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 July 22, 2026, the following has occurred: claim(s) 1, 5, 7-8, 14, have been amended, claim(s) 21-26 have been added, and claim(s) 6, 9-13 have been canceled. Now, claim(s) 1-5, 7-8, 14-26 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.
Claim(s) 1-5, 7-8, 14-26 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1-5, 7-8, 14-26: Step 1
Claims 1-5, 7 are drawn to a system, claim 8 is drawn to a method, claims 14-26 are drawn to a non-transitory computer readable media, and of which are within the four statutory categories (i.e., a machine and a process). Claims 1-5, 7-8, 14-26 are further directed to an abstract idea on the grounds set out in detail below.
Claim 1: Step 2A Prong One
Claim 1 recite(s):
collecting a plurality of physiologic measurements, of a first set of physiological variables and a second set of physiological variables, obtained from a patient at a corresponding plurality of times;
constructing, from the plurality of physiologic measurements and the corresponding plurality of times, at least one log-return time series;
determining a transfer entropy transfer entropy associated with the at least one log-return time series and a spectral coherence associated with the at least one log-return time series, wherein determining the transfer entropy and the spectral coherence comprises:
computing a measure of time-asymmetric information transfer between the first set of physiological variables and the second set of physiological variables;
generating an index, relating to one or both of a cardiovascular condition associated with the patient and a necrosis condition associated with the patient, based on the transfer entropy and on the spectral coherence;
automatically generating a diagnosis or a prediction of a cardiovascular ischemia condition relating to the patient, the diagnosis or prediction being automatically generated based on the index and without arterial anatomy being measured; and
creating, by the one or more hardware processors, a particular treatment for the patient to administer to the patient to treat a particular condition of the patient associated with the one or both of the cardiovascular condition and the necrosis condition
These limitations, as drafted, given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions), which is a subgrouping of Certain Methods of Organizing Human Activity. That is, other than reciting, “via a biomarker measurement device”, “by the one or more hardware processors” to perform these functions, nothing in the claim precludes the limitations from practically being performed by a person following instructions to make determinations of health conditions based on received data. For example, the claim encompasses a person following instructions to collect a plurality of physiologic measurements to construct at least one log-return time series, a person following instructions to determine a transfer entropy associated with the at least one log-return time series by computing a measure of time-asymmetric information transfer. Similarly, the claim encompasses a person following instructions to determine an index relating to one or both of a cardiovascular condition associated with the patient and a necrosis condition associated with the patient, based on the transfer entropy and on the spectral coherence. Similarly, the claim encompasses a person following instructions to determine a diagnosis or a prediction of a cardiovascular ischemia condition relating to the patient. Finally, the claim encompasses a person following instructions to determine a particular treatment for the patient to administer to the patient to treat a particular condition of the patient associated with the one or both of the cardiovascular condition and the necrosis condition. These steps could be accomplished by a person following instructions to make determinations using obtained information, and therefore encompass Certain Methods of Organizing Human Activity.
Claim 1: 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, insignificant extra-solution activity, and generally linking the abstract idea to a
technical environment.
Claim 1, directly or indirectly, recites the following generic computer components configured to implement the abstract idea “via a biomarker measurement device”, “by the one or more hardware processors”. 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 “by the one or more hardware processors via an invasive or imaging modality at a time of the generating” 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.
Claim 1: 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 elements of using a computer
configured to perform above identified functions amounts to no more than mere instructions to apply the exception using generic computer components. 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)).
Dependent claims 2-5, 7 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. For example, claims 2-3 further describe the particular treatment. Similarly, claims 4-5 further describe the plurality of operations. Finally, claim 7 further describes the at least one log-return time series. Therefore, these claims recite limitations that fall into the Certain Methods of Organizing Human Activity grouping of abstract ideas.
Dependent claims 2-5, 7 recite additional subject matter which amount to limitations consisted with the additional elements in independent claim 1 (such as claim 7 recites an additional limitation that amounts to a generic computer component).
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.
Claim 8 recite similar functions to claim 1, but in method form. The claims are not patent eligible.
Claims 14-20 recite similar functions to claims 1-5, 7, but in non-transitory computer readable form. Dependent claims 21-26 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. For example, claims 21, 24 further describe determining the transfer entropy and the spectral coherence. Similarly, claim 22 further describes generating the diagnosis or the prediction of the cardiovascular ischemia condition. Similarly, claim 23 further describes the operations. Finally, claims 25-26 further describe generic computer components. Therefore, these claims recite limitations that fall into the Certain Methods of Organizing Human Activity grouping of abstract ideas. Dependent claims 21-26 recite additional subject matter which amount to limitations consisted with the additional elements in independent claim 14 (such as claim 25 recites an additional limitation that amounts to a generic computer component).
