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 .
Amendment Entered
This Office action is responsive to the Amendment filed on July 1st, 2026. The examiner acknowledges the amendments to claims 1, 7, 10, 13, and 16 as well as the cancellation of claims 2-6, 8-9, 11-12, 14-15, and 17-18. New claim 19 has been added.
Claims 1, 7, 10, 13, 16 and 19 are pending in the application.
Response to Arguments
Applicant's arguments filed July 1st, 2026, with respect to the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive.
At pages 17-18, Applicant argues that the steps of collecting, estimating cardiac parameters using the CVS model, and calculating and updating pressure-volumes cannot be performed in the human mind and essentially needs machine execution that is processing by the processor and that the claimed methods transforms raw wearable ECG data into a simulated cardiovascular state and constitutes a technical operation that improves the functioning of medical signal processing systems. Examiner respectfully disagrees. The steps of estimating, via the one or more processors, one or more cardiac parameters in each cardiac cycle of the wearable ECG data associated with the subject using a cardiovascular simulation (CVS) model, wherein the continuous heart rate and the one or more cardiac compliance parameters are estimated using the wearable ECG data, the CVS model comprises a pair of atriums and ventricles functioning as a pulsatile pump and rhythmic unidirectional blood flows across the heart chambers controlled by synchronized opening and closing of four cardiac valves, and calculating pressures-volumes across cardiac chambers, wherein the pressures- volumes are updated across the cardiac chambers based on the estimated continuous heart rate and one or more cardiac parameters are directed to a mental process (estimating, calculating) and/or mathematical concepts (including mathematical relationships, mathematical formulas or equations, and mathematical calculations) (estimating, CVS model, calculating). The step of instructing the subject is directed to managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) The wearable ECG data are part of extra-solution activity, in the form of data-gathering. It is certainly possible for a clinician to look out a print out of ECG data and make diagnostic computations/decisions right away. For a more specific example, a cardiologist could review ECG readouts to diagnose a patient with a condition. There is no time limit recited for performing the steps. The claimed steps can be performed via pen and paper or in a person’s mind with no time limit. The computer is merely utilized as a tool to perform the mental steps. There is no level of complexity claimed that would preclude a person from practically completing this process in the mind. Furthermore, the improvement cannot be found in the abstract idea itself. "[I]t is important to keep in mind that an improvement in the abstract idea itself is not an improvement in technology." MPEP 2106.05(a) II. The claims recite steps for processing data. The claims do not integrate the processing into a practical application. Rather, the alleged improvement lies solely within the processing steps performed by the processor. "Merely adding generic computer components to perform the method is not sufficient. Thus, the claim must include more than mere instructions to perform the method on a generic component or machinery to qualify as an improvement to an existing technology." Id.
Regarding the CVS model, the CVS model is used to generally apply the abstract idea (i.e., perform the mental processes and/or mathematical concepts, i.e. estimating, calculating) without placing any limitations on how CVS model operates to derive the cardiac parameters. That is there is no limitations describing the decisions, computations, or rules performed (emphasis added) on the wearable ECG data to derive the cardiac parameters and the claim fails to recite how the CVS model uses the wearable ECG data. In addition, the limitations would cover every mode of implementing the recited abstract idea using the CVS model. The claim omits any details as to how the CVS model solves a technical problem and instead recites only the idea of a solution or outcome. See MPEP 2106.05(f). Therefore, the limitations “estimating, via the one or more processors, one or more cardiac parameters in each cardiac cycle of the wearable ECG data associated with the subject using a cardiovascular simulation (CVS) model” and “the CVS model comprises a pair of atriums and ventricles functioning as a pulsatile pump and rhythmic unidirectional blood flows across the heart chambers controlled by synchronized opening and closing of four cardiac valves” represents no more than mere instructions to implement the abstract idea.
At pages 18 -20, Applicant argues that the claims were not considered as a whole and demonstrate an improvement in capturing the stochastic nature of underlying conditions among individuals under stress. Examiner respectfully disagrees. Under Step 2a, prong two, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. Claims 1, 7, and 13 recite receiving, via an input/output interface, a meta-data information of a subject and collecting, via one or more hardware processors, a wearable electrocardiogram (ECG) data of the subject and utilizing, the cardiac score correlated with the weight of the subject in clinical decision support system (CDSS) in the recovery period, which is merely adding insignificant pre-solution activity and insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The receiving, collecting, and utilizing steps do not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the receiving, collecting, and utilizing, nor does the method use a particular machine to perform the Abstract Idea. Furthermore, the improvement (capturing the stochastic nature of underlying cardiac conditions among individuals under stress) cannot be found in the abstract idea itself. "[I]t is important to keep in mind that an improvement in the abstract idea itself is not an improvement in technology." MPEP 2106.05(a) II. The claims recite steps for processing data. The claims do not integrate the processing into a practical application. Rather, the alleged improvement lies solely within the processing steps performed by the processor. "Merely adding generic computer components to perform the method is not sufficient. Thus, the claim must include more than mere instructions to perform the method on a generic component or machinery to qualify as an improvement to an existing technology." Id.
