Prosecution Insights
Last updated: July 17, 2026
Application No. 18/521,410

NON-INVASIVE PREDICTION OF RISK FOR SUDDEN CARDIAC DEATH

Non-Final OA §101§DOUBLEPATENT
Filed
Nov 28, 2023
Priority
Nov 08, 2013 — provisional 61/901,800 +5 more
Examiner
GEDEON, BRIAN T
Art Unit
3796
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Spangler Scientific LLC
OA Round
1 (Non-Final)
87%
Grant Probability
Favorable
1-2
OA Rounds
0m
Est. Remaining
94%
With Interview

Examiner Intelligence

Grants 87% — above average
87%
Career Allowance Rate
1182 granted / 1354 resolved
+17.3% vs TC avg
Moderate +7% lift
Without
With
+7.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 6m
Avg Prosecution
38 currently pending
Career history
1387
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
48.8%
+8.8% vs TC avg
§102
7.8%
-32.2% vs TC avg
§112
1.3%
-38.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1354 resolved cases

Office Action

§101 §DOUBLEPATENT
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 . Priority This application is a continuation of US Application no. 17/350,381, now US Patent no. 11,839,497, filed 17 June 2021, which is a continuation of US Application no. 16/261,248, now US Patent no. 11,045,135, filed 29 January 2019, which is a continuation of US Application no. 15/693,730, now US Patent no. 10,226,196, filed 1 September 2017, which is a division of US Application no. 15/035,122, now US Patent no. 9,775,535, filed 6 May 2016, which is the national stage under 35 USC 371 of PCT/US2014/064577, filed 7 November 2014 which claims the benefit of priority from US Provisional Application no. 8 November 2013. Response to Amendment The preliminary amendment filed 14 April 2024 has been acknowledged. Claims 1-13 are pending. 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 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception (i.e., an abstract idea related to mathematical concepts/calculations and mental processes) without significantly more. Each of claims 1-13 have been analyzed to determine whether it is directed to any judicial exceptions. Step 1 The claims recite a method (process, claims 1-10) and a device (apparatus, claims 11-13) thus the claims are directed to the eligible statutory categories. Step 2A, Prong 1 Though the claims are eligible under Step 1, the claims have been found to be directed to a judicial exception. The claim(s) recite(s): The claims are directed to an abstract idea in the form of mathematical concepts and mental processes. In particular, independent claim 1 recites the steps of: receiving ECG data, determining derivatives, scoring alignment between sequences, quantitatively determining presence of risk sequences, and generating output. These steps are considered to constitute mathematical operations (e.g., derivatives, alignment scoring, error scoring), and evaluation/judgment processes (e.g., determining presence of sequences and risk). Such limitations amount to collecting information, analyzing it using mathematical relationships, and reporting the result, which is a recognized abstract idea. Similarly, independent claim 11 recites structure configured to functionally perform the steps of: storing data (SCD risk sequence ensemble), detecting sequences, determining quantitative risk based on alignment. These steps are considered to recite steps of data analysis using mathematical relationships and thus fall within the abstract idea category. Step 2A, Prong 2 The claims do not integrate the abstract idea into a practical application. Additional elements recited include: “one or more processors,” a “storage device,” an “SCD risk predictor,” a “multi-lead ECG machine,” an “implantable cardioverter-defibrillator to enable anti-tachycardia pacing (ATP-ICD),” and generating a message or display. These elements are considered to merely implement the abstract idea on generic computer components, and amount to insignificant extra-solution activity (data gathering and output). Although the specification describes signal processing techniques (e.g., denoising, derivative computation, alignment scoring), the claims do not recite these techniques in a manner that imposes a meaningful limitation on the abstract idea. Instead, the claims broadly recite results (e.g., “scores alignment,” “quantitatively determining”) without specifying a particular technological implementation. Further, it is considered that the the claims do not improve ECG acquisition technology, improve computer functionality, nor recite a specific technical solution to a technological problem. Thus, the claims remain directed to the abstract idea. Step 2B The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The recitation of the “one or more processors” in claims 1 and 11 for determining an individual’s risk of sudden cardiac death is disclosed