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 .
Applicant filed a response dated 9/3/2025 in which claims 1 and 10-11 have been amended, claim 2 has been canceled. Thus, the claims 1 and 3-11 are pending in the application.
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 and 3-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of disease risk analysis without significantly more.
Examiner has identified claim 1 as the claim that represents the claimed invention presented in independent claims 1 and 10-11.
Claim 1 is directed to an apparatus, which is one of the statutory categories of invention (Step 1: YES).
The claim 1 describes a disease risk analysis apparatus comprises a processor including hardware configured to: acquire healthcare data including genetic score data holding a genetic score for each user and temporal data including at least one of health checkup data and medical examination data for each user collected over time; determine a threshold for stratifying the genetic score; stratify the genetic score data based on the threshold to generate stratified data, the stratified data being data in which a label representing each layer is associated with each ID of the generic score data stratified by the threshold; set a criterion for at least a test value of the health checkup data and/or at least a medical examination status of the medical examination data; generate first observation target data by extracting a test value and/or a medical examination status corresponding to the criterion from the temporal data; generate starting point data based on the first observation target data and the criterion, the starting point data being data with a year in which the test value and/or medical examination status included in the first observation target data reached the criterion as a starting point; determine an observation target from at least a test value of the health checkup data and/or at least a medical examination status of the medical examination data; generate second observation target data by extracting the test value and/or the medical examination status determined as the observation target with the starting point data as a starting point from the temporal data, the second observation target data being extracted, from the temporal data with the starting point data as a starting point, and including a test value and/or a medical examination status of a relative year later than the starting point, or a test value and/or a medical examination status of a relative year earlier and later than the starting year; generate a graph of the second observation target data in time series for each of the stratified genetic score data by stratifying the second observation target data based on the stratified data; and display a graph of the second observation target date in time series for each of the stratified genetic score data on a display device. These limitations (with the exception of italicized limitations) describe the abstract idea of disease risk analysis which may correspond to a certain method of organizing human activity and thus the claim recites an abstract idea. The additional elements of a processor, hardware, and a display device do not restrict the claim from reciting an abstract idea. Thus, the claim 1 recites an abstract idea (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application because the additional elements of a processor, hardware, and a display device result in no more than simply applying the abstract idea using generic computer elements. The additional elements of a processor, hardware, and a display device are recited at a high level of generality and under their broadest reasonable interpretation comprises a generic computer arrangement. The presence of a generic computer arrangement is nothing more than to implement the claimed invention by applying the exception using a generic computer element (MPEP 2106.05(f)). Therefore, the recitations of additional elements do not meaningfully apply the abstract idea and hence do not integrate the abstract idea into a practical application. Thus, the claim 1 is directed to an abstract idea (Step 2A-Prong 2: NO).
The claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites the additional elements of a processor, hardware, and a display device are recited at a high level of generality in that it result in no more than simply applying the abstract idea using generic computer elements. The additional elements when considered separately and as an ordered combination do not amount to add significantly more as these elements provide nothing more than to simply apply the exception in a generic computer environment (Step 2B: NO). Thus, the claim 1 is not patent eligible.
Similar arguments can be presented for other independent claims 10-11 and hence these claims are rejected on similar grounds as claim 1.
Dependent claims 3-9 further define the abstract idea that is present in the independent claim 1, thus correspond to a certain method of organizing human activity, and hence are abstract in nature for the reason presented above. Dependent claims do not include any additional elements that integrate the abstract idea into a practical application or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination. Therefore, the claims 1 and 3-11 are not patent-eligible.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 3-11 are rejected under 35 U.S.C. 103 as being unpatentable over Khera, Polygenic prediction of weight and obesity trajectories from birth to adulthood, Cell. 2019 April 18; 177(3): 587-596.e9 (hereinafter NPL-Khera).
