DETAILED ACTION
Notice to Applicant
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This communication is in response to the amendment filed on 9/2/26. Claims 1-2, 4, and 6-31 are pending. Claims 6-31 are withdrawn from further consideration. Claims 1-2, and 4 will be examined on the merits.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/2/26 has been entered.
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 1-2, and 4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e, a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
35 USC 101 enumerates four categories of subject matter that Congress deemed to be appropriate subject matter for a patent: processes, machines, manufactures and compositions of matter. As explained by the courts, these “four categories together describe the exclusive reach of patentable subject matter. If a claim covers material not found in any of the four statutory categories, that claim falls outside the plainly expressed scope of Section 101 even if the subject matter is otherwise new and useful.” In re Nuijten, 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007). Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter? Applicant’s claims fall within at least one of the four categories of patent eligible subject matter because claims 1-2, and 4 are drawn to a system.
Determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 USC 101 (i.e., process, machine, manufacture, or composition of matter) in Step 1 does not complete the eligibility analysis. Claims drawn only to an abstract idea, a natural phenomenon, and laws of nature are not eligible for patent protection. As described in MPEP 2106, subsection III, Step 2A of the Office’s eligibility analysis is the first part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l,134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. at 77-78, 101 USPQ2d at 1967-68).
In 2019, the United States Patent and Trademark Office (USPTO) prepared revised guidance (2019 Revised Patent Subject Matter Eligibility Guidance) for use by USPTO personnel in evaluating subject matter eligibility. The framework for this revised guidance, which sets forth the procedures for determining whether a patent claim or patent application claim is directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas), is described in MPEP sections 2106.03 and 2106.04.
As explained in MPEP 2106.04(a)(2), the 2019 Revised Patent Subject Matter Eligibility Guidance explains that abstract ideas can be grouped as, e.g., mathematical concepts, certain methods of organizing human activity, and mental processes. Moreover, this guidance explains that a patent claim or patent application claim that recites a judicial exception is not ‘‘directed to’’ the judicial exception if the judicial exception is integrated into a practical application of the judicial exception. A claim that recites a judicial exception, but is not integrated into a practical application, is directed to the judicial exception under Step 2A and must then be evaluated under Step 2B (inventive concept) to determine the subject matter eligibility of the claim.
Step 2A asks: Does the claim recite a law of nature, a natural phenomenon (product of nature) or an abstract idea? (Prong One) If so, is the judicial exception integrated into a practical application of the judicial exception? (Prong Two) A claim recites a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is set forth or described in the claim. While the terms “set forth” and “describe” are thus both equated with “recite”, their different language is intended to indicate that there are different ways in which an exception can be recited in a claim. For instance, the claims in Diehr set forth a mathematical equation in the repetitively calculating step, while the claims in Mayo set forth laws of nature in the wherein clause, meaning that the claims in those cases contained discrete claim language that was identifiable as a judicial exception. The claims in Alice Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.” A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.
