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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/24/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/24/2026 was filed. However, references 156, 240, 257 of the Foreign Patent Documents and 13, 22, 38 of the Non-Patent Literature Documents have not been considered as there are no copies for these references.
Response to Arguments
Regarding the arguments against the rejection of claims under 35 USC 101, the Examiner respectfully disagrees. Applicant argues that that the claims integrate a judicial exception into a practical application in that the augmentation of data can be used to improve accuracy in downstream process and reduce computation expense recites an improvement to a technical field. Examiner asserts that as noted in the Desjardins decision, the claim itself must reflect the improvement in technology. As analyzed, there is no indication in the claim itself of an augmentation to the data nor a reduction in computational expense. The generation of the “generated” ECG data is performed by using the generic generative model, however there is no indication of a particular implementation of this model nor an improvement to technology related to the generative model as noted in the Step 2A Prong 2 analysis of the rejection below. There is no indication that the generated data is “augmented” in any way. The claim itself does not recite specific steps for using smaller amounts of computational expenditure and there is no indication of the generated ECG data to be used in a specific manner for diagnostic purposes. Additionally, there is no indication of a specific improvement or application over conventional gathering of ECG data related to the use of the combined first and second ECG data as the claims themselves merely recite an output of the combined data to a terminal which recites insignificant post solution activity.
Further, the use of the generative model to generate the ECG data is generically implemented to the abstract idea. The training of the model using the data as claimed recites generic functioning when training the generic model and does not recite a technology improvement. Use of the discriminator again recites generic use of computing model to carry out the abstract idea related to determining if the data is actual or generated. Again, there is no indication that the use of the generative and discriminator models to generate the generated data recites an improvement to the generated ECG and diagnostics. The generation of the ECG data (where it is not clear how the ECG is “augmented), using the generic computing components and then the insignificant application of merely outputting the data to a terminal does not recite a technology improvement nor an improvement to a technology field.
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, 5, and 11-28 are rejected under 35 USC 101 because the claimed invention is directed to an abstract idea without significantly more.
It is appropriate for the Examiner to determine whether a claim satisfies the criteria for subject matter eligibility by evaluating the claim in accordance to the Subject Matter Eligibility Test as recited in the following Steps: 1, 2A, and 2B, see MPEP 2106(III.).
Patent Subject Matter Eligibility Test: Step 1:
First, the Examiner is to establish whether the claim falls within any statutory category including a process, a machine, manufacture, or composition of matter, see MPEP 2106.03(II.) and MPEP 2106.03(I).
Claims 1, 11-16, 26-28 are related to a system, and claims 5, 17-24 are also related to a method (i.e., a process). Claim 25 recites a “non-transitory” computer readable medium. Accordingly, these claims are all within at least one of the four statutory categories.
Patent Subject Matter Eligibility Test: Step 2A- Prong One:
Step 2A of the Subject Matter Eligibility Test demonstrates whether a clam is directed to a judicial exception, see MPEP 2106.04(I.). Step 2A is a two-prong inquiry, where Prong One establishes the judicial exception. Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes, see MPEP 2106.04(II.)(A.)(1.) and 2106.04(a)(2).
Independent claim 25 includes limitations that recite at least one abstract idea. Specifically, independent claim 25 recites:
A non-transitory computer-readable medium having instructions stored thereon which, when executed by a system, cause the system to:
receive first electrocardiogram data obtained using one or more electrodes configured to respond to electrical signals of a patient when placed on a skin surface of the patient;
generate second electrocardiogram data by inputting the first electrocardiogram data of the patient to a first generative model,
wherein the first generative model comprises a generative adversarial network,
wherein the first generative model is trained by, for each subject of a plurality of subjects:
accessing a set of actual electrocardiogram data, wherein the set of actual electrocardiogram data is obtained using a plurality of electrodes placed on a skin surface of a subject;
selecting a subset of actual electrocardiogram data corresponding to a subset of the plurality of electrodes;
inputting the subset of actual electrocardiogram data to the first generative model;
generating, using the first generative model, a set of generated electrocardiogram data;
inputting the set of generated electrocardiogram data and corresponding actual electrocardiogram data to a discriminator model, wherein the corresponding actual electrocardiogram data comprises actual electrocardiogram data not included in the subset of the actual electrocardiogram data; and
determining, using the discriminator model, if generated electrocardiogram data of the set of generated electrocardiogram data is generated or actual; and
combining the first electrocardiogram data and the second electrocardiogram data for electronic transmission to a display terminal configured for generation of a graphical representation of the combined first electrocardiogram data and the second electrocardiogram data.
