DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In the amendment filed on April 28, 2026, the following has occurred: claim(s) 1, 4, 6, 8, 14-16, 18-19 have been amended, claim(s) 21-31 have been added, and claim(s) 2-3, 5, 7, 9-13, 17, 20 have been cancelled. Now, claim(s) 1, 4, 6, 8, 14-16, 18-19, 21-31 are pending.
Claim Objections
Claim 24 objected to because of the following informalities: “claim 14, where in” in p. 7, ll. 1. This appears to be a typographical error. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “claim 14, wherein”.
Claim 25 objected to because of the following informalities: “claim 14, where in” in p. 7, ll. 5. This appears to be a typographical error. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “claim 14, wherein”.
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.
Claim(s) 1, 4, 6, 8, 14-16, 18-19, 21-31 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1, 4, 6: Step 2A Prong One
Claim 1 recite(s):
collect a set of measurements of: a set of first physiological patient variables and a set of second physiological patient variables that differ from variables of the set of first physiological patient variables;
based on the set of measurements, constructing at least one set of time-series measurements representing measurement values, of the set of first physiological patient variables and of the set of second physiological patient variables, at corresponding date-time stamps;
determining, based on the set of time-series measurements and a transform selected from a group comprising a Fourier transform and a wavelet transform, a transfer entropy and a spectral coherence, wherein determining the transfer entropy and the spectral coherence comprises computing a measure of time-asymmetric information transfer between the set of first physiological patient variables and the set of second physiological patient variables;
generating a set of ischemia condition data based on the transfer entropy, the spectral coherence, and the measure of time-asymmetric information transfer, wherein generating the set of ischemia condition data comprises identifying a composite ischemia index;
automatically creating, via the one or more hardware processors and based at least in part on the set of ischemia condition data, clinical information indicating one or both of a diagnoses and a prediction for an adverse cardiovascular event; and
electronically writing, via the one or more hardware processors, encoded data to the electronic digital memory at the medical records computer system, wherein the encoded data corresponds at least partially to the clinical information and includes the composite ischemia index
These limitations, as drafted, given the broadest reasonable interpretation, managing
personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) that constitute Certain Methods of Organizing Human Activity, but for the recitation of generic computer components and generally linking the abstract idea to a technical environment. That is, other than reciting “one or more hardware processors”, “utilizing a measurement device, associated with a patient and with an electronic digital memory at a medical records computer system, to”, “via the one or more hardware processors and”, “via the one or more hardware processors,”, “to the electronic digital memory at the medical records computer system” to perform these functions, nothing in the claim precludes the limitations from practically being performed by a human following rules or instructions. For example, but for the “one or more hardware processors”, “utilizing a measurement device, associated with a patient and with an electronic digital memory at a medical records computer system, to” language, the “collect” function in the context of this claim encompasses a user following instructions to collect a set of measurements of a patient. Similarly, but for the “one or more hardware processors” language, the “constructing” function in the context of this claim encompasses a user following instructions to determine at least one set of time-series measurements representing measurement values. Similarly, but for the “one or more hardware processors” language, the “determining” and “generating” functions in the context of this claim encompasses a user following instructions to determine a transfer entropy and spectral coherence, and determine a set of ischemia condition data. Finally, but for the “via the one or more hardware processors,”, “to the electronic digital memory at the medical records computer system” language, the “creating” and “writing” functions in the context of this claim encompasses a user following instructions to determining a diagnoses and/or a prediction for an adverse cardiovascular event, and storing the diagnoses and/or the prediction for an adverse cardiovascular event in a medical records system. The claims recite steps that could be accomplished by a physician, doctor, or nurse following instructions to determine a diagnoses and/or a prediction for an adverse cardiovascular event. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people of the limitation but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, these claims recite an abstract idea.
15. Claims 4, 6 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. For example, claim 4 includes the abstract idea identified above and further describes the determination of the transfer entropy and the spectral coherence, and determining a composite index. Finally, claim 6 includes the abstract idea identified above and further describes the time-series measurements and the Fourier transform. Finally, claim 7 include the abstract idea identified above and describes presence, likelihood, or risk of inflammation, and accessing a stored arterial anatomy measurement. Therefore, these claims recite limitations that fall into the Certain Methods of Organizing Human Activity grouping of abstract ideas.
Claims 1, 4, 6: Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract idea and generally linking the abstract idea to a technical environment.
This judicial exception is not integrated into a practical application because the “one or more hardware processors”, “an electronic digital memory at a medical records computer system”, “a measurement device”, to the electronic digital memory at the medical records computer system” are recited at a high-level of generality. As set forth in the MPEP 2106.04(d) "merely including instructions to implement an abstract idea on a computer" is an example of when an abstract idea has not been integrated into a practical application.