as being a general-purpose processor, wherein the generic processor is only a tool to aid in the analysis. Nothing in the claims nor specification suggest that the processor is special purpose, or imparts and improved functioning. The recitation of the “multi-lead ECG” of claims 3 and 13 for obtaining the data is considered to be standard and conventional in the art (see the present specification at paragraph 32, or Banet et al. (US Publication no. 2014/0107509) paragraph 7). The recitation of the implantable cardioverter-defibrillator to enable anti-tachycardia pacing (ATP-ICD) is considered to be conventional in the art (see Alt (WO 01/37930) page 4 lines 10-14). Therefore, the claims do not recite significantly more than the abstract idea. The additional elements are well-understood, routine, and conventional (e.g., generic processors, storage devices, ECG machines), and perform generic functions such as receiving data, processing data, and displaying results. No element or combination of elements amounts to an inventive concept sufficient to transform the abstract idea into patent-eligible subject matter. In regard to claims 2-9, additionally recited features include: computing an alignment error score: using a multi-lead ECG machine, Receiving predetermined ECG sequences, Preprocessing, Deriving first and second derivatives, Denoising with FIR filter or wavelet packet operation, Displaying the risk. These limitations are considered to merely pertain to mathematical analysis and comparison, signal preprocessing, conventional ECG acquisition (present specification paragraph 32, or Banet et al. (US Publication no. 2014/0107509), and presentation/display of information. None of the limitations recited here pertain to technological improvements to ECG signal processing or computer elements, and instead pertain to data analysis for diagnosis and risk prediction. In regard to claim 10, the SCD risk predictor is incorporated in an anti-tachycardia pacing implantable cardioverter-defibrillator (ATP-ICD) to enable anti-tachycardia pacing. The ATP-ICD is recognized as a conventional device in the art (Alt (WO 01/37930)), and the claim fails to recite any positive step that controls the ICD to initiate a therapy, modify parameters of a therapy, or otherwise using the risk determination in a concrete treatment action. In view of this, claim 10 is considered to merely comprise the presenting the claimed method to a technological environment. In regard to claims 12 and 13, additionally recited features include: generating a display/message, and a multi-lead ECG machine. These steps are considered to merely comprise post-solution activity and data gathering features and therefore do not add significantly more. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 17-18 of U.S. Patent No. 11,839,497. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘497 patent recites steps of a method that are considered to be an obvious variation of the claimed method. PRESENT CLAIM 1: A method for one or more processors for determining an individual's risk for sudden cardiac death (SCD), the method comprising: receiving, by the one or more processors, a digital electrocardiogram (ECG) measurement taken from the individual; determining, by the one or more processors, derivatives of sequences of the ECG measurement from the individual; in an SCD risk predictor of the one or more processors, quantitatively determining, in the received ECG measurement, presences of SCD risk sequences, wherein the one or more processors scores alignment between (a) the SCD risk sequences and (b) sequences of the ECG measurement from the individual, using derivatives of the SCD risk sequences and the determined derivatives; and generating output comprising a result of the quantitative determination. CLAIM 1 of the ‘497 PATENT: A method for determining an individual's risk for sudden cardiac death (SCD), the method comprising: receiving a digital electrocardiogram (ECG) measurement taken from the individual; and in an SCD risk predictor of a processor, quantitatively determining, in the received ECG measurement, presences of SCD risk sequences, wherein the processor scores alignment between (a) the SCD risk sequences and (b) sequences of the ECG measurement from the individual, using derivatives of each of the SCD risk sequences and the sequences of the ECG measurement from the individual. The chart above illustrates the overlap in limitations between the present claim 1 and claim 1 the ‘497 patent. The present claim 1 includes additional features of 1. determining, by the one or more processors, derivatives of sequences of the ECG measurement from the individual, 2. Outputting a result of the determination, and 3. Using one or more processors to execute the method. With regard to item 1, claim 5 of