DETAILED ACTION
Applicant's response filed 7 November 2025 has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Claim Status
Claims 1-21 are currently pending and under exam herein.
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 1-21 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Any newly recited portions below are necessitated by claim amendment.
The instant rejection reflects the framework as outlined in the MPEP at 2106.04:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
With respect to step (1): yes, the claims are directed to a non-transitory storage medium to perform an aortic stenosis imaging examination analysis (claims 1-11); an aortic stenosis imaging examination device (claims 12-18); and an imaging examination analysis method (claims 19-21).
With respect to step (2A)(1), the claims recite abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and opinion).
With respect to the instant claims, under the (2A)(1) evaluation, the claims are found herein to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and mathematical concepts (in particular mathematical relationships and formulas).
The claim steps directed to abstract ideas are as follows:
Claim 1 (medium with instruction to perform analysis):
-generating for a plurality of future time intervals…a likelihood of a severe aortic stenosis grade for the patient at each future time interval using a plurality of classifiers each trained on a data set for past patients to predict the likelihood of a patient developing severe aortic stenosis (AS) within the one or more future time intervals the data set of the past patients including measurements for the set of aortic stenosis variables obtained by aortic stenosis imaging examinations of the respective past patients and labeled with diagnoses of severe aortic stenosis grades at corresponding future time intervals, wherein each of the plurality of classifiers are trained to generate a likelihood of a severe aortic stenosis grade for the patient at a different future time interval, and wherein the plurality of classifiers are configured in an enchained sequential arrangement to sequentially generate a respective likelihood of a severe aortic stenosis grade for the patient at the different future time interval; and
-determining a follow-up aortic stenosis imaging examination date recommendation by comparing a likelihood…with one or more future time intervals to a respective threshold….selecting a follow-up interval…
Claim 7:
-wherein the generating is sequentially performed for one or more successively larger future time intervals…exceeds a threshold…follow-up…recommendation is determined as the last-tested further time interval.
Claim 9:
- identifying an inconsistent measurement for the patient from the measurements for the set of aortic stenosis variables as a measurement whose value compared with the prior measurement for the same aortic stenosis variable in the retrieved prior measurements is consistent with a reduction of a constriction of the aortic valve…
Claim 10:
- identifying includes identifying at least one of: an aortic velocity or gradient variable…
Claim 11:
-identifying a missing aortic stenosis variable of the set of aortic stenosis variables (Sv)…
Claim 12:
-identifying an inconsistent measurement for the patient…compared with the prior measurement…
Claim 13:
-wherein inconsistent identified measurements include aortic velocity or gradient variable…
Claim 14:
- comprising a neural network comprising interconnected neural network nodes…to identify patterns or relationships…
Claim 15:
- generating a likelihood of a severe aortic stenosis grade for the patient at the future time interval wherein the likelihood is generated by processing a patient data set including at least the measurements for the set of aortic stenosis variables (Sv) using a classifier trained on training data sets for past patients including measurements for the set of aortic stenosis variables obtained by aortic stenosis imaging examinations of the respective past patients and labeled as to whether the respective past patients were diagnosed with severe aortic stenosis grades as of the future time interval relative to the respective imaging examination dates of the aortic stenosis imaging examinations of the respective past patients
- determining a follow-up aortic stenosis imaging examination date recommendation based on the generated likelihoods.
Claim 16:
-generating is sequentially performed for one or more successively larger future time intervals…interval exceeds a threshold…follow-up…determined as the last-tested future time interval.
Claim 19:
- generating, by processing operations performed by the electronic processor, a likelihood of a predetermined grade of the chronic medical condition for the patient at the future time interval wherein the likelihood is generated by processing the patient data set using a plurality of classifiers each trained on a training data set for past patients comprising measurements for the set of variables relating to the chronic medical condition obtained by imaging examinations of the respective past patients and labeled with a diagnosis of stenosis grades at corresponding future time intervals, wherein each of the plurality of classifiers are trained to generate a likelihood of a predetermined grade of the chronic medical condition at a different future time interval, and wherein the plurality of classifiers are configured in an enchained sequential arrangement to sequentially generate a respective likelihood of the chronic medical condition at the different future time interval; and determining a follow-up imaging examination date recommendation for performing a follow-up imaging examination to assess the chronic medical condition for the patient by comparing the likelihood that a patient will develop severe…with one or more future time intervals to a respective threshold…selecting a follow-up interval.
Claim 20:
- generating, by processing operations performed by the electronic processor, a likelihood of a predetermined grade of the chronic medical condition for the patient at the future time interval wherein the likelihood is generated by processing the patient data set using a classifier trained on training data sets for past patients including measurements for the set of variables relating to the chronic medical condition obtained by imaging examinations of the respective past patients and labeled as to whether the respective past patients were diagnosed with the predetermined grade as of the future time interval relative to the respective imaging examination dates of the imaging examinations of the respective past patients; and determining a follow-up imaging examination date recommendation for performing a follow-up imaging examination to assess the chronic medical condition for the patient based on the generated likelihoods.
