Prosecution Insights
Last updated: April 19, 2026
Application No. 17/068,546

IMMUNE RECEPTOR ANALYSIS AS DIAGNOSTIC ASSAY

Final Rejection §101§112
Filed
Oct 12, 2020
Examiner
PULLIAM, JOSEPH CONSTANTINE
Art Unit
1687
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Saint Louis University
OA Round
4 (Final)
38%
Grant Probability
At Risk
5-6
OA Rounds
5y 2m
To Grant
69%
With Interview

Examiner Intelligence

Grants only 38% of cases
38%
Career Allow Rate
19 granted / 50 resolved
-22.0% vs TC avg
Strong +31% interview lift
Without
With
+30.9%
Interview Lift
resolved cases with interview
Typical timeline
5y 2m
Avg Prosecution
34 currently pending
Career history
84
Total Applications
across all art units

Statute-Specific Performance

§101
33.0%
-7.0% vs TC avg
§103
24.1%
-15.9% vs TC avg
§102
4.4%
-35.6% vs TC avg
§112
29.4%
-10.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 50 resolved cases

Office Action

§101 §112
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 the Claims The amended claim set received 08 October 2025 has been entered into the application. Claims 1 was amended. Claims 7, 16, 18-19, 21-25, 27-29, 32-33, and 35-39 are cancelled. Claims 1-6, 8-15, 17, 20, 26, 30-31, and 34 are pending. Election/Restrictions Applicant’s election without traverse to Group I, drawn to a method of determining whether a subject has been exposed to an immunogenic antigen in the reply filed 25 March 2024 is acknowledged. Applicant’s election of species of CDR3 variable region comprising SEQID 436 of claim 12, a human CDR3 associated with smallpox vaccination in reply filed 25 March 2024 is acknowledged. The election was made without traverse. Applicant submits that elected claims 1, 2-6, 8-15, 17, and 20 read of Group I and the elected species of claim 12. Claims 1-6, 8-15, 17, 20, 26, 30-31, and 34 are pending. Claims 26, 30-31, 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/25/2024. Claims 1-6, 8-15, 17, and 20 are currently under examination. Priority Acknowledgment is made of the applicant’s priority Provisional Application No. 62/914,169 filed 11 October 2019. Information Disclosure Statement It is noted that the NPL Cite Nos. 18 and 46 references of the IDS (9 pages) were not provided. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. It is noted that copies of NPL Cite Nos 18 and 46 and an updated IDS were not provided in the response to Office Action filed 08 October 2025. Claim Rejections - 35 USC § 112 35 USC § 112(b) The rejection of claim 1 steps (b) and (d) under 35 U.S.C § 112(b) in the Office Action mailed 14 July 2025 is withdrawn in view of the amendments received 08 October 2025. The rejection of claims 2-6, 8-15, 17, and 20 under 35 U.S.C § 112(b) in the Office Action mailed 14 July 2025 is withdrawn in view of the amendments received 08 October 2025. Claim Rejections - 35 USC § 101 The instant rejection is maintained for reason for record in the Office Action mailed 14 July 2025 and modified in view of the amendments filed 08 October 2025. 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 1-6, 8-15, 17, and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Following the flowchart of the MPEP 2106. Step I – Process, Machine, Manufacturing, or Composition. Claims 1-6, 8-15, 17, and 20 are drawn to a method, so a process. 2A Prong I – Identification of an Abstract Idea Claim 1 recites: Step b analyzing the TCRB allele sequences and statistically associating a subset of the TCRB sequences using one of a machine learning and a neural network platform to identify unique TCR beta alleles sequences in T-cells of the subject to generate a TCR beta clonotype profile of the subject. This step encompasses evaluating (i.e., analyzing) information (i.e., TCRβ allele sequences) and observing, comparing, and judging statistical associations of a subset of the TCRβ sequences to identify unique TCRβ alleles to generate a TCRβ clonotype profile and therefore reads on abstract ideas. Here, it is noted that in this step a machine learning and neural network platform is utilized to analyze and statistically associate TCRβ sequences to identify unique TCRβ sequences to generate a TCRβ clonotype profile. However, the machine learning and neural network platform is generically recited and therefore reads on abstract ideas. Furthermore, this step can be performed in the human mind by organizing data of the analyzed TCRβ alleles and identified unique TCRβ sequences to generate a TCRβ clonotype profile of the subject and is therefore an abstract idea. Additionally, this step encompasses using a machine learning and neural network platform for analyzing TCRβ allele sequences and identifying unique TCRβ alleles in B-cells to generate a TCRβ clonotype profile which encompasses performing mathematical/statistical computations for statistically associating TCR β sequences and identifying unique TCR β allele sequences to generate a TCR β clonotype profile which reads on abstract ideas. Moreover, this step encompasses taking information (i.e., analyzed TCR β alleles and identified TCR β allele sequences), manipulating the information using mathematical correlations (i.e., machine learning and