DETAILED ACTION
Applicant’s response filed 04/13/2026 has been fully considered. The following rejections and/or objections are either reiterated or newly applied.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/13/2026 has been entered.
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 2, 4-5, 7-8, 10, 13-16, 18-19, 21-22, 24-25, 27, 30-35, 37-39, 41-42, 44, 48-60, 62, 65-67, and 73-131 are cancelled by Applicant.
Claims 1, 3, 6, 9, 11-12, 17, 20, 23, 26, 28-29, 36, 40, 43, 45-47, 61, 63-64 and 68-72 are currently pending.
Claims 20, 23, 26, 36, 45-46, 63-64 and 72 are withdrawn by Applicant, as discussed in the Restriction and Election section of the Office action mailed 02/12/2024.
Claims 1, 3, 6, 9, 11-12, 17, 28-29, 40, 43, 47, 61 and 68-71 are herein under examination.
Claims 1, 3, 6, 9, 11-12, 17, 28-29, 40, 43, 47, 61 and 68-71 are rejected.
Claims 3, 12 and 71 are objected.
Priority
The instant application claims domestic benefit to U.S. Provisional Application No. 62/941,012 filed 11/27/2019. The claim to the benefit of priority for claims is acknowledged. The effective filing date for claims 1, 3, 6, 9, 11-12, 17, 28-29, 40, 43, 47, 61 and 68-71 is 11/27/2019.
Claim Objections
Claims 3, 12 and 71 are objected to because of the following informalities:
Claim 3, line 4, should recite “comprises
Claim 12, line 1, recites “the classifier is further trained” which should be “the classifier was further trained” to clarify that there is no active step. This is to algin with claim 11, line 2, that recites “a classifier trained”, which indicates a product by process.
Claim 71, line 5, should recite “the method of claim 1”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
35 USC 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 6, 9, 11-12, 17, 28-29, 40, 43, 47, 61 and 68-71 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
This rejection is newly recited in view of further consideration of the claims.
Claims dependent from a rejected claim are also rejected, unless otherwise noted.
Claim 1, step (b), recites “model that is trained on time-series” which renders the claim indefinite. It is unclear if an active step of training is required, or if it equates to a product by process limitation that defines how the model was previously trained. To clarify it being a product by process limitation, Applicant can amend to recite “model
Claim 3, 2nd to last line, recites “the respective training subject” which lacks antecedent basis. Provide antecedent basis.
Claim 11, 2nd to last line, recites “the respective training subject” which lacks antecedent basis. Provide antecedent basis.
Claim 61 recites “model that is trained” which renders the claim indefinite. It is unclear if an active step of training is required, or if it equates to a product by process limitation that defines how the model was previously trained. To clarify it being a product by process limitation, Applicant can amend to recite “model was trained”. Otherwise, Applicant should clarify that an active step of training is required.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Claim 71, line 2, recites a broad limitation of “one or more processors”. Claim 71, line 4, then recites “the processors”, which is a narrower limitation of the broad limitation. The claim is indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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, 3, 6, 9, 11-12, 17, 28-29, 40, 43, 47, 61 and 68-71 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea and a natural phenomenon without significantly more.
Any newly recited portions herein are necessitated by claim amendment.
Step 1:
Step 1 asks whether the claims recite statutory subject matter. In the instant application, claims 1, 3, 6, 9, 11-12, 17, 28-29, 40, 43, 47, 61 and 68-69 recite a method, claim 70 recites a CRM, and claim 71 recites a system. As such, these claims recite statutory subject matter (Step 1: YES).