Additionally, the claims recite “utilizing a measurement device, associated with a patient”, “via the one or more hardware processors and”, “via the one or more hardware processors,” at a high degree of generality, amount no more than generally linking the abstract idea to a particular technical environment. The recitation is also similar to adding the words “apply it” to the abstract idea. As set forth in MPEP 2106.05(f), merely reciting the words “apply it” or an equivalent, is an example of when an abstract idea has not been integrated into a practical application.
Claims 1, 4, 6: Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to
significantly more than the judicial exception. As discussed above with respect to integration of
the abstract idea into a practical application, the additional element of using a computer configured to perform above identified functions amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See Alice 573 U.S. at 223 ("mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.")
Additionally, generally linking the abstract idea to a particular technological environment
does not amount to significantly more than the abstract idea (See MPEP 2106.05(h) and Affinity
Labs of Texas v. DirectTV, LLC, 838 F.3d 1253, 120 USP12d 1201 (Fed. Cir. 2016)). The claims are not patent eligible.
Claim(s) 8 mirrors claim 1 only within computer-implemented method form, and are rejected for the same reason as claim 1.
Claim 14 mirrors claim 1 only within non-transitory media form, and are rejected for the same reason as claim 1.
Claims 15-16, 18-19, 21-31 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. For example, claims 15-16, 18-19, 26 include the abstract idea identified above and further describe the determination of the transfer entropy and the spectral coherence. Similarly, claims 21-23 include the abstract idea identified above and further describe determining the set of ischemia condition data and the composite ischemia index. Similarly, claim 24 includes the abstract idea identified above and describes the utilization of the transfer entropy and the spectral coherence to determine a binary result. Similarly, claim 25 includes the abstract idea identified above and describes the determining of a particular treatment to potentially administer to the patient. Similarly, claim 27 includes the abstract idea identified above and describes filtering out non-vascular inflammatory signals and determining predictions. Similarly, claim 28 includes the abstract idea identified above and further describes the constructing of the at least one set of time-series measurements. Similarly, claim 29 includes the abstract idea identified above and further describes the clinical information. Similarly, claim 30 includes the abstract idea identified above and describes alerting another person to modify a treatment. Finally, claim 31 includes the abstract idea identified above and further describes the clinical information. Therefore, these claims recite limitations that fall into the Certain Methods of Organizing Human Activity grouping of abstract ideas.
Dependent claims recite additional subject matter which amount to limitations consisted
with the additional elements in independent claim 14 (such as claim 28 recites additional limitations that amount to no more than generic computer components).
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The claims are not patent eligible.
Allowable Subject Matter
Claims 1, 4, 6, 8, 14-16, 18-19, 21-31 are allowed over the prior art. The following is a statement of reasons for the indication of allowable subject matter: The primary reason that claims 1, 4, 6, 8, 14-16, 18-19, 21-31 distinguish over the prior art is the inclusion of the combination of the limitations of “determining, based on the set of time-series measurements and a transform selected from a group comprising a Fourier transform and a wavelet transform, a transfer entropy and a spectral coherence, wherein determining the transfer entropy and the spectral coherence comprises computing a measure of time-asymmetric information transfer between the set of first physiological patient variables and the set of second physiological patient variables”, “generating a set of ischemia condition data based on the transfer entropy, the spectral coherence, and the measure of time-asymmetric information transfer, wherein generating the set of ischemia condition data comprises identifying a composite ischemia index”, and “automatically creating, via the one or more hardware processors and based at least in part on the set of ischemia condition data, clinical information indicating one or both of a diagnoses and a prediction for an adverse cardiovascular event” as recited in independent claim 1 and similarly in independent claims 8 and 14. The closest prior art (Sullivan et al. (U.S. Patent Pre-Grant Publication No. 2019/0216350)), Moorman et al. (U.S. Patent Pre-Grant Publication No. 2016/0143594)), describes a medical premonitory event estimation system is provided, the system comprising: a non-transitory computer-readable storage medium in communication with one or more processors and having instructions stored thereon which, when executed by the one or more processors, cause the one or more processors to perform operations comprising: for a plurality of time periods, calculating an event estimation of risk score associated with a potential medical event for a subject occurring within of the associated time period based at least partly on physiological parameter data of the subject combined with methods, systems, techniques, computer readable media, and tools for detecting abnormal entrainment of multidimensional time series representations of physiological and disease processes. However, the prior art does not describe the particular steps of “determining, based on the set of time-series measurements and a transform selected from a group comprising a Fourier transform and a wavelet transform, a transfer entropy and a spectral coherence, wherein determining the transfer entropy and the spectral coherence comprises computing a measure of time-asymmetric information transfer between the set of first physiological patient variables and the set of second physiological patient variables” to then generate “a set of ischemia condition data based on the transfer entropy, the spectral coherence, and the measure of time-asymmetric information transfer, wherein generating the set of ischemia condition data comprises identifying a composite ischemia index”. The 35 U.S.C. 103 rejection(s) have been withdrawn that were applied to the claims previously.