neural network platform), and organizing the data into a different form (i.e., TCR β clonotype profile) which reads on abstract ideas. See MPEP 2106.04(a)(2)(I)(A)(iv). Step c using one of a machine learning and a neural network platform to compare the TCR β clonotype profile of the subject to a database of target associated receptor sequences (TARSs) comprising unique TCR β alleles identified as associated with exposure to the immunogenic antigen in a cohort of independent test subject generate a diagnostic classifier of the subject comprising the number of TARSs identified in the subject relative to the total number of unique TCR β alleles in the subject This can be performed in the human mind by observing, comparing, and judging information (i.e., the TCR β clonotype profile of the subject to a database of target associated receptor sequences (TARSs)) to generate a diagnostic classifier and therefore reads on abstract ideas. Here, it is noted that in this step the machine learning and neural network platform is utilized to compare the TCR β clonotype profile of the subject to a database of target associated receptor sequences (TARSs) to generate a diagnostic classifier. However, the machine learning and neural network platform is generically recited and therefore reads on abstract ideas. Furthermore, this step encompasses using information/data (i.e., compared TCRβ clonotype profile), manipulating data via mathematical correlations (i.e., machine learning and neural platform), and organizing the data into a different form (i.e., diagnostic classifier) which reads on mathematical concepts. See MPEP 2106.04(a)(2)(I)(A)(iv). Step d determining that the subject has been exposed to the immunogenic antigen if the diagnostic classifier exceeds a predetermined threshold for the diagnostic classifier. This step can be performed in the human mind by observing and evaluating information (i.e., diagnostic classifier) to determine if the diagnostic classifier exceeds a predetermined threshold for determining if the subject has been exposed to the immunogenic antigen and is therefore an abstract idea. wherein the predetermined threshold is determined by the prevalence of TARSs in the test cohort after exposure to the immunogenic antigen. This step can be performed in the human mind by observing and evaluating information (i.e., prevalence of TARS in the test cohort) to determine the predetermined threshold and is therefore an abstract idea. Claim 2-6, 11-15, 17, and 20 are further drawn to limitations that describe ideas performed in claim 1 and are therefore also abstract ideas. 2A Prong II – Consideration of Practical Application Claim 1 does not recite an additional element that integrates the recited judicial exception into a practical application. Therefore, the claim does not contain additional elements to be analyzed under 2A Prong II. Here, in the instant case, the claims merely set forth a method of data analysis for determining if a subject has been exposed to an immunogenic antigen. As such, practicing the claims merely results in generating a diagnostic classifier (i.e., numerical value) for determining if a subject has been exposed to an immunogenic antigen. Such a result only produces information and does not provide for a practical application in the physical-realm of physical things and acts, i.e., the claims do not utilize the data generated by the judicial exception to affect any type of change. See MPEP 2106.04(a)(2)(A)(iv). Therefore, the claims do not utilize the amplified and sequenced TCR beta alleles, analyzed unique TCR beta allele sequences, compared clonotype profile, generated diagnostic classifier, and determined immunogenic antigen exposure, and the abstract ideas to construct a practical application such as treating a subject, transformation of matter, or improving upon an existing technology. Additionally, claim 1 steps (b) and (d) recite “using” a machine learning and neural network platform to analyze and statistically associate a subset of TCRβ sequences (step (b)) and compare TCRβ clonotype profile to a database of target associated receptor sequences (TARS) to generate a diagnostic classifier (i.e., performing calculations) (step (c)) without placing any limitations on how the “machine learning and neural network platform” operates/functions. Here, the “machine learning and neural network platform” is described at a high level such that it amounts to using a computer with a generic “machine learning and neural network platform” to apply the abstract idea. These limitations only recite the outcomes of “analyzing and statistically associating a subset of TCRβ sequences to identify TCRβ sequences to generate a TCRβ clonotype profile (step (b))” and “compare TCRβ clonotype profile to a database of target associated receptor sequences (TARS) to generate a diagnostic classifier (i.e., performing calculations) (step (c))” without any details about how the outcomes are accomplished. Therefore, these limitation amounts to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.05(f). This judicial exception is not integrated into a practical application because the claims do not meet any of the following criteria: An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field; an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition; an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim; an additional element effects a transformation or reduction of a particular article to a different state or thing; and an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. 