Step 2A, Prong 1:
Claims that recite statutory subject matter are analyzed under Step 2A, Prong 1 to determine if they recite any concepts that equate to an abstract idea, law of nature or natural phenomena. The instant claims recite the following limitations that equate to one or more categories of judicial exception:
Claims 1, 70 and 71 recite “(A) determining . . . from a first plurality of sequence reads . . . the first plurality of sequence reads comprising hundreds of thousands of sequence reads of a first plurality of nucleic acid molecules in a first biological sample obtained from the test subject at a first test time point, a first genotypic data construct for the test subject, the first genotypic data construct comprising values for a plurality of genotypic characteristics based on the first plurality of sequence reads.” The broadest reasonable interpretation (BRI) of determining a first genotypic construct is that a human could practically identify a nucleotide variation as it would merely requiring comparing sequences. This claim therefore equates to a mental process. Claims 1, 70 and 71 recite “(B) inputting the first genotypic data construct into a model for the disease condition, thereby generating a first model score set for the disease condition, wherein the model is a machine-learning classification model that is trained on time time-series genotypic construct data”. These limitations equate to a mental process because a human could practically input data into an unspecified machine learning classification model such as a logistic regression to then produce an output. A human could also with pen and paper train a logistic regression merely by using the output to manually alter the parameters of the logistic regression. These limitations also equate to a mathematical concept because inputting data into an unspecified machine learning model that generates values is the verbal equivalent of a function that performs a calculation because the model could be a logistic regression, which performs calculations. Claims 1, 70 and 71 recite “(C) determining, from a second plurality of sequence reads . . . the second plurality of sequence reads comprising hundreds of thousands of sequence reads of a second plurality of nucleic acid molecules in a second biological sample obtained from the test subject at a second test time point, a second genotypic data construct for the test subject, the second genotypic data construct comprising values for the plurality of genotypic characteristics based on the second plurality of sequence reads; (D) inputting the second genotypic data construct into the model, thereby generating a second model score set for the disease condition.” For the reasons stated above in Steps (A), Step (C) is a mental process. For the reasons stated above in Step (B), Step (D) is a mental process and a mathematical function/calculation. Claims 1, 70 and 71 recite “(E) determining a test delta score set based on a difference between the first and second model score set”. The BRI of determining the difference between two values is performing a calculation between two numbers, which can be practically performed by a human and is considered a mental process. This limitation also equates to a mathematical calculation since determining a difference between two numbers is a verbal equivalent for performing a calculation and since delta scores are calculated. Claims 1, 70 and 71 recite “(F) refining an ability . . . to correctly identify a true positive and true negative by adjusting one or more aspects of the test delta score set to account for one or more biological factors of the test subject that affect a magnitude of the test delta score set.” These limitations equate to mental process because a human could practically with pen and paper adjust a value by using, for example, a covariate that thereby affects the newly calculated value. This limitation also equates to a mathematical concept because the BRI of this limitation includes performing a calculation using numerical values to output more numerical values. Claims 1, 70 and 71 recite “wherein the adjusting comprises: utilizing an amount of time between a respective first time point and a respective second time point for each respective reference subject in a plurality of reference subjects as a first covariate in calculating a distribution of reference delta score sets” The BRI is that a human could practically could perform calculations using covariates, which makes this a mental process. This limitation also equates to a mathematical calculation since a distribution is calculated. Claims 1, 70 and 71 recites “adjusting the test delta score set based on a second covariate representing a difference in time between the first test time point and the second test time point for the test subject.” The BRI is that a human could adjust a delta score based on a covariate as it merely requires performing calculations, thus making this limitation a mental process. This limitation also equates to a mathematical relationship since the values of the delta score are being manipulated based upon the covariate. Claims 1, 70 and 71 recite “wherein the distribution of reference delta score sets reflects empirically determined assay variability from longitudinal biological samples.” this limitation is included in the judicial exception of “utilizing” because it limits the distribution. Claims 1, 70 and 71 recite “and wherein the test delta score set is evaluated relative to the assay variability to distinguish noise from biological change.” This limitation equates to a mental process of evaluating data. Claims 1, 70 and 71 recite “(G) evaluating, subsequent to adjusting the one or more aspects of the test delta score set, the test delta score set against a plurality of reference delta score sets, thereby determining whether the test subject has the disease condition and a stage of the disease condition, wherein each reference delta score set in the plurality of reference delta scores sets is for a respective reference subject in a plurality of reference subjects.” The BRI of evaluating and determining is that a human could practically look at delta scores and decide whether or not a subject has a delta score similar to reference delta scores associated with a disease condition, which makes this limitation a mental process. Claims 1, 70 and 71 recite “(H) identifying, responsive to determining that the test subject has the disease condition, a treatment corresponding to the stage of the disease condition”. The BRI of this limitation includes evaluating data and making a determination, both of which can be practically performed by the human mind. Moreover, Steps (A) – (F) recite a natural phenomenon because these steps correlate genetic variations with the likelihood that a disease is present in a patient.