At pages 20-21, Applicant argues that the claimed invention provides a personalized CVS model tuned to using the subject’s metadata information, the one or more cardiac parameters are updated continuously across the recovery period, the cardiac score is utilized by physicians correlating the cardiac score with the weight of the subject in a clinical decision support system (CDSS) in a recovery period, and the claimed invention provides a practical application by calculating a cardiac score and recites additional elements that integrate the judicial exception into a practical application. Examiner respectfully disagrees. It seems as if Applicant is arguing is more than what is being recited in the claims. There are no limitations to how CVS model is personalized using the metadata information. Furthermore, using the cardiac score in a clinical decision support system (CDSS) in a recovery period is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The step of utilizing the cardiac score does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the cardiac score, nor does the method use a particular machine to perform the Abstract Idea. Furthermore, according to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
Applicant's arguments and amendments filed July 1st, 2026, with respect to the rejections under 35 U.S.C. 103 have been fully considered and are persuasive. It would require an unreasonable combination of references that would not suffice for a realistic case of obviousness. The rejections under 35 U.S.C. 103 are withdrawn.
Claim Objections
Claims 1, 7, 13, and 19 are objected to because of the following informalities:
Claim 1 lines 9-10 & claim 7 lines 12-13 & claim 13 lines 11-12 should recite “wherein reference blood pressures (BP)s are measured during the wearable ECG data collection for the subject”.
Claim 1 line 25 & claim 7 line 28 & claim 13 line 25 should recite “the one or more cardiac parameters”.
Claim 1 lines 43-44 & claim 7 lines 46-47 & claim 13 lines 42-43 should recite “a clinical decision support system (CDSS) in stem (CDSS) in the recovery period”.
Claim 19 line 3 should recite “wearable ECG data to assess the cardiac condition of the subject”.
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 1, 7, 10, 16, and 19 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 1 lines 18-19, Claim 7 line 21, Claim 13 line 18 (claims 10, 16, and 19 by virtue of dependency on claims 1, 7, and 13) recites the limitation "the one or more cardiac compliance parameters". There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear if this is referring to the previously estimated cardiac parameters or a different parameter. For examination purposes it will be interpreted as referring to the previously estimated parameters and the limitation is suggested to recite “the one or more cardiac parameters”.
Claim 1 line 38, Claim 7 line 41, Claim 13 line 37 (claims 10, 16, and 19 by virtue of dependency) recites the limitation “cardiac parameters”. It is unclear if this is referring to the previously estimated cardiac parameters or different parameters. For examination purposes it will be interpreted as referring to the previously estimated parameters and the limitation is suggested to recite “the one or more cardiac parameters”.
Claim 1 lines 41-42, Claim 7 line 44, Claim 13 line 40 (claims 10, 16, and 19 by virtue of dependency) recites the limitation "the stochastic nature". There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a stochastic nature”.
Claim 19 recites the limitation “cardiac parameters” in lines 2-3. It is unclear if this is referring to the previously estimated cardiac parameters of claim 1 or different parameters. For examination purposes it will be interpreted as referring to the previously estimated parameters and the limitation is suggested to recite “the one or more cardiac parameters”.
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.
Claims 10 and 16 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 10 recites “wherein the one or more hardware processors are configured to calculate pressures-volumes across cardiac chambers, wherein the pressures-volumes are updated across the cardiac chambers based on the estimated continuous heart rate and one or more cardiac compliance parameters” which is already recited in lines 26-28 of independent claim 7 from which claim 10 depends. Therefore, claim 10 does not further limit the subject matter of claim 7.
Claim 16 recites “wherein the one or more hardware processors are configured to calculate pressures-volumes across cardiac chambers, wherein the pressures-volumes are updated across the cardiac chambers based on the estimated continuous heart rate and one or more cardiac compliance parameters” which is already recited in lines 23-25 of independent claim 13 from which claim 16 depends. Therefore, claim 16 does not further limit the subject matter of claim 13.
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
Claims 1,7,10,13,16, and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claims 1, 7, and 13 follows.