Claim 21: training is performed by Extreme Gradient Boosting or neural network…
Hence, the claims explicitly recite numerous elements that, individually and in combination, are directed to abstract ideas.
The abstract ideas recited in the claims above are evaluated under the Broadest Reasonable Interpretation (BRI) and determined herein to each cover performance either in the mind and/or performance by mathematical operation because the claims include generating likelihoods (mathematical statistical calculation); using a classifier (mathematical and/or mental steps whereby data are grouped based on measurement data); determining follow-up; making a selection. Said interpretations are assigned based on the plain meaning of “generate” and “determine” as recited in the independent claims and further limited by the recitation in the dependent claims herein. For example, determining recommendations are mental activities that physicians engage in after making mental assessments of data that is gathered before them. Said mental evaluations are practically performed in the human mind. Steps directed to likelihood determinations also performed mentally, as there are no specific steps involved otherwise. As such, one can mentally perform a likelihood calculation using a pen and paper when presented with appropriate data, such as data that is obtained from classification. The steps of “using a classifier trained on training data sets” simply informs of where the data are obtained and not how the data are generated and thus do not limit the instant claims to any training step herein. For Example, the claim recites that the time intervals are generated via the use of a classifier. The classifier has been trained on data sets from past patients for the intention of predicting (“to predict the likelihood) a likelihood in the future. There are no limits on the step of “classifying” or even “training” as it is not even clear if the step of training occurs within the confines of the claim. The claim is amended to include that “wherein each of the classifiers are trained to generate a likelihood” however, this simply reinforces that the training is for the purpose of the classifier which somehow yields a likelihood. No actual training steps are limited herein. As such, the steps are generic machine learning steps and are mathematical herein, as the tool is the machine learning. That tool aids to provide the likelihood (mathematical probability). As such, the step is abstract. If Applicant intends that the step of “training” actually occur with specific steps in which to do so, then it is suggested that the claims be amended to include said steps herein.
Because the claims do recite judicial exceptions, direction under (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (MPEP 2106.04(d). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim is said to fail to integrate the abstract idea into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations, the claims recite the following additional elements:
Independent Claim 1: “non-transitory storage medium”; ”electronic processor”; receiving a patient data set for the patient including measurements for a set of aortic stenosis variables (Sv) obtained by an aortic stenosis imaging examination of the patient performed on an imaging examination date.
Claims that limit the above data and presentation of said data are: Claims 2-5: limit to types of variables of the data and patient variables; Claim 6 and 8: limit to the way in which data are presented (extra-solution activity)—“display”; Claim 9: further recites the type of data retrieved and the display; Claim 11: “display”.
Independent Claim 12: “device”; “electronic processor”; non-transitory storage medium…instructions”’ providing data on a device; retrieving data on a device; and display
Claims that limit the above data and presentation of said data are Claim 13: types of measurement data; Claim 14: type of machine learning (neural network) and measurement data; Claim 15: display; Claim 17-18: type of imaging device.
Independent claim 19: receiving, at an electronic processor, a patient data set..
Claims that limit the above data and presentation of said data are Claim 20: types of measurement data and display; Claim 21: types of medical condition.
Further with respect to the additional elements in the instant claims, those steps directed to data gathering, such perform functions of collecting the data needed to carry out the abstract idea. Data gathering does not impose any meaningful limitation on the abstract idea, or on how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g).
Further steps herein directed to additional non-abstract elements of “processor; computer; storage medium etc…” do not describe any specific computational steps by which the “computer parts” perform or carry out the abstract idea, nor do they provide any details of how specific structures of the computer, such as the computer-readable recording media, are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc… are recited so generically (i.e., no details are provided) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer. (see MPEP 2106.05(f)).
None of the recited dependent claims recite additional elements which would integrate a judicial exception into a practical application.
As such, the claims are lastly evaluated using the (2B) analysis, wherein it is determined that because the claims recite abstract ideas, and do not integrate that abstract ideas into a practical application, the claims also lack a specific inventive concept. Applicant is reminded that the judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements of data gathering described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims, activities such as data gathering do not improve the functioning of a computer, or comprise an improvement to any other technical field; they do not require or set forth a particular machine; they do not effect a transformation of matter; nor do they provide a non-conventional or unconventional step. Rather, the data gathering steps as recited in the instant claims constitute a general link to a technological environment which is insufficient to constitute an inventive concept which would render the claims significantly more than the judicial exception (MPEP2106.05(g)&(h)). Further, the claim steps of providing or receiving data amount transmitting data which are well-understood, routine and conventional activity as described in the MPEP at 2106.05(d), subsection II.
With respect to the additional elements of computing elements, said elements are set forth at such a high level of generality that they can be met by a general purpose computer. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than an abstract idea (see MPEP 2106.05(b)I-III).
