DETAILED ACTION
Status of Claims
This is a Final Office Action in response to the arguments and/or amendments filed on 1 July 2026.
Claim(s) 2, 3, 9, 11, 12, and 18 is/are canceled. Claim(s) 1, 4, 5, 7, 8, 10, 13, 14, 16, and 19 is/are amended.
Claim(s) 1, 4-8, 10, 13-16, and 19 is/are currently pending and have been examined.
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, 4-8, 10, 13-16, and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 10, which is representative of claim 1, recites a method of analyzing a biomarker, the method comprising:
generating virtual patients by reconstructing virtual data including information about survival rates of the virtual patients included in a first group, based on a Kaplan-Meier curve showing survival rates of patients in a real clinical trial;
generating control group data by classifying each of the virtual patients as a responder or a non-responder, according to a certain criterion, wherein the control group data comprises a plurality of control group data sets;
generating experimental group data based on at least one of medical images and survival data of actual patients included in a second group to which a specific regime has been applied, wherein the experimental group data comprises a plurality of experimental group data sets;
performing a plurality of simulations by iteratively executing comparative analyses on various combinations of the plurality of control group data sets and the plurality of experimental group data sets;
performing a survival rate comparison analysis between the control groups and the experimental group based on results of the plurality of simulations; and
outputting a result of comparison between the control group data and the experimental group data based on a ratio of a number of comparative analyses showing a statistically significant difference between the control group and the experimental group relative to a total number of the comparative analyses performed;
wherein the method further comprises classifying each of the virtual patients as a responder or a non-responder by classifying, according to the certain criterion, a first proportion of the virtual patients as a responder and a second proportion of the virtual patients as a non-responder, and
wherein the certain criterion is a responder proportion derived from results of a prior clinical trial.
These limitations describe a concept of rules for creating synthetic data from prior trials and analyzing it. This concept describes a mental process that a clinical investigator should follow to evaluate treatment efficacy similar to the “mental process that a neurologist should follow when testing a patient for nervous system malfunctions” given in MPEP 2106.04(a)(2)(II)(C) as an example of managing personal behavior in the methods of organizing human activity sub-grouping. As such, these limitation set forth a method of organizing human activity. Therefore the claims are determined to recite an abstract idea.
MPEP 2106, reflecting the 2019 PEG, directs examiners at Step 2A Prong Two to consider whether the additional elements of the claims integrate a recited abstract idea into a practical application.
Claim 10 recites no additional elements. As there are no additional elements, the claim is determined to be directed to an abstract idea.
Claim 1 recites the additional element of a computing device comprising: a memory and a processor. This additional element is recited at an extremely high level of generality, and is interpreted as a generic computing device used to implement the abstract idea. Per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not integrate an abstract idea into a practical application in Step 2A Prong Two, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, this additional element does not integrate the abstract idea into a practical application. There are no further additional elements. Therefore the additional element does not integrate the abstract idea into a practical application. As such, the claim is determined to be directed to an abstract idea.
At Step 2B of the Mayo/Alice analysis, examiners are to consider whether the additional elements amount to significantly more than the abstract idea.
As previously noted, claim 10 recites no additional elements. Thus there are no additional elements to amount to significantly more than the abstract idea.
As previously noted, claim 1 recites an additional element which may be interpreted as a generic computing device used to implement the abstract idea. However, per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, this additional element does not amount to significantly more. There are no further additional elements. Therefore the additional elements of the independent claims do not amount to significantly more than the abstract idea. Thus the independent claims are not patent eligible.
Dependent claims 4-8, 13-16, and 19 further describe the abstract idea, but the claims continue to recite an abstract idea, albeit narrowed. Dependent claims 4-8 recite no further additional elements. The previously identified additional element does not integrate the narrowed abstract idea into a practical application or amount to significantly more than the narrowed abstract idea for the same reasons as indicated above. Dependent claims 13-16 do not recite any additional elements, and thus remain directed to an abstract idea without additional elements that amount to significantly more than the abstract idea. Dependent claim 19 recites the additional element of a computer-readable recording medium. This additional element may be interpreted as a generic computing device used to implement the abstract idea. As previously noted, such additional elements do not either integrate an abstract idea into a practical application or amount to significantly more. Because the dependent claims remain directed to an abstract idea without reciting significantly more, the dependent claims are not patent eligible.
