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 Final Office Action is in response to the Remarks filed 10/24/2025. Claims 1-20 are currently pending and considered 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 1-20 are rejected under 35 U.S.C. §101 because they recite an abstract idea without significantly more.
Claim 1 recites, wherein the abstract idea is not emboldened:
A method for dynamically evaluating health care risk, the method being implemented by machine-readable instructions, the method comprising: managing, for a set of users, a corresponding set of digital healthcare profiles, where each digital healthcare profile includes a healthcare decision tree for the corresponding user; determining, for a first user of the set of users, a first subset of the set of users with a first set of similar digital healthcare profiles based on the corresponding set of healthcare decision trees; determining, based on correlation between a first healthcare decision tree of the first user with the first set of healthcare decision trees of the first subset of users, a first recommended action for the first user; providing, to the first user, information related to the first recommended action; updating, for a second user in the first subset of users, a second digital healthcare profile and second healthcare decision tree of the second user; determining, based on the updated second healthcare decision tree of the second user, that the updated second healthcare decision tree deviates from the first set of healthcare decision trees; removing, based on the determined deviation, the second user from the first subset of users; determining, based on the updated first set of digital healthcare profiles, a second recommended action to the first user; and providing, to the first user, information related to the second recommended action.
Independent claims 9 and 16 recite substantially similar limitations and further include a “physical processor” (Claim 9) and “A non-transitory machine-readable storage medium comprising instructions executable by a physical processor of a computing device” (Claim 16). The claimed invention is broadly directed to the abstract idea of collecting patient(s) information, analyzing the information, and determining a recommendation based on the analyses.
The limitations of “managing, for a set of users, a corresponding set of healthcare profiles, where each digital healthcare profile includes a healthcare decision tree for the corresponding user; determining, for a first user of the set of users, a first subset of the set of users with a first set of similar healthcare profiles based on the corresponding set of healthcare decision trees; determining, based on correlation between a first healthcare decision tree of the first user with the first set of healthcare decision trees of the first subset of users, a first recommended action for the first user; providing, to the first user, information related to the first recommended action; updating, for a second user in the first subset of users, a second healthcare profile and second healthcare decision tree of the second user; determining, based on the updated second healthcare decision tree of the second user, that the updated second healthcare decision tree deviates from the first set of healthcare decision trees; removing, based on the determined deviation, the second user from the first subset of users; determining, based on the updated first set of healthcare profiles, a second recommended action to the first user; and providing, to the first user, information related to the second recommended action,” as drafted, is a process that, under its broadest reasonable interpretation, is an abstract idea that covers performance of the limitation as certain methods of organizing human activity. For example, but for the generic computer system language in the preamble of claim 1 and digital profiles of claim 1, “physical processor” and digital profiles of claim 9 and “non-transitory machine-readable storage medium,” “physical processor” and digital profiles of claim 16, analyzing patient data including comparing the patient data to other patients and those data are used for recommendations, in the context of this claim, is an abstract idea that covers performance of the limitation as organizing human activity including following rules or instructions. These recited limitations fall within certain methods of organizing human activity grouping of abstract ideas because the limitations allowing users to access patient data, analyze the data, and determine actions or recommendations based on the analyses. This is a method of managing interactions between people. Under its broadest reasonable interpretation, the limitations are categorized as methods of organizing human activity, specifically associated with managing personal behavior or relationships or interactions between people including a patient and physician (e.g. patient/user data compared to other patient/user data, analyzing the comparisons/healthcare profiles, and determining a course of action for the patient/user). Therefore, the limitation falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a). The mere nominal recitation of a generic computer system and processor and non-transitory data storage medium does not remove the claims from the method of organizing human interactions grouping. Thus, the claims recite an abstract idea.
