preprocessed” ECG data, the steps of inputting data into a model is a mathematical concept in that the model itself is based on mathematical concept abstract ideas since predictive models are algorithm based. In short, one could make a judgement or opinion based on an ECG data input and output into a predictive model algorithm.
Claim 1 also recites, “wherein generating the preprocessed electrocardiogram data comprises: removing a region before a first occurring P-peak and a region after a last occurring T-peak in the electrocardiogram data, and generating the preprocessed electrocardiogram data by dividing the electrocardiogram data from which the regions have been removed into input data each having a first preset time length…”. The recited subject matter is an abstract idea mathematical concept for data processing. Removing regions of the ECG signal and dividing the data based on a preset time length is a mathematical concept abstract idea of signal processing. Removing regions of an ECG signal is a signal processing technique that can be based on filtering out sections of a signal based on an inequality (or any other criteria or threshold the signal must meet). One of ordinary skill could make a calculation to see of the data in a signal meets a criteria during the determination as to if it should be removed or not. Additionally, Dividing a signal data is a fundamental mathematical process.
Claim 1 further recites, “wherein, when determining the patient's risk of developing atrial fibrillation, the pretrained atrial fibrillation determination model determines the patient's risk of developing atrial fibrillation by applying weights to at least some values of ST segments and QRS complexes of the preprocessed electrocardiogram data, wherein the pretrained atrial fibrillation determination model is trained by; labeling the first normal sinus rhythm data and the second normal sinus rhythm data with distinguished marks; and performing training using the training electrocardiogram data associated with the distinguished marks, thereby generating the pretrained atrial fibrillation determination model configured to determine the patient's risk of developing atrial fibrillation in response to an input of the divided input data.” The subject matter of claim 1 is directed to a mathematical concept abstract idea. The steps of applying training weights, labeling training data, and performing training of a determination model are mathematical concept abstract ideas. Determination models are based on algorithms, which are mathematical concept abstract ideas. In summary, the amendments to claim 1 merely recite claimed subject matter directed to training a determination model based on assigned training weights to determine a patient’s risk of developing AFIB. The determination is based entirely on mathematical algorithms in which ECG data is input into, and the determination model is an algorithm in and of itself. Algorithms are abstract idea mental processes and are not eligible for patentability under 35 USC 101.
Regarding claim 9, the claim recites similar mental process and mathematical concept abstract ideas as detailed in claim 1. The only difference between the claimed invention is the implementation of the abstract ideas into a determination unit. The same recited subject matter directed towards a judicial exception for claim 1 is also recited in claim 9, and the same reasoning for patent ineligibility applies to claim 9.
Step 2A, prong 2- Does the claim recite additional elements that integrate the judicial exception into a practical application?
Regarding claim 1, the claim recites “a method for detecting signs of atrial fibrillation in normal sinus rhythm, the method comprising: acquiring electrocardiogram data of a patient; generating preprocessed electrocardiogram data based on at least some specific regions from the electrocardiogram data…. acquiring training electrocardiogram data including first normal sinus rhythm data of patients with a history of developing atrial fibrillation and second normal sinus rhythm data of patients without a history of developing atrial fibrillation…”. The claimed subject matter does not integrate the abstract idea into a practical application. Acquiring ECG data and generating preprocessed data from an ECG amounts to insignificant, pre-solution activity data gathering, and does not implement the abstract idea into a practical application. Further, acquiring training data is merely pre-solution data gathering, and does not implement the abstract idea into a practical application.
Regarding claim 9, the claim recites “ an electrocardiogram data processing unit configured to acquire electrocardiogram data of a patient and generate preprocessed electrocardiogram data based on at least some specific regions from the electrocardiogram data; and an atrial fibrillation determination unit.” As outlined in claim 1, the claimed subject matter does integrate the abstract idea into a practical application, and is merely insignificant pre-solution activity data gathering. Further, the claim implements the abstract idea into generic computer structures defined by the methods of performing abstract ideas. Doing so does not amount to integration of an abstract idea into a practical application. Lastly, acquiring training data is merely pre-solution data gathering, and does not implement the abstract idea into a practical application.
Step 2B- Do the additional elements add significantly more to the judicial exception?
Regarding claim 1, the claim recites “a method for detecting signs of atrial fibrillation in normal sinus rhythm, the method comprising: acquiring electrocardiogram data of a patient; generating preprocessed electrocardiogram data based on at least some specific regions from the electrocardiogram data.” The claimed subject matter does not amount to significantly more than the judicial exception. The claimed subject matter is recited with a high level of generality. Further, acquiring ECG data and generating preprocessed data from an ECG amounts to insignificant, pre-solution activity data gathering.
Regarding claim 9, the claim recites “ an electrocardiogram data processing unit configured to acquire electrocardiogram data of a patient and generate preprocessed electrocardiogram data based on at least some specific regions from the electrocardiogram data; and an atrial fibrillation determination unit.” As outlined in claim 1, the claimed subject matter does not amount to significantly more than an abstract idea, and is merely insignificant pre-solution activity data gathering. Further, the claim implements the abstract idea into generic computer structures defined by the methods of performing abstract ideas. Doing so does not amount to significantly more than an abstract idea. Further, acquiring training data is merely pre-solution data gathering, and does not amount to significantly more than an abstract idea. Lastly, acquiring ECG data and generating preprocessed data from an ECG amounts to insignificant, pre-solution activity data gathering.
Dependent claims
Claim 4 and 12 further limit a mathematical concept.
Claims 5 and 13 further limit extra-solution data gathering.
Claims 6 and 14 further limits data gathering and introduces an abstract idea mental process (comparing data to a threshold value). The claims also recite a generic computer function (transmitting).
Claims 12-14 recite the same abstract ideas of 1-8, the difference being that they are implemented using generic computer structures (processing unit and training unit).
In summary, claims 1, 4, 5, 6, 9, 12, 13, and 14 are directed to a judicial exception without significantly more and without integration into a practical application.
Allowable Subject Matter
Claims 1, 4, 5, 6, 9, 12, 13, and 14 are free of the art. However, the claims are still rejected under 35 USC 112(b) and 101.
Claims 1 and 9 are novel since they recite the steps of preprocessing ECG data by removing the first occurring P-peak and the last occurring T-peak before using the data in the determination model. Claims 1 and 9 are also novel for reciting the steps of assigning training weights to ST segments and QRS complexes of the preprocessed data. The closest prior art is Li et al. (US 20230352180 A1, “Li”). Li teaches an AFib determination model. However, Li’s preprocessing is not based on the same preprocessing steps of removing the first occurring P-peak and the last occurring T-peak of the ECG data. Li also does not assign training weights to the claimed ECG signal segments. Umemoto et al. (US 20230049898 A1, “Umemoto”) is also similar art and discloses a disease risk determination model. However, Umemoto does not disclose the preprocessing and training weight limitations either. For these reasons, the subject matter of claim 1 is novel.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/O.L.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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