2B Analysis - Consideration of Additional Elements and Significantly More The claimed method also recites "additional elements" that are not limitations drawn to an abstract idea. The recited additional element of using computer processes and components of claim 1 (computer-assisted method) does not add more than the recited judicial exception because using computer processes to analyze and evaluate abstract ideas is merely tangential to the claimed method. MPEP 2106.05(b) and 2106.05(d). The recited additional element of amplifying and sequencing nucleic acids of claim 1 step a is routine and well-known method as described in the MPEP 2106.05(d)(II)(ii)-(vii). Furthermore, the steps are drawn to routine data gathering that is deemed to be an extra-solution activity. The recited additional element of using T-cells of claims 1, 2, and 6 does not amount to significantly more than the recited judicial exception because using DNA from T-cells to analyze genotype and phenotype of a cell is routine and conventional in the art of immunology. To exemplify conventionality, Venturi et al. (Venturi) teach the convergent recombination of the T-cell and T-cell responses [abstract], teach methods for constructing CDR3ß amino acid sequence repertoire [page 233 figure 1] (Cited in the Office Action mailed 31 May 2024). Furthermore, the steps are drawn to routine data gathering that is deemed to be an extra-solution activity. The recited additional element of using splenocytes of claims 8-10 does not amount to significantly more than the recited judicial exception because using identifying splenocytes to validate immunogenic antigen exposure is routine and conventional in the art of immunology. Furthermore, the steps are drawn to routine data gathering that is deemed to be an extra-solution activity. The recited additional element of in vitro clonal expansion of claim 9 does not amount to significantly more than the recited judicial exception because using in vitro clonal expansion is routine and conventional in the art of immunology. Furthermore, the steps are drawn to routine data gathering that is deemed to be an extra-solution activity. The recited additional element of flow cytometry of claim 10 does not amount to significantly more than the recited judicial exception because using flow cytometry to analyze cells is routine and conventional in the art of immunology. Furthermore, the steps are drawn to routine data gathering that is deemed to be an extra-solution activity. The claims do not include additional elements that are sufficient to amount of significantly more than the judicial exception because it is routine and conventional to perform the acts of amplifying and sequencing nucleic acids to gathering DNA and mRNA data. See MPEP 2106.05(d)(II) (ii, iii, v, and vii). Furthermore, the steps are drawn to routine data gathering that is deemed to be an extra-solution activity. In conclusion and when viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea recited in the instantly presented claims into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself. Therefore, the claim(s) are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter. Response to Arguments Applicant's arguments filed 08 October 2025 have been fully considered but the rejection is maintained. The Applicant states “that claims 1-6, 8-15, 17, and 20 of the present application recite a patent-eligible application of the exception under Prong A of Step 2 and that the combination of elements in the claims is sufficient to ensure that the claims amount to significantly more than the judicial exception under Prong B of Step 2.” [remarks, page 7]. The Applicant states “claim 1 recites "[a] computer-assisted method for determining whether a subject has been exposed to an immunogenic antigen ... " Thus, claim 1, as currently amended, requires a computer, and thus the steps of the method are not performed in the mind of a human.” [remarks, page 9]. In response, using a computer to perform a computer-implemented method is merely tangential to the claimed method. Additionally, and as noted in the 35 U.S.C 101 analyses above, the computer elements of the claimed method are utilized in such manner as to carry out mental processes on a computer, perform mental processes in a computer environment, and using a computer a tool to perform mental process. MPEP 2106.04(a)(2)(III)(C). Furthermore, the argument is not persuasive because it is acknowledged that such computations performed mentally, or with paper and pencil, would take considerable time and effort, but that is, of course, the singular purpose of computers and computer networks, to perform large numbers of calculations, via algorithms, rapidly, and without error (assuming no error in user input). Although a general-purpose computer