The Examiner submits that the foregoing underlined limitations constitute a “mental process”, as the following abstract limitations are related to evaluations and judgements that can be practically performed in the human mind:
“Generate” second electrocardiogram data, which is an abstract limitation of analysis for generating data by considering the actual electrocardiogram data,
“Generating” a set of generated electrocardiogram data, which is an abstract limitation of analysis of the electrocardiogram data as claimed to generate the data and to make a judgments regarding the making of the set,
“Determining” if generated electrocardiogram data of the set of generated electrocardiogram data is generated or actual, which is an abstract limitation of analysis of the actual and generated electrocardiogram data to make the judgment of generated or actual,
“Combining” the first electrocardiogram data and the second electrocardiogram data, which is an abstract limitation of analysis and a judgement for the grouping of the data.
Accordingly, the claim recites the steps for generating a combination of first and second electrocardiogram data that can practically be performed in the human mind.
The abstract idea recited in claims 1 and 5 are similar to that of claim 25.
Any limitations not identified above as part of the abstract idea are deemed “additional elements” and will be discussed in further detail below.
Accordingly, the claim as a whole recites at least one abstract idea.
Furthermore, dependent claims further define the at least one abstract idea, and thus fails to make the abstract idea any less abstract as noted below:
Claims 14, 21 and 27 recite further detail of the generated electrocardiogram data, further describing the abstract idea. Claims 16, 23, and 28 recites further abstract limitations of “generating” third ECG data where it corresponds to a same set of signal indicators as the first ECG data, and further to “identify” the inputted data as actual data or generated data, further describing the abstract idea.
Patent Subject Matter Eligibility Test: Step 2A- Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. It must be determined whether any additional elements in the claim beyond the abstract idea integrates the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exceptions into a “practical application,” see MPEP 2106.04(II.)(A.)(2.) and 2106.04(d)(I.).
In the present case, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
Regarding claim 25:
A non-transitory computer-readable medium having instructions stored thereon which, when executed by a system, cause the system to (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)):
receive first electrocardiogram data obtained using one or more electrodes configured to respond to electrical signals of a patient when placed on a skin surface of the patient (merely data gathering steps as noted below, see MPEP 2106.05(g) and buySAFE, Inc. v. Google, Inc.);
generate second electrocardiogram data by inputting the first electrocardiogram data of the patient to a first generative model,
wherein the first generative model comprises a generative adversarial network,
wherein the first generative model is trained by, for each subject of a plurality of subjects:
accessing a set of actual electrocardiogram data, wherein the set of actual electrocardiogram data is obtained using a plurality of electrodes placed on a skin surface of a subject;
selecting a subset of actual electrocardiogram data corresponding to a subset of the plurality of electrodes;
inputting the subset of actual electrocardiogram data to the first generative model (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f));
generating, using the first generative model (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)), a set of generated electrocardiogram data;
inputting the set of generated electrocardiogram data and corresponding actual electrocardiogram data to a discriminator model, wherein the corresponding actual electrocardiogram data comprises actual electrocardiogram data not included in the subset of the actual electrocardiogram data; and (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f))
determining, using the discriminator model (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)), if generated electrocardiogram data of the set of generated electrocardiogram data is generated or actual; and
combining the first electrocardiogram data and the second electrocardiogram data for electronic transmission to a display terminal configured for generation of a graphical representation of the combined first electrocardiogram data and the second electrocardiogram data (merely post solution activity as noted below, see MPEP 2106.05(g) and buySAFE, Inc. v. Google, Inc.).