STEP 1
Regarding claims 1, 7, and 13, the claims recite a series of steps or acts and/or a series of structural elements, including a device. Thus, the claims are directed to a process and/or a machine, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
wherein the subject is being instructed to: complete a predefined physical activity for a predefined period; sit up straight after completing the predefined physical activity for the predefined period to collect the wearable ECG data; and remain stable with no movement during the wearable ECG data collection;
estimating, via the one or more processors, one or more cardiac parameters in each cardiac cycle of the wearable ECG data associated with the subject using a cardiovascular simulation (CVS) model, wherein the continuous heart rate and the one or more cardiac compliance parameters are estimated using the wearable ECG data;
wherein the CVS model comprises a pair of atriums and ventricles functioning as a pulsatile pump and rhythmic unidirectional blood flows across the heart chambers controlled by synchronized opening and closing of four cardiac valves;
calculating pressures-volumes across cardiac chambers, wherein the pressures- volumes are updated across the cardiac chambers based on the estimated continuous heart rate and one or more cardiac parameters;
calculating, via the one or more hardware processors, a body metabolic index (BMI) of the subject using a standard scoring method and a normal BMI range;
calculating, via the one or more hardware processors, a body-metabolic index (BMI) of the subject using a standard scoring method and a normal BMI range;
estimating, via the one or more hardware processors, a meta score by combining the received meta-data information, the estimated one or more cardiac parameters in each cardiac cycle of the wearable ECG data and the calculated BMI of the subject, wherein the meta-data information is utilized to define a total blood volume and an unstressed blood volume of the subject, wherein the total blood volume is fixed during the simulation, and the unstressed blood volume of the subject is auto-regulated by a baroreflex autoregulation principle;
determining, via the one or more hardware processors, a cardiac score in a recovery period post completion of the predefined physical activity from the estimated meta score based on a predefined normalized scale, wherein the cardiac score is determined based on temporal variation of cardiac parameters during the recovery period post completion of the predefined physical activity, wherein the one or more cardiac parameters used along with the wearable electrocardiogram (ECG) data and the meta-data information demonstrates an improvement in capturing the stochastic nature of underlying cardiac conditions among individuals under stress;
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion) (estimating, calculating, estimating, determining) and/or mathematical concepts (including mathematical relationships, mathematical formulas or equations, and mathematical calculations) (estimating, CVS model, calculating). Furthermore, the step of instructing the subject is directed to managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). Thus, the claim is drawn to a Mental Process and Certain methods of organizing human activity, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claims 1, 7, and 13 recite receiving, via an input/output interface, a meta-data information of a subject and collecting, via one or more hardware processors, a wearable electrocardiogram (ECG) data of the subject and utilizing, the cardiac score correlated with the weight of the subject in clinical decision support system (CDSS) in the recovery period, which is merely adding insignificant pre-solution activity and insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The receiving, collecting, and utilizing steps do not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the receiving, collecting, and utilizing, nor does the method use a particular machine to perform the Abstract Idea.
The recited input/output interface and wearable ECG are generic sensors configured to perform pre-solutional data gathering activity, the clinical decision support system is configured to perform insignificant extra-solution activity, and the processor is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application. STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
receiving, via an input/output interface, a meta-data information of a subject, wherein the meta-data of the subject comprising height, weight, and age of the subject;
collecting, via one or more hardware processors, a wearable electrocardiogram (ECG) data of the subject, wherein the subject is being instructed to: complete a predefined physical activity for a predefined period; sit up straight after completing the predefined physical activity for a predefined period to collect the wearable ECG data; and remain stable with no movement during the data collection;
input/output interface
memory/non-transitory information storage mediums
one or more hardware processors;
utilizing, the cardiac score correlated with the weight of the subject in clinical decision support system (CDSS) in the recovery period.
The receiving, collecting, and utilizing steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the receiving, collecting, and utilizing are each recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the receiving and collecting steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claims 1, 7, 13, the system recited in the claim is a generic system comprising generic components configured to perform the abstract idea – as evidenced by the non-patent literature of record: Roy et al., Esmaili, Roy, Fudim; Mcgrath (US 20230346231 A1) in para. [0003, 0031] discloses conventional wearable ECG monitors; Roy (US 20190335999 A1) in para. [0047] discloses conventional systems like clinical decision support systems (CDSS) and telemonitoring systems; Rong (US 20200297227 A1) in para. [0004] & [0065] discloses conventional medical devices, such as electrocardiograms (ECGs), and more recent smart devices, such as smart wearable devices and a conventional processor. The recited input/output interface and wearable ECG are generic sensors configured to perform pre-solutional data gathering activity, the clinical decision support system is configured to perform insignificant extra-solution activity, and the processor is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims. Claims 10, 16, and 19 are directed to more abstract ideas, which does not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Dibyendu et al., In-silico cardiovascular hemodynamic model to simulate the effect of physical exercise, Biomedical Signal Processing and Control, Volume 80, Part 2, 2023, 104364, ISSN 1746-8094, https://doi.org/10.1016/j.bspc.2022.104364.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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