The claims can also be classified as an abstract idea including mental processes. That is, other than reciting a generic computer system, processor and storage medium, and digital profiles nothing in the claim elements precludes the steps from practically being performed in the mind. For example, but for the generic computing devices and language, generating diagnostic results based on patient data and a mathematical model, in the context of this claim, encompasses one skilled in the pertinent art to manually determine the details of the data for comparison and prognosis for a patient. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of being implemented by machine-readable instructions on a computer system, including processors and storage medium for dynamically evaluating health care risk and analyzing digital healthcare profiles. The devices and the digital healthcare profile in these steps are recited at a high-level of generality (i.e., as a generic processor/server/storage/display performing a generic computer function of receiving inputs, analyzing the inputs, and displaying selected information, or as mathematical concepts) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements, alone or in combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The limitations appear to monopolize the abstract idea of patient analysis comparing one group of patients to another group or individual patient and general diagnostic techniques between a clinician and her patient. Furthermore, there is no clear improvement to the underlying computer technology in the claim. The claim is thus directed to an abstract idea.
The claims 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 being implemented by machine-readable instructions on a computer system, including processors and storage medium and digital healthcare profiles amounts to no more than mere instructions to apply the exception using a computer component and mathematical concepts. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Therefore, when considering the additional elements alone, and in combination, there is no inventive concept in the claim, and thus the claim is not patent eligible.
The dependent claims do not remedy the deficiencies of the independent claims with respect to patent eligible subject matter. The dependent claims further limit the abstract idea and do not overcome the rejection under 35 U.S.C. §101. Claims 2, 10 and 17 describe how to update a healthcare profile and merely limits the abstract idea. Claims 3 and 11 describe a relationship between users and decision tree and further limit the abstract idea. Claims 4 and 12 describe a comparison to decision trees that further limit the abstract idea. Claim 5 determines a new healthcare action and further limits the abstract idea. Claims 6, 13 and 18 describe determining subsequent actions and further limit the abstract idea. Claims 7, 14 and 19 further analyze information and provide a recommendation and limit the abstract idea. Claims 8, 15 and 20 prioritize an action based on analyzing information and further limits the abstract idea. Therefore, 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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 9 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2012/0232930 A1 to Schmidt et al., hereinafter “Schmidt,” in view of U.S. 2020/0303047 A1 to Bostic et al., hereinafter “Bostic” and further in view of U.S. 2015/0205921 A1 to Dick et al., hereinafter “Dick.”
Regarding claim 1, Schmidt discloses A method for dynamically evaluating health care risk, the method being implemented by machine-readable instructions, the method comprising: managing, for a set of users, a corresponding set of digital healthcare profiles, where each digital healthcare profile includes a healthcare decision tree for the corresponding user (See Schmidt at least at Abstract; Paras. [0007]-[0011], [0013]-[0014], [0030]-[0031] (decision tree), [0030]-[0032] (‘The CDS system assists the physician to figure out the optimal sequence of clinical actions from diagnosis to therapy and provides hints on alternative diagnostic and therapeutic measure […] The optimal path through the decision tree is determined by the patient and her preferences and by the availability and cost of clinical services. Each clinical path starts with the current patient state, which is documented in her medical health records (MHR). The path ends with the patient in her preferred state, either perfectly healthy or, if that is not achievable, with optimal quality of live or maximum life expectancy […] To achieve the goal of finding the optimal path for a given patient, all relevant clinical actions must be associated with a cost. In particular, a value for the clinical actions that lead to the endpoint node must be determined. By introducing a common "currency," an optimization method is used that determines the route with the lowest overall cost when following the actions and decisions from the start point to the endpoint.”), [0071]; Claim 1; Figs. 1, 2, 10 (showing decision tree)); determining, for a first user of the set of users, a first subset of the set of users with a first set of similar digital healthcare profiles based on the corresponding set of healthcare decision trees (See id. at least at Paras. [0011]-[0014], [0036]-[0038] (comparing path and path portions), [0056]; Claim 1; Figs. 1, 2, 10); determining, based on correlation between a first healthcare decision tree of the first user with the first set of healthcare decision trees of the first subset of users, a first recommended action for the first user (See id.); and providing, to the first user, information related to the first recommended action (See id. at least at Paras. [0007]-[0011], [0013]-[0014], [0056]; Claim 1); determining, based on the updated first set of digital healthcare profiles, a second recommended action to the first user; and providing, to the first user, information related to the second recommended action (See id. at least at Paras. [0024], [0050], [0059], [0068] (CDS system determines how a second clinical action should be performed); Claim 1; Figs. 1, 2, 8).