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of:
a non-transitory computer-readable medium having instructions stored thereon which, when executed by a system, cause the system to perform steps,
inputting the first electrocardiogram data of the patient to a first generative model, wherein the first generative model comprises a generative adversarial network,
wherein the first generative model is trained by, for each subject of a plurality of subjects, accessing a set of actual electrocardiogram data, wherein the set of actual electrocardiogram data is obtained using a plurality of electrodes placed on a skin surface of a subject, selecting a subset of the actual electrocardiogram data corresponding to a subset of the plurality of electrodes,
inputting the subset of the actual electrocardiogram data to the first generative model
use of the first generative model,
inputting the set of generated electrocardiogram data and corresponding actual electrocardiogram data to a discriminator model, wherein the corresponding actual electrocardiogram data comprises actual electrocardiogram data not included in the subset of the actual electrocardiogram data,
using the discriminator model,
the Examiner submits that these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components (see MPEP § 2106.05(f)). [Page 7 line 25- Page 8 line 16] of Applicant’s Specification recites the overall diagnosis system as being the generic apparatus. [Figure 2, Page 6 lines 4-7] recites the use of the generic apparatus. [Page 13 lines 5-8] recites the use of generative adversarial network algorithm as being trained in a generic matter. [Page 8 lines 4-19] recites generically inputting the data into the models. [Page 11 lines 9-22] recites the generic steps of inputting data into a first generative model and [Page 11 line 9-22] recites the inputting of data into the discriminative model, where the configuration of the models is recited without specific technical detail of how the models are implemented beyond generic computer implementation. [Page 10 lines 3-16] recites the generic training steps of the generative models and recites the training data as ECG data from subjects. The additional elements recite the use of generic computing components with a non-specific implementation to carry out steps of the abstract idea without showing an improvement to technology, computers or other technical fields, and thus recites mere instructions to implement the abstract idea on a computer.
Regarding the additional limitation of receive first electrocardiogram data obtained using one or more electrodes configured to respond to electrical signals of a patient when placed on a skin surface of the patient, this is merely pre-solution activity. The Examiner submits that these additional limitations merely add insignificant extra-solution activity of collecting data to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)). [Page 9 lines 13-23] of the Applicant’s Specification recites the use of electrodes to gather the electrocardiogram data. [Page 13 lines 1-8] recites transfer the data to a device to receive the data as input further described in [Page 6 lines 20-21]. The use of the electrodes on the body is only used to gather data, and where the transmission of data carries the data to the device for the processing related to the abstract idea. The use of the electrode devices and transmission of data recites insignificant pre-solution activities related to the data gathering.
Regarding the additional limitation of electronic transmission to a display terminal configured for generation of a graphical representation of the combined first electrocardiogram data and the second electrocardiogram data, this is merely post-solution activity. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of insignificant application to the at least one abstract idea in a manner that does not meaningfully limit the at least on abstract idea (see MPEP § 2106.05(g)). [Page 13 lines 21-27] of Applicant’s specification recites the use of the output unit for the transmission of the combined data to the terminal of the medical person to merely output or display the data using a graphical representation (where the terminal output is interpreted as the graphical representation), and therefore recites impractical application.
Claim 1 and 5 recites similar additional elements as claim 25.
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to generate a graphical representation of the combined first electrocardiogram data and the second electrocardiogram data, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use 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 not more than a drafting effort designed to monopolize the exception, see MPEP 2106.04(d), 2106.05(a), 2106.05(b).
For these reasons, the independent claims do not recite additional elements that integrate the judicial exception into a practical application.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set below:
Claims 11, 12, 13, 14, 15, 18, 19, 20, 21, 22, 26, and 27 recite further detail of the first electrocardiogram data that is gathered, however the use of these devices to gather the electrocardiogram data merely adds insignificant extra-solution activity of collecting data to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea. Claims 16, 23 and 28 recite the use of generic second generative model and second discriminator model, however these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components. Claims 17 and 24 recite further detail of the training data using subject data from subjects with diagnosed arrhythmia or heart disease, however these limitations amount to nothing more than an instruction to apply the abstract idea using generic computing components.
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Patent Subject Matter Eligibility Test: Step 2B:
Regarding Step 2B of the Subject Matter Eligibility Test, the independent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application, see additionally MPEP 2106.05(II.). Further, it may need to be established, when determining whether a claim recites significantly more than a judicial exception, that the additional elements recite well understood, routine, and conventional activities, see MPEP 2106.05(d).