NPL-Khera discloses a disease risk analysis apparatus comprising a processor including hardware configured to:
acquire healthcare data including genetic score data holding a genetic score for each user and temporal data including at least one of health checkup data and medical examination data for each user collected over time (Fig. 5, years of follow-up, polygenic score; pages 2-3, clear differences in weight during early childhood, and profound differences in weight trajectory and risk of developing severe obesity in subsequent years; measurements such as BMI);
determine a threshold for stratifying the genetic score (page 4, stratified into 5-year age bins; Fig. 5, three categories);
stratify the genetic score data based on the threshold to generate stratified data, the stratified data being data in which a label representing each layer is associated with each ID of the genetic score data stratified by the threshold (Fig. 2, polygenic score; Fig. 5, three categories);
set a criterion for at least a test value of the health checkup data and/or at least a medical examination status of the medical examination data (Fig. 5, severe obesity, Fig. 6, Table 1);
generate first observation target data by extracting a test value and/or a medical examination status corresponding to the criterion from the temporal data (Table 1, weight at birth and subsequent visits (0-18 years));
generate starting point data based on the first observation target data and the criterion, the starting point data being data with a year in which the test value and/or medical examination status include in the first observation target data reached the criterion as a starting point (Table 1, pages 7-8; Fig. 5, the data includes starting point dates; For Bottom Decile, no change for the first 5 years; for Deciles 2-9, change started right before the 5 year follow-up; Top Decile, change in obesity started around 2 year of follow-up);
determine an observation target from at least a test value of the health checkup data and/or at least a medical examination status of the medical examination data (Table 1, pages 7-8, initial baseline assessment; pages 11-12);
generate second observation target data by extracting the test value and/or the medical examination status determined as the observation target with the starting point data as a starting point from the temporal data, the second observation target data being extracted, from the temporal data with the starting point data as a starting point, and including a test value and/or a medical examination status of a relative year later than the starting point, or a test value and/or a medical examination status of a relative year earlier and later than the starting point (Table 1, pages 7-8, subsequent decades; pages 11-12; Fig. 5, the data includes starting point dates; For Bottom Decile, no change for the first 5 years; for Deciles 2-9, change started right before the 5 year follow-up; Top Decile, change in obesity started around 2 year of follow-up);
generate a graph of the second observation target data in time series for each of the stratified genetic score data by stratifying the second observation target data based on the stratified data (Table 1, pages 4, 7-8, 11-12; Fig. 5); and
display a graph of the second observation target data intime series for each of the stratified genetic score data on a display device (Fig. 5).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine different disclosure of NPL-Khera in order to summarize and display the information to a user.
Regarding claim 3, NPL-Khera discloses wherein the genetic score is PRS (pages 8-9, GPS).
Regarding claim 4, NPL-Khera discloses wherein the PRS includes at least one of PRS correlated with onset risk of obesity, hypertension, diabetes, dyslipidemia, and liver dysfunction, and PRS correlated with BMI, highest blood pressure, HbA1c, LDC, HDL, TG, GOT, GPT, and γGTP (page 6, Fig. 4).
Regarding claim 5, NPL-Khera discloses wherein the processor calculates an average of the test value for each layer from the second observation target data stratified by the stratified data (Fig. 6, average weight).
Regarding claim 6, NPL-Khera discloses wherein the processor calculates a prevalence for each layer from the second observation target data stratified by the stratified data (Fig. 2).
Regarding claim 7, NPL-Khera discloses wherein the processor performs analysis by the Kaplan-Meier method with each test value in the second observation target data as an explanatory variable and an incidence of a specific disease as an objective variable (Fig. 2, page 14).
Regarding claim 8, NPL-Khera discloses wherein the first observation target data is health checkup data and/or medical examination data that serves as a criterion for determining onset of obesity, hypertension, diabetes, dyslipidemia, or liver dysfunction (page 6, Fig. 4).
Regarding claim 9, NPL-Khera discloses wherein the second observation target data is health checkup data and/or medical examination data that serves as a criterion for determining onset of obesity, hypertension, diabetes, dyslipidemia, or liver dysfunction (page 6, Fig. 4).
Claims 10-11 are substantially similar to claim 1 and hence rejected on similar grounds.
Response to Arguments
Applicant's arguments filed dated 9/3/2025 have been fully considered but they are not persuasive due to the following reasons:
With respect to the rejection of claims 1-11 under 35 U.S.C. 101, Applicant states that the claim 1 does not fall into any of the enumerated sub-groupings of certain methods of organizing human activity.
Examiner respectfully disagrees and notes that the claims recite an abstract idea of disease risk analysis which corresponds to a certain methods of organizing human activity (i.e., managing interactions between people (including social activities, teaching, and following rules or instructions).
Applicant states that under Step 2A, Prong Two, the claim includes the components or steps of the invention that provide the improvement described in the specification. With respect to Step 2B, Applicant states that the operations recited in the claim are non-conventional, temporal data-based set of operations that is specifically designed to address shortcomings in conventional disease risk analysis apparatuses.
Examiner respectfully disagrees and notes that the additional elements are recited at a high level of generality in that it amounts to applying the abstract idea without offering any technical or technology improvement. Thus, these arguments are not persuasive.
With respect to Applicant’s arguments regarding the rejection of claims 1-11 under 35 U.S.C. 102(a)(2), these arguments are moot in view of new grounds of rejection presented above in this office action.
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 RAJESH KHATTAR whose telephone number is (571)272-7981. The examiner can normally be reached M-F 8AM-5PM.
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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.
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RAJESH KHATTAR
Primary Examiner
Art Unit 3684
/RAJESH KHATTAR/Primary Examiner, Art Unit 3684