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Response to Applicant’s Arguments
1. Applicant respectfully points to the recent USPTO Memorandum "Reminders on evaluating subject matter eligibility of claims under 35 U.S.C. 101" dated August 4, 2025 and to the recent USPTO Desjardins Rehearing Decision and requests that the Office reconsider the interpretations in view of such.
Applicant states further that, “the claimed invention improves the technical field of medicine, particularly the monitoring and treating of aortic stenosis (AS). Embodiments of the present invention address the issue of inefficiencies in monitoring a patient for AS. The embodiment recited in claim 1 addresses such inefficiencies by the generation, for a plurality of future time intervals relative to the imaging examination date, a likelihood of a severe aortic stenosis grade for the patient using a trained classifier and the determination of a follow-up aortic stenosis imaging examination date recommendation based on such generated likelihood of a severe aortic stenosis grade for the patient at each future time interval”.
It is respectfully submitted that with respect to the limitations a pointed to herein, these limitations are themselves directed to the judicial exceptions in the claim and, as such and pointed out in previous responses, cannot provide for the additional elements that include integration or significantly more herein. Applicant will further note that “an inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself." Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016). See also Alice Corp., 573 U.S. at 21-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 78, 101 USPQ2d at 1968 (after determining that a claim is directed to a judicial exception, "we then ask, ‘[w]hat else is there in the claims before us?") (emphasis added)); RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"). Instead, an "inventive concept" is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). Such is not the case in the instant claims.
2. Applicant further states that “patients with stable AS can be characterized using Artificial Intelligence (AI) methods in order to schedule follow-up AS imaging examinations that are tailored to the AS progression of specific individual patients” (page 13 remarks).
This is not persuasive as set forth in the above rejection. The steps directed to “generating…likelihood of a severe aortic stenosis grade for the patient at each future time interval using a plurality of classifiers trained on a data set for past patients to predict likelihood of a patient developing severe AS” as claimed is directed to a judicial exception. As stated above, the steps are directed to those performed mentally and/or performance by mathematical operation because the claims include generating likelihoods (mathematical statistical calculation); using a classifier (mathematical and/or mental steps whereby data are grouped based on measurement data); determining follow-up; making a selection. Said interpretations are assigned based on the plain meaning of “generate” and “determine” as recited in the independent claims and further limited by the recitation in the dependent claims herein. For example, determining recommendations are mental activities that physicians engage in after making mental assessments of data that is gathered before them. Said mental evaluations are practically performed in the human mind. Steps directed to likelihood determinations also performed mentally, as there are no specific steps involved otherwise. As such, one can mentally perform a likelihood calculation using a pen and paper when presented with appropriate data, such as data that is obtained from classification. The steps of “using a classifier trained on training data sets” simply informs of where the data are obtained and not how the data are generated and thus do not limit the instant claims to any training step herein. For Example, the claim recites that the time intervals are generated via the use of a classifier. The classifier has been trained on data sets from past patients for the intention of predicting (“to predict the likelihood) a likelihood in the future. There are no limits on the step of “classifying” or even “training” as it is not even clear if the step of training occurs within the confines of the claim. The claim is amended to include that “wherein each of the classifiers are trained to generate a likelihood” however, this simply reinforces that the training is for the purpose of the classifier which somehow yields a likelihood. No actual training steps are limited herein. As such, the steps are generic machine learning steps and are mathematical herein, as the tool is the machine learning. That tool aids to provide the likelihood (mathematical probability). As such, the step is abstract. If Applicant intends that the step of “training” actually occur with specific steps in which to do so, then it is suggested that the claims be amended to include said steps herein.
Applicant will further note that the claims in Dejardins, for example, specifically including “training” steps and wherein adjustment of values to optimize performances were claimed. This is not the case herein, as recited above.
3. Applicant states that the claims amount to “significantly more” because the contribute an inventive concept that improves the field of medicine” and that “the claimed invention generates, for a plurality of future time intervals…a likelihood of a sever aortic stenosis grade for the patient using a trained classifier…”. Applicant avers that because there is no art on this element it is not well-known, routine or conventional.
This is not persuasive. Applicant will kindly note that the portions of the claim pointed to above are, themselves the judicial exceptions and therefore, as is noted above, do not represent the “additional” elements that are required for integration and/or improvement in the instant application. The additional elements (alone and/or in combination) are considered but here do not provide for any improvement as the “addiontal elements” herein are directed to data gathering only (“receive a patient data set).
Conclusion
No claims are allowed.
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.
Inquiries
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the PTO Fax Center. The faxing of such papers must conform to the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central Fax Center Number is (571) 273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lori A. Clow, whose telephone number is (571) 272-0715. The examiner can normally be reached on Monday-Thursday from 11:00AM to 9:00PM ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz Skowronek can be reached on (571) 272-9047.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
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/Lori A. Clow/ Primary Examiner, Art Unit 1687