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.
Subject Matter Free of the Prior Art
The following is an examiner’s statement of subject matter free of the prior art.
The limitations in independent claims 1, 8, and 14 states:
“constructing, from the plurality of physiologic measurements and the corresponding plurality of times, at least one log-return time series;”
“determining a transfer entropy associated with the at least one log-return time series- and a spectral coherence associated with the at least one log-return time series, wherein determining the transfer entropy and the spectral coherence comprises:
computing a measure of time-asymmetric information transfer between the first set of physiological variables and the second set of physiological variables;”
“generating an index, relating to one or both of a cardiovascular condition associated with the patient and a necrosis condition associated with the patient, based on the transfer entropy and on the spectral coherence;”
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)), discloses a system and method for medical premonitory event estimation includes one or more processors to perform operations comprising: acquiring a first set of physiological information of a subject, and a second set of physiological information of the subject received during a second period of time; calculating first and second risk scores associated with estimating a risk of a potential cardiac arrhythmia event for the subject based on applying the first and second sets of physiological information to one or more machine learning classifier models, providing at least the first and second risk scores associated with the potential cardiac arrhythmia event as a time changing series of risk scores, and classifying the first and second risk scores associated with estimating the risk of the potential cardiac arrhythmia event for the subject based on the one or more thresholds, combined with a method, system, and computer readable medium for early detection of sub-acute potentially catastrophic illnesses, and more specifically to detecting abnormal entrainment of waveform and vital sign time series representations of physiological processes. However, the prior art does not describe the particular steps of “constructing, from the plurality of physiologic measurements and the corresponding plurality of times, at least one log-return time series;” to be utilized to “determining a transfer entropy associated with the at least one log-return time series and a spectral coherence associated with the at least one log-return time series, wherein determining the transfer entropy and the spectral coherence comprises: computing a measure of time-asymmetric information transfer between the first set of physiological variables and the second set of physiological variables;”. Therefore, the claims 1-5, 7-8, 14-26 are free of the prior art.
Response to Arguments
In the Remarks filed on July 22, 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 does not acknowledge that the newly added and/or amended claims overcome the 35 U.S.C. 101 rejection(s). The Examiner acknowledges that the newly added and/or amended claims overcome the Claim Objection(s) and 35 U.S.C. 103 rejection(s).
The Applicant argues that:
(1) claim 1 is directed to a biometric sensor device, that generates measurements of differing sets of differing physiological variables, and a prediction device performing computerized operations including (i) constructing sets of time-series measurements, (ii) determining a transfer entropy and a spectral coherence based on the sets of time-series measurements, (iii) identifying a composite ischemia index, and (iv) automatically producing, via hardware processors and based on the transfer entropy a diagnosis and further indicating a prediction for an adverse cardiovascular event. 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. Further, contrary to the assertions by the Office, the test for determining whether claims recite the abstract grouping of organizing human activity is NOT determining whether a single limitation in the claim given its broadest reasonable interpretation, ''encompass managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions), which is a subgrouping of Certain Methods of Organizing Human Activity," as used in the Office Action. Rather, the test focuses on whether the claim recites human social activities, human teaching, and humans themselves actually following rules or instructions, as explained above. Moreover, contrary to the assertions by the Office, at page 6 of the Office Action, the test for determining whether claims recite the abstract grouping of organizing human activity is NOT determining that ''nothing in the claim precludes the limitations from practically being performed by a person following instructions,,, as used in the Office Action. Rather, the test focuses on whether the claims recite human social activities, human teaching, and humans following rules or instructions, as explained above. Consequently, by virtue of at least the foregoing reasons, 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, n.b., 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) the claims are amended in view of statutory subject matter issues asserted by the Office. For example, independent claim 1 recites a combination of features similar or analogous to the combinations of elements recited in claims determined to be in compliance with§ 101 by virtue of integrating any purported instance of an abstract-idea judicial exception into a practical application. The set of claims as amended herein integrates the judicial exception purported by the Office into a practical application including generating a particular determination for a patient of a particular risk for a cardiovascular ischemic event, and providing a tailored treatment to the patient based on the particular determination. Turning to MPEP, Section 2106.04(d), in determining whether a claim integrates a judicial exception into a practical application, as in Step 2A Prong Two analysis should be made as to whether the additional elements amount to more