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 .
Status of Claims
This action is in reply to the claims filed on February 28, 2025. Claim(s) 1-20 are currently pending and have been examined.
Claim Objections
Claim 1 objected to because of the following informalities: “the operations comprising:” in p. 1, ll. 4, “or prediction” in p. 1, ll. 13. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portions as “the plurality of operations comprising:”, “or the prediction”.
Claim 4 objected to because of the following informalities: “the operations” in p. 1, ll. 25. This appears to be a typographical error. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “the plurality of operations”.
Claim 5 objected to because of the following informalities: “the operations” in p. 1, ll. 27. This appears to be a typographical error. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “the plurality of operations”.
Claim 8 objected to because of the following informalities: “or prediction” in p. 2, ll. 15. This appears to be a typographical error. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “or the prediction”.
Claim 14 objected to because of the following informalities: “One or more non-transitory media” in p. 3, ll. 6, “the operations comprising:” in p. 3, ll. 8, “or prediction” in p. 3, ll. 17. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portions as “One or more non-transitory computer readable media”, “the plurality of operations comprising:”, “or the prediction”.
Claim 15 objected to because of the following informalities: “The one or more non-transitory media” in p. 3, ll. 23. This appears to be a typographical error. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “The one or more non-transitory computer readable media”.
Claim 16 objected to because of the following informalities: “The one or more non-transitory media” in p. 4, ll. 1. This appears to be a typographical error. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “The one or more non-transitory computer readable media”.
Claim 17 objected to because of the following informalities: “The one or more non-transitory media” in p. 4, ll. 4, “the operations” in p. 4, ll. 4. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portions as “The one or more non-transitory computer readable media”, “the plurality of operations”.
Claim 18 objected to because of the following informalities: “The one or more non-transitory media” in p. 4, ll. 6, “the operations” in p. 4, ll. 6. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portions as “The one or more non-transitory computer readable media”, “the plurality of operations”.
Claim 19 objected to because of the following informalities: “The one or more non-transitory media” in p. 4, ll. 10. This appears to be a typographical error. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “The one or more non-transitory computer readable media”.
Claim 20 objected to because of the following informalities: “The one or more non-transitory media” in p. 4, ll. 12. This appears to be a typographical error. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “The one or more non-transitory computer readable media”.
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) 1-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1: Step 1
Claims 1-7 are drawn to a system, claims 8-13 are drawn to a method, claims 14-20 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 1-20 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 set of physiologic measurements obtained from a patient to determine at least one log-return time series, 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;
generating an index, relating to one or both of a cardiovascular condition associated with the patient and 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 the prediction being automatically generated based on the index and without arterial anatomy being measured; and
creating, 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 the health conditions based on received data. For example, the claim encompasses a person following instructions to collect a set of physiologic measurements to determine at least one log-return time series, 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. 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 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 by 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 2-7 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. For example, claims 2-3, 7 further describe the particular treatment. Similarly, claims 4-5 further describe the plurality of operations. Finally, claim 6 further describe 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 2-7 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.
Claims 8-13 recite similar functions to claims 1, 3-7, but in method form. The claims are not patent eligible.
Claims 14-20 recite similar functions to claims 1-7, but in non-transitory computer readable form. The claims are not patent eligible.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan et al. (U.S. Patent Pre-Grant Publication No. 2019/0216350) in view of Moorman et al. (U.S. Patent Pre-Grant Publication No. 2016/0143594).
As per independent claim 1, Sullivan discloses a system having one or more hardware processors configured to facilitate a plurality of operations, the plurality of operations comprising:
automatically generating a diagnosis or a prediction of a cardiovascular ischemia condition relating to the patient, the diagnosis or the prediction being automatically generated based on the index and without arterial anatomy being measured by the one or more hardware processors via an invasive or imaging modality at a time of the generating (See [0221], [0258]: Automatically analyzing subject data to predict conditions including medical events, for example, adverse cardiac events, which the Examiner is interpreting predict conditions to include automatically generating a diagnosis or a prediction of a cardiovascular ischemia condition relating to the patient, and when combined with Moorman's teachings of "output of the predictive model" in [0184]); 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 (See [0475]-[0477]: The cardiac event estimation of risk score may be used to initiate clinical treatment to reduce the likelihood of a cardiac event occurring and/or mitigate the adverse effects of a potential cardiac event, which the Examiner is interpreting initiate clinical treatment to encompass 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.)
While Sullivan teaches a system for automatically generating a diagnosis or a prediction of a cardiovascular ischemia condition relating to the patient, the diagnosis or the prediction being automatically generated based on the index, Sullivan may not explicitly teach collecting a set of physiologic measurements obtained via a biomarker measurement device from a patient to determine at least one log-return time series, 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;
generating an index, relating to one or both of a cardiovascular condition associated with the patient and necrosis condition associated with the patient, based on the transfer entropy and on the spectral coherence.