In the instant case, claims 1-2, and 4 recite(s) a system and method and for certain methods of organizing human activities, which is subject matter that falls within the enumerated groupings of abstract ideas described in MPEP 2106.04 (2019 Revised Patent Subject Matter Eligibility Guidance) Certain methods of organizing human activities includes fundamental economic practices, like insurance; commercial interactions (i.e. legal obligations, marketing or sales activities or behaviors, and business relations). Organizing human activity also encompasses managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions.) The recited method is drawn to determining lifestyle and health risk shape pattern and factors for a population of individuals (as related to insurance/risk assessment for underwriting )
The recited invention is also drawn to mathematical relationships, which is also subject matter that falls within the enumerated groupings of abstract ideas described in MPEP 2106.04 (2019 Revised Patent Subject Matter Eligibility Guidance)
Claim 1 recites:
perform a defined parametrization for capturing risk shape pattern for living individual, the parametrization of the risk shape pattern comprising at least lifestyle factor values measuring physical activity and sleep and nutrition and mental wellbeing and substance use and environmental conditions, wherein the risk shape pattern further comprises clinical factor values measuring (i) build factor values comprising a measured height and/or weight factor value, and (ii) lipids factor values comprising a measured total cholesterol factor value or a high-density lipoprotein factor value and/or a triglycerides factor value, and (iii) blood pressure factor values comprising a measured systolic and diastolic blood pressure factor value, and (iv) glucose metabolism factor values comprising a measured fasting/non- fasting glucose factor value or glycated hemoglobin (hemoglobin Al c) factor value or diabetes status, and (v) liver function factor values comprising a measured gamma-glutamyl-transferase (GGT) factor value or an alanine transaminase (ALT) factor value or an aspartate transaminase (AST) factor value or an alkaline phosphatase (Alk Phos), and (vi) family history of diabetes and circulatory disorders factor values,
extend the parametrization of the risk shape pattern by the input measures by performing (i) a measured waist circumference factor value, when a threshold value of one of the build factor values is exceeded, and (ii) a measured apolipoproteins factor value, when a threshold value of at least one of the lipid factor values is exceeded, and (iii) a measured relationship or relative diagnosis age of family history factor value, when a threshold value of at least one of the family history factor values is exceeded, and (iv) a factor value indicating certain diabetes sub-types, when a threshold value of at least one of the glucose metabolism factor values is exceeded, and (v) a measured sport-driven physical activity measures value, when a threshold value of at least one of the physical activity factor values is exceeded, and (vi) a measured activity intensity qualifier factor value, when a threshold value of at least one of the physical activity factor values is exceeded, and (vii) a measured binge drinking value, when a threshold value of a drinking factor value is exceeded, and (viii) measured factor values based on an additional popular screening questionnaires, when a threshold value indicating mental wellness is exceeded,
model and capture interactive effects between any of the factors of the parametrization of the risk shape pattern, wherein the factors provide the input measures to the system,
perform a dimensionality reduction for reducing the used number of parameters by an integrated feature selection and feature extraction structure,
generate subsets of attributes by selecting a subset of features containing highly correlated features with a class of features, but uncorrelated to each other based on generated correlation values …
measure correlation coefficients of the factors of the parametrization of the risk shape pattern using Spearman's rank correlation coefficients, and perform dimensionality reduction until a threshold p-value of <0.05 is reached by the measured correlation coefficients,
capture a multitude of risk shape patterns for living individuals at least by said lifestyle factor values, wherein the captured multitude of risk shape patterns are clustered by the system, each cluster defining a prototype of risk shape pattern assigned to a dedicated relative risk measurand,
wherein a newly captured risk shape pattern of a living individual is mapped by the system to one of the prototypes of risk shape pattern based on measured lifestyle factor values associated with the living individual, and
wherein the dedicated relative risk measurand assigned to the risk shape pattern is outputted as resilience score value of the living individual.
This judicial exception is not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (See MPEP 2106.04(d)(1); see also MPEP 2106.05(a)(I-II)). Moreover, the claims do not integrate the judicial exception into a practical application because the claimed invention does not: apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)); effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); or apply or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment see MPEP 2106.05(e). (Considerations for integration into a practical application in Step 2A, prong two and for recitation of significantly more than the judicial exception in Step 2B)
While abstract ideas, natural phenomena, and laws of nature are not eligible for patenting by themselves, claims that integrate these exceptions into an inventive concept are thereby transformed into patent-eligible inventions. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347, 2354, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)). Thus, the second part of the Alice/Mayo test is often referred to as a search for an inventive concept. Id. 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., 134 S. Ct. at 2355, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting “the Government’s invitation to substitute Sections 102, 103, and 112 inquiries for the better established inquiry under Section 101”). As made clear by the courts, the “‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the Section 101 categories of possibly patentable subject matter.” Intellectual Ventures I v. Symantec Corp.,838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9).
As described in MPEP 2106.05, Step 2B of the Office’s eligibility analysis is the second part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. _, 134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961 (2012)). Step 2B asks: Does the claim recite additional elements that amount to significantly more than the judicial exception? The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. .
Claim 1 recite(s) additional limitation(s), including: ”processing circuitry configured to.” The additional component(s) is/are generic components that perform well-understood, routine and conventional functions that amount to no more than implementing the abstract idea with a computerized system.