Schmidt may not specifically describe but Bostic teaches updating, for a second user in the first subset of users, a second digital healthcare profile and second healthcare decision tree of the second user (See Bostic at least at Paras. [0101], [0118], [0182]-[0183], [0185]-[0186] (update digital twin); and determining, based on the updated second healthcare decision tree of the second user, that the updated second healthcare decision tree deviates from the first set of healthcare decision trees (See id. at least at Paras. [0012]-[0013], [0096], [0174]).
Schmidt and Bostic may not specifically describe but Dick teaches removing, based on the determined deviation, the second user from the first subset of users (See Dick at least at Paras. [0067], [0069], [0095]; Figs. 2, 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Schmidt to incorporate the teachings of Bostic and Dick and provide decision tree comparison and removal of certain variables including related or unrelated patients. Bostic relates to the representation of health attributes using a digital twin. See Bostic at Abstract. Dick is directed to systems for electronic healthcare data and associations between users. See Dick at Abstract. Incorporating the healthcare data management and comparisons as in Dick with, the digital twin and population comparison as in Bostic and the clinical decision support system as in Schmidt would thereby improve the functionality and applicability of the claimed method and system for dynamically evaluating health care risk.
Regarding claims 9 and 16, claims 9 and 16 recite substantially the same limitations as included in claim 1. Thus, claims 9 and 16 are rejected under the same grounds of rejection and for the same reasoning as applied to claim 1, above. Furthermore, the physical processor of claim 9 is found in Schmidt at Fig. 2, Paras. [0007], [0036], [0060]; while the non-transitory machine-readable storage medium executable by a physical processor of a computing device of claim 16 is found at least at Fig. 2 and Paras. [0007] and [0071] of Schmidt.
Claims 2-5, 7-8, 10-12, 14-15, 17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt, in view of Bostic, in view of Dick and further in view of U.S. 11,322,250 B1 to Laster et al., hereinafter “Laster.”
Regarding claim 2, Schmidt as modified by Bostic and Dick discloses all the limitations of claim 1. The references may not specifically describe but Laster teaches updating the first healthcare profile of the first user by adding a new healthcare action to the first healthcare decision tree of the first user (See Laster at least at Col. 2, ln. 13-25; Col. 14, ln. 32-51; Col. 15 ln. 1-13; Col. 15 ln. 18-49; Col 18., ln. 41 – Col. 19, ln. 33 (peer pairing and creating new hybrid living care paths); Figs. 1, 7A-E, 8, 10-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Schmidt, Bostic and Dick to incorporate the teachings of Laster and provide adding and removing users and subsets of a patient population for analyses. Laster is directed to systems for an intelligent medical care path and comparison between patients. See Laster at Abstract. Incorporating the intelligent medical care path and patient analyses as in Laster with the healthcare data management and comparisons as in Dick, the digital twin and population comparison as in Bostic and the clinical decision support system as in Schmidt would thereby improve the functionality and applicability of the claimed method and system for dynamically evaluating health care risk.
Regarding claim 3, Schmidt as modified by Bostic and Dick discloses all the limitations of claim 1. The references may not specifically describe but Laster teaches wherein determining that the updated second healthcare decision tree deviates from the first set of healthcare decision trees comprises: determining that the updated second healthcare decision tree is statistically significantly different from the first set of healthcare decision trees. (See Laster at least at Col. 2, ln. 13-25 (differential between living care path and present performance and a plurality of measures); Col. 8, ln. 23-63; Col. 13, ln. 57 – Col. 15 ln. 67; Col. 16, ln. 33 – Col. 17 ln. 37); Figs. 1, 7A-E, 8).
Regarding claim 4, Schmidt as modified by Bostic and Dick discloses all the limitations of claim 1. The references may not specifically describe but Laster teaches wherein determining that the updated second healthcare decision tree deviates from the first set of healthcare decision trees comprises: determining that the updated second healthcare decision tree is statistically closer to a different set of healthcare decision trees than the first set of healthcare decision trees of the first subset of users (See id.).