Claim 3 recites “the first model score set comprises a probability that the test subject has the disease condition at the first test time point, the second model score set comprises of a probability that the test subject has the disease at the second test time point.” These limitations are included in the mathematical function/calculation in claim 1 of generating a first/second model score set for the disease condition since these limitations merely attempt to limit what data is associated with the model scores but does not change the fact that the model scores are part of the judicial exception. This limitation also equates to a mathematical relationship since probabilities are merely a calculation of the likelihood of an event to occur. Claim 3 recites “evaluating (G) comprises comparing the test delta score set to the distribution of the reference delta score sets, wherein each reference delta score set in the plurality of reference delta score sets is for a respective reference subject in the plurality of reference subject based on a difference between: (i) a first probability that the respective reference subject has the disease condition provided by the model using a respective first reference genotypic data construct comprising values for the plurality of genotypic features, taken using a respective first biological sample acquired at a respective first time point from the respective reference subject, and (ii) a second probability that the respective reference subject has the disease condition provided by the model using a respective second genotypic data construct comprising values for the plurality of genotypic features, taken using a respective second biological sample acquired from the respective reference subject at a respective second time point occurring after the respective first time point, and wherein the respective training subject is free of the disease condition during at least the respective first and second time points.” The BRI of comparing is that a human could practically compare delta scores to other delta scores, thereby making this limitation a mental process. These limitations also equate to a mathematical relationship since probabilities are merely a calculation of the likelihood of an event to occur.
Claim 6 recites “wherein the evaluating (G) comprises: determining a measure of central tendency of the distribution and a measure of spread of the distribution.” The BRI here is that a human could practically perform the calculations necessary to determine central tendency and spread of a distribution, which makes this limitation a mental process. This limitation also equates to a mathematical function/calculation since central tendency and spread of distribution are calculated. Claim 6 recites “determining a significance of the test delta score set using the measure of central tendency of the distribution and the measure of spread of the distribution.” The BRI is that a human could practically perform the calculations necessary to determine statistical significance of delta scores, thus making this limitation a mental process. This is also a mathematical function/calculation since central tendency and spread of distribution are calculated.
Claim 9 recites “the measure of central tendency of the distribution is the mean of the distribution, the measure of spread of the distribution is the standard deviation of the distribution, and the determining the significance of the test delta score set using the measure of central tendency of the distribution and the measure of spread of the distribution comprises determining a number of standard deviations the test delta score set is from the mean of the distribution.” The BRI of these limitations is that a human could practically perform the calculations using pen and paper, which makes these limitations a mental process. These limitations are also a mathematical function/calculation since each one requires a calculation be made using an equation. Additionally, these limitations are included in the judicial exception of claim 6 since these limitations merely attempt to alter what type of equation is used for the calculations in claim 6 but do not change the fact that claim 6 is a judicial exception.
Claim 11 recites “wherein the evaluating (G) comprises inputting the test delta score into a classifier trained against the plurality of reference delta score sets.” The BRI of inputting data into a classifier is that a human could practically input data to perform the calculation of a classifier such as a linear regression, which makes this a mental process. This also equates to a mathematical function/calculation since the specification states that the classifier may be a linear regression [147], which is an equation that calculates values. Claim 11 recites “wherein each reference delta score set in the plurality of reference delta score sets is for a respective reference subject in the plurality of reference subject based on a difference between: (i) a first probability that the respective reference subject has the disease condition provided by the model using a respective first reference genotypic data construct comprising values for the plurality of genotypic features, taken using a respective first biological sample acquired at a respective first time point from the respective reference subject, and (ii) a second probability that the respective reference subject has the disease condition provided by the model using a respective second genotypic data construct comprising values for the plurality of genotypic features, taken using a respective second biological sample acquired from the respective reference subject at a respective second time point occurring after the respective first time point, and wherein the respective training subject is free of the disease condition during at least the respective first and second time points.” These limitations are included in the judicial exception of inputting the test delta score into a classifier since they merely attempt to limit what the reference delta score sets comprise but do not change the fact that inputting the test delta score into a classifier is a judicial exception. These limitations also equate to a mathematical relationship since probabilities are merely a calculation of the likelihood of an event to occur.
