DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/02/2025 has been entered.
Response to Arguments,
Arguments filed July 18, 2025 regarding the 112(b) rejections have been fully considered and are persuasive. Applicant's arguments filed July 18, 2025 regarding the 35 USC § 101 have been fully considered but they are not persuasive.
35 USC § 101
Regarding arguments to prongs 2A and 2B of the 35 USC § 101 rejection, it is reminded that judicial exceptions are not integrated into a practical application because mere instruction to implement on a computer, merely using a computer as a tool to perform the abstract idea, adding insignificant extra solution activity, and/or generally linking the use of the abstract idea to a technological environment or field of use is not considered integration into a practical application. In the instant case, the claimed invention utilizes abstract ideas in mathematical concepts and mental processes (as stated below) while using generic computer (paragraph 0009 of the specification recites “a computer is employed for data processing”) to perform the abstract ideas of calculating, comparing, determining, etc. The claims do not purport to improve computer capabilities, but instead invokes computers merely as a tool to automate manual processes. Merely appending structures of which that are well-understood, routine and conventional in the field to the judicial exception is not considered practical application, nor tied to an improvement to computer technology or any other technical field, where ultimately the invention is tied to the comparison of calculated parameters to make a mental determination of a stenosis degree of a coronary artery.
With regards to Applicant’s arguments, a conventional computer performing known mathematical concepts/calculations is not considered an inventive concept, nor is it considered to significantly more than the abstract ideas. Step 2B in the analysis requires us to determine whether the claims do significantly more than simply describe that abstract method, however the claims are only directed ultimately to the comparison of calculated parameters to make a mental determination of a stenosis degree of a coronary artery, and therefore does not constitute significantly more than the abstract ideas of mathematical concepts and mental processes without any practical application, as described below in step 2A. The reference as taught by Rudel (US 20140134654 A1) is merely relied upon to teach the known technique of Applicant’s additional elements of a generic computer being used in a computer-based method for determining a prediction of risk and/or an indication of extent of coronary stenosis (abstract, Paragraph 0018).
Ultimately, as per steps 2A-2B below, there are no limitations in the instant claims that constitute practical application to the abstract ideas, nor are there limitations that are tied to significantly more than the abstract ideas, and thus not patent eligible under 35 USC § 101.
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an non-statutory subject matter (abstract ideas) without significantly more.
Step 1):
Claims 1-8 are tied to methods for analyzing myocardial ischemia in resting electrocardiogram (ECG), which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong |: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Step 2a) Prong One:
The claims 1 and 6 recite, “…establishing a database, comprising to collect a plurality of resting ECG data, wherein each of the resting ECG data comprises a resting ECG and decomposed into a plurality of Intrinsic Mode Functions (IMFs) as a plurality of corresponding bases C1, C2..., and Cn, wherein I Ci I= √ (∫Ci*Ci)dt), i = 1,2,…n, n is a nature number, and Ctotal = √ (Σ I Ci I* I Ci I ), wherein the corresponding bases at least comprises C1, C2, and C3, calculating a corresponding active index of each of the resting ECG data in the database, defined as (W1* I C1 I + W2* I C2 I + W3 * I C3 I )/ I Ctotal I, wherein W1, W2, W3 are the weighting parameters of C1, C2, C3 respectively, then each active index are summed up to be averaged regarding to the reference group, the first priority group, and the second priority group respectively to obtain a reference grouping threshold value VM1, a first priority grouping threshold value VM2, and a second priority grouping threshold value VM3 respectively, wherein the W1, W2, and W3 are determined according a plurality of rules: (1) (W1+W2+W3)<1,(2) Wi>W2>W3, (3) there is a statistically significant difference between VM2 and VM1, and between VM3 and VM1; receiving a to-be-determined resting ECG, and calculating a corresponding to-be-determined active index”, which directs to MATHEMATICAL CONCEPTS, which entail calculating indexes from ECG data to obtain a reference grouping threshold value VM1, a first priority grouping threshold value VM2, and a second priority grouping threshold value VM3, as well as a corresponding to-be-determined active index.
The claims further recite, “…grouping the resting ECG data, wherein a reference group is formed by the resting ECGs without any result of any computer tomography (CT) imaging, wherein a first priority group is formed by the resting ECGs accompanying with a plurality of first results of corresponding CT imaging , and each of the first results comprises a corresponding degree value of a first coronary artery stenosis above an stenosis threshold value, wherein a second priority group is formed by the resting ECGs accompanying with a plurality of second results of corresponding CT imaging, and each of the second results comprises a corresponding degree value of a second coronary artery stenosis below an stenosis threshold value... “…comparing the corresponding to-be-determined active index with the VM1, VM2, and VM3 to determine a stenosis degree of coronary artery”, which directs to MENTAL PROCESSES by evaluating data by way mentally gathering and organizing data, mentally comparing to make a mental determination, all of which can be performed by the mind and/or by pen/paper.