Response to Arguments
In the Remarks filed on April 28, 2026, the Applicant argues that the newly amended and/or added claims overcome the Claim Objection(s), 35 U.S.C. 101 rejection(s), and 35 U.S.C. 103 rejection(s). The Examiner acknowledges that the newly added and/or amended claims overcome the previous Claim Objection(s) and 35 U.S.C. 103 rejection(s). However, the Examiner does not acknowledge that the newly added and/or amended claims overcome the newly added Claim Objection(s) and 35 U.S.C. 101 rejection(s).
The Applicant argues that:
(1) the claim elements are not in any way a mechanism that manages (influences) personal behavior, nor are they a mechanism that manages (influences) interactions between people. Claim 1 beyond doubt does NOT recite an abstract idea of managing personal behavior. Claim 1 clearly does NOT recite an activity performed by humans, performable by humans is the test for a mental processes abstract-idea grouping which is not relevant to the current rejection. Since the claim does not recite an abstract idea grouping of certain methods of organizing human activity, claim 1 is statutory and patent eligible;
(2) Applicant respectfully submits that the set of claims as amended herein recite features similar or analogous to elements described above in the 2019 Guidance as statutory subject matter and therefore clearly are directed to statutory subject matter in compliance with§ 101. In the present application, the set of claims as amended herein recites diagnosing a particular patient, based on a particular composite index for the patient, and performing a treatment procedure particular to the patient based on the diagnosing particular to the patient. Applicant respectfully submits that the set of claims as amended herein recites features similar or analogous to elements described above in the MPE Section 2106.04(d)(2) as statutory subject matter and accordingly are allowable. Further, Example 42 of the USPTO’s Subject Matter Eligibility Guidance, Example Claim 1 is discussed and denoted as statutory. This example claim recites storing information, converting information, generating a message whenever updated information is stored, and transmitting the message to users. The claim as a whole is described as integrating a method of organizing human activity into a practical application. Thus, under the USPTO's subject matter eligibility two-step analysis the example claim is eligible because it is not directed to the recited judicial exception (abstract idea). Applicant respectfully submits that the set of claims as amended herein recites features similar or analogous to elements of this hypothetical claim in Example 42 and accordingly is directed to statutory subject matter. Hence, the pending amended claims are statutory by virtue of at least the foregoing precedent;
(3) the determination of whether a claim recites an inventive concept (also called ''significantly more'' per Section 2106(III) of the MPEP), as in Step 2B, must consider whether the additional claim elements, in combination with the other claim elements, amount to more than merely indicating a field of use or generally linking the judicial exception to the field of use. Claim 1 recites significantly more than the judicial exception purported by the Office.
In response to argument (1), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the claimed limitations, as drafted, given the broadest reasonable interpretation, managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) that constitute Certain Methods of Organizing Human Activity, but for the recitation of generic computer components and generally linking the abstract idea to a technical environment. The 35 U.S.C. 101 rejection(s) stand.
In response to argument (2), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner does not acknowledge that the newly amended claims recite “performing a treatment procedure particular to the patient based on the diagnosing particular to the patient” as the independent claims 1, 8, 14 recite “automatically creating, via the one or more hardware processors and based at least in part on the set of ischemia condition data, clinical information indicating one or both of a diagnoses and a prediction for an adverse cardiovascular event” and “electronically writing, via the one or more hardware processors, encoded data to the electronic digital memory at the medical records computer system, wherein the encoded data corresponds at least partially to the clinical information and includes the composite ischemia index”, the Applicant’s claims do not require a treatment or “performing a treatment procedure particular to the patient”. The Examiner does not acknowledge that the newly amended claims are similar to Example 42 Claim 1 as the Examiner maintains that the treatment or prophylaxis limitation recited by the Applicant’s claims does not impose meaningful limits on the judicial exception, and the additional elements are considered to be extra-solution activity or a field-of-use. The 35 U.S.C. 101 rejection(s) stand.
In response to argument (3), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the additional elements do not amount to significantly more than the judicial exception as the additional elements recite using a computer configured to perform above identified functions amounts to no more than mere instructions to apply the exception using a generic computer component and generally linking the abstract idea to a particular technological environment. The 35 U.S.C. 101 rejection(s) stand.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bennett S Erickson whose telephone number is (571)270-3690. The examiner can normally be reached Monday - Friday: 9:00am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bennett Stephen Erickson/Primary Examiner, Art Unit 3683
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