Claim 12 recites “wherein the classifier is further trained against, for each respective training subject in at least a subset of the plurality of reference subjects, a determination of whether the respective subject had the disease condition at a respective third time point occurring after the respective second time point.” The BRI of training a classifier based upon a determination, which is recited at such a high level of generality, is that a human could performing the calculations of a linear regression (i.e. a classifier) by using the given data of the limitation, which makes this limitation a mental process. This limitation also equates to a mathematical function/calculation since the specification states that a classifier can be a linear regression, which merely requires performing calculations to train itself.
Claim 17 recites “further comprising normalizing, wherein: each respective reference delta score set in the plurality of reference delta scores sets is normalized for an amount of time between the respective first time point and the respective second time point for the respective subject; the test delta score set is normalized for an amount of time between the first test time point and the second test time point.” The BRI of normalizing data, which is recited at such a high level of generality, is that a human could perform the steps of a normalization process as it would merely require performing calculations, which makes these limitations a mental process. These limitations are also a mathematical calculation/relationship since the BRI of normalizing includes performing calculations and/or manipulating data.
Claim 28 recites “wherein the disease condition is a cancer condition.” This limitation is included in the judicial exception of claim 1 as it merely limits the type of disease but does not change the fact that the disease condition is part of the judicial exception in claim 1. This claim also equates to a natural phenomenon since the instant invention aims to correlate genetic variations with the likelihood that a disease is present in a patient.
Claim 29 recites “wherein the disease condition is a type of disease condition in a set of disease conditions and the model provides a probability or likelihood for each disease condition in the set conditions.” These limitations are included in the judicial exception of claim 1 since they attempt to limit the type of disease and the output of the model but do not change the fact that claim 1 is a judicial exception. Additionally, the model providing a probability equates to a mathematical relationship since probabilities represent the mathematical likelihood of an event. This claim also equates to a natural phenomenon since the instant invention aims to correlate genetic variations with the likelihood that a disease is present in a patient.
Claim 40 recites “wherein the first biological sample obtained from the test subject and the second biological sample obtained from the test subject are both blood samples.” This limitation is included in the judicial exception of claim 1 since it merely limits where the biological samples are derived but does not change the fact that claim 1 is a judicial exception.
Claim 43 recites “wherein the first plurality of nucleic acid molecules and the second plurality of nucleic acid molecules are cell-free DNA molecules.” This limitation is included in the judicial exception of claim 1 since it merely limits where the nucleic acid molecules are derived but does not change the fact that claim 1 is a judicial exception.
Claim 47 recites “the plurality of genotypic characteristics for the first genotypic data structure comprises a first plurality of bin values, each respective bin value in the first plurality of bin values representing a corresponding bin in a plurality of bins, each respective bin value in the first plurality of bin values is representative of a number of unique nucleic acid fragments with a predetermined methylation pattern identified using sequence reads in the first plurality of sequence reads that map to the corresponding bin in the plurality of bins, the plurality of genotypic characteristics for the second genotypic data structure comprises a second plurality of bin values, each respective bin value in the second plurality of bin values representing a corresponding bin in the plurality of bins, each respective bin value in the second plurality of bin values is representative of a number of unique nucleic acid fragments with a predetermined methylation pattern identified using sequence reads in the second plurality of sequence reads that map to the corresponding bin in the plurality of bins, and each bin in the plurality of bins represents a non-overlapping region of a reference genome of a species of the test subject.” All the limitations of claim 47 are included in the judicial exception of claim 1 since these limitations merely attempt to limit what type of data comprises genotypic characteristics but do not change the fact that the genotypic characteristics in claim 1 are part of the judicial exception.