Moorman teaches a system for collecting a set of physiologic measurements obtained via a biomarker measurement device from a patient (See [0053], [0221]: The system may be used as a portable electronic device such as cardiological, physiological and/or biological acquisition, diagnostic and/or monitor device, which the Examiner is interpreting the cardiological, physiological and/or biological acquisition, diagnostic and/or monitor device to encompass a biomarker measurement device from a patient, and interpreting the large database of time series collected during health and the early stages of illness to encompass a set of physiologic measurements) to determine at least one log-return time series, 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 (See [0052]-[0053], [0176]-[0184]: The Examiner is interpreting calculating mathematical characteristics ([0052]) to encompass determine at least one log-return time series (time-domain [0052]-[0053]), a transfer entropy associated with the at least one log-return time series (frequency domain [0052]-[0053]), and a spectral coherence associated with the at least one log-return time series (frequency domain [0052]-[0053]) as the calculations can include time-domain, frequency domain, and non-linear form);
generating an index, relating to one or both of a cardiovascular condition associated with the patient and necrosis condition associated with the patient, based on the transfer entropy and on the spectral coherence (See [0176]-[0185]: The Examiner is interpreting process of [0177]-[0183] to encompass based on the transfer entropy and on the spectral coherence, and interpreting the output of the predictive model of [0184] to encompass an index, relating to one or both of a cardiovascular condition associated with the patient and necrosis condition associated with the patient as the output can relate to heart rate characteristics (HRC).)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Sullivan to include collecting a set of physiologic measurements obtained via a biomarker measurement device from a patient to determine at least one log-return time series, 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; generating an index, relating to one or both of a cardiovascular condition associated with the patient and necrosis condition associated with the patient, based on the transfer entropy and on the spectral coherence as taught by Moorman. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Sullivan with Moorman with the motivation of improving health outcomes (See Detailed Description of Invention of Moorman in [0066]).
Claim(s) 8 and 14 mirror claim 1 only within different statutory categories, and are rejected for the same reason as claim 1.
As per claim 2, Sullivan/Moorman discloses the system of claim 1 as described above. Sullivan further teaches wherein the particular treatment is created based on the automatic generation of the diagnosis or the prediction of the cardiovascular ischemia condition (See [0475]-[0477]: The cardiac event estimation of risk score may be used to initiate clinical treatment to reduce the likelihood of a cardiac event occurring and/or mitigate the adverse effects of a potential cardiac event, which the Examiner is interpreting the adverse cardiac event to encompass the automatic generation of the diagnosis or the prediction of the cardiovascular ischemia condition.)
Claim(s) 15 mirrors claim 2 only within a different statutory category, and is rejected for the same reason as claim 2.
As per claim 3, Sullivan/Moorman discloses the system of claim 1 as described above. Sullivan further teaches 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 (See [0473]-[0474]: If the subject is in a hospital setting, the wearable medical device may trigger an alarm which members of a MERT or MET team can respond to subjects before an arrest occurs for the purpose of preventing the arrests.)
Claim(s) 9 and 16 mirror claim 3 only within different statutory categories, and are rejected for the same reason as claim 3.
As per claim 4, Sullivan/Moorman discloses the system of claim 1 as described above. Sullivan further teaches wherein the plurality of operations further comprise detrending and demeaning the at least one log-return time series (See [0332]-[0335], [0389]-[0390]: The control unit may execute three separate analyses of the multi-variate parameter signal including the baseline parameter difference measurement, the multiple parameters as an output of the analyses can be fed into a classifier or other decision logic that may take the form of, logistic regression, to determine the event estimation of risk score, which the Examiner is interpreting logistic regression to encompass detrending and demeaning.)
Claim(s) 10 and 17 mirror claim 4 only within different statutory categories, and are rejected for the same reason as claim 4.
As per claim 5, Sullivan/Moorman discloses the system of claim 1 as described above. Sullivan may not explicitly teach wherein the plurality of operations further comprise performing a frequency based transformation operation based at least on information associated with the set of physiologic measurements to determine the transfer entropy and the spectral coherence.
Moorman teaches a system wherein the plurality of operations further comprise performing a frequency based transformation operation based at least on information associated with the set of physiologic measurements to determine the transfer entropy and the spectral coherence (See [0052]-[0053], [0176]-[0184]: The Examiner is interpreting calculating mathematical characteristics ([0052]) to encompass a transfer entropy (frequency domain [0052]-[0053]), and a spectral coherence (frequency domain [0052]-[0053]) as the calculations can include time-domain, frequency domain, and non-linear form.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Sullivan to include the plurality of operations further comprise performing a frequency based transformation operation based at least on information associated with the set of physiologic measurements to determine the transfer entropy and the spectral coherence as taught by Moorman. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Sullivan with Moorman with the motivation of improving health outcomes (See Detailed Description of Invention of Moorman in [0066]).
Claim(s) 11 and 18 mirror claim 5 only within different statutory categories, and are rejected for the same reason as claim 5.
As per claim 6, Sullivan/Moorman discloses the system of claim 1 as described above. Sullivan may not explicitly teach wherein the at least one log-return time series comprises a bivariate time series.
Moorman teaches a system wherein the at least one log-return time series comprises a bivariate time series (See [0149]-[0150]: The selected heart rate variability and respiratory rate variability as logical choices for a bivariate model, which the Examiner is interpreting a bivariate model to encompass a bivariate time series as univariate and multivariate logistic regression methods to test for association.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Sullivan to include the at least one log-return time series comprises a bivariate time series as taught by Moorman. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Sullivan with Moorman with the motivation of improving health outcomes (See Detailed Description of Invention of Moorman in [0066]).
Claim(s) 12 and 19 mirror claim 6 only within different statutory categories, and are rejected for the same reason as claim 6.
As per claim 7, Sullivan/Moorman discloses the system of claim 1 as described above. Sullivan further teaches wherein the particular treatment is initiated based on evaluating, via the one or more hardware processors, a composite index formed, via the one or more hardware processors, using the transfer entropy and the spectral coherence, against a threshold (See [0475]-[0477]: The cardiac event estimation of risk score may be used to initiate clinical treatment to reduce the likelihood of a cardiac event occurring and/or mitigate the adverse effects of a potential cardiac event, which the Examiner is interpreting a medication threshold to encompass a threshold.)
Claim(s) 13 and 20 mirror claim 7 only within different statutory categories, and are rejected for the same reason as claim 7.
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.
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