the ‘497 recites this additional limitation, and therefore reads on the additional limitation of present claim 1. With regard to item 2, claim 9 of the ‘497 recites this additional limitation, and therefore reads on this additional limitation of present claim 1. With regard to item 3, Modification to duplicate an essential part, such as processor, has been held to be obvious to one of ordinary skill in the art. Therefore, the invention of present claim 1 is an obvious variation of claim 1 of the ‘497, wherein the variation pertains to the obvious duplication of a processor element into multiple processors according to known methods to yield predictable results. In regard to present claims 2-10, similar overlap in claimed features is observed in view of claims 2-10 of the ‘497 patent. PRESENT CLAIM 11: An apparatus for determining a person's risk for sudden cardiac death (SCD), the apparatus comprising a storage device, the storage device comprising: data comprising an SCD risk sequence ensemble, wherein SCD risk sequences of the ensemble are determined by assessing quality of alignment of ECG sequences and derivatives of the ECG sequences between multiple individuals; and processor executable instructions that when executed by one or more processors configure the one or more processors to: receive a digital ECG measurement taken for the person; detect, in the person's digital ECG measurement, sequences indicative of a risk for SCD based on the SCD risk sequences in the SCD risk sequence ensemble; and by an SCD risk predictor, determine quantitative risk for an occurrence of SCD in the person based on the detected sequences indicative of a risk for SCD and their alignment. CLAIM 17 of the ‘497 PATENT: An apparatus for determining a person's risk for sudden cardiac death (SCD), the apparatus comprising: a storage device storing an SCD risk sequence ensemble, wherein SCD risk sequences of the ensemble are determined by assessing quality of alignment of ECG sequences and derivatives of the ECG sequences between multiple individuals; and a processor in communication with the storage device configured to: receive a digital ECG measurement taken for the person; detect, in the person's digital ECG measurement, sequences indicative of a risk for SCD based on the SCD risk sequences in the SCD risk sequence ensemble; and by an SCD risk predictor, determine quantitative risk for an occurrence of SCD in the person based on the detected sequences indicative of a risk for SCD and their alignment. The chart above illustrates the overlap in limitations between the present claim 11 and claim 17 of the ‘497 patent. The present claim includes additional features of using one or more processors to execute the method. Modification to duplicate an essential part, such as processor, has been held to be obvious to one of ordinary skill in the art. Therefore, the invention of present claim 11 is an obvious variation of claim 17 of the ‘497, wherein the variation pertains to the obvious duplication of a processor element into multiple processors according to known methods to yield predictable results. In regard to present claim 12, similar overlap in claimed features is observed in view of claim 18 of the ‘497 patent. Additionally, modification of claim 17 of the ‘497 patent to obtain ECG data from an multi-lead ECG is considered obvious to one of ordinary skill in the art in view of the embodiment of claim 11 in view of claims 12-14 of the ‘497 patent which demonstrates that the ECG data may be collected from a multi-lead ECG machine. The modification is considered to comprise the obvious application of a known technique to a known device as demonstrated by a similar embodiment of the invention to yield a predictable result. Claims 1-8 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 16 of U.S. Patent No. 11,045,135. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘135 patent recites steps of a method that are considered to be an obvious variation of the claimed method. PRESENT CLAIM 1: A method for one or more processors for determining an individual's risk for sudden cardiac death (SCD), the method comprising: receiving, by the one or more processors, a digital electrocardiogram (ECG) measurement taken from the individual; determining, by the one or more processors, derivatives of sequences of the ECG measurement from the individual; in an SCD risk predictor of the one or more processors, quantitatively determining, in the received ECG measurement, presences of SCD risk sequences, wherein the one or more processors scores alignment between (a) the SCD risk sequences and (b) sequences of the ECG measurement from the individual, using derivatives of the SCD risk sequences and the determined derivatives; and generating output comprising a result of the quantitative