Claim 61 recites “wherein the model is trained on a cohort of subjects in which a first portion of the cohort has the disease condition and a second portion of the cohort is free of the disease condition.” The BRI is that a human could practically perform the operations of a model such as a linear regression, then change the parameters of the model to train it, which makes this limitation a mental process. This limitation also equates to a mathematical function/calculation since the instant specification states that the model may be a linear regression [147] that performs calculations.
Claim 68 recites “prior to evaluating (G): determining a plurality of baseline genotypic data constructs for the test subject, each respective baseline genotypic data construct in the plurality of baseline genotypic data constructs comprising values for the plurality of genotypic characteristics based on a corresponding baseline plurality of sequence reads . . . of a corresponding plurality of nucleic acid molecules in a corresponding baseline biological sample, in a plurality of baseline biological samples . . .” The BRI of determining baseline genotypic data constructs is a mental process as it merely requires a human to evaluate data, which can be practically performed. Claim 68 recites “using an amount of variance in values for one or more respective genotypic characteristic, in the plurality of genotypic characteristics, between respective baseline genotypic data constructs in the plurality of baseline genotypic constructs to calculate a baseline variance covariate specific to the test subject.” The BRI of using variance to calculate a baseline variance covariate merely requires a human to perform calculations, which can be practically performed and thus equates to a mental process. This limitation also equates to a mathematical calculation as it requires calculating a baseline variance covariate. Claim 68 recites “applying the baseline covariate to the distribution of the reference delta score sets, to normalize the distribution of the reference delta score sets against the baseline variability of the test subject.” The BRI is that a human could normalize data as it merely requires calculations which can be done using pen and paper, and thus equates to a mental process. This also equates to a mathematical calculation/relationship as the normalization of data requires calculations and manipulating data to correlate information.
Claim 69 recites “wherein a span between the first test time point and the second test time point is based upon the first model score set.” This limitation is included in the judicial exception of claim 1 since it merely limits the timeframe between the test points but does not change the fact that the test points are part of the judicial exception in claim 1.
These recitations are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)), comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)), creating a formula for computing an alarm limit in Parker v. Flook, 437 U.S. 584, 585, 198 USPQ 193, 195 (1978) (B1=B0 (1.0–F) + PVL(F)), and correlating the presence of myeloperoxidase in a bodily sample (such as blood or plasma) to cardiovascular disease risk in Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017) that the courts have identified as concepts that can be practically performed in the human mind, mathematical relationships/functions/calculations, or naturally occurring relations. Therefore, these limitations fall under the “Mental process”, “Mathematical concepts”, and “Natural Phenomena” groupings of abstract ideas, respectively.
As such, claims 1, 3, 6, 9, 11-12, 17, 28-29, 40, 43, 47, 61 and 68-71 recite an abstract idea and a natural phenomenon (Step 2A, Prong 1: YES).
Additional Elements:
Once limitations have been identified that recite a judicial exception, the claims are evaluated for additional elements. The additional elements are then analyzed under Step 2A, Prong 2 then Step 2B. The instant claims recite the following additional elements:
Claims 1, 70 and 71 recite “(A) . . . using one or more processors associated with a computer system . . . in electronic form . . .”, “(C) . . . in electronic form . . .” and “(F) . . . of the computer system . . .” These limitations equate to instructions to apply an abstract idea on a generic computer.
Claim 68 recites “. . . in electronic form . . .” and “. . . obtained from the test subject at a corresponding baseline test time point occurring before the second test time point” These limitations equate to instructions to apply an abstract idea on a generic computer.
Claim 70 recites “A non-transitory computer-readable storage medium having stored thereon program code instructions that, when executed by a processor, cause the processor to perform the method of claim 1.” This equates to instructions to apply an abstract idea on a generic computer.
Claim 71 recites “A computer system comprising: one or more processors; and a non-transitory computer-readable medium including computer-executable instructions that, when executed by the one or more processors, cause the processors to perform a method of claim 1.” This equates to instructions to apply an abstract idea on a generic computer.