To support the finding of the identified features being generic and conventional, the generic nature of the computer system used to carryout steps of the recited method is underscored by the system description in the instant application, which discloses: “Further in the prior art, automated or semi-automated risk-transfer systems, typically interacting with a user via graphical user interface (GUI), are known. In particular, automated, cloud-based systems enabling an end-user (e.g. an end-user being a consumer or an employee of a business as an insurance or distribution company (e.g. broker)) to compose automatically a first-tier (insurance) and/or second-tier (reinsurance) risk-transfer product, after conducting a dialogue with a knowledge-based system, are known. Such systems reduce the dependences of first-insurers or reinsurers on both their information technology (IT) and their human experts, as e.g. actuarial experts. Such systems are able to adjust the dialogue interactively according to the specific needs of the users and ask for the relevant data needed for the desired risk-transfer product..” (par. 10-PG-pub)
The application explains: “It is an object of the present invention to provide an inventive technical teaching for automation which is easily integratable in other processes, productions chains or risk assessment and measuring systems, e.g. by appropriate APIs..” (see par. 19-Emphasis added). The applicant’s disclosure uses only general terms and references to automated and/or digital system(s), and does not describe the underlying components used to execute the functions recited by the claimed system. Such language underscores that the applicant's perceived invention/ novelty focuses on the computerized implementation of the abstract idea, not the underlying structure of generic components.
Furthermore, the courts have recognized certain computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (See MPEP 2106.05 (d) (II)). Among these are the following features, which are recited in claim 1:
- Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added));
- Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.");
- Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93)
Claims 2 and 4 are dependent from Claim 1 and include(s) all the limitations of claim(s) 1. However, the additional limitations of the claims 2 and 4 fail to recite significantly more than the abstract idea. More specifically, the additional limitations recite additional steps which further define the abstract idea Therefore, claim(s) 2 and 4 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim 1 further recite: machine learning based simulation; modelling; using the generative machine learning model; “unsupervised linear feature extraction.” As currently drafted, the recitation of models and machine learning model in the claims fails to recite significantly more, and amounts to adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984. (See MPEP 2106.05(A))
The recitation of using machine learning simulation structure, using and “unsupervised linear feature extraction “ recites only the idea of a solution or outcome, but the claims fail to recite details of how a solution to a problem is accomplished. Moreover, as drafted, the claims invoke the use of the “machine leaning” merely as a tool to perform an existing process of determining an individual’s relative health risk based on an evaluation of a plurality of health factors. More specifically, the claims recite a use of machine learning components and modelling features ( i.e. feature extraction, feature selection, dimensionality reduction; parameterization) at a high level of generality.
Because Applicant’s claimed invention recites a judicial exception that is not integrated into a practical application and does not include additional elements that are sufficient to amount to significantly more than the judicial exception itself, the claimed invention is not patent eligible.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The previous prior art has been withdrawn. The prior art of record does not disclose the details of parametrization and conditions of extended parametrization for each factor value as currently recited and in combination with additional claim limitations.
Response to Arguments
Applicant's arguments filed 9/2/26 have been fully considered but they are not persuasive.
(A) Applicant argues that the claims overcome the rejections under 35 USC 101.
In response, the claim rejections under 35 USC 112(b) have been withdrawn in light of the claim amendments filed by applicant.
(B) Applicant argues that the newly added claim limitation “the system measures correlation coefficients of the factors of the parameterization…” renders the claimed invention patient eligible.
In response the examiner disagrees. The newly added claim limitation further defines the abstract idea, as it recites mathematical relationships. Therefore, the claims remain directed to an abstract idea.
(C) Applicant argues the rejection of the claims under 35 USC 101. Applicant argues that the claimed invention is drawn to significantly more than the abstract idea because it is drawn to an improvement in a technological field.