Dependent claims 2-5 and 7-8 only further define the abstract idea in the mental process steps. There are no additional elements that integrate the abstract ideas into practical application, or amount to significantly more than the abstract idea itself. Accordingly, the dependent claims are also directed to non-statutory subject matter.
Step 2a) Prong Two:
This judicial exception is not integrated into a practical application because mere instruction to implement on a computer, or merely using a computer as a tool to perform the abstract idea, adding insignificant extra solution activity, and/or generally linking the use of the abstract idea to a technological environment or field of use is not considered integration into a practical application. The Court defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
This judicial exception is not integrated into a practical application because claims 1-8, do not disclose using the result of the calculation steps (i.e. calculating) and mental process steps (i.e. comparing), for prophylactic treatment of a particular medical condition under MPEP 2106.05(e). In the instant case, is no direct delivery of treatment (e.g. electrical stimulation/pacing, therapeutic drug, etc.) being delivered to a patient after the determination of a patient’s stenosis degree to treat a particular disease or condition.
This judicial exception is not integrated into a practical application because claims 1-8, do not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Specifically, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception since the present claims include the additional elements of a generic computer to access the database with ECG data (paragraph 0009 of the specification recites “a computer is employed for data processing”), however these concepts have not been described with sufficient detail to constitute an improvement in the tech field, as such these features merely define the field of use for the current invention by generally linking mathematical concepts and mental processes to generic computers. By failing to explain how the computer is different from conventional computers, it is reasonable that the broadest reasonable interpretation of the computer is just conventional computer performing data analysis. The conventional computers performing basic data analysis are directed to the components of a system amounting to merely field of use type limitations by generally linking the abstract ideas to generic computers and/or extra solution activity to implement the abstract idea as identified above. Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
As such, dependent claims 2-5, and 7-8 do not further recite additional elements which practically integrate the judicial exception of the current invention.
Step 2b)
Step 2B in the analysis requires us to determine whether the claims do significantly more than simply describe that abstract method. Mayo, 132 S. Ct. at 1297. We must examine the limitations of the claims to determine whether the claims contain an "inventive concept" to "transform" the claimed abstract idea into patent-eligible subject matter. Alice, 134 S. Ct. at 2357 (quoting Mayo, 132 S. Ct. at 1294, 1298). The transformation of an abstract idea into patent-eligible subject matter "requires 'more than simply stat[ing] the [abstract idea] while adding the words 'apply it."' Id. (quoting Mayo, 132 S. Ct. at 1294) (alterations in original). "A claim that recites an abstract idea must include 'additional features' to ensure 'that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].'" Id. (quoting Mayo, 132 S. Ct. at 1297) (alterations in original). Those "additional features" must be more than "well-understood, routine, conventional activity." Mayo, 132 S. Ct. at 1298.
The present claims include the additional elements other than the abstract idea which include a computer to access the database with ECG data (paragraph 0009 of the specification recites “a computer is employed for data processing”). These additional elements are merely conventional computer. Any potentially technical aspects of the claims are well-known generic computer components performing conventional functions (e.g., computer to access database for data analysis). In the instant case, the additional elements of generic computer amount to elements of which are well-understood, routine and conventional in the field, as shown in the reference Wu (US 20210161456 A1) which discloses a cardiovascular performance system which decomposes first intrinsic mode functions (IMFs) from ECG signals using a multi-channel ECG signals processing device (abstract).
Additionally, Rudel (US 20140134654 A1) teaches a computer-based method for determining a prediction of risk and/or an indication of extent of coronary stenosis (abstract, Paragraph 0018).
The present claims have been analyzed both individually and in combination and, the instant claims do not provide any improvement of the functioning of the computer or improvement to computer technology or any other technical field but instead uses generic computer elements as a tool to perform the abstract ideas (see MPEP 2106.05(a)). There do not appear to be any meaningful limitations other than those that are well-understood, routine and conventional in the field. Thus, the present claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. When looked at individually and as a whole, the claim limitations are determined to be an abstract idea without "significantly more," and thus not patent eligible.
Dependent claims 2-5 and 7-8 inherit this deficiency.
Examiner’s Note
A search conducted found no prior art to anticipate and/or render obvious to claims 1-8. Claims 1-8 remain rejected under 35 USC § 101 and 112(b).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Wu (US 20210161456 A1) discloses a cardiovascular performance system which decomposes first intrinsic mode functions (IMFs) from ECG signals.
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.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796