can perform calculations at a rate and accuracy that can far outstrip the mental performance of a skilled artisan, the nature of the activity is essentially the same, and constitutes an abstract idea. See SiRF Tech: "In order for the addition of a machine to impose a meaningful limit on the scope of a claim, it must play a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved more quickly, i.e., through the utilization of a computer for performing calculations" and Bancorp: "the fact that the required calculations could be performed more efficiently via a computer does not materially alter the patent eligibility of the claimed subject matter. … Using a computer to accelerate an ineligible mental process does not make that process patent-eligible". The Applicant states “steps b and c of claim 1, as currently emended, recite "using one of a machine learning and a neural network platform". Thus, claim 1, as currently amended, involves a specific technological implementation that cannot be performed in the human mind.” [remarks, page 9]. In response, and as described above, using a machine learning and neural network platform encompasses performing mathematical/statistical computations. Here, the machine learning and neural network platform is generically recited and therefore reads on abstract ideas, more specifically, mathematical concepts. Additionally, using a machine learning and neural network platform amounts to performing a series of mathematical calculations in order to arrive at a final mathematical function that represents a mathematical relationship between variables such as arriving at a diagnostic classifier comprising the number TARS identified relative to the total number of unique TCRβ alleles in the subject (i.e., # of TARS identified : total number of unique TCRβ alleles). Therefore, using a machine learning and neural network platform does not preclude the claimed from being performed in the human mind. Moreover, even if considered as an “additional element,” the machine learning and neural network platform are used to generally apply the abstract idea without limiting how the machine learning and neural network platform functions. The machine learning and neural network platform are described at a high level such that it amounts to using a computer to manipulate data to generate a diagnostic classifier (i.e., numerical value/quantitative data) and applying the abstract idea. See MPEP 2106.05(f). The Applicant states “Claim 1 recites a method for determining whether a subject has been exposed to an immunogenic antigen. Step a of the method of claim 1 explicitly requires amplifying and sequencing TCR~ alleles in mRNA and/or genomic DNA obtained from T-cells of the subject to generate TCR~ allele sequences. Following steps a-d, the subject is determined to have been exposed to an immunogenic antigen if the diagnostic classifier exceeds a predetermined threshold for the diagnostic classifier. Thus, the practical application of claim 1 is to determine whether a subject has been exposed to an immunogenic antigen based on analysis of amplified and sequenced TCR~ allele sequences generated from mRNA and/or genomic DNA obtained from T-cells of the subject.” [remarks, page 9]. In response, claim 1 does not contain any additional elements which integrate the judicial exception into a practical application. For example, step a recites “amplifying and sequencing” which are merely extra-solution activities for gathering nucleic acid sequence data that is subsequently processed by the abstract ideas. See MPEP 2106.05(d)(II) (i-iii, v, vii-viii). Additionally, “determining whether a subject has been exposed to an immunogenic antigen based on analysis of amplified and sequenced TCR~ allele sequences generated from mRNA and/or genomic DNA obtained from T-cells of the subject” is not a practical application but an abstract idea of making decision about determining whether a subject has been exposed to an immunogenic antigen by observing if the diagnostic classifier exceeds a predetermined threshold which reads on abstract ideas. The Applicant states “this conclusion is in error as this conclusion totally reads out step d of claim 1. In particular, step c of claim 1, as currently amended, recites Step d of claim 1, as currently amended, recites that the subject "has been exposed to the immunogenic antigen if the diagnostic classifier exceeds a predetermined threshold for the diagnostic classifier, wherein the predetermined threshold is determined by the prevalence of TARSs in the test cohort after exposure to the immunogenic antigen." Thus, the practical application of the method of claim 1 is whether a subject has or has not been exposed to an immunogenic antigen by obtaining an mRNA or genomic DNA sample from the subject performing the steps a-c to then determine whether a subject has or has not been exposed to an immunogenic antigen.” [remarks, pages 9-10]. In response and as noted in the 35 U.S.C 101 rejection above, the claims do not encompass any additional elements that integrate the recited judicial exception into a practical application. Here, in the instant case, the claims merely set forth a method