In response, the examiner disagrees. The recited judicial exception is not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (See MPEP 2106.04(d)(1); see also MPEP 2106.05(a)(I-II)). Moreover, the claims do not integrate the judicial exception into a practical application because the claimed invention does not: apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)); effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); or apply or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment see MPEP 2106.05(e). (Considerations for integration into a practical application in Step 2A, prong two and for recitation of significantly more than the judicial exception in Step 2B)
Consideration of improvements is relevant to the integration analysis regardless of the technology of the claimed invention. That is, the consideration applies equally whether it is a computer-implemented invention, an invention in the life sciences, or any other technology. See, e.g., Rapid Litigation Management Ltd. v. CellzDirect, Inc., in which the court noted that a claimed process for preserving hepatocytes could be eligible as an improvement to technology because the claim achieved a new and improved way for preserving hepatocyte cells for later use, even though the claim is based on the discovery of something natural. (See 827 F.3d 1042, 1048 (Fed. Cir. 2016)) Notably, the court did not distinguish between the types of technology when determining that the invention improved technology.
However, it is important to keep in mind that an improvement in the judicial exception itself (e.g., a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG LLC, the court determined that the claim simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology. (921 F.3d 1084, 1093-94 (Fed. Cir. 2019) . Applicant’s argued improvement is to the abstract idea of determining lifestyle and health risk shape pattern and factors for a population of individuals (as related to insurance/risk assessment for underwriting ) (i.e. making better predictions and assessments of individual relative risk)
The rejections of claims 1-2 and 4 have been maintained.
(D) Applicant also argues that the claimed invention includes improvements to the functioning/calculating power of a computer, and to the “self-adapting process optimizing data by dimensional reduction.”
In response, In accordance with MPEP 2106.05 (a), if it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. An indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art.
For example, in McRO, the court relied on the specification’s explanation of how the particular rules recited in the claim enabled the automation of specific animation tasks that previously could only be performed subjectively by humans, when determining that the claims were directed to improvements in computer animation instead of an abstract idea. McRO, 837 F.3d at 1313-14, 120 USPQ2d at 1100-01. In contrast, the court in Affinity Labs of Tex. v. DirecTV, LLC relied on the specification’s failure to provide details regarding the manner in which the invention accomplished the alleged improvement when holding the claimed methods of delivering broadcast content to cellphones ineligible. 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016).
An important consideration in determining whether a claim is directed to an improvement in technology is the extent to which the claim covers a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome. McRO, 837 F.3d at 1314-15, 120 USPQ2d at 1102-03; DDR Holdings, 773 F.3d at 1259, 113 USPQ2d at 1107. In this respect, the improvement consideration overlaps with other Step 2B considerations, specifically the particular machine consideration (see MPEP § 2106.05(b)), and the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)). Thus, evaluation of those other considerations may assist examiners in making a determination of whether a claim satisfies the improvement consideration.
Additionally, applicant’s arguments regarding improving the “self-adapting process optimizing data by dimensional reduction” is an improvement to the abstract idea, not an technological improvement In others, applicant argues that the claimed invention produces a better model to calculate/ determine lifestyle and health risk shape pattern and factors for a population of individuals.
Applicant’s arguments are not persuasive and the rejection under 35 USC 101 is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Nguyen et al (Nguyen QN, Pham ST, Do LD, Nguyen VL, Wall S, Weinehall L, Bonita R, Byass P. “Cardiovascular disease risk factor patterns and their implications for intervention strategies in Vietnam.” Int J Hypertens. 2012;2012:560397. doi: 10.1155/2012/560397. Epub 2012 Mar 4. PMID: 22500217; PMCID: PMC3303616) determining a risk pattern of CVD.
Sapir et al (US 20100191685 A1)- discloses methods and systems for selecting features for a prediction rule based on statistical metric(s) of feature contribution and/or model fitness.
Jain et al (US 11521748 B2)- discloses a system for determining a health risk score for risk stratification and compliance monitoring for creating next best action specific for that patient.
Even et al (US 20230410208 A1)- a ML-based, predictive, digital underwriting system and corresponding method providing an automated parameter-driven predictive underwriting process based on measured probability values associated with individuals of a cohort or portfolio.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachel L Porter whose telephone number is (571)272-6775. The examiner can normally be reached M-F, 10-6:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Rachel L. Porter/Primary Examiner, Art Unit 3684