determination. CLAIM 1 of the ‘135 PATENT: A method for determining an individual's risk for sudden cardiac death (SCD), the method comprising: receiving a digital electrocardiogram (ECG) measurement taken from the individual; and quantitatively determining, in a processor, in the received ECG measurement, presences of predetermined digital electrocardiogram (ECG) sequences indicative of a risk for SCD, wherein the processor assesses quality of alignment between (a) the predetermined digital ECG sequences and derivatives of the predetermined ECG sequences and (b) ECG sequences measured from the individual, and derivatives of the ECG sequences measured from the individual. The chart above illustrates where overlap in limitations between the present claim 1 and claim 1 the ‘135 patent occur. Claim 1 of the ‘135 patent is considered to recite features in a narrower scope such that they read on or anticipate the claims of the present invention. For instance, the step of the ‘135 patent for “assessing the quality of alignment” is read as being similar to the score of alignment as presently claimed. The recitation in the ‘135 for “presences of predetermined digital electrocardiogram (ECG) sequences indicative of a risk for SCD” reads on the “SCD risk sequences” as presently claimed. Additionally, the ‘135 takes the derivatives of both the SCD risk sequences and the ECG measurement from the individual for the alignment. The present claim is also found to include additional features of 1. Outputting a result of the determination, and 2. Using one or more processors to execute the method, and 3. Recitation of “a risk predictor”. With regard to item 1, outputting the result of the method is considered an obvious modification in order to indicate the determined risk to a user or caretaker. With regard to item 2, Modification to duplicate an essential part, such as processor, has been held to be obvious to one of ordinary skill in the art. With regard to item 3, the processor and functional steps of the ‘135 patent sufficiently execute steps that are performed by the claimed risk predictor, wherein the processors of the ‘135 necessarily incorporate functions of the claimed risk predictor. Therefore, the invention of present claim 1 is an obvious variation of claim 1 of the ‘135, wherein the variation pertains to the obvious duplication of a processor element into multiple processors according to known methods to yield predictable results. In regard to present claims 2-8, similar overlap in claimed features is observed in view of claims 2-9 of the ‘135 patent. PRESENT CLAIM 11: An apparatus for determining a person's risk for sudden cardiac death (SCD), the apparatus comprising a storage device, the storage device comprising: data comprising an SCD risk sequence ensemble, wherein SCD risk sequences of the ensemble are determined by assessing quality of alignment of ECG sequences and derivatives of the ECG sequences between multiple individuals; and processor executable instructions that when executed by one or more processors configure the one or more processors to: receive a digital ECG measurement taken for the person; detect, in the person's digital ECG measurement, sequences indicative of a risk for SCD based on the SCD risk sequences in the SCD risk sequence ensemble; and by an SCD risk predictor, determine quantitative risk for an occurrence of SCD in the person based on the detected sequences indicative of a risk for SCD and their alignment. CLAIM 16 of the ‘135 PATENT: An apparatus for determining an individual's risk for sudden cardiac death (SCD), the apparatus comprising: a storage device storing an SCD risk sequence ensemble, wherein SCD risk sequences of the ensemble are determined by assessing quality of alignment of ECG sequences and derivatives of the ECG sequences between multiple individuals; and a processor in communication with the storage device configured to: receive a digital ECG measurement taken from a test individual; detect in the test patient digital ECG measurement any predetermined electrocardiogram (ECG) sequences indicative of a risk for SCD based on the SCD risk sequences in the SCD risk sequence ensemble; and determine quantitative risk for the occurrence of SCD in the individual based on the detection of the predetermined ECG sequences and their alignment. The chart above illustrates the overlap in limitations between the present claim 11 and claim 16 of the ‘135 patent. The present claim includes additional features of using one or more processors to execute the method. Modification to duplicate an essential part, such as processor, has been held to be obvious to one of ordinary skill in the art. Additionally, present claim 11 includes recitation of “a risk predictor”. With regard to the risk predictor, the processor and functional steps of the ‘135 patent sufficiently execute steps that are performed by the claimed risk predictor, wherein the processors of the ‘135 necessarily incorporate functions of the claimed risk predictor. Therefore, the invention of present claim 11 is an obvious variation of claim 16 of the ‘135, wherein the variation pertains to the obvious duplication of a processor element into multiple processors according to known methods to yield predictable results. Claims 1-8 and 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 16 of U.S. Patent No. 9,775,535. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘535 patent recites steps of a method that are considered to be an obvious variation of the claimed method. PRESENT CLAIM 1: A method for one or more processors for determining an individual's risk for sudden cardiac death (SCD), the method comprising: receiving, by the one or more processors, a digital electrocardiogram (ECG) measurement taken from the individual; determining, by the one or more processors, derivatives of sequences of the ECG measurement from the individual; in an SCD risk predictor of the one or more processors, quantitatively determining, in the received ECG measurement, presences of SCD risk sequences, wherein the one or more processors scores alignment between (a) the SCD risk sequences and (b) sequences of the ECG measurement from the individual, using derivatives of the SCD risk sequences and the determined derivatives; and generating output comprising a result of the quantitative determination. CLAIM 1 of the ‘535 PATENT: A method for determining an individual's risk for sudden cardiac death (SCD), the method comprising: receiving a digital electrocardiogram (ECG) measurement taken from the individual; quantitatively determining, in a processor, in the received ECG measurement, presences of predetermined digital electrocardiogram (ECG) sequences indicative of a risk for SCD, wherein the processor assesses quality of alignment between (a) the predetermined ECG sequences, first derivatives of the predetermined ECG sequences and second derivatives of the predetermined ECG sequences and (b) ECG sequences measured from the individual, first derivatives of the ECG sequences measured from the individual and second derivatives of the ECG sequences measured from the individual. The chart above illustrates where overlap in limitations between the present claim 1 and claim 1 the ‘535 patent occur. Claim 1 of the ‘535 patent is considered to recite features in a narrower scope such that they anticipate the claims of the present invention. For instance, the step of the ‘535 patent for “assessing the quality of alignment” is read as being similar to the score of alignment as presently claimed. The recitation in the ‘535 for “presences of predetermined digital electrocardiogram (ECG) sequences indicative of a risk for SCD” reads on the “SCD risk sequences” as presently claimed. Additionally, the ‘535 takes the derivatives of both the SCD risk sequences and the ECG measurement from the individual for the alignment. The present claim is also found to include additional features of 1. Outputting a result of the determination, and 2. Using one or more processors to execute the method, and 3. Recitation of “a risk predictor”. With regard to item 1, outputting the result of the method is considered an obvious modification in order to indicate the determined risk to a user or caretaker. With regard to item 2, Modification to duplicate an essential part, such as processor, has been held to be obvious to one of ordinary skill in the art. With regard to item 3, the processor and functional steps of the ‘535 patent sufficiently execute steps that are performed by the claimed risk predictor, wherein the processors of the ‘535 necessarily incorporate functions of the claimed risk predictor. Therefore, the invention of present claim 1 is an obvious variation of claim 1 of the ‘535, wherein the variation pertains to the obvious duplication of a processor element into multiple processors according to known methods to yield predictable results. In regard to present claims 2-8, similar overlap in claimed features is observed in view of claims 2-9 of the ‘535 patent. PRESENT CLAIM 11: An apparatus for determining a person's risk for sudden cardiac death (SCD), the apparatus comprising a storage device, the storage device comprising: data comprising an SCD risk sequence ensemble, wherein SCD risk sequences of the ensemble are determined by assessing quality of alignment of ECG sequences and derivatives of the ECG sequences between multiple individuals; and processor executable instructions that when executed by one or more processors configure the one or more processors to: receive a digital ECG measurement taken for the person; detect, in the person's digital ECG