of data analysis for determining if a subject has been exposed to an immunogenic antigen. As such, practicing the claims merely results in generating a diagnostic classifier (i.e., numerical value) for determining if a subject has been exposed to an immunogenic antigen. Such a result only produces information and does not provide for a practical application in the physical realm of physical things and acts, i.e., the claims do not utilize the data generated by the judicial exception to affect any type of change. See MPEP 2106.04(a)(2)(A)(iv). The claims do not further integrate the recited judicial exception into a practical application because the claims do not recite an additional element that reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field, an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, an additional element that implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, an additional element that effects a transformation or reduction of a particular article to a different state or thing, and/or an additional element that applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Regarding step a, this step encompasses using data gathering additional element(s) (i.e., amplifying and sequencing) to gather sequencing data while steps b-c are merely nucleic acid sequencing data analysis steps used for determining whether a subject has or has not been exposed to an immunogenic antigen which is not a practical application of the judicial exception. Here, making the determination whether a subject has or has not been exposed to an immunogenic antigen based on if the diagnostic classifier is above a predetermined threshold is the judicial exception that is not integrated with any additional elements to construct a practical application and/or does not provide an improvement to an existing technology. The Applicant states “Under the Prong 2B analysis step, the Office states that the recited additional elements of "amplifying and sequencing nucleic acids", "using T-cells" and "T-cell responses", "using splenocytes", "using CDRs", "using immunogenic antigen", "in vitro clonal expansion", and "flow cytometry" are routine and conventional and are merely drawn to routine data gathering. The Applicant points to CellzDirect for guidance. The Applicant points to claim 1 steps a-d for further guidance. The Applicant states “Steps a-d are then combined in a practical application according to step e of claim 1 "to determine that the subject has been exposed to the immunogenic antigen if the diagnostic classifier exceeds a predetermined threshold for the diagnostic classifier, wherein the predetermined threshold is determined by the prevalence of TARSs in the test cohort after exposure to the immunogenic antigen". Thus, each of the elements when considered as a whole and in combination with the other steps demonstrate that claim 1, when considered as a whole, is not directed to an abstract idea.” [remarks, pages 10-11]. In response, the claims do not contain any additional elements that integrate the recited judicial exception into a practical application. Here, the claims are drawn to data analysis by gathering and analyzing information (T-cell nucleic data) using conventional techniques (i.e., amplifying and sequencing nucleic acids and computer elements) and displaying a result (i.e., determining that the subject has been exposed to the immunogenic antigen) which is insufficient to construct a practical application and/or an improvement to a technology. See MPEP 2106.05(a)(II)(iii). Furthermore, the claims are further drawn to performing clinical/laboratory tests (i.e., amplifying and sequencing nucleic acids) for obtaining input (i.e., number of T ARSs identified in the subject and total number of unique TCRβ alleles) for an equation (i.e., diagnostic classifier: number of TARSs identified in the subject relative to the total number of unique TCRβ alleles) which is an insignificant extra-solution activity that does not integrate the recited judicial exception into a practical application. See MPEP 2106.05(g). The Applicant states “While it may be well known in the art to amplify and sequence mRNA or DNA, Applicant submits that it is not well known in the art to amplify and sequence mRNA or DNA; analyze the TCRβ allele sequences and statistically associating a subset of the TCRβ sequences using one of a machine learning and a neural network platform to identify unique TCRβ allele sequences in T-cells of the subject to generate a TCRβ clonotype profile of the subject; use one of a machine learning and a neural network platform to compare the TCRβ clonotype profile of the subject to a database of target associated receptor sequences (TARSs) comprising unique TCRβ alleles identified as associated with exposure to the immunogenic antigen in a cohort of independent test subjects to generate a diagnostic classifier of the subject comprising the number of TARSs identified in the subject relative to the total number of unique TCRβ alleles in the subject, and determine that the subject has been exposed to the immunogenic antigen if the diagnostic classifier exceeds a predetermined threshold for the diagnostic