than generally linking the use of a judicial exception to a technological environment or field of use. Additionally, attention is directed to the 2019 Revised Patent Subject Matter Eligibility Guidance (the “2019 Guidance”). According to Section III(C)(ii) of the 2019 Guidance, “a claim that recites ... '[a] treating a patient having a blood glucose level over 250 mg/di with insulin' ... step is particular and integrates ... into a practical application ... [beyond] a nominal connection to [a] law of nature ... This step ... [applies] the exception in any meaningful way." Turning to the set of claims, they recite automatically diagnosing cardiovascular ischemia for a particular patient, based on evaluating a particular composite index (for an ischemic event) for the patient without applying invasive or imaging modalities, and performing a treatment procedure particular to the patient based on the automatic diagnosing particular to the patient and based further on the initiation of the intervening action for the patient. 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. Attention is also directed to MPEP Section 2106.04 cited as authoritative guidance in the Office Action. According to subsection (2) of this section, ''claims us[ing] the recited ... [exception to] treat the patients ..., thereby reducing the patient's risk of QTc prolongation," apply the judicial exception in a meaningful way and accordingly are directed to statutory subject matter. 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 MPEP Section 2106.04(d)(2) as statutory subject matter and accordingly are allowable. Further, in 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. See MPEP, Section 2106.05. Claim 1 recites significantly more than the judicial exception purported by the Office, such as ''collecting a plurality of physiologic measurements ... via a biomarker measurement device ...; determining a transfer entropy ... (by) computing a measure of time-asymmetric information transfer between the first set of physiological variables and the second set of physiological variables ...; automatically generating a diagnosis or a prediction ... without arterial anatomy being measured by the one or more hardware processors via an invasive or imaging modality at a time of the generating." Further, the fact that the Examiner has informally or preliminarily determined that claim 1 as amended may have merit for potentially overcoming the art based rejections of record subject to further review speaks as evidence for consideration of the various facts on the topic of whether the claim elements in combination recite significantly more than the purported judicial exception. Consequently, by virtue of at least the foregoing reasons, the set of claims as amended clearly is directed to statutory subject matter.
In response to argument (1), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the newly amended claims are directed to an abstract idea without significantly more. The Examiner maintains that the newly amended claims are similar to “iii. a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982)”, which is an example of managing personal behavior (See MPEP 2106.04(a)(2)(II)(C)). 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 Applicant’s newly amended claims recite additional elements that integrate the judicial exception into a practical application as the Applicant’s claims recite “creating, by the one or more hardware processors, a particular treatment for the patient to administer to the patient to treat a particular condition of the patient associated with the one or both of the cardiovascular condition and the necrosis condition” in independent claims 1, 8, and 14 and dependent claims 3 and 16 recite “wherein the particular treatment is administered by a clinician at a healthcare facility to the patient to treat the cardiovascular ischemia condition of the patient”, which are similar to “Conversely, consider a claim that recites the same abstract idea and "administering a suitable medication to a patient." This administration step is not particular, and is instead merely instructions to "apply" the exception in a generic way.” (See MPEP 2106.04(d)(2)(a)). The “administering” step is not particular as the treatment is not particular, i.e., “specifically identified so that it does not encompass all applications of the judicial exception(s)” (See MPEP 2106.04(d)(2)(a)). The Examiner does not find the Applicant’s newly amended claims to be similar to Example 42, claim 1 as the Examiner maintains the Applicant’s newly amended claims are similar to “iii. Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48” which the courts have indicated may not be sufficient to show an improvement to technology (See MPEP 2106.05(a)(II)). 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 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 elements of using a computer configured to perform above identified functions amounts to no more than mere instructions to apply the exception using generic computer components. 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 35 U.S.C. 101 rejection(s) stand.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Harrington et al. (U.S. Patent Pre-Grant Publication No. 2011/0144914), describes methods, assays and kits identify biomarkers, particularly miRNA and/or protein biomarkers, for assessing the cardiovascular health of a human.
Gill et al. (U.S. Patent Pre-Grant Publication No. 2013/0085079), describes biomarkers, methods, devices, reagents, systems, and kits for the evaluation of risk of a cardiovascular (CV) Event within 5 year.
Saglio et al. (“Evaluation of cardiovascular ischemic event rates in dasatinib-treated patients using standardized incidence ratios”), describes comparison of observed and expected event rates through standardized incidence ratios indicates that dasatinib does not increase risk for cardiovascular ischemic events compared with external reference populations.
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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/Bennett Stephen Erickson/Primary Examiner, Art Unit 3683