These above recited additional elements are analyzed below under both Step 2A, Prong 2 and Step 2B:
Step 2A, Prong 2:
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). The judicial exception is not integrated into a practical application because the claims do not recite additional elements that reflect an improvement to a computer, technology, or technical field (MPEP § 2106.04(d)(1) and 2106.5(a)), require a particular treatment or prophylaxis for a disease or medical condition (MPEP § 2106.04(d)(2)), implement the recited judicial exception with a particular machine that is integral to the claim (MPEP § 2106.05(b)), effect a transformation or reduction of a particular article to a different state or thing (MPEP § 2106.05(c)), nor provide some other meaningful limitation (MPEP § 2106.05(e)). Rather, the claims include limitations that equate to an equivalent of the words “apply it” and/or to instructions to implement an abstract idea on a computer (MPEP § 2106.05(f)) and insignificant extra-solution activity (MPEP § 2106.05(g)). The paragraphs below discuss the additional elements recited above in the instant claims.
Regarding the above cited limitations in claims 1, 68 and 70-71 of processors associated with a computer system, in electronic form, a non-transitory computer-readable storage medium, and a computer system containing processors and non-transitory computer-readable medium, there are no limitations that these components require anything other than a generic computing system. Therefore, these limitations equate to mere instructions to implement an abstract idea on a generic computer, which the courts have established does not render an abstract idea eligible in Alice Corp. 573 U.S. at 223, 110 USPQ2d at 1983.
Regarding the above cited limitation in claim 68 of obtaining data, this limitation equates to insignificant, extra-solution activity of mere data gathering because it collects data used for the recited judicial exception in claims 1 and 68.
As such, claims 1, 3, 6, 9, 11-12, 17, 28-29, 40, 43, 47, 61 and 68-71 are directed to an abstract idea and a natural phenomenon (Step 2A, Prong 2: NO).
Step 2B:
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). These claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these claims recite additional elements that equate to instructions to apply the recited exception in a generic way and/or in a generic computing environment (MPEP § 2106.05(f)) and to well-understood, routine and conventional (WURC) limitations (MPEP § 2106.05(d)). The paragraphs below discuss the additional elements recited above in the instant claims.
Regarding the above cited limitations in claims 1, 68 and 70-71, these limitations equate to instructions to implement an abstract idea on a generic computing environment, which the courts have established does not provide an inventive concept in Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).
The limitation in claim 68 of obtaining data in electronic form equates to transmitting/receiving data over a network, which the courts have established as a WURC function of a genetic computer in buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014).
When these additional elements are considered individually and in combination, they all equate to WURC functions/components of a generic computer, and thus do not comprise an inventive concept that transforms the judicial exception into a patent-eligible application of the judicial exception itself (Step 2B: NO).
As such, claims 1, 3, 6, 9, 11-12, 17, 28-29, 40, 43, 47, 61 and 68-71 are not patent eligible.
Response to Arguments under 35 USC 101
Applicant's arguments filed 04/13/2026 have been fully considered but they are not persuasive.
Applicant argues that steps (F) and (G) confer an improvement to the field of disease detection (pg. 19, para. 1 – pg. 21, para. 1). Applicant’s argument is not persuasive because:
Steps (F) and (G) recite a judicial exception. MPEP 2106.05(a) recites “the judicial exception alone cannot provide the improvement.” MPEP 2106.05(a) further recites “The improvement can be provided by one or more additional elements … In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception.” The additional elements in claim 1 equate to mere instructions to implement the abstract idea on a generic computer, which does not equate to a practical application (MPEP 2106.05(f)). See responses below regarding why computer functionality is not improved.
Applicant argues step (H) is a real-world application (pg. 21, para. 1). Applicant’s argument is not persuasive because step (H) is a mental process as it requires a mental determination and no active step of administering a treatment.
Applicant compares claims to Desjardins, and states that the claims’ computational framework changes how the system operates rather than merely applying an abstract idea on a computer to achieve a better result (pg. 21, last para. – pg. 22, para. 1) (pg. 23, para. 2). Applicant’s argument is not persuasive because:
Applicant appears to refer to steps (E)-(G). These steps do not change how the computer operates. Rather, they describe an improved abstract idea which is applied by a generic computer. MPEP 2106.05(a)(II) recites “it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology.”