Regarding claim 5, Schmidt as modified by Bostic and Dick discloses all the limitations of claim 1. The references may not specifically describe but Laster teaches wherein determining that the updated second healthcare decision tree deviates from the set of healthcare decision trees comprises: determining that a new healthcare action that caused the updating of the second healthcare caused the updated second healthcare decision tree to deviate from the first set of healthcare decision trees (See id.).
Regarding claim 7, Schmidt as modified by Bostic and Dick discloses all the limitations of claim 1 and Schmidt further discloses determining, for the first user, a second subset of users with a second set of similar digital healthcare profiles based on a second corresponding set of healthcare decision trees (See Schmidt at least at Paras. [0011]-[0014], [0036]-[0038] (comparing path and path portions), [0056]; Claim 1; Figs. 1, 2, 10).
The references may not specifically describe but Laster teaches determining, based on correlation between the first healthcare decision tree of the first user with the first set of healthcare decision trees of the first subset of users and the second set of healthcare decision trees of the second subset of users, a third recommended action for the first user; and providing, to the first user, information related to the third recommended action (See Laster at least at Col. 2, ln. 13-25; Col. 8, ln. 23-63; Col. 13, ln. 57 – Col. 15 ln. 67; Col. 16, ln. 33 – Col. 17 ln. 37); Figs. 1, 7A-E, 8).
Regarding claim 8, Schmidt as modified by Bostic and Dick discloses all the limitations of claim 1 and Schmidt further discloses wherein determining the first recommended action comprises: determining, based on the correlation between the first healthcare decision tree and the first set of healthcare decision trees of the first subset of users, a set of recommended actions, the set of recommended actions including the first recommended action; prioritizing the set of recommended actions based on factors relevant to the first user based on the first healthcare profile of the first user; and determining, based on the prioritization, the first recommended action (See Laster at least at Col. 2, ln. 13-25; Col. 8, ln. 23-63; Col. 13, ln. 57 – Col. 15 ln. 67; Col. 16, ln. 33 – Col. 17 ln. 37); Figs. 1, 7A-E, 8).
Regarding claims 10 and 17, claims 10 and 17 recite substantially the same limitations as included in claim 2. Thus, claims 10 and 17 are rejected under the same grounds of rejection and for the same reasoning as applied to claim 2, above.
Regarding claim 11, claim 11 recites substantially the same limitations as included in claim 3. Thus, claim 11 is rejected under the same grounds of rejection and for the same reasoning as applied to claim 3, above.
Regarding claim 12, claim 12 recites substantially the same limitations as included in claim 4. Thus, claim 12 is rejected under the same grounds of rejection and for the same reasoning as applied to claim 4, above.
Regarding claims 14 and 19, claims 14 and 19 recite substantially the same limitations as included in claim 7. Thus, claims 14 and 19 are rejected under the same grounds of rejection and for the same reasoning as applied to claim 7, above.
Regarding claims 15 and 20, claims 15 and 20 recite substantially the same limitations as included in claim 8. Thus, claims 15 and 20 are rejected under the same grounds of rejection and for the same reasoning as applied to claim 8, above.
Claims 6, 13 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt, in view of Bostic, in view of Dick, in view of Laster and further in view of U.S. 2016/0092641 A1 to Delaney et al., hereinafter “Delaney,”
Regarding claim 6, Schmidt as modified by Bostic and Dick discloses all the limitations of claim 1 and Schmidt further discloses updating the first healthcare decision tree based on the first recommended action; updating the first subset of users based on the updated first healthcare decision tree (See Schmidt at least at Abstract; Paras. [0007]-[0011], [0013]-[0014], [0030]-[0031] (decision tree), [0032], [0092]; Claim 1; Figs. 1, 2, 10).
The references may not specifically describe but Laster teaches determining a fourth recommended action based on the correlation between the first healthcare decision tree and the updated first subset of users; and providing the fourth recommendation to the first user (See Laster at least at Col. 2, ln. 13-25; Col. 14, ln. 32-51; Col. 15 ln. 1-13; Col. 15 ln. 18-49; Figs. 1, 7A-E, 8).