Regarding claim 25:
Regarding the additional limitations of:
a non-transitory computer-readable medium having instructions stored thereon which, when executed by a system, cause the system to perform steps,
inputting the first electrocardiogram data of the patient to a first generative model, wherein the first generative model comprises a generative adversarial network,
wherein the first generative model is trained by, for each subject of a plurality of subjects, accessing a set of actual electrocardiogram data, wherein the set of actual electrocardiogram data is obtained using a plurality of electrodes placed on a skin surface of a subject, selecting a subset of the actual electrocardiogram data corresponding to a subset of the plurality of electrodes,
inputting the subset of the actual electrocardiogram data to the first generative model
use of the first generative model,
inputting the set of generated electrocardiogram data and corresponding actual electrocardiogram data to a discriminator model, wherein the corresponding actual electrocardiogram data comprises actual electrocardiogram data not included in the subset of the actual electrocardiogram data,
using the discriminator model,
the Examiner submits that these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components (see MPEP § 2106.05(f)). [Page 7 line 25- Page 8 line 16] of Applicant’s Specification recites the overall diagnosis system as being the generic apparatus. [Figure 2, Page 6 lines 4-7] recites the use of the generic apparatus. [Page 13 lines 5-8] recites the use of generative adversarial network algorithm as being trained in a generic matter. [Page 8 lines 4-19] recites generically inputting the data into the models. [Page 11 lines 9-22] recites the generic steps of inputting data into a first generative model and [Page 11 line 9-22] recites the inputting of data into the discriminative model, where the configuration of the models is recited without specific technical detail of how the models are implemented beyond generic computer implementation. [Page 10 lines 3-16] recites the generic training steps of the generative models and recites the training data as ECG data from subjects. The additional elements recite the use of generic computing components with a non-specific implementation to carry out steps of the abstract idea without showing an improvement to technology, computers or other technical fields, and thus recites mere instructions to implement the abstract idea on a computer and does not recite significantly more than the judicial exception.
Regarding the additional limitations of receive first electrocardiogram data obtained using one or more electrodes configured to respond to electrical signals of a patient when placed on a skin surface of the patient, this is merely pre-solution activity. The Examiner submits that these additional limitations merely add insignificant extra-solution activity of collecting data to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g) and MPEP § 2106.05(d)(II), specifically “buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network)”). [Page 9 lines 13-23] of the Applicant’s Specification recites the use of electrodes to gather the electrocardiogram data. [Page 13 lines 1-8] recites transfer the data to a device to receive the data as input further described in [Page 6 lines 20-21]. The use of the electrodes on the body is only used to gather data, and where the transmission of data carries the data to the device for the processing related to the abstract idea. The use of the electrode devices and transmission of data recites insignificant pre-solution activities related to the data gathering and does not recite significantly more than the judicial exception. As recited in the Applicant’s Specification at [Page 9 lines 15-20], the electrodes are merely used to “measure” and gather the data which is then generically transmitted or sent to the device for use as an input, which recite well understood, routine, and conventional activities.
Regarding the additional limitation of electronic transmission to a display terminal configured for generation of a graphical representation of the combined first electrocardiogram data and the second electrocardiogram data, this is merely post-solution activity. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of insignificant application to the at least one abstract idea in a manner that does not meaningfully limit the at least on abstract idea (see MPEP § 2106.05(g) and MPEP § 2106.05(d)(II), specifically “buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network)). [Page 13 lines 21-27] of Applicant’s specification recites the use of the output unit for the transmission of the combined data to the terminal of the medical person to merely output or display the data using a graphical representation (where the terminal output is interpreted as the graphical representation), and therefore recites impractical application and does not recite significantly more than the judicial exception. The generic output or sending of data to the terminal to merely display the received and generated data for insignificant post solution activity recites well understood, routine, and conventional activity.
Claims 1 and 5 recite similar additional elements are analyzed in the same way as the ones in Claim 25.
The dependent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exceptions for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
For the reasons stated, the claims fail the Subject Matter Eligibility Test and therefore claims 1, 5, and 11-28 are rejected under 35 USC 101 as being directed to non-statutory subject matter.
Conclusion
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/CONSTANTINE SIOZOPOULOS/
Primary Examiner
Art Unit 3686
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