Response to Arguments
Applicant’s Argument Regarding 112(a) Rejections of claims 1-19: The Office Action indicates that the feature of “classifying each of the virtual patients as a responder or a non-responder according to a certain criterion is unsupported by the specification. Applicant respectfully disagrees.
Examiner’s Response: Applicant's arguments filed 1 July 2026 have been fully considered. Applicant’s argument is unpersuasive. However, in view of the extensive amendments further limiting the claim, the rejection is no longer applicable and is withdrawn.
Applicant’s Argument Regarding 101 Rejections of claims 1-19:
The present claims are clearly distinguished from In re Meyer.
These are not operations corresponding to any method of organizing human activity.
The claim is directed to a specific improvement to a technical problem. … Specifically, claim 1 is directed to generating virtual patients from a Kaplan-Meier graph showing survival rates of patients in a real clinical trial and using the reconstructed virtual patients to perform hypothesis testing based on clinical trial survival information.
Examiner’s Response: Applicant's arguments filed 1 July 2026 have been fully considered but they are not persuasive.
Since the 2019 Patent Eligibility Guidance, cases are not strictly evaluated on similarity to other cases in order to determine whether they recite an abstract idea. Per MPEP 2106.04(a), “the Office has set forth an approach to identifying abstract ideas that distills the relevant case law into enumerated groupings of abstract ideas” and “[e]xaminers should determine whether a claim recites an abstract idea by (1) identifying the specific limitation(s) in the claim under examination that the examiner believes recites an abstract idea, and (2) determining whether the identified limitations(s) fall within at least one of the groupings of abstract ideas listed above.” Thus distinguishing the claims from In re Meyer does not actually address the rejection.
Applicant’s basis for this assertion is unclear. Examiner notes that the relevant sub-grouping of organizing human activity (managing personal behavior), per MPEP 2106.04(a)(2)(II)(C) includes “following rules or instructions.” This portion of the disclosure provides additional examples of “following rules or instructions” of “assigning hair designs to balance head shape” and “a series of instructions of how to hedge risk.”
Per 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.” Here, the disclosure fails to provide technical details of implementation that would indicate to one of ordinary skill in the art that the claimed invention provides an actual technical improvement.
Applicant’s Argument Regarding 103 Rejections of claims 1-2, 5, 7-11, 14, and 16-19: The proposed combination is unreasonable.
Examiner’s Response: Applicant's arguments filed 1 July 2026 have been fully considered. Applicant’s argument is unpersuasive. However the extensive amendments to the claim significantly clarified the scope of the claim enabling the follow on search to turn up references describing the techniques apparently relied upon by applicant. In view of this prior art, the claimed invention does not appear to be obvious for the reasons given below.
Non-obvious Subject Matter
Claim(s) 1, 4-8, 10, 13-16, and 19 is/are understood to claim novel and non-obvious subject matter.
The following is a statement of reasons for the indication of novel and non-obvious subject matter:
The claims closely correspond the techniques of Guyot et al. (Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves) which describes generating virtual patients by reconstructing virtual data including information about survival rates of the virtual patients included in a first group based on a Kaplan-Meier curve showing survival rates of patients in a real clinical trial, perform a plurality of simulations by iteratively executing comparative analyses on various combinations of the plurality of data sets, perform a survival rate comparison analysis based on results of the plurality of simulations, and output a result of comparison based on a ratio of a number of comparative analyses showing a statistically significance difference of the comparative analyses performed.
However, neither Guyot nor the prior art generally appears to suggest, generating control group data by classifying virtual patients as a responder or a non-responder according to a certain criterion wherein the certain criterion is a responder proportion derived from results of a prior clinical trial, and using that data in the simulations. In the absence of any prior art suggesting this approach, the examiner sees no reason that one of ordinary skill in the art would expect analyzing control group patients classified simply according to a proportion of responders to produce meaningful results. As such, the claimed invention would not have been obvious to one of ordinary skill in the art at the time of filing.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bion A Shelden whose telephone number is (571)270-0515. The examiner can normally be reached M-F, 12pm-10pm EST.
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/Bion A Shelden/Primary Examiner, Art Unit 3685 2026-08-26
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