The computer itself has not been altered in any way, i.e., by changing the functioning of a processor or by changing the way in which it stores or accesses memory. Nothing about the physical components of the computer nor the way the computer operates is changed by steps (E)-(G). Therefore, claim 1 invokes a computer as a tool, which is not a practical application (MPEP 2106.05(f)(2)). Applicant has not provided any evidence or technical explanation for how the claimed invention improves the way in which the asserted abstract idea improves the way in which the computer processes or stores data.
Instant claim 1 is distinct from Desjardins because it does not improve a machine learning model by improving the training process itself.
Applicant argues that the abstract idea itself is not the improvement. Rather, the improvement is the way the system performs specific steps of the claims (pg. 22, last para). Applicant’s argument is not persuasive because:
The system in claim 1 is a generic computer because it comprises just one or more processors. A computer that performs an abstract idea equates to mere instructions to implement the abstract idea on a generic computer (MPEP 2106.05(f)).
Applicant argues that claims do not use a computer as a tool because the computer is configured to perform certain steps that provide a technical solution that improves functioning of the disease detection system for processing genomic data (pg. 23, para. 2). Applicant’s argument is not persuasive because:
As discussed above, the system is a generic computer. The alleged improved functioning of the system is a result of performing an improved abstract idea on a generic computer. MPEP 2106.05(f)(2) recites “’claiming the improved speed or efficiency inherent with applying the abstract idea on a computer’ does not integrate a judicial exception into a practical application or provide an inventive concept.” Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).
Moreover, the BRI of claim 1 does not require that the computer perform steps (E) and (G).
Applicant argues that the claims are similar to Enfish (pg. 23, para 2). Applicant’s argument is not persuasive because the instant claims do not recite a data structure, which was what improved how a computer stores and retrieves data in memory in Enfish.
Applicant argues that amended claim 1 step (F) integrates into a practical application by improving how the computer-implemented system processes and interprets data (pg. 23, last para), and these amended limitations are not just data analysis or comparison (pg. 24, para. 1). Applicant argues amended claim 1 step (G) directs the claim to a technological solution of systems that evaluate longitudinal genomics measurement, and it improves the reliability and robustness of computer-based disease detection systems (pg. 24, last para.). Applicant’s arguments are not persuasive because:
Claim 1 does not require all steps be performed by a computer, for example, steps (D), (E), and (G).
Amended steps (F) and (G) are part of the judicial exception. These amended limitations do not improve computer-based detection systems because they merely recite an improved abstract idea applied by a generic computer. MPEP 2106.05(a)(II) recites “it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology.”
Nothing about how a computer processes, stores, or retrieves data has been altered by the recited abstract idea. Any alleged improvement in functionality appears to be a result of performing an improved abstract idea on a generic computer, which does not equate to a practical application. MPEP 2106.05(f)(2) recites "’claiming the improved speed or efficiency inherent with applying the abstract idea on a computer’ does not integrate a judicial exception into a practical application or provide an inventive concept.”
Applicant argues that claims are similar to Desjardins because they improve how the system operates, and that the improvement is not in the abstract idea itself but how the system performs its computations (pg. 25, para. 2). Applicant’s arguments are not persuasive because:
The system does not perform all the steps in claim 1. The system does not perform steps (E) or (G). Even if the system did perform steps (E) and (G), it would equate to mere instructions to implement the abstract idea on a generic computer for the same reasons iterated in responses above. Any alleged improved computer performance by applying the computations of claim 1 are the result of an improved abstract idea. MPEP 2106.05(f)(2) recites "’claiming the improved speed or efficiency inherent with applying the abstract idea on a computer’ does not integrate a judicial exception into a practical application or provide an inventive concept.” Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). MPEP 2106.05(a)(2) also recites “an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology.”
The claims are not similar to Desjardins. The claims do not improve a machine learning model by improving the training process itself.
Conclusion
No claims are allowed.
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/N.A.A./Examiner, Art Unit 1687
/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685
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