While Delaney teaches determining whether the first user executed on the first recommended action (See Delaney at least at Paras. [0071], [0073], [0075], [0132], [0155], [0157], [0158], [0233]-[0234]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Schmidt and Bostic to incorporate the teachings of Laster and Delaney and provide determining a user action and adding and removing users and subsets of a patient population for analyses. Laster is directed to systems for an intelligent medical care path and comparison between patients. See Laster at Abstract. Delaney relates to facilitating clinically informed decisions to improve healthcare performance. See Delaney at Abstract. Incorporating the intelligent medical care path and patient analyses as in Laster with the clinical decision-making techniques of Delaney, the healthcare data management and comparisons as in Dick, the digital twin and population comparison as in Bostic and the clinical decision support system as in Schmidt would thereby improve the functionality and applicability of the claimed method and system for dynamically evaluating health care risk.
Response to Arguments
Applicant’s remarks filed October 24, 2025 have been fully considered, but they are not persuasive. The following explains why:
Applicant’s arguments pertaining to subject matter eligibility are not persuasive. The basis for the previous rejection under 35 U.S.C. §101 is still operative and the claims have been addressed with regard to the updated 35 U.S.C. §101 rejection discussed above, and considered under the 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG) and Updated PEG. The arguments at pages 11-14 of Applicant’s Remarks are not persuasive. At pages 11-13 the Examiner disagrees that there is not an abstract idea and there is a technological improvement in the claims. The claims are directed to the abstract idea of methods of organizing human activity (judicial exception) and mental processes, discussed above. At pages 12-13 the Examiner disagrees there is significantly more than the abstract idea or there is a practical application that is integrated in the claims. Here the healthcare profiles of various data and analysis/recommendation techniques using machine-readable instructions act as a computer tool used to employ the abstract idea. That it may be tedious or laborious to perform analyses in the mind or manually is not of consequence in the eligibility analysis. Furthermore, the Examiner respectfully disagrees with arguments at Page 14 that the claims do not preempt an abstract idea. The claims amount to collecting patient data for multiple patients and determining recommendations based on analyzing the data, a process that can be done manually and that is also a method of organizing human activity of following rules or instructions between a patient and physician/healthcare group. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. For at least these reasons and those stated above, the claims are not patent eligible.
Applicant’s arguments pertaining to prior art rejections are not persuasive. The claims have been addressed with regard to the 35 U.S.C. §103 rejection discussed above. The arguments pertaining to prior art references of the Applicant’s Remarks at Pages 15-16 are not persuasive. The arguments at Pages 15-16 regarding Schmidt are not persuasive. Schmidt is relied on for disclosing a decision tree at least at Abstract; Paras. [0007]-[0011], [0013]-[0014], [0030]-[0031] (decision tree), [0030]-[0032] (‘The CDS system assists the physician to figure out the optimal sequence of clinical actions from diagnosis to therapy and provides hints on alternative diagnostic and therapeutic measure […] The optimal path through the decision tree is determined by the patient and her preferences and by the availability and cost of clinical services. Each clinical path starts with the current patient state, which is documented in her medical health records (MHR). The path ends with the patient in her preferred state, either perfectly healthy or, if that is not achievable, with optimal quality of live or maximum life expectancy […] To achieve the goal of finding the optimal path for a given patient, all relevant clinical actions must be associated with a cost. In particular, a value for the clinical actions that lead to the endpoint node must be determined. By introducing a common "currency," an optimization method is used that determines the route with the lowest overall cost when following the actions and decisions from the start point to the endpoint.”), [0071]; Claim 1; Figs. 1, 2, 10 (showing decision tree)). For clarification, Bostic also teaches a decision tree at least at Paras. [0101], [0118]. As such, it is submitted that the cited prior art, including those identified by Applicant, in the same field of endeavor, i.e., techniques for patient data analysis and diagnoses/recommendations, teaches and/or suggests all of the limitations of the pending claims under a broad and reasonable interpretation thereof.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/WILLIAM T. MONTICELLO/Examiner, Art Unit 3681
/MARC Q JIMENEZ/Supervisory Patent Examiner, Art Unit 3681