classifier, wherein the predetermined threshold is determined by the prevalence of TARSs in the test cohort after exposure to the immunogenic antigen. For each further limitation, the proper analysis is not whether the limitation is routine and conventional in the art of immunology, the proper analysis is whether the limitation when considered as a whole with all of the limitations is routine and conventional.” [remarks, page pages 11-12]. In response, the claims as a whole and/or in any combination do not integrate the judicial exception into a practical application because the claims are drawn to gathering and analyzing information (i.e., sequence data, allelic data) using conventional techniques (i.e., amplifying and sequencing) and displaying the result (i.e., generating a diagnostic classifier to determine if subject has been exposed to the immunogenic antigen). See MPEP 2106.05(a)(II)(iii). Furthermore, the claims do not recite any additional elements that practically apply the claimed process of determining that the subject has been exposed to the immunogenic antigen because the claims as a whole are drawn to a combination of routine methods (i.e., order and/or combination of steps) for analyzing DNA to provide sequence information and/or detect allelic variants (i.e., identify unique TCR beta alleles to generate a TCR beta clonotype profile that is processed by a machine learning and neural network platform to calculate a diagnostic classifier) that are extra-solution activities and that are tangential to the recited abstract idea steps and therefore do not further limit the abstract ideas to be something significantly more. See MPEP 2106.05(d)(II) (i-ii, v, and vii). The Applicant state “the claims recite additional elements that transform a particular article to a different state. In particular, step a of claim 1 requires amplifying and sequencing TCRβ alleles in mRNA and/or genomic DNA obtained from T-cells of the subject to generate TCRβ allele sequences. Thus, step a clearly transforms the subject by removing T-cells from the subject. It transforms the T-cells from whole cells to mRNA and/or genomic DNA It transforms mRNA and/or genomic DNA to amplified copies of TCRβ alleles. It transforms the amplified mRNA and/or genomic DNA to TCRβ allele sequences. Claim 1 then transforms TCRβ allele sequences into a subset of unique TCRβ allele sequences in T-cells of the subject to generate a TCRβ clonotype profile. Claim 1 then transforms the TCRβ clonotype profile into a diagnostic classifier.” The Applicant state “claim 1 as a whole, integrates the recited judicial exception into a practical application, so Step 2A, Prong Two is "YES." [remarks, page 12]. In response, amplifying and sequencing DNA encompass additional elements that do not integrate the judicial exception (i.e.., determination whether a subject has been exposed to an immunogenic antigen) into a practical application. Here, for example, claim 1 step a requires performing clinical/laboratory techniques (i.e., amplifying and sequencing DNA) for gathering DNA from a source (i.e., T-cells) to detect allelic variant (i.e., T-cell beta alleles) to obtain data for an equation (i.e., diagnostic classifier).See MPEP 2106.05(d)(II)(i-iii, v, vii-viii) and 2106.05(g)(i) and (iv).Thus, the claimed method does not integrate the abstract idea with any additional elements (i.e., particular transformation of matter, machine, and/or treatment). For example, the abstract idea is not applied to the step of amplifying such that to treat a subject, transform matter, and/or improve an existing technology. Therefore, the claimed method does not utilize the amplified and sequenced TCR beta alleles, generated diagnostic classifier, and determined immunogenic antigen exposure, and the abstract ideas to construct a practical application such as treating a subject, transformation of matter, or improving upon an existing technology. Conclusion Claims 1-6, 8-15, 17, and 20 are rejected. No claims are allowed. Finality 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. Inquiries Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH C PULLIAM whose telephone number is (571)272-8696. The examiner can normally be reached 0730-1700 M-F. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz Skowronek can be reached at (571) 272-9047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /J.C.P./Examiner, Art Unit 1687 /Anna Skibinsky/ Primary Examiner, AU 1635
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Prosecution Timeline

Oct 12, 2020
Application Filed
May 15, 2024
Non-Final Rejection — §101, §112
Sep 30, 2024
Response Filed
Sep 30, 2024
Response after Non-Final Action
Dec 10, 2024
Final Rejection — §101, §112
Mar 13, 2025
Request for Continued Examination
Mar 17, 2025
Response after Non-Final Action
Jul 10, 2025
Non-Final Rejection — §101, §112
Oct 08, 2025
Response Filed
Jan 10, 2026
Final Rejection — §101, §112 (current)

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Prosecution Projections

5-6
Expected OA Rounds
38%
Grant Probability
69%
With Interview (+30.9%)
5y 2m
Median Time to Grant
High
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