measurement, sequences indicative of a risk for SCD based on the SCD risk sequences in the SCD risk sequence ensemble; and by an SCD risk predictor, determine quantitative risk for an occurrence of SCD in the person based on the detected sequences indicative of a risk for SCD and their alignment. CLAIM 17 of the ‘535 PATENT: An apparatus for determining a person's risk for sudden cardiac death (SCD), the apparatus comprising: a storage device storing an SCD risk sequence ensemble, wherein SCD risk sequences of the ensemble are determined by assessing quality of alignment of ECG sequences, first derivatives of the ECG sequences between multiple individuals; and a processor in communication with the storage device configured to: receive a digital ECG measurement taken from a test individual; detect, in the test patient digital ECG measurement and predetermined electrocardiogram (ECG) sequences indicative of a risk for SCD based on the SCD risk sequences in the SCD risk sequence ensemble; determine quantitative risk for an occurrence of SCD in the individual based on the detection of the predetermined ECG sequences and their alignment. The chart above illustrates where overlap in limitations between the present claim 11 and claim 17 the ‘535 patent occur. Claim 11 of the ‘535 patent is considered to recite features in a narrower scope such that they anticipate the claims of the present invention. For instance, the feature of the ‘535 patent for “assessing the quality of alignment” is read as being similar to the score of alignment as presently claimed. The recitation in the ‘535 for “presences of predetermined digital electrocardiogram (ECG) sequences indicative of a risk for SCD” reads on the “SCD risk sequences” as presently claimed. Additionally, the ‘535 takes the derivatives of both the SCD risk sequences and the ECG measurement from the individual for the alignment. The present claim 11 is also found to include additional features of 1. Outputting a result of the determination, and 2. Using one or more processors to execute the method, and 3. Recitation of “a risk predictor”. With regard to item 1, outputting the result of the method is considered an obvious modification in order to indicate the determined risk to a user or caretaker. With regard to item 2, Modification to duplicate an essential part, such as processor, has been held to be obvious to one of ordinary skill in the art. With regard to item 3, the processor and functional steps of the ‘535 patent sufficiently execute steps that are performed by the claimed risk predictor, wherein the processors of the ‘535 necessarily incorporate functions of the claimed risk predictor. Therefore, the invention of present claim 1 is an obvious variation of claim 1 of the ‘535, wherein the variation pertains to the obvious duplication of a processor element into multiple processors according to known methods to yield predictable results. Allowable Subject Matter Claims 1-13 would be allowable should Applicant's reply either comply with or specifically traverse the requirements of the 35 USC 101 and double patenting rejections set forth above. The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to teach or suggest, among other things, the steps of determining the risk of sudden cardiac death (SCD) from a score of alignment between the derivatives of a sequence of ECG measurement and derivative of determined SCD risk sequences. Guttag et al. (US Publication no. 2013/0046193 - disclosed by Applicant) describes a method for predicting patient outcomes by comparing cardiac activity from a population of individuals that experienced sudden cardiac death with a population of normal control individuals and a population of individuals having non-threatening supraventricular arrhythmias (i.e., those with heart disease). A likelihood score of sudden cardiac death was obtained from the comparisons (para 134). However, Guttag et al. fails to teach obtaining an alignment score using the derivatives of the ECG sequences aligned with the derivatives of determined SCD sequences. Absent hindsight reasoning, the Examiner has no motivation to modify the Guttag et al. reference. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET. 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, David E. Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /BRIAN T GEDEON/Primary Examiner, Art Unit 3796 2 April 2026
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Prosecution Timeline

Nov 28, 2023
Application Filed
Apr 23, 2026
Non-Final Rejection mailed — §101, §DOUBLEPATENT (current)

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Prosecution Projections

1-2
Expected OA Rounds
87%
Grant Probability
94%
With Interview (+7.1%)
2y 6m (~0m remaining)
Median Time to Grant
Low
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